How can we achieve more reliable testing for the adverse effects of prenatal exposure to substances?

Certain substances can disrupt the development of the unborn child and cause very serious deformities. The most familiar of these cases were those caused by the sedative thalidomide. For this reason, the toxicity of chemicals, pesticides and medicinal products to the unborn child must be tested reliably using harmonised international methods. New methods for testing the harmful effects of chemicals on nervous and skeletal system development in the unborn child, which are not based on the use of laboratory animals, will be the focus of discussions between researchers attending the 10th Workshop on Developmental Toxicology (DevTox) at the German Federal Institute for Risk Assessment (BfR) in Berlin on 19 to 20 February 2020. Work is also being completed on an expansion of the DevTox database and improvements to usability. Dr Roland Solecki, Vice President of the German Federal Institute for Risk Assessment (BfR): "Two key points of focus will be defining a standard set of international terms and strategies to develop test systems for improved risk assessment not based on animal experiments. The necessary groundwork will be presented at the Workshop by researchers from Brazil, China, the EU, Japan and the USA." Around 60 participants will be discussing this both in terms of reliability as well as its application to regulatory practice in toxicology.

Recent enhancements to the DevTox database ( will be presented at the 10th DevTox Workshop, which are the result of international cooperation between the BfR and partners in China as well as the respective professional societies in Europe, Japan and the USA. Another point of focus will be alternative methods for risk assessment that can be deployed in the fields of developmental neurotoxicity and bone development. One example here is the new ‘organ-on-chip’ systems with integrated bone cells: in the future, these chips may offer a way to investigate the harmful effects of substances on the development of the skeleton.

One key agenda item for the Workshop will be to clarify the extent to which new test systems that do not use laboratory animals can be standardised and validated so that they can then be used to generate new studies that will be capable of being accepted by regulatory toxicology. The overall aim here is to restrict or, where possible, entirely replace the animal experiments required to date.

The DevTox project got underway in Berlin 25 years ago and has been supported by the BfR since its foundation together with its partners Charité in Berlin and the Fraunhofer Institute for Toxicology and Experimental Medicine in Hanover (Germany). Most of the project’s work has been focused on the creation and development of a lexicon defining a uniform global vocabulary for describing deformities (birth defects) while supplying lab photos in a web-based image database for the purposes of experiment evaluation, research and teaching. One important aspect of this work involves critical questions about the harmonised assessment of deformities in limbs and organs resulting from prenatal exposure to natural and synthetic substances. Alongside images of typical deformities, the database also includes information about their agreed international descriptions and categorisation.

About the BfR

The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. It advises the German federal government and German federal states ("Laender") on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.

Additional information

This text version is a translation of the original German text which is the only legally binding version.

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