Registration Dossier

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, C11-14-iso-, C13-rich is expected to be 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, C11-14-iso-, C13-rich is expected to be not sensitising.

 

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, C11-14-iso-, C13-rich the analog read-across supports an expectation that Alcohols, C11-14-iso-, C13-rich are not sensitising.

 

QSAR predictions for hypothesized constituents of Alcohols, C11-14-iso-, C13-rich 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, C11-14-iso-, C13-rich is not sensitizing.

 

QSAR predictions for hypothesized constituents of Alcohols, C11-14-iso-, C13-rich 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, C11-14-iso-, C13-rich is not sensitizing.


Migrated from Short description of key information:
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.