Towards harmonised test methods for nanomaterials

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Livrables

Report on the existing data, test methods, and recommendations for a tiered approach for determination of bioaccumulation potential of ENMs

This report will be an opinion of the experts following stakeholder workshops to identify existing data methods and to discuss how a tiered approach to bioaccumulation testing will work The report will therefore be the output of the workshops and give the consensus opinion and recommendations

Event in Brussels

Report of event delicered with aim of knowledge transfer into policy regulatory industry and other stakeholders

Barriers in bringing scientific knowledge to the regulatory arena

Overview of identified major hurdles for the adaption of knowledge in regulation and potential options to overcome these hurdles A summary of what has identified and verified with the stakeholders in OECD Member countries scientists including industry

NanoHarmony report on library expansion, engagements, consultations, dissemination and information events and on global outreach - Update M24

Report in which the library structure and content is summarised and updated together with all external contacts and activities associated with project activities and their impact on project delivery Update in M24

NanoHarmony dissemination strategy

Report in which the dissemination framework is elaborated and defined highlighting the links with OECD SPSFs

Draft of a new GD on solubility and dissolution testing of ENMs in water and biologically relevant media with associated SOPs

D110 will form the basis for the guidelines and specific SOPs to be applied in the RR study

Report on communication between science and regulation.

Report in which an overview is given ofThe elements that will be the building blocks for the White PaperThe training materials that were developed within NanoHarmonyThe Interactive Guidance aiming at easier access to relevant information

Report on dustiness testing of HARN and establishment of dustiness ranking schemes

HARN dustiness testing is performed with selected methods like the fluidizer dustiness test following a standard operation procedure that facilitates equivalent aerosol generation mechanisms for each test and material necessary for material dustiness comparison Based on the result of a series of dustiness tests for a selection of materials those can be ranked depending on the chosen measurand total dustiness dustiness of particles of distinct morphology like single fibres dustiness of particles with distinct geometrical properties like fibres matching the WHOdefinition of harmful fibres Ranking is the basis of decadal measurand banding eg low moderate and high dustiness

Scientific document to support OECD activities on the development of GD on eco-toxicity of ENMs

The deliverable will include the scientific basis for the technical recommendations on how to apply to ENMs the aquatic ecotoxicity tests TGs 201 202 203 and the experimental data used to generate this output This activity will support the development of guidance that will be included as annexes to the Guidance Document on aquatic and sediment toxicological testing of nanomaterials which is under development at OECD level

Draft of the operational methodology for the use of dustiness for risk assessment of ENMs and HARN explosion risk in industrial scenario to support ATEX safety assessment

The aim of the deliverable will be to provide a preliminary framework to investigate to what extent and potentially for which methods dustiness data can be used to support ATEX safety risk assessment as defined in Directive 199992EC This work will focus more specifically on nonconventional nanomaterials ie reactive NMs and combustible HARNs

Awareness strategy plan

The strategy will specify targeted engagement with identified stakeholders to ensure awareness of the project and its potential outputs including templates for external communication

Report on the optimization of analytical methods and related SOPs for surface chemistry characterisation

D111 will summarize the results of intralaboratory testing and comparison of five coated nanomaterials in two laboratories to optimize protocols and as a preparation for the interlaboratory study described in Task 16 and reported in D113

Event with/at OECD

Report of event delivered through the aim of formal alignment with standards bodies and knowledge transfer achieved through such an activity

Scientific document to support OECD activities on the development of TG on toxicokinetics of ENMs including new experimental data

New experimental data to complement existing studies on toxicokinetics of ENMs in order to form a scientific basis for the minimum requirements of the study design of in vivo toxicokinetic studies on ENMs and to support the development of a OECD test guideline applicable for nanomaterials

Scientific document to support OECD activities on the development of GD on the determination of concentrations of ENMs in biological materials

A document providing recommendations and the background evidence to support them on appropriate techniques and sample preparation protocols to use to assess the concentrations of a range of relevant ENMs in a variety of biological sample types relevant to both toxicity and ecotoxicity studies to be undertaken according to OECD test guidelines The recommendations will reflect both review activities and new experimental data produced by the Task The new experimental data related primarily spICPMS and imaging will be reported in the document

Report on the results of the inter-laboratory comparison study and draft of the scientific document to support OECD activities on characterization of surface chemistry of ENMs

D113 will summarize the results from the interlaboratory testing and comparison of results using different test methods and involving several laboratories

A Powerpoint presentation of the Task 2.2 structure, calendar and target outcomes given at the kick off meeting, and to be used for reference to ensure timely completion

Information exchange within the consortium and also with wider stakeholders in order to speed up the development of the OECD TGGD

Project library established at M3 and expanded throughout project

A library of key documents for the project will be established to ensure access for all project partners It will be maintained in a dedicated interest group within the Communication and Information Resource Centre for Administrations Businesses and Citizens CIRCABC

Scientific document to support OECD activities on the development of a new GD on solubility and dissolution testing of ENMs in water and biologically relevant media

D112 will summarize the results from the interlaboratory testing and comparison of results using different test methods

NanoHarmony roadmap involving key institutions

Roadmap report that maps target stakeholders and project actions that have been undertaken to achieve engagement

Summary of current state of the art and report on the data gaps analysis on methods for determination of concentrations of ENMs in biological materials

A report containing a review of current methods for determining the concentrations of ENMs in biological samples of forms relevant to both toxicology and ecotoxicology studies The techniques to be addressed will include analytical eg spICPMS and imaging approaches eg TEM The relevance of the different techniques and their strengths and weaknesses will be summarised including detection and quantification limits Protocols for sample preparation will also be reviewed and data gaps in terms of sample types and specific ENMs will be identified and recommendations made for experimental work to address these

Report on the data gaps analysis on study design requirements for toxicokinetics of ENMs

In this deliverable the most important data gaps to determine the requirements of the study design of in vivo toxicokinetic experiments will be identified based on available reviews and toxicokinetic data from previous studies

Report on the data gaps analysis on methods for bioaccumulation of ENMs

This report will focus on data gaps in relation to the agreed testing strategy defined in D12 This may include new data to fill those gaps and data mining for existing data sets to clarify any gaps remaining for each of the steps or tiers in the overall testing strategy

Report on the data gaps analysis on applicability of OECD TGs 201, 202 and 203 to ENMs

The document will report the identified data gaps and the experimental work needed to make the protocols of the OECD TGs 201 202 and 203 applicable to ENMs

"A Powerpoint presentation of the ""Event calendar"" to be presented at the kick-off meeting and used for reference that defines event structures and organisational pathway"

Report including the Event calender with an overview of meetings during the project and the presentation

White paper recommendations on further optimisation of the OECD process for development of test guidelines and guidance documents development

The deliverable will contain general recommendations on test guidelines keeping pace with new developments in testing methods material innovations and legislative policy commitment of the scientific community and other stakeholders and on funding mechanisms These recommendations will be set out in a white paper to support further optimisation of the OECD process for test guideline development

NanoHarmony report on library expansion, engagements, consultations, dissemination and information events and on global outreach

Report in which the library structure and content is summarised and updated together with all external contacts and activities associated with project activities and their impact on project delivery

Scientific document to support OECD activities on the development of GD on intestinal fate of ENMs

The document will report some scientific based conclusions resulting from the project activities on reliable methodologies applicable to intestinal fate of ENMs They will be furnish a robust scientific substrate to the OECD GD elaboration

NanoHarmony report on engagements, consultations, dissemination and information events, global outreach and development of sustainable project legacies

Report in which the engagements with all external contacts and activities associated with project activities and their impact on project delivery is updated and project legacies are described Update in M42

Report on the data gaps analysis on methods for the determination of intestinal fate of ENMs

The report will present an overview of the main approaches utilized for investigate EMNs fate after oral ingestion It will be mainly focused on in vitro approaches and it will also aim to highlight methods data gaps

Publications

In vitro intestinal barrier models: are they ready for standardization?

Auteurs: Vincentini O., Prota V., De Angelis I.
Publié dans: Rapporti ISTISAN, Numéro 22/18, 2022, Page(s) 38-43
Éditeur: Rapporti ISTISAN

Towards Harmonisation of Testing of Nanomaterials for EU Regulatory Requirements on Chemical Safety – A Proposal for Further Actions.

Auteurs: Eric A.J. Bleeker, Elmer Swart, Hedwig Braakhuis, Maria Luisa Fernández-Cruz, Steffi Friedrichs, Ilse Gosens, Frank Herzberg, Keld Alstrup Jensen, Frank von der Kammer, Jolinde A.B. Kettelarij, Jose María Navas, Kirsten Rasmussen, Kathrin Schwirn, Maaike Visser.
Publié dans: 8th International Conference on Environmental, Health and Safety issues related to Nanomaterials, nanoSAFE’23 and NanoSafety Cluster joint conference; June 5-9, 2023 – Maison Minatec, Grenoble, France. Book of Abstracts, 2023, Page(s) 45
Éditeur: NanoSafe

On the road towards a Guidance Document for determination of the solubility and dissolution rates of nanomaterials in water and biologically relevant media.

Auteurs: Keld Alstrup Jensen, Yahia Kembouche, Benjamin Krause, Harald Jungnickel, Jutta Tentschert, Kai Werle; Wendel Wohlleben.
Publié dans: Nano-week & NanoCommons Final Conference, Cyprus, 20 – 24 June 2022. Programme and Ab-stract booklet, 2022, Page(s) 156
Éditeur: NanoCommons

NanoHarmony Training: From Science to OECD Guidelines

Auteurs: Anna Pohl, Eric Bleeker, Arno Gutleb
Publié dans: NanoSafety Training School Venice 2023, 2023, Page(s) 17
Éditeur: Sunshine

NanoHarmony: Improving the OECD Test Guidelines Process.

Auteurs: Eric Bleeker, Arno Gutleb, Anna Pohl, Elisabeth Heunisch, Sean Kelly, Elise Morel, Claus Svendsen, Rachel Smith, Karin Wiench, Dominik Geiger, Thomas Kuhlbusch
Publié dans: Nano-week & NanoCommons Final Conference, Cyprus, 20 – 24 June 2022. Programme and Ab-stract booklet, 2022, Page(s) 154
Éditeur: NanoCommons

Development of an OECD Test Guideline for the dustiness testing of manufactured nanomaterials.

Auteurs: Anna Pohl, Carla Ribalta, Ana Sofia Fonseca, Alexis Vignes, Christophe Dutouquet, Elisabeth Heu-nisch, Neeraj Shandilya, Douglas Evans, Thomas Kuhlbusch, Keld Alstrup Jensen, Jacques Bouillard
Publié dans: Nano-week & NanoCommons Final Conference, Cyprus, 20 – 24 June 2022. Programme and Ab-stract booklet, 2022, Page(s) 157
Éditeur: NanoCommons

The EU project NanoHarmony – Towards harmonized test methods for nanomaterials.

Auteurs: Elisabeth Heunisch, Seden Caglar, Anna Pohl, Tommaso Serchi, Rachel Smith, Sean Kelly, Claus Svendsen, Elise Morel, Eric Bleeker, Karin Wiench, Richard Handy, Ilse Gosens, Keld Alstrup Jensen, Jakob Nis Klenø Nøjgaard, Carla Ribalta, Jacques Bouillard, Christophe Bressot, Isabella De Angelis, María Luisa Fernández-Cruz, Flemming Cassee, Adrienne Sips, Arno Gutleb, Monique Groenewold, Susana Lo
Publié dans: 8th International Conference on Environmental, Health and Safety issues related to Nanomaterials nanoSAFE’23 and NanoSafety Cluster joint conference; June 5-9, 2023 – Maison Minatec, Grenoble, France. Book of Abstracts, 2023, Page(s) 139
Éditeur: NanoSafe

Release Tests Applicable to Nanomaterials – A New OECD Guidance Facilitating the Choice ofAppropriate Release Tests

Auteurs: Anna Pohl, Camilla Delpivo, Kathrin Schwirn, Elisabeth Heunisch, Frank S. Bierkandt, Virginia Rodriguez Unamuno, Keld Alstrup Jensen, Socorro Vázquez, Thomas A.J. Kuhlbusch
Publié dans: 8th International Conference on Environmental, Health and Safety issues related to Nanomaterials nanoSAFE’23 and NanoSafety Cluster joint conference; June 5-9, 2023 – Maison Minatec, Grenoble, France. Book of Abstracts, 2023, Page(s) 42
Éditeur: nanoSafe

From science to standards and guidelines: Making your science regulatory relevant

Auteurs: Eric Bleeker, Arno Gutleb, Anna Pohl, Elisabeth Heunisch, Sean Kelly, Elise Morel, Claus Svendsen, Rachel Smith, Karin Wiench, Dominik Geiger, Thomas Kuhlbusch
Publié dans: Nano-week & NanoCommons Final Conference, Cyprus, 20 – 24 June 2022 Programme and Abstract booklet., 2022, Page(s) 153
Éditeur: NanoCommons

Development of two OECD Guidance Documents for nanomaterials dustiness data applicability: exposure assessment and ATEX safety.

Auteurs: Carla Ribalta, Alexis Vignes, Ana Sofia Fonseca, Anna Pohl, Elisabeth Heunisch, Thomas Kuhlbusch, Keld Alstrup Jensen, Jacques Bouillard
Publié dans: Nano-week & NanoCommons Final Conference, Cyprus, 20 – 24 June 2022. Programme and Ab-stract booklet, 2022, Page(s) 158
Éditeur: NanoCommons

Towards a Guidance Document for identification and quantification of the surface chemistry and coatings on nano and microscale materials.

Auteurs: Jakob Klenø Nøjgaard, Jutta Tentschert, Harald Jungnickel, Charlotte Kromer, Andrea Haase, Alexander Roloff, Peter Laux, Andreas Luch and Keld Alstrup Jensen.
Publié dans: Nano-week & NanoCommons Final Conference, Cyprus, 20 – 24 June 2022 Programme and Abstract booklet., 2022, Page(s) 155
Éditeur: NanoCommons

Dustiness of High Aspect Ratio (Nano)Materials – Harmonisation of Test Methods Towards an OECD Test Guideline.

Auteurs: Anna Pohl, Carla Ribalta, Elisabeth Heunisch, Ana Sofia Fonseca, Jacques Bouillard, Keld Alstrup Jen-sen, Thomas A.J. Kuhlbusch.
Publié dans: 8th International Conference on Environmental, Health and Safety issues related to Nanomaterials, nanoSAFE’23 and NanoSafety Cluster joint conference; June 5-9, 2023 – Maison Minatec, Grenoble, France. Book of Abstracts, 2023, Page(s) 45
Éditeur: NanoSafe

Development and Documentation of an Atmosphere-Temperature-pH-Controlled Stirred Batch Reactor Approach for Standard Testing of Solubility and Dissolution Rate in Waters and Biological Simulant Fluids

Auteurs: Keld Alstrup Jensen and Yahia Kembouche
Publié dans: 8th International Conference on Environmental, Health and Safety issues related to Nanomaterials, nanoSAFE’23 and NanoSafety Cluster joint conference; June 5-9, 2023 – Maison Minatec, Grenoble, France. Book of Abstracts, 2023, Page(s) 40
Éditeur: NanoSafe

The EU project NanoHarmony – Towards harmonized test methods for nanomaterials

Auteurs: Elisabeth Heunisch, Melanie Müller, Anna Pohl, Tommaso Serchi, Rachel Smith, Sean Kelly, Claus Svendsen, Eric Bleeker, Karin Wiench, Richard Handy, Ilse Gosens, Keld Jensen, Jakob Nis Klenø Nøjgaard, Jacques Bouillard, Isabella de Angelis, María Luisa Fernández-Cruz, Flemming Cassee, Adrienne Sips, Arno Gutleb, Monique Groenewold, Susana Loureiro, Harald Jungnickel, Jutta Tentschert, Thomas K
Publié dans: Nano-week & NanoCommons Final Conference, Cyprus, 20 – 24 June 2022 Programme and Abstract booklet., 2022, Page(s) 152
Éditeur: NanoCommons

Metal transfer to sediments, invertebrates and fish following waterborne exposure to silver nitrate or silver sulfide nanoparticles in an indoor stream mesocosm

Auteurs: Nathaniel Clark; Joanne Vassallo; Patrícia V. Silva; Ana Rita R. Silva; Marta Baccaro; Neja Medvešček; Magdalena Grgić; Abel Ferreira; Martí Busquets-Fité; Kerstin Jurkschat; Anastasios G. Papadiamantis; Victor Puntes; Iseult Lynch; Claus Svendsen; Nico W. van den Brink; Cornelis A.M. van Gestel; Susana Loureiro; Richard D. Handy
Publié dans: Science of The Total Environment, Numéro 850, 2022, ISSN 0048-9697
Éditeur: Elsevier BV
DOI: 10.1016/j.scitotenv.2022.157912

The bioaccumulation testing strategy for manufactured nanomaterials: physico-chemical triggers and read across from earthworms in a meta-analysis

Auteurs: R. D. Handy, N. J. Clark, J. Vassallo, C. Green, F. Nasser, K. Tatsi, T. H. Hutchinson, D. Boyle, M. Baccaro, N. van den Brink, C. Svendsen
Publié dans: Environmental Science: Nano, 2021, ISSN 2051-8153
Éditeur: Royal Society of Chemistry
DOI: 10.1039/d1en00444a

The gut barrier and the fate of engineered nanomaterials: a view from comparative physiology

Auteurs: Meike van der Zande, Anita Jemec Kokalj, David J. Spurgeon, Susana Loureiro, Patrícia V. Silva, Zahra Khodaparast, Damjana Drobne, Nathaniel J. Clark, Nico W. van den Brink, Marta Baccaro, Cornelis A. M. van Gestel, Hans Bouwmeester, Richard D. Handy
Publié dans: Environmental Science: Nano, Numéro 7/7, 2020, Page(s) 1874-1898, ISSN 2051-8153
Éditeur: Royal Society of Chemistry
DOI: 10.1039/d0en00174k

Harmonizing nanomaterial exposure methodologies in ecotoxicology: the effects of two innovative nanoclays in the freshwater mi-croalgae Raphidocelis subcapitata

Auteurs: Fábio Campos, Patrícia V. Silva, Amadeu M. V. M. Soares, Roberto Mar-tins & Susana Lou-reiro
Publié dans: Nanotoxicology, 2023, ISSN 2078-2489
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.1080/17435390.2023.2231071

Dietary exposure to copper sulphate compared to a copper oxide nanomaterial in rainbow trout: bioaccumulation with minimal physiological effects

Auteurs: David Boyle, Nathaniel J. Clark, Benjamin P. Eynon, Richard D. Handy
Publié dans: Environmental Science: Nano, Numéro 8/8, 2021, Page(s) 2297-2309, ISSN 2051-8153
Éditeur: Royal Society of Chemistry
DOI: 10.1039/d1en00379h

The bioaccumulation testing strategy for nanomaterials: correlations with particle properties and a meta-analysis of <i>in vitro</i> fish alternatives to <i>in vivo</i> fish tests

Auteurs: R. D. Handy; N. J. Clark; D. Boyle; J. Vassallo; C. Green; F. Nasser; T. L. Botha; V. Wepener; N. W. van den Brink; C. Svendsen
Publié dans: Environmental Science: Nano, Numéro 9, 2022, Page(s) 684-701, ISSN 1473-7604
Éditeur: Royal Society of Chemistry
DOI: 10.1039/d1en00694k

Inter- and Intra-Laboratory Comparison of 6 Dustiness Testing Methods: Towards the Development of an OECD Testing Guideline

Auteurs: Carla Ribalta Carrasco, Ana Sofia Fonseca, Anna Pohl, Alexis Vignes, Søren S. Bjer-regaard, Neeraj Shandilya, Douglas Evans, Thomas A.J Kuhl busch, Jacques Bouillard, Keld A. Jensen
Publié dans: Annals of Work Exposures and Health, Numéro 67, 2023, Page(s) i97, ISSN 2398-7308
Éditeur: British Occupational Hygiene Society
DOI: 10.1093/annweh/wxac087.238

Determination of metallic nanoparticles in biological samples by single particle ICP-MS: a systematic review from sample collection to analysis

Auteurs: Adam Laycock, Nathaniel J. Clark, Robert Clough, Rachel Smith and Richard D. Handy
Publié dans: Environmental Science: Nano, Numéro 9, 2022, Page(s) 420-453, ISSN 2051-8153
Éditeur: Royal Society of Chemistry
DOI: 10.1039/d1en00680k

Towards the Standardization of Intestinal In Vitro Advanced Barrier Model for Nanoparticles Uptake and Crossing: The SiO2 Case Study

Auteurs: Olimpia Vincentini, Valentina Prota, Serena Cecchetti, Lucia Bertuccini, Antonella Tinari, Francesca Iosi and Isabella De Angelis
Publié dans: Cells, Numéro 11(21), 2022, Page(s) 3357, ISSN 2078-2489
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/cells11213357

Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety – A proposal for further actions

Auteurs: Eric A.J. Bleeker; Elmer Swart; Hedwig Braakhuis; María Luisa Fernández Cruz; Steffi Friedrichs; Ilse Gosens; Frank Herzberg; Keld Alstrup Jensen; Frank von der Kammer; Jolinde A.B. Kettelarij; Jose María Navas; Kirsten Rasmussen; Kathrin Schwirn; Maaike Visser
Publié dans: Regulatory Toxicology and Pharmacology, Numéro 139, 2023, ISSN 0273-2300
Éditeur: Academic Press
DOI: 10.1016/j.yrtph.2023.105360

Quantification of particulate Ag in rainbow trout organs following dietary exposure to silver nitrate, or two forms of engineered silver nanoparticles

Auteurs: Nathaniel J. Clark, Robert Clough, David Boyle, Richard D. Handy
Publié dans: Environmental Science: Nano, Numéro 8/6, 2021, Page(s) 1642-1653, ISSN 2051-8153
Éditeur: Royal Society of Chemistry
DOI: 10.1039/d1en00188d

Methods Harmonization for Nanomaterial Testing

Auteurs: Susana Lourei-ro, Patrícia V Silva, Zahra Khodaparast, Fábio Campos, Fábio Chen, Ana Lopes and Amadeu Soares
Publié dans: research@ua, Numéro 13, 2022, Page(s) 30
Éditeur: University of Aveiro

INISS-Nano: revised concept and action plan (International Network Initiative on Safe and Sustainable Nanotechnologies)

Auteurs: Andreas Falk; Pogany, Alexander; Aungkavattana, Pavadee; Bañares, Miguel A.; Beitollahi, Ali; Bim, Vinicius; Briffa, Sophie; Bochon, Anthony; Cassee, Flemming; Doridot, Fernand; Exner, Thomas; Farias, Patricia M.A.; Favre, Georges; Franzese, Giancarlo; Friedrichs, Steffi; Hristozov, Danail; Hunt, Neil; Indaraprasirt, Ramjitti; Karim, Md. E.; Khandelwal, Neha; Malsch, Ineke; Marcoulaki, Effie; Mar
Publié dans: Numéro 17, 2022
Éditeur: INISS nano
DOI: 10.5281/zenodo.7877359

Harmonizing methods to assess the ecotoxicity of layered double hydroxides nanomaterials in a freshwater microalgae

Auteurs: Fábio Campos
Publié dans: 2021
Éditeur: University UA

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