Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation

A GLP-compliant local lymph node assay in mice was performed according to OECD 429 to evaluate the sensitising potential of the test substance (Lütkenhaus, 2012). Based on a preliminary test in two female CBA/CaOlaHsd mice, the test substance at the maximum technical achievable concentration of 25% (w/v) in 4:1 (v/v) acetone/olive oil (AOO) and further dilutions of 12.5 and 6.25% (w/v) in AOO were selected as treatment concentrations for the main study. During the study period, no clinical signs of toxicity were observed and all animals showed the expected weight development compared to control animals. The mean DPM/lymph node for each test group was 598.3, 3960.9, 3446.0 and 3200.7 at concentrations of 0, 6.25, 12.5 and 25% (w/v) of the test substance, respectively. Based on these data, the mean stimulation indices (SI) relative to the negative control were calculated to be 6.6, 5.8 and 5.2 after treatment with 6.25, 12.5 and 25% (w/v) of the test substance, respectively. Since no conventional dose-response-relationship was followed, the EC3 value for the test substance could not be derived by linear extrapolation. The historical positive control p-phenylendiamine (1% in AOO) confirmed the sensitivity and reliability of the experimental technique (SI ≥ 3). Based on the results of this study, the substance is considered to be a skin sensitiser.


Migrated from Short description of key information:
Skin sensitisation (OECD 429): sensitising

Justification for selection of skin sensitisation endpoint:
There is only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VIII of Regulation (EC) No. 1907/2006.

Justification for classification or non-classification

Based on the available data on skin sensitisation, the test substance meets the criteria for classification as skin sensitiser category 1 (H317) according to Regulation (EC) No 1272/2008 and Xi (R43) according to Directive 67/548/EEC.