Division 3.2.2.3 Sub-chronic repeated dose oral toxicity studies

To investigate the sub-chronic toxic potential of the active substance, at least one study on a rodent species must be submitted with duration of at least 90 days. If deemed necessary, a second study must be performed with a non-rodent species. The test item must be administered orally with at least three levels in addition to a control group to obtain a dose response. The maximum dose used should normally be expected to reveal evidence of adverse effects. The lowest dose level should not be expected to produce any evidence of toxicity.

Protocols for these studies should be in line with the OECD Guidelines 408 (rodents) or 409 (non-rodents).