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Minimizing Experimental Testing on Fish for Legacy Pharmaceuticals.
Anja Coors1, A Ross Brown2, Samuel K Maynard3
1ECT Oekotoxikologie GmbH, Böttgerstraße 2-14, 65439 Flörsheim/Main, Germany.
Environmental Science & Technology
|January 18, 2023
Summary
This study introduces a decision tree to reduce animal testing for older pharmaceuticals. By using environmental risk quotients, in vivo fish testing can be decreased by approximately 35% without compromising environmental safety.
Area of Science:
- Environmental Science
- Toxicology
- Pharmaceutical Science
Background:
- Many human pharmaceuticals authorized before 2006 lack ecotoxicological data, posing environmental risks.
- Regulatory requirements for ecotoxicological testing were not mandatory for these legacy active pharmaceutical ingredients (APIs).
- Animal welfare concerns necessitate minimizing in vivo fish testing for environmental risk assessment.
Purpose of the Study:
- To develop a decision tree for minimizing in vivo fish testing for legacy APIs.
- To assess the environmental risk of pharmaceuticals using alternative data and models.
- To reduce animal testing while maintaining environmental protection standards.
Main Methods:
- Utilized the minimum no observed effect concentration (NOECmin) from chronic Daphnia and algal studies.
- Calculated theoretical therapeutic water concentration (TWC) using the fish plasma model.
- Derived API risk quotients (PEC/NOECmin and PEC/TWC) using predicted environmental concentration (PEC).
Main Results:
- A threshold value of 0.001 for risk quotients (PEC/NOECmin and PEC/TWC) was established.
- Implementing this threshold could reduce in vivo fish testing by approximately 35%.
- NOECmin with an assessment factor of 1000 reliably substituted for NOECfish for most APIs, with TWC serving as a safety net.
Conclusions:
- The developed decision tree effectively reduces the need for in vivo fish testing for legacy APIs.
- Environmental risk assessment can be achieved with reduced animal testing through alternative methods.
- In silico, in vitro, and mammalian toxicity data can further inform decisions on fish testing requirements.
