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Key value for chemical safety assessment

Justification for classification or non-classification

BASF (1991) reported a guinea pig maximization test, done with EU method B.6. Female guinea pigs were given the test substance intradermal and epicutaneous in concentrations of 0.2% intradermal, 10% epicutan (induction) and 5% (challenge). One animal of the test group was found dead on day 8 after application.

Skin effects: - Well-defined erythema and slight edema were seen at the injection sites in both test and control animals. - Well-defined erythema and slight edema were also seen at the injection sites of the test substance in FCA/asline in test animals. - Well defined erythema, slight edema and incrustation were noted after percutaneous induction in the test animals. - Positive skin reactions, i.e. erythema, were observed in 3/9 test animals after the challenge procedure at both readings. No reactions (0/5 animals) were seen in the control group. The positive control substance led to positive skin reations (erythema) in 10/10 animals at both readings after the challenge.

Classification proposal for skin sensitizing according to Annex I of the EU Directive 67/548/EEC with R 43.