Oxy-Powder®
14-Day Safety Study Acute Toxicity Report

PROJECT NO.12203
ACUTE ORAL TOXICITY OF OXY-POWDER®
IN SPRAGUE DAWLEY RATS

SUMMARY AND CONCLUSION

This study was designed to determine the acute oral toxicity profile of Oxy-Powder® in Sprague Dawley rats. The sighting study did not result in any signs of intoxication at the dose level of 2000 mg/kg body weight and the animal survived; therefore, one animal was treated with the higher dose of 5000 mg/kg body weight. No signs of intoxication were observed in animals treated at the dose level of 5000 mg/kg body weight. Therefore the main study was continued at the dose level of 5000 mg/kg body weight. The main study did not result in any signs of intoxication at the dose level of 5000 mg/kg body weight. All animals survived through the study period of 14 days. Gross pathological examination did not reveal any abnormalities.

It was concluded that the acute toxicity study of Oxy-Powder® supplied by Mayfair Clinical Education and Research Centre, Mumbai, when administered via oral route in Sprague Dawley rats falls into the category 5 criteria of Globally Harmonised System (GHS).