TY - JOUR
T1 - Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data
AU - Krebs, Alice
AU - Waldmann, Tanja
AU - Wilks, Martin F.
AU - van Vugt-Lussenburg, Barbara M.A.
AU - van der Burg, Bart
AU - Terron, Andrea
AU - Steger-Hartmann, Thomas
AU - Ruegg, Joelle
AU - Rovida, Costanza
AU - Pedersen, Emma
AU - Pallocca, Giorgia
AU - Luijten, Mirjam
AU - Leite, Sofia B.
AU - Kustermann, Stefan
AU - Kamp, Hennicke
AU - Hoeng, Julia
AU - Hewitt, Philip
AU - Herzler, Matthias
AU - Hengstler, Jan G.
AU - Heinonen, Tuula
AU - Hartung, Thomas
AU - Hardy, Barry
AU - Gantner, Florian
AU - Fritsche, Ellen
AU - Fant, Kristina
AU - Ezendam, Janine
AU - Exner, Thomas
AU - Dunkern, Torsten
AU - Dietrich, Daniel R.
AU - Coecke, Sandra
AU - Busquet, Francois
AU - Braeuning, Albert
AU - Bondarenko, Olesja
AU - Bennekou, Susanne H.
AU - Beilmann, Mario
AU - Leist, Marcel
N1 - Funding Information:
This work was supported by the Doerenkamp-Zbinden foundation, the Land-BW (INVITE), the BMBF (e:ToP program, Sys-BioTop), grants by EFSA and DK-EPA, Estonian Research Council grant PUT1015 as well as the projects from the European Union’s Horizon 2020 research and innovation programme EU-ToxRisk (grant agreement No 681002), ENDpoiNTs (grant agreement No 825759), and the project CERST (Center for Alternatives to Animal Testing) of the Ministry for Culture and Science of the State of North-Rhine Westphalia, Germany [233-1.08.03.03-121972]. We are grateful to many contributors not listed as authors. Especially a whole team of experts from EURL-ECVAM gave important advice.
Funding Information:
This work was supported by the Doerenkamp-Zbinden foundation, the Land-BW (INVITE), the BMBF (e:ToP program, SysBioTop), grants by EFSA and DK-EPA, Estonian Research Council grant PUT1015 as well as the projects from the European Union's Horizon 2020 research and innovation programme EU-ToxRisk (grant agreement No 681002), ENDpoiNTs (grant agreement No 825759), and the project CERST (Center for Alternatives to Animal Testing) of the Ministry for Culture and Science of the State of North-Rhine Westphalia, Germany [233-1.08.03.03-121972]. We are grateful to many contributors not listed as authors. Especially a whole team of experts from EURL-ECVAM gave important advice.
Publisher Copyright:
© The Authors, 2019.
PY - 2019/10
Y1 - 2019/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85074227776&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85074227776&partnerID=8YFLogxK
U2 - 10.14573/altex.1909271
DO - 10.14573/altex.1909271
M3 - Article
C2 - 31658359
AN - SCOPUS:85074227776
SN - 1868-596X
VL - 36
SP - 682
EP - 699
JO - ALTEX
JF - ALTEX
IS - 4
ER -