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This study recommends a 50% benchmark response (BMR) for in vivo mutagenicity testing, using Effect Size theory to establish robust values for transgenic rodent (TGR) and Pig-a assays in risk assessment.

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Area of Science:

  • Toxicology
  • Genotoxicity Testing
  • Risk Assessment

Background:

  • The benchmark dose (BMD) approach is crucial for risk assessment and regulatory decisions.
  • Defining appropriate benchmark response (BMR) values for genotoxicity is controversial.
  • Existing BMRs lack standardization for in vivo mutagenicity assays.

Purpose of the Study:

  • To apply Effect Size (ES) theory to derive robust BMR values for in vivo transgenic rodent (TGR) and Pig-a mutagenicity endpoints.
  • To investigate the influence of experimental factors on within-group variance (var) for these endpoints.
  • To recommend a standardized BMR for in vivo mutagenicity risk assessment.

Main Methods:

  • Utilized Slob (2017) ES theory to define BMR values.
  • Curated an extensive database of dose-response data for TGR and Pig-a assays.
  • Performed BMD analyses to determine endpoint-specific maxima (c) and variance (var).
  • Assessed the impact of tissue, administration route, duration, and sampling time on var.
  • Calculated BMRs using both typical var and trimmed SD of concurrent controls.

Main Results:

  • Experimental factors showed minimal influence on within-group variance (var).
  • Typical var values were 0.19 for TGR and 0.29 for Pig-a.
  • Endpoint-specific BMRs calculated using var were 47% (TGR) and 60% (Pig-a).
  • BMRs calculated using trimmed SD were 33% (TGR) and 58% (Pig-a).

Conclusions:

  • A consistent BMR value is recommended for in vivo mutagenicity endpoints.
  • A 50% BMR is proposed for interpreting mutagenicity dose-response data in risk assessments.
  • This standardized BMR enhances consistency and pragmatism in genotoxicity risk evaluation.