GHS Classification Guidance for the Japanese Government

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Category 1B. Mutagens classified as Category 3 (R68) in EU classification correspond to substances in Category2. D) Guidance concerning data Classification should be performed based on data derived from appropriate information sources. (Germ cell) Mutagenicity classification established by EU and classification of German MAK Committee are helpful. The mutagenicity in EU classification and the germ cell mutagenicity in GHS have the same objective and classification criteria. Accordingly, test methods which can be used in EU classification can also be used in GHS classification. Other test methods, if appropriate, can also be used. (4)Guidance for classification and judgment A) Background of this item and points to be noted Regarding the background of this item, refer to Part 1, Introduction. In classification, compare and examine all available data. It is preferable to seek for an expert's judgment about the evaluation of test results as needed. Substances having only in vitro mutagenicity data available shall, generally, be classified in "Classification not possible". * Regarding germ cell mutagenicity, refer to the UN GHS second revised edition and this item, and classify substances according to the Workflow in Decision logic 3.5.1, the UN GHS second revised edition. B) Classification Criteria Shown below are examples of test results corresponding to each GHS Category and the classification workflow in Fig. 3-2 for helping classification. In the workflow, positive results fundamentally take precedence, but their appropriateness may be examined when needed. “Negative” results may be the result of using only one of many indexes (for example, using a part of strains in bacterial reverse mutation tests) or the result of tests conducted inappropriately (for example, inappropriate sampling time in bone marrow micronucleus test), and examination of their validity should be performed when needed. On the whole, the validity of each set of data is considered, and the substance is determined based on the weight of evidence. 1) Category 1A:When evidence from epidemioological studies in human germ cells are available: Substances whose human heritable mutagenicity was recognized by human 148
epidemioological studies shall be classified in Category 1A. However, no such substance has been identified to date. 2) Category 1B:When in vivo mutagenicity test data and information suggesting germ cell mutagenicity are available: Since positive results have been obtained with many test methods such as in vivo mutagenicity tests using germ cells, substances which should be regarded as if they induce heritable mutation in humans shall be classified in Category 1B. Specifically, the following cases are applicable: a)Positive results from heritable mutagenicity tests in mammalian germ cells (rodent dominant lethal mutation test, mouse reciprocal translocation assay, mouse specific locus test, etc.). b)Positive results from mutagenicity tests in mammalian germ cells (mammalian spermatogonial chromosomal abnormality test, mammalian spermatid micronucleus assay, germ cell gene mutation test using transgenic mouse/rat, etc.). c)Positive results from mutagenicity tests in mammalian somatic cells (mammalian bone marrow chromosome aberration test, mammalian erythrocyte micronucleus test, mouse spot test, etc.) and some evidence that the substances have potential to induce mutation in germ cells: for example, positive results in in vivo genotoxicity tests in germ cells (sister chromosome exchange (SCE) analysis in mammalian spermatogonia, unscheduled DNA synthesis (UDS) test in mammalian testicular cells, etc.) and evidence of exposure of germ cells to the substnces or their metabolite(s). d)Positive results showing mutagenicity in human germ cells even if there is no evidence showing effects to next generation: for example, an increase in the frequency of aneuploidy in sperm cells of exposed human subjects. 3) Category 2:When in vivo mutagenicity/genotoxicity test data are available, but when no direct information suggesting mutation of germ cells is available: Substances suspected to cause heritable mutagenicity in humans shall be classified in Category 2. For example, the following cases meet this condition: a)Positive results from mutagenicity tests in mammalian somatic cells (mammalian bone marrow chromosome aberration test, mammalian erythrocyte micronucleus test, mouse spot test, etc.), b)Positive results from genotoxicity tests in mammalian somatic cells (unscheduled DNA synthesis (UDS) test in mammalian liver, sister chromosome exchange (SCE) analysis in mammalian bone marrow, etc.) and positive results from in vitro mutagenicity tests (chromosomal abnormality test in mammalian cultured cells, gene mutation test in mammalian cultured cells, bacterial reverse mutation test, etc.). 149
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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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Page 104 and 105: 3-1-3 Management of information in
Page 106 and 107: Relation between concentration(ppm)
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
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Page 156 and 157: 3-2-6 Carcinogenicity (1)Definition
Page 158 and 159: The principles of GHS classificatio
Page 160 and 161: B) Substance for which GHS classifi
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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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List 2: Useful information sources
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3-3)EU classification When classif
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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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