DevToxBackground: The DevTox project  Project partners  Technical information

DevToxBackground: The DevTox project

The potential of a pesticide or biocide to cause adverse effects in the developing embryo or fetus is an important consideration in any health risk assessment for humans and wildlife. 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. The terminology of these abnormalities, which forms the basis of the whole project, has been updated in Version 3.0 in October 2012. As a result of this, numerous terms have been modified, many new terms were added, and a new class of findings (maternal-fetal abnormalities) was introduced.

The web site under the new terminology covers new findings and is capable of reflecting most findings in new species as well as findings observed during early postnatal development. Locations in the new species not yet covered by terminology will be considered at the next update which should focus on finding in primates. As a next step, new findings should be classified as malformations, variations, or grey zone anomalies.

Consequently, the DevTox Project has three main objectives:

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

The goals and background information of this project are published:

• Solecki, R.; Heinrich, V.; Rauch, M.; Chahoud, I.; Grote, K.; Wölffel, B.; Buschmann, J.; Morawietz, G.; Kellner, R.; Lingk, W. (2010) The DevTox Site: Harmonized Terminology and Database. In: Charlene A. McQueen, Comprehensive Toxicology, volume 12, pp. 339–346, Oxford: Academic Press.

As an important backbone of the DevTox project, 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 scientific and administrative needs for a harmonized terminology for the classification of anomalies were the initial motive to launch the series of Berlin Workshops. More than 20 years ago the classification of anomalies was handled in an inconsistent way by different regulatory bodies during hazard and risk evaluation of chemicals. A chemical could be classified as teratogenic in one country and non-teratogenic in another country. The benefits of a harmonized terminology are many and include more consistent interpretation of the results of developmental toxicity studies by scientists working in different institutions and more transparency in risk assessment of pesticides, biocides and other chemicals as well as in classification and labeling under the different legislations in Europe, America and Japan.

So the idea was born to start a series of Workshops on Terminology in Developmental Toxicology in order to overcome the ambiguities and inconsistencies in the terminology of developmental toxicology studies. The Workshops were organized in Berlin with the following main goals:

• Providing public information in the field of developmental toxicology with a primary emphasis on the harmonization of the terminology.
• Establishing an electronic database, to include historical and experimental data, for use in the further evaluation of developmental toxicity studies.
• Promoting the harmonization and standardization of nomenclature and descriptive terms in the field of developmental toxicology based on discussions between scientists from academia, testing laboratories, industry and competent authorities.