Thirteen-week oral toxicity study of synthetic lycopene products in rats.

Synthetic crystalline lycopene provides an alternative to extracts of naturally occurring lycopene for use in dietary supplements and functional foods. BASF Lycopene 10 CWD and Lyco Vit 10% formulated products each contain approximately 10% synthetic lycopene. These products were evaluated for toxicological and behavioral effects during a 13-week oral dosing study with male and female Wistar rats. Doses of 0, 500, 1500 and 3000 mg/kg body weight/day Lycopene CWD and 3000 mg/kg body weight /day Lyco Vit, as well as 3000 mg/kg body weight /day of the matrices used to formulate and stabilize each product, were administered by gavage to 10 rats/sex/day. A satellite group of five rats/sex received 0 or 3000 mg/kg body weight /day of each formulated product for an interim evaluation at 4 weeks of feeding. No statistically significant, dose-related effects on body weight, body weight gain, food consumption, hematology, urinalysis, clinical chemistry or ophthalmoscopic parameters were seen in any of the lycopene product or lycopene formulation matrix groups in comparison to the vehicle control group after 4 or 13 weeks of dosing. No deaths attributed to the test articles occurred during the study and the only clinical finding and at necropsy was the presence of red pigment in the feces and gastrointestinal tract that was associated with the red-pigmented test materials. No significant or dose-related abnormalities were found at necropsy or in microscopic evaluations of tissues collected at termination. Rats evaluated in home cages or in open field tests for behavioral and sensorimotor effects during the final week of the study showed no signs of treatment-related effects. The no-observed-adverse-effect level (NOAEL) for this study was concluded to be 3000 mg/kg body weight/day for both Lycopene CWD and Lyco Vit. The results of this study thus demonstrate the absence of any significant toxicological findings with Lycopene CWD and Lyco Vit products even at very high dose levels.