Erratum to Template for the Description of Cell-Based Toxicological Test Methods to Allow Evaluation and Regulatory Use of the Data

Krebs, A. T.; Waldmann, Tanja; Wilks, Martin F.; Vugt-Lussenburg, Barbara M.A. van; Burg, Bart van der; Terron, Andrea; Steger‐Hartmann, Thomas; Rüegg, Joëlle; Rovida, Costanza; Pedersen, Emma; Pallocca, Giorgia; Luijten, Mirjam; Leite, Sofia B.; Kustermann, Stefan; Kamp, Hennicke; Hoeng, Julia; Hewitt, Philip; Herzler, Matthias; Hengstler, Jan G.; Heinonen, Tuula; Hartung, Thomas; Hardy, Barry; Gantner, Florian; Fritsche, Ellen; Fant, Kristina; Ezendam, Janine; Exner, Thomas E.; Dunkern, Torsten; Dietrich, Daniel R.; Coecke, Sandra; Busquet, François; Braeuning, Albert; Bondarenko, Olesja; Bennekou, Susanne Hougaard; Beilmann, Mario; Leist, Marcel

doi:10.14573/altex.1909271e

Cited by 23 publications

(31 citation statements)

References 16 publications

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“…It was considered important to complement the SOP by an overarching test method description (Krebs et al 2019b ; Leist et al 2010 , 2012a ; Schmidt et al 2017 ) (Fig. 3 ).…”

Section: Resultsmentioning

confidence: 99%

“…During pilot runs and test trials, it was found that users needed support by detailed guidance and explanations on all parts of the test methods questionnaire, and this system was again optimized with help of external experts. The final outcome was a template for the test method questionnaire (Krebs et al 2019b ), and a repository of comprehensive test method descriptions ( https://eu-toxrisk.douglasconnect.com/public/ ) (Fig. 4 b).…”

Section: Resultsmentioning

confidence: 99%

“…One of our most important advances was the template for a comprehensive methods description, and a related database for the methods of this study (Krebs et al 2019b ), and this achievement of the CSY has been used subsequently to document methods in read-across (RAx) case studies (Escher et al 2019 ). The regulators reviewing the case studies found the transparent disclosure of all methods very important, and they suggest the RAx studies to be submitted to the OECD as examples for good practice.…”

Section: Discussionmentioning

confidence: 99%

“…The SOPs have been deposited at the DB-ALM database ( https://ecvam-dbalm.jrc.ec.europa.eu/methods-and-protocols ). An overview of the content of the test method description template has been recently published (Krebs et al 2019b ) and public access to the test method description is possible under https://eu-toxrisk.douglasconnect.com/public/ .…”

Section: Methodsmentioning

confidence: 99%

“…To guide the user through the progress of creating a test method description, a web interface was created for internal use in the EU-ToxRisk project. The web-based guidance has been compiled and will be made publicly available in due course, while the printed version is already available now (Krebs et al 2019b ). All submitted test methods were reviewed by the project’s quality assurance group, and often several rounds of amendments followed.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2020

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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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“…It was considered important to complement the SOP by an overarching test method description (Krebs et al 2019b ; Leist et al 2010 , 2012a ; Schmidt et al 2017 ) (Fig. 3 ).…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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

et al. 2020

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Setting the stage for next-generation risk assessment with non-animal approaches: the EU-ToxRisk project experience

et al. 2020

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In 2016, the European Commission launched the EU-ToxRisk research project to develop and promote animal-free approaches in toxicology. The 36 partners of this consortium used in vitro and in silico methods in the context of case studies (CSs). These CSs included both compounds with a highly defined target (e.g. mitochondrial respiratory chain inhibitors) as well as compounds with poorly defined molecular initiation events (e.g. short-chain branched carboxylic acids). The initial project focus was on developing a science-based strategy for read-across (RAx) as an animal-free approach in chemical risk assessment. Moreover, seamless incorporation of new approach method (NAM) data into this process (= NAM-enhanced RAx) was explored. Here, the EU-ToxRisk consortium has collated its scientific and regulatory learnings from this particular project objective. For all CSs, a mechanistic hypothesis (in the form of an adverse outcome pathway) guided the safety evaluation. ADME data were generated from NAMs and used for comprehensive physiological-based kinetic modelling. Quality assurance and data management were optimized in parallel. Scientific and Regulatory Advisory Boards played a vital role in assessing the practical applicability of the new approaches. In a next step, external stakeholders evaluated the usefulness of NAMs in the context of RAx CSs for regulatory acceptance. For instance, the CSs were included in the OECD CS portfolio for the Integrated Approach to Testing and Assessment project. Feedback from regulators and other stakeholders was collected at several stages. Future chemical safety science projects can draw from this experience to implement systems toxicology-guided, animal-free next-generation risk assessment.

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Towards a qAOP framework for predictive toxicology - Linking data to decisions

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Computational Toxicology

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Erratum to Template for the Description of Cell-Based Toxicological Test Methods to Allow Evaluation and Regulatory Use of the Data

Cited by 23 publications

References 16 publications

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

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

Setting the stage for next-generation risk assessment with non-animal approaches: the EU-ToxRisk project experience

Towards a qAOP framework for predictive toxicology - Linking data to decisions

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