Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No reliable studies assessing skin sensitisation are available on the substance, and as the substance is considered to be corrosive to skin in a standard dermal irritation/corrosion study, testing is not deemed to be necessary.

A guinea pig painting study is available which is not adequate for REACH purposes (reliability is questionable). However, this has been used in the consideration of Classification and Labelling. No studies on respiratory sensitisation are available.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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 available information indicates that the substance should be classified for respiratory sensitisation or corrosivity
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information
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 available information indicates that the substance should be classified for respiratory sensitisation or corrosivity
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No reliable data is available to assess the skin or respiratory sensitisation potential of the substance. As the substance is corrosive, testing is not considered appropriate and the uses of the substance in terms of Risk Management Measures and Operating Conditions should be protective.

A guinea pig painting study is available which is not adequate for REACH purposes (reliability is questionable). However, this has been used in the consideration of Classification and Labelling and demonstrates that the substance may have skin sensitising potential. Accordingly the substance has been classified as a skin sensitiser category 1 in accordance with the CLP regulation based on a conservative assessment.