Registration Dossier
Registration Dossier
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EC number: 226-195-4 | CAS number: 5324-84-5
Endpoint summary
Administrative data
Description of key information
Skin sensitisation in vitro and in vivo: Test item corrosive (Cat. 1B); Regulation (EC) 1906/2006, Annex VII, Part 8.3, Column 2.
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:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The need for both in vitro and in vivo skin sensitisation studies are waived. An OECD 431 (EPIDERM) corrosion study was performed on the test item, and the result determined that the test item is corrosive (Cat. 1B). As per Regulation (EC) 1907/2006, Annex VII, Part 8.3, Column 2:
The study(ies) under point 8.3.1 (skin sensitisation: in vitro) and 8.3.2 (skin sensitisation: in vivo) do not need to be conducted if: the substance is classified as skin corrosion (Category 1).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
The test item is corrosive (Cat. 1B), therefore a skin sensitisation study does not need to be conducted as per Regulation (EC) 1907/2006, Annex VII, Part 8.3, Column 2:
The study(ies) under point 8.3.1 (skin sensitisation: in vitro) and 8.3.2 (skin sensitisation: in vivo) do not need to be conducted if: the substance is classified as skin corrosion (Category 1).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
A skin sensitisation test was not performed due to the corrosive classification (Cat. 1B) assigned to the substance following an OECD 431 test.
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.
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