A Systematic Review of Published Physiologically-based Kinetic Models and an Assessment of their Chemical Space Coverage DOI Creative Commons
Courtney V. Thompson, James W. Firman,

Michael R. Goldsmith

и другие.

Alternatives to Laboratory Animals, Год журнала: 2021, Номер 49(5), С. 197 - 208

Опубликована: Сен. 1, 2021

Across multiple sectors, including food, cosmetics and pharmaceutical industries, there is a need to predict the potential effects of xenobiotics. These are determined by intrinsic ability substance, or its derivatives, interact with biological system, concentration–time profile at target site. Physiologically-based kinetic (PBK) models can organ-level profiles, however, time resource intensive generate de novo. Read-across an approach used reduce replace animal testing, wherein information from data-rich chemical make predictions for data-poor chemical. The recent increase in published PBK presents opportunity use read-across modelling, that is, model one inform development evaluation similar Essential this process, identifying chemicals which already exists. Herein, results systematic review existing models, compliant Preferred Reporting Items Systematic Reviews Meta-Analyses (PRISMA) format, presented. Model information, species, sex, life-stage, route administration, software platform availability equations, was captured 7541 models. Chemical (identifiers physico-chemical properties) has also been recorded 1150 unique associated these This data set made readily accessible, as Microsoft Excel ® spreadsheet, providing valuable those developing, using evaluating industry, academia regulatory sectors.

Язык: Английский

Biocosmetics: technological advances and future outlook DOI Open Access
Nishu Goyal,

Frankline Jerold

Environmental Science and Pollution Research, Год журнала: 2021, Номер 30(10), С. 25148 - 25169

Опубликована: Ноя. 25, 2021

Язык: Английский

Процитировано

114
Application of AOPs to assist regulatory assessment of chemical risks – Case studies, needs and recommendations DOI Creative Commons
Lola Bajard, Ondřej Adamovský, Karine Audouze

и другие.

Environmental Research, Год журнала: 2022, Номер 217, С. 114650 - 114650

Опубликована: Окт. 26, 2022

While human regulatory risk assessment (RA) still largely relies on animal studies, new approach methodologies (NAMs) based in vitro, silico or non-mammalian alternative models are increasingly used to evaluate chemical hazards. Moreover, epidemiological studies with biomarkers of effect (BoE) also play an invaluable role identifying health effects associated exposures. To move towards the next generation (NGRA), it is therefore crucial establish bridges between NAMs and standard approaches, processes for increasing mechanistically-based biological plausibility studies. The Adverse Outcome Pathway (AOP) framework constitutes important tool address these needs but, despite a significant increase knowledge awareness, use AOPs RA remains limited. objective this paper issues related using context from various perspectives as was discussed workshop organized within European Union partnerships HBM4EU PARC spring 2022. presents examples where AOP has been proven useful process, particularly hazard prioritization characterization, integrated approaches testing (IATA), identification validation BoE Nevertheless, several limitations were identified that hinder optimal usability acceptance by community including lack quantitative information response-response relationships efficient ways map data (exposure toxicity) onto AOPs. summarizes suggestions, ongoing initiatives third-party tools may help overcome obstacles thus assure better implementation NGRA.

Язык: Английский

Процитировано

70
Implementing New Approach Methodologies (NAMs) in food safety assessments: Strategic objectives and actions taken by the European Food Safety Authority DOI Creative Commons
Irene Cattaneo, Maria Chiara Astuto,

Marco Binaglia

и другие.

Trends in Food Science & Technology, Год журнала: 2023, Номер 133, С. 277 - 290

Опубликована: Фев. 8, 2023

New Approach Methodologies (NAMs) comprise in silico and vitro methods applied as alternative to animal testing. Even though NAMs are already fully implemented research tools, their use regulatory risk assessments (RA) is limited currently. To promote the uptake/acceptance of NAMs, a paradigm shift assessment approaches, proper dialogue between assessors managers needed. Several reviews addressed for chemical RA generic terms, but without providing specific considerations on food/feed safety assessments. Therefore, this review, we give insights potential purposes EU. We summarise relevant projects activities coordinated by European Food Safety Authority (EFSA), which agency Union that contributes food feed chain. The review informs future developments human health RA, touches protein toxicity allergenicity, well environmental risks. Reducing testing filling some gaps via almost reality. Moreover, there growing body evidence confirming inclusion mechanistic information improves EFSA's address main challenge using intermediate effects observed non-animal models assessments, especially those linked adverse insufficiently covered or uncovered apical endpoints.

Язык: Английский

Процитировано

44
Replacement of animal testing by integrated approaches to testing and assessment (IATA): a call for in vivitrosi DOI Creative Commons
F. Caloni, I. De Ange̊lis, Thomas Härtung

и другие.

Archives of Toxicology, Год журнала: 2022, Номер 96(7), С. 1935 - 1950

Опубликована: Май 3, 2022

Abstract Alternative methods to animal use in toxicology are evolving with new advanced tools and multilevel approaches, answer from one side 3Rs requirements, on the other offering relevant valid tests for drugs chemicals, considering also their combination test strategies, a proper risk assessment. While stand-alone methods, have demonstrated be applicable some specific toxicological predictions limitations, strategy application of New Approach Methods (NAM), solve complex endpoints is addressed by Integrated Approaches Testing Assessment (IATA), aka Strategies (ITS) or Defined (DA). The central challenge evidence integration shared needs assessment systematic reviews an evidence-based Toxicology. Increasingly, machine learning (aka Artificial Intelligence, AI) lends itself integrate diverse streams. In this article, we give overview state art alternative IATA regulatory various hazards, outlining future orientation perspectives. We call leveraging synergies integrated approaches vivo, vitro silico as true vivitrosi.

Язык: Английский

Процитировано

42
Regulatory safety assessment of nanoparticles for the food chain in Europe DOI Creative Commons
Reinhilde Schoonjans, Jacqueline Castenmiller,

Qasim Chaudhry

и другие.

Trends in Food Science & Technology, Год журнала: 2023, Номер 134, С. 98 - 111

Опубликована: Фев. 3, 2023

The risk assessment of small particles (including nanoparticles) in products used the food chain EU falls within remit European Food Safety Authority (EFSA) and has been under thorough scientific considerations for over a decade. Now that more experience is gained with evaluating novel foods, contact materials, food/feed additives pesticides, outlines regulatory safety assessments data requirements are established. This paper reviews principles underlying testing particles, referring to two recently published EFSA guidance documents. Examples observations from assessing existing materials provided facilitate wider readership adequate implementation requirements. starting point physicochemical characterisation pristine material, being an engineered nanomaterial, nanostructured material or conventional contains fraction may retain properties at nanoscale. Key parameters threshold values establishing presence techniques methods complex matrices, as well approaches dietary exposure outlined. Where there likelihood remaining after gastrointestinal digestion, hazard identification required special provisions. In particular, certain nano-specific highlighted have be considered during toxicological aim demonstrate consumer Europe.

Язык: Английский

Процитировано

36
Endocrine Disruptor Compounds in Environment: Focus on Women’s Reproductive Health and Endometriosis DOI Open Access

Livia Interdonato,

Rosalba Siracusa, Roberta Fusco

и другие.

International Journal of Molecular Sciences, Год журнала: 2023, Номер 24(6), С. 5682 - 5682

Опубликована: Март 16, 2023

Endometriosis is an estrogen-dependent gynecologic illness that has long-term effects on a woman’s fertility, physical health, and overall quality of life. Growing evidence suggests endocrine-disrupting chemicals (EDCs) may be etiologically involved in the development severity disease. We consider available human EDCs endometriosis, limiting ourselves to studies have individually assessed chemical amounts women. Dioxins, BPA, Phthalates, other endocrine disruptors, like DDT, are among indicating environmental etiology for endometriosis. Collectively, this review describes how toxins linked lower fertility women, as well number reproductive diseases, focusing pathology endometriosis its treatments. Importantly, can used investigate techniques preventing negative EDC exposure.

Язык: Английский

Процитировано

33
Dermal bioavailability of perfluoroalkyl substances using in vitro 3D human skin equivalent models DOI Creative Commons
Oddný Ragnarsdóttir, Mohamed Abou‐Elwafa Abdallah, Stuart Harrad

и другие.

Environment International, Год журнала: 2024, Номер 188, С. 108772 - 108772

Опубликована: Май 23, 2024

Perfluoroalkyl substances (PFAS) have been identified in various products that come contact with human skin, ranging from school uniforms to personal care products. Despite this, knowledge on dermal uptake of PFAS is lacking. Thus, the absorption 17 was assessed, for first time, using vitro 3D-human skin equivalent models exposed 500 ng/cm

Язык: Английский

Процитировано

13
Current and emerging issues in chemical food safety DOI
Chen Liu, Danlei Wang, Ivonne M.C.M. Rietjens

и другие.

Current Opinion in Food Science, Год журнала: 2025, Номер unknown, С. 101284 - 101284

Опубликована: Фев. 1, 2025

Язык: Английский

Процитировано

2
Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology DOI Creative Commons
Monica Piergiovanni,

Milena Mennecozzi,

Erio Barale-Thomas

и другие.

Archives of Toxicology, Год журнала: 2025, Номер unknown

Опубликована: Фев. 13, 2025

Язык: Английский

Процитировано

1
Safety Testing of Cosmetic Products: Overview of Established Methods and New Approach Methodologies (NAMs) DOI Creative Commons

Manon Barthe,

Clarisse Bavoux,

F. Finot

и другие.

Cosmetics, Год журнала: 2021, Номер 8(2), С. 50 - 50

Опубликована: Июнь 11, 2021

Cosmetic products need to have a proven efficacy combined with comprehensive toxicological assessment. Before the current regulation N°1223/2009, 7th Amendment European Cosmetics Directive has banned animal testing for cosmetic and ingredients in 2004 2009, respectively. An increasing number of alternatives been developed validated safety ingredients. For example, 2D cell culture models derived from human skin can be used evaluate anti-inflammatory properties, or predict sensitization potential; 3D equivalent are irritation excised is as gold standard evaluation dermal absorption. The aim this manuscript give an overview main vitro ex vivo alternative focus on regulatory requirements, genotoxicity potential, eye irritation, endocrine Advantages limitations each model discussed novel technologies capable addressing these presented.

Язык: Английский

Процитировано

44