DOI: https://doi.org/10.22263/2312-4156.2024.2.59
V.M. Vasilkevich, A.A. Evtereva, E.V. Chernyshova
On the results of the initial toxicological assessment of the pharmaceutical substance articaine hydrochloride
Republican Unitary Enterprise «Scientific and Practical Centrе of Hygiene», Minsk, Republic of Belarus
Vestnik VGMU. 2024;23(2):59-68.
Abstract.
Objectives. To experimentally establish the main parameters of toxicometry during acute exposure, to study the skin-irritant and irritative effects, the ability for skin resorption and cumulation, to make a classification assessment of the danger of the harmful effect on the human body of the pharmaceutical substance articaine hydrochloride, taking into account the professional risks of the pharmaceutical production.
Material and methods. The object of research was the pharmaceutical substance articaine hydrochloride. Acute toxicity during intragastric, intraperitoneal and inhalation administration, skin-irritant, skin-resorptive and irritative effects, and cumulative activity were studied on laboratory animals (outbred rats, mice, albino rabbits). The average lethal doses and concentrations (DL50 and CL50) were calculated using the probit analysis method. Calculation methods with the use of logarithmic equations additionally established the coefficient of possible inhalation poisoning, the threshold and the zone of acute action (Limac and Zac).
Results. The pharmaceutical substance articaine hydrochloride, according to the majority of the studied toxicometric parameters, is a low- and moderately dangerous substance and does not possess a skin-irritant, irritative or skin-resorptive effect. The cumulative activity studied using the “death” criterion is weak. The species and sex sensitivity to articaine hydrochloride in laboratory animals is not expressed.
Conclusions. According to the limiting (having the lowest value) toxicity indicator (CL50), the substance is classified as hazard class 2 (highly hazardous substances) according to GOST 12.1.007-76, which is the basis for continuing research in the scope of a full toxicological assessment with a chronic experiment on laboratory animals and justification of maximum permissible concentration (MPC) in the air of the working area.
Keywords: pharmaceutical substance articaine hydrochloride, work area air, toxicological assessment, toxicity, health hazard, hygienic standard.
Sources of financing. The study was carried out within the framework of subprogram 2 “Regulatory legal framework” of the state scientific and technical program “The development of pharmaceutical substances, medicines and regulatory support for the pharmaceutical industry”, task 2.25.
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Information about authors:
V.M. Vasilkevich – Candidate of Medical Sciences, leading research officer of the laboratory of industrial toxicology, Republican Unitary Enterprise “Scientific and Practical Centre of Hygiene”, https://orcid.org/0000-0002-6461-0655
е-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра. – Vadim M. Vasilkevich;
A.A. Evtereva – research officer of the laboratory of industrial toxicology, Republican Unitary Enterprise “Scientific and Practical Centre of Hygiene”, https://orcid.org/0009-0005-1777-8972
E.V. Chernyshova – Candidate of Medical Sciences, leading research officer of the laboratory of industrial toxicology, Republican Unitary Enterprise “Scientific and Practical Centre of Hygiene”, https://orcid.org/0009-0007-8840-063X
