PRECLINICAL ANIMAL TOXICITY STUDIES REPEATED DOSE 28-DAY SUBACUTE ORAL TOXICITY STUDY OF OXY POWDER® IN RATS

Abstract

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