Environmental risk assessment for the serotonin re-uptake inhibitor fluoxetine: Case study using the European Risk Assessment Framework

Oakes, Ken D., Coors, Anja, Escher, Beate I., Fenner, Kathrin, Garric, Jeanne, Gust, Marion, Knacker, Thomas, Küster, Anette, Kussatz, Carola, Metcalfe, Chris D., Monteiro, Sara, Moon, Thomas W., Mennigen, Jan A., Parrott, Joanne, Péry, Alexandre R. R., Ramil, Maria, Roennefahrt, Ines, Tarazona, José V., Sánchez-Argüello, Paloma, Ternes, Thomas A., Trudeau, Vance L., Boucard, Tatiana, Van Der Kraak, Glen J. and Servos, Mark R. (2010) Environmental risk assessment for the serotonin re-uptake inhibitor fluoxetine: Case study using the European Risk Assessment Framework. Integrated Environmental Assessment and Management, 6 Supp. 1: 524-539. doi:10.1002/ieam.77

Author Oakes, Ken D.
Coors, Anja
Escher, Beate I.
Fenner, Kathrin
Garric, Jeanne
Gust, Marion
Knacker, Thomas
Küster, Anette
Kussatz, Carola
Metcalfe, Chris D.
Monteiro, Sara
Moon, Thomas W.
Mennigen, Jan A.
Parrott, Joanne
Péry, Alexandre R. R.
Ramil, Maria
Roennefahrt, Ines
Tarazona, José V.
Sánchez-Argüello, Paloma
Ternes, Thomas A.
Trudeau, Vance L.
Boucard, Tatiana
Van Der Kraak, Glen J.
Servos, Mark R.
Title Environmental risk assessment for the serotonin re-uptake inhibitor fluoxetine: Case study using the European Risk Assessment Framework
Journal name Integrated Environmental Assessment and Management   Check publisher's open access policy
ISSN 1551-3777
Publication date 2010-07
Sub-type Article (original research)
DOI 10.1002/ieam.77
Volume 6
Issue Supp. 1
Start page 524
End page 539
Total pages 16
Editor Thomas Knacker
Chris Metcalfe
Place of publication Pensacola, FL, United States
Publisher Society of Environmental Toxicology and Chemistry
Language eng
Formatted abstract
The serotonin re-uptake inhibitor fluoxetine was selected for an environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial predicted environmental concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of <0.6 µg/L. From this value, a predicted no effect concentration for surface waters (PNECSW) of 0.012 µg/L was derived. The PEC/PNEC ratio was above the trigger value of 1 in worst-case exposure scenarios indicating a potential risk to the aquatic compartment. Similarly, risks of fluoxetine for sediment-dwelling organisms could not be excluded. No risk assessment was conducted for the terrestrial compartment due to a lack of data on effects of fluoxetine on soil organisms. The need for a separate risk assessment for the main metabolite of fluoxetine, norfluoxetine, was not conducted because of a lack of fate and effect studies. Based on published data, fluoxetine and norfluoxetine appeared to have a low to moderate bioaccumulation potential, which should be confirmed in formal studies according to OECD guidelines. Exposure assessments for fluoxetine according to the current framework rely heavily on KOC and KOW values. This approach is problematic, because fluoxetine is predominantly a cationic substance at environmental pH values. Consequently, the fate of fluoxetine (and other ionic substances) cannot be predicted using partition coefficients established for nonionic compounds. Further, published estimates for partition coefficients of fluoxetine vary, resulting in considerable uncertainties in both the exposure and environmental risk assessments of fluoxetine.
Keyword Human antidepressant
Environmental risk assessment
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ
Additional Notes Special Issue: "Environmental Risk Assessment of Pharmaceuticals (ERAPharm): The focus of this special issue of Integrated Environmental Assessment and Management (IEAM) is to communicate to the scientific and regulatory community some key results of the project Environmental Risk Assessment of Pharmaceuticals (ERAPharm) that was funded within the Sixth Framework Programme of the European Union (project SSPI-CT-2003-511135) between October, 2004, and September, 2007."

Document type: Journal Article
Sub-type: Article (original research)
Collection: National Research Centre for Environmental Toxicology Publications
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Citation counts: Scopus Citation Count Cited 46 times in Scopus Article | Citations
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Created: Fri, 05 Aug 2011, 09:38:52 EST by Jon Swabey on behalf of National Res Centre For Environmental Toxicology