Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Additional information

- Reproduction/Developmental Oral Toxicity Screening Test of KS-235 in Wistar Rats:

Results: Dose formulations at each dose concentration was within the acceptance level of ± 10.0 % of nominal concentration and CV% < 10% which indicates that the dose formulation prepared were homogeneous. No mortality was observed in parental rats. No treatment related clinical sign and mortality was observed in pups. Transient salivation (approximately 15 to 20 minutes) was observed in post dosing parental rats treated with KS-235 at 250 and 1000 mg/kg b. wt./day dose groups. Body weight of parental rats was statistically significantly lower during experimental period at 1000 mg/kg b. wt./day dose group when compared with the control group. The percent body weight change, feed consumption and fertility data were comparable between control and all KS-235 the treated groups. No treatment related macroscopic/microscopic finding was observed across all the groups.

Conclusion: On the basis of the results obtained in the present study, it is concluded that though their was transient salivation and body weightreduction at 1000 mg/kg b. wt./day KS-235, but KS-235 did not produce adverse effect in reproduction and development up to the dose level of 1000 mg/kg b. wt./day when administered through oral gavage in Wistar rats prior to mating, during mating, post-mating, gestation period and until post-partum day 3.

Justification for classification or non-classification