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ORIGINAL RESEARCH
Assessing toxicity and hazard of agidol-1, the vitamin E synthetic analogue
1 All-Russian Research Center for the Safety of Bioactive Substances, Staraya Kupavna, Moscow region, Russia
2 Pirogov Russian National Research Medical University, Moscow, Russia
3 Institute of Disinfectology, Erisman Federal Scientific Centre of Hygiene of Rospotrebnadzor, Moscow, Russia
Correspondence should be addressed: Natalia I. Sheina
Ostrovityanov, 1, Moscow, 117513, Russia; ur.liam@aniehs_in
Author contribution: Golubeva MI — describing the results, literature review, manuscript writing; Sheina NI — literature review, describing the results, manuscript writing and formatting; Bidevkina MV — describing the results, manuscript w, processing and describing the study results; Bobrineva IA — testing, processing and describing the study results; Fedorova EA — experimental procedure, processing the study results.
Compliance with ethical standards: the experimental study was compliant with the necessary legal acts (Declaration of Helsinki 2013, GOST 33044-2014 “Principles of Good Laboratory Practice”; Order of the Ministry of Health of the RF No. 188n of 01.04.2016 “Rules of Good Laboratory Practice”). The study was approved by the Ethics Committee of the Pirogov Russian National Research Medical University (protocol No. 10/23 dated 15 May 2023). Correspondence should be addressed: Natalia I. Sheina
Agidol-1 belongs to non-enzymatic antioxidants and represents a synthetic vitamin E analogue, it is widely used in chemical and food industries, livestock production, cosmetology, perfumery and pharmaceutical production. The increase in its production is a prerequisite for creating optimal working conditions for employees and developing the currently not existing hygienic standard of the tentative safe exposure level (OBUV) in workplace air. The study aimed to develop and substantiate agidol-1 OBUV in workplace air through experimental study of toxicity and hazard. We studied toxicity, irritant, skin-resorptive effects and hazard of agidol-1 concentrations of 24.7 and 67.8 mg/m3 after a single inhalation. Integrated indicators and functional indicators of some organs and systems were assessed in rats after inhalation. It has been shown that based on toxicometry data (DL50) after a single intragastric injection to mice agidol-1 is a moderately dangerous substance (hazard class 3), while when administered to rats it is a slightly dangerous substance (hazard class 4). The substance has no irritant effect on the rabbit ocular mucosa and skin, it does not possess skin-resorptive or cumulative activity. Inhalation of agidol-1 concentrations of 24.7 and 67.8 mg/m3 has no toxic effect on the nervous, carviovascular, and respiratory systems, it does not alter peripheral blood composition and biochemical parameters of blood serum and urine. The lack of agidol-1 harmful effects in the study, availability of MPC levels in ambient air for the Agidol brand substances with the chemical composition similar to that of agidol-1 and hygienic standards for agidol-1 in different countries have made it possible to substantiate OBUV for production facilities of 10 mg/m3, aerosol, hazard class 4.