Uncertainty of estimates of cancer risks derived by extrapolation from high to low doses and from animals to humans

International Journal of Toxicology

Volumn 16, Issue 4-5, 1997, Pages 449-460

  Kodell, Ralph L ^a   Gaylor, David W ^a  

^a NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH   (United States)

Author keywords

Interspecies extrapolation; Linear extrapolation; Multistage model; TD50

Indexed keywords

CANCER RISK; CARCINOGENESIS; CONFERENCE PAPER; DATA ANALYSIS; DOSE RESPONSE; ENVIRONMENTAL EXPOSURE; HUMAN; MODEL; NONHUMAN; PREDICTION; RISK ASSESSMENT; RISK FACTOR; SPECIES DIFFERENTIATION;

ANIMALIA;

EID: 0030860392     PISSN: 10915818     EISSN: None     Source Type: Journal    
DOI: 10.1080/109158197227062     Document Type: Conference Paper

References (31)

1. Allen, B. C., Crump, K. S., and Shipp, A. M. 1988. Correlation between carcinogenic potency of chemicals in animals and humans. Risk Anal. 8:531-544.
2. Armitage, P., and Doll, R. 1961. Stochastic models for carcinogenesis. In Proceedings of the Fourth Berkeley Symposium on Mathematical Statistics and Probability 4, 19-38. Berkeley: University of California Press.
3. Crouch, E. A. C., and Wilson, R. 1981. Regulation of carcinogens. Risk Anal. 1:47-57.
4. Crump, K. S. 1994. Limitations of biological models of carcinogenesis for low-dose extrapolation. Risk Anal. 14:883-886.
5. Crump, K. S., Guess, H. A., and Deal, K. L. 1977. Confidence intervals and tests of hypotheses concerning dose response relations inferred from animal carcinogenicity data. Biometrics 33:437-451.
6. Crump, K. S., Hoel, D. G., Langley, C. H., and Peto, R. 1976. Fundamental carcinogenic processes and their implications for low dose risk assessment. Cancer Res. 36:2973-2979.
7. Crump, K. S., and Howe, R. B. 1985. A review of methods for calculating statistical confidence limits in low-dose extrapolation. In Toxicological Risk Assessment, Vol. 1: Biological and Statistical Criteria, ed. D. B. Clayson, D. Krewski, and I. Munro, 187-203. Boca Raton, FL: CRC Press.
8. Environmental Protection Agency (EPA). 1986. Guidelines for carcinogen risk assessment. Fed. Register 51:33993-34003.
9. Food and Drug Administration (FDA) Advisory Committee on Protocols for Safety Evaluation. 1971. Panel on carcinogenesis report on cancer testing in the safety evaluation of food additives and pesticides. Toxicol. Appl. Pharmacol. 20:419-438.
10. FDA. 1987. Sponsored compounds in food-producing animals; criteria and procedures for evaluating the safety of carcinogenic residues; final rule. Fed. Register 51:49572-49588.
11. Gaylor, D. W., and Kodell, R. L. 1980. Linear interpolation algorithm for low-dose risk assessment of toxic substances. J. Environ. Pathol. Toxicol. 4:305-312.
12. Gaylor, D. W., Chen, J. J., and Sheehan, D. M. 1993. Uncertainty in cancer risk estimates. Risk Anal. 13:149-154.
13. Gold, L. S., Wright, C., Bernstein, L., and deVeciana, M. 1987. Reproducibility of results in "near-replicate" carcinogenesis bioassays. J. Natl. Cancer Inst. 78:1149-1158.
14. Gold, L. S., Manley, N. B., Slone, T. H., Garfinkel, G. B., Rohrbach, L., and Ames, B. N. 1993. The fifth plot of the carcinogenic potency database: results of animal bioassays published in the general literature through 1988 and by the National Toxicology Program through 1989. Environ. Health Perspect. 100:65-135.
15. Haseman, J. K., Huff, J. E., Rao, G. N., and Eustis, S. L. 1989. Sources of variability in rodent carcinogenicity studies. Fund. Appl. Toxicol. 12:793-804.
16. Howe, R. B., and Crump, K. S. 1982. GLOBAL82: a computer program to extrapolate quantal animal toxicity data to low doses. Prepared for the Office of Carcinogenic Standards, OSHA, U.S. Department of Labor, Contract 41USC252C30.
17. Kociba, R. J., Keyes, D. G., Beyer, J. E., Carreon, R. M., Wade, C. E., Dittenber, D. A., Kalnins, R. P., Frauson, L. E., Park, C. N., Barrard, S. D., Hummel, R. A., Humiston, C. G. 1978. Results of a two-year chronic toxicity and carcinogenicity study of 2,3,7,8-tetrachlorodibenzo-p-dioxin in rats. Toxicol. Appl. Pharmacol. 46:279-303.
18. Kodell, R. L., and Park, C. N. 1995. Linear extrapolation in cancer risk assessment. In Low-Dose Extrapolation of Cancer Risks: Issues and Perspectives, ed. S. Olin, W. Farland, C. Park, L. Rhomberg, R. Scheuplein, T. Starr, and J. Wilson, 87-104. Washington, DC: ILSI Press.
19. Kodell, R. L., Ahn, H., Chen, J. J., Springer, J. A., Barton, C. N., and Hertzberg, R. C. 1996. Upper bound risk estimates for mixtures of carcinogens. Toxicology 105:199-208.
20. Kodell, R. L., Gaylor, D. W., and Chen, J. J. 1987. Using average lifetime dose rate for intermittent exposures to carcinogens. Risk Anal. 7:339-345.
21. Krewski, D. A., and Van Ryzin, J. A. 1981. Dose response models for quantal toxicity data. In Statistics and Related Topics, ed. M. Csorgo, D. W. Dawson, J. N. K. Rao, and A. K. Saleh, pp. 201-231. Amsterdam, North Holland.
22. Krewski, D., Szyszkowicz, M., and Rosenkranz, H. 1990. Quantitative factors in chemical carcinogenesis: variation in carcinogenic potency. Regul. Toxicol. Pharmacol. 12:13-29.
23. Krewski, D., Gaylor, D. W., Soms, A. P., and Szyszkowicz, M. 1993. Overview of report: correlation between the maximum tolerated dose and carcinogenic potency: implications for risk assessment. Risk Anal. 13:463-478.
24. Moolgavkar, S. H. 1994. Biological models of carcinogenesis and quantitative risk assessment. Risk Anal. 14:879-882.
25. National Research Council. 1987. Allometry: body size constraints in animal design. In Pharmacokinetics in Risk Assessment, Drinking Water and Health, Vol. 8. Washington, DC: National Academy Press.
26. National Toxicology Program (NTP). 1984. Report of the Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation. Research Triangle Park, NC: National Toxicology Program, Board of Scientific Counselors.
27. Office of Science and Technology Policy (OSTP). 1985. Chemical carcinogens: a review of the science and its associated principles. U.S. Interagency Staff Group on Chemical Carcinogenesis. Fed. Register 50:10371-10442.
28. Starr, T. B. 1990. Quantitative cancer risk estimation for formaldehyde. Risk Anal. 10:85-91.
29. Travis, C. C., and White, R. K. 1988. Interspecific scaling of toxicity data. Risk Anal. 8:119-125.
30. Turturro, A., Duffy, P., and Hart, R. W. 1995. The effect of caloric modulation on toxicity studies. In Dietary Restriction: Implications for the Design and Interpretation of Toxicity and Carcinogenicity Studies, ed. R. W. Hart, D. A. Neumann, and R. T. Robertson, 79-97. Washington, DC: ILSI Press.
31. Zeise, L., Wilson, R., and Crouch, E. A. C. 1987. Dose-response relationships for carcinogens: a review. Environ. Health Perspect. 73:259-308.