Registration Dossier
Registration Dossier
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EC number: 201-919-1 | CAS number: 89-57-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
HSDB summary:
Mesalazine did not produce mutagenic activity in the Ames mutagen test using Salmonella typhimurium, in mouse lymphoma cells, or in in vitro chromosomal aberrations in Chinese hamster ovary cells. In addition, there was no evidence of mutagenicity of forward mutation test or reverse mutations in an in vitro test system using an Escherichia coli strain, and there was no evidence of adverse chromosomal effects in an in vivo micronucleus test in mice receiving single oral doses of mesalazine up to 600 mg/kg or in an in vivo sister chromatid exchange test in mice receiving single oral doses up to 610 mg/kg.
( McEvoy,
G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information.
American Society of Health-System Pharmacists, Bethesda, MD. 2007., p.
3016)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
A classification for this endpoint is not required
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