Sub-Chronic Toxicity Studies

• Groups of 10 males and 10 females are treated with the test substance by gavage at 3 dose levels for 90 days; a vehicle control group is included (40 animals)
• Study measurements include daily clinical observations, weekly body weights and feed consumption, and ophthalmological examination pretest and at study termination
• Hematology and serum clinical chemistry at termination
• Necropsies are performed on any animals that die or upon termination; weights are recorded for major organs
• Full histopathological examinations are conducted on the control and high-dose groups and on any unscheduled deaths
• Target organs are examined in the intermediate groups