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 test material in acetone/ethanol produces contact sensitization, however its ability to sensitize appears to be vehicle/carrier-dependent. The test material did not produce contact sensitisation with mineral oil as vehicle. Skin sensitization was determined in a modified Buehler method in guinea pigs. The test material in acetone/ethanol produces contact sensitization (15/19 pigs with grade 1 or greater reactions). The test material (67% Primene in oil) was not sensitizing in guinea pigs when mineral oil was used as solvent vehicle.


Migrated from Short description of key information:
Skin sensitisation- sensitizing in guinea pigs in a modified Buehler assay.

Justification for classification or non-classification

The test material in acetone/ethanol produces contact sensitization (15/19 pigs with grade 1 or greater reactions).