Registration Dossier
Registration Dossier
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EC number: 604-571-2 | CAS number: 147127-20-6
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Type of information:
- experimental study
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: EPAR - Scientific Discussion
- Title:
- Viread - EPAR - Scientific Discussion
- Year:
- 2 006
- Bibliographic source:
- European Medicines Agency
Materials and methods
- GLP compliance:
- yes
Test material
- Reference substance name:
- 202138-50-9
- Cas Number:
- 202138-50-9
- IUPAC Name:
- 202138-50-9
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
doses up to 600 mg/kg.
Basis:
- Control animals:
- not specified
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- It did not affect fertility and general reproductive performance of the male and female rats at doses up to 600 mg/kg. It was neither embryotoxic nor teratogenic in rats (doses up to 450 mg/kg/day) and in rabbits (doses up to 300 mg/kg/day).
The NOEL for maternal effects was 150 mg/kg/day in rats and 100 mg in rabbits respectively. In peri- and post natal toxicity study in rats, tenofovir DF significantly reduced pups survival and animal weights. The viability index in rats was reduced in the 450 mg/kg/dose group and significantly reduced in 600 mg/kg/day. Pup weights were also decreased in these groups and there was a slight delay of sexual maturation that did not affect
reproductive performance. The non effect dose was 150 mg/kg. In a non GLP study in rhesus macaques, there was evidence of reduced birth weight and several bone lengths at a dose of30 mg/kg/day, that correspond to 25-times the human exposure. Based on these results, tenofovir DF should be used in pregnant women only if the potential benefit outweighs the potential risks to the foetus as recommended in the Summary of Product Characteristics.
Reproductive NOEL in rats: 300 mg/kg/day
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