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GHS Classification Guidance for the Japanese Government

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Is route oral or by<br />

inhalation?<br />

Yes<br />

Are rat data<br />

available?<br />

Are Rodent<br />

(mouse, guinea<br />

pig) data<br />

available?<br />

Determined as<br />

"<strong>Classification</strong><br />

not possible"<br />

*1<br />

No<br />

No<br />

Yes<br />

Yes<br />

Fig. 3-1 Handling of animal species difference<br />

*1 Data <strong>for</strong> animals o<strong>the</strong>r than rodents are not adopted <strong>for</strong> classification but are described in <strong>the</strong><br />

input sheet <strong>for</strong> future reference.<br />

*2 Data <strong>for</strong> animals o<strong>the</strong>r than rodents and rabbits are not adopted <strong>for</strong> classification but are<br />

described in <strong>the</strong> input sheet <strong>for</strong> future reference.<br />

E) Reference Value regarding Vapour inhalation in Acute Toxicity classification<br />

Since, in <strong>the</strong> classification of Acute Toxicity, <strong>the</strong> criteria <strong>for</strong> vapour inhalation are easily<br />

misunderstood when one refers only to Table 3.1.1.of <strong>the</strong> UN <strong>GHS</strong> second revised edition, it is<br />

required <strong>for</strong> classification to take notice of note (d) of Table 3.1.1.and <strong>the</strong> text paragraph<br />

3.1.2.6.2 of <strong>the</strong> same document.<br />

Determined based<br />

on <strong>the</strong> rat data<br />

Determined based<br />

on <strong>the</strong> rat data. If<br />

data of multiple<br />

kinds of species are<br />

available, adopt one<br />

with <strong>the</strong> smallest<br />

value.<br />

Note (d) attached to <strong>the</strong> column of “Vapour” in Table 3.1.1 of <strong>the</strong> UN <strong>GHS</strong> second revised<br />

edition states, “For some chemicals, <strong>the</strong> test atmosphere will not just be a vapour but will<br />

consist of a mixture of liquid and vapour phases. For o<strong>the</strong>r chemicals, <strong>the</strong> test atmosphere may<br />

consist of a vapour which is near <strong>the</strong> gaseous phase. In <strong>the</strong>se latter cases, classification should<br />

be based on ppmV as follows: Category 1 (100 ppmV), Category 2 (500 ppmV), Category 3<br />

(2500 ppmV), and Category 4 (20000 ppmV).”This instructs that, if a test is conducted with<br />

vapour that is completely gasified, classification is made with <strong>the</strong> reference value shown in ppm,<br />

111<br />

Is route<br />

dermal?<br />

Yes<br />

Are rat or<br />

rabbit data<br />

available?<br />

No<br />

Are rodent<br />

(mouse, guinea<br />

pig) data<br />

available?<br />

No<br />

Determined as<br />

"<strong>Classification</strong> not<br />

possible"*2<br />

Yes<br />

Yes<br />

Determined base on<br />

<strong>the</strong> rat or rabbit data.<br />

If both data are<br />

available, calculate <strong>for</strong><br />

each species, and<br />

adopt <strong>the</strong> one with <strong>the</strong><br />

smaller value.<br />

Determined based on<br />

<strong>the</strong> rodent data. If data<br />

of multiple kinds of<br />

species are available,<br />

adopt one with <strong>the</strong><br />

smallest value.

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