Registration Dossier
Registration Dossier
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EC number: 271-360-6 | CAS number: 68551-08-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Weight of evidence analysis for skin sensitization potential indicates Alcohols, C9-11-branched is expected not sensitising. Three pieces of evidence lead to this conclusion: analog read across to Alcohols, C9-11-iso, C10-rich, QSAR predictions for hypothesized constituents from the Danish EPA model for skin sensitisation, and QSAR predictions for hypothesized constituents from the OASIS TIMES Skin sensitisation with autooxidation model. All three pieces of evidence indicate Alcohols, C9-11-branched is expected to be not sensitizing.
In vivo skin sensitisation testing of Alcohols, C9-11-iso, C10-rich was performed. The results indicated an absence of skin sensitizing properties. Due to the high degree of similarity in structure and metabolism between Alcohols, C9-11-iso, C10-rich and Alcohols, C9-11-branched the analog read-across supports an expectation that Alcohols, C9-11-branched are not sensitizing.
QSAR predictions for hypothesized constituents of Alcohols, C9-11-branched were generated using the Danish EPA model for in vivo skin sensitisation available in QSAR Toolbox 3.3.5. The majority of hypothetical constituents were in domain for the model . No constituents were predicted to have sensitizing potential. The majority of in domain hypothetical constituents and were predicted to be non-sensitisers, with a minority predicted to be equivocal. The results support the prediction based on analog read-across that Alcohols, C9-11-branched is not sensitizing.
QSAR predictions for hypothesized constituents of Alcohols, C9-11-branched were generated using the TIMES model for in vivo skin sensitisation available in OASIS-LMC TIMES 2.27.5. The all hypothetical constituents were in domain for the model . All hypothetical constituents, and their computationally predicted metabolites, were predicted to be non-sensitisers. The results support the prediction based on analog read-across that Alcohols, C9-11-branched is not sensitizing.
Migrated from Short description of key information:
Not sensitizing.
Justification for selection of skin sensitisation endpoint:
Three lines of evidence lead to weight of evidence indicating Alcohols, C9-11-branched are not sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
There are no data on respiratory sensitization for the higher alcohols. Inhalation exposure to the higher alcohols is unlikely because of the low vapor pressure of these materials at standard temperature and pressure.
Migrated from Short description of key information:
No data
Justification for classification or non-classification
No classification for sensitization is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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