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EC number: 696-026-0 | CAS number: 1395383-69-3
In order to assess the cutaneous allergenic potential of the substance, the Maximisation-Test was performed in 40 (20 test and 20 control) males and females albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 79/831/EEC.
The intradermal induction of sensitization in the test group was performed in the nuchal region with a 0.1% dilution of the test item in sesame oil and in mixture of Adjuvant saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 30 % in vaseline one week after the intradermal induction. The animals of the control group were induced with the vehicle and Adjuvant saline.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 10 % in vaseline and vaseline alone under occlusive dressing.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.20 out of 20 animals (100%) after 24 hours and 19 out of 20 animals (95%) after 48 hours showed positive skin reactions after the challenge procedure with the substance at 10% in vaseline, no skin effects were noted in the test animals when treated with the vehicle alone. No control animal showed effects when treated with the substance at 10% in vaseline or when treated with vaseline alone. Based on the above mentioned findings the substance is considered to be a skin sensitiser.
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