Risk Assessment of Carcinogenic and Noncarcinogenic Chemicals

References

• Cohen B. L., Lee I. S. A catalog of risks. Health Phys. 1978; 11
   Google Scholar
• Crouch E. A. C., Wilson R. Risk Benefit Analysis. Ballinger, Cambridge, MA 1981
   Google Scholar
• Covello V. T. The perception of technological risks: a literature review. Technol. Forecasting Social Change 1983; 23: 285
   Web of Science ®Google Scholar
• Efron E. The Apocalyptics: How Environmental Politics Controls What We Know About Cancer. Simon & Schuster, New York 1984; 589
   Google Scholar
• Lowrance W. W. Of Acceptable Risk. Kauffmann, Los Altos, CA 1976
   Google Scholar
• Fischoff B., Lichtenstein S., Slovic P., Derby S. L., Keeney R. L. Acceptable Risk. Cambridge University Press, New York 1981
   Google Scholar
• Gori G. Regulation of cancer-causing substances: Utopia or reality. Chem. Engin. News Sept. 6, 1982; 25
   Google Scholar
• Slovic P. Perception of risk. Science 1987; 236: 280
   PubMed Web of Science ®Google Scholar
• Albert R. E., Train R. E., Anderson E. Rationale developed by the Environmental Protection Agency for the assessment of carcinogenic risks. J. Natl. Cancer Inst. 1977; 58(5)1537
   PubMed Web of Science ®Google Scholar
• Johannsen F. R. Chronic toxicity: the ultimate need for integrated risk assessment. Toxicol. Forum 1988; 11: 433
   Google Scholar
• Wilson R. Measuring and comparing risks to establish ade minimus risk level. Regul. Toxicol. Pharmacol. 1988; 8: 267
   PubMedGoogle Scholar
• Rodericks J., Taylor M. R. Application of risk assessment to food safety decision making. Regul. Toxicol. Pharmacol. 1983; 3: 275
   PubMedGoogle Scholar
• Groupement International Des Associations Nationales De Fabricants De Produit Agrochimiques (GIFAP). Carcinogenic Risk Assessment of Pesticides. Tech. Monogr. No. 12, GIFAP, Brussels July, 1987
   Google Scholar
• Lu F. C. Toxicological evaluation of carcinogens and noncarcino-gens: pros and cons of different approaches. Regul. Toxicol. Pharmacol. 1983; 3: 121
   PubMedGoogle Scholar
• Calabrese E. J. Principles of Animal Extrapolation. John Wiley & Sons, New York 1983
   Google Scholar
• Hayes W. J., Jr. Toxicity of pesticides to man: risks from present levels. Proc. R. Soc. London Ser. B. 1967; 167(1007)101
   PubMedGoogle Scholar
• Bliss C. I. The calculation of the dosage-mortality curve. Ann. Appl. Biol. 1935; 22: 134
   Google Scholar
• Weisburger J. H., Williams G. M. Carcinogen testing: current problems and new approaches. Science 1981; 214: 401
   PubMed Web of Science ®Google Scholar
• Office of Science and Technology Policy (OSTP). Chemical carcinogens; a review of the science and its associated principles. Fed. Reg. 1985; 50: 10371
   Google Scholar
• Clayson D. B. The need for biological risk assessment in reaching decisions about carcinogens, ICPEMC Publication No. 13. Mutat. Res. 1987; 185: 243
   PubMed Web of Science ®Google Scholar
• Cranmer M. F. Estimation of risks due to environmental carcinogenesis. Med. Pediatr. Oncol. 1977; 3: 169
   PubMedGoogle Scholar
• World Health Organization. Procedures for investigating intentional and unintentional food additives, Rep. WHO Scientific Group. WHO Tech. Rep. Ser. 1967; 348
   PubMedGoogle Scholar
• Lehman A. J., Fitzhugh O. G. 100-Fold margin of safety. Assoc. Food Drug Off. U.S. Q. Bull 1954; 18: 33
   Google Scholar
• Barnes J. M., Denz F. A. Experimental methods used in determining chronic toxicity. Pharmacol. Rev. 1954; 6: 191
   PubMed Web of Science ®Google Scholar
• Bigwood E. J. The acceptable daily intake of food additives. CRC Crit. Rev. Toxicol. June, 1973; 41
   Google Scholar
• Bigwood E. J., Gerard A. Fundamental Principles and Objectives of a Comparative Food Law. S. Karger, Basel 1968; Vol. 2: 217
   Google Scholar
• Vettorazzi G. Safety factors and their application in the toxicological evaluation. The Evaluation of Toxicological Data for the Protection of Public Health, W. J. Hunter, J. G. P. M. Smeets. Commission of the European Communities, Pergamon Press, Oxford 1977; 207
   Google Scholar
• Vettorazzi G. Handbook of International Food Regulatory Toxicology, Vol. I, Evaluations. Spectrum, New York 1980; 66
   Google Scholar
• Dourson M. L., Stara J. F. Regulatory history and experimental support of uncertainty (safety) factors. Regul. Toxicol. Pharmacol. 1983; 3: 224
   PubMedGoogle Scholar
• Weil C. S. Statistics versus safety factors and scientific judgement in the evaluation of safety for man. Toxicol. Appl. Pharmacol. 1972; 21: 454
   PubMed Web of Science ®Google Scholar
• Altman P. L., Dittmer D. S. Growth including reproduction and morphological development. Fed. Proc. 1962; 337
   Google Scholar
• National Academy of Sciences. Drinking Water and Health. National Academy of Sciences, Washington, D. C. 1977; II–1
   Google Scholar
• Hattis D., Erdreich L., Ballew M. Human variability in susceptibility to toxic chemicals — a preliminary analysis of pharmacokinetic data from normal volunteers. Risk Anal. 1987; 7(4)415
   PubMed Web of Science ®Google Scholar
• Calabrese E. J. Uncertainty factors and interindividual variation. Regul. Toxicol. Pharmacol. 1985; 5: 190
   PubMed Web of Science ®Google Scholar
• Schmidt-Nielsen K. How Animals Work. Cambridge University Press, London 1972
   Google Scholar
• Davidson I. W. F., Parker J. C., Beliles R. P. Biological basis for extrapolation across mammalian species. Regul. Toxicol. Pharmacol. 1986; 6: 211
   PubMed Web of Science ®Google Scholar
• Vocci F., Farber T. Extrapolation of animal toxicity data to man. Regul. Toxicol. Pharmacol. 1988; 8: 389
   PubMed Web of Science ®Google Scholar
• Allen B. C., Crump K. S., Shipp A. M. Correlation between carcinogenic potency of chemicals in animals and humans. Risk Anal. 1988; 8/4: 531
   Google Scholar
• Pinkel D. The use of body surface area as a criterion of drug dosage in cancer chemotherapy. Cancer Res. 1958; 18: 853
   PubMed Web of Science ®Google Scholar
• Freireich E. J., Gehan E. A., Rail D. P., Schmidt L. H., Skipper H. E. Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey and man. Cancer Chemother. 1966; 50(4)219
   Google Scholar
• Rall D. P. Difficulties in extrapolating the results of toxicity studies in laboratory animals to man. Environ. Res. 1969; 2: 360
   PubMed Web of Science ®Google Scholar
• Travis C. C., White R. K. Interspecies scaling of toxicity data. Risk Anal 1988; 8: 119
   PubMed Web of Science ®Google Scholar
• Brown S. L., Brett S. M., Gough M., Rodericks J. V., Tardiff R. G., Turnbull D. Review of interspecies risk comparisons. Regul. Toxicol. Pharmacol. 1988; 8: 191
   PubMed Web of Science ®Google Scholar
• Mordenti J. Dosage regimen design for pharmaceutical studies conducted in animals. J. Pharm. Sci. 1986; 75: 852
   PubMedGoogle Scholar
• Huesner A. A. Energy metabolism and body size. I. Is the 0.75 mass exponent of Kleiber's equation a statistical artifact. Respir. Physiol. 1982; 48: 1
   PubMedGoogle Scholar
• Feldman H. A., McMahon T. A. The 3/4 mass exponent for energy metabolism is not a statistical artifact. Respir. Physiol. 1983; 52: 149
   PubMedGoogle Scholar
• Weisner W. A distinction must be made between the ontogeny and the phytogeny of metabolism in order to understand the mass exponent of energy metabolism. Respir. Physiol. 1984; 55: 1
   PubMedGoogle Scholar
• Krasovskij G. N. Species and sex differences in sensitivity to toxic substances. Methods Used in the USSR for Establishing Biologically Safe Levels of Toxic Substances. World Health Organization, Geneva 1975
   Google Scholar
• Krasovskij G. N. Extrapolation of experimental data from animals to man. Environ. Health Perspect. 1976; 13: 51
   PubMed Web of Science ®Google Scholar
• Boxenbaum H. Interspecies variation in liver weight, hepatic blood flow, and antipyrene intrinsic clearance: extrapolation of data to benzodiazepines and phenytoin. J. Pharmacokinet. Biopharm. 1980; 8(2)165
   PubMedGoogle Scholar
• World Health Organization. Toxicological evaluation of certain food additives with a review of general principles and of specifications. WHO Tech. Rep. Ser. 1974; 539
   PubMedGoogle Scholar
• Mantel N., Bryan W. R. “Safety” testing of carcinogenic agents. J. Natl. Cancer Inst. 1961; 27: 455
   PubMed Web of Science ®Google Scholar
• Weil C. S., McCollister D. D. Relationship between short- and long-term feeding studies in designing an effective toxicity test. Agric. Food Chem. 1963; 11: 486
   Web of Science ®Google Scholar
• Zielhuis R. L., Van der Kreek F. W. The use of a safety factor in setting health based permissible levels for occupational exposure. Int. Arch. Occup. Environ. Health 1979; 42: 191
   PubMed Web of Science ®Google Scholar
• McNamara B. P. Concepts in health evaluation of commercial and industrial chemicals. New Concepts in Safety Evaluation, Vol. I., M. Mehlman. Halsted Pressbook, New York 1976; 61
   Google Scholar
• Wilson J. G. Environment and Birth Defects. Academic Press, New York 1973; 155
   Google Scholar
• Jackson B. A. Safety assessment of drug residues. J. Am. Vet. Med. Assoc. 1980; 176: 1141
   PubMed Web of Science ®Google Scholar
• Frankos V. FDA perspectives on the use of teratology data for human risk assessment. Fd. Appl. Toxicol. 1985; 5: 615
   PubMedGoogle Scholar
• Johnson E. M. Cross-species extrapolations and the biologic basis for safety factor determinations in developmental toxicology. Regul. Toxicol. Pharmacol. 1988; 8: 22
   PubMedGoogle Scholar
• Meistrich M. L. Estimation of human reproductive risk from animal studies: determination of interspecies extrapolation factors for steroid hormone effects on the male. Risk Anal. 1988; 8: 27
   PubMed Web of Science ®Google Scholar
• Druckrey H. Quantitative aspects in chemical carcinogenesis. Potential Carcinogenic Hazards from Drugs, R. Truhaut. UICC Monograph Series, Springer-Verlag, Berlin 1967; Vol. 7: 60
   Google Scholar
• Yanysheva N. Y., Antomonov Y. G., Albert R. E., Altshuler B., Friedman L. Approaches to the formulation of standards for carcinogenic substances in the environment. Environ. Health Persp. 1979; 30: 81
   PubMedGoogle Scholar
• Bingham E., Falk H. L. Environmental carcinogens: the modifying effect of carcinogens on the threshold response. Arch. Environ. Health 1969; 19: 779
   PubMed Web of Science ®Google Scholar
• Stockinger H. E. Toxicology and drinking water contaminants. J. Am. Water Works Assoc. July, 1977; 399
   Google Scholar
• Truhaut R. The problem of thresholds for chemical carcinogens — its importance in industrial hygiene, especially in the field of permissible limits for occupational exposure. Am. Ind. Hyg. Assoc. J. 1980; 41: 685
   PubMed Web of Science ®Google Scholar
• Truhaut R. An overview of the problem of thresholds for chemical carcinogens. IARS Sci. Publ. 1979; 74: 191
   Google Scholar
• Lu F. C. Safety assessments of chemicals with threshold effects. Regul. Toxicol. Pharmacol. 1985; 5: 460
   PubMedGoogle Scholar
• Lu F. C. Assessment of an international level of health hazards to man of chemicals shown to be carcinogenic in laboratory animals. Regulatory Aspects of Carcinogenesis, F. Coulston. Academic Press, New York 1979; 315
   Google Scholar
• Food Safety Council. A Proposed Food Safety Evaluation Process. The Nutrition Foundation, Inc., Washington, D.C. 1982
   Google Scholar
• World Health Organization. Evaluation of the toxicity of a number of antimicrobials and antioxidants. WHO Tech. Rep. Ser. 1962; 6: 228
   Google Scholar
• World Health Health Organization. Principles governing consumer safety in relation to pesticide residues, Report of a joint FAO/WHO meeting on pesticide residues. WHO Tech. Rep. Ser. 1962; 240
   Google Scholar
• U.S. Environmental Protection Agency. Guidelines and methodology used in the preparation of health effects assessment chapters of the consent decree water quality criteria. Fed. Reg. 1980; 45: 79347
   Google Scholar
• Lu F. C. Acceptable daily intake: inception, evolution and application. Regul. Toxicol. Pharmacol. 1988; 8: 45
   PubMed Web of Science ®Google Scholar
• National Academy of Sciences. Report on “no residue” and “zero tolerance”. National Academy of Sciences, Washington, D.C. 1965
   Google Scholar
• Code of Federal Regulations (U.S.A.). Title 1980; 40, Section 181.1(1)
   Google Scholar
• Food Safety Council. Proposed system for food safety assessment. Final Report of the Scientific Committee of the Food Safety Council, Washington, D.C., 1980
   Google Scholar
• Munro I. C., Krewski D. R. Risk assessment and regulatory decision making. Fd. Cosmet. Toxicol. 1981; 19: 549
   PubMedGoogle Scholar
• Oser B. L. Much ado about safety. Fd. Cosmet. Toxicol. 1969; 1: 415
   Google Scholar
• Oser B. L. Food additive: the no-effect level. Arch. Environ. Health 1971; 22: 696
   PubMed Web of Science ®Google Scholar
• Campbell D. J. Drug residues in animal tissues and their regulatory significance — the Canadian point of view. J. Assoc. Off. Anal. Chem. 1978; 61: 1194
   PubMedGoogle Scholar
• Somers E. Risk estimation for environmental chemicals as a basis for decision making. Regul. Toxicol. Pharmacol. 1984; 4: 99
   PubMedGoogle Scholar
• Ritter L., Curry P. B. Regulation of pesticides in Canada. Toxicol. Indust. Health 1988; 4: 331
   PubMedGoogle Scholar
• Uchiyama M. Risk assessment of toxic chemicals in food. J. Food Sanit. [Shokuhin Eiseigaku Zasshi] 1983; 24: 249
   Google Scholar
• Rodericks J. V., Brett S. M., Wrenn G. C. Significant risk decisions in federal regulatory agencies. Regul. Toxicol. Pharmacol. 1987; 7: 307
   PubMedGoogle Scholar
• Anderson E. L., Ehrlich A. M. New risk assessment initiatives in EPA. Toxicol. Ind. Health 1985; 1: 7
   PubMedGoogle Scholar
• Barnes D. G., Dourson M. Reference Dose (RFD): description and use in health risk assessments. Regul. Toxicol. Pharmacol. 1988; 8: 471
   PubMed Web of Science ®Google Scholar
• Anderson E. Quantitative approaches in use to assess cancer risk. Risk Anal. 1983; 3(4)277
   Google Scholar
• Finklea J., Shy C. M., Moran J. B., Nelson W. C., Larsen R. I., Akland G. G. The role of environmental health assessment in the control of air pollution. Advances in Environmental Sciences and Technology, J. N. Pitts, R. L. Metcalf. Wiley-Inter-science, New York 1977; 315
   Google Scholar
• Cothern C. R., Marcus W. L. Estimating risk for carcinogenic environmental contaminants and its impact on regulatory decision making. Regul. Toxicol. Pharmacol. 1984; 4: 265
   PubMedGoogle Scholar
• Cotruvo J. A. Drinking water standards and risk assessment. Regul. Toxicol. Pharmacol. 1988; 8: 288
   PubMed Web of Science ®Google Scholar
• Williams G. M., Weisburger J. H. Carcinogen risk assessment. Science 1983; 221: 6
   PubMedGoogle Scholar
• Gehring P. J., Watanabe P. G., Blau G. E. Risk assessment of environmental carcinogens utilizing pharmacokinetic parameters. Ann. N.Y. Acad. Sci. 1979; 329: 137
   Web of Science ®Google Scholar
• Hoel D. G., Kaplan N. L., Anderson M. W. The implication of nonlinear kinetics on risk estimation in carcinogenesis. Science 1983; 219: 1032
   PubMed Web of Science ®Google Scholar
• Bruce R. D. Low-dose extrapolation and risk assessment. Chem. Times Trends 1980; 20
   Google Scholar
• Brown C. Satistical aspects of extrapolation of dichotomous dose response data. J. Natl. Cancer Inst. 1978; 60: 101
   PubMed Web of Science ®Google Scholar
• Krewski D., Brown C. Carcinogenic risk assessment: a guide to the literature. Biometrics 1981; 37: 353
   PubMed Web of Science ®Google Scholar
• Thorslund T. W., Brown C. C., Charnley G. Biologically motivated cancer risk models. Risk Anal. 1987; 7(1)109
   PubMedGoogle Scholar
• Park C. N., Snee R. D. Quantitative risk assessment: state-of-the-art for carcinogenesis. Fund. Appl. Toxicol. 1983; 3: 320
   PubMedGoogle Scholar
• Krewski D., Van Ryzin J. Dose response models for quantal response toxicity data. Statistics and Related Topics, D. Csovogo, R. Dawson, E. Saleh. North Holland, Amsterdam 1981; 201
   Google Scholar
• Moolgavkar S. H., Venzon D. J. Two-event models for carcinogenesis: incidence curves for childhood and adult tumors. Math. Biosci. 1979; 47: 55
   Web of Science ®Google Scholar
• Moolgavkar S. H., Knudson A. G. Mutation and cancer: a model for human carcinogenesis. J. Natl. Cancer Instit. 1981; 66: 1037
   PubMed Web of Science ®Google Scholar
• Chand N., Hoel W. A comparison of models for determining safe levels of environmental agents. Reliability and Biometry, F. Proschan, R. J. Serfling. SIAM Press, Philadelphia, PA 1974; 681
   Google Scholar
• EDO1 Task Force of the Society of Toxicology. Re-examination of the EDO1 study. Fund. Appl. Toxicol. 1981; 1: 28
   PubMedGoogle Scholar
• Gross M. A., Fitzhugh O. G., Mantel N. Evaluation of safety for food additives: an illustration involving the influence of methyl salicylate on rat reproduction. Biometrics 1970; 26: 181
   PubMed Web of Science ®Google Scholar
• Hoel D. G., Gaylor D. W., Kirschstein R. L., Saffiotti U., Schneiderman M. A. Estimation of risks of irreversible delayed toxicity. J. Toxicol. Environ. Health 1975; 1: 133
   PubMed Web of Science ®Google Scholar
• Hogan M. D. Extrapolation of animal carcinogenicity data: limitations and pitfalls. Environ. Health Perspec. 1983; 47: 333
   PubMedGoogle Scholar
• Gaylor D. W., Shapiro R. E. Extrapolation and risk estimation for carcinogenesis. Advances in Modern Toxicology, Vol. I, New Concepts in Safety Evaluations, Part 2, M. A. Mehlman, R. E. Shapiro, H. Blumenthal. John Wiley & Sons, New York 1979; 65
   Google Scholar
• Gaylor D. W., Kodell R. L. Linear interpolation algorithm for low-dose risk assessment of toxic substances. J. Environ. Pathol. Toxicol. 1980; 4: 305
   PubMed Web of Science ®Google Scholar
• Van Ryzin J. Quantitative risk assessment. J. Occup. Med. 1980; 22: 321
   PubMedGoogle Scholar
• Krewski D., Brown C., Murdoch D. Determining “safe” levels of exposure: safety factors or mathematical models. Fund. Appl. Toxicol. 1984; 4: S383
   PubMedGoogle Scholar
• Krewski D., Murdoch D., Dewanji A. Statistical modelling and extrapolation of carcinogenesis data. Modern Statistical Methods in Chronic Disease Epidemiology, S. H. Moolgavkar, R. L. Prentice. Wiley-Interscience, New York 1986; 259
   Google Scholar
• Krewski D., Murdoch D. J., Withey J. R. The application of pharmacokinetic data in carcinogenic risk assessment. Pharmacokinetics in Risk Assessment — Drinking Water and Health. National Academy Press, Washington, D.C. 1987; 441
   Google Scholar
• Crump K. S., Hoel D. G., Langley C. H., Peto R. Fundamental carcinogenic processes and their implications for low-dose risk assessment. Cancer Res. 1976; 36: 2973
   PubMed Web of Science ®Google Scholar
• Guess H., Crump K., Peto R. Uncertainty estimates for low dose rate extrapolations of animal carcinogenicity data. Cancer Res. 1977; 37: 3475
   PubMed Web of Science ®Google Scholar
• Interagency Regulatory Liaison Group. The scientific basis for identification of potential carcinogens and risk estimation, Interagency Regulatory Liaison Group. J. Natl. Cancer Inst. 1979; 63: 241
   Google Scholar
• Hoel D. G. Carcinogenic risk: comments on “Regulation of Carcinogens”. Risk Anal, E. Crouch, R. Wilson, 1981; 1: 63
   Google Scholar
• Carlborg F. W. Dose-response functions in carcinogenesis and the Weibull model. Fd. Cosmet. Toxicol. 1981; 19: 255
   PubMedGoogle Scholar
• Carlborg F. W. 2-Acetylaminofluorene and the Weibull model. Fd. Cosmet. Toxicol. 1981; 19: 367
   PubMedGoogle Scholar
• Rai K., Van Ryzin J. A. A generalized multihit dose-response model for low dose extrapolation. Biometrics 1981; 37: 341
   PubMed Web of Science ®Google Scholar
• Crump K. S., Masterman D. Review and evaluation of methods of determining risk from chronic low-level carcinogenic insult. Environmental Contaminants in Food. U.S. Congress, Office of Technology Assessment, Washington, D.C. 1979; 154
   Google Scholar
• Haseman J. K., Hoel D. G., Jennrich R. I. Some practical problems arising from the use of the gamma multihit model for risk estimation. J. Toxicol. Environ. Health 1976; 8: 379
   Google Scholar
• Armitage P., Doll R. (1961) Stochastic models for carcinogenesis. Proceedings of the Fourth Berkeley Symposium on Mathematical Statistics and Probability. 1961, L. Lecam, J. Neyman. University of California Press, Berkeley, CA, 19
   Google Scholar
• Cox D. R. Regression models and life tables. J. R. Stat. Soc. Ser. B 1972; 34: 187
   Web of Science ®Google Scholar
• Crump K. S., Guess H. A., Deal K. L. Confidence intervals and tests of hypothesis concerning dose response relations inferred from animal carcinogenicity data. Biometrics 1977; 33: 437
   PubMed Web of Science ®Google Scholar
• Guess H. A., Crump K. S. Low dose rate extrapolations of data from animal carcinogenicity experiments — analysis of new statistical technique. Math. Biosci. 1976; 32: 15
   Web of Science ®Google Scholar
• Guess H. A., Crump K. S. Best-estimate low-dose extrapolation of carcinogenicity data. Environ. Health Perspect. 1978; 22: 149
   PubMed Web of Science ®Google Scholar
• Hartley H. O., Sielken R. L. Estimation of “safe doses” in carcinogenic experiments. Biometrics 1977; 33: 1
   PubMed Web of Science ®Google Scholar
• Crump K. S., Crockett P. W. Improved confidence limits for low-dose carcinogenic risk assessment from animal data. J. Hazardous Materials 1985; 10: 419
   Google Scholar
• Crouch E., Wilson R. Interspecies comparison or carcinogenic potency. J. Toxicol. Environ. Health 1979; 5: 1095
   PubMed Web of Science ®Google Scholar
• Crouch E. A. C. Uncertainties in interspecies extrapolation of carcinogenicity. Environ. Health Perspec. 1983; 50: 321
   PubMed Web of Science ®Google Scholar
• Rieth J. P., Starr T. B. Experimental design constraints on carcinogenic potency estimates. J. Toxicol. Environ. Health 1989; 27: 287
   PubMed Web of Science ®Google Scholar
• Berstein L., Gold L. S., Ames B. N., Pike M. C., Hoel D. G. Some tautologous aspects of the comparison of carcinogenic potency in rats and mice. Fund. Appl Toxicol. 1985; 5: 179
   Google Scholar
• Fishbein L. Overview of some aspects of quantitative risk assessment. J. Toxicol. Environ. Health 1980; 6: 1275
   PubMed Web of Science ®Google Scholar
• Finney D. J. Probit Analysis, 2nd Ed. Cambridge University Press, London 1964
   Google Scholar
• Port R., Schmähl D., Wahrendorf J. Some examples of dose-response studies in chemical carcinogenesis. Oncology 1976; 33: 66
   PubMedGoogle Scholar
• Schmähl D., Port R., Wahrendorf J. A dose response study on urethane carcinogenesis in rats and mice. Int. J. Cancer 1977; 19: 77
   PubMed Web of Science ®Google Scholar
• Wahrendorf J. The problem of estimating safe dose levels in chemical carcinogenesis. J. Cancer Res. Clin. Oncol. 1979; 95: 101
   PubMedGoogle Scholar
• Mantel N., Bohidar N. R., Brown C. C., Ciminera J. L., Tukey J. W. An improved “Mantel-Bryan” procedure for “safety testing” of carcinogens. Cancer Res. 1975; 35: 865
   PubMed Web of Science ®Google Scholar
• Food Safety Council. Proposed system for food safety assessment, Chapter 4: Human exposure assessment. Fd. Cosmet. Toxicol. 1978; 16(2)25
   Google Scholar
• Cornfield J. Carcinogenic risk assessment. Science 1977; 198: 693
   PubMed Web of Science ®Google Scholar
• Cornfield J., Carlborg F. W., Van Ryzin J. Setting tolerance on the basis of mathematical treatment of dose-response data extrapolated to low doses. Proc. 1st Int. Toxicol. Congr. 1978
   Google Scholar
• Cornfield J., Carlborg F. W., Van Ryzin J. Setting tolerances on the basis of mathematical treatment of dose-response data extrapolated to low doses. Proc. 1st Int. Toxicol. Congr. 1979
   Google Scholar
• Blum H. F. Carcinogenesis by Ultraviolet Light. Princeton University Press, Princeton, NJ 1959
   Google Scholar
• Albert R. E., Altshuler B. Considerations relating to the formulation of limits for unavoidable population exposures to environmental carcinogens. Radionuclide Carcinogenesis, J. E. Ballou. AEC Symposium Series CONF-72050, NTIS, Springfield, VA 1973; 233
   Google Scholar
• Sielken R. L., Jr. Re-examination of the ED01 study — adjusting for time on study. Fund. Appl. Toxicol. 1981; 1: 88
   PubMedGoogle Scholar
• Salsburg D. Re-examination of the ED01 study — adjusting for time on study. Fund. Appl. Toxicol. 1981; 1: 87
   Google Scholar
• Van Ryzin J. Review of statistics — the need for realistic statistical models for risk assessment. Fund. Appl. Toxicol. 1981; 1: 124
   PubMedGoogle Scholar
• Krewski D., Crump K. S., Farmer J., Gaylor D. W., Howe R., Potier C., Salsburg D., Sielken R. L., Van Ryzin J. A comparison of statistical methods for low dose extrapolation utilizing time-to-tumor data. Fund. Appl. Toxicol. 1983; 3: 140
   PubMedGoogle Scholar
• Jones H. B., Grendon A. Analysis of mathematical models used in data extrapolation. Clin. Toxicol. 1976; 9(5)791
   PubMed Web of Science ®Google Scholar
• Peto R., Lee P. N., Paige W. S. Statistical analysis of the bioassay of continuous carcinogens. Br. J. Cancer 1972; 26: 258
   PubMedGoogle Scholar
• Peto R., Lee P. N. Weibull distribution for continuous carcinogenesis experiments. Biometrics 1973; 29: 457
   PubMed Web of Science ®Google Scholar
• Pike M. C. A method of analysis of a certain class of experiments in carcinogenesis. Biometrics 1966; 22: 142
   PubMed Web of Science ®Google Scholar
• Day T. D. Carcinogenic action of cigarette smoke condensate on mouse skin. Br. J. Cancer 1967; 21: 56
   PubMedGoogle Scholar
• Hoel D. G. Low-dose and species-to-species extrapolation for chemically induced carcinogenesis. Banbury Report, Vol. 1: Assessing Chemical Mutagens: The Risk to Humans, V. K. McElheny, S. Abrahamson. Cold Spring Harbor Laboratory, Cold Spring Harbor, NY 1979; 135
   Google Scholar
• Wittmore A., Altschuler B. Lung cancer incidence in cigarette smokers: further analysis of Doll and Hill's data for British physicians. Biometrics 1976; 32: 805
   PubMedGoogle Scholar
• Hoel D. G. Statistical measures of risk. Drug Metab. Rev. 1982; 13: 829
   PubMed Web of Science ®Google Scholar
• Chen C. W., Blancato J. N. Role of pharmacokinetic modeling in risk assessment: perchloroethylene as an example. Pharmacokinetics in Risk Assessment — Drinking Water and Health. National Academy Press, Washington, D.C. 1987; 369
   Google Scholar
• Moolgavkar S. H. Biologically motivated two-stage model for cancer risk assessment. Toxicol. Lett. 1988; 43: 139
   PubMed Web of Science ®Google Scholar
• Armitage P., Doll R. A two-stage theory of carcinogenesis in relation to the age distribution of human cancer. Br. J. Cancer 1957; 11: 161
   PubMed Web of Science ®Google Scholar
• Neyman J., Scott E. Statistical aspects of the problem of carcinogenesis. Fifth Berkeley Symposium on Mathematical Statistics and Probability. University of California Press, Berkeley, CA 1967; 745
   Google Scholar
• Moolgavkar S., Dewanji A. Biologically based models for cancer risk assessment: a cautionary note. Risk Anal. 1988; 8: 5
   PubMedGoogle Scholar
• Miller E. C., Miller J. A. The metabolism of chemical carcinogens to reactive electrophiles and their possible mechanism of action in carcinogenesis. Chemical Carcinogens, C. E. Searle. American Chemical Society. 1976; 737
   Google Scholar
• McGaughey C. Models for carcinogenic risk assessment. Science 1978; 202: 1105
   Google Scholar
• Crump K. S. Models for carcinogenic risk assessment. Science 1978; 202: 1105
   Google Scholar
• Brown C. C., Fears T. R., Gail M. H., Schneiderman M. A., Tarone R. E., Mantel N. Models for carcinogenic risk assessment. Science 1978; 202: 1105
   Google Scholar
• Van Ryzin J., Rai K. The use of quantal response data to make predictions. The Scientific Basis of Toxicity Assessment, H. R. Witschi. Elsevier/North-Holland, Amsterdam 1980
   Google Scholar
• Gehring P. J., Blau G. E. Mechanisms of carcinogenesis: dose response. J. Environ. Pathol. Toxicol. 1977; 1: 163
   Google Scholar
• Gehring P. J., Watanabe P. G., Park C. N. Resolution of dose-response toxicity data for chemicals requiring metabolic activation: example — vinyl chloride. Toxicol. Appl. Pharmacol. 1978; 44: 581
   PubMed Web of Science ®Google Scholar
• Anderson M. W., Hoel D. G., Kaplan N. L. A general scheme for the incorporation of pharmacokinetics in low-dose risk estimation for chemical carcinogenesis: example — vinyl chloride. Toxicol. Appl. Pharmacol. 1980; 55: 154
   PubMed Web of Science ®Google Scholar
• O'Flaherty E. J. Modeling: an introduction. Pharmacokinetics in Risk Assessment — Drinking Water and Health. National Academy Press, Washingtin, D.C. 1987; 27
   Google Scholar
• Bischoff K. B. Physiologically based pharmacokinetic modeling. Pharmacokinetics in Risk Assessment — Drinking Water and Health. National Academy Press, Washington, D.C. 1987; 36
   Google Scholar
• Bischoff K. B., Brown R. G. Drug distribution in mammals. Chem. Eng. Prog. Symp. Ser. 1966; 66: 33
   Google Scholar
• Lutz R. J., Dedrick R. L. Implications of pharmacokinetic modeling in risk assessment analysis. Environ. Health Persp. 1987; 76: 97
   PubMedGoogle Scholar
• Clewell H. J., III, Andersen M. E. Dose, species, and route extrapolation using physiologically based pharmacokinetic models. Pharmacokinetics in Risk Assessment — Drinking Water and Health. National Academy Press, Washington, D.C. 1987; 159
   Google Scholar
• Reitz R. H., Mendrala A. L., Park C. N., Andersen M. E., Guengerich F. P. Incorporation ofin vitro enzyme data into the physiologically based pharmacokinetic (PB-PK) model for methylene chloride: implications for risk assessment. Toxicol. Lett. 1988; 43: 97
   PubMed Web of Science ®Google Scholar
• Bischoff K. B. Some fundamental considerations in the application of pharmacokinetics to cancer. I, Cancer Chemother. Rep. 1975; 59: 777
   PubMedGoogle Scholar
• Himmelstein K. J., Lute R. J. A review of the applications of physiologically based pharmacokinetic modeling. J. Pharmacokinet. Biopharm. 1979; 7: 127
   PubMedGoogle Scholar
• Bischoff K. B., Dedrick R. L., Zaharko D. S., Longstreth J. A. Methotrexate pharmacokinetics. J. Pharm. Sci. 1971; 60: 1128
   PubMed Web of Science ®Google Scholar
• Gerlowski L. E., Jain R. K. Physiologically based pharmacokinetic modeling: principles and applications. J. Pharm. Sci. 1983; 72: 1103
   PubMed Web of Science ®Google Scholar
• Andersen M. E., Clewell H. J., III, Reitz R. H. Physiologically based pharmacokinetics and methylene chloride cancer risk assessment considerations. Human Risk Assessment — The Role of Animal Selection and Extrapolation, M. V. Roloff. Taylor and Francis, London 1987; 129
   Google Scholar
• Bogen K. T. Pharmacokinetics of regulatory risk analysis: the case of trichloroethylene. Regul. Toxicol. Pharmacol. 1988; 8: 447
   PubMed Web of Science ®Google Scholar
• Cohn S. M., Ellwein L. B. Cell growth dynamics in long-term bladder carcinogenesis. Toxicol. Lett. 1988; 43: 151
   PubMedGoogle Scholar
• D'Souza R. W., Francis W. R., Andersen M. E. A physiologic model for tissue glutathione depletion and increased resynthesis after ethylene dichloride exposure. J. Pharmacol. Exp. Ther. 1988; 245: 563
   PubMed Web of Science ®Google Scholar
• D'Souza R. W., Francis W. R., Bruce R. D., Andersen M. E. Physiologically based pharmacokinetic model for ethylene dichloride and its application in risk assessment. Pharmacokinetics in Risk Assessment — Drinking Water and Health. National Academy Press, Washington, D.C. 1987; 286
   Google Scholar
• Leung H. W., Ku R. H., Paustenbach D. J., Andersen M. E. A physiologically based pharmacokinetic model for 2,3,7,8-tetrachlorodibenzo-p-dioxin in C57BL/6J and DBA/2J mice. Toxicol. Lett. 1988; 42: 15
   PubMed Web of Science ®Google Scholar
• Paustenbach D. J., Clewell H. J., III, Gargas M. L., Andersen M. E. Development of a physiologically based pharmacokinetic model for multiday inhalation of carbon tetrachloride. Pharmacokinetics in Risk Assessment — Drinking Water and Health. National Academy Press, Washington, D.C. 1987; 312
   Google Scholar
• King F. G., Dedrick R. L., Collins J. M., Matthews H. B., Birnbaum L. S. A physiological model for the pharmacokinetics of 2,3,7,8-tetrachlorodibenzofuran in several species. Toxicol. Appl. Pharmacol. 1983; 67: 390
   PubMed Web of Science ®Google Scholar
• Ramsey J. C., Ersen M. E. A physiologically based description of the inhalation pharmacokinetics of styrene in rats and humans. Toxicol. Appl. Pharmacol. 1984; 73: 159
   PubMed Web of Science ®Google Scholar
• Ramsey J. C., Young J. D. Pharmacokinetics of inhaled styrene in rats and humans. Scand. J. Work Environ. Health 1978; 4: 84
   PubMed Web of Science ®Google Scholar
• Ramsey J. C., Young J. D., Karbowski R., Chenoweth M. B., McCarty L. P., Braun W. H. Pharmacokinetics of inhaled styrene in human volunteers. Toxicol. Appl. Pharmacol. 1980; 53: 54
   PubMed Web of Science ®Google Scholar
• Young J. D., Ramsey J. C., Balu G. E., Karbowski R. J., Nitschke K. D., Slauter R. W., Braun W. H. (1978) Pharmacokinetics of inhaled or intraperitoneally administered styrene. Toxicology and Occupational Medicine. Proceedings of the Tenth Inter-American Conference on Toxicology and Occupational Medicine. 1978, W. B. Deichmann. Elsevier/North-Holland, Amsterdam, 297
   Google Scholar
• O'Flaherty E. J. A physiologically based model of skeletal growth in the rat. Toxicol. Lett. 1988; 43: 85
   PubMedGoogle Scholar
• Menzel D. B. Planning and using PB-PK models: an integrated inhalation and distribution model for nickel. Toxicol. Lett. 1988; 43: 67
   PubMedGoogle Scholar
• Rodericks J. V., Frankos V., Turnbull D., Tardiff R. G. Risk assessment for effects other than cancer. Food Protection Technology, C. W. Felix. Lewis Publ., Chelsea, MI 1987; 61
   Google Scholar
• Flamm W. G., Winbush J. S. Role of mathematical models in assessment of risk and in attempts to define management strategy. Fundam. Appl. Toxicol. 1984; 4: S395
   Google Scholar
• Mills W. A. Proposed changes in nuclear regulatory commission standards for protection against radiation. Regul. Toxicol. Appl. Pharmacol. 1984; 4: 265, As cited in Cothern, C. R., Marcus, W.L.
   PubMedGoogle Scholar
• Environmental Protection Agency. Interim procedures and guidelines for health risk and economic impact assessments of suspected carcinogens. Fed. Reg. 1976; 41: 21402
   Google Scholar
• Orzell R. Consumer Product Safety Commission Approaches to risk assessment. 7th Annual Meeting of the American College of Toxicology, Washington, D.C., 1986
   Google Scholar
• Occupational Safety and Health Administration (OSHA). Fed. Reg. 1980; 45: 5002
   Google Scholar
• Infante P. OSHA Approach to Risk Assessment. 7th Annual Meeting of the American College of Toxicology, Washington, D.C., 1986
   Google Scholar
• Albert R. E. Discussion. J. Air Pollut. Control Assoc 1983; 33: 836
   Web of Science ®Google Scholar
• Travis C. C., Richter S. A., Crouch E. A. C., Wilson R., Klema E. D. Cancer risk management. Environ. Sci. Technol. 1987; 21: 415
   PubMed Web of Science ®Google Scholar
• Nichols A. L., Zeckhauser R. J. The perils of prudence: how conservative risk assessments distort regulations. Regul. Toxicol. Pharmacol. 1988; 8: 61
   PubMed Web of Science ®Google Scholar
• Hayashi Y. Risk assessment for carcinogenesis. Toxicol. Forum 1988; 11: 550
   Google Scholar
• Ames B. N. Dietary carcinogens and anticarcinogens — oxygen radicals and degenerative diseases. Sci. 1983; 221: 1256
   PubMed Web of Science ®Google Scholar
• Atallah S. Assessing and managing industrial risk. Chem. Eng. Sept. 8, 1980; 99
   Google Scholar
• Food and Agriculture Organization/World Health Organization. Pesticide Residues in Food, Report of 1978 Joint meeting of the FAO Working Party of Experts on pesticide residues and the WHO expert group on pesticide residues. FAO Agricultural Studies 1979; 42(No. 15)
   Google Scholar
• Food and Agriculture Organization/World Health Organization. Pesticide Residues in Food, Report of the 1979 Joint meeting of the FAO Working Party of Experts on pesticide residues and the WHO expert group on pesticide residues. FAO Agricultural Studies 1980; 90(No. 20)
   Google Scholar
• Food and Agriculture Organization/World Health Organization. Pesticide Residues in Food, Report of the 1980 Joint meeting of the FAO Working Party of Experts on pesticide residues and the WHO expert group on pesticide residues. FAO Agricultural Studies 1981; 79(No. 26)
   Google Scholar
• Food and Agriculture Organization/World Health Organization. Pesticide Residues in Food, Report of the 1981 Joint meeting of the FAO Working Party of Experts on pesticide residues and the WHO expert group on pesticide residues. FAO Agricultural Studies 1982; 69(No. 37)
   Google Scholar
• Food and Agriculture Organization/World Health Organization. Pesticide Residues in Food, Report of the 1982 Joint meeting of the FAO Working Party of Experts on pesticide residues and the WHO expert group on pesticide residues. FAO Agricultural Studies 1983; 71(No. 46)
   Google Scholar
• Food and Agriculture Organization/World Health Organization. Pesticide Residues in Food, Report of the 1984 Joint meeting of the FAO Working Party of Experts on pesticide residues and the WHO expert group on pesticide residues. FAO Agricultural Studies 1985; 98(No. 62)
   Google Scholar
• Food and Agriculture Organization/World Health Organization. Pesticide Residues in Food, Report of the 1985 Joint meeting of the FAO Working Party of Experts on pesticide residues and the WHO expert group on pesticide residues. FAO Agricultural Studies 1986; 78
   Google Scholar
• Food and Agriculture Organization/World Health Organization. Pesticide Residues in Food, Report of the 1986 Joint meeting of the FAO Working Party of Experts on pesticide residues and the WHO expert group on pesticide residues. FAO Agricultural Studies 1987; 68(No. 77)
   Google Scholar
• Food and Agriculture Organization/World Health Organization. Pesticide Residues in Food, Report of the 1987 Joint meeting of the FAO Working Party of Experts on pesticide residues and the WHO expert group on pesticide residues. FAO Agricultural Studies 1988; 70(No. 84)
   Google Scholar
• Taylor J. M., Friedman L. Combined chronic feeding and three-generation reproduction study of sodium saccharin in the rat. Toxicol. Appl. Pharmacol. 1974; 29: 154
   Google Scholar
• Crump K. S., Howe R. B., Van Landingham C. Toxicology Risk Assessment Program (TOX-RISK), Version 1.0. Clement Associates. 1988
   Google Scholar
• Fuhremann T. W., Monsanto Co. personal communication 1989
   Google Scholar
• Butterworth B. E. Nongenotoxic carcinogens in the regulatory environment. Regul. Toxicol. Pharmacol 1989; 9: 244
   PubMed Web of Science ®Google Scholar
• Paynter O. E., Burin G. J., Jaeger R. B., Gregoria C. A. Goitrogens and thyroid follicular cell neoplasia: evidence for a threshold process. Regul. Toxicol. Pharmacol. 1988; 8: 102
   PubMed Web of Science ®Google Scholar
• Abbott W. S. A method of computing the effectiveness of an insecticide. J. Econ. Entomol. 1925; 18: 265
   Web of Science ®Google Scholar