Deterministic and probabilistic acute‐based environmental risk assessment for naproxen for Western Europe

Abstract

An environmental risk assessment (ERA) was made for the common nonsteroidal anti-inflammatory drug naproxen. The ERA was performed according to deterministic and probabilistic methods, based on different predicted environmental concentrations (PECs) and measured environmental concentrations (MECs) on the exposure side as well as on published and newly elaborated acute ecotoxicity data on the effects side. Compilation of a large set of MECs allowed a qualification of the various PEC derivations. The European Medicines Evaluation Authority (EMEA) phase I PEC was shown to be far above realistic values, while the refined EMEA phase II (A and B) PECs were not too far from the 95th percentile MEC, in agreement with their nature as local PECs. The western European continental and regional PECs extrapolated based on actual use data, using the European Union system for the evaluation of substances, with the region reconfigured for Germany where most of the available European MECs are from, were in good to very close agreement with the median MECs. No risk to surface waters is apparent by any of the methodologies applied from the current use of naproxen; however, because only insufficient chronic ecotoxicity data are available, this is a preliminary conclusion.