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EC number: 428-650-4 | CAS number: 153719-23-4
All animals survived till the end of the study.There were no treatment-related effects on body weight during the study.
Induction reactions and duration
After removal of the occlusive dressing on day 10 after epidermal induction, irritation at the application site was seen in all 40 guinea pigs of the test and positive control groups
Challenge reactions and duration
Epidermal challenge of 10 male and 10 female guinea pigs with the test substance resulted in positive response in 1 male guinea pig after 48 hours, corresponding to a sensitisation rate of 5%. No irritant skin reactions were recorded among control animals.
In a dermal sensitisation study with the test substance (98.6% a.i) in Oleum arachidis, young adult male and female Pirbright White (Tif:DHP) guinea pigs (10/sex) were tested using the Magnusson and Kligman guinea pig maximisation test (Magnusson and Kligman, 1980). Two main procedures were involved in the study; (a) the potential induction of an immune response; (b) a challenge of that response. From the findings of a pilot study the concentrations for use in the main study were selected. On the basis of the results, a 1% w/v preparation of the test substance in physiological saline was used for intradermal induction, a 30% w/v preparation in Vaseline was used for the epidermal induction and a 10% w/v preparation in Vaseline was used for the challenge. Epidermal challenge of 10 male and 10 female guinea pigs with the test substance resulted in positive response in 1 male guinea pig after 48 hours, corresponding to a sensitisation rate of 5%. No irritant skin reactions were recorded among control animals. Epidermal challenge test of 10 male and 10 female guinea pigs with Mercaptobenzothiazole (positive control groups) resulted in positive responses in 17 (8 males and 9 females) of the 20 guinea pigs after 24 and 48 hours, corresponding to a sensitisation rate of 85%. The test substance was graded as a weak sensitiser according to the Magnusson and Kligman maximisation scale. Based on the sensitisation rate of 5%, which is below the threshold of significance (i.e. below 30%), set in Commission Directive 93/21/EEC (18th adaptation to technical progress of Council Directive 67/548/EEC), classification of the test substance as to its sensitising properties is not required.
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