GHS Classification Guidance for the Japanese Government

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substance shall be classified in Category 1. In all other cases, the substance shall be classified as “Classification not possible” even if a test was carried out. ○ Animal tests on skin sensitization approved by OECD Positive data of animal test cannot be denied by the negative data of skin sensitization in humans. On the other hand, ambiguous positive data on human skin sensitization shall be categorized by referring to clear negative data of animal tests. (The concordance between human data and animal test data are reported in, 1) Magnusson B et. al. 1969: J Investigative Dermatol. 52 、 268-276 、 2) Robinson MK et. al. 1990: Toxicology 61、91-107、 3) Schneider K and Akkan Z、 2004: Reg. Toxicol. Pharmacol., etc.) OECD test Guideline Test guideline Animal Presence of Adjuvant 406 Guinea Pig Maximization Test (Magnusson and Kligman) Guinea pig Use 406 Buehler Test Guinea pig Non-use 429* LLNA (Local Lymph Node Assay) Mouse Non-use In above guinea pig tests, decision is performed based on subjective evaluation for erythema and edema, while in LLNA method, incorporation of 3H-methylthymidine is indexed by T-cell formation induced during induction phase of allergic reaction. In LLNA method, Stimulation Index(SI value) of 3 or more is positive. The following skin sensitization test methods which are not approved in Japanese classification since they are not approved by OECD. The UN GHS third revised edition (which will come into force in July 2009) will provide sub-categories (1A, 1B) based on strength of sensitization, and the animal test methods used for their decision are above 3 test methods approved by OECD. Test guideline Animal Adjuvant and Patch Test Guinea pig Use Draize Test Guinea pig Non-use Freund’s Complete Adjuvant Test Guinea pig Use Open Epicutaneous Test Guinea pig Non-use Optimization Test Guinea pig Use Split Adjuvant Test Guinea pig Use Mouse Ear Swelling Test (MEST) Mouse Non-use 140 Presence of Adjuvant
3-2-5 Germ Cell Mutagenicity (1)Definitions Definitions of Germ Cell Mutagencity in UN GHS are as follows, and they are adopted in this guidance. 【GHS 2 nd revised edition】(3.5.1) 3.5.1.1 This hazard class is primarily concerned with chemicals that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, mutagenicity/genotoxicity tests in vitro and in mammalian somatic cells in vivo are also considered in classifying substances and mixtures within this hazard class. 3.5.1.2 I n the present context, commonly found definitions of the terms mutagenic, mutagen, mutations and genotoxic are used. A mutation is defined as a permanent change in the amount or structure of the genetic material in a cell. 3.5.1.3 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 pair changes and chromosomal translocations). The term mutagenic and mutagen will be used for agents giving rise to an increased occurrence of mutations in populations of cells and/or organisms. 3.5.1.4 The more general terms genotoxic and genotoxicity apply to agents or processes which alter the structure, information content, or segregation of DNA , including those which 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 for mutagenic effects. (2)Classification criteria A) Classification criteria based on JIS Classification Table 3-7 Hazard categories for Germ Cell mutagens Category 1: Chemicals known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Category 1A:Chemicals known to induce heritable mutations in germ cells of humans. The classification is based on positive evidence from human epidemiological studies. Category 1B:Chemicals which should be regarded as if they induce heritable mutations in the germ cells of humans. 141
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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
Page 93: Note: In GHS, it is defined that if
Page 96 and 97: 1-1) Organization National Institut
Page 98 and 99: URL http://www.ecetoc.org/publicati
Page 100 and 101: List 2: Useful information sources
Page 102 and 103: http://www.cdc.gov/niosh/npg/npgdrt
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
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 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 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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formed in the mouth, which then may
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The classification criteria refer t
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(1)Sources for test data for Hazard
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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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