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

By G. Oberdörster, Andrew D. Maynard, Ken Donaldson, Vincent Castranova, Julie W. Fitzpatrick, K. Ausman, J. Carter, B. Karn, W. Kreyling, D. Lai and 4 more. Particle and Fibre Toxicology, 2005

2,187 citations recorded by the source corpus.

AbstractThe 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.

Subfields: Materials Chemistry

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In Materials Chemistry

Citations in the corpus

Characterization of the size, shape, and state of dispersion of nanoparticles for toxicological studies (2007, background): “Unfortunately, these properties are poorly understood at present, leading to a general recommendation that nanomaterials for toxicological studies should be characterized as completely as is practical (Oberdörster et al. 2005; Powers et al. 2006; Thomas & Sayre 2005).”
Grey Goo on the Skin? Nanotechnology, Cosmetic and Sunscreen Safety (2007, background): “Possible human systemic exposure from topically applied NP has also been suggested in toxicological reviews by Hoet et al. (2004), Oberdörster et al. (2005a), and even the US EPA Draft White Paper (2005a), with the last hypothesizing that nanoparticles may penetrate the skin and distribute…”
Nanodiamond Particles: Properties and Perspectives for Bioapplications (2009, background): “231 Prior to and during this time, studies began to uncover the new and unpredictable ways that nanoparticles were internalized by cells, localized to critical organelles such as mitochondria, 232 see Figure 26 , translocated from regions of the respiratory tract to various nerves 233 ”
Categorization framework to aid hazard identification of nanomaterials (2007, methodology): “…and biological properties of various nanomaterials differ quite substantially from that of specific nanoparticles, as do the expected routes of exposure, making it necessary to differentiate nanomaterials in order to identify the potential hazards and risks they pose (Oberdörster et al. 2005b).”
The nanosilica hazard: another variable entity (2010, background): “Aspects of these properties have been discussed in several reviews of nanotoxicology [2-4].”
Assessing exposure to airborne nanomaterials: Current abilities and future requirements (2007, background): “Many of these draw from the discussion of key characteristics in Oberdörster et al. (2005a).”
Nanomaterials and nanoparticles: Sources and toxicity (2007, background): “Several are comparatively general [18], [20], [30-32], while others address selected aspects of nanoparticles toxicology, such as: health effects of air pollution [33]; epidemiological reviews of exposure to particles [34]; epidemiological studies of cardiovascular effects of airborne particles [35]”