Summary of Workshop on Environmental Assessment of Human Medicines: Development and Use of Aquatic Toxicity Data
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Summary of Workshop on Environmental Assessment of Human Medicines: Development and Use of Aquatic Toxicity Data Mark H. M. M. Montforts National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands Ingvar Brandt Department of Environmental Toxicology, Uppsala University, Uppsala, Sweden Thomas H. Hutchinson AstraZeneca Global Safety, Health and Environment, Brixham Environmental Laboratory, Brixham, UK
Correspondence Address Mark H.M.M. Montforts, National Institute for Public Health and the Environment (RIVM), P.O. Box 1, NL-3720BA Bilthoven, The Netherlands (e-mail: [email protected]).
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
THE SCOPE OF THE SCIENTIFIC CHALLENGE Given the scientific complexity of understanding the multiple contaminants (including pharmaceuticals and other classes of chemicals) that may have an impact on aquatic life, over a number of years we have witnessed the development of a range of scientific approaches to risk assessment. As examples, these include deterministic risk assessment based on the calculation of the predicted no effect concentration (PNEC; 1,2), environmental monitoring programs (3), and application of environmental quality standards (4). However, because it is not practical to accurately assess the risks of all combinations of substances and uses to the environment, there is a well-established need to better model the real world. The objective of the overall environmental risk assessment model (in North America, often termed ecological risk assessment), in which effect models are an important part, is to provide comprehensive information on all environmental risks related to the use of medicines to optimize the risk-based decision. Effect models elucidate effects in model organisms or systems as a result of exposure to a medicine. These model results need to be trans-
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.
lated to the situation of interest. Effect assessment or dose-response assessment is the estimation of the relationship between th
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