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Issues in Qualitative and Quantitative Risk Analysis for Developmental Toxicology

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  • Carole A. Kimmel
  • David W. Gaylor

Abstract

The qualitative and quantitative evaluation of risk in developmental toxicology has been discussed in several recent publications.(1–3) A number of issues still are to be resolved in this area. The qualitative evaluation and interpretation of end points in developmental toxicology depends on an understanding of the biological events leading to the end points observed, the relationships among end points, and their relationship to dose and to maternal toxicity. The interpretation of these end points is also affected by the statistical power of the experiments used for detecting the various end points observed. The quantitative risk assessment attempts to estimate human risk for developmental toxicity as a function of dose. The current approach is to apply safety (uncertainty) factors to die no observed effect level (NOEL). An alternative presented and discussed here is to model the experimental data and apply a safety factor to an estimated risk level to achieve an “acceptable” level of risk. In cases where the dose‐response curves upward, this approach provides a conservative estimate of risk. This procedure does not preclude the existence of a threshold dose. More research is needed to develop appropriate dose‐response models that can provide better estimates for low‐dose extrapolation of developmental effects.

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  • Carole A. Kimmel & David W. Gaylor, 1988. "Issues in Qualitative and Quantitative Risk Analysis for Developmental Toxicology," Risk Analysis, John Wiley & Sons, vol. 8(1), pages 15-20, March.
    • Handle: RePEc:wly:riskan:v:8:y:1988:i:1:p:15-20
    DOI: 10.1111/j.1539-6924.1988.tb01149.x
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    1. Raimo I. Niemelä & Jorma Rantanen & Mirja K. Kiilunen, 1998. "Target Levels—Tools for Prevention," Risk Analysis, John Wiley & Sons, vol. 18(6), pages 679-688, December.
    2. Fereshteh Kalantari & Joakim Ringblom & Salomon Sand & Mattias Öberg, 2017. "Influence of Distribution of Animals between Dose Groups on Estimated Benchmark Dose and Animal Distress for Quantal Responses," Risk Analysis, John Wiley & Sons, vol. 37(9), pages 1716-1728, September.
    3. Christel Faes & Marc Aerts & Helena Geys & Geert Molenberghs, 2007. "Model Averaging Using Fractional Polynomials to Estimate a Safe Level of Exposure," Risk Analysis, John Wiley & Sons, vol. 27(1), pages 111-123, February.
    4. Daniel Krewski & Robert Smythe & Karen Y. Fung, 2002. "Optimal Designs for Estimating the Effective Dose in Developmental Toxicity Experiments," Risk Analysis, John Wiley & Sons, vol. 22(6), pages 1195-1205, December.
    5. Daniel O. Scharfstein & Paige L. Williams, 1994. "Design of Developmental Toxicity Studies for Assessing Joint Effects of Dose and Duration," Risk Analysis, John Wiley & Sons, vol. 14(6), pages 1057-1071, December.
    6. Meredith M. Regan & Paul J. Catalano, 1999. "Likelihood Models for Clustered Binary and Continuous Out comes: Application to Developmental Toxicology," Biometrics, The International Biometric Society, vol. 55(3), pages 760-768, September.
    7. Julie S. Najita & Paul J. Catalano, 2013. "On Determining the BMD from Multiple Outcomes in Developmental Toxicity Studies when One Outcome is Intentionally Missing," Risk Analysis, John Wiley & Sons, vol. 33(8), pages 1500-1509, August.
    8. J. Michael Davis & Annie M. Jarabek & David T. Mage & Judith A. Graham, 1998. "The EPA Health Risk Assessment of Methylcyclopentadienyl Manganese Tricarbonyl (MMT)," Risk Analysis, John Wiley & Sons, vol. 18(1), pages 57-70, February.
    9. Jeanne L. Sebaugh & James D. Wilson & Michael W. Tucker & William J. Adams, 1991. "A Study of the Shape of Dose‐Response Curves for Acute Lethality at Low Response: A “Megadaphnia Study”," Risk Analysis, John Wiley & Sons, vol. 11(4), pages 633-640, December.
    10. Jeffrey C. Swartout & Paul S. Price & Michael L. Dourson & Heather L. Carlson‐Lynch & Russell E. Keenan, 1998. "A Probabilistic Framework for the Reference Dose (Probabilistic RfD)," Risk Analysis, John Wiley & Sons, vol. 18(3), pages 271-282, June.
    11. David W. Gaylor & William Slikker, 1994. "Modeling for Risk Assessment of Neurotoxic Effects," Risk Analysis, John Wiley & Sons, vol. 14(3), pages 333-338, June.
    12. David Pennington & Pierre Crettaz & Annick Tauxe & Lorenz Rhomberg & Kevin Brand & Olivier Jolliet, 2002. "Assessing Human Health Response in Life Cycle Assessment Using ED10s and DALYs: Part 2—Noncancer Effects," Risk Analysis, John Wiley & Sons, vol. 22(5), pages 947-963, October.
    13. Ronald J. Bosch & David Wypij & Louise M. Ryan, 1996. "A Semiparametric Approach to Risk Assessment for Quantitative Outcomes," Risk Analysis, John Wiley & Sons, vol. 16(5), pages 657-665, October.
    14. Brian G. Leroux & Wendy M. Leisenring & Suresh H. Moolgavkar & Elaine M. Faustman, 1996. "A Biologically‐Based Dose—Response Model for Developmental Toxicology," Risk Analysis, John Wiley & Sons, vol. 16(4), pages 449-458, August.

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