GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government GHS Classification Guidance for the Japanese Government
http://www.cdc.gov/niosh/npg/npgdrtec.html ● WHO/IPCS “International Chemical Safety Cards” (ICSC): http://www.ilo.org/public/english/protection/safework/cis/products/icsc/dtasht/index.htm (ICSC Japanese version:http://www.nihs.go.jp/ICSC/) 3-3) EU classification ● When classification based on Annex І of EU Directive 67/548/EEC (hereinafter abbreviated as " EU classification")together with its evidence information is not available, the substance shall fall under "Classification not possible". ● If EU classification together with its evidence information is available and if classification criteria of EU classification are different from those of GHS classification, EU classification may be used for GHS classification only when the evidence information is scientifically valid. ● If EU classification together with its evidence information is available and classification criteria of EU classification accord with that of GHS classification, GHS classification may be performed according to EU classification Fundamentally, classification shall be performed based on quality, reliability, and consistency of evidence obtained from the information source, with the evidence weighted and experts judgment added where appropriate. 98
3-1-2 Order of precedence when multiple data exist (1)Order of Precedence when multiple data exist among information sources in List1 A) Data obtained from tests which were performed according to internationally recognized test guidelines (for example, those of OECD) and GLP, take precedence. B) If there are no data falling under A), data obtained from tests which were performed according to internationally recognized test guidelines (for example, those of OECD) but not clearly according to GLP, take precedence. C) When it is difficult to classify according to data based on reliability as shown in A) and B), data considered to have the highest scientific validity shall be adopted after examination of recency of data, dosage selection of the test, selected test animal species, validity of the administration route, etc. If a decision is difficult, it is necessary to seek for judgement by experts. (2)Order of Precedence when conflicting data exist among information sources other than List1 A) Among data collected from other information sources (for example, information sources shown in List 2), data considered to be reliable(data in accordance with GLP, or data for which supporting data are clearly indicated and evaluated, data considered to have the highest scientific validity after examination of dosage selection of the test, selected test animal species, validity of the administration route, etc.) are adopted. This decision procedure is the same as that in (1). B) In this case, the recency of assessment documents and databases or the reliability of cited documents are considered. C) For classification, it is required to evaluate and judge the reliability and validity of data comprehensively. When categorization of data based on reliability as shown in A) and B) is not possible, it is necessary to seek for judgement by expert’s. 99
- Page 51 and 52: Nitrogen trifluoride C і = 1.6 Nit
- Page 53 and 54: 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 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 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
http://www.cdc.gov/niosh/npg/npgdrtec.html<br />
● WHO/IPCS “International Chemical Safety Cards” (ICSC):<br />
http://www.ilo.org/public/english/protection/safework/cis/products/icsc/dtasht/index.htm<br />
(ICSC <strong>Japanese</strong> version:http://www.nihs.go.jp/ICSC/)<br />
3-3) EU classification<br />
● When classification based on Annex І of EU Directive 67/548/EEC (hereinafter abbreviated as "<br />
EU classification")toge<strong>the</strong>r with its evidence in<strong>for</strong>mation is not available, <strong>the</strong> substance shall<br />
fall under "<strong>Classification</strong> not possible".<br />
● If EU classification toge<strong>the</strong>r with its evidence in<strong>for</strong>mation is available and if classification<br />
criteria of EU classification are different from those of <strong>GHS</strong> classification, EU classification<br />
may be used <strong>for</strong> <strong>GHS</strong> classification only when <strong>the</strong> evidence in<strong>for</strong>mation is scientifically valid.<br />
● If EU classification toge<strong>the</strong>r with its evidence in<strong>for</strong>mation is available and classification criteria<br />
of EU classification accord with that of <strong>GHS</strong> classification, <strong>GHS</strong> classification may be<br />
per<strong>for</strong>med according to EU classification<br />
Fundamentally, classification shall be per<strong>for</strong>med based on quality, reliability, and consistency of<br />
evidence obtained from <strong>the</strong> in<strong>for</strong>mation source, with <strong>the</strong> evidence weighted and experts judgment<br />
added where appropriate.<br />
98
Change language