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Human medicinal products: Environmental risk assessment for volatile anaesthetics

: Krome, Kristin; Hahn, Stefan; Schwonbeck, Susanne; Könnecker, Gustav; Licht, Oliver

Naunyn-Schmiedebergs archives of pharmacology 387 (2014), Supplement 1, S.S63, A250
ISSN: 0028-1298
ISSN: 1432-1912
Deutsche Gesellschaft für Experimentelle und Klinische Pharmakologie und Toxikologie (Annual Meeting) <80, 2014, Hannover>
Zeitschriftenaufsatz, Konferenzbeitrag
Fraunhofer ITEM ()

The environmental risk assessment of medicinal products for human use requires the calculation of a worst case Predicted Environmental Concentration (PEC) in surface water. This calculation is based on the assumption that the parent active ingredient is released to the wastewater after excretion from the human body. However, commonly used volatile inhalational anaesthetics are introduced into the atmosphere as the main target compart and only minor amounts (<= 5%) are excreted via urine. For three inhalational anaesthetics modelling tools were used to determine the PECs for the environmental compartments air, water and soil after administration to humans and excretion directly into the atmosphere. In addition, for those amounts of the parent compounds as well as for its metabolites, which are expected to reach the water compartments via urinary excretion, the conventional method of exposure estimation according to European Guideline EMEA/CHMP/SWP/4447/00 (2006) was used. PEC values of the parent substances in water and soil as well as PEC values of the metabolites were compared to the Predicted No Effect Concentrations (PNEC) retrieved from literature data to calculate a reliable risk towards aquatic and terrestrial organisms. Until now, no guidelines for the estimation of environmental risks arising from atmospheric contamination have been developed in Europe. Thus, ozone depletion potential, potential contribution to global warming and long distance transport were assessed using literature data. The described procedure enables, in our view, a more appropriate way of assessing risks of volatile anaesthetics towards air, water and soil.