GHS Classification Guidance for the Japanese Government

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2-3-12 Substances and mixtures which,in contact with water,emit flammable gases............70 2-3-13 Oxidizing Liquids.......................................................................................................77 2-1-14 Oxidizing Solids .........................................................................................................79 2-3-15 Organic Peroxides ......................................................................................................82 2-3-16 Corrosive to Metals ....................................................................................................87 Part3. Health Hazards Guidance.......................................................................................91 3-1 Information and data available for classification..................................................................91 3-1-1 Sources of Information available for classification......................................................91 3-1-2 Order of precedence when multiple data exist .............................................................99 3-1-3 Management of information in special cases..............................................................100 3-2 Classification of health hazards..........................................................................................103 3-2-1 Acute Toxicity ............................................................................................................103 3-2-2 Skin Corrosion/Irritation ............................................................................................114 3-2-3 Serious Eye Damage/Eye Irritation ............................................................................125 3-2-4 Respiratory or Skin Sensitization ...............................................................................135 3-2-5 Germ Cell Mutagenicity.............................................................................................141 3-2-6 Carcinogenicity ..........................................................................................................152 3-2-7 Reproductive Toxicity ................................................................................................159 3-2-8 Specific Target Organ Toxicity-Single Exposure .......................................................170 3-2-9 Specific Target Organ Toxicity-Repeated Exposure...................................................180 3-2-10 Aspiration Hazard.....................................................................................................189 Part4. Environmental Hazards Guidance ........................................................................ 195 4-1 Information available for classification..............................................................................195 4-1-1 Sources of Information available for classification....................................................195 4-2 Classification of Hazardous to the Aquatic Environment...................................................202 Appendix EU R-Phrase referred in this guidance ........................................................... 215
Part1 Introduction 1-1. Regarding "GHS Classification Guidance" The “Globally Harmonized System of Classification and Labelling of Chemicals (GHS)” (hereinafter, abbreviated as UN GHS) was discussed in the UN for many years, and the Economic and Social Council adopted a resolution to promote implementation of GHS worldwide, and individual countries are establishing systems to introduce GHS. In Japan, the government launched the GHS Inter-ministerial Committee in 2001, which began translating UN GHS-related documents into Japanese, exchanging information to establish GHS-related domestic laws, promoting the classification of substances in Japan, and implementing the GHS classification of substances requiring MSDS under PRTR Law, Industrial Safety and Health Law, Poisonous and Deleterious Substances Control Law, etc. (about 1,500 substances) as references between FY 2006 and FY 2007, and published the classification results. To facilitate GHS classification within a short period of two years, the committee established the “GHS Classification Manual,” which defines practical methods for data collection and evaluation criteria for data reliability, and the “Technical Guidance on GHS classification,” which defines detailed technical principles and judgment criteria on health hazards. It has been pointed out that UN GHS documents include several parts for which individual countries can optionally select how to adapt GHS to its own system and to descriptions that are difficult to classify. Therefore, in FY 2007, the ministries and agencies concerned and interested parties decided the Japanese principles for these parts, while taking international harmonization into account (based on the 2007 revised edition of UN GHS), and worked to establish the Japanese Industrial Standard (JIS) for “Classification method of chemicals based on “Globally Harmonized System of Classification and Labelling of Chemicals (GHS)” ”based on the principles from FY 2008. The ministries and agencies concerned decided to begin classifying new chemicals utilizing the manual and technical guidance, however, a manual providing greater accuracy is required. Accordingly, the new and more accurate “GHS classification guidance,” which is consistent with the JIS described above and an integrated “GHS Classification Manual” and “Technical Guidance on GHS classification” that offer more convenience were produced. This guidance is a manual based on JIS, while providing for global harmonization, to allow GHS classification to be carried out correctly and effectively. It should be noted, however, that UN GHS includes classifications that are not adopted by JIS, and this guidance includes original 1
Page 1: GHS Classification Guidance for the
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
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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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substance shall be classified in Ca
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The classification is based on any
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7) Data from various kinds of tests
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Table 3-8 Test data as the basis of
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Category 1B. Mutagens classified a
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c)Exceptionally, strong positive re
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3-2-6 Carcinogenicity (1)Definition
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The principles of GHS classificatio
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B) Substance for which GHS classifi
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metabolic system, a cautious invest
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hazard warning for pregnant women a
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OECD414 Prenatal development toxici
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D) Decision logic and classificatio
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e considered to be sufficient. (Sub
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No. Test guideline Limit dose 414 P
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3-2-8 Specific Target Organ Toxicit
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specifically for these effects as d
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existing MSDSs. A literature search
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* Unless a description that definit
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g) When the affected organ can be i
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3-2-9 Specific Target Organ Toxicit
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Table 3-16: Guidance value ranges f
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(c) Any consistent and significant
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has received some degree of approva
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As for the classification of specif
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formed in the mouth, which then may
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The classification criteria refer t
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194
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(1)Sources for test data for Hazard
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List 2: Useful information sources
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3-3)EU classification When classif
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4-2 Classification of Hazardous to
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water solubility, and which are not
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Tests shall be conducted by using f
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e categorized based on chronic aqua
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endpoint. When it is not clear whet
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that the relevant information sourc
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214
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R39 Danger of very serious irrevers
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R52 Harmful to aquatic organisms. R
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GHS Classification Guidance for the Japanese Government

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