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:

After induction of 11 Guinea Pigs of the treated group by 2 topical applications with the test item diluted at 60% in liquid paraffin during 48 hours, and a II-day rest phase, the challenge phase, und er occlusive dressing for 24 hours, consisted to a single topical application of the test item diluted at 60% and at 30% in liquid paraffin.

No macroscopic cutaneous reactions attributable to allergy were recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item.

No cutaneous intolerance reaction was recorded in animals from the negative control group.


Migrated from Short description of key information:
not sensitisizing:
After induction of 11 Guinea Pigs of the treated group by 2 topical applications with the test item diluted at 60% in liquid paraffin during 48 hours, and a II-day rest phase, the challenge phase, und er occJusive dressing for 24 hours, consisted to a single topical application of the test item diluted at 60% and at 30% in liquid paraffin.
No macroscopic cutaneous reactions attributable to allergy were recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item.
No cutaneous intolerance reaction was recorded in animals from the negative control group.


Weight evolution:
Not any abnormality was recorded in the body weight gain of both groups.
Mortality:
No mortality occurred during this study.
No macroscopic cutaneous reactionsattributable to allergy were recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item.
No cutaneous intolerance reaction wasrecorded in animals from the negative control group.

Justification for classification or non-classification

not to be classified according to EC No. 1272/2008