Registration Dossier
Registration Dossier
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EC number: 608-388-9 | CAS number: 29644-97-1
Endpoint summary
Administrative data
Description of key information
Skin sensitisation:
A DEREK assessment, DPRA assay and KeratinoSensTM assay were performed in accordance with the strategy presented in ECHA Guidance on information requirements and chemical safety assessment Chapter R.7a.
DEREK NEXUS version 5.0.2 yielded an alert for test item for skin sensitization based on the presence of the aromatic amine group, the predicted EC3 was 12% (weak sensitizer). The outcome of a DPRA assay demonstrated that test item is not expected to bind to proteins. The KeratinoSensTM assay indicated that test item did not activate the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes.
The in chemico and in vitro data do not indicate that test item has skin sensitizing potential. However, based on the DEREK prediction it cannot be excluded that test item is a skin sensitizer after metabolic activation in vivo. As this aspect is not or limitedly addressed in the non-animal tests, it is recommended to conduct further testing for skin sensitizing properties in vivo.
One in vivo study was performed (LLNA conducted according to OECD No.429 (2010)) and the compound was determined to be negative for skin sensitization.
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
Skin sensitisation:
Negative result in animal test (LLNA).
According to Regulation (EC) No 1272/2008, table 3.4.2, this substance is not classified for this endpoint.
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