GHS Classification Guidance for the Japanese Government

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OECD414 Prenatal development toxicity study OECD415 One-generation reproduction toxicity study OECD416 Two-generation reproduction toxicity OECD421 Reproduction / developmental toxicity screening test OECD422 Combined repeated dose toxicity study with the reproduction / developmental toxicity screening test B) Order of Precedence when Conflicting Data Exist Refer to “3-1-2 Order of Precedence when Conflicting Data Exist” (p.97). If appropriate information sources based on data cannot be obtained easily, try to obtain the original EU assessment documents from the EU classification (R60, R61, R62, R63, and R64) corresponding to reproductive toxicity. If the assessment documents are available, classify substances based on them. C) Comparison with conventional classification systems The concept of the EU category classification on reproductive toxicity is in accord with that of the GHS category classification. Substances classified as Category 1 in EU classification with R60, R61 fall under GHS classification Category 1A. Substances classified as Category 2 in EU classification with R60, R61 fall under GHS classification Category 1B. Substances classified as Category 3 in EU classification with R62, R63 fall under GHS classification Category 2. Since substances in EU classification R64 (May be hazardous for breastfed children) fall under “the additional category for effects on or via lactation”, The hazard statement “May cause harm to breast-fed children.” Is applied to them. D) Guidance concerning data When classification is performed based on reproductive toxicity test data, substances known to have reproductive toxicity to humans are classified in Category 1A. Substances presumed to have reproductive toxicity to humans largely based on evidence from experimental animals are classified in Category 1B. Other substances suspected of reproductive toxicity to humans are classified in Category 2. (4)Guidance for classification and judgment A) Background of this item and points to be noted As for background of this item, refer to Part 1, Introduction. 162
In classification, take the following points into account. * Regarding all assessment documents in List 1, be sure to search a description relating to the substance. * Unless a description that definitely denies hazards or recognizes extremely low hazards is available in List 1, the determination of “Not classified” should be performed carefully. If there is any question, a given substance should rather be classified in “Classification not possible” due to insufficient information for judgment. B) Key points for classification Taking into account that when there is any difference between tested animal and humans regarding administration methods or action mechanisms, the results of the animal tests lose their weight as evidence. For example, if the action mechanism of a substance is different in humans and tested animals and if it is clearly proved that the hazard caused by the substance is not manifested in humans, then the substance should not be classified in this category, even if reproductive hazards are manifested in the tested animals. When a test material indicates toxicity in the bodies of mothers among the tested animal, the test material can sometimes be observed as if it indicated reproductive toxicity. Accordingly, when evidence of reproductive toxicity is secondary non-specific effects caused by other toxic actions, the evidence should not be used for classification. The same shall apply for embryos and fetuses. C) General considerations 1) Reproductive Toxicity GHS defines reproductive toxicity as toxic effects on sexual function and fertility in adult males and females, as well as on development of offspring. 2) Adverse effects on sexual function and fertility Any effect by chemicals that could interfere with sexual function and fertility. This includes alterations to the female and male reproductive organs, adverse effects on onset of puberty, gamete reproduction and transport, reproductive cycle normality, sexual behaviour, fertility, parturition, or pregnancy outcomes, premature reproductive senescence, or modifications in other normal reproductive functions. 3) A dverse effects on development of the offspring In its widest sense, developmental toxicity includes any effects which interferes with normal development of the conceptus, fetus, and born children. However, for the purpose of classification, the developmental toxicity is limited to adverse effects essentially induced during pregnancy or as a result of parental exposure. 163
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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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Relation between concentration(ppm)
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follows: Category 1 (100 ppmV), Cat
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(ii) the appropriate conversion val
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UNRTDG Class 6.1 is not sub-categor
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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
Page 124 and 125: and scaling persist to the end of 1
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 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
Page 162 and 163: metabolic system, a cautious invest
Page 164 and 165: hazard warning for pregnant women a
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
Page 194 and 195: formed in the mouth, which then may
Page 196 and 197: The classification criteria refer t
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Page 200 and 201: (1)Sources for test data for Hazard
Page 202 and 203: List 2: Useful information sources
Page 204 and 205: 3-3)EU classification When classif
Page 206 and 207: 4-2 Classification of Hazardous to
Page 208 and 209: water solubility, and which are not
Page 210 and 211: Tests shall be conducted by using f
Page 212 and 213: e categorized based on chronic aqua
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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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