Nonclinical study of oral toxicity of potassium N-acetylaminosuccinate

The literature data of nonclinical studies of potassium N-acetylaminosuccinate (CAS 3397-52-2) are summarized and chronic toxicity and genotoxicity are studied. According to the literature data: carcinogenicity was not revealed, antihypoxic, anxiolytic and gastroprotective properties were revealed. Potassium N-acetylaminosuccinate did not cause mutations in the Ames test, and clastogenic effects were not detected in Chinese hamster fibroblast cells. Fischer rats (F344) were exposed to 0, 0.3, 0.6, 1.25, 2.5, 5, 10% potassium N-acetylaminosuccinate for 13 weeks without limit. A significant decrease in body weight gain was observed in rats in the 10% group, and all rats in this group died during the first 4 weeks of the experiment. However, in the other groups receiving the drug, all rats survived to the end of the experiment. There was a decrease in body weight gain of >/=2.5%. The volume of drinking water consumed in the groups receiving the highest dose was very small, although it was greater in the group receiving 5% than in the other groups. No specific changes in any parameters related to the dose were found in the hematological and biochemical studies. Rats that died during the experiment were severely emaciated. In none of the other tested groups were specific lesions detected histologically, although organ atrophy was observed. Potassium N-acetylaminosuccinate was administered to six dogs by placing it in minced meat at a dose of 250 mg/kg daily for 14 days. Twenty to 30 minutes after administration, the dogs became slightly hyperactive (running around the enclosure, barking more than usual), but no lethal effects were observed. All symptoms disappeared within 2 to 3 hours. Subsequently, the general condition and behavior of the dogs did not differ from those of the control animals. The consumption of food and water by the animals that received the drugs did not decrease. The results of toxicometry, observation data for the experimental animals for 28 days, and necropsy data did not reveal any differences with the control group. Thus, potassium N-acetylaminosuccinate can be classified as class V of practically non-toxic drugs.