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EC number: 214-684-5 | CAS number: 1185-53-1
The purpose of this GPMT assay was to identify the contact allergenic potential of teh test material. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man.
The test material was investigated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969).
10 females were treated with the vehicle sodium chloride solution (group 1) and 20 females were treated with the test material (group 2).
Induction included intradermal injection of test material preparation (25 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation (100 g/L) for 48 hours on experimental day 8.
Challenge by topical application of the test material preparation (1 g/L) for 24 hours was performed two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After challange one positive reaction was observed in the second reading. This results in 5 % positive reactions.
According to EU Regulation No. 1272/2008 (CLP), the test material is not classified as a skin sensitizer.
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