GHS Classification Guidance for the Japanese Government

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[Decision Criteria 1]: In the cases where the substance is concluded to be positive in any assessment document in List 1 (“Is concluded” does not mean “is suggested” or “has the possibility”, but “is definitely stated (to be obviously positive).”). (Exclusion Rule) Even if the substance meets Decision Criteria 1, if it is proved that the substance induces asthma in only those who have bronchial hypersensitivity, the substance is determined as “Not classified”. [Decision Criteria 2]: If there is evidence in humans that the substance can lead to specific respiratory hypersensitivity. Regarding evidence in humans, refer to the UN GHS second revised edition 3.4.2.1.2. Evidence refers to the following points. 【GHS 2 nd revised edition】(3.4.2.1.2.3) (a) clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence which may include: (i) in vivo immunological test (e.g. skin prick test); (ii) in vitro immunological test (e.g. serological analysis); (iii) studies that may indicate other specific hypersensitivity reactions where immunological mechanisms of action have not been proven, e.g. repeated lowlevel irritation, pharmacologically mediated effects; (iv) a chemical structure related to substances known to cause respiratory hypersensitivity; (b) data from positive bronchial challenge tests with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction. [Decision Criteria 3]: If there are positive results from an appropriate animal test. (At present, since recognized animal models for the testing of respiratory hypersensitivity are not available(the UN GHS second revised edition 3.4.2.1.3 footnote 2), [Decision Criteria 3] is not adopted in this guidance. When an appropriate animal model is set, this Decision Criteria will be adopted.) 2) Skin Sensitization: Substances applicable to any of [Decision Criteria 1] through [Decision Criteria 4] below shall be determined as belonging to Category 1. In classification, take into account the UN GHS second revised edition 3.4.2.2.2. “Specific considerations”. 138
【GHS 2 nd revised edition】(3.4.2.2.2.1) For classification of a substance, evidence should include any or all of the following: (a) Positive data from patch testing, normally obtained in more than one dermatology clinic; (b) Epidemiological studies showing allergic contact dermatitis caused by the substance; Situations in w hich a high proportion of those exposed exhibit characteristic symptoms are to be looked at with special concern, even if the number of cases is small; (c) Positive data from appropriate animal studies; (d) Positive data from experimental studies in man (see Chapter 1.3, para. 1.3.2.4.7); (e) Well documented episodes of allergic contact dermatitis, normally obtained in more than one dermatology clinic. [Decision Criteria 1]: In the case where the substance is concluded as positive in any assessment document in List 1. [Decision Criteria 2]: If there is evidence in humans that can lead to specific symptom by skin contact. [Decision Criteria 3]: If there is an epidemiological study report showing allergic contact dermatitis caused by the substance, or if there are two or more care reports of allergic contact dermatitis from separate medical institutions, in List 1 or List 2. [Decision Criteria 4]: If a positive result is obtained in the following animal tests. ○ Decision Criteria for a Positive Result When using adjuvant: 30% or more of animals react, When not using adjuvant (guinea pig): 15% or more of animals react. * The ratio of sensitized animal is often not clear. When the ratio is not clear, it is preferable to review the original literature and to examine the content and the ratio carefully. The same applies when skin sensitization based on the test is reported in List 1 and the ratio is not clear. In cases where the substance is clearly concluded to include skin sensitization in List 1 based on the test, the substance is determined as belonging to Category 1. In all other cases, the substance shall be classified as “Classification not possible”. * As for List 2, if an animal test was performed by the test method approved by OECD shown below, if the ratio of sensitized animal is clear, and in the cases where the subsitance is concluded as positive in skin sensitization, then the 139
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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
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
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Page 126 and 127: 【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 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
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Page 156 and 157: 3-2-6 Carcinogenicity (1)Definition
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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
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Page 182 and 183: g) When the affected organ can be i
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Page 188 and 189: (c) Any consistent and significant
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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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