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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-419-9 | CAS number: 106-65-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
A bacterial reverse mutation assay (Ames test) has been undertaken using OECD test methods. The substance does not induce reverse mutation inSalmonella typhimurium.This issupported by literature references describing similar studies on the substance.
The ability to cause chromosomal damage in cultured human lymphocytes, followingin vitrotreatment in the absence and presence of S9 metabolic activation has been investigated according to OECD/EU test methods. No statistically significant increase in the incidence of cells bearing aberrations, including or excluding gaps, was observed at any dose level or any sampling time.
Mutagenic activity has been examined by assaying for the induction mutants in mouse lymphoma L5178Y cells afterin vitrotreatment, in the absence and presence of S9 metabolic activation, using OECD/EU test methods. No relevant increases in mutant frequencies were observed following treatment.
REACH Regulation 1907/2006 (Annex VIII, 8.4 Column 2) states that appropriatein vivomutagenicity studies should be considered in those cases of a positive result in any of the in vitro genotoxicity studies. In vitro investigations were negative and in vivo studies are therefore regarded as inappropriate and not in line with current concerns regarding animal welfare and the use of animals in scientific experiments.
Short description of key information:
Genetic toxicity:
Gene mutation (Bacterial reverse mutation assay) / Ames test): negative
Chromosome aberration test: negative
Gene mutation test ( mouse lymphoma L5178Y cells): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Non classification is justified on the basis that available data give no indication that the substance is genotoxic in 3 separate and key in-vitro tests for gene mutation / mutagenicity.
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.
