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EC number: 242-362-4
CAS number: 18479-58-8
In the GLP compliant key Guinea Pig Maximisation Test according to OECD guideline 406, the test item induced no skin sensitisation under the conditions of the test.
The allergenic potential of the test item was investigated according to one of the methods recommended in the OECD Guidelines No. 406, "Skin Sensitization", 1992 under GLP conditions. The delayed contact hypersensitivity test used was the Guinea Pig Maximization Test described by B. Magnusson and A. M. Kligman. Thirty animals divided into a test group of 20 animals and a control group of 10 animals were included in the study. The study included an induction and a challenge phase. The animals in the test group were induced with the test article, whereas the animals in the control group were induced with oleum arachidis. The induction procedure included intradermal injections and a closed patch topical application one week apart. All animals were challenged by a closed patch topical application of the test article for 24 hours. The challenge procedure included a closed patch topical treatment of the test article an the flank 3 weeks after the intradermal injection. The skin reactions were evaluated 24 and 48 hours after the challenge application. A 5% (w/w) test article concentration in oleum arachidis was used for the intradermal induction. Undiluted test article was used for the topical induction and for the challenge and rechallenge application. Under these experimental conditions no evidence of delayed contact hypersensitivity was seen after treatment with the test item.
Skin sensitisation in vivo, RL1
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the available data, the test substance is not considered to be a skin sensitiser and is thus not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for sixteenth time in Regulation (EU) No 2021/743.
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