Abstract

Iron oxide nanoparticles are an innovative and promising tool in biomedical research. A prerequisite for clinical applications is a demonstration of safety. Magnetite nanoparticles, 10 nm in diameter, were obtained by thermal decomposition and coated with meso-2,3-dimercaptosuccinic acid (DMSA). The DMSA-coated particles were administered intravenously at dose levels of 2.5, 7.5, and 15 mg Fe/kg body weight. An extended, acute toxicity study was carried out over two weeks. We report clinical observations, body weight, food consumption, gross pathology, and biodistribution in the spleen and liver. The results suggest that these materials are safe for biomedical applications. Magnetic susceptibility measurements demonstrate an accumulation of nanoparticles in liver and spleen tissues for the highest dose, whereas they are not detectable for the lowest dose.

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