29.5.2007

Official Journal of the European UnionENL 136/103

ANNEX VII
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN
QUANTITIES OF ONE TONNE OR MORE (1)Column 1 of this Annex establishes the standard information required for:(a) non-phase-in substances manufactured or imported in quantities of 1 to 10 tonnes;(b) phase-in substances manufactured or imported in quantities of 1 to 10 tonnes and meeting the criteria in Annex III inaccordance with Article 12(1)(a) and (b); and(c) substances manufactured or imported in quantities of 10 tonnes or more.
Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Forsubstances not meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of thisAnnex are required.
Column 2 of this Annex lists specific rules according to which the required standard information may be omitted,
replaced by other information, provided at a different stage or adapted in another way. If the conditions are met underwhich column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.
In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of thisAnnex according to the general rules contained in Annex XI with the exception of Section 3 on substance-tailored exposure waiving. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information
under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in
Annex XI (2).
Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data,
historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shallbe assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided.
Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.
When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of thisAnnex or in Annex XI, this fact and the reasons shall also be clearly stated.

7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCECOLUMN 1
STANDARD INFORMATIONREQUIREDCOLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

7.1.

State of the substanceat 20 °C and 101,3 kPa

7.2.

Melting/freezing point

7.2.

The study does not need to be conducted below a lower limit of - 20 °C.

7.3.

Boiling point

7.3.

The study does not need to be conducted:— for gases, or— for solids which either melt above 300 °C or decompose before boiling. In such cases the boilingpoint under reduced pressure may be estimated or measured, or— for substances which decompose before boiling (e.g. auto-oxidation, rearrangement, degradation,decomposition, etc.).

7.4.

Relative density

7.4.

The study does not need to be conducted if:— the substance is only stable in solution in a particular solvent and the solution density is similar tothat of the solvent. In such cases, an indication of whether the solution density is higher or lower
than the solvent density is sufficient, or— the substance is a gas. In this case, an estimation based on calculation shall be made from its molecular weight and the Ideal Gas Laws.

(1) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users thatare required to carry out tests under this Regulation adapted as necessary.
(2) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test
methods as specified in Article 13(3) that are not repeated in column 2, also apply.

L 136/104

Official Journal of the European Union

ENCOLUMN 1
STANDARD INFORMATIONREQUIRED

29.5.2007

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

7.5.

Vapour pressure

7.5.

The study does not need to be conducted if the melting point is above 300 °C.
If the melting point is between 200 °C and 300 °C, a limit value based on measurement or a recognised
calculation method is sufficient.

7.6.

Surface tension

7.6.

The study need only be conducted if:— based on structure, surface activity is expected or can be predicted, or— surface activity is a desired property of the material.
If the water solubility is below 1 mg/l at 20 °C the test does not need to be conducted.

7.7.

Water solubility

7.7.

The study does not need to be conducted if:— the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours), or— the substance is readily oxidisable in water.
If the substance appears ‘insoluble’ in water, a limit test up to the detection limit of the analyticalmethod shall be performed.

7.8.

Partition coefficientoctanol/water

7.8.

The study does not need to be conducted if the substance is inorganic. If the test cannot be performed(e.g. the substance decomposes, has a high surface activity, reacts violently during the performance ofthe test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently puresubstance), a calculated value for log P as well as details of the calculation method shall be provided.

7.9.

Flash-point

7.9.

The study does not need to be conducted if:— the substance is inorganic, or— the substance only contains volatile organic components with flash-points above 100 °C foraqueous solutions, or— the estimated flash-point is above 200 °C, or— the flash-point can be accurately predicted by interpolation from existing characterised materials.

7.10.

Flammability

7.10.

The study does not need to be conducted:— if the substance is a solid which possesses explosive or pyrophoric properties. These properties
should always be considered before considering flammability, or— for gases, if the concentration of the flammable gas in a mixture with inert gases is so low that,when mixed with air, the concentration is all time below the lower limit, or— for substances which spontaneously ignite when in contact with air.

7.11.

Explosive properties

7.11.

The study does not need to be conducted if:— there are no chemical groups associated with explosive properties present in the molecule, or— the substance contains chemical groups associated with explosive properties which include oxygen
and the calculated oxygen balance is less than -200, or— the organic substance or a homogenous mixture of organic substances contains chemical groups
associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g
and the onset of exothermic decomposition is below 500 °C, or— for mixtures of inorganic oxidising substances (UN Division 5.1) with organic materials, the concentration of the inorganic oxidising substance is:n-— less than 15 %, by mass, if assigned to UN Packaging Group I (high hazard) or II (mediumhazard),— less than 30 %, by mass, if assigned to UN Packaging Group III (low hazard).
Note: Neither a test for propagation of detonation nor a test for sensitivity to detonative shock isrequired if the exothermic decomposition energy of organic materials is less than 800 J/g.

29.5.2007

Official Journal of the European UnionEN

COLUMN 1
STANDARD INFORMATIONREQUIREDL 136/105

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

7.12.

Self-ignition temperature

7.12.

The study does not need to be conducted:— if the substance is explosive or ignites spontaneously with air at room temperature, or— for liquids non flammable in air, e.g. no flash point up to 200 °C, or— for gases having no flammable range, or— for solids, if the substance has a melting point ≤ 160 °C, or if preliminary results exclude selfheating of the substance up to 400 °C.

7.13.

Oxidising properties

7.13.

The study does not need to be conducted if:— the substance is explosive, or— the substance is highly flammable, or— the substance is an organic peroxide, or— the substance is incapable of reacting exothermically with combustible materials, for example on thebasis of the chemical structure (e.g. organic substances not containing oxygen or halogen atoms andthese elements are not chemically bonded to nitrogen or oxygen, or inorganic substances notcontaining oxygen or halogen atoms).
The full test does not need to be conducted for solids if the preliminary test clearly indicates that thetest substance has oxidising properties.
Note that as there is no test method to determine the oxidising properties of gaseous mixtures, theevaluation of these properties must be realised by an estimation method based on the comparison of
the oxidising potential of gases in a mixture with that of the oxidising potential of oxygen in air.

7.14.

Granulometry

7.14.

The study does not need to be conducted if the substance is marketed or used in a non solid or granularform.

8. TOXICOLOGICAL INFORMATIONCOLUMN 1
STANDARD INFORMATIONREQUIREDCOLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.1.

Skin irritation or skincorrosion
The assessment of thisendpoint shall comprise thefollowing consecutive steps:(1) an assessment of theavailable human andanimal data,(2) an assessment of theacid or alkaline reserve,(3) in vitro study for skincorrosion,(4) in vitro study for skinirritation.

8.1.

Steps 3 and 4 do not need to be conducted if:— the available information indicates that the criteria are met for classification as corrosive to the skinor irritating to eyes, or— the substance is flammable in air at room temperature, or— the substance is classified as very toxic in contact with skin, or— an acute toxicity study by the dermal route does not indicate skin irritation up to the limit doselevel (2 000 mg/kg body weight).

8.2.

Eye irritation
The assessment of thisendpoint shall comprise thefollowing consecutive steps:(1) an assessment of theavailable human andanimal data,(2) an assessment of theacid or alkaline reserve,(3) in vitro study for eyeirritation.

8.2.

Step 3 does not need to be conducted if:— the available information indicates that the criteria are met for classification as corrosive to the skinor irritating to eyes, or— the substance is flammable in air at room temperature;L 136/106

Official Journal of the European UnionEN

COLUMN 1
STANDARD INFORMATIONREQUIRED

29.5.2007

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.3.

Skin sensitisation
The assessment of thisendpoint shall comprise thefollowing consecutive steps:(1) an assessment of theavailable
human,animal and alternativedata,(2) In vivo testing.

8.3.

Step 2 does not need to be conducted if:— the available information indicates that the substance should be classified for skin sensitisation or
corrosivity, or— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or— the substance is flammable in air at room temperature.
The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Only in
exceptional circumstances should another test be used. Justification for the use of another test shall beprovided.

8.4.

Mutagenicity

8.4.

Further mutagenicity studies shall be considered in case of a positive result.

8.4.1.

In vitro gene mutation study
in bacteria

8.5.

Acute toxicity

8.5.

The study/ies do(es) not generally need to be conducted if:— the substance is classified as corrosive to the skin.

8.5.1.

By oral route

The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available.

9. ECOTOXICOLOGICAL INFORMATIONCOLUMN 1
STANDARD INFORMATIONREQUIREDCOLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.1.

Aquatic toxicity

9.1.1.

Short-term toxicity testing
on invertebrates (preferredspecies Daphnia)
The registrant may consider
long-term toxicity testing
instead of short-term.

9.1.1.

The study does not need to be conducted if:— there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if thesubstance is highly insoluble in water or the substance is unlikely to cross biological membranes, or— a long-term aquatic toxicity study on invertebrates is available, or— adequate information for environmental classification and labelling is available.
The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5) shall be considered if thesubstance is poorly water soluble.

9.1.2.

Growth inhibition study
aquaticplants(algaepreferred)

9.1.2.

The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is
unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to
cross biological membranes.

9.2.

Degradation

9.2.1.

Biotic9.2.1.1. Ready biodegradability

9.2.1.1. The study does not need to be conducted if the substance is inorganic.

Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.