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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

Referenceopen allclose all

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)
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory sensitisation

Link to relevant study records
Reference
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)
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.