How to Formulate Hypotheses and IATAs to Support Grouping and Read-Across of Nanoforms

Manufacturing and functionalizing materials at the nanoscale can lead to the generation of a whole array of nanoforms (NFs) of substances varying for example in size, morphology and surface characteristics. Due to financial, time and ethical considerations, testing every unique NF for their potential adverse effects is virtually impossible. Use of hypothesis-driven grouping and read-across approaches to produce the data needed will make the risk assessment process more efficient. The GRACIOUS Framework supports users in acquiring the necessary information and making the decisions needed to group different NFs. For each grouping hypothesis an Integrated Approach to Testing and Assessment (IATA) guides the user in data gathering and acquisition to test the hypothesis in a structured format to facilitate efficient decision-making. Here we present a template used to generate a grouping hypothesis encompassing information relevant to safety assessment. A summary of the template-derived hypotheses is provided, along with the IATAs generated by the GRACIOUS project, focusing on hypotheses relevant to human health. We discuss the application and flexibility of these resources and how they provide an opportunity to expand the application of grouping and read-across to a wider range of NFs and substances.

MURPHY Fiona;  JOHNSTON Helinor;  DEKKERS Susan;  BLEEKER Eric;  OOMEN Agnes;  FERNANDES Teresa F.;  RASMUSSEN Kirsten;  JANTUNEN Anna Paula;  RAUSCHER Hubert;  HUNT Neil;  DI CRISTO Luisana;  BRAAKHUIS Hedwig;  HAASE Andrea;  HRISTOZOV Danail;  WOHLLEBEN Wendel;  SABELLA Stefania;  STONE Vicki; 

2023-02-17

SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH

JRC128318

1868-596X (online),   

https://www.altex.org/index.php/altex/article/view/2448,    https://publications.jrc.ec.europa.eu/repository/handle/JRC128318,   

10.14573/altex.2203241 (online),