Registration Dossier
Registration Dossier
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EC number: 923-466-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The skin sensitisation potential of one NDI category substance was assessed. The KeratinoSensTMassay was inconclusive based on negative results at concentrations with sufficient cell viability, while due to precipitation and cytotoxicity not all concentrations could be tested up to and including 1000 µM. Performance of a U-Sens™ assay was considered to give no additional information, as a negative result will not yield a final conclusion and a positive result may indicate the test item is a skin sensitizer, but still no final conclusion on the potency can be derived. A DPRA assay could not be performed on this substance as it is outside the applicability domain.
Therefore, no conclusion on skin sensitisation properties and potency can be drawn from the in vitro test performed and an LLNA assay performed according to the OECD 429 guideline has been commissioned.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
- Additional information:
In the KeratinoSens assay no biologically relevant induction was measured as the test item was cytotoxic. As the test substance could not be tested at concentrations up to 1000 µM due to precipitation and, more important, cytotoxicity, the KeratinoSens assay was determined to be inconclusive according to OECD 442D. Therefore, no conclusion on skin sensitisation properties and potency can be drawn from the in vitro test performed and an LLNA assay performed according to the OECD 429 guideline has been commissioned.
Justification for classification or non-classification
Based on the currently available in vitro data available, no assessment of classification can be made, as the in vitro results were inconclusive. Therefore, in accordance with the signed study an LLNA will be performed to assess the classification requirement of the NDI category substances.
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