Safety assessment of a solid lipid curcumin particle preparation: Acute and subchronic toxicity studies

• Published in: Food and chemical toxicology 2011-08, Vol.49 (8), p.1834-1842
• Main Authors: Dadhaniya, Paresh, Patel, Chintan, Muchhara, Jayesh, Bhadja, Nilesh, Mathuria, Neeta, Vachhani, Kapil, Soni, Madhu G.
• Format: Article
• Language: English
• Subjects: Administration, Oral; adverse effects; Animals; Biological and medical sciences; Biological Availability; blood chemistry; Body Weight - drug effects; Curcuma - chemistry; Curcuma longa; Curcumin; Curcumin - toxicity; Dose-Response Relationship, Drug; feed intake; Female; Food ingredient; Hematologic Tests; hematology; histopathology; Lethal Dose 50; Lipids - chemistry; Male; Medical sciences; Mice; necropsy; No-Observed-Adverse-Effect Level; Organ Size - drug effects; Plant Extracts - toxicity; Rats; Rats, Wistar; rhizomes; Safety; safety assessment; subchronic toxicity; Toxicity; toxicity testing; Toxicity Tests, Acute - methods; Toxicity Tests, Chronic - methods; Toxicology; Turmeric; Urinalysis; weight gain; Weight Gain - drug effects
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2011.05.001

► Solid lipid curcumin particle preparation with higher bioavailability was studied for acute and subchronic toxicity. ► The LD50 of solid lipid curcumin particle was found to be greater than 2g/kg. ► In subchronic study, no adverse effects of solid lipid curcumin particle were noted at doses up to 720mg/kg/day. ► The No Observed-Adverse-Effect Level for SLCP was determined as 720mg/kg bw/day, the highest dose tested. Curcumin, a polyphenol, is obtained from turmeric, the ground rhizomes of Curcuma longa L. Extensive research over the past half century has revealed several health benefits of curcumin. The objective of the present study was to investigate potential adverse effects, if any, of a novel solid lipid curcumin particle (SLCP) preparation in rats following acute and subchronic administration. The oral LD50 of the preparation in rats as well as in mice was found to be greater than 2000mg/kg body weight (bw). In the subchronic toxicity study, Wistar rats (10/sex/group) were administered via oral gavage 0 (control), 180, 360, and 720mg/kg bw/day of SLCP preparation for 90days. Administration of the curcumin preparation did not result in any toxicologically significant treatment-related changes in clinical (including behavioral) observations, ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. No adverse effects of the curcumin preparation were noted on the hematology, serum chemistry parameters, and urinalysis. Terminal necropsy did not reveal any treatment-related gross or histopathology findings. Based on the results of this study, the No Observed-Adverse-Effect Level (NOAEL) for this standardized novel curcumin preparation was determined as 720mg/kg bw/day, the highest dose tested.