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:

A Local Lymph Node Assay according to OECD 429 has been performed with Vinyl laurate. Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, three groups of five experimental animals were treated with test substance concentrations of 10, 25 and 50 % on three consecutive days by open application on the ears. Five vehicle control animals were similarly treated but with vehicle alone (acetone/olive oil). Three days after the last exposure all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.

After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Desintegrations Per Minute (DPM) and a stimulation index was subsequently calculated for each group.

Skin irritation was observed in the animals examined. The higher dose groups showed more severe skin irritation. The irritation of the ears as shown by the animals was considered not to have a toxicologically significant effect on the activity of the nodes.

All nodes of the experimantal and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted. Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50 % were 231, 400 and 501 respectively. The mean DPM/animal value for the vehicle control was 304. The Stimulation indicees (SI) for the substance concentrations 10, 25 and 50% were 0.8, 1.3 and 1.6 respectively. Since there was no indication that the test substance could elicit an SI >= 3 when tested up to 50% it was established that the EC3 value (if any) exceeds 50%.


Migrated from Short description of key information:
Vinyl laurate is not sensitizing to the skin when administered to mice in an Local Lymph Node Assay.

Justification for classification or non-classification