What question did this study set out to answer?

To establish safety and repeated-dose oral toxicity data for KSM-66 Ashwagandha Root Extract in Wistar rats adhering to OECD Test Guideline 408.

September 9, 2023Toxicology ReportsOpen Access

Ninety-day repeated dose toxicity of Ashwagandha (Withania somnifera) root extract in Wistar rats

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Repeated-dose toxicity study demonstrates a NOAEL of 2000 mg/kg for Ashwagandha root extract in Wistar rats, indicating high oral safety.

To establish safety and repeated-dose oral toxicity data for KSM-66 Ashwagandha Root Extract in Wistar rats adhering to OECD Test Guideline 408.
Orally administered KSM-66 Ashwagandha Root Extract to Wistar rats at doses of 0, 500, 1000, and 2000 mg/kg body weight/day for 90 days, followed by a 14-day recovery evaluation for the 0 and 2000 mg/kg groups.
Conducted daily mortality checks, weekly clinical assessments, sensory and functional evaluations, and terminal analyses including hematology, clinical biochemistry, organ weights, and histopathology.
Repeated oral intake across all treatment doses produced no adverse treatment-related effects on clinical signs, body weight, food consumption, ophthalmology, or behavioral responses.
Hematological, biochemical, and histopathological examinations revealed no target-organ toxicity, establishing a no observed adverse effect level (NOAEL) of 2000 mg/kg body weight/day.

Kalaivani et al. (2023) studied this question.

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