Toxicology Reports · 6 authors, 4 centres
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A 90-day oral sub-chronic toxicity study of a cyclodextrin-formulated Boesenbergia rotunda extract (panduratin A 29% w/w, pinostrobin 32% w/w) was conducted in male and female Wistar rats at doses of 25, 50, or 100 mg/kg/day following OECD GLP 408 guidelines. No mortalities, clinical signs of toxicity, or serious adverse effects were observed at any dose, yielding a No Observed Adverse Effect Level (NOAEL) of 100 mg/kg/day.
This preclinical study evaluated the sub-chronic oral toxicity of a cyclodextrin-enhanced Boesenbergia rotunda (fingerroot) rhizome extract formulation in Wistar rats over 90 consecutive days, following OECD Test Guideline 408 under GLP conditions. Male and female rats received doses of 25, 50, or 100 mg/kg/day, with additional recovery groups (control and high-dose) observed for 14 days. Assessments included clinical observations, ophthalmological and neurological examinations, body weight, feed and water consumption, grip strength, hematology, clinical biochemistry, necropsy, and histopathology. No mortalities, clinical signs of toxicity, or dose-dependent adverse effects were observed. Statistically significant changes in white blood cells, serum creatinine, AST, and HDL cholesterol were noted in some groups but remained within normal physiological ranges and were considered clinically insignificant. The NOAEL was established at 100 mg/kg/day.
