Acute toxicity

One acute toxicity study has been conducted using AMIZATE® in rats (Shriram Institute for Industrial Research, 2008a). This study was conducted in accordance with the Organization for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals Test No. 420 (OECD, 2001). Groups of 5 female Wistar rats were orally administered a single dose of 0 (vehicle control) or 2,000 mg/kg body weight of AMIZATE® via gavage. All animals were observed for a period of 14 days following administration. Body weights were measured prior to the administration of the test article, and weekly thereafter. No mortality, clinical signs of toxicity, or adverse effects on body weights were reported in both the test and control groups.

Based on the results of this study, an acute oral median lethal dose of >2,000 mg/kg body weight of AMIZATE® was determined in female rats.