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:

The available data was adequate for the regulatory purpose required and for a basis for classification.


Migrated from Short description of key information:
Seaber, 1984, was selected as the key information for this endpoint. The study was conducted according to the OECD 406 guideline and was performed on the guinea pig in vivo. The challenge concentration was set as 5% by topical application which was left in place for 24 hours and the test sites evaluated at 24 hour intervals for 72 hours. The test material elicited sensitising reactions in all animals in the test group, at each reading. Minimal reactions were reported in single animals of the control group, each at the 24 and 72 hours reading. The study is allocated a reliability score of 2 based upon the criteria of Klimisch et al, 1997.

Justification for classification or non-classification

Based upon the key information the registered substance meets the criteria for classification according to 67/548/EEC and EC Regulation 1272/2008 and is classified as follows:

R43 - May cause sensitisation by skin contact; Skin sensitisation category 1 - H317 May cause an allergic skin reaction