Safety Evaluation of an Aqueous Root and Leaf Extract of Ashwagandha ( <scp> <i>Withania somnifera</i> </scp> )

Consumer interest in botanicals as part of their diet continues to grow with many options being offered, but the public health requirement for an understanding of potential toxicity underscores the need for safety data to be developed specific to each form (i.e., plant part and extraction method). Regulatory agencies require standard toxicology tests to be documented in the public domain to assist with the transparency of informed scientific review. For ashwagandha, despite a significant number of clinical studies, there is little publicly available toxicology data available to demonstrate safety of ashwagandha root and leaf products. We completed a broad range of older legacy but Organization for Economic Co-operation and Development (OECD) Test Guideline (TG)-compliant toxicology studies routinely recommended in regulatory safety guidelines specific to the aqueous ashwagandha root and leaf extract, Sensoril. The data summarized in this report support the conclusion that Sensoril is not toxic or genotoxic. No evidence of mutagenicity was observed in the in vitro Ames assay and Sensoril demonstrated negative findings in the in vitro micronucleus assay and in vivo mammalian bone marrow chromosome aberration assay, respectively. Sensoril was examined in rats at dose levels of 1000, 2000, and 4000 mg/kg/day over 90 days and did not exhibit mortality, morbidity, adverse clinical signs or produce test item related changes in weekly body weight, food consumption, ophthalmology, hematological or biochemical parameters. There were no test item related effects on thyroid hormones, sex hormones or microscopic pathology. The data from these studies support a no observed adverse effect level (NOAEL) of 4000 mg/kg/day in rats for an aqueous root and leaf ashwagandha extract.