[The toxicological characteristics of Gastrofenzin. III. Its chronic oral toxicity]

A risk evaluation has been carried out under conditions of chronic three-month experiment in oral application of Gastrofenzin in doses 1/20, 1/100 and 1/200 LD50 for male and female white rats, respectively 33.2 and 43.8; 6.7 and 8.8; 3.4 and 4.4 mg.kg-1. There have been applied integral, behavioural, laboratory, biochemical (serum, liver, kidney, brain, brain mitochondria), histologic and electron microscopic methods. The highest doses cause functional and biochemical changes in the nerve system, liver and the kidneys without involving the structural elements of the respective tissues. Significant changes have not been observed in the doses 1/100 LD50 and 1/200 LD50. A dose-effect increase has been found out in the level of cytochrome-P-450 in the liver tissue, but the data are insufficient for determining the type of the caused induction. The results of the complex study show that in the three-month application in doses 1/20, 1/100 and 1/200 LD50 Gastrofenzin does not cause development of significant deviation in the organism of the mice from both sexes and its toxicological characteristic is comparatively favourable.