Risk assessment of engineered nanomaterials: a review of available data and approaches from a regulatory perspective

References

• Ahlers J, Stock F, Werschkun B. 2008. Integrated testing and intelligent assessment- new challenges under REACH. Environ Sci Pollut Res 15:565–572.
   PubMed Web of Science ®Google Scholar
• Bassan A, Worth A. 2008. The integrated use of models for the properties and effects of chemicals by means of a structured workflow. QSAR Comb Sci 27:6–20.
   Google Scholar
• Bergamaschi E. 2009. Occupational exposure to nanomaterials: present knowledge and future development. Nanotoxicology 3:194–201.
   Web of Science ®Google Scholar
• Boxall ABA, Chaudhry Q, Jones A, Jefferson B, Watts CD. 2008. Current and future predicted environmental exposure to engineered nanoparticles. Central Science Laboratory York for the Department of the Environment and Rural Affairs, Sand Hutton, UK.
   Google Scholar
• British Standards Institution (BSI). 2007. PAS136 Terminology for nanomaterials. 2011 February; Accessed from the website: http://www.bsiglobal.com.
   Google Scholar
• Burello E, Worth AP. 2010. A theoretical framework for predicting the oxidative stress potential of oxide nanoparticles. Nanotoxicology 0:1–8.
   Google Scholar
• Christensen FM, Sokull-Kluettgen B, Sintes JR. 2010. Towards REACH guidance on nanomaterials. NanoImpactNet conference; 2010 March 9–12; Lausanne.
   Google Scholar
• Clark K, Van Tongeren M, Rashid S, Brouwer D, Christensen F, Nowack B, 2011. NANEX: Development of exposure scenarios for manufactured nanomaterials-scientific integration and gap analysis. 2011 July; Accessed from the website: http://nanex-project.eu/index.php/public-documents/cat_view/43-dissemination-reports/74-wps-reports.
   Google Scholar
• Council of Canadian Academies. 2008. Small is different: a science perspective on the regulatory challenges of the nanoscale. 2011 February; Accessed from the website: http://www.scienceadvice.ca/uploads/eng/assessments%20and%20publications%20and%20news%20releases/nano/(2008_07_10)_report_on_nanotechnology.pdf.
   Google Scholar
• Environmental Defense and DuPont. 2007. Nano risk framework. 2011 February; Accessed from the website: http://nanoriskframework.com/page.cfm?tagID=1095.
   Google Scholar
• ECHA. 2007a. Guidance for the implementation of REACH: guidance on information requirements and chemical safety assessment. Part A: introduction to the guidance document. 2011 February; Accessed from the website: http://guidance.echa.europa.eu/guidance_en.htm.
   Google Scholar
• ECHA. 2007b. Guidance for the implementation of REACH: guidance on information requirements and chemical safety assessment. Part B: hazard assessment. 2011 February; Accessed from the website: http://guidance.echa.europa.eu/guidance_en.htm.
   Google Scholar
• ECHA. 2007c. Guidance for the implementation of REACH: guidance on information requirements and chemical safety assessment. Part D: exposure scenario building. 2011 February; Accessed from the website: http://guidance.echa.europa.eu/guidance_en.htm.
   Google Scholar
• European Commission. 2008. Follow-up to the 6th meeting of the REACH competent authorities for the implementation of Regulation (EC) 1907/2006 (REACH): Nanomaterials in REACH. 2011 February; Accessed from the website: http://ec.europa.eu/environment/chemicals/reach/pdf/nanomaterials.pdf.
   Google Scholar
• Fransman W, Verbist K, Stuurman B, Vink S, Heussen H, Brouwer D, van Niftrik M. 2010. Stoffenmanager nano 1.0: an online control banding tool for the prioritization of risks related to working with manufactured nano objects. Nanosafe 2010 conference in Grenoble, France.
   Google Scholar
• Gosens I. 2011. RE: In vitro-in vivo extrapolation in the risk assessment of engineered nanomaterials. Type to Hristozov, D.
   Google Scholar
• Gottschalk F, Scholz RW, Nowack B. 2010b. Probabilistic material flow modeling for assessing the environmental exposure to compounds: Methodology and an application to engineered nano-TiO2 particles. Environ Model Softw 25:320–332.
   Web of Science ®Google Scholar
• Gottschalk F, Sonderer T, Scholz RW, Nowack B. 2009. Modeled environmental concentrations of engineered nanomaterials (TiO2, ZnO, Ag, CNT, fullerenes) for different regions. Environ Sci Technol 43:9216–9222.
   PubMed Web of Science ®Google Scholar
• Gottschalk F, Sonderer T, Scholz RW, Nowack B. 2010a. Possibilities and limitations of modeling environmental exposure to engineered nanomaterials by probabilistic material flow analysis. Environ Tox Chem 29:1036–1048.
   PubMed Web of Science ®Google Scholar
• Grieger K, Baun A, Owen R. 2010. Redefining risk research priorities for nanomaterials. J Nanopar Res 12:383–392.
   Google Scholar
• Grieger K, Linkov I, Hansen SF, Baun A. 2011. Environmental risk analysis for nanomaterials: Review and evaluation of frameworks. Nanotoxicology 0:1–17.
   Google Scholar
• Greim H. 2009. Alternative methods to safety studies in experimental animals. Arch Toxicol 83:5–7.
   PubMed Web of Science ®Google Scholar
• Hansen SF. 2009. Regulation and risk assessment of nanomaterials – too little, too late? 2011 February; Accessed from the website: http://www2.er.dtu.dk/publications/fulltext/2009/ENV2009-069.pdf.
   Google Scholar
• Hansen S, Michelson E, Kamper A, Borling P, Stuer-Lauridsen F, Baun A. 2008. Categorization framework to aid exposure assessment of nanomaterials in consumer products. Ecotoxicology 17:438–447.
   PubMed Web of Science ®Google Scholar
• Hansen SF, Larsen BH, Olsen SI, Baun A. 2007. Categorization framework to aid hazard identification of nanomaterials. Nanotoxicology 1:243–250.
   Web of Science ®Google Scholar
• Höck J, Epprecht T, Hofmann H, Höhner K, Krug H, Lorenz C, 2010. Guidelines on the Precautionary Matrix for synthetic nanomaterials. 2011 February; Accessed from the website: http://www.bag.admin.ch/themen/chemikalien/00228/00510/05626/index.html?lang=en.
   Google Scholar
• Hristozov D, Malsch I. 2009. Hazards and risks of engineered nanoparticles for the environment and human health. Sustainability 1:1161–1194.
   Google Scholar
• OECD. 2004. Description of selected key generic terms used in chemical hazard/risk assessment. 2011 February; Accessed from the website: http://www.who.int/ipcs/publications/methods/harmonization/en/terminol_part-I.pdf.
   Google Scholar
• International Risk Governance Council (IRGC). 2006. White paper No. 2: nanotechnology risk governance. 2011 February; Accessed from the website: http://www.irgc.org/IMG/pdf/PB_nanoFINAL2_2_.pdf.
   Google Scholar
• International Risk Governance Council. 2007. White paper No. 2: nanotechnology risk governance. 2011 December; Accessed from the website: http://www.irgc.org/IMG/pdf/PB_nanoFINAL2_2_.pdf.
   Google Scholar
• Jaworska J, Gabbert S, Aldenberg T. 2010. Towards optimization of chemical testing under REACH: a Bayesian network approach to integrated testing strategies. Regul Toxicol Pharmacol 57:157–167.
   PubMed Web of Science ®Google Scholar
• Joint Research Center (JRC). 2004. Science in trade disputes related to potential risks: comparative case studies. Series EUR 21301 EN. 2011 February; Accessed from the website: http://www.oeaw.ac.at/ita/ebene5/HT_1271.pdf.
   Google Scholar
• Kandlikar M, Ramachandran G, Maynard A, Murdock B, Toscano WA. 2006. Health risk assessment for nanoparticles: a case for using expert judgment. In: Maynard AD, Pui DYH, editors. Nanotechnology and occupational health. Dordrecht: Springer. pp 137–156.
   Google Scholar
• Kandlikar M, Ramachandran G, Maynard A, Murdock B, Toscano WA. 2007. Health risk assessment for nanoparticles: a case for using expert judgment. In: Maynard AD, Pui DYH, editors. Nanotechnology and occupational health. Dordrecht: Springer. pp 137–156.
   Google Scholar
• Kerr RA. 1996. Risk sssessment: a new way to ask the experts: rating radioactive waste risks. Science 274:913–914.
   Web of Science ®Google Scholar
• Lee HA, Leavens TL, Mason SE, Monteiro-Riviere NA, Riviere JE. 2008. Comparison of quantum dot biodistribution with a blood-flow-limited physiologically based pharmacokinetic model. Nano Lett 9:794–799.
   Web of Science ®Google Scholar
• Leeuwen C, Vermeire T. 2007. Risk assessment of chemicals: an introduction. 2nd ed. Dordrecht: Springer.
   Google Scholar
• Liao C, Chiang Y, Chio C. 2008. Model-based assessment for human inhalation exposure risk to airborne nano/fine titanium dioxide particles. Sci Total Environ 407:165–177.
   PubMed Web of Science ®Google Scholar
• Linkov I, Satterstrom FK, Kiker G, Batchelor C, Bridges T, Ferguson E. 2006. From comparative risk assessment to multi-criteria decision analysis and adaptive management: recent developments and applications. Environ Int 32:1072–1093.
   PubMed Web of Science ®Google Scholar
• Linkov I, Steevens J, Adlakha-Hutcheon G, Bennett E, Chappell M, Colvin V, 2009. Emerging methods and tools for environmental risk assessment, decision-making, and policy for nanomaterials: summary of NATO Advanced Research Workshop. J Nanopart Res 11:513–527.
   PubMed Web of Science ®Google Scholar
• Linkov I, Satterstrom F, Steevens J, Ferguson E, Pleus R. 2007. Multi-criteria decision analysis and environmental risk assessment for nanomaterials. J Nanopart Res 9:543–554.
   Web of Science ®Google Scholar
• Linkov I, Welle P, Loney D, Tkachuk A, Canis L, Kim JB, Bridges T. 2011. Use of multicriteria decision analysis to support weight of evidence evaluation. Risk Analysis 31:1211–1225.
   Google Scholar
• Lux Research. 2006. The nanotech report 4th edition. 2011 February; Accessed from the website: https://portal.luxresearchinc.com/research/document_excerpt/2778.
   Google Scholar
• Maynard AD. 2007. Nanotechnology: the next big thing, or much ado about nothing? Ann Occup Hyg 51:1–12.
   PubMed Web of Science ®Google Scholar
• Meng H, Xia T, George S, Nel AE. 2009. A predictive toxicological paradigm for the safety assessment of nanomaterials. ACS Nano 3:1620–1627.
   PubMed Web of Science ®Google Scholar
• Metcalfe C. 2009. SMARTEN: strategic management and assessment of risks and toxicity of engineered nanomaterials. In: Linkov I, Steevens J, editors. Nanomaterials: Risks and Benefits. 1st ed. Dordrecht: Springer. pp 95–109.
   Google Scholar
• Morgan K. 2005. Development of a preliminary framework for informing the risk analysis and risk management of nanoparticles. Risk Anal 25:1621–1635.
   PubMed Web of Science ®Google Scholar
• Mueller NC, Nowack B. 2008. Exposure modeling of engineered nanoparticles in the environment. Environ Sci Technol 42:4447–4453.
   PubMed Web of Science ®Google Scholar
• NanoSafer [Internet]. Copenhagen: Industriens Branchearbejsmiljøråd; 2011 Feb 22- [cited 2011 Feb 24]; Available from: http://nanosafer.i-bar.dk/.
   Google Scholar
• Nielsen E, Ostergaard G, Larsen J. 2007. Toxicological risk assessment of chemicals: a practical guide. New York: Informa Healthcare.
   Google Scholar
• Oberdorster G, Oberdorster E, Oberdorster J. 2005. Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environ Health Perspect 113:823–839.
   PubMed Web of Science ®Google Scholar
• Organization for Economic Cooperation and Development (OECD). 1982. Decision of the council concerning the minimum pre-marketing set of data in the assessment of chemicals. 2011 February; Accessed from the website: http://www.oecd.org/document/47/0,3746,en_2649_37465_1817647_1_1_1_37465,00.html.
   Google Scholar
• Pang C, Selck H, Rank J, Forbes V. 2010. The challenge to regulate manufactured nanomaterials under REACH. SETAC Europe 20th Annual Meeting in Seville, Spain.
   Google Scholar
• Patton DE. 1993. The ABCs of risk assessment. EPA J 19:10–15.
   Google Scholar
• Puzyn T, Gajewicz A, Leszczynska D, Leszczynski J. 2010. Nanomaterials-the Next Great Challenge for QSAR Modelers. In: Puzyn T, Leszczynski J, Cronin MT, editors. Recent Advances in QSAR Studies. Dordrecht: Springer. pp 383–409.
   Google Scholar
• Riviere JE. 2009. Pharmacokinetics of nanomaterials: an overview of carbon nanotubes, fullerenes and quantum dots. WIREs: Nanmed Nanobiotech 1:26–34.
   PubMed Web of Science ®Google Scholar
• Robichaud C, Tanzil D, Weilenmann U, Wiesner M. 2005. Relative risk analysis of several manufactured nanomaterials: an insurance industry context. Environ Sci Technol 39:8985–8994.
   PubMed Web of Science ®Google Scholar
• Royal Society and the Royal Academy of Engineering. 2004. Nanoscience and nanotechnologies: opportunities and uncertainties. 2011 February; Accessed from the website: http://www.nanotec.org.uk/finalReport.htm.
   Google Scholar
• SCENIHR. 2005. Opinion on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies. 2011 February; Accessed from the website: http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf.
   Google Scholar
• SCENHIR. 2007. Opinion on the appropriateness of the risk assessment methodology in accordance with the Technical Guidance Documents for new and existing substances for assessing the risks of nanomaterials. 2011 February; Accessed from the website: http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_010.pdf.
   Google Scholar
• SCENHIR. 2009. Opinion on: Risk assessment of products of nanotechnologies. 2011 July; Accessed from the website: http://ec.europa.eu/health/archive/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf.
   Google Scholar
• Slob W. 2002. Dose-response modeling of continuous endpoints. Toxicol Sci 66:298–312.
   PubMed Web of Science ®Google Scholar
• Stone V, Hankin S, Aitken RJ, Achberger K, Baun A, Christensen F, 2010. Engineered nanoparticles: review of health and environmental safety (ENRHES). 2011 February; Accessed from the website: http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report.
   Google Scholar
• Tervonen T, Linkov I, Figueira J, Steevens J, Chappell M, Merad M. 2009. Risk-based classification system of nanomaterials. J Nanopart Res 11:757–766.
   Web of Science ®Google Scholar
• Tervonen T, Linkov I, Figueira J, Steevens J, Chappell M, Merad M. 2010. Risk-based classification system of nanomaterials. J Nanopart Res 11:757–766.
   Web of Science ®Google Scholar
• Tran L. 2011. Risk assessment of ENM: the results from FP7 ENPRA project. Symposium safety issues of nanomaterials along their lifecycle in Barcelona, Spain.
   Google Scholar
• Tyshenko M, Krewski D. 2008. A risk management framework for the regulation of nanomaterials. Int J Nanotech 5:143–160.
   Web of Science ®Google Scholar
• Van Zwanenberg P, Millstone E. BSE: risk, science, and governance. Oxford: OUP; 2005.
   Google Scholar
• Warheit DB. 2008. How meaningful are the results of nanotoxicity studies in the absence of adequate material characterization? Toxicol Sci 101:183–185.
   PubMed Web of Science ®Google Scholar
• Wick P, Manser P, Limbach LK, Dettlaff-Weglikowska U, Krumeich F, Roth S, 2007. The degree and kind of agglomeration affect carbon nanotube cytotoxicity. Toxicol Lett 168:121–131.
   PubMed Web of Science ®Google Scholar
• Wijnhoven SWP, Peijnenburg WJGM, Herberts CA, Hagens WI, Oomen AG, Heugens EHW, 2009. Nano-silver: a review of available data and knowledge gaps in human and environmental risk assessment. Nanotoxicology 3:109–138.
   Web of Science ®Google Scholar
• Zuin S, Micheletti C, Critto A, Pojana G, Johnston H, Stone V, 2010. Weight of evidence approach for the relative hazard ranking of nanomaterials. Nanotoxicology 0:1–14.
   Google Scholar