Deliverables
This task has been built to guarantee that SOPs associated with the ACEnano toolbox of methods deliver outputs tailored to the needs of key descriptors for hazard and risk assessment eg describe surface coating and coating degradation under realistic exposure scenarios describe particle size distribution in polydisperse samples on a particle per particle basis suitable for regulation Therefore output guidelines related to key descriptors for hazard and risk assessment will be developed along with guidance on the domains of applicability of the methods to be applied within the respective WP and utilised in WP3 in the training activities This task will deliver D53
Guidance to usersVarious methods for the characterisation and quantification of key descriptors are developed in ACEnano and are available from other projects A guidance scheme for the selection and efficient use of the most appropriate methods according to the specific risk assessment requirements of both regulators and industry will be established Synergies and compatibility with the decision flow scheme and the NanoDefiner etool under development in NanoDefine will be sought This task will be closely linked with the newly formed EFSA SC WG Guidance on the human animal and environmental risk assessment of the application of nanoscience and nanotechnologies in agrofoodfeed via the BfR member of the WG
Guideline for Method and Protocol StandardizationDeveloping and even established nanometrology techniques require data treatment that can often be quite involved and requiring userintervention Choosing a dissolvedNM cutoff value during spICPMS data treatment is an example This kind of expert involvement is best minimized to arrive at consistent verifiable measurands that are intercomparable with each other and with similar measurands to be used in modelling and for longer term integration goals such as standardization of particular techniques into an integrated testing strategy Such activities require development of optimal objective data treatment techniques for several nanometrology techniques used within ACENano and other NSC projects which will also form an important part of the standardization efforts and user guidance
Demonstration of ToF-SIMS for surface characterization & bionanointeractionsThe aim is to systematically evaluate and optimize sample preparation methods for chemical imaging such as timeofflight secondary ion mass spectrometry ToFSIMS in order to characterize NMs in complex matrices such as biological media under close to reallife conditions Therefore sample preparation will be optimized towards lowest possible alteration of the sample including NMs localization preservation of the chemical contentspeciation of the NMs as well as cellular or extracellular structures
Final report on TRL progressionACEnano will develop the chosen methods towards specified Technology Readiness Levels This will entail active tracking and management of the development process for each method from the outset of the project PNV will act as a Technology Readiness Champion within the project and williEstablish and maintain and up to date record of all method development from innovation research methods through to benchmarking and incorporation into the final characterisation suite and decision treeiiConsult with method developers on TRL targets through all stages of development setting time goals for achievement of specific TRLs promoting the acceleration of technical advances towards the target TRLs specified for each methodology
Online training toolThe ACEnano training model is focused on the development and cascading of practical expertise in the methodologies and the analytical toolbox initially among the project partners and ultimately to the wider nanosafety community within the project lifetime As shown in Figure 2 the training model comprises three layersiTraining of a core cohort of experts who will train together in the priority methods and become trainers themselves iiThree community training events in Brussels Riga and Athens to address the needs of Northern Eastern and Southern Europe respectively iiiDevelopment of an online training tool for the wider nanosafety community made available via the NanoSafety cluster website
Organisation and minutes for Final project meeting(s) and 3rd (final) project report (M48)This deliverable will describe all activities related to the organisation and delivery of the work and meeting following the completion of final project meeting
Report on final stakeholder workshopA larger workshop for industry and regulators will take place after the first year of the project following from the activities of D31 when the scope of the virtual toolbox will be clearly developed to broaden the scope of industrial and regulatory awareness and facilitate uptake of the outcomes of ACEnano The deliverable will report the outcomes of the workshop and the final structure of the virtual toolbox
Final data management planA specific strategy to provide open access to data will be developed according to the recommendations of the Horizon2020 Open Research Data Pilot httpswwwopenaireeuopendatapilot including the development of initial and final data management plans which will outline and support implementation of procedures to ensure full access to data created within ACEnano
Simple guide for SMEsAs part of the training activities of ACEnano a simple guide to SMEs will be developed to guide industry practitioners to the use of the virtual toolbox developed by ACEnano
New support for EC definition of NMs and labellingSome of the ACEnano developed SOPs will be ideally positioned to support the EC definition of NMs and labelling Work initiated by NanoDefine will be continued within ACEnano for the selected testing methods to serve labelling requirements and support with quality assurance and product traceability Selection of methods to address product traceability will come in part from the outputs from the workshop on these topics organised within WP6 task 62 This task will deliver D55
Refined strategy for benchmarking, training, decision tree developmentBenchmarking will feed directly into the development of the decision tree approach which will guide end users through the sequence of methods to be used to obtain the required key descriptors for a given purpose Development of the decision tree will be done as followsiInitial consultation with industry and regulatory stakeholders on required uses of the decision treecharacterisation suite in relation to regulatory hazard and risk assessment needs iiFollowing each round of method benchmarking derived applicability domains will be used to reassess and refine the first round decision tree workflows for each desired use iiiThe process of ii will be repeated through the project lifetime in order to progressively refine the characterisation suite and decision tree workflows in line with stakeholder use requirements
ILC reports to underpin SOP validationThe aim of this deliverable is to ensure harmonisation of key inhouse SOPs in WP14 via conducting and evaluating interlaboratory comparisons according to international evaluation standards Therefore specific support during the design definition of measurands calibrations and traceability of measurements and data evaluation of the inter laboratory comparisons will be provided A default approach for ILCs will be developed and the application throughout the project wherever feasible will be ensured This common approach will harmonise the validation of the various methods in work packages 14
Report on experts' workshopThe deliverable will report on a workshop to be held in Brussels gathering experts in different areas such as quality control product traceability labelling and counterfeiting The purpose of this meeting is to identify the needs of stakeholders in these areas and assess the methods developed or optimized within WP1 and WP2 for potential uses in these application domains As task leader NfA will lead the logistic organization of the Workshop meeting invitation of the experts printing of workshop materials agenda posters etc preparation of agenda and minutes
Report on outcomes of kickoff stakeholder workshop: initial strategy for benchmarking, training, decision tree developmentThe developing virtual toolbox platform in ACEnano will need to be aligned with the needs and views of regulators and industry to facilitate incorporation of the ACEnano virtual toolbox and approaches into regulatory processes A regulatory workshop and teleconferences with regulators and industry will therefore be facilitated to i assess their future needs and map these to the ACEnano workflows ii present the proposed workflow of the ACEnano tiered approach with regulators and to discuss how the decision trees regarding method selection can be aligned with regulatory needs and be incorporated into existing and evolving regulatory frameworks and technical guidance documents
Proficiency testing schemeIn order to ensure a comparable performance of labs and to guarantee reliable method output data obtained from WP14 will be utilized and critically evaluated Therefore output guidelines related to key descriptors and risk assessment will be developed by WP5 and applied within the respective WPs Based on the knowledge developed within the project ACEnano will establish a proficiency testing scheme providing guidelines on parameters for comparable testing and data acquisition for risk assessment in Europe Guidance for the appropriate and efficient use of ACENanos toolbox of methods for development of the materials characterisation section of regulatory dossiers for risk assessment will be developed
Final report on method benchmarkingBenchmarking will be done by interlaboratory testing involving all partners capable of running each method Calls for external participants in each round of testing will be made to enhance reach and relevance All testing will be done in close harmony with WP5 in design specification and data evaluation to ensure harmonisation of methodological approaches across all partners and participants We will organise a minimum of five testing periods within the project lifetime with two in year 1 for established methods and at least one per year thereafter for developing and research methods that have progressed to the benchmarking stage selected on the basis of the GoNoGo milestones in WPs 1 and 2 in discussion with partners and via feedback from regulatory and industry stakeholders Efforts in Year 2 and beyond will also include repeat benchmarking of methods identified for improvement to address shortcomings in applicability domain relative to required uses
Guidelines for inter laboratory comparisons (ILC) for validation of harmonized SOPsThe aim of this deliverable is to describe activities to ensure harmonisation of key inhouse SOPs in WP14 via conducting and evaluating interlaboratory comparisons according to international evaluation standards Therefore specific support during the design definition of measurands calibrations and traceability of measurements and data evaluation of the inter laboratory comparisons will be provided A default approach for ILCs will be developed and the application throughout the project wherever feasible will be ensured This common approach will harmonise the validation of the various methods in work packages 14 Potential method candidates for inter laboratory validation will be determined at Month 12 based on GoNoGo decisions made in WPs 13
Report on developed dissemination activities (update)An update of the previous deliverable for M54
Active participation in national standardization bodies' mirror committees (DIN, BSI, etc.) to contribute to international standardization projects (CEN, ISO) related to methodology developed under WPs 1-3Establishing links and acting as contact point for standardisation organisations CEN ISO and regulatory stakeholders EC Decide on the most relevant standardization committees within CEN and ISO Presentations at national standardization bodies DIN BSI Mirror committees to CEN ISO committees will be used to identify content developed by WP 14 for 1 improvements of existing international standards or 2 preparation of New Work Item Proposals for international standards in discussions with the experts of those committees Based thereon decisions will be made whether a parallel development or improvement of EN ISO standards under the Vienna Agreement is preferable Project partners will volunteer to act as leaders for standardization projects after clearance with the responsible national mirror committees This task will deliver D56
Interim report on method benchmarkingBenchmarking of the ACEnano approved techniquesmethods Tier 1 and those coming from WPs 1 and 2 will be an essential step to developing the analytical toolbox building regulatory acceptance of the methods and their resulting outputs Task 32 In the context of methodology and toolbox development in ACEnano the goal of benchmarking is to establish best practice for as many of the studied techniquesmethodologies as possible to maximise uptake of the toolbox as best practice for NM analysis for fate and risk assessment by both regulators and industry
TGIRGCMS will be optimized for the identification and precise quantification of the organic coating on NMs and nanostructured surfaces This hyphenated platform relies on the use of thermogravimetric analysis TGA to precisely quantify the amount of mass evolved that is first identified by a spectroscopic technique tracking isolated molecular components in real time followed by precise molecular quantification using gas chromatography mass spectrometry GCMS Combining these techniques is a powerful approach for assessment of complex mixtures of capping agents on the surface of NMs
Release of the first version of the ontology for methodology part of the nanomaterial ontologyThis deliverable will describe the release of the first version of the ontology for methodology part of the ACEnano ontology The implemented data structure will be aligned to scientific research and computing standards from other ongoing activities eNanoMapper OpenTox NanoReg NanoMILE NanoFASE and other NSC data generation and management activities and will consider additional requirements for regulatory reporting eg OECD harmonized templates and Adverse Outcome Pathway AOP development In this way the warehouse will facilitate the data transfer to and from other databases
Demonstration of CE for corona characterizationStandardised capillary electrophoresis methodologies for the characterisation of NMs using optical detection methods will be developed CESIMS connection of CE to Mass Spectrometry using ultra lowflow ESI will be used for the detailed characterisation of the coronal proteome and metabolome by CESIMS This latter approach is orthogonal to published work using LCMS and can be expected to offer advantages when working with charged and polar compounds as well as intact proteins Integration with LCMS is an interesting approach and will help validating the CESIMS approach
Demonstration of NTA integration with FFF and improved sample delivery methodMalvern and coworkers will work towards making the output of the NTA system more userfriendly both by giving users more specific feedback on the quality of the NTA results and an output on data interpretation In addition Malvern will be responsible for further developing their NTA technology adapting the sample input as necessary to make it easier to hyphenate with FFF or other online technologies Following a roundrobin test an SOP will be developed
The projects website tentative wwwacenanoeu will be the backbone of the communication efforts of ACEnano and will be set up as early in the life of the project as practical in a basic form and will be expanded as appropriate This deliverable will confirm its launch and features
Publications
Author(s):
Yeonwoo Kim, Sena Yang, Yeji Kang, Byung-Kwon Kim, Hangil Lee
Published in:
Scientific Reports, Issue 8/1, 2018, ISSN 2045-2322
Publisher:
Nature Publishing Group
DOI:
10.1038/s41598-018-30962-0
Author(s):
Lee, Hangil; Kim, Joo Yeon; Lee, Si Young; Hong, Jung A.; Kim, Namdong; Baik, Jaeyoon; Hwang, Yun Jeong
Published in:
Scientific Reports, Vol 8, Iss 1, Pp 1-8 (2018), Issue 4, 2018, ISSN 2045-2322
Publisher:
Nature Publishing Group
Author(s):
Jovana Kocic, Detlef Günther, Bodo Hattendorf
Published in:
Journal of Analytical Atomic Spectrometry, Issue 36/1, 2021, Page(s) 233-242, ISSN 0267-9477
Publisher:
Royal Society of Chemistry
DOI:
10.1039/d0ja00421a
Author(s):
Peter Laux, Christian Riebeling, Andy M. Booth, Joseph D. Brain, Josephine Brunner, Cristina Cerrillo, Otto Creutzenberg, Irina Estrela-Lopis, Thomas Gebel, Gunnar Johanson, Harald Jungnickel, Heiko Kock, Jutta Tentschert, Ahmed Tlili, Andreas Schäffer, Adriënne J. A. M. Sips, Robert A. Yokel, Andreas Luch
Published in:
Environmental Science: Nano, Issue 5/1, 2018, Page(s) 48-63, ISSN 2051-8153
Publisher:
Royal Society of Chemistry
DOI:
10.1039/c7en00594f
Author(s):
Francesca Bennet, Anja Müller, Jörg Radnik, Yves Hachenberger, Harald Jungnickel, Peter Laux, Andreas Luch, Jutta Tentschert
Published in:
Journal of Visualized Experiments, Issue 163, 2020, ISSN 1940-087X
Publisher:
MYJoVE Corporation
DOI:
10.3791/61758
Author(s):
Nicolas Drouin, Marlien van Mever, Wei Zhang, Elena Tobolkina, Sabrina Ferre, Anne-Catherine Servais, Marie-Jia Gou, Laurent Nyssen, Marianne Fillet, Guinevere S.M. Lageveen-Kammeijer, Jan Nouta, Andrew J. Chetwynd, Iseult Lynch, James A. Thorn, Jens Meixner, Christopher Lößner, Myriam Taverna, Sylvie Liu, N. Thuy Tran, Yannis Francois, Antony Lechner, Reine Nehmé, Ghassan Al Hamoui Dit Banni,
Published in:
Analytical Chemistry, Issue 92/20, 2020, Page(s) 14103-14112, ISSN 0003-2700
Publisher:
American Chemical Society
DOI:
10.1021/acs.analchem.0c03129
Author(s):
Ruud Peters, Ingrid Elbers, Anna Undas, Eelco Sijtsma, Sophie Briffa, Pauline Carnell-Morris, Agnieszka Siupa, Tae-Hyun Yoon, Loïc Burr, David Schmid, Jutta Tentschert, Yves Hachenberger, Harald Jungnickel, Andreas Luch, Florian Meier, Jörg Radnik, Vasile-Dan Hodoroaba, Iseult Lynch, Eugenia Valsami-Jones
Published in:
Molecules, Issue 26/17, 2021, Page(s) 5315, ISSN 1420-3049
Publisher:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/molecules26175315
Author(s):
Klaus Faserl, Andrew J. Chetwynd, Iseult Lynch, James A. Thorn, Herbert H. Lindner
Published in:
Nanomaterials, Issue 9/6, 2019, Page(s) 898, ISSN 2079-4991
Publisher:
Nanomaterials
DOI:
10.3390/nano9060898
Author(s):
Fazel Abdolahpur Monikh, Latifeh Chupani, Daniel Arenas-Lago, Zhiling Guo, Peng Zhang, Gopala Krishna Darbha, Eugenia Valsami-Jones, Iseult Lynch, Martina G. Vijver, Peter M. van Bodegom, Willie J.G.M. Peijnenburg
Published in:
Nature Communications, Issue 12/1, 2021, ISSN 2041-1723
Publisher:
Nature Publishing Group
DOI:
10.1038/s41467-021-21164-w
Author(s):
Andrew J. Chetwynd, Iseult Lynch
Published in:
Environmental Science: Nano, Issue 7/4, 2020, Page(s) 1041-1060, ISSN 2051-8153
Publisher:
Royal Society of Chemistry
DOI:
10.1039/c9en00938h
Author(s):
S. M. Briffa, F. Nasser, E. Valsami-Jones, I. Lynch
Published in:
Environmental Science: Nano, Issue 5/7, 2018, Page(s) 1745-1756, ISSN 2051-8153
Publisher:
Royal Society of Chemistry
DOI:
10.1039/c8en00063h
Author(s):
Zhiling Guo, Peng Zhang, Swaroop Chakraborty, Andrew J Chetwynd, Fazel Abdolahpur Monikh, Christopher Stark, Hanene Ali-Boucetta, Sandra Wilson, Iseult Lynch, Eugenia Valsami-Jones
Published in:
Proceedings of the National Academy of Sciences, Issue 118/28, 2021, Page(s) e2105245118, ISSN 0027-8424
Publisher:
National Academy of Sciences
DOI:
10.1073/pnas.2105245118
Author(s):
Andrew J. Chetwynd, Wei Zhang, James A. Thorn, Iseult Lynch, Rawi Ramautar
Published in:
Small, Issue 16/21, 2020, Page(s) 2000295, ISSN 1613-6810
Publisher:
Wiley - V C H Verlag GmbbH & Co.
DOI:
10.1002/smll.202000295
Author(s):
Pietro Benettoni, Jia-Yu Ye, Timothy R. Holbrook, Federica Calabrese, Stephan Wagner, Mashaalah Zarejousheghani, Jan Griebel, Maria K. Ullrich, Niculina Musat, Matthias Schmidt, Roman Flyunt, Thorsten Reemtsma, Hans-Hermann Richnow, Hryhoriy Stryhanyuk
Published in:
Biointerphases, Issue 15/2, 2020, Page(s) 021005, ISSN 1559-4106
Publisher:
American Vacuum Society
DOI:
10.1116/1.5143203
Author(s):
Sophie M. Briffa, Jo Sullivan, Agnieszka Siupa, Pauline Carnell-Morris, Michele Carboni, Kerstin Jurkschat, Ruud J. B. Peters, Carolin Schultz, Kang Hee Seol, Sook-Jin Kwon, Sehee Park, Tae Hyun Yoon, Colin Johnston, Stephen Lofts, Eugenia Valsami-Jones
Published in:
Journal of Visualized Experiments, Issue 164, 2020, ISSN 1940-087X
Publisher:
MYJoVE Corporation
DOI:
10.3791/61741
Author(s):
F Bennet, L Burr, D Schmid, V-D Hodoroaba
Published in:
Journal of Physics: Conference Series, Issue 1953/1, 2021, Page(s) 012002, ISSN 1742-6588
Publisher:
Institute of Physics
DOI:
10.1088/1742-6596/1953/1/012002
Author(s):
Roland Drexel, Agnieszka Siupa, Pauline Carnell-Morris, Michele Carboni, Jo Sullivan, Florian Meier
Published in:
Molecules, Issue 25/20, 2020, Page(s) 4703, ISSN 1420-3049
Publisher:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/molecules25204703
Author(s):
Sena Yang, Hangil Lee
Published in:
Nanoscale Research Letters, Issue 12/1, 2017, Page(s) 582, ISSN 1931-7573
Publisher:
Springer Verlag
DOI:
10.1186/s11671-017-2355-7
Author(s):
Hangil Lee, Jung A Hong
Published in:
Nanoscale Research Letters, Issue 12/1, 2017, Page(s) 426, ISSN 1931-7573
Publisher:
Springer Verlag
DOI:
10.1186/s11671-017-2196-4
Author(s):
Hyun Woo Nho, Tae Hyun Yoon
Published in:
Scientific Reports, Issue 7/1, 2017, Page(s) 12424, ISSN 2045-2322
Publisher:
Nature Publishing Group
DOI:
10.1038/s41598-017-12831-4
Author(s):
Andrew Chetwynd, Emily Guggenheim, Sophie Briffa, James Thorn, Iseult Lynch, Eugenia Valsami-Jones
Published in:
Nanomaterials, Issue 8/2, 2018, Page(s) 99, ISSN 2079-4991
Publisher:
MDPI
DOI:
10.3390/nano8020099
Author(s):
Donghyun Ryoo, Jong Yun Kim, Pham Khac Duy, Sang Hoon Cho, Hoeil Chung, Tae Hyun Yoon
Published in:
The Analyst, Issue 143/18, 2018, Page(s) 4347-4353, ISSN 0003-2654
Publisher:
Royal Society of Chemistry
DOI:
10.1039/C8AN00351C
Author(s):
Konstantinos Giannopoulos, Oliver J. Lechtenfeld, Timothy R. Holbrook, Thorsten Reemtsma, Stephan Wagner
Published in:
Analytical and Bioanalytical Chemistry, 2020, ISSN 1618-2642
Publisher:
Springer Verlag
DOI:
10.1007/s00216-020-02740-3
Author(s):
Ana C. Quevedo, Iseult Lynch, Eugenia Valsami-Jones
Published in:
Nanoscale, Issue 13/12, 2021, Page(s) 6142-6161, ISSN 2040-3364
Publisher:
Royal Society of Chemistry
DOI:
10.1039/d0nr09024g
Author(s):
Roland Drexel, Vanessa Sogne, Magdalena Dinkel, Florian Meier, Thorsten Klein
Published in:
Journal of Visualized Experiments, Issue 163, 2020, ISSN 1940-087X
Publisher:
MYJoVE Corporation
DOI:
10.3791/61757
Author(s):
Holly A. Nel, Andrew J. Chetwynd, Catherine A. Kelly, Christopher Stark, Eugenia Valsami-Jones, Stefan Krause, Iseult Lynch
Published in:
Environmental Science & Technology, Issue 55/13, 2021, Page(s) 8721-8729, ISSN 0013-936X
Publisher:
American Chemical Society
DOI:
10.1021/acs.est.1c01085
Author(s):
Lyndsey Hendriks, Alexander Gundlach-Graham, Detlef Günther
Published in:
CHIMIA International Journal for Chemistry, Issue 72/4, 2018, Page(s) 221-226, ISSN 0009-4293
Publisher:
Schweizerische Chemische Gedellschaft
DOI:
10.2533/chimia.2018.221
Author(s):
Andrew J. Chetwynd, Wei Zhang, Klaus Faserl, James A. Thorn, Iseult Lynch, Rawi Ramautar, Herbert H. Lindner
Published in:
Journal of Visualized Experiments, Issue 164, 2020, ISSN 1940-087X
Publisher:
MYJoVE Corporation
DOI:
10.3791/61760
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