GHS Classification Guidance for the Japanese Government

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Relation between concentration(ppm)in diet and dosage per body weight(mg/kg weight /day) animal body weight (kg) Food consumption per day (g) (except for liquids) Mouse 0.02 3 Rat(Young) 0.1 10 Rat(Matured) 0.4 20 Guinea pig 0.75 30 Rabbit 2 60 Dog 10 250 Cat 2 100 Ape 5 250 Dog 10 750 102 Type of diet Dry laboratory chow diet Moist, semi-solid diet Dosage (mg/kg body weight /day)per concentration in diet of 1ppm 0.15 0.1 0.05 0.04 0.03 0.025 0.05 0.05 0.075 Lehman, A.J.(1954) Association of Food and Drug Officials Quarterly Bulletin, 18: 66, partially revised. Values in this table are the average of values obtained from many literatures. (Example)In cases of rats, what are the values in ppm and mg/kg body weight /day of a substrate which is contained in diet by 0.5%? (Solution) 0.5% is equal to 5000 ppm. From the table, in cases of matured rat, 1 ppm in the diet is equivalent to 0.050 mg/kg body weight /day. Consequently, 5000 ppm is equivalent to 250 mg/kg body weight /day (5000×0.050).
3-2 Classification of health hazards 3-2-1 Acute Toxicity (1)Definitions Definitions of Acute Toxicity in UN GHS are as follows, and they are adopted in this guidance. 【GHS 2 nd revised edition】(3.1.1) Acute toxicity refers to those adverse effects occurring following oral or dermal administration of a single dose of a substance, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours. (2)Classification criteria A) Classification criteria based on JIS Classification Table 3-1: Acute toxicity hazard categories and acute toxicity estimate (ATE) values defining the respective categories Exposure route Category 1 Category 2 Category 3 Category 4 Oral(mg/kg bodyweight) Dermal(mg/kg bodyweight) ATE≤5 5
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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
Page 55 and 56: 2-3-6 Flammable Liquids (1)Definiti
Page 57 and 58: Category 3 =UNRTDG3 III Category 4
Page 59 and 60: Table 2.7.1: Criteria for flammable
Page 61 and 62: 2-3-8 Self-reactive Substances and
Page 63 and 64: 2.8.2.3 Criteria for temperature co
Page 65 and 66: 3225 There is no article with a spe
Page 67 and 68: classified according to it. If not,
Page 69 and 70: classified”. Reference: UN GHS se
Page 71 and 72: Table 2.11.1: Criteria for self-hea
Page 73 and 74: than 30% water of crystallization 1
Page 75 and 76: transport, the same chemical is to
Page 77 and 78: 138: Water-reactive substances - em
Page 79 and 80: orohydrides, alkyl compounds, etc.)
Page 81 and 82: 2-3-13 Oxidizing Liquids (1)Definit
Page 83 and 84: 2-1-14 Oxidizing Solids (1)Definiti
Page 85 and 86: (Example of category 3)2067 AMMONIU
Page 87 and 88: 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 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 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
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3-2-6 Carcinogenicity (1)Definition
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The principles of GHS classificatio
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B) Substance for which GHS classifi
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metabolic system, a cautious invest
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hazard warning for pregnant women a
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OECD414 Prenatal development toxici
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D) Decision logic and classificatio
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e considered to be sufficient. (Sub
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No. Test guideline Limit dose 414 P
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3-2-8 Specific Target Organ Toxicit
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specifically for these effects as d
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existing MSDSs. A literature search
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* Unless a description that definit
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g) When the affected organ can be i
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3-2-9 Specific Target Organ Toxicit
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Table 3-16: Guidance value ranges f
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(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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194
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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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