Registration Dossier

Administrative data

Description of key information

Not sensitising, LLNA, OECD 429 and EU Method B.42

Key value for chemical safety assessment

Skin sensitisation

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

A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The study was conducted in accordance with the standardised guidelines OECD 429 and EU Method B.42 under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 5 % w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of the test material as a solution in 1 % pluronic L92 in distilled water at concentrations of 5, 2.5 or 1 % w/w. A further group of five animals was treated with the vehicle alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitiser alpha-hexylcinnamaldehyde at a concentration of 25 % v/v in 1 % pluronic L92 in distilled water.

The mean radioactive disintegrations per minute per animal were 2579.93, 3087.62, 3017.48 and 3353.15 for the vehicle control and 1, 2.5 and 5 % w/w dose groups respectively. The Stimulation Indices were 1.20, 1.17 and 1.30 for the 1, 2.5 and 5 % w/w dose groups respectively.

Under the conditions of this study, the test material was determined to be a non-sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to sensitisation.

 

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to sensitisation.