Registration Dossier

Administrative data

Description of key information

Not skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

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

The skin sentisation potential of the substance was evaluated in a weight of evidence approach, based on experimental data, QSAR predictions and literature data on similar substances.

Experimentally in an in vitro assay, no indication of stimulating potential on the immune cellular response by test substance, as effect on markers (CD80 and CD86) expression on dendritic cells, was reported upon treatment with the substance.

Cytotoxicity of the test substance was evaluated in a preliminary MTT assay; test concentrations in the sensitisation assay were decided based on cytotoxicity data.

Positive controls confirm the suitability of the human cells used.

QSAR predictions did not evidence any structural alert for skin sensitisation associated to the substance.

Literature data on similar substances did not indicate a skin sensitising potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A skin sensitiser refers to a substance that will lead to an allergic response following skin contact.

CLP criteria for classifying sensitisers are currently based on standard animal data, human data and data obtained from non-standard methods, e.g. read-across or non-standard test methods that may be used in combination in a weight of evidence approach. Data from in vitro experiments may also be used within the weight of evidence approach.

Overall, the skin sensitising potential of target substance was assessed based on: experimental in vitro assay (key event 3 of skin sensitisation); QSAR predictions; literature data on human and animals assays. In all the cases, no evidence of a skin sensitising potential was reported.

On these bases, the substance is not classified according to the CLP Regulation (EC 1272/2008).