Preclinical safety and efficacy of “Yubivaks,” a natural ointment for burn wounds: acute dermal toxicity and irritancy evaluation

OBJECTIVE: Natural medicines are considered an effective strategy for treating burns. A preclinical study of a new natural ointment, "Yubivaks," was conducted to study acute dermal toxicity and irritant properties to ensure its safety. METHODS: The study investigated the acute dermal toxicity, local irritant effect on the skin and mucous membranes of eyes, and the sensitizing activity of the ointment. Adult nonlinear white rats and rabbits of both sexes were used in the experiment. The rats were randomly divided into three groups, each consisting of 10 animals: group I received recommended therapeutic dose (0.003 kg/day), group II received a "conditionally toxic" dose (0.020 kg /day), and group III served as the control group. RESULTS: There were no deaths or signs of intoxication in the acute dermal toxicity study. No local irritant, resorptive, or sensitizing effect and positive immunological tests were observed at the therapeutic dose. Treatment of experimental burns with "Yubivaks" reduced the wound surface by half on the 7th day (59.6%); on the 15th day, the restoration of the histostructure of the epidermal tissue was 99.8%; and by the 25th day, the burn area was completely restored (100%) compared to "Levomekol": 43.6, 51.1, and 95.8%, respectively. Comparison with "Levomekol" was made based on its wide use as a recognized traditional medicine with complex action. CONCLUSION: At the recommended therapeutic dose, the ointment can be considered as an alternative medication due to accelerated regenerative processes, pronounced anti-inflammatory properties, and safety proven in experimental studies. A limitation of the study was that it was only conducted on rats and rabbits, without using guinea pigs or pig models for several reasons.