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Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy

  • Oberdörster, Günter1
  • Maynard, Andrew2
  • Donaldson, Ken3
  • Castranova, Vincent4
  • Fitzpatrick, Julie5
  • Ausman, Kevin6
  • Carter, Janet7
  • Karn, Barbara8, 2
  • Kreyling, Wolfgang9
  • Lai, David10
  • Olin, Stephen5
  • Monteiro-Riviere, Nancy11
  • Warheit, David12
  • Yang, Hong13
  • 1 University of Rochester, Department of Environmental Medicine, 601 Elmwood Avenue, Rochester, NY, 14642, USA , Rochester
  • 2 Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, 1300 Pennsylvania Avenue, N.W., Washington, DC, 20004-3027, USA , Washington
  • 3 MRC/University of Edinburgh Centre for Inflammation Research, ELEGI Colt Laboratory Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ, UK , Edinburgh
  • 4 National Institute for Occupational Safety and Health, Pathology and Physiology Research Branch, Health Effects Laboratory Division, 1095 Willowdale Road, Morgantown, WV, 26505, USA , Morgantown
  • 5 Risk Science Institute, ILSI Research Foundation, International Life Sciences Institute, One Thomas Circle, N.W., Suite 900, Washington, DC, 20005-5802, USA , Washington
  • 6 Center for Biological and Environmental Nanotechnology, MS-63, P.O. Box 1892, Rice University, Houston, TX, 77251-1892, USA , Houston
  • 7 Central Product Safety, Procter & Gamble Company, Respiratory/Inhalation Toxicology, Cincinnati, OH, 45253-8707, USA , Cincinnati
  • 8 United States Environmental Protection Agency, Office of Research and Development, Ariel Rios Building, Mail Code: 8722F, 1200 Pennsylvania Avenue, N.W., Washington, DC, 20460, USA , Washington
  • 9 GSF National Research Centre for Environment and Health, Institute for Inhalation Biology & Focus Network: Aerosols and Health, Ingolstadter Landstrasse 1, Neuherberg, Munich, 85764, Germany , Neuherberg
  • 10 United States Environmental Protection Agency, 7403M, Risk Assessment Division, Office of Pollution Prevention & Toxics, 1200 Pennsylvania Avenue, N.W., Washington, DC, 20460, USA , Washington
  • 11 College of Veterinary Medicine, North Carolina State University, Center for Chemical Toxicology and Research Pharmacokinetics, 4700 Hillsborough Street, Raleigh, NC, 27606, USA , Raleigh
  • 12 DuPont Haskell Laboratory for Health and Environmental Sciences, 1090 Elkton Road, Newark, DE, 19714-0050, USA , Newark
  • 13 University of Rochester, Department of Chemical Engineering, Gavett Hall 253, Rochester, NY, 14627, USA , Rochester
Published Article
Particle and Fibre Toxicology
BioMed Central
Publication Date
Oct 06, 2005
DOI: 10.1186/1743-8977-2-8
Springer Nature


The rapid proliferation of many different engineered nanomaterials (defined as materials designed and produced to have structural features with at least one dimension of 100 nanometers or less) presents a dilemma to regulators regarding hazard identification. The International Life Sciences Institute Research Foundation/Risk Science Institute convened an expert working group to develop a screening strategy for the hazard identification of engineered nanomaterials. The working group report presents the elements of a screening strategy rather than a detailed testing protocol. Based on an evaluation of the limited data currently available, the report presents a broad data gathering strategy applicable to this early stage in the development of a risk assessment process for nanomaterials. Oral, dermal, inhalation, and injection routes of exposure are included recognizing that, depending on use patterns, exposure to nanomaterials may occur by any of these routes. The three key elements of the toxicity screening strategy are: Physicochemical Characteristics, In Vitro Assays (cellular and non-cellular), and In Vivo Assays. There is a strong likelihood that biological activity of nanoparticles will depend on physicochemical parameters not routinely considered in toxicity screening studies. Physicochemical properties that may be important in understanding the toxic effects of test materials include particle size and size distribution, agglomeration state, shape, crystal structure, chemical composition, surface area, surface chemistry, surface charge, and porosity. In vitro techniques allow specific biological and mechanistic pathways to be isolated and tested under controlled conditions, in ways that are not feasible in in vivo tests. Tests are suggested for portal-of-entry toxicity for lungs, skin, and the mucosal membranes, and target organ toxicity for endothelium, blood, spleen, liver, nervous system, heart, and kidney. Non-cellular assessment of nanoparticle durability, protein interactions, complement activation, and pro-oxidant activity is also considered. Tier 1 in vivo assays are proposed for pulmonary, oral, skin and injection exposures, and Tier 2 evaluations for pulmonary exposures are also proposed. Tier 1 evaluations include markers of inflammation, oxidant stress, and cell proliferation in portal-of-entry and selected remote organs and tissues. Tier 2 evaluations for pulmonary exposures could include deposition, translocation, and toxicokinetics and biopersistence studies; effects of multiple exposures; potential effects on the reproductive system, placenta, and fetus; alternative animal models; and mechanistic studies.

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