Concern-driven integrated approaches for the grouping, testing and assessment of nanomaterials

Environmental Pollution

Volumn 218, Issue , 2016, Pages 1376-1380

  Landsiedel, Robert ^a  

^a BASF SE   (Germany)

Author keywords

Grouping; Integrated testing; Read across

Indexed keywords

INTEGRATED CONTROL; NANOSTRUCTURED MATERIALS; SAFETY TESTING;

ADVERSE EFFECT; GROUPING; HAZARD IDENTIFICATION; INTEGRATED APPROACH; READ ACROSS; TESTING AND ASSESSMENTS;

RISK ASSESSMENT;

INTEGRATED APPROACH; RISK ASSESSMENT; TESTING METHOD;

HUMAN; RISK ASSESSMENT; ANIMAL; POLLUTION; PREVENTION AND CONTROL; PROCEDURES; SYSTEMS BIOLOGY;

NANOMATERIAL;

ANIMALS; ENVIRONMENTAL POLLUTION; HUMANS; NANOSTRUCTURES; RISK ASSESSMENT; SYSTEMS BIOLOGY;

EID: 84991650771     PISSN: 02697491     EISSN: 18736424     Source Type: Journal    
DOI: 10.1016/j.envpol.2015.10.060     Document Type: Article

References (69)

1. Ankley, G.T., Bennett, R.S., Erickson, R.J., Hoff, D.J., Hornung, M.W., Johnson, R.D., Mount, D.R., Nichols, J.W., Russom, C.L., Schmieder, P.K., Serrrano, J.A., Tietge, J.E., Villeneuve, D.L., Adverse outcome pathways: a conceptual framework to support ecotoxicology research and risk assessment. Env. Toxicol. Chem. 29 (2010), 730–741.
2. Anon, 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. O. J., L 396(1), 30 December 2006.
3. Anon, 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.
4. Anzai, T., Kaminishi, M., Porth, A., Handley, J., Satoh, T., Worldwide trend in nanomaterial safety evaluation. Jpn. J. Environ. Toxicol. 15:2 (2012), 17–29.
5. Arts, J.H., Hadi, M., Keene, A.M., Kreiling, R., Lyon, D., Maier, M., Landsiedel, R., A critical appraisal of existing concepts for the grouping of nanomaterials. Regul. Toxicol. Pharmacol. 70:2 (2014), 492–506.
6. Arts, J.H., Hadi, M., Irfan, M.A., Keene, A.M., Kreiling, R., Lyon, D., Landsiedel, R., A decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping). Regul. Toxicol. Pharmacol. 71:2 Suppl. 1 (2015), 1–27.
7. Brain, Joseph D., et al. Pulmonary distribution of particles given by intratracheal instillation or by aerosol inhalation. Environ. Res. 11:1 (1976), 13–33.
8. Bräu, M., Ma-Hock, L., Hesse, C., Nicoleau, L., Strauss, V., Treumann, S., Wiench, K., Landsiedel, R., Wohlleben, W., Nanostructured calcium silicate hydrate seeds accelerate concrete hardening: a combined assessment of benefits and risks. Arch. Toxicol. 86 (2012), 1077–1087.
9. Castranova, V., Schulte, P.A., Zumwalde, R.D., Occupational nanosafety considerations for carbon nanotubes and carbon nanofibers. Acc. Chem. Res. 46:3 (2013 Mar 19), 642–649.
10. Damoiseaux, R., George, S., Li, M., Pokhrel, S., Ji, Z., France, B., Xia, T., Suarez, E., Rallo, R., Mädler, L., Cohen, Y., Hoek, E.M.V., Nel, A.E., No time to lose–high throughput screening to assess nanomaterial safety. Nanoscale 3:4 (2011), 1345–1360.
11. Dan, M., Wu, P., Grulke, E.A., Graham, U.M., Unrine, J.M., Yokel, R.A., Ceria engineered nanomaterial distribution in and clearance from blood: size matters. Nanomed 7:1 (2012), 95–110.
12. ECHA, Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.6. QSARs and Grouping of Chemicals. 2008, European Chemicals Agency, 134 Available at: http://echa.europa.eu/documents/10162/13632/information_requirements_r6_en.pdf.
13. ECHA, Guidance on Information Requirements and Chemical Safety Assessment. Appendix R7-1 Recommendations for Nanomaterials Applicable to Chapter R7a Endpoint Specific Guidance. 2012, European Chemicals Agency ECHA-12-G-03-EN, April 2012. 60 pp.; Available at: http://echa.europa.eu/documents/10162/13632/appendix_r7a_nanomaterials_en.pdf.
14. ECHA, Background Paper. An Introduction to the Assessment of Read across. 2012, European Chemicals Agency, 8 Available at: http://echa.europa.eu/documents/10162/5649897/ws_raa_20121003_background_paper_an_introduction_to_the_assessment_of_read-across_in_echa_en.pdf.
15. ECHA, Grouping of Substances and Read-across Approach. Part I. Introductory Note. 2013, European Chemicals Agency ECHA-13-R-02-EN. 11 pp.; Available at: http://echa.europa.eu/documents/10162/13628/read_across_introductory_note_en.pdf.
16. ECHA, Human health and environmental exposure assessment and risk characterization of nanomaterials. Best practice for REACH registrants. Third GAARN Meeting – Helsinki, 30 September 2013. ECHA-14-R-10-EN, 12 pp, 2014.
17. Gamer, A.O., Leibold, E., van Ravenzwaay, B., The in vitro absorption of microfine zinc oxide and titanium dioxide through porcine skin. Toxicol. Vitro 20 (2006), 301–307.
18. Gebel, T., Foth, H., Damm, G., Freyberger, A., Kramer, P.J., Lilienblum, W., Hengstler, J.G., Manufactured nanomaterials: categorization and approaches to hazard assessment. Archives Toxicol. 88:12 (2014), 2191–2211.
19. Godwin, H., Nameth, C., Avery, D., Bergeson, L.L., Bernard, D., Beryt, E., Nel, A.E., Nanomaterial categorization for assessing risk potential to facilitate regulatory decision-making. ACS Nano 9:4 (2015), 3409–3417.
20. Hankin, S.M., Peters, S.A.K., Poland, C.A., Foss Hansen, S., Holmqvist, J., Ross, B.L., Varet, J., Aitken, R.J., Specific Advice on Fulfilling Information Requirements for Nanomaterials under REACH (RIP-oN 2) – Final Project Report., 2011 REACH-NANO consultation. RNC/RIP-oN2/FPR/1/FINAL. 356 pp; Available at: http://ec.europa.eu/environment/chemicals/nanotech/pdf/report_ripon2.pdf.
21. Hristozov, D.R., Gottardo, S., Cinelli, M., Isigonis, P., Zabeo, A., Critto, A., Van Tongeren, M., Tran, L., Marcomini, A., Application of a quantitative weight of evidence approach for ranking and prioritising occupational exposure scenarios for titanium dioxide and carbon nanomaterials. Nanotoxicol 8:2 (2013), 117–131.
22. Hristozov, D.R., Zabeo, A., Foran, C., Isigonis, P., Critto, A., Marcomini, A., Linkov, I., A weight of evidence approach for hazard screening of engineered nanomaterials. Nanotoxicology 8 (2014), 72–87.
23. Klein, C.L., Wiench, K., Wiemann, M., Ma-Hock, L., van Ravenzwaay, B., Landsiedel, R., Hazard identification of inhaled nanomaterials: making use of short-term inhalation studies. Arch. Toxicol. 86:7 (2012), 1137–1151.
24. Kuempel, E.D., Castranova, V., Geraci, C.L., Schulte, P.A., Development of risk-based nanomaterial groups for occupational exposure control. J. Nanopart Res., 14, 2012, 1029.
25. Landsiedel, R., Wiench, K., Wohlleben, W., Geeignete Methoden zur Prüfung der Sicherheit von Nanomaterialien. Chem. Ing. Tech. 80 (2008), 1641–1651.
26. Landsiedel, R., Ma-Hock, L., Kroll, A., Hahn, D., Schnekenburger, J., Wiench, K., Wohlleben, W., Testing metal-oxide nanomaterials for human safety. Adv. Mater. 22 (2010), 2601–2627.
27. Landsiedel, R., Ma-Hock, L., Haussmann, H.J., van Ravenzwaay, B., Kayser, M., Wiench, K., Inhalation studies for the safety assessment of nanomaterials: status quo and the way forward. Wiley Interdiscip. Rev. Nanomed. Nanobiotechnol. 4 (2012), 399–413.
28. Landsiedel, R., Fabian, E., Ma-Hock, L., Wohlleben, W., Wiench, K., Oesch, F., van Ravenzwaay, B., Toxico-/biokinetics of nanomaterials. Arch. Toxicol. 86 (2012), 1021–1060.
29. Landsiedel, R., Ma-Hock, L., Hofmann, T., Wiemann, M., Strauss, V., Treumann, S., Wohlleben, W., Gröters, S., Wiench, K., van Ravenzwaay, Application of short-term inhalation studies to assess the inhalation toxicity of nanomaterials. Part. Fibre Toxicol., 11, 2014, 16.
30. Landsiedel, R., Sauer, U.G., Ma-Hock, L., Schnekenburger, J., Wiemann, M., Pulmonary toxicity of nanomaterials: a critical comparison of published in vitro assays with in vivo inhalation or instillation studies. Nanomedicine 9:16 (2014), 2557–2585.
31. Lankveld, D.P., Oomen, A.G., Krystek, P., Neigh, A., Troost-de Jong, A., Noorlander, C.W., Van Eijkeren, J.C., Geertsma, R.E., De Jong, W.H., The kinetics of the tissue distribution of silver nanoparticles of different sizes. Biomat 31 (2010), 8350–8361.
32. Liu, J., Legros, S., Ma, G., Veinot, J.G., von der Kammer, F., Hofmann, T., Influence of surface functionalization and particle size on the aggregation kinetics of engineered nanoparticles. Chemosphere 87:8 (2012), 918–924.
33. Lundqvist, M., Stigler, J., Cedervall, T., Berggård, T., Flanagan, M.B., Lynch, I., Elia, G., Dawson, K., The evolution of the protein corona around nanoparticles: a test study. ACS Nano 5 (2011), 7503–7509.
34. Ma-Hock, L., Burkhardt, S., Strauss, V., Gamer, A.O., Wiench, K., van Ravenzwaay, B., Landsiedel, R., Development of a short-term inhalation test in the rat using nano titanium dioxide as a model substance. Inhal. Toxicol. 21 (2009), 102–118.
35. Meng, H., Xia, T., George, S., Nel, A.E., A predictive toxicological paradigm for the safety assessment of nanomaterials. ACS Nano 3:7 (2009), 1620–1627.
36. Monteiro-Riviere, N.A., Wiench, K., Landsiedel, R., Schulte, S., Inman, A.O., Riviere, J.E., Safety evaluation of sunscreen formulations containing titanium dioxide and zinc oxide nanoparticles in UVB sunburned skin: an in vitro and in vivo study. Tox. Sci. 123:1 (Sep 2011), 264–280.
37. Moreno-Horn, M., Gebel, T., Granular biodurable nanomaterials: no convincing evidence for systemic toxicity. Crit. Rev. Toxicol. 44:10 (2014), 849–875.
38. Nel, A.E., Mädler, L., Velegol, D., Xia, T., Hoek, E.M.V., Somasundaran, P., Klaessig, F., Castranova, V., Thompson, M., Understanding biophysicochemical interactions at the nano-bio interface. Nat. Mater. 8:7 (2009), 543–557.
39. Nel, A.E., Xia, T., Meng, H., Wang, X., Lin, S., Ji, Z., Zhang, H., Nanomaterial toxicity testing in the 21st century: use of a predictive toxicological approach and high-throughput screening. Acc. Chem. Res. 46:3 (2013), 607–621.
40. Nel, A.E., Nasser, E., Godwin, H., Avery, D., Bahadori, T., Bergeson, L., Beryt, E., Bonner, J.C., Boverhof, D., Carter, J., Castranova, V., Deshazo, J.R., Hussain, S.M., Kane, A.B., Klaessig, F., Kuempel, E., Lafranconi, M., Landsiedel, R., Malloy, T., Miller, M.B., Morris, J., Moss, K., Oberdörster, G., Pinkerton, K., Pleus, R.C., Shatkin, J.A., Thomas, R., Tolaymat, T., Wang, A., Wong, J., A multi-stakeholder perspective on the use of alternative test strategies for nanomaterial safety assessment. ACS Nano 7 (2013), 6422–6433.
41. Oberdörster, G., Safety assessment for nanotechnology and nanomedicine: concepts of nanotoxicology. J. Int. Med. 267:1 (2010), 89–105.
42. OECD, Proposal for a Template, and Guidance on Developing and Assessing the Completeness of Adverse Outcome Pathways. 2012, 17 Available at: http://www.oecd.org/env/ehs/testing/49963554.pdf.
43. OECD, Appendix I. Collection of Working Definitions. 2012, OECD, Paris, France Available at: http://www.oecd.org/env/ehs/testing/49963576.pdf.
44. OECD, Guidance on Grouping of Chemicals. second ed., 14 April 2014, OECD, Paris, France Series on testing and assessment No. 194. ENV/JM/MONO(2014)4.
45. Oomen, A., Bos, P., Landsiedel, R., Chapter 16: concern-driven safety assessment of nanomaterials: an integrated approach using material properties, hazard, biokinetic and exposure data and considerations on grouping and read-across. Wohlleben, W., Kuhlbusch, T., Lehr, C.-M., Schnekenburger, J., (eds.) Safety of Nanomaterials along Their Lifecycle: Release, Exposure and Human Hazards, 2014, Taylor & Francis, 380 ISBN 978-1-46-656786-3.
46. Oomen, A.G., Bos, P.M.J., Fernandes, T.F., Hund-Rinke, K., Boraschi, D., Byrne, H.J., Aschberger, K., Gottardo, S., van der Kammer, F., Kühnel, D., Hristozov, D., Marcomini, A., Migliore, L., Scott-Fordsmand, J., Wick, P., Landsiedel, R., Concern-driven integrated approaches to nanomaterial testing and assessment – report of the NanoSafety cluster working group 10. Nanotoxicol 8 (2014), 334–348.
47. Patlewicz, G., Ball, N., Booth, E.D., Hulzebos, E., Zvinavashe, E., Hennes, C., Use of category approaches, read-across and (Q)SAR: general considerations. Regul. Toxicol. Pharmacol. 67:1 (2013 Oct), 1–12.
48. Rushton, E.K., Jiang, J., Leonard, S.S., Eberly, S., Castranova, V., Biswas, P., Elder, A., Han, X., Gelein, R., Finkelstein, J., Oberdörster, G., Concept of assessing nanoparticle hazards considering nanoparticle dosemetric and chemical/biological response metrics. J. Toxicol. Env. Health A 73:5 (2010), 445–461.
49. Russell, W.M.S., Burch, R.L., The Principles of Humane Experimental Technique. 1959 London, UK. Methuen. Reprinted by UFAW, 1992: 8 Hamilton Close, South Mimms, Potters Bar, Herts EN6 3QD England. 238 pp.
50. Sager, T.M., Porter, D.W., Robinson, V.A., Lindsley, W.G., Schwegler-Berry, D.E., Castranova, V., An improved method to disperse nanoparticles for in vitro and in vivo investigation of toxicity. Nanotoxicol 1 (2007), 118–129.
51. Sauer, U.G., Vogel, S., Aumann, A., Hess, A., Kolle, S.N., Ma-Hock, L., Wohlleben, W., Dammann, M., Strauss, V., Treumann, S., Gröters, S., Wiench, K., van Ravenzwaay, B., Landsiedel, R., Applicability of rat precision-cut lung slices in evaluating nanomaterial cytotoxicity, apoptosis, oxidative stress, and inflammation. Toxicol. Appl. Pharmacol. 276 (2014), 1–20.
52. Sauer, U.G., Aumann, A., Ma-Hock, L., Landsiedel, R., Wohlleben, W., Brief communication: Influence of dispersive agent on nanomaterial agglomeration and implications for biological effects in vivo or in vitro. Toxicol. Vitro 29:1 (2015), 182–186.
53. SUN (Sustainable Nnanotechnology; EU FP7 project) Last updated on 2015-10-20 Information source: SESAM Ret rieved on 2015-10-29 Permalink: http://cordis.europa.eu/result/rcn/171663_en.html.
54. Schilter, B., Benigni, R., Boobis, A., Chiodini, A., Cockburn, A., Cronin, M.T., Lo Piparo, E., Modi, S., Thiel, A., Worth, A., Establishing the level of safety concern for chemicals in food without the need for toxicity testing. Regul. Toxicol. Pharmacol. 68:2 (2014 Mar), 275–296.
55. Schleh, C., Kreyling, W.G., Lehr, C.-M., Pulmonary surfactant is indispensable in order to simulate the in vivo situation. Part Fibre Toxicol., 10, 2013, 6.
56. Schulze, C., Kroll, A., Lehr, C., Schäfer, U.F., Becker, K., Schnekenburger, J., Schulze Isfort, C., Landsiedel, R., Wohlleben, W., Not ready to use – overcoming pitfalls when dispersing nanoparticles in physiological media. Nanotoxicol 2:2 (2008), 51–61.
57. Scott-Fordsmand, J.J., Pozzi-Mucelli, S., Tran, L., Aschberger, K., Sabella, S., Vogel, U., Poland, C., Balharry, D., Fernandes, T., Gottardo, S., Hankin, S., Hartl, M.G.J., Hartmann, N.B., Hristozov, D., Hund-Rinke, K., Johnston, H., Marcomini, A., Panzer, O., Roncato, D., Saber, A.T., Wallin, H., Stone, V., A unified framework for nanosafety is needed. Nano Today 9 (2014), 546–549.
58. Stone, V., Pozzi-Mucelli, S., Tran, L., Aschberger, K., Sabella, S., Vogel, U., Poland, C., Balharry, D., Fernandes, T., Gottardo, S., Hankin, S., Hartl, M., Hartmann, N., Hristozov, D., Hund-Rinke, K., Johnston, H., Marcomini, A., Panzer, O., Roncato, D., Saber, A., Wallin, H., Scott-Fordsmand, J., ITS-NANO – prioritising nanosafety research to develop a stakeholder driven intelligent testing strategy. Part. Fibre Toxicol., 11, 2014, 9.
59. Teeguarden, J.G., Hinderliter, P.M., Orr, G., Thrall, B.D., Pounds, J.G., Particokinetics in vitro: dosimetry considerations for in vitro nanoparticle toxicity assessments. Toxicol. Sci. 95:2 (2007), 300–312 (erratum in: Toxicol Sci. 2007. 97(2):614).
60. Thomas, C.R., George, S., Horst, A.M., Ji, Z., Miller, R.J., Peralta-Videa, J.R., Xia, T., Pokhrel, S., Mädler, L., Gardea-Torresdey, J.L., Holden, P.A., Keller, A.A., Lenihan, H.S., Nel, A.E., Zink, J.I., Nanomaterials in the environment: from materials to high-throughput screening to organisms. ACS nano 5:1 (2011), 13–20.
61. UBA, Herman, A., Diesner, M.O., Abel, J., Hawthorne, C., Greßmann, A., (eds.) Umweltbundesamt – Federal Environmental Agency. – Assessment of Impacts of a European Register of Products Containing Nanomaterials. Texte 23/2014, 2014 Project No. (FKZ) 360 01 072; Report No. (UBA-FB) 001907/E. 142 pp.
62. Wang, X., Xia, T., Ntim, S.A., Ji, Z., George, S., Meng, H., Zhang, H., Castranova, V., Mitra, S., Nel, A.E., Quantitative techniques for assessing and controlling the dispersion and biological effects of multiwalled carbon nanotubes in mammalian tissue culture cells. ACS Nano 4:12 (2010), 7241–7252.
63. Wang, X., Xia, T., Ntim, S.A., Ji, Z., Lin, S., Meng, H., Chung, C.H., George, S., Zhang, H., Wang, M., Li, N., Yang, Y., Castranova, V., Mitra, S., Bonner, J.C., Nel, A.E., Dispersal state of multiwalled carbon nanotubes elicits profibrogenic cellular responses that correlate with fibrogenesis biomarkers and fibrosis in the murine lung. ACS Nano 5:12 (2011), 9772–9787.
64. Wohlleben, W., Brill, S., Meier, M.W., Mertler, M., Cox, G., Hirth, S., von Vacano, B., Strauss, V., Treumann, S., Wiench, K., Ma-Hock, L., Landsiedel, R., On the lifecycle of nanocomposites: comparing released fragments and their in-vivo hazards from three release mechanisms and four nanocomposites. Small 7:16 (2011 Aug 22), 2384–2395.
65. Wohlleben, W., Validity range of centrifuges for the regulation of nanomaterials: from classification to as-tested coronas. J. Nanopart Res., 14(12), 2012, 1300.
66. Wohlleben, W., Meier, M.W., Vogel, S., Landsiedel, R., Cox, G., Hirth, S., Tomović, Ž., Elastic CNT-polyurethane nanocomposite: synthesis, performance and assessment of fragments released during use. Nanoscale 5:1 (2013 Jan 7), 369–380.
67. Xia, T., Kovochich, M., Liong, M., Zink, J.I., Nel, A.E., Cationic polystyrene nanosphere toxicity depends on cell-specific endocytic and mitochondrial injury pathways. ACS Nano 2:1 (2008 Jan), 85–96.
68. Zhang, H., Ji, Z., Xia, T., Meng, H., Low-Kam, C., Liu, R., Pokhrel, S., Lin, S., Wang, X., Liao, Y.-P., Wang, M., Li, L., Rallo, R., Damoiseaux, R., Telesca, D., Mädler, L., Cohen, Y., Zink, J.I., Nel, A.E., Use of metal oxide nanoparticle band gap to develop a predictive paradigm for oxidative stress and acute pulmonary inflammation. ACS Nano 6:5 (2012), 4349–4368.
69. Zuin, S., Micheletti, C., Critto, A., Pojana, G., Johnston, H., Stone, V., Tran, L., Marcomini, A., Weight of evidence approach for the relative hazard ranking of nanomaterials. Nanotoxicol 5:3 (2011), 445–458.