GHS Classification Guidance for the Japanese Government

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3-2-6 Carcinogenicity (1)Definitions Definitions of Carcinogenicity in UN GHS are as follows, and they are adopted in this guidance. 【GHS 2 nd revised edition】(3.6.1) The term carcinogen denotes a chemical substance or a mixture of chemical substances which induce cancer or increase its incidence. Substances which have induced benign and malignant tumours 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 tumour formation is not relevant for humans. Classification of a chemical as posing a carcinogenic hazard is based on the inherent properties of the substance and does not provide information on the level of the human cancer risk which the use of the chemical may represent. (2)Classification criteria A) Classification criteria based on JIS Classification Hazard categories for carcinogens in JIS Classification are shown below. Table 3-9 Hazard categories for carcinogens Category 1: The placing of a known or presumed human carcinogen in Category 1 is done on the basis of epidemiological and/or animal data. An individual chemical may be further distinguished: Category 1A: The placing of a chemical known to have carcinogenic potential for humans in Category 1A is largely based on human evidence. Category 1B: The placing of a chemical presumed to have carcinogenic potential for humans in Category 1B is largely based on animal evidence. Based on strength of evidence together with additional considerations, such evidence may be derived from human studies that establish a causal relationship between human exposure to a chemical and the development of cancer (known human carcinogen). Alternatively, evidence may be derived from animal experiments for which there is sufficient evidence to demonstrate animal carcinogenicity (presumed human carcinogen). In addition, on a case by case basis, scientific judgment may warrant a decision of presumed human carcinogenicity derived from studies showing limited evidence of carcinogenicity in humans together with limited evidence of carcinogenicity in experimental animals. Classification: Category 1 (A and B) Carcinogen 152
Category 2:Suspected human carcinogens The placing of a chemical in Category 2 is done on the basis of evidence obtained from human and/or animal studies, but which is not sufficiently convincing to place the chemical in Category 1. Based on strength of evidence together with additional considerations, such evidence may be from either limited evidence of carcinogenicity in human studies or from limited evidence of carcinogenicity in animal studies. Classification: Category 2 Carcinogen B) Classification criteria in GHS (Reference information) In classification criteria of JIS classification and that of GHS, the same categories are adopted. (3)Items on information sources and data * Classification procedure can be referred to "3-1-1 Sources of Information available for classification". A) Data availability Many descriptions on carcinogenicity can be found in hazard-related reviews and databases. Useful rankings of carcinogenicity are reported by many organizations, which can be of reference in classification (WHO International Agency for Research on Cancer (IARC), Classification results of EU classification, the U.S. National Toxicology Program(NTP), carcinogens in “Recommendations for Acceptable Concentrations” by the Japan Society For Occupational Health, Carcinogenicity notes in “TLVs and BEIs” by ACGIH, Integrated Risk Information System(IRIS) by the U.S. EPA、Carcinogenicity notes in “List of MAK and BAT Values” by Germany DFG, etc. See [3-1]). OECD Test Guidelines include the following test methods relating to Carcinogenicity. OECD451 Carcinogenicity studies OECD453 Combined chronic toxicity / carcinogenicity studies B) Order of Precedence when Conflicting Data Exist By referring to “3-1-2 Order of Precedence when Conflicting Data Exist” (p.97),the following points should be taken into consideration. Information by IARC and EU represents conclusions by many experts, and takes precedence. Besides, information by the Japan Society For Occupational Health, US-EPA, US-NTP, ACGIH, and the Germany DFG, if any, can be of reference. C) Comparison with conventional classification systems 153
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GHS Classification Guidance for the
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2-3-12 Substances and mixtures whic
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Japanese judgments and consideratio
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(2) Points to remember when describ
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① ② Information Gathering Class
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Part2. Physical Hazards Guidance 2-
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described in the next section is of
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Information in the book can be sear
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(8) International Chemical Safety C
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guidelines can be compared with GHS
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“Liquids” are defined as substa
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When a substance does not contain c
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Table 2-2 Filled examples of "Not a
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oxygen balance = -1600 [2x +(y/2) -
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GHS classification 8)Self-reactive
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The “Dangerous Goods Regulations,
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4.2 4.3 5.1(I) 5.1(II) 5.1(III) 6.1
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Table 2-5 Filled examples of “Cla
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explosion hazard: (i) combustion of
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water, by mass (n)GUANYLNITROSAMINO
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substance 0224 BARIUM AZIDE, dry or
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1337 NITROSTARCH, WETTED with not l
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(4) Data availability Physical prop
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flame distance (ignition distance)
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Nitrogen trifluoride C і = 1.6 Nit
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2-3-5 Gases Under Pressure (1)Defin
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2-3-6 Flammable Liquids (1)Definiti
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Category 3 =UNRTDG3 III Category 4
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Table 2.7.1: Criteria for flammable
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2-3-8 Self-reactive Substances and
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2.8.2.3 Criteria for temperature co
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3225 There is no article with a spe
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classified according to it. If not,
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classified”. Reference: UN GHS se
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Table 2.11.1: Criteria for self-hea
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than 30% water of crystallization 1
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transport, the same chemical is to
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138: Water-reactive substances - em
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orohydrides, alkyl compounds, etc.)
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2-3-13 Oxidizing Liquids (1)Definit
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2-1-14 Oxidizing Solids (1)Definiti
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(Example of category 3)2067 AMMONIU
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this class, according to the follow
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The flow chart of 2.15.2.2 is exact
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2-3-16 Corrosive to Metals (1)Defin
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Note: In GHS, it is defined that if
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1-1) Organization National Institut
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URL http://www.ecetoc.org/publicati
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List 2: Useful information sources
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http://www.cdc.gov/niosh/npg/npgdrt
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3-1-3 Management of information in
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Page 108 and 109: follows: Category 1 (100 ppmV), Cat
Page 110 and 111: (ii) the appropriate conversion val
Page 112 and 113: UNRTDG Class 6.1 is not sub-categor
Page 114 and 115: possible” unless the obvious conc
Page 116 and 117: whereas the reference value is set
Page 118 and 119: 3-2-2 Skin Corrosion/Irritation (1)
Page 120 and 121: Table 3.2.2 Skin irritation categor
Page 122 and 123: possible, and to classify the subst
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Page 126 and 127: 【GHS 2 nd revised edition】 Figu
Page 128 and 129: [Note for the above figure] (a) Cla
Page 130 and 131: B) Classification criteria in GHS (
Page 132 and 133: (4)Guidance for classification and
Page 134 and 135: G) Strategy of testing and evaluati
Page 136 and 137: 2c Structure activity Skin corrosiv
Page 138 and 139: done in parallel. This stage should
Page 140 and 141: criteria given below:” a) If ther
Page 142 and 143: [Decision Criteria 1]: In the cases
Page 144 and 145: substance shall be classified in Ca
Page 146 and 147: The classification is based on any
Page 148 and 149: 7) Data from various kinds of tests
Page 150 and 151: Table 3-8 Test data as the basis of
Page 152 and 153: Category 1B. Mutagens classified a
Page 154 and 155: c)Exceptionally, strong positive re
Page 158 and 159: The principles of GHS classificatio
Page 160 and 161: B) Substance for which GHS classifi
Page 162 and 163: metabolic system, a cautious invest
Page 164 and 165: hazard warning for pregnant women a
Page 166 and 167: OECD414 Prenatal development toxici
Page 168 and 169: D) Decision logic and classificatio
Page 170 and 171: e considered to be sufficient. (Sub
Page 172 and 173: No. Test guideline Limit dose 414 P
Page 174 and 175: 3-2-8 Specific Target Organ Toxicit
Page 176 and 177: specifically for these effects as d
Page 178 and 179: existing MSDSs. A literature search
Page 180 and 181: * Unless a description that definit
Page 182 and 183: g) When the affected organ can be i
Page 184 and 185: 3-2-9 Specific Target Organ Toxicit
Page 186 and 187: Table 3-16: Guidance value ranges f
Page 188 and 189: (c) Any consistent and significant
Page 190 and 191: has received some degree of approva
Page 192 and 193: As for the classification of specif
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Page 196 and 197: The classification criteria refer t
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4-2 Classification of Hazardous to
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water solubility, and which are not
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Tests shall be conducted by using f
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e categorized based on chronic aqua
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endpoint. When it is not clear whet
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that the relevant information sourc
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214
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R39 Danger of very serious irrevers
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R52 Harmful to aquatic organisms. R
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GHS Classification Guidance for the Japanese Government

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