1,154
Views
0
CrossRef citations to date
0
Altmetric
Articles

Developing Integrated Approaches for Testing and Assessment (IATAs) in order to support nanomaterial safety

, ORCID Icon, , , , , , , , , ORCID Icon, , , & show all
Pages 484-499 | Received 18 Nov 2021, Accepted 18 Jun 2022, Published online: 01 Aug 2022

References

  • Accomasso, L., C. Cristallini, and C. Giachino. 2018. “Risk Assessment and Risk Minimization in Nanomedicine: A Need for Predictive, Alternative, and 3Rs Strategies.” Frontiers in Pharmacology 9: 228. doi:10.3389/fphar.2018.00228.
  • Ankley, G. T., R. S. Bennett, R. J. Erickson, D. J. Hoff, M. W. Hornung, R. D. Johnson, D. R. Mount, et al. 2010. “Adverse Outcome Pathways: A Conceptual Framework to Support Ecotoxicology Research and Risk Assessment.” Environmental Toxicology and Chemistry 29 (3): 730–741. doi:10.1002/etc.34.
  • Braakhuis, H. M., F. Murphy, L. Ma-Hock, S. Dekkers, J. Keller, A. G. Oomen, and V. Stone. 2021. “An Integrated Approach to Testing and Assessment to Support Grouping and Read-Across of Nanomaterials after Inhalation Exposure.” Applied in Vitro Toxicology 7 (3): 112–128. doi:10.1089/aivt.2021.0009.
  • British Standards Institution. 2007. Medical Devices: Application of Risk Management to Medical Devices. London: BSI.
  • Dai, Q., S. Wilhelm, D. Ding, A. M. Syed, S. Sindhwani, Y. Zhang, Y. Y. Chen, P. MacMillan, and W. C. W. Chan. 2018. “Quantifying the Ligand-Coated Nanoparticle Delivery to Cancer Cells in Solid Tumors.” ACS Nano 12 (8): 8423–8435. doi:10.1021/acsnano.8b03900.
  • Di Cristo, L., A. G. Oomen, S. Dekkers, C. Moore, W. Rocchia, F. Murphy, H. J. Johnston, et al. 2021. “Grouping Hypotheses and an Integrated Approach to Testing and Assessment Nanomaterials following Oral Ingestion.” Nanomaterials 11 (10): 2623. doi:10.3390/nano11102623.
  • Edwards‐Jones, V. 2009. “The Benefits of Silver in Hygiene, Personal Care and Healthcare.” Letters in Applied Microbiology 49 (2): 147–152.
  • European Chemicals Agency. 2017. Guidance on Information Requirements and Chemical Safety Assessment. Appendix R7-1 for Nanomaterials Applicable to Chapter R7a Endpoint Specific Guidance. Helsinki (Finland): European Chemicals Agency.
  • European Commission. 2017. “Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices.” Official Journal of the European Union : 175.
  • Fernández-Cruz, M. L., D. Hernández-Moreno, J. Catalán, R. K. Cross, H. Stockmann-Juvala, J. Cabellos, V. R. Lopes, et al. 2018. “Quality Evaluation of Human and Environmental Toxicity Studies Performed with Nanomaterials – the GUIDEnano Approach.” Environmental Science: Nano 5 (2): 381–397. doi:10.1039/C7EN00716G.
  • Gerloff, K., B. Landesmann, A. Worth, S. Munn, T. Palosaari, and M. Whelan. 2017. “The Adverse Outcome Pathway Approach in Nanotoxicology.” Computational Toxicology 1: 3–11. doi:10.1016/j.comtox.2016.07.001.
  • Ghasemi-Mobarakeh, L., D. Kolahreez, S. Ramakrishna, and D. Williams. 2019. “Key Terminology in Biomaterials and Biocompatibility.” Current Opinion in Biomedical Engineering 10: 45–50. doi:10.1016/j.cobme.2019.02.004.
  • Giubilato, E., V. Cazzagon, M. J. B. Amorim, M. Blosi, J. Bouillard, H. Bouwmeester, A. L. Costa, et al. 2020. “Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products.” Materials (Basel, Switzerland) 13 (20): 4532. doi:10.3390/ma13204532.
  • Halappanavar, S., S. van den Brule, P. Nymark, L. Gaté, C. Seidel, S. Valentino, V. Zhernovkov, et al. 2020. “Adverse Outcome Pathways as a Tool for the Design of Testing Strategies to Support the Safety Assessment of Emerging Advanced Materials at the Nanoscale.” Particle and Fibre Toxicology 17 (1): 16. doi:10.1186/s12989-020-00344-4.
  • Hamad, T. I., A. A. Fatalla, A. S. Waheed, Z. G. M. Azzawi, Y. Cao, and K. Song. 2018. “Biomechanical Evaluation of Nano-Zirconia Coatings on Ti-6Al-7Nb Implant Screws in Rabbit Tibias.” Current Medical Science 38 (3): 530–537. doi:10.1007/s11596-018-1911-4.
  • Horev-Azaria, L., G. Baldi, D. Beno, D. Bonacchi, U. Golla-Schindler, J. C. Kirkpatrick, S. Kolle, et al. 2013. “Predictive Toxicology of Cobalt Ferrite Nanoparticles: Comparative In-Vitro Study of Different Cellular Models Using Methods of Knowledge Discovery from Data.” Particle and Fibre Toxicology 10 (1): 32. doi:10.1186/1743-8977-10-32.
  • Houacine, C., S. S. Yousaf, I. Khan, R. K. Khurana, and K. K. Singh. 2018. “Potential of Natural Biomaterials in Nano-Scale Drug Delivery.” Current Pharmaceutical Design 24 (43): 5188–5206. doi:10.2174/1381612825666190118153057.
  • Hristozov, D. R., A. Zabeo, C. Foran, P. Isigonis, A. Critto, A. Marcomini, and I. Linkov. 2014. “A Weight of Evidence Approach for Hazard Screening of Engineered Nanomaterials.” Nanotoxicology 8 (1): 72–87. doi:10.3109/17435390.2012.750695.
  • International Organization for Standardization. 2006. BS EN ISO 10993-2:2006. Biological Evaluation of Medical Devices. Part 2: Animal Welfare Requirements. Geneva, Switzerland.
  • International Organization for Standardization. 2009. BS EN ISO 10993-11:2009. Biological Evaluation of Medical Devices. Part 11: Tests for Systemic Toxicity. Geneva, Switzerland.
  • International Organization for Standardization. 2017a. BS EN ISO 10993-4:2017. Biological Evaluation of Medical Devices. Part 4: Selection of Tests for Interactions With Blood. Geneva, Switzerland.
  • International Organization for Standardization. 2017b. PD ISO/TR 10993-22:2017. Biological Evaluation of Medical Devices. Part 22: Guidance on Nanomaterials. Geneva, Switzerland.
  • International Organization for Standardization. 2019. BS EN ISO 14971:2019. Medical Devices. Application of Risk Management to Medical Devices. Geneva, Switzerland.
  • Jeliazkova, N., C. Chomenidis, P. Doganis, B. Fadeel, R. Grafström, B. Hardy, J. Hastings, et al. 2015. “The eNanoMapper Database for Nanomaterial Safety Information.” Beilstein Journal of Nanotechnology 6: 1609–1634. doi:10.3762/bjnano.6.165.
  • Johnston, H. J., R. Verdon, S. Gillies, D. M. Brown, T. F. Fernandes, T. B. Henry, A. G. Rossi, et al. 2018. “Adoption of In Vitro Systems and Zebrafish Embryos as Alternative Models for Reducing Rodent Use in Assessments of Immunological and Oxidative Stress Responses to Nanomaterials.” Critical Reviews in Toxicology 48 (3): 252–271. doi:10.1080/10408444.2017.1404965.
  • Klimisch, H. J., M. Andreae, and U. Tillmann. 1997. “A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data.” Regulatory Toxicology and Pharmacology : RTP 25 (1): 1–5. doi:10.1006/rtph.1996.1076.
  • Kroll, A., M. H. Pillukat, D. Hahn, and J. Schnekenburger. 2009. “Current in Vitro Methods in Nanoparticle Risk Assessment: Limitations and Challenges.” European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik e.V 72 (2): 370–377. doi:10.1016/j.ejpb.2008.08.009.
  • Labib, S., A. Williams, C. L. Yauk, J. K. Nikota, H. Wallin, U. Vogel, and S. Halappanavar. 2016. “Nano-Risk Science: Application of Toxicogenomics in an Adverse Outcome Pathway Framework for Risk Assessment of Multi-Walled Carbon Nanotubes.” Particle and Fibre Toxicology 13 (1): 15. doi:10.1186/s12989-016-0125-9.
  • Labouta, H. I., N. Asgarian, K. Rinker, and D. T. Cramb. 2019. “Meta-Analysis of Nanoparticle Cytotoxicity via Data-Mining the Literature.” ACS Nano 13 (2): 1583–1594. doi:10.1021/acsnano.8b07562.
  • Lim, E.-K., T. Kim, S. Paik, S. Haam, Y.-M. Huh, and K. Lee. 2015. “Nanomaterials for Theranostics: Recent Advances and Future Challenges.” Chemical Reviews 115 (1): 327–394. doi:10.1021/cr300213b.
  • Murphy, F., S. Dekkers, H. Braakhuis, L. Ma-Hock, H. Johnston, G. Janer, L. di Cristo, et al. 2021. “An Integrated Approach to Testing and Assessment of High Aspect Ratio Nanomaterials and Its Application for Grouping Based on a Common Mesothelioma Hazard.” NanoImpact 22: 100314. doi:10.1016/j.impact.2021.100314.
  • Nieskens, T. T. G, and A.-K. Sjögren. 2019. “Emerging In Vitro Systems to Screen and Predict Drug-Induced Kidney Toxicity.” Seminars in Nephrology 39 (2): 215–226. doi:10.1016/j.semnephrol.2018.12.009.
  • OECD. 2016. Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA). Paris: OECD Publishing.
  • OECD. 2017a. Guidance Document on the Reporting of Defined Approaches to Be Used within Integrated Approaches to Testing and Assessment. Paris: OECD Publishing.
  • OECD. 2017b. Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials: current State of Knowledge and Research Needs to Advance Their Use. Paris: OECD Publishing.
  • Osorio, M., A. Cañas, J. Puerta, L. Díaz, T. Naranjo, I. Ortiz, and C. Castro. 2019. “Ex Vivo and In Vivo Biocompatibility Assessment (Blood and Tissue) of Three-Dimensional Bacterial Nanocellulose Biomaterials for Soft Tissue Implants.” Scientific Reports 9 (1): 10553. doi:10.1038/s41598-019-46918-x.
  • Park, M. V. D. Z., E. A. J. Bleeker, W. Brand, F. R. Cassee, M. Van Elk, I. Gosens, W. H. De Jong, et al. 2017. “Considerations for Safe Innovation: The Case of Graphene.” ACS Nano 11 (10): 9574–9593. doi:10.1021/acsnano.7b04120.
  • Rasmussen, K., M. González, P. Kearns, J. R. Sintes, F. Rossi, and P. Sayre. 2016. “Review of Achievements of the OECD Working Party on Manufactured Nanomaterials’ Testing and Assessment Programme. From Exploratory Testing to Test Guidelines.” Regulatory Toxicology and Pharmacology : RTP 74: 147–160. doi:10.1016/j.yrtph.2015.11.004.
  • Ratner, B. D, and S. J. Bryant. 2004. “Biomaterials: Where We Have Been and Where We Are Going.” Annual Review of Biomedical Engineering 6 (1): 41–75. doi:10.1146/annurev.bioeng.6.040803.140027.
  • Rawal, S, and M. M. Patel. 2019. “Threatening Cancer with Nanoparticle Aided Combination Oncotherapy.” Journal of Controlled Release : Official Journal of the Controlled Release Society 301: 76–109. doi:10.1016/j.jconrel.2019.03.015.
  • Rocca, M., L. L. Morford, D. L. Blanset, W. G. Halpern, J. Cavagnaro, and C. J. Bowman. 2018. “Applying a Weight of Evidence Approach to the Evaluation of Developmental Toxicity of Biopharmaceuticals.” Regulatory Toxicology and Pharmacology : RTP 98: 69–79. doi:10.1016/j.yrtph.2018.07.006.
  • Stone, V., S. Gottardo, E. A. J. Bleeker, H. Braakhuis, S. Dekkers, T. Fernandes, A. Haase, et al. 2020. “A Framework for Grouping and Read-across of Nanomaterials- Supporting Innovation and Risk Assessment.” Nano Today. 35: 100941. doi:10.1016/j.nantod.2020.100941.
  • Suter, G., S. Cormier, and M. Barron. 2017. “A Weight of Evidence Framework for Environmental Assessments: Inferring Qualities.” Integrated Environmental Assessment and Management 13 (6): 1038–1044. doi:10.1002/ieam.1954.
  • Thiagarajan, V., S. Madhurantakam, S. Sethuraman, J. B. Balaguru Rayappan, and U. Maheswari Krishnan. 2016. “Nano Interfaced Biosensor for Detection of Choline in Triple Negative Breast Cancer Cells.” Journal of Colloid and Interface Science 462: 334–340. doi:10.1016/j.jcis.2015.10.014.
  • Tombácz, E., R. Turcu, V. Socoliuc, and L. Vékás. 2015. “Magnetic Iron Oxide Nanoparticles: Recent Trends in Design and Synthesis of Magnetoresponsive Nanosystems.” Biochemical and Biophysical Research Communications 468 (3): 442–453. doi:10.1016/j.bbrc.2015.08.030.
  • U.S. Environmental Protection Agency (U.S. EPA). 1992. Guidelines for Exposure Assessment. Washington, DC: National Academy Press.
  • Vakili-Ghartavol, R., A. A. Momtazi-Borojeni, Z. Vakili-Ghartavol, H. T. Aiyelabegan, M. R. Jaafari, S. M. Rezayat, and S. Arbabi Bidgoli. 2020. “Toxicity Assessment of Superparamagnetic Iron Oxide Nanoparticles in Different Tissues.” Artificial Cells, Nanomedicine, and Biotechnology 48 (1): 443–451. doi:10.1080/21691401.2019.1709855.
  • Vietti, G., D. Lison, and S. van den Brule. 2016. “Mechanisms of Lung Fibrosis Induced by Carbon Nanotubes: Towards an Adverse Outcome Pathway (AOP).” Particle and Fibre Toxicology 13 (1): 11. doi:10.1186/s12989-016-0123-y.
  • Wang, D., Z. Lin, T. Wang, Z. Yao, M. Qin, S. Zheng, and W. Lu. 2016. “Where Does the Toxicity of Metal Oxide Nanoparticles Come from: The Nanoparticles, the Ions, or a Combination of Both?” Journal of Hazardous Materials 308: 328–334. doi:10.1016/j.jhazmat.2016.01.066.
  • Willett, C. 2019. “The Use of Adverse Outcome Pathways (AOPs) to Support Chemical Safety Decisions within the Context of Integrated Approaches to Testing and Assessment (IATA).” In Alternatives to Animal Testing, edited by H. Kojima, T. Seidle, and H. Spielmann, 83–90. Singapore: Springer.
  • Williams, D. F. 2019. “Specifications for Innovative, Enabling Biomaterials Based on the Principles of Biocompatibility Mechanisms.” Frontiers in Bioengineering and Biotechnology 7: 255. doi:10.3389/fbioe.2019.00255.
  • Yang, L., L. Zhang, and T. J. Webster. 2011. “Nanobiomaterials: State of the Art and Future Trends.” Advanced Engineering Materials 13 (6): B197–B217. doi:10.1002/adem.201080140.