GHS Classification Guidance for the Japanese Government

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g) When the affected organ can be identified, indicate the applicable category along with the affected organ in parentheses in “GHS classification”. When the affected organ cannot be identified, put “systemic toxicity” in parentheses. 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 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 b) 3) Substances applicable to [Decision criteria 3] below shall be placed in Category 3. [Decision criteria 3]: Human evidence or animal test that meets all conditions below a) When toxicity meeting criteria of respiratory tract irritation or classification criteria of narcoticsis is recognized for only a short period after exposure. b) The effect is reversible. c) The human evidence or animal test is listed in List 1 or List 2. 178
(Notes) a) Category 3 (transient target organ effects) is defined as “effects which adversely alter human function for a short duration after exposure and from which humans may recover in a reasonable period without leaving significant alteration of structure or function”. Presently in GHS, classification criteria for Category 3 are shown regarding respiratory tract irritation and narcotic effects. When descriptions suggesting narcotic effects based on inhibition of nerve system function and action are found in the original literatures, the substance in question is to be classified in Category 3. If there is any reversible effect other than these effects, such effect shall be indicated in the special remarks in the present classification work but shall not be the basis of classification. b) As for respiratory tract irritation, when a more serious organ effect, including one on respiratory system, is observed, the substance is classified in Category 1 or Category 2. As for narcotic effects, only if the effect is not essentially transient, the substance producing the effect is classified as Category 1 or Category 2. c) When a substance is either a respiratory tract irritant or a narcotic, indicate it clearly. (Example entry:Category 3 (respiratory tract irritation)) C) On treatment of vapour inhalation guidance value in classification of specific target organ toxicity (single exposure) As for the classification of specific target organ toxicity (single exposure), “guidance values” for categorization based on animal data are shown in the p.170 Table 3-14 (UN GHS second revised edition Table 3.8.1). All of them are indicated in the unit of mg/L for vapour inhalation. However, there are no notes regarding vapour inhalation like those for acute toxicity in Table 3.1.1. Therefore, regarding specific target organ toxicity (single exposure), the toxicity manifestation concentration in mg/l at vapour inhalation should be examined and evaluated by comparing it with the value shown in the Table 3.8.1. If the original data is given in ppmV, the data should be converted into mg/L and compared. If the concentration is at saturated vapour pressure or more, the value is treated as that of mist (or dust) by referring to the case of acute toxicity. 179
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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 (
Page 132 and 133: (4)Guidance for classification and
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Page 140 and 141: criteria given below:” a) If ther
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Page 156 and 157: 3-2-6 Carcinogenicity (1)Definition
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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 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
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Page 212 and 213: e categorized based on chronic aqua
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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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