John Wiley & Sons, Ltd.

Use of acute and chronic ecotoxicity data in environmental risk assessment of pharmaceuticals

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For many older pharmaceuticals, chronic aquatic toxicity data are limited. To assess risk during development, scale‐up and manufacturing processes, acute data and physicochemical properties need to be leveraged to reduce potential long‐term impacts to the environment. Aquatic toxicity data were pooled from daphnid, fish and algae studies for 102 active pharmaceutical ingredients (APIs) to evaluate the relationship between predicted no‐effect concentrations (PNECs) derived from acute and chronic tests. The relationships between acute and chronic aquatic toxicity and the n‐octanol/water distribution coefficient were also characterized. Statistically significant but weak correlations were observed between toxicity and log Dow, indicating Dow is not the only contributor to toxicity. Both acute and chronic PNEC values could be calculated for 60 of the 102 APIs. For most compounds, PNECs derived from acute data were lower than PNECs derived from chronic data, with the exception of steroid estrogens. 7% of the PNECs derived from acute data were below the EU action limit of 0.01 µg/L and all were anti‐infectives affecting algal species. 8% of available PNECs derived from chronic data were below the EU action limit and fish were the most sensitive species for all but one API. These analyses suggest that the use of acute data may be acceptable if chronic data are unavailable, unless specific mode of action concerns suggest otherwise. This article is protected by copyright. All rights reserved

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