| a) Acute Oral Toxicity (LD50)1 |
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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 LD 50 value of the product in rats by oral route was found to be greater than 2000mg/kg body weight. |
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| b) Sub-chronic Toxicity1 |
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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. |
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| c) Sub-Acute Oral Toxicity1 |
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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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1 Performed at the Indian Institute of Toxicology, Pune , India |
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| d) Single Dose Oral Toxicity in rats/LD50 in rats2 |
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Animal model studied
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: Rats, n=10 |
| Study duration |
: 14 days |
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Results |
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- LD 50
The oral LD 50 of Forslean ® is greater than 2000mg/kg.
- Mortality
All animals survived the 2000mg/kg oral dose.
- Body Weights
Body weight changes were normal in 7/10 animals. Three females lost weight during the second week of the study.
- Systemic Observations
Physical signs included diarrhea, soiling of the anogenital area and wetness of the mouth and anogenital area.
- Necropsy Findings
Necropsy results were normal in all animals.
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2 Performed at MB Research Laboratories Spinnerstown , PA 18968 . USA |
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e) Bacterial Reverse Mutation Assay with an Independent Repeat
Assay.
Coleus Forskohlii extract (ForsLean®) 3 |
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Test methodology: |
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- ForsLean® was tested in the Bacterial Reverse Mutation Assay with an Independent Repeat Assay using Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 and Escherichia coli tester strain WP2 uvrA in the presence and absence of Aroclor-induced rat liver S9.
- The assay was performed in two phases, using the plate incoropration method. The first phase, the preliminary toxicity assay, was used to establish the dose-range for the mutagenicity assay.
- The second phase, the mutagenicity assay, (initial and independent repeat assays), was used to determine the mutagenic potential of the test article.
In the preliminary toxicity assay, the maximum dose tested was 5000 ug per plate; this dose was achieved using a concentration of 100 mg/ml and 50 uL plating aliquot.
The overall evaluation and dose ranges tested are as follows:
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S9 Activation |
Overall Evaluation and Dose Range Tested ( m g/plate) |
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Low |
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None |
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25 |
5000 |
25 |
5000 |
25 |
5000 |
25 |
5000 |
25 |
5000 |
Rat |
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25 |
5000 |
25 |
5000 |
25 |
5000 |
25 |
5000 |
25 |
5000 |
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| Conclusion |
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ForsLean® was found to be non-mutagenic in the Bacterial Reverse Mutation Assay with an Independent Repeat Assay. |
