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Methods and tools for the safety assessment of nanomaterials
1 , 2 , 3 , 4 , 5, 6 , 4 , 7 , 8 , 4 , 9 , 10 , 5 , 10 , 11 , 9 , 3 , 12 , 5, 13 , 4 , 14 , * 1
1  Technology and Society Laboratory, Empa, Swiss Federal Laboratories for Materials Science and Technologies, Lerchenfeldstrasse 5, 9014 St. Gallen, Switzerland
2  TEMAS Solutions GmbH, 5212 Hausen, Switzerland
3  International Research Center in Critical Raw Materials for Advanced Industrial Technologies-ICCRAM, Universidad de Burgos, Plaza Misael Ba˜nuelos s/n, Burgos 09001, Spain
4  Department of Environmental Sciences, Informatics and Statistics, Ca’ Foscari University of Venice, Via Torino 155, 30172 Venice, Italy
5  Institute of Occupational Medicine (IOM), Edinburgh, United Kingdom
6  Centre for Biomedicine and Global Health, School of Applied Sciences, Edinburgh Napier University, Edinburgh, United Kingdom
7  ITENE Research Center, C/Albert Einstein 1, 46980 Paterna, Valencia, Spain
8  European Commission, Joint Research Centre (JRC), 21027 Ispra, Italy
9  GAIKER Technology Centre, Basque Research and Technology Alliance (BRTA), Zamudio, Spain
10  Molecular Biology and Nanotechnology Laboratory (MolBNL@UniTS), DEA, University of Trieste 34127 Trieste, Italy
11  GreenDecision s.r.l., Cannaregio 5904, 30121 Venice, VE, Italy
12  Department of Ecoscience, Aarhus University, 8000 Aarhus, Denmark
13  Heriot-Watt University, School of Engineering and Physical Sciences (EPS), Institute of Biological Chemistry, Biophysics and Bioengineering (IB3), David Brewster Building, Edinburgh EH14 4AS, United Kingdom
14  East European Research and Innovation Enterprise (EMERGE), Otets Paisiy Str. 46, 1303 Sofia, Bulgaria
Academic Editor: Eugenia Valsami-Jones

Abstract:

Nanomaterials challenge conventional safety assessment due to their dynamic physico-chemical properties and nano-specific behaviours that are not adequately captured by standard chemical testing strategies and assessments.

To address these challenges, a broad set of methodologies, tools, databases, and tool repositories supporting the safety assessment of nanomaterials were compiled and analysed, with a focus on environmental and human health dimensions. Hazard assessment methodologies were classified into in silico, in vitro, and in vivo methods and further distinguished between human and environmental endpoints, including freshwater, seawater, and soil systems. Particular attention was given to nano-specific challenges affecting hazard testing, such as particle agglomeration and sedimentation leading to reduced effective exposure concentrations.

In parallel, digital tools were classified according to their support for hazard, exposure, fate, or risk assessment and organised into Tiers 1 to 3, ranging from simpler screening approaches to more complex assessments. Tool accessibility was also evaluated in terms of readiness level, associated cost, and maintenance status, providing practical insights into their operational usability. On top of that, relevant nanomaterials databases providing physicochemical characterisation and hazard data were systematically mapped and existing tool repositories were identified to facilitate user navigation and access to established decision-support resources.

This consolidated information strengthens the operationalisation of the Safe and Sustainable by Design (SSbD) framework developed by the European Commission Joint Research Centre, which integrates safety and sustainability considerations from the earliest stages of material development. By improving access to relevant methods, tools, and data, and by clarifying their scope, tier applicability, and known limitations, the approach supports more informed and transparent evaluations at early stages of material development, where data availability is limited and design decisions are most impactful. The analysis also identifies key methodological gaps and provides recommendations to improve and expand the current assessment landscape.

Keywords: Safety assessment; Hazard; Exposure; Risk; Safe and sustainable by design

 
 
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