Registration Dossier

Administrative data

Description of key information

The test substance was predicted to be a skin sensitizer based on combined results of 3 in vitro studies, performed according to OECD 442C, 422D and an OECD draft proposal.

Key value for chemical safety assessment

Skin sensitisation

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

In the in vitro sensitisation tests DPRA (protein reactivity), LuSens (activation of keratinocytes) and h-CLAT (activation of dendritic cells) performed according to OECD guidelines 422C, 422D and an OECD draft proposal, the skin sensitisation potential of the test substance was assessed.

In the DPRA, the test substance was incubated for 24 hours at room temperature with synthetic peptides in a ratio of 1:10 (0.5 mM peptide, 5 mM test substance) and the K-containing peptide in a ratio of 1:50 (0.5 mM peptide, 25 mM test substance in triplicate. The mean peptide depletion was calculated to be 13.21%. According to the prediction model, the test substance shows a low chemical reactivity in the DPRA.

In the LuSens, the test substance was incubated for 48 hours at 37 °C, where subsequently the activity was measured with a luminometer. Concentrations used were based on a pre-test and in total 2 experimenst were performed. The test substance did not have a significant effect on relative luciferase fold induction and the concurrent relative viability. Therefore, the test substance does not have a keratinocyte activating potential.

In the h-CLAT, the test substance was exposed for 24 hours at 37 °C in 2 experiments to test concentrations that were based on a pre-test. CD86 and CD54 expression was induced in THP-1 cells affording at least 50% viability in at least two independent experiments and therefore it is concluded that the test substance induces dendritic cell activation.

Based on these combined results, the test substance is predicted to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information the test substance is predicted to be a skin sentisizer and therefore should be classified as Skin Sens.1: H317: May cause an allergic skin reaction, as in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.