Commission Directive 2001/59/EC of 6 August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance.)
Date: 2001-08-06
Institutions: European Commission
Subjects: approximation of laws, classification, dangerous substance, labelling, packaging

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I

(Acts whose publication is obligatory)

COMMISSION DIRECTIVE 2001/59/EC

of 6 August 2001

adapting to technical progress
the 28th time Council Directive 67/548/EEC on the
approximation of the laws, regulations and administrative provisions relating to the classification,
packaging and labelling of dangerous substances

for

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 67/548/EEC of 27 June
1967 on the approximation of
the laws, regulations and
classification,
administrative
packaging and labelling of dangerous substances (1), as last
amended by Commission Directive 2000/33/EC (2), and in
particular Article 28 thereof,

provisions

relating

the

to

Whereas:

(1)

(2)

to Directive 67/548/EEC contains a list of
Annex I
dangerous substances, together with particulars of the
classification and labelling of each substance. Present
scientific and technical knowledge has shown that the
list of dangerous substances in that Annex should be
adapted to technical progress. Specifically, Tables A and
B in the Foreword to Annex I require inclusion of the
Finnish and Swedish nomenclature. Certain language
versions of the Directive require technical corrections in
specific sections of the Foreword to Annex I. It is useful
to publish an updated and recast version of
the
Foreword to Annex I. Furthermore, the list itself should
be updated to include notified new substances and
further existing substances; the identity, nomenclature,
labelling and/or concentration limits for
classification,
amended to reflect
certain substances
should be
increased technical knowledge;
three
the entries for
substances should be deleted from the list, since they
are covered by other entries.

to Directive 67/548/EEC contains a list of
Annex II
for dangerous
symbols and indications of danger
substances and preparations. Annex III
to Directive
67/548/EEC contains a list of phrases indicating the
dangerous
nature

attributed

special

risks

to

of

(3)

(4)

substances and preparations. Annex IV to Directive
67/548/EEC contains a list of the phrases indicating the
safety advice concerning dangerous
substances and
preparations. Annexes II, III and IV require inclusion of
the Finnish and Swedish wordings. Certain language
versions of the Directive require technical corrections in
specific sections of Annexes II, III and IV. It is useful to
publish updated and recast versions of Annexes II, III
and IV.

Article 1 of European Parliament and Council Directive
1999/33/EC (3) permitted Sweden from 1 January 1999
until 31 December 2000 to require the use of
the
additional R-phrase R340, not listed in Annex III, for
substances classified as carcinogenic, category 3, instead
of R-phrase R40. Member State experts have agreed to
revise the text of R-phrase R40 to refer to carcinogenic,
category 3 substances. A new R-phrase R-68 should be
added to Annex III, containing the original
text of
R-phrase R40 for
labelling of
mutagenic category 3 and harmful substances listed in
and
Annex
concentration limit references in Annex I that include
R40 should therefore be revised for such mutagenic
category 3 and harmful substances.

classification and

classification

labelling

The

and

I.

It

It

Annex V to Directive 67/548/EEC lays down the
methods for the determination of the physicochemical
properties, toxicity and ecotoxicity of substances and
preparations.
that Annex to
is necessary to adapt
technical progress.
is appropriate to reduce to a
minimum the number of animals used for experimental
purposes,
accordance with Council Directive
86/609/EEC (4). Chapter B.1 should therefore be deleted,
since alternative methods, using fewer animals, are
available. Due regard should be given to methods
recognised
competent
recommended
international organisations. The methods for subchronic
toxicity in Chapters B.26 and B.27 should be
oral
revised accordingly and Chapters C.14 to C.20, on

and

by

in

(1) OJ 196, 16.8.1967, p. 1.
(2) OJ L 136, 8.6.2000, p. 90.

(3) OJ L 199, 30.7.1999, p. 57.
(4) OJ L 358, 18.12.1986, p. 1.

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(5)

(6)

(7)

(8)

(9)

environmental toxicity should be added to Annex V.
Certain language versions require technical corrections
to specific sections of Annex V.

corrections

Annex VI to Directive 67/548/EEC contains a guide to
the classification and labelling of dangerous substances
and preparations. It is necessary to adapt that Annex to
technical progress. Certain language versions of
the
in specific
require
Directive
technical
require
of Annex VI.
sections
publication in Finnish and Swedish.
to
publish an updated and recast version of Annex VI,
particularly including reference to Directive 1999/45/EC
of the European Parliament and of the Council of 31
May 1999 concerning the approximation of the laws,
regulations and administrative provisions of the Member
States
relating to the classification, packaging and
labelling of dangerous preparations (1).

is useful

sections

Specific

It

In accordance with the provisions
of Directive
67/548/EEC, any new substance placed on the market
should be notified to the competent authorities of the
Member States by means of a notification containing
certain information including a technical dossier. For
supplied and then consumed in a
new substances
chemical
controlled
reaction which
(intermediates with limited exposure),
it is technically
justifiable and appropriate to define a reduced test
package (RTP). Current technical progress can guarantee
minimum exposure for man and the environment
through rigorous containment of the process.

strictly

are

The technical dossier should contain a test package for
intermediates with limited exposure which would
supply the information necessary to evaluate their
foreseeable risk for man and the environment. Annex
VII should specify the content of this technical dossier
and Annex VIII should detail additional tests and studies
that may be required for intermediates with limited
exposure marketed in higher volumes.

The criteria for the notification of intermediates with
limited exposure may need to be revised in the light of
technical progress and experience gained with such
notifications made in accordance with the new specific
requirements laid down in this Directive.

The measures provided for in this Directive are in
accordance with the opinion of the Committee on the
Adaptation to Technical Progress of the Directives for
the Elimination of Technical Barriers
to Trade in
Dangerous Substances and Preparations,

1. Annex I is amended as follows:

(a) Tables A and B in the foreword to Annex I shall
include the Finnish and Swedish nomenclature. Certain
language versions of
include
the
corrections
technical
Foreword and Tables A and B. The Foreword including
Tables A and B is replaced by Annex 1A to this
Directive.

the Directive
in specific

shall
sections of

(b) The corresponding entries are replaced by the entries

in Annex 1B to this Directive.

(c) The entries in Annex 1C to this Directive are inserted.

(d) The entries in Annex 1D to this Directive are deleted.

(e) The entries shown in Annex 1E to this Directive are
amended by replacing classification references to (cid:145)Muta.
Cat. 3; R40(cid:146) by (cid:145)Muta. Cat. 3; R68(cid:146) and by replacing
labelling references to R40 by R68.

(f) The entries shown in Annex 1F to this Directive are
amended by replacing classification references to (cid:145)Xn;
R40(cid:146) by (cid:145)Xn; R68(cid:146) and by replacing labelling references
to R40 by R68.

(g) The entry shown in Annex 1G to this Directive is
amended by replacing concentration limit references to
(cid:145)Xn; R40/20/21/22(cid:146) by (cid:145)Xn; R68/20/21/22(cid:146).

(h) The entry shown in Annex 1H to this Directive
is amended by replacing concentration limit references
to
(cid:145)Xn;
R20/21/22-40/20/21/22(cid:146)
R20/21/22-68/20/21/22(cid:146).

(cid:145)Xn;

by

(i) The entries shown in Annex 1I to this Directive are
amended by replacing classification references to (cid:145)Muta.
Cat. 3; R40(cid:146) by (cid:145)Muta. Cat. 3; R68(cid:146).

(j) The entries shown in Annex 1J to this Directive are
amended by replacing classification references to (cid:145)Muta.
Cat. 3; R40(cid:146) by (cid:145)Muta. Cat. 3; R68(cid:146) and by adding R68
to the label.

2. Annex II shall

include the Swedish and Finnish versions
and technical corrections to certain language versions.
Annex II
therefore replaced by Annex 2 to this
Directive.

is

HAS ADOPTED THIS DIRECTIVE:

Article 1

3. Annex III shall include the Swedish and Finnish versions
and technical corrections to certain language versions.
Annex III
therefore replaced by Annex 3 to this
Directive.

is

Directive 67/548/EEC is hereby amended as follows:

(1) OJ L 200, 30.7.1999, p. 1.

4. Annex IV shall include the Swedish and Finnish versions
and technical corrections to certain language versions.
Annex IV is
therefore replaced by Annex 4 to this
Directive.

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5. Annex V is amended as follows:

(a) Chapter B.1 is deleted.

(b) The title of the English version of Chapter B13/14 is

replaced by the text in Annex 5A.

(c) The last sentence of the French version of paragraph
1.4.2.2 of Chapter B.39 is replaced by the text
in
Annex 5B.

(d) The equation in the last sentence of section 1.7.1.6 of
the English version of Chapter B.41 is replaced by the
text in Annex 5C.

(e) The test method for subchronic oral toxicity tests in
rodents is amended in accordance with Annex 5D to
this Directive, which replaces Chapter B.26.

(f) The test method for subchronic oral toxicity tests in
non-rodents is amended in accordance with Annex 5E
to this Directive, which replaces Chapter B.27.

(g) The seven new test methods for environmental toxicity
in Annex 5F to this Directive are included in Part C.

6. Annex VI shall include the Swedish and Finnish versions,
technical corrections
to certain language versions and
further detailed technical updates. Annex VI is therefore
replaced by Annex 6 to this Directive.

7. Annex VII.A shall include a technical dossier containing a
test package for
intermediates with limited exposure,
supplying the information necessary to evaluate their
foreseeable risk for man and the environment. Annex VII.A
is therefore amended as follows:

(a)

the text
before section 0 of Annex VII.A;

in Annex 7A to this Directive is inserted

(b) the text in Annex 7B to this Directive is inserted at the

end of Annex VII.A.

8. Annex VIII shall include additional tests and studies that
may be required for intermediates with limited exposure
therefore
marketed in higher volumes. Annex VIII
amended as follows:

is

(a)

the text
between (cid:145)Level 1(cid:146) and (cid:145)Physicochemical
Annex VIII;

in Annex 8A to this Directive is inserted
studies(cid:146) of

(b) the text

in Annex 8B to this Directive is inserted
between (cid:145)Level 2(cid:146) and (cid:145)Toxicological studies(cid:146) of Annex
VIII.

Article 2

1. Member States shall adopt and publish before 30 July
2002 the laws,
regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

2. Member States shall apply the laws, regulations and
administrative provisions referred to in paragraph 1:

(a) as from 30 July 2002 or an earlier date for dangerous

substances;

(b) as from 30 July 2002 for preparations not within the
scope of Council Directive 91/414/EEC (1) or European
Parliament and Council Directive 98/8/EC (2);

(c) as from 30 July 2004 for preparations within the scope of

Directive 91/414/EEC or Directive 98/8/EC.

They shall forthwith inform the Commission thereof.

those provisions,

When Member States adopt
they shall
contain a reference to this Directive or be accompanied by
such a reference on the occasion of their official publication.
Member States shall determine how such reference is to be
made.

3. Member States shall communicate to the Commission the
main provisions of national law which they adopt in the field
covered by this Directive and a correlation table between this
Directive and the national provisions adopted.

Article 3

This Directive shall enter into force on the third day following
its publication in the Official
the European
Communities.

Journal

of

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 6 August 2001.

For the Commission

Margot WALLSTR(cid:214)M

Member of the Commission

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 123, 24.4.1998, p. 1.

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ANNEX 1A

FOREWORD TO ANNEX I

Introduction

Annex I is an index of dangerous substances for which harmonised classification and labelling have been agreed at
Community level in accordance with the procedure laid down in Article 4(3) of this Directive.

Numbering of entries

Entries in Annex I are listed according to the atomic number of the element most characteristic of the substance’s
properties. A list of the chemical elements, arranged according to atomic number is shown in Table A. Organic
substances, because of their variety, have been placed in the usual classes, as shown in Table B.

The index number for each substance is in the form of a digit sequence of the type ABC-RST-VW-Y, where:

(cid:151) ABC is either the atomic number of the most characteristic chemical element (preceded by one or two zeros to

make up the sequence) or the usual class number for organic substances,

(cid:151) RST is the consecutive number of the substance in the series ABC,

(cid:151) VW denotes the form in which the substance is produced or placed on the market,

(cid:151) Y is the check-digit calculated in accordance with the ISBN (International Standard Book Number) method.

As an example, the index number for sodium chlorate is 017-005-00-9.

For dangerous substances in the European Inventory of Existing Commercial Chemical Substance (Einecs) (OJ C 146A,
15.6.1990), the Einecs number is included. This number is a seven-digit system of the type XXX-XXX-X which starts at
200-001-8.

For dangerous substances notified under the provisions of this Directive, the number of the substance in the European
List of Notified Substance (Elincs) is included. This number is a seven-digit system of the type XXX-XXX-X which starts
at 400-010-9.

For dangerous substances in the list of (cid:145)No-longer polymers(cid:146) (Document, Office for Official Publications of the European
Communities, 1997. ISBN 92-827-8995-0) the (cid:145)No-longer polymer(cid:146) number is included. This number is a seven-digit
system of the type XXX-XXX-X which starts at 500-001-0.

The Chemical Abstracts Service (CAS) number is also included to assist identification of the entry. It should be noted
that the Einecs number includes both anhydrous and hydrated forms of a substance, and there are frequently different
CAS numbers for anhydrous and hydrated forms. The CAS number included is for the anhydrous form only, and
therefore the CAS number shown does not always describe the entry as accurately as the Einecs number.

Einecs, Elincs, (cid:145)No-longer polymer(cid:146) or CAS numbers are not usually included for entries which comprise more than four
individual substances.

Nomenclature

Wherever possible, dangerous substances are designated by their Einecs, Elincs or (cid:145)No-longer polymer(cid:146) names. Other
substances not listed in Einecs, Elincs or the list of (cid:145)No-longer polymers(cid:146) are designated using an internationally
recognised chemical name (e.g. ISO, IUPAC). An additional common name is included in some cases.

Impurities, additives and minor components are normally not mentioned unless they contribute significantly to the
classification of the substance.

Some substances are described as a mixture of A and B. These entries refer to one specific mixture. In some cases
where it is necessary to characterise the substance put on the market, the proportions of the main substances in the
mixture are specified.

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Some substances are described with a specific percentage purity. Substances containing a higher content of active
material (e.g. an organic peroxide) are not included in the Annex I entry and may have other hazardous properties (e.g.
explosive). Where specific concentration limits are shown, these apply to the substance or substances shown in the
entry. In particular, in the case of entries which are mixtures of substances or substances described with a specific
percentage purity, the limits apply to the substance as described in Annex I and not the pure substance.

Article 23(2)(a) requires that for substances appearing in Annex I, the name of the substance to be used on the label
should be one of the designations given in the Annex. For certain substances, additional information has been added in
square brackets in order to help identify the substance. This additional information need not be included on the label.

entries

index No 607-190-00-X: methyl
Certain
acrylamidomethoxyacetate (containing ¯ 0,1 % acrylamide). In these cases the reference in brackets forms part of the
name, and must be included on the label.

impurities. An

reference

example

contain

to

is

a

Certain entries refer to groups of substances. An example is index No 006-007-00-5: (cid:145)hydrogen cyanide (salts of (cid:133))
with exception of complex cyanides such as ferrocyanides, ferricyanides and mercuric oxycyanide(cid:146). For individual
substances covered by these entries, the Einecs name or another internationally recognised name must be used.

Format of entries

The following information is given for each substance in Annex I:

(a)

the classification:

(i)

(ii)

the process of classification consists of placing a substance in one or more categories of danger (as defined in
Article 2(2) of Council Directive 92/32/EEC (OJ L 154, 5.6.1992, p. 1)) and assigning the qualifying risk
phrase or phrases. The classification has consequences not only for labelling but also for other legislation and
regulatory measures on dangerous substances;

the classification for each category of danger is normally presented in the form of an abbreviation representing
the category of danger together with the appropriate risk phrase or phrases. However, in some cases (i.e.
substances classified as
the
environment) the risk phrase alone is used;

sensitising and some substances classified as dangerous

flammable,

for

(iii) the abbreviation for each of the categories of danger is shown below:

(cid:151) explosive: E

(cid:151) oxidising: O

(cid:151) extremely Flammable: F+

(cid:151) highly Flammable: F

(cid:151) flammable: R10

(cid:151) very toxic: T+

(cid:151) toxic: T

(cid:151) harmful: Xn

(cid:151) corrosive: C

(cid:151) irritant: Xi

(cid:151) sensitising: R42 and/or R43

(cid:151) carcinogenic: Carc. Cat. (1)

(cid:151) mutagenic: Muta. Cat. (1)

(cid:151) toxic for reproduction: Repr. Cat. (1)

(cid:151) dangerous for the environment: N or/and R52, R53, R59;

(iv) additional risk phrases which have been assigned to describe other properties (see sections 2.2.6 and 3.2.8 of

the labelling guide) are shown although they are not formally part of the classification;

(1) The category of carcinogen, mutagen or toxic for reproduction (i.e. 1, 2 or 3) is shown as appropriate.

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(b)

the label, including:

(i)

the letter assigned to the substance in accordance with Annex II
abbreviation for the symbol and for the indication of danger (if these are assigned);

(see Article 23(2)(c)). This acts as an

(ii)

the risk phrases, denoted as a series of numbers preceded by the letter R indicating the nature of the special
risks, in accordance with Annex III (see Article 23(2)(d)). The numbers are separated by either:

(cid:151) a dash (-) to denote separate statements concerning special risks (R), or

(cid:151) an oblique stroke (/) to denote a combined statement, in a single sentence, of the special risks as set out in

Annex III;

(iii) the safety phrases denoted as a series of numbers preceded by the letter S indicating the recommended safety
precautions, in accordance with Annex IV (see Article 23(2)(e)). Again the numbers are separated by either a
dash or an oblique stroke; the significance of recommended safety precautions are set out in Annex IV. The
safety phrases shown apply only to substances; for preparations, phrases are selected according to the usual
rules.

Note that for certain dangerous substances and preparations sold to the general public certain S-phrases are
mandatory.

S1, S2 and S45 are obligatory for all very toxic, toxic and corrosive substances and preparations sold to the
general public.

S2 and S46 are obligatory for all other dangerous substances and preparations sold to the general public other
than those that have only been classified as dangerous for the environment.

Safety phrases S1 and S2 are shown in brackets in Annex I and can only be omitted from the label when the
substance or preparation is sold for industrial use only;

(c)

the concentration limits and associated classifications necessary to classify dangerous preparations containing the
substance in accordance with Directive 1999/45/EC.

Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with
reference to the total weight of the preparation.

Where no concentration limits are given, the concentration limits to be used when applying the conventional
method of assessing health hazards are those in Annex II, and when applying the conventional method of assessing
environmental hazards are those in Annex III of European Parliament and Council Directive 1999/45/EC (OJ
L 200, 30.7.1999, p. 1).

General explanatory notes

Groups of substances

A number of group entries are included in Annex I. In these cases, the classification and labelling requirements will
apply to all substances covered by the description if they are placed on the market, insofar as they are listed in Einecs
or Elincs. Where a substance that is covered by a group entry occurs as an impurity in another substance, the
classification and labelling requirements described in the group entry shall be taken into account in the labelling of the
substance.

In some cases, there are classification and labelling requirements for specific substances that would be covered by the
group entry. In such cases a specific Annex I entry will be present for the substance and the group entry will be
annotated with the phrase (cid:145)except those specified elsewhere in this Annex(cid:146).

In some cases,
individual substances may be covered by more than one group entry. Lead oxalate (Einecs No
212-413-5) is for instance covered by the entry for lead compounds (index No 082-001-00-6) as well as for salts of
oxalic acid (607-007-00-3). In these cases, the labelling of the substance reflects the labelling for each of the two group
entries. In cases where different classifications for the same hazard are given, the classification leading to the more
severe classification is used for the label of the particular substance (see section on Note A below).

Entries in Annex I for salts (under any denomination) cover both anhydrous and hydrous forms unless specifically
specified otherwise.

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Substances with an Elincs number

In Annex I, substances with an Elincs number have been notified under the provisions of this Directive. A producer or
importer who has not previously notified these substances must refer to the provisions of this Directive if he intends to
place these substances on the market.

Explanation of the notes relating to the identification, classification and labelling of substances

Note A:

The name of the substance must appear on the label in the form of one of the designations given in Annex I (see
Article 23(2)(a)).

In Annex I, use is sometimes made of a general description such as (cid:145)(cid:133) compounds(cid:146) or (cid:145)(cid:133) salts(cid:146). In this case, the
manufacturer or any other person who markets such a substance is required to state on the label the correct name, due
account being taken of the chapter entitled (cid:145)Nomenclature(cid:146) of the Foreword:

Example: for BeCl2 (Einecs No 232-116-4): beryllium chloride.

The Directive also requires that the symbols, indications of danger, R- and S-phrases to be used for each substance shall
be those shown in Annex I (Article 23(2)(c), (d) and (e)).

For substances belonging to one particular group of substances included in Annex I, the symbols, indications of danger,
R- and S-phrases to be used for each substance shall be those shown in the appropriate entry in Annex I.

For substances belonging to more than one group of substances included in Annex I, the symbols, indications of
danger, R- and S-phrases to be used for each substance shall be those shown in both the appropriate entries given in
Annex I. In cases where two different classifications are given in the two entries for the same hazard, the classification
reflecting the more severe hazard classification is used.

Example:

for substance AB - no individual entry in Annex I:

Annex I group entry for compounds of A:

Repr. Cat. 1; R61

Repr. Cat. 3; R62

Xn; R20/22

R33 N; R50-53

Annex I group entry for compounds of B:

Carc. Cat.1; R45

T; R23/25 N; R51-53

Classification of substance AB thus becomes:

Carc. Cat. 1; R45

Repr. Cat. 1; R61

Repr. Cat. 3; R62

T; R23/25

R33 N; R50-53.

Note B:

Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and,
therefore, these solutions require different labelling since the hazards vary at different concentrations.

In Annex I entries with Note B have a general designation of the following type: (cid:145)nitric acid (cid:133)%(cid:146).

In this case the manufacturer or any other person who markets such a substance in aqueous solution must state the
percentage concentration of the solution on the label.

Example: nitric acid 45 %.

Unless otherwise stated, it is assumed that the percentage concentration is calculated on a weight/weight basis.

The use of additional data (e.g. specific gravity, degrees BaumØ) or descriptive phrases (e.g. fuming or glacial)
permissible.

is

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Note C:

Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.

In Annex I, a general designation of the following type is sometimes used: (cid:145)xylenol(cid:146).

In this case the manufacturer or any other person who markets such a substance must state on the label whether the
substance is a specific isomer (a) or a mixture of isomers (b).

Example:

(a) 2,4-dimethylphenol

(b) xylenol (mixture of isomers).

Note D:

Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the
market in a stabilised form. It is in this form that they are listed in Annex I to this Directive.

However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer
or any person who places such a substance on the market must state on the label the name of the substance followed
by the words (cid:145)non-stabilised(cid:146).

Example: methacrylic acid (non-stabilised).

Note E:

Substances with specific effects on human health (see Chapter 4 of Annex VI) that are classified as carcinogenic,
mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic
(T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28,
R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the word (cid:145)Also(cid:146).

Examples:

R45-23

(cid:145)May cause cancer. Also toxic by inhalation(cid:146)

R46-27/28

(cid:145)May cause heritable genetic damage. Also very toxic in contact with skin and if
swallowed(cid:146).

Note F:

This substance may contain a stabiliser. If the stabiliser changes the dangerous properties of the substance, as indicated
by the label
in Annex I, a label should be provided in accordance with the rules for the labelling of dangerous
preparations.

Note G:

This substance may be marketed in an explosive form in which case it must be evaluated using the appropriate test
methods and a label should be provided reflecting its explosive property.

Note H:

The classification and label shown for this substance applies to the dangerous property(ies)
indicated by the risk
phrase(s) in combination with the category(ies) of danger shown. The requirements of Article 6 of this Directive on
manufacturers, distributors and importers of this substance apply to all other aspects of classification and labelling. The
final label shall follow the requirements of section 7 of Annex VI of this Directive.

This note applies to certain coal- and oil-derived substances and to certain entries for groups of substances in Annex I.

Note J:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w
benzene (Einecs No 200-753-7). This note applies only to certain complex coal- and oil-derived substances in Annex I.

21.8.2001

EN

Official Journal of the European Communities

L 225/9

Note K:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w
1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen, at least the S-phrases (2-)9-16
should apply. This note applies only to certain complex oil-derived substances in Annex I.

Note L:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO
extract as measured by IP 346. This note applies only to certain complex oil-derived substances in Annex I.

Note M:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005 % w/w
benzo[a]-pyrene (Einecs No 200-028-5). This note applies only to certain complex coal-derived substances in Annex I.

Note N:

The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the
substance from which it is produced is not a carcinogen. This note applies only to certain complex oil-derived
substances in Annex I.

Note P:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w
benzene (Einecs No 200-753-7).

When the substance is classified as a carcinogen, Note E shall also apply.

When the substance is not classified as a carcinogen at least the S-phrases (2-)23-24-62 shall apply.

This note applies only to certain complex oil-derived substances in Annex I.

Note Q:

The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following
conditions:

(cid:151) a short term biopersistence test by inhalation has shown that the fibres longer than 20 (cid:181)m have a weighted

half-life less than 10 days, or

(cid:151) a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 (cid:181)m have a

weighted half-life less than 40 days, or

(cid:151) an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity, or

(cid:151) absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test.

Note R:

The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter less two
standard geometric errors greater than 6 (cid:181)m.

Note S:

This substance may not require a label according to Article 23 (see section 8 of Annex VI).

L 225/10

EN

Official Journal of the European Communities

21.8.2001

Explanation of the notes relating to the labelling of preparations

The significance of the notes that appear to the right of the concentration limits is as follows:

Note 1:

The concentration stated or, in the absence of such concentrations, the general concentrations of Directive 1999/45/EC
are the percentages by weight of the metallic element calculated with reference to the total weight of the preparation.

Note 2:

The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to
the total weight of the preparation.

Note 3:

The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to
the total weight of the preparation.

Note 4:

Preparations containing these substances have to be classified as harmful with R65 if they meet the criteria in section
3.2.3 in Annex VI.

Note 5:

The concentration limits for gaseous preparations are expressed as volume per volume percentage.

Note 6:

Preparations containing these substances have to be assigned R67 if they meet the criteria in section 3.2.8 in Annex VI.

This note will no longer apply from the date on which the criteria for the use of R67 provided for in Directive
1999/45/EC enter into force.

21.8.2001

EN

Official Journal of the European Communities

L 225/11

TABLA A (cid:151) TABEL A (cid:151) TABELLE A (cid:151) PIMAJAR A (cid:151) TABLE A (cid:151) TABLEAU A (cid:151) TABELLA A (cid:151) TABEL A (cid:151)
TABELA A (cid:151) TABELL A (cid:151) TAULUKKO A

Lista de los elementos qu(cid:237)micos clasificados por su nœmero at(cid:243)mico (Z)
Liste over grundstoffer, ordnet efter deres atomv(cid:230)gt (Z)
Liste der chemischen Elemente, geordnet nach der Ordnungszahl (Z)
Jas(cid:220)kocoy vglij(cid:254)m rsoive(cid:223)xm sanimolgl(cid:221)mxm r(cid:253)luxma le som asolij(cid:252) soty aqihl(cid:252) (F)
List of chemical elements listed according to their atomic number (Z)
Liste des ØlØments chimiques classØs selon leur numØro atomique (Z)
Elenco degli elementi chimici ordinati secondo il loro numero atomico (Z)
Lijst van chemische elementen, gerangschikt naar atoomgewicht (Z)
Lista dos elementos qu(cid:237)micos ordenados segundo o seu nœmero at(cid:243)mico (Z)
Lista (cid:246)ver grund(cid:228)mnen, ordnade efter deras atomnummer (Z)
Alkuaineiden luettelo j(cid:228)rjestysluvun mukaan (Z)

Z

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

H

He

Li

Be

B

C

N

O

F

Ne

Na

Mg

Al

Si

P

S

Cl

Ar

K

Ca

Symbol

DE

DA

EL

EN

ES

FR

IT

NL

PT

Wasserstoff

Hydrogen
(brint)

Tdqoc(cid:252)mo

Hydrogen

Hidr(cid:243)geno

HydrogŁne

Idrogeno

Waterstof

HidrogØnio

SV

V(cid:228)te

FI

Vety

Helium

Helium

Lithium

Lithium

„kio

K(cid:223)hio

Helium

Lithium

Helio

Litio

Beryllium

Beryllium

Bgq(cid:253)kkio

Beryllium

Berilio

HØlium

Lithium

BØryllium
(Glucinium)

Elio

Litio

Helium

Lithium

HØlio

L(cid:237)tio

Helium

Helium

Litium

Litium

Berillio

Beryllium

Ber(cid:237)lio

Beryllium

Beryllium

Bor

Bor

B(cid:252)qio

Boron

Boro

Bore

Boro

Boor

Boro

Kohlenstoff

Carbon
(kulstof)

¢mhqajay

Carbon

Carbono

Carbone

Carbonio

Koolstof

Carbono

Bor

Kol

Boori

Hiili

Stickstoff

Nitrogen

¢fxso

Nitrogen

Nitr(cid:243)geno

Azote

Azoto

Stikstof

Azoto

Kv(cid:228)ve

Typpi

Sauerstoff

Oxygen (ilt)

…ntc(cid:252)mo

Oxygen

Ox(cid:237)geno

OxygŁne

Ossigeno

Zuurstof

OxigØnio

Syre

Happi

Fluor

Neon

Fluor

Neon

Uh(cid:252)qio

Fluorine

M(cid:221)om

Neon

Flœor

Ne(cid:243)n

Fluor

NØon

Fluoro

Neon

Fluor

Neon

Flœor

NØon

Fluor

Neon

Fluori

Neon

Natrium

Natrium

M(cid:220)sqio

Sodium

Sodio

Sodium

Sodio

Natrium

S(cid:243)dio

Natrium

Natrium

Magnesium

Magnesium

Lacm(cid:222)rio

Magnesium

Magnesio

MagnØsium

Magnesio

Magnesium

MagnØsio

Magnesium

Magnesium

Aluminium

Aluminium

Aqc(cid:223)kio

Aluminium

Aluminio

Aluminium

Alluminio

Aluminium

Alum(cid:237)nio

Aluminium

Alumiini

Silicium

Silicium

Ptq(cid:223)sio

Silicon

Silicio

Silicium

Silicio

Silicium

Sil(cid:237)cio

Kisel

Pii

Phosphor

Phosphor

U(cid:254)ruoqoy

Phosphorus

F(cid:243)sforo

Phosphore

Fosforo

Fosfor

F(cid:243)sforo

Fosfor

Fosfori

Schwefel

Svovl

He(cid:223)o

Sulphur

Azufre

Soufre

Chlor

Chlor

Vk(cid:254)qio

Chlorine

Cloro

Chlore

Zolfo

Cloro

Zwavel

Enxofre

Svavel

Rikki

Chloor

Cloro

Klor

Kloori

Argon

Argon

Aqc(cid:252)

Argon

Arg(cid:243)n

Argon

Argon

Argon

`rgon

Argon

Argon

Kalium

Kalium

J(cid:220)kio

Potassium

Potasio

Potassium

Potassio

Kalium

PotÆssio

Kalium

Kalium

Calcium

Calcium

Arb(cid:221)rsio

Calcium

Calcio

Calcium

Calcio

Calcium

CÆlcio

Kalcium

Kalsium

L

2
2
5
/
1
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Z

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

Symbol

DE

DA

EL

EN

ES

FR

IT

NL

PT

SV

FI

Sc

Ti

V

Cr

Scandium

Scandium

Rj(cid:220)mdio

Scandium

Escandio

Scandium

Scandio

Scandium

Esc(cid:226)ndio

Skandium

Skandium

Titan

Titan

Sis(cid:220)mio

Titanium

Titanio

Titane

Titanio

Titaan

Tit(cid:226)nio

Titan

Titaani

Vanadium

Vanadium

Bam(cid:220)dio

Vanadium

Vanadio

Vanadium

Vanadio

Vanadium

VanÆdio

Vanadin

Vanadiini

Chrom

Chrom

Vq(cid:254)lio

Chromium

Cromo

Chrome

Cromo

Chroom

Cr(cid:243)mio

Krom

Kromi

Mn

Mangan

Mangan

Lacc(cid:220)mio

Manganese

Manganeso

ManganŁse

Manganese

Mangaan

ManganŒs

Mangan

Mangaani

Fe

Co

Ni

Cu

Zn

Ga

Ge

As

Se

Br

Kr

Rb

Sr

Y

Zr

Eisen

Jern

R(cid:223)dgqoy

Iron

Hierro

Fer

Ferro

IJzer

Ferro

J(cid:228)rn

Rauta

Kobalt

Cobalt

Job(cid:220)ksio

Cobalt

Cobalto

Cobalt

Cobalto

Kobalt

Cobalto

Kobolt

Koboltti

Nickel

Nikkel

Mij(cid:221)kio

Nickel

N(cid:237)quel

Nickel

Nichel

Nikkel

N(cid:237)quel

Nickel

Nikkeli

Kupfer

Kobber

Vakj(cid:252)y

Copper

Cobre

Cuivre

Rame

Koper

Cobre

Koppar

Kupari

Zink

Zink

Wetd(cid:220)qctqoy

Zinc

Cinc

Zinc

Zinco

Zink

Zinco

Zink

Sinkki

Gallium

Gallium

C(cid:220)kkio

Gallium

Galio

Gallium

Gallio

Gallium

GÆlio

Gallium

Gallium

Germanium

Germanium

Ceql(cid:220)mio

Germanium

Germanio

Germanium

Germanio

Germanium

Germ(cid:226)nio

Germanium

Germanium

Arsen

Arsen

Aqremij(cid:252)

Arsenic

ArsØnico

Arsenic

Arsenico

Arseen

ArsØnio

Arsenik

Arseeni

Selen

Brom

Selen

Rek(cid:222)mio

Selenium

Selenio

SØlØnium

Selenio

Selenium

SelØnio

Selen

Seleeni

Brom

Bq(cid:254)lio

Bromine

Bromo

Brome

Bromo

Broom

Bromo

Brom

Bromi

Krypton

Krypton

Jqtps(cid:252)

Krypton

Cript(cid:243)n

Krypton

Krypton

Krypton

Kr(cid:237)pton

Krypton

Krypton

Rubidium

Rubidium

Qotb(cid:222)dio

Rubidium

Rubidio

Rubidium

Rubidio

Rubidium

Rub(cid:237)dio

Rubidium

Rubidium

Strontium

Strontium

Rsq(cid:252)msio

Strontium

Estroncio

Strontium

Stronzio

Strontium

Estr(cid:244)ncio

Strontium

Strontium

Yttrium

Yttrium

(cid:190)ssqio

Yttrium

Itrio

Yttrium

Ittrio

Yttrium

˝trio

Yttrium

Yttrium

Zirkon

Zirconium

Fiqj(cid:252)mio

Zirconium

Circonio

Zirconium

Zirconio

Zirkonium

Zirc(cid:243)nio

Zirkonium

Zirkonium

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
1
3

Z

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

58

59

60

Symbol

DE

DA

EL

EN

ES

FR

IT

NL

PT

SV

FI

Nb

Mo

Tc

Ru

Rh

Pd

Ag

Cd

In

Sn

Sb

Te

I

Xe

Cs

Ba

La

Ce

Pr

Niob

Niobium

Mi(cid:252)bio

Niobium

Niobio

Niobium

Niobio

Niobium

Ni(cid:243)bio

Niob

Niobium

Molybd(cid:228)n

Molybden

Loktbd(cid:221)mio

Molybdenum

Molibdeno

MolybdŁne

Molibdeno

Molybdeen

MolibdØnio

Molybden

Molybdeeni

Technetium

Technetium

Sevm(cid:222)sio

Technetium

Tecnecio

Technetium

Tecnezio

Technetium

TecnØcio

Teknetium

Teknetium

Ruthenium

Ruthenium

Qoth(cid:222)mio

Ruthenium

Rutenio

RuthØnium

Rutenio

Ruthernium

RutØnio

Rutenium

Rutenium

Rhodium

Rhodium

Q(cid:252)dio

Rhodium

Rodio

Rhodium

Rodio

Rodium

R(cid:243)dio

Rodium

Rodium

Palladium

Palladium

Pakk(cid:220)dio

Palladium

Paladio

Palladium

Palladio

Palladium

PalÆdio

Palladium

Palladium

Silber

Słlv

¢qctqoy

Silver

Plata

Argent

Argento

Zilver

Prata

Silver

Hopea

Cadmium

Cadmium

J(cid:220)dlio

Cadmium

Cadmio

Cadmium

Cadmio

Cadmium

CÆdmio

Kadmium

Kadmium

Indium

Indium

”mdio

Indium

Indio

Indium

Indio

Indium

˝ndio

Indium

Indium

Zinn

Tin

Jarr(cid:223)seqoy

Tin

Estaæo

(cid:201)tain

Stagno

Tin

Estanho

Tenn

Tina

Antimon

Antimon

Amsil(cid:252)mio

Antimony

Antimonio

Antimoine

Antimonio

Antimoon

Antim(cid:243)nio

Antimon

Antimoni

Tellur

Telur

Sekko(cid:253)qio

Tellurium

Telurio

Tellure

Tellurio

Telluur

Telœrio

Tellur

Telluuri

Jod

Jod

Xenon

Xenon

I(cid:254)dio

N(cid:221)mo

Iodine

Yodo

Iode

Iodio

Jood

Iodo

Jod

Jodi

Xenon

Xen(cid:243)n

XØnon

Xenon

Xenon

XØnon

Xenon

Ksenon

Caesium

C(cid:230)sium

Ja(cid:223)rio

Caesium

Cesio

CØsium

Cesio

Cesium

CØsio

Cesium

Cesium

Barium

Barium

B(cid:220)qio

Barium

Bario

Baryum

Bario

Barium

BÆrio

Barium

Barium

Lanthan

Lanthan

Kamh(cid:220)mio

Lanthanum

Lantano

Lanthane

Lantanio

Lanthaan

Lant(cid:226)nio

Lantan

Lantaani

Cer

Cerium

Dgl(cid:222)sqio

Cerium

Cerio

CØrium

Cerio

Cerium

CØrio

Cerium

Cerium

Praseodym

Praseodym

Pqareod(cid:253)lio

Praseodymium Praseodimio

PrasØodyme

Praseodimio

Praseodymium Praseod(cid:237)mio

Praseodym

Praseodyymi

Nd

Neodym

Neodym

Meod(cid:253)lio

Neodymium

Niodimio

NØodyme

Neodimio

Neodymium

Neod(cid:237)mio

Neodym

Neodyymi

L

2
2
5
/
1
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Z

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

Symbol

DE

DA

EL

EN

ES

FR

IT

NL

PT

SV

FI

Pm

Sm

Eu

Gd

Tb

Dy

Ho

Er

Tm

Yb

Lu

Hf

Ta

W

Re

Os

Ir

Pt

Au

Hg

Promethium Promethium

Pqol(cid:222)heio

Promethium

Prometio

PromØthium

Promezio

Promethium

PromØcio

Prometium

Prometium

Samarium

Samarium

Ral(cid:220)qio

Samarium

Samario

Samarium

Samario

Samarium

SamÆrio

Samarium

Samarium

Europium

Europium

Etq(cid:254)pio

Europium

Europio

Europium

Europio

Europium

Eur(cid:243)pio

Europium

Europium

Gadolinium

Gadolinium

Cadok(cid:223)mio

Gadolinium

Gadolinio

Gadolinium

Gadolinio

Gadolinium

Gadol(cid:237)nio

Gadolinium

Gadolinium

Terbium

Terbium

S(cid:221)qbio

Terbium

Terbio

Terbium

Terbio

Terbium

TØrbio

Terbium

Terbium

Dysprosium

Dysprosium

Dtrpq(cid:252)rio

Dysprosium

Disprosio

Dysprosium

Disprosio

Dysprosium

Dispr(cid:243)sio

Dysprosium

Dysprosium

Holmium

Holmium

…klio

Holmium

Holmio

Holmium

Olmio

Holmium

H(cid:243)lmio

Holmium

Holmium

Erbium

Erbium

‚qbio

Erbium

Erbio

Erbium

Erbio

Erbium

(cid:201)rbio

Erbium

Erbium

Thulium

Thulium

Ho(cid:253)kio

Thulium

Tulio

Thulium

Tulio

Thulium

Tœlio

Tulium

Tulium

Ytterbium

Ytterbium

Tss(cid:221)qbio

Ytterbium

Iterbio

Ytterbium

Itterbio

Ytterbium

ItØrbio

Ytterbium

Ytterbium

Lutetium

Lutetium

Kots(cid:222)sio

Lutetium

Lutecio

LutØcium

Lutezio

Lutetium

LutØcio

Lutetium

Lutetium

Hafnium

Hafnium

¢umio

Hafnium

Hafnio

Hafnium

Afnio

Hafnium

HÆfnio

Hafnium

Hafnium

Tantal

Tantal

Sams(cid:220)kio

Tantalum

TÆntalo

Tantale

Tantalio

Tantaal

T(cid:226)ntalo

Tantal

Tantaali

Wolfram

Wolfram

Bokuq(cid:220)lio
(Sotcjos(cid:221)mio)

Tungsten

Volframio

TungstŁne

Tungsteno

Wolfram

TungstØnio

Wolfram

Volframi

Rhenium

Rhenium

Q(cid:222)mio

Rhenium

Renio

RhØnium

Renio

Renium

RØnio

Rhenium

Renium

Osmium

Osmium

…rlio

Osmium

Osmio

Osmium

Osmio

Osmium

(cid:211)smio

Osmium

Osmium

Iridium

Iridium

Iq(cid:223)dio

Iridium

Iridio

Iridium

Iridio

Iridium

Ir(cid:237)dio

Iridium

Iridium

Platin

Platin

Ketj(cid:252)vqtroy

Platinum

Platino

Platine

Platino

Platinum

Platina

Platina

Platina

Gold

Guld

Vqtr(cid:252)y

Gold

Oro

Or

Oro

Goud

Ouro

Guld

Kulta

Quecksilber

Kviksłlv

Tdq(cid:220)qctqoy

Mercury

Mercurio

Mercure

Mercurio

Kwik

Mercœrio

Kvicksilver

Elohopea

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
1
5

Z

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

101

102

103

Tl

Pb

Bi

Po

At

Rn

Fr

Ra

Ac

Th

Pa

U

Np

Pu

Am

Cm

Bk

Cf

Es

Fm

Md

No

Lw

Symbol

DE

DA

EL

EN

Thallium

Thalium

H(cid:220)kkio

Thallium

ES

Talio

FR

IT

NL

Thallium

Tallio

Thallium

PT

TÆlio

SV

FI

Tallium

Tallium

Blei

Bly

L(cid:252)ktbdoy

Lead

Plomo

Plomb

Piombo

Lood

Chumbo

Bly

Lyijy

Wismuth

Bismuth

Birlo(cid:253)hio

Bismuth

Bismuto

Bismuth

Bismuto

Bismuth

Bismuto

Vismut

Vismutti

Polonium

Plonium

Pok(cid:254)mio

Polonium

Polonio

Polonium

Polonio

Polonium

Pol(cid:243)nio

Polonium

Polonium

Astat

Astat

Ars(cid:220)sio

Astatine

Astato

Radon

Radon

Qad(cid:252)mio

Radon

Rad(cid:243)n

Astate

Radon

Astato

Radon

Astaat

Radon

Astato

RÆdon

Astat

Astatiini

Radon

Radon

Francium

Francium

Uq(cid:220)cjio

Francium

Francio

Francium

Francio

Francium

Fr(cid:226)ncio

Francium

Frankium

Radium

Radium

Q(cid:220)dio

Radium

Radio

Radium

Radio

Radium

RÆdio

Radium

Radium

Actinium

Actinium

Ajs(cid:223)mio

Actinium

Actinio

Actinium

Attinio

Actinium

Act(cid:237)nio

Aktinium

Aktinium

Thorium

Thorium

H(cid:252)qio

Thorium

Torio

Thorium

Torio

Thorium

T(cid:243)rio

Torium

Torium

Protactinium Protactinium

Pqxsajs(cid:223)mio

Protactinium

Protactinio

Protactinium

Protoattinio

Protactinium

Protact(cid:237)nio

Protaktinium Protaktinium

Uran

Uran

Otq(cid:220)mio

Uranium

Uranio

Uranium

Uranio

Uranium

Ur(cid:226)nio

Uran

Uraani

Neptunium

Neptunium

Mepso(cid:253)mio
(Poreid(cid:254)mio)

Neptunium

Neptunio

Neptunium

Nettunio

Neptunium

Neptœnio

Neptunium

Neptunium

Plutonium

Plutonium

Pkots(cid:254)mio

Plutonium

Plutonio

Plutonium

Plutonio

Plutonium

Plut(cid:243)nio

Plutonium

Plutonium

Americium

Americium

Aleq(cid:223)jio

Americium

Americio

AmØricium

Americio

Americium

Amer(cid:237)cio

Americium

Amerikium

Curium

Curium

Jio(cid:253)qio

Curium

Curio

Curium

Curio

Curium

Cœrio

Curium

Curium

Berkelium

Berkelium

Lpeqj(cid:221)kio

Berkelium

Berquelio

BerkØlium

Berkelio

Berkelium

BerquØlio

Berkelium

Berkelium

Californium

Californium

Jakiu(cid:252)qmio

Californium

Californio

Californium

Californio

Californium

Calif(cid:243)rnio

Californium

Kalifornium

Einsteinium

Einsteinium

Aœmrs(cid:220)mio

Einsteinium

Einstenio

Einsteinium

Einstenio

Einsteinium

Einsteinio

Einsteinium

Einsteinium

Fermium

Fermium

U(cid:221)qlio

Fermium

Fermio

Fermium

Fermio

Fermium

FØrmio

Fermium

Fermium

Mendelevium Mendelevium

Lemsek(cid:221)bio

Mendelevium Mendelevio

MendØlØvium Mendelevio

Mendelevium MendelØvio

Mendelevium Mendelevium

Nobelium

Nobelium

Molp(cid:221)kio

Nobelium

Nobelio

NobØlium

Nobelio

Nobelium

NobØlio

Nobelium

Nobelium

Lawrentium

Lawrentium

Katq(cid:221)mrio

Lawrencium

Laurencio

Lawrencium

Lawrencio

Laurentium

LaurŒncio

Lawrentium

Lawrensium

L

2
2
5
/
1
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

21.8.2001

EN

Official Journal of the European Communities

L 225/17

TABLA B (cid:151) TABEL B (cid:151) TABELLE B (cid:151) PIMAJAR B (cid:151) TABLE B (cid:151) TABLEAU B (cid:151) TABELLA B (cid:151) TABEL B (cid:151) TABELA B (cid:151) TABELL B (cid:151)
TAULUKKO B

Clasificaci(cid:243)n especial para las sustancias orgÆnicas
S(cid:230)rlig inddeling af organiske stoffer
Spezielle Anordnung f(cid:252)r die organischen Stoffe
Eidij(cid:222) sanim(cid:252)lgrg sxm oqcamij(cid:254)m otri(cid:254)m
Special classification for organic substances
Classification particuliŁre aux substances organiques
Classificazione speciale per le sostanze organiche
Speciale indeling voor de organische stoffen
Classifica(cid:231)ªo especial para as subst(cid:226)ncias org(cid:226)nicas
S(cid:228)rskild indelning av organiska (cid:228)mnen
Erityisryhm(cid:228)t orgaanisille aineille

601

602

603

604

Hidrocarburos
Carbonhydrider (kulbrinter)
Kohlenwasserstoffe
Tdqocom(cid:220)mhqajey
Hydrocarbons
Hydrocarbures
Idrocarburi
Koolwaterstoffen
Hidrocarbonetos
Kolv(cid:228)ten
Hiilivedyt

Hidrocarburos halogenados
Halogensubstituerede carbonhydrider
Halogen-Kohlenwasserstoffe
Akocomopaq(cid:220)cxca tdqocomamhq(cid:220)jxm
Halogenated hydrocarbons
DØrivØs halogØnØs des hydrocarbures
Derivati idrocarburi alogenati
Gehalogeneerde koolwaterstoffen
Hidrocarbonetos halogenados
Halogenerade kolv(cid:228)ten
Halogenoidut hiilivedyt

Alcoholes y derivados
Alkoholer og deres derivater
Alkohole und ihre Derivate
Akjo(cid:252)key jai paq(cid:220)cxc(cid:220) soty
Alcohols and their derivatives
Alcools et dØrivØs
Alcoli e derivati
Alcoholen en derivaten
`lcoois e derivados
Alkoholer och deras derivat
Alkoholit ja niiden johdannaiset

Fenoles y derivados
Phenoler og deres derivater
Phenole und ihre Derivate
Uaim(cid:252)key jai paq(cid:220)cxc(cid:220) soty
Phenols and their derivatives
PhØnols et dØrivØs
Fenoli e derivati
Fenolen en derivaten
Fen(cid:243)is e derivados
Fenoler och deras derivat
Fenolit ja niiden johdannaiset

605

606

607

608

Aldeh(cid:237)dos y derivados
Aldehyder og deres derivater
Aldehyde und ihre Derivate
Akde(cid:224)dey jai paq(cid:220)cxc(cid:220) soty
Aldehydes and their derivatives
AldØhydes et dØrivØs
Aldeidi e derivati
Aldehyden en derivaten
Alde(cid:237)dos e derivados
Aldehyder och deras derivat
Aldehydit ja niiden johdannaiset

Cetonas y derivados
Ketoner og deres derivater
Ketone und ihre Derivate
Jes(cid:252)mey jai paq(cid:220)cxc(cid:220) soty
Ketones and their derivatives
CØtones et dØrivØs
Chetoni e derivati
Ketonen en derivaten
Cetonas e derivados
Ketoner och deras derivat
Ketonit ja niiden johdannaiset

`cidos orgÆnicos y derivados
Organiske syrer og deres derivater
Organische S(cid:228)uren und ihre Derivate
Oqcamij(cid:220) on(cid:221)a jai paq(cid:220)cxc(cid:220) soty
Organic acids and their derivatives
Acides organiques et dØrivØs
Acidi organici e derivati
Organische zuren en derivaten
`cidos org(cid:226)nicos e derivados
Organiska syror och deras derivat
Orgaaniset hapot ja niiden johdannaiset

Nitrilos
Nitriler
Nitrile
Misq(cid:223)kia
Nitriles
Nitriles
Nitrili
Nitrillen
Nitrilos
Nitriler
Nitriilit

L 225/18

EN

Official Journal of the European Communities

21.8.2001

609

610

611

612

613

614

Derivados nitrados
Nitroforbindelser
Nitroverbindungen
Misqoem(cid:254)reiy
Nitro compounds
DØrivØs nitrØs
Nitroderivati
Nitroverbindingen
Derivados nitrados
Kv(cid:228)vef(cid:246)reningar
Nitroyhdisteet

Derivados cloronitrados
Chlornitroforbindelser
Chlornitroverbindungen
Vkxqomisqoem(cid:254)reiy
Chloronitro compounds
DØrivØs chloronitrØs
Cloronitro derivati
Chloornitroverbindingen
Derivados cloronitrados
Klornitrof(cid:246)reningar
Kloorinitroyhdisteet

Derivados azoicos y azoxi
Azoxy- og azoforbindelser
Azoxy- und Azoverbindungen
Afxnt- jai afx-em(cid:254)reiy
Azoxy- and azo compounds
DØrivØs azoxy et azo(cid:239)ques
Azossi- e azoderivati
Azoxy- en azoverbindingen
Derivados azoxi e az(cid:243)icos
Azoxi- och azof(cid:246)reningar
Atsoksi- ja atsoyhdisteet

Derivados aminados
Aminer
Aminoverbindungen
Alimoem(cid:254)reiy
Amine compounds
DØrivØs aminØs
Aminoderivati
Aminoverbindingen
Derivados aminados
Aminer
Amiiniyhdisteet

Bases heteroc(cid:237)clicas y derivados
Heterocykliske baser og deres derivater
Heterocyclische Basen und ihre Derivate
Eseqojtjkij(cid:221)y b(cid:220)reiy jai paq(cid:220)cxc(cid:220) soty
Heterocyclic bases and their derivatives
Bases hØtØrocycliques et dØrivØs
Basi eterocicliche e derivati
Heterocyclische basen en hun derivaten
Bases heteroc(cid:237)clicas e derivados
Heterocykliska baser och deras derivat
Heterosykliset em(cid:228)kset ja niiden johdannaiset

Gluc(cid:243)sidos y alcaloides
Glycosider og alkaloider
Glycoside und Alkaloide
Cktjof(cid:223)sey jai akjakoeid(cid:222)
Glycosides and alkaloids
Glucosides et alcalo(cid:239)des
Glucosidi e alcaloidi
Glycosiden en alkalo(cid:239)den
Glic(cid:243)sidos e alcal(cid:243)ides
Glykosider och alkaloider
Glykosidit ja alkaloidit

615

616

617

647

648

649

Cianatos e isocianatos
Cyanater og isocyanater
Cyanate und Isocyanate
Jtamij(cid:221)y jai irojtamij(cid:221)y em(cid:254)reiy
Cyanates and isocyanates
Cyanates et isocyanates
Cianati e isocianati
Cyanaten en isocyanaten
Cianatos e isocianatos
Cyanater och isocyanater
Syanaatit ja isosyanaatit

Amidas y derivados
Amider og deres derivater
Amide und ihre Derivate
Al(cid:223)dia jai paq(cid:220)cxc(cid:220) soty
Amides and their derivatives
Amides et dØrivØs
Ammidi e derivati
Amiden en derivaten
Amidas e derivados
Amider och deras derivat
Amidit ja niiden johdannaiset

Per(cid:243)xidos orgÆnicos
Organiske peroxider
Organische Peroxide
Oqcamij(cid:220) tpeqone(cid:223)dia
Organic peroxides
Peroxydes organiques
Perossidi organici
Organische peroxiden
Per(cid:243)xidos org(cid:226)nicos
Organiska peroxider
Orgaaniset peroksidit

Enzimas
Enzymer
Enzyme
‚mftla
Enzymes
Enzymes
Enzimi
Enzymen
Enzimas
Enzymer
Entsyymit

Sustancias complejas derivadas del carb(cid:243)n
Komplekse kulderivater
Aus Kohle abgeleitete komplexe Stoffe
R(cid:253)lpkojey otr(cid:223)ey paqac(cid:252)lemey ap(cid:252) (cid:220)mhqaja
Complex substances derived from coal
Substances complexes dØrivØes du charbon
Sostanze complesse derivate dal carbone
Complexe steenkoolderivaten
Subst(cid:226)ncias complexas derivadas do carvªo
Komplexa kolderivat
Monimutkaiset hiilijohdannaiset

Sustancias complejas derivadas del petr(cid:243)leo
Komplekse oliederivater
Aus Erd(cid:246)l abgeleitete komplexe Stoffe
R(cid:253)lpkojey otr(cid:223)ey paqac(cid:252)lemey ap(cid:252) pesq(cid:221)kaio
Complex substances derived from petroleum
Substances complexes dØrivØes du pØtrole
Sostanze complesse derivate dal petrolio
Complexe aardoliederivaten
Subst(cid:226)ncias complexas derivadas do petr(cid:243)leo
Komplexa oljederivat
Monimutkaiset (cid:246)ljyjohdannaisetgo 1

21.8.2001

EN

Official Journal of the European Communities

L 225/19

650

Sustancias diversas
Diverse stoffer
Verschiedene Stoffe
Di(cid:220)uoqey otr(cid:223)ey
Miscellaneous substances
Substances diverses
Sostanze diverse
Diversen
Subst(cid:226)ncias diversas
Diverse (cid:228)mnen
Muut aineet

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

ANNEX 1B

004-002-00-2 beryllium compounds with

the
exception of aluminium beryllium
silicates, and with those specified
elsewhere in this Annex

(cid:151)

A
E

(cid:151)

006-015-00-9 diuron (ISO)

206-354-4

330-54-1

3-(3,4-dichlorophenyl)-1,1-
dimethylurea

006-024-00-8 proxan-sodium (ISO)

205-443-5

140-93-2

sodium O-isopropyldithiocarbonate

006-032-00-1 monolinuron (ISO)

217-129-5

1746-81-2

3-(4-chlorophenyl)-1-methoxy-
1-methylurea

006-041-00-0 dimethylcarbamoyl chloride

E

201-208-6

79-44-7

006-069-00-3 thiophanate-methyl (ISO)

245-740-7

23564-05-8

1,2-di-(3-methoxycarbonyl-
2-thioureido)benzene

007-015-00-1 O-ethylhydroxylamine

402-030-3

624-86-2

009-014-00-1 lead hexafluorosilicate

E

247-278-1

25808-74-6

Carc. Cat. 2; R49
T+; R26
T; R25-48/23
Xi; R36/37/38
R43
N; R51-53

T+; N
R: 49-25-26-36/37/38-43-
48/23-51/53
S: 53-45-61

Carc. Cat. 3; R40
Xn; R22-48/22
N; R50-53

Xn; N
R: 22-40-48/22-50/53
S: (2-)13-22-23-37-46-60-61

Xn; R22
Xi; R38
N; R51-53

Xn; N
R: 22-38-51/53
S: (2-)13-61

Xn; R22-48/22
N; R50-53

Xn; N
R: 22-48/22-50/53
S: (2-)22-60-61

Carc. Cat. 2; R45
T; R23
Xn; R22
Xi; R36/37/38

Muta. Cat. 3; R68
Xn; R20
R43
N; R50-53

T
R: 45-22-23-36/37/38
S: 53-45

Xn; N
R: 20-43-50/53-68
S: (2-)36/37-46-60-61

F; R11
T; R23/24/25-48/23
Xi; R36
R43
N; R50

F; T; N
R: 11-23/24/25-36-43-
48/23-50
S: (1/2-)16-26-36/37/39-45-
60-61

Repr. Cat. 1; R61
Repr. Cat. 3; R62
Xn; R20/22
R33
N; R50-53

T; N
R: 61-62-20/22-33-50/53
S: 53-45-60-61

C ¯ 25 %: T; R45-22-23-36/37/38
20 % ˜ C < 25 %: T; R45-20-36/37/38
3 % ˜ C < 20 %: T; R45-20
0,001 % ˜ C < 3 %: T; R45

1

L

2
2
5
/
2
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

013-002-00-1 aluminium powder (stabilised)

231-072-3

(cid:151)

015-003-00-2 calcium phosphide

tricalcium diphosphide

215-142-0

1305-99-3

015-004-00-8 aluminium phosphide

244-088-0

20859-73-8

015-005-00-3 magnesium phosphide

235-023-7

12057-74-8

trimagnesium diphosphide

015-006-00-9 trizinc diphosphide

zinc phosphide

215-244-5

1314-84-7

015-019-00-X dichlorvos (ISO)

200-547-7

62-73-7

2,2-dichlorovinyl dimethyl
phosphate

F; R15
R10

F; R15/29
T+; R28
N; R50

F; R15/29
T+; R28
R32
N; R50

F; R15/29
T+; R28
N; R50

F; R15/29
T+; R28
R32
N; R50-53

T+; R26
T; R24/25
R43
N; R50

F
R: 10-15
S: (2-)7/8-43

F; T+; N
R: 15/29-28-50
S: (1/2-)22-43-45-61

F; T+; N
R: 15/29-28-32-50
S: (1/2-)3/9/14-30-36/37-45-61

F; T+; N
R: 15/29-28-50
S: (1/2-)22-43-45-61

F; T+; N
R: 15/29-28-32-50/53
S: (1/2-)3/9/14-30-36/37-
45-60-61

T+; N
R: 24/25-26-43-50
S: (1/2-)28-36/37-45-61

015-106-00-2 hexamethylphosphoric triamide

211-653-8

680-31-9

hexamethylphosphoramide

Carc. Cat. 2; R45
Muta. Cat. 2; R46

T
R: 45-46
S: 53-45

C ¯ 0,1 %: T; R45-46
0,01 % ˜ C < 0,1 %: T; R45

015-121-00-4 edifenphos (ISO)

241-178-1

17109-49-8

O-ethyl S,S-diphenyl
phosphorodithioate

015-137-00-1 pyrazophos (ISO)

236-656-1

13457-18-6

O,O-diethyl O-(6-ethoxycarbonyl-
5-methylpyrazolo[2,3-a]
pyrimidin-2-yl) phosphorothioate

T; R23/25
Xn; R21
R43
N; R50-53

Xn; R20/22
N; R50-53

T; N
R: 21-23/25-43-50/53
S: (1/2-)36/37-45-60-61

Xn; N
R: 20/22-50/53
S: (2-)36/37-46-60-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
2
1

Index No

Chemical name

Notes
related to
substances

015-156-00-5 methyl 3-

[(dimethoxyphosphinothioyl)
oxy]methacrylate [1]
methacrifos (ISO) [2]
methyl (E)-3-
[(dimethoxyphosphinothioyl)oxy]
methacrylate [2]

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

250-366-2 [1]
- [2]

30864-28-9 [1]
62610-77-9 [2]

Xn; R22
R43
N; R50-53

Xn; N
R: 22-43-50/53
S: (2-)36/37-60-61

015-157-00-0 phosphonic acid [1]

phosphorous acid [2]

233-663-1 [1]
237-066-7 [2]

10294-56-1 [1]
13598-36-2 [2]

Xn; R22
C; R35

016-002-00-X barium sulphide

244-214-4

21109-95-5

016-003-00-5 barium polysulphides

256-814-3

50864-67-0

016-004-00-0 calcium sulphide

243-873-5

20548-54-3

016-005-00-6 calcium polysulphides

215-709-2

1344-81-6

016-011-00-9 sulphur dioxide

231-195-2

7446-09-5

020-002-00-5 calcium cyanide

209-740-0

592-01-8

027-001-00-9 cobalt

231-158-0

7440-48-4

027-002-00-4 cobalt oxide

215-154-6

1307-96-6

R31
Xn; R20/22
N; R50

R31
Xi; R36/37/38
N; R50

R31
Xi; R36/37/38
N; R50

R31
Xi; R36/37/38
N; R50

T; R23
C; R34

T+; R28
R32
N; R50-53

R42/43
R53

Xn; R22
R43
N; R50-53

C
R: 22-35
S: (1/2-)26-36/37/39-45

Xn; N
R: 20/22-31-50
S: (2-)28-61

Xi; N
R: 31-36/37/38-50
S: (2-)28-61

Xi; N
R: 31-36/37/38-50
S: (2-)28-61

Xi; N
R: 31-36/37/38-50
S: (2-)28-61

T
R: 23-34
S: (1/2-)9-26-36/37/39-45

C ¯ 20 %: T; R23-34
5 % ˜ C < 20 %: C; R20-34
0,5 % ˜ C < 5 %: Xi; R36/37/38

5

T+; N
R: 28-32-50/53
S: (1/2-)7/8-23-36/37-45-
60-61

Xn
R: 42/43-53
S: (2-)22-24-37-61

Xn; N
R: 22-43-50/53
S: (2-)24-37-60-61

L

2
2
5
/
2
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

.

.

2
1
8
2
0
0
1

027-003-00-X cobalt sulphide

215-273-3

1317-42-6

028-003-00-2 nickel monoxide

215-215-7

1313-99-1

028-004-00-8 nickel dioxide

234-823-3

12035-36-8

028-005-00-3 dinickel trioxide

215-217-8

1314-06-3

028-006-00-9 nickel sulphide

240-841-2

16812-54-7

028-007-00-4 nickel subsulphide
trinickel disulphide

234-829-6

12035-72-2

028-008-00-X nickel dihydroxide

235-008-5

12054-48-7

034-001-00-2 selenium

231-957-4

7782-49-2

048-010-00-4 cadmium sulphide

215-147-8

1306-23-6

050-003-00-6 fentin acetate (ISO)
triphenyltin acetate

212-984-0

900-95-8

R43
N; R50-53

Xi; N
R: 43-50/53
S: (2-)24-37-60-61

Carc. Cat. 1; R49
R43
R53

T
R: 49-43-53
S: 53-45-61

Carc. Cat. 1; R49
R43
R53

T
R: 49-43-53
S: 53-45-61

Carc. Cat. 1; R49
R43
R53

T
R: 49-43-53
S: 53-45-61

Carc. Cat. 1; R49
R43
N; R50-53

T; N
R: 49-43-50/53
S: 53-45-60-61

Carc. Cat. 1; R49
R43
N; R51-53

T; N
R: 49-43-51/53
S: 53-45-61

Carc. Cat. 3; R40
Xn; R20/22
R43
N; R50-53

Xn; N
R: 20/22-40-43-50/53
S: (2-)22-36-60-61

T; R23/25
R33
R53

T
R: 23/25-33-53
S: (1/2-)20/21-28-45-61

Carc. Cat. 3; R40
T; R48/23/25
Xn; R22
R53

Carc. Cat. 3; R40
Repr. Cat. 3; R63
T+; R26
T; R24/25-48/23
Xi; R37/38-41
N; R50-53

T
R: 22-40-48/23/25-53
S: (1/2-)22-36/37-45-61

C ¯ 10 %: T; R22-40-48/23/25
1 % ˜ C < 10 %: Xn; R40-48/20/22
0,1 % ˜ C < 1 %: Xn; R48/20/22

1

T+; N
R: 24/25-26-37/38-40-41-
48/23-50/53-63
S: (1/2-)26-28-36/37/39-45-
60-61

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
2
3

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

050-004-00-1 fentin hydroxide (ISO)
triphenyltin hydroxide

200-990-6

76-87-9

050-013-00-0 trioctyltin compounds, with the
specified

of

those
exception
elsewhere in this Annex

A (cid:151)

078-001-00-0 tetrachloroplatinates

those
exception
elsewhere in this Annex

of

with

the
specified

A (cid:151)

078-005-00-2 hexachloroplatinates

exception
those
elsewhere in this Annex

of

with

the
specified

A (cid:151)

(cid:151)

(cid:151)

(cid:151)

081-001-00-3 thallium

231-138-1

7440-28-0

092-001-00-8 uranium

231-170-6

7440-61-1

C ¯ 1 %: Xi; R36/37/38

1

Carc. Cat. 3; R40
Repr. Cat. 3; R63
T+; R26
T; R24/25-48/23
Xi; R37/38-41
N; R50-53

T+; N
R: 24/25-26-37/38-40-41-
48/23-50/53-63
S: (1/2-)26-28-36/37/39-
45-60-61

Xi; R36/37/38
R53

Xi
R: 36/37/38-53
S: (2-)61

T; R25
Xi; R41
R42/43

T; R25
Xi; R41
R42/43

T+; R26/28
R33
R53

T+; R26/28
R33
R53

T
R: 25-41-42/43
S: (2-)22-26-36/37/39-45

T
R: 25-41-42/43
S: (1/2-)22-26-36/37/39-45

T+
R: 26/28-33-53
S: (1/2-)13-28-45-61

T+
R: 26/28-33-53
S: (1/2-)20/21-45-61

601-004-01-8 butane

(containing

¯
butadiene (203-450-8)) [1]
isobutane
¯
butadiene (203-450-8)) [2]

(containing

0,1 %

0,1 %

C
S

203-448-7 [1]
200-857-2 [2]

106-97-8 [1]
75-28-5 [2]

F+; R12
Carc. Cat. 1; R45
Muta. Cat. 2; R46

F+; T
R: 45-46-12
S: 53-45

601-005-00-6 2,2-dimethylpropane

207-343-7

463-82-1

neopentane

601-007-00-7 hexane, mixture

(containing
(203-777-6))

<

of
5 %

isomers
n-hexane

C

(cid:151)

(cid:151)

F+; R12
N; R51-53

F; R11
Xn; R65
Xi; R38
R67
N; R51-53

F+; N
R: 12-51/53
S: (2-)9-16-33-61

F; Xn; N
R: 11-38-51/53-65-67
S: (2-)9-16-29-33-61-62

4
6

L

2
2
5
/
2
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Notes
related to
prepara-
tions

6

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

601-013-00-X 1,3-butadiene
buta-1,3-diene

D

203-450-8

106-99-0

601-041-00-2 dibenz[a,h]anthracene

200-181-8

53-70-3

F+; R12
Carc. Cat. 1; R45
Muta. Cat. 2; R46

F+; T
R: 45-46-12
S: 53-45

Carc. Cat. 2; R45
N; R50-53

T; N
R: 45-50/53
S: 53-45-60-61

C ¯ 0,01 %: T; R45

602-027-00-9 trichloroethylene

trichloroethene

201-167-4

79-01-6

602-037-00-3 a-chlorotoluene
benzyl chloride

E

202-853-6

100-44-7

602-073-00-X 1,4-dichlorobut-2-ene

E

212-121-8

764-41-0

602-076-00-6 2,3,4-trichlorobut-1-ene

219-397-9

2431-50-7

602-084-00-X 1,1-dichloro-1-fluoroethane

404-080-1

1717-00-6

Carc. Cat. 2; R45
Muta. Cat. 3; R68
R67
Xi; R36/38
R52-53

Carc. Cat. 2; R45
T; R23
Xn; R22-48/22
Xi; R37/38-41

Carc. Cat. 2; R45
T+; R26
T; R24/25
C; R34
N; R50-53

Carc. Cat 3; R40
T; R23
Xn; R22
Xi; R36/37/38
N; R50-53

R52-53
N; R59

T
R: 45-36/38-52/53-67
S: 53-45-61

T
R: 45-22-23-37/38-41-48/22
S: 53-45

T+; N
R: 45-24/25-26-34-50/53
S: 53-45-60-61

C ¯ 25 %: T+; R45-24/25-26-34
10 % ˜ C < 25 %: T+; R45-21/22-26-34
7 % ˜ C < 10 %: T+;
R45-21/22-26-36/37/38
5 % ˜ C < 7 %: T;
R45-21/22-23-36/37/38
3 % ˜ C < 5 %: T; R45-21/22-23
1 % ˜ C < 3 %: T; R45-23
0,1 % ˜ C < 1 %: T; R45-20
0,01 % ˜ C < 0,1 %: T; R45

T; N
R: 22-23-36/37/38-40-50/53
S: (1/2-)36/37-45-60-61

C ¯ 25 %: T; R22-23-36/37/38-40
20 % ˜ C <25 %: Xn; R20-36/37/38-40
3 % ˜ C < 20 %: Xn; R20-40
0,1 % ˜ C < 3 %: Xn; R40

N
R: 52/53-59
S: 59-61

603-014-00-0 2-butoxyethanol

203-905-0

111-76-2

ethylene glycol monobutyl ether
butyl cellosolve

Xn; R20/21/22
Xi; R36/38

Xn
R: 20/21/22-36/38
S: (2-)36/37-46

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
2
5

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

603-024-00-5 1,4-dioxane

D

204-661-8

123-91-1

603-038-00-1 allyl glycidyl ether

203-442-4

106-92-3

allyl 2,3-epoxypropyl ether
prop-2-en-1-yl 2,3-epoxypropyl
ether

603-039-00-7 butyl glycidyl ether

219-376-4

2426-08-6

butyl 2,3-epoxypropyl ether

603-044-00-4 dicofol (ISO)

204-082-0

115-32-2

2,2,2-trichloro-1,1-bis
(4-chlorophenyl)ethanol

603-046-00-5 bis (chloromethyl) ether

E

208-832-8

542-88-1

oxybis(chloromethane)

F; R11-19
Carc. Cat. 3; R40
Xi; R36/37
R66

R10
Carc. Cat. 3; R40
Muta. Cat. 3; R68
Repr. Cat. 3; R62
Xn; R20/22
Xi; R37/38-41
R43
R52-53

R10
Carc. Cat. 3; R40
Muta. Cat. 3; R68
Xn; R20/22
Xi; R37
R43
R52-53

Xn; R21/22
Xi; R38
R43
N; R50-53

R10
Carc. Cat. 1; R45
T+; R26
T; R24
Xn; R22

F; Xn
R: 11-19-36/37-40-66
S: (2-)9-16-36/37-46

Xn
R: 10-20/22-37/38-40-41-43-
52/53-62-68
S: (2-)24/25-26-36/37/39-61

Xn
R:
10-20/22-37-40-43-52/53-68
S: (2-)24/25-36/37-61

Xn; N
R: 21/22-38-43-50/53
S: (2-)36/37-60-61

T+
R: 45-10-22-24-26
S: 53-45

603-049-00-1 chlorfenethol (ISO)

201-246-3

80-06-8

1,1-bis (4-chlorophenyl) ethanol

Xn; R22
N; R51-53

Xn; N
R: 22-51/53
S: (2-)36-61

603-055-00-4 propylene oxide

E

200-879-2

75-56-9

1,2-epoxypropane
methyloxirane

F+; R12
Carc. Cat. 2; R45
Muta. Cat. 2; R46
Xn; R20/21/22
Xi; R36/37/38

F+; T
R:
45-46-12-20/21/22-36/37/38
S: 53-45

C ¯ 25 %: T+; R45-22-24-26
7 % ˜ C < 25 %: T+; R45-21-26
3 % ˜ C < 7 %: T; R45-21-23
1 % ˜ C < 3 %: T; R45-23
0,1 % ˜ C < 1 %: T; R45-20
0,001 % ˜ C < 0,1 %: T; R45

L

2
2
5
/
2
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

603-065-00-9 resorcinol diglycidyl ether

202-987-5

101-90-6

1,3-bis(2,3-epoxypropoxy)benzene

603-067-00-X phenyl glycidyl ether

E

204-557-2

122-60-1

2,3-epoxypropyl phenyl ether
1,2-epoxy-3-phenoxypropane

Xn
R:
21/22-36/38-40-43-52/53-68
S: (2-)23-36/37-61

T
R: 45-20-37/38-43-52/53
S: 53-45-61

Carc. Cat. 3; R40
Muta. Cat. 3; R68
Xn; R21/22
Xi; R36/38
R43
R52-53

Carc. Cat. 2; R45
Muta. Cat. 3; R68
Xn; R20
Xi; R37/38
R43
R52-53

603-085-00-8 bronopol (INN)

200-143-0

52-51-7

2-bromo-2-nitropropane-1,3-diol

Xn; R21/22
Xi; R37/38-41
N; R50

Xn; N
R: 21/22-37/38-41-50
S: (2-)26-37/39-61

603-091-00-0 exo-1-methyl-4-(1-methylethyl)-7-

402-470-6

87172-89-2

oxabicyclo[2.2.1]heptan-2-ol

604-011-00-7 2,4-dichlorophenol

204-429-6

120-83-2

Xn; R22
Xi; R41

T; R24
Xn; R22
C; R34
N; R51-53

Xn
R: 22-41
S: (2-)26-39

T; N
R: 22-24-34-51/53
S: (1/2-)26-36/37/39-45-61

604-021-00-1 sodium 2-biphenylate

205-055-6

132-27-4

2-phenylphenol, sodium salt

Xn; R22
Xi; R37/38-41
N; R50

Xn; N
R: 22-37/38-41-50
S: (2-)22-26-61

604-038-00-4 4-chloro-3,5-dimethylphenol [1]
chloroxylenol [2]

201-793-8 [1]
215-316-6 [2]

88-04-0 [1]
1321-23-9 [2]

605-008-00-3 acrylaldehyde

D

203-453-4

107-02-8

acrolein
prop-2-enal

Xn; R22
Xi; R36/38
R43

F; R11
T+; R26
T; R24/25
C; R34
N; R50

Xn
R: 22-36/38-43
S: (2-)24-37

F; T+; N
R: 11-24/25-26-34-50
S: 23-26-28-36/37/39-45-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
2
7

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

605-009-00-9 crotonaldehyde [1]

2-butenal [1]
(E)-2-butenal [2]
(E)-crotonaldehyde [2]

224-030-0 [1]
204-647-1 [2]

4170-30-3 [1]
123-73-9 [2]

F; T+; N
R: 11-24/25-26-37/38-41-
48/22-50-68
S: (1/2-)26-28-36/37/39-45-61

F; R11
Muta. Cat. 3; R68
T+; R26
T; R24/25
Xn; R48/22
Xi; R37/38-41
N; R50

607-004-00-7 trichloroacetic acid

200-927-2

76-03-9

607-005-00-2 TCA-sodium (ISO)

sodium trichloroacetate

211-479-2

650-51-1

607-035-00-6 methyl methacrylate

D

201-297-1

80-62-6

methyl 2-methylprop-2-enoate
methyl 2-methylpropenoate

607-039-00-8 2,4-D (ISO)

202-361-1

94-75-7

2,4-dichlorophenoxyacetic acid

607-040-00-3 salts of 2,4-D

A (cid:151)

(cid:151)

607-043-00-X dicamba (ISO)

217-635-6

1918-00-9

2,5-dichloro-6-methoxybenzoic
acid
3,6-dichloro-2-methoxybenzoic
acid

607-061-00-8 acrylic acid

prop-2-enoic acid

D

201-177-9

79-10-7

607-083-00-8 2,4-DB (ISO)

202-366-9

94-82-6

4-(2,4-dichlorophenoxy)butyric acid

C; R35
N; R50-53

Xi; R37
N; R50-53

F; R11
Xi; R37/38
R43

Xn; R22
Xi; R37-41
R43
R52-53

Xn; R22
Xi; R41
R43
N; R51-53

Xn; R22
Xi; R41
R52-53

R10
Xn; R20/21/22
C; R35
N; R50

Xn; R22
N; R51-53

C; N
R: 35-50/53
S: (1/2-)26-36/37/39-45-60-61

C ¯ 10 %: C; R35
5 % ˜ C < 10 %: C; R34
1 % ˜ C < 5 %: Xi; R36/37/38

Xi; N
R: 37-50/53
S: (2-)46-60-61

F; Xi
R: 11-37/38-43
S: (2-)24-37-46

Xn
R: 22-37-41-43-52/53
S: (2-)24/25-26-36/37/39-
46-61

Xn; N
R: 22-41-43-51/53
S: (2-)24/25-26-36/37/39-
46-61

Xn
R: 22-41-52/53
S: (2-)26-61

C; N
R: 10-20/21/22-35-50
S: (1/2-)26-36/37/39-45-61

C ¯ 25 %: C; R20/21/22-35
10 % ˜ C < 25 %: C; R35
5 % ˜ C < 10 %: C; R34
1 % ˜ C < 5 %: Xi; R36/37/38

Xn; N
R: 22-51/53
S: (2-)25-29-46-61

L

2
2
5
/
2
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

607-084-00-3 salts of 2,4-DB

A (cid:151)

(cid:151)

607-088-00-5 methacrylic acid

D

201-204-4

79-41-4

2-methylpropenoic acid

607-133-00-9 monoalkyl

or

monoaryl

or
monoalkylaryl esters of acrylic acid
with
those
exception
specified elsewhere in this Annex

the

of

607-134-00-4 monoalkyl

or

monoaryl

or
monoalkyaryl esters of methacrylic
acid with the exception of
those
specified elsewhere in this Annex

A (cid:151)

A (cid:151)

(cid:151)

(cid:151)

Xn; R22
Xi; R41
N; R51-53

Xn; R21/22
C; R35

Xn; N
R: 22-41-51/53
S: (2-)26-29-39-46-61

C
R: 21/22-35
S: (1/2-)26-36/37/39-45

Xi; R36/37/38
N; R51-53

Xi; N
R: 36/37/38-51/53
S: (2-)26-28-61

C ¯ 25 %: C; R21/22-35
10 % ˜ C < 25 %: C; R35
5 % ˜ C < 10 %: C; R34
1 % ˜ C < 5 %: Xi; R36/37/38

C ¯ 10 %: Xi; R36/37/38

Xi; R36/37/38

Xi
R: 36/37/38
S: (2-)26-28

C ¯ 10 %: Xi; R36/37/38

410-160-7

148732-74-5

Xi; R36
R43
R52-53

Xi
R: 36-43-52/53
S: (2-)22-26-36/37-61

607-288-00-2 tetrasodium (c-(3-(1-(3-(e-6-
dichloro-5-cyanopyrimidin-f-
yl(methyl)amino)propyl)-1,6-
dihydro-2-hydroxy-4-methyl-6-
oxo-3-pyridylazo)-4-
sulfonatophenylsulfamoyl)
phthalocyanine-a,b,d-
trisulfonato(6-))nickelato II, where a
is 1 or 2 or 3 or 4, b is 8 or 9 or
10 or 11, c is 15 or 16 or 17 or
18, d is 22 or 23 or 24 or 25 and
where e and f together are 2 and 4
or 4 and 2 respectively

607-300-00-6 trisodium [2-(5-chloro-2,6-

411-430-7

(cid:151)

difluoropyrimidin-4-ylamino)-
5-(b-sulfamoyl-c,d-
sulfonatophthalocyanin-a-yl-
K4,N29,N30,N31,N32-
sulfonylamino)benzoato(5-)]
cuprate(II) where
1,2,3,4
b = 8,9,10,11 c = 15,16,17,18
d = 22,23,24,25

=

a

Xi; R41
R43

Xi
R: 41-43
S: (2-)26-36/37/39

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
2
9

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

608-001-00-3 acetonitrile

cyanomethane

200-835-2

75-05-8

F; R11
Xn; R20/21/22
Xi; R36

F; Xn
R: 11-20/21/22-36
S: (1/2-)16-36/37

608-007-00-6 ioxynil (ISO)

216-881-1

1689-83-4

4-hydroxy-3,5-diiodobenzonitrile

608-014-00-4 chlorothalonil (ISO)

217-588-1

1897-45-6

tetrachloroisophthalonitrile

Repr. Cat. 3; R63
T; R25
Xn; R21
N; R50-53

Carc. Cat. 3; R40
N; R50-53

608-015-00-X dichlobenil (ISO)

2,6-dichlorobenzonitrile

214-787-5

1194-65-6

Xn; R21
N; R51-53

T; N
R: 21-25-50/53-63
S: (1/2-)36/37-45-60-61

Xn; N
R: 40-50/53
S: (2-)36/37-60-61

Xn; N
R: 21-51/53
S: (2-)36/37-61

608-017-00-0 bromoxynil octanoate (ISO)
2,6-dibromo-4-cyanophenyl
octanoate

216-885-3

1689-99-2

608-018-00-6 ioxynil octanoate (ISO)

223-375-4

3861-47-0

4-cyano-2,6-diiodophenyl octanoate

609-016-00-8 dinitrophenol [1]

2,4(or 2,6)-dinitrophenol [2]

247-096-2 [1]
275-732-9 [2]

25550-58-7 [1]
71629-74-8 [2]

609-021-00-5 sodium salt of DNOC [1]

sodium 4,6-dinitro-o-cresolate [1]
potassium salt of DNOC [2]
potassium
[2]

4,6-dinitro-o-cresolate

219-007-7 [1]
- [2]

2312-76-7 [1]
5787-96-2 [2]

609-022-00-0 ammonium salt of DNOC

221-037-0

2980-64-5

ammonium 4,6-dinitro-o-tolyl oxide

609-024-00-1 binapacryl (ISO)

E

207-612-9

485-31-4

2-sec-butyl-4,6-dinitrophenyl-
3-methylcrotonate

Repr. Cat. 3; R63
Xn; R21/22
N; R50-53

Xn; N
R: 21/22-50/53-63
S: (2-)36/37-60-61

Repr. Cat. 3; R63
Xn; R22
N; R50-53

Xn; N
R: 22-50/53-63
S: (2-)36/37-60-61

T; R23/24/25
R33
N; R50-53

T; R23/24/25
R33
N; R50-53

T; N
R: 23/24/25-33-50/53
S: (1/2-)28-37-45-60-61

T; N
R: 23/24/25-33-50/53
S: (1/2-)13-45-60-61

T+; R26/27/28
R33
N; R50-53

T+; N
R: 26/27/28-33-50/53
S: (1/2-)13-28-45-60-61

Repr. Cat. 2; R61
Xn; R21/22
N; R50-53

T; N
R: 61-21/22-50/53
S: 53-45-60-61

L

2
2
5
/
3
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

.

.

2
1
8
2
0
0
1

609-026-00-2 salts and esters of dinoseb, with the
specified

of

exception
those
elsewhere in this Annex

(cid:151)

A
E

(cid:151)

609-027-00-8 dinocton
mixture
isomers: methyl
2-octyl-4,6-dinitrophenyl carbonate,
4-octyl-2,6-dinitrophenyl
methyl
carbonate

of

(cid:151)

63919-26-6

609-028-00-3 dinex

205-042-5

131-89-5

2-cyclohexyl-4,6-dinitrophenol

609-029-00-9 salts and esters of dinex

A (cid:151)

(cid:151)

609-032-00-5 bromofenoxim (ISO)

236-129-6

13181-17-4

3,5-dibromo-4-
hydroxybenzaldehyde-O-
(2,4-dinitrophenyl)-oxime

609-033-00-0 dinosam

(cid:151)

4097-36-3

2-(1-methylbutyl)-4,6-dinitrophenol

609-034-00-6 salts and esters of dinosam

A (cid:151)

(cid:151)

609-042-00-X pendimethalin (ISO)

254-938-2

40487-42-1

N-(1-ethylpropyl)-2,6-
dinitro-3,4-xylidine

609-045-00-6 mixture of: 4,6-dinitro-2-(3-octyl)
phenyl methyl
and
4,6-dinitro-2-(4-octyl)phenyl methyl
carbonate
dinocton-6

carbonate

(cid:151)

8069-76-9

R44
Repr. Cat. 2; R61
Repr. Cat. 3; R62
T; R24/25
Xi; R36
N; R50-53

Xn; R22
N; R50-53

T; R23/24/25
N; R50-53

T; R23/24/25
N; R50-53

Xn; R22
N; R50-53

T; R23/24/25
N; R50-53

T; R23/24/25
N; R50-53

R43
N; R50-53

Xn; R22
N; R50-53

T; N
R: 61-62-24/25-36-44-50/53
S: 53-45-60-61

Xn; N
R: 22-50/53
S: (2-)60-61

T; N
R: 23/24/25-50/53
S: (1/2-)13-45-60-61

T; N
R: 23/24/25-50/53
S: (1/2-)13-45-60-61

Xn; N
R: 22-50/53
S: (2-)25-60-61

T; N
R: 23/24/25-50/53
S: (1/2-)13-45-60-61

T; N
R: 23/24/25-50/53
S: (1/2-)13-45-60-61

Xi; N
R: 43-50/53
S: (2-)24-29-37-60-61

Xn; N
R: 22-50/53
S: (2-)60-61

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
3
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

609-046-00-1 trifluralin (ISO)

216-428-8

1582-09-8

(containing < 0,5 ppm NPDA)
a,a,a-trifluoro-2,6-dinitro-N,N-
dipropyl-p-toluidine
(containing < 0,5 ppm NPDA)
2,6-dinitro-N,N-dipropyl-
4-trifluoromethylaniline
(containing < 0,5 ppm NPDA)
N,N-dipropyl-2,6-dinitro-
4-trifluoromethylaniline
(containing < 0,5 ppm NPDA)

609-053-00-X hydrazine trinitromethane

E

414-850-9

(cid:151)

611-003-00-7 fenaminosulf (ISO)

205-419-4

140-56-7

sodium 4-dimethylaminobenzene-
diazosulphonate

612-023-00-9 phenylhydrazine [1]

E

phenylhydrazinium chloride [2]
phenylhydrazine hydrochloride [3]
phenylhydrazinium sulphate (2:1)
[4]

202-873-5 [1]
200-444-7 [2]
248-259-0 [3]
257-622-2 [4]

100-63-0 [1]
59-88-1 [2]
27140-08-5 [3]
52033-74-6 [4]

Xi; R36
R43
N; R50-53

Xi; N
R: 36-43-50/53
S: (2-)24-37-60-61

E; R3
O; R8
Carc. Cat. 2; R45
T; R23/25
R43

E; T
R: 45-3-8-23/25-43
S: 53-45

T; R25
Xn; R21
R52-53

T
R: 21-25-52/53
S: (1/2-)36/37-45-61

T; N
R: 45-23/24/25-36/38-43-
48/23/24/25-50
S: 53-45-61

Carc. Cat. 2; R45
Muta. Cat. 3; R68
T; R23/24/25-
48/23/24/25
Xi; R36/38
R43
N; R50

612-024-00-4 m-toluidine

3-aminotoluene

203-583-1

108-44-1

T; R23/24/25
R33
N; R50

T; N
R: 23/24/25-33-50
S: (1/2-)28-36/37-45-61

L

2
2
5
/
3
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

612-027-00-0 xylidines with the

exception of
those specified elsewhere in this
Annex
dimethyl
those
exception
elsewhere in this Annex

the
specified

anilines
of

with

C

(cid:151)

(cid:151)

T; R23/24/25
R33
N; R51-53

T; N
R: 23/24/25-33-51/53
S: (1/2-)28-36/37-45-61

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

612-077-00-3 dimethylnitrosoamine

E

200-549-8

62-75-9

N-nitrosodimethylamine

612-083-00-6 1-methyl-3-nitro-1-nitrosoguanidine

E

200-730-1

70-25-7

Carc. Cat. 2; R45
T+; R26
T; R25-48/25
N; R51-53

T+; N
R: 45-25-26-48/25-51/53
S: 53-45-61

C ¯ 25 %: T+; R45-25-26-48/25
10 % ˜ C < 25 %: T+; R45-22-26-48/25
7 % ˜ C < 10 %: T+; R45-22-26-48/22
3 % ˜ C < 7 %: T; R45-22-23-48/22
1 % < C < 3 %: T; R45-23-48/22
0,1 % ˜ C < 1 %: T; R45-20
0,001 % ˜ C < 0,1 %: T; R45

Carc. Cat. 2; R45
Xn; R20
Xi; R36/38
N; R51-53

T; N
R: 45-20-36/38-51/53
S: 53-45-61

C ¯ 25 %: T+; R45-20-36/38
20 % < C < 25 %: T+; R45-36/38
0,01 % ˜ C < 20 %: T; R45

612-088-00-3 simazine (ISO)

204-535-2

122-34-9

6-chloro-N,N¡-diethyl-1,3,5-
triazine-2,4-diamine

Carc. Cat. 3; R40
N; R50-53

Xn; N
R: 40-50/53
S: (2-)36/37-46-60-61

612-098-00-8 nitrosodipropylamine

E

210-698-0

621-64-7

Carc. Cat. 2; R45
Xn; R22
N; R51-53

T; N
R: 45-22-51/53
S: 53-45-61

C > 25 %: T+; R45-22
0,001 % < C < 25 %: T; R45

613-025-00-2 cinerin I

246-948-0

25402-06-6

3-(but-2-enyl)-2-methyl-4-
oxocyclopent-2-enyl
2,2-dimethyl-3-(2-methylprop-1-
enyl)cyclopropanecarboxylate

613-026-00-8 cinerin II

204-454-2

121-20-0

3-(but-2-enyl)-2-methyl-
4-oxocyclopent-2-enyl
2,2-dimethyl-3-(3-methoxy-
2-methyl-3-oxoprop-1-enyl)
cyclopropanecarboxylate

Xn; R22
N; R50-53

Xn; N
R: 22-50/53
S: (2-)60-61

Xn; R22
N; R50-53

Xn; N
R: 22-50/53
S: (2-)60-61

613-033-00-6 2-methylaziridine

propyleneimine

E

200-878-7

75-55-8

F; R11
Carc. Cat. 2; R45
T+; R26/27/28
Xi; R41
N; R51-53

F; T+; N
R: 45-11-26/27/28-41-51/53
S: 53-45-61

C ¯ 10 %: T+; R45-26/27/28-41
7 % ˜ C < 10 %: T+; R45-26/27/28-36
5 % ˜ C < 7 %: T; R45-23/24/25-36
1 % ˜ C < 5 %: T; R45-23/24/25
0,1 % ˜ C < 1 %: T; R45-20/21/22
0,01 % ˜ C < 0,1 %: T; R45

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
3
3

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

613-042-00-5 imazalil (ISO)

252-615-0

35554-44-0

1-[2-(allyloxy)-2-(2,4-
dichlorophenyl)ethyl]-1H-imidazole

Xn; R20/22
Xi; R41
N; R50-53

Xn; N
R: 20/22-41-50/53
S: (2-)26-39-60-61

613-044-00-6 captan (ISO)

205-087-0

133-06-2

1,2,3,6-tetrahydro-N-
(trichloromethylthio)phthalimide

613-045-00-1 folpet (ISO)

205-088-6

133-07-3

N-(trichloromethylthio)phthalimide

613-068-00-7 atrazine (ISO)

217-617-8

1912-24-9

2-chloro-4-ethylamine-6-
isopropylamine-1,3,5-triazine

613-070-00-8 propylenethiourea

(cid:151)

2122-19-2

Carc. Cat. 3; R40
T; R23
Xi; R41
R43
N; R50

Carc. Cat. 3; R40
Xn; R20
Xi; R36
R43
N; R50

T; N
R: 23-40-41-43-50
S: (1/2-)26-29-36/37/39-45-61

Xn; N
R: 20-36-40-43-50
S: (2-)36/37-46-61

Xn; R48/22
R43
N; R50-53

Xn; N
R: 43-48/22-50/53
S: (2-)36/37-60-61

Repr. Cat. 3; R63
Xn; R22
R52-53

Xn
R: 22-52/53-63
S: (2-)36/37-46-61

613-090-00-7 paraquat dichloride [1]

1,1-dimethyl-4,4¡-bipyridinium
dichloride [1]
paraquat dimethylsulfate [2]
1,1-dimethyl-4,4¡-bipyridinium
dimethyl sulphate [2]

217-615-7 [1]
218-196-3 [2]

1910-42-5 [1]
2074-50-2 [2]

T+; R26
T; R24/25-48/25
Xi; R36/37/38
N; R50-53

T+; N
R: 24/25-26-36/37/38-48/25-
50/53
S: (1/2-)22-28-36/37/39-45-
60-61

613-116-00-7 tolylfluanid (ISO)

211-986-9

731-27-1

dichloro-N-[(dimethylamino)
sulphonyl]fluoro-N-(p-tolyl)
methanesulphenamide

T; R23
Xn; R48/20
Xi; R36/37/38
R43
N; R50-53

T; N
R:
23-36/37/38-43-48/20-50/53
S: (1/2-)24-26-37-38-45-60-61

L

2
2
5
/
3
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

EC No

CAS No

Classification

Labelling

Concentration limits

202-966-0 [1]
219-799-4 [2]
227-534-9 [3]
247-714-0 [4]

101-68-8 [1]
2536-05-2 [2]
5873-54-1 [3]
26447-40-5 [4]

Xn; R20
Xi; R36/37/38
R42/43

Xn
R: 20-36/37/38-42/43
S: (1/2-)23-36/37-45

C ¯ 25 %: Xn; R20-36/37/38-42/43
5 % ˜ C < 25 %: Xn; R36/37/38-42/43
1 % ˜ C < 5 %: Xn; R42/43
0,1 % ˜ C < 1 %: Xn; R42

Notes
related to
prepara-
tions

2

Index No

Chemical name

Notes
related to
substances

615-005-00-9 4,4¡-methylenediphenyl

C

diisocyanate [1]
diphenylmethane-4,4¡-
diisocyanate [1]
2,2¡-methylenediphenyl
diisocyanate [2]
diphenylmethane-2,2¡-
diisocyanate [2]
o-(p-isocyanatobenzyl)phenyl
isocyanate [3]
diphenylmethane-2,4¡-
diisocyanate [3]
methylenediphenyl diisocyanate [4]

616-003-00-0 acrylamide

prop-2-enamide

201-173-7

79-06-1

D
E

T
R: 45-46-20/21-25-36/38-
43-48/23/24/25-62
S: 53-45

Carc. Cat. 2; R45
Muta. Cat. 2; R46
Repr. Cat. 3; R62
T; R25-48/23/24/25
Xn; R20/21
Xi; R36/38
R43

616-004-00-6 allidochlor (ISO)

202-270-7

93-71-0

N,N-diallylchloroacetamide

616-007-00-2 diphenamid (ISO)
N,N-dimethyl-2,2-
diphenylacetamide

213-482-4

957-51-7

616-008-00-8 propachlor (ISO)

217-638-2

1918-16-7

2-chloro-N-isopropylacetanilide
a-chloro-N-isopropylacetanilide

616-009-00-3 propanil (ISO)

211-914-6

709-98-8

3¡,4¡-dichloropropionanilide

Xn; R21/22
Xi; R36/38
N; R51-53

Xn; R22
R52-53

Xn; R22
Xi; R36
R43
N; R50-53

Xn; R22
N; R50

616-011-00-4 N,N-dimethylacetamide

E

204-826-4

127-19-5

Repr. Cat. 2; R61
Xn; R20/21

Xn; N
R: 21/22-36/38-51/53
S: (2-)26-28-36/37/39-61

Xn
R: 22-52/53
S: (2-)61

Xn; N
R: 22-36-43-50/53
S: (2-)24-37-60-61

Xn; N
R: 22-50
S: (2-)22-61

T
R: 61-20/21
S: 53-45

C ¯ 25 %: T; R61-20/21
5 % ˜ C < 25 %: T; R61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
3
5

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
prepara-
tions

616-014-00-0 2-butanone oxime

202-496-6

96-29-7

ethyl methyl ketoxime
ethyl methyl ketone oxime

616-015-00-6 alachlor (ISO)

240-110-8

15972-60-8

2-chloro-2¡,6¡-diethyl-N-
(methoxymethyl)acetanilide

616-017-00-7 cartap hydrochloride

239-309-2

15263-52-2

616-018-00-2 N,N-diethyl-m-toluamide

205-149-7

134-62-3

deet

616-020-00-3 tebuthiuron (ISO)

251-793-7

34014-18-1

1-(5-tert-butyl-1,3,4-thiadiazol-
2-yl)-1,3-dimethylurea

616-021-00-9 thiazfluron (ISO)

246-901-4

25366-23-8

1,3-dimethyl-1-(5-trifluoromethyl-
1,3,4-thiadiazol-2-yl)urea

616-025-00-0 valinamide

402-840-7

20108-78-5

650-013-00-6 asbestos

E

(cid:151)
(cid:151)
(cid:151)
(cid:151)
(cid:151)
(cid:151)
(cid:151)

12001-28-4
132207-32-0
12172-73-5
77536-66-4
77536-68-6
77536-67-5
12001-29-5

Carc. Cat. 3; R40
Xn; R21
Xi; R41
R43

Carc. Cat. 3; R40
Xn; R22
R43
N; R50-53

Xn; R21/22
N; R50-53

Xn; R22
Xi; R36/38
R52-53

Xn; R22
N; R50-53

Xn; R22
N; R50-53

Xn
R: 21-40-41-43
S: (2-)13-23-26-36/37/39

Xn; N
R: 22-40-43-50/53
S: (2-)36/37/39-60-61

Xn; N
R: 21/22-50/53
S: (2-)36/37-60-61

Xn
R: 22-36/38-52/53
S: (2-)61

Xn; N
R: 22-50/53
S: (2-)37-60-61

Xn; N
R: 22-50/53
S: (2-)60-61

Repr. Cat. 3; R62
Xi; R36
R43

Xn
R: 36-43-62
S: (2-)26-36/37

Carc. Cat. 1; R45
T; R48/23

T
R: 45-48/23
S: 53-45

L

2
2
5
/
3
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

ANNEX 1C

004-003-00-8 beryllium oxide

E

215-133-1

1304-56-9

007-025-00-6 (4-hydrazinophenyl)-N-

406-090-1

81880-96-8

methylmethanesulfonamide
hydrochloride

Carc. Cat. 2; R49
T+; R26
T; R25-48/23
Xi; R36/37/38
R43

Muta. Cat. 3; R68
T; R25-48/25
R43
N; R50-53

T+
R: 49-25-26-36/37/38-43-
48/23
S: 53-45

T; N
R: 25-43-48/25-68-50/53
S: (1/2-)22-36/37/39-45-60-61

007-026-00-1 oxo-((2,2,6,6-tetramethylpiperidin-
4-yl)amino)carbonylacetohydrazide

413-230-5

122035-71-6

Xi; R41
R43

007-027-00-7 1,6-bis(3,3-bis((1-methylpentylidenimino)

420-190-2

(cid:151)

propyl)ureido)hexane

013-008-00-4 di-n-octylaluminium iodide

408-190-0

7585-14-0

Xn; R21/22
C; R34
R43
N; R50-53

R14
F; R17
C; R34
N; R50-53

Xi
R: 41-43
S: (2-)8-22-24-26-30-37/39

C; N
R: 21/22-34-43-50/53
S: (1/2-)7-26-36/37/39-45-
60-61

F; C; N
R: 14-17-34-50/53
S: (1/2-)6-16-26-36/37/39-
43-45-60-61

014-017-00-6 flusilazole (ISO)

E

(cid:151)

85509-19-9

bis(4-fluorophenyl)(methyl)(1H-1,2,4-
triazol-1-ylmethyl)silane

014-018-00-1 octamethylcyclotetrasiloxane

209-136-7

556-67-2

014-019-00-7 a mixture of: 4-[[bis-(4-

E

403-250-2

(cid:151)

fluorophenyl)methylsilyl]methyl]-
4H-1,2,4-triazole; 1-[[bis-(4-
fluorophenyl)methylsilyl]methyl]-
1H-1,2,4-triazole

Carc. Cat. 3; R40
Repr. Cat. 2; R61
Xn; R22
N; R51-53

T; N
R: 61-22-40-51/53
S: 53-45-61

Repr. Cat. 3; R62
R53

Xn
R: 53-62
S: (2-)36/37-46-51-61

Carc. Cat. 3; R40
Repr. Cat. 2; R61
Xn; R22
N; R51-53

T; N
R: 61-22-40-51/53
S: 53-45-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
3
7

Index No

Chemical name

014-020-00-2 bis(1,1-dimethyl-2-

propynyloxy)dimethylsilane

Notes
related to
substances

414-960-7

53863-99-3

Xn; R20

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

Xn
R: 20
S: (2)

N
R: 50/53
S: 60-61

014-021-00-8 tris(isopropenyloxy)phenyl silane

411-340-8

52301-18-5

N; R50-53

014-022-00-3 reaction product of: (2-hydroxy-4-(3-

401-530-9

(cid:151)

propenoxy)benzophenone and
triethoxysilane) with (hydrolysis product
of silica and methyltrimethoxysilane)

F; R11
T; R39/23/24/25
Xn; R20/21/22

F; T
R: 11-20/21/22-39/23/24/25
S: (1/2-)16-29-36/37-45

014-023-00-9 a,x-dihydroxypoly(hex-5-en-

408-160-7

125613-45-8

N; R51-53

1-ylmethylsiloxane)

014-024-00-4 1-((3-(3-chloro-4-

412-620-2

121626-74-2

N; R51-53

fluorophenyl)propyl)dimethylsilanyl)-
4-ethoxybenzene

N
R: 51/53
S: 61

N
R: 51/53
S: 61

014-025-00-X 4-[3-(diethoxymethylsilylpropoxy)-

411-400-3

102089-33-8

2,2,6,6-tetramethyl]piperidine

015-168-00-0 fosthiazate (ISO)

(cid:151)

98886-44-3

(RS)-S-sec-butyl-O-ethyl-2-oxo-1,3-
thiazolidin-3-ylphosphonothioate

015-169-00-6 tributyltetradecylphosphonium tetrafluor-

413-520-1

(cid:151)

oborate

015-170-00-1 a mixture of: di-(1-octane-N,N,N-

407-490-9

(cid:151)

trimethylammonium) octylphosphate;
1-octane-N,N,N-trimethylammonium
di-octylphosphate; 1-octane-N,N,N-
trimethylammonium octylphosphate

Xn; R22-48/21
Xi; R38-41
R52-53

Xn
R: 22-38-41-48/21-52/53
S: (2-)26-36/37/39-61

T; R23/25-39
Xn; R21
Xi; R41
R43
N; R50-53

T; N
R: 21-23/25-39-41-43-50/53
S: (1/2-)53-45-25-26-39-60-61

Xn; R22-48/22
C; R34
R43
N; R50-53

C; N
R: 22-34-43-48/22-50/53
S: (1/2-)26-28-36/37/39-45-
60-61

Xn; R21/22
C; R34

C
R: 21/22-34
S: (1/2-)26-36/37/39-45

015-171-00-7 O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl)

phosphorothioate

406-940-1

(cid:151)

N; R51-53

N
R: 51/53
S: 61

L

2
2
5
/
3
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

015-172-00-2 a mixture of: bis(isotridecylammonium)

406-240-6

(cid:151)

mono(di-(4-methylpent-2-
yloxy)thiophosphorothionylisopro-
pyl)phosphate; isotridecylammonium
bis(di-(4-methylpent-2-
yloxy)thiophosphorothionylisopropyl)
phosphate

015-173-00-8 methyl [2-(1,1-dimethylethyl)-6-

414-080-3

117291-73-3

methoxypyrimidin-4-
yl]ethylphosphonothioate

015-174-00-3 1-chloro-N,N-diethyl-1,1-diphenyl-

411-370-1

82857-68-9

1-(phenylmethyl)phosphoramine

015-175-00-9 tert-butyl (triphenylphosphoranylidene)

412-880-7

35000-38-5

acetate

R10
C; R34
N; R51-53

C; N
R: 10-34-51/53
S: (1/2-)23-26-28-36/37/39-
45-61

Xn; R22
N; R50-53

T; R25
Xi; R41
N; R51-53

T; R25
Xn; R48/22
Xi; R36
R43
N; R51-53

Xn; N
R: 22-50/53
S: (2-)23-36-60-61

T; N
R: 25-41-51/53
S: (1/2-)26-37/39-41-45-61

T; N
R: 25-36-43-48/22-51/53
S: (1/2-)26-36/37/39-45-61

N
R: 50/53
S: 60-61

015-176-00-4 P,P,P¡,P¡-tetrakis-

413-430-2

116163-96-3

N; R50-53

(o-methoxyphenyl)propane-1,3-
diphosphine

015-177-00-X ((4-phenylbutyl)hydroxyphosphoryl)acetic

412-170-7

83623-61-4

acid

015-178-00-5 (R)-a-phenylethylammonium (-)-

418-570-8

25383-07-7

(1R, 2S)-(1,2-
epoxypropyl)phosphonate monohydrate

015-179-00-0 UVCB condensation product of:

422-720-8

166242-53-1

tetrakis-hydroxymethylphosphonium
chloride, urea and distilled hydrogenated
C16-18 tallow alkylamine

016-063-00-2 sodium metabisulphite

231-673-0

7681-57-4

Xn; R48/22
Xi; R41
R43

Xn
R: 41-43-48/22
S: (2-)22-26-36/37/39

Repr. Cat. 3; R62
N; R51-53

Xn; N
R: 62-51/53
S: (2-)22-36/37-61

Muta. Cat. 3; R68
Xn; R22-48/22
C; R34
R43
N; R50-53

C; N
R: 22-34-43-48/22-68-50/53
S: (1/2-)26-36/37/39-45-60-61

Xn; R22
Xi; R41
R31

Xn
R: 22-31-41
S: (2-)26-39-46

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
3
9

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

016-072-00-1 3-amino-4-hydroxy-N-(2-methoxyethyl)-

411-520-6

112195-27-4

benzenesulfonamide

Xi; R41
R43
N; R51-53

Xi; N
R: 41-43-51/53
S: (2-)24-26-37/39-61

016-073-00-7 tetrakis(phenylmethyl)thioperoxydi
(carbothioamide)

404-310-0

10591-85-2

R53

016-074-00-2 6-fluoro-2-methyl-3-(4-
methylthiobenzyl)indene

405-410-7

(cid:151)

016-075-00-8 2,2¡-diallyl-4,4¡-sulfonyldiphenol

411-570-9

41481-66-7

Xi; R38-41
R43
N; R51-53

R43
N; R51-53

R: 53
S: 61

Xi; N
R: 38-41-43-51/53
S: (2-)26-36/37/39-61

Xi; N
R: 43-51/53
S: (2-)24-37-61

016-076-00-3 2,3-bis((2-mercaptoethyl)thio)-1-

411-290-7

131538-00-6

propanethiol

016-077-00-9 2-chloro-p-toluenesulfochloride

412-890-1

42413-03-6

Xn; R22-48/22
N; R50-53

Xn; N
R: 22-48/22-50/53
S: (2-)23-24/25-36-60-61

C; R34
R43
R52-53

C
R: 34-43-52/53
S: (1/2-)23-26-36/37/39-45-61

016-078-00-4 4-methyl-N,N-bis(2-(((4-

413-300-5

56187-04-3

R53

methylphenyl)sulfonyl)amino)ethyl)
benzenesulfonamide

016-079-00-X N,N-bis(2-(p-toluenesulfonyloxy)ethyl)-
p-toluenesulfonamide

412-920-3

16695-22-0

016-080-00-5 sodium 2-anilino-5-(2-nitro-4-(N-

412-320-1

31361-99-6

phenylsulfamoyl))anilinobenzenesulfonate

R43
R53

Xi; R41
R52-53

R: 53
S: 61

Xi
R: 43-53
S: (2-)24-37-61

Xi
R: 41-52/53
S: (2-)26-39-61

016-081-00-0 hexahydrocyclopenta[c]pyrrole-1-

418-350-1

(cid:151)

(1H)-ammonium N-ethoxycarbonyl-
N-(p-tolylsulfonyl)azanide

Muta. Cat. 3; R68
Xn; R22
Xi; R36
R43
N; R51-53

Xn; N
R: 22-36-43-68-51/53
S: (2-)26-36/37-61

016-082-00-6 ethoxysulfuron

(cid:151)

126801-58-9

N; R50-53

1-(4,6-dimethoxypyrimidin-2-yl)-
3-(2-ethoxyphenoxysulfonyl)urea

N
R: 50/53
S: 60-61

L

2
2
5
/
4
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

016-083-00-1 acibenzolar-S-methyl

420-050-0

135158-54-2

Xi; R36/37/38
R43
N; R50-53

Xi; N
R: 36/37/38-43-50/53
S: (2-)24/25-37-46-59-60-61

benzo[1,2,3]thiadiazole-7-carbothioic
acid S-methyl ester

016-084-00-7 prosulfuron

1-(4-methoxy-6-methyl-1,3,5-
triazin-2-yl)-3-[2-(3,3,3-
trifluoropropyl)phenylsulfonyl]urea

016-085-00-2 flazasulfuron

1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-
trifluoromethyl-2-pyridylsulfonyl)urea

(cid:151)

(cid:151)

94125-34-5

Xn; R22
N; R50-53

104040-78-0

N; R50-53

022-003-00-6 bis (g5-cyclopentadienyl)-bis(2,6-difluoro-

412-000-1

125051-32-3

3-[pyrrol-1-yl]-phenyl)titanium

024-018-00-3 sodium chromate

E

231-889-5

7775-11-3

F; R11
Repr. Cat. 3; R62
Xn; R48/22
N; R51-53

Carc. Cat. 2; R49
Muta. Cat. 2; R46
T+; R26
T; R25
Xn; R21
Xi; R37/38-41
R43
N; R50-53

Xn; N
R: 22-50/53
S: (2-)60-61

N
R: 50/53
S: 60-61

F; Xn; N
R: 11-48/22-62-51/53
S: (2-)7-22-33-36/37-61

T+; N
R: 49-46-21-25-26-37/38-41-
43-50/53
S: 53-45-60-61

C >¯ 7 %: T+;
R49-46-21-25-26-37/38-41-43
0,5 % ˜ C < 7 %: T; R49-46-43
0,1 % ˜ C < 0,5 %: T; R49-46

3

025-004-00-X bis(N,N¡,N¢-trimethyl-1,4,7-

411-760-1

116633-53-5

N; R51-53

triazacyclononane)-trioxo-dimanganese
(IV) di(hexafluorophosphate)
monohydrate

026-001-00-6 (g-cumene)-(g-cyclopentadienyl)iron(II)
hexafluoroantimonate

407-840-0

100011-37-8

026-002-00-1 (g-cumene)-(g-cyclopentadienyl)iron(II)

407-880-9

117549-13-0

trifluoromethane-sulfonate

Xn; R22
Xi; R41
R52-53

Xn; R22
R52-53

029-009-00-7 phthalocyanine-N-[3-(diethylamino)pro-

413-650-9

93971-95-0

R52-53

pyl]sulfonamide copper complex

N
R: 51/53
S: 61

Xn
R: 22-41-52/53
S: (2-)22-26-39-61

Xn
R: 22-52/53
S: (2-)26-61

R: 52/53
S: 61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
4
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

029-010-00-3 A mixture of compounds from

407-700-9

101408-30-4

R43

(dodecakis(p-tolylthio)phthalocyani-
nato)copper(II) to
(hexadecakis(p-tolylthio)phthalocyani-
nato)copper(II)

029-011-00-9 sodium [29H,31H-phthalocyaninato-(2-)-

412-730-0

150522-10-4

C; R34

N29,N30,N31,N32]-((3-(N-methyl-
N-(2-hydroxyethyl)amino)
propyl)amino)sulfonyl-sulfonato, copper
complex

033-007-00-2 tert-butylarsine

423-320-6

4262-43-5

035-004-00-1 2-hydroxyethylammonium perbromide

407-440-6

(cid:151)

042-004-00-5 Reaction product of ammonium

412-780-3

(cid:151)

molybdate and C12-C24-diethoxylated
alkylamine (1:5-1:3)

050-020-00-9 trioctylstannane

413-320-4

869-59-0

072-001-00-4 hafnium tetra-n-butoxide

411-740-2

22411-22-9

074-001-00-X hexasodium dihydrogen-dodecawolfra-

412-770-9

12141-67-2

mate

074-002-00-5 reaction products of tungsten

408-250-6

(cid:151)

hexachloride with 2-methylpropan-2-ol,
nonylphenol and pentane-2,4-dione

F; R17
T+; R26

O; R8
Xn; R22
C; R35
R43
N; R50

Xi; R38
R43
N; R51-53

T; R48/25
Xi; R38
R53

Xi; R41
R43

Xn; R22
Xi; R41
R52-53

F; R11
Xn; R20
C; R34
R43
N; R50-53

Xi
R: 43
S: (2-)24-37

C
R: 34
S: (1/2-)22-26-36/37/39-45

F; T+
R: 17-26
S: (1/2-)9-28-36/37-43-45

O; C; N
R: 8-22-35-43-50
S: (1/2-)3/7-14-26-36/37/39-
45-60-61

Xi; N
R: 38-43-51/53
S: 24/25-37-61

T
R: 38-48/25-53
S: (1/2-)23-36/37-45-61

Xi
R: 41-43
S: (2-)24/25-26-37/39

Xn
R: 22-41-52/53
S: (2-)22-26-39-61

F; C; N
R: 11-20-34-43-50/53
S: (1/2-)16-26-29-33-36/37/
39-45-60-61

L

2
2
5
/
4
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

601-052-00-2 naphthalene

202-049-5

91-20-3

601-053-00-8 nonylphenol [1]

4-nonylphenol, branched [2]

246-672-0 [1]
284-325-5 [2]

25154-52-3 [1]
84852-15-3 [2]

Xn; R22
N; R50-53

Xn; R22
C; R34
N; R50-53

Xn; N
R: 22-50/53
S: (2-)36/37-60-61

C; N
R: 22-34-50/53
S: (1/2-)26-36/37/39-45-60-61

601-054-00-3 a mixture of isomers of:

405-570-8

(cid:151)

N; R50-53

dibenzylbenzene; dibenzyl(methyl)ben-
zene; dibenzyl(dimethyl)benzene;
dibenzyl(trimethyl)benzene

601-055-00-9 a mixture of isomers of:

410-190-0

132983-41-6

mono-(2-tetradecyl)naphthalenes;
di-(2-tetradecyl)naphthalenes;
tri-(2-tetradecyl)naphthalenes

Xi; R36
R53

N
R: 50/53
S: 60-61

Xi
R: 36-53
S: (2-)26-61

602-085-00-5 2-bromopropane

E

200-855-1

75-26-3

F; R11
Repr. Cat. 1; R60
Xn; R48/20
R66

F; T
R: 60-11-48/20-66
S: 16-53-45

602-086-00-0 trifluoroiodomethane
trifluoromethyl iodide

219-014-5

2314-97-8

Muta. Cat. 3; R68

Xn
R: 68
S: (2-)36/37

602-087-00-6 1,2,4-trichlorobenzene

204-428-0

120-82-1

602-088-00-1 2,3-dibromopropan-1-ol
2,3-dibromo-1-propanol

E

202-480-9

96-13-9

602-089-00-7 4-bromo-2-chlorofluorobenzene

405-580-2

60811-21-4

602-090-00-2 1-allyl-3-chloro-4-fluorobenzene

406-630-6

121626-73-1

Xn; R22
Xi; R38
N; R50-53

Xn; N
R: 22-38-50/53
S: (2-)23-37/39-60-61

Carc. Cat. 2; R45
Repr. Cat. 3; R62
T; R24
Xn; R20/22
R52-53

Xn; R22
Xi; R38
N; R50-53

Xi; R38
N; R51-53

T
R: 45-20/22-24-52/53-62
S: 53-45-61

Xn; N
R: 22-38-50/53
S: (2-)26-36/37-60-61

Xi; N
R: 38-51/53
S: (2-)23-37-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
4
3

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

602-091-00-8 1,3-dichloro-4-fluorobenzene

406-160-1

1435-48-9

602-092-00-3 1-bromo-3,4,5-trifluorobenzene

418-480-9

138526-69-9

Xn; R22-48/20/22
Xi; R38
N; R51-53

Xn; N
R: 22-38-48/20/22-51/53
S: (2-)36/37-61

R10
Carc. Cat. 3; R40
Xi; R38-41
N; R51-53

Xn; N
R: 10-38-40-41-51/53
S: (2-)23-26-36/37/39-61

603-104-00-X fenarimol (ISO)

262-095-7

60168-88-9

2,4¡-dichloro-a-(pyrimidin-5-yl)benzhyd-
ryl alcohol

Repr. Cat. 3;
R62-63
R64
N; R51-53

Xn; N
R: 51/53-62-63-64
S: (2-)36/37-61

603-105-00-5 furan

E

203-727-3

110-00-9

603-139-00-0 bis(2-methoxyethyl) ether

203-924-4

111-96-6

F+; T
R: 45-12-19-20/22-38-48/
22-52/53
S: 53-45-61

F+; R12
R19
Carc. Cat. 2; R45
Muta. Cat. 3; R68
Xn; R20/22-48/22
Xi; R38
R52-53

R10
R19
Repr. Cat. 2;
R60-61

T
R: 60-61-10-19
S: 53-45

603-140-00-6 2,2¡ -oxybisethanol

diethylene glycol

203-872-2

111-46-6

Xn; R22

603-141-00-1 a mixture of: dodecyloxy-1-methyl-
1-[oxy-poly-(2-hydroxymethylethan-
oxy)]pentadecane; dodecyloxy-1-methyl-
1-[oxy-poly-(2-hydroxymethylethan-
oxy)]heptadecane

413-780-6

(cid:151)

R52-53

Xn
R: 22
S: (2-)46

R: 52/53
S: 61

603-142-00-7 2-(2-(2-hydroxyethoxy)

407-360-1

116230-20-7

ethyl)-2-aza-bicyclo[2.2.1]heptane

Xn; R21/22-48/20
Xi; R38-41

Xn
R: 21/22-38-41-48/20
S: (2-)26-36/37/39

L

2
2
5
/
4
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

603-143-00-2 R-2,3-epoxy-1-propanol

E

404-660-4

57044-25-4

E; T
R: 45-60-2-21/22-23-34
S: 53-45

E; R2
Carc. Cat. 2; R45
Muta. Cat. 3; R68
Repr. Cat. 2; R60
T; R23
Xn; R21/22
C; R34

603-144-00-8 a mixture of: 2,6,9-trimethyl-2,5,9-
cyclododecatrien-1-ol; 6,9-dimethyl-
2-methylen-5,9-cyclododecadien-1-ol

413-530-6

111850-00-1

N; R51-53

603-145-00-3 2-isopropyl-2-(1-methylbutyl)-1,3-
dimethoxypropane

406-970-5

129228-11-1

603-146-00-9 2-[(2-[2-(dimethyl-

406-080-7

83016-70-0

amino)ethoxy]ethyl)methylamino]ethanol

603-147-00-4 (-)-trans-4-(4¡-fluorophenyl)-3-hydroxy-

406-030-4

105812-81-5

methyl-N-methylpiperidine

603-148-00-X 1,4-bis[(vinyloxy)methyl]cyclohexane

413-370-7

17351-75-6

603-149-00-5 a mixture of diastereoisomers of
1-(1-hydroxyethyl)-4-(1-methyl-
ethyl)cyclohexane

407-640-3

63767-86-2

603-150-00-0 (+/ﬂ) trans-3,3-dimethyl-5-(2,2,3-

411-580-3

107898-54-4

trimethyl-cyclopent-3-en-1-yl)-pent-4-
en-2-ol

Xi; R38
N; R51-53

Xn; R22
C; R34
R52-53

Xn; R22
Xi; R41
N; R51-53

R43
N; R51-53

Xi; R36/38
N; R51-53

Xi; R38
N; R50-53

603-151-00-6 (+/ﬂ)-2-(2,4-dichlorophenyl)-

413-570-4

-

R52-53

3-(1H-1,2,4-triazol-1-yl)propan-1-ol

N
R: 51/53
S: 61

Xi; N
R: 38-51/53
S: (2-)36/37-61

C
R: 22-34-52/53
S: (1/2-)23-26-36/37/39-45-61

Xn; N
R: 22-41-51/53
S: (2-)22-24-26-37/39-61

Xi; N
R: 43-51/53
S: (2-)24-37-61

Xi; N
R: 36/38-51/53
S: (2-)26-37-61

Xi; N
R: 38-50/53
S: (2-)24/25-37-60-61

R: 52/53
S: 61

603-152-00-1 2-(4-tert-butylphenyl)ethanol

410-020-5

5406-86-0

Repr. Cat. 3; R62
Xn; R48/22
Xi; R41
N; R51-53

Xn; N
R: 41-48/22-62-51/53
S: (2-)26-36/37/39-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
4
5

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

603-153-00-7 3-((2-nitro-4-(trifluoromethyl)

phenyl)amino)propane-1,2-diol

410-010-0

104333-00-8

Xn; R22
R52-53

603-154-00-2 1-[(2-tert-butyl)cyclohexyloxy]-2-butanol

412-300-2

139504-68-0

N; R51-53

603-155-00-8 reaction products of

410-560-1

(cid:151)

N; R50-53

2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-
triazin-2-yl)-5-hydroxyphenol with
((C10-16, rich in C12-13
alkyloxy)methyl)oxyrane

Xn
R: 22-52/53
S: (2-)22-61

N
R: 51/53
S: 61

N
R: 50/53
S: 60-61

603-156-00-3 2-(2,4-dichlorophenyl)-2-(2-

411-210-0

89544-48-9

propenyl)oxirane

Xi; R38
R43
N; R50-53

Xi; N
R: 38-43-50/53
S: (2-)24-37-60-61

603-157-00-9 6,9-bis(hexadecyloxymethyl)-4,7-

411-450-6

143747-72-2

R53

dioxanonane-1,2,9-triol

603-158-00-4 a mixture of 4 diastereoisomers of
2,7-dimethyl-10-(1-methylethyl)-1-
oxaspiro[4.5]deca-3,6-diene

412-460-3

(cid:151)

Xi; R38
N; R51-53

603-159-00-X 2-cyclododecylpropan-1-ol

411-410-8

118562-73-5

N; R50-53

603-160-00-5 1,2-diethoxypropane

412-180-1

10221-57-5

F; R11
R19

603-161-00-0 1,3-diethoxypropane

413-140-6

3459-83-4

R10

R: 53
S: 61

Xi; N
R: 38-51/53
S: (2-)37-61

N
R: 50/53
S: 60-61

F
R: 11-19
S: (2-)9-16-24-33

R: 10
S: (2-)9-24

603-162-00-6 a[2-[[[(2-hydroxyethyl)methylamino]acet-
yl]amino]propyl]-c-(nonyl-
phenoxy)poly[oxo(methyl-1,2-ethane-
diyl)]

413-420-8

144736-29-8

C; R34
R43
N; R51-53

C; N
R: 34-43-51/53
S: (1/2-)26-28-36/37/39-45-61

603-163-00-1 2-phenyl-1,3-propanediol

411-810-2

1570-95-2

Xi; R41

Xi
R: 41
S: (2-)26-39

L

2
2
5
/
4
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

603-164-00-7 2-butyl-4-chloro-4,5-dihydro-5-hydroxy-

412-420-5

133909-99-6

R53

methyl-1-[2¡-(2-triphenylmethyl-
1,2,3,4-2H-tetrazol-5-yl)-1,1¡-biphenyl-
4-methyl]-1H-imidazole

R: 53
S: 61

603-165-00-2 a mixture of: 4-allyl-2,6-bis

417-470-1

(cid:151)

(2,3-epoxypropyl)phenol; 4-allyl-
6-[3-[6-[3-[6-[3-(4-allyl-2,6-bis(2,3-
epoxypropyl)phenoxy)-2-hydroxypro-
pyl]-4-allyl-2-(2,3-epoxypropyl)phen-
oxy]-2-hydroxypropyl]-4-allyl-2-(2,3-
epoxypropyl)phenoxy]-2-hydroxypro-
pyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-
6-[3-(4-allyl-2,6-bis(2,3-epoxypro-
pyl)phenoxy)-2-hydroxypropyl]-2-(2,3-
epoxypropyl)phenol; 4-allyl-
6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypro-
pyl)phenoxy)-2-hydroxypropyl]-4-allyl-
2-(2,3-epoxypropyl)phenoxy]-2-hydroxy-
propyl]-2-(2,3-epoxypropyl)phenol

Muta. Cat. 3; R68
R43

Xn
R: 43-68
S: (2-)36/37

603-166-00-8 (R)-1-chloro-2,3-epoxypropane

424-280-2

51594-55-9

R10
Carc. Cat. 2; R45
T; R23/24/25
C; R34
R43

T
R: 45-10-23/24/25-34-43
S: 53-45

604-012-00-2 4-chloro-o-cresol

4-chloro-2-methylphenol

216-381-3

1570-64-5

T; R23
C; R35
N; R50

T; C; N
R: 23-35-50
S: (1/2-)26-36/37/39-45-61

604-056-00-2 2-(2-hydroxy-3,5-dinitroanilino)ethanol

412-520-9

99610-72-7

F; R11
Repr. Cat. 3; R62
Xn; R22

F; Xn
R: 11-22-62
S: (2-)22-33-36/37

604-057-00-8 a mixture of: isomers of

401-680-5

(cid:151)

N; R51-53

2-(2H-benzotriazol-2-yl)-4-methyl-(n)-
dodecylphenol; isomers of
2-(2H-benzotriazol-2-yl)-4-methyl-(n)-
tetracosylphenol; isomers of
2-(2H-benzotriazol-2-yl)-4-methyl-5,6-
didodecyl-phenol. n = 5 or 6

N
R: 51/53
S: 61

C ¯ 25 %: T; C; R23-35
10 % ˜ C < 25 %: C; R20-35
5 % ˜ C < 10 %: C; R20-34
3 % ˜ C < 5 %: Xn;
R20-36/37/38
1 % ˜ C < 3 %: Xi; R36/37/38

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
4
7

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

604-058-00-3 1,2-bis(3-methylphenoxy)ethane

402-730-9

54914-85-1

N; R50-53

604-059-00-9 2-n-hexadecylhydroquinone

406-400-5

(cid:151)

604-060-00-4 9,9-bis(4-hydroxyphenyl)fluorene

406-950-6

3236-71-3

Xn; R48/22
Xi; R38
R43
R53

Xi; R36-38
N; R50-53

N
R: 50/53
S: 60-61

Xn
R: 38-43-48/22-53
S: (2-)22-36/37-61

Xi; N
R: 36/38-50/53
S: (2-)26-37-60-61

604-061-00-X a mixture of: 2-chloro-5-sec-

407-740-7

(cid:151)

tetradecylhydroquinones where
sec-tetradecyl = 1-methyltridecyl;
1-ethyldodecyl; 1-propylundecyl;
1-butyldecyl; 1-pentylnonyl; 1-hexyloctyl

Xi; R38
R43
R52-53

Xi
R: 38-43-52/53
S: (2-)24-37-61

604-062-00-5 2,4-dimethyl-6-(1-methyl-

pentadecyl)phenol

411-220-5

(cid:151)

604-063-00-0 5,6-dihydroxyindole

412-130-9

3131-52-0

Xi; R38
R43
N; R50-53

Xn; R22
Xi; R41
N; R51-53

Xi; N
R: 38-43-50/53
S: (2-)24-37-60-61

Xn; N
R: 22-41-51/53
S: (2-)22-26-36/37/39-61

604-064-00-6 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-

411-380-6

147315-50-2

R53

5-((hexyl)oxy)-phenol

605-028-00-2 (cid:223)-methyl-3-(1-methylethyl)-

412-050-4

125109-85-5

N; R51-53

benzenepropanal

605-029-00-8 2-cyclohexylpropanal

412-270-0

2109-22-0

R43
N; R51-53

605-030-00-3 1-(p-methoxyphenyl)acetaldehyde oxime

411-510-1

3353-51-3

R43

R: 53
S: 61

N
R: 51/53
S: 61

Xi; N
R: 43-51/53
S: (2-)24-37-61

Xi
R: 43
S: (2-)24-37

L

2
2
5
/
4
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

Index No

Chemical name

606-053-00-1 flurtamone (ISO)

(RS)-5-methylamino-2-phenyl-4-(a,a,a-
trifluoro-m-tolyl)furan-3(2H)-one

606-054-00-7 isoxaflutole (ISO)

5-cyclopropyl-1,2-oxazol-4-yl a,a,a-
trifluoro-2-mesyl-p-tolyl ketone

Notes
related to
substances

(cid:151)

(cid:151)

96525-23-4

N; R50-53

141112-29-0

Repr. Cat. 3; R63
N; R50-53

606-055-00-2 1-(2,3-dihydro-1,3,3,6-tetramethyl-

411-180-9

92836-10-7

1-(1-methylethyl)-1H-inden-5-yl)ethanone

Xn; R22-48/22
N; R51-53

606-056-00-8 4-chloro-3¡,4¡-dimethoxybenzophenone

404-610-1

116412-83-0

N; R50-53

606-057-00-3 4-propylcyclohexanone

406-810-4

40649-36-3

606-058-00-9 4¡-fluoro-2,2-dimethoxyacetophenone

407-500-1

21983-80-2

606-059-00-4 2,4-difluoro-a-(1H-1,2,4-triazol-1-yl)

412-390-3

86386-75-6

acetophenone hydrochloride

Xi; R38
R52-53

R43
R52-53

Xn; R22
Xi; R41
R43

606-060-00-X a mixture of: trans-2,4-dimethyl-

412-950-7

(cid:151)

N; R50-53

2-(5,6,7,8-tetrahydro-5,5,8,8-tetramethyl-
naphthalene-2-yl)-1,3-dioxolane; cis-
2,4-dimethyl-2-(5,6,7,8-tetrahydro-
5,5,8,8-tetramethyl-naphthalene-2-yl)-
1,3-dioxolane

N
R: 50/53
S: 60-61

Xn; N
R: 50/53-63
S: (2-)36/37-60-61

Xn; N
R: 22-48/22-51/53
S: (2-)24-36-61

N
R: 50/53
S: 60-61

Xi
R: 38-52/53
S: (2-)25-37-61

Xi
R: 43-52/53
S: (2-)24-37-61

Xn
R: 22-41-43
S: (2-)22-26-36/37/39

N
R: 50/53
S: 60-61

606-061-00-5 (3-chlorophenyl)-(4-methoxy-3-

423-290-4

66938-41-8

nitrophenyl)methanone

607-232-00-7 pyridate (ISO)

259-686-7

55512-33-9

O-(6-chloro-3-phenylpyridazin-4-yl)
S-octyl thiocarbonate

Muta. Cat. 3; R68
N; R50-53

Xn; N
R: 68-50/53
S: (2-)22-36/37-60-61

Xi; R38
R43
N; R50-53

Xi; N
R: 38-43-50/53
S: (2-)24-37-60-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
4
9

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

607-246-00-3 allyl methacrylate

202-473-0

96-05-9

2-methyl-2-propenoic acid 2-propenyl
ester

607-304-00-8 fluazifop-butyl (ISO)

274-125-6

69806-50-4

butyl (RS)-2-[4-(5-trifluoromethyl-2-
pyridyloxy)phenoxy]propionate

607-305-00-3 fluazifop-P-butyl (ISO)

(cid:151)

79241-46-6

butyl (R)-2-[4-(5-trifluoromethyl-2-
pyridyloxy)phenoxy]propionate

607-306-00-9 chlozolinate (ISO)

282-714-4

84332-86-5

ethyl (RS)-3-(3,5-dichlorophenyl)-
5-methyl-2,4-dioxo-oxazolidine-5-
carboxylate

607-307-00-4 vinclozolin (ISO)

256-599-6

50471-44-8

N-3,5-dichlorophenyl-5-methyl-5-vinyl-
1,3-oxazolidine-2,4-dione

607-308-00-X esters of 2,4-D

A

(cid:151)

(cid:151)

R10
T; R23
Xn; R21/22
N; R50

T; N
R: 10-21/22-23-50
S: (1/2-)36/37-45-61

Repr. Cat. 2; R61
N; R50-53

T; N
R: 61-50/53
S: 53-45-60-61

Repr. Cat. 3; R63
N; R50-53

Xn; N
R: 50/53-63
S: (2-)29-36/37-46-60-61

Carc. Cat. 3; R40
N; R51-53

Xn; N
R: 40-51/53
S: (2-)36/37-61

Carc. Cat. 3; R40
Repr. Cat. 2;
R60-61
R43
N; R51-53

T; N
R: 60-61-40-43-51/53
S: 53-45-61

Xn; R22
R43
N; R50-53

Xn; N
R: 22-43-50/53
S: (2-)26-29-36/37-46-60-61

607-309-00-5 carfentrazone-ethyl (ISO)

(cid:151)

128639-02-1

N; R50-53

ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-
5-[4-difluoromethyl-4,5-dihydro-
3-methyl-5-oxo-1H-1,2,4-triazol-
1-yl]phenyl]propionate

N
R: 50/53
S: 60-61

607-310-00-0 kresoxim-methyl (ISO)

(cid:151)

143390-89-0

methyl (E)-2-methoxyimino-[2-(o-
tolyloxymethyl)phenyl]acetate

Carc. Cat. 3; R40
N; R50-53

Xn; N
R: 40-50/53
S: (2-)36/37-60-61

607-311-00-6 benazolin-ethyl

246-591-0

25059-80-7

N; R51-53

ethyl 4-chloro-2-oxo-2H-
benzothiazole-3-acetate

N
R: 51/53
S: 61

L

2
2
5
/
5
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

607-312-00-1 methoxyacetic acid

E

210-894-6

625-45-6

607-313-00-7 neodecanoyl chloride

254-875-0

40292-82-8

Repr. Cat. 2;
R60-61
Xn; R22
C; R34

T
R: 60-61-22-34
S: 53-45

T+; R26
Xn; R22
C; R34

T+
R: 22-26-34
S: (1/2-)26-28-36/37/39-45

C ¯ 25 %: T; R60-61-22-34
10 % ˜ C < 25 %: T; R60-61-34
5 % ˜ C < 10 %: T;
R60-61-36/37/38
0,5 % ˜ C < 5 %: T; R60-61

C ¯ 25 %: T+; R22-26-34
10 % ˜ C < 25 %: T+; R26-34
7 % ˜ C < 10 %: T+;
R26-36/37/38
5 % ˜ C < 7 %: T; R23-36/37/38
1 % ˜ C < 5 %: T; R23
0,1 % ˜ C < 1 %: Xn; R20

607-314-00-2 ethofumesate (ISO)

247-525-3

26225-79-6

N; R51-53

(+/ﬂ)-2-ethoxy-2,3-dihydro-3,3-dimethyl-
benzofuran-5-yl methanesulfonate

607-315-00-8 glyphosate (ISO)

N-(phosphonomethyl)glycine

213-997-4

1071-83-6

607-316-00-3 glyphosate-trimesium

glyphosate-trimethylsulfonium

-

81591-81-3

Xi; R41
N; R51-53

Xn; R22
N; R51-53

N
R: 51/53
S: 61

Xi; N
R: 41-51/53
S: (2-)26-39-61

Xn; N
R: 22-51/53
S: (2-)36/37-46-61

607-317-00-9 bis(2-ethylhexyl) phthalate
di-(2-ethylhexyl) phthalate
DEHP

607-318-00-4 dibutyl phthalate

DBP

204-211-0

117-81-7

201-557-4

84-74-2

Repr. Cat. 2;
R60-61

T
R: 60-61
S: 53-45

Repr. Cat. 2; R61
Repr. Cat. 3; R62
N; R50

T; N
R: 61-50-62
S: 53-45-61

607-319-00-X deltamethrin (ISO)

258-256-6

52918-63-5

(S)-a-cyano-3-phenoxybenzyl (1R,
3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate

607-320-00-5 bis[4-(ethenyloxy)butyl] 1,3-

413-930-0

130066-57-8

benzenedicarboxylate

T; R23/25
N; R50-53

R43
N; R50-53

T; N
R: 23/25-50/53
S: (1/2-)24-28-36/37/39-38-
45-60-61

Xi; N
R: 43-50/53
S: (2-)24-37-60-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
5
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

607-321-00-0 (S)-methyl-2-chloropropionate

412-470-8

73246-45-4

607-322-00-6 4-(4,4-dimethyl-3-oxo-pyrazolidin-1-yl)-

413-120-7

107144-30-9

benzoic acid

R10
Xn; R48/22
Xi; R36

Xn; R22
N; R51-53

Xn
R: 10-36-48/22
S: (2-)23-26-36

Xn; N
R: 22-51/53
S: (2-)22-61

607-323-00-1 2-(1-(2-hydroxy-3,5-di-tert-pentyl-

413-850-6

123968-25-2

R53

phenyl)ethyl)-4,6-di-tert-pentylphenyl
acrylate

607-324-00-7 a mixture of: N,N-di(hydrogenated alkyl
C14-C18)phthalamic acid;
dihydrogenated alkyl (C14-C18)amine

413-800-3

(cid:151)

R53

R: 53
S: 61

R: 53
S: 61

607-325-00-2 (S)-2-chloropropionic acid

411-150-5

29617-66-1

607-326-00-8 a mixture of: isobutyl hydrogen

410-720-0

141847-13-4

2-(a-2,4,6-trimethylnon-2-enyl)succinate;
isobutyl hydrogen
2-((cid:223)-2,4,6-trimethylnon-2-enyl)succinate

607-327-00-3 2-(2-iodoethyl)-1,3-propanediol diacetate

411-780-0

127047-77-2

607-328-00-9 methyl 4-bromomethyl-3-methoxyben-

410-310-1

70264-94-7

zoate

Xn; R21/22
C; R35

Xi; R41
N; R51-53

Xn; R22
N; R51-53

Xi; R38-41
R43
N; R50-53

607-329-00-4 a mixture of: sodium

411-250-9

(cid:151)

R43

2-(C12-18-n-alkyl)amino-1,4-butandioate;
sodium 2-octadecenyl-amino-1,4-
butandioate

C
R: 21/22-35
S: (1/2-)23-26-28-36/37/39-45

Xi; N
R: 41-51/53
S: (2-)26-39-61

Xn; N
R: 22-51/53
S: (2-)36-61

Xi; N
R: 38-41-43-50/53
S: (2-)26-36/37/39-60-61

Xi
R: 43
S: (2-)24-26-37/39

607-330-00-X (S)-2,3-dihydro-1H-indole-2-carboxylic

410-860-2

79815-20-6

acid

Repr. Cat. 3; R62
Xn; R48/22
R43

Xn
R: 43-48/22-62
S: (2-)22-25-26-36/37

L

2
2
5
/
5
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

607-331-00-5 a mixture of:

406-750-9

(cid:151)

R53

bis(2,2,6,6-tetramethyl-1-octyloxypiperi-
din-4-yl)-1,10-decanedioate;
1,8-bis[(2,2,6,6-tetramethyl-
4-((2,2,6,6-tetramethyl-1-octyloxypiperi-
din-4-yl)-decan-1,10-dioyl)piperidin-
1-yl)oxy]octane

R: 53
S: 23-61

607-332-00-0 cyclopentyl chloroformate

411-460-0

50715-28-1

607-333-00-6 a mixture of: dodecyl

405-670-1

(cid:151)

N-(2,2,6,6-tetramethylpiperidin-4-yl)-(cid:223)-
alaninate; tetradecyl
N-(2,2,6,6-tetramethylpiperidin-4-yl)-(cid:223)-
alaninate

607-334-00-1 ethyl 1-ethyl-6,7,8-trifluoro-1,4-dihydro-

405-880-3

100501-62-0

4-oxoquinoline-3-carboxylate

607-335-00-7 methyl (R)-2-(4-(3-chloro-5-trifluor-

406-250-0

72619-32-0

omethyl-2-pyridyloxy)phenoxy)
propionate

607-336-00-2 4-methyl-8-methylenetri-

cyclo[3,3,1.13,7]dec-2-yl acetate

406-560-6

122760-85-4

607-337-00-8 di-tert-(C12-14)-alkylammonium 2-

benzothiazolylthiosuccinate

406-052-4

125078-60-6

R10
T; R23
Xn; R22-48/22
Xi; R41
R43

T
R: 10-22-23-41-43-48/22
S: (1/2-)26-36/37/39-45

Xn; R22-48/22
C; R34
N; R50-53

C; N
R: 22-34-48/22-50/53
S: (1/2-)26-36/37/39-45-60-61

R43
R52-53

Xn; R22
N; R50-53

Xi; R38
R43
N; R51-53

R10
Xn; R22
Xi; R38-41
N; R51-53

Xi
R: 43-52/53
S: (2-)24-37-61

Xn; N
R: 22-50/53
S: (2-)60-61

Xi; N
R: 38-43-51/53
S: (2-)36/37-61

Xn; N
R: 10-22-38-41-51/53
S: (2-)26-37/39-61

Xi
R: 36/38
S: (2-)26-37

607-338-00-3 2-methylpropyl 2-hydroxy-2-

406-235-9

72531-53-4

Xi; R36/38

methylbut-3-enoate

607-339-00-9 2,3,4,5-tetrachlorobenzoylchloride

406-760-3

42221-52-3

Xn; R22
C; R34
R43

C
R: 22-34-43
S: (1/2-)26-36/37/39-45

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
5
3

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

607-340-00-4 1,3-bis(4-benzoyl-3-hydroxyphen-

406-990-4

(cid:151)

N; R51-53

oxy)prop-2-yl acetate

607-341-00-X (9S)-9-amino-9-deoxyerythromycin

406-790-7

26116-56-3

607-342-00-5 4-chlorobutyl veratrate

410-950-1

69788-75-6

Xi; R41
N; R50-53

R43
N; R51-53

607-343-00-0 4,7-methanooctahydro-1H-indene-diyldi-

407-410-2

(cid:151)

R53

methyl bis(2-carboxybenzoate)

607-344-00-6 a mixture of:

407-810-7

(cid:151)

Xn; R48/22

3-(N-(3-dimethylaminopropyl)-(C4-8)per-
fluoroalkylsulfonamido)propionic acid;
N-[dimethyl-3-(C4-8-perfluoroalkylsulfon-
amido)propylammonium propionate;
3-(N-(3-dimethyl-propylammonium)-
(C4-8)perfluoroalkylsulfonamido)propionic
acid propionate

N
R: 51/53
S: 61

Xi; N
R: 41-50/53
S: (2-)26-39-60-61

Xi; N
R: 43-51/53
S: (2-)24-37-61

R: 53
S: 61

Xn
R: 48/22
S: (2-)21-22-36/37

607-345-00-1 potassium 2-(2,4-dichlorophenoxy)-(R)-

413-580-9

113963-87-4

propionate

Xn; R22
Xi; R38-41
R43

Xn
R: 22-38-41-43
S: (2-)24-26-37/39

607-346-00-7 3-icosyl-4-henicosylidene-2-oxetanone

401-210-9

83708-14-9

R53

607-347-00-2 sodium (R)-2-(2,4-dichlorophenoxy)pro-

413-340-3

119299-10-4

pionate

607-348-00-8 magnesium bis((R)-2-(2,4-dichlorophen-

413-360-2

(cid:151)

oxy)propionate)

Xn; R22
Xi; R38-41
R43

Xn; R22
Xi; R38-41
R43

607-349-00-3 mono-(tetrapropylammonium) hydrogen
2,2¡-dithiobisbenzoate

411-270-8

(cid:151)

R52-53

R: 53
S: 61

Xn
R: 22-38-41-43
S: (2-)22-26-36/37/39

Xn
R: 22-38-41-43
S: (2-)22-26-36/37/39

R: 52/53
S: 61

L

2
2
5
/
5
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

607-350-00-9 bis(4-(1,2-bis(ethoxycarbonyl)ethy-

412-060-9

136210-32-7

lamino)-3-methylcyclohexyl)methane

R43
R52-53

Xi
R: 43-52/53
S: (2-)36/37-61

607-351-00-4 methyl O-(4-amino-3,5-dichloro-6-fluor-
opyridin-2-yloxy)acetate

407-550-4

69184-17-4

N; R51-53

607-352-00-X 4,4¡-oxydiphthalic anhydride

412-830-4

1823-59-2

R52-53

607-353-00-5 a mixture of: ethyl

407-520-0

80657-64-3

exo-tricyclo[5.2.1.02,6]decane-endo-2-
carboxylate; ethyl
endo-tricyclo[5.2.1.02,6]decane-exo-2-
carboxylate

Xi; R38
N; R51-53

607-354-00-0 ethyl 2-cyclohexylpropionate

412-280-5

2511-00-4

N; R51-53

607-355-00-6 p-tolyl 4-chlorobenzoate

411-530-0

15024-10-9

607-356-00-1 ethyl trans-2,2,6-trimethylcyclohexanecar-

412-540-8

(cid:151)

boxylate

R43
N; R50-53

Xi; R38
N; R51-53

607-357-00-7 a mixture of: trans-4-acetoxy-4-

412-450-9

131766-73-9

R43

methyl-2-propyl-tetrahydro-2H-pyran;
cis-4-acetoxy-4-methyl-2-propyl-tetrahy-
dro-2H-pyran

607-358-00-2 (1S,3S,5R,6R)-(4-nitrophenylmethyl)-
1-dioxo-6-phenylacetamido-penam-3-
carboxylate

412-670-5

54275-93-3

R42

607-359-00-8 (1S,4R,6R,7R)-(4-nitrophenylme-

412-800-0

76109-32-5

R42

thyl)3-methylene-1-oxo-7-phenylaceta-
mido-cepham-4-carboxylate

N
R: 51/53
S: 20/21-61

R: 52/53
S: 61

Xi; N
R: 38-51/53
S: (2-)37-61

N
R: 51/53
S: 61

Xi; N
R: 43-50/53
S: (2-)24-37-60-61

Xi; N
R: 38-51/53
S: (2-)37-61

Xi
R: 43
S: (2-)24-37

Xn
R: 42
S: (2-)22

Xn
R: 42
S: (2-)22

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
5
5

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

607-360-00-3 sodium 3-acetoacetylamino-4-

411-680-7

133167-77-8

R43

methoxytolyl-6-sulfonate

Xi; R41
R52-53

Xi; R38-41
N; R51-53

607-361-00-9 methyl (R)-2-(4-hydroxyphenoxy)

411-950-4

96562-58-2

propionate

607-362-00-4 A mixture of:

413-500-2

(cid:151)

(3-methoxy)propylammonium/[tris-(2-hy-
droxyethyl)]ammonium 2-(2-(bis(2-hy-
droxyethyl)amino)ethoxycarbonyl-
methyl)hexadec-4-enoate; (3-me-
thoxy)propylammonium/[tris-(2-hydro-
xyethyl)]ammonium 2-(2-(bis(2-hydro-
xyethyl)amino)ethoxycarbonylmethyl)tet-
radec-4-enoate; (3-methoxy)propylam-
monium/[tris-(2-hydroxyethyl)]am-
monium 2-(3-methoxypropylcarba-
moylmethyl)hexadec-4-enoate; (3-me-
thoxy)propylammonium/[tris-(2-hydro-
xyethyl)]ammonium 2-(3-methoxypro-
pylcarbamoylmethyl)tetradec-4-enoate

Xi
R: 43
S: (2-)24-37

Xi
R: 41-52/53
S: (2-)26-39-61

Xi; N
R: 38-41-51/53
S: (2-)26-37/39-61

607-363-00-X methyl-3-methoxyacrylate

412-900-4

5788-17-0

R43

607-364-00-5 3-phenyl-7-[4-(tetrahydrofurfuryloxy)phe-

413-330-9

134724-55-3

R53

nyl]-1,5-dioxa-s-indacen-2,6-dione

607-365-00-0 2-(2-amino-1,3-thiazol-4-yl)-(Z)-2-me-

410-620-7

119154-86-8

thoxyiminoacetyl chloride hydrochloride

607-366-00-6 3,5-dimethylbenzoyl chloride

413-010-9

6613-44-1

Xn; R22
C; R34
R43

C; R34
R43

607-367-00-1 potassium bis(N-carboxymethyl)-
N-methyl-glycinato-(2-)N,O,O,N)-
ferrate-(1-) monohydrate

411-640-9

153352-59-1

Xn; R22

Xi
R: 43
S: (2-)24-37

R: 53
S: 61

C
R: 22-34-43
S: (1/2-)22-26-36/37/39-45

C
R: 34-43
S: (1/2-)26-36/37/39-45

Xn
R: 22
S: (2-)37

L

2
2
5
/
5
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

607-368-00-7 1-(N,N-dimethylcarbamoyl)-3-tert-butyl-

411-650-3

110895-43-7

5-carbethoxymethylthio-1H-1,2,4-triazole

607-369-00-2 a mixture of:

411-660-8

147027-04-1

trans-(2R)-5-acetoxy-1,3-oxathiolane-
2-carboxylic acid;
cis-(2R)-5-acetoxy-1,3-oxathiolane-2-
carboxylic acid

T; R23/25
N; R50-53

Xn; R22
Xi; R38-41
R43

T; N
R: 23/25-50/53
S: (1/2-)37-38-45-60-61

Xn
R: 22-38-41-43
S: (2-)22-24-26-37/39

607-370-00-8 2-[[2-(acetyloxy)-3-(1,1-dimethyl-ethyl)-

412-210-3

41620-33-1

N; R50-53

5-methylphenyl]methyl]-6-(1,1-dimethyl-
ethyl)-4-methylphenol

607-371-00-3 3-ethyl 5-methyl

413-410-3

88150-62-3

R53

4-(2-chlorophenyl)-1,4-dihydro-
2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-
2-yl)-ethoxymethyl]-6-methyl-3,5-
pyridinedicarboxylate

607-372-00-9 ethoxylated bis phenol A di-(norbornene

412-410-0

(cid:151)

R52-53

carboxylate)

N
R: 50/53
S: 60-61

R: 53
S: 61

R: 52/53
S: 61

607-373-00-4 (+/ﬂ) tetrahydrofurfuryl

E

414-200-4

119738-06-6

(R)-2-[4-(6-chloroquinoxalin-
2-yloxy)phenyloxy]propionate

607-374-00-X 5-amino-2,4,6-triiodo-1,3-benzenedicar-

417-220-1

37441-29-5

bonyldichloride

607-375-00-5 a mixture of: cis-4-hydroxy-3-

421-960-0

90035-08-8

(1,2,3,4-tetrahydro-3-(4-(4-trifluor-
omethylbenzyloxy)phenyl)-1-naph-
thyl)coumarin; trans-4-hydroxy-
3-(1,2,3,4-tetrahydro-3-(4-(4-trifluor-
omethylbenzyloxy)phenyl)-1-naph-
thyl)coumarin

607-376-00-0 benzyl 2,4-dibromobutanoate

420-710-8

23085-60-1

Muta. Cat. 3; R68
Repr. Cat. 2; R61
Repr. Cat. 3; R62
Xn; R22-48/22
N; R50-53

R43
N; R51-53

T; N
R: 61-22-48/22-62-68-50/53
S: 53-45-60-61

Xi; N
R: 43-51/53
S: (2-)22-36/37-61

T+; R26/27/28
T; R48/23/24/25
N; R50-53

T+; N
R: 26/27/28-48/23/24/
25-50/53
S: (1/2-)28-36/37/39-45-60-61

Repr. Cat. 3; R62
Xi; R38
R43
N; R50-53

Xn; N
R: 38-43-62-50/53
S: (2-)23-36/37-41-60-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
5
7

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

607-377-00-6 trans-4-cyclohexyl-L-proline monohydro-

419-160-1

90657-55-9

chloride

Repr. Cat. 3; R62
Xn; R22
Xi; R38-41
R43

Xn
R: 22-38-41-43-62
S: (2-)22-26-36/37/39

607-378-00-1 ammonium (Z)-a-methoxyimino-2-fury-

405-990-1

97148-39-5

F; R11

lacetate

F
R: 11
S: (2-)22-43

608-026-00-X 3-cyano-3,5,5-trimethylcyclohexanone

411-490-4

7027-11-4

Xn; R22-48/22
R43
R52-53

Xn
R: 22-43-48/22-52/53
S: (2-)36/37-61

608-027-00-5 a mixture of: 3-(4-ethylphenyl)-2,2-

412-660-0

(cid:151)

N; R51-53

dimethylpropanenitrile; 3-(2-ethylphenyl)-
2,2-dimethylpropanenitrile; 3-(3-ethyl-
phenyl)-2,2-dimethylpropanenitrile

N
R: 51/53
S: 61

608-028-00-0 4-(2-cyano-3-phenylamino)-acryloyloxy-

413-510-7

147374-67-2

methyl-cyclohexyl-methyl 2-cyano-
3-phenylamino)-acrylate

Xn; R48/20/21
R43
N; R51-53

Xn; N
R: 43-48/20/21-51/53
S: (2-)36/37-61

608-029-00-6 1,2-dihydro-6-hydroxy-4-methyl-

411-990-2

68612-94-2

R43

1-[3-(1-methylethoxy)propyl]-2-oxo-
3-pyridinecarbonitrile

608-030-00-1 N-acetyl-N-[5-cyano-3-(2-dibutylamino-

412-340-0

147741-93-3

N; R50-53

4-phenylthyazol-5-yl-methylene)-
4-methyl-2,6-dioxo-1,2,3,6-tetrahydro-
pyridin-1-yl]benzamide

Xi
R: 43
S: (2-)24-37

N
R: 50/53
S: 60-61

609-041-00-4 2,4-dinitrophenol

200-087-7

51-28-5

609-050-00-3 2,3-dinitrotoluene

E

210-013-5

602-01-7

T; R23/24/25
R33
N; R50

T; N
R: 23/24/25-33-50
S: (1/2-)28-37-45-61

Carc. Cat. 2; R45
Muta. Cat. 3; R68
Repr. Cat. 3; R62
T; R23/24/25
Xn; R48/22
N; R50-53

T; N
R: 45-23/24/25-48/22-50/
53-62
S: 53-45-60-61

L

2
2
5
/
5
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

609-051-00-9 3,4-dinitrotoluene

E

210-222-1

610-39-9

609-052-00-4 3,5-dinitrotoluene

E

210-566-2

618-85-9

Carc. Cat. 2; R45
Muta. Cat. 3; R68
Repr. Cat. 3; R62
T; R23/24/25
Xn; R48/22
N; R51-53

Carc. Cat. 2; R45
Muta. Cat. 3; R68
Repr. Cat. 3; R62
T; R23/24/25
Xn; R48/22
R52-53

T; N
R: 45-23/24/25-48/22-51/
53-62
S: 53-45-61

T
R: 45-23/24/25-48/22-52/
53-62
S: 53-45-61

609-054-00-5 2,3-dinitrophenol [1]
2,5-dinitrophenol [2]
2,6-dinitrophenol [3]
3,4-dinitrophenol [4]
salts of dinitrophenol [5]

200-628-7 [1]
206-348-1 [2]
209-357-9 [3]
209-415-3 [4]
- [5]

66-56-8 [1]
329-71-5 [2]
573-56-8 [3]
577-71-9 [4]
- [5]

T; R23/24/25
R33
N; R51-53

T; N
R: 23/24/25-33-51/53
S: (1/2-)28-37-45-61

609-055-00-0 2,5-dinitrotoluene

E

210-581-4

619-15-8

609-056-00-6 2,2-dibromo-2-nitroethanol

412-380-9

69094-18-4

Carc. Cat. 2; R45
Muta. Cat. 3; R68
Repr. Cat. 3; R62
T; R23/24/25
Xn; R48/22
N; R51-53

E; R2
Carc. Cat. 3; R40
Xn; R22-48/22
C; R35
R43
N; R50-53

T; N
R: 45-23/24/25-48/22-51/
53-62
S: 53-45-61

E; C; N
R: 2-22-35-40-43-48/
22-50/53
S: (1/2-)23-26-35-36/37/39-
45-60-61

C ¯ 10 %: C;
R22-35-40-43-48/22
5 % ˜ C < 10 %: C; R34-40-43
1 % ˜ C < 5 %: Xn;
R36/37/38-40-43

609-057-00-1 3-chloro-2,4-difluoronitrobenzene

411-980-8

3847-58-3

Xn; R22
C; R34
R43
N; R50-53

C; N
R: 22-34-43-50/53
S: (1/2-)22-26-28-36/37/
39-45-60-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
5
9

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

609-058-00-7 2-nitro-2-phenyl-1,3-propanediol

410-360-4

5428-02-4

609-059-00-2 2-chloro-6-(ethylamino)-4-nitrophenol

411-440-1

131657-78-8

609-060-00-8 4-[(3-hydroxypropyl)amino]-3-nitrophe-

406-305-9

92952-81-3

nol

609-061-00-3 (E,Z)-4-chlorophenyl(cyclopropyl)ketone

406-100-4

94097-88-8

O-(4-nitrophenylmethyl)oxime

609-062-00-9 2-bromo-2-nitropropanol

407-030-7

24403-04-1

609-063-00-4 2-[(4-chloro-2-nitrophenyl)amino]ethanol

413-280-8

59320-13-7

611-053-00-X 2,2¡-azobis[2-methylpropionamidine]

221-070-0

2997-92-4

dihydrochloride

T; R39-48/25
Xn; R21/22
Xi; R41
R43
N; R51-53

Xn; R22
R43
N; R51-53

Xi; R38
N; R51-53

R43
N; R50-53

T; R24
Xn; R22-48/22
C; R34
R43
N; R50-53

Xn; R22
N; R51-53

Xn; R22
R43

T; N
R: 21/22-39-41-43-48/
25-51/53
S: 53-45-61

Xn; N
R: 22-43-51/53
S: (2-)22-24-37/39-61

Xi; N
R: 38-51/53
S: (2-)37-61

Xi; N
R: 43-50/53
S: (2-)24-37-60-61

T; N
R: 22-24-34-43-48/22-50/53
S: (1/2-)26-36/37/39-45-60-61

Xn; N
R: 22-51/53
S: (2-)22-61

Xn
R: 22-43
S: (2-)24-37

611-055-00-0 C.I. Disperse Yellow 3

220-600-8

2832-40-8

N-[4-[(2-hydroxy-5-methylphe-
nyl)azo]phenyl]acetamide

611-056-00-6 C.I. Solvent Yellow 14

1-phenylazo-2-naphthol

212-668-2

842-07-9

Carc. Cat. 3; R40
R43

Xn
R: 40-43
S: (2-)22-36/37-46

Carc. Cat. 3; R40
Muta. Cat. 3; R68
R43
R53

Xn
R: 40-43-53-68
S: (2-)22-36/37-46-61

L

2
2
5
/
6
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

611-057-00-1 6-hydroxy-1-(3-isopropoxypropyl)-

400-340-3

85136-74-9

4-methyl-2-oxo-5-[4-(phenylazo)pheny-
lazo]-1,2-dihydro-3-pyridinecarbonitrile

Carc. Cat. 2; R45
R53

T
R: 45-53
S: 53-45-61

611-058-00-7 (6-(4-hydroxy-3-(2-methoxyphenylazo)-
2-sulfonato-7-naphthylamino)-1,3,5-tria-
zin-2,4-diyl)bis[(amino-1-methylethyl)am-
monium] formate

402-060-7

108225-03-2

Carc. Cat. 2; R45
Xi; R41
N; R51-53

T; N
R: 45-41-51/53
S: 53-45-61

Xi; R41
R43
R52-53

Xi
R: 41-43-52/53
S: (2-)22-24-26-37/39-61

Xi; R41
R43
R52-53

Xi
R: 41-43-52/53
S: (2-)22-24-26-37/39-61

611-059-00-2 octasodium 2-(6-(4-chloro-

412-960-1

148878-21-1

6-(3-(N-methyl-N-(4-chloro-6-(3,5-disul-
fonato-2-naphthylazo)-1-hydroxy-6-naph-
thylamino)-1,3,5-triazin-2-yl)amino-
methyl)phenylamino)-1,3,5-triazin-
2-ylamino)-3,5-disulfonato-1-hydroxy-
2-naphthylazo)naphthalene-1,5-disulfon-
ate

611-060-00-8 a mixture of: sodium 5-[8-[4-[4-[4-[7-

413-180-4

(cid:151)

(3,5-dicarboxylatophenylazo)-8-
hydroxy-3,6-disulfonatonaphthalen-
1-ylamino]-6-hydroxy-1,3,5-
triazin-2-yl]-2,5-dimethylpiperazin-
1-yl]-6-hydroxy-1,3,5-triazin-2-ylamino]--
1-hydroxy-3,6-disulfonato-
naphthalen-2-ylazo]-isophthalate;
ammonium 5-[8-[4-[4-[4-[7-(3,5-
dicarboxylatophenylazo)-8-hydroxy-
3,6-disulfonatonaphthalen-
1-ylamino]-6-hydroxy-1,3,5-triazin-
2-yl]-2,5-dimethylpiperazin-1-yl]-6-
hydroxy-1,3,5-triazin-2-ylamino]-1-
hydroxy-3,6-disulfonatonaphthalen-
2-ylazo]-isophthalate;
5-[8-[4-[4-[4-[7-(3,5-dicarboxylatopheny-
lazo)-8-hydroxy-3,6-disulfonatonaph-
thalen-1-ylamino]-6-hydroxy-1,3,5-tria-
zin-2-yl]-2,5-dimethylpiperazin-
1-yl]-6-hydroxy-1,3,5-triazin-
2-ylamino]-1-hydroxy-3,6-disulfonaph-
thalen-2-ylazo]-isophthalic acid

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
6
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

611-061-00-3 disodium 5-[5-[4-(5-chloro-2,6-difluor-

412-530-3

(cid:151)

opyrimidin-4-ylamino)benzamido]-2-sul-
fonatophenylazo]-1-ethyl-6-hydroxy-
4-methyl-2-oxo-3-pyridylmethylsulfonate

Xi; R41
R43

Xi
R: 41-43
S: (2-)22-24-26-37/39

611-062-00-9 octasodium 2-(8-(4-chloro-

413-550-5

(cid:151)

Xi; R38-41

6-(3-((4-chloro-6-(3,6-disulfonato-
2-(1,5-disulfonatonaphthalen-2-ylazo)-
1-hydroxynaphthalen-8-ylamino)-
1,3,5-triazin-2-yl)aminomethyl)phenylam-
ino)-1,3,5-triazin-2-ylamino)-3,6-di-
sulfonato-1-hydroxynaphthalen-
2-ylazo)naphthalene-1,5-disulfonate

611-063-00-4 trisodium [4¡-(8-acetylamino-3,6-dis-

413-590-3

(cid:151)

Carc. Cat. 2; R45

ulfonato-2-naphthylazo)-4¢-(6-benzoy-
lamino-3-sulfonato-2-naphthylazo)-biphe-
nyl-1,3¡,3¢,1¡¢-tetraolato-
O,O¡,O¢,O¡¢]copper(II)

Xi
R: 38-41
S: (2-)22-26-37/39

T
R: 45
S: 53-45

611-064-00-X 4-(3,4-dichlorophenylazo)-2,6-di-sec-

410-600-8

124719-26-2

butyl-phenol

611-065-00-5 4-(4-nitrophenylazo)-2,6-di-sec-butyl-

410-610-2

111850-24-9

phenol

611-066-00-0 tetrasodium 5-[4-chloro-6-(N-ethyl-

411-540-5

130201-57-9

anilino)-1,3,5-triazin-2-ylamino]-4-hy-
droxy-3-(1,5-disulfonatonaphthalen-
2-ylazo)-naphthalene-2,7-disulfonate

611-067-00-6 a mixture of: bis(tris(2-(2-hydroxy

406-910-8

(cid:151)

(1-methyl)ethoxy)ethyl)ammonium)
7-anilino-4-hydroxy-3-(2-methoxy-
5-methyl-4-(4-sulfonatophenylazo)pheny-
lazo)naphthalene-2-sulfonate;
bis(tris(2-(2-hydroxy(2-
methyl)ethoxy)ethyl)ammonium)
7-anilino-4-hydroxy-3-(2-methoxy-
5-methyl-4-(4-sulfonatophenylazo)pheny-
lazo)naphthalene-2-sulfonate

Xn; R48/22
Xi; R38
N; R50-53

Xn; R48/22
Xi; R36/38
R43
N; R50-53

Xi; R41
R43
N; R51-53

Xn; N
R: 38-48/22-50/53
S: (2-)23-25-36/37-60-61

Xn; N
R: 36/38-43-48/22-50/53
S: (2-)23-26-36/37-60-61

Xi; N
R: 41-43-51/53
S: (2-)22-24-26-37/39-61

Xn; R22
Xi; R41
R52-53

Xn
R: 22-41-52/53
S: (2-)26-36/39-61

L

2
2
5
/
6
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

611-068-00-1 tetrasodium 4-amino-3,6-bis(5-[4-chloro-

400-690-7

85665-98-1

N; R51-53

6-(2-hydroxyethylamino)-1,3,5-triazin-
2-ylamino]-2-sulfonatophenylazo)-5-hy-
droxynaphthalene-2,7-disulfonate

611-069-00-7 N,N-di-[poly(oxyethylene)-co-poly(oxy-
propylene)]-4-[(3,5-dicyano-4-methyl-
2-thienyl)azo)]-3-methylaniline

413-380-1

(cid:151)

N; R51-53

N
R: 51/53
S: 61

N
R: 51/53
S: 61

611-070-00-2 a mixture of: disodium

405-665-4

(cid:151)

(6-(4-anisidino)-3-sulfonato-2-(3,5-dini-
tro-2-oxidophenylazo)-1-naphtho-
lato)(1-(5-chloro-2-oxidophenylazo)-
2-naphtholato)chromate(1-); trisodium
bis(5-(4-anisidino)-3-sulfonato-2-(3,5-dini-
tro-2-oxidophenylazo)-1-naphtho-
lato)chromate(1-)

R43
N; R50-53

Xi; N
R: 43-50/53
S: (2-)24-37-60-61

611-071-00-8 tris(tetramethylammonium) 5-hydroxy-

406-073-9

131013-81-5

1-(4-sulphonatophenyl)-4-(4-sulphon-
atophenylazo)pyrazole-3-carboxylate

T; R25
R52-53

T
R: 25-52/53
S: (1/2-)37-45-61

611-072-00-3 2,4-bis[2,2¡-[2-(N,N-dimethylamino)ethy-
loxycarbonyl]phenylazo]-1,3-dihydroxy-
benzene, dihydrochloride

407-010-8

118208-02-9

Xn; R22
Xi; R41
N; R51-53

Xn; N
R: 22-41-51/53
S: (2-)26-39-61

611-073-00-9 dimethyl 3,3¡-(N-(4-(4-bromo-2,6-dicya-
nophenylazo)-3-hydroxyphenyl)imino)di-
propionate

407-310-9

122630-55-1

R53

611-074-00-4 a mixture of: sodium/potassium

407-100-7

(cid:151)

R43

(3-(4-(5-(5-chloro-2,6-difluoropyrimidin-
4-ylamino)-2-methoxy-3-sulfonatopheny-
lazo)-2-oxidophenylazo)-2,5,7-trisulfon-
ato-4-naphtholato)copper(II); sodium/po-
tassium (3-(4-(5-(5-chloro-4,6-difluor-
opyrimidin-2-ylamino)-2-methoxy-3-sul-
fonatophenylazo)-2-oxidophenylazo)-
2,5,7-trisulfonato-4-naphtho-
lato)copper(II)

R: 53
S: 61

Xi
R: 43
S: (2-)22-24-37

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
6
3

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

611-075-00-X a 2:1 mixture of: tris(3,5,5-

406-000-0

(cid:151)

trimethylhexylammonium) 4-amino-
3-(4-(4-(2-amino-4-hydroxypheny-
lazo)anilino)-3-sulfonatophenylazo)-
5,6-dihydro-5-oxo-6-phenylhydrazonon-
aphthalene-2,7-disulfonate; tris(3,5,5-tri-
methylhexylammonium) 4-amino-
3-(4-(4-(4-amino-2-hydroxypheny-
lazo)anilino)-3-sulfonatophenylazo)-
5,6-dihydro-5-oxo-6-phenylhydrazonon-
aphthalene-2,7-disulfonate

Xi; R41
N; R51-53

Xi; N
R: 41-51/53
S: (2-)26-39-61

611-076-00-5 3-(2,6-dichloro-4-nitrophenylazo)-

406-280-4

117584-16-4

N; R50-53

1-methyl-2-phenylindole

611-077-00-0 dilithium disodium

407-230-4

126637-70-5

(5,5¡-diamino-(l-4,4¡-dihydroxy-
1:2-j-2,O4,O4¡,-3,3¡-[3,3¡-dihydroxy-
1:2-j-2-O3,O3¡-biphenyl-4,4¡-ylenebi-
sazo-1:2-(N3,N4-g:N3¡,N4¡-g)]-dinaph-
thalene-2,7-disulfonato(8)))dicuprate(2-)

Xn; R22
R43

N
R: 50/53
S: 60-61

Xn
R: 22-43
S: (2-)22-24-37

611-078-00-6 (2,2¡-(3,3¡-dioxidobiphenyl-

407-240-9

159604-94-1

4,4¡-diyldiazo)bis(6-(4-(3-(diethy-
lamino)propylamino)-6-(3-(diethylam-
monio)propylamino)-1,3,5-triazin-
2-ylamino)-3-sulfonato-1-naphtholato))di-
copper(II) acetate lactate

R43
N; R51-53

Xi; N
R: 43-51/53
S: (2-)22-24-37-61

611-079-00-1 disodium 7-[4-chloro-6-(N-ethyl-o-

410-390-8

(cid:151)

Xi; R41

toluidino)-1,3,5-triazin-2-ylamino]-4-
hydroxy-3-(4-methoxy-2-sulfonatopheny-
lazo)-2-naphthalenesulfonate

611-080-00-7 sodium 3-(2-acetamido-4-(4-(2-hydroxy-
butoxy)phenylazo)phenylazo)benzenesul-
fonate

410-150-2

147703-65-9

R43

Xi
R: 41
S: (2-)22-26-39

Xi
R: 43
S: (2-)22-24-37

611-081-00-2 tetrasodium [7-(2,5-dihydroxy-KO2-7-sul-

411-470-5

141048-13-7

fonato-6-[4-(2,5,6-trichloro-pyrimidin-
4-ylamino)phenylazo]-(N1,N7-N)-1-naph-
thylazo)-8-hydroxy-KO8-naphthalene-
1,3,5-trisulfonato(6-)]cuprate(II)

R43
R52-53

Xi
R: 43-52/53
S: (2-)22-24-37-61

L

2
2
5
/
6
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

611-082-00-8 a mixture of: pentasodium bis(1-(3(or

407-570-3

(cid:151)

N; R51-53

5)-(4-anilino-3-sulfonatophenylazo)-4-hy-
droxy-2-oxidophenylazo)-6-nitro-4-sul-
fonato-2-naphtholato)ferrate(1-); pentaso-
dium [(1-(3-(4-anilino-3-sulfonatopheny-
lazo)-4-hydroxy-2-oxidophenylazo)-
6-nitro-4-sulfonato-2-naphtholato)-
(5-(4-anilino-3-sulfonatophenylazo)-4-hy-
droxy-2-oxidophenylazo)-6-nitro-4-sul-
fonato-2-naphtholato]ferrate(1-)

N
R: 51/53
S: 61

611-083-00-3 a mixture (1:1) of:

411-560-4

(cid:151)

2-[N-ethyl-4-[(5,6-dichlorobenzothiazol-
2-yl)azo]-m-toludino]ethyl acetate;
2-[N-ethyl-4-[(6,7-dichlorobenzothiazol-
2-yl)azo]-m-toludino]ethyl acetate

T; R48/25
R43
N; R51/53

T; N
R: 43-48/25-51/53
S: (1/2-)22-36/37-R45-61

611-084-00-9 a mixture of:

412-550-2

(cid:151)

R53

N-(4-chlorophenyl)-4-(2,5-dichloro-4-(di-
methylsulfamoyl)phenylazo)-3-hydroxy-
2-naphthalenecarboxamide; N-(4-chloro-
phenyl)-4-(2,5-dichloro-4-(methylsulfa-
moyl)phenylazo)-3-hydroxy-2-naphtha-
lenecarboxamide

R: 53
S: 61

611-085-00-4 a mixture of: 3-cyano-5-(2-cyano-

411-880-4

(cid:151)

4-nitrophenylazo)-2-(2-hydroxyethyl-
amino)-4-methyl-6-[3-(2-phenoxy-
ethoxy)propylamino]pyridine; 3-cyano-
5-(2-cyano-4-nitrophenylazo)-6-(2-hydro-
xyethylamino)-4-methyl-2-[3-(2-phenoxy-
ethoxy)propylamino]pyridine;
3-cyano-5-(2-cyano-4-nitrophenylazo)-2--
amino-4-methyl-6-[3-(3-hydroxypropoxy-
)propyl-
amino]pyridine;3-cyano-5-(2-cyano-4-ni-
trophenylazo)-6-amino-4-methyl-2-[3-(3--
methoxypropoxy)propylamino]pyridine

R43
N; R51-53

Xi; N
R: 43-51/53
S: (2-)24-37-61

611-086-00-X monolithium 5-[[2,4-dihydroxy-5-[(2-

411-360-7

(cid:151)

R52-53

hydroxy-3,5-dinitrophenyl)azo]phe-
nyl]azo]-2-naphthalenesulfonate], iron
complex, monohydrate

R: 52/53
S: 61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
6
5

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

611-087-00-5 a mixture of: 3-((5-cyano-1,6-

411-710-9

(cid:151)

R53

R: 53
S: 61

dihydro-1,4-dimethyl-2-hydroxy-6-oxo-
3-pyridinyl)azo)-benzoyloxy-2-phenoxy-
ethane; 3-((5-cyano-1,6-dihydro-1,4-di-
methyl-2-hydroxy-6-oxo-3-pyridinyl)azo)-
benzoyloxy-2-ethyloxy-2-(ethylphenol)

611-088-00-0 a mixture of: trilithium 4-amino-
3-((4-((4-((2-amino-4-hydroxyphe-
nyl)azo)phenyl)amino)-3-sulfophe-
nyl)azo)-5-hydroxy-6-(phenylazo)naph-
thalene-2,7-disulfonate; trilithium
4-amino-3-((4-((4-((4-amino-2-hydroxy-
phenyl)azo)phenyl)amino)-3-sulfophe-
nyl)azo)-5-hydroxy-6-(phenylazo)naph-
thalene-2,7-disulfonate

411-890-9

(cid:151)

Xn; R22
Xi; R41
R52-53

Xn
R: 22-41-52/53
S: (2-)22-26-39-61

611-089-00-6 2-((4-(ethyl-(2-hydroxyethyl)amino)-

411-100-2

136213-73-5

2-methylphenyl)azo)-6-methoxy-
3-methyl-benzothiazolium methylsulfate

611-090-00-1 2,5-dibutoxy-4-(morpholin-4-yl)benzene-

413-290-2

93672-52-7

diazonium 4-methylbenzenesulfonate

Xn; R48/22
R43
N; R50-53

Xn; N
R: 43-48/22-50/53
S: (2-)22-36/37-60-61

F; R11
Xn; R22
Xi; R41
R43
R52-53

F; Xn
R: 11-22-41-43-52/53
S: (2-)12-22-24-26-37/39-
47-61

611-091-00-7 sodium (1,0-1,95)/lithium (0,05-1)
5-((5-((5-chloro-6-fluoro-pyrimidin-
4-yl)amino)-2-sulfonatophenyl)azo)-
1,2-dihydro-6-hydroxy-1,4-dimethyl-
2-oxo-3-pyridinemethylsulfonate

413-470-0

134595-59-8

R43

611-092-00-2 tert-(dodecyl/tetradecyl)-ammonium

413-210-6

(cid:151)

N; R51-53

bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hy-
droxy-3-nitrophenyl)azo)-3-methyl-5-hy-
droxy-(1H)pyrazol-1-yl)benzenesulfon-
amidato)chromate

611-093-00-8 sodium 2-(4-(4-fluoro-6-(2-sulfoethy-

410-770-3

146177-84-6

R43

lamino)-[1,3,5]triazin-2-ylamino)-2-ure-
idophenylazo)-5-(4-sulfophenylazo)ben-
zene-1-sulfonate

Xi
R: 43
S: (2-)22-24/25-37

N
R: 51/53
S: 61

Xi
R: 43
S: (2-)22-24-37

L

2
2
5
/
6
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

611-094-00-3 a mixture (50:50) of:

411-600-0

143145-93-1

R53

2-[2-acetylamino-4-[N,N-bis[2-ethoxycar-
bonyloxy)ethyl]amino]pheny-
lazo]-5,6-dichloro-1,3-benzothiazole;
2-[2-acetylamino-4-[N,N-bis[2-ethoxycar-
bonyloxy)ethyl]amino]pheny-
lazo]-6,7-dichloro-1,3-benzotriazole

611-095-00-9 hexasodium 1,1¡-[(1-amino-8-hydroxy-

412-240-7

89797-03-5

N; R51-53

3,6-disulfonate-2,7-naphthalene-
diyl)bis(azo(4-sulfonate-1,3-phe-
nyl)imino[6-[(4-chloro-3-sulfonatophe-
nyl)amino]-1,3,5-triazin-
2,4-diyl]]]bis[3-carboxypyridinium] dihy-
droxide

R: 53
S: 61

N
R: 51/53
S: 22-61

611-096-00-4 methyl N-[3-acetylamino)-4-(2-cyano-

413-040-2

149850-30-6

R43

4-nitrophenylazo)phenyl]-N-[(1-me-
thoxy)acetyl]glycinate

Xi
R: 43
S: (2-)22-24-37

611-097-00-X a mixture of isomers of iron (1:2)

414-150-3

(cid:151)

complexes of a mixture of: isomers of:
1,3-dihydroxy-4-[(5-phenylaminosulfo-
nyl)-2-hydroxyphenylazo]-n-(5-amino-sul-
fonyl-2-hydroxyphenylazo)benzene
(n = 2,5,6); isomers of:
1,3-dihydroxy-4-[(5-phenylaminosulfo-
nyl)-2-hydroxyphenylazo]-n-[4-(4-nitro-
2-sulfophenylamino)phenylazo]benzene
(n = 2,5,6)

R43
N; R51-53

Xi; N
R: 43-51/53
S: (2-)22-24-37-61

611-098-00-5 tetrakis(tetramethylam-

405-950-3

131013-83-7

monium)3,3¡-(6-(2-hydroxyethy-
lamino)1,3,5-triazine-2,4-diylbi-
simino(2-methyl-4,1-phenyleneazo))bis-
naphthalene-1,5-disulfonate

T; R25
R52-53

T
R: 25-52/53
S: (1/2-)37-45-61

612-160-00-4 p-toluidine [1]

4-aminotoluene [1]
toluidinium chloride [2]
toluidine sulphate (1:1) [3]

203-403-1 [1]
208-740-8 [2]
208-741-3 [3]

106-49-0 [1]
540-23-8 [2]
540-25-0 [3]

Carc. Cat. 3; R40
T; R23/24/25
Xi; R36
R43
N; R50

T; N
R: 23/24/25-36-40-43-50
S: (1/2-)28-36/37-45-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
6
7

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

612-161-00-X 2,6-xylidine

2,6-dimethylaniline

201-758-7

87-62-7

612-162-00-5 dimethyldioctadecylammonium chloride

203-508-2

107-64-2

DODMAC

612-163-00-0 metalaxyl-M (ISO)

(cid:151)

70630-17-0

mefenoxam
(R)-2-[(2,6-dimethylphenyl)-methoxy-
acetylamino]propionic acid methyl ester

612-164-00-6 2-butyl-2-ethyl-1,5-diaminopentane

412-700-7

137605-95-9

Carc. Cat. 3; R40
Xn; R20/21/22
Xi; R37/38
N; R51-53

Xn; N
R: 20/21/22-37/38-40-51/53
S: (2-)23-25-36/37-61

Xi; R41
N; R50-53

Xn; R22
Xi; R41

Xi; N
R: 41-50/53
S: (2-)24-26-39-46-60-61

Xn
R: 22-41
S: (2-)26-39-46

Xn; R21/22-48/22
C; R34
R43
R52-53

C
R: 21/22-34-43-48/22-52/53
S: (1/2-)26-36/37/39-45-61

612-165-00-1 N,N¡-diphenyl-N,N¡-bis(3-methylphenyl)-

413-810-8

65181-78-4

N; R51-53

(1,1¡-diphenyl)-4,4¡-diamine

N
R: 51/53
S: 61

612-166-00-7 a mixture of: cis-(5-ammonium-

411-830-1

114765-88-7

1,3,3-trimethyl)-cyclohexanemethylam-
monium phosphate (1:1);
trans-(5-ammonium-1,3,3-trimethyl)-
cyclohexanemethylammonium phosphate
(1:1)

612-167-00-2 5-acetyl-3-amino-10,11-dihydro-5H-di-

410-490-1

(cid:151)

benz[b,f]azepine-hydrochloride

612-168-00-8 3,5-dichloro-2,6-difluoropyridine-

220-630-1

2840-00-8

4-amine

612-170-00-9 4-chlorophenyl cyclopropyl ketone

405-260-2

(cid:151)

O-(4-aminobenzyl)oxime

Xi; R41
R43
R52-53

Xi
R: 41-43-52/53
S: (2-)24-26-37/39-61

Xn; R22-48/22
Xi; R41
R43
N; R51-53

Xn; R21/22
N; R51-53

Xn; N
R: 22-41-43-48/22-51/53
S: (2-)22-26-36/37/39-61

Xn; N
R: 21/22-51/53
S: (2-)36/37-61

Xn; R22
R43
N; R50-53

Xn; N
R: 22-43-50/53
S: (2-)24-37-60-61

L

2
2
5
/
6
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

612-171-00-4 N,N,N¡,N¡-tetraglycidyl-4,4¡-diamino-

410-060-3

130728-76-6

3,3¡-diethyldiphenylmethane

612-172-00-X 4,4¡-methylenebis(N,N¡-dimethylcyclo-

412-840-9

13474-64-1

hexanamine)

Muta. Cat. 3; R68
R43
N; R51-53

Xn; N
R: 43-68-51/53
S: (2-)36/37-61

Xn; R22-48/22
C; R35
R52-53

C
R: 22-35-48/22-52/53
S: (1/2-)26-36/37/39-45-61

612-173-00-5 lithium 1-amino-4-(4-tert-butylanilino)an-
thraquinone-2-sulfonate

411-140-0

125328-86-1

612-174-00-0 4,4-dimethoxybutylamine

407-690-6

19060-15-2

612-175-00-6 2-(O-aminooxy)ethylamine dihydrochlor-

412-310-7

37866-45-8

ide

Xi; R41
R43
N; R51-53

Xn; R22
C; R34
R43
R52-53

R43
R52-53

612-176-00-1 polymer of 1,3-dibromopropane and

410-570-6

143747-73-3

N; R50-53

N,N-diethyl-N¡,N¡-dimethyl-1,3-propane-
diamine

612-177-00-7 2-naphthylamino-6-sulfomethylamide

412-120-4

(cid:151)

612-178-00-2 1,4,7,10-tetraazacyclododecane disulfate

412-080-8

112193-77-8

612-179-00-8 1-(2-propenyl)pyridinium chloride

412-740-5

25965-81-5

612-180-00-3 3-aminobenzylamine

412-230-2

4403-70-7

612-181-00-9 2-phenylthioaniline

413-030-8

1134-94-7

Xn; R48/22
R43
N; R51-53

Xn; R22
Xi; R37-41
R52-53

Xn; R22
R43

Xn; R22
C; R34
N; R51-53

R43
N; R51-53

Xi; N
R: 41-43-51/53
S: (2-)22-26-36/37/39-61

C
R: 22-34-43-52/53
S: (1/2-)26-36/37/39-45-61

Xi
R: 43-52/53
S: (2-)24-37-61

N
R: 50/53
S: 60-61

Xn; N
R: 43-48/22-51/53
S: (2-)22-36/37-61

Xn
R: 22-37-41-52/53
S: (2-)26-36/37/39-61

Xn
R: 22-43
S: (2-)24-37

C; N
R: 22-34-51/53
S: (1/2-)22-26-36/37/39-45-61

Xi; N
R: 43-51/53
S: (2-)24-37-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
6
9

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

612-182-00-4 1-ethyl-1-methylmorpholinium bromide

418-210-1

65756-41-4

Muta. Cat. 3; R68

612-183-00-X 1-ethyl-1-methylpyrrolidinium bromide

418-200-5

69227-51-6

Muta. Cat. 3; R68

613-054-00-0 thiabendazol (ISO)

2-(thiazole-4-yl)benzimidazole

205-725-8

148-79-8

N; R50-53

120162-55-2

N; R50-53

Xn
R: 68
S: (2-)36/37

Xn
R: 68
S: (2-)36/37

N
R: 50/53
S: 60-61

N
R: 50/53
S: 60-61

613-163-00-3 azimsulfuron (ISO)

1-(4,6-dimethoxypyrimidin-2-yl)-
3-[1-methyl-4-(2-methyl-2H-tetrazol-
5-yl)pyrazol-5-ylsulfonyl]urea

613-164-00-9 flufenacet (ISO)

N-(4-fluorophenyl)-N-isopropyl-2-(5-tri-
fluoromethyl-[1,3,4]thiadiazol-
2-yloxy)acetamide

613-165-00-4 flupyrsulfuron-methyl-sodium (ISO)

methyl 2-[[(4,6-dimethoxypyrimidin-
2-ylcarbamoyl)sulfamoyl]-6-trifluor-
omethyl]nicotinate, monosodium salt

613-166-00-X flumioxazin (ISO)

N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-
2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-
1-ene-1,2-dicarboxamide

613-167-00-5 a mixture of: 5-chloro-2-methyl-

2H-isothiazol-3-one [EC No 247-500-7]
and 2-methyl-2H-isothiazol-3-one
[EC No 220-239-6] (3:1)
a mixture of: 5-chloro-2-methyl-
4-isothiazolin-3-one [EC No 247-500-7]
and 2-methyl-4-isothiazolin-3-one
[EC No 220-239-6] (3:1)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

142459-58-3

Xn; R22-48/22
R43
N; R50-53

Xn; N
R: 22-43-48/22-50/53
S: (2-)13-24-37-60-61

144740-54-5

N; R50-53

N
R: 50/53
S: 60-61

103361-09-7

Repr. Cat. 2; R61
N; R50-53

T; N
R: 61-50/53
S: 53-45-60-61

55965-84-9

T; R23/24/25
C; R34
R43
N; R50-53

T; N
R: 23/24/25-34-43-50/53
S: (2-)26-28-36/37/39-45-
60-61

C ¯ 25 %: T; R23/24/25-34-43
3 % ˜ C < 25 %: C;
R20/21/22-34-43
0,6 % ˜ C < 3 %: C; R34-43
0,06 % ˜ C < 0.6 %: Xi;
R36/38-43
0,0015 % ˜ C < 0.06 %: Xi; R43

L

2
2
5
/
7
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

613-168-00-0 1-vinyl-2-pyrrolidone

D

201-800-4

88-12-0

613-169-00-6 9-vinylcarbazole

216-055-0

1484-13-5

613-170-00-1 2,2-ethylmethylthiazolidine

404-500-3

694-64-4

613-171-00-7 (RS)-2-(2,4-dichlorophenyl)-

413-050-7

79983-71-4

1-(1H-1,2,4-triazol-1-yl)hexan-2-ol

613-172-00-2 5-chloro-1,3-dihydro-2H-indol-2-one

412-200-9

17630-75-0

613-173-00-8 3-(2,4-dichlorophenyl)-6-fluoro-

411-960-9

136426-54-5

2-(1H-1,2,4-triazol-1-yl)quinazolin-
4-(3H)-one

613-174-00-3 (+/ﬂ) 2-(2,4-dichlorophenyl)-

407-760-7

112281-77-3

3-(1H-1,2,4-triazol-1-yl)propyl-
1,1,2,2-tetrafluoroethylether

613-175-00-9 (2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluor-

406-850-2

106325-08-0

ophenyl)-[(1H-1,2,4-triazol-
1-yl)methyl]oxirane

613-176-00-4 2-methyl-2-azabicyclo[2.2.1]heptane

404-810-9

4254-95-2

Carc. Cat. 3; R40
Xn;
R20/21/22-48/20
Xi; R37-41

Muta. Cat. 3; R68
Xn; R21/22
Xi; R38
R43
N; R50-53

Xn; R22
Xi; R41
R43
N; R51-53

Xn; R22
R43
N; R51-53

Repr. Cat. 3; R62
Xn; R22
R43
R52-53

T; R23/25-48/25
Xn; R21
Xi; R38
N; R50-53

Xn
R: 20/21/22-37-40-41-48/20
S: 26-36/37/39

Xn; N
R: 21/22-38-43-50/53-68
S: 22-23-36/37-60-61

Xn; N
R: 22-41-43-51/53
S: (2-)24-26-37/39-61

Xn; N
R: 22-43-51/53
S: (2-)24-37-61

Xn
R: 22-43-62-52/53
S: (2-)22-36/37-61

T; N
R: 21-23/25-38-48/25-50/53
S: (1/2-)36/37/39-38-45-60-61

Carc. Cat. 3; R40
Xn; R20/22
N; R51-53

Xn; N
R: 20/22-40-51/53
S: (2-)36/37-41-61

Carc. Cat. 3; R40
Repr. Cat. 2; R61
Repr. Cat. 3; R62
N; R51-53

T; N
R: 61-40-62-51/53
S: 53-45-61

R10
Xn; R21/22-48/20
C; R34

C
R: 10-21/22-34-48/20
S: (1/2-)16-26-36/37/39-45

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
7
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

613-177-00-X 8-amino-7-methylquinoline

412-760-4

5470-82-6

613-178-00-5 4-ethyl-2-methyl-2-isopentyl-1,3-

410-470-2

137796-06-6

oxazolidine

613-179-00-0 lithium 3-oxo-1,2(2H)-benzisothiazol-

411-690-1

111337-53-2

2-ide

Xn; R21/22
R43
N; R51/53

C; R34
R43

Xn; R22
C; R34
R43
N; R51-53

613-180-00-6 N-(1,1-dimethylethyl)bis(2-benzothiazole-

407-430-1

3741-80-8

N; R50-53

sulfen)amide

Xn; N
R: 21/22-43-51/53
S: (2-)36/37-61

C
R: 34-43
S: (1/2-)7/8-26-36/37/39-45

C ¯ 10 %: C; R34-43
5 % ˜ C < 10 %: Xi;
R36/37/38-43
1 % ˜ C < 5 %: R43

C; N
R: 22-34-43-51/53
S: (1/2-)26-36/37/39-45-61

N
R: 50/53
S: 60-61

615-024-00-2 2-phenylethylisocyanate

413-080-0

1943-82-4

615-025-00-8 4,4¡-ethylidenediphenyl dicyanate

405-740-1

47073-92-7

615-026-00-3 4,4¡-methylenebis(2,6-dimethylphenyl

405-790-4

101657-77-6

cyanate)

615-028-00-4 ethyl 2-(isocyanatosulfonyl)benzoate

410-220-2

77375-79-2

615-029-00-X 2,5-bis-isocyanatomethyl-bi-

411-280-2

(cid:151)

cyclo[2.2.1]heptane

T; R23
Xn; R22
C; R35
R42/43
N; R51-53

T; C; N
R: 22-23-35-42/43-51/53
S: (1/2-)23-26-36/37/39-43-
45-61

Xn; R20/22-48/22
Xi; R41
N; R50-53

Xn; N
R: 20/22-41-48/22-50/53
S: (2-)26-36/37/39-60-61

R43
R52-53

Xi
R: 43-52/53
S: (2-)22-24-37-61

E; R2
R14
Xn; R22-48/22
Xi; R41
R42/43

T+; R26
Xn; R22
C; R34
R42/43
R52-53

E; Xn
R: 2-14-22-41-42/43-48/22
S: (2-)8-23-26-30-35-36/37/39

T+
R: 22-26-34-42/43-52/53
S: (1/2-)23-26-28-36/37/
39-45-61

L

2
2
5
/
7
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

616-052-00-8 formamide

200-842-0

75-12-7

Repr. Cat. 2; R61

616-053-00-3 N-methylacetamide

201-182-6

79-16-3

Repr. Cat. 2; R61

T
R: 61
S: 53-45

T
R: 61
S: 53-45

616-054-00-9 iprodione (ISO)

253-178-9

36734-19-7

3-(3,5-dichlorophenyl)-2,4-dioxo-N-iso-
propylimidazolidine-1-carboxamide

616-055-00-4 propyzamide (ISO)

245-951-4

23950-58-5

3,5-dichloro-N-(1,1-dimethylprop-
2-ynyl)benzamide

616-056-00-X N-methylformamide

E

204-624-6

123-39-7

616-057-00-5 a mixture of: N-[3-hydroxy-2-

412-790-8

(cid:151)

(2-methylacryloylaminomethoxy)pro-
poxymethyl]-2-methylacrylamide;
N-[2,3-bis-(2-methylacryloylaminome-
thoxy)propoxymethyl]-2-methylacryla-
mide; methacrylamide;
2-methyl-N-(2-methylacryloylaminome-
thoxymethyl)-acrylamide; N-(2,3-dihy-
droxypropoxymethyl)-2-methylacryla-
mide

Carc. Cat. 3; R40
N; R50-53

Xn; N
R: 40-50/53
S: (2-)36/37-60-61

Carc. Cat. 3; R40
N; R50-53

Xn; N
R: 40-50/53
S: (2-)36/37-60-61

Repr. Cat. 2; R61
Xn; R21

T
R: 61-21
S: 53-45

Carc. Cat. 2; R45
Muta. Cat. 3; R68
Xn; R48/22

T
R: 45-48/22
S: 53-45

616-058-00-0 1,3-bis(3-methyl-2,5-dioxo-1H-pyrroli-

412-570-1

119462-56-5

nylmethyl)benzene

Xn; R48/22
Xi; R41
R43
N; R50-53

Xn; N
R: 41-43-48/22-50/53
S: (2-)26-36/37/39-60-61

616-059-00-6 4-((4-(diethylamino)-2-ethoxyphe-

412-650-6

121487-83-0

R53

nyl)imino)-1,4-dihydro-1-oxo-N-propyl-
2-naphthalenecarboxamide

R: 53
S: 61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
7
3

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

616-060-00-1 condensation product of:

413-770-1

(cid:151)

3-(7-carboxyhept-1-yl)-6-hexyl-4-cyclo-
hexene-1,2-dicarboxylic acid with
polyamines (primarily
aminoethylpiperazine and
triethylenetetramine)

616-061-00-7 N,N¡-1,6-hexanediylbis(N-(2,2,6,6-tetra-

413-610-0

124172-53-8

methyl-piperidin-4-yl)formamide

616-062-00-2 N-[3-[(2-acetyloxy)ethyl](phenyl-

411-590-8

70693-57-1

methyl)amino]-4-methoxyphenylaceta-
mide

616-063-00-8 3-dodecyl-(1-(1,2,2,6,6-pentamethyl-4-pi-

411-920-0

106917-30-0

peridin)-yl)-2,5-pyrrolidindione

Xn; R22
C; R34
R43
N; R50-53

Xi; R36
R52-53

C; R34
R52-53

C; N
R: 22-34-43-50/53
S: (1/2-)26-36/37/39-45-60-61

Xi
R: 36-52/53
S: (2-)26-61

C
R: 34-52/53
S: (1/2-)26-36/37/39-45-61

T; R23
Xn; R22-48/22
C; R35
N; R50-53

T; C; N
R: 22-23-35-48/22-50/53
S: (1/2-)26-28-36/37/39-45-
60-61

616-064-00-3 N-tert-butyl-3-methylpicolinamide

406-720-5

32998-95-1

R52-53

616-065-00-9 3¡-(3-acetyl-4-hydroxyphenyl)-1,1-diethy-

411-970-3

79881-89-3

Xn; R22-48/22

lurea

616-066-00-4 5,6,12,13-tetrachloroan-

405-100-1

115662-06-1

Repr. Cat. 3; R62

thra(2,1,9-def:6,5,10-d¡e¡f¡)diisoquinoline-
1,3,8,10(2H,9H)-tetrone

616-067-00-X dodecyl 3-(2-(3-benzyl-4-ethoxy-2,5-dio-
xoimidazolidin-1-yl)-4,4-dimethyl-3-ox-
ovaleramido)-4-chlorobenzoate

407-300-4

92683-20-0

R53

616-068-00-5 potassium 4-(11-methacrylamidoundec-

406-500-9

174393-75-0

R43

anamido)benzenesulfonate

616-069-00-0 1-hydroxy-5-(2-methylpropyloxycarbony-
lamino)-N-(3-dodecyloxypropyl)-2-naph-
thoamide

406-210-2

110560-22-0

R53

R: 52/53
S: 61

Xn
R: 22-48/22
S: (2-)22-36

Xn
R: 62
S: (2-)22-36/37

R: 53
S: 61

Xi
R: 43
S: (2-)22-24-37

R: 53
S: 61

L

2
2
5
/
7
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

616-070-00-6 a mixture of: 3,3¡-dicyclohexyl-

406-530-2

(cid:151)

R53

1,1¡-methylenebis(4,1-phenylene)diurea;
3-cyclohexyl-1-(4-(4-(3-octadecylure-
ido)benzyl)phenyl)urea;3,3¡-dioctadecyl-
1,1¡-methylenebis(4,1-phenylene)diurea

R: 53
S: 22-61

616-071-00-1 a mixture (1:2:1) of: bis(N-

406-550-1

(cid:151)

cyclohexyl-N¡-phenyleneureido)methyl-
ene; bis(N-octadecyl-N¡-phenyleneur-
eido)methylene; bis(N-dicyclohexyl-
N¡-phenyleneureido)methylene

R43
R53

Xi
R: 43-53
S: (2-)22-24-37-61

616-072-00-7 1-(2-deoxy-5-O-trityl-(cid:223)-D-threopentofur-

407-120-6

55612-11-8

R53

anosyl)thymine

R: 53
S: 61

616-073-00-2 4¡-ethoxy-2-benzimidazoleanilide

407-600-5

120187-29-3

Muta. Cat. 3; R68
R53

Xn
R: 68-53
S: (2-)22-36/37-61

616-074-00-8 N-butyl-2-(4-morpholinylcarbonyl)benza-

407-730-2

104958-67-0

mide

616-075-00-3 D,L-(N,N-diethyl-2-hydroxy-2-phenylace-

408-120-9

65197-96-8

tamide)

Xi; R36
R43
R52-53

Xn; R22
Xi; R41

616-076-00-9 N-tert-butyl-N¡-(4-ethylbenzoyl)-3,5-di-
methylbenzohydrazide

412-850-3

112410-23-8

N; R51-53

616-077-00-4 a mixture of: 2-(9-methyl-1,3,8,10-

411-310-4

(cid:151)

Xi; R41

tetraoxo-2,3,9,10-tetrahydro-(1H,8H)-an-
thra[2,1,9-def: 6,5,10-d¡e¡f¡]diisoquinolin-
2-ylethansulfonic acid; potassium
2-(9-methyl-1,3,8,10-tetraoxo-
2,3,9,10-tetrahydro-(1H,8H)-an-
thra[2,1,9-def: 6,5,10-d¡e¡f¡]diisoquinolin-
2-ylethansulfate

Xi
R: 36-43-52/53
S: (2-)24-26-37-61

Xn
R: 22-41
S: (2-)26-39-(46-)

N
R: 51/53
S: 61

Xi
R: 41
S: (2-)26-39

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
7
5

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

616-078-00-X 2-[2,4-bis(1,1-dimethyl-ethyl)phen-

411-330-3

104541-33-5

R53

oxy]-N-(2-hydroxy-5-methyl-phenyl)hex-
anamide

616-079-00-5 1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-

411-700-4

140921-24-0

R43

3-oxazolidinyl)ethyl)carbamate

616-080-00-0 4-(2-((3-ethyl-4-methyl-2-oxo-pyrrolin-
1-yl)carboxamido)ethyl)benzenesulfon-
amide)

411-850-0

119018-29-0

R52-53

R: 53
S: 61

Xi
R: 43
S: (2-)24-37

R: 52/53
S: 61

616-081-00-6 5-bromo-8-naphtholactam

413-480-5

24856-00-6

Xn; R22
R43
N; R50-53

Xn; N
R: 22-43-50/53
S: (2-)22-24-37-60-61

616-082-00-1 N-(5-chloro-3-((4-(diethylamino)-

413-200-1

129604-78-0

R43

2-methylphenyl)imino-4-methyl-6-oxo-
1,4-cyclohexadien-1-yl)benzamide

616-083-00-7 [2-[(4-nitrophenyl)amino]ethyl]urea

410-700-1

27080-42-8

R43
R52-53

616-084-00-2 2,4-bis[N¡-(4-methylphenyl)ureido]to-

411-790-5

(cid:151)

N; R50-53

luene

616-085-00-8 3-(2,4-dichlorophenyl)-6-fluoroquinazo-
line-2,4(1H,3H)-dione

412-190-6

168900-02-5

N; R50-53

616-086-00-3 2-acetylamino-6-chloro-4-[(4-diethy-

412-250-1

102387-48-4

R53

lamino)2-methylphenyl-imino]-5-methyl-
1-oxo-2,5-cyclohexadiene

Xi
R: 43
S: (2-)24-37

Xi
R: 43-52/53
S: (2-)24-37-61

N
R: 50/53
S: 60-61

N
R: 50/53
S: 60-61

R: 53
S: 61

616-087-00-9 a mixture of:

412-260-6

52658-19-2

7,9,9-trimethyl-3,14-dioxa-4,13-dioxo-
5,12-diazahexadecane-1,16-diyl-prop-
2-enoate; 7,7,9-trimethyl-3,14-dioxa-
4,13-dioxo-5,12-diazahexadecan-
1,16-diylprop-2-enoate

Xi; R36
R43
N; R51-53

Xi; N
R: 36-43-51/53
S: (2-)26-36/37-61

L

2
2
5
/
7
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

Index No

Chemical name

Notes
related to
substances

EC No

CAS No

Classification

Labelling

Concentration limits

Notes
related to
preparations

616-088-00-4 2-aminosulfonyl-N,N-dimethylnicotina-

413-440-7

112006-75-4

mide

R43
R52-53

616-089-00-X 5-(2,4-dioxo-1,2,3,4-tetrahydropyrimid-
ine)-3- fluoro-2-hydroxymethyltetrahy-
drofuran

415-360-8

41107-56-6

Muta. Cat. 3; R68

Xi
R: 43-52/53
S: (2-)24-37-61

Xn
R: 68
S: (2-)22-36/37

616-090-00-5 1-(1,4-benzodioxan-2-ylcarbonyl)piper-

415-660-9

70918-74-0

azine hydrochloride

616-091-00-0 1,3,5-tris-[(2S and

E

423-400-0

59653-74-6

2R)-2,3-epoxypropyl]-1,3,5-triazine-
2,4,6-(1H,3H,5H)-trione

617-016-00-4 3-hydroxy-1,1-dimethylbutyl 2-ethyl-

413-910-1

(cid:151)

2-methylheptaneperoxoate

617-017-00-X a mixture of: 2,2¡-bis(tert-pentylperoxy)-
p-diisopropylbenzene; 2,2¡-bis(tert-pen-
tylperoxy)-m-diisopropylbenzene

412-140-3

32144-25-5

T; R23/24/25
Xn; R48/22
N; R51-53

T; N
R: 23/24/25-48/22-51/53
S: 53-45-61

Muta. Cat. 2; R46
T; R23
Xn; R22-48/22
Xi; R41
R43

O; R7
R10
Xi; R38
N; R50-53

O; R7
R53

T
R: 46-22-23-41-43-48/22
S: 53-45

O; Xi; N
R: 7-10-38-50/53
S: (2-)7/47-14-36/37/39-60-61

O
R: 7-53
S: (2-)3/7-14-36/37/39-61

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
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s

L

2
2
5
/
7
7

L 225/78

EN

Official Journal of the European Communities

21.8.2001

ANNEX 1D

Index No

601-050-00-1

609-017-00-3

613-006-00-9

612-111-00-7

612-128-00-X

612-147-00-3

612-148-00-9

613-048-00-8

613-049-00-3

613-140-00-8

615-023-00-7

603-066-00-4

006-005-00-4

006-012-00-2

015-022-00-6

015-048-00-8

015-072-00-9

023-001-00-8

024-012-00-0

602-002-00-2

048-003-00-6

048-004-00-1

048-005-00-7

ANNEX 1E

Index No

602-079-00-2

603-056-00-X

604-009-00-6

604-042-00-6

604-055-00-7

605-016-00-7

609-020-00-X

612-033-00-3

ANNEX 1F

Index No

048-007-00-8

602-025-00-8

603-029-00-2

ANNEX 1G

Index No

015-015-00-8

21.8.2001

EN

Official Journal of the European Communities

L 225/79

ANNEX 1H

Index No

603-001-00-X

ANNEX 1I

Index No

605-020-00-9

609-007-00-9

609-049-00-8

ANNEX 1J

Index No

611-001-00-6

612-035-00-4

612-051-00-1

016-023-00-4

601-048-00-0

603-063-00-8

604-005-00-4

612-145-00-2

612-146-00-8

L 225/80

EN

Official Journal of the European Communities

21.8.2001

ANEXO II (cid:151) BILAG II (cid:151) ANHANG II (cid:151) PAQAQSGLA II (cid:151) ANNEX II (cid:151) ANNEXE II (cid:151) ALLEGATO II (cid:151) BIJLAGE II
(cid:151) ANEXO II (cid:151) LIITE II (cid:151) BILAGA II (cid:151)

ANNEX 2

ANEXO II

S(cid:237)mbolos e indicaciones de peligro de las sustancias y preparados peligrosos

BILAG II

Faresymboler og farebetegnelser for farlige stoffer og pr(cid:230)parater

ANHANG II

Gefahrensymbole und -bezeichnungen f(cid:252)r gef(cid:228)hrliche Stoffe und Zubereitungen

PAQAQSGLA II

R(cid:253)lboka jai emde(cid:223)neiy jimd(cid:253)mot cia epij(cid:223)mdtmey otr(cid:223)ey jai paqarjet(cid:220)rlasa

ANNEX II

Symbols and indications of danger for dangerous substances and preparations

ANNEXE II

Symboles et indications de danger des substances et prØparations dangereuses

ALLEGATO II

Simboli e indicazioni di pericolo delle sostanze e preparati pericolosi

BIJLAGE II

Gevaarsymbolen en -aanduidingen van gevaarlijke stoffen en preparaten

ANEXO II

S(cid:237)mbolos e indica(cid:231)ıes de perigo das subst(cid:226)ncias e prepara(cid:231)ıes perigosas

LIITE II

Varoitusmerkit ja niiden nimet vaarallisille aineille ja valmisteille

BILAGA II

Farosymboler och farobeteckningar f(cid:246)r farliga (cid:228)mnen och beredningar

21.8.2001

EN

Official Journal of the European Communities

L 225/81

Nota: Las letras E, O, F, F+, T, T+, C, Xn, Xi y N no forman parte del s(cid:237)mbolo.

Bem(cid:230)rkning: Bogstaverne E, O, F, F+, T, T+, C, Xn, Xi og N udgłr ikke en del af symbolet.

Anmerkung: Die Buchstaben E, O, F, F+, T, T+, C, Xn, Xi und N sind nicht Bestandteil des Gefahrensymbols.

Rgle(cid:223)xrg: Sa cq(cid:220)llasa E, O, F, F+, T, T+, C, Xn, Xi jai N dem aposeko(cid:253)m l(cid:221)qoy sot rtlb(cid:252)kot.

Note: The letters E, O, F, F+, T, T+, C, Xn, Xi and N do not form part of the symbol.

Remarque: Les lettres E, O, F, F+, T, T+, C, Xn, Xi et N ne font pas partie du symbole.

Nota: Le lettere E, O, F, F+, T, T+, C, Xn, Xi e N non fanno parte del simbolo.

Opmerking: De letters E, O, F, F+, T, T+, C, Xn, Xi en N maken geen deel uit van het gevaarsymbool.

Nota: As letras E, O, F, F+, T, T+, C, Xn, Xi e N nªo fazem parte do s(cid:237)mbolo.

Huomautus: Varoitusmerkkien kirjaintunnukset E, O, F, F+, T, T+, C, Xn, Xi ja N eiv(cid:228)t ole osa varoitusmerkki(cid:228).

Anm(cid:228)rkning: Bokst(cid:228)verna E, O, F, F+, T, T+, C, Xn, Xi och N utg(cid:246)r inte en del av symbolen.

E

ES: Explosivo
DA: Eksplosiv
DE: Explosionsgef(cid:228)hrlich
EL: Ejqgjsij(cid:252)
EN: Explosive
FR: Explosif
IT: Esplosivo
NL: Ontplofbaar
PT: Explosivo
FI: R(cid:228)j(cid:228)ht(cid:228)v(cid:228)
SV: Explosivt

O

ES: Comburente
DA: Brandn(cid:230)rende
DE: Brandf(cid:246)rdernd
EL: Oneidxsij(cid:252)
EN: Oxidising
FR: Comburant
IT: Comburente
NL: Oxiderend
PT: Comburente
FI: Hapettava
SV: Oxiderande

L 225/82

EN

Official Journal of the European Communities

21.8.2001

F

ES: FÆcilmente inflamable
DA: Meget brandfarlig
DE: Leichtentz(cid:252)ndlich
EL: Pok(cid:253) e(cid:253)ukejso
EN: Highly flammable
FR: Facilement inflammable
IT: Facilmente infiammabile
NL: Licht ontvlambaar
PT: Facilmente inflamÆvel
FI: Helposti syttyv(cid:228)
SV: Mycket brandfarligt

F+

ES: Extremadamente inflamable
DA: Yderst brandfarlig
DE: Hochentz(cid:252)ndlich
EL: Enaiqesij(cid:220) e(cid:253)ukejso
EN: Extremely flammable
FR: ExtrŒmement inflammable
IT: Estremamente infiammabile
NL: Zeer licht ontvlambaar
PT: Extremamente inflamÆvel
FI: Eritt(cid:228)in helposti syttyv(cid:228)
SV: Extremt brandfarligt

T

ES: T(cid:243)xico
DA: Giftig
DE: Giftig
EL: Sonij(cid:252)
EN: Toxic
FR: Toxique
IT: Tossico
NL: Vergiftig
PT: T(cid:243)xico
FI: Myrkyllinen
SV: Giftig

21.8.2001

EN

Official Journal of the European Communities

L 225/83

T+

ES: Muy t(cid:243)xico
DA: Meget giftig
DE: Sehr giftig
EL: Pok(cid:253) sonij(cid:252)
EN: Very toxic
FR: TrŁs toxique
IT: Molto tossico
NL: Zeer vergiftig
PT: Muito t(cid:243)xico
FI: Eritt(cid:228)in myrkyllinen
SV: Mycket giftig

C

ES: Corrosivo
DA: ˘tsende
DE: ˜tzend
EL: Diabqxsij(cid:252)
EN: Corrosive
FR: Corrosif
IT: Corrosivo
NL: Bijtend
PT: Corrosivo
FI: Sy(cid:246)vytt(cid:228)v(cid:228)
SV: Fr(cid:228)tande

Xn

ES: Nocivo
DA: Sundhedsskadelig
DE: Gesundheitssch(cid:228)dlich
EL: Epibkab(cid:221)y
EN: Harmful
FR: Nocif
IT: Nocivo
NL: Schadelijk
PT: Nocivo
FI: Haitallinen
SV: H(cid:228)lsoskadlig

L 225/84

EN

Official Journal of the European Communities

21.8.2001

Xi

ES: Irritante
DA: Lokalirriterende
DE: Reizend
EL: Eqehirsij(cid:252)
EN: Irritant
FR: Irritant
IT: Irritante
NL: Irriterend
PT: Irritante
FI: ˜rsytt(cid:228)v(cid:228)
SV: Irriterande

N

ES: Peligroso para el medio ambiente
DA: Miljłfarlig
DE: Umweltgef(cid:228)hrlich
EL: Epij(cid:223)mdtmo cia so peqib(cid:220)kkom
EN: Dangerous for the environment
FR: Dangereux pour l’environnement
IT: Pericoloso per l’ambiente
NL: Milieugevaarlijk
PT: Perigoso para o ambiente
FI: Ymp(cid:228)rist(cid:246)lle vaarallinen
SV: Milj(cid:246)farlig

21.8.2001

EN

Official Journal of the European Communities

L 225/85

ANEXO III (cid:151) BILAG III (cid:151) ANHANG III (cid:151) PAQAQSGLA III (cid:151) ANNEX III (cid:151) ANNEXE III (cid:151) ALLEGATO III (cid:151)
BIJLAGE III (cid:151) ANEXO III (cid:151) LIITE III (cid:151) BILAGA III

ANNEX 3

ANEXO III

Naturaleza de los riesgos espec(cid:237)ficos atribuidos a las sustancias y preparados peligrosos

BILAG III

Arten af de s(cid:230)rlige risici, der er forbundet med de farlige stoffer og pr(cid:230)parater

ANHANG III

Bezeichnungen der besonderen Gefahren bei gef(cid:228)hrlichen Stoffen und Zubereitungen

PAQAQSGLA III

U(cid:253)rg sxm eidij(cid:254)m jimd(cid:253)mxm pot auoqo(cid:253)m epij(cid:223)mdtmey otr(cid:223)ey jai paqarjet(cid:220)rlasa

ANNEX III

Nature of special risks attributed to dangerous substances and preparations

ANNEXE III

Nature des risques particuliers attribuØs aux substances et prØparations dangereuses

ALLEGATO III

Natura dei rischi specifici attribuiti alle sostanze e preparati pericolosi

BIJLAGE III

Aard der bijzondere gevaren toegeschreven aan gevaarlijke stoffen en preparaten

ANEXO III

Natureza dos riscos espec(cid:237)ficos atribu(cid:237)dos (cid:224)s subst(cid:226)ncias e prepara(cid:231)ıes perigosas

LIITE III

Erityisten vaarojen luonne liittyen vaarallisiin aineisiin ja valmisteisiin

BILAGA III

Riskfraser som tilldelas farliga (cid:228)mnen och beredningar

L 225/86

EN

Official Journal of the European Communities

21.8.2001

R1

ES: Explosivo en estado seco.

DA: Eksplosiv i tłr tilstand.

DE:

In trockenem Zustand explosionsgef(cid:228)hrlich.

EL: Ejqgjsij(cid:252) re ngq(cid:222) jas(cid:220)rsarg.

EN: Explosive when dry.

FR: Explosif (cid:224) l’Øtat sec.

IT: Esplosivo allo stato secco.

NL:

In droge toestand ontplofbaar.

PT: Explosivo no estado seco.

FI: R(cid:228)j(cid:228)ht(cid:228)v(cid:228)(cid:228) kuivana.

SV: Explosivt i torrt tillst(cid:229)nd.

R2

ES: Riesgo de explosi(cid:243)n por choque, fricci(cid:243)n, fuego u otras fuentes de ignici(cid:243)n.

DA: Eksplosionsfarlig ved stłd, gnidning, ild eller andre ant(cid:230)ndelseskilder.

DE: Durch Schlag, Reibung, Feuer oder andere Z(cid:252)ndquellen explosionsgef(cid:228)hrlich.

EL: J(cid:223)mdtmoy ejq(cid:222)nexy ap(cid:252) jqo(cid:253)rg, sqib(cid:222), uxsi(cid:220) (cid:222) (cid:220)kkey pgc(cid:221)y amauk(cid:221)nexy.

EN: Risk of explosion by shock, friction, fire or other sources of ignition.

FR: Risque d’explosion par le choc, la friction, le feu ou d’autres sources d’ignition.

IT: Rischio di esplosione per urto, sfregamento, fuoco o altre sorgenti d’ignizione.

NL: Ontploffingsgevaar door schok, wrijving, vuur of andere ontstekingsoorzaken.

PT: Risco de explosªo por choque, fric(cid:231)ªo, fogo ou outras fontes de igni(cid:231)ªo.

FI: R(cid:228)j(cid:228)ht(cid:228)v(cid:228)(cid:228) iskun, hankauksen, avotulen tai muun sytytysl(cid:228)hteen vaikutuksesta.

SV: Explosivt vid st(cid:246)t, friktion, eld eller annan ant(cid:228)ndningsorsak.

R3

ES: Alto riesgo de explosi(cid:243)n por choque, fricci(cid:243)n, fuego u otras fuentes de ignici(cid:243)n.

DA: Meget eksplosionsfarlig ved stłd, gnidning, ild eller andre ant(cid:230)ndelseskilder.

DE: Durch Schlag, Reibung, Feuer oder andere Z(cid:252)ndquellen besonders explosionsgef(cid:228)hrlich.

EL: Pok(cid:253) lec(cid:220)koy j(cid:223)mdtmoy ejq(cid:222)nexy ap(cid:252) jqo(cid:253)rg, sqib(cid:222), uxsi(cid:220) (cid:222) (cid:220)kkey pgc(cid:221)y amauk(cid:221)nexy.

EN: Extreme risk of explosion by shock, friction, fire or other sources of ignition.

FR: Grand risque d’explosion par le choc, la friction, le feu ou d’autres sources d’ignition.

IT: Elevato rischio di esplosione per urto, sfregamento, fuoco o altre sorgenti d’ignizione.

NL: Ernstig ontploffingsgevaar door schok, wrijving, vuur of andere ontstekingsoorzaken.

PT: Grande risco de explosªo por choque, fric(cid:231)ªo, fogo ou outras fontes de igni(cid:231)ªo.

FI:

Eritt(cid:228)in helposti r(cid:228)j(cid:228)ht(cid:228)v(cid:228)(cid:228) iskun, hankauksen, avotulen tai muun sytytysl(cid:228)hteen vaikutuksesta.

SV: Mycket explosivt vid st(cid:246)t, friktion, eld eller annan ant(cid:228)ndningsorsak.

R4

ES: Forma compuestos metÆlicos explosivos muy sensibles.

DA: Danner meget fłlsomme eksplosive metalforbindelser.

DE: Bildet hochempfindliche explosionsgef(cid:228)hrliche Metallverbindungen.

EL: Rvglas(cid:223)fei pok(cid:253) eta(cid:223)rhgsey ejqgjsij(cid:221)y lesakkij(cid:221)y em(cid:254)reiy.

EN: Forms very sensitive explosive metallic compounds.

FR: Forme des composØs mØtalliques explosifs trŁs sensibles.

21.8.2001

EN

Official Journal of the European Communities

L 225/87

IT:

Forma composti metallici esplosivi molto sensibili.

NL: Vormt met metalen zeer gemakkelijk ontplofbare verbindingen.

PT: Forma compostos metÆlicos explosivos muito sens(cid:237)veis.

FI: Muodostaa eritt(cid:228)in herk(cid:228)sti r(cid:228)j(cid:228)ht(cid:228)vi(cid:228) metalliyhdisteit(cid:228).

SV: Bildar mycket k(cid:228)nsliga explosiva metallf(cid:246)reningar.

R5

ES: Peligro de explosi(cid:243)n en caso de calentamiento.

DA: Eksplosionsfarlig ved opvarmning.

DE: Beim Erw(cid:228)rmen explosionsf(cid:228)hig.

EL: G h(cid:221)qlamrg lpoqe(cid:223) ma pqojak(cid:221)rei (cid:221)jqgng.

EN: Heating may cause an explosion.

FR: Danger d’explosion sous l’action de la chaleur.

IT:

Pericolo di esplosione per riscaldamento.

NL: Ontploffingsgevaar door verwarming.

PT: Perigo de explosªo sob a ac(cid:231)ªo do calor.

FI: R(cid:228)j(cid:228)hdysvaarallinen kuumennettaessa.

SV: Explosivt vid uppv(cid:228)rmning.

R6

ES: Peligro de explosi(cid:243)n, en contacto o sin contacto con el aire.

DA: Eksplosiv ved og uden kontakt med luft.

DE: Mit und ohne Luft explosionsf(cid:228)hig.

EL: Ejqgjsij(cid:252) re epau(cid:222) (cid:222) vxq(cid:223)y epau(cid:222) le som a(cid:221)qa.

EN: Explosive with or without contact with air.

FR: Danger d’explosion en contact ou sans contact avec l’air.

IT: Esplosivo a contatto o senza contatto con l’aria.

NL: Ontplofbaar met en zonder lucht.

PT: Perigo de explosªo com ou sem contacto com o ar.

FI: R(cid:228)j(cid:228)ht(cid:228)v(cid:228)(cid:228) sellaisenaan tai ilman kanssa.

SV: Explosivt vid kontakt och utan kontakt med luft.

R7

ES: Puede provocar incendios.

DA: Kan for(cid:229)rsage brand.

DE: Kann Brand verursachen.

EL: Lpoqe(cid:223) ma pqojak(cid:221)rei ptqjaci(cid:220).

EN: May cause fire.

FR: Peut provoquer un incendie.

IT:

Pu(cid:242) provocare un incendio.

NL: Kan brand veroorzaken.

PT: Pode provocar incŒndio.

FI: Aiheuttaa tulipalon vaaran.

SV: Kan orsaka brand.

L 225/88

EN

Official Journal of the European Communities

21.8.2001

R8

ES: Peligro de fuego en contacto con materias combustibles.

DA: Brandfarlig ved kontakt med brandbare stoffer.

DE: Feuergefahr bei Ber(cid:252)hrung mit brennbaren Stoffen.

EL: G epau(cid:222) le ja(cid:253)rilo tkij(cid:252) lpoqe(cid:223) ma pqojak(cid:221)rei ptqjaci(cid:220).

EN: Contact with combustible material may cause fire.

FR: Favorise l’inflammation des matiŁres combustibles.

IT:

Pu(cid:242) provocare l’accensione di materie combustibili.

NL: Bevordert de ontbranding van brandbare stoffen.

PT: Favorece a inflama(cid:231)ªo de matØrias combust(cid:237)veis.

FI: Aiheuttaa tulipalon vaaran palavien aineiden kanssa.

SV: Kontakt med br(cid:228)nnbart material kan orsaka brand.

R9

ES: Peligro de explosi(cid:243)n al mezclar con materias combustibles.

DA: Eksplosionsfarlig ved blanding med brandbare stoffer.

DE: Explosionsgefahr bei Mischung mit brennbaren Stoffen.

EL: Ejqgjsij(cid:252) (cid:252)sam amaleivhe(cid:223) le ja(cid:253)rila tkij(cid:220).

EN: Explosive when mixed with combustible material.

FR: Peut exploser en mØlange avec des matiŁres combustibles.

IT: Esplosivo in miscela con materie combustibili.

NL: Ontploffingsgevaar bij menging met brandbare stoffen.

PT: Pode explodir quando misturado com matØrias combust(cid:237)veis.

FI: R(cid:228)j(cid:228)ht(cid:228)v(cid:228)(cid:228) sekoitettaessa palavien aineiden kanssa.

SV: Explosivt vid blandning med br(cid:228)nnbart material.

R10

ES:

Inflamable.

DA: Brandfarlig.

DE: Entz(cid:252)ndlich.

EL: E(cid:253)ukejso.

EN: Flammable.

FR:

Inflammable.

IT:

Infiammabile.

NL: Ontvlambaar.

PT:

InflamÆvel.

FI:

Syttyv(cid:228)(cid:228).

SV: Brandfarligt.

R11

ES: FÆcilmente inflamable.

DA: Meget brandfarlig.

DE: Leichtentz(cid:252)ndlich.

EL: Pok(cid:253) e(cid:253)ukejso.

EN: Highly flammable.

FR: Facilement inflammable.

21.8.2001

EN

Official Journal of the European Communities

L 225/89

IT:

Facilmente infiammabile.

NL: Licht ontvlambaar.

PT: Facilmente inflamÆvel.

FI: Helposti syttyv(cid:228)(cid:228).

SV: Mycket brandfarligt.

R12

ES: Extremadamente inflamable.

DA: Yderst brandfarlig.

DE: Hochentz(cid:252)ndlich.

EL: Enaiqesij(cid:220) e(cid:253)ukejso.

EN: Extremely flammable.

FR: ExtrŒmement inflammable.

IT: Estremamente infiammabile.

NL: Zeer licht ontvlambaar.

PT: Extremamente inflamÆvel.

FI:

Eritt(cid:228)in helposti syttyv(cid:228)(cid:228).

SV: Extremt brandfarligt.

R14

ES: Reacciona violentamente con el agua.

DA: Reagerer voldsomt med vand.

DE: Reagiert heftig mit Wasser.

EL: Amsidq(cid:220) b(cid:223)aia le meq(cid:252).

EN: Reacts violently with water.

FR: RØagit violemment au contact de l’eau.

IT: Reagisce violentemente con l’acqua.

NL: Reageert heftig met water.

PT: Reage violentamente em contacto com a Ægua.

FI: Reagoi voimakkaasti veden kanssa.

SV: Reagerar h(cid:228)ftigt med vatten.

R15

ES: Reacciona con el agua liberando gases extremadamente inflamables.

DA: Reagerer med vand under dannelse af yderst brandfarlige gasser.

DE: Reagiert mit Wasser unter Bildung hochentz(cid:252)ndlicher Gase.

EL: Re epau(cid:222) le so meq(cid:252) ejk(cid:253)ei enaiqesij(cid:220) e(cid:253)ukejsa a(cid:221)qia.

EN: Contact with water liberates extremely flammable gases.

FR: Au contact de l’eau, dØgage des gaz extrŒmement inflammables.

IT: A contatto con l’acqua libera gas estremamente infiammabili.

NL: Vormt zeer licht ontvlambaar gas in contact met water.

PT: Em contacto com a Ægua liberta gases extremamente inflamÆveis.

FI: Vapauttaa eritt(cid:228)in helposti syttyvi(cid:228) kaasuja veden kanssa.

SV: Vid kontakt med vatten bildas extremt brandfarliga gaser.

L 225/90

EN

Official Journal of the European Communities

21.8.2001

R16

ES: Puede explosionar en mezcla con substancias comburentes.

DA: Eksplosionsfarlig ved blanding med oxiderende stoffer.

DE: Explosionsgef(cid:228)hrlich in Mischung mit brandf(cid:246)rdernden Stoffen.

EL: Ejqgjsij(cid:252) (cid:252)sam amaleivhe(cid:223) le oneidxsij(cid:221)y otr(cid:223)ey.

EN: Explosive when mixed with oxidising substances.

FR: Peut exploser en mØlange avec des substances comburantes.

IT:

Pericolo di esplosione se mescolato con sostanze comburenti.

NL: Ontploffingsgevaar bij menging met oxiderende stoffen.

PT: Explosivo quando misturado com subst(cid:226)ncias comburentes.

FI: R(cid:228)j(cid:228)ht(cid:228)v(cid:228)(cid:228) hapettavien aineiden kanssa.

SV: Explosivt vid blandning med oxiderande (cid:228)mnen.

R17

ES: Se inflama espontÆneamente en contacto con el aire.

DA: Selvant(cid:230)ndelig i luft.

DE: Selbstentz(cid:252)ndlich an der Luft.

EL: Atsoamauk(cid:221)cesai rsom a(cid:221)qa.

EN: Spontaneously flammable in air.

FR: SpontanØment inflammable (cid:224) l’air.

IT:

Spontaneamente infiammabile all’aria.

NL: Spontaan ontvlambaar in lucht.

PT: Espontaneamente inflamÆvel ao ar.

FI:

Itsest(cid:228)(cid:228)n syttyv(cid:228)(cid:228) ilmassa.

SV: Sj(cid:228)lvant(cid:228)nder i luft.

R18

ES: Al usarlo pueden formarse mezclas aire-vapor explosivas/inflamables.

DA: Ved brug kan brandbare dampe/eksplosive damp-luftblandinger dannes.

DE: Bei Gebrauch Bildung explosionsf(cid:228)higer/leichtentz(cid:252)ndlicher Dampf/Luft-Gemische m(cid:246)glich.

EL: Jas(cid:220) sg vq(cid:222)rg lpoqe(cid:223) ma rvglas(cid:223)rei e(cid:253)ukejsa/ejqgjsij(cid:220) le(cid:223)clasa aslo(cid:253)-a(cid:221)qoy.

EN:

In use, may form flammable/explosive vapour-air mixture.

FR: Lors de l’utilisation, formation possible de mØlange vapeur-air inflammable/explosif.

IT: Durante l’uso pu(cid:242) formare con aria miscele esplosive/infiammabili.

NL: Kan bij gebruik een ontvlambaar/ontplofbaar damp-luchtmengsel vormen.

PT: Pode formar mistura vapor-ar explosiva/inflamÆvel durante a utiliza(cid:231)ªo.

FI: K(cid:228)yt(cid:246)ss(cid:228) voi muodostua syttyv(cid:228)/r(cid:228)j(cid:228)ht(cid:228)v(cid:228) h(cid:246)yry-ilmaseos.

SV: Vid anv(cid:228)ndning kan br(cid:228)nnbara/explosiva (cid:229)ng-luftblandningar bildas.

R19

ES: Puede formar per(cid:243)xidos explosivos.

DA: Kan danne eksplosive peroxider.

DE: Kann explosionsf(cid:228)hige Peroxide bilden.

EL: Lpoqe(cid:223) ma rvglas(cid:223)rei ejqgjsij(cid:220) tpeqone(cid:223)dia.

EN: May form explosive peroxides.

FR: Peut former des peroxydes explosifs.

21.8.2001

EN

Official Journal of the European Communities

L 225/91

IT:

Pu(cid:242) formare perossidi esplosivi.

NL: Kan ontplofbare peroxiden vormen.

PT: Pode formar per(cid:243)xidos explosivos.

FI:

Saattaa muodostaa r(cid:228)j(cid:228)ht(cid:228)vi(cid:228) peroksideja.

SV: Kan bilda explosiva peroxider.

R20

ES: Nocivo por inhalaci(cid:243)n.

DA: Farlig ved ind(cid:229)nding.

DE: Gesundheitssch(cid:228)dlich beim Einatmen.

EL: Epibkab(cid:221)y (cid:252)sam eirpm(cid:221)esai.

EN: Harmful by inhalation.

FR: Nocif par inhalation.

IT: Nocivo per inalazione.

NL: Schadelijk bij inademing.

PT: Nocivo por inala(cid:231)ªo.

FI: Terveydelle haitallista hengitettyn(cid:228).

SV: Farligt vid inandning.

R21

ES: Nocivo en contacto con la piel.

DA: Farlig ved hudkontakt.

DE: Gesundheitssch(cid:228)dlich bei Ber(cid:252)hrung mit der Haut.

EL: Epibkab(cid:221)y re epau(cid:222) le so d(cid:221)qla.

EN: Harmful in contact with skin.

FR: Nocif par contact avec la peau.

IT: Nocivo a contatto con la pelle.

NL: Schadelijk bij aanraking met de huid.

PT: Nocivo em contacto com a pele.

FI: Terveydelle haitallista joutuessaan iholle.

SV: Farligt vid hudkontakt.

R22

ES: Nocivo por ingesti(cid:243)n.

DA: Farlig ved indtagelse.

DE: Gesundheitssch(cid:228)dlich beim Verschlucken.

EL: Epibkab(cid:221)y re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful if swallowed.

FR: Nocif en cas d’ingestion.

IT: Nocivo per ingestione.

NL: Schadelijk bij opname door de mond.

PT: Nocivo por ingestªo.

FI: Terveydelle haitallista nieltyn(cid:228).

SV: Farligt vid f(cid:246)rt(cid:228)ring.

L 225/92

EN

Official Journal of the European Communities

21.8.2001

R23

ES: T(cid:243)xico por inhalaci(cid:243)n.

DA: Giftig ved ind(cid:229)nding.

DE: Giftig beim Einatmen.

EL: Sonij(cid:252) (cid:252)sam eirpm(cid:221)esai.

EN: Toxic by inhalation.

FR: Toxique par inhalation.

IT: Tossico per inalazione.

NL: Vergiftig bij inademing.

PT: T(cid:243)xico por inala(cid:231)ªo.

FI: Myrkyllist(cid:228) hengitettyn(cid:228).

SV: Giftigt vid inandning.

R24

ES: T(cid:243)xico en contacto con la piel.

DA: Giftig ved hudkontakt.

DE: Giftig bei Ber(cid:252)hrung mit der Haut.

EL: Sonij(cid:252) re epau(cid:222) le so d(cid:221)qla.

EN: Toxic in contact with skin.

FR: Toxique par contact avec la peau.

IT: Tossico a contatto con la pelle.

NL: Vergiftig bij aanraking met de huid.

PT: T(cid:243)xico em contacto com a pele.

FI: Myrkyllist(cid:228) joutuessaan iholle.

SV: Giftigt vid hudkontakt.

R25

ES: T(cid:243)xico por ingesti(cid:243)n.

DA: Giftig ved indtagelse.

DE: Giftig beim Verschlucken.

EL: Sonij(cid:252) re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Toxic if swallowed.

FR: Toxique en cas d’ingestion.

IT: Tossico per ingestione.

NL: Vergiftig bij opname door de mond.

PT: T(cid:243)xico por ingestªo.

FI: Myrkyllist(cid:228) nieltyn(cid:228).

SV: Giftigt vid f(cid:246)rt(cid:228)ring.

R26

ES: Muy t(cid:243)xico por inhalaci(cid:243)n.

DA: Meget giftig ved ind(cid:229)nding.

DE: Sehr giftig beim Einatmen.

EL: Pok(cid:253) sonij(cid:252) (cid:252)sam eirpm(cid:221)esai.

EN: Very toxic by inhalation.

FR: TrŁs toxique par inhalation.

21.8.2001

EN

Official Journal of the European Communities

L 225/93

IT: Molto tossico per inalazione.

NL: Zeer vergiftig bij inademing.

PT: Muito t(cid:243)xico por inala(cid:231)ªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228) hengitettyn(cid:228).

SV: Mycket giftigt vid inandning.

R27

ES: Muy t(cid:243)xico en contacto con la piel.

DA: Meget giftig ved hudkontakt.

DE: Sehr giftig bei Ber(cid:252)hrung mit der Haut.

EL: Pok(cid:253) sonij(cid:252) re epau(cid:222) le so d(cid:221)qla.

EN: Very toxic in contact with skin.

FR: TrŁs toxique par contact avec la peau.

IT: Molto tossico a contatto con la pelle.

NL: Zeer vergiftig bij aanraking met de huid.

PT: Muito t(cid:243)xico em contacto com a pele.

FI:

Eritt(cid:228)in myrkyllist(cid:228) joutuessaan iholle.

SV: Mycket giftigt vid hudkontakt.

R28

ES: Muy t(cid:243)xico por ingesti(cid:243)n.

DA: Meget giftig ved indtagelse.

DE: Sehr giftig beim Verschlucken.

EL: Pok(cid:253) sonij(cid:252) re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Very toxic if swallowed.

FR: TrŁs toxique en cas d’ingestion.

IT: Molto tossico per ingestione.

NL: Zeer vergiftig bij opname door de mond.

PT: Muito t(cid:243)xico por ingestªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228) nieltyn(cid:228).

SV: Mycket giftigt vid f(cid:246)rt(cid:228)ring.

R29

ES: En contacto con agua libera gases t(cid:243)xicos.

DA: Udvikler giftig gas ved kontakt med vand.

DE: Entwickelt bei Ber(cid:252)hrung mit Wasser giftige Gase.

EL: Re epau(cid:222) le so meq(cid:252) eketheq(cid:254)momsai sonij(cid:220) a(cid:221)qia.

EN: Contact with water liberates toxic gas.

FR: Au contact de l’eau, dØgage des gaz toxiques.

IT: A contatto con l’acqua libera gas tossici.

NL: Vormt vergiftig gas in contact met water.

PT: Em contacto com a Ægua liberta gases t(cid:243)xicos.

FI: Kehitt(cid:228)(cid:228) myrkyllist(cid:228) kaasua veden kanssa.

SV: Utvecklar giftig gas vid kontakt med vatten.

L 225/94

EN

Official Journal of the European Communities

21.8.2001

R30

ES: Puede inflamarse fÆcilmente al usarlo.

DA: Kan blive meget brandfarlig under brug.

DE: Kann bei Gebrauch leicht entz(cid:252)ndlich werden.

EL: Jas(cid:220) sg vq(cid:222)rg c(cid:223)mesai pok(cid:253) e(cid:253)ukejso.

EN: Can become highly flammable in use.

FR: Peut devenir facilement inflammable pendant l’utilisation.

IT:

Pu(cid:242) divenire facilmente infiammabile durante l’uso.

NL: Kan bij gebruik licht ontvlambaar worden.

PT: Pode tornar-se facilmente inflamÆvel durante o uso.

FI: K(cid:228)ytett(cid:228)ess(cid:228) voi muuttua helposti syttyv(cid:228)ksi.

SV: Kan bli mycket brandfarligt vid anv(cid:228)ndning.

R31

ES: En contacto con Æcidos libera gases t(cid:243)xicos.

DA: Udvikler giftig gas ved kontakt med syre.

DE: Entwickelt bei Ber(cid:252)hrung mit S(cid:228)ure giftige Gase.

EL: Re epau(cid:222) le on(cid:221)a eketheq(cid:254)momsai sonij(cid:220) a(cid:221)qia.

EN: Contact with acids liberates toxic gas.

FR: Au contact d’un acide, dØgage un gaz toxique.

IT: A contatto con acidi libera gas tossico.

NL: Vormt vergiftige gassen in contact met zuren.

PT: Em contacto com Æcidos liberta gases t(cid:243)xicos.

FI: Kehitt(cid:228)(cid:228) myrkyllist(cid:228) kaasua hapon kanssa.

SV: Utvecklar giftig gas vid kontakt med syra.

R32

ES: En contacto con Æcidos libera gases muy t(cid:243)xicos.

DA: Udvikler meget giftig gas ved kontakt med syre.

DE: Entwickelt bei Ber(cid:252)hrung mit S(cid:228)ure sehr giftige Gase.

EL: Re epau(cid:222) le on(cid:221)a eketheq(cid:254)momsai pok(cid:253) sonij(cid:220) a(cid:221)qia.

EN: Contact with acids liberates very toxic gas.

FR: Au contact d’un acide, dØgage un gaz trŁs toxique.

IT: A contatto con acidi libera gas molto tossico.

NL: Vormt zeer vergiftige gassen in contact met zuren.

PT: Em contacto com Æcidos liberta gases muito t(cid:243)xicos.

FI: Kehitt(cid:228)(cid:228) eritt(cid:228)in myrkyllist(cid:228) kaasua hapon kanssa.

SV: Utvecklar mycket giftig gas vid kontakt med syra.

R33

ES: Peligro de efectos acumulativos.

DA: Kan ophobes i kroppen efter gentagen brug.

DE: Gefahr kumulativer Wirkungen.

EL: J(cid:223)mdtmoy ahqoirsij(cid:254)m epidq(cid:220)rexm.

EN: Danger of cumulative effects.

FR: Danger d’effets cumulatifs.

21.8.2001

EN

Official Journal of the European Communities

L 225/95

IT:

Pericolo di effetti cumulativi.

NL: Gevaar voor cumulatieve effecten.

PT: Perigo de efeitos cumulativos.

FI: Terveydellisten haittojen vaara pitk(cid:228)aikaisessa altistuksessa.

SV: Kan ansamlas i kroppen och ge skador.

R34

ES: Provoca quemaduras.

DA: ˘tsningsfare.

DE: Verursacht Ver(cid:228)tzungen.

EL: Pqojake(cid:223) ecja(cid:253)lasa.

EN: Causes burns.

FR: Provoque des brßlures.

IT:

Provoca ustioni.

NL: Veroorzaakt brandwonden.

PT: Provoca queimaduras.

FI:

Sy(cid:246)vytt(cid:228)v(cid:228)(cid:228).

SV: Fr(cid:228)tande.

R35

ES: Provoca quemaduras graves.

DA: Alvorlig (cid:230)tsningsfare.

DE: Verursacht schwere Ver(cid:228)tzungen.

EL: Pqojake(cid:223) robaq(cid:220) ecja(cid:253)lasa.

EN: Causes severe burns.

FR: Provoque de graves brßlures.

IT:

Provoca gravi ustioni.

NL: Veroorzaakt ernstige brandwonden.

PT: Provoca queimaduras graves.

FI: Voimakkaasti sy(cid:246)vytt(cid:228)v(cid:228)(cid:228).

SV: Starkt fr(cid:228)tande.

R36

ES:

Irrita los ojos.

DA: Irriterer łjnene.

DE: Reizt die Augen.

EL: Eqeh(cid:223)fei sa l(cid:220)sia.

EN:

Irritating to eyes.

FR:

Irritant pour les yeux.

IT:

Irritante per gli occhi.

NL:

Irriterend voor de ogen.

PT:

Irritante para os olhos.

FI: ˜rsytt(cid:228)(cid:228) silmi(cid:228).

SV:

Irriterar (cid:246)gonen.

L 225/96

EN

Official Journal of the European Communities

21.8.2001

R37

ES:

Irrita las v(cid:237)as respiratorias.

DA: Irriterer (cid:229)ndedr(cid:230)tsorganerne.

DE: Reizt die Atmungsorgane.

EL: Eqeh(cid:223)fei so amapmetrsij(cid:252) r(cid:253)rsgla.

EN:

Irritating to respiratory system.

FR:

Irritant pour les voies respiratoires.

IT:

Irritante per le vie respiratorie.

NL:

Irriterend voor de ademhalingswegen.

PT:

Irritante para as vias respirat(cid:243)rias.

FI: ˜rsytt(cid:228)(cid:228) hengityselimi(cid:228).

SV:

Irriterar andningsorganen.

R38

ES:

Irrita la piel.

DA: Irriterer huden.

DE: Reizt die Haut.

EL: Eqeh(cid:223)fei so d(cid:221)qla.

EN:

Irritating to skin.

FR:

Irritant pour la peau.

IT:

Irritante per la pelle.

NL:

Irriterend voor de huid.

PT:

Irritante para a pele.

FI: ˜rsytt(cid:228)(cid:228) ihoa.

SV:

Irriterar huden.

R39

ES: Peligro de efectos irreversibles muy graves.

DA: Fare for varig alvorlig skade p(cid:229) helbred.

DE: Ernste Gefahr irreversiblen Schadens.

EL: J(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m lom(cid:223)lxm epidq(cid:220)rexm.

EN: Danger of very serious irreversible effects.

FR: Danger d’effets irrØversibles trŁs graves.

IT:

Pericolo di effetti irreversibili molto gravi.

NL: Gevaar voor ernstige onherstelbare effecten.

PT: Perigo de efeitos irrevers(cid:237)veis muito graves.

FI:

Eritt(cid:228)in vakavien pysyvien vaurioiden vaara.

SV: Risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador.

R40

ES: Posibles efectos cancer(cid:237)genos.

DA: Mulighed for kr(cid:230)ftfremkaldende effekt.

DE: Verdacht auf krebserzeugende Wirkung.

EL: (cid:190)popso jaqjimoc(cid:221)mergy.

EN: Limited evidence of a carcinogenic effect.

FR: Effet cancØrogŁne suspectØ (cid:151) preuves insuffisantes.

21.8.2001

EN

Official Journal of the European Communities

L 225/97

IT:

Possibilit(cid:224) di effetti cancerogeni (cid:151) prove insufficienti.

NL: Carcinogene effecten zijn niet uitgesloten.

PT: Possibilidade de efeitos cancer(cid:237)genos.

FI:

Ep(cid:228)ill(cid:228)(cid:228)n aiheuttavan sy(cid:246)p(cid:228)sairauden vaaraa.

SV: Misst(cid:228)nks kunna ge cancer.

R41

ES: Riesgo de lesiones oculares graves.

DA: Risiko for alvorlig łjenskade.

DE: Gefahr ernster Augensch(cid:228)den.

EL: J(cid:223)mdtmoy robaq(cid:254)m ouhaklij(cid:254)m bkab(cid:254)m.

EN: Risk of serious damage to eyes.

FR: Risque de lØsions oculaires graves.

IT: Rischio di gravi lesioni oculari.

NL: Gevaar voor ernstig oogletsel.

PT: Risco de lesıes oculares graves .

FI: Vakavan silm(cid:228)vaurion vaara.

SV: Risk f(cid:246)r allvarliga (cid:246)gonskador.

R42

ES: Posibilidad de sensibilizaci(cid:243)n por inhalaci(cid:243)n.

DA: Kan give overfłlsomhed ved ind(cid:229)nding.

DE: Sensibilisierung durch Einatmen m(cid:246)glich.

EL: Lpoqe(cid:223) ma pqojak(cid:221)rei etairhgsopo(cid:223)grg (cid:252)sam eirpm(cid:221)esai.

EN: May cause sensitisation by inhalation.

FR: Peut entra(cid:238)ner une sensibilisation par inhalation.

IT:

Pu(cid:242) provocare sensibilizzazione per inalazione.

NL: Kan overgevoeligheid veroorzaken bij inademing.

PT: Pode causar sensibiliza(cid:231)ªo por inala(cid:231)ªo.

FI: Altistuminen hengitysteitse voi aiheuttaa herkistymist(cid:228).

SV: Kan ge allergi vid inandning

R43

ES: Posibilidad de sensibilizaci(cid:243)n en contacto con la piel.

DA: Kan give overfłlsomhed ved kontakt med huden.

DE: Sensibilisierung durch Hautkontakt m(cid:246)glich.

EL: Lpoqe(cid:223) ma pqojak(cid:221)rei etairhgsopo(cid:223)grg re epau(cid:222) le so d(cid:221)qla.

EN: May cause sensitisation by skin contact.

FR: Peut entra(cid:238)ner une sensibilisation par contact avec la peau.

IT:

Pu(cid:242) provocare sensibilizzazione per contatto con la pelle.

NL: Kan overgevoeligheid veroorzaken bij contact met de huid.

PT: Pode causar sensibiliza(cid:231)ªo em contacto com a pele.

FI:

Ihokosketus voi aiheuttaa herkistymist(cid:228).

SV: Kan ge allergi vid hudkontakt.

L 225/98

EN

Official Journal of the European Communities

21.8.2001

R44

ES: Riesgo de explosi(cid:243)n al calentarlo en ambiente confinado.

DA: Eksplosionsfarlig ved opvarmning under indeslutning.

DE: Explosionsgefahr bei Erhitzen unter Einschluss.

EL: J(cid:223)mdtmoy ejq(cid:222)nexy e(cid:220)m heqlamhe(cid:223) tp(cid:252) peqioqirl(cid:252).

EN: Risk of explosion if heated under confinement.

FR: Risque d’explosion si chauffØ en ambiance confinØe.

IT: Rischio di esplosione per riscaldamento in ambiente confinato.

NL: Ontploffingsgevaar bij verwarming in afgesloten toestand.

PT: Risco de explosªo se aquecido em ambiente fechado.

FI: R(cid:228)j(cid:228)hdysvaara kuumennettaessa suljetussa astiassa.

SV: Explosionsrisk vid uppv(cid:228)rmning i sluten beh(cid:229)llare.

R45

ES: Puede causar cÆncer.

DA: Kan fremkalde kr(cid:230)ft.

DE: Kann Krebs erzeugen.

EL: Lpoqe(cid:223) ma pqojak(cid:221)rei jaqj(cid:223)mo.

EN: May cause cancer.

FR: Peut provoquer le cancer.

IT:

Pu(cid:242) provocare il cancro.

NL: Kan kanker veroorzaken.

PT: Pode causar cancro.

FI: Aiheuttaa sy(cid:246)p(cid:228)sairauden vaaraa.

SV: Kan ge cancer.

R46

ES: Puede causar alteraciones genØticas hereditarias.

DA: Kan for(cid:229)rsage arvelige genetiske skader.

DE: Kann vererbbare Sch(cid:228)den verursachen.

EL: Lpoqe(cid:223) ma pqojak(cid:221)rei jkgqomolij(cid:221)y cemesij(cid:221)y bk(cid:220)bey.

EN: May cause heritable genetic damage.

FR: Peut provoquer des altØrations gØnØtiques hØrØditaires.

IT:

Pu(cid:242) provocare alterazioni genetiche ereditarie.

NL: Kan erfelijke genetische schade veroorzaken.

PT: Pode causar altera(cid:231)ıes genØticas hereditÆrias.

FI:

Saattaa aiheuttaa periytyvi(cid:228) perim(cid:228)vaurioita.

SV: Kan ge (cid:228)rftliga genetiska skador.

R48

ES: Riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada.

DA: Alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning.

DE: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition.

EL: J(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa apo paqasesal(cid:221)mg (cid:221)jherg.

EN: Danger of serious damage to health by prolonged exposure.

FR: Risque d’effets graves pour la santØ en cas d’exposition prolongØe.

21.8.2001

EN

Official Journal of the European Communities

L 225/99

IT:

Pericolo di gravi danni per la salute in caso di esposizione prolungata.

NL: Gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling.

PT: Risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada.

FI:

Pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle.

SV: Risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering.

R49

ES: Puede causar cÆncer por inhalaci(cid:243)n.

DA: Kan fremkalde kr(cid:230)ft ved ind(cid:229)nding.

DE: Kann Krebs erzeugen beim Einatmen.

EL: Lpoqe(cid:223) ma pqojak(cid:221)rei jaqj(cid:223)mo (cid:252)sam eirpm(cid:221)esai.

EN: May cause cancer by inhalation.

FR: Peut provoquer le cancer par inhalation.

IT:

Pu(cid:242) provocare il cancro per inalazione.

NL: Kan kanker veroorzaken bij inademing.

PT: Pode causar cancro por inala(cid:231)ªo.

FI: Aiheuttaa sy(cid:246)p(cid:228)sairauden vaaraa hengitettyn(cid:228).

SV: Kan ge cancer vid inandning.

R50

ES: Muy t(cid:243)xico para los organismos acuÆticos.

DA: Meget giftig for organismer, der lever i vand.

DE: Sehr giftig f(cid:252)r Wasserorganismen.

EL: Pok(cid:253) sonij(cid:252) cia soty tdq(cid:252)bioty oqcamirlo(cid:253)y.

EN: Very toxic to aquatic organisms.

FR: TrŁs toxique pour les organismes aquatiques.

IT: Altamente tossico per gli organismi acquatici.

NL: Zeer vergiftig voor in het water levende organismen.

PT: Muito t(cid:243)xico para os organismos aquÆticos.

FI:

Eritt(cid:228)in myrkyllist(cid:228) vesieli(cid:246)ille.

SV: Mycket giftigt f(cid:246)r vattenlevande organismer.

R51

ES: T(cid:243)xico para los organismos acuÆticos.

DA: Giftig for organismer, der lever i vand.

DE: Giftig f(cid:252)r Wasserorganismen.

EL: Sonij(cid:252) cia soty tdq(cid:252)bioty oqcamirlo(cid:253)y.

EN: Toxic to aquatic organisms.

FR: Toxique pour les organismes aquatiques.

IT: Tossico per gli organismi acquatici.

NL: Vergiftig voor in het water levende organismen.

PT: T(cid:243)xico para os organismos aquÆticos.

FI: Myrkyllist(cid:228) vesieli(cid:246)ille.

SV: Giftigt f(cid:246)r vattenlevande organismer.

L 225/100

EN

Official Journal of the European Communities

21.8.2001

R52

ES: Nocivo para los organismos acuÆticos.

DA: Skadelig for organismer, der lever i vand.

DE: Sch(cid:228)dlich f(cid:252)r Wasserorganismen.

EL: Epibkab(cid:221)y cia soty tdq(cid:252)bioty oqcamirlo(cid:253)y.

EN: Harmful to aquatic organisms.

FR: Nocif pour les organismes aquatiques.

IT: Nocivo per gli organismi acquatici.

NL: Schadelijk voor in het water levende organismen.

PT: Nocivo para os organismos aquÆticos.

FI: Haitallista vesieli(cid:246)ille.

SV: Skadligt f(cid:246)r vattenlevande organismer.

R53

ES: Puede provocar a largo plazo efectos negativos en el medio ambiente acuÆtico.

DA: Kan for(cid:229)rsage ułnskede langtidsvirkninger i vandmiljłet.

DE: Kann in Gew(cid:228)ssern l(cid:228)ngerfristig sch(cid:228)dliche Wirkungen haben.

EL: Lpoqe(cid:223) ma pqojak(cid:221)rei lajqovq(cid:252)miey dtrleme(cid:223)y epips(cid:254)reiy rso td(cid:220)simo peqib(cid:220)kkom.

EN: May cause long-term adverse effects in the aquatic environment.

FR: Peut entra(cid:238)ner des effets nØfastes (cid:224) long terme pour l’environnement aquatique.

IT:

Pu(cid:242) provocare a lungo termine effetti negativi per l’ambiente acquatico.

NL: Kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

PT: Pode causar efeitos nefastos a longo prazo no ambiente aquÆtico.

FI: Voi aiheuttaa pitk(cid:228)aikaisia haittavaikutuksia vesiymp(cid:228)rist(cid:246)ss(cid:228).

SV: Kan orsaka skadliga l(cid:229)ngtidseffekter i vattenmilj(cid:246)n.

R54

ES: T(cid:243)xico para la flora.

DA: Giftig for planter.

DE: Giftig f(cid:252)r Pflanzen.

EL: Sonij(cid:252) cia sg vkxq(cid:223)da.

EN: Toxic to flora.

FR: Toxique pour la flore.

IT: Tossico per la flora.

NL: Vergiftig voor planten.

PT: T(cid:243)xico para a flora.

FI: Myrkyllist(cid:228) kasveille.

SV: Giftigt f(cid:246)r v(cid:228)xter.

R55

ES: T(cid:243)xico para la fauna.

DA: Giftig for dyr.

DE: Giftig f(cid:252)r Tiere.

EL: Sonij(cid:252) cia sgm pam(cid:223)da.

EN: Toxic to fauna.

FR: Toxique pour la faune.

21.8.2001

EN

Official Journal of the European Communities

L 225/101

IT: Tossico per la fauna.

NL: Vergiftig voor dieren.

PT: T(cid:243)xico para a fauna.

FI: Myrkyllist(cid:228) el(cid:228)imille.

SV: Giftigt f(cid:246)r djur.

R56

ES: T(cid:243)xico para los organismos del suelo.

DA: Giftig for organismer i jordbunden.

DE: Giftig f(cid:252)r Bodenorganismen.

EL: Sonij(cid:252) cia soty oqcamirlo(cid:253)y sot ed(cid:220)uoty.

EN: Toxic to soil organisms.

FR: Toxique pour les organismes du sol.

IT: Tossico per gli organismi del terreno.

NL: Vergiftig voor bodemorganismen.

PT: T(cid:243)xico para os organismos do solo.

FI: Myrkyllist(cid:228) maaper(cid:228)eli(cid:246)ille.

SV: Giftigt f(cid:246)r marklevande organismer.

R57

ES: T(cid:243)xico para las abejas.

DA: Giftig for bier.

DE: Giftig f(cid:252)r Bienen.

EL: Sonij(cid:252) cia siy l(cid:221)kirrey.

EN: Toxic to bees.

FR: Toxique pour les abeilles.

IT: Tossico per le api.

NL: Vergiftig voor bijen.

PT: T(cid:243)xico para as abelhas.

FI: Myrkyllist(cid:228) mehil(cid:228)isille.

SV: Giftigt f(cid:246)r bin.

R58

ES: Puede provocar a largo plazo efectos negativos en el medio ambiente.

DA: Kan for(cid:229)rsage ułnskede langtidsvirkninger i miljłet.

DE: Kann l(cid:228)ngerfristig sch(cid:228)dliche Wirkungen auf die Umwelt haben.

EL: Lpoqe(cid:223) ma pqojak(cid:221)rei lajqovq(cid:252)miey dtrleme(cid:223)y epips(cid:254)reiy rso peqib(cid:220)kkom.

EN: May cause long-term adverse effects in the environment.

FR: Peut entra(cid:238)ner des effets nØfastes (cid:224) long terme pour l’environnement.

IT:

Pu(cid:242) provocare a lungo termine effetti negativi per l’ambiente.

NL: Kan in het milieu op lange termijn schadelijke effecten veroorzaken.

PT: Pode causar efeitos nefastos a longo prazo no ambiente.

FI: Voi aiheuttaa pitk(cid:228)aikaisia haittavaikutuksia ymp(cid:228)rist(cid:246)ss(cid:228).

SV: Kan orsaka skadliga l(cid:229)ngtidseffekter i milj(cid:246)n.

L 225/102

EN

Official Journal of the European Communities

21.8.2001

R59

ES: Peligroso para la capa de ozono.

DA: Farlig for ozonlaget.

DE: Gef(cid:228)hrlich f(cid:252)r die Ozonschicht.

EL: Epij(cid:223)mdtmo cia sg rsib(cid:220)da sot (cid:252)fomsoy.

EN: Dangerous for the ozone layer.

FR: Dangereux pour la couche d’ozone.

IT:

Pericoloso per lo strato di ozono.

NL: Gevaarlijk voor de ozonlaag.

PT: Perigoso para a camada de ozono .

FI: Vaarallista otsonikerrokselle.

SV: Farligt f(cid:246)r ozonskiktet.

R60

ES: Puede perjudicar la fertilidad.

DA: Kan skade forplantningsevnen.

DE: Kann die Fortpflanzungsf(cid:228)higkeit beeintr(cid:228)chtigen.

EL: Lpoqe(cid:223) ma enarhem(cid:223)rei sg comil(cid:252)sgsa.

EN: May impair fertility.

FR: Peut altØrer la fertilitØ.

IT:

Pu(cid:242) ridurre la fertilit(cid:224).

NL: Kan de vruchtbaarheid schaden.

PT: Pode comprometer a fertilidade.

FI: Voi heikent(cid:228)(cid:228) hedelm(cid:228)llisyytt(cid:228).

SV: Kan ge nedsatt fortplantningsf(cid:246)rm(cid:229)ga.

R61

ES: Riesgo durante el embarazo de efectos adversos para el feto.

DA: Kan skade barnet under graviditeten.

DE: Kann das Kind im Mutterleib sch(cid:228)digen.

EL: Lpoqe(cid:223) ma bk(cid:220)wei so (cid:221)lbqto jas(cid:220) sg di(cid:220)qjeia sgy j(cid:253)grgy.

EN: May cause harm to the unborn child.

FR: Risque pendant la grossesse d’effets nØfastes pour l’enfant.

IT:

Pu(cid:242) danneggiare i bambini non ancora nati.

NL: Kan het ongeboren kind schaden.

PT: Risco durante a gravidez com efeitos adversos na descendŒncia.

FI: Vaarallista siki(cid:246)lle.

SV: Kan ge fosterskador.

R62

ES: Posible riesgo de perjudicar la fertilidad.

DA: Mulighed for skade p(cid:229) forplantningsevnen.

DE: Kann m(cid:246)glicherweise die Fortpflanzungsf(cid:228)higkeit beeintr(cid:228)chtigen.

EL: Piham(cid:252)y j(cid:223)mdtmoy cia enarh(cid:221)mgrg sgy comil(cid:252)sgsay.

EN: Possible risk of impaired fertility.

FR: Risque possible d’altØration de la fertilitØ.

21.8.2001

EN

Official Journal of the European Communities

L 225/103

IT:

Possibile rischio di ridotta fertilit(cid:224).

NL: Mogelijk gevaar voor verminderde vruchtbaarheid.

PT: Poss(cid:237)veis riscos de comprometer a fertilidade.

FI: Voi mahdollisesti heikent(cid:228)(cid:228) hedelm(cid:228)llisyytt(cid:228).

SV: M(cid:246)jlig risk f(cid:246)r nedsatt fortplantningsf(cid:246)rm(cid:229)ga.

R63

ES: Posible riesgo durante el embarazo de efectos adversos para el feto.

DA: Mulighed for skade p(cid:229) barnet under graviditeten.

DE: Kann das Kind im Mutterleib m(cid:246)glicherweise sch(cid:228)digen.

EL: Piham(cid:252)y j(cid:223)mdtmoy dtrlem(cid:254)m epidq(cid:220)rexm rso (cid:221)lbqto jas(cid:220) sg di(cid:220)qjeia sgy j(cid:253)grgy.

EN: Possible risk of harm to the unborn child.

FR: Risque possible pendant la grossesse d’effets nØfastes pour l’enfant.

IT:

Possibile rischio di danni ai bambini non ancora nati.

NL: Mogelijk gevaar voor beschadiging van het ongeboren kind.

PT: Poss(cid:237)veis riscos durante a gravidez com efeitos adversos na descendŒncia.

FI: Voi olla vaarallista siki(cid:246)lle.

SV: M(cid:246)jlig risk f(cid:246)r fosterskador.

R64

ES: Puede perjudicar a los niæos alimentados con leche materna.

DA: Kan skade błrn i ammeperioden.

DE: Kann S(cid:228)uglinge (cid:252)ber die Muttermilch sch(cid:228)digen.

EL: Lpoqe(cid:223) ma bk(cid:220)wei sa bq(cid:221)ug pot sq(cid:221)uomsai le lgsqij(cid:252) c(cid:220)ka.

EN: May cause harm to breastfed babies.

FR: Risque possible pour les bØbØs nourris au lait maternel.

IT:

Possibile rischio per i bambini allattati al seno.

NL: Kan schadelijk zijn via de borstvoeding.

PT: Pode causar danos (cid:224)s crian(cid:231)as alimentadas com leite materno.

FI:

Saattaa aiheuttaa haittaa rintaruokinnassa oleville lapsille.

SV: Kan skada sp(cid:228)dbarn under amningsperioden.

R65

ES: Nocivo: si se ingiere puede causar daæo pulmonar.

DA: Farlig: kan give lungeskade ved indtagelse.

DE: Gesundheitssch(cid:228)dlich: kann beim Verschlucken Lungensch(cid:228)den verursachen.

EL: Epibkab(cid:221)y: lpoqe(cid:223) ma pqojak(cid:221)rei bk(cid:220)bg rsoty pme(cid:253)lomey re peq(cid:223)psxrg jas(cid:220)porgy.

EN: Harmful: may cause lung damage if swallowed.

FR: Nocif: peut provoquer une atteinte des poumons en cas d’ingestion.

IT: Nocivo: pu(cid:242) causare danni ai polmoni in caso di ingestione.

NL: Schadelijk: kan longschade veroorzaken na verslikken.

PT: Nocivo: pode causar danos nos pulmıes se ingerido.

FI: Haitallista: voi aiheuttaa keuhkovaurion nielt(cid:228)ess(cid:228).

SV: Farligt: kan ge lungskador vid f(cid:246)rt(cid:228)ring.

L 225/104

EN

Official Journal of the European Communities

21.8.2001

R66

ES: La exposici(cid:243)n repetida puede provocar sequedad o formaci(cid:243)n de grietas en la piel.

DA: Gentagen uds(cid:230)ttelse kan give tłr eller revnet hud.

DE: Wiederholter Kontakt kann zu spr(cid:246)der oder rissiger Haut f(cid:252)hren.

EL: G paqasesal(cid:221)mg (cid:221)jherg lpoqe(cid:223) ma pqojak(cid:221)rei ngq(cid:252)sgsa d(cid:221)qlasoy (cid:222) rj(cid:220)rilo.

EN: Repeated exposure may cause skin dryness or cracking.

FR: L’exposition rØpØtØe peut provoquer dessŁchement ou ger(cid:231)ures de la peau.

IT:

L’esposizione ripetuta pu(cid:242) provocare secchezza e screpolature della pelle.

NL: Herhaalde blootstelling kan een droge of een gebarsten huid veroorzaken.

PT: Pode provocar secura da pele ou fissuras, por exposi(cid:231)ªo repetida.

FI: Toistuva altistus voi aiheuttaa ihon kuivumista tai halkeilua.

SV: Upprepad kontakt kan ge torr hud eller hudsprickor.

R67

ES: La inhalaci(cid:243)n de vapores puede provocar somnolencia y vØrtigo.

DA: Dampe kan give slłvhed og svimmelhed.

DE: D(cid:228)mpfe k(cid:246)nnen Schl(cid:228)frigkeit und Benommenheit verursachen.

EL: G eirpmo(cid:222) asl(cid:254)m lpoqe(cid:223) ma pqojak(cid:221)rei tpmgk(cid:223)a jai f(cid:220)kg.

EN: Vapours may cause drowsiness and dizziness.

FR: L’inhalation de vapeurs peut provoquer somnolence et vertiges.

IT:

L’inalazione dei vapori pu(cid:242) provocare sonnolenza e vertigini.

NL: Dampen kunnen slaperigheid en duizeligheid veroorzaken.

PT: Pode provocar sonolŒncia e vertigens, por inala(cid:231)ªo dos vapores.

FI: H(cid:246)yryt voivat aiheuttaa uneliaisuutta ja huimausta.

SV: ¯ngor kan g(cid:246)ra att man blir d(cid:229)sig och omt(cid:246)cknad.

R68

ES: Posibilidad de efectos irreversibles.

DA: Mulighed for varig skade p(cid:229) helbred.

DE:

Irreversibler Schaden m(cid:246)glich.

EL: Pihamo(cid:223) j(cid:223)mdtmoi lom(cid:223)lxm epidq(cid:220)rexm.

EN: Possible risk of irreversible effects.

FR: PossibilitØ d’effets irrØversibles.

IT:

Possibilit(cid:224) di effetti irreversibili.

NL: Onherstelbare effecten zijn niet uitgesloten.

PT: Possibilidade de efeitos irrevers(cid:237)veis.

FI:

Pysyvien vaurioiden vaara.

SV: M(cid:246)jlig risk f(cid:246)r best(cid:229)ende h(cid:228)lsoskador.

21.8.2001

EN

Official Journal of the European Communities

L 225/105

Combinaci(cid:243)n de frases-R

Kombination af R-s(cid:230)tninger

Kombination der R-S(cid:228)tze

Rtmdtarl(cid:252)y sxm Q-uq(cid:220)rexm

Combination of R-phrases

Combinaison des phrases R

Combinazioni delle frasi R

Combinatie van R-zinnen

Combina(cid:231)ªo das frases R

Yhdistetyt R-lausekkeet

Sammansatta R-fraser

R14/15

ES: Reacciona violentamente con el agua, liberando gases extremadamente inflamables.

DA: Reagerer voldsomt med vand under dannelse af yderst brandfarlige gasser.

DE: Reagiert heftig mit Wasser unter Bildung hochentz(cid:252)ndlicher Gase.

EL: Amsidq(cid:220) b(cid:223)aia re epau(cid:222) le meq(cid:252) ejk(cid:253)omsay a(cid:221)qia en(cid:252)vxy e(cid:253)ukejsa.

EN: Reacts violently with water, liberating extremely flammable gases.

FR: RØagit violemment au contact de l’eau en dØgageant des gaz extrŒmement inflammables.

IT: Reagisce violentemente con l’acqua liberando gas estremamente infiammabili.

NL: Reageert heftig met water en vormt daarbij zeer ontvlambaar gas.

PT: Reage violentamente com a Ægua libertando gases extremamente inflamÆveis.

FI: Reagoi voimakkaasti veden kanssa vapauttaen helposti syttyvi(cid:228) kaasuja.

SV: Reagerar h(cid:228)ftigt med vatten varvid extremt brandfarliga gaser bildas.

R15/29

ES: En contacto con el agua, libera gases t(cid:243)xicos y extremadamente inflamables.

DA: Reagerer med vand under dannelse af giftige og yderst brandfarlige gasser.

DE: Reagiert mit Wasser unter Bildung giftiger und hochentz(cid:252)ndlicher Gase.

EL: Re epau(cid:222) le meq(cid:252) eketheq(cid:254)momsai sonij(cid:220), en(cid:252)vxy e(cid:253)ukejsa a(cid:221)qia.

EN: Contact with water liberates toxic, extremely flammable gas.

FR: Au contact de l’eau, dØgage des gaz toxiques et extrŒmement inflammables.

IT: A contatto con acqua libera gas tossici ed estremamente infiammabili.

NL: Vormt vergiftig en zeer ontvlambaar gas in contact met water.

PT: Em contacto com a Ægua liberta gases t(cid:243)xicos e extremamente inflamÆveis.

FI: Vapauttaa myrkyllisi(cid:228), helposti syttyvi(cid:228) kaasuja veden kanssa.

SV: Utvecklar giftig och extremt brandfarlig gas vid kontakt med vatten.

L 225/106

EN

Official Journal of the European Communities

21.8.2001

R20/21

ES: Nocivo por inhalaci(cid:243)n y en contacto con la piel.

DA: Farlig ved ind(cid:229)nding og ved hudkontakt.

DE: Gesundheitssch(cid:228)dlich beim Einatmen und bei Ber(cid:252)hrung mit der Haut.

EL: Epibkab(cid:221)y (cid:252)sam eirpm(cid:221)esai jai re epau(cid:222) le so d(cid:221)qla.

EN: Harmful by inhalation and in contact with skin.

FR: Nocif par inhalation et par contact avec la peau.

IT: Nocivo per inalazione e contatto con la pelle.

NL: Schadelijk bij inademing en bij aanraking met de huid.

PT: Nocivo por inala(cid:231)ªo e em contacto com a pele.

FI: Terveydelle haitallista hengitettyn(cid:228) ja joutuessaan iholle.

SV: Farligt vid inandning och hudkontakt.

R20/22

ES: Nocivo por inhalaci(cid:243)n y por ingesti(cid:243)n.

DA: Farlig ved ind(cid:229)nding og ved indtagelse.

DE: Gesundheitssch(cid:228)dlich beim Einatmen und Verschlucken.

EL: Epibkab(cid:221)y (cid:252)sam eirpm(cid:221)esai jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful by inhalation and if swallowed.

FR: Nocif par inhalation et par ingestion.

IT: Nocivo per inalazione e ingestione.

NL: Schadelijk bij inademing en opname door de mond.

PT: Nocivo por inala(cid:231)ªo e ingestªo.

FI: Terveydelle haitallista hengitettyn(cid:228) ja nieltyn(cid:228).

SV: Farligt vid inandning och f(cid:246)rt(cid:228)ring.

R20/21/22

ES: Nocivo por inhalaci(cid:243)n, por ingesti(cid:243)n y en contacto con la piel.

DA: Farlig ved ind(cid:229)nding, ved hudkontakt og ved indtagelse.

DE: Gesundheitssch(cid:228)dlich beim Einatmen, Verschlucken und Ber(cid:252)hrung mit der Haut.

EL: Epibkab(cid:221)y (cid:252)sam eirpm(cid:221)esai, re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful by inhalation, in contact with skin and if swallowed.

FR: Nocif par inhalation, par contact avec la peau et par ingestion.

IT: Nocivo per inalazione, contatto con la pelle e per ingestione.

NL: Schadelijk bij inademing, opname door de mond en aanraking met de huid.

PT: Nocivo por inala(cid:231)ªo, em contacto com a pele e por ingestªo.

FI: Terveydelle haitallista hengitettyn(cid:228), joutuessaan iholle ja nieltyn(cid:228).

SV: Farligt vid inandning, hudkontakt och f(cid:246)rt(cid:228)ring.

R21/22

ES: Nocivo en contacto con la piel y por ingesti(cid:243)n.

DA: Farlig ved hudkontakt og ved indtagelse.

DE: Gesundheitssch(cid:228)dlich bei Ber(cid:252)hrung mit der Haut und beim Verschlucken.

EL: Epibkab(cid:221)y re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful in contact with skin and if swallowed.

FR: Nocif par contact avec la peau et par ingestion.

21.8.2001

EN

Official Journal of the European Communities

L 225/107

IT: Nocivo a contatto con la pelle e per ingestione.

NL: Schadelijk bij aanraking met de huid en bij opname door de mond.

PT: Nocivo em contacto com a pele e por ingestªo.

FI: Terveydelle haitallista joutuessaan iholle ja nieltyn(cid:228).

SV: Farligt vid hudkontakt och f(cid:246)rt(cid:228)ring.

R23/24

ES: T(cid:243)xico por inhalaci(cid:243)n y en contacto con la piel.

DA: Giftig ved ind(cid:229)nding og ved hudkontakt.

DE: Giftig beim Einatmen und bei Ber(cid:252)hrung mit der Haut.

EL: Sonij(cid:252) (cid:252)sam eirpm(cid:221)esai jai re epau(cid:222) le so d(cid:221)qla.

EN: Toxic by inhalation and in contact with skin.

FR: Toxique par inhalation et par contact avec la peau.

IT: Tossico per inalazione e contatto con la pelle.

NL: Vergiftig bij inademing en bij aanraking met de huid.

PT: T(cid:243)xico por inala(cid:231)ªo e em contacto com a pele.

FI: Myrkyllist(cid:228) hengitettyn(cid:228) ja joutuessaan iholle.

SV: Giftigt vid inandning och hudkontakt.

R23/25

ES: T(cid:243)xico por inhalaci(cid:243)n y por ingesti(cid:243)n.

DA: Giftig ved ind(cid:229)nding og ved indtagelse.

DE: Giftig beim Einatmen und Verschlucken.

EL: Sonij(cid:252) (cid:252)sam eirpm(cid:221)esai jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Toxic by inhalation and if swallowed.

FR: Toxique par inhalation et par ingestion.

IT: Tossico per inalazione e ingestione.

NL: Vergiftig bij inademing en opname door de mond.

PT: T(cid:243)xico por inala(cid:231)ªo e ingestªo.

FI: Myrkyllist(cid:228) hengitettyn(cid:228) ja nieltyn(cid:228).

SV: Giftigt vid inandning och f(cid:246)rt(cid:228)ring.

R23/24/25

ES: T(cid:243)xico por inhalaci(cid:243)n, por ingesti(cid:243)n y en contacto con la piel.

DA: Giftig ved ind(cid:229)nding, ved hudkontakt og ved indtagelse.

DE: Giftig beim Einatmen, Verschlucken und Ber(cid:252)hrung mit der Haut.

EL: Sonij(cid:252) (cid:252)sam eirpm(cid:221)esai, re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Toxic by inhalation, in contact with skin and if swallowed.

FR: Toxique par inhalation, par contact avec la peau et par ingestion.

IT: Tossico per inalazione, contatto con la pelle e per ingestione.

NL: Vergiftig bij inademing, opname door de mond en aanraking met de huid.

PT: T(cid:243)xico por inala(cid:231)ªo, em contacto com a pele e por ingestªo.

FI: Myrkyllist(cid:228) hengitettyn(cid:228), joutuessaan iholle ja nieltyn(cid:228).

SV: Giftigt vid inandning, hudkontakt och f(cid:246)rt(cid:228)ring.

L 225/108

EN

Official Journal of the European Communities

21.8.2001

R24/25

ES: T(cid:243)xico en contacto con la piel y por ingesti(cid:243)n.

DA: Giftig ved hudkontakt og ved indtagelse.

DE: Giftig bei Ber(cid:252)hrung mit der Haut und beim Verschlucken.

EL: Sonij(cid:252) re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Toxic in contact with skin and if swallowed.

FR: Toxique par contact avec la peau et par ingestion.

IT: Tossico a contatto con la pelle e per ingestione.

NL: Vergiftig bij aanraking met de huid en bij opname door de mond.

PT: T(cid:243)xico em contacto com a pele e por ingestªo.

FI: Myrkyllist(cid:228) joutuessaan iholle ja nieltyn(cid:228).

SV: Giftigt vid hudkontakt och f(cid:246)rt(cid:228)ring.

R26/27

ES: Muy t(cid:243)xico por inhalaci(cid:243)n y en contacto con la piel.

DA: Meget giftig ved ind(cid:229)nding og ved hudkontakt.

DE: Sehr giftig beim Einatmen und bei Ber(cid:252)hrung mit der Haut.

EL: Pok(cid:253) sonij(cid:252) (cid:252)sam eirpm(cid:221)esai jai re epau(cid:222) le so d(cid:221)qla.

EN: Very toxic by inhalation and in contact with skin.

FR: TrŁs toxique par inhalation et par contact avec la peau.

IT: Molto tossico per inalazione e contatto con la pelle.

NL: Zeer vergiftig bij inademing en bij aanraking met de huid.

PT: Muito t(cid:243)xico por inala(cid:231)ªo e em contacto com a pele.

FI:

Eritt(cid:228)in myrkyllist(cid:228) hengitettyn(cid:228) ja joutuessaan iholle.

SV: Mycket giftigt vid inandning och hudkontakt.

R26/28

ES: Muy t(cid:243)xico por inhalaci(cid:243)n y por ingesti(cid:243)n.

DA: Meget giftig ved ind(cid:229)nding og ved indtagelse.

DE: Sehr giftig beim Einatmen und Verschlucken.

EL: Pok(cid:253) sonij(cid:252) (cid:252)sam eirpm(cid:221)esai jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Very toxic by inhalation and if swallowed.

FR: TrŁs toxique par inhalation et par ingestion.

IT: Molto tossico per inalazione e per ingestione.

NL: Zeer vergiftig bij inademing en opname door de mond.

PT: Muito t(cid:243)xico por inala(cid:231)ªo e ingestªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228) hengitettyn(cid:228) ja nieltyn(cid:228).

SV: Mycket giftigt vid inandning och f(cid:246)rt(cid:228)ring.

R26/27/28

ES: Muy t(cid:243)xico por inhalaci(cid:243)n, por ingesti(cid:243)n y en contacto con la piel.

DA: Meget giftig ved ind(cid:229)nding, ved hudkontakt og ved indtagelse.

DE: Sehr giftig beim Einatmen, Verschlucken und Ber(cid:252)hrung mit der Haut.

EL: Pok(cid:253) sonij(cid:252) (cid:252)sam eirpm(cid:221)esai, re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Very toxic by inhalation, in contact with skin and if swallowed.

FR: TrŁs toxique par inhalation, par contact avec la peau et par ingestion.

21.8.2001

EN

Official Journal of the European Communities

L 225/109

IT: Molto tossico per inalazione, contatto con la pelle e per ingestione.

NL: Zeer vergiftig bij inademing, opname door de mond en aanraking met de huid.

PT: Muito t(cid:243)xico por inala(cid:231)ªo, em contacto com a pele e por ingestªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228) hengitettyn(cid:228), joutuessaan iholle ja nieltyn(cid:228).

SV: Mycket giftigt vid inandning, hudkontakt och f(cid:246)rt(cid:228)ring.

R27/28

ES: Muy t(cid:243)xico en contacto con la piel y por ingesti(cid:243)n.

DA: Meget giftig ved hudkontakt og ved indtagelse.

DE: Sehr giftig bei Ber(cid:252)hrung mit der Haut und beim Verschlucken.

EL: Pok(cid:253) sonij(cid:252) re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Very toxic in contact with skin and if swallowed.

FR: TrŁs toxique par contact avec la peau et par ingestion.

IT: Molto tossico a contatto con la pelle e per ingestione.

NL: Zeer vergiftig bij aanraking met de huid en bij opname door de mond.

PT: Muito t(cid:243)xico em contacto com a pele e por ingestªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228) joutuessaan iholle ja nieltyn(cid:228).

SV: Mycket giftigt vid hudkontakt och f(cid:246)rt(cid:228)ring.

R36/37

ES:

Irrita los ojos y las v(cid:237)as respiratorias.

DA: Irriterer łjnene og (cid:229)ndedr(cid:230)tsorganerne.

DE: Reizt die Augen und die Atmungsorgane.

EL: Eqeh(cid:223)fei sa l(cid:220)sia jai so amapmetrsij(cid:252) r(cid:253)rsgla.

EN:

Irritating to eyes and respiratory system.

FR:

Irritant pour les yeux et les voies respiratoires.

IT:

Irritante per gli occhi e le vie respiratorie.

NL:

Irriterend voor de ogen en de ademhalingswegen.

PT:

Irritante para os olhos e vias respirat(cid:243)rias.

FI: ˜rsytt(cid:228)(cid:228) silmi(cid:228) ja hengityselimi(cid:228).

SV:

Irriterar (cid:246)gonen och andningsorganen.

R36/38

ES:

Irrita los ojos y la piel.

DA: Irriterer łjnene og huden.

DE: Reizt die Augen und die Haut.

EL: Eqeh(cid:223)fei sa l(cid:220)sia jai so d(cid:221)qla.

EN:

Irritating to eyes and skin.

FR:

Irritant pour les yeux et la peau.

IT:

Irritante per gli occhi e la pelle.

NL:

Irriterend voor de ogen en de huid.

PT:

Irritante para os olhos e pele.

FI: ˜rsytt(cid:228)(cid:228) silmi(cid:228) ja ihoa.

SV:

Irriterar (cid:246)gonen och huden.

L 225/110

EN

Official Journal of the European Communities

21.8.2001

R36/37/38

ES:

Irrita los ojos, la piel y las v(cid:237)as respiratorias.

DA: Irriterer łjnene, (cid:229)ndedr(cid:230)tsorganerne og huden.

DE: Reizt die Augen, die Atmungsorgane und die Haut.

EL: Eqeh(cid:223)fei sa l(cid:220)sia, so amapmetrsij(cid:252) r(cid:253)rsgla jai so d(cid:221)qla.

EN:

Irritating to eyes, respiratory system and skin.

FR:

Irritant pour les yeux, les voies respiratoires et la peau.

IT:

Irritante per gli occhi, le vie respiratorie e la pelle.

NL:

Irriterend voor de ogen, de ademhalingswegen en de huid.

PT:

Irritante para os olhos, vias respirat(cid:243)rias e pele.

FI: ˜rsytt(cid:228)(cid:228) silmi(cid:228), hengityselimi(cid:228) ja ihoa.

SV:

Irriterar (cid:246)gonen, andningsorganen och huden.

R37/38

ES:

Irrita las v(cid:237)as respiratorias y la piel.

DA: Irriterer (cid:229)ndedr(cid:230)tsorganerne og huden.

DE: Reizt die Atmungsorgane und die Haut.

EL: Eqeh(cid:223)fei so amapmetrsij(cid:252) r(cid:253)rsgla jai so d(cid:221)qla.

EN:

Irritating to respiratory system and skin.

FR:

Irritant pour les voies respiratoires et la peau.

IT:

Irritante per le vie respiratorie e la pelle.

NL:

Irriterend voor de ademhalingswegen en de huid.

PT:

Irritante para as vias respirat(cid:243)rias e pele.

FI: ˜rsytt(cid:228)(cid:228) hengityselimi(cid:228) ja ihoa.

SV:

Irriterar andningsorganen och huden.

R39/23

ES: T(cid:243)xico: peligro de efectos irreversibles muy graves por inhalaci(cid:243)n.

DA: Giftig: fare for varig alvorlig skade p(cid:229) helbred ved ind(cid:229)nding.

DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen.

EL: Sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai.

EN: Toxic: danger of very serious irreversible effects through inhalation.

FR: Toxique: danger d’effets irrØversibles trŁs graves par inhalation.

IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione.

NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing.

PT: T(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por inala(cid:231)ªo.

FI: Myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara hengitettyn(cid:228).

SV: Giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid inandning.

R39/24

ES: T(cid:243)xico: peligro de efectos irreversibles muy graves por contacto con la piel.

DA: Giftig: fare for varig alvorlig skade p(cid:229) helbred ved hudkontakt.

DE: Giftig: ernste Gefahr irreversiblen Schadens bei Ber(cid:252)hrung mit der Haut.

EL: Sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm re epau(cid:222) le so d(cid:221)qla.

EN: Toxic: danger of very serious irreversible effects in contact with skin.

FR: Toxique: danger d’effets irrØversibles trŁs graves par contact avec la peau.

21.8.2001

EN

Official Journal of the European Communities

L 225/111

IT: Tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle.

NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid.

PT: T(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves em contacto com a pele.

FI: Myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara joutuessaan iholle.

SV: Giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid hudkontakt.

R39/25

ES: T(cid:243)xico: peligro de efectos irreversibles muy graves por ingesti(cid:243)n.

DA: Giftig: fare for varig alvorlig skade p(cid:229) helbred ved indtagelse.

DE: Giftig: ernste Gefahr irreversiblen Schadens durch Verschlucken.

EL: Sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Toxic: danger of very serious irreversible effects if swallowed.

FR: Toxique: danger d’effets irrØversibles trŁs graves par ingestion.

IT: Tossico: pericolo di effetti irreversibili molto gravi per ingestione.

NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij opname door de mond.

PT: T(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por ingestªo.

FI: Myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara nieltyn(cid:228).

SV: Giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid f(cid:246)rt(cid:228)ring.

R39/23/24

ES: T(cid:243)xico: peligro de efectos irreversibles muy graves por inhalaci(cid:243)n y contacto con la piel.

DA: Giftig: fare for varig alvorlig skade p(cid:229) helbred ved ind(cid:229)nding og hudkontakt.

DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und bei Ber(cid:252)hrung mit der Haut.

EL: Sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai jai re epau(cid:222) le so d(cid:221)qla.

EN: Toxic: danger of very serious irreversible effects through inhalation and in contact with skin.

FR: Toxique: danger d’effets irrØversibles trŁs graves par inhalation et par contact avec la peau.

IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione e a contatto con la pelle.

NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en aanraking met de huid.

PT: T(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por inala(cid:231)ªo e em contacto com a pele.

FI: Myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara hengitettyn(cid:228) ja joutuessaan iholle.

SV: Giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid inandning och hudkontakt.

R39/23/25

ES: T(cid:243)xico: peligro de efectos irreversibles muy graves por inhalaci(cid:243)n e ingesti(cid:243)n.

DA: Giftig: fare for varig alvorlig skade p(cid:229) helbred ved ind(cid:229)nding og indtagelse.

DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und durch Verschlucken.

EL: Sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Toxic: danger of very serious irreversible effects through inhalation and if swallowed.

FR: Toxique: danger d’effets irrØversibles trŁs graves par inhalation et par ingestion.

IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione e ingestione.

NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en opname door de mond.

PT: T(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por inala(cid:231)ªo e ingestªo.

FI: Myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara hengitettyn(cid:228) ja nieltyn(cid:228).

SV: Giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid inandning och f(cid:246)rt(cid:228)ring.

L 225/112

EN

Official Journal of the European Communities

21.8.2001

R39/24/25

ES: T(cid:243)xico: peligro de efectos irreversibles muy graves por contacto con la piel e ingesti(cid:243)n.

DA: Giftig: fare for varig alvorlig skade p(cid:229) helbred ved hudkontakt og indtagelse.

DE: Giftig: ernste Gefahr irreversiblen Schadens bei Ber(cid:252)hrung mit der Haut und durch Verschlucken.

EL: Sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Toxic: danger of very serious irreversible effects in contact with skin and if swallowed.

FR: Toxique: danger d’effets irrØversibles trŁs graves par contact avec la peau et par ingestion.

IT: Tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle e per ingestione.

NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid en opname door de mond.

PT: T(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves em contacto com a pele e por ingestªo.

FI: Myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara joutuessaan iholle ja nieltyn(cid:228).

SV: Giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid hudkontakt och f(cid:246)rt(cid:228)ring.

R39/23/24/25

ES: T(cid:243)xico: peligro de efectos irreversibles muy graves por inhalaci(cid:243)n, contacto con la piel e ingesti(cid:243)n.

DA: Giftig: fare for varig alvorlig skade p(cid:229) helbred ved ind(cid:229)nding, hudkontakt og indtagelse.

DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen, Ber(cid:252)hrung mit der Haut und durch Verschlucken.

EL: Sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai, re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg

jasap(cid:252)rexy.

EN: Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.

FR: Toxique: danger d’effets irrØversibles trŁs graves par inhalation, par contact avec la peau et par ingestion.

IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione, a contatto con la pelle e per ingestione.

NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing, aanraking met de huid en opname door de

mond.

PT: T(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por inala(cid:231)ªo, em contacto com a pele e por ingestªo.

FI: Myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara hengitettyn(cid:228), joutuessaan iholle ja nieltyn(cid:228).

SV: Giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid inandning, hudkontakt och f(cid:246)rt(cid:228)ring.

R39/26

ES: Muy t(cid:243)xico: peligro de efectos irreversibles muy graves por inhalaci(cid:243)n.

DA: Meget giftig: fare for varig alvorlig skade p(cid:229) helbred ved ind(cid:229)nding.

DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen.

EL: Pok(cid:253) sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai.

EN: Very toxic: danger of very serious irreversible effects through inhalation.

FR: TrŁs toxique: danger d’effets irrØversibles trŁs graves par inhalation.

IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione.

NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing.

PT: Muito t(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por inala(cid:231)ªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara hengitettyn(cid:228).

SV: Mycket giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid inandning.

R39/27

ES: Muy t(cid:243)xico: peligro de efectos irreversibles muy graves por contacto con la piel.

DA: Meget giftig: fare for varig alvorlig skade p(cid:229) helbred ved hudkontakt.

DE: Sehr giftig: ernste Gefahr irreversiblen Schadens bei Ber(cid:252)hrung mit der Haut.

EL: Pok(cid:253) sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm re epau(cid:222) le so d(cid:221)qla.

EN: Very toxic: danger of very serious irreversible effects in contact with skin.

21.8.2001

EN

Official Journal of the European Communities

L 225/113

FR: TrŁs toxique: danger d’effets irrØversibles trŁs graves par contact avec la peau.

IT: Molto tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle.

NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid.

PT: Muito t(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves em contacto com a pele.

FI:

Eritt(cid:228)in myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara joutuessaan iholle.

SV: Mycket giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid hudkontakt.

R39/28

ES: Muy t(cid:243)xico: peligro de efectos irreversibles muy graves por ingesti(cid:243)n.

DA: Meget giftig: fare for varig alvorlig skade p(cid:229) helbred ved indtagelse.

DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Verschlucken.

EL: Pok(cid:253) sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Very toxic: danger of very serious irreversible effects if swallowed.

FR: TrŁs toxique: danger d’effets irrØversibles trŁs graves par ingestion.

IT: Molto tossico: pericolo di effetti irreversibili molto gravi per ingestione.

NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij opname door de mond.

PT: Muito t(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por ingestªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara nieltyn(cid:228).

SV: Mycket giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid f(cid:246)rt(cid:228)ring.

R39/26/27

ES: Muy t(cid:243)xico: peligro de efectos irreversibles muy graves por inhalaci(cid:243)n y contacto con la piel.

DA: Meget giftig: fare for varig alvorlig skade p(cid:229) helbred ved ind(cid:229)nding og hudkontakt.

DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und bei Ber(cid:252)hrung mit der Haut.

EL: Pok(cid:253) sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai jai re epau(cid:222) le so d(cid:221)qla.

EN: Very toxic: danger of very serious irreversible effects through inhalation and in contact with skin.

FR: TrŁs toxique: danger d’effets irrØversibles trŁs graves par inhalation et par contact avec la peau.

IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione e a contatto con la pelle.

NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en aanraking met de huid.

PT: Muito t(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por inala(cid:231)ªo e em contacto com a pele.

FI:

Eritt(cid:228)in myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara hengitettyn(cid:228) ja joutuessaan iholle.

SV: Mycket giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid inandning och hudkontakt.

R39/26/28

ES: Muy t(cid:243)xico: peligro de efectos irreversibles muy graves por inhalaci(cid:243)n e ingesti(cid:243)n.

DA: Meget giftig: fare for varig alvorlig skade p(cid:229) helbred ved ind(cid:229)nding og indtagelse.

DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und durch Verschlucken.

EL: Pok(cid:253) sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Very toxic: danger of very serious irreversible effects through inhalation and if swallowed.

FR: TrŁs toxique: danger d’effets irrØversibles trŁs graves par inhalation et par ingestion.

IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione e ingestione.

NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en opname door de mond.

PT: Muito t(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por inala(cid:231)ªo e ingestªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara hengitettyn(cid:228) ja nieltyn(cid:228).

SV: Mycket giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid inandning och f(cid:246)rt(cid:228)ring.

L 225/114

EN

Official Journal of the European Communities

21.8.2001

R39/27/28

ES: Muy t(cid:243)xico: peligro de efectos irreversibles muy graves por contacto con la piel e ingesti(cid:243)n.

DA: Meget giftig: fare for varig alvorlig skade p(cid:229) helbred ved hudkontakt og indtagelse.

DE: Sehr giftig: ernste Gefahr irreversiblen Schadens bei Ber(cid:252)hrung mit der Haut und durch Verschlucken.

EL: Pok(cid:253) sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed.

FR: TrŁs toxique: danger d’effets irrØversibles trŁs graves par contact avec la peau et par ingestion.

IT: Molto tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle e per ingestione.

NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid en opname door de mond.

PT: Muito t(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves em contacto com a pele e por ingestªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara joutuessaan iholle ja nieltyn(cid:228).

SV: Mycket giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid hudkontakt och f(cid:246)rt(cid:228)ring.

R39/26/27/28

ES: Muy t(cid:243)xico: peligro de efectos irreversibles muy graves por inhalaci(cid:243)n, contacto con la piel e ingesti(cid:243)n.

DA: Meget giftig: fare for varig alvorlig skade p(cid:229) helbred ved ind(cid:229)nding, hudkontakt og indtagelse.

DE: Sehr giftig: ernste Gefahr

irreversiblen Schadens durch Einatmen, Ber(cid:252)hrung mit der Haut und durch

Verschlucken.

EL: Pok(cid:253) sonij(cid:252): j(cid:223)mdtmoy pok(cid:253) robaq(cid:254)m l(cid:252)milxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai, re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg

jasap(cid:252)rexy.

EN: Very toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.

FR: TrŁs toxique: danger d’effets irrØversibles trŁs graves par inhalation, par contact avec la peau et par ingestion.

IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione, a contatto con la pelle e per ingestione.

NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing, aanraking met de huid en opname door

de mond.

PT: Muito t(cid:243)xico: perigo de efeitos irrevers(cid:237)veis muito graves por inala(cid:231)ªo, em contacto com a pele e por ingestªo.

FI:

Eritt(cid:228)in myrkyllist(cid:228): eritt(cid:228)in vakavien pysyvien vaurioiden vaara hengitettyn(cid:228), joutuessaan iholle ja nieltyn(cid:228).

SV: Mycket giftigt: risk f(cid:246)r mycket allvarliga best(cid:229)ende h(cid:228)lsoskador vid inandning, hudkontakt och f(cid:246)rt(cid:228)ring.

R42/43

ES: Posibilidad de sensibilizaci(cid:243)n por inhalaci(cid:243)n y por contacto con la piel.

DA: Kan give overfłlsomhed ved ind(cid:229)nding og ved kontakt med huden.

DE: Sensibilisierung durch Einatmen und Hautkontakt m(cid:246)glich.

EL: Lpoqe(cid:223) ma pqojak(cid:221)rei etairhgsopo(cid:223)grg (cid:252)sam eirpm(cid:221)esai jai re epau(cid:222) le so d(cid:221)qla.

EN: May cause sensitisation by inhalation and skin contact.

FR: Peut entra(cid:238)ner une sensibilisation par inhalation et par contact avec la peau.

IT:

Pu(cid:242) provocare sensibilizzazione per inalazione e contatto con la pelle.

NL: Kan overgevoeligheid veroorzaken bij inademing of contact met de huid.

PT: Pode causar sensibiliza(cid:231)ªo por inala(cid:231)ªo e em contacto com a pele.

FI: Altistuminen hengitysteitse ja ihokosketus voi aiheuttaa herkistymist(cid:228).

SV: Kan ge allergi vid inandning och hudkontakt.

R48/20

ES: Nocivo: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por inhalaci(cid:243)n.

DA: Farlig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved ind(cid:229)nding.

DE: Gesundheitssch(cid:228)dlich: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Einatmen.

EL: Epibkab(cid:221)y: j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg (cid:252)sam eirpm(cid:221)esai.

21.8.2001

EN

Official Journal of the European Communities

L 225/115

EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation.

FR: Nocif: risque d’effets graves pour la santØ en cas d’exposition prolongØe par inhalation.

IT: Nocivo: pericolo di gravi danni per la salute in caso di esposizione prolungata per inalazione.

NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing.

PT: Nocivo: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por inala(cid:231)ªo.

FI: Terveydelle haitallista: pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettyn(cid:228).

SV: Farligt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom inandning.

R48/21

ES: Nocivo: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por contacto con la piel.

DA: Farlig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved hudkontakt.

DE: Gesundheitssch(cid:228)dlich: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Ber(cid:252)hrung mit der Haut.

EL: Epibkab(cid:221)y: j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg re epau(cid:222) le so d(cid:221)qla.

EN: Harmful: danger of serious damage to health by prolonged exposure in contact with skin.

FR: Nocif: risque d’effets graves pour la santØ en cas d’exposition prolongØe par contact avec la peau.

IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle.

NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid.

PT: Nocivo: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada em contacto com a pele.

FI: Terveydelle haitallista: pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle.

SV: Farligt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom hudkontakt.

R48/22

ES: Nocivo: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por ingesti(cid:243)n.

DA: Farlig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved indtagelse.

DE: Gesundheitssch(cid:228)dlich: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Verschlucken.

EL: Epibkab(cid:221)y: j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful: danger of serious damage to health by prolonged exposure if swallowed.

FR: Nocif: risque d’effets graves pour la santØ en cas d’exposition prolongØe par ingestion.

IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per ingestione.

NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij opname door de mond.

PT: Nocivo: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por ingestªo.

FI: Terveydelle haitallista: pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle nieltyn(cid:228).

SV: Farligt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom f(cid:246)rt(cid:228)ring.

R48/20/21

ES: Nocivo: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por inhalaci(cid:243)n y contacto con la

piel.

DA: Farlig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved ind(cid:229)nding og hudkontakt.

DE: Gesundheitssch(cid:228)dlich: Gefahr ernster Gesundheitssch(cid:228)den bei

l(cid:228)ngerer Exposition durch Einatmen und durch

Ber(cid:252)hrung mit der Haut.

EL: Epibkab(cid:221)y: j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg (cid:252)sam eirpm(cid:221)esai jai re epau(cid:222) le so

d(cid:221)qla.

EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.

FR: Nocif: risque d’effets graves pour la santØ en cas d’exposition prolongØe par inhalation et par contact avec la peau.

IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione e a contatto con la

pelle.

NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en aanraking

met de huid.

L 225/116

EN

Official Journal of the European Communities

21.8.2001

PT: Nocivo: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por inala(cid:231)ªo e em contacto com a

pele.

FI: Terveydelle haitallista: pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettyn(cid:228) ja joutuessaan

iholle.

SV: Farligt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom inandning och hudkontakt.

R48/20/22

ES: Nocivo: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por inhalaci(cid:243)n e ingesti(cid:243)n.

DA: Farlig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved ind(cid:229)nding og indtagelse.

DE: Gesundheitssch(cid:228)dlich: Gefahr ernster Gesundheitssch(cid:228)den bei

l(cid:228)ngerer Exposition durch Einatmen und durch

Verschlucken.

EL: Epibkab(cid:221)y: j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg (cid:252)sam eirpm(cid:221)esai jai re peq(cid:223)psxrg

jasap(cid:252)rexy.

EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.

FR: Nocif: risque d’effets graves pour la santØ en cas d’exposition prolongØe par inhalation et par ingestion.

IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione e ingestione.

NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en opname

door de mond.

PT: Nocivo: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por inala(cid:231)ªo e ingestªo.

FI: Terveydelle haitallista: pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettyn(cid:228) ja nieltyn(cid:228).

SV: Farligt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom inandning och f(cid:246)rt(cid:228)ring.

R48/21/22

ES: Nocivo: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por contacto con la piel e

ingesti(cid:243)n.

DA: Farlig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved hudkontakt og indtagelse.

DE: Gesundheitssch(cid:228)dlich: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Ber(cid:252)hrung mit der Haut

und durch Verschlucken.

EL: Epibkab(cid:221)y: j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)-

psxrg jasap(cid:252)rexy.

EN: Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.

FR: Nocif: risque d’effets graves pour la santØ en cas d’exposition prolongØe par contact avec la peau et par ingestion.

IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle e per

ingestione.

NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid

en opname door de mond.

PT: Nocivo: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada em contacto com a pele e por

ingestªo.

FI: Terveydelle haitallista: pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle ja nieltyn(cid:228).

SV: Farligt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom hudkontakt och f(cid:246)rt(cid:228)ring.

R48/20/21/22

ES: Nocivo: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por inhalaci(cid:243)n, contacto con la

piel e ingesti(cid:243)n.

DA: Farlig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved ind(cid:229)nding, hudkontakt og indtagelse.

DE: Gesundheitssch(cid:228)dlich: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Einatmen, Ber(cid:252)hrung mit

der Haut und durch Verschlucken.

EL: Epibkab(cid:221)y: j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg (cid:252)sam eirpm(cid:221)esai, re epau(cid:222) le so d(cid:221)qla

jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and

if swallowed.

21.8.2001

EN

Official Journal of the European Communities

L 225/117

FR: Nocif: risque d’effets graves pour la santØ en cas d’exposition prolongØe par inhalation, par contact avec la peau et

par ingestion.

IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione, a contatto con la pelle

e per ingestione.

NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing, aanraking

met de huid en opname door de mond.

PT: Nocivo: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por inala(cid:231)ªo, em contacto com a

pele e por ingestªo.

FI: Terveydelle haitallista: pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettyn(cid:228),

joutuessaan

iholle ja nieltyn(cid:228).

SV: Farligt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom inandning, hudkontakt och f(cid:246)rt(cid:228)ring.

R48/23

ES: T(cid:243)xico: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por inhalaci(cid:243)n.

DA: Giftig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved ind(cid:229)nding.

DE: Giftig: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Einatmen.

EL: Sonij(cid:252): j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg (cid:252)sam eirpm(cid:221)esai.

EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation.

FR: Toxique: risque d’effets graves pour la santØ en cas d’exposition prolongØe par inhalation.

IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione.

NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing.

PT: T(cid:243)xico: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por inala(cid:231)ªo.

FI: Myrkyllist(cid:228): pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettyn(cid:228).

SV: Giftigt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom inandning.

R48/24

ES: T(cid:243)xico: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por contacto con la piel.

DA: Giftig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved hudkontakt.

DE: Giftig: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Ber(cid:252)hrung mit der Haut.

EL: Sonij(cid:252): j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg re epau(cid:222) le so d(cid:221)qla.

EN: Toxic: danger of serious damage to health by prolonged exposure in contact with skin.

FR: Toxique: risque d’effets graves pour la santØ en cas d’exposition prolongØe par contact avec la peau.

IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle.

NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid.

PT: T(cid:243)xico: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada em contacto com a pele.

FI: Myrkyllist(cid:228): pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle.

SV: Giftigt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom hudkontakt.

R48/25

ES: T(cid:243)xico: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por ingesti(cid:243)n.

DA: Giftig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved indtagelse.

DE: Giftig: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Verschlucken.

EL: Sonij(cid:252): j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Toxic: danger of serious damage to health by prolonged exposure if swallowed.

FR: Toxique: risque d’effets graves pour la santØ en cas d’exposition prolongØe par ingestion.

IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per ingestione.

NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij opname door de mond.

PT: T(cid:243)xico: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por ingestªo.

L 225/118

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Official Journal of the European Communities

21.8.2001

FI: Myrkyllist(cid:228): pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle nieltyn(cid:228).

SV: Giftigt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom f(cid:246)rt(cid:228)ring.

R48/23/24

ES: T(cid:243)xico: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por inhalaci(cid:243)n y contacto con la

piel.

DA: Giftig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved ind(cid:229)nding og hudkontakt.

DE: Giftig: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Einatmen und durch Ber(cid:252)hrung mit der

Haut.

EL: Sonij(cid:252): j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg (cid:252)sam eirpm(cid:221)esai jai re epau(cid:222) le so

d(cid:221)qla.

EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.

FR: Toxique: risque d’effets graves pour la santØ en cas d’exposition prolongØe par inhalation et par contact avec la

peau.

IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione e a contatto con la

pelle.

NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en aanraking

met de huid.

PT: T(cid:243)xico: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por inala(cid:231)ªo e em contacto com a

pele.

FI: Myrkyllist(cid:228): pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettyn(cid:228) ja joutuessaan iholle.

SV: Giftigt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom inandning och hudkontakt.

R48/23/25

ES: T(cid:243)xico: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por inhalaci(cid:243)n e ingesti(cid:243)n.

DA: Giftig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved ind(cid:229)nding og indtagelse.

DE: Giftig: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Einatmen und durch Verschlucken.

EL: Sonij(cid:252): j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg (cid:252)sam eirpm(cid:221)esai jai re peq(cid:223)psxrg

jasap(cid:252)rexy.

EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.

FR: Toxique: risque d’effets graves pour la santØ en cas d’exposition prolongØe par inhalation et par ingestion.

IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione ed ingestione.

NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en opname

door de mond.

PT: T(cid:243)xico: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por inala(cid:231)ªo e ingestªo.

FI: Myrkyllist(cid:228): pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettyn(cid:228) ja nieltyn(cid:228).

SV: Giftigt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom inandning och f(cid:246)rt(cid:228)ring.

R48/24/25

ES: T(cid:243)xico: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por contacto con la piel e

ingesti(cid:243)n.

DA: Giftig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved hudkontakt og indtagelse.

DE: Giftig: Gefahr ernster Gesundheitssch(cid:228)den bei

l(cid:228)ngerer Exposition durch Ber(cid:252)hrung mit der Haut und durch

Verschlucken.

EL: Sonij(cid:252): j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg

jasap(cid:252)rexy.

EN: Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.

FR: Toxique: risque d’effets graves pour la santØ en cas d’exposition prolongØe par contact avec la peau et par

ingestion.

IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle e per

ingestione.

21.8.2001

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Official Journal of the European Communities

L 225/119

NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid en

opname door de mond.

PT: T(cid:243)xico: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada em contacto com a pele e por

ingestªo.

FI: Myrkyllist(cid:228): pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle ja nieltyn(cid:228).

SV: Giftigt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom hudkontakt och f(cid:246)rt(cid:228)ring.

R48/23/24/25

ES: T(cid:243)xico: riesgo de efectos graves para la salud en caso de exposici(cid:243)n prolongada por inhalaci(cid:243)n, contacto con la

piel e ingesti(cid:243)n.

DA: Giftig: alvorlig sundhedsfare ved l(cid:230)ngere tids p(cid:229)virkning ved ind(cid:229)nding, hudkontakt og indtagelse.

DE: Giftig: Gefahr ernster Gesundheitssch(cid:228)den bei l(cid:228)ngerer Exposition durch Einatmen, Ber(cid:252)hrung mit der Haut und

durch Verschlucken.

EL: Sonij(cid:252): j(cid:223)mdtmoy robaq(cid:222)y bk(cid:220)bgy sgy tce(cid:223)ay (cid:253)rseqa ap(cid:252) paqasesal(cid:221)mg (cid:221)jherg (cid:252)sam eirpm(cid:221)esai, re epau(cid:222) le so d(cid:221)qla

jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if

swallowed.

FR: Toxique: risque d’effets graves pour la santØ en cas d’exposition prolongØe par inhalation, par contact avec la peau

et par ingestion.

IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione, a contatto con la pelle

e per ingestione.

NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing, aanraking met

de huid en opname door de mond.

PT: T(cid:243)xico: risco de efeitos graves para a saœde em caso de exposi(cid:231)ªo prolongada por inala(cid:231)ªo, em contacto com a

pele e por ingestªo.

FI: Myrkyllist(cid:228): pitk(cid:228)aikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettyn(cid:228),

joutuessaan iholle ja

nieltyn(cid:228).

SV: Giftigt: risk f(cid:246)r allvarliga h(cid:228)lsoskador vid l(cid:229)ngvarig exponering genom inandning, hudkontakt och f(cid:246)rt(cid:228)ring.

R50/53

ES: Muy t(cid:243)xico para los organismos acuÆticos, puede provocar a largo plazo efectos negativos en el medio ambiente

acuÆtico.

DA: Meget giftig for organismer, der lever i vand; kan for(cid:229)rsage ułnskede langtidsvirkninger i vandmiljłet.

DE: Sehr giftig f(cid:252)r Wasserorganismen, kann in Gew(cid:228)ssern l(cid:228)ngerfristig sch(cid:228)dliche Wirkungen haben.

EL: Pok(cid:253) sonij(cid:252) cia soty tdq(cid:252)bioty oqcamirlo(cid:253)y, lpoqe(cid:223) ma pqojak(cid:221)rei lajqovq(cid:252)miey dtrleme(cid:223)y epips(cid:254)reiy rso td(cid:220)simo

peqib(cid:220)kkom.

EN: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

FR: TrŁs toxique pour les organismes aquatiques, peut entra(cid:238)ner des effets nØfastes (cid:224) long terme pour l’environnement

aquatique.

IT: Altamente tossico per gli organismi acquatici, pu(cid:242) provocare a lungo termine effetti negativi per l’ambiente

acquatico.

NL: Zeer vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effec-

ten veroorzaken.

PT: Muito t(cid:243)xico para os organismos aquÆticos, podendo causar efeitos nefastos a longo prazo no ambiente aquÆtico.

FI:

Eritt(cid:228)in myrkyllist(cid:228) vesieli(cid:246)ille, voi aiheuttaa pitk(cid:228)aikaisia haittavaikutuksia vesiymp(cid:228)rist(cid:246)ss(cid:228).

SV: Mycket giftigt f(cid:246)r vattenlevande organismer, kan orsaka skadliga l(cid:229)ngtidseffekter i vattenmilj(cid:246)n.

R51/53

ES: T(cid:243)xico para los organismos acuÆticos, puede provocar a largo plazo efectos negativos en el medio ambiente

acuÆtico.

DA: Giftig for organismer, der lever i vand; kan for(cid:229)rsage ułnskede langtidsvirkninger i vandmiljłet.

DE: Giftig f(cid:252)r Wasserorganismen, kann in Gew(cid:228)ssern l(cid:228)ngerfristig sch(cid:228)dliche Wirkungen haben.

L 225/120

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Official Journal of the European Communities

21.8.2001

EL: Sonij(cid:252) cia soty tdq(cid:252)bioty oqcamirlo(cid:253)y, lpoqe(cid:223) ma pqojak(cid:221)rei lajqovq(cid:252)miey dtrleme(cid:223)y epips(cid:254)reiy rso td(cid:220)simo

peqib(cid:220)kkom.

EN: Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

FR: Toxique pour les organismes aquatiques, peut entra(cid:238)ner des effets nØfastes (cid:224) long terme pour l’environnement

aquatique.

IT: Tossico per gli organismi acquatici, pu(cid:242) provocare a lungo termine effetti negativi per l’ambiente acquatico.

NL: Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten

veroorzaken.

PT: T(cid:243)xico para os organismos aquÆticos, podendo causar efeitos nefastos a longo prazo no ambiente aquÆtico.

FI: Myrkyllist(cid:228) vesieli(cid:246)ille, voi aiheuttaa pitk(cid:228)aikaisia haittavaikutuksia vesiymp(cid:228)rist(cid:246)ss(cid:228).

SV: Giftigt f(cid:246)r vattenlevande organismer, kan orsaka skadliga l(cid:229)ngtidseffekter i vattenmilj(cid:246)n.

R52/53

ES: Nocivo para los organismos acuÆticos, puede provocar a largo plazo efectos negativos en el medio ambiente

acuÆtico.

DA: Skadelig for organismer, der lever i vand; kan for(cid:229)rsage ułnskede langtidsvirkninger i vandmiljłet.

DE: Sch(cid:228)dlich f(cid:252)r Wasserorganismen, kann in Gew(cid:228)ssern l(cid:228)ngerfristig sch(cid:228)dliche Wirkungen haben.

EL: Epibkab(cid:221)y cia soty tdq(cid:252)bioty oqcamirlo(cid:253)y, lpoqe(cid:223) ma pqojak(cid:221)rei lajqovq(cid:252)miey dtrleme(cid:223)y epips(cid:254)reiy rso td(cid:220)simo

peqib(cid:220)kkom.

EN: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

FR: Nocif pour les organismes aquatiques, peut entra(cid:238)ner des effets nØfastes (cid:224) long terme pour l’environnement

aquatique.

IT: Nocivo per gli organismi acquatici, pu(cid:242) provocare a lungo termine effetti negativi per l’ambiente acquatico.

NL: Schadelijk voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten

veroorzaken.

PT: Nocivo para os organismos aquÆticos, podendo causar efeitos nefastos a longo prazo no ambiente aquÆtico.

FI: Haitallista vesieli(cid:246)ille, voi aiheuttaa pitk(cid:228)aikaisia haittavaikutuksia vesiymp(cid:228)rist(cid:246)ss(cid:228).

SV: Skadligt f(cid:246)r vattenlevande organismer, kan orsaka skadliga l(cid:229)ngtidseffekter i vattenmilj(cid:246)n.

R68/20

ES: Nocivo: posibilidad de efectos irreversibles por inhalaci(cid:243)n.

DA: Farlig: mulighed for varig skade p(cid:229) helbred ved ind(cid:229)nding.

DE: Gesundheitssch(cid:228)dlich: M(cid:246)glichkeit irreversiblen Schadens durch Einatmen.

EL: Epibkab(cid:221)y: pihamo(cid:223) j(cid:223)mdtmoi lom(cid:223)lxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai.

EN: Harmful: possible risk of irreversible effects through inhalation.

FR: Nocif: possibilitØ d’effets irrØversibles par inhalation.

IT: Nocivo: possibilit(cid:224) di effetti irreversibili per inalazione.

NL: Schadelijk: bij inademing zijn onherstelbare effecten niet uitgesloten.

PT: Nocivo: possibilidade de efeitos irrevers(cid:237)veis por inala(cid:231)ªo.

FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettyn(cid:228).

SV: Farligt: m(cid:246)jlig risk f(cid:246)r best(cid:229)ende h(cid:228)lsoskador vid inandning.

R68/21

ES: Nocivo: posibilidad de efectos irreversibles por contacto con la piel

DA: Farlig: mulighed for varig skade p(cid:229) helbred ved hudkontakt.

DE: Gesundheitssch(cid:228)dlich: M(cid:246)glichkeit irreversiblen Schadens bei Ber(cid:252)hrung mit der Haut.

EL: Epibkab(cid:221)y: pihamo(cid:223) j(cid:223)mdtmoi lom(cid:223)lxm epidq(cid:220)rexm re epau(cid:222) le so d(cid:221)qla.

EN: Harmful: possible risk of irreversible effects in contact with skin.

FR: Nocif: possibilitØ d’effets irrØversibles par contact avec la peau.

21.8.2001

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Official Journal of the European Communities

L 225/121

IT: Nocivo: possibilit(cid:224) di effetti irreversibili a contatto con la pelle.

NL: Schadelijk: bij aanraking met de huid zijn onherstelbare effecten niet uitgesloten.

PT: Nocivo: possibilidade de efeitos irrevers(cid:237)veis em contacto com a pele.

FI: Terveydelle haitallista: pysyvien vaurioiden vaara joutuessaan iholle.

SV: Farligt: m(cid:246)jlig risk f(cid:246)r best(cid:229)ende h(cid:228)lsoskador vid hudkontakt.

R68/22

ES: Nocivo: posibilidad de efectos irreversibles por ingesti(cid:243)n.

DA: Farlig: mulighed for varig skade p(cid:229) helbred ved indtagelse.

DE: Gesundheitssch(cid:228)dlich: M(cid:246)glichkeit irreversiblen Schadens durch Verschlucken.

EL: Epibkab(cid:221)y: pihamo(cid:223) j(cid:223)mdtmoi lom(cid:223)lxm epidq(cid:220)rexm re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful: possible risk of irreversible effects if swallowed.

FR: Nocif: possibilitØ d’effets irrØversibles par ingestion.

IT: Nocivo: possibilit(cid:224) di effetti irreversibili per ingestione.

NL: Schadelijk: bij opname door de mond zijn onherstelbare effecten niet uitgesloten.

PT: Nocivo: possibilidade de efeitos irrevers(cid:237)veis por ingestªo.

FI: Terveydelle haitallista: pysyvien vaurioiden vaara nieltyn(cid:228).

SV: Farligt: m(cid:246)jlig risk f(cid:246)r best(cid:229)ende h(cid:228)lsoskador vid f(cid:246)rt(cid:228)ring.

R68/20/21

ES: Nocivo: posibilidad de efectos irreversibles por inhalaci(cid:243)n y contacto con la piel.

DA: Farlig: mulighed for varig skade p(cid:229) helbred ved ind(cid:229)nding og hudkontakt.

DE: Gesundheitssch(cid:228)dlich: M(cid:246)glichkeit irreversiblen Schadens durch Einatmen und bei Ber(cid:252)hrung mit der Haut.

EL: Epibkab(cid:221)y: pihamo(cid:223) j(cid:223)mdtmoi lom(cid:223)lxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai jai re epau(cid:222) le so d(cid:221)qla.

EN: Harmful: possible risk of irreversible effects through inhalation and in contact with skin.

FR: Nocif: possibilitØ d’effets irrØversibles par inhalation et par contact avec la peau.

IT: Nocivo: possibilit(cid:224) di effetti irreversibili per inalazione e a contatto con la pelle.

NL: Schadelijk: bij inademing en aanraking met de huid zijn onherstelbare effecten niet uitgesloten.

PT: Nocivo: possibilidade de efeitos irrevers(cid:237)veis por inala(cid:231)ªo e em contacto com a pele.

FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettyn(cid:228) ja joutuessaan iholle.

SV: Farligt: m(cid:246)jlig risk f(cid:246)r best(cid:229)ende h(cid:228)lsoskador vid inandning och hudkontakt.

R68/20/22

ES: Nocivo: posibilidad de efectos irreversibles por inhalaci(cid:243)n e ingesti(cid:243)n.

DA: Farlig: mulighed for varig skade p(cid:229) helbred ved ind(cid:229)nding og indtagelse.

DE: Gesundheitssch(cid:228)dlich: M(cid:246)glichkeit irreversiblen Schadens durch Einatmen und durch Verschlucken.

EL: Epibkab(cid:221)y: pihamo(cid:223) j(cid:223)mdtmoi lom(cid:223)lxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful: possible risk of irreversible effects through inhalation and if swallowed.

FR: Nocif: possibilitØ d’effets irrØversibles par inhalation et par ingestion.

IT: Nocivo: possibilit(cid:224) di effetti irreversibili per inalazione e ingestione.

NL: Schadelijk: bij inademing en opname door de mond zijn onherstelbare effecten niet uitgesloten.

PT: Nocivo: possibilidade de efeitos irrevers(cid:237)veis por inala(cid:231)ªo e ingestªo.

FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettyn(cid:228) ja nieltyn(cid:228).

SV: Farligt: m(cid:246)jlig risk f(cid:246)r best(cid:229)ende h(cid:228)lsoskador vid inandning och f(cid:246)rt(cid:228)ring.

L 225/122

EN

Official Journal of the European Communities

21.8.2001

R68/21/22

ES: Nocivo: posibilidad de efectos irreversibles por contacto con la piel e ingesti(cid:243)n.

DA: Farlig: mulighed for varig skade p(cid:229) helbred ved hudkontakt og indtagelse.

DE: Gesundheitssch(cid:228)dlich: M(cid:246)glichkeit irreversiblen Schadens bei Ber(cid:252)hrung mit der Haut und durch Verschlucken.

EL: Epibkab(cid:221)y: pihamo(cid:223) j(cid:223)mdtmoi lom(cid:223)lxm epidq(cid:220)rexm re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful: possible risk of irreversible effects in contact with skin and if swallowed.

FR: Nocif: possibilitØ d’effets irrØversibles par contact avec la peau et par ingestion.

IT: Nocivo: possibilit(cid:224) di effetti irreversibili a contatto con la pelle e per ingestione.

NL: Schadelijk: bij aanraking met de huid en opname door de mond zijn onherstelbare effecten niet uitgesloten.

PT: Nocivo: possibilidade de efeitos irrevers(cid:237)veis em contacto com a pele e por ingestªo.

FI: Terveydelle haitallista: pysyvien vaurioiden vaara joutuessaan iholle ja nieltyn(cid:228).

SV: Farligt: m(cid:246)jlig risk f(cid:246)r best(cid:229)ende h(cid:228)lsoskador vid hudkontakt och f(cid:246)rt(cid:228)ring.

R68/20/21/22

ES: Nocivo: posibilidad de efectos irreversibles por inhalaci(cid:243)n, contacto con la piel e ingesti(cid:243)n.

DA: Farlig: mulighed for varig skade p(cid:229) helbred ved ind(cid:229)nding, hudkontakt og indtagelse.

DE: Gesundheitssch(cid:228)dlich: M(cid:246)glichkeit irreversiblen Schadens durch Einatmen, Ber(cid:252)hrung mit der Haut und durch

Verschlucken.

EL: Epibkab(cid:221)y: pihamo(cid:223) j(cid:223)mdtmoi lom(cid:223)lxm epidq(cid:220)rexm (cid:252)sam eirpm(cid:221)esai, re epau(cid:222) le so d(cid:221)qla jai re peq(cid:223)psxrg jasap(cid:252)rexy.

EN: Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed.

FR: Nocif: possibilitØ d’effets irrØversibles par inhalation, par contact avec la peau et par ingestion.

IT: Nocivo: possibilit(cid:224) di effetti irreversibili per inalazione, a contatto con la pelle e per ingestione.

NL: Schadelijk: bij
uitgesloten.

inademing, aanraking met de huid en opname door de mond zijn onherstelbare effecten niet

PT: Nocivo: possibilidade de efeitos irrevers(cid:237)veis por inala(cid:231)ªo, em contacto com a pele e por ingestªo.

FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettyn(cid:228), joutuessaan iholle ja nieltyn(cid:228).

SV: Farligt: m(cid:246)jlig risk f(cid:246)r best(cid:229)ende h(cid:228)lsoskador vid inandning, hudkontakt och f(cid:246)rt(cid:228)ring.

21.8.2001

EN

Official Journal of the European Communities

L 225/123

ANEXO IV (cid:151) BILAG IV (cid:151) ANHANG IV (cid:151) PAQAQSGLA IV (cid:151) ANNEX IV (cid:151) ANNEXE IV (cid:151) ALLEGATO IV (cid:151)
BIJLAGE IV (cid:151) ANEXO IV (cid:151) LIITE IV (cid:151) BILAGA IV

ANNEX 4

ANEXO IV

Consejos de prudencia relativos a las sustancias y preparados peligrosos

BILAG IV

Forsigtighedsregler for farlige stoffer og pr(cid:230)parater

ANHANG IV

Sicherheitsratschl(cid:228)ge f(cid:252)r gef(cid:228)hrliche Stoffe und Zubereitungen

PAQAQSGLA IV

Odgc(cid:223)ey aruako(cid:253)y vq(cid:222)rgy pot auoqo(cid:253)m epij(cid:223)mdtmey vglij(cid:221)y otr(cid:223)ey jai paqarjet(cid:220)rlasa

ANNEX IV

Safety advice concerning dangerous substances and preparations

ANNEXE IV

Conseils de prudence concernant les substances et prØparations dangereuses

ALLEGATO IV

Consigli di prudenza riguardanti le sostanze e preparati pericolosi

BIJLAGE IV

Veiligheidsaanbevelingen met betrekking tot gevaarlijke stoffen en preparaten

ANEXO IV

Conselhos de prudŒncia relativos a subst(cid:226)ncias e prepara(cid:231)ıes perigosas

LIITE IV

Vaarallisten aineiden ja valmisteiden turvallisuusohjeet

BILAGA IV

Skyddsfraser f(cid:246)r farliga (cid:228)mnen och beredningar

L 225/124

EN

Official Journal of the European Communities

21.8.2001

S1

ES: ConsØrvese bajo llave.

DA: Opbevares under l(cid:229)s.

DE: Unter Verschluss aufbewahren.

EL: Ma utk(cid:220)rresai jkeidxl(cid:221)mo.

EN: Keep locked up.

FR: Conserver sous clØ.

IT: Conservare sotto chiave.

NL: Achter slot bewaren.

PT: Guardar fechado (cid:224) chave.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) lukitussa tilassa.

SV: F(cid:246)rvaras i l(cid:229)st utrymme.

S2

ES: MantØngase fuera del alcance de los niæos.

DA: Opbevares utilg(cid:230)ngeligt for błrn.

DE: Darf nicht in die H(cid:228)nde von Kindern gelangen.

EL: Lajqt(cid:220) ap(cid:252) paidi(cid:220).

EN: Keep out of the reach of children.

FR: Conserver hors de portØe des enfants.

IT: Conservare fuori della portata dei bambini.

NL: Buiten bereik van kinderen bewaren.

PT: Manter fora do alcance das crian(cid:231)as.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) lasten ulottumattomissa.

SV: F(cid:246)rvaras o(cid:229)tkomligt f(cid:246)r barn.

S3

ES: ConsØrvese en lugar fresco.

DA: Opbevares kłligt.

DE: K(cid:252)hl aufbewahren.

EL: Ma utk(cid:220)rresai re dqoreq(cid:252) l(cid:221)qoy.

EN: Keep in a cool place.

FR: Conserver dans un endroit frais.

IT: Conservare in luogo fresco.

NL: Op een koele plaats bewaren.

PT: Guardar em lugar fresco.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) viile(cid:228)ss(cid:228).

SV: F(cid:246)rvaras svalt.

S4

ES: MantØngase lejos de locales habitados.

DA: M(cid:229) ikke opbevares i n(cid:230)rheden af beboelse.

DE: Von Wohnpl(cid:228)tzen fernhalten.

EL: Lajqt(cid:220) ap(cid:252) jasoijgl(cid:221)moty v(cid:254)qoty.

EN: Keep away from living quarters.

FR: Conserver (cid:224) l’Øcart de tout local d’habitation.

21.8.2001

EN

Official Journal of the European Communities

L 225/125

IT: Conservare lontano da locali di abitazione.

NL: Verwijderd van woonruimten opbergen.

PT: Manter fora de qualquer zona de habita(cid:231)ªo.

FI:

Ei saa s(cid:228)ilytt(cid:228)(cid:228) asuintiloissa.

SV: F(cid:246)rvaras avskilt fr(cid:229)n bostadsutrymmen.

S5

ES: ConsØrvese en (cid:133) (l(cid:237)quido apropiado a especificar por el fabricante).

DA: Opbevares under (cid:133) (en egnet v(cid:230)ske, som angives af fabrikanten).

DE: Unter (cid:133) aufbewahren (geeignete Fl(cid:252)ssigkeit vom Hersteller anzugeben).

EL: Ma diasgqe(cid:223)sai so peqiev(cid:252)lemo l(cid:221)ra re (cid:133) (so e(cid:223)doy sot jas(cid:220)kkgkot tcqo(cid:253) jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: Keep contents under (cid:133) (appropriate liquid to be specified by the manufacturer).

FR: Conserver sous (cid:133) (liquide appropriØ (cid:224) spØcifier par le fabricant).

IT: Conservare sotto (cid:133) (liquido appropriato da indicarsi da parte del fabbricante).

NL: Onder (cid:133) houden (geschikte vloeistof aan te geven door fabrikant).

PT: Manter sob (cid:133) (l(cid:237)quido apropriado a especificar pelo produtor).

FI:

Sis(cid:228)lt(cid:246) s(cid:228)ilytett(cid:228)v(cid:228) (cid:133) (tarkoitukseen soveltuvan nesteen ilmoittaa valmistaja/maahantuoja).

SV: F(cid:246)rvara inneh(cid:229)llet i (cid:133) (l(cid:228)mplig v(cid:228)tska anges av tillverkaren).

S6

ES: ConsØrvese en (cid:133) (gas inerte a especificar por el fabricante).

DA: Opbevares under (cid:133) (en inaktiv gas, som angives af fabrikanten).

DE: Unter (cid:133) aufbewahren (inertes Gas vom Hersteller anzugeben).

EL: Ma diasgqe(cid:223)sai re asl(cid:252)ruaiqa (cid:133) (so e(cid:223)doy sot adqamo(cid:253)y aeq(cid:223)ot jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: Keep under (cid:133) (inert gas to be specified by the manufacturer).

FR: Conserver sous (cid:133) (gaz inerte (cid:224) spØcifier par le fabricant).

IT: Conservare sotto (cid:133) (gas inerte da indicarsi da parte del fabbricante).

NL: Onder (cid:133) houden (inert gas aan te geven door fabrikant).

PT: Manter sob (cid:133) (gÆs inerte a especificar pelo produtor).

FI:

S(cid:228)ilytett(cid:228)v(cid:228) (cid:133) (inertin kaasun ilmoittaa valmistaja/maahantuoja).

SV: F(cid:246)rvaras i (cid:133) (inert gas anges av tillverkaren).

S7

ES: MantØngase el recipiente bien cerrado.

DA: Emballagen skal holdes t(cid:230)t lukket.

DE: Beh(cid:228)lter dicht geschlossen halten.

EL: So dove(cid:223)o ma diasgqe(cid:223)sai eqlgsij(cid:220) jkeirl(cid:221)mo.

EN: Keep container tightly closed.

FR: Conserver le rØcipient bien fermØ.

IT: Conservare il recipiente ben chiuso.

NL:

In goed gesloten verpakking bewaren.

PT: Manter o recipiente bem fechado.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) tiiviisti suljettuna.

SV: F(cid:246)rpackningen f(cid:246)rvaras v(cid:228)l tillsluten.

L 225/126

EN

Official Journal of the European Communities

21.8.2001

S8

ES: MantØngase el recipiente en lugar seco.

DA: Emballagen skal opbevares tłrt.

DE: Beh(cid:228)lter trocken halten.

EL: So dove(cid:223)o ma pqorsase(cid:253)esai ap(cid:252) sgm tcqar(cid:223)a.

EN: Keep container dry.

FR: Conserver le rØcipient (cid:224) l’abri de l’humiditØ.

IT: Conservare al riparo dall’umidit(cid:224).

NL: Verpakking droog houden.

PT: Manter o recipiente ao abrigo da humidade.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) kuivana.

SV: F(cid:246)rpackningen f(cid:246)rvaras torrt.

S9

ES: ConsØrvese el recipiente en lugar bien ventilado.

DA: Emballagen skal opbevares p(cid:229) et godt ventileret sted.

DE: Beh(cid:228)lter an einem gut gel(cid:252)fteten Ort aufbewahren.

EL: So dove(cid:223)o ma diasgqe(cid:223)sai re jak(cid:220) aeqif(cid:252)lemo l(cid:221)qoy.

EN: Keep container in a well-ventilated place.

FR: Conserver le rØcipient dans un endroit bien ventilØ.

IT: Conservare il recipiente in luogo ben ventilato.

NL: Op een goed geventileerde plaats bewaren.

PT: Manter o recipiente num local bem ventilado.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) paikassa, jossa on hyv(cid:228) ilmanvaihto.

SV: F(cid:246)rpackningen f(cid:246)rvaras p(cid:229) v(cid:228)l ventilerad plats.

S12

ES: No cerrar el recipiente hermØticamente.

DA: Emballagen m(cid:229) ikke lukkes t(cid:230)t.

DE: Beh(cid:228)lter nicht gasdicht verschlie(cid:223)en.

EL: Lg diasgqe(cid:223)se so dove(cid:223)o eqlgsij(cid:220) jkeirl(cid:221)mo.

EN: Do not keep the container sealed.

FR: Ne pas fermer hermØtiquement le rØcipient.

IT: Non chiudere ermeticamente il recipiente.

NL: De verpakking niet hermetisch sluiten.

PT: Nªo fechar o recipiente hermeticamente.

FI:

Pakkausta ei saa sulkea ilmatiiviisti.

SV: F(cid:246)rpackningen f(cid:229)r inte tillslutas luftt(cid:228)tt.

S13

ES: MantØngase lejos de alimentos, bebidas y piensos.

DA: M(cid:229) ikke opbevares sammen med fłdevarer, drikkevarer og foderstoffer.

DE: Von Nahrungsmitteln, Getr(cid:228)nken und Futtermitteln fernhalten.

EL: Lajqt(cid:220) ap(cid:252) sq(cid:252)uila, pos(cid:220) jai fxosqou(cid:221)y.

EN: Keep away from food, drink and animal feedingstuffs.

FR: Conserver (cid:224) l’Øcart des aliments et boissons, y compris ceux pour animaux.

21.8.2001

EN

Official Journal of the European Communities

L 225/127

IT: Conservare lontano da alimenti o mangimi e da bevande.

NL: Verwijderd houden van eet- en drinkwaren en van diervoeder.

PT: Manter afastado de alimentos e bebidas, incluindo os dos animais.

FI:

Ei saa s(cid:228)ilytt(cid:228)(cid:228) yhdess(cid:228) elintarvikkeiden eik(cid:228) el(cid:228)inravinnon kanssa.

SV: F(cid:246)rvaras (cid:229)tskilt fr(cid:229)n livsmedel och djurfoder.

S14

ES: ConsØrvese lejos de (cid:133) (materiales incompatibles a especificar por el fabricante).

DA: Opbevares adskilt fra (cid:133) (uforligelige stoffer, som angives af fabrikanten).

DE: Von (cid:133) fernhalten (inkompatible Substanzen sind vom Hersteller anzugeben).

EL: Lajqt(cid:220) ap(cid:252) (cid:133) (ar(cid:253)lbasey otr(cid:223)ey jahoq(cid:223)fomsai ap(cid:252) som paqacxc(cid:252)).

EN: Keep away from (cid:133) (incompatible materials to be indicated by the manufacturer).

FR: Conserver (cid:224) l’Øcart des (cid:133) (matiŁres incompatibles (cid:224) indiquer par le fabricant).

IT: Conservare lontano da (cid:133) (sostanze incompatibili da precisare da parte del produttore).

NL: Verwijderd houden van (cid:133) (stoffen waarmee contact vermeden dient te worden aan te geven door de fabrikant).

PT: Manter afastado de (cid:133) (matØrias incompat(cid:237)veis a indicar pelo produtor).

FI:

S(cid:228)ilytett(cid:228)v(cid:228) erill(cid:228)(cid:228)n (cid:133) (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja).

SV: F(cid:246)rvaras (cid:229)tskilt fr(cid:229)n (cid:133) (of(cid:246)renliga (cid:228)mnen anges av tillverkaren).

S15

ES: Conservar alejado del calor.

DA: M(cid:229) ikke uds(cid:230)ttes for varme.

DE: Vor Hitze sch(cid:252)tzen.

EL: Lajqt(cid:220) ap(cid:252) heql(cid:252)sgsa.

EN: Keep away from heat.

FR: Conserver (cid:224) l’Øcart de la chaleur.

IT: Conservare lontano dal calore.

NL: Verwijderd houden van warmte.

PT: Manter afastado do calor.

FI:

Suojattava l(cid:228)mm(cid:246)lt(cid:228).

SV: F(cid:229)r inte uts(cid:228)ttas f(cid:246)r v(cid:228)rme.

S16

ES: Conservar alejado de toda llama o fuente de chispas (cid:151) No fumar.

DA: Holdes v(cid:230)k fra ant(cid:230)ndelseskilder (cid:151) Rygning forbudt.

DE: Von Z(cid:252)ndquellen fernhalten (cid:151) Nicht rauchen.

EL: Lajqt(cid:220) ap(cid:252) pgc(cid:221)y am(cid:220)ukengy (cid:151) Apacoqe(cid:253)esai so j(cid:220)pmirla.

EN: Keep away from sources of ignition (cid:151) No smoking.

FR: Conserver (cid:224) l’Øcart de toute flamme ou source d’Øtincelles (cid:151) Ne pas fumer.

IT: Conservare lontano da fiamme e scintille (cid:151) Non fumare.

NL: Verwijderd houden van ontstekingsbronnen (cid:151) Niet roken.

PT: Manter afastado de qualquer chama ou fonte de igni(cid:231)ªo (cid:151) Nªo fumar.

FI:

Eristett(cid:228)v(cid:228) sytytysl(cid:228)hteist(cid:228) (cid:151) Tupakointi kielletty.

SV: F(cid:246)rvaras (cid:229)tskilt fr(cid:229)n ant(cid:228)ndningsk(cid:228)llor (cid:150) R(cid:246)kning f(cid:246)rbjuden.

L 225/128

EN

Official Journal of the European Communities

21.8.2001

S17

ES: MantØngase lejos de materias combustibles.

DA: Holdes v(cid:230)k fra brandbare stoffer.

DE: Von brennbaren Stoffen fernhalten.

EL: Lajqt(cid:220) ap(cid:252) ja(cid:253)rila tkij(cid:220).

EN: Keep away from combustible material.

FR: Tenir (cid:224) l’Øcart des matiŁres combustibles.

IT: Tenere lontano da sostanze combustibili.

NL: Verwijderd houden van brandbare stoffen.

PT: Manter afastado de matØrias combust(cid:237)veis.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) erill(cid:228)(cid:228)n syttyvist(cid:228) kemikaaleista.

SV: F(cid:246)rvaras (cid:229)tskilt fr(cid:229)n brandfarliga (cid:228)mnen.

S18

ES: Manipœlese y Æbrase el recipiente con prudencia.

DA: Emballagen skal behandles og (cid:229)bnes med forsigtighed.

DE: Beh(cid:228)lter mit Vorsicht (cid:246)ffnen und handhaben.

EL: Veiqirse(cid:223)se jai amo(cid:223)nse so dove(cid:223)o pqorejsij(cid:220).

EN: Handle and open container with care.

FR: Manipuler et ouvrir le rØcipient avec prudence.

IT: Manipolare ed aprire il recipiente con cautela.

NL: Verpakking voorzichtig behandelen en openen.

PT: Manipular e abrir o recipiente com prudŒncia.

FI:

Pakkauksen k(cid:228)sittelyss(cid:228) ja avaamisessa on noudatettava varovaisuutta.

SV: F(cid:246)rpackningen hanteras och (cid:246)ppnas f(cid:246)rsiktigt.

S20

ES: No comer ni beber durante su utilizaci(cid:243)n.

DA: Der m(cid:229) ikke spises eller drikkes under brugen.

DE: Bei der Arbeit nicht essen und trinken.

EL: Lgm sq(cid:254)se (cid:222) p(cid:223)mese (cid:252)sam so vqgrilopoie(cid:223)se.

EN: When using do not eat or drink.

FR: Ne pas manger et ne pas boire pendant l’utilisation.

IT: Non mangiare nØ bere durante l’impiego.

NL: Niet eten of drinken tijdens gebruik.

PT: Nªo comer nem beber durante a utiliza(cid:231)ªo.

FI:

Sy(cid:246)minen ja juominen kielletty kemikaalia k(cid:228)sitelt(cid:228)ess(cid:228).

SV: ˜t inte eller drick inte under hanteringen

S21

ES: No fumar durante su utilizaci(cid:243)n.

DA: Der m(cid:229) ikke ryges under brugen.

DE: Bei der Arbeit nicht rauchen.

EL: Lgm japm(cid:223)fese (cid:252)sam so vqgrilopoie(cid:223)se.

EN: When using do not smoke.

FR: Ne pas fumer pendant l’utilisation.

21.8.2001

EN

Official Journal of the European Communities

L 225/129

IT: Non fumare durante l’impiego.

NL: Niet roken tijdens gebruik.

PT: Nªo fumar durante a utiliza(cid:231)ªo.

FI: Tupakointi kielletty kemikaalia k(cid:228)ytett(cid:228)ess(cid:228).

SV: R(cid:246)k inte under hanteringen.

S22

ES: No respirar el polvo.

DA: Undg(cid:229) ind(cid:229)nding af stłv.

DE: Staub nicht einatmen.

EL: Lgm amapm(cid:221)ese sgm rj(cid:252)mg.

EN: Do not breathe dust.

FR: Ne pas respirer les poussiŁres.

IT: Non respirare le polveri.

NL: Stof niet inademen.

PT: Nªo respirar as poeiras.

FI: V(cid:228)ltett(cid:228)v(cid:228) p(cid:246)lyn hengitt(cid:228)mist(cid:228).

SV: Undvik inandning av damm.

S23

ES: No respirar los gases/humos/vapores/aerosoles [denominaci(cid:243)n(es) adecuada(s) a especificar por el fabricante].

DA: Undg(cid:229) ind(cid:229)nding af gas/rłg/dampe/aerosol-t(cid:229)ger (den eller de p(cid:229)g(cid:230)ldende betegnelser angives af fabrikanten).

DE: Gas/Rauch/Dampf/Aerosol nicht einatmen (geeignete Bezeichnung(en) vom Hersteller anzugeben).

EL: Lgm amapm(cid:221)ese a(cid:221)qia/amahtli(cid:220)reiy/aslo(cid:253)y/ejmeu(cid:254)lasa (g jas(cid:220)kkgkg dias(cid:253)pxrg jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).

FR: Ne pas respirer les gaz/fumØes/vapeurs/aØrosols [terme(s) appropriØ(s) (cid:224) indiquer par le fabricant].

IT: Non respirare i gas/fumi/vapori/aerosoli [termine(i) appropriato(i) da precisare da parte del produttore].

NL: Gas/rook/damp/spuitnevel niet inademen (toepasselijke term(en) aan te geven door de fabrikant).

PT: Nªo respirar os gases/vapores/fumos/aeross(cid:243)is [termo(s) apropriado(s) a indicar pelo produtor].

FI: V(cid:228)ltett(cid:228)v(cid:228) kaasun/huurun/h(cid:246)yryn/sumun hengitt(cid:228)mist(cid:228) (oikean sanamuodon valitsee valmistaja/maahantuoja).

SV: Undvik inandning av gas/r(cid:246)k/(cid:229)nga/dimma (l(cid:228)mplig formulering anges av tillverkaren).

S24

ES: Ev(cid:237)tese el contacto con la piel.

DA: Undg(cid:229) kontakt med huden.

DE: Ber(cid:252)hrung mit der Haut vermeiden.

EL: Apoue(cid:253)cese sgm epau(cid:222) le so d(cid:221)qla.

EN: Avoid contact with skin.

FR: (cid:201)viter le contact avec la peau.

IT: Evitare il contatto con la pelle.

NL: Aanraking met de huid vermijden.

PT: Evitar o contacto com a pele.

FI: Varottava kemikaalin joutumista iholle.

SV: Undvik kontakt med huden.

L 225/130

EN

Official Journal of the European Communities

21.8.2001

S25

ES: Ev(cid:237)tese el contacto con los ojos.

DA: Undg(cid:229) kontakt med łjnene.

DE: Ber(cid:252)hrung mit den Augen vermeiden.

EL: Apoue(cid:253)cese sgm epau(cid:222) le sa l(cid:220)sia.

EN: Avoid contact with eyes.

FR: (cid:201)viter le contact avec les yeux.

IT: Evitare il contatto con gli occhi.

NL: Aanraking met de ogen vermijden.

PT: Evitar o contacto com os olhos.

FI: Varottava kemikaalin joutumista silmiin.

SV: Undvik kontakt med (cid:246)gonen.

S26

ES: En caso de contacto con los ojos, lÆvense inmediata y abundantemente con agua y acœdase a un mØdico.

DA: Kommer stoffet i łjnene, skylles straks grundigt med vand og l(cid:230)ge kontaktes.

DE: Bei Ber(cid:252)hrung mit den Augen sofort gr(cid:252)ndlich mit Wasser absp(cid:252)len und Arzt konsultieren.

EL: Re peq(cid:223)psxrg epau(cid:222)y le sa l(cid:220)sia pk(cid:253)mes(cid:221) sa al(cid:221)rxy le (cid:220)uhomo meq(cid:252) jai fgs(cid:222)rse iasqij(cid:222) rtlbotk(cid:222).

EN:

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

FR: En cas de contact avec les yeux, laver immØdiatement et abondamment avec de l’eau et consulter un spØcialiste.

IT:

In caso di contatto con gli occhi, lavare immediatamente e abbondantemente con acqua e consultare un medico.

NL: Bij aanraking met de ogen onmiddellijk met overvloedig water afspoelen en deskundig medisch advies inwinnen.

PT: Em caso de contacto com os olhos, lavar imediata e abundantemente com Ægua e consultar um especialista.

FI: Roiskeet silmist(cid:228) huuhdeltava v(cid:228)litt(cid:246)m(cid:228)sti runsaalla vedell(cid:228) ja ment(cid:228)v(cid:228) l(cid:228)(cid:228)k(cid:228)riin.

SV: Vid kontakt med (cid:246)gonen, spola genast med mycket vatten och kontakta l(cid:228)kare.

S27

ES: Qu(cid:237)tese inmediatamente la ropa manchada o salpicada.

DA: Tilsmudset tłj tages straks af.

DE: Beschmutzte, getr(cid:228)nkte Kleidung sofort ausziehen.

EL: Auaiq(cid:221)rse al(cid:221)rxy (cid:252)ka sa emd(cid:253)lasa pot (cid:221)votm loktmhe(cid:223).

EN: Take off immediately all contaminated clothing.

FR: Enlever immØdiatement tout vŒtement souillØ ou ØclaboussØ.

IT: Togliersi di dosso immediatamente gli indumenti contaminati.

NL: Verontreinigde kleding onmiddellijk uittrekken.

PT: Retirar imediatamente todo o vestuÆrio contaminado.

FI: Riisuttava v(cid:228)litt(cid:246)m(cid:228)sti saastunut vaatetus.

SV: Tag genast av alla nedst(cid:228)nkta kl(cid:228)der.

S28

ES: En caso de contacto con la piel, lÆvese inmediata y abundantemente con (cid:133) (productos a especificar por el fabricante).

DA: Kommer stof p(cid:229) huden vaskes straks med store m(cid:230)ngder (cid:133) (angives af fabrikanten).

DE: Bei Ber(cid:252)hrung mit der Haut sofort abwaschen mit viel (cid:133) (vom Hersteller anzugeben).

EL: Re peq(cid:223)psxrg epau(cid:222)y le so d(cid:221)qla, pkthe(cid:223)se al(cid:221)rxy le (cid:220)uhomo (cid:133) (so e(cid:223)doy sot tcqo(cid:253) jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: After contact with skin, wash immediately with plenty of (cid:133) (to be specified by the manufacturer).

21.8.2001

EN

Official Journal of the European Communities

L 225/131

FR: AprŁs contact avec la peau, se laver immØdiatement et abondamment avec (cid:133) (produits appropriØs (cid:224) indiquer par le

fabricant).

IT:

In caso di contatto con la pelle lavarsi immediatamente ed abbondantemente con (cid:133) (prodotti idonei da indicarsi da
parte del fabbricante).

NL: Na aanraking met de huid onmiddellijk wassen met veel (cid:133) (aan te geven door de fabrikant).

PT: Ap(cid:243)s contacto com a pele, lavar imediata e abundantemente com (cid:133) (produtos adequados a indicar pelo produtor).

FI: Roiskeet iholta huuhdeltava v(cid:228)litt(cid:246)m(cid:228)sti runsaalla m(cid:228)(cid:228)r(cid:228)ll(cid:228) (cid:133) (aineen ilmoittaa valmistaja/maahantuoja).

SV: Vid kontakt med huden tv(cid:228)tta genast med mycket (cid:133) (anges av tillverkaren).

S29

ES: No tirar los residuos por el desag(cid:252)e.

DA: M(cid:229) ikke tłmmes i kloakaflłb.

DE: Nicht in die Kanalisation gelangen lassen.

EL: Lgm adei(cid:220)fese so tp(cid:252)koipo sot peqievol(cid:221)mot rsgm apov(cid:221)setrg.

EN: Do not empty into drains.

FR: Ne pas jeter les rØsidus (cid:224) l’Øgout.

IT: Non gettare i residui nelle fognature.

NL: Afval niet in de gootsteen werpen.

PT: Nªo deitar os res(cid:237)duos no esgoto.

FI:

Ei saa tyhjent(cid:228)(cid:228) viem(cid:228)riin.

SV: T(cid:246)m ej i avloppet.

S30

ES: No echar jamÆs agua a este producto.

DA: H(cid:230)ld aldrig vand p(cid:229) eller i produktet.

DE: Niemals Wasser hinzugie(cid:223)en.

EL: Pos(cid:221) lgm pqorh(cid:221)sese meq(cid:252) rso pqoœ(cid:252)m ats(cid:252).

EN: Never add water to this product.

FR: Ne jamais verser de l’eau dans ce produit.

IT: Non versare acqua sul prodotto.

NL: Nooit water op deze stof gieten.

PT: Nunca adicionar Ægua a este produto.

FI: Tuotteeseen ei saa lis(cid:228)t(cid:228) vett(cid:228).

SV: H(cid:228)ll aldrig vatten p(cid:229) eller i produkten.

S33

ES: Ev(cid:237)tese la acumulaci(cid:243)n de cargas electroestÆticas.

DA: Tr(cid:230)f foranstaltninger mod statisk elektricitet.

DE: Ma(cid:223)nahmen gegen elektrostatische Aufladungen treffen.

EL: K(cid:220)bese pqorsasetsij(cid:220) l(cid:221)sqa (cid:221)mamsi gkejsqorsasij(cid:254)m ejjem(cid:254)rexm.

EN: Take precautionary measures against static discharges.

FR: (cid:201)viter l’accumulation de charges Ølectrostatiques.

IT: Evitare l’accumulo di cariche elettrostatiche.

NL: Maatregelen treffen tegen ontladingen van statische elektriciteit.

PT: Evitar acumula(cid:231)ªo de cargas electrostÆticas.

FI:

Estett(cid:228)v(cid:228) staattisen s(cid:228)hk(cid:246)n aiheuttama kipin(cid:246)inti.

SV: Vidtag (cid:229)tg(cid:228)rder mot statisk elektricitet.

L 225/132

EN

Official Journal of the European Communities

21.8.2001

S35

ES: Elim(cid:237)nense los residuos del producto y sus recipientes con todas las precauciones posibles.

DA: Materialet og dets beholder skal bortskaffes p(cid:229) en sikker m(cid:229)de.

DE: Abf(cid:228)lle und Beh(cid:228)lter m(cid:252)ssen in gesicherter Weise beseitigt werden.

EL: So tkij(cid:252) jai o peqi(cid:221)jsgy sot pq(cid:221)pei ma diasehe(cid:223) le aruak(cid:222) sq(cid:252)po.

EN: This material and its container must be disposed of in a safe way.

FR: Ne se dØbarrasser de ce produit et de son rØcipient qu’en prenant toutes les prØcautions d’usage.

IT: Non disfarsi del prodotto e del recipiente se non con le dovute precauzioni.

NL: Deze stof en de verpakking op veilige wijze afvoeren.

PT: Nªo se desfazer deste produto e do seu recipiente sem tomar as precau(cid:231)ıes de seguran(cid:231)a devidas.

FI: T(cid:228)m(cid:228) aine ja sen pakkaus on h(cid:228)vitett(cid:228)v(cid:228) turvallisesti.

SV: Produkt och f(cid:246)rpackning skall oskadligg(cid:246)ras p(cid:229) s(cid:228)kert s(cid:228)tt.

S36

ES: (cid:218)sese indumentaria protectora adecuada.

DA: Brug s(cid:230)rligt arbejdstłj.

DE: Bei der Arbeit geeignete Schutzkleidung tragen.

EL: Ma uoq(cid:220)se jas(cid:220)kkgkg pqorsasetsij(cid:222) emdtlar(cid:223)a.

EN: Wear suitable protective clothing.

FR: Porter un vŒtement de protection appropriØ.

IT: Usare indumenti protettivi adatti.

NL: Draag geschikte beschermende kleding.

PT: Usar vestuÆrio de protec(cid:231)ªo adequado.

FI: K(cid:228)ytett(cid:228)v(cid:228) sopivaa suojavaatetusta.

SV: Anv(cid:228)nd l(cid:228)mpliga skyddskl(cid:228)der.

S37

ES: (cid:218)sense guantes adecuados.

DA: Brug egnede beskyttelseshandsker under arbejdet.

DE: Geeignete Schutzhandschuhe tragen.

EL: Ma uoq(cid:220)se jas(cid:220)kkgka c(cid:220)msia.

EN: Wear suitable gloves.

FR: Porter des gants appropriØs.

IT: Usare guanti adatti.

NL: Draag geschikte handschoenen.

PT: Usar luvas adequadas.

FI: K(cid:228)ytett(cid:228)v(cid:228) sopivia suojak(cid:228)sineit(cid:228).

SV: Anv(cid:228)nd l(cid:228)mpliga skyddshandskar.

S38

ES: En caso de ventilaci(cid:243)n insuficiente, œsese equipo respiratorio adecuado.

DA: Brug egnet (cid:229)ndedr(cid:230)tsv(cid:230)rn, hvis effektiv ventilation ikke er mulig.

DE: Bei unzureichender Bel(cid:252)ftung Atemschutzger(cid:228)t anlegen.

EL: Re peq(cid:223)psxrg amepaqjo(cid:253)y aeqirlo(cid:253), vqgrilopoie(cid:223)se jas(cid:220)kkgkg amapmetrsij(cid:222) rtrjet(cid:222).

EN:

In case of insufficient ventilation, wear suitable respiratory equipment.

FR: En cas de ventilation insuffisante, porter un appareil respiratoire appropriØ.

21.8.2001

EN

Official Journal of the European Communities

L 225/133

IT:

In caso di ventilazione insufficiente, usare un apparecchio respiratorio adatto.

NL: Bij ontoereikende ventilatie een geschikte adembescherming dragen.

PT: Em caso de ventila(cid:231)ªo insuficiente, usar equipamento respirat(cid:243)rio adequado.

FI: Kemikaalin k(cid:228)ytt(cid:246) edellytt(cid:228)(cid:228) tehokasta ilmanvaihtoa tai sopivaa hengityksensuojainta.

SV: Anv(cid:228)nd l(cid:228)mpligt andningsskydd vid otillr(cid:228)cklig ventilation.

S39

ES: (cid:218)sese protecci(cid:243)n para los ojos/la cara.

DA: Brug beskyttelsesbriller/ansigtssk(cid:230)rm under arbejdet.

DE: Schutzbrille/Gesichtsschutz tragen.

EL: Vqgrilopoie(cid:223)se rtrjet(cid:222) pqorsar(cid:223)ay lasi(cid:254)m/pqor(cid:254)pot.

EN: Wear eye/face protection.

FR: Porter un appareil de protection des yeux/du visage.

IT:

Proteggersi gli occhi/la faccia.

NL: Een bescherming voor de ogen/voor het gezicht dragen.

PT: Usar um equipamento protector para os olhos/face.

FI: K(cid:228)ytett(cid:228)v(cid:228) silmien- tai kasvonsuojainta.

SV: Anv(cid:228)nd skyddsglas(cid:246)gon eller ansiktsskydd.

S40

ES: Para limpiar el suelo y los objetos contaminados por este producto, œsese (cid:133) (a especificar por el fabricante).

DA: Gulvet og tilsmudsede genstande renses med (cid:133) (midlerne angives af fabrikanten).

DE: Fu(cid:223)boden und verunreinigte Gegenst(cid:228)nde mit (cid:133) reinigen (Material vom Hersteller anzugeben).

EL: Cia som jahaqirl(cid:252) sot dap(cid:221)dot jai (cid:252)kxm sxm amsijeil(cid:221)mxm pot (cid:221)votm loktmhe(cid:223) ap(cid:252) so tkij(cid:252) ats(cid:252) vqgrilopoie(cid:223)se (cid:133) (so

e(cid:223)doy jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: To clean the floor and all objects contaminated by this material, use (cid:133) (to be specified by the manufacturer).

FR: Pour nettoyer le sol ou les objets souillØs par ce produit, utiliser (cid:133) ((cid:224) prØciser par le fabricant).

IT:

Per pulire il pavimento e gli oggetti contaminati da questo prodotto, usare (cid:133) (da precisare da parte del produttore).

NL: Voor de reiniging van de vloer en alle voorwerpen verontreinigd met dit materiaal, (cid:133) gebruiken (aan te geven door

de fabrikant).

PT: Para limpeza do chªo e objectos contaminados por este produto, utilizar (cid:133) (a especificar pelo produtor).

FI: Kemikaali puhdistettava pinnoilta k(cid:228)ytt(cid:228)en (cid:133) (kemikaalin ilmoittaa valmistaja/maahantuoja).

SV: Golv och f(cid:246)rorenade f(cid:246)rem(cid:229)l tv(cid:228)ttas med (cid:133) (anges av tillverkaren).

S41

ES: En caso de incendio y/o de explosi(cid:243)n no respire los humos.

DA: Undg(cid:229) at ind(cid:229)nde rłgen ved brand eller eksplosion.

DE: Explosions- und Brandgase nicht einatmen.

EL: Re peq(cid:223)psxrg ptqjaci(cid:220)y (cid:222)/jai ejq(cid:222)nexy lgm amapm(cid:221)ese soty japmo(cid:253)y.

EN:

In case of fire and/or explosion do not breathe fumes.

FR: En cas d’incendie et/ou d’explosion, ne pas respirer les fumØes.

IT:

In caso di incendio e/o esplosione non respirare i fumi.

NL:

In geval van brand en/of explosie inademen van rook vermijden.

PT: Em caso de incŒndio e/ou explosªo nªo respirar os fumos.

FI: V(cid:228)ltett(cid:228)v(cid:228) palamisessa tai r(cid:228)j(cid:228)hdyksess(cid:228) muodostuvan savun hengitt(cid:228)mist(cid:228).

SV: Undvik inandning av r(cid:246)k vid brand eller explosion.

L 225/134

EN

Official Journal of the European Communities

21.8.2001

S42

ES: Durante las fumigaciones/pulverizaciones, œsese equipo respiratorio adecuado [denominaci(cid:243)n(es) adecuada(s) a especifi-

car por el fabricante].

DA: Brug egnet (cid:229)ndedr(cid:230)tsv(cid:230)rn ved rygning/sprłjtning (den eller de p(cid:229)g(cid:230)ldende betegnelser angives af fabrikanten).

DE: Beim R(cid:228)uchern/Verspr(cid:252)hen geeignetes Atemschutzger(cid:228)t anlegen (geeignete Bezeichnung(en) vom Hersteller anzugeben).

EL: Jas(cid:220) sg di(cid:220)qjeia tpojapmirlo(cid:253)/wej(cid:220)rlasoy vqgrilopoie(cid:223)se jas(cid:220)kkgkg amapmetrsij(cid:222) rtrjet(cid:222) (g jas(cid:220)kkgkg dias(cid:253)pxrg

jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: During fumigation/spraying wear suitable respiratory equipment

(appropriate wording to be

specified by the

manufacturer).

FR: Pendant les fumigations/pulvØrisations, porter un appareil respiratoire appropriØ [terme(s) appropriØ(s) (cid:224) indiquer par

le fabricant].

IT: Durante le fumigazioni/polimerizzazioni usare un apparecchio respiratorio adatto [termine(i) appropriato(i) da preci-

sare da parte del produttore].

NL: Tijdens de ontsmetting/bespuiting een geschikte adembescherming dragen (geschikte term(en) door de fabrikant aan te

geven).

PT: Durante as fumiga(cid:231)ıes/pulveriza(cid:231)ıes usar equipamento respirat(cid:243)rio adequado [termo(s) adequado(s) a indicar pelo

produtor].

FI: Kaasutuksen/ruiskutuksen
valmistaja/maahantuoja).

aikana

k(cid:228)ytett(cid:228)v(cid:228)

sopivaa

hengityksensuojainta

(oikean

sanamuodon

valitsee

SV: Anv(cid:228)nd l(cid:228)mpligt andningsskydd vid gasning/sprutning (specificeras av tillverkaren).

S43

ES: En caso de incendio, utilizar (cid:133) (los medios de extinci(cid:243)n los debe especificar el fabricante). (Si el agua aumenta el riesgo, se

deberÆ aæadir: «No usar nunca agua»).

DA: Brug (cid:133) ved brandslukning (den nłjagtige type brandslukningsudstyr angives af fabrikanten. S(cid:229)fremt vand ikke m(cid:229) bruges

tilfłjes: »Brug ikke vand«).

DE: Zum L(cid:246)schen (cid:133) (vom Hersteller anzugeben) verwenden.

(Wenn Wasser die Gefahr erh(cid:246)ht, anf(cid:252)gen: (cid:132)Kein Wasser

verwenden(cid:147).).

EL: Re peq(cid:223)psxrg ptqjaci(cid:220)y vqgrilopoie(cid:223)se (cid:133) (Amau(cid:221)qesai so ajqib(cid:221)y e(cid:223)doy l(cid:221)rxm ptq(cid:252)rbergy. E(cid:220)m so meq(cid:252) atn(cid:220)mei som

j(cid:223)mdtmo, pqors(cid:223)hesai: «Lg vqgrilopoie(cid:223)se pos(cid:221) meq(cid:252)»).

EN:

In case of fire, use (cid:133) (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add (cid:145)Never use
water(cid:146)).

FR: En cas d’incendie, utiliser (cid:133) (moyens d’extinction (cid:224) prØciser par le fabricant. Si l’eau augmente les risques, ajouter: «Ne

jamais utiliser d’eau»).

IT:

In caso di incendio usare (cid:133) (mezzi estinguenti idonei da indicarsi da parte del fabbricante. Se l’acqua aumenta il rischio
precisare «Non usare acqua»).

NL:

In geval van brand (cid:133) gebruiken (blusmiddelen aan te duiden door de fabrikant. Indien water het risico vergroot toevoegen:
(cid:132)Nooit water gebruiken.(cid:148)).

PT: Em caso de incŒndio, utilizar (cid:133) (meios de extin(cid:231)ªo a especificar pelo produtor. Se a Ægua aumentar os riscos, acrescentar

«Nunca utilizar Ægua»).

FI:

Sammutukseen k(cid:228)ytett(cid:228)v(cid:228) (cid:133) (ilmoitettava sopiva sammutusmenetelm(cid:228). Jos vesi lis(cid:228)(cid:228) vaaraa, lis(cid:228)tt(cid:228)v(cid:228) sanat: Sammutuk-
seen ei saa k(cid:228)ytt(cid:228)(cid:228) vett(cid:228)).

SV: Vid brandsl(cid:228)ckning anv(cid:228)nd (cid:133) (ange l(cid:228)mplig metod. Om vatten (cid:246)kar riskerna, l(cid:228)gg till: (cid:148)Anv(cid:228)nd aldrig vatten(cid:148)).

S45

ES: En caso de accidente o malestar, acœdase inmediatamente al mØdico (si es posible, muØstresele la etiqueta).

DA: Ved ulykkestilf(cid:230)lde eller ved ildebefindende er omg(cid:229)ende l(cid:230)gebehandling nłdvendig; vis etiketten, hvis det er

muligt.

DE: Bei Unfall oder Unwohlsein sofort Arzt zuziehen (wenn m(cid:246)glich, dieses Etikett vorzeigen).

EL: Re peq(cid:223)psxrg astv(cid:222)lasoy (cid:222) am airhamhe(cid:223)se adiaher(cid:223)a fgs(cid:222)rse al(cid:221)rxy iasqij(cid:222) rtlbotk(cid:222) (de(cid:223)nse sgm esij(cid:221)ssa am e(cid:223)mai

dtmas(cid:252)).

EN:

In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).

FR: En cas d’accident ou de malaise, consulter immØdiatement un mØdecin (si possible, lui montrer l’Øtiquette).

IT:

In caso di incidente o di malessere consultare immediatamente il medico (se possibile, mostrargli l’etichetta).

21.8.2001

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Official Journal of the European Communities

L 225/135

NL: Bij een ongeval of indien men zich onwel voelt, onmiddellijk een arts raadplegen (indien mogelijk hem dit etiket

tonen).

PT: Em caso de acidente ou de indisposi(cid:231)ªo, consultar imediatamente o mØdico (se poss(cid:237)vel mostrar-lhe o r(cid:243)tulo).

FI: Onnettomuuden sattuessa tai tunnettaessa pahoinvointia hakeuduttava heti l(cid:228)(cid:228)k(cid:228)rin hoitoon (n(cid:228)ytett(cid:228)v(cid:228) t(cid:228)t(cid:228) etiket-

ti(cid:228), mik(cid:228)li mahdollista).

SV: Vid olycksfall, illam(cid:229)ende eller annan p(cid:229)verkan, kontakta omedelbart l(cid:228)kare. Visa om m(cid:246)jligt etiketten.

S46

ES: En caso de ingesti(cid:243)n, acœdase inmediatamente al mØdico y muØstresele la etiqueta o el envase.

DA: Ved indtagelse, kontakt omg(cid:229)ende l(cid:230)ge og vis denne beholder eller etiket.

DE: Bei Verschlucken sofort (cid:228)rztlichen Rat einholen und Verpackung oder Etikett vorzeigen.

EL: Re peq(cid:223)psxrg jas(cid:220)porgy fgs(cid:222)rse al(cid:221)rxy iasqij(cid:222) rtlbotk(cid:222) jai de(cid:223)nse ats(cid:252) so dove(cid:223)o (cid:222) sgm esij(cid:221)ssa.

EN:

If swallowed, seek medical advice immediately and show this container or label.

FR: En cas d’ingestion, consulter immØdiatement un mØdecin et lui montrer l’emballage ou l’Øtiquette.

IT:

In caso d’ingestione consultare immediatamente il medico e mostrargli il contenitore o l’etichetta.

NL:

In geval van inslikken onmiddellijk een arts raadplegen en verpakking of etiket tonen.

PT: Em caso de ingestªo, consultar imediatamente o mØdico e mostrar-lhe a embalagem ou o r(cid:243)tulo.

FI:

Jos ainetta on nielty, hakeuduttava heti l(cid:228)(cid:228)k(cid:228)rin hoitoon ja n(cid:228)ytett(cid:228)v(cid:228) t(cid:228)m(cid:228) pakkaus tai etiketti.

SV: Vid f(cid:246)rt(cid:228)ring kontakta genast l(cid:228)kare och visa denna f(cid:246)rpackning eller etiketten.

S47

ES: ConsØrvese a una temperatura no superior a (cid:133) (cid:176)C (a especificar por el fabricante).

DA: M(cid:229) ikke opbevares ved temperaturer p(cid:229) over (cid:133) (cid:176)C (angives af fabrikanten).

DE: Nicht bei Temperaturen (cid:252)ber (cid:133) (cid:176)C aufbewahren (vom Hersteller anzugeben).

EL: Ma diasgqe(cid:223)sai re heqlojqar(cid:223)a pot dem tpeqba(cid:223)mei soty (cid:133) (cid:176)C (jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: Keep at temperature not exceeding (cid:133) (cid:176)C (to be specified by the manufacturer).

FR: Conserver (cid:224) une tempØrature ne dØpassant pas (cid:133) (cid:176)C ((cid:224) prØciser par le fabricant).

IT: Conservare a temperatura non superiore a (cid:133) (cid:176)C (da precisare da parte del fabbricante).

NL: Bewaren bij een temperatuur beneden (cid:133) (cid:176)C (aan te geven door de fabrikant).

PT: Conservar a uma temperatura que nªo exceda (cid:133) (cid:176)C (a especificar pelo produtor).

FI:

S(cid:228)ilytett(cid:228)v(cid:228) alle (cid:133) (cid:176)C:n l(cid:228)mp(cid:246)tilassa (valmistaja/maahantuoja ilmoittaa l(cid:228)mp(cid:246)tilan).

SV: F(cid:246)rvaras vid en temperatur som inte (cid:246)verstiger (cid:133) (cid:176)C (anges av tillverkaren).

S48

ES: ConsØrvese hœmedo con (cid:133) (medio apropiado a especificar por el fabricante).

DA: Holdes befugtet med (cid:133) (passende middel angives af fabrikanten).

DE: Feucht halten mit (cid:133) (geeignetes Mittel vom Hersteller anzugeben).

EL: Ma diasgqe(cid:223)sai tcq(cid:252) le (cid:133) (so jas(cid:220)kkgko tkij(cid:252) jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: Keep wet with (cid:133) (appropriate material to be specified by the manufacturer).

FR: Maintenir humide avec (cid:133) (moyen appropriØ (cid:224) prØciser par le fabricant).

IT: Mantenere umido con (cid:133) (mezzo appropriato da precisare da parte del fabbricante).

NL:

Inhoud vochtig houden met (cid:133) (middel aan te geven door de fabrikant).

PT: Manter hœmido com (cid:133) (material adequado a especificar pelo produtor).

FI:

S(cid:228)ilytett(cid:228)v(cid:228) kosteana (cid:133) (valmistaja/maahantuoja ilmoittaa sopivan aineen).

SV:

Inneh(cid:229)llet skall h(cid:229)llas fuktigt med (cid:133) (l(cid:228)mpligt material anges av tillverkaren).

L 225/136

EN

Official Journal of the European Communities

21.8.2001

S49

ES: ConsØrvese œnicamente en el recipiente de origen.

DA: M(cid:229) kun opbevares i den originale emballage.

DE: Nur im Originalbeh(cid:228)lter aufbewahren.

EL: Diasgqe(cid:223)sai l(cid:252)mo l(cid:221)ra rso aqvij(cid:252) dove(cid:223)o.

EN: Keep only in the original container.

FR: Conserver uniquement dans le rØcipient d’origine.

IT: Conservare soltanto nel recipiente originale.

NL: Uitsluitend in de oorspronkelijke verpakking bewaren.

PT: Conservar unicamente no recipiente de origem.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) vain alkuper(cid:228)ispakkauksessa.

SV: F(cid:246)rvaras endast i originalf(cid:246)rpackningen.

S50

ES: No mezclar con (cid:133) (a especificar por el fabricante).

DA: M(cid:229) ikke blandes med (cid:133) (angives af fabrikanten).

DE: Nicht mischen mit (cid:133) (vom Hersteller anzugeben).

EL: Ma lgm amaleivhe(cid:223) le (cid:133) (jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: Do not mix with (cid:133) (to be specified by the manufacturer).

FR: Ne pas mØlanger avec (cid:133) ((cid:224) spØcifier par le fabricant).

IT: Non mescolare con (cid:133) (da specificare da parte del fabbricante).

NL: Niet vermengen met (cid:133) (aan te geven door de fabrikant).

PT: Nªo misturar com (cid:133) (a especificar pelo produtor).

FI:

Ei saa sekoittaa (cid:133) (valmistaja/maahantuoja ilmoittaa aineen) kanssa.

SV: Blanda inte med (cid:133) (anges av tillverkaren).

S51

ES: (cid:218)sese œnicamente en lugares bien ventilados.

DA: M(cid:229) kun bruges p(cid:229) steder med god ventilation.

DE: Nur in gut gel(cid:252)fteten Bereichen verwenden.

EL: Ma vqgrilopoie(cid:223)sai l(cid:252)mo re jak(cid:220) aeqif(cid:252)lemo v(cid:254)qo.

EN: Use only in well-ventilated areas.

FR: Utiliser seulement dans des zones bien ventilØes.

IT: Usare soltanto in luogo ben ventilato.

NL: Uitsluitend op goed geventileerde plaatsen gebruiken.

PT: Utilizar somente em locais bem ventilados.

FI: Huolehdittava hyv(cid:228)st(cid:228) ilmanvaihdosta.

SV: S(cid:246)rj f(cid:246)r god ventilation.

S52

ES: No usar sobre grandes superficies en locales habitados.

DA: Błr ikke anvendes til stłrre flader i beboelses- eller opholdsrum.

DE: Nicht gro(cid:223)fl(cid:228)chig f(cid:252)r Wohn- und Aufenthaltsr(cid:228)ume zu verwenden.

EL: Dem rtmirs(cid:220)sai g vq(cid:222)rg re etqe(cid:223)ey epiu(cid:220)meiey re erxseqijo(cid:253)y v(cid:254)qoty.

EN: Not recommended for interior use on large surface areas.

FR: Ne pas utiliser sur de grandes surfaces dans les locaux habitØs.

21.8.2001

EN

Official Journal of the European Communities

L 225/137

IT: Non utilizzare su grandi superfici in locali abitati.

NL: Niet voor gebruik op grote oppervlakken in woon- en verblijfruimten.

PT: Nªo utilizar em grandes superf(cid:237)cies nos locais habitados.

FI:

Ei suositella sis(cid:228)k(cid:228)ytt(cid:246)(cid:246)n laajoilla pinnoilla.

SV: Ol(cid:228)mpligt f(cid:246)r anv(cid:228)ndning inomhus vid behandling av stora ytor.

S53

ES: Ev(cid:237)tese la exposici(cid:243)n (cid:151) recÆbense instrucciones especiales antes del uso.

DA: Undg(cid:229) enhver kontakt (cid:151) indhent s(cid:230)rlige anvisninger fłr brug.

DE: Exposition vermeiden (cid:151) vor Gebrauch besondere Anweisungen einholen.

EL: Apoue(cid:253)cese sgm (cid:221)jherg (cid:151) euodiarse(cid:223)se le siy eidij(cid:221)y odgc(cid:223)ey pqim ap(cid:252) sg vq(cid:222)rg.

EN: Avoid exposure (cid:151) obtain special instructions before use.

FR: (cid:201)viter l’exposition (cid:151) se procurer des instructions spØciales avant l’utilisation.

IT: Evitare l’esposizione (cid:151) procurarsi speciali istruzioni prima dell’uso.

NL: Blootstelling vermijden (cid:151) v(cid:243)(cid:243)r gebruik speciale aanwijzingen raadplegen.

PT: Evitar a exposi(cid:231)ªo (cid:151) obter instru(cid:231)ıes espec(cid:237)ficas antes da utiliza(cid:231)ªo.

FI: V(cid:228)ltett(cid:228)v(cid:228) altistumista (cid:151) ohjeet luettava ennen k(cid:228)ytt(cid:246)(cid:228).

SV: Undvik exponering (cid:150) Beg(cid:228)r specialinstruktioner f(cid:246)re anv(cid:228)ndning.

S56

ES: Elim(cid:237)nense esta sustancia y su recipiente en un punto de recogida pœblica de residuos especiales o peligrosos.

DA: Aflever dette materiale og dets beholder til et indsamlingssted for farligt affald og problemaffald.

DE: Dieses Produkt und seinen Beh(cid:228)lter der Problemabfallentsorgung zuf(cid:252)hren.

EL: So tkij(cid:252) ats(cid:252) jai o peqi(cid:221)jsgy sot ma emaposeho(cid:253)m re v(cid:254)qo rtkkoc(cid:222)y epijimd(cid:253)mxm (cid:222) eidij(cid:254)m apobk(cid:222)sxm.

EN: Dispose of this material and its container to hazardous or special waste collection point.

FR: (cid:201)liminer ce produit et son rØcipient dans un centre de collecte des dØchets dangereux ou spØciaux.

IT:

Smaltire questo materiale e i relativi contenitori in un punto di raccolta rifiuti pericolosi o speciali.

NL: Deze stof en de verpakking naar inzamelpunt voor gevaarlijk of bijzonder afval brengen.

PT: Eliminar este produto e o seu recipiente, enviando-os para local autorizado para a recolha de res(cid:237)duos perigosos

ou especiais.

FI: T(cid:228)m(cid:228) aine ja sen pakkaus on toimitettava ongelmaj(cid:228)tteen vastaanottopaikkaan.

SV: L(cid:228)mna detta material och dess beh(cid:229)llare till insamlingsst(cid:228)lle f(cid:246)r farligt avfall.

S57

ES: Util(cid:237)cese un envase de seguridad adecuado para evitar la contaminaci(cid:243)n del medio ambiente.

DA: Skal indesluttes forsvarligt for at undg(cid:229) miljłforurening.

DE: Zur Vermeidung einer Kontamination der Umwelt geeigneten Beh(cid:228)lter verwenden.

EL: Ma vqgrilopoighe(cid:223) o jas(cid:220)kkgkoy peqi(cid:221)jsgy cia ma apouetvhe(cid:223) l(cid:252)ktmrg sot peqib(cid:220)kkomsoy.

EN: Use appropriate container to avoid environmental contamination.

FR: Utiliser un rØcipient appropriØ pour Øviter toute contamination du milieu ambiant.

IT: Usare contenitori adeguati per evitare l’inquinamento ambientale.

NL: Neem passende maatregelen om verspreiding in het milieu te voorkomen.

PT: Utilizar um recipiente adequado para evitar a contamina(cid:231)ªo do ambiente.

FI: K(cid:228)ytett(cid:228)v(cid:228) sopivaa s(cid:228)ilytystapaa ymp(cid:228)rist(cid:246)n likaantumisen ehk(cid:228)isemiseksi.

SV: F(cid:246)rvaras p(cid:229) l(cid:228)mpligt s(cid:228)tt f(cid:246)r att undvika milj(cid:246)f(cid:246)rorening.

L 225/138

EN

Official Journal of the European Communities

21.8.2001

S59

ES: Remitirse al fabricante o proveedor para obtener informaci(cid:243)n sobre su recuperaci(cid:243)n/reciclado.

DA: Indhent oplysninger om genvinding/genanvendelse hos producenten/leverandłren.

DE:

Informationen zur Wiederverwendung/Wiederverwertung beim Hersteller/Lieferanten erfragen.

EL: Fgs(cid:222)rse pkgqouoq(cid:223)ey ap(cid:252) som paqacxc(cid:252)/pqolghets(cid:222) cia am(cid:220)jsgrg/amaj(cid:253)jkxrg.

EN: Refer to manufacturer/supplier for information on recovery/recycling.

FR: Consulter le fabricant/fournisseur pour des informations relatives (cid:224) la rØcupØration/au recyclage.

IT: Richiedere informazioni al produttore/fornitore per il recupero/riciclaggio.

NL: Raadpleeg fabrikant/leverancier voor informatie over terugwinning/recycling.

PT: Solicitar ao produtor/fornecedor informa(cid:231)ıes relativas (cid:224) sua recupera(cid:231)ªo/reciclagem.

FI: Hanki valmistajalta/luovuttajalta tietoja uudelleenk(cid:228)yt(cid:246)st(cid:228)/kierr(cid:228)tyksest(cid:228).

SV: R(cid:229)dfr(cid:229)ga tillverkare/leverant(cid:246)r om (cid:229)tervinning/(cid:229)teranv(cid:228)ndning.

S60

ES: Elim(cid:237)nense el producto y su recipiente como residuos peligrosos.

DA: Dette materiale og dets beholder skal bortskaffes som farligt affald.

DE: Dieses Produkt und sein Beh(cid:228)lter sind als gef(cid:228)hrlicher Abfall zu entsorgen.

EL: So tkij(cid:252) jai o peqi(cid:221)jsgy sot ma hexqgho(cid:253)m jas(cid:220) sg di(cid:220)herg soty epij(cid:223)mdtma ap(cid:252)bkgsa.

EN: This material and its container must be disposed of as hazardous waste.

FR: (cid:201)liminer le produit et son rØcipient comme un dØchet dangereux.

IT: Questo materiale e il suo contenitore devono essere smaltiti come rifiuti pericolosi.

NL: Deze stof en de verpakking als gevaarlijk afval afvoeren.

PT: Este produto e o seu recipiente devem ser eliminados como res(cid:237)duos perigosos.

FI: T(cid:228)m(cid:228) aine ja sen pakkaus on k(cid:228)sitelt(cid:228)v(cid:228) ongelmaj(cid:228)tteen(cid:228).

SV: Detta material och dess beh(cid:229)llare skall tas om hand som farligt avfall.

S61

ES: Ev(cid:237)tese su liberaci(cid:243)n al medio ambiente. RecÆbense instrucciones espec(cid:237)ficas de la ficha de datos de seguridad.

DA: Undg(cid:229) udledning til miljłet. Se s(cid:230)rlig vejledning/leverandłrbrugsanvisning.

DE: Freisetzung in die Umwelt vermeiden. Besondere Anweisungen einholen/Sicherheitsdatenblatt zu Rate ziehen.

EL: Apou(cid:253)cese sgm eketh(cid:221)qxr(cid:222) sot rso peqib(cid:220)kkom. Amaueqhe(cid:223)se re eidij(cid:221)y odgc(cid:223)ey/deks(cid:223)o dedol(cid:221)mxm aruake(cid:223)ay.

EN: Avoid release to the environment. Refer to special instructions/safety data sheets.

FR: (cid:201)viter le rejet dans l’environnement. Consulter les instructions spØciales/la fiche de donnØes de sØcuritØ.

IT: Non disperdere nell’ambiente. Riferirsi alle istruzioni speciali/ schede informative in materia di sicurezza.

NL: Voorkom lozing in het milieu. Vraag om speciale instructies/veiligheidskaart.

PT: Evitar a liberta(cid:231)ªo para o ambiente. Obter instru(cid:231)ıes espec(cid:237)ficas/fichas de seguran(cid:231)a.

FI: V(cid:228)ltett(cid:228)v(cid:228) p(cid:228)(cid:228)st(cid:228)mist(cid:228) ymp(cid:228)rist(cid:246)(cid:246)n. Lue erityisohjeet/k(cid:228)ytt(cid:246)turvallisuustiedote.

SV: Undvik utsl(cid:228)pp till milj(cid:246)n. L(cid:228)s s(cid:228)rskilda instruktioner/varuinformationsblad.

S62

ES: En caso de ingesti(cid:243)n no provocar el v(cid:243)mito: acœdase inmediatamente al mØdico y muØstresele la etiqueta o el

envase.

DA: Ved indtagelse, undg(cid:229) at fremprovokere opkastning: kontakt omg(cid:229)ende l(cid:230)ge og vis denne beholder eller etiket.

DE: Bei Verschlucken kein Erbrechen herbeif(cid:252)hren. Sofort (cid:228)rztlichen Rat einholen und Verpackung oder dieses Etikett

vorzeigen.

EL: Re peq(cid:223)psxrg jas(cid:220)porgy ma lgm pqojkghe(cid:223) eles(cid:252)y: fgs(cid:222)rse al(cid:221)rxy iasqij(cid:222) rtlbotk(cid:222) jai de(cid:223)nse ats(cid:252) so dove(cid:223)o (cid:222) sgm

esij(cid:221)ssa sot.

21.8.2001

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Official Journal of the European Communities

L 225/139

EN:

If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label.

FR: En cas d’ingestion, ne pas faire vomir. Consulter immØdiatement un mØdecin et lui montrer l’emballage ou

l’Øtiquette.

IT:

In caso di ingestione non provocare il vomito: consultare immediatamente il medico e mostrargli il contenitore o
l’etichetta.

NL: Bij inslikken niet het braken opwekken; direct een arts raadplegen en de verpakking of het etiket tonen.

PT: Em caso de ingestªo, nªo provocar o v(cid:243)mito. Consultar imediatamente um mØdico e mostrar-lhe a embalagem ou

o r(cid:243)tulo.

FI:

Jos kemikaalia on nielty, ei saa oksennuttaa: hakeuduttava v(cid:228)litt(cid:246)m(cid:228)sti l(cid:228)(cid:228)k(cid:228)rin hoitoon ja n(cid:228)ytett(cid:228)v(cid:228) t(cid:228)m(cid:228) pakkaus
tai etiketti.

SV: Vid f(cid:246)rt(cid:228)ring, framkalla ej kr(cid:228)kning. Kontakta genast l(cid:228)kare och visa denna f(cid:246)rpackning eller etiketten.

S63

ES: En caso de accidente por inhalaci(cid:243)n, alejar a la v(cid:237)ctima de la zona contaminada y mantenerla en reposo.

DA: Ved ulykkestilf(cid:230)lde ved ind(cid:229)nding bringes tilskadekomne ud i frisk luft og holdes i ro.

DE: Bei Unfall durch Einatmen: Verunfallten an die frische Luft bringen und ruhigstellen.

EL: Re peq(cid:223)psxrg astv(cid:222)lasoy k(cid:252)cx eirpom(cid:222)y: apolajq(cid:253)mese so h(cid:253)la ap(cid:252) so loktrl(cid:221)mo v(cid:254)qo jai au(cid:222)rse so ma gqel(cid:222)rei.

EN:

In case of accident by inhalation: remove casualty to fresh air and keep at rest.

FR: En cas d’accident par inhalation, transporter la victime hors de la zone contaminØe et la garder au repos.

IT:

In caso di incidente per inalazione, allontanare l’infortunato dalla zona contaminata e mantenerlo a riposo.

NL: Bij een ongeval door inademing: slachtoffer in de frisse lucht brengen en laten rusten.

PT: Em caso de inala(cid:231)ªo acidental, remover a v(cid:237)tima da zona contaminada e mantŒ-la em repouso.

FI:

Jos ainetta on onnettomuuden sattuessa hengitetty: siirr(cid:228) henkil(cid:246) raittiiseen ilmaan ja pid(cid:228) h(cid:228)net levossa.

SV: Vid olycksfall via inandning, flytta den drabbade till frisk luft och l(cid:229)t vila.

S64

ES: En caso de ingesti(cid:243)n, enjuÆguese la boca con agua (solamente si la persona estÆ consciente).

DA: Ved indtagelse, skyl munden med vand (kun hvis personen er ved bevidsthed).

DE: Bei Verschlucken Mund mit Wasser aussp(cid:252)len (nur wenn Verunfallter bei Bewusstsein ist).

EL: Re peq(cid:223)psxrg jas(cid:220)porgy, nepk(cid:253)mese so rs(cid:252)la le meq(cid:252) (l(cid:252)mo eu(cid:252)rom so h(cid:253)la diasgqe(cid:223) siy airh(cid:222)reiy sot).

EN:

If swallowed, rinse mouth with water (only if the person is conscious).

FR: En cas d’ingestion, rincer la bouche avec de l’eau (seulement si la personne est consciente).

IT:

In caso di ingestione, sciacquare la bocca con acqua (solamente se l’infortunato Ł cosciente).

NL: Bij inslikken, mond met water spoelen (alleen als de persoon bij bewustzijn is).

PT: Em caso de ingestªo, lavar repetidamente a boca com Ægua (apenas se a v(cid:237)tima estiver consciente).

FI:

Jos ainetta on nielty, huuhtele suu vedell(cid:228) (vain jos henkil(cid:246) on tajuissaan).

SV: Vid f(cid:246)rt(cid:228)ring, sk(cid:246)lj munnen med vatten (endast om personen (cid:228)r vid medvetande)

L 225/140

EN

Official Journal of the European Communities

21.8.2001

Combinaci(cid:243)n de frases-S

Kombination af S-s(cid:230)tninger

Kombination der S-S(cid:228)tze

Rtmdtarl(cid:252)y sxm S-uq(cid:220)rexm

Combination of S-phrases

Combinaison des phrases S

Combinazioni delle frasi S

Combinatie van S-zinnen

Combina(cid:231)ªo das frases S

Yhdistetyt S-lausekkeet

Sammansatta S-fraser

S1/2

ES: ConsØrvese bajo llave y mantØngase fuera del alcance de los niæos.

DA: Opbevares under l(cid:229)s og utilg(cid:230)ngeligt for błrn.

DE: Unter Verschluss und f(cid:252)r Kinder unzug(cid:228)nglich aufbewahren.

EL: Utk(cid:220)nse so jkeidxl(cid:221)mo jai lajqt(cid:220) ap(cid:252) paidi(cid:220).

EN: Keep locked up and out of the reach of children.

FR: Conserver sous clef et hors de portØe des enfants.

IT: Conservare sotto chiave e fuori della portata dei bambini.

NL: Achter slot en buiten bereik van kinderen bewaren.

PT: Guardar fechado (cid:224) chave e fora do alcance das crian(cid:231)as.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) lukitussa tilassa ja lasten ulottumattomissa.

SV: F(cid:246)rvaras i l(cid:229)st utrymme och o(cid:229)tkomligt f(cid:246)r barn.

S3/7

ES: ConsØrvese el recipiente bien cerrado y en lugar fresco.

DA: Emballagen opbevares t(cid:230)t lukket p(cid:229) et kłligt sted.

DE: Beh(cid:228)lter dicht geschlossen halten und an einem k(cid:252)hlen Ort aufbewahren.

EL: Diasgqe(cid:223)rse so dove(cid:223)o eqlgsij(cid:220) jkeirl(cid:221)mo re dqoreq(cid:252) l(cid:221)qoy.

EN: Keep container tightly closed in a cool place.

FR: Conserver le rØcipient bien fermØ dans un endroit frais.

IT: Tenere il recipiente ben chiuso in luogo fresco.

NL: Gesloten verpakking op een koele plaats bewaren.

PT: Conservar em recipiente bem fechado em lugar fresco.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) tiiviisti suljettuna viile(cid:228)ss(cid:228) paikassa.

SV: F(cid:246)rpackningen f(cid:246)rvaras v(cid:228)l tillsluten och svalt.

S3/9/14

ES: ConsØrvese en lugar fresco y bien ventilado y lejos de (cid:133) (materiales incompatibles, a especificar por el fabricante).

DA: Opbevares kłligt, godt ventileret og adskilt fra (cid:133) (uforligelige stoffer angives af fabrikanten).

DE: An einem k(cid:252)hlen, gut gel(cid:252)fteten Ort, entfernt von (cid:133) aufbewahren (die Stoffe, mit denen Kontakt vermieden werden

muss, sind vom Hersteller anzugeben).

EL: Diasgqe(cid:223)sai re dqoreq(cid:252) jai jak(cid:220) aeqif(cid:252)lemo l(cid:221)qoy lajqt(cid:220) ap(cid:252) (cid:133) (ar(cid:253)lbasa tkij(cid:220) pot tpodeijm(cid:253)omsai ap(cid:252) som

paqacxc(cid:252)).

EN: Keep in a cool, well-ventilated place away from (cid:133) (incompatible materials to be indicated by the manufacturer).

FR: Conserver dans un endroit frais et bien ventilØ (cid:224) l’Øcart des (cid:133) (matiŁres incompatibles (cid:224) indiquer par le fabricant).

21.8.2001

EN

Official Journal of the European Communities

L 225/141

IT: Conservare in luogo fresco e ben ventilato lontano da (cid:133) (materiali incompatibili da precisare da parte del fabbricante).

NL: Bewaren op een koele, goed geventileerde plaats verwijderd van (cid:133) (stoffen waarmee contact vermeden dient te worden,

aan te geven door de fabrikant).

PT: Conservar em lugar fresco e bem ventilado ao abrigo de (cid:133) (matØrias incompat(cid:237)veis a indicar pelo produtor).

FI:

S(cid:228)ilytett(cid:228)v(cid:228) erill(cid:228)(cid:228)n (cid:133) (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja) viile(cid:228)ss(cid:228) paikassa,
ilmanvaihto.

jossa on hyv(cid:228)

SV: F(cid:246)rvaras svalt, p(cid:229) v(cid:228)l ventilerad plats (cid:229)tskilt fr(cid:229)n (cid:133) (of(cid:246)renliga (cid:228)mnen anges av tillverkaren).

S3/9/14/49

ES: ConsØrvese œnicamente en el recipiente de origen, en lugar fresco y bien ventilado y lejos de (cid:133) (materiales incompa-

tibles, a especificar por el fabricante).

DA: M(cid:229) kun opbevares i originalemballagen p(cid:229) et kłligt, godt ventileret sted og adskilt fra (cid:133) (uforligelige stoffer angives

af fabrikanten).

DE: Nur im Originalbeh(cid:228)lter an einem k(cid:252)hlen, gut gel(cid:252)fteten Ort, entfernt von (cid:133) aufbewahren (die Stoffe, mit denen

Kontakt vermieden werden muss, sind vom Hersteller anzugeben).

EL: Diasgqe(cid:223)sai l(cid:252)mo l(cid:221)ra rso aqvij(cid:252) dove(cid:223)o re dqoreq(cid:252) jai jak(cid:220) aeqif(cid:252)lemo l(cid:221)qoy lajqt(cid:220) ap(cid:252) (cid:133) (ar(cid:253)lbasa tkij(cid:220) pot

tpodeijm(cid:253)omsai ap(cid:252) som paqacxc(cid:252)).

EN: Keep only in the original container in a cool, well-ventilated place away from (cid:133) (incompatible materials to be

indicated by the manufacturer).

FR: Conserver uniquement dans le rØcipient d’origine dans un endroit frais et bien ventilØ (cid:224) l’Øcart de (cid:133) (matiŁres

incompatibles (cid:224) indiquer par le fabricant).

IT: Conservare soltanto nel contenitore originale in luogo fresco e ben ventilato lontano da (cid:133) (materiali incompatibili

da precisare da parte del fabbricante).

NL: Uitsluitend in de oorspronkelijke verpakking bewaren op een koele, goed geventileerde plaats verwijderd van (cid:133)

(stoffen waarmee contact vermeden dient te worden, aan te geven door de fabrikant).

PT: Conservar unicamente no recipiente de origem, em lugar fresco e bem ventilado ao abrigo de (cid:133) (matØrias incompa-

t(cid:237)veis a indicar pelo produtor).

FI:

S(cid:228)ilytett(cid:228)v(cid:228) alkuper(cid:228)ispakkauksessa viile(cid:228)ss(cid:228) paikassa,
aineet ilmoittaa valmistaja/maahantuoja).

jossa on hyv(cid:228) ilmanvaihto erill(cid:228)(cid:228)n (cid:133) (yhteensopimattomat

SV: F(cid:246)rvaras endast i originalf(cid:246)rpackningen p(cid:229) sval, v(cid:228)l ventilerad plats (cid:229)tskilt fr(cid:229)n (cid:133) (of(cid:246)renliga (cid:228)mnen anges av

tillverkaren).

S3/9/49

ES: ConsØrvese œnicamente en el recipiente de origen, en lugar fresco y bien ventilado.

DA: M(cid:229) kun opbevares i originalemballagen p(cid:229) et kłligt, godt ventileret sted.

DE: Nur im Originalbeh(cid:228)lter an einem k(cid:252)hlen, gut gel(cid:252)fteten Ort aufbewahren.

EL: Diasgqe(cid:223)sai l(cid:252)mo l(cid:221)ra rso aqvij(cid:252) dove(cid:223)o re dqoreq(cid:252) jai jak(cid:220) aeqif(cid:252)lemo l(cid:221)qoy.

EN: Keep only in the original container in a cool, well-ventilated place.

FR: Conserver uniquement dans le rØcipient d’origine dans un endroit frais et bien ventilØ.

IT: Conservare soltanto nel contenitore originale in luogo fresco e ben ventilato.

NL: Uitsluitend in de oorspronkelijke verpakking bewaren op een koele, goed geventileerde plaats.

PT: Conservar unicamente no recipiente de origem, em lugar fresco e bem ventilado.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) alkuper(cid:228)ispakkauksessa viile(cid:228)ss(cid:228) paikassa, jossa on hyv(cid:228) ilmanvaihto.

SV: F(cid:246)rvaras endast i originalf(cid:246)rpackningen p(cid:229) sval, v(cid:228)l ventilerad plats.

S3/14

ES: ConsØrvese en lugar fresco y lejos de (cid:133) (materiales incompatibles, a especificar por el fabricante).

DA: Opbevares kłligt og adskilt fra (cid:133) (uforligelige stoffer angives af fabrikanten).

DE: An einem k(cid:252)hlen, von (cid:133) entfernten Ort aufbewahren (die Stoffe, mit denen Kontakt vermieden werden muss, sind vom

Hersteller anzugeben).

EL: Diasgqe(cid:223)sai re dqoreq(cid:252) l(cid:221)qoy lajqt(cid:220) ap(cid:252) (cid:133) (ar(cid:253)lbasa tkij(cid:220) pot tpodeijm(cid:253)omsai ap(cid:252) som paqacxc(cid:252)).

EN: Keep in a cool place away from (cid:133) (incompatible materials to be indicated by the manufacturer).

L 225/142

EN

Official Journal of the European Communities

21.8.2001

FR: Conserver dans un endroit frais (cid:224) l’Øcart des (cid:133) (matiŁres incompatibles (cid:224) indiquer par le fabricant).

IT: Conservare in luogo fresco lontano da (cid:133) (materiali incompatibili da precisare da parte del fabbricante).

NL: Bewaren op een koele plaats verwijderd van (cid:133) (stoffen waarmee contact vermeden dient te worden, aan te geven door de

fabrikant).

PT: Conservar em lugar fresco ao abrigo de (cid:133) (matØrias incompat(cid:237)veis a indicar pelo produtor).

FI:

S(cid:228)ilytett(cid:228)v(cid:228) viile(cid:228)ss(cid:228) erill(cid:228)(cid:228)n (cid:133) (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja).

SV: F(cid:246)rvaras svalt och (cid:229)tskilt fr(cid:229)n (cid:133) (of(cid:246)renliga (cid:228)mnen anges av tillverkaren).

S7/8

ES: MantØngase el recipiente bien cerrado y en lugar seco.

DA: Emballagen skal holdes t(cid:230)t lukket og opbevares tłrt.

DE: Beh(cid:228)lter trocken und dicht geschlossen halten.

EL: So dove(cid:223)o ma diasgqe(cid:223)sai eqlgsij(cid:220) jkeirl(cid:221)mo jai ma pqorsase(cid:253)esai ap(cid:252) sgm tcqar(cid:223)a.

EN: Keep container tightly closed and dry.

FR: Conserver le rØcipient bien fermØ et (cid:224) l’abri de l’humiditØ.

IT: Conservare il recipiente ben chiuso e al riparo dall’umidit(cid:224).

NL: Droog houden en in een goed gesloten verpakking bewaren.

PT: Conservar o recipiente bem fechado e ao abrigo da humidade.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) kuivana ja tiiviisti suljettuna.

SV: F(cid:246)rpackningen f(cid:246)rvaras v(cid:228)l tillsluten och torrt.

S7/9

ES: MantØngase el recipiente bien cerrado y en lugar bien ventilado.

DA: Emballagen skal holdes t(cid:230)t lukket og opbevares p(cid:229) et godt ventileret sted.

DE: Beh(cid:228)lter dicht geschlossen an einem gut gel(cid:252)fteten Ort aufbewahren.

EL: So dove(cid:223)o ma diasgqe(cid:223)sai eqlgsij(cid:220) jkeirl(cid:221)mo jai re jak(cid:220) aeqif(cid:252)lemo l(cid:221)qoy.

EN: Keep container tightly closed and in a well-ventilated place.

FR: Conserver le rØcipient bien fermØ et dans un endroit bien ventilØ.

IT: Tenere il recipiente ben chiuso e in luogo ben ventilato.

NL: Gesloten verpakking op een goed geventileerde plaats bewaren.

PT: Manter o recipiente bem fechado em local bem ventilado.

FI:

S(cid:228)ilytett(cid:228)v(cid:228) tiiviisti suljettuna paikassa, jossa on hyv(cid:228) ilmanvaihto.

SV: F(cid:246)rpackningen f(cid:246)rvaras v(cid:228)l tillsluten p(cid:229) v(cid:228)l ventilerad plats.

S7/47

ES: MantØngase el recipiente bien cerrado y consØrvese a una temperatura no superior a (cid:133) (cid:176)C (a especificar por el

fabricante).

DA: Emballagen skal holdes t(cid:230)t lukket og opbevares ved temperaturer p(cid:229) ikke over (cid:133) (cid:176)C (angives af fabrikanten).

DE: Beh(cid:228)lter dicht geschlossen und nicht bei Temperaturen (cid:252)ber (cid:133) (cid:176)C aufbewahren (vom Hersteller anzugeben).

EL: Diasgqe(cid:223)rse so dove(cid:223)o jak(cid:220) jkeirl(cid:221)mo re heqlojqar(cid:223)a pot dem tpeqba(cid:223)mei soty (cid:133) (cid:176)C (ma jahoqirse(cid:223) ap(cid:252) som paqacxc(cid:252)).

EN: Keep container tightly closed and at a temperature not exceeding (cid:133) (cid:176)C (to be specified by the manufacturer).

FR: Conserver le rØcipient bien fermØ et (cid:224) une tempØrature ne dØpassant pas (cid:133) (cid:176)C ((cid:224) prØciser par le fabricant).

IT: Tenere il recipiente ben chiuso e a temperatura non superiore a (cid:133) (cid:176)C (da precisare da parte del fabbricante).

NL: Gesloten verpakking bewaren bij een temperatuur beneden (cid:133) (cid:176)C (aan te geven door de fabrikant).

PT: Manter o recipiente bem fechado e conservar a uma temperatura que nªo exceda (cid:133) (cid:176)C (a especificar pelo produtor).

FI:

S(cid:228)ilytett(cid:228)v(cid:228) tiiviisti suljettuna ja alle (cid:133) (cid:176)C:n l(cid:228)mp(cid:246)tilassa (valmistaja/maahantuoja ilmoittaa l(cid:228)mp(cid:246)tilan).

SV: F(cid:246)rpackningen f(cid:246)rvaras v(cid:228)l tillsluten vid en temperatur som inte (cid:246)verstiger (cid:133) (cid:176)C (anges av tillverkaren).

21.8.2001

EN

Official Journal of the European Communities

L 225/143

S20/21

ES: No comer, ni beber, ni fumar durante su utilizaci(cid:243)n.

DA: Der m(cid:229) ikke spises, drikkes eller ryges under brugen.

DE: Bei der Arbeit nicht essen, trinken oder rauchen.

EL: …sam so vqgrilopoie(cid:223)se lgm sq(cid:254)se, lgm p(cid:223)mese, lgm japm(cid:223)fese.

EN: When using do not eat, drink or smoke.

FR: Ne pas manger, ne pas boire et ne pas fumer pendant l’utilisation.

IT: Non mangiare, nØ bere, nØ fumare durante l’impiego.

NL: Niet eten, drinken of roken tijdens gebruik.

PT: Nªo comer, beber ou fumar durante a utiliza(cid:231)ªo.

FI:

Sy(cid:246)minen, juominen ja tupakointi kielletty kemikaalia k(cid:228)ytett(cid:228)ess(cid:228).

SV: ˜t inte, drick inte eller r(cid:246)k inte under hanteringen.

S24/25

ES: Ev(cid:237)tese el contacto con los ojos y la piel.

DA: Undg(cid:229) kontakt med huden og łjnene.

DE: Ber(cid:252)hrung mit den Augen und der Haut vermeiden.

EL: Apoue(cid:253)cese epau(cid:222) le so d(cid:221)qla jai sa l(cid:220)sia.

EN: Avoid contact with skin and eyes.

FR: (cid:201)viter le contact avec la peau et les yeux.

IT: Evitare il contatto con gli occhi e con la pelle.

NL: Aanraking met de ogen en de huid vermijden.

PT: Evitar o contacto com a pele e os olhos.

FI: Varottava kemikaalin joutumista iholle ja silmiin.

SV: Undvik kontakt med huden och (cid:246)gonen.

S27/28

ES: DespuØs del contacto con la piel, qu(cid:237)tese inmediatamente toda la ropa manchada o salpicada y lÆvese inmediata y

abundantemente con (cid:133) (productos a especificar por el fabricante).

DA: Kommer stof p(cid:229) huden, tages tilsmudset tłj straks af og der vaskes med store m(cid:230)ngder (cid:133) (angives af fabrikanten).

DE: Bei Ber(cid:252)hrung mit der Haut beschmutzte, getr(cid:228)nkte Kleidung sofort ausziehen und Haut sofort abwaschen mit viel

(cid:133) (vom Hersteller anzugeben).

EL: Re peq(cid:223)psxrg epau(cid:222)y le so d(cid:221)qla, auaiq(cid:221)rse al(cid:221)rxy (cid:252)ka sa loktrl(cid:221)ma qo(cid:253)va jai pk(cid:253)mese al(cid:221)rxy le (cid:220)uhomo (cid:133) (so

e(cid:223)doy sot tcqo(cid:253) jahoq(cid:223)fesai ap(cid:252) som paqacxc(cid:252)).

EN: After contact with skin, take off immediately all contaminated clothing, and wash immediately with plenty of (cid:133)

(to be specified by the manufacturer).

FR: AprŁs contact avec la peau, enlever immØdiatement tout vŒtement souillØ ou ØclaboussØ et se laver immØdiatement

et abondamment avec (cid:133) (produits appropriØs (cid:224) indiquer par le fabricant).

IT:

In caso di contatto con la pelle, togliersi di dosso immediatamente gli indumenti contaminati e lavarsi immediata-
mente e abbondantemente con (cid:133) (prodotti idonei da indicarsi da parte del fabbricante).

NL: Na contact met de huid, alle besmette kleding onmiddellijk uittrekken en de huid onmiddellijk wassen met veel (cid:133)

(aan te geven door de fabrikant).

PT: Em caso de contacto com a pele, retirar imediatamente toda a roupa contaminada e lavar imediata e abundante-

mente com (cid:133) (produto adequado a indicar pelo produtor).

FI:

Ihokosketuksen j(cid:228)lkeen, saastunut vaatetus on riisuttava v(cid:228)litt(cid:246)m(cid:228)sti ja roiskeet huuhdeltava v(cid:228)litt(cid:246)m(cid:228)sti runsaalla
m(cid:228)(cid:228)r(cid:228)ll(cid:228) (cid:133) (aineen ilmoittaa valmistaja/maahantuoja).

SV: Vid kontakt med huden,

tag genast av alla nedst(cid:228)nkta kl(cid:228)der och tv(cid:228)tta genast med mycket (cid:133) (anges av

tillverkaren).

L 225/144

EN

Official Journal of the European Communities

21.8.2001

S29/35

ES: No tirar los residuos por el desag(cid:252)e; elim(cid:237)nense los residuos del producto y sus recipientes con todas las precaucio-

nes posibles.

DA: M(cid:229) ikke tłmmes i kloakaflłb; materialet og dets beholder skal bortskaffes p(cid:229) en sikker m(cid:229)de.

DE: Nicht in die Kanalisation gelangen lassen; Abf(cid:228)lle und Beh(cid:228)lter m(cid:252)ssen in gesicherter Weise beseitigt werden.

EL: Lgm adei(cid:220)fese so tp(cid:252)koipo sotpeqievol(cid:221)mot rsgm apov(cid:221)setrg, diah(cid:221)rse ats(cid:252) so tkij(cid:252) jai som peqi(cid:221)jsg sot jas(cid:220)

aruak(cid:222) sq(cid:252)po.

EN: Do not empty into drains; dispose of this material and its container in a safe way.

FR: Ne pas jeter les rØsidus (cid:224) l’Øgout; ne se dØbarrasser de ce produit et de son rØcipient qu’en prenant toutes les prØ-

cautions d’usage.

IT: Non gettare i residui nelle fognature; non disfarsi del prodotto e del recipiente se non con le dovute precauzioni.

NL: Afval niet in de gootsteen werpen; stof en verpakking op veilige wijze afvoeren.

PT: Nªo deitar os res(cid:237)duos no esgoto; nªo eliminar o produto e o seu recipiente sem tomar as precau(cid:231)ıes de seguran(cid:231)a

devidas.

FI:

Ei saa tyhjent(cid:228)(cid:228) viem(cid:228)riin; t(cid:228)m(cid:228) aine ja sen pakkaus on h(cid:228)vitett(cid:228)v(cid:228) turvallisesti.

SV: T(cid:246)m ej i avloppet, oskadligg(cid:246)r produkt och f(cid:246)rpackning p(cid:229) s(cid:228)kert s(cid:228)tt.

S29/56

ES: No tirar los residuos por el desag(cid:252)e; elim(cid:237)nese esta sustancia y su recipiente en un punto de recogida pœblica de

residuos especiales o peligrosos.

DA: M(cid:229) ikke tłmmes i kloakaflłb, aflever dette materiale og dets beholder til et indsamlingssted for farligt affald og

problemaffald.

DE: Nicht

in die Kanalisation gelangen lassen; dieses Produkt und seinen Beh(cid:228)lter der Problemabfallentsorgung

zuf(cid:252)hren.

EL: Lgm adei(cid:220)fese so tp(cid:252)koipo sot peqievol(cid:221)mot rsgm apov(cid:221)setrg. So tkij(cid:252) ats(cid:252) jai o peqi(cid:221)jsgy sot ma emaposeho(cid:253)m re

dgl(cid:252)rio v(cid:254)qo rtkkoc(cid:222)y epijimd(cid:253)mxm (cid:222) eidij(cid:254)m apobk(cid:222)sxm.

EN: Do not empty into drains, dispose of this material and its container at hazardous or special waste collection point.

FR: Ne pas jeter les rØsidus (cid:224) l’Øgout, Øliminer ce produit et son rØcipient dans un centre de collecte des dØchets dange-

reux ou spØciaux.

IT: Non gettare i residui nelle fognature; smaltire questo materiale e i relativi contenitori in un punto di raccolta rifiuti

pericolosi o speciali.

NL: Afval niet in de gootsteen werpen; deze stof en de verpakking naar een inzamelpunt voor gevaarlijk of bijzonder

afval brengen.

PT: Nªo deitar os res(cid:237)duos no esgoto; eliminar este produto e o seu recipiente enviando-os para local autorizado para

a recolha de res(cid:237)duos perigosos ou especiais.

FI:

Ei saa tyhjent(cid:228)(cid:228) viem(cid:228)riin; t(cid:228)m(cid:228) aine ja sen pakkaus on toimitettava ongelmaj(cid:228)tteen vastaanottopaikkaan.

SV: T(cid:246)m ej i avloppet, l(cid:228)mna detta material och dess beh(cid:229)llare till insamlingsst(cid:228)lle f(cid:246)r farligt avfall.

S36/37

ES: (cid:218)sense indumentaria y guantes de protecci(cid:243)n adecuados.

DA: Brug s(cid:230)rligt arbejdstłj og egnede beskyttelseshandsker.

DE: Bei der Arbeit geeignete Schutzhandschuhe und Schutzkleidung tragen.

EL: Uoq(cid:220)se jas(cid:220)kkgkg pqorsasetsij(cid:222) emdtlar(cid:223)a jai c(cid:220)msia.

EN: Wear suitable protective clothing and gloves.

FR: Porter un vŒtement de protection et des gants appropriØs.

IT: Usare indumenti protettivi e guanti adatti.

NL: Draag geschikte handschoenen en beschermende kleding.

PT: Usar vestuÆrio de protec(cid:231)ªo e luvas adequadas.

FI: K(cid:228)ytett(cid:228)v(cid:228) sopivaa suojavaatetusta ja suojak(cid:228)sineit(cid:228).

SV: Anv(cid:228)nd l(cid:228)mpliga skyddskl(cid:228)der och skyddshandskar.

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S36/37/39

ES: (cid:218)sense indumentaria y guantes adecuados y protecci(cid:243)n para los ojos/la cara.

DA: Brug s(cid:230)rligt arbejdstłj, egnede beskyttelseshandsker og -briller/ansigtssk(cid:230)rm.

DE: Bei der Arbeit geeignete Schutzkleidung, Schutzhandschuhe und Schutzbrille/Gesichtsschutz tragen.

EL: Uoq(cid:220)se jas(cid:220)kkgkg pqorsasetsij(cid:222) emdtlar(cid:223)a, c(cid:220)msia jai rtrjet(cid:222) pqorsar(cid:223)ay lasi(cid:254)m/pqor(cid:254)pot.

EN: Wear suitable protective clothing, gloves and eye/face protection.

FR: Porter un vŒtement de protection appropriØ, des gants et un appareil de protection des yeux/du visage.

IT: Usare indumenti protettivi e guanti adatti e proteggersi gli occhi/la faccia.

NL: Draag geschikte beschermende kleding, handschoenen en een beschermingsmiddel voor de ogen/het gezicht.

PT: Usar vestuÆrio de protec(cid:231)ªo, luvas e equipamento protector para os olhos/face adequados.

FI: K(cid:228)ytett(cid:228)v(cid:228) sopivaa suojavaatetusta, suojak(cid:228)sineit(cid:228) ja silmien- tai kasvonsuojainta.

SV: Anv(cid:228)nd l(cid:228)mpliga skyddskl(cid:228)der, skyddshandskar samt skyddsglas(cid:246)gon eller ansiktsskydd.

S36/39

ES: (cid:218)sense indumentaria adecuada y protecci(cid:243)n para los ojos/la cara.

DA: Brug s(cid:230)rligt arbejdstłj og egnede beskyttelsesbriller/ansigtssk(cid:230)rm.

DE: Bei der Arbeit geeignete Schutzkleidung und Schutzbrille/Gesichtsschutz tragen.

EL: Uoq(cid:220)se jas(cid:220)kkgkg pqorsasetsij(cid:222) emdtlar(cid:223)a jai rtrjet(cid:222) pqorsar(cid:223)ay lasi(cid:254)m/pqor(cid:254)pot.

EN: Wear suitable protective clothing and eye/face protection.

FR: Porter un vŒtement de protection appropriØ et un appareil de protection des yeux/du visage.

IT: Usare indumenti protettivi adatti e proteggersi gli occhi/la faccia.

NL: Draag geschikte beschermende kleding en een beschermingsmiddel voor de ogen/het gezicht.

PT: Usar vestuÆrio de protec(cid:231)ªo e equipamento protector para os olhos/face adequados.

FI: K(cid:228)ytett(cid:228)v(cid:228) sopivaa suojavaatetusta ja silmien- tai kasvonsuojainta.

SV: Anv(cid:228)nd l(cid:228)mpliga skyddskl(cid:228)der samt skyddsglas(cid:246)gon eller ansiktsskydd.

S37/39

ES: (cid:218)sense guantes adecuados y protecci(cid:243)n para los ojos/la cara.

DA: Brug egnede beskyttelseshandsker og -briller/ansigtssk(cid:230)rm under arbejdet.

DE: Bei der Arbeit geeignete Schutzhandschuhe und Schutzbrille/Gesichtsschutz tragen.

EL: Uoq(cid:220)se jas(cid:220)kkgka c(cid:220)msia jai rtrjet(cid:222) pqorsar(cid:223)ay lasi(cid:254)m/pqor(cid:254)pot.

EN: Wear suitable gloves and eye/face protection.

FR: Porter des gants appropriØs et un appareil de protection des yeux/du visage.

IT: Usare guanti adatti e proteggersi gli occhi/la faccia.

NL: Draag geschikte handschoenen en een beschermingsmiddel voor de ogen/het gezicht.

PT: Usar luvas e equipamento protector para os olhos/face adequados.

FI: K(cid:228)ytett(cid:228)v(cid:228) sopivia suojak(cid:228)sineit(cid:228) ja silmien- tai kasvonsuojainta.

SV: Anv(cid:228)nd l(cid:228)mpliga skyddshandskar samt skyddsglas(cid:246)gon eller ansiktsskydd.

S47/49

ES: ConsØrvese œnicamente en el recipiente de origen y a temperatura no superior a (cid:133) (cid:176)C (a especificar por el

fabricante).

DA: M(cid:229) kun opbevares i originalemballagen ved en temperatur p(cid:229) ikke over (cid:133) (cid:176)C (angives af fabrikanten).

DE: Nur im Originalbeh(cid:228)lter bei einer Temperatur von nicht (cid:252)ber (cid:133) (cid:176)C (vom Hersteller anzugeben) aufbewahren.

EL: Diasgqe(cid:223)sai l(cid:252)mo l(cid:221)ra rso aqvij(cid:252) dove(cid:223)o re heqlojqar(cid:223)a pot d(cid:221)m tpeqba(cid:223)mei soty (cid:133) (cid:176)C (jahoq(cid:223)fesai ap(cid:252) som

paqacxc(cid:252)).

EN: Keep only in the original container at a temperature not exceeding (cid:133) (cid:176)C (to be specified by the manufacturer).

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FR: Conserver uniquement dans le rØcipient d’origine (cid:224) une tempØrature ne dØpassant pas (cid:133) (cid:176)C ((cid:224) prØciser par le

fabricant).

IT: Conservare soltanto nel contenitore originale a temperatura non superiore a (cid:133) (cid:176)C (da precisare da parte del

fabbricante).

NL: Uitsluitend in de oorspronkelijke verpakking bewaren bij een temperatuur beneden (cid:133) (cid:176)C (aan te geven door de

fabrikant).

PT: Conservar unicamente no recipiente de origem a temperatura que nªo exceda (cid:133) (cid:176)C (a especificar pelo produtor).

FI:

S(cid:228)ilytett(cid:228)v(cid:228) alkuper(cid:228)ispakkauksessa alle (cid:133) (cid:176)C:n l(cid:228)mp(cid:246)tilassa (valmistaja/maahantuoja ilmoittaa l(cid:228)mp(cid:246)tilan).

SV: F(cid:246)rvaras endast i originalf(cid:246)rpackningen vid en temperatur som inte (cid:246)verstiger (cid:133) (cid:176)C (anges av tillverkaren).

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EN: B.13/14. Mutagenicity (cid:151) reverse mutation test using bacteria.

ANNEX 5A

(Does not concern the ES version)

(Does not concern the DA version)

(Does not concern the DE version)

(Does not concern the EL version)

(Does not concern the FR version)

(Does not concern the IT version)

(Does not concern the NL version)

(Does not concern the PT version)

(Does not concern the FI version)

(Does not concern the SV version)

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FR: L’administration du tØmoin positif par une voie diffØrente de celle utilisØe pour la substance d’essai est acceptable.

ANNEX 5B

(Does not concern the ES version)

(Does not concern the DA version)

(Does not concern the DE version)

(Does not concern the EL version)

(Does not concern the EN version)

(Does not concern the IT version)

(Does not concern the NL version)

(Does not concern the PT version)

(Does not concern the FI version)

(Does not concern the SV version)

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ANNEX 5C

EN: t(min) =

Irradiation dose (J/cm2 (cid:215) 1 000)
Irradiance (mW/cm2 (cid:215) 60)

(1 J = 1 W sec)

(Does not concern the ES version)

(Does not concern the DA version)

(Does not concern the DE version)

(Does not concern the EL version)

(Does not concern the FR version)

(Does not concern the IT version)

(Does not concern the NL version)

(Does not concern the PT version)

(Does not concern the FI version)

(Does not concern the SV version)

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ANNEX 5D

B.26. SUBCHRONIC ORAL TOXICITY TEST

REPEATED DOSE 90-DAY ORAL TOXICITY STUDY IN RODENTS

1.

METHOD

This subchronic oral toxicity test method is a replicate of the OECD TG 408 (1998).

1.1.

INTRODUCTION

In the assessment and evaluation of the toxic characteristics of a chemical, the determination of subchronic
oral toxicity using repeated doses may be carried out after initial information on toxicity has been obtained
from acute or repeated dose 28-day toxicity tests. The 90-day study provides information on the possible
health hazards likely to arise from repeated exposure over a prolonged period of time covering post-weaning
maturation and growth well into adulthood. The study will provide information on the major toxic effects,
indicate target organs and the possibility of accumulation, and can provide an estimate of a no observed
adverse effect level of exposure which can be used in selecting dose levels for chronic studies and for
establishing safety criteria for human exposure.

The method places additional emphasis on neurological endpoints and gives an indication of immunological
and reproductive effects. The need for careful clinical observations of the animals, so as to obtain as much
information as possible, is also stressed. This study should allow for the identification of chemicals with the
immunological or reproductive organ effects, which may warrant further
potential to cause neurotoxic,
in-depth investigation.

See also General Introduction Part B.

1.2.

DEFINITIONS

Dose: is the amount of test substance administered. Dose is expressed as weight (g, mg) or as weight of test
substance per unit weight of test animal (e.g. mg/kg), or as constant dietary concentrations (ppm).

Dosage: is a general term comprising of dose, its frequency and the duration of dosing.

NOAEL:
adverse treatment-related findings are observed.

is the abbreviation for no observed adverse effect level and is the highest dose level where no

1.3.

PRINCIPLE OF THE TEST METHOD

The test substance is orally administered daily in graduated doses to several groups of experimental animals,
one dose level per group for a period of 90 days. During the period of administration the animals are
observed closely for signs of toxicity. Animals which die or are killed during the test are necropsied and, at
the conclusion of the test, surviving animals are also killed and necropsied.

1.4.

DESCRIPTION OF THE TEST METHOD

1.4.1.

Preparations of animals

Healthy animals, which have been acclimated to laboratory conditions for at least five days and have not been
subjected to previous experimental procedures, should be used. The test animals should be characterised as to
species, strain, source, sex, weight and/or age. Animals should be randomly assigned to the control and
treatment groups. Cages should be arranged in such a way that possible effects due to cage placement are
minimised. Each animal should be assigned a unique identification number.

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1.4.2.

Preparations of doses

The test substance is administered by gavage or via the diet or drinking water. The method of oral
administration is dependent on the purpose of the study, and the physical/chemical properties of the test
material.

Where necessary, the test substance is dissolved or suspended in a suitable vehicle. It is recommended that,
wherever possible, the use of an aqueous solution/suspension be considered first, followed by consideration of
a solution/emulsion in oil (e.g. corn oil) and then by possible solution in other vehicles. For vehicles other
than water the toxic characteristics of the vehicle must be known. The stability of the test substance under the
conditions of administration should be determined.

1.4.3.

Test conditions

1.4.3.1. Experimental animals

The preferred species is the rat, although other rodent species, e.g. the mouse, may be used. Commonly used
laboratory strains of young healthy adult animals should be employed. The females should be nulliparous and
non-pregnant. Dosing should begin as soon as possible after weaning and, in any case, before the animals are
nine weeks old. At the commencement of the study the weight variation of animals used should be minimal
and not exceed – 20 % of the mean weight of each sex. Where the study is conducted as a preliminary to a
long-term chronic toxicity study, animals from the same strain and source should be used in both studies.

1.4.3.2. Number and sex

At least 20 animals (10 female and 10 male) should be used at each dose level. If interim kills are planned,
the number should be increased by the number of animals scheduled to be killed before the completion of the
study. Based on previous knowledge of the chemical or a close analogue, consideration should be given to
including an additional satellite group of 10 animals (five per sex) in the control and in the top dose group
for observation, after the treatment period, of reversibility or persistence of any toxic effects. The duration of
this post-treatment period should be fixed appropriately with regard to the effects observed.

1.4.3.3. Dose levels

At least three dose levels and a concurrent control shall be used, except where a limit test is conducted (see
1.4.3.4). Dose levels may be based on the results of repeated dose or range finding studies and should take
into account any existing toxicological and toxicokinetic data available for the test substance or related
materials. Unless limited by the physical-chemical nature or biological effects of the test substance, the highest
dose level should be chosen with the aim to induce toxicity but not death or severe suffering. A descending
sequence of dose levels should be selected with a view to demonstrating any dosage related response and a no
observed adverse effect level (NOAEL) at the lowest dose level. Two to four fold intervals are frequently
optimal for setting the descending dose levels and addition of a fourth test group is often preferable to using
very large intervals (e.g. more than a factor of about 6-10) between dosages.

The control group shall be an untreated group or a vehicle-control group if a vehicle is used in administering
the test substance. Except for treatment with the test substance, animals in the control group should be
handled in an identical manner to those in the test groups. If a vehicle is used, the control group shall receive
the vehicle in the highest volume used. If a test substance is administered in the diet, and causes reduced
in distinguishing between reductions due to
dietary intake, then a pair-fed control group may be useful
palatability or toxicological alterations in the test model.

Consideration should be given to the following characteristics of
the vehicle and other additives, as
appropriate: effects on the absorption, distribution, metabolism, or retention of the test substance; effects on
the chemical properties of the test substance which may alter its toxic characteristics; and effects on the food
or water consumption or the nutritional status of the animals.

1.4.3.4. Limit test

If a test at one dose level, equivalent to at least 1 000 mg/kg body weight/day, using the procedures described
for this study, produces no observed adverse effects and if toxicity would not be expected based upon data
from structurally related substances, then a full study using three dose levels may not be considered necessary.
The limit test applies except when human exposure indicates the need for a higher dose level to be used.

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1.5.

PROCEDURE

1.5.1.

Administration of doses

The animals are dosed with the test substance daily seven days each week for a period of 90 days. Any other
dosing regime, e.g. five days per week, needs to be justified. When the test substance is administered by
gavage, this should be done in a single dose to the animals using a stomach tube or a suitable intubation
cannula. The maximum volume of liquid that can be administered at one time depends on the size of the test
animal. The volume should not exceed 1 ml/100 g body weight, except in the case of aqueous solutions
where 2 ml/100 g body weight may be used. Except for irritating or corrosive substances which will normally
reveal exacerbated effects with higher concentrations, variability in test volume should be minimised by
adjusting the concentration to ensure a constant volume at all dose levels.

For substances administered via the diet or drinking water it is important to ensure that the quantities of the
test substance involved do not interfere with normal nutrition or water balance. When the test substance is
administered in the diet either a constant dietary concentration (ppm) or a constant dose level in terms of the
animal’s body weight may be used; the alternative used must be specified. For a substance administered by
gavage, the dose should be given at similar times each day, and adjusted as necessary to maintain a constant
dose level in terms of animal body weight. Where a 90-day study is used as a preliminary to a long-term
chronic toxicity study, a similar diet should be used in both studies.

1.5.2. Observations

The observation period should be at least 90 days. Animals in a satellite group scheduled for follow-up
observations should be kept for an appropriate period without treatment to detect persistence of, or recovery
from toxic effects.

General clinical observations should be made at least once a day, preferably at the same time(s) each day,
taking into consideration the peak period of anticipated effects after dosing. The clinical condition of the
animals should be recorded. At least twice daily, usually at the beginning and end of each day, all animals are
inspected for signs of morbidity and mortality.

At least once prior to the first exposure (to allow for within-subject comparisons), and once a week thereafter,
detailed clinical observations should be made in all animals. These observations should be made outside the
home cage, preferably in a standard arena and at similar times on each occasion. They should be carefully
recorded, preferably using scoring systems, explicitly defined by the testing laboratory. Effort should be made
to ensure that variations in the observation conditions are minimal. Signs noted should include, but not be
limited to, changes in skin, fur, eyes, mucous membranes, occurrence of secretions and excretions and
autonomic activity (e.g. lacrimation, pilo-erection, pupil size, unusual respiratory pattern). Changes in gait,
posture and response to handling as well as the presence of clonic or tonic movements, stereotypes (e.g.
excessive grooming, repetitive circling) or bizarre behaviour (e.g. self-mutilation, walking backwards) should
also be recorded (1).

Ophthalmological examination, using an ophthalmoscope or equivalent suitable equipment, should be made
prior to the administration of the test substance and at the termination of the study, preferably in all animals
but at least in the high dose and control groups. If changes in the eyes are detected all animals should be
examined.

Towards the end of the exposure period and in any case not earlier than in week 11, sensory reactivity to
stimuli of different types (1) (e.g. auditory, visual and proprioceptive stimuli) (2), (3), (4), assessment of grip
strength (5) and motor activity assessment (6) should be conducted. Further details of the procedures that
could be followed are given in the respective references. However, alternative procedures than those
referenced could also be used.

Functional observations conducted towards the end of the study may be omitted when data on functional
observations are available from other studies and the daily clinical observations did not reveal any functional
deficits.

Exceptionally, functional observations may also be omitted for groups that otherwise reveal signs of toxicity
to an extent that would significantly interfere with the functional test performance.

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1.5.2.1. Body weight and food/water consumption

All animals should be weighed at least once a week. Measurements of food consumption should be made at
least weekly. If the test substance is administered via the drinking water, water consumption should also be
measured at least weekly. Water consumption may also be considered for dietary or gavage studies during
which drinking activity may be altered.

1.5.2.2. Haematology and clinical biochemistry

Blood samples should be taken from a named site and stored, if applicable, under appropriate conditions. At
the end of the test period, samples are collected just prior to or as part of the procedure for killing the
animals.

The following haematological examinations should be made at the end of the test period and when any
interim blood samples may have been collected: haematocrit, haemoglobin concentration, erythrocyte count,
total and differential leukocyte count, platelet count and a measure of blood clotting time/potential.

Clinical biochemistry determinations to investigate major toxic effects in tissues and, specifically, effects on
kidney and liver, should be performed on blood samples obtained from each animal just prior to or as part of
the procedure for killing the animals (apart from those found moribund and/or intercurrently killed). In a
similar manner to haematological
interim sampling for clinical biochemical tests may be
performed. Overnight fasting of the animals prior to blood sampling is recommended (1). Determinations in
plasma or serum should include sodium, potassium, glucose, total cholesterol, urea, blood urea nitrogen,
creatinine, total protein and albumin, and more than two enzymes indicative of hepatocellular effects (such as
alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma glutamyl transpeptidase,
and sorbitol dehydrogenase). Measurements of additional enzymes (of hepatic or other origin) and bile acids,
which may provide useful information under certain circumstances, may also be included.

investigations,

Optionally, the following urinalysis determinations could be performed during the last week of the study
using timed urine volume collection: appearance, volume, osmolality or specific gravity, pH, protein, glucose
and blood/blood cells.

In addition, studies to investigate serum markers of general tissue damage should be considered. Other
determinations that should be carried out if the known properties of the test substance may, or are suspected
to, affect related metabolic profiles include calcium, phosphorus, fasting triglycerides, specific hormones,
methaemoglobin and cholinesterase. These need to be identified for chemicals in certain classes or on a
case-by-case basis.

Overall, there is a need for a flexible approach, depending on the species and the observed and/or expected
effect from a given substance.

If historical baseline data are inadequate, consideration should be given as to whether haematological and
clinical biochemistry variables need to be determined before dosing commences;
is generally not
recommended that this data be generated before treatment (7).

it

1.5.2.3. Gross necropsy

All animals in the study shall be subjected to a full, detailed gross necropsy which includes careful
examination of the external surface of the body, all orifices, and the cranial, thoracic and abdominal cavities
and their contents. The liver, kidneys, adrenals, testes, epididymides, uterus, ovaries, thymus, spleen, brain and
heart of all animals (apart from those found moribund and/or intercurrently killed) should be trimmed of any
adherent tissue, as appropriate, and their wet weight taken as soon as possible after dissection to avoid drying.

(1) For a number of measurements in serum and plasma, most notably for glucose, overnight fasting would be preferable. The major
reason for this preference is that the increased variability which would inevitably result from non-fasting, would tend to mask more
subtle effects and make interpretation difficult. On the other hand, however, overnight fasting may interfere with the general
metabolism of the animals and, particularly in feeding studies, may disturb the daily exposure to the test substance. If overnight
fasting is adopted, clinical biochemical determinations should be performed after the conduct of functional observations of the study.

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thyroid, parathyroid,

The following tissues should be preserved in the most appropriate fixation medium for both the type of tissue
and the intended subsequent histopathological examination: all gross lesions, brain (representative regions
including cerebrum, cerebellum and medulla/pons), spinal cord (at three levels: cervical, mid-thoracic and
thymus, oesophagus, salivary glands, stomach, small and large
lumbar), pituitary,
intestines (including Peyer’s patches),
trachea and lungs
(preserved by inflation with fixative and then immersion), aorta, gonads, uterus, accessory sex organs, female
mammary gland, prostate, urinary bladder, gall bladder (mouse), lymph nodes (preferably one lymph node
covering the route of administration and another one distant from the route of administration to cover
systemic effects), peripheral nerve (sciatic or tibial) preferably in close proximity to the muscle, a section of
bone marrow (and/or a fresh bone marrow aspirate), skin and eyes (if changes were observed during
ophthalmological examinations). The clinical and other findings may suggest the need to examine additional
tissues. Also any organs considered likely to be target organs based on the known properties of the test
substance should be preserved.

liver, pancreas, kidneys, adrenals, spleen, heart,

1.5.2.4. Histopathology

Full histopathology should be carried out on the preserved organs and tissues of all animals in the control and
high dose groups. These examinations should be extended to animals of all other dosage groups,
if
treatment-related changes are observed in the high dose group.

All gross lesions should be examined.

When a satellite group is used, histopathology should be performed on tissues and organs identified as
showing effects in the treated groups.

2.

DATA AND REPORTING

2.1.

DATA

Individual data should be provided. Additionally, all data should be summarised in tabular form showing for
each test group the number of animals at the start of the test, the number of animals found dead during the
test or killed for humane reasons and the time of any death or humane kill, the number showing signs of
toxicity, a description of the signs of toxicity observed, including time of onset, duration, and severity of any
toxic effects, the number of animals showing lesions, the type of lesions and the percentage of animals
displaying each type of lesion.

When applicable, numerical results should be evaluated by an appropriate and generally acceptable statistical
method. The statistical methods and the data to be analysed should be selected during the design of the study.

2.2.

TEST REPORT

The test report must include the following information:

2.2.1.

Test substance:

(cid:151) physical nature, purity and physico-chemical properties,

(cid:151) identification data,

(cid:151) vehicle (if appropriate): justification for choice of vehicle, if other than water.

2.2.2.

Test species:

(cid:151) species and strain used,

(cid:151) number, age and sex of animals,

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(cid:151) source, housing conditions, diet etc.,

(cid:151) individual weights of animals at the start of the test.

2.2.3.

Test conditions:

(cid:151) rationale for dose level selection,

(cid:151) details of test substance formulation/diet preparation, achieved concentration, stability and homogeneity

of the preparation,

(cid:151) details of the administration of the test substance,

(cid:151) actual doses (mg/kg body weight/day), and conversion factor from diet/drinking water test substance

concentration (ppm) to the actual dose, if applicable,

(cid:151) details of food and water quality.

2.2.4.

Results:

(cid:151) body weight and body weight changes,

(cid:151) food consumption, and water consumption, if applicable,

(cid:151) toxic response data by sex and dose level, including signs of toxicity,

(cid:151) nature, severity and duration of clinical observations (whether reversible or not),

(cid:151) results of ophthalmological examination,

(cid:151) sensory activity, grip strength and motor activity assessments (when available),

(cid:151) haematological tests with relevant base-line values,

(cid:151) clinical biochemistry tests with relevant base-line values,

(cid:151) terminal body weight, organ weights and organ/body weight ratios,

(cid:151) necropsy findings,

(cid:151) a detailed description of all histopathological findings,

(cid:151) absorption data if available,

(cid:151) statistical treatment of results, where appropriate;

Discussion of results.

Conclusions.

3.

REFERENCES

(1)

(2)

IPCS (1986). Principles and Methods for the Assessment of Neurotoxicity Associated with Exposure to
Chemicals. Environmental Health Criteria Document No 60.

Tupper, D. E., Wallace, R.B. (1980). Utility of the Neurologic Examination in Rats. Acta Neurobiol. Exp.,
40, pp. 999-1003.

(3) Gad, S. C. (1982). A Neuromuscular Screen for Use in Industrial Toxicology. J. Toxicol. Environ. Health,

9, pp. 691-704.

(4) Moser, V. C., Mc Daniel, K. M., Phillips, P. M.

(1991). Rat Strain and Stock Comparisons Using a
Functional Observational Battery: Baseline Values and Effects of Amitraz. Toxicol. Appl. Pharmacol.,
108, pp. 267-283.

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(5) Meyer O. A., Tilson H. A., Byrd W. C., Riley M. T. (1979). A Method for the Routine Assessment of

Fore- and Hind- limb grip Strength of Rats and Mice. Neurobehav. Toxivol., 1, pp. 233-236.

(6)

Crofton K. M., Howard J. L., Moser V. C., Gill M. W., Reiter L. W., Tilson H. A., MacPhail R. C. (1991).
Interlaboratory Comparison of Motor Activity Experiments:
Implication for Neurotoxicological
Assessments. Neurotoxicol. Teratol., 13, pp. 599-609.

(7) Weingand K., Brown G., Hall R. et al. (1996).

(cid:145)Harmonisation of Animal Clinic Pathology Testing in

Toxicity and Safety Studies(cid:146), Fundam. & Appl. Toxicol., 29, pp. 198-201.

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ANNEX 5E

B.27. SUBCHRONIC ORAL TOXICITY TEST

REPEATED DOSE 90-DAY ORAL TOXICITY STUDY IN NON-RODENTS

1.

METHOD

This subchronic oral toxicity test method is a replicate of the OECD TG 409 (1998).

1.1.

INTRODUCTION

In the assessment and evaluation of the toxic characteristics of a chemical, the determination of subchronic
oral toxicity using repeated doses may be carried out after initial information on toxicity has been obtained
from acute or repeated dose 28-day toxicity tests. The 90-day study provides information on the possible
health hazards likely to arise from repeated exposure over a period of rapid growth and into young
adulthood. The study will provide information on the major toxic effects, indicate target organs and the
possibility of accumulation, and can provide an estimate of a no observed adverse effect level of exposure
which can be used in selecting dose levels for chronic studies and for establishing safety criteria for human
exposure.

The test method allows for the identification in non-rodent species of adverse effects of chemical exposure
and should only be used:

(cid:151) where effects observed in other studies indicate a need for clarification/characterisation in a second,

non-rodent species, or

(cid:151) where toxicokinetic studies indicate that the use of a specific non-rodent species is the most relevant

choice of laboratory animal, or

(cid:151) where other specific reasons justify the use of a non-rodent species.

See also General Introduction Part B.

1.2.

DEFINITIONS

Dose: is the amount of test substance administered. Dose is expressed as weight (g, mg) or as weight of test
substance per unit weight of test animal (e.g., mg/kg), or as constant dietary concentrations (ppm).

Dosage: is a general term comprising of dose, its frequency and the duration of dosing.

NOAEL: is the abbreviation for no observed adverse effect level and is the highest dose level where no
adverse treatment-related findings are observed.

1.3.

PRINCIPLE OF THE TEST METHOD

The test substance is orally administered daily in graduated doses to several groups of experimental animals,
one dose level per group for a period of 90 days. During the period of administration the animals are
observed closely for signs of toxicity. Animals which die or are killed during the test are necropsied and at
the conclusion of the test surviving animals are also killed and necropsied.

1.4.

DESCRIPTION OF THE TEST METHOD

1.4.1.

Selection of animal species

The commonly used non-rodent species is the dog, which should be of a defined breed; the beagle is
frequently used. Other species, e.g. swine, mini-pigs, may also be used. Primates are not recommended and
their use should be justified. Young, healthy animals should be employed, and in the case of the dog,
dosing should begin preferably at 4-6 months and not later than nine months of age. Where the study is

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conducted as a preliminary to a long-term chronic toxicity study, the same species/breed should be used in
both studies.

1.4.2.

Preparation of animals

Healthy young animals, which have been acclimated to laboratory conditions and have not been subjected
to previous experimental procedures, should be used. The duration of acclimatisation will depend upon the
selected test species and their source. At least five days for dogs or purpose bred swine from a resident
colony and at least two weeks for these animals if from external sources are recommended. The test
animals should be characterised as to species, strain, source, sex, weight and/or age. Animals should be
randomly assigned to the control and treatment groups. Cages should be arranged in such a way that
possible effects due to cage placement are minimised. Each animal should be assigned a unique
identification number.

1.4.3.

Preparations of doses

The test substance may be administered in the diet or in the drinking water, by gavage or in capsules. The
method of oral administration is dependent on the purpose of the study, and the physical-chemical
properties of the test material.

Where necessary, the test substance is dissolved or suspended in a suitable vehicle. It is recommended that,
wherever possible, the use of an aqueous solution/suspension be considered first, followed by consideration
of a solution/emulsion in oil (e.g. corn oil) and then by possible solution in other vehicles. For vehicles
other than water the toxic characteristics of the vehicle must be known. The stability of the test substance
under the conditions of administration should be determined.

1.5.

PROCEDURE

1.5.1.

Number and sex of animals

At least eight animals (four female and four male) should be used at each dose level. If interim kills are
planned, the number should be increased by the number of animals scheduled to be killed before the
completion of the study. The number of animals at the termination of the study must be adequate for a
meaningful evaluation of toxic effects. Based on previous knowledge of the substance or a close analogue,
consideration should be given to including an additional satellite group of eight animals (four per sex) in
control and in top dose group for observation after the treatment period of reversibility or persistence of
any toxic effects. The duration of this post-treatment period should be fixed appropriately with regard to
the effects observed.

1.5.2.

Dosage

At least three dose levels and a concurrent control shall be used, except where a limit test is conducted (see
1.5.3). Dose levels may be based on the results of repeated dose or range finding studies and should take
into account any existing toxicological and toxicokinetic data available for the test compound or related
materials. Unless limited by the physical-chemical nature or biological effects of the test substance, the
highest dose level should be chosen with the aim to induce toxicity but not death or severe suffering. A
descending sequence of dose levels should be selected with a view to demonstrating any dosage related
response and a no observed adverse effect level (NOAEL) at the lowest dose level. Two- to fourfold intervals
are frequently optimal for setting the descending dose levels and addition of a fourth test group is often
preferable to using very large intervals (e.g., more than a factor of about 6-10) between dosages.

The control group shall be an untreated group or a vehicle-control group if a vehicle is used in
administering the test substance. Except for treatment with the test substance, animals in the control group
should be handled in an identical manner to those in the test groups. If a vehicle is used, the control group
shall receive the vehicle in the highest volume used. If a test substance is administered in the diet, and
causes reduced dietary intake, then a pair-fed control group may be useful
in distinguishing between
reductions due to palatability or toxicological alterations in the test model.

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Consideration should be given to the following characteristics of
the vehicle and other additives, as
appropriate: effects on the absorption, distribution, metabolism, or retention of the test substance; effects
on the chemical properties of the test substance which may alter its toxic characteristics; and effects on the
food or water consumption or the nutritional status of the animals.

1.5.3.

Limit test

If a test at one dose level, equivalent to at least 1 000 mg/kg body weight/day, using the procedures
described for this study, produces no observed adverse effects and if toxicity would not be expected based
upon data from structurally related substances, then a full study using three dose levels may not be
considered necessary. The limit test applies except when human exposure indicates the need for a higher
dose level to be used.

1.5.4.

Administration of doses

The animals are dosed with the test substance daily seven days each week for a period of 90 days. Any
other dosing regime, e.g. five days per week, needs to be justified. When the test substance is administered
by gavage, this should be done in a single dose to the animals using a stomach tube or a suitable
intubation cannula. The maximum volume of liquid that can be administered at one time depends on the
size of the test animal. Normally the volume should be kept as low as possible. Except for irritating or
corrosive substances which will normally reveal exacerbated effects with higher concentrations, variability
in test volume should be minimised by adjusting the concentration to ensure a constant volume at all dose
levels.

For substances administered via the diet or drinking water it is important to ensure that the quantities of
the test substance involved do not interfere with normal nutrition or water balance. When the test
substance is administered in the diet either a constant dietary concentration (ppm) or a constant dose level
in terms of the animal’s body weight may be used; any alternative used must be specified. For a substance
administered by gavage or by capsule, the dose should be given at similar times each day, and adjusted as
necessary to maintain a constant dose level in terms of animal body weight. Where the 90-day study is
used as a preliminary to a long term chronic toxicity study, a similar diet should be used in both studies.

1.5.5.

Observations

The observation period should be at least 90 days. Animals in a satellite group scheduled for follow-up
observations should be kept for an appropriate period without treatment to detect persistence of, or
recovery from toxic effects.

General clinical observations should be made at least once a day, preferably at the same time(s) each day,
taking into consideration the peak period of anticipated effects after dosing. The clinical condition of the
animals should be recorded. At least twice daily, usually at the beginning and end of each day, all animals
should be inspected for signs of morbidity and mortality.

At least once prior to the first exposure (to allow for within-subject comparisons), and once a week
thereafter, detailed clinical observations should be made in all animals. These observations should be made,
where practical outside the home cage in a standard arena and preferably at similar times on each occasion.
Effort should be made to ensure that variations in the observation conditions are minimal. Signs of toxicity
should be carefully recorded, including time of onset, degree and duration. Observations should include, but
not be limited to, changes in skin, fur, eyes, mucous membranes, occurrence of secretions and excretions
and autonomic activity (e.g. lacrimation, pilo-erection, pupil size, unusual respiratory pattern). Changes in
gait, posture and response to handling as well as the presence of clonic or tonic movements, stereotypes
(e.g. excessive grooming, repetitive circling) or any bizarre behaviour should also be recorded.

Ophthalmological examination, using an ophthalmoscope or equivalent suitable equipment, should be
made prior to the administration of the test substance and at the termination of the study, preferably in all
animals but at least in the high dose and control groups. If treatment related changes in the eyes are
detected all animals should be examined.

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1.5.5.1.

Body weight and food/water consumption

All animals should be weighed at least once a week. Measurements of food consumption should be made at
least weekly. If the test substance is administered via the drinking water, water consumption should also be
measured at least weekly. Water consumption may also be considered for dietary or gavage studies during
which drinking activity may be altered.

1.5.5.2.

Haematology and clinical biochemistry

Blood samples should be taken from a named site and stored, if applicable, under appropriate conditions.
At the end of the test period, samples are collected just prior to or as part of the procedure for killing the
animals.

Haematology, including haematocrit, haemoglobin concentration, erythrocyte count, total and differential
leukocyte count, platelet count and a measure of clotting potential such as clotting time, prothrombin time,
or thromboplastin time should be investigated at the start of the study, then either at monthly intervals or
midway through the test period and finally at the end of the test period.

Clinical biochemistry determinations to investigate major toxic effects in tissues and, specifically, effects on
kidney and liver, should be performed on blood samples obtained from all animals at the start, then either
at monthly intervals or midway through the test and finally at the end of the test period. Test areas which
should be considered are electrolyte balance, carbohydrate metabolism, and liver and kidney function. The
selection of specific tests will be influenced by observations on the mode of action of the test substance.
Animals should be fasted for a period appropriate to the species prior to blood sampling. Suggested
determinations
fasting glucose, alanine
aminotransferase, aspartate aminotransferase, ornithine decarboxylase, gamma glutamyl transpeptidase, urea
nitrogen, albumin, blood creatinine, total bilirubin and total serum protein measurements.

include calcium, phosphorus, chloride,

sodium, potassium,

Urinalysis determinations should be performed at least at the start, then midway and finally at the end of
the study using timed urine volume collection. Urinalysis determinations include appearance, volume,
osmolality or specific gravity, pH, protein, glucose and blood/blood cells. Additional parameters may be
employed where necessary to extend the investigation of observed effect(s).

tissue damage should be considered. Other
In addition, studies to investigate markers of general
determinations which may be necessary for an adequate toxicological evaluation include analyses of lipids,
hormones,
clinical
biochemistry may be employed where necessary to extend the investigation of observed effects. These need
to be identified for chemicals in certain classes or on a case-by-case basis.

acid/base balance, methaemoglobin,

inhibition. Additional

and cholinesterase

Overall, there is a need for a flexible approach, depending on the species and the observed and/or expected
effect from a given substance.

1.5.5.3.

Gross necropsy

All animals in the study shall be subjected to a full, detailed gross necropsy which includes careful
examination of the external surface of the body, all orifices, and the cranial, thoracic and abdominal cavities
and their contents. The liver with gall bladder, kidneys, adrenals, testes, epididymides, ovaries, uterus,
thyroid (with parathyroids),
from those found
moribund and/or inter-currently killed) should be trimmed of any adherent tissue, as appropriate, and their
wet weight taken as soon as possible after dissection to avoid drying.

thymus, spleen, brain and heart of all animals (apart

including cerebrum, cerebellum and medulla/pons),

The following tissues should be preserved in the most appropriate fixation medium for both the type of
tissue and the intended subsequent histopathological examination: all gross lesions, brain (representative
three levels: cervical,
regions
thymus, oesophagus, salivary glands,
mid-thoracic and lumbar), pituitary, eyes,
thyroid, parathyroid,
stomach, small and large intestines (including Peyer’s patches),
liver, gall bladder, pancreas, kidneys,
adrenals, spleen, heart, trachea and lungs, aorta, gonads, uterus, accessory sex organs, female mammary
lymph nodes (preferably one lymph node covering the route of
gland, prostate, urinary bladder,
administration and another one distant
from the route of administration to cover systemic effects),
peripheral nerve (sciatic or tibial) preferably in close proximity to the muscle, a section of bone marrow

spinal cord (at

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(and/or a fresh bone marrow aspirate) and skin. The clinical and other findings may suggest the need to
examine additional tissues. Also any organs considered likely to be target organs based on the known
properties of the test substance should be preserved.

1.5.5.4.

Histopathology

Full histopathology should be carried out on the preserved organs and tissues in at least all animals in
control and high dose group. The examination should be extended to animals of all other dosage groups, if
treatment-related changes are observed in the high dose group.

All gross lesions should be examined.

When a satellite group is used, histopathology should be performed on tissues and organs identified as
showing effects in the treated groups.

2.

DATA AND REPORTING

2.1.

DATA

Individual data should be provided. Additionally, all data should be summarised in tabular form showing
for each test group the number of animals at the start of the test, the number of animals found dead during
the test or killed for humane reasons and the time of any death or humane kill, the number showing signs
of toxicity, a description of the signs of toxicity observed, including time of onset, duration, and severity of
any toxic effects, the number of animals showing lesions, the type of lesions and the percentage of animals
displaying each type of lesion.

When applicable, numerical results should be evaluated by an appropriate and generally acceptable
statistical method. The statistical methods and the data to be analysed should be selected during the design
of the study.

2.2.

TEST REPORT

The test report must include the following information:

2.2.1.

Test substance:

(cid:151) physical nature, purity and physico-chemical properties,

(cid:151) identification data.

(cid:151) vehicle (if appropriate): justification for choice of vehicle, if other than water.

2.2.2.

Test species:

(cid:151) species and strain used,

(cid:151) number, age and sex of animals,

(cid:151) source, housing conditions, diet etc.,

(cid:151) individual weights of animals at the start of the test.

2.2.3.

Test conditions:

(cid:151) rationale for dose level selection,

(cid:151) details of

test

substance

formulation/diet preparation,

achieved concentration,

stability

and

homogeneity of the preparation,

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(cid:151) details of the administration of the test substance,

(cid:151) actual doses (mg/kg body weight/day), and conversion factor from diet/drinking water test substance

concentration (ppm) to the actual dose, if applicable,

(cid:151) details of food and water quality.

2.2.4.

Results

(cid:151) body weight/body weight changes,

(cid:151) food consumption, and water consumption, if applicable,

(cid:151) toxic response data by sex and dose level, including signs of toxicity,

(cid:151) nature, severity and duration of clinical observations (whether reversible or not),

(cid:151) ophthalmological examination,

(cid:151) haematological tests with relevant base-line values,

(cid:151) clinical biochemistry tests with relevant base-line values,

(cid:151) terminal body weight, organ weights and organ/body weight ratios,

(cid:151) necropsy findings,

(cid:151) a detailed description of all histopathological findings,

(cid:151) statistical treatment of results, where appropriate.

Discussion of results.

Conclusions.

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ANNEX 5F

C.14. FISH JUVENILE GROWTH TEST

1.

METHOD

This growth toxicity test method is a replicate of the OECD TG 215 (2000).

1.1.

INTRODUCTION

This test is designed to assess the effects of prolonged exposure to chemicals on the growth of juvenile fish. It
is based on a method, developed and ring-tested (1) (3) within the European Union, for assessing the effects of
chemicals on the growth of juvenile rainbow trout (Oncorynchus mykiss) under flow-through conditions. Other
well documented species may be used. For example, experience has been gained from growth tests with
zebrafish (Danio rerio) (2) (4) (5) and ricefish (medaka, Oryzias latipes) (6) (7) (8).

See also General Introduction Part C.

1.2.

DEFINITIONS

Lowest observed effect concentration (LOEC): is the lowest tested concentration of a test substance at
which the substance is observed to have a significant effect (at p < 0,05) when compared with the control.
However, all test concentrations above the LOEC must have a harmful effect equal to or greater than those
observed at the LOEC.

No observed effect concentration (NOEC): is the test concentration immediately below the LOEC.

ECx: in this test method is the concentration of the test substance which causes a x % variation in growth rate
of the fish when compared with controls.

Loading rate: is the wet weight of fish per volume of water.

Stocking density: is the number of fish per volume of water.

Individual fish specific growth rate: expresses the growth rate of one individual based on its initial weight.

Tank-average specific growth rate: expresses the mean growth rate of a tank population at one
concentration.

Pseudo specific growth rate: expresses the individual growth rate compared to the mean initial weight of
the tank population.

1.3.

PRINCIPLE OF THE TEST METHOD

Juvenile fish in exponential growth phase are placed, after being weighted, in test chambers and are exposed
to a range of sublethal concentrations of the test substance dissolved in water preferably under flow-through,
or, if not possible, under appropriate semi-static (static-renewal) conditions. The test duration is 28 days. Fish
are fed daily. The food ration is based on initial fish weights and may be recalculated after 14 days. At the
end of the test, the fish are weighed again. Effects on growth rates are analysed using a regression model in
order to estimate the concentration that would cause a x % variation in growth rate, i.e. ECx (e.g. EC10, EC20,
or EC30). Alternatively, the data may be compared with control values in order to determine the lowest
observed effect concentration (LOEC) and hence the no observed effect concentration (NOEC).

1.4.

INFORMATION ON THE TEST SUBSTANCE

Results of an acute toxicity test (see test method C.1) preferably performed with the species chosen for this
test, should be available. This implies that the water solubility and the vapour pressure of the test substance
are known and a reliable analytical method is available for the quantification of the substance in the test
solutions with known and reported accuracy and limit of detection is available.

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Useful information includes the structural formula, purity of the substance, stability in water and light, pKa,
Pow and results of a test for ready biodegradability (see test method C.4).

1.5.

VALIDITY OF THE TEST

For the test to be valid the following conditions apply:

(cid:151) the mortality in the control(s) must not exceed 10 % at the end of the test,

(cid:151) the mean weight of fish in the control(s) must have increased enough to permit the detection of the
minimum variation of growth rate considered as significant. A ring-test (3) has shown that for rainbow
trout the mean weight of fish in the controls must have increased by at least the half (i.e. 50 %) of their
mean initial weight over 28 days; e.g. initial weight: 1 g/fish (= 100 %), final weight after 28 days: ¯ 1,5
g/fish (¯ 150 %),

(cid:151) the dissolved oxygen concentration must have been at least 60 % of the air saturation value (ASV)

throughout the test,

(cid:151) the water temperature must not differ by more than – 1 (cid:176)C between test chambers at any one time
during the test and should be maintained within a range of 2 (cid:176)C within the temperature ranges specified
for the test species (Appendix 1).

1.6.

DESCRIPTION OF THE TEST METHOD

1.6.1.

Apparatus

Normal laboratory equipment and especially the following:

(a) oxygen and pH meters;

(b) equipment for determination of water hardness and alkalinity;

(c) adequate apparatus for temperature control and preferably continuous monitoring;

(d)

tanks made of chemically inert material and of suitable capacity in relation to the recommended loading
and stocking density (see section 1.8.5 and Appendix 1);

(e)

suitably accurate balance (i.e. accurate to – 0,5 %).

1.6.2. Water

Any water in which the test species shows suitable long-term survival and growth may be used as a test
water. It should be of constant quality during the period of the test. The pH of the water should be within the
range 6,5 to 8,5, but during a given test it should be within a range of – 0,5 pH units. Hardness above 140
mg/l (as CaCO3) is recommended. In order to ensure that the dilution water will not unduly influence the test
result (for example by complexion of test substance), samples should be taken at intervals for analysis.
Measurements of heavy metals (e.g. Cu, Pb, Zn, Hg, Cd and Ni), major anions and cations (e.g. Ca, Mg, Na, K,
Cl and SO4), pesticides (e.g. total organophosphorus and total organochlorine pesticides), total organic carbon
and suspended solids should be made, for example, every three months where a dilution water is known to be
relatively constant in quality. If water quality has been demonstrated to be constant over at least one year,
frequent and intervals extended (e.g. every six months). Some chemical
determinations can be less
characteristics of an acceptable dilution water are listed in Appendix 2.

1.6.3.

Test solutions

Test solutions of the chosen concentrations are prepared by dilution of a stock solution.

The stock solution should preferably be prepared by simply mixing or agitating the test substance in the
diluition water by using mechanical means (e.g. stirring or ultrasonication). Saturation columns (solubility
columns) can be used for achieving a suitable concentrated stock solution.

The use of solvents or dispersants (solubilising agents) may be required in some cases in order to produce a
suitably concentrated stock solution. Examples of
suitable solvents are acetone, ethanol, methanol,
dimethylsulfoxide, dimethylformamide and triethyleneglycol. Examples of suitable dispersants are Cremophor

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RH40, Tween 80, Methylcellulose 0,01 % and HCO-40. Care should be taken when using readily
biodegradable agents (e.g. acetone) and/or highly volatile compounds as these can cause problems with
bacterial built-up in flow-through tests. When a solubilising agent is used it must have no significant effects
on the fish growth nor visible adverse effects on the juvenile as revealed by a solvent-only control.

For flow-through tests, a system which continually dispenses and dilutes a stock solution of the test substance
(e.g. metering pump, proportional diluter, saturator system) is required to deliver a series of concentrations to
the test chambers. The flow rates of stock solutions and dilution water should be checked at intervals,
preferably daily, during the test and should not vary by more than 10 % throughout the test. A ring-test (3)
has shown that, for rainbow trout, a frequency of water removal during the test of 6 litres/g of fish/day is
acceptable (see section 1.8.2.2).

For semi-static (renewal) tests, the frequency of medium renewal will depend on the stability of the test
substance, but a daily water renewal is recommended. If, from preliminary stability tests (see section 1.4), the
test substance concentration is not stable (i.e. outside the range 80-120 % of nominal or falling below 80 % of
the measured initial concentration) over the renewal period, consideration should be given to the use of a
flow-through test.

1.6.4.

Selection of species

Rainbow trout (Oncorhynchus mykiss) is the recommended species for this test since most experience has been
gained from ring-test with this species (1) (3). However, other well documented species can be used but the
test procedure may have to be adapted to provide suitable test conditions. For example, experience is also
available with zebrafish (Danio rerio) (4) (5) and ricefish (medaka, Oryzias latipes) (6) (7) (8). The rationale for
the selection of the species and the experimental method should be reported in this case.

1.6.5.

Holding of fish

The test fish shall be selected from a population of a single stock, preferably from the same spawning, which
has been held for at least two weeks prior to the test under conditions of water quality and illumination
similar to those used in the test. They should be fed a minimum ration of 2 % body weight per day and
preferably 4 % body weight per day throughout the holding period and during the test.

Following a 48-hour setting-in period, mortalities are recorded and the following criteria applied:

(cid:151) mortalities of greater than 10 % of the population in seven days: reject the entire batch,

(cid:151) mortalities of between 5 % and 10 % of the population: acclimation for seven additional days; if more

than 5 % mortality during the second seven days, reject the entire batch,

(cid:151) mortalities of less than 5 % of the population in seven days: accept the batch.

Fish should not receive treatment for disease in the two weeks preceding the test, or during the test.

1.7.

TEST DESIGN

The (cid:145)test design(cid:146) relates to the selection of the number and spacing of the test concentrations, the number of
tanks at each concentration level and the number of fish per tank. Ideally, the test design should be chosen
with regard to:

(a)

the objective of the study;

(b)

the method of statistical analysis that will be used;

(c)

the availability and cost of experimental resources.

The statement of the objective should,
if possible, specify the statistical power at which a given size of
difference (e.g. in growth rate) is required to be detected or, alternatively, the precision with which the ECx
(e.g. with x = 10, 20, or 30, and preferably not less than 10) is required to be estimated. Without this, a firm
prescription of the size of the study cannot be given.

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It is important to recognise that a design which is optimal (makes best use of resources) for use with one
for another. The recommended design for the
method of statistical analysis is not necessarily optimal
estimation of a LOEC/NOEC would not therefore be the same as that recommended for analysis by regression.

In most of cases, regression analysis is preferable to the analysis of variance, for reasons discussed by Stephan
and Rogers (9). However, when no suitable regression model is found (r2 < 0,9) NOEC/LOEC should be used.

1.7.1.

Design for analysis by regression

The important considerations in the design of a test to be analysed by regression are:

(a)

(b)

the effect concentration (e.g. EC10,20,30) and the concentration range over which the effect of the test
substance is of interest, should necessarily be spanned by the concentrations included in the test. The
precision with which estimates of effect concentrations can be made, will be best when the effect
concentration is in the middle of the range of concentrations tested. A preliminary range-finding test may
be helpful in selecting appropriate test concentrations;

to enable satisfactory statistical modelling, the test should include at least one control tank and five
additional tanks at different concentrations. Where appropriate, when a solubilising agent is used, one
control containing the solubilising agent at the highest tested concentration should be run in addition to
the test series (see sections 1.8.3 and 1.8.4);

(c) an appropriate geometric series or logarithmic series (10) (see Appendix 3) may be used. Logarithmic

spacing of test concentration is to be preferred;

(d)

if more than six tanks are available, the additional tanks should either be used to provide replication or
distributed across the range of concentrations in order to enable closer spacing of the levels. Either of
these measures are equally desirable.

1.7.2.

Design for estimation of a NOEC/LOEC using analysis of variance (ANOVA)

There should preferably be replicate tanks at each concentration, and statistical analysis should be at the tank
level (11). Without replicate tanks, no allowance can be made for variability between tanks beyond that due to
individual fish. However, experience has shown (12) that between-tank variability was very small compared
with within-tank (i.e. between-fish) variability in the case examined. Therefore a relatively acceptable
alternative is to perform statistical analysis at the level of individual fish.

Conventionally, at least five test concentrations in a geometric series with a factor preferably not exceeding
3,2 are used.

Generally, when tests are performed with replicate tanks, the number of replicate control tanks and therefore
the number of fish should be the double of the number in each of the test concentrations, which should be of
equal size (13) (14) (15). On the opposite, in absence of replicate tanks, the number of fish in the control
group should be the same as the number in each test concentration.

If the ANOVA is to be based on tanks rather than individual fish (which would entail either individual
marking of the fish or the use of (cid:145)pseudo(cid:146) specific growth rates (see section 2.1.2)), there is a need for enough
replication of tanks to enable the standard deviation of (cid:145)tanks within concentrations(cid:146) to be determined. This
means that the degrees of freedom for error in the analysis of variance should be at least 5 (11). If only the
controls are replicated, there is a danger that the error variability will be biased because it may increase with
the mean value of the growth rate in question. Since growth rate is likely to decrease with increasing
concentration, this will tend to lead to an overestimate of the variability.

1.8.

PROCEDURE

1.8.1.

Selection and weighing of test fish

It is important to minimise variation in weight of the fish at the beginning of the test. Suitable size ranges for
the different species recommended for use in this test are given in Appendix 1. For the whole batch of fish
used in the test, the range in individual weights at the start of the test should ideally be kept to within – 10 %

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of the arithmetic mean weight and, in any case, should not exceed 25 %. It is recommended to weight a
subsample of fish before the test in order to estimate the mean weigh.

Food should be withheld from the stock population for 24 hours prior to the start of the test. Fish should
then be chosen at random. Using a general anaesthetic (e.g. an aqueous solution of 100 mg/l tricaine methane
sulphonate (MS 222) neutralised by the addition of two parts of sodium bicarbonate per part of MS 222), fish
should be weighted individually as wet weights (blotted dry) to the precision given in Appendix 1. Those fish
with weights within the intended range should be retained and then should be randomly distributed between
the test vessels. The total wet weight of fish in each test vessel should be recorded. The use of anaesthetics
likewise handling of fish (including blotting and weighing) may cause stress and injuries to the juvenile fish, in
particular for those species of small size. Therefore handling of juvenile fish must be done with the utmost
care to avoid stressing and injuring test animals.

The fish are weighed again on day 28 of the test (see section 1.8.6). However, if it is deemed necessary to
recalculate the food ration, fish can be weighed again on day 14 of the test (see section 1.8.2.3). Another
method such as the photographic method could be used to determine changes in fish size on the basis of
which food rations could be adjusted.

1.8.2.

Conditions of exposure

1.8.2.1. Duration

The test duration is ¯ 28 days.

1.8.2.2. Loading rates and stocking densities

It is important that the loading rate and stocking density is appropriate for the test species used (see Appendix
1). If the stocking density is too high, then overcrowding stress will occur leading to reduced growth rates and
possibly to disease. If it is too low, territorial behaviour may be induced which could also affect growth. In
any case, the loading rate should be low enough in order that a dissolved oxygen concentration of at least
60 % ASV can be maintained without aeration. A ring-test (3) has shown that, for rainbow trout, a loading
rate of 16 trouts of 3-5 g in a 40-litre volume is acceptable. Recommended frequency of water removal
during the test is 6 litres/g of fish/day.

1.8.2.3. Feeding

The fish should be fed with an appropriate food (Appendix 1) at a sufficient rate to induce acceptable growth
rate. Care should be taken to avoid microbial growth and water turbidity. For rainbow trout, a rate of 4 % of
their body weight per day is likely to satisfy these conditions (3) (16) (17) (18). The daily ration may be
divided into two equal portions and given to the fish in two feeds per day, separated by at least five hours.
The ration is based on the initial total fish weight for each test vessel. If the fish are weighted again on day
14, the ration is then recalculated. Food should be withheld from the fish 24 hours prior to weighing.

Uneaten food and fecal material should be removed from the test vessels each day by carefully cleaning the
bottom of each tank using a suction.

1.8.2.4. Light and temperature

The photoperiod and water temperature should be appropriate for the test species (Appendix 1).

1.8.3.

Test concentrations

Normally five concentrations of the test substance are required, regardless of the test design (see section
1.7.2). Prior knowledge of the toxicity of the test substance (e.g. from an acute test and/or from range-finding
studies) should help in selecting appropriate test concentrations. Justification should be given if fewer than five
concentrations are used. The highest tested concentration should not exceed the substance solubility limit in
water.

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Where a solubilising agent is used to assist in stock solution preparation, its final concentration should not be
greater than 0,1 ml/l and should preferably be the same in all test vessels (see section 1.6.3). However, every
effort should be made to avoid use of such materials.

1.8.4.

Controls

The number of dilution-water controls depends on the test design (see sections 1.7-1.7.2). If a solubilising
agent is used, then the same number of solubilising-agent controls as dilution-water controls should also be
included.

1.8.5.

Frequency of analytical determinations and measurements

During the test, the concentrations of test substance are determined at regular intervals (see below).

In flow-through tests, the flow rates of diluent and toxicant stock solution should be checked at intervals,
preferably daily, and should not vary by more than 10 % throughout the test. Where the test substance
concentrations are expected to be within – 20 % of the nominal values (i.e. within the range 80-120 %; see
sections 1.6.2 and 1.6.3), it is recommended that, as a minimum, the highest and lowest test concentrations
be analysed at the start of the test and at weekly intervals thereafter. For the test where the concentration of
the test substance is not expected to remain within – 20 % of nominal (on the basis of stability data of the
test substance), it is necessary to analyse all test concentrations, but following the same regime.

the nominal values,

In semi-static (renewal) tests where the concentration of the test substance is expected to remain within
– 20 % of
test
concentrations be analysed when freshly prepared and immediately prior to renewal at the start of the study
and weekly thereafter. For tests where the concentration of the test substance is not expected to remain within
– 20 % of nominal, all test concentrations must be analysed following the same regime as for more stable
substances.

is recommended that, as a minimum,

the highest and lowest

it

It is recommended that results be based on measured concentrations. However, if evidence is available to
demonstrate that the concentration of the test substance in solution has been satisfactorily maintained within
– 20 % of the nominal or measured initial concentration throughout the test, then the results can be based on
nominal or measured values.

Samples may need to be filtered (e.g. using a 0,45 lm pore size) or centrifuged. Centrifugation is the
recommended procedure. However,
if the test material does not adsorb to filters, filtration may also be
acceptable.

During the test, dissolved oxygen, pH and temperature should be measured in all test vessels. Total hardness,
alkalinity and salinity (if relevant) should be measured in the controls and one vessel at
the highest
concentration. As a minimum, dissolved oxygen and salinity (if relevant) should be measured three times (at
the beginning, middle and end of the test). In semi-static tests, it is recommended that dissolved oxygen be
measured more frequently, preferably before and after each water renewal or at least once a week. The pH
should be measured at the beginning and end of each water renewal in static renewal test and at least weekly
in flow-through tests. Hardness and alkalinity should be measured once each test. Temperature should
preferably be monitored continuously in at least one test vessel.

1.8.6. Observations

Weight: at the end of the test all surviving fish must be weighed as wet weights (blotted dry) either in groups
by test vessel or individually. Weighing of animals by test vessel is preferred to individual weights which
require that
individual weights for
In the case of
determination of individual fish specific growth rate, the marking technique selected should avoid stressing the
animals (alternatives to freeze marking may be appropriate, e.g. the use of coloured fine fishing line).

fish be individually marked.

the measurement of

The fish should be examined daily during the test period and any external abnormalities (such as
haemorrhage, discoloration) and abnormal behaviour noted. Any mortalities should be recorded and the dead
fish removed as soon as possible. Dead fish are not replaced, the loading rate and stocking density being
sufficient to avoid effects on growth through changes in number of fish per tank. However, the feeding rate
will need to be adjusted.

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2.

DATA AND REPORTING

2.1.

TREATMENT OF RESULTS

It is recommended that a statistician be involved in both the design and analysis of the test since this test
method allows for considerable variation in experimental design as for example,
in the number of test
chambers, number of test concentrations, number of fish, etc. In view of the options available in test design,
specific guidance on statistical procedure is not given here.

Growth rates should not be calculated for test vessels where the mortality exceeds 10 %. However, mortality
rate should be indicated for all test concentrations.

Whichever method is used to analyse the data, the central concept is the specific growth rate r between time
t1 and time t2. This can be defined in several ways depending on whether fish are individually marked or not
or whether a tank average is required.

r1 =

logew2 ﬂ logew1
t2 ﬂ t1

(cid:215) 100

r2 =

logew2 ﬂ logew1
t2 ﬂ t1

(cid:215) 100

r3 =

logew2 ﬂ logew1
t2 ﬂ t1

(cid:215) 100

where,

r1

r2

r3

= individual fish specific growth rate

= tank-average specific growth rate

= (cid:145)pseudo(cid:146) specific growth rate

w1, w2

= weights of a particular fish at times t1 and t2, respectively

loge w1 = logarithm of the weight of an individual fish at the start of the study period

loge w2 = logarithm of the weight of an individual fish at the end of the study period

loge w1 = average of the logarithms of the values w1 for the fish in the tank at the start of the study period

loge w2 = average of the logarithms of the values w2 for the fish in the tank at the end of the study period

t1, t2

= time (days) at start and end of study period

r1, r2, r3 can be calculated for the 0-28 days period and, where appropriate (i.e. when measurement at day 14
has been done) for the 0-14 and 14-28 days periods.

2.1.1.

Analysis of results by regression (concentration-response modelling)

This method of analysis fits a suitable mathematical relationship between the specific growth rate and
concentration, and hence enables the estimation of the (cid:145)ECx(cid:146) i.e. any required EC value. Using this method the
calculation of r for individual
is not necessary and instead, the analysis can be based on the
tank-average value of r (r2). This last method is preferred. It is also more appropriate in case of the use of
smallest species.

fish (r1)

The tank-average specific growth rates (r2) should be plotted graphically against concentration, in order to
inspect the concentration response relationship.

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For expressing the relationship between r2 and concentration, an appropriate model should be chosen and its
choice must be supported by appropriate reasoning.

If the numbers of fish surviving in each tank are unequal, then the process of model fitting, whether simple or
non-linear, should be weighted to allow for unequal sizes of groups.

The method of fitting the model must enable an estimate of, for example, the EC20 and of its dispersion
(either standard error or confidence interval) to be derived. The graph of the fitted model should be shown in
relation to the data so that the adequacy of the fit of the model can be seen (9) (19) (20) (21).

2.1.2.

Analysis of results for the estimation of the LOEC

If the test has included replication of tanks at all concentration levels, the estimation of the LOEC could be
based on an analysis of variance (ANOVA) of the tank-average specific growth rate (see section 2.1), followed
by a suitable method (e.g. Dunnett’s or Williams’ test (13) (14) (15) (22)) of comparing the average r for each
concentration with the average r for the controls to identify the lowest concentration for which this difference
is significant at a 0,05 probability level. If the required assumptions for parametric methods are not met (cid:151)
non-normal distribution (e.g. Shapiro-Wilk’s test) or heterogeneous variance (Bartlett’s test), consideration
should be given to transforming the data to homogenise variances prior to performing the ANOVA, or to
carrying out a weighted ANOVA.

If the test has not included replication of tanks at each concentration, an ANOVA based on tanks will be
insensitive or impossible. In this situation, an acceptable compromise is to base the ANOVA on the (cid:145)pseudo(cid:146)
specific growth rate r3 for individual fish.

The average r3 for each test concentration may then be compared with the average r3 for the controls. The
LOEC can then be identified as before. It must be recognised that this method provides no allowance for, nor
protection against, variability between tanks, beyond that which is accounted for by the variability between
individual fish. However, experience has shown (9) that between-tank variability was very small compared
with within-tank (i.e. between-fish) variability. If individual fish are not included in the analysis, the method of
outlier identification and justification for its use must be provided.

2.2.

INTERPRETATION OF RESULTS

The results should be interpreted with caution where measured toxicant concentrations in test solutions occur
at levels near the detection limit of the analytical method or, in semi static tests, when the concentration of
the test substance decreases between freshly prepared solution and before renewal.

2.3.

TEST REPORT

The test report must include the following information:

2.3.1.

Test substance:

(cid:151) physical nature and relevant physical-chemical properties,

(cid:151) chemical identification data including purity and analytical method for quantification of the test substance

where appropriate.

2.3.2.

Test species

(cid:151) scientific name, possibly,

(cid:151) strain, size, supplier, any pre-treatment, etc.

2.3.3.

Test conditions:

(cid:151) test procedure used (e.g. semi-static/renewal, flow-through, loading, stocking density, etc.),

(cid:151) test design (e.g. number of test vessels, test concentrations and replicates, number of fish per vessel),

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(cid:151) method of preparation of stock solutions and frequency of renewal

(the solubilising agent and its

concentration must be given, when used),

(cid:151) the nominal test concentrations, the means of the measured values and their standard deviations in the
test vessels and the method by which these were attained and evidence that the measurements refer to the
concentrations of the test substance in true solution,

(cid:151) dilution water characteristics: pH, hardness, alkalinity,

temperature, dissolved oxygen concentration,
residual chlorine levels (if measured), total organic carbon, suspended solids, salinity of the test medium
(if measured) and any other measurements made,

(cid:151) water quality within test vessels: pH, hardness, temperature and dissolved oxygen concentration,

(cid:151) detailed information on feeding, (e.g. type of food(s), source, amount given and frequency).

2.3.4.

Results:

(cid:151) evidence that controls met the validity criterion for survival, and data on mortalities occurring in any of

the test concentrations,

(cid:151) statistical analytical

techniques used, statistics based on replicates or fish,

treatment of data and

justification of techniques used,

(cid:151) tabulated data on individual and mean fish weights on days 0, 14 (if measured) and 28 values of
tank-average or pseudo specific growth rates (as appropriate) for the periods 0-28 days or possibly 0-14
and 14-28,

(cid:151) results of the statistical analysis (i.e. regression analysis or ANOVA) preferably in tabular and graphical
form and the LOEC (p = 0,05) and the NOEC or ECx with, when possible, standard errors, as appropriate,

(cid:151) incidence of any unusual reactions by the fish and any visible effects produced by the test substance.

3.

REFERENCES

(1)

Solbe J. F. de LG (1987). Environmental Effects of Chemicals (CFM 9350 SLD). Report on a UK Ring
Test of a Method for Studying the Effects of Chemicals on the Growth Rate of Fish. WRc Report No
PRD 1388-M/2.

(2) Meyer, A., Bierman, C. H. and Orti, G. (1993). The phylogenetic position of the zebrafish (Danio rerio), a
model system in developmental biology: an invitation to the comparative method. Proc. R. Soc. Lond. B.
252, pp. 231-236.

(3) Ashley S., Mallett M. J. and Grandy N. J. (1990). EEC Ring Test of a Method for Determining the Effects
the European

to the Commission of

of Chemicals on the Growth Rate of Fish. Final Report
Communities. WRc Report No EEC 2600-M.

(4)

Crossland N. O. (1985). A method to evaluate effects of toxic chemicals on fish growth. Chemosphere,
14, pp. 1855-1870.

(5) Nagel R., Bresh H., Caspers N., Hansen P. D., Market M., Munk R., Scholz N. and H(cid:246)fte B. B. (1991).
Effect of 3,4-dichloroaniline on the early life stages of the Zebrafish (Brachydanio rerio): results of a
comparative laboratory study. Ecotox. Environ. Safety, 21, pp. 157-164.

(6)

Yamamoto, Tokio. (1975). Series of stock cultures in biological field. Medaka (killifish) biology and
strains. Keigaku Publish. Tokio, Japan.

(7) Holcombe, G. W., Benoit D. A., Hammermeister, D. E., Leonard, E. N. and Johnson, R. D. (1995). Acute
and long-term effects of nine chemicals on the Japanese medaka (Oryzias latipes). Arch. Environ. Conta.
Toxicol. 28, pp. 287-297.

(8)

Benoit, D. A., Holcombe, G. W. and Spehar, R. L. (1991). Guidelines for conducting early life toxicity
tests with Japanese medaka (Oryzias
latipes). Ecological Research Series EPA-600/3-91-063. US
Environmental Protection Agency, Duluth, Minnesota.

L 225/172

EN

(9)

Official Journal of the European Communities

21.8.2001

Stephan C. E. and Rogers J. W. (1985). Advantages of using regression analysis to calculate results of
chronic toxicity tests. Aquatic Toxicology and Hazard Assessment: Eighth Symposium, ASTM STP 891,
R. C. Bahner and D. J. Hansen, eds., American Society for Testing and Materials, Philadelphia, pp.
328-338.

(10) Environment Canada (1992). Biological test method: toxicity tests using early life stages of salmonid fish
(rainbow trout, coho salmon, or atlantic salmon). Conservation and Protection, Ontario, Report EPS
1/RM/28, 81 pp.

(11) Cox D. R. (1958). Planning of experiments. Wiley Edt.

(12) Pack S. (1991). Statistical issues concerning the design of tests for determining the effects of chemicals
fish. Room Document 4, OECD Ad Hoc Meeting of Experts on Aquatic

on the growth rate of
Toxicology, WRc Medmenham, UK, 10-12 December 1991.

(13) Dunnett C. W. (1955). A Multiple Comparisons Procedure for Comparing Several Treatments with a

Control, J. Amer. Statist. Assoc., 50, pp. 1096-1121.

(14) Dunnett C. W.
482-491.

(1964). New tables for multiple comparisons with a control. Biometrics, 20, pp.

(15) Williams D. A. (1971). A test for differences between treatment means when several dose levels are

compared with a zero dose control. Biometrics 27, pp. 103-117.

(16)

Johnston, W. L., Atkinson, J. L., Glanville N. T. (1994). A technique using sequential feedings of different
coloured food to determine food intake by individual rainbow trout, Oncorhynchus mykiss: effect of
feeding level. Aquaculture 120, pp. 123-133.

(17) Quinton, J. C. and Blake, R. W. (1990). The effect of feed cycling and ration level on the compensatory

growth response in rainbow trout, Oncorhynchus mykiss. Journal of Fish Biology, 37, pp. 33-41.

(18) Post, G. (1987). Nutrition and Nutritional Diseases of Fish. Chapter IX in Testbook of Fish Health. T.F.H.

Publications, Inc. Neptune City, New Jersey, USA. 288 pp.

(19) Bruce, R. D. and Versteeg D. J. (1992). A statistical procedure for modelling continuous toxicity data .

Environ. Toxicol. Chem. 11, pp. 1485-1494.

(20) DeGraeve, G. M., Cooney, J. M., Pollock, T. L., Reichenbach, J. H., Dean, Marcus, M. D. and McIntyre, D.
O.
intra and
(1989). Precision of EPA seven-day fathead minnow larval survival and growth test;
interlaboratory study. Report EA-6189 (American Petroleum Institute Publication, No 4468). Electric
Power Research Institute, Palo Alto, CA.

(21) Norbert-King T.

the ICp approach. US
Environmental Protection Agency. Environmental Research Lab., Duluth, Minnesota. Tech. Rep. No
05-88 of National Effluent Toxicity Assesment Center. Sept. 1988. 12 pp.

(1988). An interpolation estimate for chronic toxicity:

J.

(22) Williams D. A. (1972). The comparison of several dose levels with a zero dose control. Biometrics 28,

pp. 510-531.

APPENDIX 1

FISH SPECIES RECOMMENDED FOR TESTING AND SUITABLE TEST CONDITIONS

.

.

2
1
8
2
0
0
1

Species

Recommended test
temperature range
((cid:176)C)

Photoperiod
(hours)

Recommended
range for initial
fish weight
(g)

Required measurement
precision

Loading rate
(g/l)

Stocking density
(per litre)

Food

Test duration
(days)

E
N

Recommended species:

Oncorhynchus mykiss
Rainbow trout

Other well documented species:

Danio rerio
Zebrafish

Oryzias latipes
Ricefish (Medaka)

12,5-16,0

12-16

1-5

To nearest 100 mg

1,2-2,0

4

Dry propietary salmonid fry food

¯ 28

21-25

12-16

0,050-0,100

To nearest 1 mg

0,2-1,0

21-25

12-16

0,050-0,100

To nearest 1 mg

0,2-1,0

5-10

5-20

Live food
(Brachionus Artemia)

Live food
(Brachionus Artemia)

¯ 28

¯ 28

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
1
7
3

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APPENDIX 2

SOME CHEMICAL CHARACTERISTICS OF AN ACCEPTABLE DILUTION WATER

Substance

Particulate matter

Total organic carbon

Unionised ammonia

Residual chlorine

Total organophosphorus pesticides

Total organochlorine pesticides plus polychlorinated biphenyls

Total organic chlorine

Concentrations

< 20 mg/l

< 2 mg/l

< 1 lg/l

< 10 lg/l

< 50 ng/l

< 50 ng/l

< 25 ng/l

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APPENDIX 3

LOGARITHMIC SERIES OF CONCENTRATIONS SUITABLE FOR TOXICITY TEST (9)

Column (number of concentrations between 100 and 10, or between 10 and 1) (1)

1

100

32

10

3,2

1,0

2

100

46

22

10

4,6

2,2

1,0

3

100

56

32

18

10

5,6

3,2

1,8

1,0

4

100

63

40

25

16

10

6,3

4,0

2,5

1,6

1,0

5

100

68

46

32

22

15

10

6,8

4,6

3,2

2,2

1,5

1,0

6

100

72

52

37

27

19

14

10

7,2

5,2

3,7

2,7

1,9

1,4

1,0

7

100

75

56

42

32

24

18

13

10

7,5

5,6

4,2

3,2

2,4

1,8

1,3

1,0

(1) A series of five (or more) successive concentrations may be chosen from a column. Mid-points between concentrations in column (x)
are found in column (2x + 1). The values listed can represent concentrations expressed as percentage per volume or weight (mg/l or
lg/l). Values can be multiplied or divided by any power of 10 as appropriate. Column 1 might be used if there was considerable
uncertainty on the toxicity level.

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C.15. FISH, SHORT-TERM TOXICITY TEST ON EMBRYO AND SAC-FRY STAGES

1.

METHOD

This short-term toxicity test method is a replicate of the OECD TG 212 (1998).

1.1.

INTRODUCTION

This short-term toxicity test on fish embryo and sac-fry stages is a short-term test in which the life stages
from the newly fertilised egg to the end of the sac-fry stage are exposed. No feeding is provided in the
embryo and sac-fry test, and the test should thus be terminated while the sac-fry are still nourished from the
yolk sac.

The test is intended to define lethal, and to a limited extent, sublethal effects of chemicals on the specific
stages and species tested. This test would provide useful information in that it could (a) form a bridge between
lethal and sublethal tests, (b) be used as a screening test for either a full early life stage test or for chronic
toxicity tests and (c) be used for testing species where husbandry techniques are not sufficiently advanced to
cover the period of change from endogenous to exogenous feeding.

It should be borne in mind that only tests incorporating all stages of the life-cycle of fish are generally liable
to give an accurate estimate of the chronic toxicity of chemicals to fish, and that any reduced exposure with
respect to life stages may reduce the sensitivity and thus underestimate the chronic toxicity. It is therefore
expected that the embryo and sac-fry test would be less sensitive than a full early life stage test, particularly
with respect to chemicals with high lipophilicity (log Pow > 4) and chemicals with a specific mode of toxic
action. However smaller differences in sensitivity between the two tests would be expected for chemicals with
a non-specific, narcotic mode of action (1).

Prior to the publication of this test, most experience with this embryo and sac-fry test has been with the
freshwater fish Danio rerio Hamilton-Buchanan (Teleostei, Cyprinidae (cid:151) common name zebrafish). More
detailed guidance on test performance for this species is therefore given in Appendix 1. This does not
preclude the use of other species for which experience is also available (Tables IA and IB).

1.2.

DEFINITIONS

Lowest observed effect concentration (LOEC): is the lowest tested concentration of a test substance at
which the substance is observed to have a significant effect (at p < 0,05) when compared with the control.
However, all test concentrations above the LOEC must have a harmful effect equal to or greater than those
observed at the LOEC.

No observed effect concentration (NOEC): is the test concentration immediately below the LOEC.

1.3.

PRINCIPLE OF THE TEST

The embryo and sac-fry stages of fish are exposed to a range of concentrations of the test substance dissolved
in water. Within the protocol a choice is possible between a semi-static and a flow-through procedure. The
choice depends on the nature of the test substance. The test is begun by placing fertilised eggs in the test
chambers and is terminated just before the yolk sac of any larvae in any of the test chambers has been
completely absorbed or before mortalities by starvation start in controls. Lethal and sub-lethal effects are
assessed and compared with control values to determine the lowest observed effect concentration and hence
the no observed effect concentration. Alternatively, they may be analysed using a regression model in order to
estimate the concentration that would cause a given percentage effect (i.e. LC/ECx, where x is a defined %
effect).

1.4.

INFORMATION ON THE TEST SUBSTANCE

Results of an acute toxicity test (see method C.1) preferably performed with the species chosen for this test,
should be available. The results may be useful in selecting an appropiate range of test concentrations in the
early life stages test. Water solubility (including solubility in the test water) and the vapour pressure of the test
substance should be known. A reliable analytical method for the quantification of the substance in the test
solutions with known and reported accuracy and limit of detection should be available.

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Information on the test substance which is useful in establishing the test conditions includes the structural
formula, purity of the substance, stability in light, stability under the conditions of the test, pKa, Pow and
results of a test for ready biodegradability (see method C.4).

1.5.

VALIDITY OF THE TEST

For a test to be valid, the following conditions apply:

(cid:151) overall survival of fertilised eggs in the controls and where relevant, in the solvent-only vessels must be

greater than or equal to the limits defined in Appendices 2 and 3,

(cid:151) the dissolved oxygen concentration must be between 60 and 100 % of the air saturation value (ASV)

throughout the test,

(cid:151) the water temperature must not differ by more than – 1,5 (cid:176)C between test chambers or between
successive days at any time during the test and should be within the temperature ranges specified for the
test species (Appendices 2 and 3).

1.6.

DESCRIPTION OF THE TEST METHOD

1.6.1.

Test chambers

Any glass or other chemically inert vessels can be used. The dimensions of the vessels should be large enough
to allow compliance with the loading rate (see section 1.7.1.2). It is recommended that test chambers be
randomly positioned in the test area. A randomised block design with each treatment being present in each
block is preferable to a completely randomised design when there are systematic effects in the laboratory that
can be controlled using blocking. Blocking,
if used, should be taken account of in the subsequent data
analysis. The test chambers should be shielded from unwanted disturbance.

1.6.2.

Selection of fish species

Recommended fish species are given in Table 1A. This does not preclude the use of other species (examples
are given in Table 1B), but the test procedure may have to be adapted to provide suitable test conditions. The
rationale for the selection of the species and the experimental method should be reported in this case.

1.6.3.

Holding of the brood fish

Details on holding the brood stock under satisfactory conditions may be found in OECD TG 210 (1) and in
references (2) (3) (4) (5) (6).

1.6.4.

Handling of embryos and larvae

Embryos and larvae may be exposed, within the main vessel, in smaller vessels fitted with mesh sides or ends
to permit a flow of test solution through the vessel. Non-turbulent flow through these small vessels may be
induced by suspending them from an arm arranged to move the vessel up and down but always keeping the
organisms submerged; a siphon-flush system can also be used. Fertilised eggs of salmonid fishes can be
supported on racks or meshes with apertures sufficiently large to allow larvae to drop through after hatching.
The use of pasteur pipettes is appropriate to remove the embryos and larvaes in the semi-static tests with
complete daily renewal (see paragraph 1.6.6).

Where egg containers, grids or meshes have been used to hold eggs within the main test vessel, these
restraints should be removed after the larvae hatch (1), except that meshes should be retained to prevent the
escape of the fish. If there is a need to transfer the larvae, they should not be exposed to the air and nets
should not be used to release fish from egg containers (such a caution may not be necessary for some less
fragile species, e.g. the carp). The timing of this transfer varies with the species and transfer may not always
be necessary. For the semi-static technique, beakers or shallow containers may be used, and, if necessary,
equipped with a mesh screen slightly elevated above the bottom of the beaker.
If the volume of these
containers is sufficient to comply with loading requirements, (see 1.7.1.2) no transfer of embryo or larvae
may be necessary.

(1) OECD, Paris, 1992, Test Guideline 210, Fish, Early-life Stage Toxicity Test.

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1.6.5. Water

Any water which conforms to the chemical characteristics of an acceptable dilution water as listed in
Appendix 4 and in which the test species shows control survival at least as good as that described in
Appendices 2 and 3 is suitable as a test water. It should be of constant quality during the period of the test.
The pH should remain within a range of – 0,5 pH units. In order to ensure that the dilution water will not
unduly influence the test result (for example by complexation of test substance), or adversely affect the
performance of the brood stock, samples should be taken at intervals for analysis. Measurements of heavy
metals (e.g. Cu, Pb, Zn, Hg, Cd and Ni), major anions and cations (e.g. Ca, Mg, Na, K, Cl and SO4), pesticides
(e.g. total organophosphorus and total organochlorine pesticides), total organic carbon and suspended solids
should be made, for example, every three months, where a dilution water is known to be relatively constant
in quality. If water quality has been demonstrated to be constant over at least one year, determinations can be
less frequent and intervals extended (e.g. every six months).

1.6.6.

Test solutions

Test solutions of the chosen concentrations are prepared by dilution of a stock solution.

The stock solution should preferably be prepared by simply mixing or agitating the test substance in the
dilution water by using mechanical means (e.g. stirring and ultrasonication). Saturation colums (solubility
columns) can be used for achieving a suitable concentrated stock solution. As far as possible, the use of
solvents or dispersants (solubilising agents) should be avoided; however, such coupounds may be required in
some cases in order to produced a suitably concentrated stock solution. Examples of suitable solvents are
acetone, ethanol, methanol, dimethylformamide and triethyleneglycol. Examples of suitable dispersants are
Cremophor RH40, Tween 80, methylcellulose 0,01 % and HCO-40. Care should be taken when using readily
biodegradable agents (e.g. acetone) and/or highly volatile as these can cause problems with bacterial built-up
in flow-through tests. When a solubilising agent is used it must have no significant effect on survival nor
visible adverse effect on the early-life stages as revealed by a solvent-only control. However, every effort
should be made to avoid the use of such materials.

For the semi-static technique, two different renewal procedures may be followed; either (i) new test solutions
are prepared in clean vessels and surviving eggs and larvae gently transferred into the new vessels in a small
volume of old solution, avoiding exposure to air, or (ii) the test organisms are retained in the vessels whilst a
proportion (at least three quarters) of the test water is changed. The frequency of medium renewal will depend
on the stability of the test substance, but a daily water renewal is recommended. If, from preliminary stability
tests (see section 1.4), the test substance concentration is not stable (i.e.outside the range 80-120 % of
nominal or falling below 80 % of the measured initial concentration) over the renewal period, consideration
should be given to the use of a flow-through test. In any case, care should be taken to avoid stressing the
larvae during the water renewal operation.

For flow-through tests, a system which continually dispenses and dilutes a stock solution of the test substance
(e.g. metering pump, proportional diluter, saturator system) is required to deliver a series of concentrations to
the test chambers. The flow rates of stock solutions and dilution water should be checked at intervals,
preferably daily, and should not vary by more than 10 % throughout the test. A flow rate equivalent to at
least five test chamber volumes per 24 hours has been found suitable (2).

1.7.

PROCEDURE

Useful information on the performance of fish embryo and sac-fry toxicity tests is available in the literature,
some examples of which are included in the literature section of this text (7) (8) (9).

1.7.1.

Conditions of exposure

1.7.1.1. Duration

The test should start preferably within 30 minutes after the eggs have been fertilised. The embryos are
immersed in the test solution before, or as soon as possible after, commencement of the blastodisc cleavage
stage and in any case before the onset of the gastrula stage. For eggs obtained from commercial supplier, it
may not be possible to start the test immediately after fertilisation. As the sensitivity of the test may be
seriously influenced by delaying the start of the test, the test should be initiated within eight hours after
fertilisation. As larvae are not fed during the exposure period, the test should be terminated just before the

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yolk sac of any larvae in any of the test chambers has been completely absorbed or before mortalities by
starvation start in controls. The duration will depend upon the species used. Some recommended durations
are given in Appendices 2 and 3.

1.7.1.2. Loading

The number of fertilised eggs at the start of the test should be sufficient to meet statistical requirements. They
should be randomly distributed among treatments, and at least 30 fertilised eggs, divided equally (or as equally
as possible since it can be difficult to obtain equal batches when using some species) between at least three
replicate test chambers, should be used per concentration. The loading rate (biomass per volume of test
solution) should be low enough in order that a dissolved oxygen concentration of at least 60 % ASV can be
maintained without aeration. For flow-through tests, a loading rate not exceeding 0,5 g/l per 24 hours and
not exceeding 5 g/l of solution at any time has bean recommended (2).

1.7.1.3. Light and temperature

The photoperiod and test water temperature should be appropriate for the test species (Appendices 2 and 3).
For the purpose of temperature monitoring, it may be appropriate to use an additional test vessel.

1.7.2.

Test concentrations

Normally, five concentrations of the test substance spaced by a constant factor not exceeding 3,2 are required.
The curve relating LC50 to period of exposure in the acute study should be considered when selecting the
range of test concentrations. The use of fewer than five concentrations, for example in limit tests, and a
narrower concentration interval may be appropriate in some circumstances. Justification should be provided if
fewer than five concentrations are used. Concentrations of the substance higher than the 96 hour LC50 or
100 mg/l, whichever is the lower, need not be tested. Substances should not be tested above their solubility
limit in in the test water.

When a solubilising agent is used to aid preparation of test solutions (see section 1.6.6), its final concentration
in the test vessels should not be greater than 0,1 ml/l and should be the same in all test vessels.

1.7.3.

Controls

One dilution-water control
solubilising-agent (replicated as appropriate) should be run in addition to the test series.

(replicated as appropriate) and also,

if relevant, one control containing the

1.7.4.

Frequency of analytical determinations and measurements

During the test, the concentrations of the test substance are determined at regular intervals.

In semi-static tests where the concentration of the test substance is expected to remain within – 20 % of the
nominal (i.e. within the range 80-120 %; see section 1.4 and 1.6.6), it is recommended that, as a minimum,
the highest and lowest test concentrations be analysed when freshly prepared and immediately prior to
renewal on at least three occasions spaced evenly over the test (i.e. analyses should be made on a sample from
the same solution (cid:151) when freshly prepared and at renewal).

For tests where the concentration of the test substance is not expected to remain within – 20 % of nominal
(on the basis of stability data of the substance), it is necessary to analyse all test concentrations, when freshly
prepared and at renewal, but following the same regime (i.e. on at least three occasions spaced evenly over
the test). Determination of test substance concentrations prior to renewal need only be performed on one
replicate vessel at each test concentration. Determinations should be made no more than seven days apart. It
is recommended that results be based on measured concentrations. However,
if evidence is available to
demonstrate that the concentration of the test substance in solution has been satisfactorily maintained within
– 20 % of the nominal or measured initial concentration throughout the test, then results can be based on
nominal or measured initial values.

For flow-through tests, a similar sampling regime to that described for semi-static tests is appropriate (but
measurement of (cid:145)old(cid:146) solutions is not applicable in this case). However, if the test duration is more than seven
days, it may be advisable to increase the number of sampling occasions during the first week (e.g. three sets of
measurements) to ensure that the test concentrations are remaining stable.

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Samples may need to be centrifuged or filtered (e.g. using a 0,45 lm pore size). However, since neither
centrifuging nor filtration appears always to separate the non-bioavailable fraction of the test substance from
that which is bioavailable, samples may not be subjected to those treatments.

During the test, dissolved oxygen, pH and temperature should be measured in all test vessels. Total hardness
and salinity (if relevant) should be measured in the controls and one vessel at the highest concentration. As a
minimum, dissolved oxygen and salinity (if relevant) should be measured three times (at the beginning, middle
and end of the test).
it is recommended that dissolved oxygen be measured more
frequently, preferably before and after each water renewal or at least once at week. The pH should be
measured at
least weekly in
flow-through tests. Hardness should be measured once each test. Temperature should be measured daily and it
should preferably be monitored continuously in at least one test vessel.

the beginning and end of each water renewal

in semi-static test and at

In semi-static tests,

1.7.5. Observations

1.7.5.1. Stage of embryonic development

The embryonic stage (i.e. gastrula stage) at the beginning of exposure to the test substance should be verified
as precisely as possible. This can be done using a representative sample of eggs suitably preserved and cleared.
The literature may also be consulted for the description and illustration of embryonic stages (2) (5) (10) (11).

1.7.5.2. Hatching and survival

Observations on hatching and survival should be made at least once daily and numbers recorded. It may be
desirable to make more frequent observations at the beginning of the test (e.g. each 30 minutes during the
first three hours), since in some cases, survival times can be more relevant than only the number of deaths
(e.g. when there are acute toxic effects). Dead embryos and larvae should be removed as soon as observed
since they can decompose rapidly. Extreme care should be taken when removing dead individuals not to
knock or physically damage adjacent eggs/larvae, these being extremely delicate and sensitive. Criteria for
death vary according to life stage:

(cid:151) for eggs: particularly in the early stages, a marked loss of translucency and change in colouration, caused

by coagulation and/or precipitation of protein, leading to a white opaque appearance,

(cid:151) for embryos: absence of body movement and/or absence of heartbeat and/or opaque discoloration in

species whose embryos are normally translucent,

(cid:151) for larvae: immobility and/or absence of respiratory movement and/or absence of heartbeat and/or white

opaque colouration of central nervous system and/or lack of reaction mechanical stimulus.

1.7.5.3. Abnormal appearance

The number of larvae showing abnormality of body form and/or pigmentation, and the stage of yolk-sac
absorption, should be recorded at adequate intervals depending on the duration of the test and the nature of
the abnormality described. It should be noted that abnormal embryos and larvae occur naturally and can be of
the order of several per cent in the control(s) in some species. Abnormal animals should only be removed
from the test vessels on death.

1.7.5.4. Abnormal behaviour

Abnormalities, e.g. hyperventilation, uncoordinated swimming, and atypical quiescence should be recorded at
adequate intervals depending on the duration of the test. These effects, although difficult to quantify, can,
when observed, aid in the interpretation of mortality data i.e. provide information on the mode of toxic
action of the substance.

1.7.5.5. Length

At the end of the test, measurement of individual lengths is recommended; standard, fork or total length may
be used. If however, caudal fin rot or fin erosion occurs, standard lengths should be used. Generally, in a
well-run test, the coefficient of variation for length among replicates in the controls should be ˜ 20 %.

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1.7.5.6. Weight

At the end of the test, individual weights can be measured; dry weights (24 hours at 60 (cid:176)C) are preferable to
wet weights (blotted dry). Generally, in a well-run test, the coefficient of variation for weight among replicates
in the controls should be ˜ 20 %.

These observations will result in some or all of the following data being available for statistical analysis:

(cid:151) cumulative mortality,

(cid:151) numbers of healthy larvae at end of test,

(cid:151) time to start of hatching and end of hatching (i.e. 90 % hatching in each replicate),

(cid:151) numbers of larvae hatching each day,

(cid:151) length (and weight) of surviving animals at end of the test,

(cid:151) numbers of larvae that are deformed or of abnormal appearance,

(cid:151) numbers of larvae exhibiting abnormal behaviour.

2.

DATA AND REPORTING

2.1.

TREATMENT OF RESULTS

It is recommended that a statistician be involved in both the design and analysis of the test since the method
allows for considerable variation in experimental design as, for example, in the number of test chambers,
number of test concentrations, starting number of fertilised eggs and in the parameters measured. In view of
the options available in test design, specific guidance on statistical procedures is not given here.

If LOEC/NOECs are to be estimated, it will be necessary for variations to be analysed within each set of
replicates using analysis of variance (ANOVA) or contingency table procedures. In order to make a multiple
comparison between the results at the individual concentrations and those for the controls, Dunnett’s method
may be found useful (12) (13). Other useful examples are also available (14) (15). The size of the effect
detectable using ANOVA or other procedures (i.e. the power of the test) should be calculated and reported. It
should be noted that not all the observations listed in section 1.7.5.6 are suitable for statistical analysis using
ANOVA. For example, cumulative mortality and numbers of healthy larvae at the end of the test could be
analysed using probit methods.

If LC/ECxs are to be estimated, (a) suitable curve(s), such as the logistic curve, should be fitted to the data of
interest using a statistical method such as least squares or non-linear least squares. The curve(s) should be
parameterised so that the LC/ECx of interest and its standard error can be estimated directly. This will greatly
ease the calculation of the confidence limits around the LC/ECx. Unless there are good reasons to prefer
different confidence levels,
two-sided 95 % confidence should be quoted. The fitting procedure should
preferably provide a means for assessing the significance of the lack of fit. Graphical methods for fitting
curves can be used. Regression analysis is suitable for all observations listed in section 1.7.5.6.

2.2.

INTERPRETATION OF RESULTS

The results should be interpreted with caution where measured toxicant concentrations in test solutions occur
at levels near the detection limit of the analytical method. The interpretation of results for concentrations
above the water solubility of the substance should also be made with care.

2.3.

TEST REPORT

The test report must include the following information:

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2.3.1.

Test substance:

(cid:151) physical nature and relevant physical-chemical properties,

(cid:151) chemical

identification data,
substance where appropriate.

including purity and analytical method for quantification of

the tests

2.3.2.

Test species:

(cid:151) scientific name, strain, numbers of parental fish (i.e. how many females were used for providing the
the fertilised eggs and

required numbers of eggs in the test), source and method of collection of
subsequent handling.

2.3.3.

Test conditions:

(cid:151) test procedure used (e.g. semi-static or flow-through, time period from fertilisation to start the test,

loading, etc),

(cid:151) photoperiod(s),

(cid:151) test design (e.g. number of test chambers and replicates, number of embryos per replicate),

(cid:151) method of preparation of stock solutions and frequency of renewal

(the solubilising agent and its

concentration must be given, when used),

(cid:151) the nominal test concentrations, the measured values, their means and their standard deviations in the test
vessels and the method by which these were attained and, if the test substance is soluble in water at
concentrations below those tested, evidence should be provided that the measurements refer to the
concentrations of the test substance in solution,

(cid:151) dilution water characteristics: pH, hardness,

residual
chlorine levels (if measured), total organic carbon, suspended solids, salinity of the test medium (if
measured) and any other measurements made,

temperature, dissolved oxygen concentration,

(cid:151) water quality within test vessels: pH, hardness, temperature and dissolved oxygen concentration.

2.3.4.

Results:

(cid:151) results from any preliminary studies on the stability of the test substance,

(cid:151) evidence that controls met the overall survival acceptability standard of the test species (Appendices 2 and

3),

(cid:151) data on mortality/survival at embryo and larval stages and overall mortality/survival,

(cid:151) days to hatch and numbers hatched,

(cid:151) data for length (and weight),

(cid:151) incidence and description of morphological abnormalities, if any,

(cid:151) incidence and description of behavioural effects, if any,

(cid:151) statistical analysis and treatment of data,

(cid:151) for tests analysed using ANOVA, the lowest observed effect concentration (LOEC) at p = 0,05 and the no
observed effect concentration (NOEC) for each response assessed, including a description of the statistical
procedures used and an indication of what size of effect could be detected,

(cid:151) for tests analysed using regression techniques, the LC/ECx and confidence intervals and a graph of the

fitted model used for its calculation,

(cid:151) explanation for any deviation from this testing method.

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3.

REFERENCES

(1)

Kristensen P. (1990). Evaluation of the Sensitivity of Short Term Fish Early Life Stage Tests in Relation
to other FELS Test Methods. Final report to the Commission of the European Communities, 60 pp. June
1990.

(2) ASTM (1988). Standard Guide for Conducting Early Life-Stage Toxicity Tests with Fishes. American

Society for Testing and Materials. E 1241-88. 26 pp.

(3)

(4)

(5)

(6)

Brauhn J. L. and Schoettger R. A. (1975). Acquisition and Culture of Research Fish: Rainbow trout,
Fathead minnows, Channel Catfish and Bluegills. p. 54, Ecological Research Series, EPA-660/3-75-011,
Duluth, Minnesota.

Brungs W. A. and Jones B. R. (1977). Temperature Criteria for Freshwater Fish: Protocol and Procedures.
p. 128, Ecological Research Series EPA-600/3-77-061, Duluth, Minnesota.

Laale H. W. (1977). The Biology and Use of the Zebrafish (Brachydanio rerio) in Fisheries Research. A
Literature Review. J. Biol. 10, pp. 121-173.

Legault R. (1958). A Technique for Controlling the Time of Daily Spawning and Collecting Eggs of the
Zebrafish, Brachydanio rerio (Hamilton-Buchanan) Copeia, 4, pp. 328-330.

(7) Dave G., Damgaard B., Grande M., Martelin J. E., Rosander B. and Viktor T. (1987). Ring Test of an
Embryo-larval Toxicity Test with Zebrafish (Brachydanio rerio) Using Chromium and Zinc as Toxicants.
Environmental Toxicology and Chemistry, 6, pp. 61-71.

(8)

Birge J. W., Black J. A. and Westerman A. G. (1985). Short-term Fish and Amphibian Embryo-larval
Tests for Determining the Effects of Toxicant Stress on Early Life Stages and Estimating Chronic Values
for Single Compounds and Complex Effluents. Environmental Toxicology and Chemistry 4, pp.
807-821.

(9) Van Leeuwen C. J., Espeldoorn A. and Mol F. (1986). Aquatic Toxicological Aspects of Dithiocarbamates
J. Aquatic

III. Embryolarval Studies with Rainbow Trout (Salmo gairdneri).

and Related Compounds.
Toxicology, 9, pp. 129-145.

(10) Kirchen R. V. and W. R. West (1969). Teleostean Development. Carolina Tips 32(4): 1-4. Carolina

Biological Supply Company.

(11) Kirchen R. V. and W. R. West (1976). The Japanese Medaka.

Its care and Development. Carolina

Biological Supply Company, North Carolina. 36 pp.

(12) Dunnett C. W.

(1955). A Multiple Comparisons Procedure for Comparing Several Treatments with

Control. J. Amer. Statist. Assoc., 50, pp. 1096-1121.

(13) Dunnett C. W.
482-491.

(1964). New Tables for Multiple Comparisons with a Control. Biometrics, 20, pp.

(14) Mc Clave J. T., Sullivan J. H. and Pearson J.G. (1980). Statistical Analysis of Fish Chronic Toxicity Test

Data. Proceedings of 4th Aquatic Toxicology Symposium, ASTM, Philadelphia.

(15) Van Leeuwen C. J., Adema D. M. M. and Hermes J. (1990). Quantitative Structure-Activity Relationships

for Fish Early Life Stage Toxicity. Aquatic Toxicology, 16, pp. 321-334.

(16) Environment Canada. (1992). Toxicity Tests Using Early Life Stages of Salmonid Fish (Rainbow Trout,
Coho Salmon or Atlantic Salmon). Biological Test Method Series. Report EPS 1/RM/28, December 1992,
81 pp.

(17) Dave G. and Xiu R. (1991). Toxicity of Mercury, Nickel, Lead and Cobalt to Embryos and Larvae of
Zebrafish, Brachydanio rerio. Arch. of Environmental Contamination and Toxicology, 21, pp. 126-134.

(18) Meyer A., Bierman C. H. and Orti G. (1993). The phylogenetic position of the Zebrafish (Danio rerio), a
model system in developmental biology (cid:151) an invitation to the comperative methods. Proc. Royal
Society of London, Series B, 252: pp. 231-236.

(19) Ghillebaert F., Chaillou C., Deschamps F. and Roubaud P. (1995). Toxic Effects, at Three pH Levels, of
Two Reference Molecules on Common Carp Embryo. Ecotoxicology and Environmental Safety 32, pp.
19-28.

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(20) US EPA,

(1991). Guidelines
EPA/600/3-91/064, Dec. 1991, EPA, Duluth.

for Culturing the

Japanese Medaka, Oryzias

latipes. EPA report

(21) US EPA,

(1991). Guidelines for Conducting Early Life Stage Toxicity Tests with Japanese Medaka,

(Oryzias latipes). EPA report EPA/600/3-91/063, Dec. 1991, EPA, Duluth.

(22) De Graeve G. M., Cooney J. D., McIntyre D. O., Poccocic T. L., Reichenbach N. G., Dean J. H. and
Marcus M. D. (1991). Validity in the performance of the seven-day Fathead minnow (Pimephales promelas)
larval survival and growth test: an intra- and interlaboratory study. Environ. Tox. Chem. 10, pp.
1189-1203.

(23) Calow P.

(1993). Handbook of Ecotoxicology, Blackwells, Oxford. Vol. 1, Chapter 10: Methods for

spawning, culturing and conducting toxicity tests with Early Life stages of Estuarine and Marine fish.

(24) Balon E. K.

(1985). Early life history of
perspectives, Junk Publ., Dordrecht, 280 pp.

fishes: New developmental, ecological and evolutionary

(25) Blaxter J. H. S. (1988). Pattern and variety in development, in: W. S. Hoar and D. J. Randall eds., Fish

Physiology, Vol. XIA, Academic press, pp. 1-58.

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TABLE 1A: Fish species recommended for testing

Freshwater

Oncorhynchus mykiss
Rainbow trout (9) (16)

Danio rerio
Zebrafish (7) (17) (18)

Cyprinus caprio
Common carp (8) (19)

Oryzias latipes
Japanese ricefish/Medaka (20) (21)

Pimephales promelas
Fathead minnow (8) (22)

TABLE 1B: Examples of other well-documented species which have also been used

Freshwater

Saltwater

Carassius auratus
Goldfish (8)

Lepomis macrochirus
Bluegill (8)

Menidia peninsulae
Tidewater silverside (23) (24) (25)

Clupea harengus
Herring (24) (25)

Gadus morhua
Cod (24) (25)

Cyprinodon variegatus
Sheepshead minnow (23)
(25)

(24)

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GUIDANCE ON PERFORMANCE OF A TOXICITY TEST ON EMBRYOS AND SAC-FRY OF ZEBRAFISH
(BRACHYDANIO RERIO)

APPENDIX 1

INTRODUCTION

The zebrafish originates from the Coromandel coast of India where it inhabits fast-flowing streams. It is a common
aquarium fish of the carp family, and information about procedures for its care and culture can be found in standard
reference books on tropical fish. Its biology and use in fishery research have been reviewed by Laale (1).

The fish rarely exceeds 45 mm in length. The body is cylindrical with 7-9 dark-blue horizontal silvery stripes. These
stripes run into the caudal and anal fins. The back is olive-green. Males are slimmer than females. Females are more
silvery and the abdomen is distended, particularly prior to spawning.

Adult fishes are able to tolerate large fluctuations in temperature, pH and hardness. However, in order to get healthy
fish which produce eggs of good quality, optimal conditions should be provided.

During spawning the male pursues and butts the female, and as the eggs are expelled they are fertilised. The eggs,
which are transparent and non-adhesive, fall to the bottom where they may be eaten by the parents. Spawning is
influenced by light. If the morning light is adequate, the fish usually spawns in the early hours following daybreak.

A female can produce batches of several hundreds of eggs at weekly intervals.

CONDITIONS OF PARENTAL FISH, REPRODUCTION AND EARLY-LIFE STAGES

Select a suitable number of healthy fish and keep these in a suitable water (e.g. Appendix 4) for at least two weeks
prior to the intended spawning. The group of fish should be allowed to breed at least once before producing the batch
of eggs used in the test. The density of fish during this period should not exceed 1 gram of fish per litre. Regular
changes of water or the use of purification systems will enable the density to be higher. The temperature in the holding
tanks should be maintained at 25 – 2 (cid:176)C. The fish should be provided with a varied diet, which may consist of, for
example, appropriate commercial dry food,
live newly hatched Arthemia, chironomids, Daphnia, white worms
(Enchytraeids).

Two procedures are outlined below, which in practice have led to a sufficient batch of healthy, fertilised eggs for a test
to be run:

(i)

Eight females and 16 males are placed in a tank containing 50 litres of dilution water, shielded from direct light
and left as undisturbed as possible for at least 48 hours. A spawning tray is placed at the bottom of the aquarium
in the afternoon the day before start of the test. The spawning tray consists of a frame (plexi-glass or other suitable
material), 5-7 cm high with a 2-5 mm coarse net attached at the top and a 10-30 lm fine net at the bottom. A
number of (cid:145)spawning-trees(cid:146), consisting of untwisted nylon rope, are attached to the coarse net of the frame. After
the fish have been left in dark for 12 hours, a faint light is turned on which will initiate the spawning. Two to four
hours after spawning, the spawning tray is removed and the eggs collected. The spawning tray will prevent the fish
from eating the eggs and at the same time permit an easy collection of the eggs. The group of fish should have
spawned at least once before the spawning from which eggs are used for testing.

(ii) Five to 10 male and female fish are housed individually at least two weeks prior to the intended spawning. After
5-10 days, the abdomens of the females will be distended and their genital papillae visible. Male fish lack papillae.
Spawning is performed in spawning tanks equipped with a false mesh bottom (as above). The tank is filled with
dilution water, so that the depth of water above the mesh is 5-10 cm. One female and two males are placed in the
tank the day before the intended spawning. The water temperature is gradually increased one degree higher than
the acclimatisation temperature. The light is turned off and the tank is left as undisturbed as possible. In the
morning a faint light is turned on which will initiate spawning. After 2-4 hours, the fish are removed and the eggs
collected. If larger batches of eggs are needed than can be obtained from one female, a sufficient number of
spawning tanks may be set-up in parallel. By recording the reproduction success of the individual females prior to
the test (size of batch and quality), those females with highest reproduction success may be selected for breeding.

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The eggs should be transferred to the test vessels by means of glass tubes (inner diameter not less than 4 mm) provided
with a flexible suction bulb. The amount of water accompanying the eggs on their transfer should be as small as
possible. The eggs are heavier than water and sink out of the tube. Care should be taken to prevent eggs (and larvae)
coming into contact with the air. Microscopic examination of sample(s) of the batch(es) should be carried out to ensure
that there are no irregularities in the first developmental stages. Disinfection of the eggs is not allowed.

The mortality rate of the eggs is highest within the first 24 hours after fertilisation. A mortality of 5-40 % is often seen
during this period. Eggs degenerate as a result of unsuccessful fertilisation or development failures. The quality of the
batch of eggs seems to depend on the female fish, as some females consistently produce good quality eggs, others never
will. Also the development rate and the rate of hatching vary from one batch to another. The successfully fertilised eggs
and the yolk sac larvae survive well, normally above 90 %. At 25 (cid:176)C the eggs will hatch 3-5 days after fertilization and
the yolk sac will be absorbed approximately 13 days after fertilisation.

The embryonic development has been well defined by Hisaoka and Battle (2). Due to the transparency of the eggs and
post-hatch larvae, the development of the fish may be followed and the presence of malformations may be observed.
Approximately four hours after spawning, the non-fertilised eggs may be distinguished from the fertilised (3). For this
examination, eggs and larvae are placed in test vessels of small volume and studied under a microscope.

The test conditions, which apply to the early life stages, are listed in Appendix 2. Optimal values for pH values and
hardness of the dilution water are 7,8 and 250 mg CaCO3/l respectively.

CALCULATIONS AND STATISTICS

A two-stage approach is proposed. First, the data on mortality, abnormal development and hatching-time are analysed
statistically. Then, for those concentrations at which no adverse effects on any of these parameters have been detected,
the body length is statistically evaluated. This approach is advisable since the toxicant may selectively kill smaller fish,
delay hatching-time and induce gross malformations, thus leading to biased length measurements. Furthermore, there
will be roughly the same number of fish to be measured per treatment, ensuring the validity of the test statistics.

LC50 AND EC50 DETERMINATIONS

The percentage of surviving eggs and larvae is calculated and corrected for mortality in the controls in accordance with
Abbott’s formula (4):

P = 100 ﬂ

(cid:18)

C ﬂ P0
C

(cid:19)

(cid:215) 100

where,

P = corrected % survival

P¡ = % survival observed in the test concentration

C = survival in the control

If possible, the LC50 is determined by a suitable method at the end of the test.

If the inclusion of morphological abnormalities in the EC50 statistic is desired, guidance can be found in Stephan (5).

ESTIMATION OF LOEC AND NOEC

An objective of the egg and sac-fry test is to compare the non-zero concentrations with the control, i.e. to determine
the LOEC. Therefore multiple comparison procedures should be utilised (6) (7) (8) (9) (10).

REFERENCES

(1)

Laale H. W. (1977). The Biology and Use of the Zebrafish (Brachydanio rerio) in Fisheries Research. A Literature
Review. J. Fish Biol. 10, pp. 121-173.

(2) Hisaoka K. K. and Battle H.

I.

(1958). The Normal Development Stages of the Zebrafish Brachydanio rerio

(Hamilton-Buchanan) J. Morph., 102, 311 pp.

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(3) Nagel R. (1986). Untersuchungen zur Eiproduktion beim Zebrab(cid:228)rbling (Brachydanio rerio Hamilton-Buchanan).

Journal of Applied Ichthyology, 2, pp. 173-181.

(4)

Finney D. J. (1971). Probit Analysis, 3rd ed., Cambridge University Press, Great Britain, pp. 1-333.

(5)

(1982).

Stephan C. E.
Increasing the Usefulness of Acute Toxicity Tests. Aquatic Toxicology and Hazard
Assessment: Fifth Conference, ASTM STP 766, J. G. Pearson, R. B. Foster and W. E. Bishop, Eds., American
Society for Testing and Materials, pp. 69-81.

(6) Dunnett C. W. (1955). A Multiple Comparisons Procedure for Comparing Several Treatments with a Control. J.

Amer. Statist. Assoc., 50, pp. 1096-1121.

(7) Dunnett C. W. (1964). New Tables for Multiple Comparisons with a Control. Biometrics, 20, pp. 482-491.

(8) Williams D. A. (1971). A Test for Differences Between Treatment Means when Several Dose Levels are Compared

with a Zero Dose Control. Biometrics, 27, pp. 103-117.

(9) Williams D. A. (1972). The Comparison of Several Dose Levels with a Zero Dose Control. Biometrics 28, pp.

519-531.

(10) Sokal R. R. and Rohlf F. J. (1981). Biometry, the Principles and Practice of Statistics in Biological Research, W. H.

Freeman and Co., San Francisco.

TEST CONDITIONS, DURATION AND SURVIVAL CRITERIA FOR RECOMMENDED SPECIES

APPENDIX 2

Species

Temperature
((cid:176)C)

Salinity
(0/00)

Photoperiod
(hours)

Duration of stages
(days)

Embryo

Sac-fry

Typical duration of test

Survival of control
(minimum %)

Hatching success

Post-hatch

FRESHWATER

Brachydanio rerio
Zebrafish

Oncorhynchus mykiss
Rainbow trout

Cyprinus carpio
Common carp

Oryzias latipes
Japanese ricefish/Medaka

Pimephales promelas
Fathead minnow

25 – 1

10 – 1 (1)
12 – 1 (2)

21-25

24 – 1 (1)
23 – 1 (2)

25 – 2

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

12-16

3-5

8-10

As soon as possible after fertilisation (early gastrula
stage) to 5 days post-hatch (8-10 days)

0 (3)

30-35

25-30

As soon as possible after fertilisation (early gastrula
stage) to 20 days post-hatch (50-55 days)

12-16

5

12-16

8-11

16

4-5

> 4

4-8

5

As soon as possible after fertilisation (early gastrula
stage) to 4 days post-hatch (8-9 days)

As soon as possible after fertilisation (early gastrula
stage) to 5 days post-hatch (13-16 days)

As soon as possible after fertilisation (early gastrula
stage) to 4 days post-hatch (8-9 days)

80

66

80

80

60

90

70

75

80

70

(1) For embryos.
(2) For larvae.
(3) Darkness for embryo and larvae until one week after hatching except when they are being inspected. Then subdued lighting throughout the test.

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
1
8
9

TEST CONDITIONS, DURATION AND SURVIVAL CRITERIA FOR OTHER WELL-DOCUMENTED SPECIES

APPENDIX 3

Species

Temperature
((cid:176)C)

Salinity
(0/00)

Photoperiod
(hours)

Duration of stages
(days)

Embryo

Sac-fry test

Typical duration of embryo and sac-fry test

Survival of control
(minimum %)

Hatching success

Post-hatch

FRESHWATER

Carassius auratus
Goldfish

Leopomis macrochirus
Blugill sunfish

SALTWATER

Menidia peninsulae
Tidewater silverside

Clupea harengus
Herring

Gadus morhua
Cod

Cyprinodon variegatus
Sheepshead minnow

24 – 1

21 – 1

(cid:151)

(cid:151)

22-25

15-22

10 – 1

5 – 1

8-15

5-30

25 – 1

15-30

(cid:151)

16

12

12

12

12

3-4

3

1,5

20-25

14-16

(cid:151)

> 4

> 4

10

3-5

3-5

(cid:151)

As soon as possible after fertilisation (early gastrula
stage) to 4 days post-hatch (7 days)

As soon as possible after fertilisation (early gastrula
stage) to 4 days post-hatch (7 days)

As soon as possible after fertilisation (early gastrula
stage) to 5 days post-hatch (6-7 days)

As soon as possible after fertilisation (early gastrula
stage) to 3 days post-hatch (23-27 days)

As soon as possible after fertilisation (early gastrula
stage) to 3 days post-hatch (18 days)

(cid:151)

(cid:151)

80

60

60

As soon as possible after fertilisation (early gastrula
stage) to 4/7 days post-hatch (28 days)

> 75

80

75

60

80

80

80

L

2
2
5
/
1
9
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

21.8.2001

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APPENDIX 4

SOME CHEMICAL CHARACTERISTICS OF AN ACCEPTABLE DILUTION WATER

Substance

Particulate matter

Total organic carbon

Unionised ammonia

Residual chlorine

Total organophosphorus pesticides

Total organochlorine pesticides plus polychlorinated biphenyls

Total organic chlorine

Concentrations

< 20 mg/l

< 2 mg/l

< 1 lg/l

< 10 lg/l

< 50 ng/l

< 50 ng/l

< 25 ng/l

L 225/192

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C.16. HONEYBEES (cid:151) ACUTE ORAL TOXICITY TEST

1.

METHOD

This acute toxicity test method is a replicate of the OECD TG 213 (1998).

1.1.

INTRODUCTION

This toxicity test is a laboratory method, designed to assess the oral acute toxicity of plant protection products
and other chemicals, to adult worker honeybees.

In the assessment and evaluation of toxic characteristics of substances, determination of acute oral toxicity in
honeybees may be required, e.g. when exposure of bees to a given chemical is likely. The acute oral toxicity
test is carried out to determine the inherent toxicity of pesticides and other chemicals to bees. The results of
this test should be used to define the need for further evaluation. In particular, this method can be used in
step-wise programmes for evaluating the hazards of pesticides to bees, based on sequential progression from
laboratory toxicity tests to semi-field and field experiments (1). Pesticides can be tested as active substances
(a.s.) or as formulated products.

A toxic standard should be used to verify the sensitivity of the bees and the precision of the test procedure.

1.2.

DEFINITIONS

Acute oral toxicity: is the adverse effects occurring within a maximum period of 96 hours (h) of an oral
administration of a single dose of test substance.

Dose: is the amount of test substance consumed. Dose is expressed as mass (lg) of test substance per test
animal (lg/bee). The real dose for each bee can not be calculated as the bees are fed collectively, but an
average dose can be estimated (totally consumed test substance/number of test bees in one cage).

LD50 (median lethal dose) oral: is a statistically derived single dose of a substance that can cause death in
50 % of animals when administered by the oral route. The LD50 value is expressed in (lg) of test substance
per bee. For pesticides, the test substance may be either an active substance (a.s.) or a formulated product
containing one or more than one active substance.

Mortality: an animal is recorded as dead when it is completely immobile.

1.3.

PRINCIPLE OF THE TEST METHOD

Adult worker honeybees (Apis mellifera) are exposed to a range of doses of the test substance dispersed in
sucrose solution. The bees are then fed the same diet, free of the test substance. Mortality is recorded daily
during at least 48 h and compared with control values. If the mortality rate is increasing between 24 h and
48 h whilst control mortality remains at an accepted level, i.e. ˜ 10 %, it is appropriate to extend the duration
of the test to a maximum of 96 h. The results are analysed in order to calculate the LD50 at 24 h and 48 h
and, in case the study is prolonged, at 72 h and 96 h.

1.4.

VALIDITY OF THE TEST

For a test to be valid, the following conditions apply:

(cid:151) the average mortality for the total number of controls must not exceed 10 % at the end of the test,

(cid:151) the LD50 of the toxic standard meets the specified range.

1.5.

DESCRIPTION OF THE TEST METHOD

1.5.1.

Collection of bees

Young adult worker bees of the same race should be used, i.e. bees of the same age, feeding status, etc. Bees
should be obtained from adequately fed, healthy, as far as possible disease-free and queen-right colonies with
known history and physiological status. They could be collected in the morning of use or in the evening

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before test and kept under test conditions to the next day. Bees collected from frames without brood are
suitable. Collection in early spring or late autumn should be avoided as the bees have a changed physiology
during this time. If tests must be conduced in early spring or late autumn, bees can be emerged in an
incubator and reared for one week with (cid:145)bee bread(cid:146) (pollen collected from the comb) and sucrose solution.
Bees treated with chemical substances, such as antibiotics, anti-varroa products, etc., should not be used for
toxicity test for four weeks from the time of the end of the last treatment.

1.5.2.

Housing and feeding conditions

Easy to clean and well-ventilated cages are used. Any appropriate material can be used, e.g. stainless steel, wire
mesh, plastic or disposable wooden cages, etc. Groups of 10 bees per cage are preferred. The size of test cages
should be appropriate to the number of bees, i.e. providing adequate space.

The bees should be held in the dark in an experimental room at a temperature of 25 – 2 (cid:176)C. The relative
humidity, normally around 50(cid:151)70 %, should be recorded throughout the test. Handling procedures, including
treatment and observations may be conducted under (day)
light. Sucrose solution in water with a final
concentration of 500 g/l (50 % w/v) is used as food. After given test doses, food should be provided ad
libitum. The feeding system should allow recording food intake for each cage (see section 1.6.3.1). A glass tube
(approximately 50 mm long and 10 mm wide with the open end narrowed to about 2 mm diameter) can be
used.

1.5.3.

Preparation of bees

The collected bees are randomly allocated to test cages, which are randomly placed in the experimental room.

The bees may be starved for up to 2 h before the initiation of the test. It is recommended that the bees are
deprived of food prior to treatment so that all bees are equal in terms of their gut contents at the start of the
test. Moribund bees should be rejected and replaced by healthy bees before starting the test.

1.5.4.

Preparation of doses

Where the test substance is a water miscible compound this may be dispersed directly in 50 % sucrose
solution. For technical products and substances of low water solubility, vehicles such as organic solvent,
emulsifiers or dispersants of
low toxicity to bees may be used (e.g. acetone, dimethylformamide,
dimethylsulfoxide). The concentration of the vehicle depends on the solubility of the test substance and it
should be the same for all concentrations tested. However, a concentration of the vehicle of 1 % is generally
appropriate and should not be exceeded.

Appropriate control solutions should be prepared, i.e. where a solvent or a dispersant is used to solubilise the
test substance, two separate control groups should be used: a solution in water, and a sucrose solution with
the solvent/carrier at the concentration used in dosing solutions.

1.6.

PROCEDURE

1.6.1.

Test and control groups

The number of doses and replicates tested should meet the statistical requirements for determination of LD50
with 95 % confidence limits. Normally, five doses in a geometric series, with a factor not exceeding 2,2, and
covering the range for LD50, are required for the test. However, the dilution factor and the number of
concentrations for dosage have to be determined in relation to the slope of the toxicity curve (dose versus
mortality) and with consideration taken to the statistical method which is chosen for analysis of the results. A
range-finding test enables the choice of the appropriate concentrations for dosage.

A minimum of three replicate test groups, each of 10 bees, should be dosed with each test concentration. A
minimum of three control batches, each of 10 bees, should be run in addition to the test series. Control
batches should also be included for the solvents/carriers used (see section 1.5.4).

1.6.2.

Toxic standard

A toxic standard should be included in the test series. At least three doses should be selected to cover the
expected LD50 value. A minimum of three replicate cages, each containing ten bees, should be used with each
test dose. The preferred toxic standard is dimethoate, for which the reported oral LD50-24 h is in the range
0,10-0,35 lg a.s./bee (2). However, other toxic standards would be acceptable where sufficient data can be
provided to verify the expected dose response (e.g. parathion).

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1.6.3.

Exposure

1.6.3.1. Administration of doses

Each test group of bees must be provided with 100-200 ll of 50 % sucrose solution in water, containing the
test substance at the appropriate concentration. A larger volume is required for products of low solubility, low
toxicity or low concentration in the formulation, as higher proportions in the sucrose solution have to be
used. The amount of treated diet consumed per group should be monitored. Once consumed (usually within
3-4 h), the feeder should be removed from the cage and replaced with one containing sucrose solution alone.
The sucrose solutions are then provided ad libitum. For some compounds, at higher concentrations rejection of
test dose may result in little or no food being consumed. After a maximum of 6 h, unconsumed treated diet
should be replaced with the sucrose solution alone. The amount of treated diet consumed should be assessed
(e.g. measurement of volume/weight of treated diet remaining).

1.6.3.2. Duration

The duration of the test is preferably 48 h after the test solution has been replaced with sucrose solution
alone. If mortality continues to rise by more than 10 % after the first 24 h, the test duration should be
extended to a maximum of 96 h provided that control mortality does not exceed 10 %.

1.6.4. Observations

Mortality is recorded at 4 h after starting the test and thereafter at 24 h and 48 h (i.e. after giving dose). If a
prolonged observation period is required, further assessments should be made at 24-h intervals, up to a
maximum of 96 h, provided that the control mortality does not exceed 10 %.

The amount of diet consumed per group should be estimated. Comparison of the rates of consumption of
treated and untreated diet within the given 6 h can provide information about palatability of the treated diet.

All abnormal behavioural effects observed during the testing period should be recorded.

1.6.5.

Limit test

In some cases (e.g. when a test substance is expected to be of low toxicity) a limit test may be performed,
using 100 lg a.s./bee in order to demonstrate that the LD50 is greater than this value. The same procedure
should be used, including three replicate test groups for the test dose, the relevant controls, the assessment of
the amount of treated diet comsumed, and the use of the toxic standard. If mortalities occur, a full study
should be conducted. If sublethal effects are observed (see section 1.6.4), these should be recorded.

2.

DATA AND REPORTING

2.1.

DATA

Data should be summarised in tabular form, showing for each treatment group, as well as control and toxic
standard groups, the number of bees used, mortality at each observation time and number of bees with
adverse behaviour. Analyse the mortality data by appropriate statistical methods (e.g. probit analysis, moving
average, binomial probability) (3) (4). Plot dose-response curves at each recommended observation time and
calculate the slopes of the curves and the median lethal doses (LD50) with 95 % confidence limits. Corrections
for control mortality could be made using Abbott’s correction (4) (5). Where treated diet is not completely
consumed, the dose of test substance consumed per group should be determined. LD50 should be expressed in
lg of test substance per bee.

2.2.

TEST REPORT

The test report must include the following information:

2.2.1.

Test substance:

(cid:151) physical nature and relevant physical-chemical properties (e.g. stability in water, vapour pressure),

(cid:151) chemical

identification data,

including structural

formula, purity (i.e.

for pesticides, the identity and

concentration of active substance(s)).

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2.2.2.

Test species:

(cid:151) scientific name, race, approximate age (in weeks), collection method, date of collection,

(cid:151) information on colonies used for collection of

test bees including health, any adult disease, any

pre-treatment, etc.

2.2.3.

Test conditions:

(cid:151) temperature and relative humidity of experimental room,

(cid:151) housing conditions including type, size and material of cages,

(cid:151) methods of preparation of stock and test solutions (the solvent and its concentration must be given, when

used),

(cid:151) method of preparation of stock solutions and frequency of renewal

(the solubilising agent and its

concentration must be given, when used),

(cid:151) test design, e.g. number and test concentrations used, number of controls; for each test concentration and

control, number of replicate cages and number of bees per cage,

(cid:151) date of test.

2.2.4.

Results:

(cid:151) results of preliminary range-finding study if performed,

(cid:151) raw data: mortality at each dose tested at each observation time,

(cid:151) graph of the dose-response curves at the end of the test,

(cid:151) LD50 values with 95 % confidence limits, at each of

substance and toxic standard,

the recommended observation times,

for test

(cid:151) statistical procedures used for determining the LD50,

(cid:151) mortality in controls,

(cid:151) other biological effects observed or measured e.g. abnormal behaviour of the bees (including rejection of

the test dose), rate of consumption of diet in treated and untreated groups,

(cid:151) any deviation from the test procedures described here and any other relevant information.

3.

REFERENCES

(1) EPPO/Council of Europe (1993). Decision-Making Scheme for the Environmental Risk Assessment of Plant

Protection Products (cid:151) Honeybees. EPPO Bulletin, Vol. 23, N.1, pp. 151-165. March 1993.

(2) Gough, H. J., McIndoe, E.C., Lewis, G.B. (1994). The use of dimethoate as a reference compound in
laboratory acute toxicity tests on honeybees (Apis mellifera L.) 1981-1992. Journal of Apicultural Research,
22, pp. 119-125.

(3) Litchfield, J.T. and Wilcoxon, F. (1949). A simplified method of evaluating dose-effect experiments. Jour.

Pharmacol. and Exper. Ther., 96, pp. 99-113.

(4) Finney, D. J. (1971). Probit Analysis. 3rd ed., Cambridge, London and New York.

(5) Abbott, W. S. (1925). A method for computing the effectiveness of an insecticide. Jour. Econ. Entomol.,

18, pp. 265-267.

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C.17. HONEYBEES (cid:151) ACUTE CONTACT TOXICITY TEST

1.

METHOD

This acute toxicity test method is a replicate of the OECD TG 214 (1998).

1.1.

INTRODUCTION

This toxicity test is a laboratory method, designed to assess the acute contact toxicity of plant protection
products and other chemicals to adult worker honeybees.

In the assessment and evaluation of toxic characteristics of substances, determination of acute contact toxicity
in honeybees may be required, e.g. when exposure of bees to a given chemical is likely. The acute contact
toxicity test is carried out to determine the inherent toxicity of pesticides and other chemicals to bees. The
results of this test should be used to define the need for further evaluation. In particular, this method can be
used in step-wise programmes for evaluating the hazards of pesticides to bees, based on sequential
progression from laboratory toxicity tests to semi-field and field experiments (1). Pesticides can be tested as
active substances (a.s.) or as formulated products.

A toxic standard should be used to verify the sensitivity of the bees and the precision of the test procedure.

1.2.

DEFINITIONS

Acute oral toxicity: is the adverse effects occurring within a maximum period of 96 hours of a topical
application of a single dose of a substance.

Dose: is the amount of test substance applied. Dose is expressed as mass (lg) of test substance per test animal
(lg/bee).

LD50 (median lethal dose) contact: is a statistically derived single dose of a substance that can cause death
in 50 % of animals when administered by the contact. The LD50 value is given in lg of test substance per bee.
For pesticides, the test substance may be either an active substance (a.s.) or a formulated product containing
one or more than one active substance.

Mortality: an animal is recorded as dead when it is completely immobile.

1.3.

PRINCIPLE OF THE TEST METHOD

Adult worker honeybees (Apis mellifera) are exposed to a range of doses of the test substance dissolved in
appropriate carrier, by direct application to the thorax (droplets). The test duration is 48 h. If the mortality
rate is increasing between 24 h and 48 h whilst control mortality remains at an accepted level, i.e. ˜ 10 %, it
is appropriate to extend the duration of the test to a maximum of 96 h. Mortality is recorded daily and
compared with control values. The results are analysed in order to calculate the LD50 at 24 h and 48 h, and in
case the study is prolonged at 72 h and 96 h.

1.4.

VALIDITY OF THE TEST

For a test to be valid, the following conditions apply:

(cid:151) the average mortality for the total numbers of controls must not exceed 10 % at the end of the test,

(cid:151) the LD50 of the toxic standard meets the specified range.

1.5.

DESCRIPTION OF THE TEST METHOD

1.5.1.

Collection of bees

Young adult worker bees should be used, i.e. bees of the same age, feeding status, race etc. Bees should be
obtained from adequately fed, healthy, as far as possible disease-free and queen-right colonies with known
history and physiological status. They could be collected in the morning of use or in the evening before test

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and kept under test conditions to the next day. Bees collected from frames without brood are suitable.
Collection in early spring or late autumn should be avoided, as the bees have a changed physiology during the
time. If tests have to be conduced in early spring or late autumn, bees can be emerged in an incubator and
reared for one week with (cid:145)bee bread(cid:146) (pollen collected from the comb) and sucrose solution. Bees treated with
chemical substances, such as antibiotics, anti-varroa products, etc., should not be used for toxicity test for four
weeks from the time of the end of the last treatment.

1.5.2.

Housing and feeding conditions

Easy to clean and well-ventilated cages are used. Any appropriate material can be used, e.g. stainless steel, wire
mesh, plastic, disposable wooden cages, etc. The size of test cages should be appropriate to the number of
bees, i.e. providing adequate space. Groups of ten bees per cage are preferred.

The bees should be held in the dark in an experimental room at a temperature of 25 – 2 (cid:176)C. The relative
humidity, normally around 50-70 %, should be recorded throughout the test. Handling procedures, including
treatment and observations may be conducted under (day)
light. Sucrose solution in water with a final
concentration of 500 g/l (50 % w/v) should be used as food and provided ad libitum during the test time,
using a bee feeder. This can be a glass tube (approximately 50 mm long and 10 mm wide with the open end
narrowed to about 2 mm diameter).

1.5.3.

Preparation of bees

The collected bees may be anaesthetised with carbon dioxide or nitrogen for application of the test substance.
The amount of anaesthetic used and time of exposure should be minimised. Moribund bees should be rejected
and replaced by healthy bees before starting the test.

1.5.4.

Preparation of doses

The test substance is to be applied as solution in a carrier, i.e. an organic solvent or a water solution with a
wetting agent. As organic solvent, acetone is preferred but other organic solvents of low toxicity to bees may
be used (e.g. dimethylformamide, dimethylsulfoxide). For water dispersed formulated products and highly
polar organic substances not soluble in organic carrier solvents, solutions may be easier to apply if prepared
in a weak solution of a commercial wetting agent (e.g. Agral, Cittowett, Lubrol, Triton, Tween).

Appropriate control solutions should be prepared, i.e. where a solvent or a dispersant is used to solubilise the
test substance, two separate control groups should be used, one treated with water, and one treated with the
solvent/dispersant.

1.6.

PROCEDURE

1.6.1.

Test and control groups

The number of doses and replicates tested should meet the statistical requirements for determination LD50
with 95 % confidence limits. Normally five doses in a geometric series, with a factor not exceeding 2,2, and
covering the range for LD50, are required for the test. However, the number of doses have to be determined in
relation to the slope of the toxicity curve (dose versus mortality) and with consideration taken to the statistical
method which is chosen for analysis of the results. A range-finding test enables the choice of the appropriate
doses.

A minimum of three replicate test groups, each of 10 bees, should be dosed with each test concentration.

A minimum of three control batches, each of 10 bees, should be run in addition to the test series. If an
organic solvent or a wetting agent is used three additional control batches of each 10 bees for the solvent or
the wetting agent have to be included.

1.6.2.

Toxic standard

A toxic standard must be included in the test series. At least three doses should be selected to cover the
expected LD50 value. A minimum of three replicate cages, each containing 10 bees, should be used with each
test dose. The preferred toxic standard is dimethoate, for which the reported contact LD50-24 h is in the range
0,10-0,30 lg a.s./bee (2). However, other toxic standards would be acceptable where sufficient data can be
provided to verify the expected dose response (e.g. parathion).

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1.6.3.

Exposure

1.6.3.1. Administration of doses

Anaesthetised bees are individually treated by topical application.The bees are randomly assigned to the
different test doses and controls. A volume of 1 ll of solution containing the test substance at the suitable
concentration should be applied with a microapplicator to the dorsal side of the thorax of each bee. Other
volumes may be used, if justified. After application, the bees are allocated to test cages and supplied with
sucrose solutions.

1.6.3.2. Duration

The duration of the test is preferably 48 h. If mortality increases by more than 10 % between 24 h and 48 h,
the test duration should be extended up to a maximum of 96 h provided that control mortality does not
exceed 10 %.

1.6.4. Observations

Mortality is recorded at 4 h after dosing and thereafter at 24(cid:150)h and 48 h. If a prolonged observation period is
required, further assessments should be made, at 24-h intervals, to a maximum of 96 h, provided that the
control mortality does not exceeding 10 %.

All abnormal behavioural effects observed during the testing period should be recorded.

1.6.5.

Limit test

In some cases (e.g. when a test substance is expected to be of low toxicity) limit test may be performed, using
100 lg a.s./bee in order to demonstrate that the LD50 is greater than this value. The same procedure should
be used, including three replicate test groups for the test dose, the relevant controls, and the use of the toxic
standard. If mortalities occur, a full study should be conducted. If sublethal effects are observed (see section
1.6.4) these should be recorded.

2.

DATA AND REPORTING

2.1.

DATA

Data should be summarised in tabular form, showing for each treatment group, as well as, control and toxic
standard groups, the number of bees used, mortality at each observation time and number of bees with
adverse behaviour. Analyse the mortality data by appropriate statistical methods (e.g. probit analysis, moving
average, binomial probability) (3) (4). Plot dose-response curves at each recommended observation time (i.e.
24 h, 48 h and, if relevant, 72 h, 96 h) and calculate the slopes of the curves and the median lethal doses
(LD50) with 95 % confidence limits. Corrections for control mortality could be made using Abbott’s correction
(4) (5). LD50 should be expressed in lg of test substance per bee.

2.2.

TEST REPORT

The test report must include the following information:

2.2.1.

Test substance:

(cid:151) physical nature and physical-chemical properties (e.g. stability in water, vapour pressure),

(cid:151) chemical

identification data,

including structural

formula, purity (i.e.

for pesticides, the identity and

concentration of active substance(s)).

2.2.2.

Test species:

(cid:151) scientific name, race, approximate age (in weeks), collection method, date of collection,

(cid:151) information on colonies used for collection of

test bees including health, any adult disease, any

pre-treatment, etc.

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2.2.3.

Test conditions:

(cid:151) temperature and relative humidity of experimental room,

(cid:151) housing conditions including type, size and material of cages,

(cid:151) methods of administration of test substance, e.g. carrier solvent used, volume of test solution applied

anaesthetics used,

(cid:151) test design, e.g. number and test doses used, number of controls; for each test dose and control, number

of replicate cages and number of bees per cage,

(cid:151) date of test.

2.2.4.

Results:

(cid:151) results of preliminary range-finding study if performed,

(cid:151) raw data: mortality at each concentration tested at each observation time,

(cid:151) graph of the dose-response curves at the end of the test,

(cid:151) LD50 values, with 95 % confidence limits, at each of the recommended observation times,

substance and toxic standard,

for test

(cid:151) statistical procedures used for determining the LD50,

(cid:151) mortality in controls,

(cid:151) other biological effects observed or measured and any abnormal responses of the bees,

(cid:151) any deviation from the test method procedures described here and any other relevant information.

3.

REFERENCES

(1) EPPO/Council of Europe (1993). Decision-Making Scheme for the Environmental Risk Assessment of Plant

Protection Products (cid:151) Honeybees. EPPO bulletin, Vol. 23, N.1, pp. 151-165. March 1993.

(2) Gough, H. J., McIndoe, E. C., Lewis, G. B. (1994). The use of dimethoate as a reference compound in
laboratory acute toxicity tests on honeybees (Apis mellifera L.), 1981-1992. Journal of Apicultural Research
22, pp. 119-125.

(3) Litchfield, J. T. and Wilcoxon, F. (1949). A simplified method of evaluating dose-effect experiments. Jour.

Pharmacol. and Exper. Ther., 96, pp. 99-113.

(4) Finney, D. J. (1971). Probit Analysis. 3rd ed., Cambridge, London and New York.

(5) Abbott, W. S. (1925). A method for computing the effectiveness of an insecticide. Jour. Econ. Entomol.

18, pp. 265-267.

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C.18. ADSORPTION/DESORPTION USING A BATCH EQUILIBRIUM METHOD

1.

METHOD

This method is a replicate of the OECD TG 106, for the Determination of Soil Adsorption/Desorption, using a
Batch Equilibrium Method (2000).

1.1.

INTRODUCTION

The method takes into account a ring test and a workshop for soil selection for the development of an
adsorption test (1) (2) (3) (4) and also existing guidelines at national level (5) (6) (7) (8) (9) (10) (11).

Adsorption/desorption studies are useful for generating essential information on the mobility of chemicals and
their distribution in the soil, water and air compartments of the biosphere (12) (13) (14) (15) (16) (17) (18)
(19) (20) (21). The information can be used in the prediction or estimation, for example, of the availability of
a chemical for degradation (22) (23), transformation and uptake by organisms (24); leaching through the soil
profile (16) (18) (19) (21) (25) (26) (27) (28); volatility from soil (21) (29) (30); run-off from land surfaces into
natural waters (18) (31) (32). Adsorption data can be used for comparative and modelling purposes (19) (33)
(34) (35).

(4)

(12)

(13)

The distribution of a chemical between soil and aqueous phases is a complex process depending on a number
of different factors: the chemical nature of the substance (12) (36) (37) (38) (39) (40), the characteristics of the
(49), and climatic factors such as rainfall,
soil
temperature, sunlight and wind. Thus, the numerous phenomena and mechanisms involved in the process of
adsorption of a chemical by soil cannot be completely defined by a simplified laboratory model such as the
present method. However, even if this attempt cannot cover all the environmentally possible cases, it provides
valuable information on the environmental relevance of the adsorption of a chemical.

(42)

(14)

(41)

(48)

(46)

(47)

(43)

(44)

(45)

See also General Introduction.

1.2.

SCOPE

The method is aimed at estimating the adsorption/desorption behaviour of a substance on soils. The goal is to
obtain a sorption value which can be used to predict partitioning under a variety of environmental conditions;
to this end, equilibrium adsorption coefficients for a chemical on various soils are determined as a function of
soil characteristics (e.g. organic carbon content, clay content and soil texture and pH). Different soil types
have to be used in order to cover as widely as possible the interactions of a given substance with naturally
occurring soils.

In this method, adsorption represents the process of the binding of a chemical to surfaces of soils; it does not
distinguish between different adsorption processes (physical and chemical adsorption) and such processes as
surface catalysed degradation, bulk adsorption or chemical reaction. Adsorption that will occur on colloids
particles (diameter < 0,2 lm) generated by the soils is not taken into account.

The soil parameters that are believed most important for adsorption are: organic carbon content (3) (4) (12)
(13) (14) (41) (43) (44) (45) (46) (47) (48); clay content and soil texture (3) (4) (41) (42) (43) (44) (45) (46)
(47) (48) and pH for ionisable compounds (3) (4) (42). Other soil parameters which may have an impact on
the adsorption/desorption of a particular substance are the effective cation exchange capacity (ECEC), the
content of amorphous iron and aluminium oxides, particularly for volcanic and tropical soils (4), as well as
the specific surface (49).

The test is designed to evaluate the adsorption of a chemical on different soil types with a varying range of
organic carbon content, clay content and soil texture, and pH. It comprises three tiers:

Tier 1:

Preliminary study in order to determine:

(cid:151) the soil/solution ratio,

(cid:151) the equilibrium time for adsorption and the amount of test substance adsorbed at equilibrium,

(cid:151) the adsorption of the test substance on the surfaces of the test vessels and the stability of the

test substance during the test period.

Tier 2:

Screening test: the adsorption is studied in five different soil types by means of adsorption kinetics
at a single concentration and determination of distribution coefficient Kd and Koc.

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Tier 3: Determination of Freundlich adsorption isotherms to determine the influence of concentration on

the extent of adsorption on soils.

Study of desorption by means of desorption kinetics/Freundlich desorption isotherms (Appendix 1).

1.3.

DEFINITIONS AND UNITS

Symbol

Ati

Aeq

mm

ads(ti)

ads(eq)

maq

msoil

Cst

C0

ads(ti)
Caq

ads(eq)
Cs

ads(eq)

Caq

V0

A
va

Kd

Koc

Kom

ads

KF

1/n

Dti

DDti

Kdes

des
KF

Definition

Units

adsorption percentage at the time ti

adsorption percentage at adsorption equilibrium

ms

ads(ti)

mass of the test substance adsorbed on the soil at the time ti

ms

ads(Dti)

ads(eq)

ms

mass of the test substance adsorbed on the soil during the time
interval Dti

mass of
equilibrium

the test

substance adsorbed on the soil at adsorption

m0

mass of the test substance in the test tube, at the beginning of the
adsorption test

mass of the test substance measured in an aliquot (va
point ti

A) at the time

mass of the substance in the solution at adsorption equilibrium

quantity of the soil phase, expressed in dry mass of soil

mass concentration of the stock solution of the substance

initial mass concentration of the test solution in contact with the soil

mass concentration of the substance in the aqueous phase at the time
ti that the analysis is performed

%

%

lg

lg

lg

lg

lg

lg

g

lg cmﬂ3

lg cmﬂ3

lg cmﬂ3

content of the substance adsorbed on soil at adsorption equilibrium

lg gﬂ1

mass concentration of
adsorption equilibrium

the substance in the aqueous phase at

lg cmﬂ3

initial volume of the aqueous phase in contact with the soil during
the adsorption test

volume of the aliquot in which the test substance is measured

distribution coefficient for adsorption

organic carbon normalised adsorption coefficient

organic matter normalised distribution coefficient

cm3

cm3

cm3 gﬂ1

cm3 gﬂ1

cm3 gﬂ1

Freundlich adsorption coefficient

lg 1ﬂ1/n (cm3) 1/n gﬂ1

Freundlich exponent

desorption percentage at a point time ti

desorption percentage corresponding to a time interval Dti

apparent desorption coefficient

%

%

cm3 gﬂ1

Freundlich desorption coefficient

lg 1-1/n (cm3) 1/n gﬂ1

maq

des (ti)

mass of the test substance desorbed from soil at the time ti

lg

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Symbol

Definition

Units

maq

des (Dti)

mass of the test substance desorbed from soil during the time Dti

des(eq)

mm

des(eq)

maq

ms

des(Dti)

A
maq

des(eq)
Cs

des(eq)

Caq

VT

VR

D

va

i
Vr

F
Vr

MB

mE

Vrec

Pow

pKa

Sw

mass of the substance determined analytically in the aqueous phase at
desorption equilibrium

total mass of the test substance desorbed at desorption equilibrium

mass of the substance remaining adsorbed on the soil after the time
interval Dti

mass of the substance left over from the adsorption equilibrium due
to incomplete volume replacement

content of
desorption equilibrium

the test substance remaining adsorbed on the soil at

mass concentration of the test substance in the aqueous phase at
desorption equilibrium

total volume of the aqueous phase in contact with the soil during the
desorption kinetics experiment performed with the serial method

the supernatant

the
volume of
attainment of adsorption equilibrium and replaced by the same
volume of a 0,01 M CaCl2 solution

removed from the tube after

volume of the aliquot sampled for analytical purpose from the time
(i), during the desorption kinetics experiment performed with the
serial method

volume of the solution taken from the tube (i) for the measurement of
the test substance, in desorption kinetics experiment (parallel method)

volume of the solution taken from the tube for the measurement of
the test substance, at desorption equilibrium

mass balance

total mass of the test substance extracted from soil and walls of the
test vessel in two steps

volume of the supernatant recovered after the adsorption equilibrium

octanol/water partition coefficient

dissociation constant

water solubility

lg

lg

lg

lg

lg

lg gﬂ1

lg cmﬂ3

cm3

cm3

cm3

cm3

cm3

%

lg

cm3

g lﬂ1

1.4.

PRINCIPLE OF THE TEST METHOD

Known volumes of solutions of the test substance, non-labelled or radiolabelled, at known concentrations in
0,01 M CaCl2 are added to soil samples of known dry weight which have been pre-equilibrated in 0,01 M
CaCl2. The mixture is agitated for an appropriate time. The soil suspensions are then separated by
centrifugation and, if so wished, filtration and the aqueous phase is analysed. The amount of test substance
adsorbed on the soil sample is calculated as the difference between the amount of test substance initially
present in solution and the amount remaining at the end of the experiment (indirect method).

As an option, the amount of the test substance adsorbed can also be directly determined by analysis of soil
(direct method). This procedure which involves step-wise soil extraction with appropriate solvent,
is
recommended in cases where the difference in the solution concentration of
the substance cannot be
accurately determined. Examples of such cases are: adsorption of the test substance on surface of the test
vessels, instability of the test substance in the time scale of the experiment, weak adsorption giving only small
concentration change in the solution; and strong adsorption yielding low concentration which cannot be

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accurately determined. If radiolabelled substance is used, the soil extraction may be avoided by analysis of the
liquid scintillation counting is an
soil phase by combustion and liquid scintillation counting. However,
unspecific technique which cannot differentiate between parental and transformation products; therefore it
should be used only if the test chemical is stable for the duration of the study.

1.5.

INFORMATION ON THE TEST SUBSTANCE

Chemical reagents should be of analytical grade. The use of non-labelled test substances with known
composition and preferably at least 95 % purity or of radiolabelled test substances with known composition
and radio-purity, is recommended. In the case of short half-life tracers, decay corrections should be applied.

Before carrying out a test for adsorption-desorption, the following information about the test substance
should be available:

(a) water solubility (A.6);

(b) vapour pressure (A.4) and/or Henry’s Law Constant;

(c) abiotic degradation: hydrolysis as a function of pH (C.7);

(d) partition coefficient (A.8);

(e)

ready biodegradability (C.4) or aerobic and anaerobic transformation in soil;

(f) pKa of ionisable substances;

(g) direct photolysis

in water

(i.e. UV-Vis

absorption spectrum in water, quantum yield)

and

photodegradation on soil.

1.6.

APPLICABILITY OF THE TEST

The test is applicable to chemical substances for which an analytical method with sufficient accuracy is
available. An important parameter that can influence the reliability of the results, especially when the indirect
method is followed, is the stability of the test substance in the time scale of the test. Thus, it is a prerequisite
to check the stability in a preliminary study; if a transformation in the time scale of the test is observed, it is
recommended that the main study be performed by analysing both soil and aqueous phases.

Difficulties may arise in conducting this test for test substances with low water solubility (Sw < 10ﬂ4 g lﬂ1), as
well as for highly charged substances, due to the fact that the concentration in the aqueous phase cannot be
measured analytically with sufficient accuracy. In these cases, additional steps have to be taken. Guidance on
how to deal with these problems is given in the relevant sections of this method.

When testing volatile substances, care should be taken to avoid losses during the study.

1.7.

DESCRIPTION OF THE METHOD

1.7.1.

Apparatus and chemical reagents

Standard laboratory equipment, especially the following:

(a) Tubes or vessels to conduct the experiments. It is important that these tubes or vessels:

(cid:151) fit directly in the centrifuge apparatus in order to minimise handling and transfer errors,

(cid:151) be made of an inert material, which minimises adsorption of the test substance on its surface.

(b) Agitation device: overhead shaker or equivalent equipment; the agitation device should keep the soil in

suspension during shaking.

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(c) Centrifuge: preferably high-speed, e.g. centrifugation forces > 3 000 g, temperature controlled, capable of
removing particles with a diameter greater than 0,2 lm from aqueous solution. The containers should be
capped during agitation and centrifugation to avoid volatility and water losses; to minimise adsorption on
them, deactivated caps such as teflon lined screw caps should be used.

(d) Optional: filtration device; filters of 0,2 lm porosity, sterile, single use. Special care should be taken in the
choice of the filter material, to avoid any losses of the test substance on it; for poorly soluble test
substances, organic filter material is not recommended.

(e) Analytical instrumentation, suitable for measuring the concentration of the test chemical.

(f) Laboratory oven, capable of maintaining a temperature of 103 (cid:176)C to 110 (cid:176)C.

1.7.2.

Characterisation and selection of soils

The soils should be characterised by three parameters considered to be largely responsible for the adsorptive
capacity: organic carbon, clay content and soil texture, and pH. As already mentioned (see Scope) other
physico-chemical properties of the soil may have an impact on the adsorption/desorption of a particular
substance and should be considered in such cases.

solution used in adsorption/desorption testing)

The methods used for soil characterisation are very important and can have a significant influence on the
results. Therefore, it is recommended that soil pH should be measured in a solution of 0,01 M CaCl2 (that is
the
corresponding ISO method
(ISO-10390-1). It is also recommended that the other relevant soil properties be determined according to
standard methods (for example ISO (cid:145)Handbook of Soil Analysis(cid:146)); this permits the analysis of sorption data to
be based on globally standardised soil parameters. Some guidance for existing standard methods of soil
analysis and characterisation is given in references (50-52). For calibration of soil test methods, the use of
reference soils is recommended.

according to the

Guidance for selection of soils for adsorption/desorption experiments is given in Table 1. The seven selected
soils cover soil types encountered in temperate geographical zones. For ionisable test substances, the selected
soils should cover a wide range of pH, in order to be able to evaluate the adsorption of the substance in its
ionised and unionised forms. Guidance on how many different soils to use at the various stages of the test is
given under 1.9. Performance of the test.

If other soil types are preferred, they should be characterised by the same parameters and should have similar
variation in properties to those described in Table 1, even if they do not match the criteria exactly.

Table 1: Guidance for selection of soil samples for adsorption-desorption

Soil type

pH range
(in 0,01 M CaCl2)

Organic carbon content
(%)

Clay content
(%)

Soil texture (1)

1

2

3

4

5

6

7

4,5-5,5

> 7,5

5,5-7,0

4,0-5,5

1,0-2,0

3,5-5,0

1,5-3,0

3,0-4,0

65-80

20-40

15-25

15-30

clay

clay loam

silt loam

loam

< 4,0-6,0 (2)

< 0,5-1,5 (2) (3)

< 10-15 (2)

loamy sand

> 7,0

< 4,5

< 0,5-1,0 (2) (3)

> 10

40-65

< 10

clay loam/clay

sand/loamy sand

(1) According to FAO and the US system (85).
(2) The respective variables should preferably show values within the range given.
appropriate soil material occur, values below the indicated minimum are accepted.

If, however, difficulties in finding

(3) Soils with less than 0,3 % organic carbon may disturb correlation between organic content and adsorption. Thus, it is

recommended the use of soils with a minimum organic carbon content of 0,3 %.

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1.7.3.

Collection and storage of soil samples

1.7.3.1. Collection

No specific sampling techniques or tools are recommended; the sampling technique depends on the purpose
of the study (53) (54) (55) (56) (57) (58).

The following should be considered:

(a) detailed information on the history of the field site is necessary; this includes location, vegetation cover,
treatments with pesticides
contamination.
fertilisers, biological
Recommendations of the ISO standard on soil sampling (ISO 10381-6) should be followed with respect
to the description of the sampling site;

additions or

accidental

and/or

(b)

the sampling site has to be defined by UTM (Universal Transversal Mercator-Projection/European
Horizontal Datum) or geographical coordinates; this could allow recollection of a particular soil in the
future or could help in defining soil under various classification systems used in different countries. Also,
only A horizon up to a maximum depth of 20 cm should be collected. Especially for the soil type n. 7 if
a Oh horizon is present as part of the soil, it should be included in the sampling.

The soil samples should be transported using containers and under temperature conditions which guarantee
that the initial soil properties are not significantly altered.

1.7.3.2. Storage

The use of soils freshly taken from the field is preferred. Only if this is not possible soil can be stored at
ambient temperature and should be kept air-dried. No limit on the storage time is recommended, but soils
stored for more than three years should be re-analysed prior to the use with respect to their organic carbon
content, pH and CEC.

1.7.3.3. Handling and preparation of soil samples for the test

The soils are air-dried at ambient temperature (preferably between 20-25 (cid:176)C). Disaggregation should be
performed with minimal force, so that the original texture of the soil will be changed as little as possible. The
soils are sieved to a particle size ˜ 2 mm; recommendations of the ISO standard on soil sampling (ISO
10381-6) should be followed with respect to the sieving process. Careful homogenisation is recommended, as
this enhances the reproducibility of the results. The moisture content of each soil is determined on three
aliquots with heating at 105 (cid:176)C until there is no significant change in weight (approximately 12 h). For all
calculations the mass of soil refers to oven dry mass, i.e. the weight of soil corrected for moisture content.

1.7.4.

Preparation of the test substance for application to soil

The test substance is dissolved in a solution of 0,01 M CaCl2 in distilled or deionised water; the CaCl2 solution
is used as the aqueous solvent phase to improve centrifugation and minimise cation exchange. The
concentration of the stock solution should preferably be three orders of magnitude higher than the detection
limit of the analytical method used. This threshold safeguards accurate measurements with respect to the
methodology followed in this method; additionally, the stock solution concentration should be below water
solubility of the test substance.

The stock solution should preferably be prepared just before application to soil samples and should be kept
the test substance and its
closed in the dark at 4 (cid:176)C. The storage time depends on the stability of
concentration in the solution.

Only for poorly soluble substances (Sw < 10ﬂ4 g lﬂ1), an appropriate solubilising agent may be needed when it
is difficult to dissolve the test substance. This solubilising agent: (a) should be miscible with water such as
methanol or acetonitrile; (b) its concentration should not exceed 1 % of the total volume of the stock solution
and should constitute less than that in the solution of the test substance which will come in contact with the
soil (preferably less than 0,1 %); and (c) should not be a surfactant or undergo solvolytic reactions with the
test chemical. The use of a solubilising agent should be stipulated and justified in the reporting of the data.

Another alternative for poorly soluble substances is to add the test substance to the test system by spiking: the
test substance is dissolved in an organic solvent, an aliquot of which is added to the system of soil and 0,01
M solution of CaCl2 in distilled or deionised water. The content of organic solvent in the aqueous phase
should be kept as low as possible, normally not exceeding 0,1 %. Spiking from an organic solution may suffer
from volume unreproducibility. Thus, an additional error may be introduced as the test substance and
co-solvent concentration would not be the same in all tests.

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1.8.

PREREQUISITES FOR PERFORMING THE ADSORPTION/DESORPTION TEST

1.8.1.

Analytical method

The key parameters that can influence the accuracy of sorption measurements include the accuracy of the
analytical method in analysis of both the solution and adsorbed phases, the stability and purity of the test
substance, the attainment of sorption equilibrium, the magnitude of the solution concentration change, the
soil/solution ratio and changes in the soil structure during the equilibration process (35)
(59-62). Some
examples bearing upon the accuracy issues are given in Appendix 2.

The reliability of the analytical method used must be checked at the concentration range which is likely to
occur during the test. The experimenter should feel free to develop an appropriate method with appropriate
accuracy, precision, reproducibility, detection limits and recovery. Guidance on how to perform such a test is
given by the experiment below.

An appropriate volume of 0,01 M CaCl2, e.g. 100 cm3, is agitated during 4 h with a weight of soil, e.g. 20 g,
of high adsorbability, i.e. with high organic carbon and clay content; these weights and volumes may vary
depending on analytical needs, but a soil/solution ratio of 1:5 is a convenient starting point. The mixture is
centrifuged and the aqueous phase may be filtrated. A certain volume of the test substance stock solution is
added to the latter to reach a nominal concentration within the concentration range which is likely to occur
during the test. This volume should not exceed 10 % of the final volume of the aqueous phase, in order to
change as little as possible the nature of the pre-equilibration solution. The solution is analysed.

One blank run consisting of the system soil + CaCl2 solution (without test substance) must be included, in
order to check for artefacts in the analytical method and for matrix effects caused by the soil.

The analytical methods which can be used for sorption measurements include gas-liquid chromatography
(GLC), high-performance liquid chromatography (HPLC), spectrometry (e.g. GC/mass spectrometry, HPLC/mass
spectrometry) and liquid scintillation counting (for radiolabelled substances). Independent of the analytical
method used, it is considered suitable if the recoveries are between 90 % and 110 % of the nominal value. In
order to allow for detection and evaluation after partitioning has taken place, the detection limits of the
analytical method should be at least two orders of magnitude below the nominal concentration.

The characteristics and detection limits of the analytical method available for carrying out adsorption studies
play an important role in defining the test conditions and the whole experimental performance of the test.
This method follows a general experimental path and provides recommendations and guidance for alternative
solutions where the analytical method and laboratory facilities may impose limitations.

1.8.2.

Selection of optimal soil/solution ratios

Selection of appropriate soil to solution ratios for sorption studies depends on the distribution coefficient Kd
and the relative degree of adsorption desired. The change of the substance concentration in the solution
determines the statistical accuracy of the measurement based on the form of adsorption equation and the limit
of the analytical methodology, in detecting the concentration of the chemical in solution. Therefore, in general
practice it is useful to settle on a few fixed ratios, for which the percentage adsorbed is above 20 %, and
preferably > 50 % (62), while care should be taken to keep the test substance concentration in the aqueous
phase high enough to be measured accurately. This is particularly important in the case of high adsorption
percentages.

A convenient approach to selecting the appropriate soil/water ratios, is based on an estimate of the Kd value
either by preliminary studies or by established estimation techniques (Appendix 3). Selection of an appropriate
ratio can then be made based on a plot of soil/solution ratio versus Kd for fixed percentages of adsorption
(Fig. 1). In this plot it is assumed that the adsorption equation is linear (1). The applicable relationship is
obtained by rearranging equation (4) of the Kd in the form of equation (1):

(cid:19)

(cid:18)

m0
s (cid:133)eq(cid:134)

mads

ﬂ 1

Kd

(cid:133)1(cid:134)

V0
msoil

=

(1) Cs

ads(eq) = Kd • Caq

ads(eq)

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or in its logarithmic form assuming that R = msoil=V0 and Aeq%=100 =

log R = ﬂ log Kd + log

(cid:20)

(cid:133)Aeq%=100(cid:134)
(cid:133)1 ﬂ Aeq%=100(cid:134)

mads

s (cid:133)eq(cid:134)
m0
(cid:21)

:

(cid:133)2(cid:134)

10

1

A = 20 %

A = 50 %

A = 80 %

A = 90 %

0,1

A = 1 %

A = 10 %

0,01

o
i
t
a
r

n
o
i
t
u
o
s

l

o
t

l
i

o
S

A = 99 %

R = 1/1

R = 1/5

R = 1/25

R = 1/50

R = 1/100

0,1

1

10

100

1 000

Distribution coefficient Kd (cm3 g(cid:150)1)

Fig. 1. Relationship between soil to solution ratios and Kd at various percentages of adsorbed test substance

Fig. 1 shows soil/solution ratios required as a function of Kd for different levels of adsorption. For example,
with a soil/solution ratio of 1:5 and a Kd of 20, approximately 80 % adsorption would occur. To obtain 50 %
adsorption for the same Kd, a 1:25 ratio must be used. This approach to selecting the appropriate soil/solution
ratios gives the investigator the flexibility to meet experimental needs.

Areas which are more difficult to deal with are those where the chemical is highly or very slightly adsorbed.
Where low adsorption occurs, a 1:1 soil/solution ratio is recommended, although for some very organic soil
types smaller ratios may be necessary to obtain a slurry. Care must be taken with the analytical methodology
to measure small changes in solution concentration; otherwise the adsorption measurement will be inaccurate.
On the other hand, at very high distribution coefficients Kd, one can go up to a 1:100 soil/solution ratio in
order to leave a significant amount of chemical in solution. However, care must be taken to ensure good
mixing, and adequate time must be allowed for the system to equilibrate. An alternative approach to deal with
these extreme cases when adequate analytical methodology is missing, is to predict the Kd value applying
estimation techniques based, for example, on Pow values (Appendix 3). This could be useful especially for low
adsorbed/polar chemicals with Pow < 20 and for lipophilic/highly sorptive chemicals with Pow > 104.

1.9.

PERFORMANCE OF THE TEST

1.9.1.

Test conditions

All experiments are done at ambient temperature and, if possible, at a constant temperature between 20 (cid:176)C
and 25 (cid:176)C.

Centrifugation conditions should allow the removal of particles larger than 0,2 lm from the solution. This
value triggers the smallest sized particle that is considered as a solid particle, and is the limit between solid
and colloid particles. Guidance on how to determine the centrifugation conditions is given in Appendix 4.

If the centrifugation facilities cannot guarantee the removal of particles larger than 0,2 lm, a combination of
centrifugation and filtration with 0,2 lm filters could be used. These filters should be made of a suitable inert
material to avoid any losses of the test substance on them. In any case, it should be proven that no losses of
the test substance occur during filtration.

 
 
 
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1.9.2.

Tier 1 (cid:151) Preliminary study

The purpose of conducting a preliminary study has already been given in section Scope. Guidance for setting
up such a test is given with the experiment suggested below.

1.9.2.1. Selection of optimal soil/solution ratios

Two soil types and three soil/solution ratios (six experiments) are used. One soil type has high organic carbon
and low clay content, and the other low organic carbon and high clay content. The following soil to solution
ratios are suggested:

(cid:151) 50 g soil and 50 cm3 aqueous solution of the test substance (ratio 1/1),

(cid:151) 10 g soil and 50 cm3 aqueous solution of the test substance (ratio 1/5),

(cid:151) 2 g soil and 50 cm3 aqueous solution of the test substance (ratio 1/25).

The minimum amount of soil on which the experiment can be carried out depends on the laboratory facilities
and the performance of analytical methods used. However,
it is recommended to use at least 1 g, and
preferably 2 g, in order to obtain reliable results from the test.

One control sample with only the test substance in 0,01 M CaCl2 solution (no soil) is subjected to precisely
the same steps as the test systems, in order to check the stability of the test substance in CaCl2 solution and
its possible adsorption on the surfaces of the test vessels.

A blank run per soil with the same amount of soil and total volume of 50 cm3 0,01 M CaCl2 solution
(without test substance) is subjected to the same test procedure. This serves as a background control during
the analysis to detect interfering substances or contaminated soils.

All the experiments, included controls and blanks, should be performed at least in duplicate. The total number
of the samples which should be prepared for the study can be calculated with respect to the methodology
which will be followed.

Methods for the preliminary study and the main study are generally the same, exceptions are mentioned
where relevant.

The air-dried soil samples are equilibrated by shaking with a minimum volume of 45 cm3 of 0,01 M CaCl2
overnight (12 h) before the day of the experiment. Afterwards, a certain volume of the stock solution of the
test substance is added in order to adjust the final volume to 50 cm3. This volume of the stock solution
added: (a) should not exceed 10 % of the final 50 cm3 volume of the aqueous phase in order to change as
little as possible the nature of the pre-equilibration solution; and (b) should preferably result in an initial
concentration of the test substance being in contact with the soil (C0) at least two orders of magnitude higher
than the detection limit of the analytical method; this threshold safeguards the ability to perform accurate
measurements even when strong adsorption occurs (> 90 %) and to determine later the adsorption isotherms.
It is also recommended, if possible, that the initial substance concentration (C0) not exceed half of its solubility
limit.

An example of how to calculate the concentration of the stock solution (Cst) is given below. A detection limit
of 0,01 lg cmﬂ3 and 90 % adsorption are assumed; thus, the initial concentration of the test substance in
contact with the soil should preferably be 1lg cmﬂ3 (two orders of magnitude higher than the detection limit).
Supposing that the maximum recommended volume of the stock solution is added, i.e. 5 to 45 cm3 0,01 M
CaCl2 equilibration solution (= 10 % of the stock solution to 50 cm3 total volume of aqueous phase), the
concentration of the stock solution should be 10 lg cmﬂ3; this is three orders of magnitude higher than the
detection limit of the analytical method.

The pH of the aqueous phase should be measured before and after contact with the soil since it plays an
important role in the whole adsorption process, especially for ionisable substances.

The mixture is shaken until adsorption equilibrium is reached. The equilibrium time in soils is highly variable,
depending on the chemical and the soil; a period of 24 h is generally sufficient (77). In the preliminary study,
samples may be collected sequentially over a 48 h period of mixing (for example at 4, 8, 24, 48 h). However,
times of analysis should be considered with flexibility with respect to the work schedule of the laboratory.

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There are two options for the analysis of the test substance in the aqueous solution: (a) the parallel method
and (b) the serial method. It should be stressed that, although the parallel method is experimentally more
tedious, the mathematical treatment of the results is simpler (Appendix 5). However, the choice of the
methodology to be followed, is left to the experimenter who will need to consider the available laboratory
facilities and resources.

(a) Parallel method: samples with the same soil/solution ratio are prepared, as many as the time intervals at
which it is desired to study the adsorption kinetics. After centrifugation and if so wished filtration, the
aqueous phase of the first tube is recovered as completely as possible and is measured after, for example,
4 h, that of the second tube after 8 h, that of the third after 24, etc.

(b) Serial method: only a duplicate sample is prepared for each soil/solution ratio. At defined time intervals
the mixture is centrifuged to separate the phases. A small aliquot of the aqueous phase is immediately
analysed for the test substance; then the experiment continues with the original mixture. If filtration is
applied after centrifugation, the laboratory should have facilities to handle filtration of small aqueous
aliquots. It is recommended that the total volume of the aliquots taken not exceed 1 % of the total
volume of the solution, in order not to change significantly the soil/solution ratio and to decrease the
mass of solute available for adsorption during the test.

is calculated at each time point (ti) on the basis of the nominal

The percentage adsorption Ati
initial
concentration and the measured concentration at the sampling time (ti), corrected for the value of the blank.
Plots of the Ati versus time (Fig. 1 Appendix 5) are generated in order to estimate the achievement of
equilibrium plateau (1). The Kd value at equilibrium is also calculated. Based on this Kd value, appropriate
soil/solution ratios are selected from Fig.1, so that
the percentage adsorption reaches above 20 % and
preferably > 50 % (61). All the applicable equations and principles of plotting are given in the section on Data
and reporting and in Appendix 5.

1.9.2.2. Determination of adsorption equilibration time and of the amount of test substance adsorbed at equilibrium

As already mentioned, plots of Ati
the
adsorption equilibrium and the amount of test substance adsorbed at equilibrium. Figs. 1 and 2 in the
Appendix 5 show examples of such plots. Equilibration time is the system needs to reach a plateau.

ads versus time permit estimation of

the achievement of

or Caq

If, with a particular soil, no plateau but a steady increase is found, this may be due to complicating factors
such as biodegradation or slow diffusion. Biodegradation can be shown by repeating the experiment with a
sterilised sample of the soil. If no plateau is achieved even in this case, the experimenter should search for
other phenomena that could be involved in his specific studies;
this could be done with appropriate
modifications of the experiment conditions (temperature, shaking times, soil/solution ratios). It is left to the
experimenter to decide whether to continue the test procedure in spite of a possible failure to achieve an
equilibrium.

1.9.2.3. Adsorption on the surface of the test vessel and stability of the test substance

Some information on the adsorption of the test substance on the surface of test vessels, as well as its stability,
can be derived by analysing the control samples. If a depletion more than the standard error of the analytical
method is observed, abiotic degradation and/or adsorption on the surface of the test vessel could be involved.
Distinction between these two phenomena could be achieved by thoroughly washing the walls of the vessel
with a known volume of an appropriate solvent and subjecting the wash solution to analysis for the test
substance. If no adsorption on the surface of the test vessels is observed, the depletion demonstrates abiotic
unstability of the test substance. If adsorption is found, changing the material of the test vessels is necessary.
However, data on the adsorption on the surface of the test vessels gained from this experiment cannot be
directly extrapolated to soil/solution experiment. The presence of soil will affect this adsorption.

Additional information on the stability of the test substance can be derived by determination of the parental
mass balance over time. This means that the aqueous phase, extracts of soil and test vessel walls are analysed
for the test substance. The difference between the mass of the test chemical added and the sum of the test
chemical masses in the aqueous phase, extracts of the soil and test vessel walls is equal to the mass degraded
and/or volatilised and/or not extracted. In order to perform a mass balance determination, the adsorbion
equilibrium should have been reached within the period of the experiment.

The mass balance is performed on both soils and for one soil/solution ratio per soil that gives a depletion
above 20 % and preferably > 50 % at equilibrium. When the ratio-finding experiment is completed with the

(1) Plots of the concentration of the test substance in the aqueous phase (Caq

achievement of the equilibrium plateau (see Fig. 2 in Appendix 5).

ads) versus time could also be used to estimate the

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analysis of the last sample of the aqueous phase after 48 h, the phases are separated by centrifugation and, if
so wished, filtration. The aqueous phase is recovered as much as possible, and a suitable extraction solvent
(extraction coefficient of at least 95 %)
is added to the soil to extract the test substance. At least two
successive extractions are recommended. The amount of test substance in the soil and test vessel extracts is
determined and the mass balance is calculated (equation 10, Data and reporting). If it is less than 90 %, the
test substance is considered to be unstable in the time scale of the test. However, studies could still be
continued, taking into account the unstability of the test substance; in this case it is recommended to analyse
both phases in the main study.

1.9.3.

Tier 2 (cid:151) Adsorption kinetics at one concentration of the test substance

Five soils are used, selected from Table 1. There is an advantage to including some or all of the soils used in
the preliminary study, if appropriate, among these five soils. In this case, Tier 2 has not to be repeated for the
soils used in preliminary study.

The equilibration time, the soil/solution ratio, the weight of the soil sample, the volume of the aqueous phase
in contact with the soil and concentration of the test substance in the solution are chosen based on the
preliminary study results. Analysis should preferably be done approximately after 2, 4, 6, 8 (possibly also 10)
and 24 h contact time; the agitation time may be extended to a maximum of 48 h in case a chemical requires
longer equilibration time with respect to ratio-finding results. However, times of analysis could be considered
with flexibility.

Each experiment (one soil and one solution) is done at least in duplicate to allow estimation of the variance of
the results. In every experiment one blank is run. It consists of the soil and 0,01 M CaCl2 solution, without
test substance, and of weight and volume, respectively, identical to those of the experiment. A control sample
with only the test substance in 0,01 M CaCl2 solution (without soil) is subjected to the same test procedure,
serving to safeguard against the unexpected.

The percentage adsorption is calculated at each time point Ati
(according to the need)
and is plotted versus time. The distribution coefficient Kd at equilibrium, as well as the organic carbon
normalised adsorption coefficient Koc (for non-polar organic chemicals), are also calculated.

and/or time interval ADti

Results of the adsorption kinetics test

The linear Kd value is generally accurate to describe sorptive behaviour in soil (35) (78) and represents an
expression of inherent mobility of chemicals in soil. For example, in general chemicals with Kd ˜ 1 cm3 gﬂ1
are considered to be qualitatively mobile. Similarly, a mobility classification scheme based on Koc values has
been developed by MacCall et al.
leaching classification schemes exist based on a
relationship between Koc and DT-50 (1) (32) (79).

(16). Additionally,

Also, according to error analysis studies (61), Kd values below 0,3 cm3 gﬂ1 cannot be estimated accurately
from a decrease in concentration in the aqueous phase, even when the most favourable (from point of view of
accuracy) soil/solution ratio is applied,
is
recommended.

i.e. 1:1. In this case analysis of both phases, soil and solution,

it is recommended that the study of the adsorptive behaviour of a
With respect to the above remarks,
chemical in soil and its potential mobility be continued by determining Freundlich adsorption isotherms for
these systems, for which an accurate determination of Kd is possible with the experimental protocol followed
in this test method. Accurate determination is possible if the value which results by multiplying the Kd with
the soil/solution ratio is > 0,3, when measurements are based on concentration decrease in the aqueous phase
(indirect method), or > 0,1, when both phases are analysed (direct method) (61).

1.9.4.

Tier 3 (cid:151) Adsorption isotherms and desorption kinetics/desorption isotherms

1.9.4.1. Adsorption isotherms

Five test substance concentrations are used, covering preferably two orders of magnitude; in the choice of
these concentrations the water solubility and the resulting aqueous equilibrium concentrations should be taken
into account. The same soil/solution ratio per soil should be kept along the study. The adsorption test is
performed as described above, with the only difference that the aqueous phase is analysed only once at the
time necessary to reach equilibrium as determined before in Tier 2. The equilibrium concentrations in the

(1) DT-50: degradation time for 50 % of the test substance.

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solution are determined and the amount adsorbed is calculated from the depletion of the test substance in the
solution or with the direct method. The adsorbed mass per unit mass of soil is plotted as a function of the
equilibrium concentration of the test substance (see Data and reporting).

Results from the adsorption isotherms experiment

Among the mathematical adsorption models proposed so far, the Freundlich isotherm is the one most
frequently used to describe adsorption processes. More detailed information on the interpretation and
importance of adsorption models is provided in the references (41) (45) (80) (81) (82).

Note: It should be mentioned that a comparison of KF (Freundlich adsorption coefficient) values for different
substances is only possible if these KF values are expressed in the same units (83).

1.9.4.2. Desorption kinetics

The purpose of this experiment is to investigate whether a chemical is reversibly or irreversibly adsorbed on a
soil. This information is important, since the desorption process also plays an important role in the behaviour
of a chemical in field soil. Moreover, desorption data are useful inputs in the computer modelling of leaching
and dissolved run-off simulation. If a desorption study is desired, it is recommended that the study described
below be carried out on each system for which an accurate determination of Kd in the preceding adsorption
kinetics experiment was possible.

Likewise with the adsorption kinetics study, there are two options to proceed with the desorption kinetics
experiment: (a) the parallel method and (b) the serial method. The choice of methodology to be followed is
left to the experimenter who will need to consider the available laboratory facilities and resources.

(a) Parallel method: for each soil which is chosen to proceed with the desorption study, samples with the
same soil/solution ratio are prepared, as many as the time intervals at which it is desired to study the
desorption kinetics. Preferably, the same time intervals as in the adsorption kinetics experiment should be
used; however, the total time may be extended as appropriate in order the system to reach desorption
equilibrium. In every experiment (one soil, one solution) one blank is run. It consists of the soil and 0,01
M CaCl2 solution, without test substance, and of weight and volume, respectively, identical to those of the
experiment. As a control sample the test substance in 0,01 M CaCl2 solution (without soil) is subjected to
the same test procedure. All the mixtures of the soil with the solution is agitating until to reach
adsorption equilibrium (as determined before in Tier 2). Then, the phases are separated by centrifugation
and the aqueous phases are removed as much as possible. The volume of solution removed is replaced by
an equal volume of 0,01 M CaCl2 without test substance and the new mixtures are agitated again. The
aqueous phase of the first tube is recovered as completely as possible and is measured after, for example,
2 h, that of the second tube after 4 h, that of the third after 6 h, etc. until the desorption equilibrium is
reached.

(b) Serial method: after the adsorption kinetics experiment, the mixture is centrifuged and the aqueous phase
is removed as much as possible. The volume of solution removed is replaced by an equal volume of 0,01
M CaCl2 without test substance. The new mixture is agitated until the desorption equilibrium is reached.
During this time period, at defined time intervals, the mixture is centrifuged to separate the phases. A
small aliquot of the aqueous phase is immediately analysed for the test substance; then, the experiment
continues with the original mixture. The volume of each individual aliquot should be less than 1 % of the
total volume. The same quantity of fresh 0,01 M CaCl2 solution is added to the mixture to maintain the
soil to solution ratio, and the agitation continues until the next time interval.

The percentage desorption is calculated at each time point (Dti
) (according to the
needs of the study) and is plotted versus time. The desorption coefficient of Kdes at equilibrium is also
calculated. All applicable equations are given in Data and reporting and Appendix 5.

) and/or time interval (DDti

Results from desorption kinetics experiment

Common plots of the percentage desorption Dti
versus time, allow estimation of the
reversibility of the adsorption process. If the desorption equilibrium is attained even within twice the time of
the adsorption equilibrium, and the total desorption is more than 75 % of
the
adsorption is considered to be reversible.

and adsorption Ati

the amount adsorbed,

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1.9.4.3. Desorption isotherms

Freundlich desorption isotherms are determined on the soils used in the adsorption isotherms experiment. The
desorption test is performed as described in the section Desorption kinetics, with the only difference that the
aqueous phase is analysed only once, at desorption equilibrium. The amount of the test substance desorbed is
calculated. The content of test substance remaining adsorbed on soil at desorption equilibrium is plotted as a
function of the equilibrium concentration of the test substance in solution (see Data and reporting and
Appendix 5).

2.

DATA AND REPORTING

The analytical data are presented in tabular form (see Appendix 6). Individual measurements and averages
calculated are given. Graphical representations of adsorption isotherms are provided. The calculations are
made as described below.

For the purpose of the test,
soil/solution ratio may be expressed in units of w/w or w/vol with the same figure.

it is considered that the weight of 1 cm3 of aqueous solution is 1 g. The

2.1.

ADSORPTION

The adsorption (Ati
) is defined as the percentage of substance adsorbed on the soil related to the quantity
present at the beginning of the test, under the test conditions. If the test substance is stable and does not
adsorb significantly to the container wall, Ati

is calculated at each time point ti, according to the equation:

At i

=

mads

s (cid:133)ti(cid:134) • 100
m0

(cid:133)%(cid:134)

(cid:133)3(cid:134)

where:

Ati

= adsorption percentage at the time point ti (%);

ms

ads(ti)

= mass of the test substance adsorbed on the soil at the time ti (lg);

m0

= mass of the test substance in the test tube, at the beginning of the test (lg).

Detailed information on how to calculate the percentage of adsorption Ati
is given in Appendix 5.

for the parallel and serial methods

The distribution coefficient Kd is the ratio between the content of the substance in the soil phase and the mass
concentration of
the substance in the aqueous solution, under the test conditions, when adsorption
equilibrium is reached.

Kd =

Cads
s (cid:133)eq(cid:134)
Cads
aq (cid:133)eq(cid:134)

=

mads
mads

s (cid:133)eq(cid:134)
aq (cid:133)eq(cid:134)

V0
msoil

(cid:133)cm3 gﬂ1(cid:134)

(cid:133)4(cid:134)

where:

ads(eq)
Cs

= content of the substance adsorbed on the soil at adsorption equilibrium (lg gﬂ1)

ads(eq)
Caq

= mass concentration of the substance in the aqueous phase at adsorption equilibrium (lg cmﬂ3).
This concentration is analytically determined taking into account the values given by the blanks

ads(eq) = mass of the substance adsorbed on the soil at adsorption equilibrium (lg)

ms

ads(eq) = mass of the substance in the solution at adsorption equilibrium (lg)

maq

msoil

v0

= quantity of the soil phase, expressed in dry mass of soil (g)

= initial volume of the aqueous phase in contact with the soil (cm3).

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The relation between Aeq and Kd is given by:

Kd =

Aeq
100 ﬂ Aeq

V0
msoil

(cid:133)cm3 gﬂ1(cid:134)

(cid:133)5(cid:134)

where:

Aeq

= percentage of adsorption at adsorption equilibrium, %.

The organic carbon normalised adsorption coefficient Koc relates the distribution coefficient Kd to the content
of organic carbon of the soil sample:

Koc = Kd •

100
%oc

(cid:133)cm3 gﬂ1(cid:134)

(cid:133)6(cid:134)

where:

% oc

= percentage of organic carbon in the soil sample (g gﬂ1).

Koc coefficient represents a single value which characterises the partitioning mainly of non-polar organic
chemicals between organic carbon in the soil or sediment and water. The adsorption of these chemicals is
correlated with the organic content of
thus, Koc values depend on the specific
the sorbing solid (7);
characteristics of the humic fractions which differ considerably in sorption capacity, due to differences in
origin, genesis, etc.

2.1.1.

Adsorption isotherms

The Freundlich adsorption isotherms equation relates the amount of the test substance adsorbed to the
concentration of the test substance in solution at equilibrium (equation 8).

(cid:133)7(cid:134)

(cid:133)8(cid:134)

(cid:133)9(cid:134)

The data are treated as under (cid:145)Adsorption(cid:146) and, for each test tube, the content of the test substance adsorbed
ads(eq), elsewhere denoted as x/m) is calculated. It is assumed that
on the soil after the adsorption test (Cs
ads(eq) represents the equilibrium value:
equilibrium has been attained and that Cs

Cads
s (cid:133)eq(cid:134) =

mads

s (cid:133)eq(cid:134)
msoil

=

(cid:2)
C0 ﬂ Cads

(cid:3)

aq (cid:133)eq(cid:134)
msoil

• V0

(cid:133)(cid:22)g gﬂ1(cid:134)

The Freundlich adsorption equation is shown in (8):

s (cid:133)eq(cid:134) = Kads
Cads
F

• Cads

aq (cid:133)eq(cid:134)1=n (cid:133)(cid:22)g gﬂ1(cid:134)

or in the linear form:

logCads

s (cid:133)eq(cid:134) = logKads

F + 1=n • logCads

aq (cid:133)eq(cid:134)

where:

ads

KF

= Freundlich adsorption coefficient; its dimension is cm3 gﬂ1 only if 1/n = 1; in all other cases, the

slope 1/n is introduced in the dimension of KF

ads (lg1ﬂ1/n (cm3)1/n gﬂ1)

n

= regression constant; 1/n generally ranges between 0,7-1,0,

indicating that sorption data is

frequently slightly non-linear.

ads and 1/n are calculated by regression analysis using
Equations (8) and (9) are plotted and the values of KF
equation 9. The correlation coefficient r2 of the log equation is also calculated. An example of such plots is
given in Fig. 2.

ASoil

ASoil

Fig. 2. Freundlich adsorption plot, normal and linearised

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2.1.2. Mass balance

The mass balance (MB) is defined as the percentage of substance which can be analytically recovered after an
adsorption test versus the nominal amount of substance at the beginning of the test.

The treatment of data will differ if the solvent is completely miscible with water. In the case of water-miscible
solvent, the treatment of data described under (cid:145)Desorption(cid:146) may be applied to determine the amount of
substance recovered by solvent extraction. If the solvent is less miscible with water, the determination of the
amount recovered has to be made.

The mass balance MB for the adsorption is calculated as follows; it is assumed that the term (mE) corresponds
to the sum of the test chemical masses extracted from the soil and surface of the test vessel with an organic
solvent:

MB =

(cid:255)
Vrec • Cads

aq (cid:133)eq(cid:134) + mE
V0 • C0

(cid:1)

• 100

(cid:133)%(cid:134)

(cid:133)10(cid:134)

where:

MB

= mass balance (%)

mE

C0

Vrec

= total mass of test substance extracted from the soil and walls of the test vessel in two steps (lg)

= initial mass concentration of the test solution in contact with the soil (lg cmﬂ3)

= volume of the supernatant recovered after the adsorption equilibrium (cmﬂ3).

2.2.

DESORPTION

The desorption (D) is defined as the percentage of the test substance which is desorbed, related to the quantity
of substance previously adsorbed, under the test conditions:

Dt i

=

mdes
aq (cid:133)ti(cid:134)
s (cid:133)eq(cid:134)

mads

• 100 (cid:133)%(cid:134)

(cid:133)11(cid:134)

where:

Dti

= desorption percentage at a time point ti (%)

maq

des(ti)

= mass of the test substance desorbed from soil at a time point ti (lg)

des(eq) = mass of the test substance adsorbed on soil at adsorption equilibrium (lg).

ms

Detailed information on how to calculate the percentage of desorption Dti
is given in Appendix 5.

for the parallel and serial methods

The apparent desorption coefficient (Kdes) is, under the test conditions, the ratio between the content of the
substance remaining in the soil phase and the mass concentration of the desorbed substance in the aqueous
solution, when desorption equilibrium is reached:

Kdes =

mads

s (cid:133)eq(cid:134) ﬂ mdes
mdes
aq (cid:133)eq(cid:134)

aq (cid:133)eq(cid:134)

VT
msoil

(cid:133)cm3 gﬂ1(cid:134)

(cid:133)12(cid:134)

where:

Kdes

= desorption coefficient (cm3 gﬂ1)

des(eq) = total mass of the test substance desorbed from soil at desorption equilibrium (lg)

maq

VT

= total volume of the aqueous phase in contact with the soil during the desorption kinetics test

(cm3).

Guidance for calculating the maq

des(eq) is given in Appendix 5 under the heading (cid:145)Desorption(cid:146).

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Remark:

If the adsorption test which was preceded, was performed with the parallel method the volume VT in equation
12 is considered to be equal to V0.

2.2.1.

Desorption isotherms

The Freundlich desorption isotherms equation relates the content of the test substance remaining adsorbed on
the soil to the concentration of the test substance in solution at desorption equilibrium (equation 16).

For each test tube, the content of the substance remaining adsorbed on soil at desorption equilibrium is
calculated as follows:

Cdes
s (cid:133)eq(cid:134) =

des(eq) is defined as:

maq

mads

s (cid:133)eq(cid:134) ﬂ mdes
msoil

aq (cid:133)eq(cid:134)

(cid:133)(cid:22)g gﬂ1(cid:134)

mdes

aq (cid:133)eq(cid:134) = mdes

m (cid:133)eq(cid:134) •

V0
VF
r

ﬂ mA

aq(cid:133)(cid:22)g(cid:134)

(cid:133)13(cid:134)

(cid:133)14(cid:134)

where:

des(eq)
Cs

= content of the test substance remaining adsorbed on the soil at desorption equilibrium (lg gﬂ1)

mm

des(eq) = mass of substance determined analytically in the aqueous phase at desorption equilibrium (lg)

A
maq

= mass of the test substance left over from the adsorption equilibrium due to incomplete volume

replacement (lg)

des(eq) = mass of the substance in the solution at adsorption equilibrium (lg)

maq

mA

aq = mads

aq (cid:133)eq(cid:134) •

(cid:19)

(cid:18)

V0 ﬂ VR
V0

(cid:133)15(cid:134)

F
Vr

VR

= volume of the solution taken from the tube for the measurement of the test substance, at

desorption equilibrium (cm3)

= volume of the supernatant removed from the tube after the attainment of adsorption equilibrium

and replaced by the same volume of a 0,01 M CaCl2 solution (cm3).

The Freundlich desorption equation is shown in (16):

s (cid:133)eq(cid:134) = Kdes
Cdes
F

• Cdes

aq (cid:133)eq(cid:134)1=n(cid:133)(cid:22)g gﬂ1(cid:134)

or in the linear form:

logCdes

s (cid:133)eq(cid:134) = logKdes

F + 1=n • logCdes

aq (cid:133)eq(cid:134)

(cid:133)16(cid:134)

(cid:133)17(cid:134)

where:

des

KF

= Freundlich desorption coefficient

n

= regression constant

des(eq)
Caq

= mass concentration of the substance in the aqueous phase at desorption equilibrium (lg cmﬂ3).

The equations 16 and 17 can be plotted and the value of KF
using the equation 17.

des and 1/n are calculated by regression analysis

Remark:

If the Freundlich adsorption or desorption exponent 1/n is equal to 1, the Freundlich adsorption or desorption
des) will be equal to the adsorption or desorption equilibrium constants (Kd and
binding constant (KF
Kdes) respectively, and plots of Cs vs Caq will be linear. If the exponents are not equal to 1, plots of Cs vs Caq
will be non-linear and the adsorption and desorption constants will vary along the isotherms.

ads and KF

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2.2.2.

Testreport

The test report should include the following information:

(cid:151) Complete identification of the soil samples used including:

(cid:151) geographical reference of the site (latitude, longitude),

(cid:151) date of sampling,

(cid:151) use pattern (e.g. agricultural soil, forest, etc.),

(cid:151) depth of sampling,

(cid:151) sand/silt/clay content,

(cid:151) pH values (in 0,01 M CaCl2),

(cid:151) organic carbon content,

(cid:151) organic matter content,

(cid:151) nitrogen content,

(cid:151) C/N ratio,

(cid:151) cation exchange capacity (mmol/kg),

(cid:151) all information relating to the collection and storage of soil samples,

(cid:151) where appropriate, all relevant information for the interpretation of the adsorption/desorption of the

test substance,

(cid:151) reference of the methods used for the determination of each parameter,

(cid:151) information on the test substance as appropriate,

(cid:151) temperature of the experiments,

(cid:151) centrifugation conditions,

(cid:151) analytical procedure used to analyse the test substance,

(cid:151) justification for any use of solubilising agent for the preparation of the stock solution of the test

substance,

(cid:151) explanations of corrections made in the calculations, if relevant,

(cid:151) data according to the form sheet (Appendix 6) and graphical presentations,

(cid:151) all information and observations helpful for the interpretation of the test results.

3.

REFERENCES

(1)

(2)

(3)

Kukowski H. and Br(cid:252)mmer G., (1987). Investigations on the Adsorption and Desorption of Selected
Chemicals in Soils. UBA Report 106 02 045, Part II.

Fr(cid:228)nzle O., Kuhnt G. and Vetter L., (1987). Selection of Representative Soils in the EC-Territory. UBA
Report 106 02 045, Part I.

Kuhnt G. and Muntau H.
Special Publication No 1.94.60, Joint Research Centre. European Commission, ISPRA, December 1994.

Identification, Collection, Treatment, Characterisation.

(Eds.) EURO-Soils:

(4) OECD Test Guidelines Programme,

Final Report of

the OECD Workshop on Selection of

Soils/Sediments, Belgirate, Italy, 18-20 January 1995 (June 1995).

(5) US Environment Protection Agency: Pesticide Assessment Guidelines, Subdivision N, Chemistry:
Environmental Fate, Series 163-1, Leaching and Adsorption/Desorption Studies, Addendum 6 on Data
Reporting, 540/09-88-096, Date: 1/1988.

(6) US Environment Protection Agency: Prevention, Pesticides and Toxic Substances, OPPTS Harmonized
Test Guidelines, Series 835-Fate, Transport and Transformation Test Guidelines, 0PPTS No: 835.1220
Sediment and Soil Adsorption/Desorption Isotherm. EPA No: 712-C-96-048, April 1996.

21.8.2001

EN

Official Journal of the European Communities

L 225/217

(7) ASTM Standards, E 1195-85, Standard Test Method for Determining a Sorption Constant (Koc) for an

Organic Chemical in Soil and Sediments.

(8) Agriculture Canada: Environmental Chemistry and Fate. Guidelines for registration of pesticides in

Canada, 15 July 1987.

(9) Netherlands Commission Registration Pesticides (1995): Application for registration of a pesticide.

Section G. Behaviour of the product and its metabolites in soil, water and air.

(10) Danish National Agency of Environmental Protection (October 1988): Criteria for registration of

pesticides as especially dangerous to health or especially harmful to the environment.

(11) BBA (1990), Guidelines for the Official Testing of Plant Protection Products, Biological Research Centre

for Agriculture and Forestry, Braunschweig, Germany.

(12) Calvet R., (1989), (cid:145)Evaluation of adsorption coefficients and the prediction of the mobilities of pesticides
in soils(cid:146), in Methodological Aspects of the Study of Pesticide Behaviour in Soil (ed. P. Jamet), INRA, Paris,
(Review).

(13) Calvet R., (1980), (cid:145)Adsorption-Desorption Phenomena(cid:146) in Interactions between herbicides and the soil.

(R. J. Hance ed.), Academic Press, London, pp. 83-122.

(14) Hasset J. J., and Banwart W.L., (1989),

(cid:145)The sorption of nonpolar organics by soils and sediments(cid:146) in
Reactions and Movement of Organic Chemicals in Soils. Soil Science Society of America (S.S.S.A),
Special Publication no. 22, pp. 31-44.

(15) van Genuchten M. Th., Davidson J. M., and Wierenga P.

(cid:145)An evaluation of kinetic and
equilibrium equations for the prediction of pesticide movement through porous media(cid:146). Soil Sci. Soc.
Am. Proc., Vol. 38(1), pp. 29-35.

(1974),

J.,

(16) McCall P. J., Laskowski D. A., Swann R. L., and Dishburger H. J., (1981),

(cid:145)Measurement of sorption
coefficients of organic chemicals and their use, in environmental fate analysis(cid:146), in Test Protocols for
Environmental Fate and Movement of Toxicants. Proceedings of AOAC Symposium, AOAC, Washington
DC.

(17) Lambert S. M., Porter P. E., and Schieferrstein R. H., (1965),

(cid:145)Movement and sorption of chemicals

applied to the soil(cid:146). Weeds, 13, pp. 185-190.

(18) Rhodes R. C., Belasco I.

J., and Pease H. L.,

(1970)

(cid:145)Determination of mobility and adsorption of

agrochemicals in soils(cid:146). J.Agric.Food Chem., 18, pp. 524-528.

(19) Russell M. H., (1995), (cid:145)Recommended approaches to assess pesticide mobility in soil(cid:146) in Environmental

Behavior of Agrochemicals (ed. T. R. Roberts and P. C. Kearney). John Wiley & Sons Ltd.

(20) Esser H. O., Hemingway R.

(1988),
(cid:145)Recommended approach to the evaluation of the environmental behavior of pesticides(cid:146), IUPAC Reports
on Pesticides (24). Pure Appl. Chem., 60, pp. 901-932.

J., Klein W., Sharp D. B., Vonk J. W. and Holland P. T.,

(21) Guth J. A., Burkhard N., and D. O. Eberle, (1976), (cid:145)Experimental models for studying the persistence of
pesticides in soils(cid:146). Proc. BCPC Symposium: Persistence of Insecticides and Herbicides, pp. 137-157,
BCPC, Surrey, UK.

(22) Furminge C. G. L., and Osgerby J. M., (1967), (cid:145)Persistence of herbicides in soil(cid:146). J. Sci. Fd Agric., 18, pp.

269-273.

(23) Burkhard N., and Guth J. A., (1981), (cid:145)Chemical hydrolysis of 2-Chloro-4,6-bis(alkylamino)-1,3,5-triazine
herbicides and their breakdown in soil under the influence of adsorption(cid:146). Pestic. Sci. 12, pp. 45-52.

(24) Guth J. A., Gerber H. R., and Schlaepfer T., (1977), (cid:145)Effect of adsorption, movement and persistence on

the biological availability of soil-applied pesticides(cid:146). Proc. Br. Crop Prot. Conf., 3, pp. 961-971.

(25) Osgerby J. M., (1973), (cid:145)Process affecting herbicide action in soil(cid:146). Pestic. Sci., 4, pp. 247-258.

(26) Guth J. A., (1972),

(cid:145)Adsorptions- und Einwascheverhalten von Pflanzenschutzmitteln in B(cid:246)den(cid:146). Schr.

Reihe Ver. Wass. -Boden-Lufthyg. Berlin-Dahlem, Heft 37, pp. 143-154.

(27) Hamaker J. W., (1975), (cid:145)The interpretation of soil leaching experiments(cid:146), in Environmental Dynamics of

Pesticides (eds R. Haque and V.H. freed), pp. 135-172, Plenum Press, NY.

(28) Helling C. S., (1971), (cid:145)Pesticide mobility in soils(cid:146). Soil Sci. Soc. Amer. Proc., 35, pp. 732-210.

(29) Hamaker J. W., (1972), (cid:145)Diffusion and volatilization(cid:146) in Organic chemicals in the soil environment (C.A.I.

Goring and J. W. Hamaker eds), Vol. I, pp. 49-143.

L 225/218

EN

Official Journal of the European Communities

21.8.2001

(30) Burkhard N. and Guth J. A., (1981), (cid:145)Rate of volatilisation of pesticides from soil surfaces; Comparison of
calculated results with those determined in a laboratory model system(cid:146). Pestic. Sci. 12, pp. 37-44.

(31) Cohen S. Z., Creeger S. M., Carsel R.F., and Enfield C.G., (1984), (cid:145)Potential pesticide contamination of
groundwater from agricultural uses(cid:146), in Treatment and Disposal of Pesticide Wastes, pp. 297-325, Acs
Symp. Ser. 259, American Chemical Society, Washington, DC.

(32) Gustafson D.

I.,

(1989),

(cid:145)Groundwater ubiquity score: a simple method for assessing pesticide

leachability(cid:146). J. Environ. Toxic. Chem., 8(4), pp. 339-357.

(33) Leistra M., and Dekkers W. A., (1976). (cid:145)Computed effects of adsorption kinetics on pesticide movement

in soils(cid:146). J. of Soil Sci., 28, pp. 340-350.

(34) Bromilov R. H., and Leistra M., (1980), (cid:145)Measured and simulated behavior of aldicarb and its oxydation

products in fallow soils(cid:146). Pest. Sci., 11, pp. 389-395.

(35) Green R. E., and Karickoff S. W., (1990),

(cid:145)Sorption estimates for modeling(cid:146), in Pesticides in the Soil
Environment: Process, Impacts and Modeling (ed. H.H. Cheng). Soil Sci. Soc. Am., Book Series no. 2, pp.
80-101,

(36) Lambert S. M., (1967), (cid:145)Functional relationship between sorption in soil and chemical structure(cid:146). J. Agri.

Food Chem., 15, pp. 572-576.

(37) Hance R. J., (1969),

(cid:145)An empirical relationship between chemical structure and the sorption of some

herbicides by soils(cid:146). J. Agri. Food Chem., 17, pp. 667-668.

(38) Briggs G. G. (1969), (cid:145)Molecular structure of herbicides and their sorption by soils(cid:146). Nature, 223, 1288.

(39) Briggs G. G. (1981). (cid:145)Theoretical and experimental relationships between soil adsorption, octanol-water
J. Agric. Food

partition coefficients, water solubilities, bioconcentration factors, and the parachor(cid:146).
Chem., 29, pp. 1050-1059.

(40) Sabljic A.,

(1984),

(cid:145)Predictions of the nature and strength of soil sorption of organic polutance by

molecular topology(cid:146). J. Agric. Food Chem., 32, pp. 243-246.

(41) Bailey G. W., and White J. L., (1970), (cid:145)Factors influencing the adsorption, desorption, and movement of

pesticides in soil(cid:146). Residue Rev., 32, pp. 29-92.

(42) Bailey G. W.,

(cid:145)Adsorption of organic herbicides by
montomorillonite: Role of pH and chemical character of adsorbate(cid:146). Soil Sci. Soc. Amer. Proc. 32: pp.
222-234.

J. L. White and Y. Rothberg.,

(1968),

(43) Karickhoff S. W., (1981),

(cid:145)Semi-empirical estimation of sorption of hydrophobic pollutants on natural

sediments and soils(cid:146). Chemosphere 10, pp. 833-846.

(44) Paya-Perez A., Riaz M. and Larsen B.,

(1989),
Congeners(cid:146). Environ. Toxicol. Safety 21, pp. 1-17.

(cid:145)Soil Sorption of 6 Chlorobenzenes and 20 PCB

(45) Hamaker J. W., and Thompson J. M., (1972), (cid:145)Adsorption in organic chemicals(cid:146) in Organic Chemicals in
the Soil Environment (Goring C.A.I. and Hamaker J.W., eds), Vol I and II, Marcel Dekker, Inc., New
York, NY, 1972, pp. 49-143.

(46) Deli J., and Warren G. F., 1971, (cid:145)Adsorption, desorption and leaching of diphenamid in soils(cid:146). Weed Sci.

19: pp. 67-69.

(47) Chu-Huang Wu, Buehring N., Davinson J. M. and Santelmann,

(1975),

(cid:145)Napropamide Adsorption,

desorption and Movement in soils(cid:146). Weed Science, Vol. 23, pp. 454-457.

(48) Haues M. H. B., Stacey M., and Thompson J. M., (1968),

(cid:145)Adsorption of s-triazine herbicides by soil
in Isotopes and Radiation in Soil Organic Studies, p.75, International. Atomic

organic preparations(cid:146)
Energy Agency, Vienna.

(49) Pionke H. B., and Deangelis R. J., (1980), (cid:145)Methods for distributing pesticide loss in field run-off between
the solution and adsorbed phase(cid:146), CREAMS, in A Field Scale Model for Chemicals, Run-off and Erosion
from Agricultural Management Systems, Chapter 19, Vol.
III: Supporting Documentation, USDA
Conservation Research report.

(50)

ISO Standard Compendium Environment: Soil Quality (cid:151) General aspects; chemical and physical
methods of analysis; biological methods of analysis. First Edition (1994).

(51) Scheffer F., and Schachtschabel, Lehrbuch der Bodenkunde, F. Enke Verlag, Stuttgart (1982), 11th

edition.

21.8.2001

EN

Official Journal of the European Communities

L 225/219

(52) Black, Evans D. D., White J. L., Ensminger L. E., and Clark F. E., eds. (cid:145)Methods of Soil Analysis(cid:146), Vol 1

and 2, American Society of Agronomy, Madison, WI, 1982.

(53)

ISO/DIS 10381-1 Soil Quality (cid:151) Sampling (cid:151) Part 1: Guidance on the design of sampling programmes.

(54)

ISO/DIS 10381-2 Soil Quality (cid:151) Sampling (cid:151) Part 2: Guidance on sampling techniques.

(55)

ISO/DIS 10381-3 Soil Quality (cid:151) Sampling (cid:151) Part 3: Guidance on safety of sampling.

(56)

ISO/DIS 10381-4 Soil Quality (cid:151) Sampling (cid:151) Part 4: Guidance on the investigation of natural and
cultivated soils.

(57)

ISO/DIS 10381-5 Soil Quality (cid:151) Sampling (cid:151) Part 5: Guidance on the investigation of
contamination of urban and industrial sites.

soil

(58)

ISO 10381-6, 1993: Soil Quality (cid:151) Sampling (cid:151) Part 6: Guidance on the collection, handling and
storage of soil for the assessment of aerobic microbial processes in the laboratory.

(59) Green R. E., and Yamane V. K., (1970), (cid:145)Precision in pesticide adsorption measurements(cid:146). Soil Sci. Am.

Proc., 34, pp. 353-354.

(60) Grover R., and Hance R. J. (1970), (cid:145)Effect of ratio of soil to water on adsorption of linuron and atrazine(cid:146).

Soil Sci., pp. 109-138.

(61) Boesten, J. J. T. I,

(cid:145)Influence of soil/liquid ratio on the experimental error of sorption coefficients in

pesticide/soil system(cid:146). Pest. Sci. 1990, 30, pp. 31-41.

(62) Boesten, J. J. T. I.

(cid:145)Influence of soil/liquid ratio on the experimental error of sorption coefficients in
relation to OECD guideline 106(cid:146). Proceedings of 5th international workshop on environmental
behaviour of pesticides and regulatory aspects, Brussels, 26-29 April 1994.

(63) Bastide J., Cantier J. M., et Coste C., (1980),

(cid:145)Comportement de substances herbicides dans le sol en

fonction de leur structure chimique(cid:146). Weed Res. 21, pp. 227-231.

(64) Brown D. S., and Flagg E. W., (1981),

(cid:145)Empirical prediction of organic pollutants sorption in natural

sediments(cid:146). J. Environ.Qual., 10(3), pp. 382-386.

(65) Chiou C. T., Porter P. E., and Schmedding D. W.,

(1983),

(cid:145)Partition equilibria of non-ionic organic

compounds between soil organic matter and water(cid:146). Environ. Sci. Technol., 17(4), pp. 227-231.

(66) Gerstl Z., and Mingelgrin U.,

(1984),

(cid:145)Sorption of organic substances by soils and sediments(cid:146).

J.

Environm. Sci. Health, B19 (3), pp. 297-312.

(67) Vowles P. D., and Mantoura R. F. C., (1987), (cid:145)Sediment-water partition coefficient and HPLC retention

factors of aromatic hydrocarbons(cid:146). Chemosphere, 16(1), pp. 109-116.

(68) Lyman W. J.

, Reehl W. F.and Rosenblatt D. H. (1990). Handbook of Chemical Property Estimation
Methods. Environmental Behaviour of Organic Compounds. American Chemical Society, Washington
DC.

(69) Keniga E. E., and Goring, C. A.

(cid:145)Relationship between water solubility, soil sorption,
octanol-water partitioning and concentration of chemicals in the biota(cid:146) in Aquatic Toxicology (eds J.G.
Eaton, et al.), pp.78-115, ASTM STP 707, Philadelphia.

(1980).

I.

(70) Chiou C. T., Peters L.

J., and Freed V. H.,

(1979),

(cid:145)A physical concept of soil-water equilibria for

non-ionic organic compounds(cid:146). Science, Vol. 206, pp. 831-832.

(71) Hassett J. J., Banwart W. I., Wood S. G., and Means J. C., (1981), (cid:145)Sorption of /-Naphtol: implications

concerning the limits of hydrophobic sorption(cid:146). Soil Sci. Soc. Am. J. 45, pp. 38-42.

(72) Karickhoff S. W., (1981),

(cid:145)Semi-empirical estimation of sorption of hydrophobic pollutants on natural

sediments and soils(cid:146). Chemosphere, Vol. 10(8), pp. 833-846.

(73) Moreale A., van Bladel R.,

(1981),

(cid:145)Adsorption de 13 herbicides et insecticides par le sol. Relation

solubilitØ-reactivitØ(cid:146). Revue de l’Agric., 34 (4), pp. 319-322.

(74) M(cid:252)ller M., K(cid:246)rdel W. (1996),

(cid:145)Comparison of screening methods for the determination/estimation of

adsorption coefficients on soil(cid:146). Chemosphere, 32(12), pp. 2493-2504.

(75) K(cid:246)rdel W., Kotthoff G., M(cid:252)ller M. (1995),

(cid:145)HPLC (cid:151) screening method for the determination of the

adsorption coefficient on soil (cid:151) results of a ring test(cid:146). Chemosphere 30 (7), pp. 1373-1384.

L 225/220

EN

Official Journal of the European Communities

21.8.2001

(76) K(cid:246)rdel W., Stutte J., Kotthoff G.

(cid:145)HPLC (cid:151) screening method for the determination of the
adsorption coefficient on soil (cid:151) comparison of different stationary phases(cid:146). Chemosphere 27 (12), pp.
2341-2352.

(1993),

(77) Hance, R.

J.,

(1967),

(cid:145)The Speed of Attainment of Sorption Equilibria in Some Systems Involving

Herbicides(cid:146). Weed Research, Vol. 7, pp. 29-36.

(78) Koskinen W. C., and Harper S. S., (1990), (cid:145)The retention processes: mechanisms(cid:146) in Pesticides in the Soil
Environment: Processes, Impacts and Modelling (ed. H.H. Cheng). Soil Sci. Soc. Am. Book Series, No. 2,
Madison, Wisconsin.

(79) Cohen S. Z., Creeger S. M., Carsel R. F., and Enfield C. G. (1984), (cid:145)Potential pesticide contamination of
groundwater from agricultural uses(cid:146), in Treatment and Disposal of Pesticide Wastes, pp.297-325, ACS
Symp. Ser. 259, American Chemical Society, Washington, DC.

(80) Giles C. H., (1970), (cid:145)Interpretation and use of sorption isotherms(cid:146) in Sorption and Transport Processes in

Soils. S.C.I. Monograph No. 37, pp. 14-32.

(81) Giles, C. H.; McEwan J. H.; Nakhwa, S.N. and Smith, D, (1960), (cid:145)Studies in adsorption: XI. A system of
classification of solution adsorption isotherms and its use in the diagnosis of adsorption mechanisms
and in measurements of pesticides surface areas of soils(cid:146). J. Chem. Soc., pp. 3973-93.

(82) Calvet R., TercØ M., and Arvien J. C., (1980), (cid:145)Adsorption des pesticides par les sols et leurs constituants:

3. CaractØristiques gØnØrales de l’adsorption(cid:146). Ann. Agron. 31: pp. 239-251.

(83) Bedbur E., (1996), (cid:145)Anomalies in the Freundlich equation(cid:146), Proc. COST 66 Workshop, Pesticides in soil

and the environment, 13-15 May 1996, Stratford-upon-Avon, UK.

(84) Guth,

J. A.,

(1985),

(cid:145)Adsorption/desorption(cid:146),

in Joint

International Symposium, Physicochemical

Properties and their Role in Environmental Hazard Assessment, July 1-3, Canterbury, UK.

(85) Soil Texture Classification (US and FAO systems): Weed Science, 33, Suppl. 1 (1985) and Soil Sci. Soc.

Amer. Proc. 26:305 (1962).

21.8.2001

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APPENDIX 1

TESTING SCHEME

Set up of a suitable analytical method

Available?

Yes

No

No further test

Preliminary study

2 soils

Selection of optimal 
soil/solution ratios

Determination of 
equilibrium time

Check for adsorption 
on the vessel surface

Check of the stability by means
of parental mass balance

If mass balance < 90 %, test substance 
is unstable in the time scale of the test. The test 
can continue by analysing both phases 
(soil and aqueous solution)

Equilibrium plateau 
is achieved?

Yes

Adsorption kinetics

5 soils

Kd* (msoil/V0) > 0,3 (indirect method: measurement of solution depletion)
Kd* (msoil/V0) > 0,1 (direct method: measurement of both phases)

as appropriate

Adsorption isotherms

Desorption kinetics

Desorption isotherms

e
t
i
s
i
u
q
e
r
e
r
P

1

r
e
i
T

2

r
e
i
T

3

r
e
i
T

 
 
 
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INFLUENCE OF ACCURACY OF ANALYTICAL METHOD AND CONCENTRATION CHANGE ON ACCURACY
OF ADSORPTION RESULTS

APPENDIX 2

From the following table (84) it becomes obvious that when the difference between the initial mass (m0 = 110 lg) and
equilibrium mass (mads
aq (eq) = 100 lg) of the test substance in the solution is very small, an error of 5 % in the
measurement of equilibrium concentration results in an error of 50 % in the calculation of the mass of the substance
adsorbed in soil (mads

(eq)) and of 52,4 % in the calculation of the Kd.

s

Amount of soil
Volume of solution

msoil = 10 g
V0

= 100 cm3

mads

aq (eq)
(lg)

Cads
aq (eq)
(lg cmﬂ3)

R

(eq)*

(mads
s
(lg)

Cads
(eq)*
s
(lg gﬂ1)

R(cid:135)

Kd*

R(cid:135)

1,000

1,010

1,050

1,090

0,500

0,505

0,525

0,550

FOR A = 9 %

true value

10

1 %

5 %

9 %

9

5

1

1,00

0,90

0,50

0,10

FOR A = 55 %

true value

1

10 %

50 %

90 %

true value

1 %

5 %

10 %

60,0

59,5

57,5

55,0

6,00

5,95

5,75

5,50

true value

0,8 %

4,0 %

8,3 %

FOR A = 99 %

0,011

true value

108,9

10,89

true value

0,01111

0,01155

1 %

5 %

108,889

10,8889

0,01 %

108,845

10,8845

0,05 %

0,0121

10 %

108,790

10,8790

0,10 %

0,891

0,476

0,092

12,00

11,78

10,95

10,00

990

980

942

899

10,9 %

52,4 %

90,8 %

1,8 %

8,8 %

16,7 %

1,0 %

4,8 %

9,2 %

3

m
c
/
g
l

0
0
1
1

,

r
o

g
l

0
1
1

=

0

=

m

0
C

3

m
c
/
g
l

0
0
1
1

,

r
o

g
l

0
1
1

=

0

=

m

0
C

3

m
c
/
g
l

0
0
1
1

,

r
o

g
l

0
1
1

=

0

=

m

0
C

100

101

105

109

50,0

50,5

52,5

55,0

1,100

1,111

1,155

1,21

Where:

(eq)= m0 ﬂ mads

s (cid:133)eq(cid:134)
aq (cid:133)eq(cid:134)
(eq) = mass of the test substance in the soil phase at equilibrium, lg

aq (cid:133)eq(cid:134); Cads

s (cid:133)eq(cid:134) =

mbodem

; Kd =

mads
mads

aq (cid:133)eq(cid:134)

V0

V0
mbodem

*mads
s

mads
s

(cid:2)
C0 ﬂ Cads

(cid:3)

mads

aq (eq) = mass of the test substance in the aqueous phase at equilibrium, lg

Cads
s

(eq) = content of the test substance in the soil phase at equilibrium, lg gﬂ1

Cads

aq (eq) = mass concentration of the test substance in the aqueous phase at equilibrium, lg cmﬂ3

R

R(cid:135)

= analytical error in the determination of the mads

aq (eq)

= calculated error due to the analytical error R.

21.8.2001

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APPENDIX 3

ESTIMATION TECHNIQUES FOR Kd

1.

(39)
Estimation techniques permit prediction of Kd based on correlations with, for example, Pow values (12)
(63-68), water solubility data (12) (19) (21) (39) (68-73), or polarity data derived by application of HPLC on
reversed phase (74-76). As shown in Tables 1 and 2, is the Koc or Kom that are calculated from these equations and
then, indirectly, the Kd from the equations:

Koc = Kd •

100
%oc

(cid:133)cm3 gﬂ1(cid:134)

Kom =

Kd
1; 724

100
%oc

•

(cid:133)cm3 gﬂ1(cid:134)

2. The concept of these correlations is based on two assumptions: (1) it is the organic matter of the soil that mainly
influences the adsorption of a substance; and (2) the interactions involved are mainly non-polar. As a result, these
correlations: (1) are not, or are only to some extent, applicable to polar substances, and (2) are not applicable in
cases where the organic matter content of the soil is very small (12). In addition, although satisfactory correlations
have been found between Pow and adsorption (19), the same cannot be said for the relationship between water
solubility and extent of adsorption (19) (21); so far the studies are very contradictory.

3.

Some examples of correlations between the adsorption coefficient and the octanol-water partition coefficient, as
well as water solubility are given in Tables 1 and 2, respectively.

Table 1. Examples of correlations between the adsorption distribution coefficient and the octanol-water partition

coefficient; for further examples (12) (68)

Substances

Correlations

Authors

Substituted ureas

log Kom = 0,69 + 0,52 log Pow

Briggs (1981) (39)

Aromatic chlorinated

log Koc = ﬂ0,779 + 0,904 log Pow

Chiou et al. (1983) (65)

Various pesticides

log Kom = 4,4 + 0,72 log Pow

Gerstl and Mingelgrin (1984) (66)

Aromatic hydrocarbons

log Koc = ﬂ2,53 + 1,15 log Pow

Vowles and Mantoura (1987) (67)

Table 2. Examples of correlations between the adsorption distribution coefficient and water solubility; for further

examples see (68) (69)

Compounds

Correlations

Authors

Various pesticides

log Kom = 3,8 - 0,561 log Sw

Gerstl and Mingelgrin (1984) (66)

Aliphatic, aromatic
chlorinated substances

log Kom = (4,040 +/ﬂ 0,038) (cid:150)
(0,557 +/ﬂ 0,012) log Sw

Chiou et al. (1979) (70)

a-naphtol

log Koc = 4,273 - 0,686 log Sw

Hasset et al. (1981) (71)

Cyclic, aliphatic aromatic
substances

log Koc = ﬂ1,405 (cid:150) 0,921 log Sw (cid:150)
0,00953 (mp-25)

Karickhoff (1981) (72)

Various compounds

log Kom = 2,75 - 0,45 log Sw

Moreale van Blade (1982) (73)

L 225/224

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21.8.2001

APPENDIX 4

CALCULATIONS FOR DEFINING THE CENTRIFUGATION CONDITIONS

1. The centrifugation time is given by the following formula, assuming spherical particles:

t =

9
2

(cid:20)

(cid:17)
!2rp2(cid:133)(cid:26)s ﬂ (cid:26)aq(cid:134)

(cid:21)

ln(cid:133)Rb=Rt

(cid:134)

(cid:133)1(cid:134)

For simplification purposes, all parameters are described in non-SI units (g, cm).

where:

x

= rotational speed (=2 p rpm/60), rad sﬂ1

rpm = revolutions per minute

g

rp

qs

qaq

Rt

Rb

= viscosity of solution, g sﬂ1 cmﬂ1

= particle radius, cm

= soil density, g cmﬂ3

= solution density, g cmﬂ3

= distance from the centre of centrifuge rotor to top of solution in centrifuge tube, cm

= distance from the centre of centrifuge rotor to bottom in centrifuge tube, cm

Rb-Rt = length of the soil/solution mixture in the centrifuge tube, cm.

In general practice, double the calculated times is used to ensure complete separation.

2. The equation (1) can be simplified further if we consider the viscosity (g) and the density (qaq) of the solution as

equal to the viscosity and density of water at 25 (cid:176)C; thus, g = 8,95 (cid:215) 10ﬂ3 g sﬂ1 cmﬂ1 and qaq = 1,0 g, cmﬂ3.

Then, the centrifugation time is given by the equation (2):

t =

3; 7
(cid:133)rpm(cid:134)2 • rp

2(cid:133)(cid:26)s ﬂ 1(cid:134)

ln

Rb
Rt

(cid:133)2(cid:134)

3.

4.

From the equation 2 it becomes apparent that two parameters are important in defining the centrifugation
condition, i.e. time (t) and speed (rpm), in order to achieve separation of particles with a specific size (in our case
0,1 lm radius): (1) the density of the soil and (2) the length of the mixture in the centrifuge tube (Rb-Rt), i.e. the
distance which a soil particle covers from the top of the solution to the bottom of the tube; obviously, for a fixed
volume the length of the mixture in the tube will depend on the square of the radius of the tube.

Fig. 1 presents variations in the centrifugation time (t) versus centrifugation speed (rpm) for different soil densities
(qs) (Fig. 1a) and different lengths of the mixture in the centrifuge tubes (Fig. 1b). From Fig. 1a the influence of the
soil density appears obvious; for example, for a classical centrifugation of 3 000 rpm the centrifugation time is
approximately 240 min. for 1,2 g cm3 soil density, while it is only 50 min. for 2,0 g cm3. Similarly, from Fig. 1b,
for a classical centrifugation of 3 000 rpm the centrifugation time is approximately 50 min. for a length of the
mixture of 10 cm and only 7 min. for a length of 1 cm. However, it is important to find an optimal relation
between centrifugation which requires the less length possible and easy handling for the experimenter in separating
the phases after centrifugation.

21.8.2001

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L 225/225

5. Moreover, when defining the experimental conditions for the separation of soil/solution phases, it is important to
consider the possible existence of a third (cid:145)pseudo-phase(cid:146), the colloids. These particles, with a size less than 0,2 lm,
can have an important impact on the whole adsorption mechanism of a substance in a soil suspension. When
centrifugation is performed as described above, colloids remain in the aqueous phase and are subjected to analysis
together with the aqueous phase. Thus, the information about their impact is lost.

If the conducting laboratory has ultracentrifugation or ultrafiltration facilities, the adsorption/desorption of a
substance in soil could be studied more in depth, including information on the adsorption of the substance on the
colloids. In this case, an ultracentrifugation at 60 000 rpm/min. or an ultrafiltration with filter porosity of 100 000
Daltons should be applied in order to separate the three phases soil, colloids, solution. The test protocol should
also be modified accordingly, in order all three phases to be subjected to substance analysis.

.

) 1 000
n
m

i

(

e
m

i
t

n
o
i
t
a
g
u
f
i
r
t
n
e
C

100

10

1

æ
s= 1,2 g cm3
æ
s= 1,5 g cm3
æ
s= 2 g cm3

1 day

1 hour

æ
s= 4 g cm3
æ
s= 6 g cm3

1 000

10 000

Centrifugation speed (rpm)

Fig. 1a. Variations of centrifugation time (t) versus centrifugation speed (rpm) for different soil densities (qs).

Rt = 10 cm, Rb-Rt = 10 cm, g = 8,95 (cid:215) 10ﬂ3 g sﬂ1 cmﬂ1 and qaq = 1,0 g cmﬂ3 at 25 (cid:176)C.

.

) 1 000
n
m

i

(

e
m

i
t

n
o
i
t
a
g
u
f
i
r
t
n
e
C

100

10

1
100

L = 20 cm
L = 10 cm

1 day

1 hour

L = 5 cmL = 2 cmL = 1 cm

1 000

10 000

Centrifugation speed (rpm)

Fig. 1b. Variations of centrifugation time (t) versus centrifugation speed (rpm) for different lengths of the mixture
in the centrifuge tube (Rb-Rt) = L; Rt = 10 cm, g = 8,95 (cid:215) 10ﬂ3 g sﬂ1 cmﬂ1, qaq = 1,0 g cmﬂ3 at 25 (cid:176)C and
qs = 2,0 g cmﬂ3.

 
 
 
 
L 225/226

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APPENDIX 5

CALCULATION OF ADSORPTION A (%) AND DESORPTION D (%)

The time scheme of the procedure is:

˜t1

˜t2

˜tn(cid:150)1

˜tn

t0

t1

t2

tn(cid:150)2

tn(cid:150)1

tn

Time t

For all the calculations it is assumed that the test substance is stable and does not adsorb significantly to the container
walls.

ADSORPTION A (A%)

(a) Parallel method

The percentage adsorption is calculated for each test tube (i) at each time point (ti), according to the equation:

At i =

mads

s (cid:133)ti(cid:134) • 100
m0

(cid:133)%(cid:134)

The terms of this equation may be calculated as follows:

m0 = C0 • V0 (cid:133)lg(cid:134)

mads

s (cid:133)ti(cid:134) = m0 ﬂ Cads

aq (cid:133)ti(cid:134) • V0 (cid:133)lg(cid:134)

(cid:133)1(cid:134) (1)

(cid:133)2(cid:134)

(cid:133)3(cid:134)

where:

Ati

= adsorption percentage (%) at the time point ti

ms

ads(ti)

= mass of the test substance on soil at the time ti that the analysis is performed (lg)

m0

C0

ads(ti)
Caq

= mass of test substance in the test tube, at the beginning of the test (lg)

= initial mass concentration of the test solution in contact with the soil (lg cmﬂ3)

= mass concentration of the substance in the aqueous phase at the time ti that the analysis is performed
(lg cmﬂ3); this concentration is analytically determined taking into account the values given by the
blanks

V0

= initial volume of the test solution in contact with the soil (cm3).

The values of the adsorption percentage Ati
equilibrium is attained is determined. Examples of such plots are given in Fig. 1 and Fig. 2 respectively.

ads(ti) are plotted versus time and the time after which the sorption

or Caq

(1) Equation applicable to both direct and indirect methods. All the other equations are applicable only to indirect method.

21.8.2001

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)

%

(

i

t

A
n
o
i
t
p
r
o
s
d
a

e
g
a
t
n
e
c
r
e
P

100

90

80

70

60

50

40

30

20

10

0

)
3
-

m
c

g
(cid:236)
(

s
d
q
a
a
C
n
o
i
t
a
r
t
n
e
c
n
o
C

100

90

80

70

60

50

40

30

20

10

0

00

5 

10 

15 

20 

25 

30 

35 

40 

45 

50

Equilibration time ti (h)

Fig. 1. Adsorption equilibrium plot

C0

Cads (eq)

aq

00

5 

10 

15 

20 

25 

30 

35 

40 

45 

50

Equilibration time ti (h)

Fig. 2. Mass concentration of the test substance in the aqueous phase (Caq) versus time

(b) Serial method

The following equations take into account that the adsorption procedure is carried out by measurements of the test
substance in small aliquots of the aqueous phase at specific time intervals.

(cid:151) During each time interval the amount of the substance adsorbed on the soil is calculated as follows:

(cid:151) for the first time interval Dti = tiﬂ t0

mads

s (cid:133)Dt1(cid:134) = m0 ﬂ mads

m (cid:133)t1(cid:134) •

(cid:18) (cid:19)
V0
vA
a

(cid:151) for the second time interval Dt2 = t2 ﬂ t1

mads

s (cid:133)Dt2(cid:134) = mads

m (cid:133)t1(cid:134) •

(cid:18) (cid:19)
V0
vA
a

ﬂ mads

m (cid:133)t2(cid:134) •

(cid:19)

(cid:18)

V0 ﬂ vA
a
vA
a

(cid:133)4(cid:134)

(cid:133)5(cid:134)

 
 
 
 
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(cid:151) for the third time interval Dt3 = t3 ﬂ t2

mads

s (cid:133)Dt3(cid:134) = mads

m (cid:133)t2(cid:134) •

(cid:19)

(cid:18)

V0 ﬂ vA
a
vA
a

ﬂ mads

m (cid:133)t3(cid:134) •

(cid:19)

(cid:18)

V0 ﬂ 2 • vA
a
vA
a

(cid:151) for the nth time interval Dtn = tn ﬂ tnﬂ1
(cid:18)

mads

s (cid:133)Dtn(cid:134) = mads

m (cid:133)tn ﬂ 1(cid:134) •

V0 ﬂ (cid:133)n ﬂ 2(cid:134) • vA
a
vA
a

(cid:19)

(cid:255)
(cid:18)

ﬂ mads

m (cid:133)tn(cid:134) •

(cid:1)
(cid:19)

V0 ﬂ (cid:133)n ﬂ 1(cid:134) • vA
a
vA
a

(cid:151) The percentage of adsorption at each time interval, ADti
s (cid:133)Dti(cid:134)
m0

ADti =

mads

• 100 (cid:133)%(cid:134)

, is calculated using the following equation:

while the percentage of adsorption (Ati

) at a time point ti is given by the equation:

XDti

j(cid:136)Dt1

mads

s (cid:133)j(cid:134)

m0

Ati =

• 100 (cid:133)%(cid:134)

(cid:133)6(cid:134)

(cid:133)7(cid:134)

(cid:133)8(cid:134) (1)

(cid:133)9(cid:134) (1)

The values of the adsorption Ati
time after which the sorption equilibrium is attained is determined.

or ADti

(with respect to the needs of the study) are plotted versus time and the

(cid:151) At the equilibration time teq:

(cid:151) the mass of the test substance adsorbed on the soil is:

mads

s (cid:133)eq(cid:134) =

Xn

Dti = 1

mads

s (cid:133)Dti(cid:134)

(cid:151) the mass of the test substance in the solution is:

mads

aq (cid:133)eq(cid:134) = m0 ﬂ

Xn

Dti(cid:136)1

mads

s (cid:133)Dti(cid:134)

(cid:151) and the percentage of adsorption at equilibrium is:

Aeq =

mads

s (cid:133)eq(cid:134)
m0

• 100 (cid:133)%(cid:134)

The parameters used above are defined as:

(cid:133)10(cid:134) (1)

(cid:133)11(cid:134) (1)

(cid:133)12(cid:134) (1)

ms

ads(Dt1), ms

ads(Dt2), (cid:133), ms

ads(Dtn)

= mass of the substance adsorbed on the soil during the time intervals Dt1, Dt2,

(cid:133), Dtn respectively (lg)

mm

ads(t1), mm

ads(t2), (cid:133), mn

ads(tn)

= mass of the substance measured in an aliquot va

A at the time points t1, t2, (cid:133),

tn respectively (lg)

ads(eq)

ms

ads(eq)

maq

A
va

ADti

Aeq

= mass of the substance adsorbed on the soil at adsorption equilibrium (lg)

= mass of the substance in the solution at adsorption equilibrium (lg)

= volume of the aliquot in which the test substance is measured (cm3)

= percentage of adsorption corresponding at a time interval Dti (%)

= percentage of adsorption at adsorption equilibrium (%).

(1) Equation applicable to both direct and indirect methods. All the other equations are applicable only to indirect method.

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L 225/229

DESORPTION D (%)

The time t0 that the desorption kinetics experiment begins, is considered as the moment that the maximal recovered
volume of the test substance solution (after that the adsorption equilibrium is attained) is replaced by an equal volume
of 0,01 M CaCl2 solution.

(a) Parallel method

At a time point ti, the mass of the test substance is measured in the aqueous phase taken from the tube i (Vr
the mass desorbed is calculated according to the equation:

i ), and

mdes

aq (cid:133)ti(cid:134) = mdes

m (cid:133)ti(cid:134) •

(cid:18) (cid:19)
V0
vi
r

ﬂ mA
aq

At desorption equilibrium ti = teq and therefore maq

ads(ti) = maq

ads(eq).

The mass of the test substance desorbed during a time interval (Dti) is given by the equation:

mdes

aq (cid:133)Dti(cid:134) = mdes

aq (cid:133)ti(cid:134) ﬂ

Xi ﬂ 1

j(cid:136)1

mdes

aq (cid:133)j(cid:134)

The percentage of desorption is calculated:

(cid:151) at a time point ti from the equation:

Dti =

mdes
aq (cid:133)ti(cid:134)
s (cid:133)eq(cid:134)

mads

• 100 (cid:133)%(cid:134)

(cid:151) and during a time interval (Dti) from the equation:

DDti =

mdes

aq (cid:133)Dti(cid:134)
s (cid:133)eq(cid:134)

mads

• 100 (cid:133)%(cid:134)

(cid:133)13(cid:134)

(cid:133)14(cid:134)

(cid:133)15(cid:134)

(cid:133)16(cid:134)

where:

Dti

DDti

maq

des(ti)

=

=

=

desorption percentage at a time point ti (%)

desorption percentage corresponding to a time interval Dti (%)

mass of the test substance desorbed at a time point ti, (lg)

maq

des(Dti) =

mass of the test substance desorbed during a time interval Dti (lg)

mm

des(ti)

A
maq

=

=

mass of the test substance analytically measured at a time ti in a solution volume Vr
taken for the analysis (lg)

i, which is

mass of the test substance left over from the adsorption equilibrium due to incomplete volume
replacement (lg)

mA

aq = mads

aq (cid:133)eq(cid:134) •

(cid:19)

(cid:18)

V0 ﬂ VR
V0

(cid:133)17(cid:134)

ads(eq) =

maq

mass of the test substance in the solution at adsorption equilibrium (lg)

VR

i
Vr

=

=

volume of the supernatant removed from the tube after the attainment of adsorption equilibrium
and replaced by the same volume of a 0,01 M CaCl2 solution (cm3)

volume of the solution taken from the tube (i) for the measurement of the test substance, in
desorption kinetics experiment (cm3).

L 225/230

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Official Journal of the European Communities

21.8.2001

The values of desorption Dti
which the desorption equilibrium is attained is determined.

or DDti

(according to the needs of the study) are plotted versus time and the time after

(b) Serial method

The following equations take into account that the adsorption procedure, which was preceded, was carried out by
A) of the aqueous phase (serial method in 1.9. Performance of
measurement of test substance in small aliquots (va
the test). It is assumed that: (a) the volume of the supernatant removed from the tube after the adsorption kinetics
experiment was replaced by the same volume of 0,01 M CaCl2 solution (VR) and (b) and the total volume of the
aqueous phase in contact with the soil (VT) during the desorption kinetics experiment remains constant and is
given by the equation:

VT = V0 ﬂ

Xn

i(cid:136)1

vA
a (cid:133)i(cid:134)

(cid:133)18(cid:134)

At a time point ti:

(cid:151) the mass of the test substance is measured in a small aliquot (va

D) and the mass desorbed is calculated,

according to the equation:

mdes

aq (cid:133)ti(cid:134) = mdes

m (cid:133)ti(cid:134) •

(cid:18) (cid:19)
VT
vD
a

ﬂ mA

aq •

(cid:18)

(cid:255)
VT ﬂ (cid:133)i ﬂ 1(cid:134) • vD
a
VT

(cid:1)
(cid:19)

(cid:151) at desorption equilibrium ti = teq and therefore maq

des(ti) = maq

des(eq).

(cid:151) the percentage of desorption Dti

is calculated, from the following equation:

Dti =

mdes
aq (cid:133)ti(cid:134)
s (cid:133)eq(cid:134)

mads

• 100 (cid:133)%(cid:134)

At a time interval (Dti):

During each time interval the amount of the substance desorbed is calculated as follows:

(cid:151) for the first time interval Dt1 = t1ﬂt0

mdes

aq (cid:133)Dt1(cid:134) = mdes

m (cid:133)t1(cid:134) •

ﬂ mA
aq

and mdes

s (cid:133)t1(cid:134) = maq

s (cid:133)eq(cid:134) ﬂ mdes

aq (cid:133)Dt1(cid:134)

(cid:18) (cid:19)
VT
vD
a

(cid:151) for the second time interval Dt2 = t2ﬂt1
(cid:18) (cid:19)
VT
vD
a

aq (cid:133)Dt2(cid:134) = mdes

m (cid:133)t2(cid:134) •

mdes

ﬂ mdes

aq (cid:133)Dt1(cid:134) •

(cid:18)

(cid:133)VT ﬂ vD
a (cid:134)
VT

(cid:19)

(cid:18)

ﬂ mA

aq •

(cid:19)

(cid:133)VT ﬂ vD
a (cid:134)
VT

and

mdes

s (cid:133)t2(cid:134) = mads

s (cid:133)eq(cid:134) ﬂ mdes

aq (cid:133)Dt1(cid:134) + mdes

aq (cid:133)Dt2(cid:134)

h

i

(cid:133)19(cid:134)

(cid:133)20(cid:134)

(21)

(cid:133)22(cid:134)

(cid:151) for the nth interval Dtn = tn-tnﬂ1
"
(cid:18) (cid:19)
VT
vD
a

aq (cid:133)Dtn(cid:134) = mdes

m (cid:133)tn(cid:134) •

mdes

ﬂ mA

aq •

(cid:255)
(cid:18)

VT ﬂ (cid:133)n ﬂ 1(cid:134) • vD
a
VT

(cid:1)
(cid:19)

ﬂ

Xn ﬂ 1

i = 1; n˚1

(cid:18)

(cid:1)

(cid:255)
VT ﬂ (cid:133)n ﬂ i(cid:134) • vD
a
VT

#

(cid:19)

• mdes

aq (cid:133)Dti(cid:134)

and

mdes

s (cid:133)tn(cid:134) = mads

s (cid:133)eq(cid:134) ﬂ

Xn

i(cid:136)1; n˚1

mdes

aq (cid:133)Dti(cid:134)

(cid:133)23(cid:134)

21.8.2001

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Official Journal of the European Communities

L 225/231

Finally, the percentage of desorption at each time interval, DDti

, is calculated using the following equation:

DDti =

mdes

aq (cid:133)Dti(cid:134)
s (cid:133)eq(cid:134)

mads

• 100 (cid:133)%(cid:134)

while the percentage of desorption Dti

at a time point ti is given by the equation:

XDti

j = Dt1

mdes

aq (cid:133)j(cid:134)

mads

s (cid:133)eq(cid:134)

Dti =

• 100 =

mdes
aq (cid:133)ti(cid:134)
s (cid:133)eq(cid:134)

mads

• 100 (cid:133)%(cid:134)

where the above used parameters are defined as:

(cid:133)24(cid:134)

(cid:133)25(cid:134)

ms

des(Dt1), ms

des(Dt2), (cid:133), ms

des(Dtn) = mass of the substance remaining adsorbed on the soil after the time intervals

Dt1, Dt2, (cid:133), Dtn respectively (lg)

maq

des(Dt1), maq

des(Dt2), (cid:133), maq

des(Dtn) = mass of the test substance desorbed during the time intervals Dt1, D t2, (cid:133), Dtn

respectively (lg)

mm

des(t1), mm

des(t2), (cid:133) mm

des(tn)

VT

A
maq

VR

D
va

= mass of the substance measured in an aliquot va

D at time points t1, t2, (cid:133), tn,

respectively (lg)

= total volume of

the aqueous phase in contact with the soil during the

desorption kinetics experiment performed with the serial method (cm3)

= mass of the test substance left over from the adsorption equilibrium due to

incomplete volume replacement (lg)

0

(cid:18)

B
B
B
B
@

mA

aq =

V0 ﬂ
(cid:18)

(cid:19)

vA
a (cid:133)i(cid:134)

Xn

i = 1

V0 ﬂ

vA
a (cid:133)i(cid:134)

Xn

i = 1

ﬂ VR
(cid:19)

1

C
C
C
C
A

• mads

aq (cid:133)eq(cid:134)

(cid:133)26(cid:134)

= volume of the supernatant removed from the tube after the attainment of
adsorption equilibrium and replaced by the same volume of a 0,01 M CaCl2
solution (cm3)

= volume of the aliquot sampled for analytical purpose from the tube (i), during
the desorption kinetics experiment performed with the serialmethod (cm3)

vD
a ˜ 0,02 • VT

(cid:133)27(cid:134)

L 225/232

EN

Official Journal of the European Communities

21.8.2001

APPENDIX 6

ADSORPTION-DESORPTION IN SOILS: DATA REPORTING SHEETS

Substance tested:

Soil tested:

Dry mass content of the soil (105 (cid:176)C, 12 h):

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . %

Temperature:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(cid:176)C

Suitability of the analytical method

Weighed soil

Soil: dry mass

Volume CaCl2 solution

Nominal concentration final solution

Analytical concentration final solution

Principle of the analytical method used:

Calibration of the analytical method:

g

g

cm3

lg cmﬂ3

lg cmﬂ3

21.8.2001

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Official Journal of the European Communities

L 225/233

Substance tested:

Soil tested:

Dry mass content of the soil (105 (cid:176)C, 12 h):

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . %

Temperature:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(cid:176)C

Analytical methodology followed:

Indirect n

Parallel n

Serial

n

Direct

n

Adsorption test: test samples

Symbol

Units

Equilibration time Equilibration time Equilibration time Equilibration time

Tube No

Weighed soil

Soil: dry mass

Water volume in weighed soil
(calculated)

Volume 0,01 M CaCl2 solution
to equilibrate the soil

Volume of stock solution

Total volume of aqueous phase
in contact with soil

Initial concentration test solution

Mass test substance at beginning
of test

(cid:151)

msoil

VWS

V0

C0

m0

g

g

cm3

cm3

cm3

cm3

lg cmﬂ3

lg

After agitation and centrifugation

Indirect method

Parallel method

Concentration test substance
aqueous phase, blank correction
included

aq (ti) lg cmﬂ3
Cads

Measured mass test substance in
aliquot VA
a

mads

aq (ti)

lg

Mass test substance adsorbed on
soil

mads
s

(ti)

lg

Serial method

Direct method

Adsorption

Means

Calculation of adsorption

Ati

ADti

%

%

Adsorption coefficient

Kd

cm3 gﬂ1

Means

Adsorption coefficient

Koc

cm3 gﬂ1

Means

L 225/234

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Official Journal of the European Communities

21.8.2001

Substance tested:

Soil tested:

Dry mass content of the soil (105 (cid:176)C, 12 h):

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . %

Temperature:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(cid:176)C

Adsorption test: blanks and control

Symbol

Units

Blank

Blank

Control

Tube No

Weighed soils

Water amount in weighed soil
(calculated)

Volume of 0,01 M CaCl2 solution
added

Volume of stock solution of test
substance added

Total volume of aqueous phase
(calculated)

Initial concentration of test substance
in aqueous phase

g

cm3

cm3

cm3

0

0

cm3

lg cmﬂ3

Concentration in aqueous phase

lg cmﬂ3

After agitation and centrifugation

Remark: Add columns if necessary.

0

(cid:151)

0

(cid:151)

(cid:151)

(cid:151)

21.8.2001

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Official Journal of the European Communities

L 225/235

Substance tested:

Soil tested:

Dry mass content of the soil (105 (cid:176)C, 12 h):

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . %

Temperature:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(cid:176)C

Tube No

Weighed soil

Soil: dry mass

Water volume in weighed soil (calculated)

Volume 0,01 M CaCl2 solution to equilibrate
soil

Volume of stock solution

Total volume of aqueous phase in contact with
soil

Initial concentration test solution

Equilibration time

Mass balance

Symbol

Units

(cid:151)

msoil

VWS

V0

C0

(cid:151)

g

g

ml

ml

cm3

cm3

lg cmﬂ3

h

After agitation and centrifugation

Concentration test substance aqueous phase at
adsorption, equilibrium blank correction
included

Cads
aq (eq)

lg cmﬂ3

Equalibration time

teq

h

1st dilution with solvent

Removed volume aqueous phase

Added volume of solvent

Vrec

DV

cm3

cm3

1st extraction with solvent

Signal analysed in solvent

Concentration test substance in solvent

Mass of substance extracted from soil and
vessel walls

SE1

CE1

mE1

var.

lg cm-3

lg

Removed volume of solvent

Added volume of solvent

2nd dilution with solvent

DVs

DV¡

cm3

cm3

2nd extraction with solvent

Signal analysed in solvent phase

Concentration test substance in solvent

Mass of substance extracted from soil and
vessel walls

Total mass test substance extracted in two
steps

Mass balance

SE2

CE2

mE2

mE

MB

var.

lg cm-3

lg

lg

%

L 225/236

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Official Journal of the European Communities

21.8.2001

Substance tested:

Soil tested:

Dry mass content of the soil (105 (cid:176)C, 12 h):

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . %

Temperature:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(cid:176)C

Adsorption isotherms

Symbol

Units

Tube No

Weighed soil

Soil: dry mass

Water volume in weighed
soil (calculated)

Volume 0,01 M CaCl2
solution to equilibrate soil

Volume of stock solution
added

Total volume of aqueous
phase in contact with soil
(calculated)

Concentration solution

Equilibration time

Concentration substance
aqueous phase, blank
correction included

Temperature

(cid:151)

E

VWS

V0

C0

(cid:151)

g

g

cm3

cm3

cm3

cm3

lg cmﬂ3

h

After agitation and centrifugation

Cads
aq (eq)

lg cm-3

(cid:176)C

lg gﬂ1

Adsorption mass per unit
soil

Cads
s

(eq)

Regression analysis:

value of Kads

F

:

value of l/n:

regression coefficient r2:

21.8.2001

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Official Journal of the European Communities

L 225/237

Substance tested:

Soil tested:

Dry mass content of the soil (105 (cid:176)C, 12 h):

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . %

Temperature:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(cid:176)C

Analytical methodology followed:

Indirect n

Parallel n

Serial

n

Desorption test

Symbol

Units

Time
interval

Time
interval

Time
interval

Time
interval

Tube No coming from adsorption step

Mass of substance adsorbed on soil at adsorption
equilibrium

mads
s

(eq)

lg

Removed volume aqueous phase, replaced by 0,01 M
CaCl2

Total volume of aqueous phase in contact
with soil

PM
SM

Mass test substance left over the adsorption
equilibrium due to incomplete volume replacement

VR

V0
VT

mA
aq

cm3

cm3
cm3

lg

Desorption kinetics

Measured mass of substance desorbed from soil at
time ti

mdes

m (ti)

lg

Volume of the solution taken from the
tube (i) for the measurement of the test
substance

PM

SM

Mass of substance desorbed from soil at time ti
(calculated)

Mass of substance desorbed from soil during time
interval Dti (calculated)

Vi
r

VD
a

mdes

aq (ti)

mdes
aq

(Dti)

cm3

cm3

lg

lg

Desorption percentage

%

%

Dti

DDti

Kdes

Desorption at time ti

Desorption at time interval Dti

Apparent desorption coefficient

PM: Parallel method

SM: Serial method

L 225/238

EN

Official Journal of the European Communities

21.8.2001

C.19. ESTIMATION OF THE ADSORPTION COEFFICIENT (KOC) ON SOIL AND ON SEWAGE SLUDGE
USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)

1.

METHOD

This method is a replicate of OECD TG121 (2000).

1.1.

INTRODUCTION

The sorption behavior of substances in soils or sewage sludges can be described through parameters
experimentally determined by means of the test method C.18. An important parameter is the adsorption
coefficient which is defined as the ratio between the concentration of the substance in the soil/sludge and the
concentration of the substance in the aqueous phase at adsorption equilibrium. The adsorption coefficient
normalised to the organic carbon content of the soil Koc is a useful indicator of the binding capacity of a
chemical on organic matter of soil and sewage sludge and allows comparisons to be made between different
chemicals. This parameter can be estimated through correlations with the water
solubility and the
n-octanol/water partition coefficient (1) (2) (3) (4) (5) (6) (7).

The experimental method described in this test uses HPLC for the estimation of the adsorption coefficient Koc
in soil and in sewage sludge (8). The estimates are of higher reliability than those from QSAR calculations (9).
As an estimation method it cannot fully replace batch equilibrium experiments used in the test method C18.
However, the estimated Koc may be useful for choosing appropriate test parameters for adsorption/desorption
studies according to the test method C.18 by calculating Kd (distribution coefficient) or Kf
(Freundlich
adsorption coefficient) according to the equation 3 (see section 1.2).

1.2.

DEFINITIONS

Kd: Distribution coefficient is defined as the ratio of equilibrium concentrations C of a dissolved test substance
it is a
in a two phase system consisting of a sorbent
dimensionless value when concentrations in both phases are expressed on a weight/weight base. In case the
concentration in the aqueous phase is given on a weight/volume base then the units are ml • gﬂ1. Kd can vary
with sorbent properties and can be concentration dependent.

(soil or sewage sludge) and an aqueous phase;

Kd =

Csoil
Caq

or

Csludge
Caq

(cid:133)1(cid:134)

where:

Csoil

= concentration of test substance in soil at equilibrium (lg • gﬂ1)

Csludge = concentration of test substance in sludge at equilibrium (lg • gﬂ1)

Caq

= concentration of test substance in aqueous phase at equilibrium (lg • gﬂ1, lg • mlﬂ1).

Kf: Freundlich adsorption coefficient is defined as the concentration of the test substance in soil or sewage
sludge (x/m) when the equilibrium concentration Caq in the aqueous phase is equal to one; units are lg • gﬂ1
sorbent. The value can vary with sorbent properties.

log

x
m

= log Kf +

1
n

• log Caq

(cid:133)2(cid:134)

where:

x/m = amount of test substance x (lg) adsorbed on amount of sorbent m (g) at equilibrium

1/n

= slope of Freundlich adsorption isotherm

Caq

= concentration of test substance in aqueous phase at equilibrium (lg • mlﬂ1)

At Caq = 1;

log Kf = log

x
m

21.8.2001

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Official Journal of the European Communities

L 225/239

Koc: Distribution coefficient (Kd) or Freundlich adsorption coefficient (Kf) normalised to the organic carbon
content (foc) of a sorbent; particularly for non-ionised chemicals, it is an approximate indicator for the extent
of adsorption between a substance and the sorbent and allows comparisons to be made between different
chemicals. Depending on the dimensions of Kd and Kf, Koc can be dimensionless or have the units ml • gﬂ1 or
lg • gﬂ1 organic matter.

Koc =

Kd
foc

(cid:133)dimensionless or ml • gﬂ1(cid:134) or

Kf
foc

(cid:133)(cid:22)g • gﬂ1(cid:134)

(cid:133)3(cid:134)

The relationship between Koc and Kd is not always linear and thus Koc values can vary from soil to soil but
their variability is greatly reduced compared to Kd or Kf values.

The adsorption coefficient (Koc) is deduced from the capacity factor (k¡) using a calibration plot of log k¡
versus log Koc of the selected reference compounds.

k0 =

tR ﬂ t0
t0

(cid:133)4(cid:134)

where:

tR: HPLC retention time of test and reference substance (minutes)

t0: HPLC dead time (minutes) (see section 1.8.2).

POW: The octanol-water partition coefficient
substance in n-octanol and water; it is a dimensionless value.

is defined as the ratio of

the concentrations of dissolved

Pow =

Coctanol
Caq

(cid:133)= Kow(cid:134)

(cid:133)5(cid:134)

1.3.

REFERENCE SUBSTANCES

The structural formula, the purity and the dissociation constant (if appropriate) should be known before using
the method. Information on solubility in water and organic solvents, on octanol-water partition coefficient
and on hydrolysis characteristics is useful.

To correlate the measured HPLC-retention data of a test substance with its adsorption coefficient Koc, a
calibration graph of log Koc versus log k’ has to be established. A minimum of six reference points, at least
one above and one below the expected value of the test substance should be used. The accuracy of the
method will be significantly improved if reference substances that are structurally related to the test substance
are used. If such data are not available, it is up to the user to select the appropriate calibration substances. A
more general set of structurally heterogeneous substances should be chosen in this case. Substances and
Koc-values which may be used are listed in the Appendix in Table 1 for sewage sludge and in Table 3 for soil.
The selection of other calibration substances should be justified.

1.4.

PRINCIPLE OF THE TEST METHOD

HPLC is performed on analytical columns packed with a commercially available cyanopropyl solid phase
containing lipophilic and polar moieties. A moderately polar stationary phase based on a silica matrix is used:

(cid:150) O (cid:150) Si

silica

|

|

|

|

|

|

|

|

(cid:150) CH2 (cid:150) CH2 (cid:150) CH2

non-polar spacer

|

|

|

|

|

|

|

|

(cid:150) CN

polar moiety

L 225/240

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The principle of the test method is similar to testing method A.8 (partition coefficient, HPLC method). While
passing through the column along with the mobile phase the test substance interacts with the stationary
phase. As a result o partitioning between mobile and stationary phases the test substance is retarded. The dual
composition of the stationary phase having polar and non-polar sites allows for interaction of polar and
non-polar groups of a molecule in a similar way as is the case for organic matter in soil or sewage sludge
matrices. This enables the relationship between the retention time on the column and the adsorption
coefficient on organic matter to be established.

pH has a significant influence on sorption behavior in particular for polar substances. For agricultural soils or
tanks of sewage treatment plants pH normally varies between pH 5,5 and 7,5. For ionisable substances, two
tests should be performed with both ionised and non-ionised forms in appropriate buffer solutions but only in
cases where at least 10 % of the test compound will be dissociated within pH 5,5 to 7,5.

Since only the relationship between the retention on the HPLC column and the adsorption coefficient is
employed for the evaluation, no quantitative analytical method is required and only the determination of the
retention time is necessary. If a suitable set of reference substances is available and standard experimental
conditions can be used, the method provides a fast and efficient way to estimate the adsorption coefficient
Koc.

1.5.

APPLICABILITY OF THE TEST

The HPLC method is applicable to chemical substances (unlabelled or labelled) for which an appropriate
detection system (e.g. spectrophotometer, radioactivity detector) is available and which are sufficiently stable
during the duration of the experiment. It may be particularly useful for chemicals which are difficult to study
in other experimental systems (i.e. volatile substances; substances which are not soluble in water at a
concentration which can be measured analytically; substances with a high affinity to the surface of incubation
systems). The method can be used for mixtures which give unresolved elution bands. In such a case, upper
and lower limits of the log Koc values of the compounds of the test mixture should be stated.

Impurities may sometimes cause problems for interpretation of HPLC results, but
they are of minor
importance as long as the test substance can analytically be clearly identified and separated from the
impurities.

The method is validated for the substances listed in Table 1 in the Appendix and was also applied to a variety
of other chemicals belonging to the following chemical classes:

(cid:151) aromatic amines (e.g.
1-naphthylamine),

trifluralin, 4-chloroaniline, 3,5-dinitroaniline, 4-methylaniline, N-methylaniline,

(cid:151) aromatic carboxilic acid esters (e.g. benzoic acid methylester, 3,5-dinitrobenzoic acid ethylester),

(cid:151) aromatic hydrocarbons (e.g. toluene, xylene, ethylbenzene, nitrobenzene),

(cid:151) aryloxyphenoxypropionic acid esters (e.g. diclofop-methyl, fenoxaprop-ethyl, fenoxaprop-P-ethyl),

(cid:151) benzimidazole and imidazole fungicides (e.g. carbendazim, fuberidazole, triazoxide),

(cid:151) carboxilic

(e.g.
N-methylbenzamide, 2-nitrobenzamide, 3-nitrobenzamide),

amides

acid

2-chlorobenzamide, N,N-dimethylbenzamide,

3,5-dinitrobenzamide,

(cid:151) chlorinated hydrocarbons (e.g. endosulfan, DDT, hexachlorobenzene, quintozene, 1,2,3-trichlorobenzene),

(cid:151) organophosphorus insecticides (e.g. azinphos-methyl, disulfoton,

fenamiphos,

isofenphos, pyrazophos,

sulprofos, triazophos),

(cid:151) phenols (e.g. phenol, 2-nitrophenol, 4-nitrophenol, pentachlorophenol, 2,4,6-trichlorophenol, 1-naphthol),

(cid:151) phenylurea derivatives (e.g. isoproturon, monolinuron, pencycuron),

(cid:151) pigment dyestuffs (e.g. Acid Yellow 219, Basic Blue 41, Direct Red 81),

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(cid:151) polyaromatic hydrocarbons (e.g. acenaphthene, naphthalene),

(cid:151) 1,3,5-triazine herbicides (e.g. prometryn, propazine, simazine, terbutryn),

(cid:151) triazole derivatives (e.g. tebuconazole, triadimefon, tradimenol, triapenthenol).

The method is not applicable for substances which react either with the eluent or the stationary phase. It is
also not applicable for substances that interact in a specific way with inorganic components (e.g. formation of
cluster complexes with clay minerals). The method may not work for surface active substances, inorganic
compounds and moderate or strong organic acids and bases. Log Koc values ranging from 1,5 to 5,0 can be
determined. Ionisable substances must be measured using a buffered mobile phase, but care has to be taken to
avoid precipitation of buffer components or test substance.

1.6.

QUALITY CRITERIA

1.6.1.

Accuracy

Normally, the adsorption coefficient of a test substance can be estimated to within – 0,5 log unit of the value
determined by the batch equilibrium method (see Table 1 in the Appendix). Higher accuracy may be achieved
if the reference substances used are structurally related to the test substance.

1.6.2.

Repeatability

Determinations should be run at
measurements should be within a range of 0,25 log unit.

least

in duplicate. The values of

log Koc derived from individual

1.6.3.

Reproducibility

Experience gained so far in the application of the method is supportive of its validity. An investigation of the
HPLC method, using 48 substances (mostly pesticides) for which reliable data on Koc on soils were available
gave a correlation coefficient of R = 0,95 (10) (11).

An inter-laboratory comparison test with 11 participating laboratories was performed to improve and validate
the method (12). Results are given in Table 2 of the Appendix.

1.7.

DESCRIPTION OF THE TEST METHOD

1.7.1.

Preliminary estimation of the adsorption coefficient

The octanol-water partition coefficient Pow (= Kow) and, to some extent, the water solubility can be used as
indicators for the extent of adsorption, particularly for non-ionised substances, and thus may be used for
preliminary range finding. A variety of useful correlations have been published for several groups of chemicals
(1) (2) (3) (4) (5) (6) (7).

1.7.2.

Apparatus

A liquid chromatograph, fitted with a pulse-free pump and a suitable detection device is required. The use of
an injection valve with an injection loop is recommended. Commercial cyanopropyl chemically bound resins
on a silica base shall be used (e.g. Hypersil and Zorbax CN). A guard column of the same material may be
positioned between the injection system and the analytical column. Columns from different suppliers may
vary considerably in their separation efficiency. As a guidance, the following capacity factors k¡ should be
reached:
log k¡ > 0,0 for log Koc = 3,0 and log k¡ > 0,4 for log Koc = 2,0 when using methanol/water
55/45 % as mobile phase.

1.7.3. Mobile phases

Several mobile phases have been tested, and the following two are recommended:

(cid:151) methanol/water (55/45 % v/v),

(cid:151) methanol/0,01M citrate-buffer pH 6,0 (55/45 % v/v).

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HPLC grade methanol and distilled water or citrate buffer are used to prepare the eluting solvent. The mixture
is degassed before use. Isocratic elution should be employed. If methanol/water mixtures are not appropriate,
other organic solvent/water mixtures may be tried, e.g. ethanol/water or acetonitrile/water mixtures. For
ionisable compounds the use of buffer solution is recommended to stabilise pH. Care must be taken to avoid
salt precipitation and column deterioration, which may occur with some organic phase/buffer mixtures.

No additives such as ion pair reagents may be used because they can affect the sorption properties of the
stationary phase. Such changes of the stationary phase may be irreversible. For this reason, it is mandatory
that experiments using additives are carried out on separate columns.

1.7.4.

Solutes

Test and reference substances should be dissolved in the mobile phase.

1.8.

PERFORMANCE OF THE TEST

1.8.1.

Test condition

The temperature during the measurements should be recorded. The use of a temperature controlled column
compartment is highly recommended to guarantee constant conditions during calibration and estimation runs
and measurement of the test substance.

1.8.2.

Determination of dead time to

For the determination of the dead time to two different methods may be used (see also section 1.2).

1.8.2.1. Determination of the dead time to by means of a homologous series

This procedure has proven to yield reliable and standardised to values. For details see testing method A.8:
partition coefficient (n-octanol/water), HPLC method.

1.8.2.2. Determination of the dead time to by inert substances which are not retained by the column

This technique is based on the injection of solutions of formamide, urea or sodium nitrate. Measurements
should be performed at least in duplicate.

1.8.3.

Determination of the retention times tR

Reference substances should be selected as described in section 1.3. They may be injected as a mixed standard
to determine their retention times, provided it has been confirmed that the retention time of each reference
standard is unaffected by the presence of the other reference standards. The calibration should be performed
at regular intervals at least twice daily in order to account for unexpected changes in column performance.
For best practice the calibration injections should be carried out before and after injections of the test
substance to confirm retention times have not drifted. The test substances are injected separately in quantities
as small as possible (to avoid column overload) and their retention times are determined.

In order to increase the confidence in the measurement, at least duplicate determinations should be made. The
values of log Koc derived from individual measurements should fall within a range of 0,25 log unit.

1.8.4.

Evaluation

The capacity factors k¡ are calculated from the dead time to and retention times tR of the selected reference
substances according to equation 4 (see section 1.2). The log k¡ data of the reference substances are then
plotted against their log Koc values from batch equilibrium experiments given in Tables 1 and 3 of the
Appendix. Using this plot, the log k¡ value of a test substance is then used to determine its log Koc value. If
the actual results show that the log Koc of the test substance is outside the calibration range the test should be
repeated using different, more appropriate reference substances.

2.

DATA AND REPORTING

The report must include the following information:

(cid:151) identity of test and reference substances and their purity, and pKa values if relevant,

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(cid:151) description of equipment and operating conditions, e.g. type and dimension of analytical (and guard)
column, means of detection, mobile phase (ratio of components and pH), temperature range during
measurements,

(cid:151) dead time and the method used for its determination,

(cid:151) quantities of test and reference substances introduced in the column,

(cid:151) retention times of reference compounds used for calibration,

(cid:151) details of fitted regression line (log k¡ vs log Koc) and a graph of the regression line,

(cid:151) average retention data and estimated d log Koc value for the test compound.

(cid:151) chromatograms.

3.

REFERENCES

(1) W. J. Lyman, W. F. Reehl, D. H. Rosenblatt (ed). (1990). Handbook of chemical property estimation

methods, Chap. 4, McGraw-Hill, New York.

(2)

J. Hodson, N. A. Williams (1988). The estimation of the adsorption coefficient (Koc) for soils by HPLC.
Chemosphere, 17, 1 67.

(3) G. G. Briggs (1981). Theoretical and experimental relationships between soil adsorption, octanol-water
partition coefficients, water solubilities, bioconcentration factors, and the parachor. J. Agric. Food Chem.,
29, pp. 1050-1059.

(4)

C. T. Chiou, P. E. Porter, D.W. Schmedding (1983). Partition equilibria of nonionic organic compounds
between soil organic matter and water. Environ. Sci. Technol., 17, pp. 227-231.

(5) Z. Gerstl, U. Mingelgrin (1984). Sorption of organic substances by soils and sediment. J. Environm. Sci.

Health, B19, pp. 297-312.

(6)

(7)

C. T. Chiou, L. J. Peters, V. H. Freed (1979). A physical concept of soil water equilibria for nonionic
organic compounds, Science, 106, pp. 831-832.

S. W. Karickhoff (1981). Semi-empirical estimation of sorption of hydrophobic pollutants on natural
sediments and soils. Chemosphere, 10, pp. 833-846.

(8) W. K(cid:246)rdel, D. Hennecke, M. Herrmann (1997). Application of the HPLC-screening method for the
determination of the adsorption coefficient on sewage sludges. Chemosphere, 35(1/2), pp. 121-128.

(9) M. Mueller, W. K(cid:246)rdel

(1996). Comparison of screening methods for the estimation of adsorption

coefficients on soil. Chemosphere, 32(12), pp. 2493-2504.

(10) W. K(cid:246)rdel, J. Stutte, G. Kotthoff (1993). HPLC-screening method for the determination of the adsorption
coefficient in soil-comparison of different stationary phases, Chemosphere, 27(12), pp. 2341-2352.

(11) B. von Oepen, W. K(cid:246)rdel, W. Klein (1991). Sorption of nonpolar and polar compounds to soils:
Processes, measurements and experience with the applicability of the modified OECD Guideline 106,
Chemosphere, 22, pp. 285-304.

(12) W. K(cid:246)rdel, G. Kotthoff,

J. M(cid:252)ller (1995). HPLC-screening method for the determination of

the

adsorption coefficient on soil-results of a ring test. Chemosphere, 30(7), pp. 1373-1384.

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APPENDIX

TABLE 1

Comparison of Koc values for soils and sewage sludges, and calculated values by the HPLC screening
method (1) (2)

Substance

CAS No

Log Koc
sewage
sludges

Log Koc
HPLC

1912-24-9

1,66

Atrazine

Linuron

Fenthion

Monuron

Phenanthrene

330-55-2

55-38-9

150-68-5

85-01-8

Benzoic acid phenylester

93-99-2

Benzamide

4-Nitrobenzamide

Acetanilide

Aniline

2,5-Dichloroaniline

55-21-0

619-80-7

103-84-4

62-53-3

95-82-9

2,43

3,75

1,46

4,35

3,26

1,60

1,52

1,52

1,74

2,45

2,14

2,96

3,58

2,21

3,72

3,03

1,00

1,49

1,53

1,47

2,59

D

0,48

0,53

0,17

0,75

0,63

0,23

0,60

0,03

0,01

0,27

0,14

Log Koc
soils

Log Koc
HPLC

1,81

2,59

3,31

1,99

4,09

2,87

1,26

1,93

1,26

2,07

2,55

2,20

2,89

3,40

2,26

3,52

2,94

1,25

1,66

1,69

1,64

2,58

D

0,39

0,30

0,09

0,27

0,57

0,07

0,01

0,27

0,08

0,43

0,03

(1) W. K(cid:246)rdel, D. Hennecke, M. Herrmann (1997). Application of the HPLC-screening method for the determination of the adsorption

coefficient on sewage sludges. Chemosphere, 35(1/2), pp. 121-128.

(2) W. K(cid:246)rdel, D. Hennecke, C. Franke (1997). Determination of the adsorption-coefficients of organic substances on sewage sludges.

Chemosphere, 35 (1/2), pp. 107-119.

Results of a laboratory inter-comparison test (11 participating laboratories) performed to improve and validate
the HPLC-method (1)

TABLE 2

Substance

CAS No

Log Koc
(OECD 106)

Koc

Log Koc

[HPLC method]

Atrazine

Monuron

Triapenthenol

Linuron

Fenthion

1912-24-9

150-68-5

77608-88-3

330-55-2

55-38-9

1,81

1,99

2,37

2,59

3,31

78 – 16

100 – 8

292 – 58

465 – 62

2062 – 648

1,89

2,00

2,47

2,67

3,31

(1) W. K(cid:246)rdel, G. Kotthoff, J. M(cid:252)ller (1995). HPLC-screening method for the determination of the adsorption coefficient on soil-results

of a ring test. Chemosphere, 30(7), pp. 1373-1384.

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Recommended reference substances for the HPLC screening method based on soil adsorption data

TABLE 3

Reference substance

CAS No

Log Koc mean
values from batch
equilibrium

Number
of Koc data

Log S.D.

Source

Acetanilide

Phenol

2-Nitrobenzamide

103-84-4

108-95-2

610-15-1

N.N-dimethylbenzamide

611-74-5

4-Methylbenzamide

Methylbenzoate

Atrazine

Isoproturon

3-Nitrobenzamide

Aniline

619-55-6

93-58-3

1912-24-9

34123-59-6

645-09-0

62-53-3

3,5-Dinitrobenzamide

121-81-3

Carbendazim

Triadimenol

Triazoxide

Triazophos

Linuron

Naphthalene

Endosulfan-diol

Methiocarb

10605-21-7

55219-65-3

72459-58-6

24017-47-8

330-55-2

91-20-3

2157-19-9

2032-65-7

Acid Yellow 219

63405-85-6

1,2,3-Trichlorobenzene

c-HCH

Fenthion

Direct Red 81

Pyrazophos

a-Endosulfan

87-61-6

58-89-9

55-38-9

2610-11-9

13457-18-6

959-98-8

Diclofop-methyl

51338-27-3

Phenanthrene

85-01-8

Basic Blue 41 (mix)

26850-47-5

12270-13-2

1,25

1,32

1,45

1,52

1,78

1,80

1,81

1,86

1,95

2,07

2,31

2,35

2,40

2,44

2,55

2,59

2,75

3,02

3,10

3,16

3,16

3,23

3,31

3,43

3,65

4,09

4,20

4,09

4,89

DDT

50-29-3

5,63

4

4

3

2

3

4

3

5

3

4

3

3

3

3

3

3

4

5

4

4

4

5

3

4

3

5

3

4

4

1

0,48

0,70

0,90

0,45

1,76

1,08

1,08

1,53

1,31

1,73

1,27

1,37

1,85

1,66

1,78

1,97

2,20

2,29

2,39

2,83

1,40

2,94

2,49

2,68

2,70

3,74

3,77

3,83

4,46

(cid:151)

(a)

(a)

(b)

(a)

(a)

(a)

(c)

(c)

(b)

(a)

(b)

(c)

(c)

(c)

(c)

(c)

(a)

(c)

(c)

(a)

(a)

(a)

(c)

(a)

(c)

(c)

(c)

(a)

(a)

(b)

(a) W. K(cid:246)rdel, J. M(cid:252)ller (1994). Bestimmung des Adsorptionskoeffizienten organischer Chemikalien mit der HPLC. UBA R & D Report

No 106 01 044 (1994).

(b) B.V. Oepen, W. K(cid:246)rdel, W. Klein (1991). Chemosphere, 22, pp. 285-304.
(c) Data provided by industry.

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C.20. DAPHNIA MAGNA REPRODUCTION TEST

1.

METHOD

This reproduction toxicity test method is a replicate of the OECD TG 211 (1998).

1.1.

INTRODUCTION

The primary objective of the test is to assess the effect of chemicals on the reproductive output of Daphnia
magna.

1.2.

DEFINITIONS AND UNITS

Parent animals: are those female Daphnia present at the start of the test and of which the reproductive
output is the object of the study.

Offspring: are the young Daphnia produced by the parent animals in the course of the test.

Lowest observed effect concentration (LOEC): is the lowest tested concentration at which the substance is
observed to have a statistically significant effect on reproduction and parent mortality (at p < 0,05) when
compared with the control, within a stated exposure period. However, all test concentrations above the LOEC
must have a harmful effect equal to or greater than those observed at the LOEC. When these two conditions
cannot be satisfied, a full explanation must be given for how the LOEC (and hence the NOEC) has been
selected.

No observed effect concentration (NOEC): is the test concentration immediately below the LOEC, which
when compared with the control, has no statistically significant effect (p < 0,05), within a stated exposure
period.

is the concentration of the test substance dissolved in water that results in an x % reduction in

ECx:
reproduction of Daphnia magna within a stated exposure period.

Intrinsic rate of increase: is a measure of population growth which integrates reproductive output and
age-specific mortality (20) (21) (22). In steady state populations it will be zero. For growing populations it
will be positive and for shrinking populations it will be negative. Clearly, the latter is not sustainable and
ultimately will lead to extinction.

Limit of detection: is the lowest concentration that can be detected but not quantified.

Limit of determination: is the lowest concentration that can be measured quantitatively.

Mortality: an animal is recorded as dead when it is immobile, i.e. when it is not able to swim, or if there is
no observed movement of appendages or post-abdomen, within 15 seconds after gentle agitation of the test
container. (If another definition is used, this must be reported together with its reference.)

1.3.

PRINCIPLE OF THE TEST METHOD

Young female Daphnia (the parent animals), aged less than 24 hours at the start of the test, are exposed to
the test substance added to water at a range of concentrations. The test duration is 21 days. At the end of the
test, the total number of living offspring produced per parent animal alive at the end of the test is assessed.
This means that juveniles produced by adults that die during the test are excluded from the calculations.
Reproductive output of parent animals can be expressed in other ways (e.g. number of living offspring
produced per animal per day from the first day offspring were observed) but these should be reported in
addition to the total number of juveniles produced per parent alive at the end of the test. The reproductive
output of the animals exposed to the test substance is compared to that of the control(s)
in order to
determine the lowest observed effect concentration (LOEC) and hence the no observed effect concentration
(NOEC). In addition, and as far as possible, the data are analysed using a regression model
in order to
estimate the concentration that would cause an x % reduction in reproductive output (i.e. the EC50, EC20, or
EC10).

The survival of the parent animals and time to production of first brood must also be reported. Other
substance-related effects on parameters such as growth (e.g. length) and possibly intrinsic rate of increase,
may also be examined.

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1.4.

INFORMATION ON THE TEST SUBSTANCE

Results of an acute toxicity test (see method C.2, Part I) performed with Daphnia magna should be available.
The result may be useful in selecting an appropriate range of test concentrations in the reproduction tests.
The water solubility and the vapour pressure of the test substance should be known and a reliable analytical
method for the quantification of the substance in the test solutions with reported recovery efficiency and
limit of determination should be available.

Information on the test substance which may be useful
in establishing the test conditions includes the
structural formula, purity of the substance, stability in light, stability under the conditions of the test, pKa,
Pow and results of the test for ready biodegradability (see method C.4).

1.5.

VALIDITY OF THE TEST

For a test to be valid, the following performance criteria should be met in the control(s):

(cid:151) the mortality of the parent animals (female Daphnia) does not exceed 20 % at the end of the test,

(cid:151) the mean number of live offspring produced per parent animal surviving at the end of the test is ¯ 60.

1.6.

DESCRIPTION OF THE TEST METHOD

1.6.1.

Apparatus

Test vessels and other apparatus which will come into contact with the test solutions should be made entirely
of glass or other chemically inert material. The test vessels will normally be glass beakers.

In addition, some or all of the following equipment will be required:

(cid:151) oxygen meter (with microelectrode or other suitable equipment for measuring dissolved oxygen in low

volume samples),

(cid:151) adequate apparatus for temperature control,

(cid:151) pH meter,

(cid:151) equipment for the determination of the hardness of water,

(cid:151) equipment for the determination of the total organic carbon concentration (TOC) of water or equipment

for the determination of the chemical oxygen demand (COD),

(cid:151) adequate apparatus for the control of the lighting regime and the measurement of light intensity.

1.6.2.

Test organism

The species to be used in the test is Daphnia magna Straus. Other Daphnia species may be used providing
they meet the validity criteria as appropriate (the validity criterion relating to the reproductive output in the
controls should be relevant for the Daphnia species). If other species of Daphnia are used they must be clearly
identified and their use justified.

Preferably, the clone should have been identified by genotyping. Research (1) has shown that the reproductive
performance of Clone A (which originated from IRCHA in France) (3) consistently meets the validity criterion
of a mean of ¯ 60 offspring per parent animal surviving when cultured under the conditions described in this
method. However, other clones are acceptable provided that the Daphnia culture is shown to meet the
validity criteria for a test.

At the start of the test, the animals should be less than 24 hours old and must not be first brood progeny.
They should be derived from a healthy stock (i.e. showing no signs of stress such as high mortality, presence
of males and ephippia, delay in the production of the first brood, discoloured animals etc.). The stock animals
must be maintained in culture conditions (light, temperature, medium, feeding and animals per unit volume)
similar to those to be used in the test. If the Daphnia culture medium to be used in the test is different from
that used for routine Daphnia culture, it is good practice to include a pre-test acclimation period of normally
about three weeks (i.e. one generation) to avoid stressing the parent animals.

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1.6.3.

Test medium

It is recommended that a fully defined medium be used in this test. This can avoid the use of additives (e.g.
seaweed, soil extract, etc.), which are difficult to characterise, and therefore improves the opportunities for
standardisation between laboratories. Elendt M4 (4) and M7 media (see Appendix 1) have been found to be
suitable for this purpose. However, other media (e.g. (5) (6)) are acceptable providing the performance of the
Daphnia culture is shown to meet the validity criteria for the test.

If media are used which include undefined additives,
these additives should be specified clearly and
information should be provided in the test report on composition, particularly with regard to carbon content
as this may contribute to the diet provided. It is recommended that the total organic carbon (TOC) and/or
chemical oxygen demand (COD) of the stock preparation of the organic additive is determined and an
estimate of the resulting contribution to the TOC/COD in the test medium made. It is recommended that
TOC levels in the medium (i.e. before addition of the algae) be below 2 mg/l (7).

When testing substances containing metals,
it is important to recognise that the properties of the test
medium (e.g. hardness, chelating capacity) may have a bearing on the toxicity of the test substance. For this
reason, a fully defined medium is desirable. However, at present, the only fully defined media which are
known to be suitable for long-term culture of Daphnia magna are Elendt M4 and M7. Both media contain the
chelating agent EDTA. Work has shown (2) that the (cid:145)apparent toxicity(cid:146) of cadmium is generally lower when
the reproduction test is performed in M4 and M7 media than in media containing no EDTA. M4 and M7 are
not, therefore, recommended for testing substances containing metals, and other media containing known
chelating agents should also be avoided. For metal-containing substances it may be advisable to use an
alternative medium such as, for example, ASTM reconstituted hard fresh water (7), which contains no EDTA,
with added seaweed extract (8). This combination of ASTM reconstituted hard fresh water and seaweed
extract is also suitable for long-term culture and testing of Daphnia magna (2), although it still exerts a mild
chelating action due to the organic component in the added seaweed extract.

At the beginning and during the test, the dissolved oxygen concentration should be above 3 mg/l. The pH
should be within the range 6-9, and normally it should not vary by more than 1,5 units in any one test.
Hardness above 140 mg/l (as CaCO3) is recommended. Tests at this level and above have demonstrated
reproductive performance in compliance with the validity criteria (9) (10).

1.6.4.

Test solutions

Test solutions of the chosen concentrations are usually prepared by dilution of a stock solution. Stock
solutions should preferably be prepared by dissolving the substance in test medium.

The use of organic solvents or dispersants may be required in some cases in order to produce a suitably
concentrated stock solution, but every effort should be made to avoid the use of such materials. Examples of
suitable solvents are acetone, ethanol, methanol, dimethylformamide and triethylene glycol. Examples of
suitable dispersants are Cremophor RH40, methylcellulose 0,01 % and HCO-40.
the test
substance in the test solutions should not exceed the limit of solubility in the test medium.

In any case,

Solvents are used to produce a stock solution which can be dosed accurately into water. At the recommended
solvent concentration in the final test medium (i.e. ˜ 0,1 ml/l), the solvents listed above will not be toxic and
will not increase the water solubility of a substance.

Dispersants may assist in accurate dosing and dispersion. At the recommended concentration in the final test
medium (˜ 0,1 ml/l), the dispersants listed above will not be toxic and will not increase the water solubility
of a substance.

1.7.

TEST DESIGN

Treatments should be allocated to the test vessels and all subsequent handling of the test vessels should be
done in a random fashion. Failure to do this may result in bias that could be construed as being a
concentration effect. In particular, if experimental units are handled in treatment or concentration order, then
some time-related effect, such as operator fatigue or other error, could lead to greater effects at the higher
concentrations. Furthermore,
if the test results are likely to be affected by an initial or environmental
condition of the test, such as position in the laboratory, then consideration should be given to blocking the
test.

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1.8.

PROCEDURE

1.8.1.

Conditions of exposure

1.8.1.1. Duration

The test duration is 21 days.

1.8.1.2.

Loading

Parent animals are maintained individually, one per test vessel, with 50-100 ml of medium in each vessel.

Larger volumes may sometimes be necessary to meet requirements of the analytical procedure used for
determination of the test substance concentration, although pooling of replicates for chemical analysis is also
allowable. If volumes greater than 100 ml are used, the ration given to the Daphnia may need to be increased
to ensure adequate food availability and compliance with the validity criteria. For flow-through tests,
alternative designs may, for technical reasons, be considered (e.g. four groups of 10 animals in a larger test
volume), but any changes to the test design should be reported.

1.8.1.3. Number of animals

For semi-static tests, at least 10 animals individually held at each test concentration and at least 10 animals
individually held in the control series.

For flow-through tests, 40 animals divided into four groups of 10 animals at each test concentration has been
shown to be suitable (1). A smaller number of test organisms may be used and a minimum of 20 animals per
concentration divided into two or more replicates with an equal number of animals (e.g. four replicates each
with five daphnids) is recommended. Note that for tests where animals are held in groups, it will not be
possible to express the reproductive output as the total number of living offspring produced per parent
if parent animals die. In these cases reproductive output should be
animal alive at the end of the test,
expressed as (cid:145)total number of living offspring produced per parent present at the beginning of the test(cid:146).

1.8.1.4.

Feeding

For semi-static tests,
corresponding to media changes). Deviations from this (e.g. for flow-through tests) should be reported.

feeding should preferably be done daily, but at

three times per week (i.e.

least

During the test the diet of the parent animals should preferably be living algal cells of one or more of the
following: Chlorella sp., Selenastrum capricornutum (now Pseudokirchneriella subcapitata (11)) and Scenedesmus
subspicatus. The supplied diet should be based on the amount of organic carbon (C) provided to each parent
animal. Research (12) has shown that,
for Daphnia magna, ration levels of between 0,1 and 0,2 mg
C/Daphnia/day are sufficient for achieving the required number of offspring to meet the test validity criteria.
The ration can be supplied either at a consistent rate throughout the period of the test, or, if desired, a lower
rate can be used at the beginning and then increased during the test to take account of growth of the parent
animals.
the ration should still remain within the recommended range of 0,1-0,2 mg
C/Daphnia/day at all times.

In this case,

If surrogate measures, such as algal cell number or light absorbance, are to be used to feed the required
ration level (i.e. for convenience since measurement of carbon content is time consuming), each laboratory
must produce its own nomograph relating the surrogate measure to carbon content of the algal culture (see
Appendix 2 for advice on nomograph production). Nomographs should be checked at least annually and
more frequently if algal culture conditions have changed. Light absorbance has been found to be a better
surrogate for carbon content than cell number (13).

A concentrated algal suspension should be fed to the Daphnia to minimise the volume of algal culture
medium transferred to the test vessels. Concentration of the algae can be achieved by centrifugation followed
by resuspension in distilled water, deionised water or Daphnia culture medium.

1.8.1.5.

Light

16 hours light at an intensity not exceeding 15-20 lE • mﬂ2 • sﬂ1.

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1.8.1.6. Temperature

The temperature of the test media should be within the range 18-22 (cid:176)C. However, for any one test, the
temperature should not,
if possible, vary by more than 2 (cid:176)C within these limits (e.g. 18-20, 19-21 or
20-22 (cid:176)C). It may be appropriate to use an additional test vessel for the purposes of temperature monitoring.

1.8.1.7. Aeration

The test vessels must not be aerated during the test.

1.8.2.

Test concentration

Normally, there should be at least five test concentrations arranged in a geometric series with a separation
factor preferably not exceeding 3,2, and the appropriate number of replicates for each test concentration
should be used (see section 1.8.1.3). Justification should be provided if fewer than five concentrations are
used. Substances should not be tested above their solubility limit in the test medium.

In setting the range of concentrations, the following should be borne in mind:

(i)

(ii)

if the aim is to obtain the LOEC/NOEC, the lowest test concentration must be low enough so that the
fecundity at that concentration is not significantly lower than that in the control. If this is not the case,
the test will have to be repeated with a reduced lowest concentration;

if the aim is to obtain the LOEC/NOEC, the highest test concentration must be high enough so that the
fecundity at that concentration is significantly lower than that in the control. If this is not the case, the
test will have to be repeated with an increased highest concentration;

(iii) if the ECX for effects on reproduction is estimated, it is advisable that sufficient concentrations are used
to define the ECX with an appropriate level of confidence. If the EC50 for effects on reproduction is
estimated, it is advisable that the highest test concentration is greater than this EC50. Otherwise, although
it will still be possible to estimate the EC50, the confidence interval for the EC50 will be very wide and it
may not be possible to satisfactorily assess the adequacy of the fitted model;

(iv) the range of test concentration should preferably not include any concentrations that have a statistically
significant effect on adult survival since this would change the nature of
from simply a
reproduction test to a combined reproduction and mortality test requiring much more complex statistical
analysis.

the test

Prior knowledge of the toxicity of the test substance (e.g. from an acute test and/or from range-finding
studies) should help in selecting appropriate test concentrations.

Where a solvent or dispersant is used to aid preparation of test solutions (see section 1.6.4),
its final
concentration in the test vessels should not be greater than 0,1 ml/l and should be the same in all test vessels.

1.8.3.

Controls

One test-medium control series and also, if relevant, one control series containing the solvent or dispersant
should be run in addition to the test series. When used, the solvent or dispersant concentration should be the
same as that used in the vessels containing the test substance. The appropriate number of replicates should
be used (see section 1.8.1.3).

in a well-run test,

Generally,
living offspring
produced per parent animal in the control(s) should be ˜ 25 %, and this should be reported for test designs
using individually held animals.

the coefficient of variation around the mean number of

1.8.4.

Test medium renewal

The frequency of medium renewal will depend on the stability of the test substance, but should be at least
three times per week. If, from preliminary stability tests (see section 1.4) the test substance concentration is
not stable (i.e. outside the range 80-120 % of nominal or falling below 80 % of the measured initial
concentration) over the maximum renewal period (i.e. three days), consideration should be given to more
frequent medium renewal, or to the use of a flow-through test.

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When the medium is renewed in semi-static tests, a second series of test vessels are prepared and the parent
animals transferred to them by, for example, a glass pipette of suitable diameter. The volume of medium
transferred with the Daphnia should be minimised.

1.8.5.

Observations

The results of the observations made during the test should be recorded on data sheets (see examples in
Appendices 3 and 4). If other measurements are required (see 1.3 and 1.8.8) additional observations may be
required.

1.8.6.

Offspring

The offspring produced by each parent animal should preferably be removed and counted daily from the
appearance of the first brood, to prevent them consuming food intended for the adult. For the purpose of
this method it is only the number of living offspring that needs to be counted, but the presence of aborted
eggs or dead offspring should be recorded.

1.8.7.

Mortality

Mortality among the parent animals should be recorded preferably daily, at least at the same times as
offspring are counted.

1.8.8.

Other parameters

Although this method is designed principally to assess effects on reproduction, it is possible that other effects
may also be sufficiently quantified to allow statistical analysis. Growth measurements are highly desirable
since they provide information on possible sublethal effects, which may be more useful than reproduction
measurement alone; the measurement of the length of the parent animals (i.e. body length excluding the anal
spine) at the end of the test is recommended. Other parameters that can be measured or calculated include
time to production of first brood (and subsequent broods), number and size of broods per animal, number of
aborted broods, presence of males or ephippia and the intrinsic rate of population increase.

1.8.9.

Frequency of analytical determinations and measurements

Oxygen concentration, temperature, hardness and pH values should be measured at least once a week, in
fresh and old media, in the control(s) and in the highest test substance concentration.

During the test, the concentrations of test substance are determined at regular intervals.

In semi-static tests where the concentration of the test substance is expected to remain within – 20 % of the
nominal (i.e. within the range 80-120 % (cid:151) see 1.4 and 1.8.4), it is recommended that, as a minimum, the
highest and lowest test concentrations be analysed when freshly prepared and at the time of renewal on one
occasion during the first week of the test (i.e. analyses should be made on a sample from the same solution
(cid:151) when freshly prepared and at renewal). These determinations should be repeated at least at weekly
intervals thereafter.

For tests where the concentration of the test substance is not expected to remain within – 20 % of the
nominal, it is necessary to analyse all test concentrations, when freshly prepared and at renewal. However, for
those tests where the measured initial concentration of the test substance is not within – 20 % of nominal
but where sufficient evidence can be provided to show that the initial concentrations are repeatable and
stable (i.e. within the range 80-120 % of initial concentrations), chemical determinations could be reduced in
weeks 2 and 3 of the test to the highest and lowest test concentrations. In all cases, determination of test
substance concentrations prior to renewal need only be performed on one replicate vessel at each test
concentration.

If a flow-through test is used, a similar sampling regime to that described for semi-static tests is appropriate
(but measurement of (cid:145)old(cid:146) solutions is not applicable in this case). However, it may be advisable to increase
the number of sampling occasions during the first week (e.g. three sets of measurements) to ensure that the
test concentrations are remaining stable. In these types of test, the flow-rate of diluent and test substance
should be checked daily.

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If there is evidence that the concentration of the substance being tested has been satisfactorily maintained
within – 20 % of the nominal or measured initial concentration throughout the test, then results can be
based on nominal or measured initial values.
the deviation from the nominal or measured initial
concentration is greater than – 20 %, results should be expressed in terms of the time-weighed mean (see
Appendix 5).

If

2.

DATA AND REPORTING

2.1.

TREATMENT OF RESULTS

The purpose of this test is to determine the effect of the test substance on the total number of living
offspring produced per parent animal alive at the end of the test. The total number of offspring per parent
animal should be calculated for each test vessel (i.e. replicate). If, in any replicate the parent animal dies
during the test or turns out to be male, then the replicate is excluded from the analysis. The analysis will then
be based on a reduced number of replicates.

For the estimation of the LOEC, and hence the NOEC, for effects of the chemical on reproductive output, it is
necessary to calculate the mean reproductive output across replicates for each concentration and the pooled
residual standard deviation, and this can be done using analysis of variance (ANOVA). The mean for each
concentration must then be compared with the control mean using an appropriate multiple comparison
method. Dunnett’s or Williams’ tests may be useful (14) (15) (16) (17). It is necessary to check whether the
ANOVA assumption of homogeneity of variance holds. It is recommended that this be done graphically
rather than via a formal significance test (18); a suitable alternative is to run a Bartlett’s test.
If this
assumption does not hold, then consideration should be given to transforming the data to homogenise
variances prior to performing the ANOVA, or to carrying out a weighted ANOVA. The size of the effect
detectable using ANOVA (i.e. the least significant difference) should be calculated and reported.

For the estimation of the concentration which would cause a 50 % reduction in reproductive output (i.e. the
EC50), a suitable curve, such as the logistic curve, should be fitted to the data using a statistical method such
as least squares. The curve could be parameterised so that the EC50 and its standard error can be estimated
directly. This would greatly ease the calculation of the confidence limits about the EC50. Unless there are
good reasons to prefer different confidence levels, two-sided 95 % confidence limits should be quoted. The
fitting procedure should preferably provide a means for assessing the significance of the lack of fit. This can
be done graphically or by dividing the residual sum of squares into (cid:145)lack of fit(cid:146) and (cid:145)pure error components(cid:146)
and performing a significance test for lack of fit. Since treatments giving high fecundity are likely to have
greater variance in the number of juveniles produced than treatments giving low fecundity, consideration to
weighting the observed values to reflect the different variances in the different treatment groups should be
given (see for background information reference (18)).

In the analysis of the data from the final ring test (2), a logistic curve was fitted using the following model,
although other suitable models can be used:

Y =

c
(cid:18) (cid:19)b
x
x0

1 +

where:

Y:

the total number of juveniles per parent animal alive at the end of the test (calculated for each vessel)

x:

c:

the substance concentration

the expected number of juveniles when x = 0

x0:

the EC50 in the population

b:

the slope parameter.

This model is likely to be adequate in a large number of situations, but there will be tests for which it is not
appropriate. A check should be made on the validity of the model as suggested above. In some cases, a
hormesis model in which low concentrations give enhanced effects may be appropriate (19).

Other effect concentrations, such as the EC10 or EC20 can also be estimated, although it may be preferable to
use a different parameterisation of the model from that used to estimate the EC50.

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2.2.

TEST REPORT

The test report must include the following:

2.2.1.

Test substance:

(cid:151) physical nature and relevant physicochemical properties,

(cid:151) chemical identification data, including purity.

2.2.2.

Test species:

(cid:151) the clone (whether it has been genetically typed), supplier or source (if known) and the culture
conditions used. If a different species to Daphnia magna is used, this should be reported and justified.

2.2.3.

Test conditions:

(cid:151) test procedure used (e.g. semi-static or flow-through, volume, loading in number of Daphnia per litre),

(cid:151) photoperiod and light intensity,

(cid:151) test design (e.g. number of replicates, number of parents per replicate),

(cid:151) details of culture medium used,

(cid:151) if used, additions of organic material

including the composition, source, method of preparation,

TOC/COD of stock preparations, estimation of resulting TOC/COD in test medium,

(cid:151) detailed information on feeding,

including amount (in mg C/Daphnia/day) and schedule (e.g. type of

food(s), including for algae the specific name(species) and, if known, the strain, the culture conditions),

(cid:151) method of preparation of stock solutions and frequency of renewal (the solvent or dispersant and its

concentration must be given, when used).

2.2.4.

Results:

(cid:151) results from any preliminary studies on the stability of the test substance,

(cid:151) the nominal test concentrations and the results of all analyses to determine the concentration of the test
substance in the test vessels (see example data sheets in Appendix 4); the recovery efficiency of the
method and the limit of determination should also be reported,

(cid:151) water quality within the test vessels (i.e. pH, temperature and dissolved oxygen concentration, and TOC

and/or COD and hardness where applicable) (see example data sheet in Appendix 3),

(cid:151) the full record of living offspring by each parent animal (see example data sheet in Appendix 3),

(cid:151) the number of deaths among the parent animals and the day on which they occurred (see example data

sheet in Appendix 3),

(cid:151) the coefficient of variation for control fecundity (based on total number of living offspring per parent

animal alive at the end of the test),

(cid:151) plot of total number of living offspring per parent animal (for each replicate) alive at the end of the test

vs concentration of the test substance,

(cid:151) the lowest observed effect concentration (LOEC)

the
statistical procedures used and an indication of what size of effect could be detected and the no observed
effect concentration (NOEC) for reproduction; where appropriate, the LOEC/NOEC for mortality of the
parent animals should also be reported,

including a description of

for reproduction,

(cid:151) where appropriate, the ECx for reproduction and confidence intervals and a graph of the fitted model

used for its calculation, the slope of the dose-response curve and its standard error,

(cid:151) other observed biological effects or measurements: report any other biological effects which were

observed or measured (e.g. growth of parent animals) including any appropriate justification,

(cid:151) an explanation for any deviation from the test method.

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3.

REFERENCES

(1) OECD Test Guideline Programme, Report of the Workshop on the Daphnia magna Pilot Ring Test,

Sheffield University, UK, 20-21 March 1993.

(2) OECD Environmental Health and Safety Publications. Series on Testing and Assessment No. 6. Report of

the Final Ring Test of the Daphnia magna Reproduction Test Paris. 1997.

(3)

(4)

(5)

Baird D. J., Barber J., Bradley M. C., Soares A. M. V. M. and Calow P. (1991). A comparative study of
genotype sensitivity to acute toxic stress using clones of Daphnia magna Strauss. Ecotoxicology and
Environmental Safety, 21, pp. 257-265.

Elendt B. P., (1990). Selenium deficiency in Crustacea; An ultrastructural approach to antennal damage
in Daphnia magna Straus. Protoplasma, 154, pp. 25-33.

EPA (1993). Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater
and Marine Organisms. (Fourth ed.). EPA/600/4-90/027F. C. I. Weber (ed), USEPA, Cincinnati, Ohio.

(6) Vigano L., (1991) Suitability of commercially available spring waters as standard medium for culturing

Daphnia magna. Bull. Environ. Contam. Toxicol., 47, pp. 775-782.

(7) ASTM (1988). Standard Guide for Conducting Acute Toxicity Tests with Fishes, Macroinvertebrates and

Amphibians. E729-88a. American Society for Testing and Materials, Philadelphia P.A. 20 pp.

(8)

Baird D. J., Soares A. M. V. M., Girling A., Barber J., Bradley M. C. and Calow P. (1989). The long term
maintenance of Daphnia magna Straus for use in ecotoxicological tests; problems and prospects. In:
Proceedings of the 1st European Conference on Ecotoxicology. Copenhagen 1988 (H.Lłkke, H. Tyle &
F. Bro-Rasmussen. Eds.), pp. 144-148.

(9)

Parkhurst B. R., Forte J. L. and Wright G. P. (1981). Reproducibility of a life-cycle toxicity test with
Daphnia magna. Bull. Environ. Contam. and Toxicol., 26, pp. 1-8.

(10) Cowgill U. M. and Milazzo D. P. (1990) The sensitivity of two cladocerans to water quality variables:

salinity and hardness. Arch. Hydrobiol., 120(2), pp. 185-196.

(11) Korshikov (1990). Pseudokirchneriella subcapitata Hindak, F-1990. Biologice Prace, 36, 209.

(12) Sims I. R., Watson S. and Holmes D. (1993). Toward a standard Daphnia juvenile production test.

Environmental Toxicology and Chemistry, 12, pp. 2053-2058.

(13) Sims I. (1993). Measuring the growth of phytoplankton: the relationship between total organic carbon

with three commonly used parameters of algal growth. Arch. Hydrobiol., 128, pp. 459-466.

(14) Dunnett C. W., (1955). A multiple comparisons procedure for comparing several treatments with a

control. J. Amer. Statist. Assoc., 50, pp. 1096-1121.

(15) Dunnett C. W.,
482-491.

(1964). New tables for multiple comparisons with a control. Biometrics, 20, pp.

(16) Williams D. A. (1971). A test for differences between treatment means when several dose levels are

compared with a zero dose control. Biometrics 27, pp. 103-117.

(17) Williams D. A. (1972). The comparison of several dose levels with a zero dose control. Biometrics, 28,

pp. 510-531.

(18) Draper N. R. and Smith H. (1981). Applied Regression Analysis, second edition, Wiley, N.Y.

(19) Brain P. and Cousens R. (1989). An equation to describe dose responses where there is stimulation of

growth at low doses. Weed Research, 29, pp. 93-96.

(20) Wilson E. O. and Bossert, W. H.

(1971). A Primer of Population Biology. Sinauer Associates Inc.

Publishers.

(21) Poole R. W. (1974). An Introduction to quantitative Ecology. McGraw-Hill Series in Population Biology,

New York, pp. 532.

(22) Meyer J. S.,

Ingersoll C. G., McDonald L. L. and Boyce M. S.

(1986). Estimating uncertainty in

population growth rates: Jackknife vs bootstrap techniques. Ecology, 67, pp. 1156-1166.

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APPENDIX 1

PREPARATION OF FULLY DEFINED ELENDT M7 AND M4 MEDIA

Acclimation to Elendt M7 and M4 media

Some laboratories have experienced difficulty in directly transferring Daphnia to M4 (1) and M7 media. However, some
success has been achieved with gradual acclimation, i.e. moving from own medium to 30 % Elendt, then to 60 % Elendt
and then to 100 % Elendt. The acclimation periods may need to be as long as one month.

PREPARATION

Trace elements

Separate stock solutions (I) of individual trace elements are first prepared in water of suitable purity, e.g. deionised,
distilled or reverse osmosis. From these different stock solutions (I) a second single stock solution (II) is prepared, which
contains all trace elements (combined solution), i.e.:

Stock solutions I
(single substance)

Amount added to
water
(mg/l)

Concentration (in
relation to medium
M4)
(fold)

To prepare the combined stock-solution II
add the following amount of stock solution I
to water
(ml/l)

M 4

M 7

H3BO3

MnCl2 * 4 H2O

LiCl

RbCl

SrCl2 * 6 H2O

NaBr

Na2MoO4 * 2 H2O

CuCl2 * 2 H2O

ZnCl2

CoCl2 * 6 H2O

KI

Na2SeO3

NH4VO3

Na2EDTA * 2 H2O

FeSO4 * 7 H2O

57 190

7 210

6 120

1 420

3 040

320

1 260

335

260

200

65

43,8

11,5

5 000

1 991

20 000

20 000

20 000

20 000

20 000

20 000

20 000

20 000

20 000

20 000

20 000

20 000

20 000

2 000

2 000

1,0

1,0

1,0

1,0

1,0

1,0

1,0

1,0

1,0

1,0

1,0

1,0

1,0

(cid:150)

(cid:150)

0,25

0,25

0,25

0,25

0,25

0,25

0,25

0,25

1,0

1,0

1,0

1,0

1,0

(cid:150)

(cid:150)

Both Na2EDTA and FeSO4 solutions are prepared singly, poured together and autoclaved immediately. This gives:

21 Fe-EDTA solution

1 000

20,0

5,0

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M4 and M7 media

M4 and M7 media are prepared using stock solution II, the macro-nutrients and vitamins as follows:

Amount added to
water
(mg/l)

Concentration (related
to medium M4)
(fold)

Amount of stock solution added to prepare
medium
(ml/l)

Stock solution II combined trace
elements

Macro-nutrient stock solutions (single substance)

CaCl2 * 2 H2O

MgSO4 * 7 H2O

KCl

NaHCO3

Na2SiO3 * 9 H2O

NaNO3

KH2PO4

K2HPO4

Combined vitamin stock

293 800

246 600

58 000

64 800

50 000

2 740

1 430

1 840

(cid:150)

20

1 000

2 000

10 000

1 000

5 000

10 000

10 000

10 000

10 000

M 4

50

1,0

0,5

0,1

1,0

0,2

0,1

0,1

0,1

0,1

M 7

50

1,0

0,5

0,1

1,0

0,2

0,1

0,1

0,1

0,1

The combined vitamin stock solution is prepared by adding the 3 vitamins to 1 litre water as shown below:

Thiamine hydrochloride

Cyanocobalamine (B12)

750

10

10 000

10 000

Biotine

7,5

10 000

(cid:150)

(cid:150)

(cid:150)

(cid:150)

(cid:150)

(cid:150)

The combined vitamin stock is stored frozen in small aliquots. Vitamins are added to the media shortly before use.

Notes: To avoid precipitation of salts when preparing the complete media, add the aliquots of stock solutions to about 500-800 ml

deionised water and then fill up to 1 litre.

The first publication of the M4 medium can be found in Elendt, B.P. (1990). Selenium deficiency in crustacea; an ultrastructural
approach to antennal damage in Daphnia magna Straus. Protoplasma, 154, pp. 25-33.

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APPENDIX 2

TOTAL ORGANIC CARBON (TOC) ANALYSIS AND PRODUCTION OF A NOMOGRAPH FOR TOC
CONTENT OF ALGAL FEED

It is recognised that the carbon content of the algal feed will not normally be measured directly but from correlations
(i.e. nomographs) with surrogate measures such as algal cell number or light absorbance).

TOC should be measured by high temperature oxidation rather than by UV or persulphate methods.
(See: The
Instrumental Determination of Total Organic Carbon, Total Oxygen Demand and Related Determinands 1979, HMSO
1980; 49 High Holborn, London WC1V 6HB).

For nomograph production, algae should be separated from the growth medium by centrifugation followed by
resuspension in distilled water. Measure the surrogate parameter and TOC concentration in each sample in triplicate.
Distilled water blanks should be analysed and the TOC concentration deducted from that of the algal sample TOC
concentration.

Nomograph should be linear over the required range of carbon concentrations. Examples are shown below.

NB: These should not be used for conversions; it is essential that laboratories prepare their own nomographs.

mg/l dry weight
of concentrated
algal feed

1700

1600

1500

1400

1300

1200

1100

1000

900

800

700

600

500

400

300

200

100

0

–100

Chlorella vulgaris, var. viridis (CCAP 211/12).
Regression of mg/l dry weight on mg C/l.
Data  from  concentrated  suspensions  of  semi-continous
batch cultured cells, re-suspended in distilled water.

Correlation coefficient (cid:151) 0,980

000 500 100  150  200  250  300  350  400  450  500  550  600  650  700  750

mg C/l of concentrated algal feed

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Chlorella vulgaris, var. viridis (CCAP 211/12).
Regression of cell number on mg C/l.
Data  from  concentrated  suspensions  of  semi-continous
batch cultured cells, re-suspended in distilled water.

115
110
105
100
95
90
85
80
75
70
65
60
55
50
45
40
35
30
25
20
15
10
5
0
000 050  100  150  200  250  300  350  400  450  500  550  600  650  700  750

Correlation coefficient (cid:151) 0,926

mg C/l of concentrated algal feed

Chlorella vulgaris, var. viridis (CCAP 112/12).
Regression of absorbance on mg C/l. (1 cm path length)
Data from concentrated suspensions of semi-continous 
batch cultured cells, re-suspended in distilled water.

Correlation coefficient (cid:151) 0,998

No cells/l (x 108)
of concentrated
algal feed

Absorbance at
440 mm of a
1/10 dilution of
concentrated
algal feed

1.10
1.05
1.00
0.95
0.90
0.85
0.80
0.75
0.70
0.65
0.60
0.55
0.50
0.45
0.40
0.35
0.30
0.25
0.20
0.15
0.10
0.05
0.00

000 050  100  150  200  250  300  350  400  450  500  550  600  650  700  750

mg C/l of concentrated algal feed

EXAMPLE DATA SHEET RECORDING MEDIUM RENEWAL, PHYSICAL/CHEMICAL MONITORING DATA, FEEDING, DAPHNIA REPRODUCTION AND ADULT MORTALITY

APPENDIX 3

Experiment No:

Data started:

Clone:

Medium:

Type of food:

Test substance:

Nominal conc.:

Day

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

Medium renewal
(tick)

PH (1)

O2 mg/l (1)

Temperature ((cid:176)C) (1)

Food provided (tick)

No live offspring (2)

Vessel 1

2

3

4

5

6

7

8

9

10

Cumulative adult
mortality (3)

(1) Indicate which vessel was used for the experiment.
(2) Record aborted broods as (cid:145)AB(cid:146) in relevant box.
(3) Record mortality of any adult animals as (cid:145)M(cid:146) in relevant box.

Total

new

old

new

old

new

old

Total

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
2
5
9

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EXAMPLE DATA SHEET FOR RECORDING RESULTS OF CHEMICAL ANALYSIS

APPENDIX 4

(a) Measured concentrations

Nominal conc.

Week 1 sample

Week 2 sample

Week 3 sample

Fresh

Old

Fresh

Old

Fresh

Old

(b) Measured concentrations as a percentage of nominal

Nominal conc.

Week 1 sample

Week 2 sample

Week 3 sample

Fresh

Old

Fresh

Old

Fresh

Old

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APPENDIX 5

CALCULATION OF A TIME-WEIGHTED MEAN

Time-weighted mean

Given that the concentration of the test substance can decline over the period between medium renewals,
it is
necessary to consider what concentration should be chosen as representative of the range of concentrations experienced
by the parent Daphnia. The selection should be based on biological considerations as well as statistical ones. For
example, if reproduction is thought to be affected mostly by the peak concentration experienced, then the maximum
concentration should be used. However, if the accumulated or longer term effect of the toxic substance is considered to
be more important, then an average concentration is more relevant. In this case, an appropriate average to use is the
time-weighted mean concentration, since this takes account of the variation in instantaneous concentration over time.

12

10

8

6

4

2

0

0

1

2

3

4

5

6

7

Days

Figure 1: Example of time-weighted mean

Figure 1 shows an example of a (simplified) test lasting seven days with medium renewal at days 0, 2 and 4.

(cid:151) The thin zig-zag line represents the concentration at any point in time. The fall in concentration is assumed to

follow an exponential decay process.

(cid:151) The six plotted points represent the observed concentrations measured at the start and end of each renewal period.

(cid:151) The thick solid line indicates the position of the time-weighted mean.

The time-weighted mean is calculated so that the area under the time-weighted mean is equal to the area under the
concentration curve. The calculation for the above example is illustrated in Table 1.

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Table 1: Calculation of time-weighted mean

Renewal No

Days

1

2

3

Total days: 7

2

2

3

Conc0

10,000

11,000

10,000

Conc1

4,493

6,037

4,066

Ln(Conc0)

Ln(Conc1)

Area

2,303

2,398

2,303

1,503

1,798

1,403

Total area

13,767

16,544

19,781

50,091

TW mean

7,156

(cid:145)Days(cid:146) is the number of days in the renewal period.

(cid:145)Conc0(cid:146) is the measured concentration at the start of each renewal period.

(cid:145)Conc1(cid:146) is the measured concentration at the end of each renewal period.

(cid:145)Ln(Conc0)(cid:146) is the natural logarithm of Conc0.

(cid:145)Ln(Conc1)(cid:146) is the natural logarithm of Conc1.

(cid:145)Area(cid:146) is the area under the exponential curve for each renewal period. It is calculated by:

Area (cid:136)

Conc0 ﬂ Conc1
Ln(cid:133)Conc0(cid:134) ﬂ Ln(cid:133)Conc1(cid:134)

(cid:215) Days

The time-weighted mean ((cid:145)TW mean(cid:146)) is the (cid:145)Total area(cid:146) divided by the (cid:145)Total days(cid:146).

Of course, for the Daphnia reproduction test the table would have to be extended to cover 21 days.

It is clear that when observation are taken only at the start and end of each renewal period, it is not possible to
confirm that the decay process is, in fact, exponential. A different curve would result in a different calculation for
(cid:145)Area(cid:146). However, an exponential decay process is not implausible and is probably the best curve to use in the absence
of other information.

However, a work of caution is required if the chemical analysis fails to find any substance at the end of the renewal
period. Unless it is possible to estimate how quickly the substance disappeared from the solution, it is impossible to
obtain a realistic area under the curve, and hence it is impossible to obtain a reasonable time-weighted mean.

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ANNEX 6

ANNEX VI

GENERAL CLASSIFICATION AND LABELLING REQUIREMENTS FOR DANGEROUS SUBSTANCES AND
PREPARATIONS

Contents

1.

2.

2.1.

2.2.

2.2.1.

2.2.2.

2.2.3.

2.2.4.

2.2.5.

2.2.6.

3.

3.1.

3.2.

3.2.1.

3.2.2.

3.2.3.

3.2.4.

3.2.5.

3.2.6.

3.2.7.

3.2.8.

4.

4.1.

4.2.

4.2.1.

4.2.2.

4.2.3.

4.2.4.

GENERAL INTRODUCTION

CLASSIFICATION ON THE BASIS OF PHYSICOCHEMICAL PROPERTIES

Introduction

Criteria for classification, choice of symbols, indication of danger, choice of risk phrases

Explosive

Oxidising

Extremely flammable

Highly flammable

Flammable

Other physico-chemical properties

CLASSIFICATION ON THE BASIS OF TOXICOLOGICAL PROPERTIES

Introduction

Criteria for classification, choice of symbols, indication of danger, choice of risk phrases

Very toxic

Toxic

Harmful

Comments regarding the use of R48

Corrosive

Irritant

Sensitisation

Other toxicological properties

CLASSIFICATION ON THE BASIS OF SPECIFIC EFFECTS ON HUMAN HEALTH

Introduction

Criteria for classification, indication of danger, choice of risk phrases

Carcinogenic substances

Mutagenic substances

Substances toxic to reproduction

Procedure for the classification of preparations concerning specific effects on health

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5.

5.1.

5.2.

5.2.1.

5.2.2.

6.

6.1.

6.2.

7.

8.

8.1.

8.2.

8.3.

8.4.

9.

9.1.

9.2.

9.3.

9.4.

9.5.

9.6.

CLASSIFICATION ON THE BASIS OF ENVIRONMENTAL EFFECTS

Introduction

Criteria for classification, indication of danger, choice of risk phrases

Aquatic environment

Non-aquatic environment

CHOICE OF SAFETY ADVICE PHRASES

Introduction

Safety phrases for substances and preparations

LABELLING

SPECIAL CASES: Substances

Mobile gas cylinders

Gas containers intended for propane, butane or liquefied petroleum gas (LPG)

Metals in massive form

Substances classified with R65

SPECIAL CASES: Preparations

Gaseous preparations (gas mixtures)

Gas containers intended for preparations containing stenched propane, butane or liquefied petroleum
gas (LPG)

Alloys, preparations containing polymers, preparations containing elastomers

Preparations classified with R65

Organic peroxides

Additional labelling requirements for certain preparations

COMMISSION STATEMENT

1.

GENERAL INTRODUCTION

1.1.

1.2.

1.3.

The object of classification is to identify all the physico-chemical, toxicological and ecotoxicological properties
of substances and preparations which may constitute a risk during normal handling or use. Having identified
any hazardous properties, the substance or preparation must then be labelled to indicate the hazard(s) in
order to protect the user, the general public and the environment.

This Annex sets out the general principles governing the classification and labelling of substances and
preparations referred to in Article 4 of this Directive and in Article 4 of Directive 1999/45/EC and other
relevant Directives on dangerous preparations.

is addressed to all

It
classifying and labelling dangerous substances and preparations.

those concerned (manufacturers,

importers, national authorities) with methods of

The requirements of this Directive and of Directive 1999/45/EC are intended to provide a primary means by
which the general public and persons at work are given essential information about dangerous substances and
preparations. The label draws the attention of persons handling or using substances and preparations to the
inherent danger of certain such materials.

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The label may also serve to draw attention to more comprehensive product information on safety and use
available in other forms.

1.4.

The label takes account of all potential hazards which are likely to be faced in the normal handling and use of
dangerous substances and preparations when in the form in which they are placed on the market, but not
necessarily in any different form in which they may finally be used, e.g. diluted. The most severe hazards are
highlighted by symbols, such hazards and those arising from other dangerous properties are specified in
standard risk phrases, and safety phrases give advice on necessary precautions.

In the case of substances, the information is completed by the name of the substance under an internationally
recognised chemical nomenclature, the preferred name being the one used in the European Inventory of
Existing Commercial Chemical Substances (Einecs), or in the European List of Notified Chemical Substances
(Elincs), the EC number and the name, address and telephone number of the person established in the
Community who is responsible for placing the substance on the market.

In the case of preparations, the information in accordance with Article 10(2) of Directive 1999/45/EC, is
completed by:

(cid:151) the trade name or the designation of the preparation,

(cid:151) the chemical name of the substance or substances present in the preparation, and

(cid:151) the name, full address and telephone number of the person established in the Community who is

responsible for placing the preparation on the market.

1.5.

Article 6 requires that manufacturers, distributors and importers of dangerous substances which appear in the
Einecs but which have not yet been introduced into Annex I shall be obliged to carry out an investigation to
make themselves aware of the relevant and accessible data which exist concerning the properties of such
substances. On the basis of this information, they shall package and provisionally label these substances
according to the rules laid down in Articles 22 to 25 and the criteria in this Annex.

1.6.

Data required for classification and labelling

1.6.1.

For substances the data required for classification and labelling may be obtained:

(a) as regards substances for which the information specified in Annex VII is required, most of the necessary
data for classification and labelling appear in the (cid:145)base set(cid:146). This classification and labelling must be
reviewed, if necessary, when further information is available (Annex VIII);

(b) as regards other substances (e.g. those referred to in section 1.5), the data required for classification and

labelling may, if necessary, be obtained from a number of different sources, for example:

(cid:151) the results of previous tests,

(cid:151) information required by international rules on the transport of dangerous substances,

(cid:151) information taken from reference works and the literature, or

(cid:151) information derived from practical experience.

The results of validated structure-activity relationships and expert judgement may also be taken into
account where appropriate.

1.6.2.

For preparations, normally the data required for classification and labelling may be obtained:

(a)

if it concerns physicochemical data, by the application of the methods specified in Annex V. This applies
also to preparations covered by Directive 91/414/EEC unless other internationally recognised methods are
acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC (Article 5(5)
of Directive 1999/45/EC). For gaseous preparations a calculation method may be used for flammable and
oxidising properties (see 9.1.1.1 and 9.1.1.2). For non-gaseous preparations containing organic peroxides
a calculation method may be used for oxidising properties (see 2.2.2.1);

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(b)

if it concerns data on health effects:

(cid:151) by the application of the methods specified in Annex V, unless,

in the case of plant protection
products, other internationally recognised methods are acceptable in accordance with the provisions
of Annexes II and III to Directive 91/414/EEC (Article 6(1) (b) of Directive 1999/45/EC),

(cid:151) and/or by the application of a conventional method referred to in Article 6 of and Annex II, Parts

A.1-6 and B.1-5, to Directive 1999/45/EC, or,

(cid:151) in the case of R65, by the application of the rules under 3.2.3,

(cid:151) however,

if it concerns the evaluation of the carcinogenic, mutagenic and reproductive toxicity
properties, by the application of a conventional method referred to in Article 6 of and Annex II, Parts
A.7-9 and B.6, to Directive 1999/45/EC;

(c)

if it concerns data on ecotoxicological properties:

(i)

for aquatic toxicity only:

(cid:151) by the application of the methods specified in Annex V, subject to the conditions referred to in
Annex III, Part C, to Directive 1999/45/EC, unless, in the case of plant protection products, other
internationally recognised methods are acceptable in accordance with the provisions of Annexes
II and III to Directive 91/414/EEC (Article 7(1)(b) of Directive 1999/45/EC), or

(cid:151) by application of a conventional method referred to in Article 7 of and Annex III, Parts A and B,

to Directive 1999/45/EC;

(ii)

for the evaluation of the potential for (or actual) bioaccumulation through the determination of log
Pow (or BCF), or the evaluation of degradability, by application of a conventional method referred to
in Article 7 of and Annex III, Parts A and B, to Directive 1999/45/EC;

(iii) for dangers of the ozone layer by application of a conventional method referred to in Article 7 of

and Annex III, Parts A and B, to Directive 1999/45/EC.

Note concerning the performance of animal tests:

The performance of animal tests to establish experimental data is subject to the provisions of Directive
86/609/EEC regarding the protection of animals used for experimental purposes.

Note concerning physicochemical properties:

For organic peroxides and organic peroxide preparations data may be derived from the calculation method set
out in section 9.5. For gaseous preparations a calculation method may be used for flammable and oxidising
properties (see section 9).

1.7.

Application of the guide criteria

Classification must cover the physicochemical, toxicological and ecotoxicological properties of substances and
preparations.

Classification of substances and preparations is made according to section 1.6, on the basis of the criteria in
sections 2 to 5 (substances) and sections 2, 3, 4.2.4 and 5 of this Annex. All types of hazard must be
considered. For instance, classification under 3.2.1 does not imply that the sections such as 3.2.2 or 3.2.4 can
be ignored.

The choice of symbol(s) and risk phrase(s) is made on the basis of the classification in order to ensure that the
specific nature of the potential dangers identified in classification is expressed on the label.

Notwithstanding the criteria given under 2.2.3, 2.2.4 and 2.2.5, substances and preparations in the form of
aerosols shall be subject to the provisions of Directive 75/324/EEC as amended and adapted to technical
progress.

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1.7.1.

Definitions

(cid:145)Substances(cid:146) means chemical elements and their compounds in the natural state or obtained by any production
process, including any additive necessary to preserve the stability of the product, and any impurity deriving
from the production process used, but excluding any solvent which may be separated without affecting the
stability of the substance or changing its composition.

A substance may be chemically very well defined (e.g. acetone) or a complex mixture of constituents of
variable composition (e.g. aromatic distillates). For certain complex substances, some individual constituents
have been identified.

(cid:145)Preparations(cid:146) means mixtures or solutions composed of two or more substances.

1.7.2.

Application of the guide criteria for substances

The guidance criteria set out in this Annex are directly applicable when the data in question have been
obtained from test methods comparable with those described in Annex V. In other cases, the available data
must be evaluated by comparing the test methods employed with those indicated in Annex V and the rules
specified in this Annex for determining the appropriate classification and labelling.

In some cases there may be doubt over the application of the relevant criteria, especially where these require
the use of expert judgement. In such cases the manufacturer, distributor or importer should provisionally
classify and label the substance on the basis of an assessment of the evidence by a competent person.

Without prejudice to Article 6, where the above procedure has been followed and there is concern over
possible inconsistencies then a proposal may be submitted for the entry of the provisional classification into
Annex I. The proposal should be made to one of the Member States and should be accompanied by
appropriate scientific data (see also section 4.1).

A similar procedure may be followed when information is identified which gives cause for concern over the
accuracy of an existing entry in Annex I.

1.7.2.1. Classification of substances containing impurities, additives or individual constituents

Where impurities, additives or individual constituents of substances have been identified, they shall be taken
into account if their concentration is greater than or equal to the limits specified:

(cid:151) 0,1 % for substances classified as very toxic, toxic, carcinogenic (category 1 or 2), mutagenic (category 1
or 2), toxic to reproduction (category 1 or 2), or dangerous for the environment (assigned the symbol (cid:145)N(cid:146)
for the aquatic environment, dangerous for the ozone layer),

(cid:151) 1 % for

substances classified as harmful, corrosive,

sensitising, carcinogenic (category 3),
mutagenic (category 3), toxic to reproduction (category 3), or dangerous for the environment (not
assigned the symbol (cid:145)N(cid:146), i.e. harmful to aquatic organisms, may cause long-term adverse effects),

irritant

unless lower values have been specified in Annex I.

With the exception of substances listed specifically in Annex I, classification should be carried out according
to the requirements of Articles 5, 6 and 7 of Council Directive 1999/45/EC.

In the case of asbestos (650-013-00-6) this general rule does not apply until a concentration limit has been
fixed in Annex I. Substances in which asbestos is present must be classified and labelled according to the
principles in Article 6 of this Directive.

1.7.3.

Application of the guide criteria for preparations

The guidance criteria set out in this Annex are directly applicable when the data in question have been
obtained from test methods comparable with those described in Annex V with the exception of the criteria of
section 4 for which only the conventional method is applicable. A conventional method is also applicable in
relation to the criteria of section 5, with the exception of aquatic toxicity, subject to the conditions referred to

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in Annex III, Part C, to Directive 1999/45/EC. For preparations covered by Directive 91/414/EEC data for
classification and labelling are also acceptable from other internationally recognised methods (see special
provisions in section 1.6 of this Annex). In other cases, the available data must be evaluated by comparing the
test methods employed with those indicated in Annex V and the rules specified in this Annex for determining
the appropriate classification and labelling.

Where the health and environmental hazards are assessed by applying a conventional method referred to in
Articles 6 and 7 and Annexes II and III to Directive 1999/45/EC the individual concentration limits to be used
are those set out either:

(cid:151) in Annex I to this Directive, or

(cid:151) in Annex II, Part B, and/or Annex III, Part B, to Directive 1999/45/EC where the substance or substances

do not appear in Annex I to this Directive or appear in it without concentration limits.

to the health and
In the case of preparations containing mixtures of gases, classification with respect
environmental effects will be established by the calculation method on the basis of
the individual
concentration limits from Annex I to this Directive or when these limits are not in Annex I on the basis of
the criteria of Annexes II and III to Directive 1999/45/EC.

1.7.3.1. Preparations or substances described in section 1.7.2.1 used as constituents of another preparation

The labelling of such preparations must be in conformity with the provisions of Article 10 according to the
principles set out in Articles 3 and 4 of Directive 1999/45/EC. However, in certain cases, the information on
the label of
to enable other
manufacturers who wish to use it as a constituent of their own preparation(s) to carry out the classification
and labelling of their preparation(s) correctly.

the preparation or substance described in section 1.7.2.1 is insufficient

In these cases, the person established within the Community responsible for placing the original preparation
or substance described in section 1.7.2.1 on the market, whether it be the manufacturer, the importer or the
distributor shall supply upon justified request and as soon as possible all necessary data concerning the
dangerous substances present to enable correct classification and labelling of the new preparation. This data is
also necessary to enable the person responsible for placing the new preparation on the market to comply with
other requirements of Directive 1999/45/EC.

2.

CLASSIFICATION ON THE BASIS OF PHYSICOCHEMICAL PROPERTIES

2.1.

Introduction

The test methods relating to explosive, oxidising and flammable properties included in Annex V serve to give
specific meaning to the general definitions given in Article 2(2)(a) to (e). Criteria follow directly from the test
methods in Annex V as far as they are mentioned.

If adequate information is available to demonstrate in practice that
the physico-chemical properties of
substances and preparations (apart from organic peroxides) are different from those revealed by the test
methods given in Annex V, then such substances and preparations should be classified according to the
hazard they present, if any, to those handling the substances and preparations or to other persons.

2.2.

Criteria for classification, choice of symbols, indication of danger and choice of risk phrases

In the case of preparations, the criteria referred to in Article 5 of Directive 1999/45/EC need to be taken into
consideration.

2.2.1.

Explosive

Substances and preparations shall be classified as explosive and assigned the symbol (cid:145)E(cid:146) and the indication of
danger (cid:145)explosive(cid:146) in accordance with the results of the tests given in Annex V and in so far as the substances

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and preparations are explosive as placed on the market. One risk phrase is obligatory, it is to be specified on
the basis of the following:

R2 Risk of explosion by shock, friction, fire or other sources of ignition

(cid:151) Substances and preparations except those set out below.

R3 Extreme risk of explosion by shock, friction, fire or other source of ignition

(cid:151) Substances and preparations which are particularly sensitive such as picric acid salts or PETN.

2.2.2.

Oxidising

Substances and preparations shall be classified as oxidising and assigned the symbol (cid:145)O(cid:146) and the indication of
danger (cid:145)oxidising(cid:146) in accordance with the results of the tests given in Annex V. One risk phrase is obligatory,
it is to be specified on the basis of the test results but subject to the following:

R7 May cause fire

(cid:151) Organic peroxides which have flammable properties even when not

in contact with other

combustible material.

R8 Contact with combustible material may cause fire

(cid:151) Other oxidising substances and preparations, including inorganic peroxides, which may cause fire or

enhance the risk of fire when in contact with combustible material.

R9 Explosive when mixed with combustible material

(cid:151) Other substances and preparations, including inorganic peroxides, which become explosive when

mixed with combustible materials, e.g. certain chlorates.

2.2.2.1. Remarks concerning peroxides

For the explosive properties, an organic peroxide or preparation thereof in the form in which it is placed on
the market is classified according to the criteria in section 2.2.1 on the basis of tests carried out in accordance
with the methods given in Annex V.

For the oxidising properties the existing methods in Annex V cannot be applied to organic peroxides.

For substances, organic peroxides not already classified as explosive are classified as dangerous on the basis of
their structure (e.g. R-O-O-H; R1-O-O-R2).

Preparations not already classified as explosive shall be classified using the calculation method based on the
percentage of active oxygen shown in section 9.5.

Any organic peroxide or preparation thereof not already classified as explosive is classified as oxidising, if the
peroxide or its formulation contains:

(cid:151) more than 5 % of organic peroxides, or

(cid:151) more than 0,5 % available oxygen from the organic peroxides, and more than 5 % hydrogen peroxide.

2.2.3.

Extremely flammable

Substances and preparations shall be classified as extremely flammable and assigned the symbol (cid:145)F+(cid:146) and the
indication of danger (cid:145)extremely flammable(cid:146) in accordance with the results of the tests given in Annex V. The
risk phrase shall be assigned in accordance with the following criteria:

R12 Extremely flammable

(cid:151) Liquid substances and preparations which have a flash point lower than 0 (cid:176)C and a boiling point (or

in case of a boiling range the initial boiling point) lower than or equal to 35 (cid:176)C.

(cid:151) Gaseous

substances and preparations which are flammable in contact with air at ambient

temperature and pressure.

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2.2.4.

Highly flammable

Substances and preparations shall be classified as highly flammable and assigned the symbol
(cid:145)F(cid:146) and the
indication of danger (cid:145)highly flammable(cid:146) in accordance with the results of the tests given in Annex V. Risk
phrases shall be assigned in accordance with the following criteria:

R11 Highly flammable

(cid:151) Solid substances and preparations which may readily catch fire after brief contact with a source of
ignition and which continue to burn or to be consumed after removal of the source of ignition.

(cid:151) Liquid substances and preparations having a flash point below 21 (cid:176)C but which are not extremely

flammable.

R15 Contact with water liberates extremely flammable gases

(cid:151) Substances and preparations which, in contact with water or damp air, evolve extremely flammable

gases in dangerous quantities, at a minimum rate of 1 litre per kilogram per hour.

R17 Spontaneously flammable in air

(cid:151) Substances and preparations which may become hot and finally catch fire in contact with air at

ambient temperature without any input of energy.

2.2.5.

Flammable

Substances and preparations shall be classified as flammable in accordance with the results of the tests given
in Annex V. The risk phrase shall be assigned in accordance with the criteria mentioned below.

R10 Flammable

(cid:151) Liquid substances and preparations having a flash point equal to or greater than 21 (cid:176)C, and less than

or equal to 55 (cid:176)C.

However, in practice it has been shown that a preparation having a flash point equal to or greater than 21 (cid:176)C
and less than or equal to 55 (cid:176)C need not be classified as flammable if the preparation could not in any way
support combustion and only so long as there is no reason to fear risks to those handling these preparations
or to other persons.

2.2.6.

Other physico-chemical properties

Additional risk phrases shall be assigned to substances and preparations which have been classified by virtue
of sections 2.2.1 to 2.2.5 or by sections 3, 4 and 5, in accordance with the following criteria (based on
experience obtained during compilation of Annex I):

R1 Explosive when dry

For explosive substances and preparations put on the market in solution or in a wetted form, e.g.
nitrocellulose with more than 12,6 % nitrogen.

R4 Forms very sensitive explosive metallic compounds

For substances and preparations which may form sensitive explosive metallic derivatives, e.g. picric acid,
styphnic acid.

R5 Heating may cause an explosion

For thermally unstable substances and preparations not classified as explosive, e.g. perchloric acid
> 50 %.

R6 Explosive with or without contact with air

For substances and preparations which are unstable at ambient temperatures, e.g. acetylene.

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R7 May cause fire

For reactive substances and preparations, e.g. fluorine, sodium hydrosulphite.

R14 Reacts violently with water

For substances and preparations which react violently with water, e.g. acetyl chloride, alkali metals,
titanium tetrachloride.

R16 Explosive when mixed with oxidising substances

For substances and preparations which react explosively with an oxidising agent, e.g. red phosphorus.

R18 In use, may form flammable/explosive vapour-air mixture

For preparations not in themselves classified as flammable, which contain volatile components which are
flammable in air.

R19 May form explosive peroxides

For substances and preparations which may form explosive peroxides during storage, e.g. diethyl ether,
1,4-dioxan.

R30 Can become highly flammable in use

For preparations not in themselves classified as flammable, which may become flammable due to the loss
of non-flammable volatile components.

R44 Risk of explosion if heated under confinement

For substances and preparations not in themselves classified as explosive in accordance with section 2.2.1
above but which may nevertheless display explosive properties in practice if heated under sufficient
confinement. For example, certain substances which would decompose explosively if heated in a steel
drum do not show this effect if heated in less-strong containers.

For other additional risk phrases see section 3.2.8.

3.

CLASSIFICATION ON THE BASIS OF TOXICOLOGICAL PROPERTIES

3.1.

Introduction

3.1.1.

Classification is concerned with both the acute and long-term effects of substances and preparations, whether
resulting from a single instance of exposure or repeated or prolonged exposure.

Where it can be demonstrated by epidemiological studies, by scientifically valid case studies as specified in this
Annex or by statistically backed experience, such as the assessment of data from poison information units or
concerning occupational diseases,
toxicological effects on man differ from those suggested by the
application of the methods outlined in section 1.6 of this Annex, then the substance or preparation shall be
classified according to its effects on man. However, tests on man should be discouraged and should not
normally be used to negate positive animal data.

that

Directive 86/609/EEC seeks to protect animals used for experimental and other scientific purposes. For several
endpoints there are validated in vitro test methods in Annex V to this Directive and these tests should be used
where appropriate.

3.1.2.

The classification of substances must be made on the basis of the experimental data available in accordance
with the following criteria which take into account the magnitude of these effects:

(a)

for acute toxicity (lethal and irreversible effects after a single exposure), the criteria under sections 3.2.1
to 3.2.3 are to be used;

(b)

for subacute, subchronic or chronic toxicity the criteria under sections 3.2.2 to 3.2.4 are to be used;

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(c)

for corrosive and irritant effects the criteria under sections 3.2.5 and 3.2.6 are to be used;

(d)

for sensitising effects the criteria under section 3.2.7 are to be used;

(e)

for specific effects on health (carcinogenicity, mutagenicity and reproductive toxicity), the criteria in
section 4 are to be used.

3.1.3.

For preparations, the classification relating to dangerous for health is carried out:

(a)

on the basis of a conventional method referred to in Article 6 of and Annex II to Directive 1999/45/EC
in the absence of experimental data.
the classification is based on the individual
concentration limits:

In this case,

(cid:151) either taken from Annex I to this Directive, or

(cid:151) from Annex II, Part B, to Directive 1999/45/EC where the substance or substances do not appear in

Annex I to this Directive or appear in it without concentration limits;

(b) or when experimental data are available, according to the criteria described under section 3.1.2 excluding
the carcinogenic, mutagenic and toxic to reproduction properties referred to under 3.1.2(e) which must
be evaluated by a conventional method referred to in Article 6 of and Annex II, Parts A.7-9 and B.6, to
Directive 1999/45/EC.

Note: Without prejudice to requirements of Directive 91/414/EEC, only where it can be scientifically
demonstrated by the person responsible for placing the preparation on the market that the toxicological
properties of the preparation cannot correctly be determined by the method outlined in paragraph 3.1.3(a), or
on the basis of existing test results on animals, the methods outlined in paragraph 3.1.3(b) may be used,
provided they are justified or specifically authorised under Article 12 of Directive 86/609/EEC.

Whichever method is used for the evaluation of the danger of a preparation, all the dangerous effects on
health as defined in Annex II, Part B, to Directive 1999/45/EC must be taken into consideration.

3.1.4. When the classification is to be established from experimental results obtained in animal tests the results

should have validity for man in that the tests reflect, in an appropriate way, the risks to man.

3.1.5.

The acute oral toxicity of substances or preparations placed on the market may be established either by a
method permitting assessment of the LD50 value, or by determining the discriminating dose (the fixed dose
method, or by determining the range of exposure where lethality is expected (the acute toxic class method).

3.1.5.1. The discriminating dose is the dose which causes evident toxicity but not mortality and must be one of the

four dosage levels specified in Annex V (5, 50, 500 or 2 000 mg per kg body weight).

The concept (cid:145)evident toxicity(cid:146) is used to designate toxic effects, after exposure to the substance tested, which
are so severe that exposure to the next highest fixed dose would probably lead to mortality.

The results of testing at a particular dose following the fixed dose method may be either:

(cid:151) less than 100 % survival,

(cid:151) 100 % survival, but evident toxicity,

(cid:151) 100 % survival, but no evident toxicity.

In the criteria in sections 3.2.1, 3.2.2 and 3.2.3 only the final test result is shown. The 2 000 mg/kg dose
should be used primarily to obtain information on the toxic effects of substances which are of low acute
toxicity and which are not classified on the basis of acute toxicity.

The fixed dose method requires in some cases testing at higher or lower doses, if not already tested at the
relevant dose level. Refer also to the evaluation table in test method B.1 bis.

3.1.5.2. The range of exposure where lethality is expected is derived from the observed absence or presence of
substance related mortality following the acute toxic class method. For initial testing one of three fixed
starting doses (25, 200 or 2 000 mg per kg body weight) is used.

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The acute toxic class method requires in some cases testing at higher or lower doses, if not already tested at
the relevant dose level. Refer also to the test procedure flow charts in test method B.1 ter of Annex V.

3.2.

Criteria for classification, choice of symbols, indication of danger, choice of risk phrases

3.2.1.

Very toxic

Substances and preparations shall be classified as very toxic, and assigned the symbol (cid:145)T+(cid:146) and indication of
danger (cid:145)very toxic(cid:146) in accordance with the criteria specified below.

Risk phrases shall be assigned in accordance with the following criteria:

R28 Very toxic if swallowed

Acute toxicity results:

(cid:151) LD50 oral, rat ˜ 25 mg/kg,

(cid:151) less than 100 % survival at 5 mg/kg oral, rat by the fixed dose procedure, or

(cid:151) high mortality at doses ˜ 25 mg/kg oral, rat, by the acute toxic class method (for test result

interpretation see flow charts in Appendix 2 to test method B.1 ter of Annex V).

R27 Very toxic in contact with skin

Acute toxicity results:

(cid:151) LD50 dermal, rat or rabbit: ˜ 50 mg/kg.

R26 Very toxic by inhalation

Acute toxicity results:

(cid:151) LC50 inhalation, rat, for aerosols or particulates: ˜ 0,25 mg/litre/4h,

(cid:151) LC50 inhalation, rat, for gases and vapours: ˜ 0,5 mg/litre/4h.

R39 Danger of very serious irreversible effects

(cid:151) Strong evidence that irreversible damage other than the effects referred to in section 4 is likely to be
caused by a single exposure by an appropriate route, generally in the above-mentioned dose range.

In order to indicate the route of administration/exposure one of the following combinations shall be
used: R39/26, R39/27, R39/28, R39/26/27, R39/26/28, R39/27/28, R39/26/27/28.

3.2.2.

Toxic

Substances and preparations shall be classified as toxic and assigned the symbol (cid:145)T(cid:146) and the indication of
danger (cid:145)toxic(cid:146) in accordance with the criteria specified below. Risk phrases shall be assigned in accordance
with the following criteria.

R25 Toxic if swallowed

Acute toxicity results:

(cid:151) LD50 oral, rat: 25 < LD50 ˜ 200 mg/kg,

(cid:151) discriminating dose, oral, rat, 5 mg/kg: 100 % survival but evident toxicity, or

(cid:151) high mortality in the dose range > 25 to ˜ 200 mg/kg oral, rat, by the acute toxic class method (for

test result interpretation see flow charts in Appendix 2 to test method B.1 ter of Annex V).

R24 Toxic in contact with skin

Acute toxicity results:

(cid:151) LD50 dermal, rat or rabbit: 50 < LD50 ˜ 400 mg/kg.

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R23 Toxic by inhalation

Acute toxicity results:

(cid:151) LC50 inhalation, rat, for aerosols or particulates: 0,25 < LC50 ˜ 1 mg/litre/4h,

(cid:151) LC50 inhalation, rat, for gases and vapours: 0,5 < LC50 ˜ 2 mg/litre/4h.

R39 Danger of very serious irreversible effects

(cid:151) strong evidence that irreversible damage other than the effects referred to in section 4 is likely to be
caused by a single exposure by an appropriate route, generally in the above-mentioned dose range.

In order to indicate the route of administration/exposure one of the following combinations shall be
used: R39/23, R39/24, R39/25, R39/23/24, R39/23/25, R39/24/25, R39/23/24/25.

R48 Danger of serious damage to health by prolonged exposure

(cid:151) serious damage (clear functional disturbance or morphological change which have toxicological
significance) is likely to be caused by repeated or prolonged exposure by an appropriate route.

Substances and preparations are classified at least as toxic when these effects are observed at levels of
one order of magnitude lower (i.e. 10-fold) than those set out for R48 in section 3.2.3.

In order to indicate the route of administration/exposure one of the following combinations shall be
used: R48/23, R48/24, R48/25, R48/23/24, R48/23/25, R48/24/25, R48/23/24/25.

3.2.3.

Harmful

Substances and preparations shall be classified as harmful and assigned the symbol (cid:145)Xn(cid:146) and the indication of
danger (cid:145)harmful(cid:146) in accordance with the criteria specified below. Risk phrases shall be assigned in accordance
with the following criteria:

R22 Harmful if swallowed

Acute toxicity results:

(cid:151) LD50 per oral, rat: 200 < LD50 ˜ 2 000 mg/kg,

(cid:151) discriminating dose, oral, rat, 50 mg/kg: 100 % survival but evident toxicity,

(cid:151) less than 100 % survival at 500 mg/kg, rat oral by the fixed dose procedure. Refer to the evaluation

table in the test method B.1 bis of Annex V, or

(cid:151) high mortality in the dose range > 200 to ˜ 2 000 mg/kg oral, rat, by the acute toxic class method
(for test result interpretation see flow charts in Appendix 2 of test method B.1 ter of Annex V).

R21 Harmful in contact with skin

Acute toxicity results:

(cid:151) LD50 dermal, rat or rabbit: 400 < LD50 ˜ 2 000 mg/kg.

R20 Harmful by inhalation

Acute toxicity results:

(cid:151) LC50 inhalation, rat, for aerosols or particulates: 1 < LC50 ˜ 5 mg/litre/4h,

(cid:151) LC50 inhalation, rat, for gases or vapours: 2 < LC50 ˜ 20 mg/litre/4h.

R65 Harmful: may cause lung damage if swallowed

Liquid substances and preparations presenting an aspiration hazard in humans because of their low
viscosity:

(a)

for substances and preparations containing aliphatic, alicyclic and aromatic hydrocarbons in a total
concentration equal to or greater than 10 % and having either:

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(cid:151) a flow time of less than 30 sec. in a 3 mm ISO cup according to ISO 2431 (April 1996/July
1999 edition) relating to (cid:145)Paints and varnishes (cid:151) Determination of flow time by use of flow
cups(cid:146),

(cid:151) a kinematic viscosity measured by a calibrated glass capillary viscometer in accordance with ISO
less than 7 (cid:215) 10ﬂ6 m2/sec. at 40 (cid:176)C (ISO 3104, 1994 edition, relating to
3104/3105 of
(cid:145)Petroleum products (cid:151) Transparent and opaque liquids (cid:151) Determination of kinematic viscosity
and calculation of dynamic viscosity(cid:146);
ISO 3105, 1994 edition, relating to (cid:145)Glass capillary
kinematic viscometers (cid:151) Specifications and operating instructions(cid:146)), or

(cid:151) a kinematic viscosity derived from measurements of rotational viscometry in accordance with
ISO 3219 of less than 7 (cid:215) 10ﬂ6 m2/sec. at 40 (cid:176)C (ISO 3219, 1993 edition, relating to (cid:145)Plastics (cid:151)
Polymers/resins in the liquid state or as emulsions or dispersions (cid:151) Determination of viscosity
using a rotational viscometer with defined shear rate(cid:146)).

Note that substances and preparations meeting these criteria need not be classified if they have a
mean surface tension greater than 33 mN/m at 25 (cid:176)C as measured by the du Nouy tensiometer or
by the test methods shown in Annex V, Part A.5;

(b)

for substances and preparations, based on practical experience in humans.

R68 Possible risk of irreversible effects

(cid:151) strong evidence that irreversible damage other than the effects referred to in section 4 is likely to be
caused by a single exposure by an appropriate route, generally in the above-mentioned dose range.

In order to indicate route of administration/exposure one of the following combinations shall be used:
R68/20, R68/21, R68/22, R68/20/21, R68/20/22, R68/21/22, R68/20/21/22.

R48 Danger of serious damage to health by prolonged exposure

(cid:151) serious damage (clear functional disturbance or morphological change which has toxicological
significance) is likely to be caused by repeated or prolonged exposure by an appropriate route.

Substances and preparations are classified at least as harmful when these effects are observed at levels of
the order of:

(cid:151) oral, rat ˜ 50 mg/kg (bodyweight)/day,

(cid:151) dermal, rat or rabbit ˜ 100 mg/kg (bodyweight)/day,

(cid:151) inhalation, rat ˜ 0,25 mg/l, 6 h/day.

These guide values can apply directly when severe lesions have been observed in a subchronic (90 days)
toxicity test. When interpreting the results of a subacute (28 days) toxicity test these figures should be
increased approximately threefold. If a chronic (two years) toxicity test is available it should be evaluated on a
case-by-case basis. If results of studies of more than one duration are available, then those from the study of
the longest duration should normally be used.

In order to indicate route of administration/exposure one of the following combinations shall be used:
R48/20, R48/21, R48/22, R48/20/21, R48/20/22, R48/21/22, R48/20/21/22.

3.2.3.1. Comments regarding volatile substances

For certain substances with a high saturated vapour concentration evidence may be available to indicate
effects that give cause for concern. Such substances may not be classified under the criteria for health effects
in this guide (3.2.3) or not covered by section 3.2.8. However, where there is appropriate evidence that such
substances may present a risk in normal handling and use, then classification on a case-by-case basis in Annex
I may be necessary.

3.2.4.

Comments regarding the use of R48

Use of this risk phrase refers to the specific range of biological effects within the terms described below. For
application of this risk phrase serious damage to health is to be considered to include death, clear functional
disturbance or morphological changes which are toxicologically significant. It is particularly important when

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these changes are irreversible. It is also important to consider not only specific severe changes in a single
organ or biological system but also generalised changes of a less severe nature involving several organs, or
severe changes in general health status.

When assessing whether there is evidence for these types of effects reference should be made to the following
guidelines:

1.

Evidence indicating that R48 should be applied:

(a)

substance-related deaths;

(b)

(i) major functional changes in the central or peripheral nervous systems, including sight, hearing
and the sense of smell, assessed by clinical observations or other appropriate methods (e.g.
electrophysiology);

(ii) major functional changes in other organ systems (for example the lung);

(c) any consistent changes in clinical biochemistry, haematology or urinalysis parameters which indicate
severe organ dysfunction. Haematological disturbances are considered to be particularly important if
the evidence suggests that they are due to decreased bone marrow production of blood cells;

(d)

severe organ damage noted on microscopic examination following autopsy:

(i) widespread or severe necrosis, fibrosis or granuloma formation in vital organs with regenerative

capacity (e.g. liver);

(ii)

severe morphological changes that are potentially reversible but are clear evidence of marked
organ dysfunction (e.g. severe fatty change in the liver, severe acute tubular nephrosis in the
kidney, ulcerative gastritis); or

(iii) evidence of appreciable cell death in vital organs incapable of regeneration (e.g. fibrosis of the
myocardium or dying back of a nerve) or in stem cell populations (e.g. aplasia or hypoplasia of
the bone marrow).

The above evidence will most usually be obtained from animal experiments. When considering data
derived from practical experience special attention should be given to exposure levels.

2.

Evidence indicating that R48 should not be applied:

The use of this risk phrase is restricted to (cid:145)serious damage to health by prolonged exposure(cid:146). A number
of substance-related effects may be observed in both humans and animals that would not justify the use
for a chemical
of R48. These effects are relevant when attempting to determine a no-effect
substance.

level

Examples of well-documented changes which would not normally justify classification with R48,
irrespective of their statistical significance, include:

(a) clinical observations or changes in bodyweight gain, food consumption or water intake, which may
have some toxicological importance but which do not, by themselves, indicate (cid:145)serious damage(cid:146);

(b)

small changes in clinical biochemistry, haematology or urinalysis parameters which are of doubtful
or minimal toxicological importance;

(c) changes in organ weights with no evidence of organ dysfunction;

(d) adaptative responses (e.g. macrophage migration in the lung,

liver hypertrophy and enzyme
induction, hyperplastic responses to irritants). Local effects on the skin produced by repeated dermal
application of a substance which are more appropriately classified with R38 (cid:145)irritating to skin(cid:146); or

(e) where a species-specific mechanism of

toxicity (e.g.

specific metabolic pathways) has been

demonstrated.

3.2.5.

Corrosive

The substance or preparation shall be classified as corrosive and assigned the symbol (cid:145)C(cid:146) and the indication of
danger (cid:145)corrosive(cid:146) in accordance with the following criteria:

(cid:151) a substance or a preparation is considered to be corrosive if, when it is applied to healthy intact animal
skin, it produces full thickness destruction of skin tissue on at least one animal during the test for skin
irritation cited in Annex V or during an equivalent method,

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(cid:151) classification can be based on the results of a validated in vitro test, such as that cited in Annex V (B.40.

Skin corrosion: rat skin transcutaneous electrical resistance assay and human skin model assay),

(cid:151) a substance or a preparation should also be considered corrosive if the result can be predicted, for
example from strongly acid or alkaline reactions indicated by a pH of 2 or less or 11,5 or greater.
However, where extreme pH is the basis for classification, acid/alkali reserve (1) may also be taken into
consideration. If consideration of alkali/acid reserve suggests the substance or preparation may not be
corrosive then further testing should be carried out to confirm this, preferably by use of an appropriate
validated in vitro test. Consideration of acid/alkali reserve should not be used alone to exonerate
substances or preparations from classification as corrosive.

Risk phrases shall be assigned in accordance with the following criteria:

R35 Causes severe burns

(cid:151) if, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a

result of up to three minutes exposure, or if this result can be predicted.

R34 Causes burns

(cid:151) if, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a

result of up to four hours exposure, or if this result can be predicted,

(cid:151) organic hydroperoxides, except where evidence to the contrary is available.

Notes:

Where classification is based on results of a validated in vitro test R35 or R34 should be applied according to
the capacity of the test method to discriminate between these.

Where classification is based upon consideration of extreme pH alone, R35 should be applied.

3.2.6.

Irritant

Substances and preparations shall be classified as irritant and assigned the symbol (cid:145)Xi(cid:146) and the indication of
danger (cid:145)irritant(cid:146) in accordance with the criteria given below.

3.2.6.1.

Inflammation of the skin

The following risk phrase shall be assigned in accordance with the criteria given:

R38 Irritating to skin

(cid:151) Substances and preparations which cause significant inflammation of the skin which persists for at
least 24 hours after an exposure period of up to four hours determined on the rabbit according to
the cutaneous irritation test method cited in Annex V.

Inflammation of the skin is significant if:

(a)

(b)

the mean value of the scores for either erythema and eschar formation or oedema formation,
calculated over all the animals tested, is 2 or more; or

in the case where the Annex V test has been completed using three animals, either erythema
and eschar formation or oedema formation equivalent to a mean value of 2 or more calculated
for each animal separately has been observed in two or more animals.

In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be
used in calculating respective mean values.

Inflammation of the skin is also significant if it persists in at least two animals at the end of the
observation time. Particular effects e.g. hyperplasia, scaling, discoloration, fissures, scabs and alopecia
should be taken into account.

(1) J. R. Young, M. J. How, A. P. Walker and W. M. H. Worth (1988),

(cid:145)Classification as corrosive or irritant to skin of preparations

containing acidic or alkaline substances, without testing on animals(cid:146), Toxic. In Vitro 2(1): pp. 19-26.

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Relevant data may also be available from non-acute animal studies (see comments on R48, section
2.d). These are considered significant if the effects seen are comparable to those described above.

(cid:151) Substances and preparations which cause significant inflammation of the skin, based on practical

observations in humans on immediate, prolonged or repeated contact.

(cid:151) Organic peroxides, except where evidence to the contrary is available.

Paresthesia:

Paresthesia caused in humans by skin contact with pyrethroid pesticides is not regarded as an irritant effect
justifying classification as Xi; R38. The S-phrase S24 should however be applied for substances seen to cause
this effect.

3.2.6.2. Ocular lesions

The following risk phrases shall also be assigned in accordance with the criteria given:

R36 Irritating to eyes

(cid:151) Substances and preparations which, when applied to the eye of the animal, cause significant ocular

lesions which occur within 72 hours after exposure and which persist for at least 24 hours.

Ocular lesions are significant if the mean scores of the eye irritation test cited in Annex V have any of
the following values:

(cid:151) cornea opacity equal to or greater than 2 but less than 3,

(cid:151) iris lesion equal to or greater than 1 but not greater than 1,5,

(cid:151) redness of the conjunctivae equal to or greater than 2,5,

(cid:151) oedema of the conjunctivae (chemosis) equal to or greater than 2,

or, in the case where the Annex V test has been completed using three animals if the lesions, on two or
more animals, are equivalent to any of the above values except that for iris lesion the value should be
equal to or greater than 1 but less than 2 and for redness of the conjunctivae the value should be equal
to or greater than 2,5.

In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be used
in calculating the respective mean values.

(cid:151) Substances or preparations which cause significant ocular lesions, based on practical experience in

humans.

(cid:151) Organic peroxides except where evidence to the contrary is available.

R41 Risk of serious damage to eyes

(cid:151) Substances and preparations which, when applied to the eye of the animal cause severe ocular

lesions which occur within 72 hours after exposure and which persist for at least 24 hours.

Ocular lesions are severe if the means of the scores of the eye irritation test in Annex V have any of the
values:

(cid:151) cornea opacity equal to or greater than 3,

(cid:151) iris lesion greater than 1,5.

The same shall be the case where the test has been completed using three animals if these lesions, on
two or more animals, have any of the values:

(cid:151) cornea opacity equal to or greater than 3,

(cid:151) iris lesion equal to 2.

In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be used
in calculating the respective mean values.

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Ocular lesions are also severe when they are still present at the end of the observation time.

Ocular lesions are also severe if the substance or preparation causes irreversible colouration of the eyes.

(cid:151) Substances and preparations which cause severe ocular lesions, based on practical experience in humans.

Note:

When a substance or preparation is classified as corrosive and assigned R34 or R35, the risk of severe damage
to eyes is considered implicit and R41 is not included in the label.

3.2.6.3. Respiratory system irritation

The following risk phrase shall be assigned in accordance with the criteria given:

R37 Irritating to respiratory system

Substances and preparations which cause serious irritation to the respiratory system based on:

(cid:151) practical observation in humans

(cid:151) positive results from appropriate animal tests.

Comments regarding the use of R37:

In interpreting practical observations in humans, care should be taken to distinguish between effects which
lead to classification with R48 (see section 3.2.4) from those leading to classification with R37. Conditions
normally leading to classification with R37 are reversible and usually limited to the upper airways.

Positive results from appropriate animal tests may include data obtained in a general toxicity test, including
histopathological data from the respiratory system. Data from the measurement of experimental bradypnea
may also be used to assess airway irritation.

3.2.7.

Sensitisation

3.2.7.1. Sensitisation by inhalation

Substances and preparations shall be classified as sensitising and assigned the symbol (cid:145)Xn(cid:146), the indication of
danger (cid:145)Harmful(cid:146) and the risk phrase R42 in accordance with the criteria given below.

R42 May cause sensitisation by inhalation

(cid:151) if there is evidence that the substance or preparation can induce specific respiratory hypersensitivity,

(cid:151) where there are positive results from appropriate animal tests, or

(cid:151) if the substance is an isocyanate, unless there is evidence that the specific isocyanate does not cause

respiratory hypersensitivity.

Comments regarding the use of R42:

Human evidence

Evidence that the substance or preparation can induce specific respiratory hypersensitivity will normally
be based on human experience. In this context hypersensitivity is normally seen as asthma, but other
hypersensitivity reactions such as rhinitis and alveolitis are also considered. The condition will have the
clinical character of an allergic reaction. However,
immunological mechanisms do not have to be
demonstrated.

When considering the evidence from human exposure, it is necessary for a decision on classification to
take into account in addition to the evidence from the cases:

(cid:151) the size of the population exposed,

(cid:151) the extent of exposure.

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The evidence referred to above could be:

(cid:151) clinical history and data from appropriate lung function tests related to exposure to the substance,

confirmed by other supportive evidence which may include:

(cid:151) a chemical structure related to substances known to cause respiratory hypersensitivity,

(cid:151) an in vivo immunological test (e.g. skin prick test),

(cid:151) an in vitro immunological test (e.g. serological analysis),

(cid:151) studies indicating other specific but non-immunological mechanisms of action, e.g. repeated

low-level irritation, pharmacologically mediated effects, or

(cid:151) data from a positive bronchial challenge test with the substance conducted according to

accepted guidelines for the determination of a specific hypersensitivity reaction.

Clinical history should include both medical and occupational history to determine a relationship
between exposure to a specific substance or preparation and development of respiratory hypersensitivity.
Relevant information includes aggravating factors both in the home and workplace, the onset and
progress of the disease, family history and medical history of the patient in question. The medical history
should also include a note of other allergic or airway disorders from childhood, and smoking history.

The results of positive bronchial challenge tests are considered to provide sufficient evidence for
classification on their own. It is however recognised that in practice many of the examinations listed
above will already have been carried out.

Substances that elicit symptoms of asthma by irritation only in people with bronchial hyperreactivity
should not be assigned R42.

Animal studies

Data from tests which may be indicative of the potential of a substance or preparation to cause
sensitisation by inhalation in humans may include:

(cid:151) IgE measurements (e.g. in mice), or

(cid:151) specific pulmonary responses in guinea pigs.

3.2.7.2. Sensitisation by skin contact

Substances and preparations shall be classified as sensitising and assigned the symbol (cid:145)Xi(cid:146), the indication of
danger (cid:145)Irritant(cid:146) and the risk phrase R43 in accordance with the criteria given below:

R43 May cause sensitisation by skin contact

(cid:151) if practical experience shows the substance or preparation to be capable of inducing a sensitisation

by skin contact in a substantial number of persons, or

(cid:151) where there are positive results from an appropriate animal test.

Comments regarding the use of R43:

Human evidence

The following evidence (practical experience) is sufficient to classify a substance or preparation with R43:

(cid:151) positive data from appropriate patch testing, normally in more than one dermatological clinic, or

(cid:151) epidemiological studies showing allergic contacts dermatitis caused by the substance or preparation.
Situations in which a high proportion of those exposed exhibit characteristic symptoms are to be
looked at with special concern, even if the number of cases is small, or

(cid:151) positive data from experimental studies in man (see also 3.1.1).

The following is sufficient to classify a substance with R43 when there is supportive evidence:

(cid:151) isolated episodes of allergic contact dermatitis, or

(cid:151) epidemiological studies where chance, bias or confounders have not been ruled out fully with

reasonable confidence.

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Supportive evidence may include:

(cid:151) data from animal tests performed according to existing guidelines, with a result that does not meet
the criteria given in the section on animal studies but is sufficiently close to the limit to be
considered significant, or

(cid:151) data from non-standard methods, or

(cid:151) appropriate structure-activity relationships.

Animal studies

Positive results from appropriate animal tests are:

(cid:151) in the case of the adjuvant type test method for skin sensitisation detailed in Annex V or in the case
of other adjuvant-type test methods, a response of at least 30 % of the animals is considered positive,

(cid:151) for any other test method a response of at least 15 % of the animals is considered positive.

3.2.7.3.

Immunological contact urticaria

Some substances or preparations, which meet the criteria for R42 may in addition cause immunological
contact urticaria. In these cases, information concerning contact urticaria should be included by the use of
appropriate S-phrases, usually S24 and S36/37, and in the safety data sheet.

For substances or preparations, which produce signs of immunological contact urticaria which do not fulfil
the criteria for R42, consideration should be given to classification with R43.

There is no recognised animal model available to identify substances which cause immunological contact
urticaria. Therefore, classification will normally be based on human evidence which will be similar to that for
skin sensitisation (R43).

3.2.8.

Other toxicological properties

Additional risk phrases shall be assigned in accordance with the following criteria (based on experience
obtained during compilation of Annex I) to substances and preparations classified by virtue of 2.2.1 to 3.2.7
and/or sections 4 and 5:

R29 Contact with water liberates toxic gas

For substances and preparations which in contact with water or damp air, evolve very toxic/toxic gases
in potentially dangerous amounts, e.g. aluminium phosphide, phosphorus pentasulphide.

R31 Contact with acids liberates toxic gas

For substances and preparations which react with acids to evolve toxic gases in dangerous amounts, e.g.
sodium hypochlorite, barium polysulphide. For substances used by members of the general public, the
use of S50 (do not mix with (cid:133) (to be specified by the manufacturer)) would be more suitable.

R32 Contact with acids liberates very toxic gas

For substances and preparations which react with acids to evolve very toxic gases in dangerous amounts;
e.g. salts of hydrogen cyanide, sodium azide. For substances used by members of the general public, the
use of S50 (do not mix with (cid:133) (to be specified by the manufacturer)) would be more suitable.

R33 Danger of cumulative effects

For substances and preparations when accumulation in the human body is likely and may cause some
concern which, however, is not sufficient to justify the use of R48.

For comments on the use of this R-phrase see section 4.2.3.3 for substances and Annex V, Part A.3, to
Directive 1999/45/EC for preparations.

R64 May cause harm to breastfed babies

For substances and preparations which are absorbed by women and may interfere with lactation or
which may be present (including metabolites) in breast milk in amounts sufficient to cause concern for
the health of a breastfed child.

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For comments on the use of this R-phrase see section 4.2.3.3 for substances and Annex V, Part A.4, to
Directive 1999/45/EC for preparations.

R66 Repeated exposure may cause skin dryness or cracking

For substances and preparations which may cause concern as a result of skin dryness, flaking or cracking
but which do not meet the criteria for R38 based on either:

(cid:151) practical observation after normal handling and use, or

(cid:151) relevant evidence concerning their predicted effects on the skin.

See also sections 1.6 and 1.7.

R67 Vapours may cause drowsiness and dizziness

For volatile substances and preparations containing such substances which cause clear symptoms of
central nervous system depression by inhalation and which are not already classified with respect to
acute inhalation toxicity (R20, R23, R26 , R68/20, R39/23 or R39/26).

The following evidence may be used:

(a) data from animal studies showing clear signs of CNS depression such as narcotic effects, lethargy,

lack of coordination (including loss of righting reflex) and ataxia either:

(cid:151) at concentrations/exposure times not exceeding 20 mg/l/4h or,

(cid:151) for which the ratio of the effect concentration at ˜ 4 h to the saturated vapour concentration

(SVC) at 20 (cid:176)C is ˜ 1/10;

(b) practical experience in humans (e.g. narcosis, drowsiness, reduced alertness, loss of reflexes, lack of
coordination, vertigo) from well documented reports under comparable exposure conditions to the
effects specified above for animals.

See also sections 1.6 and 1.7.

For other supplementary risk phrases, see section 2.2.6.

4.

CLASSIFICATION ON THE BASIS OF SPECIFIC EFFECTS ON HUMAN HEALTH

4.1.

Introduction

4.1.1.

This chapter sets out the procedure for the classification of substances which may have the effects mentioned
below. For preparations see section 4.2.4.

4.1.2.

If a manufacturer, distributor or importer has information available which indicates that a substance should be
classified and labelled in accordance with the criteria given in section 4.2.1, 4.2.2 or 4.2.3, he shall
provisionally label the substance in accordance with these criteria, on the basis of the assessment of the
evidence by a competent person.

4.1.3.

The manufacturer, distributor or importer shall submit as soon as possible a document summarising all
information to one Member State in which the substance is placed on the market. Relevant
relevant
information in this context comprises in particular all available published and unpublished information
required for appropriate classification of the substance in question, on the basis of the intrinsic properties
according to the categories laid down in Article 2(2) and in accordance with the criteria in this Annex. The
submitted summary document should include a bibliography containing all relevant references, including any
relevant unpublished data.

4.1.4.

Furthermore, a manufacturer, distributor or
to the
classification and labelling of a substance in accordance with the criteria given in section 4.2.1, 4.2.2 or 4.2.3,
shall submit this data as soon as possible to one Member State in which the substance is placed on the
market.

importer who has new data which are relevant

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4.1.5.

this Directive, Member States which have relevant

To obtain as quickly as possible a harmonised classification for the Community by the procedure defined in
information available justifying the
Article 28 of
classification of a substance in one of these categories, whether submitted by the manufacturer or not, should
forward such information together with suggestions for classification and labelling, to the Commission as
soon as possible.

The Commission will forward to the other Member States the classification and labelling proposal that it
receives. Any Member State may ask the Commission for the information it has received.

Any Member State which has good reason to believe that
the suggested classification and labelling is
inappropriate as far as the carcinogenic, mutagenic or reproductive toxicity effects are concerned shall notify
the Commission thereof.

4.2.

Criteria for classification, indication of danger, choice of risk phrases

4.2.1.

Carcinogenic substances

For the purpose of classification and labelling, and having regard to the current state of knowledge, such
substances are divided into three categories:

Category 1

Substances known to be carcinogenic to man. There is sufficient evidence to establish a causal association
between human exposure to a substance and the development of cancer.

Category 2

Substances which should be regarded as if they are carcinogenic to man. There is sufficient evidence to
provide a strong presumption that human exposure to a substance may result in the development of cancer,
generally on the basis of:

(cid:151) appropriate long-term animal studies,

(cid:151) other relevant information.

Category 3

Substances which cause concern for man owing to possible carcinogenic effects but in respect of which the
available information is not adequate for making a satisfactory assessment. There is some evidence from
appropriate animal studies, but this is insufficient to place the substance in category 2.

4.2.1.1. The following symbols and specific risk phrases apply:

Categories 1 and 2:

Substances classified carcinogenic category 1 or 2 shall be assigned the symbol (cid:145)T(cid:146) and the risk phrase

R45 May cause cancer

However, substances and preparations which present a carcinogenic risk only when inhaled, for example, as
dust, vapour or fumes, (other routes of exposure e.g. by swallowing or in contact with skin do not present
any carcinogenic risk), shall be assigned the symbol (cid:145)T(cid:146) and the risk phrase

R49 May cause cancer by inhalation

Categories 3:

Substances classified as carcinogenic category 3 shall be assigned the symbol (cid:145)Xn(cid:146) and the risk phrase

R40 Limited evidence of a carcinogenic effect

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4.2.1.2. Comments regarding the categorisation of carcinogenic substances

The placing of a substance into category 1 is done on the basis of epidemiological data; placing into
categories 2 and 3 is based primarily on animal experiments.

For classification as a category 2 carcinogen either positive results in two animal species should be available
or clear positive evidence in one species, together with supporting evidence such as genotoxicity data,
metabolic or biochemical studies,
induction of benign tumours, structural relationship with other known
carcinogens, or data from epidemiological studies suggesting an association.

Category 3 actually comprises 2 subcategories:

(a)

(b)

substances which are well
is
insufficient for classification in category 2. Additional experiments would not be expected to yield further
relevant information with respect to classification;

for which the evidence of a tumour-inducing effect

investigated but

substances which are insufficiently investigated. The available date are inadequate, but they raise concern
for man. This classification is provisional; further experiments are necessary before a final decision can be
made.

For a distinction between categories 2 and 3 the arguments listed below are relevant which reduce the
significance of experimental
tumour induction in view of possible human exposure. These arguments,
especially in combination, would lead in most cases to classification in category 3, even though tumours have
been induced in animals:

(cid:151) carcinogenic effects only at very high dose levels exceeding the (cid:145)maximal tolerated dose(cid:146). The maximal
tolerated dose is characterised by toxic effects which, although not yet reducing lifespan, go along with
physical changes such as about 10 % retardation in weight gain,

(cid:151) appearance of tumours, especially at high dose levels, only in particular organs of certain species known

to be susceptible to a high spontaneous tumour formation,

(cid:151) appearance of tumours, only at the site of application, in very sensitive test systems (e.g. i.p. or s.c.

application of certain locally active compounds), if the particular target is not relevant to man,

(cid:151) lack of genotoxicity in short-term tests in vivo and in vitro,

(cid:151) existence of a secondary mechanism of action with the implication of a practical threshold above a
certain dose level (e.g., hormonal effects on target organs or on mechanisms of physiological regulation,
chronic stimulation of cell proliferation),

(cid:151) existence of a species-specific mechanism of tumour formation (e.g. by specific metabolic pathways)

irrelevant for man.

For a distinction between category 3 and no classification arguments are relevant which exclude a concern for
man:

(cid:151) a substance should not be classified in any of the categories if the mechanism of experimental tumour
formation is clearly identified, with good evidence that this process cannot be extrapolated to man,

(cid:151) if the only available tumour data are liver tumours in certain sensitive strains of mice, without any other

supplementary evidence, the substance may not be classified in any of the categories,

(cid:151) particular attention should be paid to cases where the only available tumour data are the occurrence of
neoplasms at sites and in strains where they are well known to occur spontaneously with a high
incidence.

4.2.2. Mutagenic substances

4.2.2.1. For the purposes of classification and labelling, and having regard to the current state of knowledge, such

substances are divided into three categories:

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Category 1

Substances known to be mutagenic to man.

There is sufficient evidence to establish a causal association between human exposure to a substance and
heritable genetic damage.

Category 2

Substances which should be regarded as if they are mutagenic to man.

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result
in the development of heritable genetic damage, generally on the basis of:

(cid:151) appropriate animal studies,

(cid:151) other relevant information.

Category 3

Substances which cause concern for man owing to possible mutagenic effects. There is evidence from
appropriate mutagenicity studies, but this is insufficient to place the substance in category 2.

4.2.2.2. The following symbols and specific risk phrases apply:

Categories 1 and 2:

Substances classified as mutagenic category 1 or 2 shall be assigned the symbol (cid:145)T(cid:146) and the risk phrase

R46 May cause heritable genetic damage

Categories 3:

Substances classified as mutagenic category 3 shall be assigned the symbol (cid:145)Xn(cid:146) and the risk phrase

R68 Possible risk of irreversible effects.

4.2.2.3. Comments regarding the categorisation of mutagenic substances

Definition of terms:

A mutation is a permanent change in the amount or structure of the genetic material
in an organism,
resulting in a change of the phenotypic characteristics of the organism. The alterations may involve a single
gene, a block of genes, or a whole chromosome. Effects involving single genes may be a consequence of
effects on single DNA bases (point mutations) or of large changes, including deletions, within the gene. Effects
on whole chromosomes may involve structural or numerical changes. A mutation in the germ cells in sexually
reproducing organisms may be transmitted to the offspring. A mutagen is an agent that gives rise to an
enhanced occurrence of mutations.

It should be noted that substances are classified as mutagens with specific reference to inherited genetic
damage. However, the type of results leading to classification of chemicals in category 3:
(cid:145)induction of
genetically relevant events in somatic cells(cid:146) is generally also regarded as an alert for possible carcinogenic
activity.

Method development for mutagenicity testing is an ongoing process. For many new tests no standardised
protocols and evaluation criteria are presently available. For the evaluation of mutagenicity data the quality of
the test performance and the degree of validation of the test method have to be considered.

Category 1

To place a substance in category 1, positive evidence from human mutation epidemiology studies will be
needed. Examples of such substances are not known to date. It is recognised that it is extremely difficult to

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obtain reliable information from studies on the incidence of mutations in human populations, or on possible
increases in their frequencies.

Category 2

To place a substance in category 2, positive results are needed from assays showing (a) mutagenic effects, or
(b) other cellular interactions relevant to mutagenicity, in germ cells of mammals in vivo, or (c) mutagenic
effects in somatic cells of mammals in vivo in combination with clear evidence that the substance or a relevant
metabolite reaches the germ cells.

With respect to placement in category 2, at present the following methods are appropriate:

2(a) In vivo germ cell mutagenicity assays:

(cid:151) specific locus mutation test,

(cid:151) heritable translocation test,

(cid:151) dominant lethal mutation test.

These assays actually demonstrate the appearance of affected progeny or a defect in the developing embryo.

2(b) In vivo assays showing relevant interaction with germ cells (usually DNA):

(cid:151) assays for chromosomal abnormalities, as detected by cytogenetic analysis,

including aneuploidy,

caused by malsegregation of chromosomes,

(cid:151) test for sister chromatid exchanges (SCEs),

(cid:151) test for unscheduled DNA synthesis (UDS),

(cid:151) assay of (covalent) binding of mutagen to germ cell DNA,

(cid:151) assaying other kinds of DNA damage.

These assays provide evidence of a more or less indirect nature. Positive results in these assays would
normally be supported by positive results from in vivo somatic cell mutagenicity assays, in mammals or in
man (see under category 3, preferably methods as under 3(a)).

2(c) In vivo assays showing mutagenic effects in somatic cells of mammals (see under 3(a)), in combination
with toxicokinetic methods, or other methodologies capable of demonstrating that the compound or a
relevant metabolite reaches the germ cells.

For 2(b) and 2(c), positive results from host-mediated assays or the demonstration of unequivocal effects in in
vitro assays can be considered as supporting evidence.

Category 3

To place a substance in category 3, positive results are needed in assays showing (a) mutagenic effects or (b)
other cellular interaction relevant to mutagenicity, in somatic cells in mammals in vivo. The latter especially
would normally be supported by positive results from in vitro mutagenicity assays.

For effects in somatic cells in vivo at present the following methods are appropriate:

3(a) In vivo somatic cell mutagenicity assays:

(cid:151) bone marrow micronucleus test or metaphase analysis,

(cid:151) metaphase analysis of peripheral lymphocytes,

(cid:151) mouse coat colour spot test.

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3(b) In vivo somatic cell DNA interaction assays:

(cid:151) test for SCEs in somatic cells,

(cid:151) test for UDS in somatic cells,

(cid:151) assay for the (covalent) binding of mutagen to somatic cell DNA,

(cid:151) assay for DNA damage, e.g. by alkaline elution, in somatic cells.

Substances showing positive results only in one or more in vitro mutagenicity assays should normally not be
classified. Their further investigation using in vivo assays, however, is strongly indicated. In exceptional cases,
e.g. for a substance showing pronounced responses in several in vitro assays, for which no relevant in vivo data
are available, and which shows resemblance to known mutagens/carcinogens, classification in category 3
could be considered.

4.2.3.

Substances toxic to reproduction

4.2.3.1. For the purposes of classification and labelling and having regard to the present state of knowledge, such

substances are divided into three categories:

Category 1

Substances known to impair fertility in humans

There is sufficient evidence to establish a causal relationship between human exposure to the substance and
impaired fertility.

Substances known to cause developmental toxicity in humans

There is sufficient evidence to establish a causal relationship between human exposure to the substance and
subsequent developmental toxic effects in the progeny.

Category 2

Substances which should be regarded as if they impair fertility in humans

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result
in impaired fertility on the basis of:

(cid:151) clear evidence in animal studies of impaired fertility in the absence of toxic effects, or, evidence of
impaired fertility occurring at around the same dose levels as other toxic effects but which is not a
secondary non-specific consequence of the other toxic effects,

(cid:151) other relevant information.

Substances which should be regarded as if they cause developmental toxicity to humans

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result
in developmental toxicity, generally on the basis of:

(cid:151) clear results in appropriate animal studies where effects have been observed in the absence of signs of
marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a
secondary non-specific consequence of the other toxic effects,

(cid:151) other relevant information.

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Category 3

Substances which cause concern for human fertility

Generally on the basis of:

(cid:151) results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of
impaired fertility in the absence of toxic effects, or evidence of impaired fertility occuring at around the
same dose levels as other toxic effects, but which is not a secondary non-specific consequence of the
other toxic effects, but where the evidence is insufficient to place the substance in category 2,

(cid:151) other relevant information.

Substances which cause concern for humans owing to possible developmental toxic effects

Generally on the basis of:

(cid:151) results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of
developmental toxicity in the absence of signs of marked maternal toxicity, or at around the same dose
levels as other toxic effects but which are not a secondary non-specific consequence of the other toxic
effects, but where the evidence is insufficient to place the substance in category 2,

(cid:151) other relevant information.

4.2.3.2. The following symbols and specific risk phrases apply:

Category 1:

for substances that impair fertility in humans:

Substances classified as toxic to reproduction category 1 shall be assigned the symbol (cid:145)T(cid:146) and the risk phrase

R60 May impair fertility

for substances that cause developmental toxicity:

Substances classified as toxic to reproduction category 1 shall be assigned the symbol (cid:145)T(cid:146) and the risk phrase

R61 May cause harm to the unborn child

Category 2:

for substances that should be regarded as if they impair fertility in humans:

Substances classified as toxic to reproduction category 2 shall be assigned the symbol (cid:145)T(cid:146) and the risk phrase

R60 May impair fertility

for substances that should be regarded as if they cause developmental toxicity in humans:

Substances classified as toxic to reproduction category 2 shall be assigned the symbol (cid:145)T(cid:146) and the risk phrase

R61 May cause harm to the unborn child

Category 3:

for substances which cause concern for human fertility:

Substances classified as toxic to reproduction category 3 shall be assigned the symbol (cid:145)Xn(cid:146) and the risk phrase

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R62 Possible risk of impaired fertility

for substances which cause concern for humans owing to possible developmental toxic effects:

Substances classified as toxic to reproduction category 3 shall be assigned the symbol (cid:145)Xn(cid:146) and the risk phrase

R63 Possible risk of harm to the unborn child.

4.2.3.3. Comments regarding the categorisation of substances toxic to reproduction

Reproductive toxicity includes impairment of male and female reproductive functions or capacity and the
induction of non-inheritable harmful effects on the progeny. This may be classified under two main headings
of 1. Effects on male or female fertility; 2. Developmental toxicity.

1

2

Effects on male or female fertility, includes adverse effects on libido, sexual behaviour, any aspect of
spermatogenesis or oogenesis, or on hormonal activity or physiological response which would interfere
with the capacity to fertilise, fertilisation itself or the development of the fertilised ovum up to and
including implantation.

toxicity,

interfering with normal
is taken in its widest sense to include any effect
Developmental
development, both before and after birth. It includes effects induced or manifested prenatally as well as
those manifested postnatally. This includes embrytoxic/fetotoxic effects such as reduced body weight,
growth and developmental retardation, organ toxicity, death, abortion, structural defects (teratogenic
effects), functional defects, peri-postnatal defects, and impaired postnatal mental or physical development
up to and including normal pubertal development.

Classification of chemicals as toxic to reproduction is intended to be used for chemicals which have an
intrinsic or specific property to produce such toxic effects. Chemicals should not be classified as toxic to
reproduction where such effects are solely produced as a non-specific secondary consequence of other toxic
effects. Chemicals of most concern are those which are toxic to reproduction at exposure levels which do not
produce other signs of toxicity.

The placing of a compound in category 1 for effects on fertility and/or developmental toxicity is done on the
basis of epidemiological data. Placing in categories 2 or 3 is done primarily on the basis of animal data. Data
from in vitro studies, or studies on avian eggs, are regarded as (cid:145)supportive evidence(cid:146) and would only
exceptionally lead to classification in the absence of in vivo data.

In common with most other types of toxic effect, substances demonstrating reproductive toxicity will be
expected to have a threshold below which adverse effects would not be demonstrated. Even when clear effects
have been demonstrated in animal studies the relevance for humans may be doubtful because of the doses
administered, for example, where effects have been demonstrated only at high doses, or where marked
toxicokinetic differences exist, or the route of administration is inappropriate. For these or similar reasons it
may be that classification in category 3, or even no classification, will be warranted.

Annex V to the Directive specifies a limit test in the case of substances of low toxicity. If a dose level of at
least 1 000 mg/kg orally produces no evidence of effects toxic to reproduction, studies at other dose levels
may not be considered necessary. If data are available from studies carried out with doses higher than the
above limit dose, this data must be evaluated together with other relevant data. Under normal circumstances it
is considered that effects seen only at doses in excess of the limit dose would not necessarily lead to
classification as (cid:145)Toxic to reproduction(cid:146).

EFFECTS ON FERTILITY

For the classification of a substance in category 2 for impaired fertility, there should normally be clear
evidence in one animal species, with supporting evidence on mechanism of action or site of action, or
chemical relationship to other known anti-fertility agents or other information from humans which would
lead to the conclusion that effects would be likely to be seen in humans. Where there are studies in only one
species without other relevant supporting evidence then classification in category 3 may be appropriate.

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Since impaired fertility may occur as a non-specific accompaniment to severe generalised toxicity or where
there is severe inanition, classification in category 2 should only be made where there is evidence that there is
some degree of specificity of toxicity for the reproductive system. If it was demonstrated that impaired fertility
in animal studies was due to failure to mate, then for classification in category 2, it would normally be
necessary to have evidence on the mechanism of action in order to interpret whether any adverse effect such
as alteration in pattern of hormonal release would be likely to occur in humans.

DEVELOPMENTAL TOXICITY

For classification in category 2 there should be clear evidence of adverse effects in well conducted studies in
one or more species. Since adverse effects in pregnancy or postnatally may result as a secondary consequence
lack of maternal care, specific dietary
of maternal toxicity, reduced food or water intake, maternal stress,
deficiencies, poor animal husbandry,
that the effects
observed should occur in well conducted studies and at dose levels which are not associated with marked
maternal toxicity. The route of exposure is also important. In particular, the injection of irritant material
intraperitoneally may result in local damage to the uterus and its contents, and the results of such studies
must be interpreted with caution and on their own would not normally lead to classification.

infections, and so on,

is important

intercurrent

it

Classification in category 3 is based on similar criteria as for category 2 but may be used where the
experimental design has deficiencies which make the conclusions less convincing, or where the possibility that
the effects may have been due to non-specific influences such as generalised toxicity cannot be excluded.

In general, classification in category 3 or no category would be assigned on an ad hoc basis where the only
effects recorded are small changes in the incidences of spontaneous defects, small changes in the proportions
of common variants such as are observed in skeletal examinations, or small differences in postnatal
developmental assessments.

Effects during lactation

Substances which are classified as toxic to reproduction and which also cause concern due to their effects on
lactation should in addition be labelled with R64 (see criteria in section 3.2.8).

For the purpose of classification, toxic effects on offspring resulting only from exposure via the breast milk, or
toxic effects resulting from direct exposure of children will not be regarded as (cid:145)Toxic to reproduction(cid:146), unless
such effects result in impaired development of the offspring.

Substances which are not classified as toxic to reproduction but which cause concern due to toxicity when
transferred to the baby during the period of lactation should be labelled with R64 (see criteria in section
3.2.8). This R-phrase may also be appropriate for substances which affect the quantity or quality of the milk.

R64 would normally be assigned on the basis of:

(a)

toxicokinetic studies that would indicate the likelihood that the substance would be present in potentially
toxic levels in breast milk; and/or

(b) on the basis of results of one or two generation studies in animals which indicate the presence of adverse

effects on the offspring due to transfer in the milk; and/or

(c)

on the basis of evidence in humans indicating a risk to babies during the lactational period.

Substances which are known to accumulate in the body and which subsequently may be released into milk
during lactation may be labelled with R33 and R64.

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4.2.4.

Procedure for the classification of preparations concerning specific effects on health

If a preparation contains one or more substances classified with respect to the criteria laid out above, it must
be classified according to the criteria referred to in Annex II, Part A.7-9 and Part B.6, to Directive 1999/45/EC
(the concentration limits are either in Annex I to this Directive, or in Annex II, Part B.6, to Directive
1999/45/EC where the substance or substances under consideration do not appear in Annex I or appear in it
without concentration limits).

5.

CLASSIFICATION ON THE BASIS OF ENVIRONMENTAL EFFECTS

5.1.

Introduction

The primary objective of classifying substances and preparations dangerous for the environment is to alert the
user to the hazards these substances and preparations present to ecosystems. Although the present criteria
refer to aquatic ecosystems it is recognised that certain substances and preparations may simultaneously or
alternatively affect other ecosystems whose constituents may range from soil microflora and microfauna to
primates.

The criteria set out below follow directly from the test methods set out in Annex V in so far as they are
mentioned. The test methods required for the (cid:145)base set(cid:146) referred to in Annex VII are limited and the
information derived from them may be insufficient for an appropriate classification. Classification may require
additional data derived from level 1 (Annex VIII) or other equivalent studies. Furthermore, classified substances
may be subject to review in the light of other new data.

For the purposes of classification and labelling and having regard to the current state of knowledge such
substances and preparations are divided into two groups according to their acute and/or long-term effects in
aquatic systems or their acute and/or long-term effects in non-aquatic systems.

5.1.1.

The classification of substances is usually made on the basis of experimental data for acute aquatic toxicity,
degradation, and log Pow (or BCF if available).

5.1.2.

The classification of preparations shall normally be carried out on the basis of a conventional method referred
to in Article 7 of and Annex III, Parts A and B, to Directive 1999/45/EC. In this case, the classification is
based on the individual concentration limits

(cid:151) in Annex I to this Directive

(cid:151) or in Annex III, Part B, to Directive 1999/45/EC where the substance or substances do not appear in

Annex I to this Directive or appear in it without concentration limits.

5.1.3.

Normally, the classification of a preparation is made on the basis of a conventional method. However, for the
determination of the acute aquatic toxicity, there may be cases for which it is appropriate to carry out tests
on the preparation. The result of these tests on the preparation may only modify the classification concerning
acute aquatic toxicity which would have been obtained by the application of a conventional method. If such
tests are chosen by the person responsible for the placing on the market, it must be ensured that the quality
criteria of the test methods in Part C of Annex V to this Directive have been complied with. Furthermore, the
tests are to be carried out on all three groups of species in conformity with the criteria in this Annex (algae,
daphnia and fish), unless the highest hazard classification relating to acute aquatic toxicity has been assigned
to the preparation after testing on one of the species or a test result was already available before Directive
1999/45/EC entered into force.

5.2.

Criteria for classification, indication of danger, choice of risk phrases

The classification criteria for substances in section 5.2.1 only apply to preparations where they have been
tested in accordance with 5.1.3.

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5.2.1.

Aquatic environment

5.2.1.1. Substances shall be classified as dangerous for the environment and assigned the symbol

(cid:145)N(cid:146) and the

appropriate indication of danger, and assigned risk phrases in accordance with the following criteria:

R50 Very toxic to aquatic organisms, and

R53 May cause long-term adverse effects in the aquatic environment

Acute toxicity:

96 h LC50 (for fish)

or

or

48 h EC50 (for daphnia)

72 h IC50 (for algae)

˜ 1 mg/l

˜ 1 mg/l

˜ 1 mg/l

and:

(cid:151) the substance is not readily degradable, or

(cid:151) the log Pow (log octanol/water partition coefficient) ¯ 3,0 (unless the experimentally determined BCF

˜ 100).

R50 Very toxic to aquatic organisms

Acute toxicity:

96 h LC50 (for fish)

or

or

48 h EC50 (for daphnia)

72 h IC50 (for algae)

˜ 1 mg/l

˜ 1 mg/l

˜ 1 mg/l

R51 Toxic to aquatic organisms, and

R53 May cause long-term adverse effects in the aquatic environment

Acute toxicity:

96 h LC50 (for fish)

1 mg/l < LC50 ˜ 10 mg/l

or

or

48 h EC50 (for daphnia)

1 mg/l < EC50 ˜ 10 mg/l

72 h IC50 (for algae)

1 mg/l < IC50 ˜ 10 mg/l

and:

(cid:151) the substance is not readily degradable, or

(cid:151) the log Pow ¯ 3,0 (unless the experimentally determined BCF ˜ 100).

5.2.1.2. Substances shall be classified as dangerous for the environment in accordance with the criteria set out below.

Risk phrases shall also be assigned in accordance with the following criteria

R52 Harmful to aquatic organisms, and

R53 May cause long-term adverse effects in the aquatic environment

Acute toxicity:

96 h LC50 (for fish)

10 mg/l < LC50 ˜ 100 mg/l

or

or

48 h EC50 (for daphnia)

10 mg/l < EC50 ˜ 100 mg/l

72 h IC50 (for algae)

10 mg/l < IC50 ˜ 100 mg/l

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the substance is not readily degradable.

This criterion applies unless there exists additional scientific evidence concerning degradation and/or toxicity
sufficient to provide an adequate assurance that neither the substance nor its degradation products will
constitute a potential long-term and/or delayed danger to the aquatic environment. Such additional scientific
evidence should normally be based on the studies required at level 1 (Annex VIII), or studies of equivalent
value, and could include:

(i)

a proven potential to degrade rapidly in the aquatic environment;

(ii)

an absence of chronic toxicity effects at a concentration of 1,0 mg/litre, e.g. a no-observed effect
concentration of greater than 1,0 mg/litre determined in a prolonged toxicity study with fish or daphnia.

R52 Harmful to aquatic organisms

Substances not falling under the criteria listed above in this chapter, but which on the basis of the available
evidence concerning their toxicity may nevertheless present a danger to the structure and/or functioning of
aquatic ecosystems.

R53 May cause long-term adverse effects in the aquatic environment

Substances not falling under the criteria listed above in this chapter, but which, on the basis of the available
evidence concerning their persistence, potential to accumulate, and predicted or observed environmental fate
and behaviour may nevertheless present a long-term and/or delayed danger
to the structure and/or
functioning of aquatic ecosystems.

For example, poorly water-soluble substances, i.e. substances with a solubility of less than 1 mg/l will be
covered by this criterion if:

(a)

they are not readily degradable; and

(b)

the log Pow ¯ 3,0 (unless the experimentally determined BCF ˜ 100).

This criterion applies to substances unless there exists additional scientific evidence concerning degradation
and/or toxicity sufficient to provide an adequate assurance that neither the substance nor its degradation
products will constitute a potential long-term and/or delayed danger to the aquatic environment.

Such additional scientific evidence should normally be based on the studies required at level 1 (Annex VIII), or
studies of equivalent value, and could include

(i)

a proven potential to degrade rapidly in the aquatic environment;

(ii)

an absence of chronic toxicity effects at the solubility limit e.g. a no-observed effect concentration of
greater than the solubility limit determined in a prolonged toxicity study with fish or daphnia.

5.2.1.3. Comments on the determination of IC50 for algae and of degradability

(cid:151) where it can be demonstrated in the case of highly coloured substances that algal growth is inhibited
solely as a result of a reduction in light intensity, then the 72h IC50 for algae should not be used as a
basis for classification,

(cid:151) substances are considered readily degradable if the following criteria hold true.

(a)

if in 28-day biodegradation studies the following levels of degradation are achieved

(cid:151) in tests based upon dissolved organic carbon: 70 %,

(cid:151) in tests based upon oxygen depletion or carbon dioxide generation: 60 % of the theoretical

maxima.

These levels of biodegradation must be achieved within 10 days of the start of degradation, which
point is taken as the time when 10 % of the substance has been degraded; or

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(b)

(c)

if in those cases where only COD and BOD5 data are available when the ratio of BOD5/COD is
greater than or equal to 0,5; or

if other convincing scientific evidence is available to demonstrate that the substance can be degraded
(biotically and/or abiotically) in the aquatic environment to a level of > 70 % within a 28-day period.

5.2.2.

Non-aquatic environment

5.2.2.1. Substances and preparations shall be classified as dangerous for the environment and assigned the symbol (cid:145)N(cid:146)

and the appropriate indication of danger, and assigned risk phrases in accordance with the following criteria:

R54 Toxic to flora

R55 Toxic to fauna

R56 Toxic to soil organisms

R57 Toxic to bees

R58 May cause long-term adverse effects in the environment

toxicity,
Substances and preparations which on the basis of
persistence, potential to accumulate and predicted or observed environmental fate and behaviour may present
a danger, immediate or long-term and/or delayed, to the structure and/or functioning of natural ecosystems
other than those covered under 5.2.1. Detailed criteria will be elaborated later.

the available evidence concerning their

5.2.2.2. Substances and preparations shall be classified as dangerous for the environment, and assigned the symbol (cid:145)N(cid:146)
and the appropriate indication of danger, where applicable, and assigned risk phrases in accordance with the
following criteria:

R59 Dangerous for the ozone layer

Substances which on the basis of the available evidence concerning their properties and their predicted
or observed environmental
fate and behaviour may present a danger to the structure and/or the
functioning of the stratospheric ozone layer. This includes the substances which are listed in Annex I to
Council Regulation (EC) No 2037/2000 on substances that deplete the ozone layer (OJ L 244,
29.9.2000, p.1) and its subsequent amendments.

Preparations shall be classified on the basis of a conventional method referred to in Article 7 of and
Annex III, Parts A and B, to Directive 1999/45/EC.

6.

CHOICE OF SAFETY ADVICE PHRASES

6.1.

Introduction

Safety advice phrases (S-phrases) shall be assigned to dangerous substances and preparations in accordance
with the following general criteria. In addition, for certain preparations, the safety advice listed in Annex V to
Directive 1999/45/EC is mandatory.

Whenever the manufacturer is mentioned in Chapter 6 it refers to the person responsible for placing the
substance or preparation on the market.

6.2.

Safety phrases for substances and preparations

S1 Keep locked up

(cid:151) Applicability:

(cid:151) very toxic, toxic and corrosive substances and preparations.

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(cid:151) Criteria for use:

(cid:151) obligatory for those substances and preparations mentioned above if sold to the general public.

S2 Keep out of the reach of children

(cid:151) Applicability:

(cid:151) all dangerous substances and preparations.

(cid:151) Criteria for use:

(cid:151) obligatory for all dangerous substances and preparations sold to the general public, except for

those only classified as dangerous for the environment.

S3 Keep in a cool place

(cid:151) Applicability:

(cid:151) organic peroxides,

(cid:151) other dangerous substances and preparations having a boiling point of ˜ 40 (cid:176)C.

(cid:151) Criteria for use:

(cid:151) obligatory for organic peroxides unless S47 is used,

(cid:151) recommended for other dangerous substances and preparations having a boiling point of ˜ 40 (cid:176)C.

S4 Keep away from living quarters

(cid:151) Applicability:

(cid:151) very toxic and toxic substances and preparations.

(cid:151) Criteria for use:

(cid:151) normally limited to very toxic and toxic substances and preparations when desirable to
supplement S13; for example when there is an inhalation risk and the substance or preparation
should be stored away from living quarters. The advice is not intended to preclude proper use of
the substance or preparation in living quarters.

S5 Keep contents under (cid:133) (appropriate liquid to be specified by the manufacturer)

(cid:151) Applicability:

(cid:151) spontaneously flammable solid substances and preparations.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases, e.g. sodium, potassium or white phosphorous.

S6 Keep under (cid:133) (inert gas to be specified by the manufacturer)

(cid:151) Applicability:

(cid:151) dangerous substances and preparations which must be kept under an inert atmosphere.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases, e.g. certain organo-metallic compounds.

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S7 Keep container tightly closed

(cid:151) Applicability:

(cid:151) organic peroxides,

(cid:151) substances and preparations which can give off very toxic,

toxic, harmful or extremely

flammable gases,

(cid:151) substances and preparations which in contact with moisture give off extremely flammable gases,

(cid:151) highly flammable solids.

(cid:151) Criteria for use:

(cid:151) obligatory for organic peroxides,

(cid:151) recommended for the other fields of application mentioned above.

S8 Keep container dry

(cid:151) Applicability:

(cid:151) substances and preparations which may react violently with water,

(cid:151) substances and preparations which on contact with water liberate extremely flammable gases,

(cid:151) substances and preparations which on contact with water liberate very toxic or toxic gases.

(cid:151) Criteria for use:

(cid:151) normally limited to the fields of application mentioned above when necessary to reinforce

warnings given by R14, R15 in particular, and R29.

S9 Keep container in a well-ventilated place

(cid:151) Applicability:

(cid:151) volatile substances and preparations which may give off very toxic, toxic or harmful vapours,

(cid:151) extremely flammable or highly flammable liquids and extremely flammable gases.

(cid:151) Criteria for use:

(cid:151) recommended for volatile substances and preparations which may give off very toxic, toxic or

harmful vapours,

(cid:151) recommended for extremely flammable or highly flammable liquids or extremely flammable

gases.

S12 Do not keep the container sealed

(cid:151) Applicability:

(cid:151) substances and preparations which will by giving off gases or vapours be liable to burst the

container.

(cid:151) Criteria for use:

(cid:151) normally limited to the special cases mentioned above.

S13 Keep away from food, drink and animal feedingstuffs

(cid:151) Applicability:

(cid:151) very toxic, toxic and harmful substances and preparations.

(cid:151) Criteria for use:

(cid:151) recommended when such substances and preparations are likely to be used by the general

public.

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S14 Keep away from (cid:133) (incompatible materials to be indicated by the manufacturer)

(cid:151) Applicability:

(cid:151) organic peroxides.

(cid:151) Criteria for use:

(cid:151) obligatory for and normally limited to organic peroxides. However, may be useful in exceptional

cases when incompatibility is likely to product a particular risk

S15 Keep away from heat

(cid:151) Applicability:

(cid:151) substances and preparations which may decompose or which may react spontaneously under

the effect of heat.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases, e.g. monomers, but not assigned if risk phrases R2, R3 and/or

R5 have already been applied.

S16 Keep away from sources of ignition (cid:151) No smoking

(cid:151) Applicability:

(cid:151) extremely flammable or highly flammable liquids and extremely flammable gases.

(cid:151) Criteria for use:

(cid:151) recommended for the substances and preparations mentioned above but not assigned if risk

phrases R2, R3 and/or R5 have already been applied.

S17 Keep away from combustible material

(cid:151) Applicability:

(cid:151) substances and preparations which may form explosive or spontaneously flammable mixtures

with combustible material.

(cid:151) Criteria for use:

(cid:151) available for use in special cases, e.g. to emphasise R8 and R9.

S18 Handle and open container with care

(cid:151) Applicability:

(cid:151) substances and preparations liable to produce an overpressure in the container,

(cid:151) substances and preparations which may form explosive peroxides.

(cid:151) Criteria for use:

(cid:151) normally limited to the abovementioned cases when there is risk of damage to the eyes and/or

when the substances and preparations are likely to be used by the general public.

S20 When using do not eat or drink

(cid:151) Applicability:

(cid:151) very toxic, toxic and corrosive substances and preparations.

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(cid:151) Criteria for use:

(cid:151) normally limited to special cases (e.g. arsenic and arsenic compounds; fluoracetates) in particular

when any of these are likely to be used by the general public.

S21 When using do not smoke

(cid:151) Applicability:

(cid:151) substances and preparations which produce toxic products on combustion.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases (e.g. halogenated compounds).

S22 Do not breathe dust

(cid:151) Applicability:

(cid:151) all solid substances and preparations dangerous for health.

(cid:151) Criteria for use:

(cid:151) obligatory for those substances and preparations mentioned above to which R42 is assigned,

(cid:151) recommended for those substances and preparations mentioned above which are supplied in the
form of an inhalable dust and for which the health hazards following inhalation are not known.

S23 Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer)

(cid:151) Applicability:

(cid:151) all liquid or gaseous substances and preparations dangerous to health.

(cid:151) Criteria for use:

(cid:151) obligatory for those substances and preparations mentioned above to which R42 is assigned,

(cid:151) obligatory for substances and preparations intended for use by spraying. Either S38 or S51 must

be ascribed in addition,

(cid:151) recommended when it is necessary to draw the attention of the user to inhalation risks not

mentioned in the risk phrases which have to be ascribed.

S24 Avoid contact with skin

(cid:151) Applicability:

(cid:151) all substances and preparations dangerous for health.

(cid:151) Criteria for use:

(cid:151) obligatory for those substances and preparations to which R43 has been ascribed, unless S36 has

also been ascribed,

(cid:151) recommended when it is necessary to draw the attention of the user to skin contact risks not
mentioned in the risk phrases (e.g. paresthesia) which have to be ascribed. However, may be
used to emphasise such risk phrases.

S25 Avoid contact with eyes

(cid:151) Applicability:

(cid:151) all substances and preparations dangerous to health.

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(cid:151) Criteria for use:

(cid:151) recommended when it is necessary to draw the attention of the user to eye contact risks not
mentioned in the risk phrases which have to be applied. However, may be used to emphasise
such risk phrases,

(cid:151) recommended for substances ascribed R34, R35, R36 or R41 which are likely to be used by the

general public.

S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice

(cid:151) Applicability:

(cid:151) corrosive or irritant substances and preparations.

(cid:151) Criteria for use:

(cid:151) obligatory for corrosive substances and preparations and those to which R41 has already been

ascribed,

(cid:151) recommended for irritant substances and preparations to which the risk phrase R36 has already

been ascribed.

S27 Take off immediately all contaminated clothing

(cid:151) Applicability:

(cid:151) very toxic, toxic or corrosive substances and preparations.

(cid:151) Criteria for use:

(cid:151) obligatory for very toxic substances and preparations to which R27 has been ascribed and which

are likely to be used by the general public,

(cid:151) recommended for very toxic substances and preparations to which R27 has been ascribed used

in industry. However, this safety phrase should not be used if S36 has been ascribed,

(cid:151) recommended for toxic substances and preparations to which R24 has been ascribed as well as

corrosive substances and preparations which are likely to be used by the general public.

S28 After contact with skin, wash immediately with plenty of (cid:133) (to be specified by the manufacturer)

(cid:151) Applicability:

(cid:151) very toxic, toxic or corrosive substances and preparations.

(cid:151) Criteria for use:

(cid:151) obligatory for very toxic substances and preparations,

(cid:151) recommended for the other substances and preparations mentioned above, in particular when

water is not the most appropriate rinsing fluid,

(cid:151) recommended for corrosive substances and preparations which are likely to be used by the

general public.

S29 Do not empty into drains

(cid:151) Applicability:

(cid:151) extremely or highly flammable liquids immiscible with water,

(cid:151) very toxic and toxic substances and preparations,

(cid:151) substances and preparations dangerous for the environment.

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(cid:151) Criteria for use:

(cid:151) obligatory for substances and preparations dangerous for the environment and assigned the
symbol (cid:145)N(cid:146), which are likely to be used by the general public, unless this is the intended use,

(cid:151) recommended for other substances and preparations mentioned above which are likely to be

used by the general public, unless this is the intended use.

S30 Never add water to this product

(cid:151) Applicability:

(cid:151) substances and preparations which react violently with water.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases (e.g. sulphuric acid) and may be used, as appropriate, to give

the clearest possible information, either to emphasise R14 or as an alternative to R14.

S33 Take precautionary measures against static discharges

(cid:151) Applicability:

(cid:151) extremely or highly flammable substances and preparations.

(cid:151) Criteria for use:

(cid:151) recommended for substances and preparations used in industry which do not absorb moisture.
Virtually never used for substances and preparations as placed on the market for use by the
general public.

S35 This material and its container must be disposed of in a safe way

(cid:151) Applicability:

(cid:151) all dangerous substances and preparations.

(cid:151) Criteria for use:

(cid:151) recommended for substances and preparations where special guidance is needed to ensure

proper disposal.

S36 Wear suitable protective clothing

(cid:151) Applicability:

(cid:151) organic peroxides,

(cid:151) very toxic, toxic or harmful substances and preparations,

(cid:151) corrosive substances and preparations.

(cid:151) Criteria for use:

(cid:151) obligatory for very toxic and corrosive substances and preparations,

(cid:151) obligatory for those substances and preparations to which either R21 or R24 has been ascribed,

(cid:151) obligatory for category 3 carcinogens, mutagens and substances toxic to reproduction unless the

effects are produced solely by inhalation of the substance or preparation,

(cid:151) obligatory for organic peroxides,

(cid:151) recommended for toxic substances and preparations if the LD50 dermal value is unknown but

the substance or preparation is likely to be toxic through skin contact,

(cid:151) recommended for substances and preparations used in industry which are liable to damage

health by prolonged exposure.

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S37 Wear suitable gloves

(cid:151) Applicability:

(cid:151) very toxic, toxic, harmful or corrosive substances and preparations,

(cid:151) organic peroxides,

(cid:151) substances and preparations irritating to the skin or causing sensitisation by skin contact.

(cid:151) Criteria for use:

(cid:151) obligatory for very toxic and corrosive substances and preparations,

(cid:151) obligatory for those substances and preparations to which either R21, R24 or R43 has been

ascribed,

(cid:151) obligatory for category 3 carcinogens, mutagens and substances toxic to reproduction unless the

effects are produced solely by inhalation of the substances and preparations,

(cid:151) obligatory for organic peroxides,

(cid:151) recommended for toxic substances and preparations if the LD50 dermal value is unknown but

the substance or preparation is likely to be harmful by skin contact,

(cid:151) recommended for substances and preparations irritating to the skin.

S38 In case of insufficient ventilation, wear suitable respiratory equipment

(cid:151) Applicability:

(cid:151) very toxic or toxic substances and preparations.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases involving the use of very toxic or toxic substances and

preparations in industry or in agriculture.

S39 Wear eye/face protection

(cid:151) Applicability:

(cid:151) organic peroxides,

(cid:151) corrosive substances and preparations,

including irritants which give rise to risk of serious

damage to the eyes,

(cid:151) very toxic and toxic substances and preparations.

(cid:151) Criteria for use:

(cid:151) obligatory for those substances and preparations to which R34, R35 or R41 have been ascribed,

(cid:151) obligatory for organic peroxides,

(cid:151) recommended when it is necessary to draw the attention of the user to eye contact risks not

mentioned in the risk phrases which have to be ascribed,

(cid:151) normally limited to exceptional cases for very toxic and toxic substances and preparations,

where there is a risk of splashing and they are likely to be easily absorbed by the skin.

S40 To clean the floor and all objects contaminated by this material use (cid:133) (to be specified by the manufacturer)

(cid:151) Applicability:

(cid:151) all dangerous substances and preparations.

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(cid:151) Criteria for use:

(cid:151) normally limited to those dangerous substances and preparations for which water is not
(e.g. where absorption by powdered material,
is necessary) and where it is important for health and/or safety

considered to be a suitable cleansing agent
dissolution by solvent etc.
reasons to provide a warning on the label.

S41 In case of fire and/or explosion do not breathe fumes

(cid:151) Applicability:

(cid:151) dangerous substances and preparations which on combustion give off very toxic or toxic gases.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases.

S42 During fumigation/spraying wear suitable respiratory equipment

(appropriate wording to be specified by the

manufacturer)

(cid:151) Applicability:

(cid:151) substances and preparations intended for such use but which may endanger the health and

safety of the user unless proper precautions are taken.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases.

S43 In case of fire use (cid:133) (indicate in the space the precise type of fire-fighting equipment. If water increases the risk

add: Never use water)

(cid:151) Applicability:

(cid:151) extremely flammable, highly flammable and flammable substances and preparations.

(cid:151) Criteria for use:

(cid:151) obligatory for substances and preparations which,

in contact with water or damp air, evolve

extremely flammable gases,

(cid:151) recommended for extremely flammable, highly flammable and flammable substances and

preparations, particularly when they are immiscible with water.

S45 In case of accident or if you feel unwell seek medical advice immediately (show the label where possible).

(cid:151) Applicability:

(cid:151) very toxic substances and preparations,

(cid:151) toxic and corrosive substances and preparations,

(cid:151) substances and preparations causing sensitisation by inhalation.

(cid:151) Criteria for use:

(cid:151) obligatory for the substances and preparations mentioned above.

S46 If swallowed, seek medical advice immediately and show this container or label

(cid:151) Applicability:

(cid:151) all dangerous substances and preparations other than those which are very toxic, toxic, corrosive

or dangerous to the environment.

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(cid:151) Criteria for use:

(cid:151) obligatory for all dangerous substances and preparations mentioned above which are likely to be
used by the general public, unless there is no reason to fear any danger from swallowing,
particularly by children.

S47 Keep at temperature not exceeding (cid:133) (cid:176)C (to be specified by the manufacturer)

(cid:151) Applicability:

(cid:151) substances and preparations which become unstable at a certain temperature.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases (e.g. certain organic peroxides).

S48 Keep wetted with (cid:133) (appropriate material to be specified by the manufacturer)

(cid:151) Applicability:

(cid:151) substances and preparations which may become very sensitive to sparks, friction or impact if

allowed to dry out.

(cid:151) Criteria for use:

(cid:151) normally limited to special cases, e.g. nitrocelluloses.

S49 Keep only in the original container

(cid:151) Applicability:

(cid:151) substances and preparations sensitive to catalytic decomposition.

(cid:151) Criteria for use:

(cid:151) substances and preparations sensitive to catalytic decomposition, e.g. certain organic peroxides.

S50 Do not mix with (cid:133) (to be specified by the manufacturer)

(cid:151) Applicability:

(cid:151) substances and preparations which may react with the specified product to evolve very toxic or

toxic gases,

(cid:151) organic peroxides.

(cid:151) Criteria for use:

(cid:151) recommended for substances and preparations mentioned above which are likely to be used by

the general public, when it is a better alternative to R31 or R32,

(cid:151) obligatory with certain peroxides which may give violent reaction with accelerators or promoters.

S51 Use only in well-ventilated areas

(cid:151) Applicability:

(cid:151) substances and preparations likely to or intended to produce vapours, dusts, sprays, fumes,

mists, etc. which give rise to inhalation risks or to a fire or explosion risk.

(cid:151) Criteria for use:

(cid:151) recommended when use of S38 would not be appropriate. Thus important when such

substances and preparations are likely to be used by the general public.

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S52 Not recommended for interior use on large surface areas

(cid:151) Applicability:

(cid:151) volatile, very toxic, toxic and harmful substances and preparations containing them.

(cid:151) Criteria for use:

(cid:151) recommended when damage to health is likely to be caused by prolonged exposure to these
substances and preparations by reason of their volatilisation from large treated surfaces in the
home or other enclosed places where persons congregate.

S53 Avoid exposure (cid:151) Obtain special instructions before use

(cid:151) Applicability:

(cid:151) substances and preparations that are carcinogenic, mutagenic and/or toxic to reproduction.

(cid:151) Criteria for use:

(cid:151) obligatory for the abovementioned substances and preparations to which at least one of the

following R-phrases has been assigned : R45, R46, R49, R60 or R61.

S56 Dispose of this material and its container to hazardous or special waste collection point

(cid:151) Applicability:

(cid:151) all dangerous substances and preparations.

(cid:151) Criteria for use:

(cid:151) recommended for all dangerous substances and preparations likely to be used by the general

public for which special disposal is required.

S57 Use appropriate containment to avoid environmental contamination

(cid:151) Applicability:

(cid:151) substances and preparations which have been assigned the symbol (cid:145)N(cid:146).

(cid:151) Criteria for use:

(cid:151) normally limited to substances and preparations not likely to be used by the general public.

S59 Refer to manufacturer for information on recovery/recycling

(cid:151) Applicability:

(cid:151) all dangerous substances and preparations.

(cid:151) Criteria for use:

(cid:151) obligatory for substances and preparations dangerous for the ozone layer,

(cid:151) recommended for other

substances

and preparations

for which recovery/recycling is

recommended.

S60 This material and its container must be disposed of as hazardous waste

(cid:151) Applicability:

(cid:151) all dangerous substances and preparations.

(cid:151) Criteria for use:

(cid:151) recommended for substances and preparations not likely to be used by the general public and

where S35 is not assigned.

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S61 Avoid release to the environment. Refer to special instructions/safety data sheet

(cid:151) Applicability:

(cid:151) substances and preparations dangerous for the environment.

(cid:151) Criteria for use:

(cid:151) normally used for substances and preparations which have been assigned the symbol (cid:145)N(cid:146),

(cid:151) recommended for all substances and preparations classified dangerous for the environment not

covered above.

S62 If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label

(cid:151) Applicability:

(cid:151) substances and preparations classified as harmful with R65 in accordance with the criteria in

section 3.2.3,

(cid:151) not applicable to substances and preparations which are placed on the market in aerosol

containers (or in containers fitted with a sealed spray attachment), see sections 8 and 9.

(cid:151) Criteria for use:

(cid:151) obligatory for substances and preparations mentioned above, if sold to, or likely to be used by

the general public, except when S45 or S46 are obligatory,

(cid:151) recommended for the substances and preparations mentioned above when used in industry,

except where S45 or S46 are obligatory.

S63 In case of accident by inhalation: remove casualty to fresh air and keep at rest

(cid:151) Applicability:

(cid:151) very toxic and toxic substances and preparations (gases, vapours, particulates, volatile liquids),

(cid:151) substances and preparations causing respiratory sensitisation.

(cid:151) Criteria for use:

(cid:151) obligatory for substances and preparations to which R26, R23 or R42 has been assigned which

are likely to be used by the general public in a way which could result in inhalation.

S64 If swallowed, rinse mouth with water (only if the person is conscious)

(cid:151) Applicability:

(cid:151) corrosive or irritant substances and preparations.

(cid:151) Criteria for use:

(cid:151) recommended for the above substances and preparations which are likely to be used by the

general public and where the above treatment is suitable.

7.

LABELLING

7.1.

When a substance or preparation has been classified the appropriate label is determined with reference to the
requirements of Article 23 of this Directive and Article 10 of Directive 1999/45/EC for substances and
preparations respectively. This section explains how the label is determined and, in particular, gives guidance
on how to choose the appropriate risk and safety phrases.

The label contains the following information:

(a)

for preparations the trade name or designation;

(b)

for substances the name of the substance and for preparations the names of the substances present in the
preparations in accordance with the rules set out in Article 10(2)(3) of Directive 1999/45/EC;

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the name, full address and telephone number of the person responsible for placing the substance or
preparation on the market, whether manufacturer, importer or distributor;

(d)

the symbol(s) and indication(s) of danger;

(e)

phrases indicating particular hazards (R-phrases);

(f)

phrases indicating safety advice (S-phrases);

(g)

for substances, the EC number, and in addition for substances appearing in Annex I, the word (cid:145)EC label(cid:146);

(h)

for preparations offered or sold to the general public the nominal quantity of the contents unless
specified elsewhere on the package.

Note:

For certain preparations there are additional labelling requirements set out in Article 10(1)(2) of and Annex V
to Directive 1999/45/EC and in Article 20 of Directive 98/8/EC.

7.1.1.

Final choice of risk and safety phrases

Although the final choice of the most appropriate risk and safety phrases is primarily governed by the need to
give all necessary information, consideration should also be given in the clarity and impact of the label. With
clarity in mind, the necessary information should be expressed in a minimum number of phrases.

In the case of substances which are irritant, highly flammable, flammable and oxidising, an indication of
R-phrases and S-phrases need not be given where the package does not contain more than 125 ml. This shall
also apply in the case of the same volume of harmful substances not retailed to the general public.

For preparations, if the contents of the package do not exceed 125 ml:

(cid:151) if classified as highly flammable, oxidising,

those assigned R41, or
dangerous for the environment and assigned the (cid:145)N(cid:146) symbol it shall not be necessary to indicate the
R-phrases or the S-phrases,

irritant, with the exception of

(cid:151) if classified as flammable or dangerous to the environment and not assigned the (cid:145)N(cid:146) symbol it shall be

necessary to indicate the R-phrases but it shall not be necessary to indicate the S-phrases.

7.1.2. Without prejudice to Article 16(4) of Directive 91/414/EEC and to Directive 98/8/EC, indications such as
(cid:145)non-toxic(cid:146), (cid:145)non-harmful(cid:146), (cid:145)non-polluting(cid:146), (cid:145)ecological(cid:146) or any other statement indicating that the substance or
the substance or
preparation is not dangerous or likely to lead to underestimation of
preparation in question shall not appear on the label or packaging of substances or preparations subject to
this Directive or to Directive 1999/45/EC.

the dangers of

7.2.

Chemical name(s) to be displayed on the label

7.2.1.

For substances listed in Annex I the label shall show the name of the substances under one of the designations
given in Annex I.

For substances not listed in Annex I, the name is established according to an internationally recognised
chemical nomenclature as defined in section 1.4.

7.2.2.

For preparations, the choice of names to be displayed on the label follows the rules of Article 10(2)(3) of
Directive 1999/45/EC.

Note:

Subject to Annex V, B.9 to Directive 1999/45/EC,

(cid:151) the name of the sensitising substance must be chosen in accordance with section 7.2.1 of this Annex,

(cid:151) in the case of concentrate preparations which are intended for the perfume industry:

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(cid:151) the person responsible for placing them on the market may identify merely the one sensitising

substance judged by him to be primarily responsible for the sensitisation hazard,

(cid:151) in the case of a natural substance, the chemical name may be of the type: (cid:145)essential oil of (cid:133)(cid:146)

(cid:145)extract

of (cid:133)(cid:146), rather than the name of the constituents of that essential oil or extract.

7.3.

Choice of danger symbols

The design of the danger symbols and the wording of the indications of danger shall comply with those laid
down in Annex II. The symbol shall be printed in black on an orange-yellow background.

7.3.1.

For substances appearing in Annex I the danger symbols and indications of danger shall be those shown in
the Annex.

7.3.2.

For dangerous substances not yet appearing in Annex I and for preparations, the danger symbols and
indications of danger shall be assigned according to the rules laid down in this Annex.

Where more than one danger symbol is assigned to a substance or preparation:

(cid:151) the obligation to indicate the symbol (cid:145)E(cid:146) makes the symbols (cid:145)F+(cid:146), (cid:145)F(cid:146) and (cid:145)O(cid:146) optional,

(cid:151) the obligation to indicate the symbol (cid:145)T+(cid:146) or (cid:145)T(cid:146) makes the symbols (cid:145)Xn(cid:146), (cid:145)Xi(cid:146) and (cid:145)C(cid:146) optional,

(cid:151) the obligation to indicate the symbol (cid:145)C(cid:146) makes the symbols (cid:145)Xn(cid:146) and (cid:145)Xi(cid:146) optional,

(cid:151) if the symbol (cid:145)Xn(cid:146) is assigned, the symbol (cid:145)Xi(cid:146) is optional.

7.4.

Choice of risk phrases

The wording of the R-phrases shall comply with that laid down in Annex III.

The combined R-phrases in Annex III shall be used where applicable.

7.4.1.

For substances appearing in Annex I, the R-phrases shall be those shown in the Annex.

7.4.2.

For substances not appearing in Annex I, R-phrases will be selected according to the following criteria and
priorities:

(a)

in the case of dangers which give rise to health effects:

(i) R-phrases corresponding to the category of danger illustrated by a symbol must appear on the label;

(ii) R-phrases corresponding to other categories of danger which are not illustrated by a symbol by

virtue of Article 23;

(b)

in the case of dangers arising from physicochemical properties:

(cid:151) R-phrases corresponding to the category of danger illustrated by a symbol must appear on the label;

(c)

in the case of dangers for the environment

(cid:151) the R-phrase(s) corresponding to the classification category (cid:145)dangerous for the environment(cid:146) must

appear on the label.

7.4.3.

For preparations, R-phrases will be selected according to the following criteria and priorities:

(a)

in the case of dangers which give rise to health effects:

(i) R-phrases which correspond to the category of danger illustrated by a symbol. In certain cases the
R-phrases must be adopted according to the tables of Annex II, Part B, to Directive 1999/45/EC.
More specifically, the R-phrases of the constituent(s) which are responsible for the assignment of the
preparation to a danger category must appear on the label;

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(ii) R-phrases which correspond to other categories of danger which have been attributed to the
constituents but which are not illustrated by a symbol by virtue of Article 10(2)(4) of Directive
1999/45/EC;

(b)

in the case of dangers arising from physicochemical properties:

(cid:151) the criteria described under 7.4.3(a) are applicable, except that the risk phrases (cid:145)extremely flammable(cid:146)
or (cid:145)highly flammable(cid:146) need not be indicated where they repeat the wording of the indication of
danger used with a symbol;

(c)

in the case of dangers for the environment:

(i)

the R-phrase(s) corresponding to the classification category (cid:145)dangerous for the environment(cid:146) must
appear on the label;

(ii) where the R-phrase R50 has been assigned in addition to a combined R-phrase R51/53 or R52/53

or to the R-phrase 53 alone, the combined R-phrase R50/53 shall be used.

As a general rule, for preparations a maximum of six R-phrases shall suffice to describe the risk; for this
if the
purpose the combined phrases listed in Annex III shall be regarded as single phrases. However,
preparation falls within more than one danger category, those standard phrases shall cover all the principal
hazards associated with the preparation. In some cases, more than six R-phrases may be necessary.

7.5.

Safety phrases

The wording of S-phrases shall comply with that laid down in Annex IV.

The combined S-phrases in Annex IV shall be used where applicable.

7.5.1.

For substances appearing in Annex I, the S-phrases shall be those shown in the Annex. Where no S-phrases
are shown, the manufacturer/importer may include any appropriate S-phrase(s). For substances not in Annex I
and for preparations, the manufacturer shall include S-phrases in accordance with the criteria given in Chapter
6 of this Annex.

7.5.2.

Choice of safety phrases

The final choice of safety phrases must have regard to the risk phrases indicated on the label and to the
intended use of the substance or preparation:

(cid:151) as a general rule, a maximum of six S-phrases shall suffice to formulate the most appropriate safety
advice; for this purpose the combined phrases listed in Annex IV shall be regarded as single phrases,

(cid:151) in the case of S-phrases concerning disposal, one S-phrase shall be used, unless it is clear that disposal of
the material and its container does not present a danger for human health or the environment. In
particular, advice on safe disposal is important for substances and preparations sold to the general public,

(cid:151) some R-phrases become superfluous if a careful selection is made of S-phrases and vice versa; S-phrases
which obviously correspond to R-phrases will appear on the label only if it is intended to emphasise a
specific warning,

(cid:151) particular attention must be given, in the choice of safety phrases, to the foreseen conditions of use of
certain substances and preparations, e.g. spraying or other aerosol effects. Phrases should be chosen with
the intended use in view,

(cid:151) the safety phrases S1, S2 and S45 are obligatory for all very toxic, toxic and corrosive substances and

preparations sold to the general public,

(cid:151) the safety phrases S2 and S46 are obligatory for all other dangerous substances and preparations (except

those only classified as dangerous for the environment) sold to the general public.

Where the phrases selected according to the strict criteria in 6.2 result in redundancy or ambiguity or are
clearly unnecessary given the specific product/package then some phrases may be deleted.

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7.6.

EC number

If a substance named on the label
is listed in the European Inventory of Existing Commercial Chemical
Substances (Einecs) or in the European List of Notified Substances (Elincs), the Einecs or Elincs number of the
substances shall be shown on the label. This requirement does not apply to preparations.

7.7.

Dimensions of the label for preparations

The dimensions of the label shall be as follows:

Capacity of the package

(cid:151) not exceeding 3 litres:

Dimensions (in millimetres)

if possible, at least 52 (cid:215) 74

(cid:151) greater than 3 litres but not exceeding 50 litres:

at least 74 (cid:215) 105

(cid:151) greater than 50 litres but not exceeding 500 litres:

at least 105 (cid:215) 148

(cid:151) greater than 500 litres:

at least 148 (cid:215) 210.

Each symbol shall cover at least one-tenth of the surface area of the label but shall not be less than 1cm2. The
label shall be firmly affixed to one or more surfaces of the packaging immediately containing the preparation.

The information required on the label shall stand out clearly from its background and shall be of such size
and spacing as to be easily read.

8.

SPECIAL CASES: SUBSTANCES

8.1.

Mobile gas cylinders

For mobile gas cylinders the requirements concerning labelling are considered to be satisfied when they are in
agreement with Article 23 or Article 24(6)(b).

However, by way of derogation from Article 24(1) and (2), one of the following alternatives can be used for
gas cylinders with a water capacity of less than or equal to 150 litres:

(cid:151) the format and dimensions of the label can follow the prescriptions of the ISO Standard ISO/DP 7225

(1994 edition) relating to (cid:145)Gas cylinders (cid:151) Precautionary labels(cid:146),

(cid:151) the information specified in Article 23(2) may be provided on a durable information disc or label held

captive on the cylinder.

8.2.

Gas containers intended for propane, butane or liquefied petroleum gas (LPG)

These substances are classified in Annex I. Although classified in accordance with Article 2, they do not
present a danger to human health when they are placed on the market in closed refillable cylinders or in
non-refillable cartridges within the scope of EN 417 as fuel gases which are only released for combustion (EN
417, September 1992 edition, relating to (cid:145)Non-refillable metallic gas cartridges for liquefied petroleum gases,
with or without a valve, for use with portable appliances; construction, inspection, testing and marking(cid:146)).

These cylinders or cartridges must be labelled with the appropriate symbol and the R- and S-phrases
concerning flammability. No information concerning the effects on human health is required on the label.
However, the information concerning effects on human health which should have appeared on the label shall
be transmitted to the professional user by the person responsible for placing the substance on the market in

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foreseen in Article 27 of

the format
information shall be
transmitted to enable them to take all necessary measures for health and safety as foreseen in Article 1(3) of
Directive 91/155/EEC, as amended by Directive 93/112/EEC.

the Directive. For the consumer, sufficient

8.3.

Metals in massive form

These substances are classified in Annex I or shall be classified in accordance with Article 6. However, some
of these substances, although classified in accordance with Article 2 do not present a danger to human health
by inhalation, ingestion or contact with skin or to the aquatic environment in the form in which they are
placed on the market. Such substances do not require a label according to Article 23. However, all the
information which should have appeared on the label shall be transmitted to the user by the person
responsible for placing the metal on the market, in a format foreseen in Article 27.

8.4.

Substances classified with R65

Substances classified as harmful on the basis of an aspiration hazard need not be labelled as harmful with R65
when placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

9.

SPECIAL CASES: PREPARATIONS

9.1.

Gaseous preparations (gas mixtures)

For gaseous preparations, consideration must be given to:

(cid:151) the evaluation of the physico-chemical properties,

(cid:151) the evaluation of health hazards,

(cid:151) the evaluation of the environmental hazards.

9.1.1.

Evaluation of physico-chemical properties

9.1.1.1. Flammability

The flammable properties of these preparations are determined in accordance with Article 5 of Directive
1999/45/EC according to the methods specified in Part A of Annex V to this Directive.

These preparations will be classified according to the results of the tests carried out and with respect to the
criteria of Annex V and to the criteria of the labelling guide.

However, by derogation, in the case where gaseous preparations are produced to order in small amounts, the
flammability of these gaseous mixtures can be evaluated by the following calculation method:

the expression of the gaseous mixture

A1F1 + (cid:133) + AiFi + (cid:133) AnFn + B1I1 + (cid:133) + BiIi + (cid:133) BpIp

where: Ai and Bi are the molar fractions

Fi flammable gas

Ii inert gas

n number of flammable gases

p number of inert gases

can be transformed in a form where all the Ii (inert gases) are expressed by a nitrogen equivalent using a
coefficient Ki and where the equivalent content of inflammable gas A¡i is expressed as follows:

A¡i = Ai (cid:215) (100 / (Ai + KiBi))

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By using the value of the maximum content of flammable gas which, in a mixture with nitrogen, gives a
composition which is not flammable in air (Tci), the following expression can be obtained:

Ri A¡i / Tci ˜ 1

The gas mixture is flammable if the value of the above expression is greater than one. The preparation is
classified extremely flammable and, the phrase R12 is assigned.

Coefficients of equivalency (Ki)

The values of the coefficients of equivalency Ki, between the inert gases and nitrogen and the values of the
maximum contents of flammable gas (Tci) may be found in Tables 1 and 2 of the ISO Standard ISO 10156
edition 15.12.1990 (new: 1996 edition) relating to (cid:145)Gases and gas mixtures (cid:151) Determination of fire potential
and oxidising ability for the selection of cylinder valve outlets(cid:146).

Maximum content of flammable gas (Tci)

The value of the maximum content of flammable gas (Tci) may be found in Table 2 of the ISO Standard ISO
10156 edition 15.12.1990 (new: 1996 edition) relating to (cid:145)Gases and gas mixtures (cid:151) Determination of fire
potential and oxidising ability for the selection of cylinder valve outlets(cid:146).

When a Tci value for a flammable gas does not appear in the above standard, the corresponding lower
explosivity limit (LEL) will be used. If no LEL value exists, the value of Tci will be set at 1 % by volume.

Remarks:

(cid:151) the expression above can be used to allow an appropriate labelling of gaseous preparations, however, it
should not be regarded as a method for replacing experimentation for the determination of technical
safety parameters,

(cid:151) furthermore, this expression gives no information as to whether a mixture containing oxidising gases can
be prepared safely. When estimating flammability these oxidising gases are not taken into account,

(cid:151) the expression above will give reliable results only if the flammable gases do not influence each other as
far as their flammability is concerned. This has to be considered, e.g. with halogenated hydrocarbons.

9.1.1.2. Oxidising properties

Given the fact that Annex V to this Directive does not contain a method to determine the oxidising properties
of gaseous mixtures, the evaluation of these properties must be realised according to the following estimation
method.

The principle of the method is comparison of the oxidising potential of gases in a mixture with that of the
oxidising potential of oxygen in air. The concentrations of gases in the mixture are expressed in % vol.

It is considered that the gas mixture is as oxidant as or more oxidant than air, if the following condition is
verified:

Ri xiCi ¯ 21

where:

xi is the concentration of gas i in % vol,

Ci is the coefficient of oxygen equivalency.

In this case, the preparation is classified as oxidising and the phrase R8 will be assigned.

Coefficients of equivalency between oxidising gases and oxygen

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21.8.2001

The coefficients used in the calculation to determine the oxidising capacity of certain gases in a mixture with
respect to the oxidising capacity of oxygen in air, listed under 5.2 in the ISO Standard ISO 10156 edition
15.12.1990 (new: 1996 edition) relating to (cid:145)Gases and gas mixtures (cid:151) Determination of fire potential and
oxidising ability for the selection of cylinder valve outlets(cid:146), are the following.

O2

N2O

1

0,6

When no value for the Ci coefficient exists for a gas in the cited standard a value of 40 is attributed to this
coefficient.

9.1.2.

Labelling

For mobile gas containers the requirements concerning labelling are considered to be satisfied when they are
in agreement with Article 11(6)(b) of Directive 1999/45/EC.

However, by way of derogation from Article 11(1) and (2), for gas containers with a water capacity of less
than or equal to 150 litres, the format and dimensions of the label can follow the prescriptions of the ISO
Standard 7225 (1994 edition) relating to (cid:145)Gas cylinders (cid:151) Precautionary labels(cid:146). In this case, the label can
bear the generic name or industrial/commercial name of
the dangerous
component substances of the preparation are shown on the body of the gas cylinder in a clear and indelible
way.

the preparation provided that

The information specified in Article 10 may be provided on a durable information disc or label held captive
on the containers.

9.2.

Gas containers intended for preparations containing stenched propane, butane or liquefied petroleum
gas (LPG)

Propane, butane and liquefied petroleum gas are classified in Annex I. Although preparations containing these
substances are classified in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, they do not present
a danger to human health when they are placed on the market in closed refillable cylinders or non-refillable
cartridges within the scope on EN 417 as fuel gases which are only released for combustion (EN 417,
September 1992 edition, relating to (cid:145)Non-refillable metallic gas cartridges for liquefied petroleum gases, with
or without a valve, for use with portable appliances; construction, inspection, testing and marking(cid:146)).

These cylinders and cartridges must be labelled with the appropriate symbol and the R- and S-phrases
concerning flammability. No information concerning the effects on human health is required on the label.
However, the information concerning effects on human health which should have appeared on the label shall
be transmitted to the professional user by the person responsible for placing the substance on the market in
the format foreseen in Article 14 of Directive 1999/45/EC. For the consumer, sufficient information shall be
transmitted to enable them to take all necessary measures for health and safety as foreseen in Article 1(3) of
Directive 91/155/EEC.

9.3.

Alloys, preparations containing polymers, preparations containing elastomers

These preparations shall be classified according to the requirements of Articles 5, 6 and 7 and labelled
according to the requirements of Article 10 of Directive 1999/45/EC.

However some of these preparations although classified in accordance with Articles 6 and 7 do not present a
danger to human health by inhalation, ingestion or contact with the skin or to the aquatic environment in the
form in which they are placed on the market. Such preparations do not require a label according to Article
10 or according to Annex V.B.9. However, all the information which would have appeared on the label shall
be transmitted to the professional user by means of an information system in a format foreseen in Article 14
of the abovementioned Directive.

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9.4.

Preparations classified with R65

Preparations classified as harmful on the basis of an aspiration hazard need not be labelled as harmful with
R65 when placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

9.5.

Organic peroxides

Organic peroxides combine the properties of an oxidiser and a combustible substance in one molecule: when
an organic peroxide decomposes,
the molecule reacts exothermically with the
combustible (oxidisable) part. For the oxidising properties the existing methods in Annex V cannot be applied
to the organic peroxides.

the oxidising part of

The following calculation method based on the presence of active oxygen must be used.

The available oxygen content (%) of an organic peroxide preparation is given by the formula:

16 (cid:215) R (ni (cid:215) ci/mi)

where:

ni = number of peroxygen groups per molecule of organic peroxide i

ci = concentration (mass %) of organic peroxide i

mi = molecular mass of organic peroxide i.

9.6.

Additional labelling requirements for certain preparations

For certain preparations there are additional labelling requirements set out in Article 10(1)(2) of and Annex V
to Directive 1999/45/EC and Article 20 of Directive 98/8/EC.

L 225/314

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Official Journal of the European Communities

21.8.2001

COMMISSION STATEMENT

With regard to section 4.1.5 and in particular to the last paragraph of section 4.1.5, the Commission states that, should
it envisage making use of the procedure of Article 28,
it is prepared to consult in advance appropriate experts
designated by Members States and having special qualifications with respect to either carcinogenicity, mutagenicity or
reproductive toxicity.

This consultation will take place in the framework of the normal consultation procedure with national experts and/or
in the framework of existing committees. The same will be the case when substances already included in Annex I must
be reclassified in respect of their carcinogenic, mutagenic effects, or effects toxic to reproduction.

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L 225/315

For intermediates with limited exposure the provisions under point 7 apply.

ANNEX 7A

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ANNEX 7B

7. Reduced test package for intermediates at quantities ¯1 tonne/annum

1. Definitions

Without prejudice to other Community legislation, the following definitions apply:

(cid:151) (cid:145)intermediate(cid:146) is a chemical substance that is solely manufactured for and consumed in or used for chemical

processing in order to be transformed into another chemical substance(s),

(cid:151) (cid:145)emission(cid:146) concerns the release of a substance from a system, for example when a system is breached. To
guarantee a maximum level of protection for workers and the environment minimisation of emission through
rigorous containment of the process must therefore be the primary aim,

(cid:151) (cid:145)exposure(cid:146) is concerned with what happens to a substance after it has been emitted, whether this is into the
wider environment or whether the substance can be potentially inhaled or come in contact with the skin of a
If emissions can be anticipated to occur, rigorous exposure control must be
member of the workforce.
achieved by appropriate techniques, noting the need to adopt
the precautionary principle in that
physico-chemical, toxicological and ecotoxicological properties which had not been tested shall be assumed as
being hazardous,

(cid:151) (cid:145)integrated exhaust ventilation system(cid:146)

is an exhaust ventilation system of closed type which is used in
combination with locks, enclosures, housings, containers etc. in order to restrict the chemical agents to the
inner part of the closed functional unit. Process-related openings must be as small as possible. The power of
extraction and the air ducting must be designed so that there is sufficient underpressure within the extraction
unit to ensure that all of the gases, vapours and/or dusts that occur are fully captured and carried away.
Back-flow of the extracted hazardous substances into the working area must be prevented. This means that
hazardous substances are prevented from escaping from the closed functional unit into the working area,

(cid:151) (cid:145)highly effective exhaust ventilation(cid:146) is an exhaust ventilation system of open and semi-open type which is
dimensioned in such a way that chemical agents remain within the catchment area. This means that the
occurrence of chemical agents in the workplace atmosphere can practically be excluded,

(cid:151) (cid:145)effective exhaust ventilation system(cid:146) is an exhaust ventilation system of open and semi-open type which is
dimensioned in such a way that the chemical agents remain within the catchment area, i.e. the occurrence of
chemical agents in the workplace atmosphere can be largely excluded or proof of adherence to the limit value
is furnished,

(cid:151) (cid:145)other exhaust ventilation system(cid:146)

is an exhaust ventilation system of open and semi-open type which is
dimensioned in such a way that the occurrence of chemical agents in the workplace atmosphere cannot be
excluded,

(cid:151) (cid:145)low-emission forms of use(cid:146) are, for example:

(cid:151) expendable packaging,

i.e. the hazardous substance is enclosed in appropriate packaging and, without

opening the packaging, is introduced into a reaction system together with this packaging,

(cid:151) change in consistency, i.e. the substance is used, for example, in the form of a paste or a granulate instead

of in powder form,

(cid:151) master batch; this means that the hazardous substance is surrounded by a plastic matrix which prevents
is not a hazardous substance.

direct contact with the hazardous substance. The plastic matrix itself
Abrasion of the plastic matrix and therefore of the hazardous substance, is, however, possible,

(cid:151) (cid:145)emission-free forms of use(cid:146) are, for example, master batches without abrasion, i.e. the plastic matrix is so

resistant to abrasion that no hazardous substance can be released,

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L 225/317

(cid:151) (cid:145)technically leakproof(cid:146) is applied to a subunit if a leak is not discernible during testing, monitoring or checking
for leakproofness, e.g. using foaming agents or leak searching/indicating equipment performed for the
particular use. Systems, subsystems and functional elements are technically leakproof, if the rate of leakage is
< 0,00001 mbar*l*sﬂ1.

2. Application of a reduced test package

For intermediates, the notifier may request the competent authority to grant permission to apply a reduced test
package (RTP). This RTP represents a minimum data set designed to produce a first preliminary risk assessment for
any chemical intermediate to be placed on the market. Any additional test result might be required, in accordance
with Article 16(1), based on the outcome of the risk assessment.

3. Conditions for a application of a reduced test package

The notifier must demonstrate to the satisfaction of the competent authority where the substance is notified that
the following conditions are fulfilled:

(a)

the substance is solely manufactured for and consumed in or used for chemical processing. Monomers are
excluded. When processed the substance is transformed into chemically different molecules, not being
polymers;

(b)

the substance is restricted to a maximum number of two users’ sites. For example, it may be manufactured by
one company and then transported to one or two others for processing. Note that if supply is intended to
progress to more than two users’ sites, the conditions for a RTP are no longer met and the dossier must be
upgraded to the appropriate level;

(c)

the supply to the enterprise which uses the intermediate for further processing must be directly from the
notifier and not through an intermediate supplier;

(d)

the substance must be rigorously contained by technical means during its whole lifecycle. This includes
production, transportation, purification, cleaning and maintenance, sampling, analysis, loading and unloading
of equipment/vessels, waste disposal/purification and storage. In general, an appropriate process would have all
functional elements of the plant such as filling ports, emptying equipment, etc. either of a closed construction
type with assured leakproofness or of a closed construction type with integrated exhaust ventilation;

(e) where there is the potential for exposure, procedural and control technologies must be used which minimise

emission and the resulting exposure;

(f)

in case of cleaning and maintenance works special procedures such as purging and washing must be applied
before the system is opened or entered;

(g)

transport operations will be in compliance with the requirements of Council Directive 94/55/EC as amended
from time to time;

(h)

in case of accident and where waste is generated following purification or cleaning and maintenance
procedures, environmental exposure may occur. In either case, procedural and/or control technologies are used
which minimise emissions and the resulting exposures;

(i)

a management system must exist which identifies the roles of the individuals in the organisation;

(j)

the packaging of
additionally with the following sentence: (cid:145)Caution (cid:151) substance not yet fully tested(cid:146);

the substance will be labelled according to Annex VI

to Directive 67/548/EEC and

(k)

the notifier must operate a system of product stewardship and must monitor the users (a maximum of two) to
ensure compliance with the conditions listed above.

L 225/318

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Official Journal of the European Communities

21.8.2001

4. Technical dossier to be supplied for a reduced test package

A notifier requesting an RTP for a substance must supply the following technical dossier to the competent
authority for all production and user sites:

(a) a statement that the notifier and each user accepts the conditions listed in 3;

(b) a description of the technical measures by which rigorous containment of the substance is achieved (1),
including procedures for charging, sampling, transfer and cleaning. It is not necessary to provide details of the
integrity of every seal or efficiency of integrated exhaust ventilation. However, whatever means are used to
achieve rigorous containment of the process it is important that the information is available, if needed, to
verify that the assertions made for achievement of control are true;

(c)

if the criteria for the assessment of closed systems during handling of chemical agents detailed in section 5
below are not fulfilled, the notifier must submit exposure data based on representative monitoring data and/or
reliable model calculations to enable the competent authority to make a decision whether to accept an RTP
request or not;

(d) a detailed description of the processes at all sites involved in production and use. In particular, it must be
liquid or solid waste is

stated whether production and/or processing wastes are discharged to waste-water,
incinerated, and how the cleaning and maintenance of all equipment is made;

(e) a detailed assessment of the possible emissions and possible exposure to man and the environment during the
whole life cycle, including details of the various chemical reactions involved in the process and the ways in
which residues are dealt with. Where emissions may lead to exposure, the means by which these are controlled
must be described in sufficient detail to enable the competent authority to make a decision whether to accept
the statement or to calculate an emission rate according to the EU Technical Guidance Document;

(f)

changes which might affect exposure to man or the environment must be notified in advance, e.g. any change
in the functional elements of the plant, new user or site;

(g)

the information prescribed for the RTP is the following:

Annex VII.B plus the following tests from this Annex:

(cid:151) vapour pressure (3.4),

(cid:151) explosive properties (3.11),

(cid:151) self-ignition temperature (3.12),

(cid:151) oxidising properties (3.13),

(cid:151) granulometry (3.15),

(cid:151) acute toxicity for daphnia (5.1.2).

The notifier must also include other relevant information to enable the competent authority to make an
informed decision and to enable proper controls to be put in place by the user at the intermediate processing
site. For example,
information and/or information
about the environmental behaviour is available this data must also be submitted. Additionally, the notifier
must review the available toxicity and ecotoxicity data on substances having close structural relationship to the
notified substance.
If relevant data are available, especially on chronic and reproductive toxicity and
carcinogenicity, then a summary of these data must be provided;

if supplementary physico-chemical and/or toxicological

(h)

identities of the notifier, producer and the user(s).

(1) The type of construction and the technical specifications (e.g.

leakproofness) of the closed functional element determines the
effectiveness of the containment. To enable the competent authority to make a decision as to whether rigorous containment is
achieved or not, it is essential that the notifier includes details on these aspects. The technical measures must normally fulfil the
conditions of the (cid:145)Criteria for the assessment of closed systems during handling of chemical agents(cid:146), which are included for guidance
in section 7.5 and Table 1 of this Annex. This must be stated by the notifier, however it is not necessary to address every type of
closed functional element in the description provided of the technical measures. Any deviation from the conditions of the criteria
must be fully described, with justification.

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5. Criteria for the assessment of closed systems during the handling of chemical agents

5.1. Use

An assessment index is used in the assessment of the plant. The assessment index classifies the handling of the
substance and the resultant process-related exposure potential. The notifier shall examine the plant or plant unit is
in order to determine the assessment index. Each individual functional element must be assessed.

Systems are regarded as closed if the assessment of all of the available functional elements corresponds to the
index 0,5 and if only functional elements are involved which are of closed type with assured
assessment
leakproofness and/or equipped with integrated exhaust ventilation.
In addition, direct skin contact must be
excluded.

In the collection of examples relevant functional elements are indicated by 0,5 in bold type.

Functional elements of partially open type with highly effective exhaust ventilation (also indicated by the
assessment index 0,5, but in normal type) are not regarded as closed according to the meaning of this rule.

In the case of functional elements assigned the assessment index 1, the safe adherence to the limit value on a
permanent basis is not always assured. Such functional elements are:

1 (cid:151) closed type, leakproofness not assured

1 (cid:151) partially open type with effective exhaust ventilation.

In the case of functional elements assigned the assessment indices 2 and 4 the adherence to the limit values is not
always assured. Such functional elements are:

2 (cid:151) of a partially open type, opening as intended with simple exhaust ventilation

2 (cid:151) open with simple exhaust ventilation

4 (cid:151) open type or partially open type

4 (cid:151) natural ventilation.

The catalogue of examples in Table 1 facilitates the classification of the functional elements. Functional elements
which are not included in the collection of examples can be classified by means of conclusions drawn by analogy.
The plant or plant unit is then classified using the index value of the functional element which has received the
highest assessment index.

5.2. Checking

Use of this criterion requires adherence to the process parameters which have been laid down as well as the
performance of the checks cited in the collection of examples (e.g. inspection and maintenance).

6. Application of a reduced test package

If the competent authority accepts the notifier’s application for a RTP, then information from the tests and/or
studies set out in point 7.4 shall be required for the technical dossier referred to in Article 7. Note that for
quantities below 1 tonne/annum the usual Annex VIIB/VIIC testing requirements apply.

No

1

Functional element

Constructional type

Examples of constructional type

2

3

4

Without

5

Assessment index

With additional measures

6

Explanations

7

TABLE 1

Collection of examples

1

static seals

1.1

static seals

inseparable connections

(cid:151) welded

(cid:151) soldered

1.2

static seals

separable connections

(cid:151) welded lip seal

(cid:151) cutting ring and clamping ring

connection ˜ DN 32

0,5

0,5

0,5

0,5

(cid:151) NPT thread ˜ DN 50, D t ˜ 100 (cid:176)C

0,5

(cid:151) cutting ring and clamping ring

connection > DN 32

(cid:151) NPT thread > DN 50, D t > 100 (cid:176)C

(cid:151) flange with tongue and groove with

suitable seal

(cid:151) flange with projection and recess

with suitable seal

(cid:151) flange with V-groove and suitable

V-groove seal

(cid:151) flange with smooth seal rail and

suitable seals

1

1

1

1

1

1

0,5 assurance of leakproofness by
means of monitoring and
repair (*)

0,5 assurance of leakproofness by
means of monitoring and
repair (*)

0,5 assurance of leakproofness by
means of monitoring and
repair (*)

0,5 assurance of leakproofness by
means of monitoring and
repair (*)

0,5 assurance of leakproofness by
means of monitoring and
repair (*)

0,5 assurance of leakproofness by
means of monitoring and
repair (*)

(cid:151) reduce

connections

to

number

required

(cid:151) open connections as little as possible

(cid:151) leak tests prior

to resumption of

operation

(cid:151) use new seals in case of resumption of
separated

involving

operation
connections

(cid:151) where possible, flanges to be opened
for operational reasons should not be
equipped with tongue and groove
misalignment)
(danger

of

L

2
2
5
/
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2
0

E
N

O

f
f
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c
i
a
l

J
o
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a
l

o
f

t
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e

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a
n

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o
m
m
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n
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t
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s

.

.

2
1
8
2
0
0
1

6

7

1 in the case of regular monitoring

and repair

0,5 technically leakproof

0,5 with monitoring of the barrier

pressure system

by means of regular visual checks or
process control technology equipment

0,5 technically leakproof

0,5 assurance that technically leakproof
by means of monitoring and repair

0,5 technically leakproof

1 in the case of regular monitoring

and repair

0,5 technically leakproof

0,5 with monitoring of the barrier

pressure system

by means of regular visual checks or
process control technology equipment

1

2

3

4

1.3

quasi-static seals

1.3.1

fittings

shafts and spindle seals of
fittings e.g. ball valves,
stopcocks, valves,
butterfly valves, slide
valves

(cid:151) stuffing box seals

(cid:151) stuffing box seals with

self-adjustment (spring-loaded)

(cid:151) double stuffing box with barrier seal

(cid:151) O-ring seal

(cid:151) stopcock liner seal

(cid:151) piston seal

(cid:151) bellows seal

(cid:151) diaphragm seal

(cid:151) magnetic clutch

1.3.2

others

control rods

(cid:151) stuffing box seals

(cid:151) stuffing box seals with

self-adjustment (spring-loaded)

(cid:151) double stuffing box with barrier seal

(cid:151) O-ring seal

(cid:151) piston seal

(cid:151) bellows seal

(cid:151) diaphragm seal

2

2.1

dynamic seals

seals with revolving
parts

hermetically sealed

(cid:151) canned motor

seals which are not
contactless

(cid:151) magnetic clutches

(cid:151) single-axial face seal

(cid:151) double-axial face seal

5

2

1

1

1

1

1

0,5

0,5

0,5

2

1

1

1

1

0,5

0,5

0,5

0,5

1

1

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
l

o
f

t
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e

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u
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a
n

C
o
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m
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n
i
t
i
e
s

L

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/
3
2
1

1

2

3

4

(cid:151) double-axial face seal with barrier

fluid

(cid:151) stuffing box seal

(cid:151) stuffing box seal with self-adjustment

(spring-loaded)

contactless seals

(cid:151) labyrinth seal

(cid:151) gas-lubricated seal

2.2

seals for oscillating
parts

(cid:151) bellows seal

(cid:151) bellows valves

(cid:151) reciprocating pumps with bellows

seal

(cid:151) diaphragm seals

(cid:151) diaphragm pumps

(cid:151) conical diaphragm valves

(cid:151) cups

(cid:151) reciprocating pumps

(cid:151) scraper rings

5

1

2

2

2

1

0,5

0,5

0,5

0,5

1

1

6

7

0,5 with monitoring of the barrier
pressure system by means of
regular checking, as a rule, 1 x
day or, for example, process
control technology equipment
with alarm

1 in the case of regular monitoring

and repair

0,5 technically leakproof

0,5 with monitoring of the gas flow

3.

substance transfer and
filling points

3.1

for solid substances

3.1.1

sacks

3.1.1.1 sacks (emptying)

open manhole, open
container

(cid:151) manual emptying

4

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

1 low emission form of use, no further

hazardous substance present

0,5 with highly effective exhaust

ventilation equipment

0,5 emission-free form of use (e.g.
master batch without abrasion)

if a hazardous substance is present in the
container due account must be taken of
this

L

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3
2
2

E
N

O

f
f
i
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i
a
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J
o
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n
a
l

o
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a
n

C
o
m
m
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n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

1

2

3

4

5

6

7

sack-slitting and emptying
machine

encapsulated sack-slitting
and emptying machine
with integrated exhaust
ventilation equipment

0,5 emission-free form of use (e.g.
master batch without abrasion)

1

0,5 compression and packing of the

empty sacks within the
encapsulated area, assurance of
leakproofness by means of
monitoring and repair

3.1.1.2 sacks (filling)

manual filling, open sack
filling

(cid:151) manual filling

4

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

1 low emission form of use, no further

hazardous substance present

0,5 with highly effective exhaust

ventilation equipment

0,5 emission-free form of use (e.g.
master batch without abrasion)

sack-filling equipment

(cid:151) valve-sack filling machine, e.g.

4

2 with other exhaust ventilation

pneumatic packer, spiral packer, net
filling scales

equipment

1 with effective exhaust ventilation

equipment

0,5 with highly effective exhaust

ventilation equipment

(cid:151) vacuum packer

2

1 with effective exhaust ventilation

(cid:151) completely encapsulated filling

machine with integrated exhaust
ventilation equipment

(cid:151) bag forming, filling and sealing

machine

1

1

equipment

0,5 with highly effective exhaust

ventilation equipment

0,5 assurance of leakproofness by
means of monitoring and
repair (*)

0,5 assurance of leakproofness by
means of monitoring and
repair (*)

3.1.2

big bags, intermediate
bulk containers

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
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n
a
l

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s

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2
3

1

2

3

4

3.1.2.1 big bags, intermediate
bulk containers
(emptying)

open manhole

(cid:151) manual emptying

5

4

6

7

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

1 low emission form of use, no further

hazardous substance present

0,5 with highly effective exhaust

ventilation equipment

0,5 emission-free form of use (e.g.
master batch without abrasion)

3.1.2.2 big bags, intermediate
bulk containers (filling)

big bag emptying
equipment

4

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

1 low emission form of use, no further

hazardous substance present

0,5 with highly effective exhaust

ventilation equipment

0,5 emission-free form of use (e.g.
master batch without abrasion)

filling of open large sacks (cid:151) manual filling

4

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

1 low emission form of use, no further

hazardous substance present

0,5 with highly effective exhaust

ventilation equipment

0,5 emission-free form of use (e.g.
master batch without abrasion)

big bag filling equipment (cid:151) open filling

4

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

1 low emission form of use, no further

hazardous substance present

0,5 with highly effective exhaust

ventilation equipment

0,5 emission-free form of use (e.g.
master batch without abrasion)

L

2
2
5
/
3
2
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

1

2

3

4

big-bag filling equipment (cid:151) completely encapsulated filling

machine with integrated exhaust
ventilation equipment

5

1

6

7

0,5 with special filling heads (e.g.

laterally sealing) dust-free closing
technology; late trickling from the
filling head is prevented,
assurance of leakproofness by
means of monitoring and repair

(cid:151) large sack scales

4

2 with other exhaust ventilation

3.1.3

containers

3.1.3.1 containers (emptying)

with closed emptying
equipment

open container

the container’s cover seal must meet the
demands of 1.2

equipment

1 with effective exhaust ventilation

equipment

1 low emission form of use, no further

hazardous substance present

0,5 with highly effective exhaust

ventilation equipment

0,5 emission-free form of use (e.g.
master batch without abrasion)

1

0,5 if leakproofness is assured by

means of special measures (e.g.
monitored self-locking
connection) and integrated
exhaust ventilation equipment is
present, assurance of
leakproofness by means of
monitoring and repair (*)

0,5 if leakproofness is assured by means
of special measures (e.g. monitored
self-locking connection) and highly
effective exhaust ventilation
equipment is present, assurance of
leakproofness by means of
monitoring and repair

4

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

0,5 with highly effective exhaust

ventilation equipment

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

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2
5
/
3
2
5

1

2

3

4

3.1.3.2 container (filling)

with special filling
equipment

5

1

6

7

0,5 if leakproofness is assured by

means of special measures (e.g.
monitored self-locking
connection), assurance of
leakproofness by means of
monitoring and repair (*)

open filling

4

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

0,5 with highly effective exhaust

ventilation equipment, assurance of
leakproofness by means of
monitoring and repair (*)

3.1.4

drums

with emptying equipment (cid:151) closed

1

0,5 if leakproofness is assured by

3.1.4.1

drums (emptying)

(cid:151) mechanical conveyance, e.g. by spiral

4

conveyor

means of special measures (e.g.
monitored self-locking
connection) and integrated
exhaust ventilation equipment is
present

0,5 if leakproofness is assured by means
of special measures (e.g. monitored
self-locking connection) and exhaust
ventilation equipment or highly
effective exhaust ventilation
equipment is present

L

2
2
5
/
3
2
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

(cid:151) pneumatic conveyance, e.g.

4

2 with other exhaust ventilation

air-blaster

equipment

1 with effective exhaust ventilation

equipment

0,5 with highly effective exhaust

ventilation equipment

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

0,5 with highly effective exhaust

ventilation equipment

.

.

2
1
8
2
0
0
1

1

2

3

4

open container

(cid:151) mechanical conveyance, e.g. by spiral

conveyor

(cid:151) pneumatic conveyance, e.g.

air-blaster

3.1.4.2 drums (filling)

with special filling
equipment

open filling

5

4

4

1

4

6

7

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

0,5 with highly effective exhaust

ventilation equipment

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

0,5 with highly effective exhaust

ventilation equipment

0,5 if leakproofness is assured by

means of special measures (e.g.
monitored self-locking
connection) and integrated
exhaust ventilation equipment is
present

0,5 if leakproofness is assured by means
of special measures (e.g. monitored
self-locking connection) and highly
effective exhaust ventilation
equipment is present

2 other exhaust ventilation equipment

1 with effective exhaust ventilation

equipment

0,5 with highly effective exhaust

ventilation equipment

3.1.5

silo vehicles

3.1.5.1 silo vehicles (emptying)

fixed pipework, articulated
arm

hose connection

(cid:151) fixed use (connecting hoses and
couplings are provided by the
company)

1

0,5 assurance of leakproofness by means

of monitoring and repair (*);
complete capture of residual
quantities during decoupling and
coupling processes

1

0,5 assurance of leakproofness by means

of monitoring and repair (*);
complete capture of residual
quantities during decoupling and
coupling processes

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
3
2
7

1

2

3

4

(cid:151) other use (connecting hoses and

couplings are not provided by the
company)

3.1.5.2 silo vehicles (filling)

fixed pipework, articulated
arm

5

2

1

6

7

1 complete capture of the residual

quantities

0,5 assurance of leakproofness by means

of monitoring and repair (*);
complete capture of residual
quantities during decoupling and
coupling processes

hose connection

(cid:151) fixed use (connecting hoses and
couplings are provided by the
company)

(cid:151) other use (connecting hoses and

couplings are not provided by the
company)

3.1.6

inlet and outlet fittings

for silos, filling
equipment, bulk-material
containers

(cid:151) butterfly valves

(cid:151) cocks and stopcocks

(cid:151) flat slide valves

(cid:151) slide valve plate

(cid:151) pinch valve with soft seal

(cid:151) iris diaphragm valve

(cid:151) hose valve

1

0,5 assurance of leakproofness by means

of monitoring and repair (*);
complete capture of residual
quantities during decoupling and
coupling processes

1 Complete capture of the residual

quantities

0,5 assurance of leakproofness by
means of monitoring and
repair (*): regular cleaning

0,5 assurance of leakproofness by
means of monitoring and
repair (*): regular cleaning

0,5 assurance of leakproofness by
means of monitoring and
repair (*): regular cleaning

0,5 assurance of leakproofness by
means of monitoring and
repair (*): regular cleaning

2

1

1

1

1

1

1

1

3.2

substance transfer
points for liquids

3.2.1

small containers and
drums

L

2
2
5
/
3
2
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

1

2

3

4

3.2.1.1 small containers and

drums (emptying)

fixed connections
(pipework, hose
connections, articulated
arm)

(cid:151) with gas-displacement or gas offtake

at a safe point or transfer to a
treatment or incineration plant

(cid:151) without gas-displacement and

without gas offtake at a safe point

open packing drums

(cid:151) with drum pump or hose

5

1

4

4

6

7

0,5 assurance of leakproofness by
means of monitoring and
repair (*); leak test after
establishing the connection,
complete capture of the residual
quantities

with regard to connection elements see 1

1 in the case of a construction which

is free from leaks and drip quantities
as well as being equipped with
highly effective exhaust ventilation
equipment

regular checking of the exhaust
ventilation equipment; the small container
or drum must be closed immediately after
the filling process

emptying in closed units (cid:151) encapsulation

1

0,5 with integrated exhaust

3.2.1.2 small containers and
drums (filling)

fixed connections
(pipework, hose
connections, articulated
arm)

(cid:151) with gas-displacement or gas offtake

1

at a safe point or transfer to a
treatment or incineration plant

ventilation equipment and
opening and closing of the
packing drums in the closed unit

0,5 assurance of leakproofness by
means of monitoring and
repair (*); leak test after
establishing the connection,
complete capture of the residual
quantities

regular checking of the exhaust
ventilation equipment

with regard to connection elements see 1

(cid:151) without gas-displacement and

4

1 in the case of a construction which

without gas offtake

is free from leaks and drip quantities
as well as being equipped with
effective exhaust ventilation
equipment

open packing drums

(cid:151) with filling hose

4

0,5 in the case of a construction which

is free from leaks and drip quantities
as well as being equipped with
highly effective exhaust ventilation
equipment

(cid:151) encapsulation

1

0,5 with integrated exhaust

ventilation equipment and closing
of the packing drums in the
closed unit

regular checking of the exhaust
ventilation equipment; the small container
or drum must be closed immediately after
the filling process

regular checking of the exhaust
ventilation equipment

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

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2
5
/
3
2
9

1

3.2.2

2

3

4

5

6

7

tanker, tank wagon,
large containers

3.2.2.1 tanker, tank wagon,

large containers

fixed connection. e.g.
fixed pipework, hose
connections, steel

(cid:151) with gas displacement or gas offtake

1

at a safe point or transfer to a
treatment or incineration plant

0,5 Assurance of leakproofness by
means of monitoring and
repair (*); leak test after
establishing the connection,
complete capture of the residual
quantities

with regard to connection elements see 1

(cid:151) without gas displacement and

without gas offtake

other hose connections

3.2.2.2 tankers/tank wagons,

large containers (filling)

fixed pipework, hose
connections, steel loading
arms

(cid:151) with gas displacement or gas offtake

at a safe point or transfer to a
treatment or incineration plant

(cid:151) without gas displacement and

without gas offtake

open filling

(cid:151) filling pipe

3.3

substance transfer
points gases

3.3.1

gases
(filling and emptying)

4

2

1

4

4

1

1 complete capture of the residual

quantities

0,5 assurance of leakproofness by means
of monitoring and repair, leak test
after establishing the connection,
complete capture of residual
quantities

the containers must be closed
immediately after filling

1 with highly effective exhaust

ventilation, complete capture of the
residual quantities

the containers must be closed
immediately after filling

with regard to the functional elements see
1

0,5 Assurance of leakproofness by
means of monitoring and
repair (*); leak test after
establishing the connection; gas
displacement or offtake of
residual gas at a safe point or
transfer to a treatment or
incineration plant

closed plant systems, parts of units and
functional elements must be operated,
monitored and maintained in such a way
that they remain technically leakproof in
the case of the mechanical, chemical and
thermal stresses that can be expected for
the envisaged type of operation

L

2
2
5
/
3
3
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

1

2

3

4

4

sampling points

4.1

open sampling

valve, stopcock

4.2

closed sampling

5

4

1

6

7

2 with other exhaust ventilation

equipment

1 with highly effective exhaust

ventilation equipment

0,5 assurance of leakproofness by
means of monitoring and
repair (*)

sampling must be done by a closed
sampling system avoiding uncontrolled
escape of product. Uncontrolled escape of
product is understood as:

(cid:151) the splashing of liquid during

sampling from pressurised plant parts

(cid:151) after-run of liquid from pipe

connection pieces of tubes which are
mounted on the sampling unit

(cid:151) escape of product vapours

(cid:151) overflow from overfilled sampling

vessels

5

5.1

Storage in packing
drums

solid substances, with
the exception of certain
explosives

transport packaging
according to
ADR-regulations

(cid:151) drums, containers

0,5

with sufficient ventilation (min. twofold
change of air)

(cid:151) bags; plastic, textile, paper and

0,5

multi-layered sacks

with sufficient ventilation (min. twofold
change of air)

5.2

solid substances, certain
explosives (containing
nitro-glycerine)

transport packaging
according to
ADR-regulations

4

2 with other exhaust ventilation

equipment

1 with effective exhaust ventilation

equipment

0,5 with highly effective exhaust

ventilation equipment

5.3

liquids

transport packaging
according to
ADR-regulations

(cid:151) containers, metal drums, sheet iron
cans, plastic drums, tubes, cans,
containers

0,5

with sufficient ventilation (min. twofold
change of air)

.

.

2
1
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

L

2
2
5
/
3
3
1

1

2

3

4

5.4

Gases

transport packaging
according to
ADR-regulations

compressed gas cylinders,

5

1

compressed gas containers,

compressed gas drums

6

7

0,5 assurance of leakproofness by

means of monitoring and repair

with sufficient ventilation (min. twofold
change of air)

with regard to functional elements see 1;
closed plant systems, parts of units and
functional elements must be operated,
monitored and maintained in such a way
that they remain technically leakproof in
the case of the mechanical, chemical and
thermal stresses that can be expected for
the envisaged type of operation

(*) The leakproofness of separable connections between plant units and parts of the equipment can be assured by taking the following measures on a permanent basis:

1. Monitoring or inspection measures in order to determine and assess the actual state of the separable connection according to EN 13306 (in preparation)
This must occur at predetermined times and in accordance with a plan geared to the specific needs of the company, the type of connection and its construction as well as to the nature and the properties of the chemical agents which
are conveyed. Examples of such measures are:
(cid:151) leak testing,
(cid:151) visual examination of the plant to establish clear leakage points such as places where liquids are leaking, examination to establish streaks, odours, noises, the formation of ice, etc.,
(cid:151) inspection of the plant with mobile leak-indicating and leak-detection devices (e.g. gas test tubes, FID, portable gas detectors),
(cid:151) the application of foaming agents to the separable connections,
(cid:151) the use of gas detectors to monitor the atmosphere,
(cid:151) the use of an automatic leak-testing device at the articulated hose or the loading hose.
2. Repair measures to restore the desired state of the separable connection according to EN 13306 (in preparation)
The measures which are possibly required must be planned and performed on an individual basis in accordance with:

(cid:151) the particular hazardous substance,
(cid:151) the type and extent of the damage,
(cid:151) the protection and safety measures which must be taken.
Before the plant returns to operation the repaired connections must be subjected to thorough leak testing.

L

2
2
5
/
3
3
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

C
o
m
m
u
n
i
t
i
e
s

.

.

2
1
8
2
0
0
1

21.8.2001

EN

Official Journal of the European Communities

L 225/333

ANNEX 8A

Where, in accordance with the provisions of Annex VII.A related to intermediates, the relevant competent authority has
authorised the application of a reduced test package to a chemical substance, the requirements of this section shall be
reduced as follows:

(cid:151) when the quantity of the substance placed on the market reaches 10 tonnes per year per manufacturer or when
the total quantity of the substance placed on the market reaches 50 tonnes per manufacturer; in this case the
relevant competent authority shall require all those test and studies laid down in points 3 to 6 of Annex VII.A
(excepting those already performed); in addition, the relevant competent authority may require those level 1 tests
and studies related to aquatic organisms,

(cid:151) when the quantity of the substance placed on the market reaches 100 tonnes per year per manufacturer or when
the total quantity of the substance placed on the market reaches 500 tonnes per manufacturer; in this case the
relevant competent authority shall require the level 1 tests or studies related to reproductive toxicity. The relevant
competent authority may decide that the classification of the substance as an intermediate qualifying for a reduced
test package constitutes a good reason why one or more tests and studies, except those related to reproductive
toxicity, are not appropriate.

ANNEX 8B

When the quantity of the substance placed on the market reaches 1 000 tonnes per year per manufacturer or when the
total quantity of the substance placed on the market reaches 5 000 tonnes per manufacturer, additional studies
mentioned in level 1 or 2 would normally not be required. The relevant competent authority should, however, consider
additional tests and may require additional tests including the tests laid down in levels 1 and 2 of this Annex.