Registration Dossier

Administrative data

Description of key information

A close homologue of the registered substance (C9 side chain instead of C11-12 side chain) tested in a LLNA study showed stimulation indices larger than the cut-off of 3. Based on a read across approach the registered substance is also considered to be a skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

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

The skin sensitisation potential of a close homologue of the test substance (C9 side chain instead of C11-12 side chain) was investigated in a Local Lymph Node Assay. Three groups of four femal mice were treated by topical application to the dorsum of each ear daily for three days with the concentrations 10, 25 and 50%. Acetone:olive oil (4 +1) was used as vehicle. Five days after study initiation, the mice were injected intravenously into a tail vein with radio-labeled thymidine and sacrificed five hours later.

No mortality occured and no signs of local irritation or systemic toxicity were present. Stimulation indexes were 12.80, 16.10 and 15.74, all being larger than the cut-off of 3. Consequently, the test substance is considered to be a skin sensitiser. Based on the available data, no sub-classification into Cat. 1A or 1B was possible.

A read across justification document is attached in chapter 13 of this IUCLID.

Justification for classification or non-classification

According to the findings of the available studies, the test substance has to be classified R43 (Directive 67/548/EEC) and Skin sensitisation Cat. 1 (CLP). A subcategorization into 1A and 1B is not possible based on the available data.