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GRACIOUS: Grouping, Read-Across, CharacterIsation and classificatiOn framework for regUlatory risk assessment of manufactured nanomaterials and Safer design of nano-enabled products

Deliverables

Prioritised methods and their reproducibility for intrinsic physicochemical properties

Methodical guidance on physicochemical characterization for grouping and read-across purposes. This includes a proof of reproducibility on benchmark materials between the lead lab and the backup labs for each property.

Report of the NMs/NFs, NEPs and released NMs/NFs supplied to other WPs

Table of NMs, NFs NEP and released NMs/NFs distributed to WP3, 4 and 5 for characterization / testing.

Guidance Document

A Guidance Document detailing the entire Framework and its individual components will be generated It will provide details of how to conduct grouping and use the results for readacross for risk assessment andor classification The Guidance Document will further detail how the software module cf Task 67 can be employed in current risk assessment and management tools eg SUN DSS GUIDEnano Tool

Data curation system

Interim deliverable due month 12 and 24Data curation system based on the eNanoMapper database with tools for data curation and ontology mapping

Requirements for data quality criteria, data sources, modelling tools and terminology

Interim deliverable due month 6 and 18This report describes the criteria and requirements for data quality terminology and modelling to be incorporated in the GRACIOUS Framework

Stakeholder events, training and conference

Interim deliverable due month 6 and 27We will have three stakeholder events together with WP1 to gather feedback on the development of the tool We will also run two training schools if possible together with other EC funded initiatives to transfer knowledge to the next generation of researchers and a final event to disseminate the projects results to stakeholders

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Publications

Predicting dissolution and transformation of inhaled nanoparticles in the lung using abiotic flow 1 cells: The case of barium sulfate

Author(s): Keller, Johannes G.; Graham, Uschi; Koltermann-Jülly, Johanna; Gelein, Robert; Ma-Hock, Lan; Landsiedel, Robert; Wiemann, Martin; Oberdörster, Günter; Alison Elder; Wohlleben, Wendel
Published in: Scientific Reports, 458 (2020), 2020, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.5281/zenodo.3239013

Understanding Dissolution Rates via Continuous Flow Systems with Physiologically Relevant Metal Ion Saturation in Lysosome

Author(s): Johannes Keller, Willie Peijnenburg, Kai Werle, Robert Landsiedel, Wendel Wohlleben
Published in: Nanomaterials, 10/2, 2020, Page(s) 311, ISSN 2079-4991
Publisher: Multidisciplinary Digital Publishing Institute
DOI: 10.3390/nano10020311

Variation in dissolution behavior among different nanoforms and its implication for grouping approaches in inhalation toxicity

Author(s): Johannes G. Keller, Michael Persson, Philipp Müller, Lan Ma-Hock, Kai Werle, Josje Arts, Robert Landsiedel, Wendel Wohlleben
Published in: NanoImpact, 23, 2021, Page(s) 100341, ISSN 2452-0748
Publisher: Elsevier B.V.
DOI: 10.1016/j.impact.2021.100341

Chemical transformation and surface functionalisation affect the potential to group nanoparticles for risk assessment

Author(s): Carolin L. Schultz, Jessica Adams, Kerstin Jurkschat, Stephen Lofts, David J. Spurgeon
Published in: Environmental Science: Nano, 7/10, 2020, Page(s) 3100-3107, ISSN 2051-8153
Publisher: Royal Society of Chemistry
DOI: 10.1039/d0en00578a

Organomodified nanoclays induce less inflammation, acute phase response, and genotoxicity than pristine nanoclays in mice lungs

Author(s): Emilio Di Ianni, Peter Møller, Alicja Mortensen, Józef Szarek, Per Axel Clausen, Anne Thoustrup Saber, Ulla Vogel, Nicklas Raun Jacobsen
Published in: Nanotoxicology, 14/7, 2020, Page(s) 869-892, ISSN 1743-5390
Publisher: Informa Healthcare
DOI: 10.1080/17435390.2020.1771786

Composites of epoxy and graphene-related materials: Nanostructure characterization and release quantification

Author(s): Tobias Hammer, Woranan Netkueakul, Peter Zolliker, Claudia Schreiner, Renato Figi, Oliver Braun, Jing Wang
Published in: NanoImpact, 20, 2020, Page(s) 100266, ISSN 2452-0748
Publisher: Elsevier
DOI: 10.1016/j.impact.2020.100266

Acute waterborne and chronic sediment toxicity of silver and titanium dioxide nanomaterials towards the oligochaete, Lumbriculus variegatus

Author(s): Simon Little, Helinor J. Johnston, Vicki Stone, Teresa F. Fernandes
Published in: NanoImpact, 21, 2021, Page(s) 100291, ISSN 2452-0748
Publisher: Elsevier
DOI: 10.1016/j.impact.2020.100291

A framework for grouping and read-across of nanomaterials- supporting innovation and risk assessment

Author(s): Vicki Stone, Stefania Gottardo, Eric A.J. Bleeker, Hedwig Braakhuis, Susan Dekkers, Teresa Fernandes, Andrea Haase, Neil Hunt, Danail Hristozov, Paula Jantunen, Nina Jeliazkova, Helinor Johnston, Lara Lamon, Fiona Murphy, Kirsten Rasmussen, Hubert Rauscher, Araceli Sánchez Jiménez, Claus Svendsen, David Spurgeon, Socorro Vázquez-Campos, Wendel Wohlleben, Agnes G. Oomen
Published in: Nano Today, 35, 2020, Page(s) 100941, ISSN 1748-0132
Publisher: Elsevier BV
DOI: 10.1016/j.nantod.2020.100941

A Method to Assess the Relevance of Nanomaterial Dissolution during Reactivity Testing

Author(s): Willie J. G. M. Peijnenburg, Emmanuel Ruggiero, Matthew Boyles, Fiona Murphy, Vicki Stone, Derek A. Elam, Kai Werle, Wendel Wohlleben
Published in: Materials, 13/10, 2020, Page(s) 2235, ISSN 1996-1944
Publisher: MDPI Open Access Publishing
DOI: 10.3390/ma13102235

A review to support the derivation of a worst-case dermal penetration value for nanoparticles

Author(s): Irene Gimeno-Benito, Anna Giusti, Susan Dekkers, Andrea Haase, Gemma Janer
Published in: Regulatory Toxicology and Pharmacology, 119, 2021, Page(s) 104836, ISSN 0273-2300
Publisher: Academic Press
DOI: 10.1016/j.yrtph.2020.104836

The effect of capping agents on the toxicity of silver nanoparticles to Danio rerio embryos

Author(s): N. Abramenko, T. B. Demidova, Yu. A. Krutyakov, P. M. Zherebin, E. Y. Krysanov, L. M. Kustov, W. Peijnenburg
Published in: Nanotoxicology, 13/1, 2018, Page(s) 1-13, ISSN 1743-5390
Publisher: Informa Healthcare
DOI: 10.1080/17435390.2018.1498931

Making use of available and emerging data to predict the hazards of engineered nanomaterials by means of in silico tools: A critical review

Author(s): G. Basei, D. Hristozov, L. Lamon, A. Zabeo, N. Jeliazkova, G. Tsiliki, A. Marcomini, A. Torsello
Published in: NanoImpact, 13, 2019, Page(s) 76-99, ISSN 2452-0748
Publisher: Elsevier
DOI: 10.1016/j.impact.2019.01.003

In vitro-in vivo correlations of pulmonary inflammogenicity and genotoxicity of MWCNT

Author(s): Emilio Di Ianni, Johanna Samulin Erdem, Peter Møller, Nicklas Mønster Sahlgren, Sarah Søs Poulsen, Kristina Bram Knudsen, Shan Zienolddiny, Anne Thoustrup Saber, Håkan Wallin, Ulla Vogel, Nicklas Raun Jacobsen
Published in: Particle and Fibre Toxicology, 18/1, 2021, Page(s) Article number: 25 (2021), ISSN 1743-8977
Publisher: BioMed Central
DOI: 10.1186/s12989-021-00413-2

Importance of the number emission factor of combustion-generated aerosols from nano-enabled products

Author(s): Tobias Hammer, Nathan Bossa, Michael Persson, Adrian Wichser, Ken Lehner, Emmanuel Ruggiero, Ana Sofia Fonseca, Milijana Jovic, Sabyasachi Gaan, Wendel Wohlleben, Jing Wang
Published in: NanoImpact, 22, 2021, Page(s) 100307, ISSN 2452-0748
Publisher: Elsevier B.V.
DOI: 10.1016/j.impact.2021.100307

An integrated approach to testing and assessment of high aspect ratio nanomaterials and its application for grouping based on a common mesothelioma hazard

Author(s): Fiona Murphy, Susan Dekkers, Hedwig Braakhuis, Lan Ma-Hock, Helinor Johnston, Gemma Janer, Luisana di Cristo, Stefania Sabella, Nicklas Raun Jacobsen, Agnes G. Oomen, Andrea Haase, Teresa Fernandes, Vicki Stone
Published in: NanoImpact, 22, 2021, Page(s) 100314, ISSN 2452-0748
Publisher: Elsevier
DOI: 10.1016/j.impact.2021.100314

Source specific exposure and risk assessment for indoor aerosols

Author(s): Antti Joonas Koivisto, Kirsten Inga Kling, Otto Hänninen, Michael Jayjock, Jakob Löndahl, Aneta Wierzbicka, Ana Sofia Fonseca, Katrine Uhrbrand, Brandon E. Boor, Araceli Sánchez Jiménez, Kaarle Hämeri, Miikka Dal Maso, Susan F. Arnold, Keld A. Jensen, Mar Viana, Lidia Morawska, Tareq Hussein
Published in: Science of The Total Environment, 668, 2019, Page(s) 13-24, ISSN 0048-9697
Publisher: Elsevier BV
DOI: 10.1016/j.scitotenv.2019.02.398

Quality of physicochemical data on nanomaterials: an assessment of data completeness and variability

Author(s): Daniele Comandella, Stefania Gottardo, Iria Maria Rio-Echevarria, Hubert Rauscher
Published in: Nanoscale, 12/7, 2020, Page(s) 4695-4708, ISSN 2040-3364
Publisher: Royal Society of Chemistry
DOI: 10.1039/c9nr08323e

Aerogels are not regulated as nanomaterials, but can be assessed by tiered testing and grouping strategies for nanomaterials

Author(s): Johannes G. Keller, Martin Wiemann, Sibylle Gröters, Kai Werle, Antje Vennemann, Robert Landsiedel, Wendel Wohlleben
Published in: Nanoscale Advances, 3/13, 2021, Page(s) 3881-3893, ISSN 2516-0230
Publisher: Royal Society of Chemistry
DOI: 10.1039/d1na00044f

A Weight of Evidence approach to classify nanomaterials according to the EU Classification, Labelling and Packaging Regulation criteria

Author(s): Gianpietro Basei, Alex Zabeo, Kirsten Rasmussen, Georgia Tsiliki, Danail Hristozov
Published in: NanoImpact, 24, 2021, Page(s) 100359, ISSN 2452-0748
Publisher: Elsevier B.V.
DOI: 10.1016/j.impact.2021.100359

Pro-inflammatory response and genotoxicity caused by clay and graphene nanomaterials in A549 and THP-1 cells

Author(s): Emilio Di Ianni, Peter Møller, Ulla Birgitte Vogel, Nicklas Raun Jacobsen
Published in: Mutation Research/Genetic Toxicology and Environmental Mutagenesis, 872, 2021, Page(s) 503405, ISSN 1383-5718
Publisher: Elsevier BV
DOI: 10.1016/j.mrgentox.2021.503405

Guidance in a Nutshell: GRACIOUS Framework for grouping and read-across of nanomaterials and nanoforms

Author(s): Neil Hunt
Published in: 1, 2021
Publisher: GRACIOUS
DOI: 10.5281/zenodo.5534105

Guidance on the FRACIOUS Framework for grouping and read-across of nanomaterials and nanoforms

Author(s): Neil Hunt
Published in: 2021
Publisher: GRACIOUS
DOI: 10.5281/zenodo.5534466