The State of the Art and Challenges of In Vitro Methods for Human Hazard Assessment of Nanomaterials in the Context of Safe-by-Design

Nienke Ruijter, Lya G Soeteman-Hernández, Marie Carrière, Matthew Boyles, Polly McLean, Julia Catalán, Alberto Katsumiti, Joan Cabellos, Camilla Delpivo, Araceli Sánchez Jiménez, Ana Candalija, Isabel Rodríguez-Llopis, Socorro Vázquez-Campos, Flemming R Cassee, Hedwig Braakhuis*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

Abstract

The Safe-by-Design (SbD) concept aims to facilitate the development of safer materials/products, safer production, and safer use and end-of-life by performing timely SbD interventions to reduce hazard, exposure, or both. Early hazard screening is a crucial first step in this process. In this review, for the first time, commonly used in vitro assays are evaluated for their suitability for SbD hazard testing of nanomaterials (NMs). The goal of SbD hazard testing is identifying hazard warnings in the early stages of innovation. For this purpose, assays should be simple, cost-effective, predictive, robust, and compatible. For several toxicological endpoints, there are indications that commonly used in vitro assays are able to predict hazard warnings. In addition to the evaluation of assays, this review provides insights into the effects of the choice of cell type, exposure and dispersion protocol, and the (in)accurate determination of dose delivered to cells on predictivity. Furthermore, compatibility of assays with challenging advanced materials and NMs released from nano-enabled products (NEPs) during the lifecycle is assessed, as these aspects are crucial for SbD hazard testing. To conclude, hazard screening of NMs is complex and joint efforts between innovators, scientists, and regulators are needed to further improve SbD hazard testing.

Original languageEnglish
Article number472
Pages (from-to)1-47
Number of pages47
JournalNanomaterials (Basel, Switzerland)
Volume13
Issue number3
Early online date24 Jan 2023
DOIs
Publication statusPublished - 1 Feb 2023

Bibliographical note

Funding Information:
This research was funded by the SAbyNA project, European Union’s Horizon 2020 research and innovation program under grant agreement No 862419, and by the Dutch Ministry of Infrastructure and Water Management.

Publisher Copyright:
© 2023 by the authors.

Keywords

  • SAbyNA
  • advanced materials
  • hazard testing
  • in vitro methods
  • nanomaterials
  • safe-by-design

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