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:

In a local lymph node assay (Ashby et al., (1995)) groups of mice received open applications of 0, 2.5, 5, or 10% of the test substance in the vehicle (acetone, olive oil, 4:1 v/v) to the dorsum of each ear; days 2 and 3 this procedure was repeated. Five days following the initiation of experiment the mice were injected i.v. with 3H-thymidine; the activity was measured as a function of incorporation into the draining auricular lymph nodes. The stimulation index was 1.2, 1.0, and 1.6, respectively. The results demonstrated that the test item is not sensitising (a positive response includes a stimulation index ≥ 3).

Furthermore, no sensitization was observed in a guinea pig maximisation test conducted by Lawrence et al., (1971).


Migrated from Short description of key information:
The test substance is not sensitizing to the skin.

Justification for classification or non-classification

Based on the available data, the test item is not subject to C&L according to Directive 67/548/EEC or the Regulation 1272/2008/EC.