Registration Dossier
Registration Dossier
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EC number: 279-481-6 | CAS number: 80475-32-7
Endpoint summary
Administrative data
Description of key information
OECD 442D, in vitro sensitization ARE-Nrf2 Luciferase test. Predicted to be a non-sensitizer. Reliability = 1; Key study
OECD 442C, in chemico sensitization Direct Peptide Reactivity assay. Predicted to be a non-sensitizer. Reliability = 1; Key study
skin sensitisation: in vivo (non-LLNA). The test substance does not induce delayed contact hypersensitivity in guinea pigs according to the maximization method of Magnusson and Kligman. Reliability = 2; supporting study
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The Induction of Antioxidant-Response-Element Dependent Gene Activity in the Keratinocyte ARE- Reporter Cell Line KeratinoSens assay was used to assess the skin sensitization potential of the test article. A test article was predicted to have sensitization potential if: 1) The ECI.5 value fell below 1000 μM in at least 2 of 3 repetitions; 2) At the lowest concentration with a gene induction above 1.5, cellular viability was greater than 70%; and 3) There was an apparent overall dose response which was similar between the three definitive assays. According to the current prediction model, the test article was predicted to be a non-sensitizer.
The test article was evaluated for skin sensitisation potential using the Direct Peptide Reactivity Assay in accordance with OECD Guideline 442C. Synthetic peptides containing cysteine or lysine were reacted with the test articles for 24 ± 2 hours. After that incubation period the extent of peptide depletion was analysed using High Performance Liquid Chromatography (HPLC) coupled with ultra-violet (UV) spectrometric detection. The percent depletion of the peptide for the test article was calculated by comparing peak area of the individual test article sample to the mean peak area of the solvent control replicates. This percent depletion correlates to the sensitizing potential of the test article. The Mean Peptide Depletion of Cysteine and Lysine for the test substance was 5% and 0.53%, respectively, and for the positive control, cinnamic aldehyde, 74.60% and 62.52%, respectively. Therefore, the test substance is not predicted to be a skin sensitizer.
An in vivo study in guinea pigs supports the above in vitro and in chemico findings.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test substance was predicted not to be a sensitzer when tested in vitro, in chemico, and in vivo studies. Therefore, no classification is required for skin sensitisation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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