The DevTox Site: Harmonized Terminology and Database

Abstract

Harmonization of terminology in developmental toxicology studies has high priority, since regulatory decisions are currently impeded by ambiguities and inconsistencies in the terminology used to describe structural anomalies. This was one of the reasons why the DevTox project was initiated by the German Federal Institute for Risk Assessment (BfR) and was sponsored by the German Federal Ministry of the Environment, Nature Conservation and Nuclear Safety (Environmental Research Plan/UFO-Plan), under the auspices of the International Programme on Chemical Safety. The website is freely accessible in the internet. The DevTox project consists of three main parts. The first is DevTox information. This aspect includes information on the project itself, the publications of the Berlin workshops, and a list of project partners. The second is the DevTox nomenclature, which is a harmonized terminology for developmental toxicology, based on the International Federation of Teratology Societies (IFTS) terminology with more than 1400 images of fetuses showing examples of external observations, skeletal defects, and soft tissue anomalies. The third is the DevTox database, which is currently under development and is intended to include historical and experimental data for the evaluation and comparison of developmental toxicity studies. The project is conducted in close cooperation between the BfR Berlin, the Institute of Clinical Pharmacology and Toxicology, Charite University Medical School, Berlin, and the Fraunhofer Institute of Toxicology and Experimental Medicine, Hannover, as well as further project partners from industry and government. The project benefited from the valuable contribution of many prominent international scientists from research institutions, regulatory agencies, and industry, and the support is gratefully acknowledged. The use of a harmonized and internationally accepted nomenclature is a basic requirement for the operation of a database like DevTox. A first approach to establishing such a harmonized terminology for developmental toxicology was made in 1997 by a publication of the IFTS from the 1995 Berlin workshop. Subsequent workshops had the goal to eliminate ambiguities and inconsistencies within the IFTS terminology and to establish working definitions for the two classification categories malformation and variation. The DevTox project has emerged from developments over many years. There are more challenges in the future, primarily related to an update of the current first version of the terminology. One of the next steps will be to implement the updated terminology in the DevTox project, and the authors will also in the future highly appreciate any critical remarks and, in particular, the submission of new images to complete this tool.