Abstract |
The test material was administered by gavage to 4 groups of male and female rats at dosages of 0, 25, 100, or 250 mg/kg/day for approximately 90 days. In the subchronic study, body weights, food consumption, and clinical signs were evaluated weekly. Clinical pathology endpoints were evaluated on weeks 7 and 13 of the study, and following a 36- and 92-day recovery period. The rate of hepatic oxidation, a measure of peroxisome proliferation, was determined in rats following approximately 10 or 90 days oftreatment and after a 36- and 92-day recovery period. Neurobehavioral and ophthalmology assessments were also performed prior to dosing, during week 13, and near the end of the 36-day recovery period. After approximately 90 days of dosing, 10 rats/sex/dose level were sacrificed and given a gross and microscopic pathology examination. After 36 days of recovery, 10 rats/sex from the control and high dose group were evaluated and an additional 5/sex/dose were evaluated at the 92-day recovery period. |