Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals

被引:32
作者
Agerstrand, M. [1 ]
Kuester, A. [2 ]
Bachmann, J. [2 ]
Breitholtz, M. [3 ]
Ebert, I. [2 ]
Rechenberg, B. [2 ]
Ruden, C. [1 ]
机构
[1] Royal Inst Technol, Kungliga Tekniska Hgsk, Dept Philosophy & Hist Technol, SE-10044 Stockholm, Sweden
[2] Fed Environm Agcy UBA Pharmaceut Washing & Cleani, D-06813 Dessau, Germany
[3] Stockholm Univ, Dept Appl Environm Sci, SE-10691 Stockholm, Sweden
基金
瑞典研究理事会;
关键词
Reliability; Relevance; Data evaluation; Data reporting; Non-standard data/studies/tests; ENDOCRINE ACTIVE-CHEMICALS; MINNOW PIMEPHALES-PROMELAS; LIFE STAGE TEST; INFORMATION-SYSTEM; CHRONIC TESTS; DATA QUALITY; CLASSIFICATION; TRICHLOROETHYLENE;
D O I
10.1016/j.envpol.2011.06.023
中图分类号
X [环境科学、安全科学];
学科分类号
08 ; 0830 ;
摘要
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. (C) 2011 Elsevier Ltd. All rights reserved.
引用
收藏
页码:2487 / 2492
页数:6
相关论文
共 25 条
[1]   The Swedish Environmental Classification and Information System for Pharmaceuticals - An empirical investigation of the motivations, intentions and expectations underlying its development and implementation [J].
Agerstrand, M. ;
Wester, M. ;
Ruden, C. .
ENVIRONMENT INTERNATIONAL, 2009, 35 (05) :778-786
[2]   Comparison of four different methods for reliability evaluation of ecotoxicity data: A case study of non-standard test data used in environmental risk assessments of pharmaceutical substances [J].
Ågerstrand M. ;
Breitholtz M. ;
Rudén C. .
Environmental Sciences Europe, 23 (1)
[3]   Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals [J].
Agerstrand, Marlene ;
Ruden, Christina .
SCIENCE OF THE TOTAL ENVIRONMENT, 2010, 408 (11) :2327-2339
[4]   Risk to all or none? A comparative analysis of controversies in the health risk assessment of Bisphenol A [J].
Beronius, Anna ;
Ruden, Christina ;
Hakansson, Helen ;
Hanberg, Annika .
REPRODUCTIVE TOXICOLOGY, 2010, 29 (02) :132-146
[5]   Development of chronic tests for endocrine active chemicals -: Part 2:: An extended fish early-life stage test with an androgenic chemical in the fathead minnow (Pimephales promelas) [J].
Bogers, Rinus ;
De Vries-Buitenweg, Selinda ;
Van Gils, Marielle ;
Baltussen, Erik ;
Hargreaves, Adam ;
van de Waart, Beppy ;
De Roode, Daphne ;
Legler, Juliette ;
Murk, Albertinka .
AQUATIC TOXICOLOGY, 2006, 80 (02) :119-130
[6]   Data quality evaluation of toxicological studies used to derive ecotoxicological benchmarks [J].
Durda, JL ;
Preziosi, DV .
HUMAN AND ECOLOGICAL RISK ASSESSMENT, 2000, 6 (05) :747-765
[7]  
European Chemicals Agency (ECHA), 2008, GUID INF IMPL REACH
[8]  
[European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP)], 2006, EMEACRMPSWP444700 EM
[9]   Evolutionary conservation of human drug targets in organisms used for environmental risk assessments [J].
Gunnarsson, Lina ;
Jauhiainen, Alexandra ;
Kristiansson, Erik ;
Nerman, Olle ;
Larsson, D. G. Joakim .
ENVIRONMENTAL SCIENCE & TECHNOLOGY, 2008, 42 (15) :5807-5813
[10]   Towards, a theory of tiered testing. [J].
Hansson, Sven Ove ;
Ruden, Christina .
REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2007, 48 (01) :35-44