ABSTRACT:
Preclinical studies on the safety and biological efficacy of a carbon dioxide extract from the herb Scabiosa ochroleuca L. have been conducted. Acute toxicity studies were conducted on test subjects, Saccharomyces cerevisiae and Artemia salina L., as well as on laboratory animals (mice). An express study showed that in the presence of components of a CO2-extract from the herb Scabiosa ochroleuca L. the fermentation process is inhibited in the initial phase of the cell cycle, when the synthesis of enzymes necessary for further growth and reproduction of the microorganism takes place. The control, CO2-extract from the herb scabiosa pale yellow, had an inhibitory effect on the test organism Saccharomyces cerevisiae. At a dilution of 1/20, a sample of CO2-extract from the herb Scabiosa ochroleuca L. presented the highest toxic activity, compared with dilutions: of 1/40 and 1/80 of the same sample. When the toxicity level of the Artemia salina L. test object was detected on the basis of GOST 31959- 2012 (ISO 14669: 1999),: the degree of toxicity of the carbon dioxide extract at a concentration of 10mg/ml was established as follows: "has acute toxicity" - highly toxic (58, A, %); at a concentration of 5mg/ml – "does not have acute toxicity" - slightly toxic (23, A, %); and at a concentration of 1 mg/ml – "no general toxicity" - nontoxic (up to and including 0, A, %). With intragastric administration in the dose range of 500–2000mg/kg, with a single administration, there were no pathological changes in animal behavior at any of the studied doses. The general condition and behavior of the animals were normal and did not differ from those of the animals in the control group. Motor activity and reactions to tactile, painful, sound and light stimuli were unchanged. No animal deaths were observed during the study period. The results of the present study revealed slight negative dynamics of body weight gain in the animals receiving the tested doses of the extract throughout the observation period, whereas the control group presented positive dynamics of body weight gain (according to the international "System of Hazard Classification and Labeling of Chemical Products" (United Nations, New York–Geneva, 2009). Part 3, P.109) CO2-extract of Scabiosa ochroleuca L. is classified as Class V, which includes practically nontoxic substances.