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EC number: 437-760-1 | CAS number: -
Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time
Score at time point
Erythema (Animal no 1 / 2 / 3)
Max. score 4
Oedema (Animal no 1 / 2 / 3)
1 h (D1)
2 / 1 / 0
0 / 0 / 0
24 h (D2)
1 / 1 / 0
48 h (D3)
1 / 0 / 0
72 h (D4)
1 / - / -
0 / - / -
Average 24, 48 and 72 h
1.0 / 0.3 / 0.0
0.0 / 0.0 / 0.0
-:Cutaneous examination not performed
In a primary dermal irritation study performed according to the OECD Guideline No. 404/EU Method B.4, and in compliance with GLP, 500 mg of test material moistened with purified water was applied on the clipped skin of the right flank area of 3 male New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 h. The untreated skin served as control. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions.
In one animal, a well-defined erythema was noted on day 1, then a very slight erythema persisted up to day 5. Dryness of the skin was recorded between day 6 and day 10. In a second animal, a very slight erythema was observed on days 1 and 2 only. No cutaneous reactions were observed in the third animal. Mean scores over 24, 48 and 72 hours for each animal were 1.0, 0.3 and 0.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
Therefore, test material is not classified as irritating to skin according to the annex I of the Regulation EC No. 1272/2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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