Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Data source: European Directorate for the Quality of Medicines & HealthCare (EDQM) - Catalogue code: M1850000, USP Reference Standards - Catalog Number: 1442009, National Library of Medicine CCRIS Database, National Library of Medicine GENE-TOX Database, DailyMed, Muller J J A, Bos P M J, 2004. The occurrence of Carcinogenic, Mutagenic and Reprotoxic (CMR) substances in consumer preparations. RIVM report 320010001, pag. 63; EMEA, 1997. Committee for veterinary medicinal products Metronidazole. Summary Report

Justification for classification or non-classification

Metronidazole induces gene mutations in various test systems and microbial fungi, as well as mitotic gene conversion in yeast. In hypoxic conditions were observed chromosomal mutations in mammalian cells. The substance induces chromosomal mutations in mice in vivo. In systems of indicators (UDS) occurred genotoxic effects in human and rat primary hepatocytes in vitro. Recent studies in humans indicate a genotoxic mechanism in vivo. At concentrations below the therapeutic plasma concentrations, in vitro, were seen genotoxic effects in human lymphocytes. Also, genotoxic effects (chromosome aberration in peripheral lymphocytes) in humans after oral treatment with metronidazole are known.