Toxicology and safety of antioxidant of bamboo leaves. Part 2: developmental toxicity test in rats with antioxidant of bamboo leaves.

The antioxidant of bamboo leaves (AOB) is a kind of polyphenols-rich extract from bamboo leaves of the Phyllostachys Sieb. et Zucc. family. It has been certificated as a natural antioxidant by the Ministry of Health of the People's Republic of China in 2003, which has a warrant for use in edible oil, meat product, aquatic product and puffed food as a novel food additive. For safely using AOB, it was required to systemic safety evaluation studies. As part of an extensive program of safety evaluation studies, the traditional teratogenicity test and the reproduction study were conducted in Sprague-Dawley rats. In the traditional teratogenicity test, the treatment was well tolerated and no mortality occurred at doses of 0, 1.43, 2.87 and 4.30 g/kg bw per day; weight gain during gestation, food consumption, and food efficiency were similar in all groups; reproductive performance was not effected by the treatment; examination of the fetuses for external, visceral, and skeletal alterations did not reveal any fetotoxic, embryotoxic, or teratogenic effects of AOB. Therefore, a nominal dietary AOB level of 4.30 g/kg bw per day (The value of intended use and potential exposure to human is 860 mg/60 kg bw per day dependent on the period of the study.) was considered to be the no-observed-adverse-effect level following daily oral administration of AOB. The results of our studies indicate safety of AOB and support the use of AOB as a food additive.