Affiliation:
1. Scientific and Practical Center of Hygiene (State Enterprise
"SPCH")
Abstract
Introduction. Ambroxol hydrochloride is a biologically active substance used as a
pharmaceutical substance in the manufacture of medicines for secretolytic therapy in the case
of acute and chronic bronchopulmonary diseases. To date, there is no hygienic standard for the
safe content of substances in the air of the working area in the republic.
The study aims
to substantiate and develop the maximum permissible concentrations and hazard class of the
pharmaceutical substance ambroxol hydrochloride in the air of the working area.
Materials
and methods. The authors have conducted experimental toxicological studies of the
pharmaceutical substance on animals (rats, mice, rabbits) in accordance with the requirements
of technical regulatory legal acts and recommendations of methodological documents regulating
the justification of hygienic standards.
Results. Scientists have found that the
pharmaceutical substance ambroxol hydrochloride, when injected into the stomach and inhaled,
is classified as a low-hazard substance at an average lethal dose/concentration (according to
GOST 12.1.007-76), has a mild irritant effect on the skin and moderate on the mucous membranes
of the eyes, does not exhibit a skin-resorptive effect, is characterized by a weak cumulative
effect and does not it has sensitizing activity. Under the conditions of inhalation of the
substance into the body of laboratory animals (rats), the threshold values of acute and
chronic harmful effects of this pharmaceutical substance were at the level of 90 mg/m3 (in
terms of the effect on the functional state of the nervous activity of rats) and 30 mg/m3,
respectively (in terms of changes in behavioral indicators, weight and mass coefficient
spleen, blood glucose, alanine aminotransferases and urea) accordingly.
Conclusion. Based
on the experimental results of the toxicological assessment, the authors have justified the
standard of permissible content of the pharmaceutical substance ambroxol hydrochloride in the
air of the working area at the level of 4.0 mg/m3, they also have established the hazard class
of the substance according to GOST 12.1.007-76 (class 3, medium-hazard substances).
Ethics. The Bioethics Commission of the State Enterprise "SPCH” has approved the use of
laboratory animals for experimental purposes (Protocol No. 1 dated 03/04/2020). The treatment
of animals was in accordance with the provisions of Directive 2010/63/EU of the European
Parliament and of the Council of the European Union of September 22, 2010 on the protection of
animals used for scientific purposes.
Publisher
FSBI Research Institute of Occupational Health RAMS