GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government GHS Classification Guidance for the Japanese Government
possible” unless the obvious conclusion can be given based on physical properties such as vapour pressure. The reason why the decision cannot be made shall be clearly described, for example, “If the test condition is vapour, the substance is determined to fall under Category ○○, and, if it is mist, it falls under category △△. But it cannot be determined whether it is vapour or mist based on information obtained, therefore the substance is determined as “Classification not possible”. 3) Although a substance is mist, its LC50 may be described in ppmV, or for gas, its LC50 may be described in mg/L. In many assessment documents, LC50 values without test conditions such as temperature are found. If an accurate conversion is not possible, conversion shall be performed according to the following formula. ppmV ≒ mg/L × 1000 × 24.45 / molecular weight(for convertion at 25°C and atmospheric pressure) D) Considerations for managing GHS classification criteria newly added by the UN committee in December 2004 The GHS was largely revised for the following: Definitions of dust, mist, and vapour were added. 110
Is route oral or by inhalation? Yes Are rat data available? Are Rodent (mouse, guinea pig) data available? Determined as "Classification not possible" *1 No No Yes Yes Fig. 3-1 Handling of animal species difference *1 Data for animals other than rodents are not adopted for classification but are described in the input sheet for future reference. *2 Data for animals other than rodents and rabbits are not adopted for classification but are described in the input sheet for future reference. E) Reference Value regarding Vapour inhalation in Acute Toxicity classification Since, in the classification of Acute Toxicity, the criteria for vapour inhalation are easily misunderstood when one refers only to Table 3.1.1.of the UN GHS second revised edition, it is required for classification to take notice of note (d) of Table 3.1.1.and the text paragraph 3.1.2.6.2 of the same document. Determined based on the rat data Determined based on the rat data. If data of multiple kinds of species are available, adopt one with the smallest value. Note (d) attached to the column of “Vapour” in Table 3.1.1 of the UN GHS second revised edition states, “For some chemicals, the test atmosphere will not just be a vapour but will consist of a mixture of liquid and vapour phases. For other chemicals, the test atmosphere may consist of a vapour which is near the gaseous phase. In these latter cases, classification should be based on ppmV as follows: Category 1 (100 ppmV), Category 2 (500 ppmV), Category 3 (2500 ppmV), and Category 4 (20000 ppmV).”This instructs that, if a test is conducted with vapour that is completely gasified, classification is made with the reference value shown in ppm, 111 Is route dermal? Yes Are rat or rabbit data available? No Are rodent (mouse, guinea pig) data available? No Determined as "Classification not possible"*2 Yes Yes Determined base on the rat or rabbit data. If both data are available, calculate for each species, and adopt the one with the smaller value. Determined based on the rodent data. If data of multiple kinds of species are available, adopt one with the smallest value.
- Page 63 and 64: 2.8.2.3 Criteria for temperature co
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- Page 71 and 72: Table 2.11.1: Criteria for self-hea
- Page 73 and 74: than 30% water of crystallization 1
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- Page 81 and 82: 2-3-13 Oxidizing Liquids (1)Definit
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- Page 85 and 86: (Example of category 3)2067 AMMONIU
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- 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
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- Page 108 and 109: follows: Category 1 (100 ppmV), Cat
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- Page 116 and 117: whereas the reference value is set
- Page 118 and 119: 3-2-2 Skin Corrosion/Irritation (1)
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- Page 126 and 127: 【GHS 2 nd revised edition】 Figu
- Page 128 and 129: [Note for the above figure] (a) Cla
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- 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
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possible” unless <strong>the</strong> obvious conclusion can be given based on physical properties such as<br />
vapour pressure. The reason why <strong>the</strong> decision cannot be made shall be clearly described,<br />
<strong>for</strong> example, “If <strong>the</strong> test condition is vapour, <strong>the</strong> substance is determined to fall under<br />
Category ○○, and, if it is mist, it falls under category △△. But it cannot be determined<br />
whe<strong>the</strong>r it is vapour or mist based on in<strong>for</strong>mation obtained, <strong>the</strong>re<strong>for</strong>e <strong>the</strong> substance is<br />
determined as “<strong>Classification</strong> not possible”.<br />
3) Although a substance is mist, its LC50 may be described in ppmV, or <strong>for</strong> gas, its LC50 may<br />
be described in mg/L. In many assessment documents, LC50 values without test conditions<br />
such as temperature are found. If an accurate conversion is not possible, conversion shall<br />
be per<strong>for</strong>med according to <strong>the</strong> following <strong>for</strong>mula.<br />
ppmV ≒ mg/L × 1000 × 24.45 / molecular weight(<strong>for</strong> convertion at 25°C and atmospheric<br />
pressure)<br />
D) Considerations <strong>for</strong> managing <strong>GHS</strong> classification criteria newly added by <strong>the</strong> UN<br />
committee in December 2004<br />
The <strong>GHS</strong> was largely revised <strong>for</strong> <strong>the</strong> following:<br />
Definitions of dust, mist, and vapour were added.<br />
110