GHS Classification Guidance for the Japanese Government

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has received some degree of approval (review by plural persons) (Animal tests) A standard animal test is a 28-day, 90-day or life test (up to 2 years) in rats or mice, and includes hematological examination, clinical chemical examination, and close macroscopic and histopathological examinations to demonstrate toxic effects on target tissues/organs. Refer also to data of repeated dose studies conducted using animal species other than rat and mouse. Take into account that other long-term exposure tests, such as a carcinogenicity test, (Notes) neurotoxicity test or reproductive toxicity test, can provide evidence of specific target organ/systemic toxicity used for classification evaluation. a) As for toxic effects, read the UN GHS second revised edition and the following documents carefully. b) Effects on organs that are obviously known to be secondary effects shall be excluded from the description. Judgement by experts shall be sought for where necessary as to whether the effects are secondary effects or not. c) Effects on respiratory system by site of contact are included here and are placed in Category 1 (pneumoconiosis, etc.). However, such effects by site of contact in other than respiratory tract, for example, irritation/inflammation reaction in digestive system in a case of oral administration of a corrosive/irritant, are considered to be subsumed under other toxicity items such as skin corrosion and are not classified in specific target organ toxicity. d) When only minimal symptoms (slight fever, etc.) are reported, the substance is placed in “Not classified”. e) All organs described as affected in List 1 shall be indicated. However, when descriptions of organs listed in multiple assessment documents based on the same type of tests are the same, indicate the commonly listed organs. When a toxic symptom alone is described and the affected organ cannot be identified, put “systemic toxicity” instead. When the target organ is identified, fundamentally, description of toxic symptom is not required. f) Data required for repeated exposure include those for repeated exposure for 14 days or more (and in case of inhalation exposure, exposure period is one hour or more for each exposure). When comparing the exposure amount with the guidance value, the guidance value shall be corrected (inverse proportional calculation by the number of exposed day and exposed time per day) by comparing the number of days and exposed time per day 186
with the conditions of the guidance value (90 days, 6 hours/day). When repeated exposure period is longer than 90 days, however, the exposure time per day alone shall be corrected, and correction by the number of days shall not be performed. g) When the affected organ can be identified, indicate the applicable category along with the affected organ given in parentheses in “GHS classification”. When the affected organ cannot be identified, put “systemic toxicity” in parentheses. (Example entry: Category 1 (liver, kidney, blood), or Category 1 (systemic toxicity)) 2) Substances meeting [Decision criteria 2a] or [Decision criteria 2b] below are placed in Category 2. [Decision criteria 2a]: Substances for which evidence of inducing toxic effects in humans are (Notes) available in List 2. According to 1) [Decision criteria 1a](Notes)a) through e) [Decision criteria 2b]: Animal tests meeting all of conditions below a) Any animal species is applicable b) Exposure amount is identified and toxic symptom is induced within the guidance value range of Category 2. (When multiple documents are available, judgment shall be based on one with the smallest exposure amount.) c) The test that is described in List 1 or List 2 (Exception) When a test for any animal species in which the exposure amount is identified and is within the guidance value range of Category 1, but when the test is described in List 2 alone and does not meet the condition of [Decision criteria 1b] c)(does not meet the condition that is according to GLP and has received some degree of approval (by multiple reviewers)), substances with such test results are exceptionally classified in Category 2. Indicate as follows as special remarks, "This substance can be placed in Category 1 judging from the guidance value, but its data in List 2 alone are available, and its test does not meet the [Decision criteria 1b] c). Consequently, the substance is classified in Category 2 in accordance with the guidance. (Notes) According to 1) [Decision criteria 1b](Notes)a) through g) C) On treatment of vapour inhalation guidance value in classification of specific target organ toxicity (repeated exposure) 187
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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
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2-3-16 Corrosive to Metals (1)Defin
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Note: In GHS, it is defined that if
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1-1) Organization National Institut
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URL http://www.ecetoc.org/publicati
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List 2: Useful information sources
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http://www.cdc.gov/niosh/npg/npgdrt
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3-1-3 Management of information in
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Relation between concentration(ppm)
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follows: Category 1 (100 ppmV), Cat
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(ii) the appropriate conversion val
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UNRTDG Class 6.1 is not sub-categor
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possible” unless the obvious conc
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whereas the reference value is set
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3-2-2 Skin Corrosion/Irritation (1)
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Table 3.2.2 Skin irritation categor
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possible, and to classify the subst
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and scaling persist to the end of 1
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【GHS 2 nd revised edition】 Figu
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[Note for the above figure] (a) Cla
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B) Classification criteria in GHS (
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(4)Guidance for classification and
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G) Strategy of testing and evaluati
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2c Structure activity Skin corrosiv
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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
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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
Page 158 and 159: The principles of GHS classificatio
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
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 192 and 193: As for the classification of specif
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Page 200 and 201: (1)Sources for test data for Hazard
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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
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Page 220 and 221: R39 Danger of very serious irrevers
Page 222: R52 Harmful to aquatic organisms. R
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GHS Classification Guidance for the Japanese Government

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