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EC number: 405-290-6 | CAS number: 12036-37-2
1. Intradermal and Topical Sighting Studies
Based on the results, the following concentrations were selected for the main study:
Intradermal Induction: 25% (w/v) in distilled water
Topical Induction: 75% (w/w) in distilled water
Topical Challenge: 75% (w/w) in distilled water
2. Main Study
Scattered mild redness (grade 1) was noted at five test group skin sites one hour after removal of the patches.
No other adverse reactions were noted during the induction period.
Individual reactions at the challenge sites of test and control animals are summarised as follows:
Incidence of sensitisation Responses in Test Animals
% Sensitisation Response
One control group animal was found dead on day twenty-one. The absence of this animal did not affect the purpose or integrity of the study.
Scattered mild redness (grade 1) was noted at the test material site of one test group animal at the 24-hour observation. Similar skin reactions were also noted at the test material site of two control group animals at this time. These reactions were, therefore, considered to be skin irritation and were not indicative of skin sensitisation. No adverse skin reactions were noted at the 48-hour observation.
No adverse reactions were noted at the vehicle control sites of the test or control animals at the 24 and 48-hour observations.
The test material, therefore, produced a 0% (0/20) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin.
Bodyweight gains of guinea pigs in the test group, between day 0 and day 24, were comparable to those observed in the control group animals over the same period.
The test material, was found to be a non-sensitiser to guinea pig skin. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 406 "Skin Sensitisation" - Magnusson and Kligman Maximisation Test, referenced as method B6 in Annex V of EEC Commission Directive 84/449/EEC.
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