Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In two skin sensitization studies, performed according to OECD guideline 406, guinea pigs were treated with test substance or vehicle. The induction was a two-stage operation. For the first induction three pairs of intradermal injections (0.1 mL per injection) were made into the shaved neck of the guinea pigs as follows: 1) adjuvant and vehicle, 2) test substance in saline, 3) test substance in the adjuvant vehicle mixture. The concentration of test substance in vehicle and adjuvant mixture was 1 %. Second induction was performed one week later by, epidermal application over the injection sites. The test substance was applied on a filter paper patch to the injection sites of the animals (administration for 48 hours). The dose of application was approx 30 % test substance in the first study (CG 1986) and 25% in the second study (RCC 1988). Two weeks after the epidermal induction application the animals were tested on the flank with test substance (10%) and the vehicle alone, 24 hour administration. Twenty four hours after removing the dressings, the challenge reactions were graded. A second evaluation was made 48 hours after removing the dressings. A second challenge was performed in study two (RCC 1988) equal to that described for the first challenge with the exception that the flanks were changed. Under the experimental conditions employed, 17 out of 20 animals of the test group showed skin reactions 24 and 48 hours after removing the dressings in study one (CG 1986). However, in the second study (RCC 1988) nine respectively eight animals from the test group (20 animals) showed positive reactions after the 24 and 48 hours reading and after the second challenge twelve respectively eleven animals showed positive reactions after the 24 and 48 hours reading out of the 20 animals tested. The allergenic potency of the test article is considered to be of a moderate grade following the grading of Magnusson and Kligman.

Migrated from Short description of key information:
Based on two skin sensitisation studies the test substance was found to be a sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the findings in the skin sensitisation study, the substance needs to be classified with Xi, R43 according to the Directive 67/548/EEC and Skin sens 1B, H317 according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.