Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data

  1. Krebs, Alice
  2. Waldmann, Tanja
  3. Wilks, Martin F.
  4. van Vugt-Lussenburg, Barbara M. A.
  5. van der Burg, Bart
  6. Terron, Andrea
  7. Steger-Hartmann, Thomas
  8. Ruegg,Joelle
  9. Rovida, Costanze
  10. Pedersen, Emma
  11. Pallocca, Giorgia
  12. Luijten, Mirjam
  13. Leite, Sofia B.
  14. Kustermann, Stefan
  15. Kamp, Hennicke
  16. Hoeng, Julia
  17. Hewitt, Philip
  18. Herzler, Matthias
  19. Hengstler, Jan ORCID logo
  20. Heinonen, Tuula
  21. Hartung, Thomas
  22. Hardy, Barry
  23. Gantner, Florian
  24. Fritsche, Ellen
  25. Fant, Kristina
  26. Ezendam, Janine
  27. Exner, Thomas
  28. Dunkern, Torsten
  29. Dietrich, Daniel R.
  30. Coecke, Sandra
  31. Busquet, Francois
  32. Braeuning, Albert
  33. Bondarenko, Olesja
  34. Bennekou, Susanne H.
  35. Beilmann, Mario
  36. Leist, Marcel ORCID logo

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1000 Titel
  • Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data
1000 Autor/in
  1. Krebs, Alice |
  2. Waldmann, Tanja |
  3. Wilks, Martin F. |
  4. van Vugt-Lussenburg, Barbara M. A. |
  5. van der Burg, Bart |
  6. Terron, Andrea |
  7. Steger-Hartmann, Thomas |
  8. Ruegg,Joelle |
  9. Rovida, Costanze |
  10. Pedersen, Emma |
  11. Pallocca, Giorgia |
  12. Luijten, Mirjam |
  13. Leite, Sofia B. |
  14. Kustermann, Stefan |
  15. Kamp, Hennicke |
  16. Hoeng, Julia |
  17. Hewitt, Philip |
  18. Herzler, Matthias |
  19. Hengstler, Jan |
  20. Heinonen, Tuula |
  21. Hartung, Thomas |
  22. Hardy, Barry |
  23. Gantner, Florian |
  24. Fritsche, Ellen |
  25. Fant, Kristina |
  26. Ezendam, Janine |
  27. Exner, Thomas |
  28. Dunkern, Torsten |
  29. Dietrich, Daniel R. |
  30. Coecke, Sandra |
  31. Busquet, Francois |
  32. Braeuning, Albert |
  33. Bondarenko, Olesja |
  34. Bennekou, Susanne H. |
  35. Beilmann, Mario |
  36. Leist, Marcel |
1000 Erscheinungsjahr 2019
1000 LeibnizOpen
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2019-10-24
1000 Erschienen in
1000 Quellenangabe
  • 36(4):682-699
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2019
1000 Lizenz
1000 Verlagsversion
  • https://dx.doi.org/10.14573/altex.1909271 |
1000 Ergänzendes Material
  • https://www.altex.org/index.php/altex/article/view/1433/1456 |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Only few cell-based test methods are described by Organisation for Economic Co-operation and Development (OECD) test guidelines or other regulatory references (e.g., the European Pharmacopoeia). The majority of toxicity tests still falls into the category of non-guideline methods. Data from these tests may nevertheless be used to support regulatory decisions or to guide strategies to assess compounds (e.g., drugs, agrochemicals) during research and development if they fulfill basic requirements concerning their relevance, reproducibility and predictivity. Only a method description of sufficient clarity and detail allows interpretation and use of the data. To guide regulators faced with increasing amounts of data from non-guideline studies, the OECD formulated Guidance Document 211 (GD211) on method documentation for the purpose of safety assessment. As GD211 is targeted mainly at regulators, it leaves scientists less familiar with regulation uncertain as to what level of detail is required and how individual questions should be answered. Moreover, little attention was given to the description of the test system (i.e., cell culture) and the steps leading to it being established in the guidance. To address these issues, an annotated toxicity test method template (ToxTemp) was developed (i) to fulfill all requirements of GD211, (ii) to guide the user concerning the types of answers and detail of information required, (iii) to include acceptance criteria for test elements, and (iv) to define the cells sufficiently and transparently. The fully annotated ToxTemp is provided here, together with reference to a database containing exemplary descriptions of more than 20 cell-based tests.
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
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1000 Label
1000 Förderer
  1. Doerenkamp-Zbinden Foundation |
  2. Land Baden-Württemberg |
  3. Bundesministerium für Bildung und Forschung |
  4. EFSA |
  5. DK-EPA |
  6. Estonian Research Council |
  7. Horizon 2020 Framework Programme |
  8. Ministry for Culture and Science of the State of North-Rhine Westphalia |
1000 Fördernummer
  1. -
  2. -
  3. -
  4. -
  5. -
  6. PUT1015
  7. 681002; 825759
  8. 233-1.08.03.03-121972
1000 Förderprogramm
  1. -
  2. INVITE
  3. e:ToP program, Sys - BioTop
  4. -
  5. -
  6. -
  7. EU-ToxRisk; ENDpoiNTs
  8. CERST (Center for Alternatives to Animal Testing)
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer Doerenkamp-Zbinden Foundation |
    1000 Förderprogramm -
    1000 Fördernummer -
  2. 1000 joinedFunding-child
    1000 Förderer Land Baden-Württemberg |
    1000 Förderprogramm INVITE
    1000 Fördernummer -
  3. 1000 joinedFunding-child
    1000 Förderer Bundesministerium für Bildung und Forschung |
    1000 Förderprogramm e:ToP program, Sys - BioTop
    1000 Fördernummer -
  4. 1000 joinedFunding-child
    1000 Förderer EFSA |
    1000 Förderprogramm -
    1000 Fördernummer -
  5. 1000 joinedFunding-child
    1000 Förderer DK-EPA |
    1000 Förderprogramm -
    1000 Fördernummer -
  6. 1000 joinedFunding-child
    1000 Förderer Estonian Research Council |
    1000 Förderprogramm -
    1000 Fördernummer PUT1015
  7. 1000 joinedFunding-child
    1000 Förderer Horizon 2020 Framework Programme |
    1000 Förderprogramm EU-ToxRisk; ENDpoiNTs
    1000 Fördernummer 681002; 825759
  8. 1000 joinedFunding-child
    1000 Förderer Ministry for Culture and Science of the State of North-Rhine Westphalia |
    1000 Förderprogramm CERST (Center for Alternatives to Animal Testing)
    1000 Fördernummer 233-1.08.03.03-121972
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6419242.rdf
1000 Erstellt am 2020-03-18T13:22:44.439+0100
1000 Erstellt von 254
1000 beschreibt frl:6419242
1000 Bearbeitet von 25
1000 Zuletzt bearbeitet 2020-03-23T07:24:29.992+0100
1000 Objekt bearb. Mon Mar 23 07:24:17 CET 2020
1000 Vgl. frl:6419242
1000 Oai Id
  1. oai:frl.publisso.de:frl:6419242 |
1000 Sichtbarkeit Metadaten public
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