Registration Dossier

Administrative data

Description of key information

Skin sensitisation: Not a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a key Guideline (OECD 442b) skin sensitisation study, the potential of the test material, to cause skin sensitisation reactions was evaluated following topical application to the skin of CBA/JN mice using the LLNA: BrdU-ELISA method.

 

A preliminary test was conducted where five concentrations of the test material [25 (maximum feasible concentration), 10, 5, 2.5 and 1 % w/w in acetone:olive oil 4:1 (v/v)] were in order to identify a nontoxic and minimally irritant concentration and to avoid false positive results. No signs of toxicity (significant clinical signs or body weight losses) were observed at the tested concentrations. According to the results of the irritation screening, the concentration of 25% w/w was judged to be not irritant.

 

In the main assay, the test material was topically administered at concentrations of 25, 10 and 5% (w/w), in acetone:olive oil 4:1 (v/v). No mortality or clinical signs were observed in any animal. Changes in body weight observed during the study were within the expected range for this strain and age of animals. No increase in cell proliferation of draining lymph nodes was observed in any treatment group. The calculated Stimulation Indices (SI) were 1.43, 1.51, and 0.98 for the low, mid-and high dose levels [5, 10, and 25% w/w], respectively. No correlation with the doses or statistical significance was observed.

 

The above results indicate that the test material did not elicit any sensitisation response/s in mice following dermal exposure and is therefore not considered to be a dermal sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Not classified for skin sensitisation according to according to the CLP Regulation (EC 1272/2008), section 3.4.