Registration Dossier

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:

A Buehler test was performed in female guinea pigs according to OECD TG 406 (adopted 1981), with the restriction, that only 10 instead of 20 animals were used in the treatment group. No skin reactions were observed 24, 48, and 72 hours after challenge procedure. Furthermore a maximisation test was performed with 25 human subjects. The test substance was administered as a 8% solution in petrolatum. No sensitization was observed. Thus, the test substance is not sensitizing to the skin.

Migrated from Short description of key information:
The test substance showed no sensitizing potential in a Buehler test in guinea pigs (OECD TG 406, adopted 1981). Furthermore no sensitization was observed in a maximisation test performed in 25 human subjects with a 8% test substance solution.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

- No classification required for skin sensitization.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008 (last amended by EC/286/2008 (2011-03-10)):

- No classification required for skin sensitization.