title: A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment.
abstract: Tests with vertebrates are an integral part of environmental hazard identification and risk assessment of chemicals, plant protection products, pharmaceuticals, biocides, feed additives and effluents. These tests raise ethical and economic concerns and are considered as inappropriate for assessing all of the substances and effluents that require regulatory testing. Hence, there is a strong demand for replacement, reduction and refinement strategies and methods. However, until now alternative approaches have only rarely been used in regulatory settings. This review provides an overview on current regulations of chemicals and the requirements for animal tests in environmental hazard and risk assessment. It aims to highlight the potential areas for alternative approaches in environmental hazard identification and risk assessment. Perspectives and limitations of alternative approaches to animal tests using vertebrates in environmental toxicology, i.e. mainly fish and amphibians, are discussed. Free access to existing (proprietary) animal test data, availability of validated alternative methods and a practical implementation of conceptual approaches such as the Adverse Outcome Pathways and Integrated Testing Strategies were identified as major requirements towards the successful development and implementation of alternative approaches. Although this article focusses on European regulations, its considerations and conclusions are of global relevance.
authors.affiliation: UFZ - Helmholtz Centre for Environmental Research, Department of Bioanalytical Ecotoxicology, 04318 Leipzig, Germany. Electronic address: stefan.scholz@ufz.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Scholz
authors.forename: Erika
authors.initials: E
authors.lastname: Sela
authors.forename: Ludek
authors.initials: L
authors.lastname: Blaha
authors.forename: Thomas
authors.initials: T
authors.lastname: Braunbeck
authors.forename: Malyka
authors.initials: M
authors.lastname: Galay-Burgos
authors.forename: Mauricio
authors.initials: M
authors.lastname: García-Franco
authors.forename: Joaquin
authors.initials: J
authors.lastname: Guinea
authors.forename: Nils
authors.initials: N
authors.lastname: Klüver
authors.forename: Kristin
authors.initials: K
authors.lastname: Schirmer
authors.forename: Katrin
authors.initials: K
authors.lastname: Tanneberger
authors.forename: Marysia
authors.initials: M
authors.lastname: Tobor-Kapłon
authors.forename: Hilda
authors.initials: H
authors.lastname: Witters
authors.forename: Scott
authors.initials: S
authors.lastname: Belanger
authors.forename: Emilio
authors.initials: E
authors.lastname: Benfenati
authors.forename: Stuart
authors.initials: S
authors.lastname: Creton
authors.forename: Mark T D
authors.initials: MT
authors.lastname: Cronin
authors.forename: Rik I L
authors.initials: RI
authors.lastname: Eggen
authors.forename: Michelle
authors.initials: M
authors.lastname: Embry
authors.forename: Drew
authors.initials: D
authors.lastname: Ekman
authors.forename: Anne
authors.initials: A
authors.lastname: Gourmelon
authors.forename: Marlies
authors.initials: M
authors.lastname: Halder
authors.forename: Barry
authors.initials: B
authors.lastname: Hardy
authors.forename: Thomas
authors.initials: T
authors.lastname: Hartung
authors.forename: Bruno
authors.initials: B
authors.lastname: Hubesch
authors.forename: Dirk
authors.initials: D
authors.lastname: Jungmann
authors.forename: Mark A
authors.initials: MA
authors.lastname: Lampi
authors.forename: Lucy
authors.initials: L
authors.lastname: Lee
authors.forename: Marc
authors.initials: M
authors.lastname: Léonard
authors.forename: Eberhard
authors.initials: E
authors.lastname: Küster
authors.forename: Adam
authors.initials: A
authors.lastname: Lillicrap
authors.forename: Till
authors.initials: T
authors.lastname: Luckenbach
authors.forename: Albertinka J
authors.initials: AJ
authors.lastname: Murk
authors.forename: José M
authors.initials: JM
authors.lastname: Navas
authors.forename: Willie
authors.initials: W
authors.lastname: Peijnenburg
authors.forename: Guillermo
authors.initials: G
authors.lastname: Repetto
authors.forename: Edward
authors.initials: E
authors.lastname: Salinas
authors.forename: Gerrit
authors.initials: G
authors.lastname: Schüürmann
authors.forename: Horst
authors.initials: H
authors.lastname: Spielmann
authors.forename: Knut Erik
authors.initials: KE
authors.lastname: Tollefsen
authors.forename: Susanne
authors.initials: S
authors.lastname: Walter-Rohde
authors.forename: Graham
authors.initials: G
authors.lastname: Whale
authors.forename: James R
authors.initials: JR
authors.lastname: Wheeler
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Winter
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends; D000818:Animals; D004785:Environmental Pollutants / Q000737:chemistry / Q000633:toxicity*; D005062:European Union; D033161:Government Regulation; D017408:Guidelines as Topic; D015386:Hazardous Substances / Q000737:chemistry / Q000633:toxicity*; D012107:Research Design; D018570:Risk Assessment
chemical_list: D004785:Environmental Pollutants; D015386:Hazardous Substances
keywords: 3Rs; Acute toxicity; Bioconcentration; Cell lines; Chronic toxicity; Endocrine disruption; Exposure-based waiving; Fish embryo test; QSAR; Read-across