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.

Effluent‐dominated streams. Part 2: Presence and possible effects of pharmaceuticals and personal care products in Wascana Creek, Saskatchewan, Canada

“…Naproxen, also a COX inhibitor, is removed at fairly high rates (35 to greater than 99%) during sewage treatment by biodegradation. In surface waters, photolysis and biodegradation contribute to naproxen's relatively short half-life of 14 d [55]. With regard to toxicity, microbial growth in batch cultures at naproxen concentrations of 4.0 and 433 ng/L was lower than controls.…”

Fate and Transport of Naproxen in a Sandy Aquifer Material: Saturated Column Studies and Model Evaluation

“…Although no acute-based environmental risk for aquatic organisms has been found, an enhanced phototoxicity of its transformation products has been observed for both acute and chronic exposure (Isidori et al, 2005;Straub and Stewart, 2007).…”

An overall risk probability-based method for quantification of synergistic and antagonistic effects in health risk assessment for mixtures: theoretical concepts

“…The larger the value of the hazard quotient, the higher the health risks of adverse effects being observed. A margin of safety can also be calculated to be the inverse of the hazard quotient (Solomon et al 2000;Straub and Stewart 2007). Typically in a conventional method of risk characterization, the statistical distributions of the exposure and/or adverse effects data are not taken into account.…”

“…The disadvantage is that many more data points are needed. In recent years, the probabilistic risk assessment method has been used in several case studies of health risk assessment of environmental chemicals (Straub and Stewart 2007;Hamidin et al 2008;Cao et al 2011;Chowdhury et al 2009). …”