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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
PubMed
Summary
This summary is machine-generated.

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.

Keywords:
animal welfareecotoxicityenvironmental risk assessmentfish plasma modelvertebrate testing

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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.