SINGLE DOSE ORAL TOXICITY IN RATS / LD50 IN RATS
Single dose oral toxicity study with Coleus forskohlii extract 10% (ForsLean®) was conducted in Wistar rats. Groups of 5 healthy male and 5 healthy female rats were dosed orally with Coleus Forskohlii Extract at 2000 mg/kg body weight. The rats were observed 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for mortality. Body weights were recorded immediately – pretest, weekly, at death and at termination of the survivors. All animals were examined for gross pathology.
a. All animals survived the 2000 mg/kg oral dose.
b. Body weight changes were normal in 7/10 animals. Three females lost weight during the second week of the study.
c. Physical signs included diarrhea, soiling of the anogenital area and wetness of the mouth and anogenital area.
d. Necropsy results were normal in all animals.
Conclusion: The oral LD 50 of Coleus Forskohlii Extract 10% was found to be greater than 2000 mg/kg.
BACTERIAL REVERSE MUTATION ASSAY OF COLEUS FORSKOHLII EXTRACT 10% WITH AN INDEPENDENT REPEAT ASSAY
Bacterial reverse mutation assay with Coleus forskohlii 10% extract (ForsLean®) was conducted using Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 and Escherichia coli tester strain WP2 uvr A in the presence and absence of Aroclor-induced rat liver S9.
The assay was performed in two phases using the plate incorporation method.
In the preliminary toxicity assay, the maximum dose tested was 5000µg per plate; this dose was achieved using a concentration of 100 mg/ml and 50 µl plating aliquot.
The overall evaluation and dose ranges tested are as follows:
Conclusion: Coleus forskohlii extract (ForsLean®) was concluded to be negative in the Bacterial Reverse Mutation Assay with an Independent Repeat Assay (AMES Test).
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