Abstract

ACUTE AND SUB-ACUTE TOXICITY STUDIES OF STAY-ON POWER CAPSULES IN RABBITS

Saiprasanna Behera*, Mrinmoy Gautam, Prasanta Kumar Choudhury, Jayesh Mehta and Mangesh Chandrakant Khadakban 

ABSTRACT

The present investigation deals with Toxicity Studies (Both acute and sub-acute toxicity) of Stay-On Power Capsules in Rabbits administered by oral gavage in accordance with the schedule Y of drugs and Cosmetic Act (2005). The acute toxicity study of Stay-On Power Capsules was done by up and down method. The animals were fasted for 18 hours with water ad libitum and then administered with six different doses: 250, 500, 750, 1000, 1500 and 2000 mg/kg body weight, per oral. Sub-Acute toxicity studies were conducted in rabbits (n=5/sex/group) by administering a single dose of 300, 900 and 1500 mg/kg Stay-On Power Capsules or vehicle (0.5% carboxymethylcellulose) by oral gavage. No mortality or gross lesions in both sexes observed at necropsy on Day 7. Although there were no effects on body weight, food consumption was increased. Based on findings at all dose levels the NOAEL was identified as 6 mg/kg/day for both sexes and changes in albumin levels observed at 15 mg/kg/day. Serum enzymes ALT, AST, ALP levels, as well as serum total and direct bilirubin, serum protein, albumin, glucose, haemoglobin, urea, uric acid and creatinine levels were not significantly altered. However, the treatment for 28 days decreased LDL and Total cholesterol and triglycerides levels, whereas no significant influence on HDL levels was observed at the dose of 5 and 10 mg/kg. In sub-acute toxicity dose was found to be 10 mg/kg. Therefore, this study concluded that the Stay-On Power Capsules, at doses investigated, did not provoke toxic effects to the animals.

Keywords: Acute and Sub-Acute Toxicity Studies, Stay-On Power Capsules, Mortality, NOEAL.