Registration Dossier
Registration Dossier
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EC number: 947-969-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Studies on skin sensitisation were waived on the grounds that the test substance is corrosive to the skin.
However, the test material contains between 20 - 40% of the parent alcohol Alcohols, C11-14-iso-, C13-rich (EC 271-235-6). In consideration of this, in the REACH registration for that substance, it was not interpreted to be a sensitising substance. The interpretation was based on two QSAR models (Danish EPA Skin Sensitisation model and TIMES Skin Sensitisation with Autooxidation model); a large number of structural analogues were modelled, and the preponderance of the predictions was for non-sensitisation. In human volunteer studies, with related alcohols, little evidence of dermal sensitisation was apparent.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation: in vivo
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Studies on skin sensitisation were waived on the grounds that the test substance is corrosive to the skin.
However, the test material may contain between 20 -40% of the parent alcohol Alcohols, C11-14-iso-, C13-rich (EC 271-235-6). In consideration of this, in the REACH registration for that substance, it was not interpreted to be a sensitising substance. The interpretation was based on two QSAR models (Danish EPA Skin Sensitisation model and TIMES Skin Sensitisation with Autooxidation model); a large number of structural analogues was modelled, and the preponderance of the predictions were for non-sensitisation. In human volunteer studies, with related alcohols, little evidence of dermal sensitisation was apparent.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
