Application of the “filter model” to a risk assessment for vinyl chloride

References

• Ames , B. N. 1983 . Dietary carcinogens and anticarcinogens . Science , 221 : 1256 – 1264 .
   PubMed Web of Science ®Google Scholar
• Bergman , K. 1982 . Reactions of vinyl chloride with RNA and DNA of various mouse tissues in vivo . Arch. Toxicol. , 49 : 117 – 129 .
   PubMed Web of Science ®Google Scholar
• Bolt , H. M. , Filser , J. G. , Laib , R. J. and Ottenwalder , H. 1980 . Binding kinetics of vinyl chloride and vinyl bromide at very low doses . Arch. Toxicol. Suppl. , 3 : 129 – 142 .
   Google Scholar
• Bolt , H. M. , Laib , R. J. , Filser , J. C. , Ottenwalder , H. and Buchter , A. 1981 . “ Vinyl chloride and related compounds: Mechanisms of action on the liver ” . In Frontiers in Liver Disease , Edited by: Berk , P. D. and Chalmers , T. C. 80 – 92 . New York : Thieme‐Stratton .
   Google Scholar
• Caputo , A. , Viola , P. L. and Bigotti , A. 1974 . Oncogenicity of vinyl chloride at low concentrations in rats and rabbits . IRCS Med. Sci: Libr. Compend. , 2 : 1582
   Google Scholar
• Carlborg , F. W. 1981 . Dose‐response functions in carcinogenesis and the Weibull model . Food Cosmet. Toxicol. , 19 : 255 – 263 .
   PubMedGoogle Scholar
• Cornfield , J. , Rai , K. and Van Ryzin , J. 1980 . Procedures for assessing risk at low levels of exposure . Arch. Toxicol. Suppl. , 3 : 295 – 303 .
   PubMedGoogle Scholar
• Crouch , E. and Wilson , R. 1979 . Interspecies comparison of carcinogenic potency . J. Toxicol. Environ. Health , 5 : 1095 – 1118 .
   PubMed Web of Science ®Google Scholar
• Crouch , E. , Wilson , R. and Zeise , L. 1983 . The risks of drinking water . Water Resour. Res. , 19 : 1359 – 1375 .
   Web of Science ®Google Scholar
• Crump , K. S. , Guess , H. A. and Deal , K. L. 1977 . Confidence intervals and test of hypothesis concerning dose response relations inferred from animal carcinogenicity data . Biometrics , 33 : 437 – 451 .
   PubMed Web of Science ®Google Scholar
• Drew , R. T. , Boorman , G. A. , Haseman , J. K. , McConnell , E. E. , Busey , W. M. and Moore , J. A. 1983 . The effect of age and exposure duration on cancer induction by a known carcinogen in rats, mice and hamsters . Toxicol. Appl. Pharmacol. , 68 : 120 – 130 .
   PubMed Web of Science ®Google Scholar
• Druckrey , H. Pharmacological approach to carcinogenesis . Ciba Foundation Symposium on Carcinogenesis: Mechanisms of Action . Edited by: Wolstenholme , G. E. W. and O'Connor , M. pp. 110 Boston : Little, Brown .
   Google Scholar
• Eyring , H. and Stover , B. J. 1970 . The dynamics of life. II. The steady‐state theory of mutation rates . Proc. Natl. Acad. Sci. U.S.A. , 66 : 441 – 444 .
   PubMed Web of Science ®Google Scholar
• Eyring , H. , Stover , B. J. and Brown , R. A. 1971 . The dynamics of life. V. Applying the steady‐state theory of mutations to human cancer . Proc. Natl. Acad. Sci. U.S.A. , 68 : 1670 – 1672 .
   Google Scholar
• Feron , V. J. , Hendriksen , C. F. M. , Speck , A. S. , Til , H. P. and Spit , B. J. 1981 . Lifespan oral toxicity study of vinyl chloride in rats . Food Cosmet. Toxicol. , 19 : 317 – 333 .
   PubMedGoogle Scholar
• Fishbein , L. 1980 . Overview of some aspects of quantitative risk assessment . J. Toxicol. Environ. Health , 6 : 1275 – 1296 .
   PubMed Web of Science ®Google Scholar
• Fitch , W. M. and Atchely , W. R. 1985 . Evolution in inbred strains of mice appears rapid . Science , 228 : 1169 – 1175 .
   PubMed Web of Science ®Google Scholar
• Food Safety Council . 1978 . Quantitative risk assessment . Food Cosmet. Toxicol. , 16 : 109 – 136 .
   Google Scholar
• Gaylor , D. W. 1980 . The ED01 study: Summary and conclusions . J. Environ. Pathol. Toxicol. , 3 (3) : 179 – 183 .
   PubMedGoogle Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Gold , L. S. , Sawyer , C. B. , Magaw , R. , Backman , G. M. , de Veciana , M. , Levinson , R. , Hooper , N. K. , Havender , W. R. , Bernstein , L. , Peto , R. , Pike , M. C. and Ames , B. N. 1984 . A carcinogenic potency database of the standardized results of animal bioassays . Environ. Health Perspect. , 56 : 9 – 319 .
   Google Scholar
• Groth , D. H. , Coate , W. B. , Ulland , B. M. and Hornung , R. W. 1981 . Effects of aging on the induction of angiosarcoma . Environ. Health Perspect. , 41 : 53 – 57 .
   PubMed Web of Science ®Google Scholar
• Guengerich , F. P. and Watanabe , P. G. 1979 . Metabolism of [14C] and [36CI]‐labeled vinyl chloride in vivo and in vitro . Biochem. Pharmacol. , 28 : 589 – 596 .
   PubMedGoogle Scholar
• Guess , H. , Crump , K. and Peto , R. 1977 . Uncertainty estimates for low‐dose‐rate extrapolations of animal carcinogenicity data . Cancer Res. , 37 : 3475 – 3483 .
   PubMed Web of Science ®Google Scholar
• Harris , C. C. , Trump , B. F. , Grafstrom , R. and Autrup , H. 1982 . Differences in metabolism of chemical carcinogens in cultured human epithelial tissues and cells . J. Cell. Biochem. , 18 : 285 – 294 .
   Google Scholar
• Hart , R. W. and Setlow , R. B. 1974 . Correlation between DNA excission‐repair and life‐span in a number of mammalian species . Proc. Natl. Acad. Sci. U.S.A. , 76 : 2169 – 2173 .
   Google Scholar
• Haseman , J. K. , Hoel , D. C. and Jennrich , R. I. 1981 . Some practical problems arising from use of the gamma multihit model for risk estimation . J. Toxicol. Environ. Health , 8 : 379 – 386 .
   PubMed Web of Science ®Google Scholar
• Hehir , R. M. , McNamara , B. P. , McLaughlin , J. Jr. , Willigan , D. A. , Bierbower , C. and Hardisty , J. F. 1981 . Cancer induction following single and multiple exposures to a constant amount of vinyl chloride monomer . Environ. Health Perspect. , 41 : 63 – 72 .
   PubMed Web of Science ®Google Scholar
• Hoel , O. C. , Kaplan , N. L. and Anderson , M. W. 1983 . Implication of nonlinear kinetics on risk estimation in carcinogenesis . Science , 219 : 1032 – 1037 .
   PubMed Web of Science ®Google Scholar
• Hong , C. B. , Winston , J. M. , Thornburg , L. P. and Lee , C. C. 1981 . Follow‐up study on the car‐cinogenicity of vinyl chloride and vinylidene chloride in rats and mice: Tumor incidence and mortality subsequent to exposure . J. Toxicol. Environ. Health , 7 : 909 – 924 .
   PubMed Web of Science ®Google Scholar
• Jakoby , W. B. 1980 . “ Detoxication enzymes ” . In Enzymatic Basis of Detoxication , Edited by: Jakoby , W. B. 1 – 6 . New York : Academic .
   Google Scholar
• Janardan , K. C. and Schaeffer , D. J. 1977 . Models for the analysis of chromosomal aberrations in human leukocytes . Biom. J. , 19 : 599 – 612 .
   Google Scholar
• Janardan , K. G. and Schaeffer , D. J. Aug 13–16 1984 . “ Risk assessment of toxic substances using a Lagrange‐gamma multi‐hit dose response model ” . In Proc. Social Stat. Section Am. Statistical Assoc Aug 13–16 , 244 – 249 . Philadelphia, Penna. 1984:, 1984.
   Google Scholar
• Jenner , P. , Testa , B. and DiCarlo , F. J. 1981 . Xenobiotic and endobiotic metabolizing enzymes: An overstretched discrimination . Trends Pharmaceut. Sci. , 2 : 135 – 137 .
   Web of Science ®Google Scholar
• Krewski , D. and Van Ryzin , J. Dose response models for quantal response toxicity data . Statistics and Related Topics. Proceedings of a Conference . May 5–7 1980 , Ottawa. Edited by: Sorgo , M. C. , Dawson , D. R. , Rao , J. N. K. and Salch , A. K. M. E. pp. 201 – 231 . North Holland . New York
   Google Scholar
• Kuester , J. L. and Mize , J. H. 1973 . Optimization Techniques with FORTRAN , New York : McGraw‐Hill .
   Google Scholar
• Kuzmack , A. M. and McGaughy , R. E. December 1975 . Quantitative Risk Assessment for Community Exposure to VC , U.S. Environmental Protection Agency report December ,
   Google Scholar
• Lee , C. C. , Bhandari , J. C. , Winston , J. M. , House , W. B. , Dixon , R. L. and Woods , J. C. 1978 . Carcinogenicity of vinyl chloride and vinylidene chloride . J. Toxicol. Environ. Health , 4 : 15 – 30 .
   PubMed Web of Science ®Google Scholar
• Lewin , R. 1985 . Why do inbred mice evolve so quickly? . Science , 228 : 1187
   Google Scholar
• Maltoni , Cesare . 1979 . “ Vinyl chloride carcinogenicity: An experimental model for carcinogenesis studies ” . In Origins of Human Cancer , Edited by: Hiatt , H. H. , Watson , J. D. and Winston , J. A. 119 – 146 . Cold Spring Harbor, N.Y. : Cold Spring Harbor Laboratory . book A
   Google Scholar
• Maltoni , C. and Lefemine , G. 1975 . Carcinogenicity bioassays of vinyl chloride: Current results . Ann. N.Y. Acad. Sci. , 246 : 195 – 218 .
   PubMed Web of Science ®Google Scholar
• Maltoni , C. , Lefemine , G. , Ciliberti , A. , Cotti , G. and Carretti , D. 1981 . Carcinogenicity bioassays of vinyl chloride monomer: A model of risk assessment on an experimental basis . Environ. Health Perspect. , 41 : 3 – 29 .
   PubMed Web of Science ®Google Scholar
• National Academy of Sciences . 1975 . Pest Control: An Assessment of Present and Alternative Technologies. Vol. I. Contemporary Pest Control Practices and Prospects. A Report of the Executive Committee , Vol. I , 77 Washington, D.C. : National Academy of Sciences .
   Google Scholar
• OSHA. Occupational Safety and Health Administration . 1980 . Identification, Classification and Regulation of Potential Occupational Carcinogens . Fed. Reg. , 45 (15) Jan. 22 : 5001 – 5296 .
   Google Scholar
• Oser , B. L. 1981 . The rat as a model for human toxicological evaluation . J. Toxicol. Environ. Health , 8 : 521 – 542 .
   PubMed Web of Science ®Google Scholar
• Peto , R. , Pike , M. C. , Bernstein , L. , Gold , L. S. and Ames , B. N. 1984 . The TD50: A proposed general convention for the numerical description of the carcinogenic potency of chemicals in chronic‐exposure animal experiments . Environ. Health Perspect. , 58 : 1 – 8 .
   PubMed Web of Science ®Google Scholar
• Rai , K. and Van Ryzin , J. 1979 . “ Risk assessment of toxic substances using a generalized multi‐hit dose response model ” . In Energy and Health , Edited by: Breslow , N. E. and Whittenmore , A. S. 99 – 117 . Philadelphia : SIAM Institute for Mathematics and Society .
   Google Scholar
• Rosen , J. B. 1960 . The gradient projection method for nonlinear programming. Part I. Linear constraints . J. Soc. Ind. Appl. Math. , 8 : 181 – 217 .
   Google Scholar
• Schach von Wittenau , M. and Estes , P. C. 1983 . The redundancy of mouse carcinogenicity bioassays . Fundam. Appl. Toxicol. , 3 : 631 – 639 .
   Google Scholar
• Schaeffer , D. 1983 . Thresholds for carcinogenesis and their significance to medical practice . Med. Hypotheses. , 10 : 175 – 184 .
   PubMed Web of Science ®Google Scholar
• Schaeffer , D. J. , Janardan , K. G. and Kerster , H. W. 1980 . Threshold and dose response estimation using the “filter model.” . Environ. Int. , 4 : 157 – 162 .
   Google Scholar
• Schaeffer , D. J. , Janardan , K. G. and Kerster , H. W. 1981 . Threshold estimation from the linear dose‐response model: Method and radiation data . Environ. Manage. , 5 : 515 – 520 .
   Web of Science ®Google Scholar
• Schaeffer , D. J. , Olson , C. , Kerster , H. W. and Janardan , K. G. 1982 . The low dose extrapolation problem: a review and a new model . Am J. Math. Manage. Sci. , 2 : 223 – 251 .
   Google Scholar
• Schaeffer , D. J. , Janardan , K. G. , Kerster , H. W. and Clarke , A. C. M. 1983 . Statistically estimated free energies of chromosome aberration production from frequency data . Biom. J. , 25 : 275 – 282 .
   Google Scholar
• Schneiderman , M. A. , Mantel , N. and Brown , C. C. 1975 . From mouse to man—Or how to get from the laboratory to Park Avenue and 59th St . Ann. N.Y. Acad. Sci. , 246 : 237 – 248 .
   PubMed Web of Science ®Google Scholar
• Society of Toxicology . 1981 . Re‐examination of the ED01 study . Fundam. Appl. Toxicol. , 1 : 26 – 128 .
   Google Scholar
• Society of Toxicology, Task Force of Past Presidents . 1982 . Animal data in hazard evaluation: Paths and pitfalls . Fundam. Appl. Toxicol. , 2 : 101 – 107 .
   Google Scholar
• Stott , W. T. and Watanabe , P. G. 1982 . Differentiation of genetic versus epigenetic mechanisms of toxicity and its application to risk assessment . Drug Metab. Rev. , 13 : 853 – 873 .
   PubMed Web of Science ®Google Scholar
• Stover , B. J. and Eyring , H. 1970a . The dynamics of life. I. Death from internal irradiation by 231 Pu and 226 Ra, aging, cancer, and other diseases . Proc. Natl. Acad. Sci. U.S.A. , 66 : 132 – 139 .
   Google Scholar
• Stover , B. J. and Eyring , H. 1970b . The dynamics of life. III. Mechanisms of nonsurvival and the relation of dose size . Proc. Natl. Acad. Sci. U.S.A. , 66 : 672 – 676 .
   Google Scholar
• Sugimura , T. 1982 . “ A view of a cancer researcher on environmental mutagens ” . In Environmental Mutagens and Carcinogens , Edited by: Sugimura , T. , Konda , S. and Takebe , H. 737 – 741 . New York : Liss .
   Google Scholar
• Suzuki , Y. 1983 . Neoplastic effect of vinyl chloride in mouse lung—Lower doses and short term exposure . Environ. Res. , 32 : 91 – 103 .
   PubMed Web of Science ®Google Scholar
• Thompson , D. E. 1985 . Heavy radiation and mammalian cells . Science News , 127 : 394 – 395 .
   Google Scholar
• Thompson , W. A. Jr. and Funderlic , R. E. 1981 . “ A simple threshold model for the classical bioassay problem ” . In Measurement of Risks , Edited by: Berg , G. C. and Maillie , H. D. 521 – 533 . New York : Plenum .
   Google Scholar
• U.S. Environmental Protection Agency . 1975 . Scientific and Technical Assessment Report on VC and PVC , Washington, D.C. : U.S. Environmental Protection Agency, Office of Research and Development . EPA‐600/6–75–004 STAR series
   Google Scholar
• U.S. Environmental Protection Agency . Oct. 1980 . Ambient Water Quality Criteria for VC , Oct. , Washington, D.C. : U.S. Environmental Protection Agency, Office of Water Regulations and Standards, Criteria and Standards Division . EPA 440/5–080–078, 1980
   Google Scholar
• Van Ryzin , J. and Rai , K. 1980 . “ The use of quantal response data to make predictions ” . In The Scientific Basis of Toxicity Assessment , Edited by: Witschi , H. 273 – 290 . New York : Elsevier .
   Google Scholar
• Von Borstal , R. C. 1982 . “ Thresholds and negative slopes in dose‐mutation curves ” . In Environmental Mutagens and Carcinogens , Edited by: Sugimura , T. , Konda , S. and Takebe , H. 737 – 741 . New York : Liss .
   Google Scholar
• Vysocanskii , D. F. and Petunin , J. I. 1980 . Justification of the 3‐sigma rule for unimodal distributions . Theory of Probability and Mathematical Statistics (USSR) , 21 : 25 – 35 .
   Google Scholar
• Watanabe , P. G. , Zempel , J. H. , Pegg , D. G. and Gehring , P. J. 1978 . Hepatic macromolecular binding following exposure to vinyl chloride . Toxicol. Appl. Pharmacol. , 44 : 571 – 579 .
   PubMed Web of Science ®Google Scholar
• Waxweiler , R. J. , Landrigan , P. J. , Infante , P. and Shapiro , R. 1981 . Conference to reevaluate the toxicity of vinyl chloride, poly(vinyl chloride) and structural analogs . Environ. Health Perspect. , 41 : 1 – 234 .
   Google Scholar
• Withey , J. R. and Collins , B. T. 1976 . A statistical assessment of the quantitative uptake of VCM from aqueous solution . J. Toxicol. Environ. Health , 2 : 311 – 321 .
   PubMed Web of Science ®Google Scholar