Control Performance Of Amphibian Metamorphosis Assays With Xenopus Laevis.

Autor: Wheeler JR; Corteva Agriscience, Zuid-Oostsingel 24D, 4611 BB Bergen op Zoom, The Netherlands. Electronic address: james.wheeler@corteva.com., Puglisi R; Health and Environmental Sciences Institute, Washington, DC, USA. Electronic address: rpuglisi@hesiglobal.org., Bejarano AC; Corteva Agriscience, Zuid-Oostsingel 24D, 4611 BB Bergen op Zoom, The Netherlands., Gao Z; Bayer AG R&D Crop Science, Alfred-Nobel-Strasse 50, Monheim am Rhein, 40789, Germany., Lagadic L; Bayer AG R&D Crop Science, Alfred-Nobel-Strasse 50, Monheim am Rhein, 40789, Germany. Electronic address: laurent.lagadic@bayer.com., Glaberman S; Department of Environmental Science and Policy, George Mason University, Fairfax, Virginia, USA. Electronic address: sglaberm@gmu.edu., Mitchell CA; Health and Environmental Sciences Institute, Washington, DC, USA. Electronic address: cmitchell@hesiglobal.org., Burden N; National Centre for the 3Rs (NC3Rs), London, United Kingdom. Electronic address: natalie.burden@nc3rs.org.uk., Mingo V; Corteva Agriscience, Riedenburger Str. 7, 81677 München, Germany. Electronic address: valentin.mingo@corteva.com., Lynn SG; Office of Pesticide Programs, US Environmental Protection Agency, Washington, USA. Electronic address: lynn.scott@epa.gov., Embry MR; Health and Environmental Sciences Institute, Washington, DC, USA.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2025 Jan 18, pp. 105773. Date of Electronic Publication: 2025 Jan 18.
DOI: 10.1016/j.yrtph.2025.105773
Abstrakt: The amphibian metamorphosis assay (AMA) is an in vivo screen to assess potential interactions of chemicals with the amphibian thyroid system. Tadpoles are exposed for 21-days, then assessed for development and growth after 7 days and at test termination. This paper presents data from studies performed to satisfy test orders from the US EPA's Endocrine Disruptor Screening Program. Data Evaluation Records were used to collate the control variability and performance of biological endpoints in AMAs conducted in different laboratories, then supplemented with recent studies. We examine the statistical power of AMA endpoint analysis and assess whether historical control data (HCD) can assist evidence-based interpretation of the endpoints, with 52 studies from 7 different laboratories. HCD can be used to understand assay performance post validation. The analysis identifies some need for flexibility in the interpretation of the Test Guidelines' performance criteria, including latitude with analytical variability and statistical analysis of late-stage animals. Additionally, more guidance is suggested for feed regiments and the selection criteria for batches of animals to initiate the assay. Potential Guideline refinements that improve interpretation of the data and have potential to reduce the number of vertebrate animals used in the conduct of AMAs are identified and discussed.
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. The following author initials are employed by the private sector: JRW, ACB, ZG, LL, and VM.
(Copyright © 2025. Published by Elsevier Inc.)
Databáze: MEDLINE
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