GHS Classification Guidance for the Japanese Government

More documents

Recommendations

Info

Table 3-16: Guidance value ranges for toxicity-repeated exposure 182 Guidance values (dose/concentration) Route of exposure Units Category 1 Category 2 Oral (rat) mg/kg bw/d C≤10 10
1) Data from evaluation by reliable organizations (for example, data obtained from reference documents shown in List 1, R-48). 2) If appropriate sources of information based on data cannot be obtained easily, try to obtain the original EU assessment documents from the EU classification R-Phrase 13 (R48) corresponding to specific target organ toxicity-repeated exposure. When the assessment documents become available, classify on the basis of the documents. 3) Report data which can be considered to be reliable (Measurements are according to GLP, or which are the basis of judgment are clearly shown and evaluated, etc.). 4) Data collected from other sources of information (for example, data from references shown in List 2 or List 3). C) Comparison with conventional classification systems Systems in accord with GHS includes R-Phrase R48 in EU classification. D) Guidance concerning data If information on specific, non lethal, target organ toxicity arising from a single exposure are available, experts should judge whether the toxicity has significant health effects in humans or not. The exposure route by which the classified substance has produced damage should be specified. Examples are provided below of toxic effects in humans or experimental animals that must be taken into consideration in classification of specific target organ toxicity. 【GHS 2 nd revised edition】(3.9.2.7.3) Evidence from appropriate studies in experimental animals can furnish much more detail, in the form of clinical observations, haematology, clinical chemistry, macroscopic and microscopic pathological examination and this can often reveal hazards that may not be life-threatening but could indicate functional impairment. Consequently all available evidence, and relevance to human health, must be taken into consideration in the classification process. Examples of relevant toxic effects in humans and/or animals are provided below: (a) Morbidity or death resulting from repeated or long-term exposure. Morbidity or death may result from repeated exposure, even to relatively low doses/concentrations, due to bioaccumulation of the substance or its metabolites, or due to the overwhelming of the de-toxification process by repeated exposure; (b) Significant functional changes in the central or peripheral nervous systems or other organ systems, including signs of central nervous system depression and effects on special senses (e.g. sight, hearing and sense of smell); 183
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 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 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

Create successful ePaper yourself

Delete template?

Save as template?