Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
In a modified method of the Maguire method the test procedure consisted of topical application of a 0.1 ml aliquot of the test material to the clipped and depilated backs of 10 Hartley guinea pigs for four times in 10 days. At the time of the third application, 0.2 ml of Freund´s adjuvant was injected intradermally at one point adjacent to the insult site. After a 2-week rest period, the guinea pigs were challenged on the clipped flanks with the test material on one flank and a solvent on the other flank. The challenge site was evaluated for erythema and edema at 24 and 48 hours. In 0/10 animals effects were observed, therefore the test substance was not found to be sensitizing (Rao, 1081).

This finding was supported by a skin sensitization test in female Hartley guinea pigs where the test substance also proved to be non-sensitizing (Sarlo, 1992).

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
In a respiratory allergenicity test in female Hartley guinea pigs the test substance proved to be non-sensitizing (Sarlo, 1992).

Justification for classification or non-classification

Based on the available studies, the test substance needs no classification for sensitization according to EU guidelines.