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 skin sensitisation study was conducted to determine the potential for the test material to cause skin sensitization. The study was conducted in compliance with GLP, and the methodology used, the Magnusson-Kligman Maximisation Test, is a well recognised test for this effect.

A test group and a control group, each of 20 Guinea Pigs, were exposed to the test material (or untreated vehicle, paraffin oil, in the case of the control group) by intradermal injection followed one week later by a topical application during the induction phase of the study. Three weeks after the commencement of the induction procedure, the challenge procedure was performed by topical application of test material and vehicle to all animals.

No positive reactions to the challenge procedure were seen in any of the test group animals. In the control group, three animals showed a reaction to the test material, and one to the vehicle.

On the basis of these results, there is no evidence of skin sensitisation by the test material.

Migrated from Short description of key information:
No evidence of sensitisation seen in Guinea Pigs (Magnusson-Kligman method).

Justification for classification or non-classification

In the Magnusson-Kligman Maximisation test, no evidence of skin sensitisation was observed. On the basis of this, there is no need for classification as a skin sensitizer.