GHS Classification Guidance for the Japanese Government

More documents

Recommendations

Info

B) Substance for which GHS classification is possible without expert's judgment For substances classified in accordance with the following procedures, the GHS classification can be adopted without an expert's judgment. 1) Substances already evaluated by the following organizations are subject to GHS classification according to the correspondence table (Table 3-10 Correspondence table of GHS classification and classifications of other organizations (Carcinogenicity)). The evaluation results of IARC take precedence. If multiple assessment documents classified a substance in different categories, the substance is classified in accordance with the latest document in principle. If the latest documents (for example, EPA and NTP) classified the substance in different categories and if GHS classification is not possible, classification shall be properly carried out by referring to previous assessment documents (expert’s judgement shall be sought for where necessary). (Example) If a substance is classified in K/L by the EPA classification(1996), and in 2A by the IARC classification(1997), the substance shall be classified in Category 1B by GHS classification. (Reference document:“Carcinogenicity assessment of chemical substances and their classification criteria (sixth edition)”, JETOC special document No.190(2004)) ・International Agency for Research on Cancer:IARC ・Japan Society For Occupational Health ・American conference of Governmental Industrial Hygienists:ACGIH ・Environmental Protection Agency:EPA (The Guideline draft (1996) and the Guideline (2005) do not use numbers/letters in classification. Therefore, in this guidance, the following abbreviations are used for the sake of convenience.) Guideline in 1996 (tentative): K:Known human carcinogens L:Likely to produce cancer in humans CBD:Cannot be determined NL:Not likely to be carcinogenic in humans Guideline in 2005: CaH:Carcinogenic to humans L:Likely to be carcinogenic to humans S:Suggestive evidence of carcinogenic potential I:Inadequate information to assess carcinogenic potential NL:Not likely to be carcinogenic to humans ・the U.S. National Toxicology Program:NTP 2) When a substance is definitely determined to be classified in “Classification not possible” due to the absence of relevant information in “Table 3-10 Correspondence table of GHS 156
classification and classifications of other organizations (Carcinogenicity)” and insufficiency of other hazard information, it should be classified as such. 3) Data are not available →”Classification not possible”, Positive data are not available (only negative data are available) for a substance → the substance shall be classified in “Not classified” based on an expert's judgment 4) If EU classification together with its evidence information is not available, the substance shall be classified in “Classification not possible”. If EU classification together with its evidence information is not available but if the criteria for EU classification are different from those for GHS classification, EU classification may be utilized in GHS classification provided that the information on which the former is based is scientifically appropriate. If EU classification together with its evidence information is not available and the criteria for EU classification are the same as those for GHS classification, GHS classification may be performed according to EU classification. C) Descriptions requiring an expert's judgment B) As for substances whose classification it is difficult to or impossible to determine in accordance with B) 1) and B) 2) above and those for which human carcinogenicity is strongly presumed to be impossible due to species difference and other factors as the result of a proof or estimation of the mechanism of animal carcinogenicity, all the descriptions regarding carcinogenicity cited in the assessment documents shall be collected and an expert's judgment shall be sought for, as follows. 1) Descriptions relating to Carcinogenicity, or descriptions suggesting Carcinogenicity in List 1 (except for assessment documents shown in B) 1)) 2) Descriptions shown below in List 2 and List 3. This prescription shall not prohibit persons responsible for classification from presenting the documents and descriptions which they judged to be considered in the template. ・Descriptions given in a section clearly intended for “carcinogenicity” ・ Descriptions which confirmed the occurrence of tumor(s) after conducting histopathological inspection in a long-term administration test with animals (or descriptions clearly referring to the presence or absence of or suggestion of carcinogenicity or tumor) ・Epidemiological studies in human groups D) Substances especially requiring an expert's judment 1) The following substances are generally classified as carcinogens and need careful examination. Since some substances induce cancer inherent to animals (with species difference) through the mechanism different from that of humans, such as the different 157
Page 1:
GHS Classification Guidance for the
Page 4 and 5:
2-3-12 Substances and mixtures whic
Page 6 and 7:
Japanese judgments and consideratio
Page 8 and 9:
(2) Points to remember when describ
Page 10 and 11:
① ② Information Gathering Class
Page 13 and 14:
Part2. Physical Hazards Guidance 2-
Page 15 and 16:
described in the next section is of
Page 17 and 18:
Information in the book can be sear
Page 19 and 20:
(8) International Chemical Safety C
Page 21 and 22:
guidelines can be compared with GHS
Page 23 and 24:
“Liquids” are defined as substa
Page 25 and 26:
When a substance does not contain c
Page 27 and 28:
Table 2-2 Filled examples of "Not a
Page 29 and 30:
oxygen balance = -1600 [2x +(y/2) -
Page 31 and 32:
GHS classification 8)Self-reactive
Page 33 and 34:
The “Dangerous Goods Regulations,
Page 35 and 36:
4.2 4.3 5.1(I) 5.1(II) 5.1(III) 6.1
Page 37 and 38:
Table 2-5 Filled examples of “Cla
Page 39 and 40:
explosion hazard: (i) combustion of
Page 41 and 42:
water, by mass (n)GUANYLNITROSAMINO
Page 43 and 44:
substance 0224 BARIUM AZIDE, dry or
Page 45 and 46:
1337 NITROSTARCH, WETTED with not l
Page 47 and 48:
(4) Data availability Physical prop
Page 49 and 50:
flame distance (ignition distance)
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 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 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 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
Page 194 and 195: formed in the mouth, which then may
Page 196 and 197: The classification criteria refer t
Page 198 and 199: 194
Page 200 and 201: (1)Sources for test data for Hazard
Page 202 and 203: List 2: Useful information sources
Page 204 and 205: 3-3)EU classification When classif
Page 206 and 207: 4-2 Classification of Hazardous to
Page 208 and 209: water solubility, and which are not
Page 210 and 211:
Tests shall be conducted by using f
Page 212 and 213:
e categorized based on chronic aqua
Page 214 and 215:
endpoint. When it is not clear whet
Page 216 and 217:
that the relevant information sourc
Page 218 and 219:
214
Page 220 and 221:
R39 Danger of very serious irrevers
Page 222:
R52 Harmful to aquatic organisms. R
show all

GHS Classification Guidance for the Japanese Government

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?