Nano Today
Volume 35, December 2020, 100941
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A framework for grouping and read-across of nanomaterials- supporting innovation and risk assessment

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Highlights

  • The GRACIOUS Framework supports industrial and regulatory users to streamline innovation and risk assessment of nanomaterials.

  • The GRACIOUS Framework guides users to identify the most appropriate hypothesis that defines how specific nanoforms can be grouped.

  • Tailored Integrated Approaches to Testing and Assessment allow the user to gather evidence to test their grouping hypothesis.

  • The GRACIOUS Framework combines outputs of the IATA into a data matrix to support risk decision making or risk assessment.

Abstract

According to some legislation grouping can streamline data gap filling for the hazard assessment of substances. The GRACIOUS Framework aims to facilitate the application of grouping of nanomaterials or nanoforms (NFs), in a regulatory context and to support innovation. This includes using grouping to enable read-across from (a) source(s), for which data and information exist, to a similar target NF where information is lacking.

The Framework provides an initial set of hypotheses for the grouping of NFs which take into account the identity and use(s) of the NFs, as well as the purpose of grouping. Initial collection of basic information allows selection of an appropriate pre-defined grouping hypothesis and a tailored Integrated Approach to Testing and Assessment (IATA), designed to generate new evidence to support acceptance or rejection of the hypothesis. Users needing to develop their own user-defined hypothesis (and IATA) are also supported by the Framework. In addition, the IATA guides acquisition of the information needed to support read-across.

This approach gathers information to render risk assessment more efficient, affordable, as well as reducing the use of test animals.

Abbreviations

ECHA
European Chemicals Agency
HARN
high aspect ratio nanomaterials
IATA
integrated approach to testing and assessment
ISO
International Organization for Standardization
JRC
Joint Research Centre
NF
nanoform
NEP
nano-enabled product
OECD
Organisation for Economic Co-operation and Development
PC
physicochemical
Prc
precautionary measures to reduce risk
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals
Reg
regulatory compliance
SbD
safe(r) by design
SNEP
solid matrix nano-enabled products
TSCA
Toxic Substances Control Act

Keywords

Nanoform
Grouping
Read-across
Risk assessment
Regulation
Safe(r) by design
Integrated approach to testing and assessment

Cited by (0)

Vicki Stone is Director of the Institute of Biological Chemistry, Biophysics and Bioengineering at Heriot-Watt University, Edinburgh, UK. Vicki is a toxicologist and has published over 165 publications with a h-index of 62. Vicki is coordinator of GRACIOUS https://www.h2020gracious.eu/. She was the holder of the Royal Society of Chemistries Toxicology Award (2015−16) was recognised (2015–2018) by Clarivate Analytics (formerly Thomson Reuters) as one of the top 1% of all researchers in the world for the most cited publications in the field of Pharmacology and Toxicology.

Dr. Stefania Gottardo holds a Ph.D. in Environmental Sciences from University Ca' Foscari Venice (UCV, Italy). She is an expert on risk assessment of nanomaterials and associated regulatory aspects at European level (e.g. REACH). She has been involved in several EU-funded research projects dealing with nanosafety, and contributed to the inventory of nanotechnology applications in agriculture, food and feed commissioned by the European Food Safety Agency (EFSA). She has also knowledge on chemicals and nanomaterials used for hydraulic fracturing of shale gas reservoirs. She has attended several international events and published peer-reviewed papers.

Eric A.J. Bleeker. Senior researcher, environmental toxicologist. Work package leader, co-leader and steering board member in several European projects (e.g. Gov4nano, NanoHarmony, GRACIOUS). He also contributed to several other European projects (e.g. NanoReg, ProSafe). He is active member in ECHA’s Nanomaterial Expert Group and OECD Working Party on Manufactured Nanomaterials. He continues to actively contribute to guidance and test guidelines for regulatory risk assessment of nanomaterials. His research focusses on the interface between science and policy.

Hedwig Braakhuis. Researcher and European Registered Toxicologist. She is WP-leader in SAbyNA that focuses on safe-by-design methodologies for nanomaterials. She also contributes to PATROLS and GRACIOUS, and participated in GUIDEnano and NanoReg2. Her research focusses on the development of innovative, animal-free methods and strategies for assessing the hazard of nanomaterials and medical devices.

Susan Dekkers. Senior researcher, risk assessor human toxicology. She has acted as co-WP-leader in NANoREG and contributed or is still contributing to several other projects on the risk assessment of nanomaterials, including NanoMILE, NanoReg2, caLIBRAte, Gracious, REFINE and Gov4Nano. She is involved in scientific projects and advisory work on human risk assessment of chemical substances and nanomaterials in food, consumer products and occupational settings. She is a member of the ISO Technical Committee on nanotechnology and leading the OECD project on the development of a test guideline on the toxicokinetics of nanoparticles.

Teresa F. Fernandes is Professor of Environmental Science and Director of the Institute of Life and Earth Sciences at Heriot-Watt University, Edinburgh, UK. She is also co-Director of the Nanosafety Research Group at Heriot-Watt. She has over 25 years’ experience working on the effects of stressors in natural systems and recovery. Over the last 15 years TF’s work has concentrated mostly on the effects of nanomaterials (NMs) in the environment, closely working with scientists assessing the effects of NMs in human systems. This close collaboration is unique and has paved the way to the current approach assessing risk of NMs. Funded research projects include EU projects NanoImpactNet, Marina, NanoReg, FutureNanoNeeds, NanoSolutions, SUN, Nanomicex, Biobeauty, Gracious, Biorima, Patrols, amongst others.

Andrea Haase studied biochemistry at the University of Tübingen, obtained a PhD from the University of Heidelberg, finished a postgraduate toxicology study at the University of Leipzig and completed her habilitation in toxicology at the Freie Universität Berlin. Since 2008 she is working at the German Federal Institute for Risk Assessment (BfR) in Berlin, where she heading the unit “Fibre- and Nanotoxicology”. Since 2008 Andrea’s work is focused on nanomaterials, addressing the integration of nanomaterials in different EU regulatory frameworks and including nanosafety research. Andrea has published more than 50 scientific publications and was involved in several large research projects.

Dr Neil Hunt has worked in the regulatory arena for Yordas Ltd for over eight years. During this time he has managed all aspects of the REACH and heads the services for nanomaterials. Neil has played an active role in a variety of EU funded projects (inc. MARINA, SUN, GRACIOUS). He has presented internationally to both industry and the research community. Neil has represented the Nanotechnology Industry Association on ECHA's Partner Expert Group for nanomaterials. Previously, he was a process development chemist and is a named inventor on a number of process patents.

Dr. Danail Hristozov is the Head of Research at Greendecision Srl, a spin-off company of University of Venice in Italy. There he researches the risks of nano and biomaterials used in consumer products and medicine as part of several EU H2020 projects. Danail has been a senior researcher at University of Venice, where he coordinated the large EU FP7 project SUN. Over the last decade Danail has worked also for the private sector companies Venice Research Consortium and Veneto Nanotech. In his early years, Danail worked at the Chair of Industrial Sustainability of the Brandenburg University of Technology in Germany.

Dr. Paula Jantunen is an environmental scientist and obtained a PhD in ecotoxicology from the University of Eastern Finland in 2011. After finishing her doctoral thesis work on the role of sorption in the ecological risk assessment of xenobiotics, she worked in chemical safety consulting in Finland until joining the Nanosafety and Regulatory Methods team at the European Commission’s Joint Research Centre in 2015. Her interests include the environmental fate of nanomaterials and tools for their regulatory safety assessment.

Nina Jeliazkova received MSc in Computer Science from the ITMO University, St. Petersburg, Russia in 1991, and PhD in Computer Science in 2001 (joint supervision by the Laboratory for Mathematical Chemistry, Burgas, Bulgaria and Bulgarian Academy of Science in Sofia). She is founder and co-owner of Ideaconsult Ltd and is technical manager of the company since 2009. She has expertise in machine learning, cheminformatics, databases and data management for chemicals and nanomaterials, software engineering and cloud computing. She is associate editor in Journal of Cheminformatics since 2018.

Dr Helinor Johnston is an associate professor of toxicology at Heriot Watt University and specialises in the assessment of nanomaterial hazard to human health. Her current research focuses on investigating the suitability of employing alternative, non-rodent systems to screen nanomaterial safety (e.g. in vitro models and zebrafish larvae) at different target sites including the lung, liver, intestine, skin and immune system. Helinor was previously a scientific advisor at DEFRA and worked as a post-doc on desk based projects which identified knowledge gaps in nanotoxicology. Helinor’s PhD evaluated the toxicity of nanomaterials to the liver in vitro (Edinburgh Napier University).

Lara Lamon’s research activity has been focusing on pollutants emissions and fate in environmental compartments, and on their exposure and effects on human health and on ecosystems. Her field of expertise covers Chemicals environmental risk assessment, including environmental fate of chemicals and their impact on the environment and on human health. Her expertise also encompasses the field of Nanosafety, regarding the classification and grouping of nanomaterials for the purpose of hazard assessment. She is also interested in how in silico methods are implemented and accepted by regulators when assessing the impact of chemicals on the environment and on human health.

Dr Fiona Murphy is a Research Associate in the Nano-Safety Research Group at Heriot-Watt University, Edinburgh. Prior to joining Heriot-Watt in 2018, Fiona held the positions of Research Assistant in the Centre for Inflammation Research at the University of Edinburgh and Career Development Fellow with the MRC Toxicology Unit, Leicester. Fiona completed her PhD entitled ‘The role of carbon nanotube structure in their retention and pathogenicity in the pleural cavity’ at the University of Edinburgh under the supervision of Prof Ken Donaldson. Fiona has a particular interest in assessing the inhalation toxicity of high aspect ratio and fibrous (nano)materials.

Kirsten Rasmussen. Since 1988 Kirsten Rasmussen, MSc Chem. Eng. from the Technical University of Denmark, has worked for the European Commission's Joint Research Centre. Since 2008 she has studied the scientific/regulatory aspects of nanomaterials, e.g. in the OECD Working Party on Manufactured Nanomaterials, and nanotechnology standardisation in ISO and CEN. She was detached to the European Chemicals Agency 2007/2008 to start-up its Committee on Risk Assessment, based on her experience with chemicals legislation and risk assessment e.g. from her role as co-ordinator of the JRC support to the new (1998) Biocides Directive, defining the processes for the review and assessment of active substances, and chairing the Biocides technical committee.

Dr. Hubert Rauscher is a Scientific Officer and Principal Administrator at the European Commission’s Joint Research Centre (JRC) and holds a PhD in Physics from the Technical University of Munich (Germany). He carried out postdoctoral research at the University of Wisconsin-Madison (USA) and worked on the physical chemistry of nanomaterials at the University of Ulm (Germany), where he was appointed Lecturer in Physical Chemistry in 1999. He joined the JRC in 2005. Hubert is an expert on the physico-chemical characterisation of nanomaterials and supports the European Commission in the implementation of nanomaterial-specific provisions in Community legislation related to the characterisation and safety of nanomaterials. He leads the JRC's activities on the review, revision and implementation of the EC's definition of nanomaterial.

Araceli Sánchez Jiménez is a Senior Exposure Scientist at the Institute of Occupational Medicine in the UK. Her research focuses on the understanding of the processes that chemical, biological or physical agents undergo from emission through transport and final uptake by humans. Specifically she addresses exposure markers, and develops exposure assessment methodologies and models that can be used in risk assessment and epidemiological research. She graduated in Chemistry from University Complutense in Madrid and obtained an MPhil and then a PhD in Environmental Pollution and Health from Strathclyde University in Glasgow. She also holds an MSc in Occupational Hygiene from Manchester University.

Dr Claus Svendsen (PhD in Ecotoxicology Reading University 2000) is Group Leader for Ecotoxicology and Chemical Risk at the UKRI-CEH. Leads projects on nanoecotoxicology, microplastics, pesticides and biological pest control, comparative environmental genomics, bioavailability, and mixture toxicity with funding from UK and EU sources and stakeholders. Cooordinated the EU NMBP projects NanoFATE and NanoFASE, WP leader in GUIDEnano, NanoCommons, GRACIOUS, and participating in ACEnano, CaLIBRAte, NanoSolveIt. Co-chairs the Exposure Working Group of the EU NanoSafety Cluster and contributes to the EU-US CoRs. Has acted as advisor to ECHA and EFSA on nano risk assessment. 120+ papers; H-index = 42; > 5100 citations.

Prof David Spurgeon undertakes research on the ecotoxicological effects of contaminants including industrial pollutants, pesticides, nanomaterials and microplastics. Current research interests includes the assessment, modelling and mechanistic understanding of mixture toxicity, the fate and effect of micro-organic chemicals in waters and projects on the environmental hazards of micro- and nanoplastics in soil. He has contributed extensively to EU projects investigating the exposure and risk assessment of nanomaterials including in pristine and transformed form (EU GRACIOUS, H2020 caLIBRAte & NanoFASE). He has to date published over 130 ISI papers that have collectively been cited >9000 times.

Socorro Vázquez-Campos. Manager of the Human & Environmental Health & Safety (HEHS) Division at LEITAT Technological Centre. Her research aims at assessing the potential impact of nanomaterials and nanotechnology-based products on human health and the environment. Research activities in her group include: Monitoring the properties of nano-enabled products along the life cycle, nanomaterial characterization in complex matrices, human & environmental exposure assessment, nano(eco)toxicology and risk assessment. In the last ten years, she has coordinated and participated in numerous European and national projects in nanosafety, leading to numerous papers, contributions to several book chapters, conference proceedings, and presentations in international conferences and workshops.

Wendel Wohlleben is Senior Principal Scientist at BASF, Dept. of Material Physics, second affiliation with Dept. of Experimental Toxicology and Ecology. Research projects on advanced materials development and on the safety of particles. Studied physics (minor: chemistry) at the University Heidelberg and at the Ecole Normale Supérieure in Paris. PhD in 2003 from LMU Munich with a biophysical thesis on energy harvesting in photosynthesis, performed at the Max-Planck-Institute for Quantum Optics. Post-doc at Physical Chemistry, University Marburg. Visiting scientist relations at Dept. of Materials and Interfaces, Weizmann Institute, Rehovot and at Harvard TH Chan School of Public Health, Boston.

Agnes G. Oomen. Senior Researcher, toxicokineticist and experienced project leader. She has been acting as (co-)WP-leader and member of the steering board in a series of European projects such as MARINA, NANoREG and GRACIOUS. She is and has been project leader of a series of projects on grouping and read-across of nanomaterials as well as projects on human health risks and risk assessment methodologies, for example on the exposure and health risks of nanomaterials in food. She is an active member of the EFSA crosscutting Working Group on Nanotechnologies. Her work takes often place at the interface between science and policy.