Registration Dossier
Registration Dossier
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EC number: 446-220-4 | CAS number: 365411-50-3
Carcinogenicity
Administrative data
Description of key information
In accordance with Annex VIII information on carcinogenicity is not required for a substance manufactured/imported in amounts 10-100 tons. The substance has shown to be not genotoxic in vitro and in vivo. Therefore no genotoxic carcinogenicity is expected, via the oral, inhalation and dermal route.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The quality of the database is adequate because the genotoxicity endpoints have been covered by adequate and reliable genotoxicity tests.
Justification for classification or non-classification
The genotoxicity of the substance has been assessed in vitro for two genotoxicity endpoints: genotoxicity in bacteria and chromosomal aberrations in CHL cells, resulting in the absence of genotoxicity. Also in an in vivo micronucleus test no effects were seen. Therefore no genotoxic carcinogenicity is expected, via the oral, inhalation and dermal route. The substance does not have to be classified for genotoxic carcinogenicity via the oral, inhalation and dermal route in accordance with the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex 1 of 1272/2008/EEC (CLP).
Additional information
For this endpoint the conclusion is based on the absence of positive results in the genotoxicity testing and therefore no genotoxic carcinogenicity is expected and the conclusion is adequate for this endpoint.
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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