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

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

doi:10.1016/j.nantod.2020.100941

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

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-CamposWendel Wohlleben, Agnes G. Oomen

^*Corresponding author for this work

Strathclyde Institute Of Pharmacy And Biomedical Sciences

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	100941
Number of pages	15
Journal	Nano Today
Volume	35
Early online date	8 Aug 2020
DOIs	https://doi.org/10.1016/j.nantod.2020.100941
Publication status	Published - 31 Dec 2020

Keywords

grouping
integrated approach to testing and assessment
nanoform
read-across
regulation
risk assessment
Safe(r) by design

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Stone, V., Gottardo, S., Bleeker, E. A. J., Braakhuis, H., Dekkers, S., Fernandes, T., Haase, A., Hunt, N., Hristozov, D., Jantunen, P., Jeliazkova, N., Johnston, H., Lamon, L., Murphy, F., Rasmussen, K., Rauscher, H., Jiménez, A. S., Svendsen, C., Spurgeon, D., ... Oomen, A. G. (2020). A framework for grouping and read-across of nanomaterials- supporting innovation and risk assessment. Nano Today, 35, Article 100941. https://doi.org/10.1016/j.nantod.2020.100941

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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.",

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author = "Vicki Stone and Stefania Gottardo and Bleeker, {Eric A.J.} and Hedwig Braakhuis and Susan Dekkers and Teresa Fernandes and Andrea Haase and Neil Hunt and Danail Hristozov and Paula Jantunen and Nina Jeliazkova and Helinor Johnston and Lara Lamon and Fiona Murphy and Kirsten Rasmussen and Hubert Rauscher and Jim{\'e}nez, {Araceli S{\'a}nchez} and Claus Svendsen and David Spurgeon and Socorro V{\'a}zquez-Campos and Wendel Wohlleben and Oomen, {Agnes G.}",

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Stone, V, Gottardo, S, Bleeker, EAJ, Braakhuis, H, Dekkers, S, Fernandes, T, Haase, A, Hunt, N, Hristozov, D, Jantunen, P, Jeliazkova, N, Johnston, H, Lamon, L, Murphy, F, Rasmussen, K, Rauscher, H, Jiménez, AS, Svendsen, C, Spurgeon, D, Vázquez-Campos, S, Wohlleben, W & Oomen, AG 2020, 'A framework for grouping and read-across of nanomaterials- supporting innovation and risk assessment', Nano Today, vol. 35, 100941. https://doi.org/10.1016/j.nantod.2020.100941

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AU - Haase, Andrea

AU - Hunt, Neil

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AU - Jeliazkova, Nina

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AU - Lamon, Lara

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AU - Rasmussen, Kirsten

AU - Rauscher, Hubert

AU - Jiménez, Araceli Sánchez

AU - Svendsen, Claus

AU - Spurgeon, David

AU - Vázquez-Campos, Socorro

AU - Wohlleben, Wendel

AU - Oomen, Agnes G.

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AB - 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.

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KW - integrated approach to testing and assessment

KW - nanoform

KW - read-across

KW - regulation

KW - risk assessment

KW - Safe(r) by design

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DO - 10.1016/j.nantod.2020.100941

M3 - Article

AN - SCOPUS:85089499769

SN - 1748-0132

VL - 35

JO - Nano Today

JF - Nano Today

M1 - 100941

ER -

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

Abstract

Keywords

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