Registration Dossier

Administrative data

Description of key information

Skin sensitisation (OECD 406): not sensisiting

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitising potential of the test substance was investigated in a guinea pig maximisation test (GPMT test) performed according to OECD Guideline 406 and in compliance with GLP (2006). 15 male Albino Hartley guinea pigs were used (10 animals as test group, 5 animals as control group) to evaluate the sensitising potential of the test substance. The induction and challenge concentrations were determined in a range-finding study. During the induction procedure the test group was exposed to 1% test substance in 1% (w/v) carboxymethylcellulose via intradermal injection on Day 1. The skin site was treated with 10% SDS approximately 24 h before the topical induction. On Day 9 the animals were treated with 100% test item via topical application. The control group was exposed to vehicle only during this procedure. All the animals were challenged with 100% test substance. At challenge 0/5 and 0/10 positive responses were noted in the control and test group, respectively, after 24 or 48 hours following treatment. Under the conditions of the study, the test substance was considered to be not skin sensitising.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.