Environmental risk assessment of veterinary medicines

Abstract

Environmental effects of veterinary medicines are assessed according to the guidelines of the European Medicines Agency (EMA) and the VICH GL 38 (ECOTOXICITY PHASE II). According to the guideline a terrestrial plant test in phase II is required because residues of pharmaceuticals release with dung and manure from treated animals on agriculture land. The terrestrial plant test is conducted using thestandardisedtest protocol OECD 208 (Seedling Emergence and Seedling Growth Test).<BR>The current regulations take into account only the parent compound and not transformation products and NER (Non Extractable Residues). That might result in incorrect estimation of risk in case of substances applied on agricultural soils with manure. For these substances the German Federal Environmental Agency (UBA) has thus initiated a research project to develop a special terrestrial plant test with a more realistic exposure scenario. In order to evaluate the potential phytotoxicity of transformation products and NER the test substance is applied in manure and stored over a defined period prior to testing. After storing this mixture is tested in a standard terrestrial plant test according to OECD 208. The approach is currently developed with different plant species, different manures and storing periods by two research partners:Fraunhofer IME Schmallenberg and ECT Oekotoxikologie GmbH Flörsheim. The poster presents the regulatory background of this special plant testing approach and first results of the research project.<BR>Quelle: ©Ute Kühnen