Safety evaluation of alpha- glycerylphosphorylcholine as a novel food.

Abstract

To evaluate the safety of alpha- glycerylphosphorylcholine (α-GPC) as a novel food, the study of acute oral toxicity, subchronic toxicity, teratogenic toxicity and genotoxicity were conducted. In acute oral toxicity, no toxic effects were observed in rats of both genders administrated 10.0g/kg BW α-GPC. In 90-day oral toxicity, female high-dose group (2,000mg/kg) had lower body weight, body weight gain, empty stomach body weight, total protein (TP), albumin (ALB), and higher alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) in contrast to control group. In teratogenic toxicity, the body weights of pregnant rats on the 9th day (d9), the 12th day (d12), the 15th day (d15), and the 20th day (d20), body weight gains, and net body weight gains in high-dose group (2,000mg/kg) decreased, the other parameters had no difference compared to control group. In genotoxicity tests (Mammalian erythrocyte micronucleus, Chromosome aberration and Ames test), all dose groups didn't display significant change compared with negative control group. Based on above results, α-GPC is actually low hazard novel food, has a NOAEL of 1,000mg/kg BW for female rats and 2,000mg/kg BW for male rats following 13-week oral exposure, has a NOAEL of 1,000mg/kg BW for pregnant rats and 2,000mg/kg BW for fetal rats in teratogenic toxicity, has no genotoxicity in vitro or in vivo.