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

Environmental Pollution

Volumn 159, Issue 10, 2011, Pages 2487-2492

  Agerstrand M ^a   Kuster A ^b   Bachmann, J ^b   Breitholtz, M ^c   Ebert, I ^b   Rechenberg, B ^b   Ruden C ^a  

^a ROYAL INSTITUTE OF TECHNOLOGY   (Sweden)

^b UMWELTBUNDESAMT   (Germany)

^c STOCKHOLM UNIVERSITY   (Sweden)

Author keywords

Data evaluation; Data reporting; Non standard data studies tests; Relevance; Reliability

Indexed keywords

ORGANIC POLLUTANTS; RELIABILITY;

DATA EVALUATION; DATA REPORTING; ENVIRONMENTAL RISK ASSESSMENT; EVALUATION CRITERIA; NON-STANDARD DATA/STUDIES/TESTS; PEER-REVIEW PROCESS; RELEVANCE; STRUCTURED APPROACH;

RISK ASSESSMENT;

DRUG;

DRUG; ECOTOXICOLOGY; ENVIRONMENTAL RISK; INDUSTRIAL WASTE; OECD; RELIABILITY ANALYSIS; RISK ASSESSMENT;

ARTICLE; CONTROLLED STUDY; DATA ANALYSIS; ECOTOXICITY; ECOTOXICOLOGY; ENVIRONMENTAL RISK ASSESSMENT; HEALTH EDUCATION; INFORMATION PROCESSING; PEER REVIEW; PREDICTION; RELIABILITY; RISK ASSESSMENT; SCIENTIFIC LITERATURE;

EID: 80052305439     PISSN: 02697491     EISSN: 18736424     Source Type: Journal    
DOI: 10.1016/j.envpol.2011.06.023     Document Type: Article

References (26)

1. M. gerstrand, M. Wester, and C. Rudén The Swedish environmental classification and information system for pharmaceuticals - an empirical investigation of the motivations, intentions and expectations underlying its development and implementation Environment International 35 5 2009 778 786
2. M. gerstrand, and C. Rudén Evaluation of the accuracy and consistency of the Swedish environmental classification and information system for pharmaceuticals Science of the Total Environment 408 2010 2327 2339
3. M. gerstrand, M. Breitholtz, and C. Rudén 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 Environmental Science Europe 23 2011 17
4. A. Beronius, C. Rudén, H. Hkansson, and A. Hanberg Risk to all or none? A comparative analysis of controversies in the health risk assessment of bisphenol A Reproductive Toxicology 29 2010 132 146
5. R. Bogers, S. De Vries-Buitenweg, M. Van Gils, E. Baltussen, A. Hargreaves, B. van de Waart, D. De Roode, J. Legler, and A. Murk 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) Aquatic Toxicology 80 2 2006 119 130 (Pubitemid 44740036)
6. J.L. Durda, and D.V. Preziosi Data quality evaluation of toxicological studies used to derive ecotoxicological benchmarks Human and Ecological Risk Assessment 6 5 2000 747 765
7. European Chemicals Agency (ECHA) Guidance Information for the Implementation of REACH. Guidance on Information Requirements and Chemical Safety Assessment 2008 (Chapter R.4): Evaluation of available information
8. European Commission European Commission Technical Guidance Document (TGD) in Support of Commission Directive 93/67/EEC on Risk Assessment for New Notified Substances and Commission Regulation (EC) 2003 http://ecb.jrc.it/home. php?CONTENU=/Technical-Guidance-Document/sommaire.php No 1488/94 on Risk Assessment for Existing Substances, Part II
9. European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use 1 June 2006 Ref EMEA/CRMP/SWP/4447/00
10. L. Gunnarsson, A. Jauhiainen, E. Kristiansson, O. Nerman, and D.G. Larsson Evolutionary conservation of human drug targets in organisms used for environmental risk assessments Environmental Science and Technology 42 15 2008 5807 5813
11. S.O. Hansson, and C. Rudén Towards a theory of tiered testing Regulatory Toxicology and Pharmacology 48 1 2007 35 44 (Pubitemid 46783172)
12. D.A. Hobbs, M.St. J. Warne, and S.J. Markich Evaluation of criteria used to assess the quality of aquatic toxicity data Integrated Environmental Assessment and Management 1 3 2005 174 180
13. A. Küster, J. Bachmann, U. Brandt, I. Ebert, S. Hickmann, J. Klein-Goedicke, G. Maack, S. Schmitz, E. Thumm, and B. Rechenberg Regulatory demands on data quality for the environmental risk assessment of pharmaceuticals Regulatory Toxicology and Pharmacology 55 3 2009 276 280
14. H.J. Klimisch, M. Andreae, and U. Tillmann A systematic approach for evaluating the quality of experimental toxicological and exotoxicological data Regulatory Toxicology and Pharmacology 25 1997 1 5 (Pubitemid 27117571)
15. B. Mattson A voluntary environmental classification system for pharmaceutical substances Drug Information Journal 41 2 2007 187 191 (Pubitemid 46435422)
16. L. Molander, M. gerstrand, and C. Rudén WikiPharma - a freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals Regulatory Toxicology and Pharmacology 55 2009 367 371
17. M.H.M.M. Montforts Methodological aspects concerning the environmental risk assessment for medicinal products; research challenges K. Kümmerer, Pharmaceuticals in the Environment, Sources, Fate, Effects and Risks third ed. 2008 Springer 978-3-540-74663-8
18. J.L. Oaks, M. Gilbert, M.Z. Virani, R.T. Watson, B.A. Rideout, H.L. Shivaprasad, S. Ahmed, M.J. Chaudhry, M. Arshad, S. Mahmood, A. Ali, and A.A. Khan Diclofenac residues as the cause of vulture population decline in Pakistan Nature 427 2004 630 633 (Pubitemid 38248481)
19. OECD Environment Directorate Environment, Health and Safety Publications Series on Testing and Assessment, No. 95, Detailed Review Paper on Fish Full-Life-Cycle Tests, ENV/JM/MONO 22 2008 Paris 2008
20. G.H. Panter, T.H. Hutchinson, K.S. Hurd, J. Bamforth, D. StanleyR, S. Duffell, A. Hargreaves, S. Gimeno, and C.R. Tyler Development of chronic tests for endocrine active chemicals: part 1. An extended fish early-life stage test for oestrogenic active chemicals in the fathead minnow (Pimephales promelas) Aquatic Toxicology 77 3 2006 279 290
21. C.E. Purdom, P.A. Hardiman, V.V.J. Bye, N.C. Eno, C.R. Tyler, and J.P. Sumpter Estrogenic effects of effluents from sewage treatment works Chemistry and Ecology 8 4 1994 275 285
22. C. Rudén Science and transscience in carcinogen risk assessment - the European regulatory process for trichloroethylene Journal of Toxicology and Environmental Health, Part B Critical Reviews 6 3 2003 257 277 (Pubitemid 36520935)
23. C. Rudén "The use of mechanistic data and the handling of scientific uncertainty in carcinogen risk assessment - the trichloroethylene example Regulatory Toxicology and Pharmacology 35 1 2002 80 94 (Pubitemid 34174543)
24. L. Schenk Comparison of data used for setting occupational exposure limits International Journal of Occupational and Environmental Health 16 2010 249 262
25. K. Schneider, M. Schwarz, I. Burkholder, A. Kopp-Schneider, L. Edler, A. Kinsner-Ovaskainen, T. Hartung, and S. Hoffmann "ToxRTool", a new tool to assess the reliability of toxicological data Toxicology Letters 189 2 2009 138 144
26. A.D. Vethaak, G.B.J. Rijs, S.M. Schrap, H. Ruiter, A. Gerritsen, and J. Lahr Estrogens and Xeno-estrogens in the Aquatic Environment of The Netherlands: Occurrence, Potency and Biological Effects. Report No. 2002.001. Dutch National Institute of Inland Water Management and Waste Water Treatment 2002 Lelystad The Netherlands