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Administrative data

Description of key information

Two studies are available to assess the skin sensitising potential of the test substance: a Direct Peptide Reactivity Assay (DPRA) study and an in vitro Human Cell Line Activation Test (h-CLAT) study. It concerns recent OECD and GLP compliant studies. The test item was found to be non-sensitising in both studies.

Key value for chemical safety assessment

Skin sensitisation

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

There are two studies available for the current endpoint.

In the first study the skin sensitisation effect of the test item was assessed in the Direct Peptide Reactivity Assay (DPRA) in chemico assay according to OECD 442C and GLP. The mean C-peptide depletion was found to be 2.52% and the mean K-peptide depletion 1.59%. Following the depletion model the reactivity class is 'no to minimal reactivity' and the DPRA prediction is negative. Under the current conditions the test item is not a sensitiser.

In the second study an in vitro Human Cell Line Activation Test (h-CLAT) was performed to assess the skin sensitising potential of the test item dissolved in culture medium when administered to THP-1 cells for 24 ± 0.5 hours. The test was performed in accordance to the OECD test guideline 442E and under GLP. The test item with a log Pow of 2.7 did not activate THP-1 cells up to a concentration of 156.3 μg/mL (limited by precipitation, oily droplets) under the test conditions of this study. Therefore the test item is considered to be negative for this key event of the skin sensitisation Adverse Outcome Pathway (AOP).

Based on the above it is apparent that in vitro testing towards two out of the three key events yielded a negative result. Hence, the test item is not considered to be a skin sensitizer. Further in vitro or in vivo testing is not needed.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Taking into account the results of the available in vitro and in vivo tests, the test item is not considered to be as a skin sensitiser.

The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.