GHS Classification Guidance for the Japanese Government

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formed in the mouth, which then may be aspirated. If the mist or aerosol from a pressurized container is fine, a pool may not be formed. On the other hand, if a pressurized container dispenses product in a stream, a pool may be formed that may then be aspirated. Usually, the mist produced by trigger and pump sprayers is coarse and therefore, a pool may be formed that then may be aspirated. When the pump mechanism may be removed and contents are available to be swallowed then the classifi cation of the products should be considered. (2)Classification criteria A) Classification criteria based on JIS Classification Table 3-17: Hazard categories for aspiration toxicity Categories Criteria Category 1: Chemicals known to A substance is classified in Category 1: cause human aspiration toxicity a) Based on reliable and good quality human evidence hazards or to be regarded as if they cause human aspiration toxicity (See note);OR hazard b) If it is a hydrocarbon and has a kinematic viscosity ≤20.5 mm 2 /s, measured at 40°C. Note: Examples of substances included in Category 1 are certain hydrocarbons, turpentine, and pine oil. B) Classification criteria in GHS (Reference information) In GHS classification, in addition to JIS classification, category 2 is set.Explanation of classification criteria by GHS is as follow. 【GHS 2 nd revised edition】 Table 3.10.1: Hazard categories for aspiration toxicity Categories Criteria Category 1: Chemicals known to cause human aspiration toxicity hazards or to be regarded as if they cause human aspiration toxicity hazard Category 2: Chemicals which cause concern owing to the presumption that they cause human A substance is classified in Category 1: (a) Based on reliable and good quality human evidence (See note 1); or (b) If it is a hydrocarbon and has a kinematic viscosity ≤20.5 mm 2 /s, measured at 40°C. On the basis of existing animal studies and expert judgment that takes into account surface tension, water solubility, boiling point, and volatility, substances, other than those classified in Category 1, which 190
aspiration toxicity hazard have a kinematic viscosity≤14mm 2 /s, measured at 40°C (See note 2). NOTE 1: Examples of substances included in Category 1 are certain hydrocarbons, turpentine And pine oil. NOTE 2: Taking this into account, some authorities would consider the following to be included in this Category: n-primary alcohols with a composition of at least 3 carbon atoms but not more than 13; isobutyl alcohol, and ketones with a composition of no more than 13 carbon atoms. * It should be noted that, although the definition of aspiration hazard shown in the UN GHS second revised edition (3.10.1.2 described above) includes aspiration of solids into respiratory system, the UN GHS Sub-Committee, at the 15 th session (ST/SG/AC.10/C.4/30 25 July 2008), so amended the definition that Category 1 (b) or Category 2 in the UN GHS second revised edition (Table 3.10.1) are applicable only to liquids and mixtures. (3)Items on information sources and data *Regarding procedure of classification, refer to “3-1-1Sources of informationavailable for classification” A) Data availability Although some methodologies for determining aspiration hazards in animals have been utilized, none of them has been standardized. Positive experimental evidence with animal merely serves as a guide to possible aspiration toxicity hazard to humans. B) Order of Precedence when Conflicting Data Exist Refer to “3-1-2 Order of Precedence when Conflicting Data Exist” (p.97) C) Comparison with conventional classification systems This class represents a new concept for classification, but R65 in EU classification is in accord with it. D) Guidance concerning data A review of the medical literature on chemical aspiration (for example, p45.2-2:ICSC) revealed that some hydrocarbons (petroleum distillates) and certain chlorinated hydrocarbons have been shown to pose an aspiration hazard to humans. Primary alcohols, and ketones have been shown to pose an aspiration hazard only in animal studies. Examples of substances falling under Category 1 and Category 2 are shown in (2) Classification criteria B), the UN GHS second revised edition, and Notes 1 and 2 of Table 3.10.1, respectively. 191
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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
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criteria given below:” a) If ther
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[Decision Criteria 1]: In the cases
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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 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 210 and 211: Tests shall be conducted by using f
Page 212 and 213: e categorized based on chronic aqua
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Page 220 and 221: R39 Danger of very serious irrevers
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GHS Classification Guidance for the Japanese Government

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