- Yuasa Koki (Central Research Institute, Marudai Food Co. Ltd. / firstname.lastname@example.org)
1) Central Research Institute, Marudai Food Co. Ltd. , 2) Ina research Inc
To evaluate the safety of chicken breast extract containing plasmalogen, the following three tests were conducted: i) chromosome aberration study with mammalian cells; ii) bacterial reverse mutation test; and iii) 90-day repeated oral dose study in rats. The chromosome aberration study showed that there was no statistically significant increase in the structural aberration rate and the polyploidy aberration rate between the group that was treated with chicken breast extract and the negative-control group. Under the present test conditions, chicken breast extract did not induce chromosomal aberrations. Similarly, in the reverse mutation test, there was no increase in the number of revertant colonies in all of the bacterial strains that more than doubled the negative-control value related to the dose, regardless of the presence or absence of metabolic activation. In other words, chicken breast extract did not exhibit a gene mutation–inducing effect under the present test conditions. No effects were observed in the 90-day repeated oral dose study with the administration of chicken breast extract. Under the present test conditions, the no-observed-adverse-effect level for both male and female rats was 1000 mg/kg/day.