Division Circumstances in which required

The short-term oral toxicity of the active substance to rodents (90-day), usually the rat, a different rodent species shall be justified, and non rodents (90-day toxicity study in dogs), shall always be reported.

In the 90-day study, potential neurotoxic and immunotoxic effects, genotoxicity by way of micronuclei formation and effects potentially related to changes in the hormonal system shall be carefully addressed.