Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
Migrated from Short description of key information:
406 Male guinea pigs were tested with the Maximisation test (MAGNUSSON and KLINGMAN) according to OECD guideline 406. The test was executed with following concentrations of the test substance: Intradermal Induction: 2,5% Topical Induction: 50% 1. Provokation: 50% 2. Provokation: 5% and 25 % The test substance was formulated with Cremophor EL (2% v/v) in sterile, physiological NaCl-solution. After the 1. provocation in 9 of 20 animals an obvious skin sensitization was observed with 50% test substance-formulation. After the 2. provocation with the 25% test substance-formulation in 10 animals and with the 5% test substance-formulation in 4 animals a skin sensitization was observed. The test substance was found to be sensitizing to the skin (Diesing 1989). No respiratory sensitization study is available.

Justification for classification or non-classification