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Acute Oral Toxicity Study in Monkeys

Sucrose Acetate Isobutyrate was administered to 2 male and 2 female cynomolgus monkeys in orange juice concentrate. Incremental doses starting with 1.25 g/kg were administered. Each successive dose was increased by a factor of two, until a dose of 20.0 g/kg was reached. Each dose was separated by a 72 hour rest period. A constant dose volume (30 ml/kg) was used at each dose level. All animals were observed daily for signs of pharmacologic and toxicologic effects. Body weight and food consumption was recorded daily. Complete gross postmortem examinations were performed on all animals killed at the termination of the study. All animals survived the duration of the study. Moderate amounts of yellow watery emesis and/or yellow/tan watery stools were observed in some males and females 1 to 5 hours post-dosing. Visual estimation o f food consumption was slightly less during the treatment period than it was pretest. Gross postmortem examinations did not reveal any effects attributable to the administration of Sucrose Acetate Isobutyrate and were considered unremarkable.

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