Registration Dossier

Administrative data

Description of key information

in vivo LLNA (according to the EU Method B.42, Skin sensitization: Local Lymph Node Assay, Council Regulation (EC) No. 440/2008, published in O.J. Ll42, 2008; GLP): not sensitizing

Key value for chemical safety assessment

Skin sensitisation

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

In a dermal sensitization study with the test substance dissolved in DAE 433 (mixture of 40% dimethylacetamide, 30% acetone and 30% ethanol), female mice (Balb/c) were tested using the method of Local Lymph Node Assay (LLNA). The animals did not show any signs of systemic toxicity or local skin irritation during the study period. No deaths occurred during the study period.

 

In this study Stimulation Indices (S.I.) of 1.01, 1.07, and 0.84 were determined with the test item at concentrations of 0.3, 3, and 30% (w/v) in DAE 433, respectively. Ear punch weight was not increased in all dose groups in comparison to the control group. The positive control substance DNCB (Dinitrochlorobenzene) elicited a reaction pattern with statistically significant increases in ear weights and a Stimulation Index of cell proliferation of 9.19, which was in congruence with its expected mode of action as a contact allergen. The test substance was not a skin sensitiser under the conditions of this study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.