GHS Classification Guidance for the Japanese Government

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existing MSDSs. A literature search should be carried out for reliable reviews and primary information relevant to toxic actions. Substances with R-Phrases 8 (R39, R68, R37, and R67) in EU classification are feared to possess specific target organ toxicity (single exposure). T + , R39 and T, R39 correspond to Category 1. R68 corresponds to Category 2. R37 and R67 correspond to Single Exposure Category 3 respiratory tract irritation and narcotic effects, respectively. B) Order of Precedence when Conflicting Data Exist 1) Data from evaluation by reliable organizations (for example, data obtained from reference documents shown in List 1). 2) If appropriate sources of information based on data cannot be obtained easily, try to obtain the original EU assessment documents for the EU classification (R39, R68, and R67) corresponding to Specific Target Organ Toxicity-Single Exposure. When the assessment documents are obtained, classify on the basis of the documents. 3) Report data which can be considered to be reliable (Measurements are according to GLP, or data which are the basis of judgment are clearly shown and evaluated, etc.). 4) Data collected from other sources of information (for example, data from references shown in List 2 or 3) C) Comparison with conventional classification systems Systems in accord with GHS include R-Phrases 9 (R39, R68, R37, and R67) in EU classification. D) Guidance concerning data If information on specific, non lethal, target organ toxicity arising from a single exposure are available, experts should judge whether the toxicity has significant health effects in humans or not. The exposure route by which the classified substance has produced damage should be specified. Examples are provided below of toxic effects in humans or experimental animals that must be taken into consideration in classification of specific target organ toxicity. 【GHS 2 nd revised edition】(3.8.2.1.7.3) Evidence from appropriate studies in experimental animals can furnish much more detail, in the form of clinical observations, and macroscopic and microscopic 8 For R-Phrase, see Appendix. 9 For R-Phrase, see Appendix. 174
pathological examination and this can often reveal hazards that may not be life-threatening but could indicate functional impairment. Consequently all available evidence, and relevance to human health, must be taken into consideration in the classification process. Examples of relevant toxic effects in humans and/or animals 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, other organs or other organ 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 in clinical biochemistry, haematology, or urinalysis parameters; (d) Significant organ damage that may be noted at necropsy and/or subsequently seen or confirmed at microscopic examination; (e) Multifocal or diffuse necrosis, fibrosis or granuloma formation in vital organs 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 and reduced cell number) in vital organs incapable of regeneration. Hazards listed below are treated separately in the UN GHS second revised edition and hence are not included in specific target organ toxicity. - Acute Toxicity (3-2-1) - Skin Corrosion/Irritation (3-2-2) - Serious Eye Damage/Eye Irritation (3-2-3) - Respiratory or Skin Sensitization (3-2-4) - Germ Cell Mutagenicity (3-2-5) - Carcinogenicity (3-2-6) - Reproductive Toxicity (3-2-7) - Aspiration Hazard (3-2-10) (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. In classification, take the following points into account. 175
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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
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whereas the reference value is set
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3-2-2 Skin Corrosion/Irritation (1)
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Table 3.2.2 Skin irritation categor
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possible, and to classify the subst
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and scaling persist to the end of 1
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【GHS 2 nd revised edition】 Figu
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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 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 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
Page 214 and 215: endpoint. When it is not clear whet
Page 216 and 217: that the relevant information sourc
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Page 220 and 221: R39 Danger of very serious irrevers
Page 222: R52 Harmful to aquatic organisms. R
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GHS Classification Guidance for the Japanese Government

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