Registration Dossier
Registration Dossier
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EC number: 206-420-2 | CAS number: 338-83-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro studies cannot be conducted with this test article as the substance is not soluble in any solvent compatible with cell culture media. See the study report attached to this record and the in vitro waiver records for additional detail regarding solubility trials conducted.
The study report concluded:
As part of the in vitro chomosomal aberration test, solubility of the test substance in various solvents suitable for in vitro genotoxicity tests was investigated. The results of the solubility test are enclosed in the study report. Based on these results, it was concluded that the performance of in vitro genotoxicity tests is technically impossible due to issues with the solubility of the test substance in a solvent suitable for these tests.
The following solvents were investigated in various concentrations (see test report for more detail):
Culture medium (RPMI 1640)
DMSO
Ethanol
Acetone
N,N-dimethylformamide
Hexane
Toluene
Fetal calf serum
As a result, in vivo studies have been proposed to fulfill the genetic toxicity information requirements.
Genetic toxicity in vivo
Description of key information
Test proposals for the following in vivo studies are included in the dossier:
OECD 489 - In Vivo Mammalian Alkaline Comet Assay
OECD 474 - Mammalian Erythrocyte Micronucleus Test
Additional information
Justification for classification or non-classification
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.
