Environmental risk assessment of human pharmaceuticals in the European union: A case study with the β-blocker atenolol

Integrated Environmental Assessment and Management

Volumn 6, Issue SUPPL. 1, 2010, Pages 514-523

  Küster, Anette ^a   Alder, Alfredo C ^b   Escher, Beate I ^b,c   Duis, Karen ^d   Fenner, Kathrin ^b,e   Garric, Jeanne ^f   Hutchinson, Thomas H ^g,h   Lapen, David R ⁱ   Péry, Alexandre ^f,j   Römbke, Jörg ^d   Snape, Jason ^g   Ternes, Thomas ^k   Topp, Ed ⁱ   Wehrhan, Anne ^a,l   Knackerk, Thomas ^d  

^a UMWELTBUNDESAMT   (Germany)

^b SWISS FEDERAL INSTITUTE OF AQUATIC SCIENCE AND TECHNOLOGY   (Switzerland)

^c UNIVERSITY OF QUEENSLAND   (Australia)

^d ECT OEKOTOXIKOLOGIE GMBH   (Germany)

^e ETH ZURICH   (Switzerland)

^f CEMAGREF   (France)

^g ASTRAZENECA   (United Kingdom)

^h CENTRE FOR ENVIRONMENT   (United Kingdom)

ⁱ AGRICULTURE AND AGRI FOOD CANADA   (Canada)

^j INSTITUT NATIONAL DE L ENVIRONNEMENT INDUSTRIEL ET DES RISQUES INERIS   (France)

^k FEDERAL INSTITUTE OF HYDROLOGY   (Germany)

^l Harlan   (Switzerland)

more..

Author keywords

Blocker; Atenolol; Environmental risk assessment; Human pharmaceutical

Indexed keywords

ATENOLOL; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; WATER;

ANIMAL; ARTICLE; CHEMISTRY; ECOTOXICOLOGY; ENVIRONMENTAL MONITORING; EUROPEAN UNION; HUMAN; METHODOLOGY; PHYSICAL CHEMISTRY; POLLUTANT; PRACTICE GUIDELINE; RISK ASSESSMENT; THEORETICAL MODEL;

ADRENERGIC BETA-ANTAGONISTS; ANIMALS; ATENOLOL; ECOTOXICOLOGY; ENVIRONMENTAL MONITORING; ENVIRONMENTAL POLLUTANTS; EUROPEAN UNION; GUIDELINES AS TOPIC; HUMANS; MODELS, THEORETICAL; PHYSICOCHEMICAL PROCESSES; RISK ASSESSMENT; WATER;

EID: 77956372587     PISSN: 15513793     EISSN: None     Source Type: Journal    
DOI: 10.1897/IEAM-2009-050.1     Document Type: Article

References (59)

1. Alder A, Schaffner C, Majewsky M, Klasmeier J, Fenner K. 2009. Fate of b-blocker human pharmaceuticals in surface water: Comparison of measured and simulated concentrations in the Glatt Valley watershed, Switzerland. Water Res 44:936-948.
2. Ankley GT, Jensen KM, Kahl MD, Korte JJ, Makynen EA. 2001. Description and evaluation of a short-term reproduction test with the fathead minnow (Pimephales promelas). Environ Toxicol Chem 20:1276-1290.
3. Balon K, Riebesehl BU, Muller BW. 1999. Drug liposome partitioning as a tool for the prediction of human passive intestinal absorption. Pharmacol Res 16:882-888.
4. Betageri GV, Rogers JA. 1987. Thermodynamics of partitioning of b-blockers in the n-octanol-buffer and liposome systems. Int J Pharm 36:165-173.
5. BLAC. 2003. Arzneimittel in der Umwelt-Auswertung der Untersuchung-sergebnisse. Hamburg (DE): Bund/Länderausschuss für Chemikalien-sicherheit, 173 p.
6. Calamari D, Zuccato E, Castiglioni S, Bagnati R, Fanelli R. 2006. Strategic survey of therapeutic drugs in the rivers Po and Lambro in Northern Italy. Environ Sci Technol 37:1241-1248.
7. Carlsson C, Johansson AK, Alvan G, Bergman K, Kühler T. 2006a. Are pharmaceuticals potent environmental pollutants? Part I: Environmental risk assessment of selected active pharmaceutical ingredients. Sci Tot Environ 364:67-87. (Pubitemid 44218712)
8. Carlsson C, Johansson AK, Alvan G, Bergman K, Kühler T. 2006b. Are pharmaceuticals potent pollutants? Part II: Environmental risk assessments of selected pharmaceutical excipients. Sci Tot Environ 364:88-95. (Pubitemid 43775997)
9. Castiglioni S, Bagnati R, Fanelli R, Pomati R, Calamari D, Zuccato E. 2006. Removal of pharmaceuticals in sewage treatment plants in Italy. Environ Sci Technol 40:357-363.
10. Cleuvers M. 2005. Initial risk assessment for three b-blockers found in the aquatic environment. Chemosphere 59:199-205.
11. Crane M, Watts CD, Boucard T. 2006. Chronic aquatic environmental risks from exposure to human pharmaceuticals. Sci Tot Environ 367:23-41.
12. Dzialowski EM, Turner PK, Brooks BW. 2006. Physological and reproductive effects of beta adrenergic receptor antagonists in Daphnia magna. Arch Environ Contam Toxicol 50:503-510.
13. [EC] European Commission. 1993. Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products. European Commission Joint Research Centre.
14. Edwards CA, Atiyeh RM, Römbke J. 2001. Environmental impact of avermectins. Rev Environ Contam 171:111-137.
15. [EMEA/CHMP] European Medicines Agency/Committee for Medicinal Products for Human Use. 2006. Guideline on the environmental risk assessment of medicinal products for human use. London, UK: EMEA. EMEA/CHMP/SWP/ 4447/00.
16. Escher B, Bramaz N, Richter M, Lienert J. 2006. Comparative ecotoxicological hazard assessment of b-blockers and their human metabolites using a mode-of-action-based test battery and a QSAR approach. Environ Sci Technol 40:7402-7408.
17. Ferrari B, Mons R, Vollat B, Fraysse B, Pax́eus NA. 2004. Environmental risk assessment of six human pharmaceuticals: are the current environmental risk assessment procedures sufficient for the protection of the aquatic environment? Environ Toxicol Chem 23:1344-1354.
18. Fraysse B, Garric J. 2005. Prediction and experimental validation of acute toxicity of b-blockers in Ceriodaphnia dubia. Environ Toxicol Chem 24:2470-2476.
19. Halling-Sørensen B, Nors Nielsen S, Lanzky PF, Ingerslev F, Holten Lützhøft HC, Jørgensen SE. 1998. Occurrence, fate and effects of pharmaceutical substances in the environment - a review. Chemosphere 36:357-393.
20. Hansch C, Leo A, Hoekman D. 1995. Exploring QSAR. Hydrophobic, electronic and steric constants. Washington DC. American Chemical Society.
21. Huggett DB, Brooks BW, Peterson B, Foran CM, Schlenk D. 2002. Toxicity of selected beta-andrenergic receptor-blocking pharmaceuticals on aquatic organisms. Arch Environ Contam Toxicol 23:229-235.
22. [ISO] International Organization for Standardization. 1996. Water quality- determination of the inhibitory effect of water samples on the light emission of Vibrio fischeri (Luminescent bacteria test). Geneva (CH). ISO/DIS11348-3.
23. [ISO] International Organization for Standardization. 1999. Soil quality-Inhibition of reproduction of collembola (Folsomia candida) by soil pollutants. Geneva (CH). ISO 11267:1999- 04-01.
24. Jones OA, Voulvoulis N, Lester NJ. 2002. Aquatic environmental assessment of the top 25 English prescription pharmaceuticals. Water Res 36:5013-5022
25. Klimisch HJ, Andreae M, Tillmann U. 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Reg Toxicol Pharmacol 25:1-5.
26. Knacker T, Duis K, Ternes T, Fenner K, Escher B, Schmitt H, Römbke J, Garric J, Hutchinson T, Boxall ABA. 2005. The EU-project ERAPharm. Incentives for the further development of guidance documents? ESPR Environ Sci Pollut Res 12:62-65.
27. Koormann F, Rominger J, Schowanek D, Wagner JO, Schroder R, Wind T, Silvani M, Whelan MJ. 2006. Modeling the fate of down-the-drain chemicals in rivers: An improved software for GREAT-ER. Environ Model Softw 21:925-936
28. Lapen DR, Topp E, Metcalfe CD, Li H, Edwards M, Gottschall N, Bolton P, Curnoe W, Payne M, Beck A. 2008. Pharmaceuticals and personal care products in tile drainage following land application of liquid municipal biosolids. Sci Total Environ 399:50-65.
29. Maurer M, Escher BI, Richle P, Schaffner C, Alder AC. 2007. Elimination of b-blockers in sewage treatment plants. Water Res 41:1614-1622.
30. Nguyen TH, Goss KU, Ball WP. 2005. Polyparameter linear free energy relationships for estimating the equilibrium partition of organic compounds between water and the natural organic matter in soils and sediments. Environ Sci Technol 39:913-924.
31. [OECD] Organisation for Economic Co-Operation and Development. 1984. Guideline for the testing of chemicals No. 209. Activated sludge, respiration inhibition test. Paris (FR): OECD
32. [OECD] Organisation for Economic Co-Operation and Development. 1992. Guideline for the testing of chemicals No. 301. Ready biodegradability. Paris (FR): OECD
33. [OECD] Organisation for Economic Co-Operation and Development. 1998. Guideline for the testing of chemicals No. 211. Daphnia magna reproduction test. Paris (FR): OECD
34. [OECD] Organisation for Economic Co-Operation and Development. 1999. Guideline for the testing of chemicals No. 210. Fish, early-life stage toxicity test. Paris (FR): OECD
35. [OECD] Organisation for Economic Co-Operation and Development. 2000a. Guideline for the testing of chemicals No. 201. Freshwater algae and cyanobacteria, growth inhibition test. Proposal for updating guideline 201, July 2002. Paris (FR): OECD
36. [OECD] Organisation for Economic Co-Operation and Development. 2000b. Guideline for the testing of chemicals No. 106. Adsorption-desorption using a batch equilibrium method. Paris (FR): OECD
37. [OECD] Organisation for Economic Co-Operation and Development. 2004a. Guideline for the testing of chemicals No. 208. Terrestrial plant test: Seedling emergence and seedling growth test. Paris (FR): OECD
38. [OECD] Organisation for Economic Co-Operation and Development. 2004b. Guideline for the testing of chemicals No. 222. Earthworm reproduction test. Paris (FR): OECD
39. 2 in sealed vessels (headspace test). Paris (FR): OECD.
40. [OECD] Organisation for Economic Co-Operation and Development. 2006b. Guideline for the testing of chemicals (draft). Predatory mite reproduction test in soil (Hypoaspis [Geoalelaps] aculeifer). Paris (FR): OECD
41. [OECD] Organisation for Economic Co-Operation and Development. 2006c. Guideline for the testing of chemicals No. 201. Freshwater algae and cyanobacteria, growth inhibition test. Paris (FR): OECD.
42. Owen SF, Giltrow E, Huggett DB, Hutchinson TH, Saye J, Winter MJ, Sumpter JP. 2007. Comparative physiology, pharmacology and toxicology of b-blockers: Mammals versus fish. Aquat Toxicol 82:145-162
43. Pascoe D, Karntanut W, Müller CT. 2003. Do pharmaceuticals affect freshwater invertebrates? A study with the cnidarian Hydra vulgaris. Chemosphere 51:521-528
44. Platts JA, Abraham MH, Butina D, Hersey A. 2000. Estimation of molecular linear free energy relationship descriptors by a group contribution approach. 2. Prediction of partition coefficients. J Chem Inf Comput Sci 40:71-80
45. Poole SK, Poole CF. 1999. Chromatographic models for the sorption of neutral organic compounds by soil from water and air. J Chromatogr A 845:381-400
46. Ramil M, El Arelf T, Fink G, Scheurer M, Ternes T. 2010. Fate of b-blockers in aquatic sediment systems: sorption and biodegradation. Environ Sci Technol 44:962-970
47. Rohweder U. 2003. Arzneimittel in der Umwelt-Auswertung der Untersuchungsergebnisse; Behörde für Umwelt und Gesundheit-Freie und Hansestadt Hamburg/ Umweltuntersuchungen im Auftrag des BundLä nderausschusses für Chemikaliensicherheit (BLAC). Hamburg (DE)
48. Routledge E, Sumpter J. 1996. Estrogenic activity of surfactants and some of their degradation products assessed during a recombinant yeast estrogen screen. Environ Toxicol Chem 15:241-248.
49. Sacher F, Lange FT, Brauch HJ, Blankenhorn I. 2001. Pharmaceuticals in groundwaters-analytical methods and results of a monitoring program in Baden-Würtemberg, Germany. J Chromatogr A 938:199-210
50. Schmitt H, Boucard T, Garric J, Jensen J, Parrott J, Péry A, Römbke J, Straub JO, Hutchinson TH, Sanchez-Argüello P, Wennmalm A, Duis K. 2009. Recommendations on the environmental risk assessment of pharmaceuticals: Effect characterization. Integr Environ Assess Manag 6:588-602 (this issue)
51. Schreiber U. 2004. Pulse-amplitude (PAM) fluorometry and saturation pulse method. In: Papageorgiou G, Govindjee, editors, Chlorophyll fluorescence: A signature of photosynthesis. Dordrecht (NL): Kluwer Academic, p 279-319
52. Schwarzenbach R, Gschwend PM, Imboden DM. 2003. Environmental organic chemistry 2nd ed. Hoboken (NJ): John Wiley & Sons, 1313 p. [cited 2009 July]. Available from: http://www.syrres.com/esc/physdemo.htm
53. Stanley JK, Ramirez AJ, Mottaleb M, Chambliss CK, Brooks BW. 2006. Enantiospecific toxicity of the b-blocker propranolol to Daphnia magna and Pimephales promelas. Environ Toxicol Chem 25:1780-1786
54. Ternes T. 1998. Occurrence of drugs in German sewage treatment plants and rivers. Water Res 32:3245-3260
55. Topp E, Monteiro SC, Beck A, Coelho BB, Boxall AB, Duenk PW, Kleywegt S, Lapen DR, Payne M, Sabourin L, Li H, Metcalfe CD. 2008. Runoff of pharmaceuticals and personal care products following application of biosolids to an agricultural field. Sci Total Environ 396:52-59
56. [VICH] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. 2005. Environmental impact assessment (EIAs) for veterinary medicinal products (VMPs)-Phase II Guidance. VICH Guideline 38 (Ecotoxicity Phase II). London, UK: VICH. CVMP/VICH/790/03-FINAL
57. Vieno N, Tuhkanen T, Kronbeg L. 2007. Elimination of pharmaceuticals in sewage treatment plants in Finland. Water Res 41:1001-1012
58. Webb SF. 2004. A data-based perspective on the environmental risk assessment of human pharmaceuticals I-aquatic risk characterisation. In Kümmerer K, editor. Pharmaceuticals in the environment-sources, fate, effects and risks. Berlin (DE): Springer Verlag. p 317-341
59. Winter MJ, Lillicrap AD, Caunter JE, Schaffner C, Alder AC, Ramil M, Ternes TA, Giltrow E, Sumpter JP, Hutchinson TH. 2008. Defining the chronic impacts of atenolol on embryolarval development and reproduction in the fathead minnow (Pimephales promelas). Aquat Toxicol 86:361-369.