Registration Dossier

Diss Factsheets

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)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the Guidance on the application of CLP criteria (ECHA, 2017): ''Validated in vitro/in chemico methods exist with the aim to identify a sensitising potential of a chemical. These include OECD TG442C (Peptide/protein binding), TG442D (keratinocyte response) and TG 442E (monocytic/dendritic cell response). The in vitro/in chemico tests are not regarded as stand alone tests and the result from such a test should be used together with other data in an overall WoE assessment. Further, at present there is no agreed strategy on how to use in vitro/in chemico methods for direct estimation of sensitising potency, but data from such tests can be used in a WoE assessment together with other data in order to assess skin sensitisation potency. See also the Guidance on IR&CSA, especially Section R.''

The OECD guideline 442C was not applied as the test item is an UVCB substance. Nevertheless data from the in vitro tests performed and the in vivo study has been used to allow a clear conclusion about the skin sesnitisation potential of the substance under investigation.

Based on the results obtained in the three tests described above the test substance has not been classified as skin sensitizer according to the CLP Regulation (EC) No.1272/2008.