GUIDANCE MANUAL FOR DEPARTMENTADMINISTRATIVE ORDER 2015-09, “RULESAND PROCEDURES FOR THE
IMPLEMENTATION OF THE GLOBALLYHARMONIZED SYSTEM (GHS) OF
CLASSIFICATION AND LABELLING OF
CHEMICALS IN PREPARATION OF SAFETYDATA SHEET (SDS) AND LABELINGREQUIREMENTS OF TOXIC CHEMICALSUBSTANCES”

Page 1TABLE OF CONTENTS
A. GUIDANCE MANUAL FOR CLASSIFICATION OF CHEMICALSPart 1 : General rules

6Part 2 : Classification guidance

6

Section 2.1 Physical Hazards

7

Section 2.2 Physical Hazards Guidance

7

Section 2.3 Definition of Physico-Chemical in GHS

9Section 2.4 Physical Hazards

10

Section 2.4.1 Explosives

10

Section 2.4.2 Flammable gases (including chemically unstable gases) 18
Section 2.4.3 Aerosols

22

Section 2.4.4 Oxidizing gases

25

Chapter 2.4.5 Gases under pressure

28

Section 2.4.6 Flammable liquids

31

Section 2.4.7 Flammable solids

36

Section 2.4.8 Self-reactive substances and mixtures

39

Section 2.4.9 Pyrophoric liquids

44

Section 2.4.10 Pyrophoric solids

47

Section 2.4.11 Self-heating substances and mixtures

50

Section 2.4.12 Substances and mixtures which, in contact with water,
emit flammable gases
54
Section 2.4.13 Oxidizing liquids

58

Section 2.4.14 Oxidizing solids

61
Page 2Section 2.4.15 Organic peroxides

64

Section 2.4.16 Corrosive to metals

69

Section 2.5 Health Hazards

72

Section 2.5.1 Information useful for classification

72

Section 2.5.2 Health hazards

72

Section 2.5.2.1 Acute toxicity

73

Section 2.5.2.2 Skin corrosion/ irritation

80

Section 2.5.2.3 Serious eye damage/ eye irritation

86

Section 2.5.2.4 Respiratory or skin sensitization

91

Section 2.5.2.5 Germ cell mutagenicity

94

Section 2.5.2.6 Carcinogenicity

99

Section 2.5.2.7 Reproductive toxicity

106

Section 2.5.2.8 Specific target organ toxicity – single exposure

111

Section 2.5.2.9 Specific target organ toxicity– repeated exposure 118
Section 2.5.2.10 Aspiration hazard
Section 2.6 Environmental Hazards

123
126

Section 2.6.1 Hazardous to the aquatic environment

126

Section 2.6.2 Hazardous to the ozone layer

136

B. INITIAL LIST OF SINGLE SUBSTANCES AND COMPOUNDS COVEREDUNDER CHEMICAL CONTROL ORDER (CCO) AND PRIORITY
CHEMICAL LIST (PCL)
138
C. GHS PICTOGRAMS

140

Page 3

D. GUIDANCE MANUAL ON THE PREPARATION OF GHS LABELSPart 1 General rules, requirements and procedures

142

1.1 General rules

142

1.2 Specific rules

142

1.2.1 Label elements

142

1.2.2 Reproduction of the symbol

142

1.2.3 Pictograms and reproduction of the hazard pictograms

143

1.2.4 Allocation of label elements

144

1.2.5 Precedence for the allocation of symbols

145

1.2.6 Precedence for the allocation of signal words

146

1.2.7 Precedence for the allocation of hazard statements

146

1.2.8 Arrangements for presenting the GHS label elements

146

1.2.9 Packaging specification

147

1.2.10 Label sizes and specification

147

E. GUIDANCE MANUAL ON PREPARATION OF SAFETY DATA SHEET(SDS)Part 1. General rules, requirements and procedures

148

1.1 General rules

148

1.2 SDS Format

149

1.2.1

Section 1. Identification

149

1.2.2

Section 2. Hazard identification

150

1.2.3

Section 3. Composition / information of ingredients

150

Page 4

1.2.4

Section 4. First-aid measures

151

1.2.5

Section 5. Fire-fighting measures

152

1.2.6

Section 6. Accidental release measures

153

1.2.7

Section 7. Handling and storage

154

1.2.8

Section 8. Exposure controls / personal protection

156

1.2.9

Section 9. Physical and chemical properties

157

1.2.10 Section 10. Stability and reactivity

158

1.2.11 Section 11. Toxicological information

159

1.2.12 Section 12. Ecological information

161

1.2.13 Section 13. Disposal consideration

162

1.2.14 Section 14. Transport information

162

1.2.15 Section 15. Regulatory information

163

1.2.16 Section 16. Other information

163

1.3 Submission of SDS

164

1.4 Maintenance of SDS

164

Page 5

A. Guidance Manual for Classificationof Chemicals
This “GHS Guidance Manual” for the Classification and Labeling of Substances
has been prepared to assist companies, primarily the Small and Medium
Enterprises (SMEs) and other business entities who are engaged in the
manufacture, selling, trading, retailing and repacking of chemicals, in theclassification and labeling of substances including preparation of Safety Data
Sheet (SDS) for the initial sixty-four (64) pure chemicals on the basis of theirhealth and environmental effects such as persistency to the environment,
carcinogenicity, mutagenicity and reproductive toxicity as prescribed by thisOrder. The purpose is to provide practical methods for data collection andevaluation criteria for data reliability necessary in arriving at the appropriateclassification.
This GHS Guidance is a manual based on the UN Purple Book Globally
Harmonized System of Classification and Labeling of Chemicals fourth (4th)revised edition to consistently present global harmonization and allow GHS
classification to be carried out correctly and effectively by the companies. Any
results of classification obtained from the use of this guidance manual, including
the responsibility of the results, shall be that of the company.
1.0 General rules
1.1 Classify all chemicals covered under the Priority Chemical List (PCL) andChemical Control Order (CCO) according to the GHS classification criteria.
1.2 Classification shall be conducted by a competent person to ensure accuracy of
information.
1.3 Testing of animals is discouraged during the classification of substances.
Utilize the available information from recognized websites and information
sources.
1.4 If classification is already provided by the original or principal manufacturerof the substance, an importer or trader will use such classification.
2.0 Classification guidanceThis section presents the guidelines for the proper classification of chemicals
including determination of appropriate category for each hazard class.

Page 6

2.1 PHYSICAL HAZARDSThis section defines and explains the 16 hazard classes based on GHS physicalhazards. However, during classification, they can be reduced depending on the stateof the substance (gas, liquid and solid). Furthermore, they can also be narrowed
down depending on their chemical structures. Figures below explain the narrowing
down of classification.
2.2 PHYSICAL HAZARDS GUIDANCE
Figure 2.2.1 Narrowing Down the Applicable Hazard Classes
Narrowing down based on states of the chemicals
Aerosol articles

Applicable hazards
for aerosol articles

Ejected chemicals

Injection
Gases

Chemicals to be classified

Gas Flammable
Aerosols

Solid
Gas? Solid?
Liquid?

LiquidApplicable hazards forgaseous chemicals

Applicable hazards for liquid
chemicals

Applicable hazards for solid
chemicals Flammable Gases
 Oxidizing Gases
 Gases Under Pressure Corrosive to Metals

 Explosives
 Flammable Liquids Self-Reactive Substances Pyrophoric Liquids Self-Heating Substances Substances, which in contact
with water, emit flammablegases
 Oxidizing Liquids Organic Peroxides
 Corrosive to Metals

 Explosives
 Flammable Solids
 Self-Reactive Substances Pyrophoric Solids
 Self-Heating Substances Substances, which in contact withwater, emit flammable gases
 Oxidizing Solids
 Organic Peroxides
 Corrosive to Metals

As for other classes, designate
as “Not Applicable”

 Explosives
 Self-Reactive Substances Substances, which in contact
with water, emit flammablegases
 Oxidizing Liquids
 Oxidizing Solids
 Organic Peroxides

As for other classes, designate as“Not Applicable”

Narrowing down basedon chemical structuresof ingredient chemicals
are shown in the next
page

Go to Figure 5.2.2

Page 7

Figure 2.2.2 Narrowing Down the Applicable Hazard Classes
Narrowing down based on molecular structures of ingredient chemicals

If chemicals (mixture ingredients) do not contain in their molecules chemical groups
shown in Table 2.5.2
As for Explosives, designate as “Not Applicable”
If chemicals (mixture ingredients) do not contain in their molecules chemical groups
shown in Table 2.5.2 or Table 2.5.3
As for Self-Reactive Substances, designate as “Not Applicable”
If chemicals (mixture ingredients) do not contain in their molecules metals or mettaloids
As for Substances which, in contact with water, emit flammable gases, designate as “NotApplicable”

1. Organic substances which do not contain oxygen, chlorine, or fluorine, or which containany of these elements that are bound to carbon or hydrogen only.
2. Inorganic substances not containing oxygen or any halogen element.
As for Oxidizing Liquids and Oxidizing Solids, designate as “Not Applicable”
1. Inorganic substances
2. Organic compounds which in their molecules do not contain any of O-O- linkage

As for Organic Peroxides, designate as “Not Applicable”

Narrowing down based on contents of ingredient chemicals and the like
1. Containing chemical groups in Table 2.5.2 including oxygen but the calculated resultof oxygen balance is less than -200
(Calculation) As for carbon, hydrogen, and oxygen in molecular formula (CxHyOz).
Oxygen balance = -1600 x (2x +y/2-z) / molecular weight
As for Explosives, designate as “Not Classified”

Page 8

2.3 DEFINITION OF PHYSICO-CHEMICAL IN GHS
In GHS context, a substance means chemical elements and their compounds in the naturalstate or obtained by any production process, including any additive necessary to preserve
the stability of the product and any impurities deriving from the process used, but excluding
any solvent which may be separated without affecting the stability of the substance orchanging its composition.
2.3.1 GASES
Gas is defined as a substance which (i) at 50°C has a vapour pressure greater than 300 kPa(absolute); or (ii) is completely gaseous at 20°C at a standard pressure of 101.3 kPa.
2.3.2 LIQUIDS
Liquid is defined as a substance which at 50°C has a vapour pressure of not more than 300
kPa (3 bar), which is not completely gaseous at 20°C and at a standard pressure of 101.3 kPa,
and which has a melting point or initial melting point of 20°C or less at a standard pressureof 101.3 kPa. A viscous substance for which a specific melting point cannot be determinedshall be subjected to the ASTM 2 4359-90 test; or to the test for determining fluidity(pemetrometer test) prescribed in section 2.3.4 of Annex A of the European Agreement
concerning the International Carriage of Dangerous Goods by Road (ADR).
2.3.3 SOLIDS
Solid is defined as a substance which does not meet the definitions of liquid or gas. Solids
may be in the form of powder, granules, paste, mass, fiber, tablet, etc. It must be noted thatthe hazards of powdered substances vary depending on their particle size. That is why,hazards that a substance has in its current form should be assessed instead of hazards
inherent to the substance.

Page 9

SECTION 2.4
PHYSICAL HAZARDSSECTION 2.4.1
EXPLOSIVES
2.4.1.1Definitions
2.4.1.1.1 An explosive substance (or mixture) is a solid or liquid substance (ormixture of substances) which is in itself capable by chemical reaction of producing
gas at such a temperature and pressure and at such a speed as to cause damage tothe surroundings. Pyrotechnic substances are included even when they do not
evolve gases.
2.4.1.1.2 A pyrotechnic substance (or mixture) is a substance or mixture of substances
designed to produce an effect by heat, light, sound, gas or smoke or a combination ofthese as the result of non-detonative self-sustaining exothermic chemical reactions.
2.4.1.1.3 An explosive article is an article containing one or more explosive
substances or mixtures.
2.4.1.1.4 A pyrotechnic article is an article containing one or more pyrotechnic
substances or mixtures.
The class of explosives comprises:(a)Explosive substances and mixtures;(b)

Explosive articles, except devices containing explosive substancesor mixtures in such quantity or of such a character that their
inadvertent or accidental ignition or initiation shall not cause any
effect external to the device either by projection, fire, smoke, heator loud noise; and(c)Substances, mixtures and articles not mentioned under (a) and (b)above which are manufactured with the view to producing apractical, explosive or pyrotechnic effect.

Page 10

2.4.1.2Classification criteria in GHS
2.4.1.2.1 Substances, mixtures and articles of this class, which are not classified as an
unstable explosive, are assigned to one of the following six divisions depending on
the type of hazard they present:(a) Division 1.1 Substances, mixtures and articles which have a mass explosion
hazard (a mass explosion is one which affects almost the entire quantity
present virtually instantaneously);(b) Division 1.2 Substances, mixtures and articles which have a projection
hazard but not a mass explosion hazard;(c) Division 1.3 Substances, mixtures and articles which have a fire hazard andeither a minor blast hazard or a minor projection hazard or both, but not amass explosion hazard:(i) combustion of which gives rise to considerable radiant heat; or(ii) which burn one after another, producing minor blast or projection
effects or both;(d) Division 1.4 Substances, mixtures and articles which present no significant
hazard: substances, mixtures and articles which present only a small hazard
in the event of ignition or initiation. The effects are largely confined to the
package and no projection of fragments of appreciable size or range is to be
expected. An external fire shall not cause virtually instantaneous explosion ofalmost the entire contents of the package;(e) Division 1.5 Very insensitive substances or mixtures which have a mass
explosion hazard: substances and mixtures which have a mass explosion
hazard but are so insensitive that there is very little probability of initiation orof transition from burning to detonation under normal conditions;(f) Division 1.6 Extremely insensitive articles which do not have a mass
explosion hazard: articles which contain only extremely insensitive
detonating substances or mixtures and which demonstrate a negligible
probability of accidental initiation or propagation.
2.4.1.2.2 Explosives, which are not classified as an unstable explosive, are classified
in one of the six divisions above based on Test Series 2 to 8 in Part I of the UN
Recommendations on the Transport of Dangerous Goods, Manual of Tests andCriteria according to the following table:

Page 11

Table 2.4.1.1: Criteria for explosives
Category

Criteria

Unstable a explosives
or explosives ofDivision 1.1 to 1.6

For explosives of Divisions 1.1 to 1.6, the following are thecore set of tests that need to be performed:
Explosibility: according to UN Test Series 2 (Section 12 of
the UN Recommendations on the Transport ofDangerous Goods, Manual of Tests and Criteria).
Intentional explosives b are not subject to UN
Test series 2.
Sensitiveness: according to UN Test Series 3 (Section 13 of
the UN Recommendations on the Transport ofDangerous Goods, Manual of Tests and Criteria).
Thermal stability:
according to UN Test 3(c) (Sub-section
13.6.1 of the UN Recommendations on theTransport of Dangerous Goods, Manual of Tests
and Criteria).
Further tests are necessary to allocate the correct Division.

a Unstable explosives are those which are thermally unstable and/or too sensitive for normal
handling, transport and use. Special precautions are necessary.
b This comprises substances, mixtures and articles which are manufactured with a view to
producing a practical, explosive or pyrotechnic effect.
NOTE 1:
Explosive substances or mixtures in packaged form and articles may beclassified under divisions 1.1 to 1.6 and, for some regulatory purposes, are further subdivided
into compatibility groups A to S to distinguish technical requirements (see UN
Recommendations on the Transport of Dangerous Goods, Model Regulations, Chapter 2.1).
NOTE 2:
Some explosive substances and mixtures are wetted with water or alcohols or
diluted with other substances to suppress their explosives properties. They may be treateddifferently from explosive substances and mixtures (as desensitized explosives) for someregulatory purposes (e.g. transport).
NOTE 3:For classification tests on solid substances or mixtures, the tests should be
performed on the substance or mixture as presented. If for example, for the purposes of supply
or transport, the same chemical is to be presented in a physical form different from that which
was tested and which is considered likely to materially alter its performance in a classification
test, the substance or mixture must also be tested in the new form.
2.4.1.3

Guidance for classification

2.4.1.3.1Explosive properties are associated with the presence of certain chemicalgroups in a molecule which can react to produce very rapid increases intemperature or pressure. The screening procedure is aimed at identifying
Page 12the presence of such reactive groups and the potential for rapid energy
release. If the screening procedure identifies the substance to be a potential
explosive, the acceptance procedure (see section 10.3 of the UN
Recommendations on the Transport of Dangerous Goods, Manual of Tests
and Criteria) has to be performed.
2.4.1.3.2 A substance shall not be classified as explosive if:a.

There are no chemical groups associated with explosive properties
present in the molecule. Examples of groups which may indicate
explosive properties are given in Table A6.1 in Appendix 6 of the UN
Recommendations on the Transport of Dangerous Goods, Manual ofTests and Criteria; orb. The substance contains chemical groups associated with explosive
properties which include oxygen and the calculated oxygen balance isless than -200.
The oxygen balance is calculated for the chemical reaction:
CxHyOz +[x + (y/4)] O2→ x. CO2 + (y/2) H2O
Using the formula :Oxygen balance = -1600 [2x + (y/2) – z]/ molecular weight;c.

When the organic substance or a homogeneous mixture of organic
substances contain 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. (Thetemperature limit is to prevent the procedure being applied to a large
number of organic materials which are not explosive but which will
decompose slowly above 500°C to release more than 500 J/g). The
exothermic decomposition energy may be determined using a suitable
calorimetric technique2.4.1.3.3 Judgment of: “Not Applicable” (Narrowing down the applicable classes by
the state and molecular structure of the substance)
2.4.1.2.3.1 If a substance falls under Gases, its “Classification result” shall be“Not Applicable”, and indicate “a gas according to GHS definition” for“Classification Grounds”
2.4.1.2.3.2 If a substance does not contain chemical groups related to
explosivity, it shall be “Not Applicable”, and indicate “It does not containchemical groups related to explosivity” for “Classification Grounds”.
Page 13

2.4.1.3.4 Judgment of “Not Classified” (Narrowing down the applicable classes by
the contents of ingredients or preliminary measurement results)
2.4.1.3.4.1 For substances having explosive chemical groups including
oxygen and falling under the provisions of the following UN GHS thefourth edition 2.1.4.2.2 (b)-(d) (based on calculation result of oxygen balance,
exothermic decomposition energy, and content of inorganic compounds),“Classification result” shall be “Not Classified”, and “based on calculation
result calculated value : XX)” shall be indicated for “Classification
Grounds”.
2.4.1.3.5 Judgment of “Classified”
When the existing classification results shown in Table 5.4.1.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.1.3.6 Classification based on existing classifications such as UNRTDG
2.4.1.3.6.1 If the category is not determined after following the proceduredescribed below, perform the pre-determined tests (or tests providing theequivalent judgment), and determine the Category.
2.4.1.3.6.1.1 Substances cited in (8.4.1.6) shall be classified according to
the UNRTDG Classification
2.4.1.3.6.1.2 Based on results of test series for UNRTDG classification,“Desensitized Explosives” do not fall under Classes 1.1 – 1.6, andaccordingly, not in “explosives” in GHS either. For substances falling
under“Desensitized
Explosives”,
regarding“Explosives”,“Classification result” shall be “Classification Not Possible”, and “Testmethod not determined” shall be indicated for “Classification
Grounds”.
2.4.1.4

Testing Methods

2.4.1.4.1 Classify unstable explosives and explosives of Category 1.1 throughCategory 1.6 with the following tests:
2.4.1.4.1.1

Explosive properties : UNRTDG Manual of Tests and Criteria
Item 12, Test series 2

2.4.1.4.1.2

Sensitivity : UNRTDG Manual of Tests and Criteira Item 13,
test series 3
Page 14

2.4.1.4.1.3

Thermal Stability : UNRTDG Manual of Tests and Criteria Item
13.6.1, Test series (C)2.4.1.4.1.4

Articles designated as packaged articles may be categorized
into Categories 1.1. to 1.6, and UNRTDG furthermore subcategories to clearly show the technical requirements.

2.4.1.4.1.5

If explosives are desensitized by wetting with water or alcohols
or dilutin with other substances, they may be classified otherthan explosives as desensitized explosives.

2.4.1.4.1.6

Unstable explosives are explosives being thermally unstable
and too sensitive for usual handling.

2.4.1.5 Data availability
It must be noted that the performance of explosives depends on their composition,and data regarding explosive performance of each substant are limited.
2.4.1.6 Comparison with conventional classification systems
Divisions 1.1 – 1.6 described above follow the definition of Divisions of UNRTDG
2.1.1.4
2.4.1.7 Sources of information for classification results under conventional
systems
The UNRTDG list of dangerous goods (for example, the Annex 1: Dangerous Goods
Regulations) includes the following substance:
Division

Explanation

Examples of UN Number and Substance
0004 AMMONIUM PICRATE dry or wetted with less than
10% water, by mass
0028 BLACK POWDER (GUNPOWDER), COMPRESSEDor BLACK POWDER (GUNPOWDER), IN PELLETS

Division 1.1

Equivalent to
UNRTDG 1.1

0072 CYCLOTIMETHYLENETRINITAMINE (CYCLONITE;
HEXOGEN; RDX), WETTED with not less than 15%
water, by mass
0074 DIAZODINITROPHENOL, WETTED with not lessthan 40% water, or mixture of alcohol and water, by
mass
0075 DIETHYLENEGLYCOL DINITRATE, DESENSITIZEDPage 15

with not less than 25% non-volatile, water-insoluble
phlegmatizer, by mass

Division 1.2

Equivalent to
UNRTDG 1.2

0076 DINITORPHENOL, dry or wetted with less than 15%
water, by mass
At present, only articles have UN numbers, but substances
may be included in accordance with the definition.
0161 POWDER, SMOKELESS0234 SODIUM DINITRO-o-CRESOLATE, dry or wettedwith less than 15% water, by mass

Division 1.3

Equivalent to
UNRTDG 1.3

0235 SODIUM PICRAMATE, dry or wetted with less than
20% water, by mass
0236 ZIRCONIUM PICRAMATE, dry or wetted with lessthan 20% water, by mass

Division 1.4

Equivalent to
UNRTDG 1.4

Division 1.5

Equivalent to
UNRTDG 1.5

Division 1.6

Equvalent to
UNRTDG 1.6

Division

0342 NITROCELLULOSE, WETTED with not less than 25%
alcohol by mass
0407 TETRAZOL-1-ACETIC ACID
0448 5-MERCAPTOTETRAZOL-1-ACETIC ACID
0331 EXPLOSIVE, BLASTING, TYPE B (AGENT,
BLASTING, TYPE B)
There is no article with a specific name that fall under thisdivision

Explanation

Examples of UN Number and Substance

Explosive substances and (a) AMMONIUM BROMATE
articles whose transport is (b) AMMONIUM BROMATE SOLUTION
prohibited, and explosives (c) AMMONIUM CHLORATE
listed in 1979 Notice 549 from (d) AMMONIUM CHLORATE
Unstablethe Ministry of Transport”
SOLUTION
explosives
Public Notice to provide (e) AMMONIUM CHLORITE
Standards, etc., for Carriage of (f) AMMONIUM NITRATE (excluding
Dangerous Goods by ship”
those listed in Annex 1)
Article 5 (1).
Some explosives which are UNRTDG 3*EmS:F-E
wetted with water or alcohols, 1204 NITROGLYCERIN SOLUTION IN
Desensitized
etc. to suppress their explosive
ALCOHOL with not more than 1%
explosives
properties does not meet thenitroglycerin(GHS 2.1.2.2
criteria for GHS Explosives. 2059 NITROCELLULOSE SOLUTION,
Note 2)
They are included in Class 3
FLAMMABLE with not more thanand a part of Class 4.1 in
12.6% nitrogen, by dry mass, and not

Page 16

UNRTDG, and they fall under
the substance specified in
Schedule 113 (Flammable
Solids-Toxic
substances(wetted/desensitized
explosives) in ERG. They are
F-E (Flammable Liquids notreacting with water) and S-J(wetted explosives and selfexothermic substances) in EmS

more than 55% nitrocellulose
UNRTDG 4.1*ERG113
1310 AMMONIUM PICRATE, WETTED
with not less than 10% water, by mass
UNRTDG 4.1*EmS:S-J
1320 DINITROPHENOL, WETTED withnot less than 15% water by mass1336 NITROGUANDINE (PICRITE),WETTED with not less than 20%
water, by mass1337 NITROSTARCH, WETTED with notless than 20% water, by mass1354 TRINITOBENZENE, WETTED withnot less than 30% water, by mass1355 TRINITROBENZOIC ACID,WETTED with not less than 30%
water, by mass

2.4.1.8 Hazard Communication
General and specific considerations concerning labeling requirements are provided
in Hazard communication: Labelling (Chapter 1.4) of the UN Purple Book. Annex 2
contains summary tables about classification and labeling. Annex 3 contains
examples of precautionary statements and pictograms which can be used where
allowed by the competent authority.
Table 2.4.1.2: Label elements for explosives
Unstable
Explosive

Division
1.1

Division
1.2

Division
1.3

Division
1.4

Division
1.5

Division
1.6

SymbolExplodingbomb

Explodingbomb

Explodingbomb

Explodingbomb

Explodingbomb;or
1.4 on orange
backgrounda

1.5 on orange
backgrounda

1.6 on orange
backgrounda

Signalword

DangerDangerDangerDangerWarning

DangerNo signal word

Hazardstatement

Unstable
Explosive

Explosive;
mass
explosion
hazardExplosive;
severeprojection
hazardExplosive;
fire, blast or
projection
hazard.

Fire orprojection
hazardMay mass
explode in fire

No hazard
statementaApplies to substances, mixtures and articles subject to some regulatory purposes (e.g. transport).

Page 17

SECTION 2.4.2
FLAMMABLE GASES (INCLUDING CHEMICALLYUNSTABLE GASES)
2.4.2.1

Definitions

2.4.2.1.1 A flammable gas is a gas having a flammable range with air at 20 °C and astandard pressure of 101.3 kPa.
2.4.2.1.2 A chemically unstable gas is a flammable gas that is able to react
explosively even in the absence of air or oxygen.
2.4.2.2 Classification Criteria in GHS
2.4.2.2.1 A flammable gas shall be classified in one of the two categories for this classaccording to the following table:
Table 2.4.2.1 Criteria for Flammable Gases
Category

1

2

Criteria
Gases, which at 20°C and a standard pressure of 101.3 kPa:(a) Are ignitable when in a mixture of 13% or less by volume
in air; or(b) Have a flammable range with air of at least 12 percentage
points regardless of the lower flammable limit.
Gases, other than those of Category 1, which, at 20°C and astandard pressure of 101.3 kPa, have a flammable range while
mixed in air.

Note 1: Ammonia and methyl bromide may be regarded as special cases for someregulatory purposes.
Note 2: Aerosols should not be classified as flammable gases.
2.4.2.2.2 A flammable gas that is also chemically unstable is additionally classified in
one of the two categories for chemically unstable gases using the methods describedin Part III of the Manual of Tests and Criteria according to the following table:

Page 18

Table 2.4.2.2 Criteria for chemically unstable gases
Category

Criteria
Flammable gases which are chemically unstable at 20°C and astandard pressure of 101.3 kPa
Flammable gases which are chemically unstable at atemperature greater than 20°C and/or a pressure greater than
101.3 kPa

A
B

2.4.2.3 Hazard Communication
General and specific considerations concerning labeling requirements are provided
in Hazard communication: Labelling (Chapter 1.4) of the UN Purple Book. Annex 2
contains summary tables about classification and labeling. Annex 3 contains
examples of precautionary statements and pictograms which can be used where
allowed by the competent authority.
Table 2.4.2.3 Label Elements for Flammable Gases (including chemical unstable gases)
Flammable gas
Category 1
Category 2
SymbolFlame

No symbol

Signal word

DangerWarning

Hazardstatement

Extremely
flammable gas

Flammable gas

2.4.2.4

Chemically unstable gas
Category A
Category B
No additional
No additional
symbolsymbolNo additional
No additionalsignal word
signal word
May react
May react
explosively even
explosively even in the absence ofin the absence of
air at elevatedairpressure and/or
temperature

Guidance for classification

2.4.2.4.1 Flammability shall be determined by tests or by calculation in accordancewith methods adopted by ISO (see ISO 10156:2010 “Gases and gas
mixtures – Determination of fire potential and oxidizing ability for theselection of cylinder valve outlets”). Where insufficient data are available
to use these methods, tests by a comparable method recognized by thecompetent authority may be used.
2.4.2.4.2 Chemical instability shall be determined in accordance with the method
described in Part III of the Manual of Tests and Criteria. If the calculationsin accordance with ISO 10156:2010 show that a gas mixture is not
flammable it is not necessary to carry out the tests for determining
chemical instability for classification purposes.

Page 19

2.4.2.4.3 Judgmentof “Not Applicable” (Narrowing down the applicable classes by
the state and molecular structure of the substance)
A product which does not meet the GHS definition for gases shall be
judged as “Not Applicable”.
2.4.2.4.4 Judgment of “Not Classified”
Non-combustible and oxidative gases shall be judged as “Not classified”.
2.4.2.4.5 Judgment of “Classified”
When the existing classification results shown in Table 2.4.2.1 or Table
2.4.2.2 are available, after examination of the classification result and theevidence data, the Category shall be determined.
2.4.2.6

Classification based on existing classifications and the like (such as
UNRTDG)
Substances designated as Class 2.1 (or Subsidiary Class 2.1) in the
UNRTDG classification Table shall be categorized in GHS Category 1.

2.4.2.6.1 Classification based on data from prescribed literatures
Classification shall be performed based on data of combustible range or
explosion limit in prescribed review documents according to the UN GHS
4th revised edition 2.2.2
2.4.2.7

Data availability
Physical properties of gaseous substances with single ingredient are
relatively easy to obtain from such as literatures. All of combustible /flammable gases at ambient temperature and pressure shall be flammablegases. When data of combustible range (what is called explosive limit) areavailable, it is easy to pass a judgment for classification of a single gas

2.4.2.8

Sources of information for classification results under conventional
systems

2.4.2.8.1 UN Dangerous Goods Transportation
The definition of Division 2.1 described in UNRTDG 2.2.2.1 is inaccordance with that of GHS Category 1
Category 1 = UNRTDG 2.1 and 2.3.2 (2.1)
Page 20

Category 2 = Flammable gas which is not included in Category 1
2.4.2.8.2 In GHS, “flammable gases” may include gases with ambient pressure
because of the omission of the condition of gases under pressure.
Category

1

2

Explanation

Examples of UN Number and Substance

1012 BUTYLENE
1036 ETHYLAMINE
1049 HYDROGEN, COMPRESSED1978 PROPANE
Equivalentto2203 SILANE
UNRTDG 2.1
2454 METHYL FLOURIDE (REFRIGERANTGAS R-41)
3153 PERFLUORO (METHYL VINYLETHER)
1053 HYDROGEN SULPHIDE
1082 RIFLUOROCHLOROETHYLENE,
Equivalent 2.3 (2.1)
STABILIZED
2188 ARSINE
2204 CARBONYL SULPHIDE
1062 METHYL BROMIDE

2.4.2.8.3 Other classification
It corresponds to Schedule F-D in EmS. S-U also includes toxic gases. In
ERG, the provisions for flammable gases are divided into Schedules 115,
116, 117, 118 and 119.
In EU DSD classification, gaseous substances with R-phrase 12 meet thesecriteria (Categories 1 and 2), but no categorization is shown

Page 21

SECTION 2.4.3
AEROSOLS
2.4.3.1 Definitions
2.4.3.1.1 Aerosols, this means aerosol dispensers, are any non-refillable receptacles
made of metal, glass or plastics and containing a gas compressed, liquefied or
dissolved under pressure, with or without a liquid, paste or powder, and fitted witha release device allowing the contents to be ejected as solid or liquid particles insuspension in a gas, as a foam, paste or powder or in a liquid state or in a gaseousstate.
2.4.3.2 Classification Criteria
2.4.3.2.1 Aerosols shall be considered for classification as flammable if they containany component which is classified as flammable according to the GHS criteria, i.e.:
Flammable liquids (see 2.4.6)
Flammable gases (see 5.4.2)
Flammable solids (see 5.4.7)
Note 1: Flammable components do not cover pyrophoric, self-heating or waterreactive substances because such components are never used as aerosol contents.
Note 2: Aerosols do not fall additionally within the scope of section 2.4.2 (Flammablegases), section 2.4.5 (Gases under pressure), section 2.4.6 (Flammable liquids) andsection 2.4.7 (Flammable solids). Depending on their contents, aerosols may however
fall within the scope of other hazard classes, inclusding their labelling elements.
2.4.3.2.2An aerosol is classified in one of the three categories for this Class on thebasis of its components, of its chemical heat of combustion and, if applicable, of theresults of the foam test (for foam aerosols) and of the ignition distance test andenclosed space test (for spray aerosols). Aerosols which do not meet the criteria forinclusion in Category 1 or Category 2 (extremely flammable or flammable aerosols)
should be classified in Category 3 (non-flammable aerosols).

Page 22

2.4.3.2.3 The GHS classification criteria are summarized as follows:
Category 1 : Aerosols whose content of flammable components is 85% ormore and whose heat of combustion is 30kJ/ g or larger, orSpray aerosols for which ignition occurs at a distance of 75 cm
or more in the ignition distance test, orFoam aerosols which have, in the foam test, 20 cm or more of
the flame height and 2 seconds or longer of the flame
duration of have 4 cm or more of the flame height and 7
seconds or longer of the flame duration
Category 2 : Spray aerosols for which the heat of combustion is 20kJ/g orlarger and either for which ignition occurs at a distance of 15
cm or more in the ignition distance test or for which the timeequivalent is 300 second/ m3 or less, or the deflagration
density is 300 g/m3 or less, in the enclosed space ignition test
Foam aerosols which have, in the foam test, 4 cm or more of
the flame height and 2 seconds or longer of the flame
duration
Not Classified : (1) aerosols whose content of flammable components is 1%
or less and the heat of combustion is smaller than 20
kJ/g(2) aerosols which was not judged as “ Category 1 or 2” inthe enclosed space ignition test for spray aerosols(3) aerosols which was not judged as “Category 1 or 2” inthe foam test for foam aerosols
2.4.3.3

Guidance for classification

2.4.3.3.1 Judgment of “Not Applicable”
In classification of a chemical substance, regarding “flammable aerosols”,“classification result” shall be “Not Applicable”, and “not an aerosol
product” shall be indicated for “Classification Grounds and Problems”
2.4.3.3.2 Judgment of “Not Classified”
A product which has no flammable components or whose flammablecomponents is 1% or less and whose heat of combustion smaller than
20kJ/g shall be “Not Classified”.
Page 23

2.4.3.3.3 Judgment of “Classified”
When the existing classification results shown in 2.4.3.2.3 are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.3.4

Data availability
The composition of an aerosol product shall be determined by its productmanufacturer. The categories of spray solutions and propellant gases
should be determined according to the 2.3.4.1 of theGHS Purple book withnecessary test, if any.

2.4.3.5

Comparison with conventional classification systems
A judging method in the Special provision 63 of the UN Number 1950
(Aerosols) in UNRTDG 3.2.1 Dangerous Goods List has been adopted to
the GHS decision logic.

2.4.3.6 Hazard communication
General and specific considerations concerning labeling requirements are provided
in Hazard communication: Labelling (Chapter 1.4) of the UN Purple Book. Annex 2
contains summary tables about classification and labeling. Annex 3 contains
examples of precautionary statements and pictograms which can be used where
allowed by the competent authority.
Table 2.4.3.1 Label elements for flammable and non-flammable aerosols
SymbolSignal word
Hazard statement

Category 1
FlameDangerExtremely flammableaerosolPressurized container;
May burst if heatedCategory 2
FlameWarning

Category 3
No symbol
Warning

Flammable aerosol
Pressurized container:
May burst if heatedPressurized
container: May
burst if heatedPage 24

SECTION 2.4.4
OXIDIZING GASES
2.4.4.1 Definitions
2.4.4.1.1 An oxidizing gas is any gas which may, generally by providing oxygen,cause or contribute to the combustion of other material more than the air does.
2.4.4.1.2 Note : “Gases which cause or contribute to the combustion of other material
more than air does” means pure gases or gas mixtures with an oxidizing power
greater than 23.5% as determined by a method specified in ISO 10156:2010.
2.4.4.2 Classification criteria
2.4.4.2.1 An oxidizing gas shall be classified in a single category for this classaccording to the following table:
Table 2.4.4.1 Criteria for oxidizing gases
Category
1

2.4.4.3

Criteria
Any gas which may, generally by providing oxygen, cause orcontribute to the combustion of other materials more than air does

Guidance for classification

2.4.4.3.1 Judgment of “Not Applicable”
A product which does not meet the GHS definition of gases shall be
judged as “Not Applicable”
2.4.4.3.2 Classification based on existing classifications such as UNRTDG
The substance to be evaluated that is listed as a dangerous good (a gas
product whose division number of for its subsidiary hazard is 5.1) in theDangerous Goods List based on UNRTDG classification shall belong to“Category 1”.
The following gases described in ISO 10156-2 shall also belong to“Category 1”.
Name of gas
Bis-trifluoromethylperoxide
Bromine pentafluoride
Bromine trifluoride

Oxygen equivalency coefficient (Ci)C i = 40
C i = 40
C i = 40

Page 25

Chlorine
Chlorine pentafluoride
Chlorine trifluoride
Fluorine
Iodine pentafluoride
Nitric oxide
Nitrogen dioxide
Nitrogen trifluoride
Nitrogen trioxide
Oxygen difluoride
Ozone
Tetrafluorohydrazine

C i = 0.7
C i = 40
C i = 40
C i = 40
C i = 40
C i = 0.3
Ci=1
C i = 1.6
C i = 40
C i = 40
C i = 40
C i = 40

For reference: ISO 10156-2, describing an international test method on“oxidizing gases” was established in August 2005. Because this test requires
an immense amount of time and effort and involves risk of explosion, themeasurement results for coefficient of oxygen equivalency have beenobtained only for a few substances before the establishment of the ISO.
2.4.4.3.3 Judgment of “Not Classified”
Other (non-oxidizing) gases than described above shall be judged as “Not
Classified”.
2.4.4.3.4 Judgment of “Classified”
When the existing classification results shown in Table 8.4.4.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.4.4 Data availability
Calculation shall be performed in accordance with ISO 10156: 2010 based on
the composition as prescribed in GHS 2.4.4.2 4th edition of the UN Purple
Book.
2.4.4.5 Comparison with conventional classification systems
The UNRTDG definition (UNRTDG 2.5.2) for oxidizing substances (Division
5.1) is limited to liquids and solids. In UNRTDG, no classification criteria are
available for oxidizing gases, while some gases assigned with the division
number 5.1 for their subsidiary hazard, but the assignment is notcomprehensive. Oxidizing gases fall under Schedule 122 in ERG and S-W in
EmS on the basis of which oxidizing gases can be selected.

Page 26

2.4.4.6 Hazard communication
General and specific considerations concerning labeling requirements are provided
in Hazard communication: Labelling (Chapter 1.4) of the UN Purple Book. Annex 2
contains summary tables about classification and labeling. Annex 3 contains
examples of precautionary statements and pictograms which can be used where
allowed by the competent authority.
Table 2.4.4.2 Label elements for oxidizing gases
SymbolSignal word
Hazard statement

Category 1
Flame over circle
DangerMay cause or intensify fire; oxidizer

Page 27

SECTION 2.4.5
GASES UNDER PRESSURE
2.4.5.1 Definitions
2.4.5.1.1 Gases under pressure are gases which are contained in a receptacle at apressure of 200 kPa (gauge) or more at 20°C, or which are liquefied or liquefied andrefrigerated.
2.4.5.1.2 Gases under pressure comprise compressed gases, liquefied gases, dissolved
gases and refrigerated liquefied gases.
2.4.5.2 Classification criteria
2.4.5.2.1 Gases under pressure shall be classified, according to their physical state
when packaged, in one of four groups in the following table:
Table 2.4.5.1 Criteria for gases under pressureGroup
Compressed gas

Liquefied gas

Refrigerated liquefied gas
Dissolved gas

Criteria
A gas which when packaged under pressure is entirely
gaseous at -50°C; including all gases with a criticaltemperature < -50°C
A gas which when packaged under pressure, is partiallyliquid at temperatures above -50°C. A distinction is madebetween:(a) High pressure liquefied gas: a gas with a criticaltemperature between -50°C and +65°C; and(b) Low pressure liquefied gas: a gas with a criticaltemperature above +65°C
A gas which when packaged is made partially liquidbecause of its low temperature
A gas which when packaged under pressure is dissolved ina liquid phase solvent

The critical temperature is the temperature above which a pure gas cannot beliquefied, regardless of the degree compression.
2.4.5.3

Guidance for classification

2.4.5.3.1 Judgment of “Not Applicable”
Substances that are liquid or solid according to the GHS definition shall be
judged ad “Not Applicable”.

Page 28

2.4.5.3.2 Classification based on data from prescribed literatures
In GHS classes of gas, “gases under pressure” are conditions made in thepressure vessels by manufacturers depending on their purposes such astransport and use. And other properties (flammable gases, oxidizing
gases, acute inhalation toxicity) are based on hazards when these gases
exist in air at a standard pressure.
2.4.5.3.3 Judgment of “Classified”
When the existing classification results shown in Table 5.4.5.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.5.4 Data availability
The data required are vapor pressure at 50°C physical properties at 20°C
and atmospheric pressure, and critical temperature (GHS 2.5.4.2). All ofthem can be obtained easily. Physical conditions, pressure and the like,when compresses in cylinders, depend on the design of manufacturers.
In order to classify a gas, the above data are needed. Data can be found inliterature, calculated or determined by testing. Most pure gases are alreadyclassified in the UN Recommendations on the Transport of Dangerous
Goods, Model Regulations.
2.4.5.5 Comparison with conventional classification systems
The definition of Class 2 (gas) set in UNRTDG 2.2.1.2 is in accordance withthat of gas in GHS: “a substance that at 50°C has a vapor pressure greaterthan 300 kPa (absolute pressue); or is completely gaseous at 20°C at astandard pressure of 101.3 kPa”.
On the other hand, UNRTDG does not provide the definition of “gases
under pressure”, which are newly defined by GHS as “gases with vapor
pressure of 200 kPa or more”.
2.4.5.6

Sources of information for classification results under conventional
systems
These depend on the design selected by the manufactuers. Inaddition totemperature range and intrinsic pressure of the gas substance set by the
manufactuers, literature data such as temperature, vapor pressure curveand critical temperature should be used for classification.

Page 29

2.4.5.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labelling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms which
can be used where allowed by the competent authority.
Table 2.4.5.2 Label elements for gases under pressure

SymbolSignal word
Hazardstatement

Compressed gas

Liquefied gas

Gas cylinder
Warning
Contains gas
under pressure;
may explode if
heatedGas cylinder
Warning
Contains gas
under pressure;
may explode if
heatedRefrigeratedliquefied gas
Gas cylinder
Warning
Contains
refrigerated gas;
may cause
cryogenic burns
or injury

Dissolved gas
Gas cylinder
Warning
Contains gas
under pressure;
may explode if
heatedPage 30

SECTION 2.4.6
FLAMMABLE LIQUIDS
2.4.6.1 Definitions
2.4.6.1.1 A flammable liquid means a liquid having a flash point of not more than
93°C.
2.4.6.2 Classification criteria
2.4.6.2.1 A flammable liquid shall be classified in one of the four categories for thisclass according to the following table:
Table 2.4.6.1 Criteria for flammable liquids
Category
1
23

Criteria
Flash point <23°C and initial boiling point <35°C
Flash point <23°C and initial boiling point >35°C
Flash point > 23°C and < 60°C

Note 1: Gas oils, diesel and light heating oils in the flash point range of 55°C
to 75°C may be regarded as a special group for some regulatory
purposes.
Note 2: Liquids with a flash point of more than 35°C and not more than 60°C
may be regarded as non-flammable liquids for some regulatory
purposes (e.g. transport) if negative results have been obtained in thesustained combustibility test L.2 of Part III, section 32 of the UN
Recommendations on the Transport of Dangerous, Manual of Tests
and Criteria.
Note 3: Viscous flammable liquids such as paints, enamels, lacquers,
varnishes, adhesives and polishes may be regarded as a special groupfor some regulatory purposes (e.g. transport)> The classification or thedecision to consider these liquids as non-flammable may be
determined by the pertinent regulation or competent authority.
Note 4: Aerosols should not be classified as flammable liquids. See Section
2.4.3

Page 312.4.6.3 Guidance for classification
2.4.6.3.1 Judgment of “Not Applicable”
Substances that are gases and solids shall be judged as “Not Applicable”.
2.4.6.3.2 Judgment of “Not Classified”
Non-combustible liquids shall be judged as “Not Classified”. (Dangerous
goods among Class 4, Type 4 petroleum and animal oils, and liquids ofspecified combustible substances shall also be deemed as “Not Classified”
with regard to these classes, but the boundary between combustibility andflame resistance is not clearly defined. Accordingly, if judgment is
impossible, measure the flash point, and determine the classification.
2.4.6.3.3 Classification based on data from existing literatures
With regards to GHS classification of flammable liquids, categories based on
flash points obtained from various information sources and in-house data
shall take precedence, and classification based on UNRTDG shall be
adopted only when flash points data are not available.
Since Category 4 of flammable liquids in GHS classification does not fallunder Dangerous Goods in UNRTDG classification, as for Category 4,
UNRTDG classification results cannot be used for GHS classification.
2.4.6.3.4 Judgment of “Classified”
When the existing classification results shown in Table 2.4.6.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.6.4 Comparison with conventional classification systems
In general, Categories 1-3 is in accordance with Class 3 of UNRTDG.
Category 1 = UNRTDG 3I (No upper limits are provided for flash points,
but no combustible substance with an initial boiling point of
35°C and lower and a flash point of 23°C or higher has beenreported)Category 2 = UNRTDG 3II
Category 3 = UNRTDG 3III
Page 32

Category 4 = They are non-dangerous articles in UNRTDG
2.4.6.5 Test Methods
2.4.6.5.1 The following test methods for determining the flash point of flammableliquids shall be used:
International standards:
ISO 1516
ISO 1523
ISO 2719
ISO 13736
ISO 3679
ISO 3680
National standards:
American Society for Testing Materials International, 100Barr Harbor Drive,
PO Box C 700, West Conshohocken, Pennsylvannia, USA 19428-2959:
ASTM D3828-07a, “Standard Test Methods for Flash Point by Small Scale
Closed Cup tester”
ASTM D56-05, “Standard Test Method for Flash Point by Tag Closed Cup
Tester”
ASTM D3278-96 (2004)el, “Standard Test Methods for Flash Point of Liquids
by Small Scale Closed Cup Apparatus”
ASTM D93-08, “Standard Test Methods for Flash Point by Pensky- Martens
Closed Cup Tester”
Association francaise de normalization, AFNOR, 11, rue de Pressense. 93571
La Plaine Saint-Denis Cedex”
French Standard NF M 07-109
French Standards NF M 07-011/ NF T 30-050/ NF T 66-009
French Standard NF M 07-036
Deutsches Institut fur Normung, Burggrafenstr. 6, D-10787 Berlin:Standard DIN 51755 (flash points below 65°C)
State Committee of the Council of Ministers for Standardization, 113813,
GSP, Moscow, M-49 Leninsky Prospect, 9GOST 12.1.044-84
Page 33

2.4.6.5.2 The following methods for determining the initial boiling point offlammable liquids shall be used:
International standards:
ISO 3924
ISO 4626
ISO 3405
National standards
American Society for Testing Materials International, 100Barr Harbor Drive,
PO Box C 700, West Conshohocken, Pennsylvannia, USA 19428-2959:
ASTM D86-07a, “Standard Test Method for Distillation of Petroleum
Products at Atmospheric Pressure”
ASTM D1078-05, “Standard Test Method for Distillation Range of Volatile
Organic Liquids”
Further acceptable methods:
Method A.2 as described in Part A of the Annex to Commission Regulation(EC) No.440/2008
2.4.6.5 Sources of information for classification results under conventional
systems
2.4.6.5.1 UN Recommendations on the Transport of Dangerous Goods
Category 1 = UNRTDG 3I
Category 2 = UNRTDG 3II
Category 3 = UNRTDG 3III
Category 4
2.4.6.6 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labelling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms which
can be used where allowed by the competent authority.

Page 34

Table 2.4.6.2 Label elements for flammable liquids
SymbolSignal word
Hazardstatement

Category 1
FlameDangerExtremely
flammable liquidand vapour

Category 2
FlameDangerCategory 3
FlameWarning

Highly flammableliquid and vapour

Flammable liquidand vapour

Page 35

SECTION 2.4.7
FLAMMABLE SOLIDS
2.4.7.1 Definitions
2.4.7.1.1 A flammable solid is a solid which is readily combustible, or may cause orcontribute to fire through friction.
2.4.7.1.2 Readily combustible solids are powdered, granular, or pasty substances
which are dangerous if they can be easily ignited by brief contact with anignition source, such as a burning match, and if the flame spreads rapidly.
2.4.7.2 Classification criteria
2.4.7.2.1 Powdered, granular or pasty substances shall be classified as readily
combustible solids when the time of burning of one or more of the test
runs, performed in accordance with the test method described in the UN
Recommendations on the Transport of Dangerous Goods, Manual of Tests
and Criteria, Part III, sub-section 33.2.1, is less than 45 s or the rate ofburning is more than 2.2 mm/s.
2.4.7.2.2 Powders of metals or metal alloys shall be classified as flammable solids
when they can be ignited and the reaction spreads over the whole length of
the sample in 10 min or less.
2.4.7.2.3 Solids which may cause fire through friction shall be classified in this classby analogy with existing entries (e.g. matches) until definitive criteria areestablished.
2.4.7.2.4 A flammable solid shall be classified in one of the two categories for thisclass using Method N.1 as described in Part III, sub-section 33.2.1 of the UN
Recommendations on the Transport of Dangerous Goods, Manual of Tests
and Criteria, according to the following table:
Table 2.4.7.1 Criteria for flammable solids
Category

Criteria
Burning rate test:

1

2

Substances other than metal powders:(a) Wetted zone does not stop fire; and(b) Burning time <45 s or burning rate > 2.2 mm/s
Metal powders: burning time < 5 min
Burning rate test:

Page 36

Substances other than metal powders:(a) Wetted zone stops the fire for at least 4 min; and(b) Burning time <45 s or burning rate> 2.2 mm/s
Metal powders: burning time > 5 min and < 10 min

Note 1: For classification test on solid substances, the tests should be performed on
the substance as presented. If for example, forthe purposes of supply ortransport, the same chemical is to be presented in a physical form different
from that which was tested and which is considered likely to materiallyalter its performance in a classification test, the substance must also be
tested in the new form.
Note 2: Aerosols shall not be classified as flammable solids. See Section 2.4.8
2.4.7.3 Guidance for classification
2.4.7.3.1 Judgment of “Not Applicable”
Substances that are gases and liquids shall be judged as “Not Applicable”
2.4.7.3.2 Judgment of “Not Classified”
Solids known to be non-combustible or flame-resistant by literatures and inhouse data, or knowledge regarding oxidation/ reduction reactions, shall be“Not Classified”.
2.4.7.3.3 Classification based on existing classifications and the like such as UNRTDG
If the name of the substance is included in UNRTDG classification, thesubstance may be classified according to UNRTDG; however, it shall be
categorized after good examination since hazards of solid articles depend on
their shapes and particle sizes.
If in doubt, perform the pre-determined test on the article, and categorize.
2.4.7.3.4 Judgment of “Classified”
When the existing classification results shown in Table 2.4.7.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.

Page 37

2.4.7.4 Data availability
Few result values of the rate of burning tests have been published.
2.4.7.5 Comparison with conventional classification systems
2.4.7.5.1 Flammable solid is in accordance with Class 4.1 of UNRTDG.
2.4.7.5.2 Category 4.1 also included 2.4.9 “Self-Reactive Substances” and 2.4.1
Explosives. Therefore, ERG shall also be considered.
Related ERG Schedules are as follows:
133 Flammable Solid
133 Flammable Solid – toxic/ corrosive
170 Metal (powder, dust, shavings, drilling chips, lathe chips, swarf,
etc.)
2.4.7.5.3 In EmS, “Flammable Solid” is included in Schedule S-G along with “Selreactive Substances”.
2.4.7.5.4 These classification are also applied to the solids of R11 in EU DSD
classification
2.4.7.6 Sources on information for classification results under conventional
systems
2.4.7.6.1 UN Recommendations on the Transport of Dangerous Goods
Category 1 = UNRTDG 4.1 II ERG 133, 134, 170
Category 2 = UNRTDG 4.1 III ERG 133, 134, 170
2.4.7.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labelling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms which
can be used where allowed by the competent authority.
Table 2.4.7.2 Label elements for flammable solids
SymbolSignal word
Hazard statement

Category 1
FlameDangerFlammable solid

Category 2
FlameWarning
Flammable solid

Page 38

SECTION 2.4.8
SELF-REACTIVE SUBSTANCES
2.4.8.1 Definitions
2.4.8.1.1 Self-reactive substances are thermally unstable liquid or solid substances or
mixtures liable to undergo a strongly exothermic decomposition even
without participation of oxygen (air). This definition excludes substancesclassified under the GHS as explosives, organic peroxides or as oxidizing.
2.4.8.1.2 A self-reactive substance is regarded as possessing explosive properties
when in laboratory testing the formulation is liable to detonate, todeflagrate rapidly or to show a violent effect when heated underconfinement.
2.4.8.2 Classification criteria
2.4.8.2.1 Any self-reactive substance shall be considered for classification in this classunless:(a) They are explosives, according to the GHS criteria of Chapter 2.1;(b) They are oxidizing liquids or solids, according to the criteria ofChapters 2.13 or 2.14, except that mixtures of oxidizing substances
which contain 5% or more of combustible organic substances shall beclassified as self-reactive substances according to the procedure definedin the note below;(c) They are organic peroxides, according to the GHS criteria of Chapter
2.15;(d) Their heat of combustion is less than 300 J/g; or(e) Their self-accelerating decomposition temperature (SADT) is greaterthan 75°C for 50 kg package.
Note: Mixtures of oxidizing substances, meeting the criteria for classification
as oxidizing substances, which contain 5.0% or more of combustibleorganic substances and which do not meet the criteria mentioned in (a),(c), (d) or (e) above, shall be subjected to the self-reactive substancesclassification procedure;
Such a mixture showing the properties of a self-reactive substance type
B to F shall be classified as a self-reactive substance.
Page 392.4.8.2.2 Self-reactive substances are classified in one of the seven categories of“types A to G” for this class, according to the following principles:(a) Any self-reactive substance which can detonate or deflagrate rapidly, as
packaged, will be defined as self-reactive substance TYPE A.
(b) Any self-reactive substance possessing explosive properties and which,as packaged, neither detonates nor deflagrates rapidly, but is liable toundergo a thermal explosion in that package will be defined as selfreactive substance TYPE B.
(c) Any self-reactive substance possessing explosive properties when thesubstance as packaged cannot detonate or deflagrate rapidly or undergo
a thermal explosion will be defined as self-reactive substance TYPE C.
(d) Any self-reactive substance which in laboratory testing:a. Detonates partially, does not deflagrate rapidly and shows noviolent effect when heated under confinement; orb. Does not detonate at all, deflagrates slowly and shows no violent
effect when heated under confinement; orc. Does not detonate or deflagrate at all and shows a medium effectwhen heated under confinement;
shall be defined as self-reactive substance TYPE D.
(e) Any self-reactive substance which, in laboratory testing, neither
detonates nor deflagrates at all and shows low or no effect when heatedunder confinement will e defined as self-reactive TYPE E.
(f) Any self-reactive substance which, in laboratory testing, neither
detonates in the cavitated state nor deflagrates at all and shows only a
low or no effect when heated under confinement as well as low or no
explosive power will be defined as self-reactive substance TYPE F.
(g) Any self-reactive substance which, in laboratory testing, neither
detonates in the cavitated state nor deflagrates at all and shows no effectwhen heated under confinement nor any explosive power, provided
that it is thermally stable (self-accelerating decomposition temperature
is 60°C to 75°C for a 5o kg package), and, for liquid mixtures, a diluents
having a boiling point greater than or equal to 150°C is used fordesensitization will be defined as self-reactive substance TYPE G. If the
mixture is not thermally stable or a diluent having a boiling point lessPage 40than 150°C is used for desensitization, the mixture shall be defined as
self-reactive substance TYPE F.
Note 1: Type G has no hazard communication elements assigned but should
be considered for properties belonging to other hazard classes.
Note 2: Types A to G may not be necessary for all systems.
2.4.8.3 Criteria for temperature control
Self-reactive substances need to be subjected to temperature control if theirself-accelerating decomposition temperature (SADT) is less than or equal to55C. Test methods for determining the SADT as well as the derivation ofcontrol and emergency temperatures are given in the UN Recommendations
for the Transport of Dangerous Goods, Manual of Tests and Criteria, Part II,
section 28. The test selected shall be conducted in a manner which isrepresentative, both in size and material, of the package.
2.4.8.4 Guidance for classification
2.4.8.4.1 Judgment of “Not Applicable”
Gas, explosives, organic peroxides, and liquids and solid classified asoxidizing substances shall be “Not Applicable”.
Substances not containing chemical groups concerned with explosive
properties or self-reactivity shall not be “Not Applicable”.
2.4.8.4.2 Judgment of “Not Classified”
Regarding the substances containing chemical groups related to explosive
properties or self-reactivity, if data on SADT or exothermic decomposition
are obtained from various information sources and in-house data and theguidance in the UN GHS 4th revised edition is applicable to the substances,
fill in “Classification result” with “Not Classified”, and fill in “Classification
Grounds and Problems” with “SADT” ** °C (** is filled with a specificvalue).
2.4.8.4.3 Judgment of “Classified”
When the existing classification results shown in 2.4.8.2.1 and 2.4.8.2.2 areavailable, after examination of the classification result and the evidencedata, the Category shall be determined.

Page 41

2.4.8.4.4 Classification based on existing classifications (such as UNRTDG)
If the name of a substance is included in UNRTDG classification, thesubstance shall be classified according to it.
2.4.8.5 Data availability
Few measurement data related to the flow chart of UN GHS 4threvised edition
2.8.4 have been published. Mostly, self-reactive substances are traded andused as prepared chemicals in which diluents and/ or stabilizing agents areadded to them, rather than as pure substance. Classification into TYPE A to G
should be made based on a test for individual prepared chemicals.
2.4.8.6 Comparison with conventional classification systems
2.4.8.6.1 The flow chart of UN GHS 4threvised edition 2.8.4 is exactly the same as thatof UNRDTG.
2.4.8.6.2 In EmS, self-reactive substances not requiring temperature control areclassified into Schedule S-G along with Flammable Solid, and thoserequiring are classified into Schedule S-K.
2.4.8.7 Sources of information for classification results under conventional
systems
2.4.8.7.1 UN Recommendations on the Transport of Dangerous Goods
Chemicals belonging to UNRTDG 4.1 ERG 149, 150 in UNRTDG andNorth- American Emergency Response Guidebook (NAERG) fall under
this class.
The temperaturenecessity (150)
LiquidType A
Type B
Type CType D
Type E
Type F
Type G

Solid

Temperature management
is unnecessary (149)
LiquidTransportation prohibition substanceUN 32213222
3231
UN 32233224
3233
UN 3225
3226
3235
UN 3227
3228
3237
UN 32293230
3239
Non-dangerous articles

Solid

3232
3234
3236
3238
3240

Page 42

2.4.8.8 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labelling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms which
can be used where allowed by the competent authority.
Table 2.4.8.1 Label elements for self-reactive substancesType A
SymbolSignal word
Hazardstatement

Explodingbomb
DangerHeating
may causean explosion

Type B
Explodingbomb andflame
DangerHeating
may cause
an a fire andexplosion

Type C andDType E and
F

Flame

Flame

DangerWarningHeating
may causea fireHeating
may causea fireType Ga
There areno labelelements
allocated tothis hazard
categoryaType

G has no hazard communication elements assigned but should beconsidered for properties belonging to other hazard classes.

Page 43

SECTION 2.4.9
PYROPHORIC LIQUIDS
2.4.9.1 Definitions
2.4.9.1.1 A pyrophoric liquid is a liquid which, even in small quantities, is liable toignite within five minutes after coming into contact with air.
2.4.9.2 Classification criteria
2.4.9.2.1 A pyrophoric liquid shall classified in a single category for this class using
test N.3 in Part III, sub-section 33.3.1.5 of the UN Recommendations on theTransport of Dangerous Goods, Manual of Tests and Criteria, according to
the following table:
Table 2.4.9.1 Criteria for pyrophoric liquids
Category
1

Criteria
The liquid ignites within 5 min when added to an inert carrier
and exposed to air, or it ignites or chars a filter paper on contact
with air within 5 min.

2.4.9.3 Guidance for classification
2.4.9.3.1 Judgment of “Not Applicable”
Substances that are gases and solids shall be judged as “Not Applicable”.
2.4.9.3.2 Judgment of “Not Classified”
If it is confirmed based on various information sources and handlingexperiences that a substance to be assessed does not self-ignite on contact
with air of ambient temperature, fill in “Classification result” with “Notclassified”, and fill in “Classification Grounds” with “Do not self-ignite incontact with air of ambient temperature”.
2.4.9.3.3 Judgment of “Classified”
When the existing classification results shown in Table 2.4.9.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.

Page 442.4.9.3.4 Classification based on existing classification such as UNRTDG
When the name of a substance is included in UNRTDG classification, even if
the article is considered not to self-ignite, the pre-determined tests shall be
performed for the article and confirmed. When the UNRTDG classification is
not conducted, judge based on handling experience. If it is confirmed that thesubstance does not self-ignite on contact with air of ambient temperature, thesubstance shall be classified as “Not Classified”.
2.4.9.4 Data availability
Data are described in reliable literatures and Safety Data Sheet (SDS).
2.4.9.5 Comparison with conventional classification systems
2.4.9.5.1 The definition of Pyrophoric Liquids in UN GHS fourth revised edition is
identical with that of UNRTDG 2.4.3.2.2. In addition, as stated in 2.4.3.3.1,
the Packing Group for it is defined as “I”.
2.4.9.5.2 In EmS, Pyrophoric Liquids, along with Solid described in 2-4-10, areclassified into Schedule S-M (Pyrophoric Hazards) or S-L (Pyrophoric
substances and water-reactive substances).
2.4.9.5.3 In ERG, they are included in Schedule 135 and 136 (Pyrophoric substances),but are not distinguished from Self-heating Substances and Mixturesdescribed in 2-4-11.
2.4.9.6 Sources of information for classification results under conventional
systems
2.4.9.6.1 UN Recommendations on the Transport of Dangerous Goods
It is judged that Class 1 is identical with UNRTDG 4.2.1 (Liquids). These
substances may also have the property of “Substances and Mixtures which,in contact with water, emit flammable gses Z” mentioned in 2.4.12.
2.4.9.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labelling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms which
can be used where allowed by the competent authority.

Page 45

Table 2.5.9.2 Label elements for pyrophoric liquids
SymbolSignal word
Hazard statement

Category 1
FlameDangerCatches fire spontaneously if exposed to air

Page 46

SECTION 2.4.10
PYROPHORIC SOLIDS
2.4.10.1 Definitions
2.4.10.1.1 A pyrophoric solid is a solid which, even in small quantities, is liable toignite within five minutes after comning into contact with air.
2.4.10.2 Classification criteria
2.4.10.2.1 A pyrophoric solid shall be classified in a single category for this classusing test N.2 in Part III, sub-section 33.3.1.4 of the UN Recommendations
on the Transport of Dangerous Goods, Manual of Tests and Criteria
according to the following table:
Table 2.4.10.1 Criteria for pyrophoric solids
Category
1

Criteria
The solid ignites within 5 min of coming into contact with air.

Note: For classification tests on solid substances, the tests should be
performed on the substance as presented. If for example, for the
purposes of supply or transport, the same chemical is to be presented
in a physical form different from that which was tested and which isconsidered likely to materially alter its performance in a classification
test, the substance must also be tested in the new form.
2.4.10.3 Guidance for classification
2.4.10.3.1 Judgment of “Not Applicable”
Substances that are gases and liquids shall be judged as “Not Applicable”.
2.4.10.3.2 Judgment of “Not Classified”
If it is confirmed based on various information sources and handlingexperiences that a substance to be assessed does not self-ignite on contact
with air of ambient temperature, fill in “Classification result” with “Notclassified”, and fill in “Classification Grounds” with “Do not self-ignite incontact with air of ambient temperature”.

Page 47

2.4.10.3.3 Judgment of “Classified”
When the existing classification results shown in Table 2.4.10.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.10.3.4 Classification based on existing classification such as UNRTDG
When the name of a substance is included in UNRTDG classification, even if
the article is considered not to self-ignite, the pre-determined tests shall be
performed for the article and confirmed. When the UNRTDG classification is
not conducted, judge based on handling experience. If it is confirmed that thesubstance does not self-ignite on contact with air of ambient temperature, thesubstance shall be classified as “Not Classified”.
2.4.10.4 Data availability
Data are described in reliable literatures and Material Safety Data Sheet(MSDS).
2.4.10.5 Comparison with conventional classification systems
2.4.10.5.1 The definition of Pyrophoric Solids in UN GHS fourth revised edition is
identical with that of UNRTDG 2.4.3.2.1. In addition, as stated in 2.4.3.3.1,
the Packing Group for it is defined as “I”.
2.4.9.5.2 In EmS, Pyrophoric Solids, along with Liquids described in 2-4-9, areclassified into Schedule S-M (Pyrophoric Hazards) or S-L (Pyrophoric
substances and water-reactive substances).
2.4.9.5.3 In ERG, they are included in Schedule 135 and 136 (Pyrophoric substances),but are not distinguished from Self-heating Substances and Mixturesdescribed in 2-4-11.
2.4.10.6 Sources of information for classification results under conventional
systems
2.4.10.6.1 UN Recommendations on the Transport of Dangerous Goods
It is judged that Class 1 identical with UNRTDG 4.2.1 (Solid). These
substances may also have the property of “Substances and mixtures which,in contact with water, emit flammable gases” mentioned in 2.4.12.

Page 48

2.4.10.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labelling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms which
can be used where allowed by the competent authority.
Table 2.4.10.2 Label elements for pyrophoric solids
SymbolSignal word
Hazard statement

Category 1
FlameDangerCatches fire spontaneously if exposed to air

Page 49

SECTION 2.4.11
SELF-HEATING SUBSTANCES
2.4.11.1 Definition
2.4.11.1.1 A self-heating substance is a solid o liquid substance, other than apyrophoric liquid or solid, which, by reaction with air and without
energy supply, is liable to self-heat; this substance differs from apyrophoric liquid or solid in that it will ignite only when in large
amounts (kilograms) and after long periods of time (hours or days).
Note: Self-heating of a substance is a process where the gradual reactionof that substance with oxygen (in air) generated heat. If the rate ofheat production exceeds the rate of heat loss, then the temperatureof the substance will rise which, after an induction time, may leadto self-ignition and combustion.
2.4.11.2 Classification criteria
2.4.11.2.1 A substance shall be classified as a self-heating substance of this class, if in
tests performed in accordance with the test method given in the UN
Recommendations on the Transport of Dangerous Goods, Manual of Tests
and Criteria, Part III, sub-section 33.3.1.6.
(a) A positive result is obtained using a 25 mm cube sample at 140 °C;(b) A positive result is obtained in a test using a 100 mm sample cube a
140°C and a negative result is obtained in a test using a 100 mm cube
sample at 120°C and the substance is to be packed in packages with avolume of more than 3 m3;(c) A positive result is obtained in a test using a 100 mm sample cube at
140°C and a negative result is obtained in a test using a 100 mm cube
sample at 100°C and the substance is to be packed in packages with avolume of more than 450 liters;(d) A positive result is obtained in a test using a 100 mm cube sample at
100°C

2.4.11.2.2A self-heating substance shall be classified in one of the twocategories for this class if, in test performed in accordance with thetest method N.4 in Part III, sub-section 33.3.1.6 of the UN
Recommendations on the Transport of Dangerous Goods, Manual
Page 50

of Tests and Criteria, the result meets the criteria shown in Table
2.11.1 of the GHS Purple Book.
Table 2.4.11.1 Criteria for self-heating substances
Category
1

2

Criteria
A positive result is obtained in a test using a 25 mm sample
cube at 140C(a) A positive result is obtained in a test using a 100 mm
sample cube a 140°C and a negative result is obtained ina test using a 100 mm cube sample at 120°C and thesubstance is to be packed in packages with a volume ofmore than 3 m3;(b) A positive result is obtained in a test using a 100 mm
sample cube at 140°C and a negative result is obtained ina test using a 100 mm cube sample at 100°C and thesubstance is to be packed in packages with a volume ofmore than 450 liters;(c) A positive result is obtained in a test using a 100 mm
cube sample at 100°C

Note 1: For classification tests on solid substances, the tests should be
performed on the substance as presented. If for example, for the
purposes of supply or transport, the same chemical is to bepresented in a physical form different from that which was tested
and which is considered likely to materially alter its performance ina classification test, the substance must also be tested in the newform.
Note 2: The criteria are based on the self-ignition temperature of charcoal,
which is 50°C for a sample cube of 27 m3. Substances with atemperature of spontaneous combustion higher than 50°C for a
volume of 27 m3 should not be assigned to this hazard class.
Substances with a self-ignition temperature higher than 50°C for a
volume of 450 liters should not be assigned to hazard Category 1 ofthis hazard class.
2.4.11.3 Guidance for classification
2.4.11.3.1 Judgment of “Not Applicable”
1.) Substances that are gases shall be judged “Not Applicable”.
2.) Pyrophoric liquids and solids shall be judged as “Not Applicable”.
Page 51

2.4.11.3.2 Judgment of “Not Classified”
Non-flammable liquids and solids shall be judged as “Not Classified”.
2.4.11.3.3 Classification based on existing classifications such as UNRTDG
When the name of the substance is included in the UNRTDG classification,
it is preferable to test the article. When the UNRTDG classification is notconducted, judge whether or not to perform the tests with referencing the
judging results of combustibility and the like.
2.4.11.3.4 Classification based on information on various literatures
If the data of screening test described in the UN GHS 4threvised edition
2.11.4.2 are obtained for a substance from prescribed review documents,
and the data show that it is not a self-heating substance, it shall beclassified as “Not Classified”, and “Classification Grounds and Problems”
shall be filled in with the result of the test.
2.4.11.3.4.1 Screening Test
2.4.11.3.4.1.1 The Grewer Oven Test (VDI Guideline 2263, part I, 1990, Test
Methods for the Determination of the Safety Characteristics
of Dusts) with an onset temperature 80K above the reference
temperature for a volume of 1L;
2.4.11.3.4.1.2 The Bulk Powder Screening Test (Gibson, N. Harper, D.J.
Rogers, R. Evaluation of the fire and explosion risks indrying powders, Plant Operations Progress, 4 (3), 181-189,
1985) with an onset temperature 60K above the reference
temperature for a volume o 1L
2.4.11.3.5 Judgment of “Classified”
When the existing classification results shown in Table 2.4.11.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.11.4 Data availability
Few data for each substance have been published.
2.4.11.5 Comparison with conventional systems
5.4.11.5.1 In classification 4.2 described in UNRTDG 2.4.3.2.3, the definition of Selfheating substances is in accordance with the criteria of GHS 2.11.2.
Page 52

Packing Group II corresponds to GHS Classification 1, and Packing GroupIII corresponds to Classification2. Classification 4.2 also includes
Pyrophoric Solids (2.4.3.2.1) and Pyrophoric Liquids (2.4.3.2.2).
2.4.11.5.2 In ERG, self-heating substances are included in Schedule 135 and 136 (Selfheating Substances).
2.4.11.5.3 In EmS, they are included in Schedule S-J (wetted explosives and selfheating substances).
2.4.11.6 Sources of information for classification results under conventional
systems
2.4.11.6.1 UN Recommendations on the Transport of Dangerous Goods
Substances classified into UNRTDG 4.2 EmS : S-J fall under this class.
2.4.11.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labelling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms which
can be used where allowed by the competent authority.

Table 2.4.11.2 Label elements for self-heating substances
SymbolSignal word
Hazard statement

Category 1
FlameDanger
Self-heating; may catchfireCategory 2
FlameWarning
Self-heating in large
quantities; may catch fire

Page 53

SECTION 2.4.12
SUBSTANCES AND MIXTURES WHICH, IN CONTACT
WITH WATER, EMIT FLAMMABLE GASES
2.4.12.1 Definitions
2.4.12.1.1 Substances or mixtures which, in contact with water, emit flammable gases
are solid or liquids substances which, by interaction with water, are liable
to become spontaneously flammable or to give off flammable gases indangerous quantities.
2.4.12.2 Classification criteria
2.4.12.2.1 A substance or mixture which, in contact with water, emit flammable gases
shall be classified in one of the three categories for this class, using test
N.5 in Part III, sub-section 33.4.1.4 of the UN Recommendations on theTransport of Dangerous Goods, Manual of Tests and Criteria, according
to the following table:
Table 2.4.12.1 Criteria for substances which, in contact with water,
emit flammable gases
Category

1

23

Criteria
Any substance or mixture which reacts vigorously with water atambient temperatures and demonstrates generally a tendency forthe gas produced to ignite spontaneously, or which reacts readily
with water at ambient temperatures such that the rate of evolutionof flammable gas is equal to or greater than 10 liters per kilogram ofsubstance over any one minute.
Any substance or mixture which reacts readily with water atambient temperatures such that the maximum rate of evolution of
flammable gas is equal to or greater than 20 liters per kilogram ofsubstance per hour, and which does not meet the criteria for
Category 1.
Any substance or mixture which reacts slowly with water atambient temperatures such that the maximum rate of evolution of
flammable gas is equal to or greater than 1 liter per kilogram ofsubstance per hour, and which does not meet the criteria for
Categories 1 and 2.

Note 1: A substance or mixture is classified as a substance which, in contact
with water, emits flammable gases if spontaneous ignition takes
place in any step of the test procedure.

Page 54

Note 2: For classification tests on solid substances or mixtures, the test shouldbe performed on the substance as presented. If for example, for the
purposes of supply or transport, the same chemical is to be presented
in a physical form different from that which was tested and which isconsidered likely to materially alter its performance in a classification
test, the substance must also be tested in the new form.
2.4.12.3 Guidance for classification
2.4.12.3.1 Judgment of “Not Applicable”
2.4.12.3.1.1 Substances that are gases shall be judged as “Not Applicable”.
2.4.12.3.1.2 Substances not containing metals or metalloids in theirchemical structure shall be judged as “Not Applicable”.
2.4.12.3.2 Judgment of “Not Classified”
If it is judged based on various information sources and in-house data thata substance containing metals or metalloids is stable even if it is in contact
with water, fill in “Classification result” with “Not Classified”, and fill in“Classification Grounds” with “Stable to water” with reference to UN
GHS fourth revised edition 2.12.4.2 (b)(c).
2.4.12.3.3 Judgment of “Classified”
When the existing classification results shown in Table 2.4.12.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.12.3.4 Classification based on existing classifications and the like such as
UNRTDG
If the name of the substance is included in UNRTDG classification, thesubstance shall be classified according to it. As for substances whosecapability was discussed in the following discussion on GHS Water
Reactive Flammable Substances and Metalloids, perform test N.5 andcategorize depending on the result.
2.4.12.4 Data availability
Few numerical data on the rate of evolution of gas have been published.
2.4.12.5 Comparison with conventional systems

Page 55

2.4.12.5.1 Judgment criteria of GHS 2.12.2 completely in accordance with thedefinition of UNRTDG Classification 4.3.
Category 1 = UNRDTG 4.3 I
Category 2 = UNRTDG 4.3 II
Category 3 = UNRTDG 4.3 III
2.4.12.5.2 Substances classified into EU DSD Classification R15 meet GHS judgment
criteria, but they do not correspond to Category 1, 2 and 3.
Judgment criteria of EU classification are in accordance with those of
GHS, but further categorization is not given for the former.
2.4.12.5.3 In ERG, Schedules related to “Substances which, in contact with water,
emit flammable gases” of GHS are as follows:
135 : Pyrophoric substances
138 : Water-reactive substances – emitting flammable gas
138 : Water-reactive substances – emitting flammable / toxic gas
2.4.12.6 Sources of information for classification results under conventional
systems
2.4.12.6.1 UN Recommendations on the Transport of Dangerous Goods
Category 1 = UNRTDG 4.3 I
Category 2 = UNRTDG 4.3 II
Category 3 = UNRTDG 4.3 III
Substances classified into UNRTDG 4.2 (4.3) correspond to GHS Category1.
2.4.12.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.

Page 56

Table 2.4.12.2 Label elements for substances, which in contact with water,
emit flammable gases
SymbolSignal word

Hazard statement

Category 1
FlameDangerIn contact withwater releases
flammable gases
which may ignite
spontaneously

Category 2
FlameDangerCategory 3
FlameWarning

In contact withwater releases
flammable gases

In contact withwater releases
flammable gases

Page 57

SECTION 2.4.13
OXIDIZING LIQUIDS
2.4.13.1 Definition
2.4.13.1.1 An oxidizing liquid is a liquid which, while in itself not necessarily
combustible, may, generally by yielding oxygen, cause, or contribute to,the combustion of other material.
2.4.13.2 Classification criteria
2.4.13.2.1 An oxidizing liquid shall be classified in one of the three categories for thisclass using test O.2 in Part III, sub-section 34.4.2 of the UN
Recommendations on the Transport of Dangerous Goods, Manual ofTests and Criteria, according to the following table:
Table 2.4.13.1 Criteria for oxidizing liquids
Category

1

23

Criteria
Any substance or mixture which, in the 1:1 mixture, by mass, of
substance and cellulose tested, spontaneously ignites; or the meanpressure rise time of a 1:1 mixture, by mass, of substance andcellulose is less than that of a 1:1 mixture, by mass, of 50%
perchloric acid and cellulose;
Any substance or mixture which, in the 1:1 mixture, by mass, of
substance and cellulose tested, exhibits a mean pressure rise timeless than or equal to the mean pressure rise time of a 1:1 mixture,by mass, of 40% aqueous sodium chlorate solution and cellulose;
and the criteria for Category 1 are not met;
Any substance or mixture which, in the 1:1 mixture, by mass, of
substance and cellulose tested, exhibits a mean pressure rise timeless than or equal to the mean pressure rise time of a 1:1 mixtures,by mass, of 65% aqueous nitric acid and cellulose; and the criteria
for Categories 1 and 2 are met.

2.4.13.3 Guidance for classification
2.4.13.3.1 Judgment of “Not Applicable”
2.4.13.3.1.1 Substances of gases and solids shall be judged as “Not Applicable”.
2.4.13.3.1.2 Organic substances which do not contain oxygen, fluorine, or chlorine or
which containany of these elements that are bound to carbon orhydrogen only shall be judged “Not Applicable”.

Page 58

2.4.13.3.1.3 Inorganic substances not containing oxygen or a halogen element shall be
judged “Not Applicable”.
2.4.13.3.2 Judgment of “Not Classified
If it is confirmed that a substance based on review documents that asubstance to be assessed is a “reductive material”, fill in the“Classification result” with “Not Classified”, and fill in “Classification
Grounds” with “Reductive material”.
2.4.13.3.3 Classification based on existing classifications such as UNRTDG
If the name of the substance is included in the UNRTDG classification,
the substance shall be classified according to it. As for a substances
doubted as an oxidizing, if evident information for judging are notavailable, perform the pre-determined tests, and categorize
2.4.13.3.4 Judgment of “Classified”
When the existing classification results shown in Table 2.4.13.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.13.4 Data availability
Few experimental data on oxidative materials have been published.
2.4.13.5 Comparison with conventional classification system
2.4.13.5.1 The definition in GHS 2.13.2 is equivalent to that of UNRTDGClassification 5.1 “Liquids” (UNRTDG 2.5.2.3.2).
2.4.13.5.2 In ERG, oxidative materials (including solids) are classified into Schedules
140, 141, 142, 143 and 144, but it does not serve as a reference for this GHS
classification.
2.4.13.5.3 In EmS, oxidative materials (including solid) are classified into Schedule SQ.
2.4.13.6 Sources of information for classification results under conventional
systems
2.4.13.6.1 UN Recommendations on the Transport of Dangerous Goods
Category 1 = UNRTDG 5.1 I (Liquids)
Category 2 = UNRTDG 5.1 II (Liquids)
Page 59Category 3 = UNRTDG 5.1 III (Liquids)
2.4.13.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.4.13.2 Label elements for oxidizing liquids

SymbolSignal word
Hazardstatement

Category 1
Flame overcircleDangerMay cause fireor explosion;strong oxidizer

Category 2
Flame overcircleDangerCategory 3
Flame overcircleWarning

May intensify
fire; oxidizer

May intensify
fire; oxidizer

Page 60

SECTION 2.4.14
OXIDIZING SOLIDS
2.4.14.1 Definitions
2.4.14.1.1 An oxidizing solid is a solid which, while in itself is not necessarily
combustible, may, generally by yielding oxygen, cause, or contribute to,the combustion of other material.
2.4.14.2 Classification criteria
2.4.14.2.1 An oxidizing solid shall be classified in one of the three categories for thisclass using test O.1 in Part III, sub-section 34.4.1 of the UN
Recommendations on the Recommendations on the transport ofDangerous Goods, Manual of Tests and Criteria, according to thefollowing table:
Table 2.4.14.1 Criteria for oxidizing solids
Category
1

23

Criteria
Any substance or mixture which, in the 4:1 or 1:1 sample-tocellulose ratio (by mass) tested, exhibits a mean burning time lessthan the mean burning time of a 3:2 mixture, by mass, ofpotassium bromate and cellulose.
Any substance or mixture which, in the 4:1 or 1:1 sample-tocellulose ratio (by mass) tested, exhibits a mean burning timeequal to or less than the mean burning time of a 2:3 mixtures (bymass) of potassium bromated and cellulose and the criteria for
Category 1 are not met.
Any substance or mixture which, in the 4:1 or 1:1 sample-tocellulose ratio (by mass) tested, exhibits a mean burning timeequal to or less than the mean burning time of a 3:7 mixture (bymass) of potassium bromated and cellulose and the criteria for
Categories 1 and 2 are not met.

Note 1: Some oxidizing solids may also present explosion hazards undercertain conditions (e.g. when stored in large quantities). For
example, some types of ammonium nitrate may give rise to an
explosion hazard under extreme conditions and the “Resistance todetonate test” (BC Code1, Annex 3, Test 5) may be used to assess
this hazard. Appropriate comments should be made in the Safety
Data Sheet.
1 Code of Safe Practice for Solid Bulk Cargoes, IMO, 2005

Page 61

Note 2: For classification tests on solid substances, the tests should be
performed on the substance as presented. If for example, for the
purposes of supply or transport, the same chemical is to bepresented in a physical form different from that which was tested
and which is considered likely to materially alter its performancein a classification test, the substance must also be tested in the
new form.
2.4.14.3 Guidance for classification
2.4.14.3.1 Judgment of “Not Applicable”
2.4.14.3.1.1 Gases and liquid substances shall be judged as “NotApplicable”.
2.4.14.3.1.2 Organic substances which do not contain oxygen, fluorine, or
chlorine or which contain any of these elements that arebound to carbon or hydrogen only shall be judged “NotApplicable”.
2.4.14.3.1.3 Inorganic substances not containing oxygen or any halogen
element shall be judged “Not Applicable”.
2.4.14.3.2 Classification based on existing classifications such as UNRTDG
If the name of a substance is included in UNRTDG classification, thesubstance shall be classified according to it. As for substances being
doubted to be oxidizing, if evident information for judging is notavailable, perform the predetermined tests, and categorize.
2.4.14.3.3 Judgment of “Classified”
When the existing classification results shown in Table 2.4.14.1are available,
after examination of the classification result and the evidence data, theCategory shall be determined.
2.4.14.4 Data availability
Few experimental data on oxidative materials have been published.
2.4.14.5 Comparison with conventional classification systems
2.4.14.5.1 The classification criteria of GHS 2.14.2 are equivalent to the definition of
UNRTDG Classification 5.1 “Solid” (UNRTDG 2.5.2.2.2).

Page 622.4.14.5.2 In ERG, oxidative materials (including liquids) are classified into Schedules
140, 141, 142, 143 and 144, but it does not serve as a reference for this GHS
classification.
2.4.14.5.3 In EmS, oxidative materials (including Liquids) are classified into Schedule
S-Q.
2.4.14.6 Sources of information for classification results under conventional
systems
2.4.14.6.1 UN Recommendations on the Transport of Dangerous Goods
Category 1 = UNRTDG 5.1 I (Solid)
Category 2 = UNRTDG 5.1 II (Solid)
Category 3 = UNRTDG 5.1 III (Solid)
2.4.14.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.14.2 Label elements for oxidizing solids

SymbolSignal word
Hazardstatement

Category 1
Flame overcircleDangerMay cause fireor explosion;strong oxidizer

Category 2
Flame overcircleDangerCategory 3
Flame overcircleWarning

May intensify
fire; oxidizer

May intensify
fire; oxidizer

Page 63

SECTION 2.4.15
ORGANIC PEROXIDES
2.4.15.1 Definition
2.4.15.1.1 Organic peroxides are liquid or solid organic substances which contain thebivalent –O-O- structure and may be considered derivatives of hydrogen
peroxide, where one or both of the hydrogen atoms have been replaced byorganic radicals. The term also includes organic peroxide formulations(mixtures).
2.4.15.1.2 Organic peroxides are thermally unstable substances, which may undergo
exothermic self-accelerating decomposition. In addition, they may be one
or more of the following properties:(a) be liable to explosive decomposition;(b) burn rapidly;(c) be sensitive to impact or friction;(d) react dangerously with other substances.
2.4.15.1.3 An organic peroxide is regarded as possessing explosive properties whenin laboratory testing the formulation is liable to detonate, to deflagrate
rapidly or to show a violent effect when heated under confinement.
2.4.15.2 Classification criteria
2.4.15.2.1 Any organic peroxide shall be considered for classification in this class,unless it contains:(a) not more than 1.0% available oxygen from the organic peroxides whencontaining not more than 1.0% hydrogen peroxide; or(b) not more than 0.5% available oxygen from the organic peroxides whencontaining more than 1.0% but not more than 7.0% hydrogen peroxide.
Note: The available oxygen content (%) of an organic peroxide mixture isgiven by the formula:

Page 64

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.
5.4.15.2.2 Organic peroxides are classified in one of the seven categories of “Types A
to G” for this class, according to the following principles:
1) Any organic peroxide which, as packaged, can detonate or deflagrate rapidly will
be defined as organic peroxide TYPE A;
2) Any organic peroxide possessing explosive properties and which, as packaged,neither detonates nor deflagrates rapidly, but is liable to undergo a thermal
explosion in that package will be defined as organic peroxide TYPE B;
3) Any organic peroxide possessing explosive properties when the substance as
packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion
will be defined as organic peroxide TYPE C;
4) Any organic peroxide which in laboratory testing:a) detonates partially, does not deflagrate rapidly and shows no violent effectwhen heated under confinement; orb) does not detonate at all, deflagrates slowly and shows no violent effect whenheated under confinement; orc) does not detonate or deflagrate at all and shows a medium effect when heatedunder confinement
will be defined as organic peroxide TYPE D;
5) Any organic peroxide which, in laboratory testing, neither detonates nor
deflagrates at all and shows low or no effect when heated under confinement will
be defined as organic peroxide TYPE E;
6) Any organic peroxide which, in laboratory testing, neither detonates in thecavitated state nor deflagrates at all and shows only a low or no effect when
Page 65

heated under confinement as well as low or no explosive power will be definedas organic peroxide TYPE F;
7) Any organic peroxide which, in laboratory testing, neither detonates in thecavitated state nor deflagrates at all and shows no effect when heated underconfinement nor any explosive power, provided that it is thermally stable (selfaccelerating decomposition temperature is 60◦C or higher for a 50 kg package),
and, for liquid mixtures, a diluents having a boiling point of not less than 150◦C
is used for desensitization, will be defined as organic peroxide TYPE G. If theorganic peroxide is not thermally stable or a diluent having a boiling point lessthan 150◦C is used for desensitization, it shall be defined as organic peroxide
TYPE F.
Note 1: Type G has no hazard communication elements assigned but should
be considered for properties belonging to other hazard classes.
Note 2: Type A to G may not be necessary for all systems.
2.4.15.3 Criteria for temperature control
The following organic peroxides need to be subjected to temperature
control:(a) Organic peroxide types B and C with an SADT <50◦C;(b) Organic peroxide type D showing a medium effect when heated underconfinement with an SADT < 50◦C or showing a low or no effect whenheated under confinement with an SADT < 45◦C; and(c) Organic peroxide types E and F with an SADT < 45◦C.
Tests methods for determining the SADT as well as the derivation of control
and emergency temperatures are given in the UN Recommendations on theTransport of Dangerous Goods, Manual of Tests and Criteria, Part II, section
28. The test selected shall be conducted in a manner which is representative,
both in size and material, of the package.
2.4.15.4 Guidance for classification
2.4.15.4.1 Judgment of “Not Applicable”
Inorganic substances and organic substances except Organic Peroxides
shall be judged “Not Applicable”.

Page 66

2.4.15.4.2 Judgment of “Not Classified”
If the hydrogen peroxide content and the amount of available oxygen in
an Organic Peroxide fall below the values stipulated in UN GHS fourth
revised edition 2.15.2.1, fill in “Classification Result” with “Not
Classified”, and in “Classification Ground” with “Active oxygen amountfails to satisfy the definition”.
2.4.15.4.3 Classification based on existing classification such as UNRTDG
If the name of a substance is included in UNRTDG classification (forexample, it is listed in the table of TMDGC 2.5.3.2.4), the substance shall beclassified according to the UN number.
2.4.15.4.4 Judgment of “Classified”
When the existing classification results shown in 2.4.15.2.1 and 2.4.15.2.2 areavailable, after examination of the classification result and the evidencedata, the Category shall be determined.
2.4.15.5 Data availability
Few data of measurement experiments related to the flowchart of GHS
2.15.4 have been published.
2.4.15.6 Sources of information for classification results under conventional
systems
2.4.15.6.1 UN Recommendations on the Transport of Dangerous Goods
Chemicals which belong to UNRTDG 5.2 ERG 147, 148 in UNRTDG andNorth- American Emergency Response Guidebook (NAERG) fall under
this class.
The temperaturenecessity (147)
LiquidType A
Type B
Type CType D
Type E
Type F
Type G

Solid

Temperature management
is unnecessary (148)LiquidTransportation prohibition substanceUN 3101
3102
3111
UN 3103
3104
3113
UN 3105
3106
3115
UN 31073108
3117
UN 31093110
3119
Non-dangerous articles

Solid

3112
3114
3116
3118
3120
Page 672.4.15.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.4.15.2 Label elements for organic peroxides
Type A
SymbolSignal word
Hazardstatement

Explodingbomb
DangerHeating
may causeanexplosion

Type B
Explodingbomb andflame
DangerHeating
may cause afire and
explosion

Type C andDType E and
F

Flame

Flame

DangerWarningHeatingHeating
may cause a may cause a
fire
fire

Type Ga
There areno labelelements
allocated tothis hazard
category

Type G has no hazard communication elements assigned but should beconsidered for properties belonging to other hazard classes.
aPage 68

SECTION 2.4.16
CORROSIVE METALS
2.4.16.1 Definition
2.4.16.1.1 A substance or a mixture which is corrosive to metals is a substance whichby chemical reaction will materially damage, or even destroy metals.
2.4.16.2 Classification criteria
2.4.16.2.1 A substance or a mixture which is corrosive to metals shall be classified ina single category for this class, using the test in Part III, sub-section 37.4 of
the UN Recommendations on the Transport of Dangerous Goods, Manualof Tests and Criteria, according to the following table:
Table 2.4.16.1 Criteria for substances corrosive to metal
Category
1

Criteria
Corrosion rate on either steel or aluminum surfaces exceeding
6.25 mm per year at a test temperature of 55◦C when tested on
both materials.

Note: Where an initial test on either steel or aluminum indicates thesubstance being tested is corrosive the follow-up test on the other metal is
not required.
2.4.16.3 Guidance for classification
2.4.16.3.1 Judgment of “Not Classified”
Regarding “Corrosive to Metals”, if it is confirmed based on various
information sources and in-house data that both steel and aluminum canbe used as a container for the substance, fill in “Classification result” with“Not Classified”, and fill in “Classification Grounds” with “Steel andaluminum can be used as a container”.
2.4.16.3.2 Judgment for substances that cannot be classified
2.4.16.3.2.1 In case the test method is not establishedThe test method for “Corrosive to Metals” defined in UNRTDG
classification and adopted in GHS classification cannot be applied togases. It cannot be applied to liquids with a boiling point of 55◦C or
lower, either. In case of solid, it cannot be applied to those with a melting
point of 55◦C or lower.
Page 69

Hence, indicate as follows:In case of gases, fill in “Classification result” with “Classification notpossible” regarding “corrosive to metals”, and fill in “classification
grounds” with “No established test method suitable for Gas
substances”.
In the case of liquids with a boiling point of 55◦C or lower, fill in“classification result” with “Classification not possible” regarding“Corrosive to Metals”, and fill in “Classification Grounds” with “Noestablished test method suitable for low-temperature boiling Liquids”.
In the case of solid with a melting point of higher than 55C, fill in“Classification result” with “Classification not Possible” regarding“Corrosive to Metals”, and fill in “Classification Grounds” with “Noestablished test method suitable for Solid substances”.
2.4.16.3.4 Judgment of “Classification not Possible”
For hazard items that cannot be classified by the above procedure, fill in“Classification result” with “Classification not Possible”, and fill in“Classification grounds” with “No data”.
2.4.16.3.5 Judgment of “Classified”
When the existing classification results shown in Table 2.4.16.1areavailable, after examination of the classification result and the evidencedata, the Category shall be determined.
2.4.16.4 Data availability
Few numerical data on metal corrosion rate have been published.
2.4.16.5 Comparison with conventional classification systems
The definition completely in accordance with that of the Class 8 III “Metal
corrosive properties” described in UNRTDG 2.8.2.5 (c) (ii).
2.4.16.6 Sources of information for classification results under conventional
systems

Page 70

2.4.16.6.1 UN Recommendations on the Transport of Dangerous Goods
Since metal corrosive properties is classified into UNRTDG Class 8 alongwith the skin corrosive properties, whether a substance has metal
corrosive properties or cannot be judged from the fact that the substance isclassified in Class 8. Metal corrosive properties thus cannot be attributed
to a substance based on “Dangerous Goods Regulations Annex 1” alone.
Therefore, a substance that clearly has metal corrosive properties shall beclassified into this class.
2.4.16.7 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.4.16.1.2 Label elements for substances corrosive to metals
Category
SymbolSignal word
Hazard statement

Criteria
Corrosion
Warning
May be corrosive to metals

Page 71

SECTION 2.5
HEALTH HAZARDS
2.5 HEALTH HAZARDSThis section defines and explains the 10 hazard classes based on GHS healthhazards.
2.5.1 Information useful for classification
2.5.1.1 Substance shall be classified according to the GHS Classification Criteria,
obtaining the required data from the information sources specified in the firstpart of this Guidance Manual.
2.5.1.2 When an in-house data or existing data from literature on the health hazards
for the chemical substance are available, use the data to classify.
2.5.1.3 When there are several and conflicting existing data available, the company
should verify the reliability of the data based on the following:
2.5.1.3.1Data verified by credible agencies, such as those derived from thematerials specified in “Priority 1”.
2.5.1.3.2 Data that are deemed reliable, such as those obtained by Good
Laboratory Practice (GLP)-conforming laboratories or those whose
scientific basis is available and verified.
2.5.1.3.3 Data obtained from other information sources, such as thosederived from the materials specified in “Priority 2” and “Priority
3”.
2.5.1.3.4 Latest data (where conflicting data of the same priority areavailable) or data derived from reliable publications.
2.5.1.3.5 Finally, conservative data shall be adopted, excluding measurement
values that are considered abnormal when compared with otherrelevant data. When classification results based on conflicting data
belong to several hazard categories, that supported by the largest
amount of data shall be adopted.
2.5.1.4 In some cases, where there are no data available, classification may be carriedout by utilizing the existing classifications derived from Safety Data Sheets(SDSs) as reference.
5.5.1.4.1 Preferably, check the evidence data for such as EU Classification(EU CLP classification).
Page 72

SECTION 2.5.2.1
ACUTE TOXICITY
2.5.2.1.1 Definition
Acute toxicity refers to those adverse effects occurring following oral ordermal administration of a single dose of a substance, or multiple doses given within
24 hours, or an inhalation exposure of 4 hours.
2.5.2.1.2 Classification criteria
2.5.2.1.2.1 Substances shall be allocated to one of the five toxicity categories based onacute toxicity by the oral, dermal or inhalation route according to the numeric cut-off
criteria as shown in the table below. Acute toxicity values shall be expressed as(approximate) LD50 (oral, dermal) or LC50 (inhalation) values. Explanatory notes areshown following the Table 5.5.2.1.1.
Table 2.5.2.1.1 Acute toxicity hazard categories values defining therespective categories

Oral (mg/kg bodyweight)
See notes (a) and (b)Dermal (mg/kg
bodyweight)
See notes (a) and (b)Gases (ppmV)
See notes (a), (b) and (c)Vapors (mg/L)
See notes (a), (b), (c), (d)and (e)Dusts and Mists (mg/L)
See notes (a), (b), (c) and(f)

Category 1

Category 2

Category 3

Category 4

5

50

300

2000

50

200

1000

2000

100

500

2500

5000

0.5

2.0

10

20

0.05

0.5

1.0

5

Note : Gases concentration are expressed in parts per million per volume (ppmV).
Notes to Table 5.5.2.1.1(a) The acute toxicity estimate (ATE) for the classification of a substances isderived using the LD50/LC50 where available;(b) The acute toxicity estimate (ATE) for a substance in a mixture is derived
using:
Page 73

a. the LD50/LC50where available; otherwise,b. the appropriate conversion value from Table 5.5.2.1.2 that relates to theresults of a range test; orc. the appropriate conversion value from Table 5.5.2.1.2 that relates to aclassification category;(c) Inhalation cut-off values in the table are based on 4 hour testing exposures.
Conversion of existing inhalation toxicity data which has been generated
according to 1 hour exposures should be by dividing by a factor of 2 for gases
and vapors and 4 for dusts and mists;(d) It is recognized that saturated vapor concentration may be used as anadditional element by some regulatory systems to provide for specific healthand safety protection (e.g. UN Recommendations on the Transport ofDangerous Goods);(e) For some substances the test atmosphere will not just be a vapor but willconsist of a mixture of liquid and vapor phases. For other substances the test
atmosphere may consist of a vapor which is near the gaseous phase. In theselatter cases, classification should be based on ppmV as follows: Category 1(100 ppmV), Category 2 (500 ppmV), Category 3 (2500 ppmV), Category 4(20000 ppmV).
The terms “dust”, “mist” and “vapor” are defined as follows:(i) Dust: solid particles of a substance suspended in a gas (usually air);(ii)

Mist: liquid droplets of a substance suspended in a gas (usually air);(iii) Vapor: the gaseous form of a substance released from its liquid or solid
state
Dust is generally formed by mechanical processes. Mist is generally formed bycondensation of supersaturated vapors or by physical shearing of liquids.
Dusts and mists generally have sizes ranging from less than 1 to about 100 µm;(f) The values for dusts and mists should be reviewed to adapt to any futurechanges to OECD Test Guidelines with respect to technical limitation in
generating maintaining and measuring dust and mist concentrations in
respirable form;
2.5.2.1.3 Data availability
Page 74

2.5.2.1.3.1 Classification shall be performed based on the toxicity values reported in
information available for classification.
2.5.2.1.3.2 If the same Acute Toxicity value is found, check the original document toavoid overlapping of the same data. This is especially true, since theinformation from literature sources are often cited the same during
reviews.
2.5.2.1.3.3 The following Test Methods are included in the OECD Test Guidelines
relating to Acute Toxicity.
OECD TG 420
OECD TG 423
OECD TG 425
OECD TG 402
OECD TG 403

Acute oral toxicity – Fixed dose procedure
Acute oral toxicity – Acute toxic class method
Acute oral toxicity – Up and down procedure
Acute dermal toxicity
Acute inhalation toxicity

2.5.2.1.3.4 EU CLP classification criteria are in accordance with the UN GHS.
2.5.2.1.3.5 R-Phrase 20, R-Phrase 21, R-Phrase 22, R-Phrase 23, R-Phrase 24, R-Phrase
25, R-Phrase 26 R-Phrase 28 (hereinafter abbreviated as R20 and so on)
regarding Acute toxicity of EU DSD (Dangerous Substances Directive)classification may be used as reference.
2.5.2.1.4 Comparison with conventional classification systems
2.5.2.1.4.1 EU DSD classification shall be referred to as a rough guide but is not inaccordance with UN GHS completely.
2.5.2.1.4.2 In EU CLP Regulations Annex VII, conversion to the acute toxicity of UN
GHS classification is made using the R-phrases and symbol mark of EU
DSD classification as shown in the following table:
Category

1

GHS
Oral
(mg/kg)

EU CLP Classification
EU DSD classification
GHS

Dermal(mg/kg)

EU CLP Classification
EU DSD classification
GHS

Gases
(ppmV)
Vapors

EU CLP Classification
EU DSD classification
GHS

2

4
2000
H300
H300
H301
H302
T+ ; R28
T ; R25
Xn ; R22
R28
25 R25 200 R22
2000
50
200
1000
2000
H310
H310
H311
H312
T+ ; R27
T ; R24
Xn ; R22
R27 50 R24
400 R21
2000
100
500
2500
20000
H330
H330
H331
H332
T+ ; R26
T ; R23
Xn ; R20
Not defined
0.5
2
10
20
5

3

50

300

Page 75

(mg/l)EU CLP Classification
EU DSD classification
GHS

Dust / mist
(mg/l)EU CLP Classification
EU DSD classification

H330
T+ ; R26
R26 0.5
0.05
H330
R26

H330
T ; R23
R23
2
0.5
H330
T+ ; R26
0.25 R23

H331

H332
Xn ; R20
R20
20
1
5
H331
H332
T ; R23
Xn; R20
1 R20
5Note : Oral and Dermal are LD50 values while Vapors and Dusts and Mists are
LC50 values. Gases are not defined in the present EU DSD classification.
2.5.2.1.4.3 UNRTDG Class 6.1 is not sub-categorized by exposure route.
2.5.2.1.5 Guidance concerning data
2.5.2.1.5.1 Units vary depending on the shape of the inhaled substance for inhalation
toxicity.
2.5.2.1.5.2 Classification shall be performed on the basis of the values for gases(ppmV) if the test atmosphere consists of a gaseous phase including
vapor that is substantially a gaseous phase, values for vapors (mg/L) if
the test atmosphere consists of a liquid with a relatively low boiling point,
and values for mists (mg/L) for other cases.
Conversion of ppmV and mg/L units (at 25◦C and atmospheric pressure)(ppmV) = {(mg/L) x 24.45 x 103} / molecular weight(mg/L) = {(ppmV) x molecular weight x 103} / 24.45
2.5.2.1.6 Guidance for classification and judgment
2.5.2.1.6.1 When multiple data exists for Acute Toxicity given the high reliability of
data, and when they fall under multiple categories, basis for the selection
and judgment of data for the determination of category will be
determined according to Section 5.5.1.3.
However, when the substance falls under multiple categories under theorder of precedence, the category under which the greatest number ofdata fall is adopted.
Furthermore, if the numbers of data for the categories thus singled out
are the same, the category with the higher degree of hazard is adopted.
2.5.2.1.6.2 Consideration in assessing the Acute Toxicity LC50 in inhalation route

Page 762.5.2.1.6.2.1 Values for inhalation toxicity should be based on a 4-hour animal test.
2.5.2.1.6.2.2When multiple data exists for Acute Inhalation Toxicity given the highreliability of data, and when they fall under multiple categories, basis forthe selection and judgment of data for the determination of category will
be determined according to Section 5.5.1.3.
2.5.2.1.6.2.3 However, if those data have the same reliability, data are adopted basedon the following criteria, converted to the 4-hour values, and calculated.
(c) Use 4-hour data, and evaluate(d) If the data satisfying the conditions in (a) are not available, use 1-hour
data, converted to 4-hour values and evaluate.
(e) If the data satisfying the conditions in (a) and (b) are not available,
use data from 30 minutes to 24 hours, converted to 4-hour values andevaluate(f) If the data classifying the conditions in (a), (b) and (c) are notavailable, the substance is classified as “Classification not possible”.
However, a substance which shows lethal effect by exposure of 4hours or less (including less than 30 minutes) with the concentrationof the criterion value or below for Category 1 is classified as Category
1 (inhalation).
Method for converting LC50 value B for A hours into LC50 estimate value
D for C hours:
Gas / vapor :D = B √ A/C

Dust / mist :D = BA/ C

When performing GHS classification, enter 4 (hours) for C
2.5.2.1.6.2.4 In some cases, it is not clear whether the adopted data is from the vapor
inhalation test or mist inhalation test. In these cases, the substance shallbe determined as “Classification not possible” unless the obvious
conclusion can be given based on physical properties such as vapor
pressure.

2.5.2.1.7 Notes for handling of animal species difference
Page 77

Figure 2.5.2.1.7 Handling of animal species difference
Is route dermal?

Is route oral or byinhalation?

Yes

Determinedbased on the
rat or rabbit
data. If bothareavailable,
calculate foreach species,
and adopt
one with thesmallervalue.

Yes

Are rat data available?
Yes

Determinedbased on the
rat data

No
Are rodent (mouse,guinea pig) data
available?

No
Determined as“Classification notpossible”*1

Yes

Determinedbased on the
rat data. If
data ofmultiplekinds ofspecies areavailable,
adopt onewith thesmallest
value.

Are rat or rabbit data
available?

YesNo
Are rodent (mouse,guinea pig) data
available?

Yes

Determinedbased on therodent data.
If data ofmultiplekinds ofspecies areavailable,
adopt onewith thesmallest
value.

No
Determined as“Classification notpossible”*2*1 Data for animals other than rodents are not adopted for classification*2 Data for animals other than rodents and rabbits are not adopted for classification
2.5.2.1.8 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.

Table 2.5.2.1 Label elements for acute toxicity
SymbolSignal word
HazardCategory 1
Skull andcrossbones
DangerFatal if

Category 2
Skull andcrossbones
DangerFatal if

Category 3
Skull andcrossbones
DangerToxic if

Category 4
Exclamation
mark
Warning
Harmful if

Page 78

statement:
Oral
Hazardstatement:
DermalHazardstatement:
Inhalation
See Note

swallowed

swallowed

swallowed

swallowed

Fatal in contact
with skin

Fatal in contact
with skin

Toxic incontact withskin

Harmful incontact withskin

Fatal if inhaled

Fatal if inhaled

Toxic if inhaled

Harmful if
inhaledNote: If a substance is also determined to be corrosive (based on data such as
skin or eye data), corrosivity hazard may also be communicated by someauthorities as symbol and/ or hazard statement. That is, in addition to an
appropriate acute toxicity symbol, a corrosivity symbol (used for skin and eye
corrosivity) may be added along with the corrosivity hazard statement suchas “corrosive” or “corrosive to the respiratory tract”.

Page 79

SECTION 2.5.2.2
SKIN CORROSION/ IRRITATION
2.5.2.2.1 Definition
2.5.2.2.1.1 Skin corrosion is the production of irreversible damage to the skin;namely, visible necrosis through, the epidermis and into the dermis,
following the application of a test substance for up to 4 hours. Corrosive
reactions are typified by ulcers, bleeding, bloody scabs, and, by the end ofobservation at 14 days, by discoloration due to blanching of the skin,complete areas of alopecia, and scars. Hispathology shall be considered toevaluate questionable lesions.
2.5.2.2.1.2 Skin irritation is the production of reversible damage to the skin following
the application of a test substance for up to 4 hours.
2.5.2.2.2 Classification criteria
2.5.2.2.2.1 Corrosion
A single harmonized corrosion category is provided in Table 2.5.2.2.2.1,
using the results of animal testing. A corrosive is a test material that
produces destruction of skin tissue, namely, visible necrosis through theepidermis and into the dermis, in at least 1 of 3 tested animals after
exposure up to a 4 hour duration. Corrosive reactions are typified byulcers, bleeding, bloody scabs, and, by the end of observation at 14 days,by discoloration due to blanching of the skin, complete areas of alopecia,
and scars. Hispathology shall be considered to evaluate questionablelesions.
Table 2.5.2.2.2.1 Skin corrosion category and sub-categories
Category 1:
Corrosive(applies to
auhtorities notusing subcategories
Corrosive

Corrosive subcategories(only applies tosome authorities)

1A
1B
1C

Corrosive in > 1 of 3 animals
Exposure

Observation< 3 min>3 min ≤ 1 h> 1 h≤ 4 h<1h< 14 days< 14 days

Page 80

2.5.2.2.2.2 Irritation
A single irritant category is provided in Table 2.5.2.2.2.2 that:(a) is centrist in sensitivity among existing classifications;(b) recognizes that some test materials may lead to effects which persist
throughout the length of the test; and(c) acknowledges that animal responses in a test may be quite variable. An
additional mild irritant category is available for those authorities thatwant to have more than one skin irritant category.
Table 2.5.2.2.2.2 Skin irritation categories
Categories

Irritant(Category 2)

Criteria(1) mean value of > 2.3 < 4.0 for erythema / eschar or for oedema
in at least 2 of 3 tested animals from gradings at 24, 48 and 72
hours after patch removal or, if reactions are delayed, from
grades on 3 consecutive days after the onset of skin reactions;or(2) inflammation that persists to the end of the observation
period normally 14 days in at least 2 animals, particularly
taking into account alopecia (limited area), hyperkeratosis,
hyperplasia,
andscaling;or(3) in some cases where there is pronounced variability of
response among animals, with very definite positive effects
related to chemical exposure in a single animal but less thanthe criteria above.

2.5.2.2.3 Data availability
2.5.2.2.3.1 Few data books that contain Draize scores to which GHS criteria can beapplied.
2.5.2.2.3.2 OECD has proposed test method guideline (OECD TG) 435 (In vitro
membrane barrier test method) for the classification into skin corrosion
sub-categories (1A, 1B and 1C) since classification into sub-categories
under Category 1 may not be possible without detailed data on exposure
and observation time.
2.5.2.2.3.3 Finding of “Severe”, “Moderate”, “Mild (Slightly)” and others for skincorrosion/ irritation in test reports may be used as reference if irritation
score (avergaed score values) based on appropriate irritation data cannot
be easily obtained.
Page 812.5.2.2.3.4 R-Phrases (R34, R35, R38, R36/37, R36/38, R37/38, R36/37/38) in EU
DSD classification relating to skin corrosion/ irritation be used as
reference.
2.5.2.2.3.5 The following Test Methods are OECD Test Guidelines relating to skincorrosion/ irritation:
OECD TG 404
OECD RG 430
OECD TG 431
OECD TG 435

Acute dermal irritation/ corrosion
In vitro skin corrosion: Transcutaneous electricalresistance test
In vitro skin corrosion: Human skin model test
In vitro membrane barrier test method for skin corrosion

2.5.2.2.3.6 When multiple data exists for skin corrosion/ irritation given the highreliability of data, and when they fall under multiple categories, basis forthe selection and judgment of data for the determination of category will
be determined according to Section 5.5.1.3.
2.5.2.2.4 Comparison with conventional classification systems
2.5.2.2.4.1 Substances shall be classified as Corrosive (C) with R34, R35 in EU DSD
classification fall under Category 1.
2.5.2.2.4.2 Substances shall be classified as Irritant (Xi) with R38 and combination of
R-Phrases (R36/38, R37/38, R36/37/38) in EU DSD classification fallunder Category 2 (in GHS classification). But confirmation with detailed
data is required.
2.5.2.2.4.3 EU CLP classification H314 is in accordance with Category 1, H315 is inaccordance with Category 2.
2.5.2.2.4.4 Comparison between EU classification and GHS classification is asfollows:
Skin corrosion
EU DSD classification
EU CLP classification
GHS classification

C

R35

Category 1A

C R34
H314 (Note)
Category 1B

Category 1C

Skin irritation
EU DSD classification
EU CLP classification
GHS classification

Xi R38
H315
Category 2

Category 3

Page 82

Note: According to the criteria, H314 includes Category 1 B and 1C.
However, in EU CLP regulations Annex VII, H314 is stated as 1B.
2.5.2.2.4.5 Findings of test reports
The following correlation may also be used as reference guide:

Corrosive

SevereModerate

Mild (Slightly)

2

3

Irreversible
effects

GHS Category
Skin corrosion/ irritation

1( 1A, 1B, 1C)

2.5.2.2.4.6 Decision based on physicochemical properties
2.5.2.2.4.6.1 Substances considered as strong acids (pH > 2) or strong alkalis(pH<11.5) based on their physicochemical properties shall be classified as
Category 1.
2.5.2.2.5 Guidance for classification
2.5.2.2.5.1 Judgment by reliable existing revelation course such as accidental cases
When a substance has cases to be judged as corrosion (any sub-categories
1A, 1B and 1C, or Category 1) or irritation (Category 2) in human or
animal results, the substance shall be classified as such.
2.5.2.2.5.2 Judgment by existing test data
1.) Decision by in vivo test result
Corrosion (any sub-categories 1A, 1B and 1C or Category 1) in at least 1
of 3 animals after exposure for up to 4 hours:(a) necrosis into the dermis(b) ulcer, bleeding or bloody scabs in the applied area
Page 83(c) blanching of the skin, complete areas of alopecia and remaining scars
are found at the end of the observation period of 14 days(d) in the case of erythema/ eschar or oedema score of 4 more, thesubstance is determined as Corrosion (Category 1). When, however,no irreversible lesion is found, the substance is determined as
irritation (Category2).
Irritation (Category 2) at 24, 48 and 72 hours after application:(a) mean value of Draize Score (for each animal) is > 2.3 to < 4.0 for
erythema/ eschar or oedema in at least 2 of 3 tested animal,(b) inflammation and alopecia of limited area, hyperkeratosis,
hyperplasia and scaling persist to the end of 14 days after application
in at least 2 of 3 tested animal, or(c) definite positive effects are recognized in an animal, but its extent
does not satisfy criteria (a) and (b) above.
2.) Decision by comparison with existing classification(a) the substance shall be classified as Severe or Corrosive is determined
as Corrosive (Category 1) and the substance classified as Severe withno irreversible lesion observed is determined as Irritant (Category 2).
(b) the substance shall be classified as Moderate is determined as
Irritation (Category 2).
3.) Decision by symptom when no other information is available
When described as necrosis, the substance is determined as corrosive(Category 1).
4.) Decision by in vivo test
If the data of a test based on OECD TG 431 (human skin model,
Epiderm), OECD TG 430 (skin electric conductivity test) or OECD TG
435 is available, the substance is classified in accordance with thedecision criteria with which each of the test is internationallyaccepted.
2.5.2.2.6 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Page 84

Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.2.2 Label elements for skin corrosion/ irritation
1A
SymbolSignalword
Hazardstatement

Category 1
1B

Category 2
1C

Corrosion

Corrosion

Corrosion

Exclamation
mark

DangerDangerDangerWarning

Causessevere skinburns andeyedamageCausessevere skinburns andeyedamageCauses severe
skin burns andeye damage

Causes skinirritation

Page 85

SECTION 2.5.2.3
SERIOUS EYE DAMAGE/ EYE IRRITATION
2.5.2.3.1 Definition
2.5.2.3.1.1 Serious eye damage is the production of tissue damage in the eye, or
serious physical decay of vision, following application of a test substanceto the anterior surface of the eye, which is not fully reversible within 21
days of application.
2.5.2.3.1.2 Eye irritation is the production of changes in the eye following theapplication of test substance to the anterior surface of the eye, which are
fully reversible within 21 days of application.
2.5.2.3.2 Classification criteria
2.5.2.3.2.1 Irreversible effects on the eye/ serious damage to the eyes (Category 1)
A single harmonized hazard category shall be adopted for substances thathave the potential to serious damage the eyes. This hazard category –Category 1 includes the criteria listed below:
Table 2.5.2.3.2.1 Irreversible eye effects categories
An eye irritant Category 1 (irreversible effects on the eye) is a test material that
produces:(a) At least in one animal effects on the cornea, iris or conjunctiva that are
not expected to reverse or have not fully reversed within an observation
period of normally 21 days; and/or(b) At least in 2 of 3 tested animals, a positive response of:(i) corneal opacity > 3; and/or(ii) iritis > 1.5;
calculated as the mean scores following grading at 24, 48 and 72 hours
after installation of the test material.

Page 86

2.5.2.3.2.2 Reversible effects on the eye (Category 2)
A single harmonized category shall be adopted for substances that havethe potential to induce reversible eye irritation. This single hazard
category provides the option to identify within the category a subcategory for substances inducing eye irritant effects reversing within an
observation time of 7 days.
Table 2.5.2.3.2.2 Reversible eye effects categories
An eye irritant Category 2 (irritating to eyes) is a test material that produces:(a) At least in 2 of 3 tested animals, a positive response of:(i) corneal opacity >1; and/or(ii) iritis > 1; and/or(iii) conjunctival redness >; and/or(iv) conjunctival oedema (chemosis) > 2
calculated as the mean scores following grading at 24, 48 and 72 hours
after installation of the test material, and which fully reverses within an
observation period of normally 21 days.

2.5.2.3.3 Data availability
2.5.2.3.3.1 Few data books contain detailed Draize scores to which GHS classification
criteria shall be applied.
2.5.2.3.3.2 Tests by application to animal eyes of corrosive materials are not typicallyconducted. Thus, in cases where eye irritation test are not available, a skincorrosive material shall be classified as a substance causing serious eye
damage (Category 1).
2.5.2.3.3.3 Since data based on irritation score (mean score value) of appropriate
irritation data cannot be easily obtained, “Severe”, “Moderate”, “Mild(Slightly)” and others for eye damage/ eye irritation test report findings
shall be used as reference.
2.5.2.3.3.5 R-Phrases (R36, R41, R36/37, R36/38, R37/38, R36/37/38) in EU DSD
classification relating to serious eye damage/ eye irritation shall be used as
reference.

Page 87

2.5.2.3.3.6 The following Test Methods are OECD Test Guidelines relating to Serious
Eye Damage/ Eye Irritation:
OECD TG 405

Acute eye irritation/ corrosion

2.5.2.3.3.7 When multiple data exists for skin corrosion/ irritation given the highreliability of data, and when they fall under multiple categories, basis forthe selection and judgment of data for the determination of category
shall be determined according to Section 2.5.1.3.
2.5.2.3.4 Comparison with conventional classification systems
2.5.2.3.4.1 Substances classified as R41 in EU DSD classification fall under Category 1
2.5.2.3.4.2 Substances classified in R36 and combination of R-Phrases (R36/37,
R36/38, R36/37/38) in EU DSD classification fall under Category 2.
2.5.2.3.4.3 EU CLP classification H318 is in accordance with Category 1, and H319 isin accordance with Category 2.
2.5.2.3.4.4 Comparison between EU classification and GHS classification:
EU DSD classification
EU CLP classification
GHS classification

Xi R41
H318
Category 1

Xi R36
H319
Category 2ACategory 2B

2.5.2.3.4.5 Findings of test reports
The following correlation may also be used as reference guide:
Corrosive

SevereModerate

Mild (Slightly)

2A

2B

Irreversible
effects

GHS Category

1

Serious Eye Damage/Eye Irritation

Page 88

2.5.2.3.5 Guidance for classification
2.5.2.3.5.1 Judgment by reliable existing revelation course such as accidental cases
If there is a case that attributes to a substance irreversible effects on eye(Category 1) or reversible effects on eye (Category 2) in human or animal
results, the substance shall be classified as such.
2.5.2.4.5.2

Judgment by liable existing test data
(1) Decision by in vivo test (Draize test) result:a. Decision criteria for serious eye damage (irreversible effects)(Category 1):
At least in one animal effects on the cornea, iris or
conjunctiva that are not expected to reverse or have notfully reversed within an observation period of normally
21 daysAt least in 2 of 3 tested animals, the calculated meanscored following grading at 24, 48 and 72 hours after
installation of the test material are corneal opacity > 3
and/or iritis > 1.5.

b. Decision criteria for irritation (reversible effects) (Categories 2A,
2B or Category 2):In the Draize test conducted using 3 animals, thecalcluated mean values of the scores following grading at
24, 48 and 72 hours after installation of the test material
are corneal opacity > 1 and/or iritis > 1 and/or
conjunctival redness > 2 and/or conjunctival oedema > 2.



The effects are fully reversed within an observation
period of 21 days.

The substance is classified as mildly irritant to eyes
(Category 2B) when the above description applies to thesubstance and the effects reverse within an observation
period of 7 days.

Page 89

(2) Decision by existing classifications:(a) A substance which is classified as Severe or Corrosive is classified
in Category 1(b) A substance which is classified as Moderate is classified as
Category 2A.
(c) A substance which is classified as Mild (Slightly) is classified as
Category 2B.
(3) Decision by physicochemical properties
In the case of pH < 2 or pH > 11.5, the substance is classified in
Category 1.
(4) Decision by In vitro test methods
Accepted validated in vitro test methods for eye irritation are OECD
TG 437 and OECD TG 438.
2.5.2.3.6 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.2.3 Label elements for serious eye damage/ eye irritation
SymbolSignal word
Hazardstatement

Category 1
Corrosion
DangerCategory 2
Exclamation markWarning

Causes serious eye damage

Causes serious eye irritation

Page 90

SECTION 2.5.2.4
RESPIRATORY OR SKIN SENSITIZATION
2.5.2.4.1 Definition
2.5.2.4.1.1 A respiratory sensitizer is a substance that will lead to hypersensitivity of
the airways following inhalation of the substance.
2.5.2.4.1.2 A skin sensitizer is a substance that will lead to an allergic response
following skin contact.
2.5.2.4.2 Classification criteria
2.5.2.4.2.1 Respiratory sensitizers
Respiratory sensitizers shall be classified in Category 1:
Table 2.5.2.4.2.1 Hazard category for respiratory sensitizers
Category

Respiratory sensitizer
A substance shall be classified as a respiratory sensitizer:(a) If there is evidence in humans that the substance canlead to specific respiratory hypersensitivity and/or

1(b) If there are positive results from an appropriate
animal test

2.5.2.4.2.2 Skin sensitizers
Skin sensitizers shall be classified in Category 1:
Table 5.5.2.4.2.2 Hazard category for skin sensitizers
Category

1

Skin sensitizer
A substance shall be classified as a skin sensitizer:(a) If there is evidence in humans that the substance canlead to sensitization by skin contact in a substantial
number of persons, or(b) If there are positive results from an appropriate
animal test

Page 912.5.2.4.3 Data availability
2.5.2.4.3.1 Decision on classification is performed based on the weight of evidence forrespiratory or skin sensitization. Size of the populatin exposed and theextent of exposure shall be considered when looking into humanevidenced.
2.5.2.4.3.2 A single category is adopted for classification of respiratory and skinsensitization. Judgment of expert shall be taken into consideration.
2.5.2.4.3.3 If there are appropriate animal test data showing positive results,
classification for skin sensitization shall be based on these data.
2.5.2.4.3.4 The signal word used for skin sensitization Category 1 is “Warning”,
while the signal word for respiratory sensitization Category 1 is“Danger” since the latter is considered to produce more serious effects
on human health.
2.5.2.4.3.5 Some helpful information:-

Frosch et al. Contact Dermatitis 4th Ed. Springer (413 substances)-“Allergen List” Japanese Society for Contact Dermatitis (25 substances)

2.5.2.4.3.6 EU DSD classification: R42, R43, R42/43
2.5.2.4.3.7 Recommendation of Acceptable Concentration by the Japan Society for
Occupational Health: Respiratory tract sensitization and skin sensitization
2.5.2.4.3.8 TLV Table of ACGIH: SEN or Sensitization substances
2.5.2.4.3.9 MAK (Germany): Labeling of Sensitization Substance (Sa, Sh, Sah)2.5.2.4.3.10 OECD TG for respiratory or skin sensitization
OECD TG 406 Skin sensitization
OECD TG 429 Skin sensitization: Local Lymph Node Assay (LLNA)
2.5.2.4.3.11When multiple data exists for skin / respiratory sensitization given thehigh reliability of data, and when they fall under multiple categories,
basis for the selection and judgment of data for the determination of
category will be determined according to Section 8.5.1.3.

Page 92

2.5.2.4.4 Comparison with conventional classification systems
2.5.2.4.4.1 EU DSD classification categories related to sensitization are R42, R43 andR42/43.
2.5.2.4.4.2 The Recommendation of Acceptable Concentration of the Japan Society for
Occupational Health includes the list of substances recognized assensitizers.
2.5.2.4.4.3 In the TLV table of ACGIH, SEN Mark is assigned to sensitizers.
2.5.2.4.4.4 In the MAK table of MAK 9Germany), Sa, Sh, Sah marks are assigned.
2.5.2.4.4.5 EU DSD classification R42 and R42/43, as well as respiratory tract
sensitization in the Recommendation of Acceptable Concentration by theJapan Society for Occupational Health, correspond to respiratory
sensitization Category 1.
2.5.2.4.4.6 EU DSD classification R43 and R42/43, as well as skin sensitization in theJapan Society for Occupational Health, correspond to skin sensitization
Category 1
2.5.2.4.4.7 EU CLP classification H334 is in accordance with respiratory sensitization
Category 1, and H317 is in accordance with skin sensitization Category 1.
2.5.2.4.4.8 Whether SEN substances in ACGIH are respiratory sensitizers or skinsensitizers must be confirmed by reviewing the ACGIH documentations.
2.5.2.4.5 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.2.4.1 Label elements for respiratory or skin sensitization

SymbolSignal word
Hazard statement

Respiratory sensitization
Category 1
Health hazard
DangerMay cause allergy or asthma
symptoms or breathingdifficulties if inhaled

Skin sensitization
Category 1
Exclamation markWarning
May cause an allergic skinreaction

Page 93

SECTION 2.5.2.5
GERM CELL MUTAGENICITY
2.5.2.5.1 Definition
2.5.2.5.1.1 This hazard class is primarily concerned with chemicals that may cause
mutations in the germ cells of humans that can be transmitted to theprogeny. However, mutagenicity/ genotoxicity tests in vitro and in
mammalian somatic cells in vivo are also considered in classifying
substances within this hazard class.
2.5.2.5.1.2 In the present context, commonly found definitions of the terms
mutagenic, mutagen, mutations and genotoxic are sued. A mutation isdefined as a permanent change in the amount or structure of the genericmaterial in a cell.
2.5.2.5.1.3 The term mutation applies both to heritable genetic changes that may be
manifested at the phenotypic level and to the underlying DNA
modifications when known (including, for example, specific base pairchanges and chromosomal translocations). The term mutagenic andmutagen will be used for agents giving rise to an increased occurrence ofmutations in populations of cells and/or organisms.
2.5.2.5.1.4 Genotoxic and genotoxicity apply to agents or processes which alter the
structure, information content, or segregation of DNA, including thosewhich cause DNA damage by interfering with normal replication
processes, or which in a non-physiological manner (temporarily) alter its
replication. Genotoxicity test results are usually taken as indicators formutagenic effects.
2.5.2.5.2 Classification criteria
2.5.2.5.2.1Classification for heritable effects in human germ cells shall be made on thebasis of well conducted, sufficiently validated tests, preferably as
described in OECD Test Guidelines. Evaluation of the test results should
be done using expert judgment and all available evidence shall beweighed for classification.
2.5.2.5.2.1.1 Examples of in vivo heritable germ cell mutagenicity tests are:Rodent dominant lethal mutation test (OECD 478)
Mouse heritable translocation assay (OECD 485)
Mouse specific locus test
Page 942.5.2.5.2.1.2 Examples of in vivo somatic cell mutagenicity tests are:
Mammalian bone marrow chromosome aberration test (OECD475)
Mouse spot test (OECD 484)
Mammalian erythrocyte micronucleus test (OECD 474)
Table 2.5.2.5.1 Hazard categories for germ cell mutagens
Category 1
Category 1A

Substances known to induce heritable mutations or to be regarded
as if they induce heritable mutations in the germ cells of humans
Substances known to induce heritable mutations in germ cells ofhuman
Positive evidence from human epidemiological studies.
Substances which should be regarded as if they induce heritable
mutations in the germ cells of humans(a) Positive result (s) from in vivo heritable germ cellmutagenicity tests in mammals; orCategory 1B(b) Positive result (s) from in vivo somatic cell mutagenicity
tests in mammals, in combination with some evidence thatthe substance has potential to cause mutations to germ cells.
This supporting evidence may, for example, be derived frommutagenicity/ genotoxic tests in germ cells in vivo, or bydemonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells; or(c) Positive results from tests showing mutagenic effects in thegerm cells of humans, without demonstration oftransmission to progeny; for example, an increase in thefrequency of aneuploidy in sperm cells of exposed people.
Substances which cause concern for humans owing to thepossibility that they may induce heritable mutations in the germ
cells of humans
Positive evidence obtained from experiments in mammals and/or insome cases from in vitro experiments, obtained from:

Category 2(a) Somatic cell mutagenicity tests in vivo, in mammals; or(b) Other in vivo somatic cell genotoxicity tests which aresupported by positive results from in vivo mutagenicity
assays.
Note: Substances which are positive in in vitro mammalianmutagenicity assays, and which also show structure activity
relationship to known germ cell mutagens, should be considered forclassification as Category 2 mutagens.

Page 95

2.5.2.5.3 Data availability
2.5.2.5.3.1 Results from many mutagenicity tests (or genotoxicity tests) are reported
including in vitro tests, but results from in vivo tests using mammaliangerm cells are rare. Expert’s judgment is required.
2.5.2.5.3.2 Chemicals having dataset from in vivo and in vitro tests are less in number
than chemicals having in vitro test data only. Generally, it is difficult todetermine the existence of heritable mutagenicity based on results of invitro tests only.
2.5.2.5.3.3 Results from rodent sperm shape abnormality test are better not to be usedin this classification in principle since they may be affected by effects toother than genetic materials.
2.5.2.5.3.4 Data from various kinds of tests using drosophila (sex-linked or recessive
lethal test, wing spot test, etc) are, generally, better not to be used in thisclassification since biological dynamics and reproduction development
process are not the same between insects and mammals. However, whenother suitable mammalian in vivo mutagenicity / genotoxicity test data
are not available, and especially when positive results from drosophila
sex-linked or recessive lethal test are available, judgment by experts inthese fields shall be sought for using the data and GHS classification
category.
2.5.2.5.3.5 There exist many kinds of in vitro genotoxicity tests (Comet testing
mammalian culture cells, UDS test in mammalian culture cells, DNA (Reassay) in Bacillus subtilis, umu test in Salmonella typhimurium, SOS testin Escherichia coli, chromatid aberration with aneuploid test in yeast) and
Host-mediated assay, but results of these tests are, in principle, not usedin this classification.
2.5.2.5.3.6 In in vivo mutagenicity/ genotoxicity tests, various administration routes
are used. Although the common human exposure routes take precedence,
test data with any administration route may be utilized unless theinappropriateness of the route is rationally explained.
2.5.2.5.3.7 Substances that have been concluded by epidemiological studies to induce
heritable mutation in human population shall be classified in Category
1A.
2.5.2.5.3.8 Substances which have the potential to induce genetic mutations or
chromosomal abnormality in human germ cells based on otherinformation shall be classified in Category 2. Category 2 includes
substances having positive evidence from in vivo somatic cell
Page 96

mutagenicity tests in mammals (mammaliam bone marrow chromosomal
abnormality test, mammalian erythrocyte micronucleus test, mouse spottest), or positive results in in vivo somatic cell genotoxocity tests (in vivo
liver unscheduled DNA synthesis (UDS) test, mammalian bone marrowsister chromatid exchange (SCE) test) and positive results from in vitro
mutagenicity tests (in vitro mammalian chromosomal abnormality test, in
vitro mammalian cell genetic mutation test, bacterial reverse mutationtest). Substances which have positive results from in vitro mammalianmutagenicity tests only but show (strong) structural similarity withknown germ cell mutagens (category 1) shall be classified in Category 2.
2.5.2.5.3.9 OECD Test Guidelines include the following test methods relating tomutagenicity/ genotoxicity.
TG 471 Bacterial Reverse Mutation Test (Ames Test)
TG 473 In Vitro Mammalian Chromosome Aberration Test
TG 474 Mammalian Erythrocyte Micronucleus Test
TG 475 Mammalian Bone Marrow Chromosome Aberration Test)
TG 476 In Vitro Mammalian Cell Gene Mutation Test
TG 477 Genetic Toxicology: Sex-linked Recessive Lethal Test in
Drosophila MelanogasterTG 478 Genetic Toxicology: Rodent Dominant Lethal Test
TG 479 Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in
Mammalian Cells
TG 480 Genetic Toxicolgy: Saccharomyces Cerevisiae Gene Mutation
Assay
TG 481 Genetic Toxicolgy: Saccharomyces Cerevisiae Mitotic
Recombination Assay
TG 482 Genetic Toxicolgy: DNA Damage and Repair, Unscheduled DNA
Synthesis in Mammalian Cells In Vitro
TG 483 Mammalian Spermatogonial Chromosome Aberration Test
TG 484 Genetic Toxicology: Mouse Spot Test
TG 485 Genetic Toxicology: Mouse Heritable Translocation Assay
TG 486 Unscheduled DNA Synthesis (UDS) Test with Mouse Liver Cells
In Vitro
TG 487 In Vitro Mammalian Cell Micronucleus Test, Draft
2.5.2.5.4 Comparison with conventional classification systems
2.5.2.5.4.1 The concept of GHS classification for Germ Cell Mutagenicity is inaccordance with that for Mutagen Categories 1,2, and 3 in EU DSD
classification.
2.5.2.5.4.2 Mutagens classified as Category 1 (R46) in EU DSD classification
corresponds to substances in Category 1A.
Page 972.5.2.5.4.3 Mutagens classified as Category 2 (R46) in EU DSD classification
corresponds to substances in Category 1B.
2.5.2.5.4.4 Mutagens classified as Category 3 (R68) in EU DSD classification
corresponds to substances in Category 2.
2.5.2.5.4.5 EU CLP classification H340 is in accordance with Category 1B and H341
with Category 2.
2.5.2.5.5 Guidance for classification
2.5.2.5.5.1 Data concerning mutagenicity tests are relatively abundant, and the data
concerning mutagenicity in human germ cells (in vivo tests rather thanin vitro, tests using human cells rather than mammalian cells, tests using
germ cells rather than somatic cells) shall be given a high priority.
2.5.2.5.5.2 As can be seen from the classification criteria described in the GHS
document, generally, positive results from in vitro mutagenicity tests
alone do not serve as a basis for classification to Category 2. Similarattention should be paid to results from in vivo mutagenicity tests indrosophila. Some test reports may contain several negative or positive
results, and classification based on only some of the positive results
needs to be verified.
2.5.2.5.6 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.2.5.1 Label elements for gem cell mutagenicity

SymbolSignal word
Hazardstatement

Category 1(Category 1A, 1B)
Health hazard
DangerMay cause genetic defects (stateroute of exposure if it isconclusively proven that no otherroutes of exposure cause thehazard)Category 2
Health hazard
Warning
Suspected of causing genetic
defects (state route of exposure if it
is conclusively proven that no otherroutes of exposure cause thehazard)Page 98

SECTION 2.5.2.6
CARCINOGENICITY
2.5.2.6.1 Definition
2.5.2.6.1.1 Carcinogen denotes a substance which induces cancer or increases its
incidence. Substances which have induced benign and malignant tumors
in well performed experimental studies on animals are considered also to
be presumed or suspected human carcinogens unless there is strong
evidence that the mechanism of tumor formation is not relevant forhumans.
2.5.2.6.1.2 Classification of a substance as posing a carcinogenic hazard is based on
its inherent properties and does not provide information on the level ofthe human cancer risk which the use of the substance may represent.
2.5.2.6.2 Classification criteria
Table 2.5.2.6.1 Hazard categories for carcinogens
Category

1

1A

1B

Criteria
Known or presumed human carcinogens
The placing of a substance in Category 1 is done on thebasis of epidemiological and/or animal data. An individual
substance may be further distinguished:
Known to have carcinogenic potential for humans; theplacing of a substance is largely based on humanevidence.
Presumed to have carcinogenic potential for humans; theplacing of a substance is largely based on animal
evidence.
Based on strength of evidence together with additional
considerations, such evidence may be derived from humanstudies that establish a causal relationship between human
exposure to a substance and the development of cancer(known human carcinogen). Alternatively, evidence may bederived from animal experiments for which there issufficient evidence to demonstrate animal carcinogenicity(presumed human carcinogen). In addition, on a case bycase basis, scientific judgment may warrant a decision ofpresumed human carcinogenicity derived from studies
showing limited evidence of carcinogenicity in humans
together with limited evidence of carcinogenicity inexperimental animals

Page 99

Classification: Category 1 (A and B) Carcinogen
Suspected human carcinogen2

The placing of a substance in Category 2 is done on thebasis of evidence obtained from human and/or animalstudies, but which is not sufficiently convincing to place thesubstance in Category 1. Based on strength of evidence
together with additional considerations, such evidence may
be from either limited evidence of carcinogenicity in humanstudies of from limited evidence of carcinogenicity inanimal studies.
Classification: Category 2 Carcinogen

2.5.2.6.2.1Carcinogen classification is a one-step, criterion-based process thatinvolves two interrelated determinations; evaluation of strength ofevidence and consideration of all other relevant information to placesubstances with human cancer potential into hazard categories.
2.5.2.6.2.2 Strength of evidence involves the enumeration of tumors in human andanimal studies and determination of their level of statistical significance.
Sufficient human evidence demonstrates causality between human
exposure and the development of cancer, whereas sufficient evidence inanimals shows a causal relationship between the agent and an increased
incidence of tumors. Limited evidence in humans is demonstrated by apositive association between exposure and cancer, but a causal
relationship cannot be stated. Limited evidence in animals is provided
when the data suggest a carcinogenic effect, but are less than sufficient.
The terms “sufficient” and “limited” are used here as they have been
defined by the International Agency for Research on Cancer (IARC).
2.5.2.6.2.3 Additional considerations (weight of evidence): beyond the determination of
the strength of evidence for carcinogenicity, a number of other factors
should be considered that influence the overall likelihood that an agent
may pose a carcinogenic hazard in humans. The full list of factors that
influence this determination is very lengthy, but some of the importantones are considered here.
2.5.2.6.2.4 Some important factors which may be taken into consideration, whenassessing the overall level of concern are:(a) Tumor type and background incidence;(b) Multisite responses;(c) Progression of lesions to malignancy;(d) Reduced tumor latency;
Page 100

Additional factors which may increase or decrease the level of concern
include:(e) Whether responses are in single or both sexes;(f) Whether responses are in a single species or several species;(g) Structural similarity or not to a substance (s) for which there is goodevidence of carcinogenicity;(h) Routes of exposure;(i) Comparison of absorption, distribution, metabolism and excretion
between test animals and humans;(j) The possibility of a confounding effect of excessive toxicity at test
doses;(k) Mode of action and its relevance for humans, such as mutagenicity,
cytotoxicity
withgrowthstimulation,
mitogenesis,
immunosuppression.
2.5.2.6.3 Data availability
2.5.2.6.3.1 Descriptions of carcinogenicity are found frequently in hazard-related
reviews or data collections.
2.5.2.6.3.2 Several organizations have reported ranking of carcinogenicity, whichshould be useful for classification:(a) (WHO International Agency for Research on Cancer (IARC)(b) Classification results in Annex I of EU 7th Amendment to Council
Directive(c) National Toxicology Program (NTP)(d) Carcinogens in “Recommendations for allowable concentrations” by
Japan Society for Occupational Health,(e) Carcinogenicity notes in “TLV and BEIs” by ACGIH(f) US-EPA Integrated Risk Information System (IRIS)

Page 101(g) Carcinogenicity notes in “List of MAK and BAT values” by German
DFG
2.5.2.6.3.3 Evaluation by IARC and EU represents a consensus of many expert
opinions and therefore shall be given the 1st priority.
2.5.2.6.3.4 Refer to any information released by the Japan Society for Occupational
Health, US-EPA, US-NTP, ACGIH, or German DGF, which is given thenext priority.
2.5.2.6.3.5 OECD Test Guidelines include the following test methods in relation to
Carcinogenicity:
OECD TG 451 Carcinogenicity studies
OECD TG 453 Combined chronic toxicity/ carcinogenicity studies
2.5.2.6.3.6 When multiple data exists for Carcinogenicity given the high reliability of
data, and when they fall under multiple categories, basis for the selection
and judgment of data for the determination of category will be
determined according to Section 5.5.1.3.
2.5.2.6.4 Comparison with conventional classification systems
2.5.2.6.4.1 The principles of GHS classification for Carcinogenicity are in accordancewith those of the IARC Carcinogenicity group classification and theCarcinogenicity category classification of EU classification.
2.5.2.6.4.2 The GHS classification categories are generally the same as those inconventional classification systems.
Table 2.5.2.6.4.2 Correspondence table between GHS classification andclassifications by other organizations on Carcinogenicity
EPA
1996

A3

EPA
1986
A
B1,
B2
C

3

A4

D

CBD

I

4

A5

E

NL

NL

GHS

IARC

JSOH

ACGIH

1A

1

1

A1

1B

2A

2A

A2

2
Classification
not possible
Not classified

2B

2B

3
4

K/L

EPA
2005
CaH
L
S

NTP

EU

K

1

R

2
3

Note 1: When classification for carcinogenicity is performed according to theabove table, data need not to be input into other items such as
toxicity information or epidemiological/ occupational exposure/
Page 102When EU classification alone is available, however, searching forevidence supporting the classifications is needed.
Note 2: Note that the abbreviations of EPA classification change from year toyear.
Abbreviations in the 1986 Guideline:A:

Human carcinogen

B1: Probably human carcinogen 9Limited human evidence of
carcinogenicity in human)
B2: Probably human carcinogen (sufficient animal evidence, but
inadequate human evidence for carcinogenicity)
C:

Possible human carcinogen (human data are inadequate andanimal data demonstrate limited evidence of carcinogenicity)

D:

Not classifiable as to human carcinogenicity

E:

Evidence of non-carcinogenicity for humanAbbreviations in the 1996 Guideline:
K:

Known human carcinogens

L:

Likely to produce cancer in humans

CBD: Cannot be determined
NL: Not likely to be carcinogenic in humans
Abbreviations in the 2005 Guideline:
CaH: Carcinogenic to humans
L:

Likely to be carcinogenic in humans

S:

Suggestive evidence of carcinogenic potential

I:

Inadequate information to assess carcinogenic potential

NL: Not likely to be carcinogenic to humans

Page 103

Abbreviations in the IARC classification:
Group 1:

Carcinogen To humans

Group 2A:

Probably carcinogenic to humans

Group 2B:

Possibly carcinogenic to humans

Group 3:Not classifiable as to carcinogenicity to humans

Group 4:

Probably not carcinogenic to humans

Abbreviations in the Japan Society for Occupational Healthclassification:
Group 1:

Carcinogenic to humans

Group 2A:

Probably carcinogenic to humans

Group 2B:

Possibly carcinogenic to humans

Abbreviations in the ACGIH classification:
A1:

Confirmed human carcinogen

A2:

Suspected human carcinogen

A3:

Confirmed animal carcinogen with unknown relevance tohumansA4:

Not classifiable as a human carcinogen

A5:

Not suspected as a human carcinogen

Abbreviationsclassification:

in

the

National

K:

Known

R:

Reasonably suspected

Toxicology

Program(NTP)

Page 1042.5.2.6.5 Guidance for classification
2.5.2.6.5.1 Data verified by credible agencies, such as those derived from thematerials specified in “Priority 1”. Evaluation by IARC and EU
represents a consensus of many expert opinions and therefore shall begiven a high priority. Refer to any information released by Japan Society
for Occupational Health, US-EPA, US-NTP, ACGIH or German DGF,
which is given the next priority.
2.5.2.6.5.2 Data that are deemed reliable, such as those obtained by GLP-conforming
laboratories or those whose scientific basis is available and verified.
2.5.2.6.5.3 Data obtained from other information sources, such as those derived fromthe materials specified in “Priority 2” and “Priority 3”.
2.5.2.6.6 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.2.6.1 Label elements for carcinogenicity

SymbolSignal word
Hazardstatement

Category 1(Category 1A, 1B)
Health hazard
DangerMay cause cancer (state route of
exposure if it is conclusively
proven that no other routes of
exposure cause the hazard)

Category 2
Health hazard
Warning
Suspected of causing cancer (stateroute of exposure if it isconclusively proven that no otherroutes of exposure cause thehazard)Page 105

SECTION 2.5.2.7
REPRODUCTIVE TOXICITY
2.5.2.7.1 Definition
2.5.2.7.1.1 Reproductive toxicity includes adverse effects on sexual function andfertility in adult males and females, as well as developmental toxicity inthe offspring. The definitions presented below are adapted from thoseagreed as working definitions in IPCS/EHC Document N◦225 Principles
for evaluating health risks to reproducyion associated with exposure tochemicals. For classification purposes, the known induction of genetically
based inheritable effects in the offspring is addressed in Germ Cell
Mutagenicity since in the present classification system it is consideredmore appropriate to address such effects under the separate hazard classof germ cell mutagenicity.
2.5.2.7.1.2 In this classification system, reproductive toxicity is subdivided under two
main headings:(a) Adverse effects on sexual function and fertility;(b) Adverse effects on development of the offspring
2.5.2.7.1.3 Adverse effects on sexual function and fertility
Any effect of chemicals that would interfere with sexual function andfertility. This may include, but not limited to, alterations to the female
and male reproductive system, adverse effects on onset of puberty,
gamete production and transport, reproductive cycle normality, sexual
behavior, fertility, parturition, pregnancy outcomes, premature
reproductive senescence, or modifications in other functions that are
dependent on the integrity of the reproductive systems.
Adverse effects on or via lactation are also included in reproductive
toxicity, but for classification purposes, such effects are treated separately.
This is because it is desirable to be able to classify chemicals specificallyfor an adverse effect on lactation so that a specific hazard warning about
this effect can be provided for lactating mothers.

Page 1062.5.2.7.1.4 Adverse effects on development of the offspring
Taken in its widest sense, developmental toxicity includes any effectwhich interferes with normal development of the conceptus, either before
or after birth, and resulting from exposure of either parent prior toconception, or exposure of the developing offspring during prenatal
development, or post natally, to the time of sexual maturation. However,
it is considered that classification under the heading of developmental
toxicity is primarily intended to provide a hazard warning for pregnant
women and men and women of reproductive capacity. Theredore, forpragmatic purposes of classification, developmental toxicity essentiallymeans adverse effects induced during pregnancy, or as a result of
parental exposure. These effects can be manifested at any point in the life
span of the organism. The major manifestations of developmental toxicity
include death of the developing organism, structural abnormality, altered
growth and functional deficiency.
2.5.2.7.2 Classification criteria
Table 2.5.2.7.1 Hazard categories of reproductive toxicantsCategory 1:Known or presumed human reproductive toxicant
This category includes substances which are known to have produced
an adverse effect on sexual function and fertility or on development in
humans or for which there is evidence from animal studies, possibly
supplemented with other information, to providea strongpresumptionthat the substance has the capacity to interfere with reproduction inhumans. For regulatory purposes, a substance can be further
distinguished on the basis of whether the evidence for classification is
primarily from human data (Category 1A) or from animal data
(Category 1B).
Category 1A: Known human reproductive toxicant
The placing of the substance in this category is largely based onevidence from humans.

Category 1B: Presumed human reproductive toxicant
The placing of the substance in this category is largely based onevidence from experimental animals. Data from animal studies should
provide clear evidence of adverse effect on sexual function andfertility or on development in the absence of other toxic effects, or if
occurring together with other toxic effects the adverse effect on
reproduction is considered not to be a secondary non-specificconsequence of other toxic effects. However, when there isPage 107mechanistic information that raises doubt about the relevance of theeffect for humans, classification in Category 2 may be more
appropriate.
Category 2: Suspected human reproductive toxicant
This category includes substances for which there is some evidence
from humans or experimental animals, possibly supplemented withother information, of adverse effect on sexual function and fertility, oron development, in the absence of other toxic effects, or if occurring
together with other toxic effects, adverse effects on reproduction isconsidered not to be a secondary non-specific consequence of the othertoxic effects, and where the evidence is not sufficiently convincing toplace the substance in Category 1. For instance, deficiencies in the
study may make the quality of evidence less convincing, and in view ofthis Category 2 could be the more appropriate classification.

Table 2.5.2.7.2 Hazard categoriy for effects on or via lactation
EFFECTS ON OR VIA LACTATION
Effects on or via lactation are allocated to a separate single category. It isappreciated that for many substances there is no information on the potential tocause adverse effects on the offspring via lactation. However, substances which areabsorbed by women and have been shown to 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, should be classified to indicate thisproperty hazardous to breastfed babies. This classification can be assigned on thebasis of:(a) absorption, metabolism, distribution and excretion studies that would indicate
the likelihood the substance would bepresent in potentially toxic level in breast
milk; and/or(b) results of one or twogeneration studies in animals which provide clear evidenceof adverse effect in the offspring due to the transfer in the milk or adverse effecton the quality of the milk; and/or(c) human evidence indicating a hazard to babies during the lactation period.

2.5.2.7.3 Data availability
2.5.2.7.3.1 Evaluation of reproductive toxicity has been reported in “Chemical
Substance Hazard Data” prepared by CERI, EHC, ECETOC, SIDS, etc.
2.5.2.7.3.2 A large amount of data is available from reports on reproductive toxicity,
but whether they meet the criteria must be checked by experts by tracing
back to their original publication.
Page 1082.5.2.7.3.3 Testing methods (OECD Test Guidelines include the following testing
methods in relation to Reproductive Toxicity)
OECD TG 414
OECD TG 415
OECD TG 416
OECD TG 421
OECD TG 422

Prenatal development toxicity study
One-generation reproduction toxicity study
Two-generation reproduction toxicity
reproduction/ developmental toxicity screening test
Combined repeated does toxicity study with thereproduction/ developmental toxicity screening test

2.5.2.7.3.4 When multiple data exists for Reproductive Toxicity given the highreliability of data, and when they fall under multiple categories, basis forthe selection and judgment of data for the determination of category will
be determined according to Section 8.5.1.3.
2.5.2.7.4 Comparison with conventional classification systems
2.5.2.7.4.1 The concept of the EU category classification on reproductive toxicity is inaccordance with that of the GHS category classification.
2.5.2.7.4.2 Substances classified as Category 1 in EU DSD classification with R60, R61
fall under GHS classification Category 1A.
2.5.2.7.4.3 Substances classified as Category 2 in EU DSD classification with R60, R61
fall under GHS classification Category 1B.
2.5.2.7.4.4 Substances classified as category 3 in EU DSD classification with R62, R63
fall under GHS classification Category 2.
2.5.2.7.4.5 Substances in EU DSD classification R64 (May be hazardous for breastfedchildren) fall under “the additional category for effects on or via
lactation”.
2.5.2.7.4.6 EU CLP classification H360D and H360F are in accordance with Category
1A or Category 1B, and H361d and H361f are in accordance with Category
2. H360FD, H360Fd and H360Df are in accordance with Category 1A or 7
2.5.2.7.5 Guidance for classification
The following shall be given a high priority:
2.5.2.7.5.1

Data verified by credible agencies, such as those derived from thematerials specified in “Priority 1”.

2.5.2.7.5.2

If appropriate information sources based on data cannot be obtained
Page 109

easily, classification is performed based on the evaluation by the EU,
the only organization performing evaluation on reproductive toxicity.
2.5.2.7.3 Data that are deemed reliable, such as those obtained by GLPconforming laboratories or those whose scientific basis is available andverified.
2.5.2.7.4 Data obtained from other information sources, such as those derived
from the materials specified in “Priority 2” and “Priority 3”.
2.5.2.7.6 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.2.7.1 Label elements for reproductive toxicity

SymbolSignalword

Hazardstatement

Category 1(Category 1A, 1B)

Category 2

Health hazard

Health hazard

Additional category
for effects on or via
lactation
No symbol

DangerWarning

No signal word

May damage fertilityor the unborn child(state specific effect if
known) (state route of
exposure if it isconclusively proventhat no other routes of
exposure cause thehazard)Suspected ofdamaging fertility or
the unborn child(state specific effect if
known) (state route of
exposure if it isconclusively proventhat no other routes of
exposure cause thehazard)May cause harm tobreast-fed children

Page 110SECTION 2.5.2.8
SPECIFIC TARGET ORGAN TOXICITYSINGLE EXPOSURE
2.5.2.8.1 Definition
2.5.2.8.1.1 The purpose of this chapter is to provide a means of classifying substancesthat produce specific, non-lethal target organ toxicity arising from asingle exposure. All significant health effects that can impair function,
reversible and irreversible, immediate and/or delayed and not
specifically addressed in section 2.5.2.1 to 2.5.2.7 and 2.5.2.10 are
included.
2.5.2.8.1.2 Classification identifies the substance as being a specific target organ
toxicant and, as such, it may present a potential for adverse health effects
in people who are exposed to it.
2.5.2.8.1.3 Classification depends upon the availability of reliable evidence that asingle exposure to the substance has produced a consistent andidentifiable toxic effects in humans, or, in experimental animals,
toxicologically significant changes which have affected the function ormorphology of a tissue/organ, or has produced serious changes to thebiochemistry or hematology of the organism and these changes are
relevant for human health. It is recognized that human data will be theprimary source of evidence for this hazard class.
2.5.2.8.1.4 Assessment should take into consideration not only significant changes ina single organ or biological system but also generalized changes of a lesssevere nature involving several organs.
2.5.2.8.1.5 Specific target organ toxicity can occur by any route that is relevant forhumans, i.e. principally oral, dermal or inhalation.
2.5.2.8.1.6 Specific target organ toxicity following a repeated exposure is classified in
the GHS as described in Specific target organ toxicity- repeated exposure(Section 5.5.2.9) and is therefore excluded from the present section. Other
specific toxic effects, listed below are assessed separately in the GHS andconsequently are not included here:(a) Acute toxicity (Section 2.5.2.1);(b) Skin corrosion/ irritation (Section 2.5.2.2)(c) Serious eye damage/ eye irritation (Section 5.5.2.3)
Page 111

(d) Respiratory or skin sensitization (Section 2.5.2.4)(e) Germ cell mutagenicity (Section 2.5.2.5)(f) Carcinogenicity (Section 2.5.2.6)(g) Reproductive toxicity (Section 2.5.2.7)(h) Aspiration toxicity (Section 2.5.2.10)
2.5.2.8.2 Classification criteria
2.5.2.8.2.1 Criteria for respiratory tract irritation
The criteria for respiratory tract irritation are:(a) Respiratory irritant effects characterized by localized redness, edema,pruritis and/or pain) that impair function with symptoms such as
cough, pain, choking, and breathing difficulties are included. It is
recognized that this evaluation is based primarily on human data;(b) Subjective human observations could be supported by objective
measurements for clear respiratory tract irritation (RTI) (e.g.
electrophysiological responses, biomarkers of inflammation in nasal or
bronchoalveolar lavage fluids);(c) The symptoms observed in humans should also be typical of those thatwould be produced in the exposed population rather than being an
isolated idiosyncratic reaction or response triggered only in individuals
with hypersensisitive airways. Ambiguous reports simply of“irritation” should be excluded as this term is commonly used todescribe a wide range of sensations including those such as smell,
unpleasant taste, a tickling sensation, and dryness, which are outside
the scope of this classification endpoint;(d) There are currently no validated animal tests that deal specifically with
RTI, however, useful information may be obtained from the single andrepeated inhalation toxicity tests. For example, animal studies may
provide useful information in terms of clinical signs of toxicity(dyspnoea, rhinitis etc) and hispathology (e.g. hyperemia, edema,
minimal inflammation, and thickened mucous layer) which arereversible and may be reflective of the characteristic clinical symptoms
described above. Such animal studies can be used as part of weight ofevidence evaluation;
Page 112(e) This special classification would occur only when more severe organ
effects including in the respiratory system are not observed.
2.5.2.8.2.2 Criteria for narcotic effects
The criteria narcotic effects are:(a) Central nervous system depression including narcotic effects inhumans such as drowsiness, narcosis, reduced alertness, loss ofreflexes, lack of coordination, and vertigo are included. These effects
can also be manifested as severe headache or nausea, and can lead to
reduce judgment, dizziness, irritability, fatigue, impaired memory
function, deficits in perception and coordination, reaction time, or
sleepiness;(b) Narcotic effects observed in animal studies may include lethargy, lackof coordination righting reflex, narcosis, and ataxia. If these effects are
not transient in nature, then they should be considered forclassification as Category 1 and 2.

Table 2.5.2.8.1 Hazard categories for specific target organ toxicity
following single exposure
Category 1: Substances that have produced significant toxicity in humans
or that, on the basis of evidence from studies in experimental
animals, can be presumed to have the potential to produce
significant toxicity in humans following a single exposure
Placing a substance in Category 1 is done on the basis of:(a) reliable and goodquality evidence from human cases or
epidemiological studies; or(b) observations from appropriate studies in experimental
animals in which significant and/or severe toxic effects ofrelevance to human health were produced at generally low
exposure concentrations. Guidance dose/ concentration
values are provided below to be used as part of weight-ofevidence evaluation.
Category 2:Substances that, on the basis of evidence from studies inexperimental animals can be presumed to have the potential
to be harmful to human health following a single exposure
Placing a substance in Category 2 is done on the basis ofPage 113

observations from appropriate studies in experimental
animals in which significant toxic effects, of relevance tohuman health, were produced at generally moderate exposure
concentrations. Guidance dose/ concentration values areprovided below in order to help in classification.
In exceptional cases, human evidence can also be used toplace a substance in Category 2.
Category 3:Transient target organs effects
There are target organ effects for which a substance may notmeet the criteria to be classified in Categories 1 or 2 indicatedabove. These are effects which adversely alter human function
for a short duration after exposure and from which humans
may recover in a reasonable period without leaving significant
alteration of structure or function. This category also includes
narcotic effects and respiratory tract irritation. Substances may
be classified specifically for these effects as discussed in 3.8.2.2of the UN GHS.
Note: For these categories, the specific target organ/system that has been primarily
affected by the classified substance may be identified, or the substance may be
identified as a general toxicant. Attempts should be made to determine the primarytarget organ of toxicity and classify for that purpose, e.g. as hepatotoxicants,
neurotoxicants. One should carefully evaluate the data and, where possible, notinclude secondary effects, e.g. a hepatotoxicant can produce secondary effects in the
nervous or gastro-intestinal systems.
Table 2.5.2.8.2 Guidance value ranges for single-dose exposures
Guidance value ranges for:
Routes of
exposure
Oral (rat)Dermal (rat or
rabbit)Inhalation (rat)gasInhalation (rat)vaporInhalation (rat)dust/mist/fumeUnits
mg/kg bodyweightmg/kg bodyweightPpm
mg/L
mg/L 4hCategory 1

Category 2

C < 300

300 < C < 2000

C <1000
C <2500
C <10
C <1.0Category 31000 < C < 2000
2500 < C <20000*

Guidancevalues do not
apply

10< C < 20
1.0< C <5.0

Page 114

2.5.2.8.3 Data availability
2.5.2.8.3.1 When utilizing descriptions in existing MSDSs, the quoted original reports
must be reviewed. Even if MSDSs according to GHS classification are
utilized, for confirmation of the classification, the original reports shall be
reviewed.
2.5.2.8.3.2 Sufficient information for classification cannot be obtained from the brief
descriptions in existing SDSs. A literature search shall be conducted toobtain solid information from reviews or primary information concerning
toxicity.
2.5.2.8.3.3Substances with R-Phrases (R39, R68 R37 and R67) in EU DSD classification
are feared to possess specific target organ toxicity (single exposure)
2.5.2.8.3.4 T+, R39 and T, R39 correspond to Category 1. R68 corresponds toCategory 2. R37 and R67 correspond to Single Exposure Category 3
respiratory tract irritation and narcotic effects, respectively.
2.5.2.8.3.5 When multiple data exists for Specific Target Organ Toxicity (STOT) given
the high reliability of data, and when they fall under multiple categories,
basis for the selection and judgment of data for the determination of
category will be determined according to Section 5.5.1.3.
2.5.2.8.4 Comparison with conventional classification systems
2.5.2.8.4.1 Systems in accordance with GHS include R-Phrases (R39, R68, R37 andR67) in EU DSD classification.
2.5.2.8.4.2 EU CLP classification H370 accords with Category 1, H371 accords with
Category 2 and H335 or H336 accord with Category 3.
2.5.2.8.5 Guidance for classification
2.5.2.8.5.1 If information concerning specific, non-lethal, specific organ/systemic
toxicity arising from a single is obtained, whether the toxicity issignificant to human health shall be determined through expert
judgment.
2.5.2.8.5.2 The relevant route of exposure by which the classified substance has
produced damage shall be identified.

Page 115

2.5.2.8.5.3 Examples of toxic effects in humans or experimental animals that must be
taken into consideration in the classification of specific organ/systemic
toxicity are provided below:(a) Morbidity resulting from single exposure;(b) Significant functional changes, more than transient in nature, in the
respiratory system, central or peripheral nervous systems, or otherorgan systems, including signs of central nervous system depression
and effects on special senses (e.g. sight, hearing and sense of smell);(c) Any consistent and significant adverse change
biochemistry, hematology or urinalysis parameters;inclinical(d) Significant organ damage that may be noted at necropsy and/or
confirmed at microscopic examination;(e) Multifocal or diffuse necrosis, fibrosis or granuloma formation in vitalorgans with regenerative capacity;(f) Morphological changes that are potentially reversible but provide
clear evidence of marked organ dysfunction;(g) Evidence of appreciable cell death (including cell degeneration andreduced cell number) in vital organs incapable of regeneration.
2.5.2.8.5.4 Hazards listed below are treated separately in the UN GHS fourth revised
edition hence are not included in specific target organ toxicity.
(a) Acute toxicity (Section 2.5.2.1);(b) Skin corrosion/ irritation (Section 2.5.2.2)(c) Serious eye damage/ eye irritation (Section 2.5.2.3)(d) Respiratory or skin sensitization (Section 2.5.2.4)(e) Germ cell mutagenicity (Section 2.5.2.5)(f) Carcinogenicity (Section 2.5.2.6)(g) Reproductive toxicity (Section 2.5.2.7)(h) Aspiration toxicity (Section 2.5.2.10)

Page 1162.5.2.8.6 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.2.8.1 Label elements for specific target organ toxicity after single
exposure
Category 1
SymbolSignalword

Hazardstatement

Category 2

Category 3

Health hazard

Health hazard

Exclamation markDangerWarning

Warning

Causes damage toorgans (or state allorgans affected, if
known) (state route of
exposure if it isconclusively proventhat no other routes of
exposure cause thehazard)May cause damage toorgans (or state allorgans affected, if
known) (state route of
exposure if it isconclusively proventhat no other routes of
exposure cause thehazard)May cause respiratory
irritation;orMay cause
drowsiness ordizziness

Page 117

SECTION 2.5.2.9
SPECIFIC TARGET ORGAN TOXICITYREPEATED EXPOSURE
2.5.2.9.1 Definition
2.5.2.9.1.1 The purpose of this chapter is to provide a means of classifying substancesthat produce specific target organ toxicity arising from a repeatedexposure. All significant health effects that can impair function, reversible
and irreversible, immediate and/or delayed are included.
2.5.2.9.1.2 Classification identifies the substance as being a specific target organ
toxicant and, as such, it may present a potential for adverse health effects
in people who are exposed to it.
2.5.2.9.1.3 Classification depends upon the availability of reliable evidence that a
repeated exposure to the substance has produced a consistent andidentifiable toxic effects in humans, or, in experimental animals,
toxicologically significant changes which have affected the function ormorphology of a tissue/organ, or has produced serious changes to thebiochemistry or hematology of the organism and these changes are
relevant for human health. It is recognized that human data will be theprimary source of evidence for this hazard class.
2.5.2.9.1.4 Assessment shall be taken into consideration not only significant changes
in a single organ or biological system but also generalized changes of aless severe nature involving several organs.
2.5.2.9.1.5 Specific target organ toxicity can occur by any route that is relevant forhumans, i.e. principally oral, dermal or inhalation.
2.5.2.9.2 Classification criteria
Table 2.5.2.9.1 Hazard categories for specific target organ toxicity
following repeated exposure
Category 1: Substances that have produced significant toxicity in humans
or that, on the basis of evidence from studies in experimental
animals, can be presumed to have the potential to produce
significant toxicity in humans following a repeated exposure

Page 118

Placing a substance in Category 1 is done on the basis of:(a) reliable and good quality evidence from human cases or
epidemiological studies; or(b) observations from appropriate studies in experimental
animals in which significant and/or severe toxic effects ofrelevance to human health were produced at generally low
exposure concentrations. Guidance dose/ concentration
values are provided below to be used as part of weight-ofevidence evaluation.
Category 2:Substances that, on the basis of evidence from studies inexperimental animals can be presumed to have the potential
to be harmful to human health following a repeatedexposure
Placing a substance in Category 2 is done on the basis ofobservations from appropriate studies in experimental
animals in which significant toxic effects, of relevance tohuman health, were produced at generally moderate exposure
concentrations. Guidance dose/ concentration values areprovided below inorder to help in classification.
In exceptional cases, human evidence can also be used toplace a substance in Category 2.
Note: For these categories, the specific target organ/system that has been primarily
affected by the classified substance may be identified, or the substance may be
identified as a general toxicant. Attempts should be made to determine the primarytarget organ of toxicity and classify for that purpose, e.g. as hepatotoxicants,
neurotoxicants. One should carefully evaluate the data and, where possible, notinclude secondary effects, e.g. a hepatotoxicant can produce secondary effects in the
nervous or gastro-intestinal systems.
Table 2.5.2.9.2 Guidance value ranges for toxicity - repeated exposures
Guidance values (dose/concentration)
Routes of
exposure
Oral (rat)Dermal (rat or
rabbit)Inhalation (rat)
gas

Units
mg/kg bodyweightmg/kg bodyweightPpmV/6h/d

Category 1

Category 2

10

10 – 100

20

20 – 500

50

50 – 250

Page 119Inhalation (rat)vaporInhalation (rat)dust/mist/fume

mg/L/6h/d

0.2

0.2 – 1.0

mg/L 6h/ d

0.02

0.02 – 0.2

2.5.2.9.3 Data availability
2.5.2.9.3.1 When utilizing descriptions in existing SDSs, the quoted original reports
must be reviewed. Even if SDSs according to GHS classification are
utilized, for confirmation of the classification, the original reports should
be reviewed.
2.5.2.9.3.2 Sufficient information for classification cannot be obtained from the brief
descriptions in existing SDSs. In often cases, especially information on thetarget organs is not described, and a literature search should be carriedout for reliable reviews and primary information relevant to toxicity.
2.5.2.9.3.3 Substances with R-Phrases (R39, R48 or combination of these) in EU DSD
classification are feared to possess specific target organ toxicity (repeatedexposure)
2.5.2.9.3.4 T+, R48 correspond to Category 1. R33 and Xn, R48 correspond toCategory 2.
2.5.2.9.3.5 When multiple data exists for Specific Target Organ Toxicity (STOT) given
the high reliability of data, and when they fall under multiple categories,
basis for the selection and judgment of data for the determination of
category will be determined according to Section 5.5.1.3.
2.5.2.9.4 Comparison with conventional classification systems
2.5.2.9.4.1 Systems in accordance with GHS include R-Phrase R48 in EU DSD
classification.
2.5.2.9.4.2 EU CLP classification H372 accords with Category 1, H373 accords with
Category 2.
2.5.2.9.5 Guidance for classification
2.5.2.9.5.1 If information concerning specific, non-lethal, specific organ/systemic
toxicity arising from a single is obtained, whether the toxicity issignificant to human health shall be determined through expert
judgment.
2.5.2.9.5.2 The relevant route of exposure by which the classified substance has
produced damage shall be identified.
Page 120

2.5.2.9.5.3 Examples of toxic effects in humans or experimental animals that must be
taken into consideration in the classification of specific organ/systemic
toxicity are provided below:(a) Morbidity resulting from single exposure;(b) Significant functional changes, more than transient in nature, in the
respiratory system, central or peripheral nervous systems, or otherorgan systems, including signs of central nervous system depression
and effects on special senses (e.g. sight, hearing and sense of smell);(c) Any consistent and significant adverse change
biochemistry, hematology or urinalysis parameters;inclinical(d) Significant organ damage that may be noted at necropsy and/or
confirmed at microscopic examination;(e) Multifocal or diffuse necrosis, fibrosis or granuloma formation in vitalorgans with regenerative capacity;(f) Morphological changes that are potentially reversible but provide
clear evidence of marked organ dysfunction;(g) Evidence of appreciable cell death (including cell degeneration andreduced cell number) in vital organs incapable of regeneration.
2.5.2.9.5.4 Hazards listed below are treated separately in the UN GHS fourth revised
edition hence are not included in specific target organ toxicity.
(a) Acute toxicity (Section 2.5.2.1);(b) Skin corrosion/ irritation (Section 2.5.2.2)(c) Serious eye damage/ eye irritation (Section 2.5.2.3)(d) Respiratory or skin sensitization (Section 2.5.2.4)(e) Germ cell mutagenicity (Section 2.5.2.5)(f) Carcinogenicity (Section 2.5.2.6)(g) Reproductive toxicity (Section 2.5.2.7)

Page 1212.5.2.9.6 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.2.9.1 Label elements for specific target organ toxicity following
repeated exposure
Category 1
SymbolSignalword

Hazardstatement

Category 2

Health hazard

Health hazard

DangerWarning

Causes damage to organs (orstate all organs affected, if
known) through prolonged orrepeated exposure (state routeof exposure if it is conclusively
proven that no other routes of
exposure cause the hazard)

May cause damage to organs (orstate all organs affected, if
known) through prolonged orrepeated exposure (state route of
exposure if it is conclusively
proven that no other routes of
exposure cause the hazard)

Page 122SECTION 2.5.2.10
ASPIRATION HAZARD
2.5.2.10.1 Definition
2.5.2.10.1.1 Aspiration means the entry of a liquid or solid chemical directly throughthe oral or nasal cavity, or directly from vomiting, into the trachea andlower respiratory system.
2.5.2.10.1.2 Aspiration toxicity includes severe acute effects such as chemical
pneumonia, varying degrees of pulmonary injury or death following
aspiration.
2.5.2.10.1.3 Aspiration is initiated at the moment of inspiration, in the time required
to take one breath, as the causative material lodges at the crossroad of
the upper respiratory and digestive tracts in the laryngopharyngeal
region.
2.5.2.10.1.4 Aspiration of a substance can occur as it is vomited following ingestion.
This may have consequences for labeling, particularly where, due toacute toxicity, a recommendation may be considered to induce vomiting
after ingestion. However, if the substance also presents an aspiration
toxicity hazard, the recommendation to induce vomiting may need to bemodified.
2.5.2.10.1.5 Specific considerations
2.5.2.10.1.5.1 A review of the medical literature on chemical aspiration revealed thatsome hydrocarbons (petroleum distillates) and certain chlorinatedhydrocarbons have been shown to pose an aspiration hazard in
humans. Primary alcohols and ketones have been shown to pose anaspiration hazard only in animal studies.
2.5.2.10.1.5.2 While a methodology for determination of aspiration hazard in animals
has been utilized, it has not been standardized. Positive experimental
evidence with animals can only serve as a guide to possible aspiration
toxicity in humans. Particular care must be taken in evaluating animal
data for aspiration hazards.
2.5.2.10.1.5.3 The classification criteria refer to kinematic viscosity. The following
provides the conversion between dynamic and kinematic viscosity:
Dynamic viscosity (mPa.s) = Kinematic viscosity (mm2/s)
Density (g/cm3)

Page 1232.5.2.10.1.6 Classification of aerosol/mist products
Aerosol and mist products are usually dispensed in containers such as
self-pressurized containers trigger and pump sprayers. The key toclassifying these products is whether a pool of product is formed in themouth, which then may be aspirated. If the mist or aerosol from apressurized container is fine, a pool may not be formed. On the other
hand, if a pressurized container dispenses product in a stream, a pool
may be formed that may be aspirated. Usually, the mist produced bytrigger and pump sprayers is coarse and therefore, a pool may be formedthat then may be aspirated. When the pump mechanism may beremoved and contents are available to be swallowed then theclassification of the products should be considered.
2.5.2.10.2 Classification criteria
Table 2.5.2.10.1 Hazard categories for aspiration toxicity
Categories
Category 1: Chemicals
known to cause humanaspiration toxicity
hazards or to be regarded
as if they cause humanaspiration toxicity hazard

Decision criteria
A substance is classified as Category 1:(a) based on reliable and goodquality humanevidence (see note 1); or(b) if it is a hydrocarbon and has a kinematic
viscosity of ≦20.5 mm2/s measured at 40℃.

Note 1: Examples of substances included in Category 1 are certainhydrocarbons, turpentine and pine oil.
2.5.2.10.3 Data availability
2.5.2.10.3.1 Aspiration toxicity is a severe acute effect that induces chemical
pneumonitis or lung injuries of various severities after aspiration, or
death. The term “aspiration” refers to invasion of a liquid or solid
chemical into the trachea or the lower respiratory tract, either directly
through the mouth or the nasal cavity or indirectly through vomiting.
2.5.2.10.3.2 Although some methodologies for determining aspiration toxicity inanimals exist, none has been standardized. Positive evidence fromanimal tests merely serves as a guideline for the potential to induce
effects classified as aspiration toxicity in humans.
2.5.2.10.3.3When multiple data exists for Aspiration Hazard given the high reliabilityof data, and when they fall under multiple categories, basis for theselection and judgment of data for the determination of category will be
determined according to Section 2.5.1.3.
Page 124

2.5.2.10.4 Comparison with conventional classification systems
2.5.2.10.4.1 This class represents a new concept for classification, but R65 in EU DSD
classification is in accordance with it.
2.5.2.10.4.2 In EU CLP classification, H304 is in accordance with Category 1.
2.5.2.10.5 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.5.2.10.1 Label elements for aspiration toxicity
SymbolSignal word
Hazard statement

Category 1
Health hazard
DangerMay be fatal if swallowed and enter airways

Page 125SECTION 2.6
ENVIRONMENTAL HAZARDSSECTION 2.6.1
HAZARDOUS TO THE AQUATIC ENVIRONMENT
2.6.1.1 Definitions
2.6.1.1.1 Acute aquatic toxicity means the intrinsic property of a substance to be
injurious to an organism in a short-term aquatic exposure to that substance.
2.6.1.1.2 Acute (short-term) hazard, for classification purposes, means the hazard of achemical caused by its acute toxicity to an organism during short-term aquatic
exposure to that chemical.
2.6.1.1.3 Availability of a substance means the extent to which this substancebecomes a soluble or disaggregates species. For metal availability, the extent towhich the metal ion portion of a metal (M◦) compound can disaggregate from therest of the compound (molecule).
2.6.1.1.4 Bioavailability (or biological availability) means the extent to which asubstance is taken up by an organism, and distributed to an area within theorganism. It is dependent upon physic-chemical properties of the substance,
anatomy and physiology of the organism, pharmacokinetics, and route of exposure.
Availability is not a prerequisite for bioavailability.
2.6.1.1.5 Bioaccumulation means net result of uptake, transformation and eliminationof a substance in an organism due to all routes of exposure (i.e air, water, sediment/
soil and food).
2.6.1.1.6 Bioconcentration means net result of uptake, transformation and eliminationof a substance in an organism due to waterborne exposure.
2.6.1.1.7 Chronic aquatic toxicity means the intrinsic property of a substance to cause
adverse effects to aquatic organisms during aquatic exposures which are determinedin relation to the life-cycle of the organism.
2.6.1.1.8 Degradation means the decomposition of organic molecules to smallermolecules eventually to carbon dioxide, water and salts.
2.6.1.1.9 ECx means the concentration associated with x% response.
Page 1262.6.1.1.10 NOEC (No Observed Effect Concentration) means the test concentration
immediately below the lowest tested concentration with statistically significant
adverse effect. The NOEC has no statistically significant adverse effect compared tothe control.
2.6.1.2 Basic elements
2.6.1.2.1 The basic elements for use within the harmonized system are:(a) Acute aquatic toxicity(b) Chronic aquatic toxicity(c) Potential for or actual bioaccumulation ; and(d) Degradation (biotic or abiotic) for organic chemicals
2.6.1.3 Acute aquatic toxicity
Acute aquatic toxicity would normally be determined using a fish 96 hour
LC50 (OECD Test Guideline 203 or equivalent), a crustacean species 48 hour EC50
(OECD Test Guideline 202 or equivalent) and/ or algal species 72 or 96 hour EC50
(OECD Test Guideline 201 or equivalent). These species are considered as surrogate
for all aquatic organisms and data on other species such as Lemna may also be
considered if the test methodology is suitable.
2.6.1.4 Chronic aquatic toxicity
Chronic toxicity data are less available than acute data and the range oftesting procedures less standardized. Data generated according the OECD Test
Guidelines 210 (fish Early Life Stage), or 211 (Daphnia Reproduction) and 201 (Algal
Growth Inhibition) can be accepted. Other validated and internationally accepted
test could also be used. The NOECs or other equivalent ECx should be used.
2.6.1.5 Bioaccumulation potential
The potential for bioaccumulation would normally be determined by using
the octanol/ water partition coefficient, usually reported as a log Kow determinedby OECD Test Guideline 107 or 117. While this represents a potential tobioaccumulate, an experimentally determined Bioconcentration Factor (BCF)
provides a better measure and should be used in preference when available. A BCF
should be determined according to OECD Test Guideline 305.
2.6.1.6 Rapid degradability

Page 127

Environmental degradation may be biotic or abiotic (e.g. hydrolysis) and thecriteria used reflect this fact. Ready biodegradation can most easily be defined using
the biodegradability tests (A-F) of OECD Test Guideline 301. A pass level in thesetests can be considered as indicative or rapid degradation in most environments.
These are freshwater tests and thus the use of the results from OECD Test Guideline
306 which is more suitable for marine environments has also been included. Where
such data are not available, a BOD (5 days)/ CO ratio > 0.5 is considered asindicative of rapid degradation.
2.6.1.7 Classification criteria. Categories for substances hazardous to the aquatic
environment (Note 1)
2.6.1.7.1Acute (short-term) aquatic hazard
Category Acute 1: (Note 2)
96 hr LC50(for fish)
48 hr EC50(for crustacea)
72 or 96 hr ErC50(for algae or other aquatic plants)< 1 mg/L and/or< 1 mg/L and/or< 1 mg/L(Note 3)

2.6.1.7.2Long-term aquatic hazard(a) Non-rapidly degradable substances (Note 4) for which there are adequate
chronic toxicity data available
Category Chronic 1: (Note 2)
Chronic NOEC or ECx (for fish)
Chronic NOEC or ECx (for crustacea)
Chronic NOEC or ECx (for algae or other aquatic plants)< 0.1 mg/L and/or< 0.1 mg/L and/or< 0.1 mg/L

Category Chronic 2:
Chronic NOEC or ECx (for fish)
Chronic NOEC or ECx (for crustacea)
Chronic NOEC or ECx (for algae or other aquatic plants)< 1 mg/L and/or< 1 mg/L and/or< 1 mg/L(b) Rapidly degradable substances for which there are adequate chronic
toxicity data available
Category Chronic 1: (Note 2)
Chronic NOEC or ECx (for fish)
Chronic NOEC or ECx (for crustacea)
Chronic NOEC or ECx (for algae or other aquatic plants)< 0.01 mg/L and/or< 0.01 mg/L and/or< 0.01 mg/L

Page 128

Category Chronic 2:
Chronic NOEC or ECx (for fish)
Chronic NOEC or ECx (for crustacea)
Chronic NOEC or ECx (for algae or other aquatic plants)< 0.1 mg/L and/or< 0.1 mg/L and/or< 0.1 mg/L(c) Substances for which adequate chronic toxicity are not available
Category Chronic 1: (Note 2)
Chronic NOEC or ECx (for fish)
Chronic NOEC or ECx (for crustacea)
Chronic NOEC or ECx (for algae or other aquatic plants)< 1 mg/L and/or< 1 mg/L and/or< 1 mg/L (Note 3)

and the substance is not rapidly degradable and/or the experimentally
determined BCF is > 500 (or, if absent, the log Kow > 4). (Notes 4 and 5)
Category Chronic 2:
96 hr LC50(for fish)
48 hr EC50(for crustacea)
72 or 96 hr ErC50(for algae or other aquatic plants)>1 but < 10 mg/L and/or>1 but < 10 mg/L and/or>1 but < 10 mg/L (Note 3)

and the substance is not rapidly degradable and/or the experimentally
determined BCF is > 500 (or, if absent, the log Kow > 4). (Notes 4 and 5)
2.6.1.7.3 “Safety net” classification
Category Chronic 4
Poorly soluble substances for which no acute toxicity is recorded at levels up
to the water solubility, and which are not rapidly degradable and have a log
Kow > 4, indicating a potential to bioaccumulate, will be classified in thiscategory unless other scientific evidence exists showing classification to beunnecessary. Such evidence would include an experimentally determined
BCF < 500, or a chronic toxicity NOECs > 1 mg/L, or evidence of rapid
degradation in the environment.
Note 1: The organism fish, crustacean and algae are tested as surrogate
species covering a range of trophic levels and taxa, and the test methods arehighly standardized. Data on other organisms may also be considered,however, provided they represent equivalent species and test endpoints.

Page 129

Note 2: When classifying substances as Acute 1 and/or Chronic 1 it isnecessary at the same time to indicate an appropriate M factor to apply thesummation method.
Note 3: Where the algal toxicity ErC50 [ = EC50 (growth rate)] falls more than
100 times below the next most sensitive species and results in a classification
based solely on this effect, consideration should be given to whether thistoxicity is representative of the toxicity to aquatic plants. Where it can beshown that this is not the case, professional judgment should be used indeciding if classification should be applied. Classification should be based on
the ErC50. In circumstances where the basis of the EC50 is not specified and no
ErC50is recorded, classification should be based on the lowest EC50 available.
Note 4: lack of rapid degradability is based on either a lack of readybiodegradability or other evidence of lack of rapid degradation. When no
useful data on degradability are available, either experimentally determinedor estimated data, the substance should be regarded as not rapidly
degradable.
Note 5: Potential to bioaccumulate, based on an experimentally derived BCF >500 or, if absent, a log Kow > 4, provided log Kow is an appropriate
descriptor for the bioaccumulation potential of the substance. Measured log
Kow values take precedence over estimated values and measured BCF values
take precedence over log Kow values.
2.6.1.8 Data availability
2.6.1.8.1Data for classification on acute aquatic toxicity, bioconcentration(Bioconcentration factor, octanol/ water partition coefficient), rapid
degradability (biotic or abiotic), and chronic aquatic toxicity can be easily
accessed from websites.
2.6.1.8.2 EU classification results, which are similar to GHS classification, are alsoavailable but as a reference information only. Mainly because, resultscannot be used directly for GHS classification since the classification
criteria for chronic aquatic toxicity is slightly different from EUclassification compared to GHS classification.
2.6.1.9 Data to be collected and utilized for acute aquatic toxicity hazard
2.6.1.9.1 Tests shall be conducted by using fish, crustacean and algae (or otheraquatic plants) especially those organisms recommended by standard test
methods such as OECD Test Guidelines and ASTM.

Page 130

The test period and endpoints (effect indicators) are as follows:(a) Fish : 96 hour LC50 (lethal)(b) Crustacea : 24 or 48 hour EC50 (immobile), LC50 (lethal)(c) Daphnia : 24 or 48 hour EC50 (immobile), LC50 (lethal)(d) Decapoda, Amphipoda, Mysidacea : 24, 48 or 96 hour EC50 (immobile),
LC50 (lethal)(e) Algae (or other aquatic plants): 72 or 96 hour with Algae, 7 day or 14 daywith ErC50 (growth rate method: the concentration at which mean growthrate during test period is inhibited by 50%) and other higher aquaticplants.
2.6.1.9.2 TLm (median Tolerance Limit) is treated as the same with LC50 and IC50
(50% inhibition concentration) with EC50.
2.6.1.9.3 Data according to GLP shall be used in the classification for aquatic
environment hazard. However, even if the test result is not based on GLP,
if an expert judgment states that the result is reliable, the data can be used
for categorization judgment.
2.6.1.9.4 Similarly, even if the test results is based on GLP, if an expert judgment
concludes that there is doubt about the test procedure, the data from thetest shall not be used as a basis of classification especially for values ofaquatic toxicity levels above the water solubility.
2.6.1.9.5 Acceptable test guidelines for acute aquatic toxicity are as follows:(a) Fish : 96 hour LC50 according to OECD TG 203 or corresponding test
methods(b) Crustacea: 48 hour EC50 according to OECD TG 202 (Daphnia Acute
Immobilization test) or corresponding test methods should be thestandard test. If 48 hour EC50 is not available, 24 hour EC50 (according
to the previous OECD TG 202) may be referred.
(c) Algae, Cyanobacteria and higher aquatic plants: OECD TG 201
includes growth inhibition tests for Algae and Cyanobacteria.
(d) Other higher aquatic plants: OECD Test Guideline 221 (approved2004) showing a growth inhibition test method using a higher plant,
Lemna, and acute EC50 according to US EPA850.4400 may be utilized.

Page 1315.6.1.10 Data to be collected and utilized for chronic aquatic toxicity hazard
2.6.1.10.1 Tests shall be conducted by using fish, crustacean and algae (or otheraquatic plants) especially those organisms recommended by standard test
methods such as OECD Test Guidelines and ASTM.
The test period and endpoints (effect indicators) are as follows:(a) Fish : in early life stage test, 28 days or more, NOEC 9hatching successrate, growth (change of length and weight), spawning success rate andsurvival rate)(b) Crustacea : 7 days or more, NOEC (the period up to the first spawning,
number of eggs per female, growth and survival rate)(c) Algae (or other aquatic plants):
a. Algae : 72 or 96 hours, NOEC (growth inhibition)b. Other aquatic plants, no available long-term chronic toxicity test
2.6.1.10.2 Data above the water solubility shall not be used for classification foraquatic environmental hazard.
2.6.1.10.3 Data according to GLP shall be used in the classification for aquatic
environment hazard. However, even if the test result is not based on GLP,
if an expert judgment states that the result is reliable, the data can be used
for categorization judgment.
2.6.1.10.4 Similarly, even if the test results is based on GLP, if an expert judgment
concludes that there is doubt about the test procedure, the data from thetest shall not be used as a basis of classification.
2.6.1.10.5 Chronic or long term toxicity test using fish shall be conducted according
to OECD TG 210 (Fish early life stage test), Fish Life Cycle Test (US EPA
850.1500).
5.6.1.10.6 Chronic toxicity tests using crustacean shall be conducted in accordancewith OECD TG 211 (Daphnia Magna Reproduction Test), US EPA
OPPTS 850.1035 (Mysidaccea Chronic Toxicity), or corresponding test
methods (NOECs of 21 days for Daphnia, NOECs of 7 days or more for
Ceriodaphnia).

Page 132

2.6.1.10.7 For algae, since OECD TG 201 (Algae growth inhibition test, 72 or 96
hours) is not a long-term test, its NOEC are not generally used as
evidence for exclusion from chronic aquatic toxicity. When NOECs
exceed 1 mg/L for other species of algae, NOECs may be used as
evidence for exclusion.
2.6.1.11 Acceptable test guidelines bioaccumulation and rapid degradability are as
follows:
2.6.1.11.1 Test methods for bioaccumulation (BCF, log Kow), rapid degradability (biodegradability, hydrolysis) shall be based on the methods prescribed by
OECD test Guidelines, ASTM Standard Test Methods or other appropriate
test guidelines.
(a) Bioaccumulation acceptable test methods
OECD TG 305 and the former 305A-D (BCF)
OECD TG 107 and 117 (Kow)(b) Rapid degrability acceptable methods
When data on rapid degradability are not available, the substance isassumed to be without rapid degradability.
OECD TG 301A-F (readily degradability test)(c) When test results using OECD TG 301A-F are not available, results fromthe following test methods may be adopted and used.
OECD TG 302A, 302B, 302C, 303A, 303B, 304A, 306, 307, 308 and 309
OECD TG 310 and 311
2.6.1.12 Precedence of data
2.6.1.12.1 Data derived from OECD Test Guidelines and GLP shall be used.
2.6.1.12.2 When data are not available using the OECD TG or GLP, data from tests
conducted according to internationally recognized test guidelines but
whose compliance to GLP is not clear take precedence.
2.6.1.12.3 Where data cannot be derived using the above principles, the latest datatake precedence.

Page 133

2.6.1.12.4 In the presence of multiple data, the smallest concentration for aquatic
environment hazards, the highest value for bioaccumulation and thelowest value for rapid degradability shall be adopted which areconsidered the safer data.
2.6.1.13 Comparison with conventional classification systems
2.6.1.13.1 EU DSD classifications are almost in accordance with the GHS categories:
R50 : Very toxic to aquatic organisms
R51 : Toxic to aquatic organisms
R52 : Harmful to aquatic organisms
R53 : May cause long-term adverse effects in the aquatic environment
Based on the relevant R-phrases mentioned above, the following
categories from GHS may be estimated:
Category : Acute 1 = R50 (and R50/R53)
Category : Acute 2 = R51 (and R51/ R53)
Category : Acute 3 = R52 (and R52/ R53)
Category : Chronic 1 ≠ R50/53
Category : Chronic 2 ≠ R51/ 53
Category : Chronic 3 ≠ R52/ 53
5.6.1.13.2 EU CLP classifications are almost in accordance with the GHS categories:
Category : Acute 1 = CLP H400
Category : Chronic 1 = CLP H400
Category : Chronic 2 = CLP H410
Category : Chronic 3 = CLP H411
Category : Chronic 4 = CLP H413

Page 1342.6.1.14 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.
Table 2.6.1.14.1 Label elements for hazardous to the aquatic environment
ACUTE
SymbolSignal word
Hazard statement

Category 1
Environment
Warning
Very toxic to aquatic life

CHRONIC
SymbolSignal word
Hazardstatement

Category 1
Environment
Warning
Very toxic to aquatic life withlong lasting effects

Category 2
Environment
No signal word
Toxic to aquatic life with long
lasting effects

Page 135

SECTION 2.6.2
HAZARDOUS TO THE OZONE LAYER
2.6.2.1 Definitions
2.6.2.1.1 Ozone Depleting Potential (ODP) is an integrative quantity, distinct for eachhalocarbon sources species, that represents the extent of ozone depletion in thestratosphere expected from the halocarbon on a mass-for-mass basis relative to CFC11.
2.6.2.1.2 Ozone Depleting Potential (ODP) is the ratio of integrated perturbations tototal ozone, for a differential mass emission of a particular compound relative to an
equal emission of CFC-11.
2.6.2.1.3 Montreal Protocol is the Montreal Protocol on Substances that Deplete the
Ozone Layer as either adjusted and/ or amended by the Parties to the Protocol.
2.6.2.2 Classification criteria
A substance or mixture shall be classified as Category 1 according to thefollowing table:
Table 2.6.2 Criteria for substances and mixtures hazardous to the ozone layer
Category

Criteria
Any of the controlled substances listed in Annexes to the Montreal
Protocol; or

1
Any mixture containing at least one ingredient listed in the
Annexes to the Montreal Protocol, at a concentration > 0.1%.

2.6.2.3 Hazard communication
General and specific considerations concerning labeling requirements areprovided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple
Book. Annex 2 contains summary tables about classification and labeling.
Annex 3 contains examples of precautionary statements and pictograms
which can be used where allowed by the competent authority.

Page 136

Table 2.6.2.3 Label elements for substances and mixtures hazardous to theozone layer
SymbolSignal word
Hazard statement

Category 1
Exclamation markWarning
Harms public health and the environment by destroying
ozone in the upper atmosphere

Page 137

B.

INITIAL LIST OF SINGLE SUBSTANCES AND COMPOUNDSCOVERED UNDER CHEMICAL CONTROL ORDER (CCO) AND
PRIORITY CHEMICAL LIST (PCL)No.

CAS No.

PICCS Name

1.

106-93-4

1,2-Dibromoethane2.

95-50-1

0-Dichlorobenzene

3.

106-46-7

1,4-Dichlorobenzene

4.

107-06-2

1,2-Dichloroethane5.

122-66-7

1,2 Diphenylhydrazine

6.

108-46-3

3-Hydroxyphenol

7.

7647-18-9

Antimony pentachloride

8.

7778-39-4

Arsenic Acid

9.

22441-45-8

Arsenic pentachloride

10.

1303-28-2

Arsenic pentoxide

11.

7784-34-1

Arsenic trichloride

12.

1327-53-3

Arsenic trioxide

13.

1332-21-4

Asbestos

14.

71-43-2

Benzene15.

13327-32-7

Beryllium hydroxide

16.

7787-49-7

Beryllium fluoride

17.

1304-56-9

Beryllium oxide18.

13510-49-1

Beryllium sulfate

19.

543-90-8

Cadmium acetate

20.

10108-64-2

Cadmium chloride

21.

10325-94-7

Cadmium nitrate

22.

10124-36-4

Cadmium sulfate

23.

1306-23-6

Cadmium sulfide

24.

67-66-3

Chloroform

25.

76-06-2

Chloropicrin

26.

100025-73-7

Chromium chloride

27.

7789-02-8

Chromium nitrate

28.

1333-82-0

Chromium trioxide

29.

7789-00-6

Potassium Chromate

30.

7775-11-3

Sodium Chromate

31.

74-90-8

Hydrogen Cyanide
Page 13832.

143-33-9

Potassium Cyanide

33.

151-50-8

Sodium Cyanide

34.

64-67-5

Diethyl sulfate

35.

106-93-4Ethylene dibromide

36.

75-21-8Ethylene Oxide

37.

50-00-0

Formaldehyde

38.

111-30-8

Glutaraldehyde

39.

9002-83-9

Halons40.

67-72-1

Hexachloroethane41.

302-01-2

Hydrazine

42.

598-63-0

Lead carbonate

43.

1309-60-0

Lead dioxide

44.

15245-44-0

Lead styphnate45.

1314-91-6

Lead telluride46.

1314-41-6

Lead tetroxide

47.

1317-36-8

Lead (II) oxide

48.

10099-74-8

Lead (II) nitrate49.

149-30-4

MBT (2-Mercaptobenzothiazole)

50.

594-42-3

Mercaptan, Perchloromethyl

51.

7774-29-0

Mercury(II) iodide

52.

592-85-8

Mercury thiocyanate

53.

7439-97-6

Mercury metal

54.

7783-34-8

Mercuric nitrate monohydrate

55.

74-87-3

Methyl Chloride

56.

75-09-2

Methylenechloride

57.

87-86-5

Pentachlorophenol

58.

127-18-4

Perchloroethylene59.

108-95-2

Phenic Acid60.

75-44-5

Phosgene

61.

85-44-9Phthalic Anhydride62.

7782-49-2

Selenium

63.

79-01-6

Trichloroethylene

64.

75-01-4

Vinyl Chloride

Page 139C.

GHS PICTOGRAMS

Explosives
PICTOGRA
Organic
peroxides
Self-reactive

substances

Oxidizers
Organic peroxides

Corrosive to metal
Skin corrosion
Serious eye damage

Irritant (skin and eye)
Acute Toxicity (harmful)
Dermal Sensitizer
Target Organ toxicity(narcotics or respiratory

Flammable subs.
Self reactive
Pyrophoric & selfHeating substances
Organic peroxides

Compressed gas(Gases under
Pressure)

Acute
Toxicity(Severe)Carcinogen
Respiratory Sensitive
Mutagenicity
Reproductive Toxicity
Target Organ Toxicity

Aspiration Hazard.

Compressed gas

Oxidizing
SolidsPage 140

Environmental

HazardSensitization(Respiratory)
Mutagenicity
Carcinogenicity
Reproductive
Toxicity
Target Organ
Toxicity

Aspiration
Hazard.
Eye irritation
Acute Toxicity
Skin irritation
Eye irritation
Sensitization(Dermal)Target Organ
toxicity

Page 141

D. Guidance Manual on the Preparationof GHS Labels
1.0 General rules, requirements and proceduresThis Section shall provide specific guidance to be observed and followed in labeling or
re-labelling to comply with the requirements of the Department Administrative Order(DAO): Rules and Procedures for the Safety Data Sheet (SDS), Labeling Requirements
and Hazards Classification under DENR Administrative Order No. 29, Series of 1992 of
Republic Act 6969 for the Adoption and Implementation of the Globally Harmonized
System (GHS).
1.1 General rules
1.1.1 Label, tag or mark each container within the workplace.
1.1.2 Labels shall clearly covey the hazards and risks associated with the substancesor mixtures.
1.1.3 Place appropriate pictograms, signal words, hazard and precautionary
statements at the storage facility/ premise and on transport.
1.1.4 Importer, manufacturer, supplier and distributor of chemicals and mixtures
shall conduct appropriate education and training for GHS for the different
target audiences.
1.2 Specific rules
1.2.1 Label elements
1.2.1.1 Label elements are composed of the symbol, signal word and hazard
statement. A summary of the allocation of label elements is provided in Annex
A- Allocation of Label Elements.
1.2.1.2 The GHS hazard pictograms, signal word and hazard statements should
be located together on the label.
1.2.2 Reproduction of the symbol
1.2.2.1 Use the standard symbols in the GHS, except for the exclamation marksymbol, all other symbols are part of the UN Recommendations on theTransport of Dangerous Goods, Model Regulations.

Page 1421.2.3 Pictograms and reproduction of the hazard pictograms
1.2.3.1 Shape and color
1.2.3.1.1 Hazard pictograms used in the GHS shall be in the shape of asquare set at point.
1.2.3.1.2 Transport pictograms prescribed by the UN Recommendations
on the Transport of Dangerous Goods, Model Regulations shallbe used for chemicals for transport.
1.2.3.1.3 Transport pictograms shall be in the require minimum
dimensions of 100 mm by 100 mm, with some exceptions forallowing smaller pictograms for very small packagings and forgas cylinders.
Example:Pictogram for flammable liquid in the UN Model Regulations(Symbol: black or white; Background: Red;
Figure 3 in bottom corner; minimum dimensions: 100mm x 100mm)

1.2.3.1.4 The transport pictogram shall be printed or affixed to a
packaging on a background of contrasting color.
1.2.3.1.5 Pictograms prescribed by the GHS shall have a black symbolon a white background with a red frame.

Page 143

Example:

1.2.3.1.6 Packaging of materials which are not to be exported or for local
use only, can use the black border.
Example:Pictogram for hazardous to aquatic life

1.2.4 Allocation of Label Elements
1.2.4.1 Where a UN Model Regulations on the Transport of Dangerous Goods
pictogram appears on the label, a GHS pictogram for the same hazard
shall not appear.
1.2.4.2 GHS pictograms not required for the transport of dangerous goods shallnot be displayed on freight containers, road vehicles or railway wagons/
tanks.
1.2.4.3 The following GHS label elements shall appear on the packaging ofchemicals:
1.2.4.3.1Signal words to be used shall be “Danger” or “Warning”.
1.2.4.3.2“Danger” shall be used for the more severe hazard categories,
while “Warning” shall be used for the less severe.
1.2.4.4 Hazard statements
1.2.4.4.1 A complete hazard statement shall consist of hazard statement
and a hazard statement code (H-Code).
1.2.4.4.2 A hazard statement shall be appropriate with the degree of
hazard.
Page 144

1.2.4.4.3 A hazard statement code shall be consistent with the hazard
statement and shall be used as a reference only.
1.2.4.5 Precautionary statement
1.2.4.5.1 A complete precautionary statement shall consist of
precautionary statement and a precautionary statement code
(P-Code).
1.2.4.5.2 Precautionary
statement
precautionary information.

shall

includeappropriate

1.2.4.5.3 A precautionary statement code shall be consistent with the
precautionary statement and shall be used as a reference only.
1.2.4.6 Product identifier/ declaration of ingredients/ chemical identity
1.2.4.6.1 Product identifier used in the label shall be consistent withthe product identifier used in the SDS.
1.2.4.6.2 UN proper shipping shall be used on the package if asubstance or mixture is covered under UN Model
Regulations on the Transport of Dangerous Goods.
1.2.4.6.3 The label of a substance shall include the chemical identityof the substance, also consistent with the composition
declared in the SDS.
1.2.4.6.4 The labels for containers of hazardous chemical substancesor mixtures must clearly indicate the ingredients unlesscovered by the CBI agreement.
1.2.4.7 Supplier identification
1.2.4.7.1 The name, address and telephone number of the manufacturer
or supplier of the substance or mixture shall be indicated on
the label consistent with the information used in the SDS.
1.2.5 Precedence for the allocation of symbols
1.2.5.1The precedence of symbols for physical hazards shall follow the rulesof the UN Model Regulations if a substance and mixture are coveredby the UN Recommendations on the Transport on Dangerous Goods.
1.2.5.2 For health hazards, the following precedence shall apply:
1.2.5.2.1 If the skull and crossbones applies, the exclamation markshould not appear;
1.2.5.2.2 If the corrosive symbol applies, the exclamation mark should
not appear where it is used for skin or eye irritation;
Page 145

1.2.5.2.3 If the health hazard symbol appears for respiratory
sensitization, the exclamation mark should not appear where
it is used for skin sensitization or for skin or eye irritation.
1.2.6 Precedence for the allocation of signal words
1.2.6.1 If the signal word “Danger” applies, the signal word “Warning”
should not appear.
1.2.7 Precedence for the allocation of hazard statements
1.2.7.1 All assigned hazard statements should appear on the label, except for
the following conditions:1.2.7.1.1 If the statement H410 “Very toxic to aquatic life with long
lasting effects” is assigned, the statement H400 “Very toxic
to aquatic life” may be omitted;
1.2.7.1.2 If the statement H411 “Toxic to aquatic life with long lasting
effects” is assigned, the statement H401 “Toxic to aquaticlife” may be omitted;
1.2.7.1.3 If the statement H412 “Harmful to aquatic life long lasting
effects” is assigned, the statement H402 “Harmful to aquaticlife” may be omitted;
1.2.7.1.4 If the statement H314 “Causes severe skin burns and eye
damage” is assigned, the statement H318 “Causes serious eye
damage” may be omitted.
1.2.8 Arrangements for presenting the GHS label elements
1.2.8.1 Location of GHS information on the label
1.2.8.1.1 The GHS hazard pictograms, signal word and hazard
statements shall be located together on the label.
1.2.8.2 Supplemental information
1.2.8.2.1The placement of the supplemental information shall not
impede identification of GHS information.
1.2.8.3 Use of color outside pictograms
1.2.8.3.1 Color can be used on other areas of the label to implement
special labeling requirements such as the use of the pesticide
bands in the FAO Labeling Guide.

Page 146

1.2.9 Packaging specification
1.2.9.1 Chemicals shall be packed in good quality packagings, which shall bestrong enough to withstand the shocks and loadings encountered duringtransport, storage or manual or mechanical handling.
1.2.9.2 Inner packagings shall be packed in an outer packaging in such a waythat they cannot break, be punctured or leak their contents into the outer
packaging.
1.2.10 Label sizes and specification
1.2.10.1 All the applicable GHS label elements should appear on theimmediate container of a hazardous substance or mixture.
1.2.10.1.1

GHS Pictogram

1.2.10.1.2

Signal word

1.2.10.1.3

Hazard statement

1.2.10.1.4

Precautionary statement

1.2.10.1.5

Product identifier/ declaration of ingredients/ chemical
identity

1.2.10.1.6

Supplier identification

1.2.10.1.7

Supplemental information

1.2.10.2 GHS label sizes and requirements depend on the size of thecontainer. The minimum label dimensions based on the container sizeare given below:
Container Capacity
Less than 1 liter
Greater than 1 - 4 liters(0.066 – 0.792 gallons)Greater than 4 – 50 liters(3.17 – 13.2 gallons)Greater than 50 – 500 liters(13.2 – 132 gallons)Greater than 500 liters(> 132 gallons)Required GHS Label Dimensions
No size specification required but label should
be readable.
52 mm x 74 mm(2.04” x 2.91”)
74 mm x 105 mm(2.91” x 4.133”)
105 mm x 148 mm(4.133” x 5.82”)
148 mm x 210 mm(5.82” x 8.26”)

Page 147

E. Guidance Manual for the Preparationof Safety Data Sheet (SDS)
1.0 General rules, requirements and proceduresThis Section provides the specific guidance to be observed and followed in the
preparation of the Safety Data Sheet (SDS) to comply with the requirements of the
Department Administrative Order (DAO): Rules and Procedures for the Safety Data
Sheet (SDS), Labeling Requirements and Hazards Classification under DENR
Administrative Order No. 29, Series of 1992 of Republic Act 6969 for the Adoption and
Implementation of the Globally Harmonized System (GHS).
1.1 General rules
1.1.1 SDS shall be composed of sixteen (16) sections in the order of arrangement andpresentation within the SDS document based on GHS.
1.1.2 English shall be used as the primary language in preparing the SDS.
1.1.3 Safety Data Sheet shall be termed as such instead of Material Safety Data Sheet(MSDS) or Chemical Safety Data Sheet (CSDS).
1.1.4 SDS shall be written in a simple, clear and precise manner that isunderstandable by all stakeholders.
1.1.5 Avoid using vague and misleading expressions such as “may be dangerous”,“no health effects” “safe under most conditions of use” or “harmless”.
1.1.6 Indicate the date of issuance of SDS, it must be visible and clearly stated in the
document. The date of issue is the date of the SDS version when it was madepublic.
1.1.7 All pages of the SDS shall be numbered indicating if there are following pages
or end of pages.
1.1.8 Update SDS every 5 years or earlier where there are known changes in productcomposition that may affect the classification of the substance and/or product.
1.1.9 SDS shall be prepared by a competent person in the company to assure theaccuracy of information of the document.
1.1.10 SDS shall be made available and accessible to all workers at all times.
1.1.11 Training on the use of SDS shall be conducted by a competent person within
the company to ensure that all information is properly understood by theworkers.
Page 148

1.2 SDS format
1.2.1 Section 1. Identification
This section shall describe the GHS information requirements for SDSs.
1.2.1.1 Identify the substance name or mixture
1.2.1.1.1 The identity of the substance or mixture shall be exactly thesame as found on the label.
1.2.1.1.2 All names and variants shall be listed on the SDS if an SDS
is used to cover several minor variants of a substance or
mixture.
1.2.1.1.3 Alternative names, numbers, company products codes orother unique identifiers shall also be used as an alternative to
GHS product identifier.
1.2.1.2 Provide the name of the supplier1.2.1.2.1 Name of the supplier1.2.1.2.2 Complete address
1.2.1.3 Provide the recommended uses of the chemical, mixtures or product1.2.1.3.1 Provide a brief description of what the chemical or mixture
actually does.
1.2.1.3.2 Provide restrictions on use
1.2.1.3.3 State non-statutory recommendations of the chemical or
mixture1.2.1.4 Provide the contact detail information of the supplier1.2.1.4.1 Telephone number
1.2.1.5 Provide the emergency contact number
1.2.1.5.1 References to emergency information services
1.2.1.5.2 Include restrictions such as hours of operation (e.g Monday– Friday 0800 am – 05:00 pm)
1.2.1.5.3 Limits of specific types of information (e.g. medical
emergencies, or transportation emergencies)

Page 149

1.2.1.5.4 If the principal supplier or the manufacturer is a foreigncompany, and is most likely that contact numbers are fromthe said supplier, provide emergency contact numbers of thelocal distributor and/ or importer.

1.2.2 Section 2. Hazard identification
This section shall include a brief summary and/ or conclusion of the data
given, that even non-experts in the can identify all the hazards for thehazardous substance or mixture.
1.2.2.1 Hazard of the substance or mixture
1.2.2.1.1 Indicate the appropriate hazard class and category/ subcategory if a substance or mixture is classified in accordancewith physical, health and environmental hazards of GHS.
1.2.2.1.2 When classification is differentiated within a hazard classand resulted in unique hazard statements, the difference inclassification shall also be reflected e.g route of exposure
differentiates the acute toxicity classification: oral, dermal
and inhalation
1.2.2.1.3 If a substance or mixture is classified into more than one
category in a hazard class that is differentiated, allclassifications shall be indicated and communicated in theSDS.
1.2.2.2 Appropriate signal word, hazard statements and precautionary
statements associated with identified hazards
1.2.2.2.1 Provide appropriate label elements as indicated in Annexes
A, B and C of the Guidance Manual
1.2.2.2.2 Pictograms (or hazard symbols) shall be provided as agraphical reproduction of the symbols in black and white or
the name of the symbol, e.g. “flame”, “skull andcrossbones”.
1.2.2.2.3 Provide information on other hazards which do not result inclassification but may contribute to the overall hazards of thematerial, e.g. formation of air contaminants during
hardening or dust explosion hazards
1.2.3 Section 3. Composition/ information on ingredients
This section shall identify the ingredients of the product.
1.2.3.1 Chemical identity of the substance
Page 150

1.2.3.1.1 Common chemical name1.2.3.1.1.1 Chemical Abstract Service (CAS) registry
number
1.2.3.1.1.2 European Community (EC) number can be used
as other unique identifiers
1.2.3.1.1.3 International Union of Pure and Applied
Chemistry (IUPAC) name1.2.3.1.1.4 Trade name1.2.3.1.1.5 Brand name1.2.3.1.1.6 Product code
1.2.3.1.1.7 Impurities and stabilizing additives which arethemselves classified and which contribute to
the classification of the substance.
1.2.3.2 Mixture
1.2.3.2.1 Chemical identity
1.2.3.2.2 Identification number
1.2.3.2.3 Concentration or concentration ranges of all hazardous
ingredients, hazardous to health or the environment within
the context of GHS, and are present above their cut-off
levels.
1.2.3.2.3.1 Exact percentages in descending order by mass orvolume or;
1.2.3.2.3.2 Ranges of percentages in descending order bymass or by volume
1.2.4 Section 4. First-aid measures
This section shall describe the initial care that can be given by an untrained
responder without the use of sophisticated equipment and without a wide
selection of medications available.
1.2.4.1 Description of necessary first-aid measures
1.2.4.1.1 Provide first-aid instructions by relevant routes of exposure.
1.2.4.1.2 Provide advice whether:
Page 151

1.2.4.1.2.1 Immediate medical attention is required and if
delayed effects can be expected after exposure;
1.2.4.1.2.2 Movement of the exposed individual from the area
to fresh air is recommended;
1.2.4.1.2.3 Removal and handling of clothing and shoes fromthe individual is recommended;
1.2.4.1.2.4 Personal protective equipment (PPE) for first-aid
responders is recommended.
1.2.4.2 Most important symptoms / effects, acute and delayed
1.2.4.2.1 Provide information on the most important symptoms /effects, acute and delayed, from exposure
1.2.4.3 Indication of immediate medical attention and special treatment
needed, if necessary
1.2.4.3.1 Provide information on clinical testing and medical
monitoring for delayed effects, specific details on antidotes(if known) and contraindications.
1.2.5 Section 5. Fire-fighting measures
This section shall cover the requirements for fighting a fire caused by thesubstance or mixture, or arising in its vicinity.
1.2.5.1 Suitable extinguishing media
1.2.5.1.1 Provide information on the appropriate extinguishing media.
1.2.5.1.2 Indicate whether any extinguishing media are inappropriate
for a particular situation involving the substance or mixture.
1.2.5.2 Specific hazards arising from the chemical
1.2.5.2.1 Provide advice on specific hazards that may arise from thechemical, such as hazardous combustion products that form
when the substance or mixture burns.
1.2.5.2.1.1 “may produce toxic fumes of carbon monoxide if
burning”; or
1.2.5.2.1.2 “produces oxides of sulphur and nitrogen on
combustion”
1.2.5.3 Special protective actions for fire fighters
Page 1521.2.5.3.1 Provide advice on any protective actions to be taken during
fire fighting. E.g “keep containers cool with water spray”.

1.2.6 Section 6. Accidental release measures
This section shall recommend the appropriate response to spills, leaks, or
releases in order to minimize the adverse effects on persons, property and theenvironment. In this section, distinguish the response to small and large spills.
1.2.6.1 Personal precautions, protective equipment and emergency procedures
for non-emergency personnel
1.2.6.1.1 Provide advice related to accidental spills and release of thesubstance or mixture such as:
1.2.6.1.1.1 The wearing of suitable protective equipment(including PPE) to prevent any contamination ofskin, eyes and personal clothing;
1.2.6.1.1.2 Removal of ignition sources and provision of
sufficient ventilation;
1.2.6.1.1.3 Emergency procedures such as the necessity toevacuate the danger area or to consult an expert.
1.2.6.2 Personal precautions, protective equipment and emergency proceduresfor emergency responders
1.2.6.2.1 Provide advice related to suitable fabric for personal
protective clothing (e.g. “appropriate: butylenes; notappropriate: PVC”)
1.2.6.3 Environmental precautions
1.2.6.3.1 Provide advice on any environmental precautions related toaccidental spills and release of the substance or mixture, suchas keeping away from drains, surface or ground water.
1.2.6.4 Methods and materials for containment and cleaning up
1.2.6.4.1 Provide appropriate advice on how to contain and clean up a
spill.
1.2.6.4.2 Appropriate containment techniques include the following:
1.2.6.4.2.1 Bunding, covering of drains; and1.2.6.4.2.2 Capping procedures
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1.2.6.4.3 Appropriate clean up techniques include the following:
1.2.6.4.3.1 Neutralization;
1.2.6.4.3.2 Decontamination;
1.2.6.4.3.3 Use of adsorbent materials;
1.2.6.4.3.4 Cleaning techniques;1.2.6.4.3.5 Vacuuming; and1.2.6.4.3.6 Equipment required for containment/ clean up
which include non-spark producing tools andequipment
1.2.6.4.4 Provide any other issues relating to spills and releases. E.g
advice on inappropriate containment or clean up techniques.
1.2.7 Section 7. Handling and storage
This section shall describe the guidance on safe handling practices thatminimize the potential hazards to people, property and the environment fromthe substance or mixture.
1.2.7.1 Precautions for safe handling
1.2.7.1.1 Provide advice that:
1.2.7.1.1.1 Allows safe handling of the substance or mixture;
1.2.7.1.1.2 Prevents handling of incompatible substances or
mixtures; and1.2.7.1.1.3 Minimizes the release of the substance or mixture
to the environment.
1.2.7.1.2 Provide advice on general hygiene:1.2.7.1.2.1 “Eating, drinking and smoking in work areas isprohibited”;
1.2.7.1.2.2 “Wash hands after use”; and1.2.7.1.2.3 “remove contaminated clothing and protective
equipment before entering eating areas”.
1.2.7.2 Conditions for safe storage, including any incompatibilities

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1.2.7.2.1 Provide advice that is consistent with the physical andchemical properties of the substances or mixture as discussed
in Section 9 of the SDS:
1.2.7.2.1.1 How to avoid:1.2.7.2.1.1.1 Explosive atmospheres;
1.2.7.2.1.1.2 Corrosive conditions;1.2.7.2.1.1.3 Flammability hazards;
1.2.7.2.1.1.4 Incompatible substances or mixtures;
1.2.7.2.1.1.5 Evaporative conditions;1.2.7.2.1.1.6 Potential ignition sources including
electrical equipment.
1.2.7.2.1.2 How to control the effects of:
1.2.7.2.1.2.1 Weather conditions;1.2.7.2.1.2.2 Ambient pressure;
1.2.7.2.1.2.3 Temperature;
1.2.7.2.1.2.4 Sunlight;
1.2.7.2.1.2.5 Humidity; and1.2.7.2.1.2.6 Vibration.
1.2.7.2.1.3 How to maintain the integrity of the substance or
mixture by the use of:
1.2.7.2.1.3.1 Stabilizers; and1.2.7.2.1.3.2 Anti-oxidants.
1.2.7.2.1.4 Other advice including:
1.2.7.2.1.4.1 Ventilation requirements;
1.2.7.2.1.4.2 Specific designs for storage rooms/
vessels;
1.2.7.2.1.4.3 Quantity limits
conditions; andunderstorage

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1.2.7.2.1.4.4 Packaging compatibilities.

1.2.8 Section 8. Exposure controls / personal protection
This section shall provide guidance on “occupational exposure limits” andexposure controls necessary to minimize worker and environmental exposure.
1.2.8.1 Control parameters1.2.8.1.1 Provide list of occupational exposure and biological (ifavailable) limits including notations, for a substance or
mixture and for each ingredients of a mixture.
1.2.8.1.2 Occupational limits and biological limits (if available) for a
substance or mixture and for each ingredients of a mixture
for the country or region in which SDS is being supplied.
1.2.8.1.3 Sources of occupational exposure limits and biological limits
1.2.8.1.4 List of occupational exposure and biological limits of theingredients listed in Section 3 of the SDS.
1.2.8.2 Appropriate engineering controls
1.2.8.2.1 Description of appropriate exposure control measures related
to the intended modes of use of the substance or mixture
1.2.8.2.1.1 “maintain air concentrations below occupational
exposure standards”, using engineering controls;
1.2.8.2.1.2 “use local exhaust ventilation when”;
1.2.8.2.1.3 “use only in an enclosed system”;
1.2.8.2.1.4 “use only in spray paint booth or enclosure”;
1.2.8.2.1.5 “use mechanical handling to reduce humancontact with materials”; or
1.2.8.2.1.6 “use explosive dust handling controls”.
1.2.8.2.2 Advices in this section shall complement the information
provided under Section 7 of the SDS.
1.2.8.3 Individual protection measures, such as personal protective equipment(PPE)
1.2.8.3.1 PPE shall be in consistent with occupational hygiene
practices, and in conjunction with other control measures
including engineering controls, ventilation and isolation.
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1.2.8.3.2 Identify the PPE needed to minimize the potential for illness
or injury due to exposure from the substance or mixture:
1.2.8.3.2.1 Eye/ face protection: specify the type of eye
protection and/or face shield required, based on
the hazard of the substance or mixture andpotential for contact;
1.2.8.3.2.2 Skin protection: specify the protective equipment
to be worn (e.g. type of gloves, boots and bodysuit) based on the hazard of the substance or
mixture and potential for contact;
1.2.8.3.2.3 Respiratory protection: specify the appropriate
types of respiratory protection based on thehazard of the substance or mixture and potential
for exposure, including air-purifying respiratorsand the proper purifying element (cartridge orcanister) or breathing apparatus; and1.2.8.3.2.4 Thermal hazards: when specifying protective
equipment to be worn for materials that representa thermal hazard, special consideration shall begiven to the construction of the PPE.
1.2.8.3.3 Clearly specify the type of PPE where special requirements
may exist such as the type of gloves or other protective
clothing to prevent skin, eye or lung exposure. E.g “PVC
gloves” or “nitrile gloves”.

1.2.9 Section 9. Physical and chemical properties
This section shall describe the empirical data of the substance or mixture (ifpossible).
1.2.9.1 Identify the properties and specify appropriate units of measure
and/or reference conditions.
1.2.9.2 The method of determination for the interpretation of thenumerical value shall be provided.
1.2.9.2.1 Appearance (physical state, color, etc);
1.2.9.2.2 Odor;
1.2.9.2.3 Odor threshold;
1.2.9.2.4 pH;
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1.2.9.2.5 melting point/ freezing point;
1.2.9.2.6 initial boiling point and boiling range;
1.2.9.2.7 flash point;
1.2.9.2.8 evaporation rate;
1.2.9.2.9 flammability (solid, gas);
1.2.9.2.10 upper/lower flammability or explosive limits;
1.2.9.2.11 vapor pressure;
1.2.9.2.12 vapor density;
1.2.9.2.13 relative density;
1.2.9.2.14 solubilites;
1.2.9.2.15 partition coefficient: n-octanol / water
1.2.9.2.16 auto-ignition temperature;
1.2.9.2.17 decomposition temperature;
1.2.9.2.18 viscosity
1.2.9.3 If specific characteristics do not apply or not available, they shallstill be listed on the SDS with a statement that they “do not apply”
or “data not available”.
1.2.9.4 Other physical or chemical properties in addition to those listed
above may also be included in this section of SDS.

1.2.10Section 10. Stability and reactivity
This section shall describe the reactivity hazards of the substance or mixture.
1.2.10.1 Reactivity
1.2.10.1.1 Provide specific test data for the substance or mixture as awhole.
1.2.10.1.2 Information may also be based on general data for theclass or family of chemical if such data adequate represent
the anticipated hazard of the substance or mixture.
1.2.10.2 Chemical stability
Page 1581.2.10.2.1 Indicate if the substance or mixture is stable or unstable
under normal ambient and anticipated storage and handlingconditions of temperature and pressure.
1.2.10.2.2 Describe any stabilizers which are, or may need to be, used
to maintain the product.
1.2.10.2.3 Indicate the safety significance of any changes in thephysical appearance of the product.
1.2.10.3 Possibility of hazardous reactions
1.2.10.3.1 State if the substance or mixture will react or polymerize,
releasing excess pressure or heat, or creating otherhazardous conditions.
1.2.10.3.2 Describe under what conditions the hazardous reactions
may occur.
1.2.10.4 Conditions to avoid
1.2.10.4.1 List conditions such as heat, pressure, shock, static
discharge, vibrations or other physical stresses that might
result in hazardous situation.
1.2.10.5 Incompatible materials
1.2.10.5.1 List classes of chemicals or specific substances with which
the substance or mixture could react to produce a hazardous
situation.
1.2.10.6 Hazardous decomposition products
1.2.10.6.1 List
known
reasonably
anticipatedhazardous
decomposition products produces as a result of use, storage
and heating.
1.2.11

Section 11. Toxicological information
This section shall provide information to be used by medical professionals,
occupational health and safety professionals and toxicologists.
1.2.11.1 Describe various toxicological health effects from relevant hazards
derived from GHS classification:
1.2.11.1.1 Acute toxicity;
1.2.11.1.2 Skin corrosion / irritation;
1.2.11.1.3 Serious eye damage/ irritation;
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1.2.11.1.4 Respiratory or skin sensitization;
1.2.11.1.5 Germ cell mutagenicity;
1.2.11.1.6 Carcinogenicity;
1.2.11.1.7 Reproductive toxicity;
1.2.11.1.8 STOT- single exposure;
1.2.11.1.9 STOT- repeated exposure; and1.2.11.1.10Aspiration hazard.
1.2.11.2 If data from the GHS classification is not available, they shall still belisted in the SDS with a statement that “data is not available”
1.2.11.3 Information on the likely routes of exposure
1.2.11.3.1 Provide information on the likely routes of exposure andthe effects of the substance or mixture via each possible
route of exposure, that is, through ingestion, inhalation or
skin/ eye exposure.
1.2.11.3.2 A statement should be made if health effects are notknown.
1.2.11.4 Symptoms related to the physical, chemical and toxicologicalcharacteristics
1.2.11.4.1 Describe the potential adverse health effects andsymptoms associated with exposure to the substance or
mixture and its ingredients or known by-products.
1.2.11.4.2 Provide information on the symptoms related to thephysical, chemical and toxicological characteristics of thesubstance or mixture following exposure to intended uses.
1.2.11.4.3 Describe the first symptoms at the lowest exposuresthrough to the consequences of severe exposures.
1.2.11.5 Delayed and immediate effects and also chronic effects from shortand long term exposure
1.2.11.5.1 Provide information on whether delayed or immediate
effects can be expected after short or long term exposure.
1.2.11.5.2 Provide information on acute and chronic health effects
relating to human exposure to the substance or mixture.
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1.2.11.5.3 If human data are not available. Animal data should besummarized. Identify if the data is from human or animaldata.
1.2.11.6 Numerical measures of toxicity (such as acute toxicity estimates)
1.2.11.6.1 Provide information on the dose, concentration orconditions of exposure that may cause adverse healtheffect.
1.2.11.6.2 Doses shall be linked to symptoms and effects, including
period of exposure likely to cause harm.
1.2.12

Section 12. Ecological information
This section shall provide information to evaluate the environmental impact of
the substances or mixture if it is released to the environment.
1.2.12.1 Provide information available for assisting user in:
1.2.12.1.1 Handling spills;
1.2.12.1.2 Evaluating waste treatment practices;
1.2.12.1.3 Provide summary of data given under toxicity and otheradverse effects
1.2.12.2 Provide information on toxicity using data from tests performed on
aquatic and/or terrestrial organisms and relevant data on both acuteand chronic aquatic toxicity.
1.2.12.3 Provide test results that can assess persistence and degradability.
1.2.12.3.1 Indicate whether half-lives refer to mineralization or to
primary degradation.
1.2.12.3.2 Degradation
mentioned.

insewagetreatment

plantsshallbe

1.2.12.4 Provide test results that can assess bioaccumulative potential.
1.2.12.4.1 Octanol-water coefficient (Kow);
1.2.12.4.2 Bioconcentration factor (BCF);
1.2.12.5 Provide information on mobility from related mobility data such as:
1.2.12.5.1 Adsorption studies;
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1.2.12.5.2 Leaching studies;1.2.12.6 Provide information on any other adverse effects to the environment:
1.2.12.6.1 Environmental fate;1.2.12.6.2 Ozone depletion potential;
1.2.12.6.3 Photochemical ozone creation potential;
1.2.12.6.4 Endocrine disrupting potential; and / or1.2.12.6.5 Global warming potential
1.2.13

Section 13. Disposal consideration
This section shall provide information for proper disposal, recycling or
reclamation of the substance or mixture and/ or its container to assist in thedetermination of safe and environmentally preferred waste management
options, consistent with the requirements of the national competent authority.
1.2.13.1 Specify disposal containers and methods;
1.2.13.2 Discuss physical/ chemical properties that may affect disposal
options;
1.2.13.3 Discourage sewage disposal;
1.2.13.4 Identify any special precautions for incineration or landfill.

1.2.14

Section 14. Transport information
This section shall provide basic classification information for the transporting
shipment of hazardous substance or mixture by road, rail, sea or air.
1.2.14.1 Provide UN number (four-figure identification number of thesubstance or article0 from the UN Model Regulations.
1.2.14.2 Provide the UN proper shipping name from the UN Model
Regulations.
1.2.14.3 Provide the transport hazard class (and subsidiary risks) assigned tothe substances or mixtures according to the most predominant hazard
that may be present in accordance with the UN Model Regulations.
1.2.14.4 Provide the packing group number from the UN Model Regulations if
applicable. The packing group number is assigned to certain
substances in accordance with their degree of hazard.
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1.2.14.5 Indicate whether the substance or mixture is known marine pollutant
according to the IMDG Code, and if so, whether it is “marine
pollutant” or a “severe marine pollutant”.
1.2.14.6 Indicate whether the substance or mixture is environmentallyhazardous according to the UN Model Regulations, ADR, RID and
ADN.
1.2.14.7 Provide information on any special precautions, which a user needs tobe aware of, or needs to comply with in connection with transport.
1.2.14.8 Provide sub-section when cargoes are intended to be carried in bulk
according to the IMO instruments: Annex II of MARPOL 73/78 andthe IBC Code.
1.2.15

Section 15. Regulatory information
This section shall describe any other regulatory information on the substanceor mixture that is not provided elsewhere in the SDS.
1.2.15.1 Specify if the substance or mixture is covered under Montreal
Protocol, Stockholm Convention or the Rotterdam Convention.
1.2.15.2 Specify if the product is under Chemical Control Order (CCO),
Priority Chemical List (PCL) for local chemical substance or
mixtures.
1.2.15.3 Provide safety, health and environmental regulations specific for the
product in question

1.2.16

Section 16. Other information
This section shall provide information relevant to the preparation of the SDS.
It shall incorporate other information that does not belong in Sections 1 to 15of the SDS.
1.2.16.1 The date of preparation of the latest revision of the SDS. Whenrevisions are made to an SDS, indicate clearly where the changes
have been made to the previous version of the SDS.
1.2.16.1.1 Suppliers shall maintain an explanation of the changes
and be willing to provide to the requesting party uponrequest;1.2.16.2 Key / legend to abbreviations and acronyms used in the SDS; and1.2.16.3 Key literature references and sources for data used to compile the
SDS.
Page 1631.3 Submission of SDS
1.3.1 An importer, distributor, supplier and manufacturer shall submit a hard copyof the latest revision SDS in the GHS format as an additional requirement insecuring the necessary Permits/ Licenses and Clearances from DENR-EMB.
1.3.2 Electronic copy of the latest revision of SDS shall be submitted to DENREMB for compilation of SDS. The SDS shall be used to:
1.3.2.1 monitor the inventory of chemicals in the country;
1.3.2.2 update the information in the existing Philippine Inventory ofChemicals and Chemical Substances (PICCS);
1.3.2.3 provide information during emergency situations involving thechemicals and/ or mixtures;
1.3.2.4 gather information for future establishment of a comprehensive
chemical database.
1.3.3 An importer, distributor, supplier and manufacturer shall submit to DENREMB an updated revision of the SDS every 5 years of submission or any
changes in the product composition.
1.4 Maintenance of SDS
1.4.1 DENR-EMB GHS Review Committee shall review the completeness of thesixteen (16) sections of the submitted SDS upon submission of SDS.
1.4.2 DENR-EMB shall allocate resources and designate an individual for the
maintenance of these SDSs.
1.4.3 DENR-EMB shall compile the electronic copies of SDS.

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