ReadEDTest: A tool to assess the readiness of in vitro test methods under development for identifying endocrine disruptors.

Autor: Crouzet T; Université Paris Cité, T3S, Inserm UMR S-1124, F-75006 Paris, France., Grignard E; PEPPER, 22 rue Charcot, F-75013 Paris, France., Brion F; INERIS, Ecotoxicologie des substances et des milieux (ESMI), UMR I-02 SEBIO, Verneuil-en-Halatte, France., Blanc EB; Université Paris Cité, T3S, Inserm UMR S-1124, F-75006 Paris, France., Podechard N; Univ Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085, 35043 Rennes, France., Langouet S; Univ Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085, 35043 Rennes, France., Alonso-Magdalena P; Instituto de Investigación, Desarrollo e Innovación en Biotecnología Sanitaria de Elche (IDiBE), Universidad Miguel Hernández, Elche, Spain and Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Spain., Hubert P; PEPPER, 22 rue Charcot, F-75013 Paris, France., Kim MJ; Université Sorbonne Paris Nord, T3S, Inserm UMR S-1124, F-75006 Paris, France. Electronic address: min-ji.kim@inserm.fr., Audouze K; Université Paris Cité, T3S, Inserm UMR S-1124, F-75006 Paris, France. Electronic address: karine.audouze@u-paris.fr.
Jazyk: angličtina
Zdroj: Environment international [Environ Int] 2023 Apr; Vol. 174, pp. 107910. Date of Electronic Publication: 2023 Mar 31.
DOI: 10.1016/j.envint.2023.107910
Abstrakt: Growing evidence shows that endocrine disruptors (EDs), known to affect the reproductive system, may also disturb other hormone-regulated functions leading to cancers, neurodevelopmental defects, metabolic and immune diseases. To reduce exposure to EDs and limit their health effects, development of screening and mechanism-based assays to identify EDs is encouraged. Nevertheless, the crucial validation step of test methods by regulatory bodies is a time- and resource-consuming process. One of the main raisons of this long duration process is that method developers, mainly researchers, are not fully aware of the regulatory needs to validate a test. We propose an online self-assessment questionnaire (SAQ) called ReadEDTest easy to be used by all researchers. The aim of ReadEDTest is to speed up the validation process by assessing readiness criteria of in vitro and fish embryo ED test methods under development. The SAQ is divided into 7 sections and 13 sub-sections containing essential information requested by the validating bodies. The readiness of the tests can be assessed by specific score limits for each sub-section. Results are displayed via a graphical representation to help identification of the sub-sections having sufficient or insufficient information. The relevance of the proposed innovative tool was supported using two test methods already validated by the OECD and four under development test methods.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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