Registration Dossier
Registration Dossier
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EC number: 801-893-7 | CAS number: 83799-24-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
In rat fertility studies, dose-related reductions in implants and increases in postimplantation losses were observed at an oral dose of 150 mg/kg of terfenadine (which led to fexofenadine exposures that were approximately 3 times the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride based on comparison of AUCs).
In mice, fexofenadine hydrochloride produced no effect on male or female fertility at average oral doses up to 4438 mg/kg (which led to fexofenadine exposures that were approximately 13 times the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride in adults based on comparison of AUCs).
Short description of key information:
Source DailyMed data base, Current Medication Information
ALLEGRA (fexofenadine hydrochloride)
Effects on developmental toxicity
Description of key information
Source DailyMed data base, Current Medication Information
ALLEGRA (fexofenadine hydrochloride)
Additional information
Teratogenic Effects: Category C. There was no evidence of teratogenicity in rats or rabbits at oral doses of terfenadine up to 300 mg/kg (which led to fexofenadine exposures that were approximately 4 and 30 times, respectively, the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride in adults based on comparison of AUCs).
In mice, no adverse effects and no teratogenic effects during gestation were observed with fexofenadine hydrochloride at oral doses up to 3730 mg/kg (which led to fexofenadine exposures that were approximately 15 times the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride in adults based on comparison of AUCs).
Justification for classification or non-classification
There was no evidence of teratogenicity in rats or rabbits at oral doses of terfenadine (the prodrug of fexofenadine) up to 300 mg/kg. In mice, no adverse effects and no teratogenic effects during gestation were observed with fexofenadine hydrochloride at oral doses up to
3730 mg/kg. Dose-related decreases in pup weight gain and survival were observed in rats exposed to an oral dose of 150 mg/kg of terfenadine.
Additional information
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