GHS Classification Guidance for the Japanese Government

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criteria given below:” a) If there is evidence in humans that the substance can lead to sensitization by skin contact in a substantial number(*) of persons, and/or b) If there are positive results from an appropriate animal test. (*) “a substantial number” depends on the person responsible for classification. The grounds for judging a given number to be substantial shall be indicated in the reason for judgment. 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 Classification is performed based on the weight of evidence for respiratory or skin sensitization. When considering the human evidence, it is necessary for a decision on classification to take into account the size of the population exposed and the extent of exposure. A single category each is adopted for classification of respiratory sensitization and skin sensitization, i.e., whether the substance induces sensitization (Category 1) or not (Not classified). The signal word used for skin sensitization Category 1 is “Warning”, while the word for respiratory sensitization Category 1 is “Danger”, since the latter is considered to produce more serious effects on human health. Reference may be made to the following items in each of classification systems below. EU classification: R42・R43・R42/43 Recommendation of Acceptable Concentration by the Japan Society For Occupational Health: respiratory tract sensitization and skin sensitization TLV table of ACGIH:SEN or Sensitization substances MAK (Germany): Labeling of Sensitization substance (Sa、Sh、Sah) OECD test guidelines include the following test methods relating to respiratory or skin sensitization. OECD406 Skin sensitization OECD429 Skin sensitization: Local Lymph Node Assay B) Order of Precedence when Conflicting Data Exist Refer to “3-1-2 Order of Precedence when Conflicting Data Exist” (p.97). 136
C) Comparison with conventional classification systems EU classification categories relating to sensitization are R42, R43, and R42/43. The Recommendation of Acceptable Concentration of the Japan Society For Occupational Health includes the list of substances recognized as sensitizers. In the TLV table of ACGIH, SEN mark is assigned to sensitizers, and, in the MAK table of MAK (Germany), Sa・Sh・ Sah marks are assigned. EU classification・R42 and R42/43, as well as respiratory tract sensitization in the Recommendation of Acceptable Concentration by the Japan Society For Occupational Health, correspond to respiratory sensitization Category 1. EU classification・R43 and R42/43, as well as skin sensitization in the Recomendation of Acceptable Concentration of the Japan Society For Occupational Health, corresponds to skin sensitization Category 1. Whether SEN substances in ACGIH is respiratory sensitizers or skin sensitizers must be confirmed by reviewing the ACGIH Documentations. When necessary, classification criteria of exposure situation, the size of the population exposed, and the existence of sensitization should be examined by reviewing the quoted original literature. D) Guidance concerning data Classification should be performed on the basis of any description concerning sensitization found in test reports, reviews, assessment documents, etc. (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. Also in classification, take the points below into account. *Unless description that definitely denies hazards or recognizes extremely low hazards is available in List 1, determination of “Not classified” should be performed carefully. If there is any question, not “Not classified” but “Classification not possible,” which is based on the absence of sufficient information for judging, is preferable. B) Classification procedures 1) Respiratory Sensitization: Substances meeting [Decision Criteria 1] through [Decision Criteria 3] below shall be determined as belonging to Category 1. 137
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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
Page 89 and 90: The flow chart of 2.15.2.2 is exact
Page 91 and 92: 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 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 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
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has received some degree of approva
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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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