Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

In a GLP compliant skin sensitisation study, performed according to OECD Guideline 429, the skin sensitisation potential of Polypropoxylated p-nonylphenol-formaldehyde-diethanolamine, Mannich base was investigated in a mouse Local Lymph Node Assay (LLNA) (TOXI-COOP Zrt. 2013). The main test consisted of two independent experiments. In experiment 1, five groups of 4 female CBA mice each were treated with 75, 50, 25, 10, and 5% of the test substance and in experiment 2, four groups of 4 females each were treated with 2.5, 1, 0.5, and 0.25% of the test substance. In both experiments the test substance was applied by means of open application of 25μL to each ear for three consecutive days. Three days after the last treatment, all animals received an intravenous injection of 3H-thymidine. Five hours later, the 3H-thymidine incorporation in the draining auricular lymph nodes was determined. The results were compared with those of a negative control group which was treated with the vehicle (acetone/olive oil, 4:1 v/v). In experiment 1 significant loss of body weights was observed at test item concentrations of 75 %, 50 % and 25 %: the mean values decreased by 9 %, 9 % or 7 %, respectively. As a local effect loss of hair around the treatment site was observed at the 25 %, 10 % and 5 % dose groups. The ear thickness increase was 33.3 % or 42.9 % at day 6 in the 25 % and 10 % dose groups, respectively. The stimulation indices ranged between 15.0 and 21.7. Based on the local and systemic effects observed it was considered that the observed effects may indicate irritation and/or toxic effect of the test item at higher concentrations which could contribute to increase of the lymphoproliferation. This suggestion was supported by the lack of a significant dose-response relationship at the tested concentration range. Therefore, a second experiment was performed. In experiment 2 no systemic and local effects were observed. The stimulation indices in experiment 2 were 15.8, 5.5, 2.6, and 3.1 for the 2.5, 1.0, 0.5, 0.25% dose-group, respectively. Based on these results, the test substance is considered to be a skin sensitizer.

Migrated from Short description of key information:
The test substance is, in a GLP compliant OECD 429 guideline study, considered to be a skin sensitser.

Justification for selection of skin sensitisation endpoint:
The study available is a GLP-compliant guideline study, fully adequate for assessment.

Justification for classification or non-classification

Based on the findings in the skin sensitisation study, the test substance has to be classified as Catagory 1A:H317 for skin sensitisation according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and as Xi:R43 according to Directive 67/548/EEC (DSD).