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:

In a GLP compliant Local Lymph Node Assay, tested according to OECD guideline 429, 4 male CBA mice per dose were treated daily with the test item by topical application to the dorsum of each ear (left and right) for three consecutive days. Initially concentrations of 1%, 3% and 10% w/v in acetone were applied. A concentration-related reduction in isotope incorporation was seen at 3% and 10%. This can be indicative of a cytotoxic response which could mask a sensitisation reaction. Consequently, additional levels of 0.1%, 0.3% and 1% w/v in acetone were tested. In both experiments, a control group of four mice was treated with the vehicle (acetone) only. Three days after the last topical application the test animals received an intravenous injection of radio labelled thymidine (³H-methyl thymidine) into a tail vein. Approximately five hours thereafter the mice were sacrificed and the draining auricular lymph nodes were excised and pooled per group. The proliferative capacity of pooled lymph node cells was determined by the incorporation of ³H-methyl thymidine. In the first experiment, stimulation indices of 1.69, 1.30, 1.01 were determined with the test item at concentrations of 1, 3, and 10% (w/v), respectively in acetone. In the second experiment, stimulation indices of 1.66, 1.23, and 1.43 were determined with the test substance at concentrations of 0.1, 0.3 and 1% w/v in acetone, respectively. Based on the described study, it is concluded that the test substance is unlikely to be a moderate to strong skin sensitizer under the conditions of the test. No classification for skin sensitisation is warranted.


Migrated from Short description of key information:
Non-skin sensitizer, LLNA, mice, OECD 429, Johnson 2000

Justification for selection of skin sensitisation endpoint:
Only study available, GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the local lymph node assay, classification for skin sensitization is not warranted according to Directive 67/548/EEC.

Based on the local lymph node assay, classification for skin sensitization is not warranted according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.