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WIREs Nanomed Nanobiotechnol
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Toward toxicity testing of nanomaterials in the 21st century: a paradigm for moving forward

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A challenge facing hazard identification and safety evaluation of engineered nanomaterials being introduced to market is the diversity and complexity of the types of materials with varying physicochemical properties, many of which can affect their toxicity by different mechanisms. In general, in vitro test systems have limited usefulness for hazard identification of nanoparticles due to various issues. Meanwhile, conducting chronic toxicity/carcinogenicity studies in rodents for every new nanomaterial introduced into the commerce is impractical if not impossible. New toxicity testing systems which rely on predictive, high‐throughput technologies may be the ultimate goal of evaluating the potential hazard of nanomaterials. However, at present, this approach alone is unlikely to succeed in evaluating the toxicity of the wide array of nanomaterials and requires validation from in vivo studies. This article proposes a paradigm for toxicity testing and elucidation of the molecular mechanisms of reference materials for specific nanomaterial classes/subclasses using short‐term in vivo animal studies in conjunction with high‐throughput screenings and mechanism‐based short‐term in vitro assays. The hazard potential of a particular nanomaterial can be evaluated by conducting only in vitro high‐throughput assays and mechanistic studies and comparing the data with those of the reference materials in the specific class/subclass—an approach in line with the vision for ‘Toxicity Testing in the 21st Century’ of chemicals. With well‐designed experiments, testing nanomaterials of varying/selected physicochemical parameters may be able to identify the physicochemical parameters contributing to toxicity. The data so derived could be used for the development of computer model systems to predict the hazard potential of specific nanoparticles based on property–activity relationships. WIREs Nanomed Nanobiotechnol 2012, 4:1–15. doi: 10.1002/wnan.162

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Figure 1.

Some physical and chemical factors that can influence biological effects of nanomaterials.

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Figure 2.

Proposed paradigm for toxicity testing of nanomaterials.

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Toxicology and Regulatory Issues in Nanomedicine > Toxicology of Nanomaterials
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In the Spotlight

James F. Leary

James F. Leary
has been contributing to nanomedical research and technologies throughout his career. Such contributions include the invention of high-speed flow cytometry, cell sorting techniques, and rare-event methods. Dr. Leary’s current research spans across three general areas in nanomedicine. The first is the development of high-throughput single-cell flow cytometry and cell sorting technologies. The second explores BioMEMS technologies. These include miniaturized cell sorters, portable devices for detection of microbial pathogens in food and water, and artificial human “organ-on-a-chip” technologies which consists of developing cell culture chips capable of simulating the activities and mechanics of entire organs and organ systems. His third area of research aims at developing smart nano-engineered systems for single-cell drug or gene delivery for nanomedicine. Dr. Leary currently holds nine issued U.S. Patents with four currently pending, and he has received NIH funding for over 25 years.

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