Safety evaluation of a novel effervescent curcumin-ascorbic acid-polysaccharide-β-cyclodextrin inclusion complex: Acute oral toxicity - fixed dose procedure (OECD TG 420) in mice.

Curcumin, the principal bioactive compound in turmeric, is known for its antioxidant, anti-inflammatory, and anti-cancer activities. A previous study developed the effervescent curcumin-ascorbic acid-polysaccharide-β-cyclodextrin (CUR-A-Poly-β-CD) inclusion complex with enhanced solubility and anticancer activity; however, its toxicity has not been thoroughly assessed. The present study evaluated the acute oral toxicity of the CUR-A-Poly-β-CD complex in seven Jcl: ICR female mice, administered single oral doses of 300 mg/kg and 2000 mg/kg body weight, following OECD Test Guideline 420. A sighting study was initially conducted using a single mouse administered 300 mg/kg. As no toxicity was observed within 48 h, the main study was conducted with five mice at a dose of 2000 mg/kg. The results showed that the acute oral LD₅₀ of the CUR-A-Poly-β-CD inclusion complex in mice exceeds 2000 mg/kg BW. All mice exhibited normal food and water consumption during the testing period. No signs of toxicity were observed at 24 h, 48 h, or 14 days post-administration. Clinical observations and gross examinations of vital organs, including the liver, kidneys, spleen, gastrointestinal tract, reproductive organs, heart, lungs, and thymus, revealed no abnormalities in appearance, size, color, or position. Histological analyses of major organs, including the heart, lung, stomach, duodenum, ileum, cecum, rectum, kidney, liver, and spleen, confirmed the preservation of normal tissue architecture at both tested doses. These results suggest that the CUR-A-Poly-β-CD complex is well tolerated at the evaluated doses, supporting its potential for further development as a safe curcumin-based dietary supplement or pharmaceutical product.