Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 944-041-0 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
- Read-Across - OECD 471 (in vitro gene mutation study in bacteria) - Ames NR-deficient strains - KS (key study) - positive with and without S9;
- Read-Across - OECD 476 (In vitro gene mutation study in mammalian cells) - KS (Key study) - negative.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
- Read-Across - OECD 474 (in vivo mammalian somatic cell study: cytogenicity/erythrocyte micronucleus) - KS (Key study) - negative;
- Read-Across - OECD 486 (In vivo mammalian cell study: DNA damage and/or repair) - KS (Key study) - negative.
- OECD 489 (Comet Assay): Read-Across in progress.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
For further details refer to the attached document on genotoxicity assessment.
Justification for classification or non-classification
Classification for mutagenicity is warranted for substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans
The classification in Category 2 is based on:
— Positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:
— Somatic cell mutagenicity tests in vivo, in mammals; or
— Other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Based on the results of the in vivo and in vitro tests no classification for mutagenicity is applied following Regulation 1272/2008.
A new evaluation of the genotoxic potential will be performed once results of the "in vivo" COMET Assay on the similar substance 02 will be available.
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.
