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EC number: 206-108-6 | CAS number: 301-10-0
During the primary irritation experiments, no signs of systemic toxicity were observed; however, body weight loss was noted in 3 of the 5 animals tested. During the main study, no symptoms of systemic toxicity were observed and no mortality occurred. Average body weight gain of test and control animals was comparable. After the 48 hours occluded epidermal induction exposure, test animals showed slight to severe erythema and slight to well-defined edema. In the challenge test, 20, 16 and 13 test animals showed a positive skin reaction in response to the 10%, 5% and 2% test substance concentrations, respectively. Based on these results, a sensitization rate of 85% was determined. The test substance should be considered to have extreme sensitizing properties.
The purpose of the study was to obtain information on the potential of the test substance to induce delayed contact hypersensitivity (skin sensitization) in the guinea pig after intradermal and epidermal exposures.
This study was carried out in accordance with the OECD Guideline No. 406, the EEC Directive 84/449/EEC, Part B.6, and the method described by Magnusson and Kligman.
After identification of the slightly irritating and the non-irritating test substance concentrations in the primary irritation experiments, a main study was performed with the selected test substance concentrations. The experimental animals were intradermally injected with a 2% concentration and epidermally exposed to a 50% concentration, while control animals were similarly treated, but with the vehicle only. Immediately after the epidermal exposure, the skin irritation was scored. Two weeks after the epidermal application all animals were challenged with test substance concentrations of 10%, 5% and 2%, and the vehicle. The challenge reactions were assessed 24 and 48 hours after bandage removal.
The epidermal exposure of the test substance in the induction phase resulted in slight to severe skin irritation. The epidermal exposure of the test substance in the challenge phase resulted in seventeen positive sensitization reactions in response to the 10% test substance concentration.
Under the conditions used in this study, the test substance resulted in a sensitization rate of 85 per cent.
Applying the rating of allergenicity described by Kligman, A.M. (1966) on the results obtained in this test, the test substance is considered to have extreme sesitizing properties.
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