Toward Rigorous Materials Production: New Approach Methodologies Have Extensive Potential to Improve Current Safety Assessment Practices. Issue 6 (8th January 2020)

• Record Type: Journal Article
• Authors: Nymark, Penny; Bakker, Martine; Dekkers, Susan; Franken, Remy; Fransman, Wouter; García‐Bilbao, Amaia; Greco, Dario; Gulumian, Mary; Hadrup, Niels; Halappanavar, Sabina; Hongisto, Vesa; Hougaard, Karin Sørig; Jensen, Keld Alstrup; Kohonen, Pekka; Koivisto, Antti Joonas; Dal Maso, Miikka; Oosterwijk, Thies; Poikkimäki, Mikko; Rodriguez‐Llopis, Isabel; Stierum, Rob; Sørli, Jorid Birkelund; Grafström, Roland
• Is Part Of: Small. Volume 16:Issue 6(2020)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-01-08
• Subjects: human risk assessment tools -- nanomaterials -- new approach methodologies -- safer by design -- Stage‐Gate innovation funnel; Nanotechnology -- Periodicals; Nanoparticles -- Periodicals; Microtechnology -- Periodicals; 620.5
• DOI: 10.1002/smll.201904749
• Languages: English
• ISSNs: 1613-6810

Abstract

Abstract: 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. Abstract : Safety assessment of advanced materials, such as nanomaterials, should optimally be inherent to material discovery and technological innovation. The 50 New Approach Methodologies (NAMs) covering eight overlapping conceptual categories are shown to substantially provide added value and decision support to current safety assessment practices by bringing in more data, higher precision, and deeper understanding of toxicity mechanisms.