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Reproductive and Developmental Risks from Ethylene Oxide: A Probabilistic Characterization of Possible Regulatory Thresholds

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  • J. S. Evans
  • L. R. Rhomberg
  • P. L. Williams
  • A. M. Wilson
  • S. J. S. Baird

Abstract

Ethylene oxide is a gas produced in large quantities in the United States that is used primarily as a chemical intermediate in the production of ethylene glycol, propylene glycol, nonionic surfactants, ethanolamines, glycol ethers, and other chemicals. It has been well established that ethylene oxide can induce cancer, genetic, reproductive and developmental, and acute health effects in animals. The U.S. Environmental Protection Agency is currently developing both a cancer potency factor and a reference concentration (RfC) for ethylene oxide. This study used the rich database on the reproductive and developmental effects of ethylene oxide to develop a probabilistic characterization of possible regulatory thresholds for ethylene oxide. This analysis was based on the standard regulatory approach for noncancer risk assessment, but involved several innovative elements, such as: (1) the use of advanced statistical methods to account for correlations in developmental outcomes among littermates and allow for simultaneous control of covariates (such as litter size); (2) the application of a probabilistic approach for characterizing the uncertainty in extrapolating the animal results to humans; and (3) the use of a quantitative approach to account for the variation in heterogeneity among the human population. This article presents several classes of results, including: (1) probabilistic characterizations of ED10s for two quantal reproductive outcomes—resorption and fetal death, (2) probabilistic characterizations of one developmental outcome—the dose expected to yield a 5% reduction in fetal (or pup) weight, (3) estimates of the RfCs that would result from using these values in the standard regulatory approach for noncancer risk assessment, and (4) a probabilistic characterization of the level of ethylene oxide exposure that would be expected to yield a 1/1000 increase in the risk of reproductive or developmental outcomes in exposed human populations.

Suggested Citation

  • J. S. Evans & L. R. Rhomberg & P. L. Williams & A. M. Wilson & S. J. S. Baird, 2001. "Reproductive and Developmental Risks from Ethylene Oxide: A Probabilistic Characterization of Possible Regulatory Thresholds," Risk Analysis, John Wiley & Sons, vol. 21(4), pages 697-718, August.
    • Handle: RePEc:wly:riskan:v:21:y:2001:i:4:p:697-718
    DOI: 10.1111/0272-4332.214144
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    Cited by:

    1. Jane G. Pouzou & Alison C. Cullen & Michael G. Yost & John C. Kissel & Richard A. Fenske, 2018. "Comparative Probabilistic Assessment of Occupational Pesticide Exposures Based on Regulatory Assessments," Risk Analysis, John Wiley & Sons, vol. 38(6), pages 1223-1238, June.
    2. Hilko Van Der Voet & Wout Slob, 2007. "Integration of Probabilistic Exposure Assessment and Probabilistic Hazard Characterization," Risk Analysis, John Wiley & Sons, vol. 27(2), pages 351-371, April.
    3. Richard R. Lester & Laura C. Green & Igor Linkov, 2007. "Site‐Specific Applications of Probabilistic Health Risk Assessment: Review of the Literature Since 2000," Risk Analysis, John Wiley & Sons, vol. 27(3), pages 635-658, June.
    4. Kan Shao & Bruce C. Allen & Matthew W. Wheeler, 2017. "Bayesian Hierarchical Structure for Quantifying Population Variability to Inform Probabilistic Health Risk Assessments," Risk Analysis, John Wiley & Sons, vol. 37(10), pages 1865-1878, October.

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