Registration Dossier
Registration Dossier
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EC number: 617-500-5 | CAS number: 83905-01-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Justification for classification or non-classification
Pregnancy Category B. Reproduction studies have been performed in rats and mice at doses up to 200 mg/kg/day. The highest dose was associated with moderate maternal toxicity. These doses are estimated to be approximately 5,000 times the maximum human ocular daily dose of 2 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found.
No evidence of impaired fertility due to azithromycin was found in mice or rats that received oral doses of up to 200 mg/kg/day.
Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.
Source DailyMed - Current Medication Information data base
Additional information
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