Concern-driven integrated approaches to nanomaterial testing and assessment – report of the NanoSafety Cluster Working Group 10

References

• Ankley GT, Bennett RS, Erickson RJ, Hoff DJ, Hornung MW, Johnson RD, et al. 2010. Adverse outcome pathways: A conceptual framework to support ecotoxicology research and risk assessment. Env Toxicol Chem 29:730–741.
   PubMed Web of Science ®Google Scholar
• Anon. 2006. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. OJ L 396/1, 30 December 2006.
   Google Scholar
• Anon. 2008. Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council. OJ L 348/84, 24 December 2008.
   Google Scholar
• Anon. 2010a. Communication from the Commission. Europe 2020 – A European strategy for smart, sustainable and inclusive growth. COM(2010)2020. Brussels, 3 March 2010. 37–http://ec.europa.eu/research/era/docs/en/investing-in-research-european-commission-europe-2020-2010.pdf.
   Google Scholar
• Anon. 2010b. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. O.J. L 276/33, 20 October 2010.
   Google Scholar
• Anon. 2011a. Proposal for a regulation of the European Parliament and of the Council establishing Horizon 2020 – The Framework Programme for Research and Innovation (2014 – 2020). COM(2011)809 final, Brussels, 30 November 2011. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2011:0809:FIN:en:PDF.
   Google Scholar
• Anon. 2011b. Commission recommendation on the definition of nanomaterial. OJ L 275/38, 18 October 2011.
   Google Scholar
• Anon. 2012a. Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee. Second regulatory review on nanomaterials. COM(2012)572 final. Brussels, 3 October 2012. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0572:FIN:en:PDF.
   Google Scholar
• Anon. 2012b. Commission staff working paper. Types and uses of nanomaterials, including safety aspects; accompanying the Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the Second Regulatory Review on Nanomaterials (COM(2012) 572 final. SWD(2012) 288 final. Brussels, 3 October 2012. 111–http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0288:FIN:EN:PDF.
   Google Scholar
• Aschberger K, Micheletti C, Sokull-Klüttgen B, Christensen FM. 2011. Analysis of currently available data for characterising the risk of engineered nanomaterials to the environment and human health - lessons learned from four case studies. Environ Int 37(6):1143–1156.
   PubMed Web of Science ®Google Scholar
• Becker H, Herzberg F, Schulte A, Kolossa-Gehring M. 2011. The carcinogenic potential of nanomaterials, their release from products and options for regulating them. Int J Hygiene Environ Health 214(3):231–238.
   PubMed Web of Science ®Google Scholar
• Bhattacharya K, Naha PC, Naydenova I, Mintova S, Byrne HJ. 2012. Reactive oxygen species mediated DNA damage in human lung alveolar epithelial (A549) cells from exposure to non-cytotoxic MFI-type zeolite nanoparticles. Toxicol Lett 215(3):151–160.
   PubMed Web of Science ®Google Scholar
• Bleeker EA, de Jong WH, Geertsma RE, Groenewold M, Heugens EH, Koers-Jacquemijns M, et al. 2013. Considerations on the EU definition of a nanomaterial: science to support policy making. Regul Toxicol Pharmacol 65(1):119–125.
   PubMed Web of Science ®Google Scholar
• Boraschi D, Costantino L, Italiani P. 2012. Interaction of nanoparticles with immunocompetent cells: nanosafety considerations. Nanomed 7(1):121–131.
   PubMed Web of Science ®Google Scholar
• Burlinson B. 2012. The in vitro and in vivo Comet assays. Methods Mol Biol 817:143–163.
   PubMedGoogle Scholar
• Card JW, Magnuson BA. 2009. Letter to the Editor. J Food Sci 74:vi–vii. doi: 10.1111/j.1750-3841.2009.01366.x.
   PubMed Web of Science ®Google Scholar
• Card JW, Magnuson BA. 2010. A method to assess the quality of studies that examine the toxicity of engineered nanomaterials. Int J Toxicol 29(4):402–410.
   PubMed Web of Science ®Google Scholar
• Cheng JB, Cho RJ. 2012. Genetics and epigenetics of the skin meet deep sequence. J Invest Dermatol 132(3 Pt 2):923–932.
   PubMed Web of Science ®Google Scholar
• Cockburn A, Bradford R, Buck N, Constable A, Edwards G, Haber B, et al. 2012. Approaches to the safety assessment of engineered nanomaterials (ENM) in food. Food Chem Toxicol 50(6):2224–2242.
   PubMed Web of Science ®Google Scholar
• Colognato R, Coppedè F, Ponti J, Sabbioni E, Migliore L. 2007. Genotoxicity induced by arsenic compounds in peripheral human lymphocytes analysed by cytokinesis-block micronucleus assay. Mutagenesis 22(4):255–261.
   PubMed Web of Science ®Google Scholar
• Dan M, Wu P, Grulke EA, Graham UM, Unrine JM, Yokel RA. 2012. Ceria engineered nanomaterial distribution in and clearance from blood: size matters. Nanomed 7(1):95–110.
   PubMed Web of Science ®Google Scholar
• Dekkers S, Bouwmeester H, Bos PMJ, Peters RJB, Rietveld AG, Oomen AG. 2012. Knowledge gaps in risk assessment of nanosilica in food: evaluation of the dissolution and toxicity of different forms of silica. Nanotoxicology Epub ahead of print; doi: 10.3109,17435390.2012.662250.
   PubMed Web of Science ®Google Scholar
• Dekkers S, Krystek P, Peters RJB, Lankveld DPK, Bokkers BGH, van Hoeven-Arentzen PH, et al. 2011. Presence and risks of nanosilica in food products. Nanotoxicology 5(3):393–405.
   PubMed Web of Science ®Google Scholar
• ECHA. 2012. European Chemicals Agency – Guidance on information requirements and chemical safety assessment. Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance. ECHA; 12-G-03-EN.
   Google Scholar
• EFSA. 2011. European Food Safety Authority - Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. EFSA J 9(5):2140.
   Google Scholar
• Fenech M. 2007. Cytokinesis-block micronucleus cytome assay. Nat Protoc 2(5):1084–1104.
   PubMed Web of Science ®Google Scholar
• Firestone M, Kavlock R, Zenick H, Kramer M; US Environmental Protection Agency Working Group on the Future of Toxicity Testing. 2010. The U.S. Environmental Protection Agency strategic plan for evaluating the toxicity of chemicals. J Toxicol Environ Health B Crit Rev 13(2-4):139–162.
   PubMed Web of Science ®Google Scholar
• Gasser M, Rothen-Rutishauser B, Krug HF, Gehr P, Nelle M, Yan B, et al. 2010. Lipids of the pulmonary surfactant and functional groups on multi-walled carbon nanotubes influence blood plasma proteins adsorption differently. J Nanobiotech 8:31.
   PubMed Web of Science ®Google Scholar
• Handy RD, Cornelis G, Fernandes TF, Tsyusko O, Decho A, Sabo-Attwood T, et al. 2012b. Ecotoxicity test methods for engineered nanomaterials: Practical experiences and recommendations from the bench. Environ Toxicol Chem 31:15–31.
   PubMed Web of Science ®Google Scholar
• Handy RD, van den Brink N, Chappell M, Mühling M, Behra R, Dušinská M, et al. 2012a. Practical considerations for conducting ecotoxicity test methods with manufactured nanomaterials: what have we learnt so far? Ecotoxicology 21(4):933–972.
   PubMed Web of Science ®Google Scholar
• Hartung T. 2009. Toxicology for the twenty first century. Nature 460(7252):208–212.
   PubMed Web of Science ®Google Scholar
• Hassellov M, Readman J, Rabville J, Tiede K. 2008. Nanoparticle analysis and characterization methodologies in environmental risk assessment of engineered nanoparticles. Ecotoxicology 17:344–361.
   PubMed Web of Science ®Google Scholar
• Holloway JW, Savarimuthu Francis S, Fong KM, Yang IA. 2012. Genomics and the respiratory effects of air pollution exposure. Respirology 17(4):590–600.
   PubMed Web of Science ®Google Scholar
• Hristozov DR, Gottardo S, Cinelli M, Isigonis P, Zabeo A, Critto A, et al. 2013. Application of a quantitative weight of evidence approach for ranking and prioritising occupational exposure scenarios for titanium dioxide and carbon nanomaterials. Nanotoxicology Epub ahead of print; doi:10.3109/17435390.2012.760013.
   Web of Science ®Google Scholar
• Johnston H, Brown D, Kermanizadeh A, Gubbins E, Stone V. 2012. Investigating the relationship between nanomaterial hazard and physicochemical properties: Informing the exploitation of nanomaterials within therapeutic and diagnostic applications. J Controll Rel 164(3):307–313.
   PubMed Web of Science ®Google Scholar
• Johnston H, Pojana G, Zuin S, Jacobsen NR, Møller P, Loft S, et al. 2013. Engineered nanomaterial risk. Lessons learnt from completed nanotoxicology studies: potential solutions to current and future challenges. Crit Rev Toxicol 43(1):1–20.
   PubMed Web of Science ®Google Scholar
• Klaine SJ, Alvarez PJ, Batley GE, Fernandes TF, Handy RD, Lyon DY, et al. 2008. Nanomaterials in the environment: behavior, fate, bioavailability, and effects. Environ Toxicol Chem 27(9):1825–1851.
   PubMed Web of Science ®Google Scholar
• Klein CL, Wiench K, Wiemann M, Ma-Hock L, van Ravenzwaay B, Landsiedel R. 2012. Hazard identification of inhaled nanomaterials: making use of short-term inhalation studies. Arch Toxicol 86(7):1137–1151.
   PubMed Web of Science ®Google Scholar
• Koturbash I, Simpson NE, Beland FA, Pogribny IP. 2012. Alterations in histone H4 lysine 20 methylation: implications for cancer detection and prevention. Antioxid Redox Signal 17(2):365–374.
   PubMed Web of Science ®Google Scholar
• Krug HF, Wick P. 2011. Nanotoxicology: An interdisciplinary challenge. Angew Chem Int Ed Engl 50:1260–1278.
   PubMed Web of Science ®Google Scholar
• Kühnel D, Scheffler K, Wellner P, Meißner T, Potthoff A, Busch W, et al. 2012. Comparative evaluation of particle properties, formation of reactive oxygen species and genotoxic potential of tungsten carbide based nanoparticles in vitro. J Hazard Mat 227-228:418–426.
   PubMed Web of Science ®Google Scholar
• Lai ZW, Yan Y, Caruso F, Nice EC. 2012. Emerging techniques in proteomics for probing nano-bio interactions. ACS Nano 6(12):10438–10448.
   PubMed Web of Science ®Google Scholar
• Landsiedel R, Fabian E, Ma-Hock L, Wohlleben W, Wiench K, Oesch F, et al. 2012. Toxico-/biokinetics of nanomaterials. Arch Toxicol 86(7):1021–1060.
   PubMed Web of Science ®Google Scholar
• Landsiedel R, Kapp MD, Schulz M, Wiench K, Oesch F. 2009. Genotoxicity investigations on nanomaterials: methods, preparation and characterization of test material, potential artifacts and limitations - many questions, some answers. Mutat Res 681(2-3):241–258.
   PubMed Web of Science ®Google Scholar
• Landsiedel R, Ma-Hock L, Kroll A, Hahn D, Schnekenburger J, Wiench K, et al. 2010. Testing metal-oxide nanomaterials for human safety. Adv Mat 22:2601–2627.
   PubMed Web of Science ®Google Scholar
• Lankveld DP, Oomen AG, Krystek P, Neigh A, Troost-de Jong A, Noorlander CW, et al. 2010. The kinetics of the tissue distribution of silver nanoparticles of different sizes. Biomaterials 31:8350–8361.
   PubMed Web of Science ®Google Scholar
• Leonard F, Ali H, Collnot E.-M, Crielaard BJ, Lammers T, Storm G, et al. 2012. Screening of budesonide nanoformulations for treatment of inflammatory bowel disease in an inflamed 3D cell-culture model. ALTEX 29(3):275–285.
   PubMedGoogle Scholar
• Liu J, Legros S, Ma G, Veinot JG, von der Kammer F, Hofmann T. 2012. Influence of surface functionalization and particle size on the aggregation kinetics of engineered nanoparticles. Chemosphere 87(8):918–924.
   PubMed Web of Science ®Google Scholar
• Lundqvist M, Stigler J, Cedervall T, Berggård T, Flanagan MB, Lynch I, et al. 2011. The evolution of the protein corona around nanoparticles: a test study. ACS Nano 5:7503–7509.
   PubMed Web of Science ®Google Scholar
• Lynch AM, Sasaki JC, Elespuru R, Jacobson-Kram D, Thybaud V, De Boeck M, et al. 2011. New and emerging technologies for genetic toxicity testing. Environ Mol Mutagen 52(3):205–223.
   PubMed Web of Science ®Google Scholar
• Ma-Hock L, Burkhardt S, Strauss V, Gamer AO, Wiench K, van Ravenzwaay B, et al. 2009. Development of a short-term inhalation test in the rat using nano titanium dioxide as a model substance. Inhal Toxicol 21:102–118.
   PubMed Web of Science ®Google Scholar
• NanoSafety Cluster. 2011. Nanosafety 2015-2020: A Strategic Research Agenda towards safe and sustainable nanomaterial and nanotechnology innovations. Identified key-areas of nanosafety research and expected and necessary achievements in these areas by 2015-2020. 37. http://www.nanosafetycluster.eu/intranet/intra_strategic-research- agenda.html.
   Google Scholar
• Nel AE, Mädler L, Velegol D, Xia T, Hoek EMV, Somasundaran P, et al. 2009. Understanding biophysicochemical interactions at the nano- bio interface. Nat Mater 8(7):543–557.
   PubMed Web of Science ®Google Scholar
• Nel AE, Xia T, Meng H, Wang X, Lin S, Ji Z, et al. 2013. Nanomaterial toxicity testing in the 21st century: use of a predictive toxicological approach and high-throughput screening. Acc Chem Res 46(3):607–621.
   PubMed Web of Science ®Google Scholar
• Oberdörster G. 2009. Safety assessment for nanotechnology and nanomedicine: concepts of nanotoxicology. J Int Med 267(1):89–105.
   Web of Science ®Google Scholar
• OECD. 2010. Guidance manual for the testing of manufactured nanomaterials: OECD's sponsorship programme; first revision. ENV/JM-MONO(2009)20/REV, OECD; 2 June 2010; Paris, France.
   Google Scholar
• OECD. 2011. A steering group 7 case-study for hazard identification of inhaled nanomaterials: an integrated approach with short-term inhalation studies. ENV/CHEM/NANO(2011)6/REV1. 10th Meeting of the Working Party on Manufactured Nanomaterials, OECD; 27-29 June 2012; Paris, France.
   Google Scholar
• OECD. 2012. Proposal for a template, and guidance on developing and assessing the completeness of adverse outcome pathways. 17. http://www.oecd.org/env/ehs/testing/49963554.pdf.
   Google Scholar
• OECD. 2013. Revised Draft Recommendation of the Council on the safety testing and assessment of manufactured nanomaterials. ENV/CHEM/NANO(2013)3/REV1 Working Party on Manufactured Nanomaterials. OECD; 25 February 2013; Paris, France.
   Google Scholar
• Oostingh GJ, Casals E, Italiani P, Colognato R, Stritzinger R, Ponti J, et al. 2012. Problems and challenges in the development and validation of human cell-based assays to determine nanoparticle-induced immunomodulatory effects. Part Fibre Toxicol 8(1):8.
   Google Scholar
• Peters R, Kramer E, Oomen AG, Rivera ZE, Oegema G, Tromp PC, et al. 2012. Presence of nano-sized silica during in vitro digestion of foods containing silica as a food additive. ACS Nano 6(3):2441–2451.
   PubMed Web of Science ®Google Scholar
• RIP-oN 1. 2011. European Commission REACH Implementation Project. Substance Identification of Nanomaterials. AA N°070307/2009/DI/534733 between DG ENV and JRC. Advisory report, March 2011. http://ec.europa.eu/environment/chemicals/nanotech/pdf/report_ ripon1.pdf.
   Google Scholar
• RIP-oN 2. 2011. Hankin SM, Peters SAK, Poland CA, Foss Hansen S, Holmqvist J, Ross BL, et al. 2011. Specific advice on fulfilling information requirements for nanomaterials under Reach (RIP-oN 2) – final project report. Reach-Nano consultation. RNC/RIP-oN2/FPR/1/Final. http://ec.europa.eu/environment/chemicals/nanotech/pdf/report_ripon2.pdf.
   Google Scholar
• Rossini GP, Hartung T. 2012. Food for thought. Towards tailored assays for cell based approaches to toxicity testing. ALTEX 29:359–372.
   PubMedGoogle Scholar
• Rothen-Rutishauser B, Brown DM, Piallier-Boyles M, Kinloch IA, Windle AH, Gehr P, et al. 2010. Relating the physicochemical characteristics and dispersion of multiwalled carbon nanotubes in different suspension media to their oxidative reactivity in vitro and inflammation in vivo. Nanotoxicol 4(3):331–342.
   PubMed Web of Science ®Google Scholar
• Russell WMS, Burch RL. 1959. The principles of humane experimental technique. London, UK: Methuen; Reprinted by UFAW, 1992, 238 pp., 8 Hamilton Close, South Mimms, Potters Bar, Herts EN6 3QD England.
   Google Scholar
• SCENIHR. 2009. The Scientific committee on emerging and newly identified health risks opinion on risk assessment of products of nanotechnologies. 19 January 2009. http://ec.europa.eu/health/archive/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf.
   Google Scholar
• Schulze C, Kroll A, Lehr C, Schäfer U.F, Becker K, Schnekenburger J, et al. 2008. Not ready to use - overcoming pitfalls when dispersing nanoparticles in physiological media. Nanotoxicol 2(2):51–61.
   Web of Science ®Google Scholar
• Silbergeld EK, Contreras EQ, Hartung T, Hirsch C, Hogberg H, Jachak AC, et al. 2011; tτ workshop report. Nanotoxicology: "the end of the beginning" - signs on the roadmap to a strategy for assuring the safe application and use of nanomaterials. ALTEX 28(3):236–241.
   PubMedGoogle Scholar
• Som C, Nowack B, Krug HF, Wick P. 2012. Toward the development of decision supporting tools that can be used for safe production and use of nanomaterials. Acc Chem Res epub ahead of print; doi: 10.1021/ar3000458.
   PubMed Web of Science ®Google Scholar
• Stoccoro A, Karlsson HL, Coppedè F, Migliore L. 2012. Epigenetic effects of nano-sized materials. Toxicol Epub ahead of print; doi:pii: S0300-483X(12)00421-0.
   PubMed Web of Science ®Google Scholar
• Stone V, Nowack B, Baun A, van den Brink N, von der Kammer F, Dusinska M, et al. 2010. Nanomaterials for environmental studies: classification, reference material issues, and strategies for physico- chemical characterisation. Sci Total Env 408(7):1745–1754.
   PubMed Web of Science ®Google Scholar
• Szyf M. 2011. The implications of DNA methylation for toxicology: toward toxicomethylomics, the toxicology of DNA methylation. Toxicol Sci 120(2):235–255.
   PubMed Web of Science ®Google Scholar
• Tiede K, Boxal A, Tear A, Lewis J, David H, Hassellov M. 2008. Detection and characterization of engineered nanoparticles in food and the environment. Food Addit Contam 25:795–821.
   Web of Science ®Google Scholar
• van Leeuwen CJ, Patlewicz GY, Worth AP. 2007. Intelligent testing strategies. In: van Leeuwen CJ, Vermeire TG, Vermeire T, editors. Risk assessment of chemicals: an introduction. Heidelberg, Germany: Springer. 467–509.
   Google Scholar
• von der Kammer F, Ferguson PL, Holden PA, Masion A, Rogers KR, Klaine SJ, et al. 2012. Analysis of engineered nanomaterials in complex matrices (environment and biota): general considerations and conceptual case studies. Environ Toxicol Chem 31(1):32–49.
   PubMed Web of Science ®Google Scholar
• Zuin S, Micheletti C, Critto A, Pojana G, Johnston H, Stone V, et al. 2011. Weight of evidence approach for the relative hazard ranking of nanomaterials. Nanotoxicol 5(3):445–458.
   PubMed Web of Science ®Google Scholar