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DevTox project: Harmonized evaluation of anomalies in developmental toxicity studies

The DevTox project comprises the development of a lexicon and a data base as an electronic resource to support the assessment of developmental toxicity studies and classification and labelling of developmental anomalies with regard to the human health risk assessment procedure of plant protection products, biocides, other chemicals and chemical products. Such information is usually derived from experimental studies in which pregnant laboratory animals are exposed to various concentrations of compounds during critical stages of fetal development. The terms and diagnostic criteria used to describe fetal anomalies need to be consistent from one laboratory to another. Consequently, the DevTox Project has three main objectives:

• harmonize nomenclature used to describe developmental anomalies in laboratory animals
• assist in the visual recognition of developmental anomalies with the aid of photographs,
• provide a historical control database of developmental effects in laboratory animals.

A series of workshops held in Berlin brought together international participants from research, regulatory agencies and industry. The results of these meetings have been compiled and presented in a form which is likely to be of most benefit to professionals working in the field of developmental toxicology.

The lexicon of the DevTox project is based on a harmonized nomenclature, which was proposed by the International Federation of Teratological Societies (IFTS) and a classification system for external, visceral and skeletal anomalies in common laboratory animals. During the last two years, a new version of the Terminology in Developmental Toxicology was developed by the Teratology Society, the European and the Japanese Teratology Societies and afterwards published in all three Societies’ journals, which will be integrated into the current lexicon. The lexicon is connected to date with more than 1.700 images, show examples for external, skeletal and soft tissue anomalies. Further images will be continously added during the course of a new project in the next few years. A data base with historical control data is under development.

The project was initiated by the BfR (formerly BGA) under the auspices of the International Programme of Chemical Safety (IPCS), which is part of the World Health Organisation (WHO). DevTox is developed in collaboration with the Institute of Clinical Pharmacology and Toxicology Department of Toxicology CHARITÉ – Academical Medicin Berlin and the Fraunhofer Institute of Toxicology and Experimental Medicine (ITEM) in Hannover.

DevTox is free of charge! Visit the new DevTox Web site www.DevTox.org and let us know what you think. With the aim of further development of DevTox we would acknowledge the cooperation with further project partners.

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