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EC number: 619-230-3 | CAS number: 96624-41-8
The purpose of this assay was to identify the skin irritation/corrosion potential of the test material when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions.
This study should provide a rational basis for risk assessment to the irritating potential of the test item in man.
To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of liquid paraffin to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal. This animal showed signs of irritation (well defined erythema, edema, brittle skin, and scales) and no more animals were treated. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 14 days.
No signs of pain were observed after administration. The body weight developent corresponded to that of the untreated rabbits of the same age. No mortality was observed during the course of the study.
In the primary skin irritation test, erythema (scores 1 and 2) were observed from day 2 - 14, and edema (scores 1 and 2) from day 3 - 10 of the study. In two rabbits scales were observed from day 8 - 12 of the study.
According to the result of the irritation scores, the test material has not to be classified as irritant for the skin.
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