Safe Dose of Lycopene2015-07-22
The safe dose of lycopene is controversial topic as no one has found its toxic side effect. Even U.S. FDA has not set the safe dosage for lycopene. Thus, the safety studies for lycopene as the health food were widely conducted over the world.
★ The most recent study about toxicity of lycopene was conducted by Taiwan Green Seasons Biotech in 2008. This subchronic toxicity test demonstrated that there were no observed toxic effects in any treatment rats which were administered lycopene daily by gavage up to 2000 mg / kg • day. This study result was also published in the toxicology journal. Jian WQ，et al. Twenty-eight-day oral toxicity study of lycopene from recombinant Escherichia coli in rats. Regul. Toxicol. Pharmacol. 2008；52:163-168.
Lycopene is believed to be a safe supplement, as evidenced by the fact that researchers felt comfortable giving it to pregnant women. No teratogenicity has been observed so far.
In one of the toxicity studies, the pregnant rats were administered with lycopene at doses of up to 1000 mg/kg • day for 200 days, and no abortion and teratogenic effect were observed.
★ Zbinden, G. & Studer, A. Tierexperimentelle untersuchungen uber die chronische vertraglichkeit von _-carotin, lycopin, 7,7_-dihydro-_-carotin und bixin. Zeitsch. Lebensmittelunters. Forsch. 1958；108: 114–134.
★ McClain, R. M. & Bausch, J. (2003) Summary of safety studies conducted with synthetic lycopene. Regul. Toxicol. Pharmacol. 2003; 37: 274–285.
Another lycopene toxicity study was in rates and rabbits with maximum dosage of 3000 mg/ kg • day. The result showed that lycopene did not cause any direct maternal or developmental toxicity in rats or rabbits. Thus, we could easily calculate the tolerable daily dose of lycopene for a 70kg human adult which is 210g/day. Christian, M. S., et al. Developmental (embryo-fetal toxicity/teratogenicity) toxicity studies of synthetic crystalline lycopene in rats and rabbits. Food Chem. Toxicol. 2003; 41: 773–783.
Lycopene is non-toxic and is commonly found in the diet, but cases of excessive carotenoid intake have been reported. In a middle aged woman who had prolonged and excessive consumption of tomato juice, her skin and liver were colored orange-yellow and she had elevated levels of lycopene in her blood. After three weeks on a lycopene-free diet her skin color returned to normal. This discoloration of the skin is known as lycopenodermia and is non-toxic.
Based on the data of animal tests and clinic trials, Institute of Medicine under American National Academy of Sciences decided not to set tolerable upper intake level for lycopene. 【Please refer to Dietary Reference Intakes: The Essential Guide to Nutrient Requirements，Jennifer J. Otten, Jennifer Pitzi Hellwig, Linda D. Meyers, Editors，http://www.nap.edu/catalog/11537.html】
★ In 2003, scientists from New Zealand and Spain conducted a study of subchronic toxicity test in rats. In the study, lycopene was tested by administration at dietary concentration up to 616 mg/kg for 3 months. No toxic effects were observed in rats. This article was published in the professional academic journal of toxicology. Jonker, D. et al. Ninety-day oral toxicity study of lycopene from Blakeslea trispora in rats. Regul. Toxicol. Pharmacol., 2003 Jun; 37(3):396-406.