Do new generations of active pharmaceuticals for human use require an adaption of the environmental risk assessment? : part II: case studies : final report / by Eilebrecht Elke, Schlich Karsten, Franzen Kornelija, Göckener Bernd (Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Schmallenberg), Coors Anja, Weil Mirco (ECT Oekotoxikologie GmbH, Flörsheim) ; on behalf of the German Environment Agency ; edited by: Section IV 2.2, Pharmaceuticals - Jasmin Brückner (Fachbegleitung), Ute Kühnen (Lemna), Kathi Westphal-Settele

Abstract

In view of the advanced development of new specific active pharmaceutical ingredients, the question arises as to whether the established standard procedures for the environmental risk assessment in the context of marketing authorization are still sufficient to adequately cover relevant effects on environmental organisms. The focus of this project is on specific test strategies for substances from the group of oncologicals, cardiologicals and statins, as well as their experimental verification in case studies. Studies with aquatic plants in the Lemna sp. Growth Inhibition Test (⁠OECD⁠ 221), the zebrafish embryo toxicity test (OECD 236) amended with sublethal endpoints and the comet assay with environmentally relevant cell types are discussed as possible adaptations, although not all of them proved to be suitable.