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
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Do new generations of active pharmaceuticals for human use require an adaption of the environmental risk assessment?
Discovery
188170159X
URN
urn:nbn:de:gbv:3:2-1048533
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Publication history
Dessau-Roßlau : Umweltbundesamt, February 2024
Content
1 Online-Ressource (135 Seiten, 3,18 MB) : Illustration
Edition
Language
eng
Comment
Literaturverzeichnis: Seite 115-118
Report completed in: June 2023
Sprache der Zusammenfassung: Englisch, Deutsch
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.
Series
Texte ; 2024, 21 ppn:505871920