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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 691-719-4 | CAS number: 1072957-71-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
SYN545192 has been examined in a range ofin vitroandin vivogenotoxicity assays, including endpoints of bacterial and mammalian gene mutation and chromosomal damage.
In vitro, SYN545192 was negative for gene mutation in bacterial (Ames test) and mammalian cells (L5178Y TK+/-mouse lymphoma). The L5178Y TK+/-assay, which is also able to detect chromosomal damage by assessment of colony sizes (small and large colony sizes are associated with clastogenic or mutagenic effects respectively), was also negative for clastogenicity. In thein vitrocytogenetic assay using primary human lymphocyte cultures, SYN545192 did not induce any treatment-related chromosomal aberrations.
In vivo, SYN545192 was found to be non-clastogenic in the rat bone marrow micronucleus assayand did not induce micronuclei in bone marrow cells when tested to the maximum tolerated doses of 175 mg/kg/day in male and 75 mg/kg/day in female Wistar (Han) rats using a 0 hour and 24 hour oral dosing and 48 hour sampling regimen.
Short description of key information:
Not genotoxic in vitro or in vivo
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Germ cell mutagenicity: Based on the available information the substance does not meet the criteria for classification (germ cell mutagenicity) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.5.2; reason for non-classification: conclusive but not sufficient for 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.
