Estimating noncancer uncertainty factors: Are ratios NOAELs informative?

Risk Analysis

Volumn 19, Issue 2, 1999, Pages 295-308

  Brand, Kevin P ^a   Rhomberg, Lorenz ^a   Evans, John S ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Calibration; Censoring; Noncancer risk assessment; Relative potency; Safety factor; Systematic error; Uncertainty analysis

Indexed keywords

BIOASSAY; HEALTH RISKS; SAFETY FACTOR; STATISTICAL METHODS; SYSTEMATIC ERRORS; TOXICITY;

NONCANCER RISK ASSESSMENT;

RISK ASSESSMENT;

ARTICLE; BIOASSAY; CALIBRATION; DECISION MAKING; DOSE RESPONSE; HUMAN; MATHEMATICAL ANALYSIS; METHODOLOGY; RISK ASSESSMENT;

ALGORITHMS; ANIMALS; BIAS (EPIDEMIOLOGY); BIOLOGICAL ASSAY; CALIBRATION; COMPUTER SIMULATION; CONFIDENCE INTERVALS; DECISION MAKING; DOSE-RESPONSE RELATIONSHIP, DRUG; ENVIRONMENTAL POLLUTANTS; HEALTH POLICY; HUMANS; MICE; MODELS, BIOLOGICAL; NEOPLASMS, EXPERIMENTAL; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PROBABILITY; RATS; RESEARCH DESIGN; RISK ASSESSMENT; TOXICOLOGY;

EID: 0032865933     PISSN: 02724332     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1006981829124     Document Type: Article

References (45)

1. A. J. Lehman, and O. G. Fitzhugh, "100-fold margin of safety," Assoc. Food Drug Off. U.S. Quart. Bull. 18, 33-35 (1954).
2. I. C. Munro, and D. R. Krewski, "Risk assessment and regulatory decision making," Food Cosmet. Toxicol. 19, 549-560 (1981).
3. M. L. Dourson, and J. F. Stara, "Regulatory history and experimental support of uncertainty (safety) factors," Reg. Tox. Pharm. 3, 224-238 (1983).
4. D. Krewski, C. Brown, and D. Murdoch. "Determining "safe" levels of exposure: Safety factors or mathematical models," Fund. Appl. Tox. 4, s383-s394 (1984).
5. M. L. Doursen, S. P. Felter, and D. Robinson, "Evolution of science-based uncertainty factors in noncancer risk assessment," Regul. Tox. Pharm. 24, 108-120 (1996).
6. F. C. Lu, "Safety assessments of chemicals with thresholded effects," Regul. Tox. Pharm. 5, 460-464 (1985).
7. F. C. Lu, "Acceptable daily intake: Inception, evolution, and application," Regul. Tox. Pharm. 8, 45-60 (1988).
8. M. L. Dourson, L. A. Knauf, and J. C. Swartout, "On reference dose (RFD) and its underlying toxicity data base," Tox. Ind. Health 8, 171-189 (1992).
9. S. J. Baird, J. C. Cohen, J. D. Graham, A. I. Shlyakhter, and J. S. Evans, "Noncancer risk assessment: A probabilistic alternative to current practices," 2, 79-102 (1996).
10. R. S. Nair, J. H. Sherman, M. W. Stevens, and R. R. Johannsen, "Selecting a more realistic uncertainty factor: Reducing compounding effects of multiple uncertainties," HERA 1, 576-589 (1995).
11. P. S. Price, R. E. Keenan, J. C. Swartout, C. A. Gillis, H. Carlson-Lynch, and M. L. Dourson, "An approach for modeling noncancer dose-responses with an emphasis on uncertainty," Risk Anal. 17, 427-438 (August 1997).
12. C. S. Weil, and D. D. McCollister, "Relationship between short and long-term feeding studies in designing an effective toxicity test," Agr. Food Chem. 11, 486-491 (1963).
13. B. P. McNamera, "Concepts in health evaluation of commercial and industrial chemicals," in M. A. Mehlman, R. E. Shapiro, and H. Blumenthal, eds., New Concepts in Safety Evaluation (Hemisphere, Washington, DC, 1976), pp. 61-140.
14. R. A. Woutersen, H. P. Till, and V. J. Feron, "Sub-acute versus subchronic oral toxicity study in rats: Comparative study of 82 compounds," J. Appl. Toxicol. 5, 277-280 (1984).
15. A. M. Kadry, et al., "Evaluation of the use of uncertainty factors in deriving RfDs for some chlorinated compounds," J. Toxic. Env. Health 44, 83-95 (1995).
16. A. M. Kadry, G. A. Skowronski, A. I. Khodair, and M. S. Abdel-Rahman, "Determining safe levels of exposure: The validity of the use of 10x safety factors," Hum. Ecol. Risk Assess. 1, 565-575 (1995).
17. M. S. Abdel-Rahman, and A. M. Kadry, "Studies on the use of uncertainty factors in deriving RfDs," Hum. Ecol. Risk Assess. 1, 614-624 (1995).
18. S. C. Lewis, "Reducing uncertainty with adjustment factors. Improvements in quantitative noncancer risk assessment," Fund. Appl. Tox. 14, 401 (1994).
19. B. D. Beck, R. B. Conolly, M. L. Dourson, D. Guth, D. Hattis, C. Kimmel, and S. C. Lewis, "Symposium overview: Improvements in quantitative noncancer risk assessment," Fund. Appl. Tox. 20, 1-14 (1993).
20. S. C. Lewis, and C. S. Nessel, "Extrapolating subchronic test results to estimate chronic no-observed-adverse-effect levels: Factors of 10 are larger than necessary," Toxicologist 14, 401 (1994).
21. C. S. Nessel, S. C. Lewis, K. L. Stauber, and J. L. Adgate, "Subchronic to chronic exposure extrapolation: Toxicologic evidence for a reduced uncertainty factor," Hum. Ecol. Risk Assess. 1, 516-526 (1995).
22. Sielken RL, and Valdez-Flores C, "Comprehensive realism's weight-of-evidence based distributional dose-response characterization," Hum. Ecol. Risk Assess. 2, 175-193 (1996).
23. J. Swartout, "Exposure-duration uncertainty factors for the RfD," Fund. Appl. Tox: Suppl. p. 209 (1997).
24. J. S. Evans, and S. J. Baird, "Accounting for missing data in noncancer risk assessment," HERA 4, 291-317 (1998).
25. J. C. Swartout, P. S. Price, M. L. Dourson, H. L. Carlson-Lynch, and R. E. Keenan, "A probabilistic framework for the reference dose," Risk Anal. 18, 271-282 (1998).
26. C. W. Schmidt, C. A. Gillis, R. E. Keenan, and P. S. Price, "Characterizing interchemical variation in the interspecies uncertainty factor (UFa)," Fund. Appl. Tox. Suppl. (1997).
27. R. W. Setzer, and J. M. Rogers, "Assessing developmental hazard: The reliability of the A/D Ratio," Teratology 44, 653-665 (1991).
28. A. G. Renwick, "Data-derived safety factors for the evaluation of food additives and environmental contaminants," Food Additives Contam. 10, 275-305 (1993).
29. D. Gaylor, "The use of safety factors for controlling risk," J. Toxicol. Environ. Health. 15, 329-336 (1983).
30. K. S. Crump, "A new method for determining allowable daily intakes," Fund. Appl. Tox. 4, 854-871 (1984).
31. W. Leisenring, and L. Ryan, "Statistical properties of the NOAEL," Regul. Tox. Pharm. 15, 161-171 (1992).
32. B. C. Allen, R. J. Kavlock, C. A. Kimmel, and E. M. Faustman, "Dose-response assessment for developmental toxicity: II. Comparison of generic BMD estimate with NOAELs," Fund. Appl. Tox. 23, 487-495 (1994).
33. D. G. Barnes, G. P. Daston, J. S. Evans, A. M. Jarabek, R. J. Kavelock, C. A. Kimmel, and H. L. Spitzer, "Benchmark dose workshop: Criteria for use of a benchmark dose to estimate a reference dose," Regul. Tox. Pharm. 21, 296-306 (1995).
34. B. J. T. Morgan, Analysis of Quantal Response Data (Chapman & Hall, 1992).
35. D. J. Finney, Statistical Method in Biological Assay (Charles Griffen & Co. LTD, 1978).
36. W. R. Ott, "A physical explanation of lognormality of pollutant concentrations," J. Air Waste Manage. Assoc. 40, 1378-1383 (1990).
37. B. Efron, and R. J. Tibshirani, An Introduction to the Bootstrap. (Chapman & Hall, 1993).
38. K. P. Brand, Interpreting Bioassays for Policy: Analysis of Extrapolation Uncertainties. Sc.D. thesis, Harvard School of Public Health (1999).
39. StatSci Division, S-PLUS User's Manual: Version 3.3 for Windows. MathSoft, Inc., Seattle, WA (September 1995).
40. W. N. Venables, and B. D. Ripley, Modern Applied Statistics With S-Plus (Springer-Verlag, 1994).
41. E. J. Freireich, et al., "Quantitative comparison of toxicity of anti-cancer agents in mouse, rat hamster, dog, monkey, and man," Cancer Chemother. Rep. 50, 219-244 (1966).
42. C. C. Travis, and R. K. White, "Interspecific scaling of toxicity data," Risk Anal. 8, 119-125 (1988).
43. L. R. Rhomberg, and S. K. Wolff, "Empirical scaling of single oral lethal doses across mammalian species based on a large database," Risk Anal. 18(6), 741-753 (1998).
44. D. A. Freedman, L. S. Gold, and T. H. Slone, "How tautological are interspecies correlations of carcinogenic potencies?," Risk Anal. 13, 265-272 (1993).
45. D. Freedman, L. S. Gold, and T. H. Lin, "Concordance between rats and mice in bioassays for carcinogenesis," Reg. Tox. Pharm. 23, 225-232 (1996).