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Small. 2020 Feb;16(6):e1904749. doi: 10.1002/smll.201904749. Epub 2020 Jan 8.

Toward Rigorous Materials Production: New Approach Methodologies Have Extensive Potential to Improve Current Safety Assessment Practices.

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Karolinska Institutet, Institute of Environmental Medicine, Nobels väg 13, 171 77, Stockholm, Sweden.
Department of Toxicology, Misvik Biology, Karjakatu 35 B, 20520, Turku, Finland.
National Institute for Public Health and the Environment, RIVM, P.O. Box 1, 3720 BA, Bilthoven, The Netherlands.
Netherlands Organisation for Applied Scientific Research, TNO, P.O. Box 96800, NL-2509 JE, The Hague, The Netherlands.
GAIKER Technology Centre, Parque Tecnológico, Ed. 202, 48170, Zamudio, Bizkaia, Spain.
Faculty of Medicine and Health Technology, Tampere University, Korkeakoulunkatu 6, 33720, Tampere, Finland.
Institute of Biotechnology, University of Helsinki, P.O. Box 56, FI-00014, Helsinki, Finland.
National Institute for Occupational Health, 25 Hospital St, Constitution Hill, 2000, Johannesburg, South Africa.
Haematology and Molecular Medicine Department, University of the Witwatersrand, 7 York Road, Parktown, 2193, Johannesburg, South Africa.
National Research Center for the Work Environment, Lersø Parkallé 105, 2100, Copenhagen, Denmark.
Environmental Health Science and Research Bureau, Health Canada, 50 Colombine Driveway, Ottawa, ON, K1A 0K9, Canada.
Aerosol Physics Laboratory, Physics Unit, Tampere University, Korkeakoulunkatu 6, 33720, Tampere, Finland.


Advanced material development, including at the nanoscale, comprises costly and complex challenges coupled to ensuring human and environmental safety. Governmental agencies regulating safety have announced interest toward acceptance of safety data generated under the collective term New Approach Methodologies (NAMs), as such technologies/approaches offer marked potential to progress the integration of safety testing measures during innovation from idea to product launch of nanomaterials. Divided in overall eight main categories, searchable databases for grouping and read across purposes, exposure assessment and modeling, in silico modeling of physicochemical structure and hazard data, in vitro high-throughput and high-content screening assays, dose-response assessments and modeling, analyses of biological processes and toxicity pathways, kinetics and dose extrapolation, consideration of relevant exposure levels and biomarker endpoints typify such useful NAMs. Their application generally agrees with articulated stakeholder needs for improvement of safety testing procedures. They further fit for inclusion and add value in nanomaterials risk assessment tools. Overall 37 of 50 evaluated NAMs and tiered workflows applying NAMs are recommended for considering safer-by-design innovation, including guidance to the selection of specific NAMs in the eight categories. An innovation funnel enriched with safety methods is ultimately proposed under the central aim of promoting rigorous nanomaterials innovation.


Stage-Gate innovation funnel; human risk assessment tools; nanomaterials; new approach methodologies; safer by design


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