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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Published inArchives of toxicology Vol. 94; no. 7; pp. 2435 - 2461
Main Authors 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
LanguageEnglish
Published Berlin/Heidelberg Springer Berlin Heidelberg 01.07.2020
Springer Nature B.V
Subjects
Assaying
Biomedical and Life Sciences
Biomedicine
Colchicine
Data processing
Documentation
Environmental Health
Evaluation
GIVIMP
Hazard assessment
In Vitro Systems
In vitro toxicology
Medicin och hälsovetenskap
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
Online AccessGet full text

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Abstract 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.
AbstractList Abstract 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.
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.
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.
Author Vrijenhoek, Nanette G.
Albrecht, Wiebke
Braunbeck, Thomas
ter Braak, Bas
Waldmann, Tanja
Stöber, Regina
Krebs, Alice
Boei, Jan
Fluri, David
Brajnik, Maja
Busquet, Francois
Moritz, Wolfgang
van der Burg, Bart
Dokler, Joh
Rovida, Costanza
Forsby, Anna
van Vugt-Lussenburg, Barbara M. A.
Dolde, Xenia
Sarkans, Ugis
Wilmes, Anja
Vrieling, Harry
Exner, Thomas E.
Mihalik, Balázs
Pallocca, Giorgia
Ulloa, Andrea Paola Cediel
Leist, Marcel
Janstova, Zofia
Lundqvist, Jessica
Fisher, Ciarán
Hengstler, Jan G.
Kumar, Manoj
Schimming, Johannes P.
Limonciel, Alice
Pastor, Manuel
Dinnyes, Andras
Kobolak, Julianna
Holzer, Anna-Katharina
von Hellfeld, Rebecca
Kisitu, Jaffar
Jennings, Paul
Schmidt, Bela Z.
Brecklinghaus, Tim
van de Water, Bob
Strassfeld, Tobias
Verfaillie, Catherine M.
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Issue 7
Keywords Metadata
Data processing
Nuclear receptor
In vitro toxicology
GIVIMP
Language English
License Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
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Snippet Hazard assessment, based on new approach methods (NAM), requires the use of batteries of assays, where individual tests may be contributed by different...
Abstract Hazard assessment, based on new approach methods (NAM), requires the use of batteries of assays, where individual tests may be contributed by...
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Biomedical and Life Sciences
Biomedicine
Colchicine
Data processing
Documentation
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Evaluation
GIVIMP
Hazard assessment
In Vitro Systems
In vitro toxicology
Medicin och hälsovetenskap
Mercury
Metadata
Nuclear receptor
Occupational Medicine/Industrial Medicine
Paclitaxel
Paracetamol
Paraquat
Pharmacology/Toxicology
Rotenone
Scientific validity
Strategy
Taxol
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Title The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods
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