Registration Dossier

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

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.