Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The skin sensitisation potential of the substance in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear was tested.

The skin sensitising test described above meet the requirements of OECD Test Guideline 429 (LLNA) and is assigned to be reliability 1 data according to the scoring system of Klimisch et al (Klimisch et al., 1997). This ranking was deemed appropriate because the study was conducted the GLP certified laboratory and was in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.


Migrated from Short description of key information:
The skin sensitisation potential of the substance in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear was tested. The test methodology complies OECD TG 429 (LLNA). The results showed the dose-dependent positive reaction in the test condition.

Respiratory sensitisation

Endpoint conclusion
Additional information:

There are no information available to assess sensitisation potential of the substance in the respiratory tract.


Migrated from Short description of key information:
There are no information available to assess sensitisation potential of the substance in the respiratory tract.

Justification for classification or non-classification

The test material was considered to be a sensitiser under the conditions of the test, based on the skin sensitising test (LLNA). The test material is classified as R43 May cause sensitisation by skin contact under Council Directive 67/548/EEC and Category 1 H317: May cause an allergic skin reaction under under Regulation (EC) No 1272/2008.