Registration Dossier

Administrative data

Description of key information

Skin Sensitisation: Positive, Mouse LLNA , OECD 429, Hargitai (2012)

Key value for chemical safety assessment

Skin sensitisation

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

In-vivo study was performed for a chemical registration scheme outside of the European Economic Area. Unreliable screening studies which were not conducted for the purposes of REACH were discarded. Only studies conducted according to guidelines and under OECD GLP were selected as key studies for use in classification.

A skin sensitisation study was carried out according to OECD TG 429 and under OECD GLP. No mortality was observed during the study. No treatment related effects were observed on animal body weights in any treated groups. Hyperactivity, intermittent tremors or increased aggressiveness were observed after treatment on Day 2 for some animals in the 100 and 50 % (w/v) dose groups. Similarly, hyperactivity, increased aggressiveness and intermittent tremors were observed after treatment on Day 3 for all animals in the 100 and 50 % (w/v) dose groups. Due to the observed effects, animals were repeatedly observed after treatment on these days; 4 hours after treatment all the animals became symptom-free on both days. Alopecia was observed on Day 6 in some animals of the 100, 50 and 25 % (w/v) dose groups. Very slight erythema (score 1) was detected after treatments at the site of application in the 100 % (w/v) dose group on Days 1-3, furthermore in the 50 % (w/v) dose group on Days 2-3. Quantification of the ear thickness was performed in the main experiment by ear punch weight determination. The revealing ear punch weights were in the historical control range; although in the highest dose group slightly higher values were observed when compared to the negative control group. Larger than normal lymph nodes were observed in all test item treated groups. The observed stimulation index values were 51.6, 59.5, 53.0 and 33.9 at concentrations of 100, 50, 25 and 10 % (w/v), respectively. In conclusion, under the conditions of the assay, tested in a suitable vehicle, the test substance was shown to have skin sensitisation potential (sensitiser) in the Local Lymph Node Assay.

The data provided for this endpoint is considered to be relevant, adequate, reliable and complete for the purposes of classification and risk assessment.

Justification for classification or non-classification

Based on the positive results (stimulation index>3) in the mouse LLNA, the test item is classified as a Catagory 1A Skin Senistiser according to CLP (regulation (EC) No 1272/2008).