The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods

Hazard assessment, based on new approach methods (NAM), requires the use of batteries of assays, where individual tests may be contributed by different laboratories. A unified strategy for such collaborative testing is presented. It details all procedures required to allow test information to be usa...

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Veröffentlicht in:ARCHIVES OF TOXICOLOGY Jg. 94; H. 7; S. 2435 - 2461
Hauptverfasser: Krebs, Alice, van Vugt-Lussenburg, Barbara M. A., Waldmann, Tanja, Albrecht, Wiebke, Boei, Jan, ter Braak, Bas, Brajnik, Maja, Braunbeck, Thomas, Brecklinghaus, Tim, Busquet, Francois, Dinnyes, Andras, Dokler, Joh, Dolde, Xenia, Exner, Thomas E., Fisher, Ciarán, Fluri, David, Forsby, Anna, Hengstler, Jan G., Holzer, Anna-Katharina, Janstova, Zofia, Jennings, Paul, Kisitu, Jaffar, Kobolak, Julianna, Kumar, Manoj, Limonciel, Alice, Lundqvist, Jessica, Mihalik, Balázs, Moritz, Wolfgang, Pallocca, Giorgia, Ulloa, Andrea Paola Cediel, Pastor, Manuel, Rovida, Costanza, Sarkans, Ugis, Schimming, Johannes P., Schmidt, Bela Z., Stöber, Regina, Strassfeld, Tobias, van de Water, Bob, Wilmes, Anja, van der Burg, Bart, Verfaillie, Catherine M., von Hellfeld, Rebecca, Vrieling, Harry, Vrijenhoek, Nanette G., Leist, Marcel
Format: Journal Article Verlag
Sprache:Englisch
Veröffentlicht: Berlin/Heidelberg Springer Berlin Heidelberg 01.07.2020
Springer Nature B.V
Schlagworte:
Assaying
Biomedical and Life Sciences
Biomedicine
Colchicine
Data processing
Documentation
Environmental Health
Evaluation
GIVIMP
Hazard assessment
In Vitro Systems
In vitro toxicology
Mercury
Metadata
Nuclear receptor
Occupational Medicine/Industrial Medicine
Paclitaxel
Paracetamol
Paraquat
Pharmacology/Toxicology
Rotenone
Scientific validity
Strategy
Taxol
Metadata
Data processing
Nuclear receptor
In vitro toxicology
GIVIMP
ISSN:0340-5761, 1432-0738, 1432-0738
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Zusammenfassung:Hazard assessment, based on new approach methods (NAM), requires the use of batteries of assays, where individual tests may be contributed by different laboratories. A unified strategy for such collaborative testing is presented. It details all procedures required to allow test information to be usable for integrated hazard assessment, strategic project decisions and/or for regulatory purposes. The EU-ToxRisk project developed a strategy to provide regulatorily valid data, and exemplified this using a panel of > 20 assays (with > 50 individual endpoints), each exposed to 19 well-known test compounds (e.g. rotenone, colchicine, mercury, paracetamol, rifampicine, paraquat, taxol). Examples of strategy implementation are provided for all aspects required to ensure data validity: (i) documentation of test methods in a publicly accessible database; (ii) deposition of standard operating procedures (SOP) at the European Union DB-ALM repository; (iii) test readiness scoring accoding to defined criteria; (iv) disclosure of the pipeline for data processing; (v) link of uncertainty measures and metadata to the data; (vi) definition of test chemicals, their handling and their behavior in test media; (vii) specification of the test purpose and overall evaluation plans. Moreover, data generation was exemplified by providing results from 25 reporter assays. A complete evaluation of the entire test battery will be described elsewhere. A major learning from the retrospective analysis of this large testing project was the need for thorough definitions of the above strategy aspects, ideally in form of a study pre-registration, to allow adequate interpretation of the data and to ensure overall scientific/toxicological validity.
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ISSN:0340-5761
1432-0738
1432-0738
DOI:10.1007/s00204-020-02802-6