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:

An LLNA skin sensitisation study was performed according to OECD/EC test guidelines and GLP principles. The test substance was tested up to 50%. No mortality occurred, no clinical signs of systemic toxicity were observed and body weights and body weight gain of experimental animals remained in the same range as controls over the study period. Only minor skin irritation was seen on day 3 and 4 in animals treated with 50%.

The SI values calculated for the substance concentrations 10, 25 and 50% were 1.4, 1.6 and 2.8 respectively. Based on these results Oxooil LS13 is not considered to be a skin sensitizer.

Migrated from Short description of key information:
In an LLNA skin sensitisation study, performed according to OECD/EC test guidelines, the substance was considered not to be a skin sensitiser, as the SI appeared not to be ≥ 3 when tested up to 50%.

Justification for selection of skin sensitisation endpoint:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available study, the test substance is not classified for sensitisation according to EC Regulation No. 1272/2008.