TY - JOUR
T1 - "ToxRTool", a new tool to assess the reliability of toxicological data
AU - Schneider, Klaus
AU - Schwarz, Markus
AU - Burkholder, Iris
AU - Kopp-Schneider, Annette
AU - Edler, Lutz
AU - Kinsner-Ovaskainen, Agnieszka
AU - Hartung, Thomas
AU - Hoffmann, Sebastian
N1 - Funding Information:
The project was funded by ECVAM (contract no. CCR_IHCP_C433199_XO). The valuable comments to the manuscript by Claudius Griesinger (ECVAM) are appreciated. We are most grateful to the members of the expert group and all participants of the inter-rater experiments for their contributions.
Copyright:
Copyright 2009 Elsevier B.V., All rights reserved.
PY - 2009/9/10
Y1 - 2009/9/10
N2 - Evaluation of the reliability of toxicological data is of key importance for regulatory decision-making. In particular, the new EU Regulations concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) and classification, labelling and packaging (CLP) according to the new globally harmonised system (GHS) rely on the integration of all available toxicological information. The so-called Klimisch categories, although well established and widely used, lack detailed criteria for assigning data quality to categories. A software-based tool (ToxRTool) was developed within the context of a project funded by the European Commission to provide comprehensive criteria and guidance for reliability evaluations of toxicological data. It is applicable to various types of experimental data, endpoints and studies (study reports, peer-reviewed publications) and leads to the assignment to Klimisch categories 1, 2 or 3. The tool aims to increase transparency and to harmonise approaches of reliability assessment. The tool consists of two parts, one to evaluate in vivo and one to evaluate in vitro data. The prototypes of the tool were tested in two independent inter-rater experiments. This approach allowed the analysis of the performance of the tool in practice and the identification and minimisation of sources of heterogeneity in evaluation results. The final version, ToxRTool, is publicly available for testing and use.
AB - Evaluation of the reliability of toxicological data is of key importance for regulatory decision-making. In particular, the new EU Regulations concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) and classification, labelling and packaging (CLP) according to the new globally harmonised system (GHS) rely on the integration of all available toxicological information. The so-called Klimisch categories, although well established and widely used, lack detailed criteria for assigning data quality to categories. A software-based tool (ToxRTool) was developed within the context of a project funded by the European Commission to provide comprehensive criteria and guidance for reliability evaluations of toxicological data. It is applicable to various types of experimental data, endpoints and studies (study reports, peer-reviewed publications) and leads to the assignment to Klimisch categories 1, 2 or 3. The tool aims to increase transparency and to harmonise approaches of reliability assessment. The tool consists of two parts, one to evaluate in vivo and one to evaluate in vitro data. The prototypes of the tool were tested in two independent inter-rater experiments. This approach allowed the analysis of the performance of the tool in practice and the identification and minimisation of sources of heterogeneity in evaluation results. The final version, ToxRTool, is publicly available for testing and use.
KW - Data quality
KW - In vitro data
KW - In vivo data
KW - Klimisch categories
KW - Relevance
KW - Reliability
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U2 - 10.1016/j.toxlet.2009.05.013
DO - 10.1016/j.toxlet.2009.05.013
M3 - Article
C2 - 19477248
AN - SCOPUS:67649607491
SN - 0378-4274
VL - 189
SP - 138
EP - 144
JO - Toxicology Letters
JF - Toxicology Letters
IS - 2
ER -