a) Acute Oral Toxicity (LD50)
Acute oral toxicity of Coleus forskohlii 10% was determined in Sprague Dawley rats. The test substance suspended in water was administered by oral route and the experimental animals were observed for 14 days for product-related symptoms. The test substance did not produce any signs of intoxication after dosing and all animals survived the study period of 14 days. The LD50 value of the product in rats by oral route was found to be greater than 2000mg/kg body weight.
b) Sub-chronic Toxicity
Sub-chronic oral toxicity study was designed and conducted to determine the toxicity profile of ForsLean® when administered daily for 28 days in Sprague Dawley rats. ForsLean® suspended in 0.1% aqueous CMC was administered to animals at varied doses. Their body weight and biochemistry were monitored during the period of experimentation. Based on the findings the no observed effect level (NOEL) of ForsLean® in these experimental animals over a period of 28 days was found to be 100 mg/kg for male and female animals.
c) Sub-Acute Oral Toxicity
Sub-acute oral toxicity study was designed and conducted to determine the toxicity profile of ForsLean® when administered daily for 28 days in Sprague Dawley rats. Test material suspended in 0.1% aqueous CMC was administered to the animals at various dose levels. Hematological and biochemical analyses were carried out at the end of experimentation. All the animals survived the experimentation period and did not present any signs of intoxication. No abnormalities were detected. Based on these findings it was concluded that the no observed effect level (NOEL) of this product administered to rats orally over a period of 28 days was found to be 1000 mg/kg body weight for both male and female animals.
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