Implementation of alternative test strategies for the safety assessment of engineered nanomaterials

Journal of Internal Medicine

Volumn 274, Issue 6, 2013, Pages 561-577

  Nel, A E ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Alternative test strategies; Nanomaterials; Predictive toxicology; Safety assessment

Indexed keywords

CARBON NANOTUBE; METAL OXIDE; NANOMATERIAL;

ALTERNATIVE TEST STRATEGIES; ANIMAL USE; DISSOLUTION; ELECTRIC POTENTIAL; HAZARD; HAZARD ASSESSMENT; HUMAN; NANOENGINEERING; NANOTECHNOLOGY; NONHUMAN; OXIDATION REDUCTION POTENTIAL; PATHOPHYSIOLOGY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; TOXICOLOGY; WETTABILITY; ZETA POTENTIAL;

ALTERNATIVE TEST STRATEGIES; NANOMATERIALS; PREDICTIVE TOXICOLOGY; SAFETY ASSESSMENT;

ANIMALS; HUMANS; MATERIALS TESTING; NANOSTRUCTURES; NANOTECHNOLOGY; RISK ASSESSMENT; SAFETY;

EID: 84887407466     PISSN: 09546820     EISSN: 13652796     Source Type: Journal    
DOI: 10.1111/joim.12109     Document Type: Review

References (90)

1. Roco MM, Mirkin C, Hersam M. Nanotechnology Research Directions for Societal Needs in 2010. Boston and Berlin: Springer, 2010.
2. Nel AE, Xia T, Maëdler L, Li N. Toxic potential of materials at the nanolevel. Science 2006; 311: 622-7.
3. Meng H, Xia T, George S, Nel AE. A predictive toxicological paradigm for the safety assessment of nanomaterials. ACS Nano 2009; 3: 1620-7.
4. Oberdorster G, Oberdorster E, Oberdorster J. Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environ Health Perspect 2005; 113: 823-39.
5. Nel A, Xia T, Meng H et al. Nanomaterial toxicity testing in the 21st century: use of a predictive toxicological approach and high-throughput screening. Acc Chem Res 2012; [Epub ahead of print].
6. Xia T, Malasarn D, Lin S et al. Implementation of a multidisciplinary approach to solve complex nano EHS Problems by the UC Center for the Environmental Implications of Nanotechnology. Small 2012; 9: 1428-43.
7. Clark KA, White RH, Silbergeld EK. Predictive models for nanotoxicology: current challenges and future opportunities. Regul Toxicol Pharmacol 2011; 59: 361-3.
8. Dix DJ, Houck KA, Judson RS et al. Incorporating biological, chemical, and toxicological knowledge into predictive models of toxicity. Toxicol Sci 2012; 130: 440-1; author reply 442-3.
9. Puzyn T, Leszczynska D, Leszczynski J. Toward the development of "nano-QSARs": advances and challenges. Small 2009; 5: 2494-509.
10. Liu R, Rallo R, George S et al. Classification NanoSAR development for cytotoxicity of metal oxide nanoparticles. Small 2011; 7: 1118-26.
11. Rallo R, France B, Liu R et al. Self-organizing map analysis of toxicity-related cell signaling pathways for metal and metal oxide nanoparticles. Environ Sci Technol 2011; 45: 1695-702.
12. Judson R, Kavlock R, Martin M et al. Perspectives on validation of high-throughput assays supporting 21st century toxicity testing. ALTEX 2013; 30: 51-6.
13. OECD. Important Issues on Risk Assessment of Manufactured Nanomaterials, in Series on the Safety of Manufactured Nanomaterials 2012.
14. Hartung T. Toxicology for the twenty-first century. Nature 2009; 460: 208-12.
15. Committee on Toxicity Testing and Assessment of Environmental Agents, N.R.C. Toxicity Testing in the 21st Century: A Vision and Strategy. Washington, DC: Committee on Toxicity Testing and Assessment of Environmental Agents, N.R.C., 2007.
16. Hartung T, van Vliet E, Jaworska J, Bonilla L, Skinner N, Thomas R. Systems toxicology. ALTEX 2012; 29: 119-28.
17. Dix DJ, Houck KA, Martin MT, Richard AM, Setzer RW, Kavlock RJ. The ToxCast program for prioritizing toxicity testing of environmental chemicals. Toxicol Sci 2007; 95: 5-12.
18. Judson RS, Houck KA, Kavlock RJ et al. In vitro screening of environmental chemicals for targeted testing prioritization: the ToxCast project. Environ Health Perspect 2010; 118: 485-92.
19. Kavlock R, Chandler K, Houck K et al. Update on EPA's ToxCast program: providing high throughput decision support tools for chemical risk management. Chem Res Toxicol 2012; 25: 1287-302.
20. Collins FS, Gray GM, Bucher JR. Toxicology. Transforming environmental health protection. Science 2008; 319: 906-7.
21. Schmidt CW. TOX 21: new dimensions of toxicity testing. Environ Health Perspect 2009; 117: A348-53.
22. George S, Pokhrel S, Xia T et al. Use of a rapid cytotoxicity screening approach to engineer a safer zinc oxide nanoparticle through iron doping. ACS Nano 2010; 4: 15-29.
23. Zhang H, Ji Z, Xia T et al. Use of metal oxide nanoparticle band gap to develop a predictive paradigm for oxidative stress and acute pulmonary inflammation. ACS Nano 2012; 6: 4349-68.
24. Liu R, Rallo R, Weissleder R, Tassa C, Shaw S, Cohen Y. Nano-SAR development for bioactivity of nanoparticles with considerations of decision boundaries. Small 2013; 9: 1842-52.
25. Wang X, Xia T, Ntim SA et al. Dispersal state of multiwalled carbon nanotubes elicits profibrogenic cellular responses that correlate with fibrogenesis biomarkers and fibrosis in the murine lung. ACS Nano 2011; 5: 9772-87.
26. Wang X, Xia T, Duch MC et al. Pluronic F108 coating decreases the lung fibrosis potential of multiwall carbon nanotubes by reducing lysosomal injury. Nano Lett 2012; 12: 3050-61.
27. Wang X, Xia T, Ntim SA et al. Quantitative techniques for assessing and controlling the dispersion and biological effects of multiwalled carbon nanotubes in mammalian tissue culture cells. ACS Nano 2010; 4: 7241-52.
28. Li R, Wang X, Ji Z et al. Surface charge and cellular processing of covalently functionalized multiwall carbon nanotubes determine pulmonary toxicity. ACS Nano 2013; 7: 2352-68.
29. Xia T, Li N, Nel AE. Potential health impact of nanoparticles. Annu Rev Public Health 2009; 30: 137-50.
30. Oberdörster G. Safety assessment for nanotechnology and nanomedicine: concepts of nanotoxicology. J Intern Med 2010; 267: 89-105.
31. Oberdörster G, Maynard A, Donaldson K et al. Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy. Part Fibre Toxicol 2005; 2: 8.
32. OECD. Overview of the Organization for Economic Cooperation and Development's strategies related to nanomaterials. Available from: http://www.oecd.org/science/nanosafety/.
33. Becher R, Hetland RB, Refsnes M, Dahl JE, Dahlman HJ, Schwarze PE. Rat lung inflammatory responses after in vivo and in vitro exposure to various stone particles. Inhal Toxicol 2001; 13: 789-805.
34. Sayes CM, Reed KL, Warheit DB. Assessing toxicity of fine and nanoparticles: comparing in vitro measurements to in vivo pulmonary toxicity profiles. Toxicol Sci 2007; 97: 163-80.
35. Rushton EK, Jiang J, Leonard SS et al. Concept of assessing nanoparticle hazards considering nanoparticle dosemetric and chemical/biological response metrics. J Toxicol Environ Health A 2010; 73: 445-61.
36. Duffin R, Tran L, Brown D, Stone V, Donaldson K. Proinflammogenic effects of low-toxicity and metal nanoparticles in vivo and in vitro: highlighting the role of particle surface area and surface reactivity. Inhal Toxicol 2007; 19: 849-56.
37. Monteiller C, Tran L, MacNee W et al. The pro-inflammatory effects of low-toxicity low-solubility particles, nanoparticles and fine particles, on epithelial cells in vitro: the role of surface area. Occup Environ Med 2007; 64: 609-15.
38. Xia T, Kovochich M, Brant J et al. Comparison of the abilities of ambient and manufactured nanoparticles to induce cellular toxicity according to an oxidative stress paradigm. Nano Lett 2006; 6: 1794-807.
39. Xiao GG, Wang M, Li N, Loo JA, Nel AE. Use of proteomics to demonstrate a hierarchical oxidative stress response to diesel exhaust particle chemicals in a macrophage cell line. J Biol Chem 2003; 278: 50781-90.
40. Xia T, Kovochich M, Liong M et al. Comparison of the mechanism of toxicity of zinc oxide and cerium oxide nanoparticles based on dissolution and oxidative stress properties. ACS Nano 2008; 2: 2121-34.
41. George S, Xia T, Rallo R et al. Use of a high-throughput screening approach coupled with in vivo zebrafish embryo screening to develop hazard ranking for engineered nanomaterials. ACS Nano 2011; 5: 1805-17.
42. George S, Pokhrel S, Ji Z et al. Role of Fe doping in tuning the band gap of TiO(2) for the photo-oxidation-induced cytotoxicity paradigm. J Am Chem Soc 2011; 133: 11270-8.
43. Damoiseaux R, George S, Li M et al. No time to lose-high throughput screening to assess nanomaterial safety. Nanoscale 2011; 3: 1345-60.
44. Patel T, Telesca D, George S, Nel AE. Toxicity profiling of engineered nanomaterials via multivariate dose response surface modeling. Ann Appl Stat 2012; 6: 1707-29.
45. Patel TT, Rallo R, George S, Xia T, Nel AE. Hierarchical rank aggregation with applications to nanotoxicology. JSTOR, 2013; 18: 159-177.
46. Burello E, Worth AP. A theoretical framework for predicting the oxidative stress potential of oxide nanoparticles. Nanotoxicology 2011; 5: 228-35.
47. Porter DW, Hubbs AF, Mercer RR et al. Mouse pulmonary dose- and time course-responses induced by exposure to multi-walled carbon nanotubes. Toxicology 2010; 269: 136-47.
48. NIOSH. Current Intelligence Bulletin: Occupational Exposure to Carbon Nanotubes. 2011; Available from: www.cdc.gov/niosh/docket/review/docket161A/.
49. Johnston HJ, Hutchison GR, Christensen FM et al. A critical review of the biological mechanisms underlying the in vivo and in vitro toxicity of carbon nanotubes: the contribution of physico-chemical characteristics. Nanotoxicology 2010; 4: 207-46.
50. Kagan VE, Tyurina YY, Tyurin VA et al. Direct and indirect effects of single walled carbon nanotubes on RAW 264.7 macrophages: role of iron. Toxicol Lett 2006; 165: 88-100.
51. Mercer RR, Scabilloni J, Wang L et al. Alteration of deposition pattern and pulmonary response as a result of improved dispersion of aspirated single-walled carbon nanotubes in a mouse model. Am J Physiol Lung Cell Mol Physiol 2008; 294: L87-97.
52. Muller J, Huaux F, Fonseca A, et al. Structural defects play a major role in the acute lung toxicity of multiwall carbon nanotubes: toxicological aspects. Chem Res Toxicol 2008; 21: 1698-705.
53. Ryman-Rasmussen JP, Cesta MF, Brody AR et al. Inhaled carbon nanotubes reach the subpleural tissue in mice. Nat Nanotechnol 2009; 4: 747-51.
54. Shvedova AA, Kisin ER, Mercer R et al. Unusual inflammatory and fibrogenic pulmonary responses to single-walled carbon nanotubes in mice. Am J Physiol Lung Cell Mol Physiol 2005; 289: L698-708.
55. Poland CA, Duffin R, Kinloch I et al. Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study. Nat Nanotechnol 2008; 3: 423-8.
56. Donaldson K, Murphy FA, Duffin R, Poland CA. Asbestos, carbon nanotubes and the pleural mesothelium: a review of the hypothesis regarding the role of long fibre retention in the parietal pleura, inflammation and mesothelioma. Part Fibre Toxicol 2010; 7: 5.
57. Palomäki J, Välimäki E, Sund J et al. Long, needle-like carbon nanotubes and asbestos activate the NLRP3 inflammasome through a similar mechanism. ACS Nano 2011; 5: 6861-70.
58. Sargent LM, Hubbs AF, Young SH et al. Single-walled carbon nanotube-induced mitotic disruption. Mutat Res 2012; 745: 28-37.
59. Bonner JC. Mesenchymal cell survival in airway and interstitial pulmonary fibrosis. Fibrogenesis Tissue Repair 2010; 3: 15.
60. Hamilton RF, Wu N, Porter D, Buford M, Wolfarth M, Holian A. Particle length-dependent titanium dioxide nanomaterials toxicity and bioactivity. Part Fibre Toxicol 2009; 6: 35.
61. Gangwal S, Brown JS, Wang A et al. Informing selection of nanomaterial concentrations for ToxCast in vitro testing based on occupational exposure potential. Environ Health Perspect 2011; 119: 1539-46.
62. Oberdorster G. Nanotoxicology: in vitro-in vivo dosimetry. Environ Health Perspect 2012; 120: A13; author reply A13.
63. Chen BT, Schwegler-Berry D, McKinney W et al. Multi-walled carbon nanotubes: sampling criteria and aerosol characterization. Inhal Toxicol 2012; 24: 798-820.
64. Kuempel ED, Castranova V. Hazard and risk assessment of workplace exposure to engineered nanoparticles: methods, issues, and carbon nanotube case study. In: Ramachandran G, ed. Assessing Nanoparticle Risk to Human Health. Oxford: Elsevier, Inc, 2012; 65-97.
65. Kuempel ED, Geraci CL, Schulte PA. Risk assessment and risk management of nanomaterials in the workplace: translating research to practice. Ann Occup Hyg 2012; 56: 491-505.
66. Kuempel ED, Castranova V, Geraci CL, Schulte PA. Development of risk-based nanomaterial groups for occupational exposure control. J Nanopart Res 2012; 14: 1-15.
67. Stone KC, Mercer RR, Gehr P, Stockstill B, Crapo JD. Allometric relationships of cell numbers and size in the mammalian lung. Am J Respir Cell Mol Biol 1992; 6: 235-43.
68. Oberdorster G, Ferin J, Morrow PE. Volumetric loading of alveolar macrophages (AM): a possible basis for diminished AM-mediated particle clearance. Exp Lung Res 1992; 18: 87-104.
69. Brain JD, Knudson DE, Sorokin SP, Davis MA. Pulmonary distribution of particles given by intratracheal instillation or by aerosol inhalation. Environ Res 1976; 11: 13-33.
70. Warheit DB, Webb TR, Reed KL, Frerichs S, Sayes CM. Pulmonary toxicity study in rats with three forms of ultrafine-TiO2 particles: differential responses related to surface properties. Toxicology 2007; 230: 90-104.
71. Henderson RF, Driscoll KE, Harkema JR et al. A comparison of the inflammatory response of the lung to inhaled versus instilled particles in F344 rats. Fundam Appl Toxicol 1995; 24: 183-97.
72. Bernstein D, Castranova V, Donaldson K et al. Testing of fibrous particles: short-term assays and strategies. Inhal Toxicol 2005; 17: 497-537.
73. Rao GV, Tinkle S, Weissman DN et al. Efficacy of a technique for exposing the mouse lung to particles aspirated from the pharynx. J Toxicol Environ Health A 2003; 66: 1441-52.
74. Sager TM, Porter D, Robinson V, Lindsley W, Schwegler-Berry, Castranova V. Improved method to disperse nanoparticles for in vitro and in vivo investigation of toxicity. Nanotoxicology 2007; 1: 118-29.
75. Mercer RR, Hubbs AF, Scabilloni JF et al. Distribution and persistence of pleural penetrations by multi-walled carbon nanotubes. Part Fibre Toxicol 2010; 7: 28.
76. Shvedova AA, Kisin E, Murray AR et al. Inhalation vs. aspiration of single-walled carbon nanotubes in C57BL/6 mice: inflammation, fibrosis, oxidative stress, and mutagenesis. Am J Physiol Lung Cell Mol Physiol 2008; 295: L552-65.
77. Porter DW, Hubbs AF, Chen BT et al. Acute pulmonary dose-responses to inhaled multi-walled carbon nanotubes. Nanotoxicology 2012; [Epub ahead of print].
78. Piegorsch WW, Bailer AF. Quantitative risk assessment with stimulus-response data. Analyzing Environmental Data. Chicester, West Sussex: John Wiley & Sons, 2005.
79. NRC. Science and decisions: advancing risk assessment. Committee on improving risk analysis approaches used by the U.S. EPA, Board on Environmental Studies and Toxicology, Division on Eath and Life Studies, 2009.
80. Risk assessment forum US Environmental Protection Agency. Benchmark dose Technical Guidance. Washington, DC: 2012 http://www.epa.gov/osa/raf/publications/benchmark_dose_guidance.pdf.
81. Kuempel ED, Geraci CL, Schulte PA. Risk assessment approaches and research needs for nanoparticles: an examination of data and information from current studies. In: Simeonova P, Opopol N, Luster M, eds. Proceedings of the NATO Advanced Research Workshop on Nanotechnology: Toxicological Issues and Environmental Safety in Nanotechnology: Toxicological Issues and Environmental Safety. New York, NY: Springer, 2007; 119-45.
82. OECD. Guidance on grouping of chemicals in Series on Testing and Assessment 2007.
83. Zalk DM, Nelson DI. History and evolution of control banding: a review. J Occup Environ Hyg 2008; 5: 330-46.
84. Brouwer DH. Control banding approaches for nanomaterials. Ann Occup Hyg 2012; 56: 506-14.
85. Mutlu GM, Budinger GR, Green AA et al. Biocompatible nanoscale dispersion of single-walled carbon nanotubes minimizes in vivo pulmonary toxicity. Nano Lett, 2010; 10: 1664-70.
86. Hersam MC. Progress towards monodisperse single-walled carbon nanotubes. Nat Nanotechnol 2008; 3: 387-94.
87. Bus JS, Becker RA. Toxicity testing in the 21st century: a view from the chemical industry. Toxicol Sci 2009; 112: 297-302.
88. Stokstad E. Putting chemicals on a path to better risk assessment. Science 2009; 325: 694-5.
89. EDF. Challenges and Limitations of High Throughput in Vitro Testing. Available from: http://www.edf.org/health/section-6-challenges-and-limitations-high-throughput-vitro-testing.
90. Thomas RS, Black MB, Li L et al. A comprehensive statistical analysis of predicting in vivo hazard using high-throughput in vitro screening. Toxicol Sci 2012; 128: 398-417.