Registration Dossier
Registration Dossier
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EC number: 204-977-6 | CAS number: 130-15-4
Endpoint summary
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
- 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
Referenceopen allclose all
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.
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.
