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Kindly provide me information regarding,
1) How much dose of a liquide finished product to be used for acute toxicity testing in rats (according to OECD guidelines)? Is it 2.0 gm and the volume calculated (without dilution of the test product) as per weight per ml basis?
Rajendra H. Dhande.
Department of Pharmacology and Toxicology,
Bombay College of Pharmacy, Kalina,
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The following message was posted to: PharmPK
The maximum dose volume for oral dose administration is 20 ml/kg body weight if the testing product is in solution form and 10 ml/kg body weight if it's in suspension form.OECD recommends maximum 2000 mg/kg dose for acute oral toxicity in rodents. Please refer above maximum dose volume to confirm or calculate maximum dose to be administered on the basis of your finished liquid product to be evaluated for acute toxicity. If you would like to follow OECD guidance, I would suggest you to refer following guideline OECD GUIDELINE FOR TESTING OF CHEMICALS, Acute Oral Toxicity - Acute Toxic Class Method, TG-423 in which you will have liberty to choose any of four different dose levels (i.e. 5, 50,300 and 2000 mg/kg dose) on the basis of finished liquid product concentration.
I hope this will help you to decide the dose levels in study design.
Sachin More, Sr.Research Scientist,
Sai Advantium Pharma Limited, Pune
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