Evidence of prenatal toxicity of herbal based indigenous formulations for sex selection in rat models.

UNLABELLED

Indigenous preparations(IPs) for a male child is reported from some parts of India. The present study aims to explore the effects of IPs for sex selection or sex selection drugs (SSDs) on pregnancy outcomes in rat models. SSDs contain along with other ingredients.

METHODS

An experimental design with successfully mated female rats were randomized into control and treatment groups. Phase 1 had 2 interventional arms while phase 2 had 3 interventional arms (12 rats/arm) besides control arm. In phase-1, pregnant females were dosed two SSDs(1000 mg/kg) on gestation days 1-5 whereas, in phase-2, on gestation days 6-19 to correlate the effect of the SSDs (500/1000/1500 mg/kg) consumption during different stages of pregnancy. Pregnant females were observed for clinical signs following treatment. The rats were sacrificed one day before expected day of delivery for evaluation. Pregnancy rate, gestation index, number of corpora lutea, and litter size were assessed. Foetuses were examined for sex, skeletal and soft tissue alterations.

DISCUSSION AND CONCLUSION

In phase 1, no appreciable findings were there with SSD exposure. In phase 2, intrauterine growth and survival of foetuses were affected when SSDs were administered during organogenesis period. Decreased number of live foetuses and increased incidence of early and late resorption, reduced fetal growth with significant alteration in skeleton and viscera were found in treatment groups in a dose-dependent manner. This correlates well with findings from observational studies in pregnant women. However, such treatment at any dose did not effect sex differentiation.