scholarly journals Genetic Toxicity Assessment: Employing the Best Science for Human Safety Evaluation

2006 ◽  
Vol 96 (1) ◽  
pp. 1-1 ◽  
Author(s):  
J. I. Goodman ◽  
B. Gollapudi ◽  
L. D. Lehman-McKeeman
Keyword(s):  
Safety Evaluation ◽  
Toxicity Assessment ◽  
Genetic Toxicity ◽  
Human Safety

Acute and Sub-acute Oral Toxicity Assessment of a Standardized Polyherbal Preparation POL-6 in Rats

2019 ◽  
Vol 9 (3) ◽  
pp. 207-216
Author(s):  
Lalit Sharma ◽  
Aditi Sharma ◽  
Girdhari L. Gupta ◽  
Gopal Singh Bisht
Keyword(s):  
Histopathological Examination ◽  
Safety Evaluation ◽  
Centella Asiatica ◽  
Toxicity Assessment ◽  
Ocimum Sanctum ◽  
Oral Toxicity ◽  
Significant Treatment ◽  
Body Weights ◽  
Total Body ◽  
Hematobiochemical Parameters

Background: A standardized polyherbal preparation (POL-6) containing six plant extracts Hypericum perforatum, Bacopa monnieri, Centella asiatica, Withania somnifera, Ocimum sanctum and Camellia sinesis have good antioxidant, anti-inflammatory, and immunomodulatory activities. The present study was carried out to evaluate the safety profile of POL-6 through acute and subacute oral toxicity models in Wistar rats. Methods: In acute safety evaluation, a single dose of 2000mg/kg of POL-6 was given orally to five rats and was observed for 14 days. In subacute safety evaluation POL-6 at the doses of 250, 500 and 1000 mg/kg was given orally to the rats once a day for 28 days. The animals were observed for the signs of toxicity and mortality during the study period. Results: In acute toxicity evaluation, POL-6 treatment did not show any toxic signs and mortality in animals during the observation period. In subacute toxicity studies, no changes were seen in any of the dose levels of POL-6 treatment during the total body weights, organ weights and hematobiochemical parameters examination of the rats. No lesions were seen during the gross/histopathological examination. Conclusion: The study revealed that administration of POL-6 for 28 days showed no significant treatment generated toxic effects in the animals, hence it can be considered as non-toxic if it is ingested in a time not greater than a month.

scholarly journals Empirical analysis of BMD metrics in genetic toxicology part II:in vivopotency comparisons to promote reductions in the use of experimental animals for genetic toxicity assessment

Mutagenesis ◽  
2016 ◽  
Vol 31 (3) ◽  
pp. 265-275 ◽  
Author(s):  
John W. Wills ◽  
Alexandra S. Long ◽  
George E. Johnson ◽  
Jeffrey C. Bemis ◽  
Stephen D. Dertinger ◽  
...  
Keyword(s):  
Empirical Analysis ◽  
Toxicity Assessment ◽  
Genetic Toxicology ◽  
Experimental Animals ◽  
Genetic Toxicity
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