Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

The substance administered in feed at the 0.4% dose level adversely affected reproduction in CD1 mice. Continued treatment at this dose level also resulted in a significant drop in body weight. The crossover mating study showed that it was the reproductive performance of female mice that was affected by treatment with the substance at the 0.4% dose level. The number of live pups per litter delivered by the 0.4% female x control male group being significantly lower than the 0.4% male x control female group. The reproductive performance of second generation CD-1 mice exposed to the substance at the 0.4% dose level was adversely affected with respect to the number of live pups per litter and the adjusted live pup weight. Second generation animals in the 0.4% group weighed less than the control group at weaning, through maturation and at necropsy.


Short description of key information:
2-generation toxicity study in CD mice is available.

Effects on developmental toxicity

Description of key information
The study is waived based on previous findings and consideration of animal welfare.

Justification for classification or non-classification