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EC number: 204-152-0 | CAS number: 116-71-2
The structural analogue substance does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test.
Body weights: The expected body weight gain has generally been observed in the course of the study.
Mortality: One animal of control group 2 and 2 animals of the test group died 6, 8 or 10 days after the beginning of the study. Macroscopic examination revealed that the animals suffered from pneumonia.
The test substance was tested for its sensitizing effect on the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman.
The intradermal induction with 5% test substance preparations caused slight oedema in all test group animals. The index for erythema could not be determined because of staining due to the colour of the test substance.
After the percutaneous induction with a 50% test substance preparation incrustation, partially open (caused by the intradermal induction) could be observed in addition to well-defined erythema and slight oedema in all test group animals. The application areas were stained due to the colour of the test substance but it was possible to clean the treated area thoroughly, thus the index for erythema could be determined.
Two challenges were performed 14 and 21 days after the percutaneous induction. After the first challenge with a 50% test substance preparation very slight to well-defined skin reactions were observed in test group animals and animals of control group 1. Olive oil DAB 10 applied as vehicle caused very slight to well-defined erythema in one test group animal and in animals of control group 1 and 2. The second challenge with a 50% test substance preparation did not cause any skin reactions in all animals. Olive oil DAB 10 caused very slight erythema in one animal of control group 2.
Based on the results of this study, it was concluded that the test substance does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
No sensitising effect was observed with the structural analogue substance; hence, no classification is necessary.
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