Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

The aim of this study was to investigate if non-standard ecotoxicity data can be evaluated systematically in risk assessments of pharmaceuticals. This has been done by evaluating the usefulness of four reliability evaluation methods, and by investigating whether recently published non-standard ecotoxicity studies from the open scientific literature fulfill the criteria that these methods propose.The same test data were evaluated differently by the four methods in seven out of nine cases. The selected non-standard test data were considered reliable/acceptable in only 14 out of 36 cases.The four evaluation methods differ in scope, user friendliness, and how criteria are weighted and summarized. This affected the outcome of the data evaluation.The results suggest that there is room for improvements in how data are reported in the open scientific literature. Reliability evaluation criteria could be used as a checklist to ensure that all important aspects are reported and thereby increasing the possibility that the data could be used for regulatory risk assessment.In 2006, the European Medicines Agency (EMA) decided that all new marketing authorisation applications for human pharmaceuticals should be accompanied by an environmental risk assessment [1]. The EMA risk assessment has a PEC/PNEC (predicted environmental concentration/predicted no effect concentration) approach and is divided into two phases. In phase II, data on the substance's physicochemical properties, persistence and bioaccumulation, and ecotoxicity are reviewed and the PNEC is estimated. All relevant data should be taken into account. Experimental studies should preferably follow standard test protocols but it is recognized that there are other acceptable methods. However, their use should be justified and studies should be conducted in compliance with good laboratory practices (GLP) [1].Ecotoxicological testing can be done using a variety of methods and models. There are two general approaches: using st