Hygienic regulation of the antiretroviral drug tenofovir in the air of the working area

Introduction. Tenofovir is an antiviral drug of the group of nucleoside reverse transcriptase inhibitors of retrovirus – human immunodeficiency virus.

Material and methods. A toxicological and hygienic study of the toxicity and danger of tenofovir in laboratory animals (mice, rats, rabbits) was carried out with various routes of intake: orally (mice, rats), intraperitoneally (mice), cutaneous (mice, rabbits), inhalation (rats) for development and justification of indicative limit values of tenofovir in the air of the working area.

Results. When injected into the stomach, tenofovir belongs to the 4^th hazard class in terms of DL₅₀ for mice and rats over 10,000 mg/kg (GOST 12.1.007-76). When injected into the abdominal cavity DL₅₀ for male mice 1443 mg/kg (OECD toxicity class 5). Tenofovir has a moderate irritant effect on the mucous membranes of the eyes of rabbits, does not irritate the skin; does not have a skin-resorptive, cumulative and sensitizing effect. In a subacute experiment in rats with intragastric administration (1000 mg/kg, 28 days), tenofovir had a general toxic effect with a predominant impairment of kidney and liver function. Tenofovir Limac is set at 17.3 mg/m³ for effects on renal function.

Limitations. When developing and substantiating hygienic standards for the anti-retroviral drug tenofovir in the air of the working area.

Conclusion. The recommended indicative limit values for tenofovir disoproxil fumarate aerosol in the air of the working area is 0.1 mg/m³.

Compliance with ethical standards. The study complies with the rules for the humane treatment of animals.

Autors contribution:
Golubeva M.I., Bidevkina M.V. — research concept and design, text writing, editing;
Bobrineva I.A., Krymova L.I. — collection and processing of material, editing;
Fedorova E.A. — material processing, statistical analysis, editing. 
All co-authors — approval of the final version of the article, responsibility for the integrity of all parts of the article.

Conflict of interests. The authors declare no conflict of interest. 

Funding. The study was not sponsored.

Received: November 10, 2021 / Accepted: July 21, 2022 / Published: August 30, 2022