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:

The skin sensitising properties of AC-6000 were determined in a GLP study according OECD guideline 429 (Local Lymph Node Assay (LLNA)) (NOTOX B.V., 2007). For this purpose, three groups of five experimental animals were treated with test substance concentrations of 25%, 50% or 100% on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with the vehicle alone (Acetone / Olive oil). Three days after the last exposure, all animals were injected with3H-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 Disintegrations Per Minute (DPM) and a stimulation index (SI) was subsequently calculated for each group.

No skin irritation was observed in any of the animals examined. All nodes of the experimental and control groups were considered normal in size. Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 400, 291 and 264 respectively. The mean DPM/animal value for the vehicle control group was 226. The SI values calculated for the substance concentrations 25, 50 and 100% were 1.8, 1.3 and 1.2 respectively. There was no indication that the test substance could elicit an SI 3 when tested up to 100%. Based on these results AC-6000 should not be considered a skin sensitiser.

Migrated from Short description of key information:
The substance was not a skin sensitiser in a local lymph node assay in the mouse.

Justification for classification or non-classification

Based on the results of the skin sensitisation study, classification according to EU Directive 67/584/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not needed.