GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government GHS Classification Guidance for the Japanese Government
Table 3.2.2 Skin irritation categories a Categories Criteria Irritant (Category 2) (applies to all authorities) Mild irritant (Category 3) (applies to only some authorities) (1) Mean value of ≥2.3≤4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or (2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or (3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above. Mean value of 1.5
R-Phrase5s (R34, R35, R38、R36/37、R36/38、R37/38、R36/37/38)in EU classification relating to Skin Corrosion/Irritation may be referred. The OECD test guideline includes the following test methods relating to Skin Corrosion/Irritation. OECD404 Acute dermal irritation / corrosion OECD430 In vitro skin corrosion: Transcutaneous electrical resistance test OECD431 In vitro skin corrosion: Human skin model test OECD435 In vitro membrane barrier test method for skin corrosion 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 Substances classified as Corrosive (C) with R34、R35 in EU classification fall under Category 1. Substances classified as Irritant (Xi) with R38 and combination of R-Phrases(R36/38, R37/38, R36/37/38)in EU classification fall under Category 2 or 3 (in GHS classification). Confirmation with detailed data is required. If evidence information other than EU classification results is not available, the substance shall be judged “Classification not possible”. Comparison between EU classification and GHS classification is as follows. Skin corrosion EU cassification GHS cassification Skin irritation EU cassification GHS cassification D) Guidance concerning data C R35 C R34 Category1A Category1B Category1C Xi R38 Category2 Category3 In many cases, findings of test reports are given using the evaluative scale of “severe”, “moderate”, and “mild”, and these can be considered to correspond to Categories 1, 2, and 3, respectively. It is preferable to confirm PII(skin primary irritation index)and the like as far as 5 For R-Phrase, see Appendix. 117
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R-Phrase5s (R34, R35, R38、R36/37、R36/38、R37/38、R36/37/38)in EU classification<br />
relating to Skin Corrosion/Irritation may be referred.<br />
The OECD test guideline includes <strong>the</strong> following test methods relating to Skin<br />
Corrosion/Irritation.<br />
OECD404 Acute dermal irritation / corrosion<br />
OECD430 In vitro skin corrosion: Transcutaneous electrical resistance test<br />
OECD431 In vitro skin corrosion: Human skin model test<br />
OECD435 In vitro membrane barrier test method <strong>for</strong> skin corrosion<br />
B) Order of Precedence when Conflicting Data Exist<br />
Refer to “3-1-2 Order of Precedence when Conflicting Data Exist” (p.97).<br />
C) Comparison with conventional classification systems<br />
Substances classified as Corrosive (C) with R34、R35 in EU classification fall under<br />
Category 1.<br />
Substances classified as Irritant (Xi) with R38 and combination of R-Phrases(R36/38,<br />
R37/38, R36/37/38)in EU classification fall under Category 2 or 3 (in <strong>GHS</strong> classification).<br />
Confirmation with detailed data is required. If evidence in<strong>for</strong>mation o<strong>the</strong>r than EU<br />
classification results is not available, <strong>the</strong> substance shall be judged “<strong>Classification</strong> not<br />
possible”.<br />
Comparison between EU classification and <strong>GHS</strong> classification is as follows.<br />
Skin corrosion<br />
EU<br />
cassification<br />
<strong>GHS</strong><br />
cassification<br />
Skin irritation<br />
EU<br />
cassification<br />
<strong>GHS</strong><br />
cassification<br />
D) <strong>Guidance</strong> concerning data<br />
C R35 C R34<br />
Category1A Category1B Category1C<br />
Xi R38<br />
Category2 Category3<br />
In many cases, findings of test reports are given using <strong>the</strong> evaluative scale of “severe”,<br />
“moderate”, and “mild”, and <strong>the</strong>se can be considered to correspond to Categories 1, 2, and 3,<br />
respectively. It is preferable to confirm PII(skin primary irritation index)and <strong>the</strong> like as far as<br />
5 For R-Phrase, see Appendix.<br />
117
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