The aim of the work was to estimate biosafety of iron nanoparticles’ substance according to in vitro and in vivo tests. Materials and Methods: biosafety of the substance of 40 nm sized spherical zero-valent iron nanoparticles has been established in vitro using cytotoxicity and genotoxicity tests. Biosafety in vivo has been determined according to the acute toxicity parameter (LD50) and the effect on cardiac function and state of rabbits’ hemodynamics. Results: there were no cytotoxic and genotoxic effects of iron nanoparticles’ substance on the test culture of eukaryotic cells. In case of intravenous injection of nanoparticles the average LD50 for BALB/с mice was 220.3 mg/kg. Iron nanoparticles’ substance injected intravenously was safe according to hemodynamic parameters. Conclusion: obtained data on biosafety estimation denotes low level of potential risks associated with iron nanoparticles’ substance.
Stefanov O. Preclinical studies of drugs (Guidelines). Avitsenna. 2002; 527.
Guidelines “Safety assessment of medical nanopreparations” approved by the Scientific Expert Council of the State Expert Centre of the Ministry of Health of Ukraine (protocol №8, 09.26.2013). Kyiv. 2013; 108.
Moskalenko V.F., Chekman I.S., Chernykh V.P., et al. Nanoscience, nanopharmacology, nanopharmacy: perspectives of research, implementation in medical practice. Klinichna farmatsiia. 2010; 14, 1: 1-5.
Moskalenko V.F., Lisovyi V.M., Chekman I.S., et al. Scientific basis of nanomedicine, nanopharmacology, and nanopharmacy. Visnyk NMU im. O.O.Bohomoltsia. 2009; 2: 17-31.
Paton B., Moskalenko V., Chekman I., Movchan B. Nanoscience and nanotechnology: technological, medical, and social aspects. Visn. NAN Ukrainy. 2009; 6: 18–26.
Kundiiev Yu.I., Ulberg Z.R., Trakhtenberg I.M., et al. Problem of assessing the potential risks of nanomaterials and its solving. Dopovidi NAN Ukrainy. 2013; 1: 177 – 184.
Chekman I.S. Nanopharmacology. Kyiv. Zadruha. 2011; 424.
Balarajan Y., Ramakrishnan U., Ozaltin E., et al. Anaemia in low-income and middle-income countries. Lancet 2011; 378(9809): 2123-2135.
Finney D.J. Probit Analisis. – 3rd edition, chapt. 3 and 4. Cambridge: Cambridge University Press, 1971: 333.
Hodge Н.С., Sterner L.H. Tabulation of toxicity classes. Am Industr Hyg Ass Quart 1943; 10: 93.
Macdougall I.C., Geisser P. Use of intravenous iron supplementation in chronic kidney disease: an update. Iran J Kidney Dis 2013; 7: 9-22.
Pumera M. Nanotoxicology: the molecular science point of view. Chem Asian J 2011, 6: 340.
Qunibi W.Y. The efficacy and safety of current intravenous iron preparations for the management of iron-deficiency anaemia: a review. Arzneimittelforschung 2010; 60: 399.
Santamaria A. Historical overview of nanotechnology and nanotoxicology. Methods Mol Biol 2012; 926: 1.
Worldwide prevalence of anaemia 1993–2005: WHO global database on anaemia / Ed. by B. de Benoist, E. McLean, I. Egli and M. Cogswell, 2008; 48.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.