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ments on this article. An earlier version of this paper was presented on September 6, 1990 in Washington, D.C. at the Workshop on Maximum Tolerated Dose: Implications for Risk Assessment sponsored by the U.S. National Academy of Sciences Committee on Risk Assessment Methodology, and discussed by Drs. Edmund Crouch and Lauren Zeise. A draft of this paper was also presented at the International Environmetrics Conference held in Como, Italy, from September 27-October 2, 1990.

9. References

Allen, B., Crump, K. & Shipp, A. (1988a). Carcinogenic potencies of chemicals in animals and humans. Risk Analysis 8, 531-544.

Allen, B., Crump, K. & Shipp, A. (1988b). Is it possible to predict the carcinogenic potency of a chemical in humans using animal data? (with discussion). In Banbury Report 31: Carcinogen Risk Assessment: New Directions in the Qualitative and Quantitative Aspects. Cold Spring Harbor Laboratory, Cold Spring Harbor, pp. 197-209.

Ames, B.N., Magaw, R. & Gold, L.S. (1987). Ranking possible carcinogenic hazards. Science 236, 271-280.

Ames, B.N. & Gold, L.S. (1990). Too many rodent carcinogens: mitogenesis increases mutagenesis. Science 249, 970-971.

Andersen, M.A., Clewell, H.J., Gargas, M.L., Smith, F.A. & Reitz, R.H. (1987). Physiologically based pharmacokinetics and the risk assessment process for vinyl chloride. Toxicology and Applied Pharmacology 87, 185-205.

Apostolou, A. (1990). Relevance of maximum tolerated dose to human carcinogenic risk. Regulatory Toxicology and Pharmacology 11, 68-80.

Armitage, P. (1985). Multistage models of carcinogenesis. Environmental Health Perspectives 63, 195-201.

Ashby, J. & Tenant, R.W. (1988). Chemical structure, Salmonella mutagenicity and extent of carcinogenicity as indicators of genotoxic carcinogenesis among 222 chemicals tested in rodents by the U.S. NCI/NTP. Mutation Research 204, 17-115.


Bailar, A.J. & Portier, C.J. (1992). An index of tumorigenic potency. Biometrics. In press.



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APPENDIX F 150 original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. ments on this article. An earlier version of this paper was presented on September 6, 1990 in Washington, D.C. at the Workshop on Maximum Tolerated Dose: Implications for Risk Assessment sponsored by the U.S. National Academy of Sciences Committee on Risk Assessment Methodology, and discussed by Drs. Edmund Crouch and Lauren Zeise. A draft of this paper was also presented at the International Environmetrics Conference held in Como, Italy, from September 27-October 2, 1990. 9. REFERENCES Allen, B., Crump, K. & Shipp, A. (1988a). Carcinogenic potencies of chemicals in animals and humans. Risk Analysis 8, 531-544. Allen, B., Crump, K. & Shipp, A. (1988b). Is it possible to predict the carcinogenic potency of a chemical in humans using animal data? (with discussion). In Banbury Report 31: Carcinogen Risk Assessment: New Directions in the Qualitative and Quantitative Aspects. Cold Spring Harbor Laboratory, Cold Spring Harbor, pp. 197-209. Ames, B.N., Magaw, R. & Gold, L.S. (1987). Ranking possible carcinogenic hazards. Science 236, 271-280. Ames, B.N. & Gold, L.S. (1990). Too many rodent carcinogens: mitogenesis increases mutagenesis. Science 249, 970-971. Andersen, M.A., Clewell, H.J., Gargas, M.L., Smith, F.A. & Reitz, R.H. (1987). Physiologically based pharmacokinetics and the risk assessment process for vinyl chloride. Toxicology and Applied Pharmacology 87, 185-205. Apostolou, A. (1990). Relevance of maximum tolerated dose to human carcinogenic risk. Regulatory Toxicology and Pharmacology 11, 68-80. Armitage, P. (1985). Multistage models of carcinogenesis. Environmental Health Perspectives 63, 195-201. Ashby, J. & Tenant, R.W. (1988). Chemical structure, Salmonella mutagenicity and extent of carcinogenicity as indicators of genotoxic carcinogenesis among 222 chemicals tested in rodents by the U.S. NCI/NTP. Mutation Research 204, 17-115. Bailar, A.J. & Portier, C.J. (1992). An index of tumorigenic potency. Biometrics. In press.

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APPENDIX F 151 original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. Bailar, J.C., III, Crouch, A.E.C., Shaikh, R. & Spiegelman, D. (1988). One-hit models of carcinogenesis: conservative or not? Risk Analysis 8, 485-497. Barr, J.T. (1985). The calculation and use of carcinogenic potency: a review. Regulatory toxicology and Pharmacology 5, 432-459. Bartsch, H. & Malaveille, C. (1989). Prevalence of genotoxic carcinogens among animal and human carcinogens in the IARC Monograph Series. Cell Biology and Toxicology 5, 115-127. Bernstein, L., Gold, L.S., Ames, B.N., Pike, M.C. & Hoel, D.G. (1985). Some tautologous aspects of the comparison of carcinogenic potency in rats and mice. Fundamental and Applied Toxicology 5, 79-87. Butterworth, B.E. (1990). Consideration of both genotoxic and nongenotoxic mechanisms in predicting carcinogen potential. Mutation Research 239, 117-132. Carr, C.J. & Kolbye, A.C.(Jr.) (1991). A critique of the use of the maximum tolerated dose in bioassays to assess cancer risks from chemicals. Regulatory Toxicology and Pharmacology 14, 78-87. Chen, J.J. & Gaylor, D.W. (1987). Carcinogenic risk assessment: comparison of of estimated safe doses for rats and mice. Environmental Health Perspectives 72, 305-309. Clayson, D.B. (1987). The need for biological risk assessment in reaching decisions about carcinogens. Mutation Research 185, 243-269. Clayson, D.B. & Clegg, D.J. (1991). Classification of carcinogens: polemics, pedantics, or progress? Regulatory Toxicology and Pharmacology 14, 147-166. Clayson, D.B., Iverson, F. & Mueller, R. (1992). An appreciation of the maximum tolerated dose: an inadequately precise point in the designing a carcinogesis bioassay. Teratogenesis, Carcinogenesis, and Mutagenesis. In press. Cogliano, V.J. (1986). The U.S. EPA's methodology for adjusting the reportable quantities of potential carcinogens. Proceedings of the 7th National Conference on Management of Uncontrollable Hazardous Wastes (Superfund '86). Hazardous Wastes Control Institute, Washington, DC, 182-185. Cohen, S.M. & Ellwein, L.B. (1990). Cell proliferation in carcinogenesis. Science 249, 1007-1011. Crouch, E.A.C. & Wilson, R. (1979). Interspecies comparison of

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APPENDIX F 152 original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. carcinogenic potency. Journal of Toxicology and Environmental Health 5, 1095-1118. Crouch, E.A.C. & Wilson, R. (1981). Regulation of carcinogens (with discussion). Risk Analysis 7, 47-66. Crouch, E.A.C. (1983). Uncertainties in interspecies extrapolation of carcinogenicity. Environmental Health Perspectives 50, 321-327. Crouch, E.A.C., Wilson, R. & Zeise, L. (1987). Tautology or not tautology? Journal of Toxicology and Environmental Health 20, 1-10. Crump, K.S. (1984a). An improved procedure for low dose carcinogenic risk assessment for animal data. Journal of Environmental Pathology, Toxicology and Oncology 5, 339-348. Crump, K.S. (1984b). A new method for determining allowable daily intakes. Fundamental and Applied Toxicology 4, 854-871. Crump, K., Allen, B. & Shipp, A. (1989). Choice of a dose measure for extrapolating carcinogenic risk from animals to humans: an empirical investigation of 23 chemicals (with discussion). Health Physics 57 (Supplement 1), 387-393. Cunningham, M.L., Foley, J., Maronpot, R.R. & Matthews, H.B. (1991). Correlation of hepatocellular proliferation with hepatocarcinogenicity induced by the mutagenic noncarcinogen: carcinogen pair - 2,6- and 2,4-diaminotoluene. Toxicology and Applied Pharmacology 107, 562-567. Dewanji, A., Krewski, D. & Goddard, M.J. (1992). A Weibull model for estimating tumorigenic potency. Biometrics. In press. Ennever, F.K., Noonan, T.J. & Rosenkranz, H.S. (1987). The predictivity of animal bioassays and short-term genotoxicity tests for carcinogenicity and non-carcinogenicity to humans. Mutagenesis 2, 73-78. Farmer, J.H., Kodell, R.L. & Gaylor, D.W. (1982). Estimation and extrapolation of tumor probabilities from a mouse bioassay with survival/sacrifice components. Risk Analysis 23, 27-34. Finkelstein, D.M. & Ryan, L.M. (1987). Estimating carcinogenic potency from a rodent tumorigenicity experiment. Applied Statistics 36, 121-133. Finkelstein, D.M. (1991). (1991). Modeling the effect of dose on the lifetime tumor rats from an animal carcinogenicity experiment. Biometrics 47, 669-680. Freedman, D.A. & Zeisel, H. (1988). From mouse-to-man: the quantitative assessment of cancer risk. Statistical Science 3, 3-56.

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APPENDIX F 153 original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. Freedman, D.A., Gold, L.S. & Slone, T.H. (1992). How tautological are interspecies correlations of carcinogenic potencies? Technical Report No. 334, Department of Statistics, University of California, Berkeley. Gaylor, D.W. (1983). The use of safety factors for controlling risk. Journal of Toxicology and Environmental Health 11, 329-336. Gaylor, D.W. (1989). Preliminary estimates of the virtually safe dose for tumors obtained from the maximum tolerated dose. Regulatory Toxicology Pharmacology 9, 1-18. Gaylor, D.W. and Kodell, R.L. (1980). Linear interpolation algorithm for low dose risk assessment of toxic substances. Journal of Environmental Pathology and Toxicology 4, 305-312. Gaylor, D.W. & Chen, J.J. (1986). Relative potency of chemical carcinogens in rodents. Risk Analysis 6, 283-290. Gold, L.S., Sawyer, C.B., Mcgaw, R., Backman, G.M., de Veciana, M., Levinson, R., Hooper, N.K., Havender, W.R., Bernstein, L., Peto, R., Pike, M.C. & Ames, B.N. (1984). A carcinogenic potency database of the standardized results of animal bioassays. Environmental Health Perspectives 58, 9-319. Gold, L.S., de Veciana, M., Backman, G.M., Mcgaw, R., Lopipero, P., Smith, M., Blumenthal, M., Levinson, R., Gevson, J., Bernstein, L. & Ames, B.N. (1986a). Chronological supplement to the carcinogenic potency database: standardized results of animal bioassays published through December 1982. Environmental Health Perspectives 67, 161-200. Gold, L.S., Bernstein, L., Kaldor, J., Backman, G. & Hoel, D. (1986b). An empirical comparison of methods used to estimate carcinogenic potency in long-term animal bioassays: lifetable vs. summary incidence data. Fundamental and Applied Toxicology 6, 263-269. Gold, L.S., Slone, T.H., Backman, G.M., Mcgaw, R., DaCosta, M., Lopipero, P., Blumenthal, M. & Ames, B.N. (1987). Second chronological supplement to the carcinogenic potency database: standardized results of animal bioassays published through December 1984 and by the National Toxicology Program through May 1986. Environmental Health Perspectives 74, 237-329. Gold, L.S., Slone, T.H. & Bernstein, L. (1989). Summary of carcinogenic potency and positivity for 492 rodent carcinogens in the carcinogenic potency database. Environmental Health Perspectives 79, 259-272.

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APPENDIX F 154 original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. Gold, L.L. & Ames, B.N. (1990). The importance of ranking possible carcinogenic hazards using HERP. Risk Analysis. In press. Gold, L.S., Slone, T.H., Backman, G.M., Eisenberg, S., Da Costa, M., Wong, M., Manley, N.B., Rohrbach, L. & Ames, B.N. (1990). Third chronological supplement to the Carcinogenic Potency Database: Standardized results of animal bioassays published through December 1986 and by the National Toxicology Program through June 1987. Environmental Health Perspectives 84, 215-286. Gold, L.S., Slone, T.H., Stern, B.R., Manley, N.B. & Ames, B.N. (1992). Rodent carcinogens: setting priorities. Science 258, 261-265. Goodman, G., Shlyakhter, A. & Wilson, R. (1991). The relationship between carcinogenic potency and maximum tolerated dose is similar for mutagens and nonmutagens. In: Chemically Induced Cell Proliferation: Implications for Risk Assessment (Butterworth, B.B., Slaga, T.J., Garland, W. & McLean, M., eds.), Wiley-Liss, New York, pp. 501-516. Goodman, G. & Wilson, R. (1991a). Predicting the carcinogenicity of chemicals in humans from rodent bioassay data. Environmental Health Perspectives 94, 195-218. Goodman, G. & Wilson, R. (1991b). Quantitative prediction of human cancer risk from rodent carcinogenic potencies: a closer look at the epidemiological evidence for some chemicals not definitively carcinogenic in humans. Regulatory Toxicology and Pharmacology 14, 118-146. Goodman, G. & Wilson, R. (1992). Comparison of the dependence of the TD50 on maximum tolerated dose for mutagens and nonmutagens. Risk Analysis. To appear. Haseman, J.K. (1985). Issues in carcinogenicity testing: dose selection. Fundamental and Applied Toxicology 5, 66-78. Haseman, J.K. & Huff, J.E. (1987). Species correlation in long-term carcinogenicity studies. Cancer Letters 37, 125-132. Hoel, D.G., Haseman, J.K., Hogan, M.D., Huff, J. & McConnell, E.E. (1988). The impact of toxicity on carcinogenicity studies: implication for risk assessment. Carcinogenesis 9, 2045-2053. International Agency for Research on Cancer (1987). Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes

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APPENDIX F 159 original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. carcinogen hazards using the TD50 (with discussion). Risk Analysis 10, 609-614. U.S. Environmental Protection Agency (1986). Guidelines for carcinogen risk assessment. Federal Register 51, 33992-34003. Van Ryzin, J. (1980). Quantitative risk assessment. Journal of Occupational Medicine 22, 321-326. Williams, P. & Portier, C.J. (1992). The importance of mutagenicity and chemical structure in the shape of carcinogenicity dose-response curves. Submitted. Woodward, K.N., McDonald, A. & Joshi, S. (1991). Ranking of chemicals for carcinogenic potency - a comparative study of 13 carcinogenic chemicals and an examination of some of the issues involved. Carcinogenesis 12, 1061-1066. Zeiger, E., Anderson, B., Haworth, S., Lawlor, T. & Mortelmans, K. (1988). Salmonella mutagenicity tests: IV. Results from the testing of 300 chemicals. Environmental and Molecular Mutagenesis 11(Suppl. 12), 1-158. Zeise, L., Wilson, R. & Crouch, E.A.C. (1984). Use of acute toxicity to estimate carcinogenic risk. Risk Analysis 4, 187-199. Zeise, L., Crouch, E.A.C. & Wilson, R. (1986). A possible relationship between toxicity and carcinogenicity. Journal of the American College of Toxicology 5, 137-151. 1. Health Protection Branch, Health & Welfare Canada, Ottawa, Ontario, Canada 2. Department of Mathematics & Statistics, Carleton University, Ottawa, Canada 3. National Center for Toxicological Research, Food & Drug Administration, Jefferson, Arkansas 4. Center for Mathematical Sciences, University of Wisconsin-Madison, Madison, Wisconsin 5. Department of Mathematical Sciences, University of Wisconsin-Milwaukee, Milwaukee, Wisconsin