Registration Dossier
Registration Dossier
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EC number: 252-501-0 | CAS number: 35303-76-5
Endpoint summary
Administrative data
Description of key information
Skin sensitisation:
A DEREK assessment, DPRA assay, a KeratinoSensTM assay and a U-SensTM assay were available.
DEREK NEXUS version 5.0.2 did not yield any alerts for skin sensitization for the test item.
In the cysteine reactivity assay the test item showed 0.0% SPCC depletion while in the lysine reactivity assay the test item showed 5.4% SPCL depletion. The mean of the SPCC and SPCL depletion was 2.7%. As a result the test item was considered to be negative in the DPRA and was classified in the “no or minimal reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model.
The test item is classified as positive in the KeratinoSensTM assay since positive results (>1.5-fold induction) were observed at test concentrations of <1000 μM with a cell viability of >70% compared to the vehicle control in two out of three experiments. In addition, test item is classified as positive (increase in the expression levels of CD86 cell surface marker in the U937 cell line) when tested in the U937 cell line activation Test (U-SensTM) assay.
In conclusion, there are indications that test item has skin sensitizing potential via binding to proteins followed by activation of dendritic cells. Moreover, in absence of non-animal tests to determine its potency adequately for classification purposes, it is recommended to perform an in vivo test with test item.
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 in animal test (LLNA).
According to Regulation (EC) No 1272/2008, table 3.4.4, this substance should not be classified for this endpoint.
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