Human-based New Approach Methodologies in Developmental Toxicity Testing: A Step Ahead from the State-of-the-art with a Feto-placental Organ-on-a-chip Platform

Michaela Luconi; Miguel Angel Sogorb; Udo R. Markert; Emilio Benfenati; Tobias May; Susanne Wolbank; Alessandra Roncaglioni; Astrid Schmidt; Marco Straccia; Sabrina Tait

doi:10.20944/preprints202211.0206.v1

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preprints.org > biology and life sciences > toxicology > doi: 10.20944/preprints202211.0206.v1

Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Human-based New Approach Methodologies in Developmental Toxicity Testing: A Step Ahead from the State-of-the-art with a Feto-placental Organ-on-a-chip Platform

Alessandra Roncaglioni

Astrid Schmidt

Marco Straccia

Sabrina Tait

Version 1 : Received: 9 November 2022 / Approved: 11 November 2022 / Online: 11 November 2022 (02:00:48 CET)

A peer-reviewed article of this Preprint also exists.

Luconi, M.; Sogorb, M.A.; Markert, U.R.; Benfenati, E.; May, T.; Wolbank, S.; Roncaglioni, A.; Schmidt, A.; Straccia, M.; Tait, S. Human-Based New Approach Methodologies in Developmental Toxicity Testing: A Step Ahead from the State of the Art with a Feto–Placental Organ-on-Chip Platform. Int. J. Environ. Res. Public Health 2022, 19, 15828. Luconi, M.; Sogorb, M.A.; Markert, U.R.; Benfenati, E.; May, T.; Wolbank, S.; Roncaglioni, A.; Schmidt, A.; Straccia, M.; Tait, S. Human-Based New Approach Methodologies in Developmental Toxicity Testing: A Step Ahead from the State of the Art with a Feto–Placental Organ-on-Chip Platform. Int. J. Environ. Res. Public Health 2022, 19, 15828.

Abstract

Developmental toxicity testing urgently requires the implementation of human relevant new approach methodologies (NAMs) that better recapitulate the peculiar nature of human physiology during pregnancy, especially the placenta and the maternal/fetal interface, which represent a key stage for the human lifelong health. Fit-for-purpose NAMs for the placental-fetal interface are desirable to improve the biological knowledge of environmental exposure at molecular level and to reduce the high cost, time and ethical impact of animal studies. This article reviews the state of the art on the available in vitro (placental, fetal and amniotic cell-based systems) and in silico NAMs of human relevance for developmental toxicity testing purposes, as well as of the available Adverse Outcome Pathways related to developmental toxicity. The OECD TG 414 for the identification and assessment of deleterious effects of prenatal exposure to chemicals on developing organisms will be discussed to delineate the regulatory context and to better debate what is missing and needed in the context of the developmental origins of health and disease hypothesis to significantly improve this sector. Starting from this analysis, the development of a novel human feto-placental organ-on-chip platform will be introduced as an innovative alternative tool for developmental toxicity testing, considering possible implementation and validation strategies to overcome the limitation of the current animal studies and NAMs available in regulatory toxicology and in the biomedical field.

Keywords

new approach methodologies (NAMs); adverse outcome pathways (AOPs); endocrine disruptors; animal replacement; OECD TG 414

Subject

Biology and Life Sciences, Toxicology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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