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

Küster, Anette, Alder, Alfredo C., Escher, Beate I., Duis, Karen, Fenner, Kathrin, Garric, Jeanne, Hutchinson, Thomas H., Lapen, David R., Péry, Alexandre, Römbke, Jörg, Snape, Jason, Ternes, Thomas, Topp, Ed, Wehrhan, Anne and Knacker, Thomas (2010) Environmental risk assessment of human pharmaceuticals in the European Union: A case study with the beta-blocker atenolol. Integrated Environmental Assessment and Management, 6 Supp. 1: 514-523. doi:10.1897/IEAM_2009-050.1


Author Küster, Anette
Alder, Alfredo C.
Escher, Beate I.
Duis, Karen
Fenner, Kathrin
Garric, Jeanne
Hutchinson, Thomas H.
Lapen, David R.
Péry, Alexandre
Römbke, Jörg
Snape, Jason
Ternes, Thomas
Topp, Ed
Wehrhan, Anne
Knacker, Thomas
Title Environmental risk assessment of human pharmaceuticals in the European Union: A case study with the beta-blocker atenolol
Formatted title
Environmental risk assessment of human pharmaceuticals in the European Union: A case study with the β-blocker atenolol
Journal name Integrated Environmental Assessment and Management   Check publisher's open access policy
ISSN 1551-3777
1551-3793
Publication date 2010-07-01
Year available 2009
Sub-type Article (original research)
DOI 10.1897/IEAM_2009-050.1
Open Access Status Not Open Access
Volume 6
Issue Supp. 1
Start page 514
End page 523
Total pages 10
Place of publication Pensacola, FL, U.S.A.
Publisher Society of Environmental Toxicology and Chemistry
Language eng
Subject 1115 Pharmacology and Pharmaceutical Sciences
Formatted abstract
ß-Adrenergic receptor blockers (ß-blockers) are applied to treat high blood pressure, ischemic heart disease, and heart rhythm disturbances. Due to their widespread use and limited human metabolism, ß-blockers are widely detected in sewage effluents and surface waters. ß-Adrenergic receptors have been characterized in fish and other aquatic animals, so it can be expected that physiological processes regulated by these receptors in wild animals may be affected by the presence of ß-blockers. Because ecotoxicological data on ß-blockers are scarce, it was decided to choose the ß-blocker atenolol as a case study pharmaceutical within the project ERAPharm. A starting point for the assessment of potential environmental risks was the European guideline on the environmental risk assessment of medicinal products forhumanuse. In Phase I of the risk assessment, the initial predicted environmental concentration (PEC) of atenolol in surface water (500 ng L-1) exceeded the action limit of 10 ng L-1. Thus, a Phase II risk assessment was conducted showing acceptable risks for surface water, for groundwater, and for aquatic microorganisms. Furthermore, atenolol showed a low potential for bioaccumulation as indicated by its low lipophilicity (log KOW=0.16), a low potential for exposure of the terrestrial compartment via sludge (log KOC=2.17), and a low affinity for sorption to the sediment. Thus, the risk assessment according to Phase II-Tier A did not reveal any unacceptable risk for atenolol. Beyond the requirements of the guideline, additional data on effects and fate were generated within ERAPharm. A2-generation reproduction test with the waterflea Daphnia magna resulted in the most sensitive no-observed-effect concentration (NOEC) of 1.8mg L-1. However, even with this NOEC, a risk quotient of 0.003 was calculated, which is still well below the risk threshold limit of 1. Additional studies confirm the outcome of the environmental risk assessment according to EMEA/CHMP (2006). However, atenolol should not be considered as representative for other ß-blockers, such as metoprolol, oxprenolol, and propranolol, some of which show significantly different physicochemical characteristics and varying toxicological profiles in mammalian studies.
© 2009 SETAC
Keyword Beta-blockers
Toxicology
Environmental risk assessment
Atenolol
Human pharmaceutical
β-Blocker
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article first published online: 30 October 2009. Special Issue: Environmental Risk Assessment of Pharmaceuticals (ERAPharm)

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2011 Collection
National Research Centre for Environmental Toxicology Publications
 
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Created: Wed, 15 Sep 2010, 22:16:54 EST by Ms May Balasaize on behalf of Faculty Of Health Sciences