Two- and Three-Dimensional Culture Systems: Respiratory In Vitro Tissue Models for Chemical Screening and Risk-Based Decision Making DOI Creative Commons
Joanne Wallace,

Mary McElroy,

Mitchell Klausner

et al.

Pharmaceuticals, Journal Year: 2025, Volume and Issue: 18(1), P. 113 - 113

Published: Jan. 16, 2025

Risk of lung damage from inhaled chemicals or substances has long been assessed using animal models. However, New Approach Methodologies (NAMs) that replace, reduce, and/or refine the use animals in safety testing such as 2D and 3D cultures are increasingly being used to understand human-relevant toxicity responses for assessment hazard identification. Here we review models terms their application inhalation assessment. We highlight a key case study Organization Economic Cooperation Development (OECD), which model was assess human replace requirement 90-day rats. Finally, consider regulatory guidelines NAMs potential different aerosol studies depending on requirement/context use.

Language: Английский

Review of New Approach Methodologies for Application in Risk Assessment of Nanoparticles in the Food and Feed Sector: Status and Challenges DOI Open Access

Shirin M. Usmani,

Susanne Bremer‐Hoffmann, Karlien Cheyns

et al.

EFSA Supporting Publications, Journal Year: 2024, Volume and Issue: 21(9)

Published: Sept. 1, 2024

Abstract New Approach Methodologies (NAMs), broadly understood to include in silico, chemico, vitro and ex vivo methods, show great potential advancing risk assessment albeit their regulatory implementation is lagging. The EFSA Guidance on of nanomaterials (EFSA Nano‐RA) suggests nano‐specific best achieved through Integrated Approaches Testing Assessment (IATAs) with NAMs as the first choice generate new information. Integrating promises several advantages such a better human focus, more detailed insights into molecular mechanisms higher efficacy. However, applying NMs also poses considerable challenges issues related dispersion stability, dosimetry, agglomeration, dissolution, transformations or assay interferences. Significant efforts are being undertaken by standardisation organisations research projects establish various for NMs. Here thorough review provided covering that will be potentially useful food feed sector. It follows structure Nano‐RA expands it, where needed, support decision‐making selection NM assessment. begins an overview NAM‐frameworks, followed description individual including those relevant physicochemical characterisation, exposure hazard toxicodynamics toxicokinetics. focus concerning degradation/dissolution, genotoxicity, cytotoxicity, oxidative stress, (pro‐)inflammation, barrier integrity important endpoints initial screening according framework. As result, total 267 nano‐relevant NAMs, mostly “not validated” (with few notable exceptions), were included this review. Validation notwithstanding, could already prove reliable NMs, especially integrated approaches.

Language: Английский

Citations

4
On the dose-response association of fine and ultrafine particles in an urban atmosphere: toxicological outcomes on bronchial cells at realistic doses of exposure at the Air Liquid Interface DOI Creative Commons
Maurizio Gualtieri, Gloria Melzi, Francesca Costabile

et al.

Chemosphere, Journal Year: 2024, Volume and Issue: unknown, P. 143417 - 143417

Published: Sept. 1, 2024

Language: Английский

Citations

4
Using transcriptomics, proteomics and phosphoproteomics as new approach methodology (NAM) to define biological responses for chemical safety assessment DOI
Yuan Li,

Zhenpeng Zhang,

Songhao Jiang

et al.

Chemosphere, Journal Year: 2022, Volume and Issue: 313, P. 137359 - 137359

Published: Nov. 22, 2022

Language: Английский

Citations

17
Systems toxicology to advance human and environmental hazard assessment: A roadmap for advanced materials DOI Creative Commons
Mónica J.B. Amorim, Willie J.G.M. Peijnenburg, Dario Greco

et al.

Nano Today, Journal Year: 2022, Volume and Issue: 48, P. 101735 - 101735

Published: Dec. 21, 2022

Ideally, a Systems Toxicology (ST) approach is aimed at by (eco)toxicologists, i.e. multidisciplinary area incorporating classical toxicological concepts with omics technologies, and the understanding of this through computational data sciences, chemistry, mathematics, physics modelling. As outlined in several public reports (e.g. from ECHA-European Chemical Agency EFSA-European Food Safety Authority), way forward coming years Europe to integrate New Approach Methodologies (NAMs) (including technologies) into hazard hence risk assessment (RA). Adverse Outcome Pathways (AOPs) describe sequence events response stress, molecular initiating event until an adverse outcome, which relevant RA or regulatory decision-making. AOPs are one facilitators mechanistic RA, but it urgent increase inclusion vast knowledge available, especially for novel smart advanced materials (AdMa) multifunctional characteristics. There still many challenges routine usage NAMs, e.g. omics-based information. Here, we summarise current state art ST, benefits human environmental health cross available methods output. The importance has been highlighted even more pressing context AdMa. Furthermore, outline suggest recommendations future implementation.

Language: Английский

Citations

17
Two- and Three-Dimensional Culture Systems: Respiratory In Vitro Tissue Models for Chemical Screening and Risk-Based Decision Making DOI Creative Commons
Joanne Wallace,

Mary McElroy,

Mitchell Klausner

et al.

Pharmaceuticals, Journal Year: 2025, Volume and Issue: 18(1), P. 113 - 113

Published: Jan. 16, 2025

Risk of lung damage from inhaled chemicals or substances has long been assessed using animal models. However, New Approach Methodologies (NAMs) that replace, reduce, and/or refine the use animals in safety testing such as 2D and 3D cultures are increasingly being used to understand human-relevant toxicity responses for assessment hazard identification. Here we review models terms their application inhalation assessment. We highlight a key case study Organization Economic Cooperation Development (OECD), which model was assess human replace requirement 90-day rats. Finally, consider regulatory guidelines NAMs potential different aerosol studies depending on requirement/context use.

Language: Английский

Citations

0