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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 616-123-3 | CAS number: 746595-79-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Bacterial reverse mutation (Ames test): Positive
Only a single summary report on a parallel study with the concentrated test material (92.2%) and a dilute solution (15.2%) is available (Callander 2004). It was conducted according to guideline OECD 471 in a GLP-certified testing facility, following UK and OECD principles of GLP, but without GLP inspections for this particular study. Only two S. typhimurium strains (TA98 and TA100) were tested with and without metabolic activation. The experimental details and the results are only documented in a summary manner. Although a full study report is not available, the results are sufficiently detailed and unambiguous. The study is considered to be relevant, reliable (Klimisch 2) and adequate for the purposes of classification and labelling.
Positive (mutagenic) responses were elicited by the concentrated test material in both strains of S. typhimurium, TA 98 and TA 100, with and without metabolic activation. The diluted solution caused a positive response only in TA 100 (with and without S9 mix). It is therefore concluded that the test material is mutagenic, and that further testing of bacterial mutagenicity is not necessary.
Cytogenetic test (chromosome aberration): No data available
Short description of key information:
Ames test: positive (mutagenic), S. typhimurium TA98 and TA100 with + without metabolic activation, OECD 471, Callander 2004
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The available study investigated whether the test substance induced gene mutation in certain strains of the bacteria. The study is considered to be relevant, reliable (Klimisch 2) and adequate for the purposes of classification and labelling.
The test substance showed positive results in an in vitro bacterial gene mutation assay. In accordance with Directive 67/548/EEC as amended and in accordance with Regulation (EC) No. 1272/2008, Annex I, 3.5.2, based on the available data the test substance is not considered to be classified as mutagenic. The endpoint is not considered to be conclusive.
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.
