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 potential of the test substance was assessed in a GLP compliant study according to OECD guideline 429 and EU method B.42. Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, three experimental groups of five female CBA/J mice were treated with test substance concentrations of 5, 10 or 25 % w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (1 % pluronic L92 in distilled water).

Five days following the first topical application, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. 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.

Orange coloured residual test item on the ears and orange coloured staining of the fur were commonly noted in all test animals. There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period. Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 10 and 25 % were 2073, 2476 and 2934 DPM respectively. The mean DPM/animal value for the vehicle control group was 1125 DPM. The SI values calculated for the substance concentrations 5, 10 and 25 % were 1.84, 2.20 and 2.61 respectively. These values are below the threshold SI value of 3.

The test item is therefore considered to be a non-sensitiser under the conditions of the test.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008,as amended for the seventh time in Regulation (EC) No 2015/1221.