Safety evaluation of a natural tomato oleoresin extract derived from food-processing tomatoes

Experimental and epidemiological studies indicate that consumption of tomato products containing high amounts of lycopene is associated with lowered cancer risk. The protective effects of lycopene may be related to its antioxidant potential. Lycopene has been demonstrated to inhibit oxidation. A proprietary, natural tomato oleoresin extract (NTOE), is a purified tomato oleoresin containing 6% lycopene produced from tomatoes. NTOE was evaluated for toxicological effects, and found the 50% lethal dose (LD50), derived from the acute oral toxicity study, was greater than 5000 mg/kg body weight. The no-observed-adverse-effect level (NOAEL) derived from the 13-week study was 4500 mg/kg/day. Acute dermal toxicity study of NTOE found no toxicity at 2000 mg/kg body weight. NTOE lacked dermal irritation in the rabbit model, but was found to have moderate eye-irritant capabilities. NTOE tested at 5% (w/w) in petroleum jelly was a moderate sensitizer in the guinea pig model. There was no evidence of mutagenic potential up to 5000 μg/plate, as determined by the Ames assay. These results demonstrate the inability of NTOE to produce oral, dermal or mutagenic toxicity in animal models at doses greater than 300 times the normal human consumption of lycopene. Consumption analysis of lycopene-containing foods estimated mean daily intake of lycopene at 8.2 mg/day.