Summary of Workshop on Environmental Assessment of Human Medicines: Development and Use of Aquatic Toxicity Data

Abstract

Current approaches to generating and interpreting ecotoxicological effects data in aquatic organisms were discussed in a workshop. Scientific principles underpinning historical “base set” acute testing (typically using freshwater algae, daphnids, fish) and the more recent requirement to adopt chronic sublethal test guidelines were discussed. Participants discussed ideas to develop improved testing methods for chronic pharmacological and toxic effects based on the premise that useful ecotoxicity information can be leveraged from both in vitro and in vivo preclinical studies. For example, one approach is to consider a primary pharmacological mechanism in mammals (the mammalian-fish leverage model) and to use these mechanistic biomarker data as “signposts” to guide the efficient assessment of sublethal chronic testing in aquatic life. The usefulness of data obtained in test systems on the molecular, cellular, organ-organismal, and population levels of biological organization for environmental risk assessment was evaluated and integrated with animal (vertebrate) welfare considerations.