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

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

ABSTRACT

The objective of the study is to evaluate the acute and sub-acute toxicity of Stay-On Power Capsules in rats administered by oral gavage in accordance with the schedule Y of D & C 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. The Stay-On Power Capsules was administered in six different doses: 250, 500, 750, 1000, 1500, and 2000 mg/kg body weight. Sub-Acute toxicity studies were conducted in rats (n=5/sex/group) by administering single dose of 300, 900, and 1500 mg/kg Stay-On Power Capsules or vehicle (0.5% carboxy-methylcellulose). No mortalities/morbidities and gross lesions observed at necropsy on Day 7 in both sexes. Although there were no effects on body weight, food consumption was increased. The NOAEL was identified as 6 mg/kg/day at all dose levels for both sexes and changes in albumin levels observed at 15 mg/kg/day. Serum enzymes ALT, AST, ALP levels and serum total and direct bilirubin, serum protein, albumin, glucose, haemoglobin, urea, uric acid and creatinine levels were not significantly altered by the treatment. However, the treatment for 28 days decreased LDL, Total cholesterol and triglycerides levels whereas no significant influence on HDL levels were observed at the dose of 5 and 10 mg/kg. In sub-acute toxicity dose was investigated as 10 mg/kg. which didn’t show any toxic effect. Therefore, this study concluded that the Stay-On Power Capsules, at doses investigated, did not provoke toxic effects to the animals.

Keywords: Stay on power capsules, acute and sub-acute toxicity, oral gavage, mortality and morbidity, NOAEL.