Registration Dossier
Registration Dossier
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EC number: 207-136-1 | CAS number: 443-48-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Justification for classification or non-classification
Retrospective studies during pregnancy in humans with therapeutic doses of metronidazole, have had mixed results. In mice to which were administered oral doses of metronidazole 20 mg/kg/day during pregnancy or a dose 200 times higher than the clinical dose provided there has been no increase in foetotoxicity in the offspring. In mice treated with intraperitoneal doses of metronidazole 15 mg/kg/day, it was found a significant
increase in the number of dead fetuses or unsteady. No adverse effects on fertility or testicular function occurred in male rats that were given metronidazole in doses up to 400 mg/kg/day for 28 days, and no evidence of impaired fertility or birth defects occurred in rats treated with 5 times the usual human doses of metronidazole.
Data source: USP Reference Standards - Catalog Number: 1442009; Daily Med; National Library of Medicine GENE-TOX Database; EMEA, 1997. Committee for veterinary medicinal products Metronidazole. Summary Report.
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