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:

In a Guinea pig maximization test (GPMT) performed according to OECD TG 406 with 10 animals in control and treament groups each, the test substance, suspended in Miglyol 812, revealed a negative result. Intradermal induction concentration was chosen with 5 % followed by a topical induction concentration of 25 %. Challenge was performed by topical treatment with a 12.5% suspension in Miglyol 812.

Based on this study the test item does not possess a skin sensitizing effect in Guinea pigs.

Migrated from Short description of key information:
Skin Sensitisation, Maximization Test according to Magnusson and Kligman (Guinea pig, GLP, comparable to OECD TG 406): not sensitizing

Justification for selection of skin sensitisation endpoint:
only one study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.