10.22376/ijpbs.2019.10.1.p1-12 Volume 1 Issue 2 2010 (April - June) Objectives: lessThan br / greaterThan 1) To assess the Sub-chronic toxicity of Oxy Powder® administered orally to rats for 28 days,  lessThan br / greaterThan 2) To determine (i) Target organ toxicity (ii) "No observed effect level (NOEL)" (iii) Reversibility of signs of toxicity after  lessThan br / greaterThan recovery period.  lessThan br / greaterThan Background: lessThan br / greaterThan US FDA does not evaluate safety, efficacy and quality of dietary supplement ingredients or products. GHC decided to  lessThan br / greaterThan study safety of Oxy Powder®, a dietary supplement used in Chronic Constipation and IBS.  lessThan br / greaterThan Guidelines followed: lessThan br / greaterThan (a) OECD Guidelines No. 407, (b) WHO GCP Guidelines lessThan br / greaterThan (c) UCSF IACUC POLICY (d) Schedule "Y" in Drugs and Cosmetics Rules, (India).  lessThan br / greaterThan Study Design and Controls:  lessThan br / greaterThan 1) Rats of both sexes in controlled age and body weight were selected. lessThan br / greaterThan 2) Oxy Powder® was administered at 250, 500 and 1000 mg/kg body weight as aqueous suspensions along with a  lessThan br / greaterThan blank lessThan br / greaterThan 3) The results were recorded on day 0, throughout the dosing period of 28 days and during recovery period of 14 days lessThan br / greaterThan End Points:  lessThan br / greaterThan 1) Ophthalmoscopic examination on days 0+29,  lessThan br / greaterThan 2) Haematological analysis, biochemical analysis and urine analysis on days 0+29+43. lessThan br / greaterThan 3) Organ weights, histopathological and gross pathological observations of sacrificed animals recorded after recovery  lessThan br / greaterThan period. lessThan br / greaterThan Observations:  lessThan br / greaterThan 1) No abnormalities attributable to the treatment with Oxy Powder® lessThan br / greaterThan 2) No target organ toxicity  lessThan br / greaterThan 3) No reversibility of any signs of toxicity at the end of recovery period of 14 days.  lessThan br / greaterThan Conclusion: NOEL of Oxy Powder® administered orally to Sprague Dawley rats for 28 days was found to be 1000 mg/kg body  lessThan br / greaterThan weight for male and female animals.  Prof. Jogender K. Lalla,Meena U. Shah,Edward F. III Group GHC’s Oxy Powder® – Dietary supplement – 28-Day Subchronic Oral Toxicity – Sprague Dawley Rats – OECD Guidelines Test No.407 -