Evaluation of subacute toxicity of highly bioavailable curcuRouge® formulation by a repeated dose 28-day oral exposure toxicology study in sprague dawley rats with safety assessment

Abstract

CurcuRouge®, a high-bioavailability amorphous curcumin formulation, was orally administered to male and female Sprague–Dawley (Slc) rats at a dose of 750 mg/kg/day (equivalent to 300 mg/kg/day of curcumin) for 28 days to evaluate its subacute toxicity. Clinical signs, body weight, urinalysis, hematological and biochemical parameters, and gross pathological findings were assessed. No mortality, morbidity, or treatment-related clinical signs were observed. Body weights and gross organ appearance remained comparable to those of the control groups in both sexes, with no evidence of overt systemic toxicity. Serum albumin levels and albumin/globulin (A/G) ratios were significantly increased in both male and female rats; however, these changes were not associated with corresponding pathological findings. No curcuRouge®-related abnormalities were detected in any major organs at autopsy. Cecal dilatation was observed in treated rats; however, this finding was considered to reflect an anatomical and physiological adaptation rather than a toxic effect. The findings indicate that CurcuRouge® was well tolerated at 750 mg/kg/day, which was identified as the no-observed-adverse-effect level (NOAEL) under the conditions of this study. Overall, the results support the conclusion that CurcuRouge® has a favorable safety profile at the tested dose. The formulation demonstrated a high safety margin (>16-fold) and is expected to pose negligible risk at anticipated exposure levels, providing a basis for concluding that there is no evidence of subacute toxicity. The mild, sex-dependent changes observed in hepatic and hematological parameters remained within normal physiological ranges and were not considered indicative of systemic toxicity.