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Related Experiment Videos

Evaluation of the benchmark dose method for dichotomous data: model dependence and model selection.

Salomon Sand1, Agneta Falk Filipsson, Katarina Victorin

  • 1Institute of Environmental Medicine, Karolinska Institutet, PO Box 210, 17177 Stockholm, Sweden. salomon.sand@imm.ki.se

Regulatory Toxicology and Pharmacology : RTP
|December 4, 2002
PubMed
Summary

The benchmark dose (BMD) method effectively analyzes dose-response data for polyhalogenated aromatic compounds. A 5% benchmark response (BMR) is recommended for risk assessment, ensuring consistent results across models.

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Area of Science:

  • Toxicology
  • Environmental Health
  • Risk Assessment

Background:

  • The benchmark dose (BMD) method is a key tool in toxicological risk assessment.
  • Evaluating the performance of BMD software with real-world dose-response data is crucial.
  • Polyhalogenated aromatic compounds serve as a relevant case study for toxicological endpoints.

Purpose of the Study:

  • To evaluate the United States Environmental Protection Agency (USEPA) Benchmark Dose (BMD) software.
  • To assess dose-response data for cleft palate and hydronephrosis endpoints.
  • To determine appropriate benchmark response (BMR) levels for risk assessment.

Main Methods:

  • Utilized the USEPA BMD software for analysis.
  • Obtained dose-response data from literature for polyhalogenated aromatic compounds.

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  • Applied chi(2) test statistics and global goodness-of-fit for model evaluation.
  • Considered Akaike's information criterion (AIC) for model comparison.

    • Main Results:

    • USEPA dichotomous models adequately described 11 of 12 cleft palate datasets.
    • Model discrimination for hydronephrosis was higher based on goodness-of-fit.
    • Benchmark dose lower confidence limits (BMDLs) for cleft palate corresponded to NOAELs at 5% or lower extra risk.
    • BMDL estimates showed greater model dependence at lower benchmark response (BMR) levels.
    • BMDLs were minimally affected by confidence limit size (90-99%) at BMRs of 5-10%.

    Conclusions:

    • A BMR of 5% is recommended for cleft palate risk assessment due to limited model differences.
    • A conservative model selection approach, favoring the multistage model, is suggested for cleft palate.
    • Further analysis is needed to confirm the appropriateness of these methods in dose-response applications.