Registration Dossier
Registration Dossier
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EC number: 939-946-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Positive in vitro gen mutation, OECD 471, Thompson (2011)
Positive in vitro gene mutation study in bacteria, OECD 473, Bohnenberger (2011)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
Non-genotoxic, UDS Assay, OECD 486, Merker (2011)
Non-mutagenic, Mammalian Micronucleous Assay, OECD 474, Roth (2012)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The in-vivo studies were performed for a chemical registration scheme outside of the European Economic Area.
The test substance has been assessed for genotoxic activity, in a tiered manner, in two in vitro and two in vivo assays. The test substance was mutagenic in an in vitro bacterial mutation (Ames) assay, this activity was shown to be absent in vivo in an unscheduled DNA synthesis assay and the test substance is considered non-mutagenic. The test substance was clastogenic in an in vitro chromosome aberration assay, this activity was shown to be absent in vivo in a mammalian erythrocyte micronucleus assay and the test substance is considered non-clastogenic. On the basis of two in vivo assays the test substance has been shown to be non-genotoxic in vivo.
The available studies are considered to be reliable, adequate and conclusive for the purposes of risk assessment and classification.
Justification for classification or non-classification
The potential for the test item to cause genotoxicity has been fully evaluated in vitro and in vivo. Although the in vitro studies were positive, there was no indication of clastogenicity or mutagenicity in the in vivo studies leading to a clear conclusion that the test item is not genotoxic in vivo in accordance with the Globally Harmonized System of classification (2013) and Labelling Regulation (EC) No 1272/2008 (CLP Regulation) .
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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