title: Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals.
abstract: Ecotoxicity data with high reliability and relevance are needed to guarantee the scientific quality of environmental risk assessments of pharmaceuticals. The main advantages of a more structured approach to data evaluation include increased transparency and predictability of the risk assessment process, and the possibility to use non-standard data. In this collaboration, between the research project MistraPharma and the German Federal Environment Agency, a new set of reporting and evaluation criteria is presented and discussed. The new criteria are based on the approaches in the literature and the OECD reporting requirements, and have been further developed to include both reliability and relevance of test data. Intended users are risk assessors and researchers performing ecotoxicological experiments, but the criteria can also be used for education purposes and in the peer-review process for scientific papers. This approach intends to bridge the gap between the regulator and the scientist's needs and way of work.
authors.affiliation: Royal Institute of Technology/Kungliga Tekniska Högskolan, Department of Philosophy and the History of Technology, Teknikringen 78B, SE-100 44 Stockholm, Sweden. maa2@kth.se
authors.forename: M
authors.initials: M
authors.lastname: Ågerstrand
authors.forename: A
authors.initials: A
authors.lastname: Küster
authors.forename: J
authors.initials: J
authors.lastname: Bachmann
authors.forename: M
authors.initials: M
authors.lastname: Breitholtz
authors.forename: I
authors.initials: I
authors.lastname: Ebert
authors.forename: B
authors.initials: B
authors.lastname: Rechenberg
authors.forename: C
authors.initials: C
authors.lastname: Rudén
mesh_terms: D030881:Disclosure / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D054750:Ecotoxicology; D004784:Environmental Monitoring / Q000379:methods* / Q000592:standards; D004785:Environmental Pollutants / Q000592:standards / Q000633:toxicity*; D004364:Pharmaceutical Preparations / Q000592:standards; D012107:Research Design; D018570:Risk Assessment / Q000379:methods
chemical_list: D004785:Environmental Pollutants; D004364:Pharmaceutical Preparations