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Reproductive studies of NY-198 in rats. I. Fertility study
J M Tesh1, P A McAnulty, C R Willoughby
1Life Science Research, Eye, Suffolk, England.
The Japanese Journal of Antibiotics
|October 1, 1988
Summary
Lomefloxacin (NY-198), a novel antibacterial agent, showed no adverse effects on rat reproduction or fetal development at tested dosages. The no-observed-adverse-effect level for reproductive parameters was 300 mg/kg/day.
Area of Science:
- Pharmacology
- Toxicology
- Reproductive Science
Background:
- Lomefloxacin (NY-198) is a new antibacterial agent.
- Assessing the reproductive and developmental toxicity of new pharmaceuticals is crucial.
Purpose of the Study:
- To evaluate the effects of lomefloxacin on the reproductive performance and in utero development of rats.
- To determine the no-observed-adverse-effect level (NOAEL) for reproductive and developmental toxicity.
Main Methods:
- Rats were administered lomefloxacin daily by gavage at 30, 100, or 300 mg/kg/day.
- Dosing duration varied for males and females, encompassing pre-mating, mating, and gestation periods.
- Reproductive organs were weighed, and uterine contents were examined for fetal development.
Main Results:
- Slight increases in salivation and water intake, and transient reductions in food intake were observed at higher doses.
- No adverse effects on mating performance, fertility, or in utero survival, growth, and development were noted at any dosage.
- The NOAEL for reproductive and breeding performance and in utero development was 300 mg/kg/day.
- The NOAEL for somatic changes in F0 animals was 100 mg/kg/day.
Conclusions:
- Lomefloxacin does not adversely affect the reproductive capacity or fetal development of rats at dosages up to 300 mg/kg/day.
- The compound is considered safe regarding reproductive and developmental endpoints within the tested dose range.