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EC number: 615-063-5 | CAS number: 700863-48-5
The test item was investigated for skin sensitizing properties in the guinea pig maximization test according to Magnusson and Kligman (1969). A pre-test with intradermal or topical administrations of the vehicles and the test material was performed to select the concentrations suitable for the main study. In the main study, 5 females were treated with the vehicles liquid paraffin (intradermal) and polyethylene glycol 400 (group 1), 10 females were treated with the test material (group 2). Induction included intradermal injection of test material preparation in liquid paraffin (10 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation in polyethylene gylcol 400 (200 g/L) for 48 hours on experimental day 8. Challenge by topical application of the test material preparation in polyethylene glycol 400 (100 g/L) for 24 hours was performed two weeks after topical induction and readings were taken at 48 and 72 hours after start of the treatment. After intradermal injection, the common signs of irritation after injection of Freund's complete adjuvant were observed. The injection sites were swollen and red with subsequent scab formation. The challenge was performed on the right side of the animals. Group 1 (negative control group): After challenge with polyethylene glycol 400, no erythema or edema was observed. A single treatment was performed with test material (100 g/L preparation in polyethylene glycol 400) to exclude primary irritation of the test material concentration. No positive reactions were observed in the treated areas at any time point. Group 2 (test material group): After challenge with test material (100 g/L preparation in polyethylene gylcol 400) no positive skin reactions were observed. This results in 0 % positive reactions after challenge. After challenge, no positive reactions were observed in the areas treated with polyethylene glycol 400 alone at any time. The clinical behaviour of the guinea pigs was normal during the experimental part and all animals survived. The body weight development corresponded to that of the animals of the vehicle group.
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