Registration Dossier

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Test substance was evaluated for its sensitizing potential in Guinea Pigs in the Maurer Optimization test (Ciba 1979). The study was performed prior to GLP requirements, but is reported in adequate detail for assessment. The protocol used is similar to OECD testing guideline 406. It uses an intracutaneous sensitization procedure similar to the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension in propylene glycol 70 %. One control group was treated with the vehicle alone ("negative control"). Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % suspension in propylene glycol 70 % was administered into the skin of the left flank. Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded. Ten days after the intracutaneous challenge injection a subirritant dose of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The substance was found to be non-sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified as a skin sensitizer under Regulation (EC) No. 1272/2008. Experimental data regarding respiratory sensitization is not available. Considering the absence of a skin sensitizing potential, a hazard of respiratory sensitization is not expected.