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EC number: 239-825-8 | CAS number: 15733-22-9
A study for skin sensitisation in guinea pigs was conducted with the test substance using the Magnusson-Kligman method similar to the OECD Guideline 406 (1992). Groups of 15 Pirbright White guinea pigs each were used in two parts of the study. In the first study, male animals received intradermal induction treatments consisting of three pairs of injections. The first pair of injections was of Freund's complete adjuvant (FCA) 50% diluted in water, the second pair was of 25% of the test substance in the vehicle, and the third pair of injections was of 25% of the test substance with FCA. The control group received three pairs of injections that were the same as the test group except for the absence of the test material. One week following intradermal induction an epicutaneous induction under occlusive conditions for 48 h was performed. In the test group, 25% of the test substance in vehicle was applied, while for the control group only vehicle was applied. Three weeks after the intradermal induction the animals were challenged with 25% (right flank) or 12.5% (left flank) of the test substance in vehicle under occlusive conditions for 24 h. In the second study, female animals received were induced and challenged in the same way compared to the male animals of the first study with different test substance concentrations: For the intradermal and the topical induction 1% of the test substance was applied while 25% (left flank) and 50% (right flank) were used for topical challenge. Skin reactions were evaluated at 24 and 48 h after patch removal. The Magnusson-Kligman scoring system was used to rate the skin reactions. In the first study (25% induction concentration) a skin reaction was observed in 1/15 animals (6%) after challenging with 12.5% of the test substance at 24 h and in 3/15 animals (20%) at 48 h. The application of a challenging concentration of 25% led to sensitizing effects in 7/15 males (47%) at 24 and in 13/15 animals (87%) at 48 h. In the second study (1% induction concentration) no reactions were observed after challenging with 25% the test substance at 24 and 48 h while skin reactions were noted after topical challenge with 50% test substance (4/15 females at 24 h and 2/15 females at 48 h; 27 and 13%, respectively). Thus, under the conditions of this study, the test substance is classified as Skin Sensitizer Category 1B according to Regulation (EC) No 1272/2008.
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