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Human-relevant potency threshold (HRPT) for ERα agonism.

Christopher J Borgert1, John C Matthews2, Stephen P Baker3

  • 1Applied Pharmacology and Toxicology, Inc. and CEHT, Univ. FL College of Vet. Med., Gainesville, FL, USA. cjborgert@apt-pharmatox.com.

Archives of Toxicology
|April 11, 2018
PubMed
Summary

This study introduces a new method to identify endocrine disrupting chemicals (EDCs) by measuring mechanistic potency. A human-relevant potency threshold (HRPT) was established for estrogen receptor alpha (ERα) agonism to assess potential hazards.

Keywords:
Endocrine disruptor/disruptionEstrogen systemEuropean CommissionHRPTHazard identificationPotency

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Area of Science:

  • Toxicology
  • Endocrinology
  • Pharmacology

Background:

  • The European Commission proposes new criteria for identifying endocrine disrupting chemicals (EDCs).
  • Traditional hazard identification focuses on adverse effects, but new approaches require understanding the mode of action (MoA).
  • Chemical hazard assessment necessitates evaluating pharmacokinetic properties and mechanistic potency for specific MoAs.

Purpose of the Study:

  • To develop an empirical method for determining a human-relevant potency threshold (HRPT).
  • To establish an HRPT for estrogen receptor alpha (ERα) agonism.
  • To provide a practical approach for hazard identification of EDCs.

Main Methods:

  • Defined mechanistic potency based on affinity and activity at functional components of a MoA.
  • Utilized the agonist mode of action via ERα to illustrate the HRPT determination method.
  • Compared ERα agonist potencies of chemicals with their ERα-mediated responses in human clinical trials.

Main Results:

  • Proposed a human-relevant potency threshold (HRPT) for ERα agonism.
  • Established the HRPT at 1E-04 relative to 17β-estradiol or 17α-ethinylestradiol.
  • Demonstrated a method to distinguish chemicals capable of producing adverse effects from those unlikely to.

Conclusions:

  • The developed HRPT provides a practical tool for EDC hazard identification.
  • This approach aligns with the European Commission's draft criteria for EDC identification.
  • The method allows for a more precise assessment of chemical hazards based on MoA.