Registration Dossier

Diss Factsheets

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:

The study was performed according to a method equivalent to guideline OECD TG 406 EU Method B.6 and EPA OPPTS 870.2600 and JMAFF Guidelines and consistent with Magnusson-Kligman Guinea Pig Maximisation test to assess the skin sensitisation potential of the test substance. Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 50% concentration and epidermally exposed to a 100% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). Two weeks after the epidermal application all animals were epidermally challenged with a 50% test substance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals. There was no evidence that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 50% test substance concentration in the challenge phase. Under the conditions of this study, the test substance is not considered to be a contact skin sensitizer.

Migrated from Short description of key information:
non-sensitising, Guinea Pig (male), eq. to OECD TG 406, Wil Research B.V. 2015

Justification for selection of skin sensitisation endpoint:
one in vivo study Klimisch 1 and following Magnusson-Kligman GPMT Method methodology.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for skin sensitisation.

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for skin sensitisation.

In the GPMT test the severity of effects were non-existent (erythema score < 0.5) in all organisms. The test was consistent with established adjuvant-test methodology. Under EU criteria no significant effects were observed in the in vivo GPMT study on exposure to the substance at > 1% v/v intradermal induction dose. The substance cannot be considered a skin sensitiser.