National Academy of Sciences | 150 Year Anniversary

Questions? Call 800-624-6242

| Items in cart [0]

The National Academies Press

PAPERBACK
price:$49.00
add to cart

Rights & Permissions

topleft topright

Issues in Risk Assessment (1993)
Commission on Life Sciences (CLS)

Citation Manager

. "REFERENCES." Issues in Risk Assessment. Washington, DC: The National Academies Press, 1993.

Please select a format:

BibTeX EndNote RefMan


Page
67
bottomleft bottomright

The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy.


Issues in Risk Assessment

References

Agency for Toxic Substances and Disease Registry (ATSDR). 1990. Toxicological Profile for Polycyclic Aromatic Hydrocarbons. TP-90-20. U.S. Department of Health and Human Services, Washington, D.C.

Albert, R.E., M.L. Miller, T.E. Cody, W. Barkley, and R. Shukla. 1991. Cell kinetics and benzo[a]pyrene-DNA adducts in mouse skin tumorigenesis. Pp. 115-122 in Chemically-Induced Cell Proliferation: Implications for Risk Assessment, B.E. Butterworth, T.J. Slaga, W. Farland, and M. McClain, eds. New York: Wiley-Liss.

Allen B., K.S. Crump, and A.M. Shipp. 1988. Is it possible to predict the carcinogenic potency of a chemical in humans using animal data? Pp. 197-209 in Carcinogen Risk Assessment: New Directions in the Qualitative and Quantitative Aspects, R.W. Hart and F.D. Hoerger, eds. Banbury Report #31. Cold Spring Harbor Laboratory, Cold Spring Harbor, N.Y.

Ames, B.N., and L.S. Gold. 1990. Too many rodent carcinogens: Mitogenesis increases mutagenesis. Science 249:970-971.

Anderson, R.L., and the Carcinogen Assessment Group of the U.S. Environmental Protection Agency. 1983. Quantitative approaches in use to assess cancer risk. Risk Anal. 3:277-295.

Andersen M.E., H.J. Clewell, III, M.L. Gargas, F.A. Smith, and R.H. Reitz. 1987. Physiologically based pharmacokinetics and the risk assessment process for methylene chloride. Toxicol. Appl. Pharmacol. 87:185-205.

Page
67
Front Matter (R1-R18)
Executive Summary (1-2)
USE OF THE MAXIMUM TOLERATED DOSE IN ANIMAL BIOASSAYS FOR CARCINOGENICITY (3-8)
THE TWO-STAGE MODEL OF CARCINOGENESIS (9-9)
A PARADIGM FOR ECOLOGIC RISK ASSESSMENT (10-12)
Issues In Risk Assessment Use Of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity (13-14)
BACKGROUND (15-17)
SCOPE OF REPORT (18-20)
DEFINITIONS AND BACKGROUND (21-23)
CORRELATIONS (24-32)
RELATIONSHIP BETWEEN TOXICITY AND CARCINOGENICITY OBSERVED AT MTD (33-42)
QUALITATIVE INFORMATION (43-48)
QUANTITATIVE INFORMATION (49-52)
OPTION 1 (53-53)
OPTION 2 (54-54)
OPTION 3 (55-56)
Option 4A (57-58)
Option 4B (59-60)
5 Conclusions and Recommendations (61-66)
REFERENCES (67-78)
BACKGROUND (79-79)
DEFINING AND DETERMINING THE MTD (80-90)
Appendix B Organizing Subcommittee (91-92)
Appendix C Federal Liaison Group (93-94)
Appendix D Workshop Program (95-96)
Appendix E Workshop Attendees (97-110)
1. INTRODUCTION (111-112)
2.1 Measures of Carcinogenic Potency (113-115)
2.2 Carcinogenic Potency Database (CPDB) (116-116)
2.3 Variation in Carcinogen Potency (117-118)
2.4 Classification of Carcinogens (119-120)
3.1 Empirical Correlations (121-124)
3.2 Range of Possible TD50 Values (125-125)
3.3 Analytical Correlations (126-127)
3.4 Model Dependency (128-129)
3.5 Genotoxic vs. Nongenotoxic Carcinogens (130-130)
4.1 Predictions Based on the MDT (131-131)
4.2 Predictions Based on Mutagenicity and Acute Toxicity (132-134)
5.1 Correlation Between Upper Bounds On the Low Dose Slope and MTD (135-135)
5.2 Correlation Between q1* and the TD50 (136-138)
5.3. Preliminary Estimate of Risk (139-139)
6. INTERSPECIES EXTRAPOLATION (140-140)
6.1 Extrapolation from Rats to Mice (141-143)
6.2 Extrapolation from Rodents to Humans (144-145)
7. CONCLUSIONS (146-148)
8. ACKNOWLEDGEMENTS (149-149)
9. REFERENCES (150-159)
ANNEX A: MAXIMUM LIKELIHOOD METHODS FOR FITTING THE WEIBULL MODEL (160-161)
ANNEX B. SHRINKAGE ESTIMATORS OF THE DISTRIBUTION OF CARCINOGENIC POTENCY (162-163)
ANNEX C: ADJUSTMENT OF POTENCY VALUES FOR LESS THAN LIFETIME EXPOSURE (164-165)
ANNEX D: CORRELATION BETWEEN TD50 AND MTD (166-168)
ANNEX E: CORRELATION BETWEEN TD50S FOR RATS AND MICE (169-172)
Appendix G Informal Search for ''Supercarcinogens" (173-174)
CRITERIA AND CANDIDATE CHEMICALS (175-176)
DATA (177-180)
RESULTS (181-181)
DISCUSSION (182-184)
Issues in Risk Assessment The Two-Stage Model Of Carcinogenesis (185-186)
INTRODUCTION (187-187)
BIOLOGIC CONSIDERATIONS (188-189)
THE TWO-STAGE MODEL (190-195)
APPLICATIONS OF THE TWO-STAGE MODEL TO ANIMAL DATA (196-211)
Data Needs (212-212)
Criteria for Adoption (213-213)
Prospects (214-214)
CONCLUSIONS AND RECOMMENDATIONS (215-216)
REFERENCES (217-222)
BIOLOGICAL FACTORS IN TWO-STAGE MODELS (223-225)
TWO-STAGE MODEL OF CLONAL EXPANSION (226-227)
APPLICATION OF THE TWO-STAGE MODEL TO ANIMAL DATA (228-232)
Appendix B Workshop Program (233-234)
Appendix C Workshop Federal Liaison Group (235-236)
TOPIC GROUP MEMBERS (237-238)
Appendix E Workshop Organizing Task Group (239-240)
Isuees In Risk Assessment A Paradigm for Ecological Risk Assessment (241-242)
1 Introduction (243-246)
2 Scope of Ecological Risk Assessment (247-248)
COMPONENTS OF THE 1983 FRAMEWORK (249-250)
CONSISTENCY OF CASE STUDIES WITH THE 1983 FRAMEWORK (251-253)
INTEGRATION OF ECOLOGICAL RISK INTO THE 1983 FRAMEWORK (254-254)
DEFINITION OF FRAMEWORK COMPONENTS FOR ECOLOGICAL RISK ASSESSMENT (255-258)
EXTRAPOLATION ACROSS SCALES (259-260)
QUANTIFICATION OF UNCERTAINTY (261-261)
VALIDATION OF PREDICTIVE TOOLS (262-262)
VALUATION (263-264)
5 Conclusions (265-266)
6 Recommendations (267-268)
REFERENCES (269-272)
Appendix A Workshop Participants (273-278)
Appendix B Workshop Organizing Subcommittee and Federal Liaison Group (279-280)
Appendix C Workshop Introduction (281-282)
TERRY F. YOSIE BUILDING ECOLOGICAL RISK ASSESSMENT AS A POLICY TOOL (283-285)
D. WARNER NORTH: RELATIONSHIP OF WORKSHOP TO NRC'S 1983 RED BOOK REPORT (286-288)
MICHAEL SLIMAK: U.S. ENVIRONMENTAL PROTECTION AGENCY ACTIVITIES IN ECOLOGICAL RISK ASSESSMENT (289-292)
CASE STUDY 1: TRIBUTYLTIN RISK MANAGEMENT IN THE UNITED STATES (293-293)
Discussion (294-294)
CASE STUDY 2: ECOLOGICAL RISK ASSESSMENT FOR TERRESTRIAL WILDLIFE EXPOSED TO AGRICULTURAL CHEMICALS (295-296)
CASE STUDY 3A: MODELS OF TOXIC CHEMICALS IN THE GREAT LAKES: STRUCTURE, APPLICATIONS, AND UNCERTAINTY ANALYSIS (297-298)
CASE STUDY 3B: ECOLOGICAL RISK ASSESSMENT OF TCDD AND TCDF (299-299)
Discussion (300-300)
CASE STUDY 4: RISK ASSESSMENT METHODS IN ANIMAL POPULATIONS: THE NORTHERN SPOTTED OWL AS AN EXAMPLE (301-301)
Discussion (302-302)
CASE STUDY 5: ECOLOGICAL BENEFITS AND RISKS ASSOCIATED WITH THE INTRODUCTION OF EXOTIC SPECIES FOR BIOLOGICAL CONTROL OF A... (303-303)
Discussion (304-304)
CASE STUDY 1: UNCERTAINTY AND RISK IN AN EXPLOITED ECOSYSTEM: A CASE STUDY OF GEORGES BANK (305-306)
Discussion (307-308)
Generic Issues (309-309)
Analysis of Case Studies (310-310)
DOSE-RESPONSE ASSESSMENT (311-311)
Selection of End Points (312-312)
Consideration of Nonlinearities And Discontinuities (313-313)
Understanding the Stressor (314-314)
Additions to the 1983 Paradigm Needed for Ecological Risk Assessment (315-315)
Modeling Needs for Stress-Response Relationships (316-316)
Methods of Measuring Stressors for Ecological Exposure Assessment (317-317)
Definition of Risk Characterization (318-318)
Components of Risk Characterization (319-319)
Organization and Presentation (320-320)
Differences from and Similarities To the 1983 Report (321-321)
Application to the Case Studies (322-323)
Agricultural Chemicals (324-324)
Northern Spotted Owl (325-325)
General Discussion: Models and Risk Assessment (326-326)
Uncertainties Identified In the Case Studies (327-327)
Implications of Uncertainty for Ecological Risk Assessment (328-328)
VALUATION (329-330)
Risk Assessment Has Many Uses (331-332)
Different Risk Assessment Methods Are Suited to Different Risk Assessment Needs (333-333)
Risk Assessors and Risk Managers Need to Communicate (334-334)
Credibility is Crucial (335-336)
Appendix G Contemplations on Ecological Risk Assessment (337-342)
Appendix H Workshop Summary (343-346)
Appendix I References for Appendixes (347-350)
Appendix J Workshop Program (351-356)

Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 67
Issues in Risk Assessment References Agency for Toxic Substances and Disease Registry (ATSDR). 1990. Toxicological Profile for Polycyclic Aromatic Hydrocarbons. TP-90-20. U.S. Department of Health and Human Services, Washington, D.C. Albert, R.E., M.L. Miller, T.E. Cody, W. Barkley, and R. Shukla. 1991. Cell kinetics and benzo[a]pyrene-DNA adducts in mouse skin tumorigenesis. Pp. 115-122 in Chemically-Induced Cell Proliferation: Implications for Risk Assessment, B.E. Butterworth, T.J. Slaga, W. Farland, and M. McClain, eds. New York: Wiley-Liss. Allen B., K.S. Crump, and A.M. Shipp. 1988. Is it possible to predict the carcinogenic potency of a chemical in humans using animal data? Pp. 197-209 in Carcinogen Risk Assessment: New Directions in the Qualitative and Quantitative Aspects, R.W. Hart and F.D. Hoerger, eds. Banbury Report #31. Cold Spring Harbor Laboratory, Cold Spring Harbor, N.Y. Ames, B.N., and L.S. Gold. 1990. Too many rodent carcinogens: Mitogenesis increases mutagenesis. Science 249:970-971. Anderson, R.L., and the Carcinogen Assessment Group of the U.S. Environmental Protection Agency. 1983. Quantitative approaches in use to assess cancer risk. Risk Anal. 3:277-295. Andersen M.E., H.J. Clewell, III, M.L. Gargas, F.A. Smith, and R.H. Reitz. 1987. Physiologically based pharmacokinetics and the risk assessment process for methylene chloride. Toxicol. Appl. Pharmacol. 87:185-205.

OCR for page 68
Issues in Risk Assessment Anderson, R.L., R.R. Lefever, and J.K. Maurer. 1988. Comparison of the responses of male rats to dietary sodium saccharin exposure initiated during nursing with responses to exposure initiated at weaning . Food Chem. Toxicol. 26:899-907. Armitage, P., and R. Doll. 1961. Stochastic Models for Carcinogenesis. Pp. 19-38 in Proceedings of the 4th Berkeley Symposium on Mathematical Statistics and Probability, Vol. 4. Berkeley and Los Angeles: University of California Press. Bernstein, L., L.S. Gold, B.N. Ames, M.C. Pike, and D.G. Hoel. 1985. Some tautologous aspects of the comparison of carcinogenic potency in rats and mice. Fundam. Appl. Toxicol. 5:79-86. Cavalieri, R.R., and R. Pitt-Rivers. 1981. The effects of drugs on the distribution and metabolism of thyroid hormones. Pharmacol. Rev. 33:55-80. Cohen, S.M., and L.B. Ellwein. 1990a. Cell proliferation in carcinogenesis. Science 249:1007-1011. Cohen, S.M., and L.B. Ellwein. 1990b. Proliferative and genotoxic cellular effects in 2-acetylaminofluorene bladder and liver carcinogenesis: Biological modeling of the ED01 study. Toxicol. Appl. Pharmacol. 104:79-93. Crouch, E.A.C., R. Wilson, and L. Zeise. 1987. Tautology or not tautology? J. Toxicol. Environ. Health 20:1-10. Crump, K. 1984. An improved procedure for low dose carcinogenic risk assessment from animal data. J. Environ. Pathol. Toxicol. Oncol. 5(4-5):339-348. Danse, L.H., F.L. van Velsen, and L.A. van der Heijden. 1984. Methylbromide: Carcinogenic effects in the rat forestomach. Toxicol. Appl. Pharmacol. 72:262-271. DeVito, M.J., T.H. Umbreit, T. Thomas, and M.A. Gallo. 1991. An Analogy Between the Actions of the Ah Receptor and the Estrogen Receptor for Use in the Biological Basis for Risk Assessment of Dioxin. Banbury Conference on the Biological Basis for Dioxin Risk. Cold Spring Harbor, N.Y. DHEW (Department of Health Education and Welfare). 1979. Bioassay of Reserpine for Possible Carcinogenicity. DHEW Publication No. NIH 79-1749. Department of Health Education and Welfare, National Institute of Health, Bethesda, Maryland. Diehl, J.H., R.A. Guilmette, B.A. Muggenberg, F.F. Hahn, and I.Y.

OCR for page 69
Issues in Risk Assessment Chang. 1992. Influence of dose rate on survival time for 239PuO2-induced radiation pneumonitis or pulmonary fibrosis in dogs. Radiat. Res. 129:53-60. Doll, R. 1971. The age distribution of cancer: Implications for models of carcinogenesis. J. R. Stat. Soc. A37:133-166. EPA (U.S. Environmental Protection Agency). 1986. Health and Environmental Effects Profile for Methyl Bromide. Prepared by the Office of Health and Environmental Assessment and the Environmental Criteria and Assessment Office for the Office of Solid Waste and Emergency Response. Washington, D.C. Feron, V., C.F. Hendriksen, A.J. Speek, H.P. Til, and B.J. Spit. 1981. Lifespan oral toxicity study of vinyl chloride in rats. Food Cosmet. Toxicol. 19:317-333. Fox, A., and P. Collier. 1977. Mortality experience of workers exposed to vinyl chloride monomer in the manufacture of polyvinyl chloride in Great Britain. Brit. J. Ind. Med. 344:1-10. Gaylor, D.W. 1989. Preliminary estimates of the virtually safe dose for tumors obtained from the maximum tolerated dose. Regul. Toxicol. Pharmacol. 9:101-108. Gold, L.S., C.B. Sawyer, R. Magaw, G.M. Backman, M. de Veciana, R. Levinson, N.K. Hooper, W.R. Havender, L. Bernstein, R. Peto, M.C. Pike, and B.N. Ames. 1984. A carcinogenic potency database of the standardized results of animal bioassays. Environ. Health Perspect. 58:9-21. Gold, L.S., M. de Veciana, G.M. Backman, R. Magaw, P. Lopipero, M. Smith, M. Blumenthal, R. Levinson, L. Bernstein, and B.N. Ames. 1986a. Chronological supplement to the carcinogenic potency database: Standardized results of animal bioassays published through December 1982. Environ. Health Perspect. 67:161-200. Gold, L.S., L. Bernstein, J. Kaldor, G. Backman, and D. Hoel. 1986b. An empirical comparison of methods used to estimate carcinogenic potency in long-term animal bioassays: Lifetable vs summary incidence data. Fundam. Appl. Toxicol. 6:263-269. Gold, L.S., J.M. Ward, L. Bernstein, and B. Stern. 1986c. Association between carcinogenic potency and tumor pathology in rodent carcinogenesis bioassays. Fundam. Appl. Toxicol. 6:677-690. Gold, L.S., T.H. Slone, G.M. Backman, R. Magaw, M. Da Costa, P. Lopipero, M. Blumenthal, and B.N. Ames. 1987a. Second chro-

OCR for page 70
Issues in Risk Assessment nological supplement to the carcinogenic potency database: Standardized results of animal bioassays published through December 1984 and by the National Toxicology Program through May 1986. Environ. Health Perspect. 74:237-329. Gold, L.S., G.M. Backman, M.K. Hooper, and R. Peto. 1987b. Ranking the potential carcinogenic hazards to workers from exposures to chemicals that are tumorigenic in rodents. Environ. Health Perspect. 76:211-219. Gold, L.S., T.H. Slone, and L. Bernstein. 1989a. Summary of carcinogenic potency and positivity for 492 rodent carcinogens in the carcinogenic potency database. Environ. Health Perspect. 79:259-272. Gold, L.S., L. Bernstein, R. Magaw, and T.H. Slone. 1989b. Interspecies extrapolation in carcinogenesis: Prediction between rats and mice. Environ. Health Perspect. 81:211-219. Gold, L.S., T.H. Slone, G.M. Backman, S. Eisenberg, M. Da Costa, M. Wong, N.B. Manley, L. Rohrbach, and B.N. Ames. 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 . Environ. Health Perspect. 84:215-286. Haseman, J.K. 1985. Issues in carcinogenicity testing: Dose selection. Fund. Appl. toxicol. 5:66-6678. Henderson, B., and S. Preston-Martin. 1990. Increased cell proliferation as a cause of human cancer. In Proceedings of the Annual Meeting of the American Association of Cancer Research 31:513-515. Hiasa, Y., Y. Kitahori, M. Ohshima, T. Fujita, T. Yuasa, N. Konishi, and A. Miyashiro. 1982. Promoting effects of phenobarbital and barbital on development of thyroid tumors in rats treated with N-bis(2-hydroxypropyl) nitrosamine. Carcinogenesis 3:1187-1190. Hill, R.N., L.S. Erdreich, O.E. Paynter, P.A. Roberts, S.L. Rosenthal, and C.F. Wilkinson. 1989. Thyroid follicular cell carcinogenesis. Fundam. Appl. Toxicol. 12:629-697. Hiraga, K., and Fujii, T. 1981. Induction of tumors of the urinary system in F344 rats by dietary administration of sodium o-phenylphenate. Food Cosmet. Toxicol. 19:303-310. Hiraga, K., and Fujii, T. 1984. Induction of tumors of the urinary bladder in F344 rats by dietary administration of o-phenylphenol.

OCR for page 71
Issues in Risk Assessment Food. Cosmet. Toxicol. 22:865-870. Hoel, D.G., J.K. Haseman, M.D. Hogan, J. Huff, and E.E. McConnell. 1988. The impact of toxicity on carcinogenicity studies: Implications for risk assessment. Carcinogenesis 9:2045-2052. Huff, J., and D.P. Rall. 1992. Relevance to humans of carcinogenesis results from laboratory animals toxicology studies. Pp. 433-440 and 453-457 in Maxcy-Rosenau-Last Public Health and Preventive Medicine, 13th ed., J.M. Last and R.B. Wallace, eds. Norwalk, Ct.: Appleton & Lange. IARC (International Agency for Research on Cancer). 1974. Some aromatic amines, hydrazine, and related substances, N-nitroso compounds and miscellaneous alkylating agents. Pp. 271-275 in IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man, Vol. 4. Lyon, France: International Agency for Research on Cancer. IARC (International Agency for Research on Cancer). 1979. Some monomers, plastic and synthetic elastomers, and acrolein. Pp. 377-438 in IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans, Vol. 19. Lyon, France: International Agency for Research on Cancer. IARC (International Agency for Research on Cancer). 1986a. Long-term and Short-term Assays for Carcinogens: A Critical Appraisal, R. Montesano, H. Bartsch, H. Vainio, J. Wilbourn, and H. Yamasaki, eds. IARC Science Publications #83. Lyon, France: International Agency for Research on Cancer. 575 pp. IARC (International Agency for Research on Cancer). 1986b. Statistical Methods in Cancer Research, Vol. 3. The Design and Analysis of Long-term Animal Experiments, J.J. Gart, D. Krewski, P.N. Lee, R.E. Tarone, and J. Wahrendorf, eds. IARC Science Publications #79. Lyon, France: International Agency for Research on Cancer. 219 pp. IARC (International Agency for Research on Cancer). 1991. Preamble. Pg. 21 in chlorinated drinking-water; chlorination by-products; some other halogenated compounds; cobalt and cobalt compounds. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 52. Lyon, France: International Agency for Research on Cancer. Ito, N., M. Hirose, and S. Takahashi. 1991. Cellular proliferation and

OCR for page 72
Issues in Risk Assessment stomach carcinogenesis induced by antioxidants. Pp. 43-52 in Chemically Induced Cell Proliferation: Implications for Risk Assessment, B.E. Butterworth , T.J. Slaga, W. Farland, and M. McClain, eds. New York: Wiley-Liss. Jordan, V.C., and C.S. Murphy. 1990. Endocrine pharmacology of antiestrogens as antitumor agents. Endocr. Rev. 11:578-610. Karstadt, M., R. Bobal, and I.J. Selikoff. 1981. A survey of availability of epidemiologic data on humans exposed to animal carcinogens. Pp. 223-245 in Quantification of Occupational Cancer, R. Peto and M. Schneiderman, eds. Banbury Report #9. Cold Spring Harbor Laboratory, Cold Spring Harbor, N.Y. Kimbrough, R., and R.E. Linder. 1974. Induction of adenofibrosis and hepatomas of the liver in BALB/cJ mice by polychorinated biphenyls (Aroclor 1254). J. Natl. Cancer Inst. 53:547-552. Kimbrough, R.D., R.A. Squire, R.E. Linder, J.D. Strandberg, R.J. Montalli, and V.W. Burse. 1975. Induction of liver tumors in Sherman strain female rats by polychlorinated biphenyl Aroclor 1260. J. Natl. Cancer Inst. 55:1453-1459. Kluwe, K.M., J.K. Haseman, J.F. Douglas, and J.E. Huff. 1982. The carcinogenicity of dietary DEHP in Fischer 344 rats and B6C3F1 mice. J. Toxicol. Environ. Health 10:797-815. Kodell, R.L., D.W. Gaylor, and J.J. Chen. 1990. Carcinogenic potency correlations: Real or artifactual? J. Toxicol. Ind. Health. Submitted. Konishi, N., B.A. Diwan, and J.W. Ward. 1990. Amelioration of sodium barbital-induced nephropathy and regenerative tubular hyperplasia after a single injection of streptozotocin does not abolish the renal tumor-promoting effect of barbital sodium in male F344/NCr rats. Carcinogenesis 11:2149-2156. Krewski, D., D.W. Gaylor, A.P. Soms, and M. Szyszkowicz. 1990 (Appendix B). Correlation Between Carcinogenic Potency and the Maximum Tolerated Dose: Implications for Risk Assessment. Paper prepared for the Committee on Risk Assessment Methodology, September 4, 1990, Washington, D.C. Krewski, D., D. W. Gaylor, and M. Szyszkowicz. 1991. A model-free approach to low dose extrapolation. Environ. Health Perspect. 90:279-285. Landers, J.P., and N.J. Bunce. 1991. The Ah receptor and the mecha-

OCR for page 73
Issues in Risk Assessment nism of dioxin toxicity. Biochem. J. 276:273-287. Lee, K.P., H.J. Trochimowicz, and C.F. Reinhardt. 1985. Pulmonary response of rats exposed to titanium dioxide by inhalation for 2 years. Toxicol. Appl. Pharmacol. 79:179-192. Maltoni, C., G. Lefemine, A. Ciliberti, G. Cotti, and D. Carretti. 1981. Carcinogenicity bioassays of vinyl chloride monomer: A model of risk assessment on an experimental basis. Environ. Health Perspect. 41:3-29. Mantel, N., and W.R. Bryan. 1961. Safety testing of carcinogenic agents. J. Nat. Canc. Inst. 27:455-470. Mauderly, J.L., R.K. Jones, W.C. Griffith, R.F. Henderson, and R.O. McClellan. 1987. Diesel exhaust is a pulmonary carcinogen in rats exposed chronically by inhalation. Fundam. Appl. Toxicol. 9:208-221. McClain, R.M. 1989. The significance of hepatic microsomal enzyme induction and altered thyroid function in rats: Implications for thyroid gland neoplasia. Toxicol. Pathol. 17:294-306. McClain, R.M., R.C. Posch, T. Bosakowski, and J.M. Armstrong. 1988. Studies on the mode of action for thyroid gland tumor promotion in rats by phenobarbital. Toxicol. Appl. Pharmacol. 94:254-265. McClain, R.M., A.A. Levin, R.C. Posch, and J.C. Downing. 1989. The effect of phenobarbital on the metabolism and excretion of thyroxine in rats. Toxicol. Appl. Pharmacol. 99:216-228. McConnell, E.E. 1989. The maximum tolerated dose: The debate. J. Amer. Coll. Toxicol. 8:1115-1120. Medinsky, M.A., J.S. Dutcher, J.A. Bond, R.F. Henderson, M.B. Snipes, J.W. McWhinney, L.S. Birnbaum, and Y.S. Cheng. 1985. Uptake and excretion of carbon-14 methyl bromide as influenced by exposure concentration. Toxicol. Appl. Pharmacol. 78:215-225. Melnick, R.L., J. Huff, B.J. Chou, and R.A. Miller. 1990. Carcinogenicity of 1,3-butadiene in C57BL/6 × C3HF1 mice at low exposure concentrations. Cancer Res. 50:6592-6599. Metzger, B., E. Crouch, and R. Wilson. 1989. On the relationship between carcinogenicity and acute toxicity. Risk Anal. 9:169-177. Mitchell, A.M., J.C. Lhugenot, J.W. Bridges, and C.R. Elcombe. 1985. Identification of the proximate peroxisome proliferator(s) derived from DEHP. Toxicol. Appl. Pharmacol. 80:23-32.

OCR for page 74
Issues in Risk Assessment Moolgavkar, S.H., and D.J. Venzon. 1979. Two-event models for carcinogenesis: Incidence curves for childhood and adult tumors. Mathemat. Biosci. 47:55-77. Moolgavkar, S.H., and A.G. Knudson. 1981. Mutation and cancer. A model for human carcinogenesis. J. Natl. Cancer Inst. 66:1037-1052. Neal, J., and R.H. Rigdon. 1967. Gastric tumors in mice fed benzo( a)pyrene: A quantitative study. Tex. Rep. Biol. Med. 25:553-557. Nebert, D.W. 1991. Proposed role of drug-metabolizing enzymes: Regulation of steady state levels of the ligands that affect growth, homeostasis, differentiation, and neuroendocrine functions. Mol. Endrocrin. 5:1203-1214. Oppenheimer, J.H., G. Bernstein, and M.I. Surks. 1968. Increased thyroxine turnover and thyroidal function after stimulation of hepatocellular binding of thyroxine by phenobarbital. J. Clin. Invest. 47:1399-1406. OTA (Office of Technology Assessment), U.S. Congress. 1987. Identifying and Regulating Carcinogens. OTA-BP-H-42. Washington, D.C.: U.S. Government Printing Office. November. Paynter, O.E., G.J.Burin, R.B. Jaeger, and C.A. Gregorio. 1988. Goitrogens and thyroid follicular cell neoplasia: Evidence for a threshold process. Regul. Toxicol. Pharmacol. 8:102-119. Peto, R., M.C. Pike, L. Bernstein, L. S. Gold, and B.N. Ames. 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. Poland, A., and J.C. Knutson. 1982. 2,3,7,8-tetrachlorodibenzo-p-dioxin and related halogenated aromatic hydrocarbons: Examination of the mechanism of toxicity. Annu. Rev. Pharmacol. Toxicol. 22:517-554. Portier, C.J., S.C. Hedges, and D.G. Hoel. 1980. Age-specific models of mortality and tumor onset for historical control animals in the National Toxicology Program's carcinogenicity experiments. Cancer Res. 46:4372-4378. Preston-Martin, S., M.C. Pike, R.K. Ross, and B.E. Henderson. 1991. Epidemiologic evidence for the increased cell proliferation model of carcinogenesis. Pp. 21-34 in Chemically Induced Cell Proliferation: Implications for Risk Assessment, B.E. Butterworth, T.J. Slaga, W.

OCR for page 75
Issues in Risk Assessment Farland, and M. McClain, eds. New York: Wiley-Liss. Reitz, R.H., P.G. Watanabe, M.J. McKenna, J.F. Quast, and P.J. Gehring. 1980. Effects of vinylidene chloride on DNA synthesis and DNA repair in the rat and mouse: A comparative study with dimethylnitrosamine. Toxicol. Appl. Pharmacol. 52:357-370. Reitz, R.H., T.R. Fox, J.F. Quast, E.A. Hermann, and P.J. Watanabe. 1984a. Molecular mechanisms involved in the toxicity of orthophenylphenol and its sodium salt. Chem. Biol. Interact. 43:99-119. Reitz, R.H., T.R. Fox, J.F. Quast, E.A. Hermann, H.D. Kirk, and P.J. Watanabe. 1984b. Biochemical factors involved in the effects of orthophenylphenol (OPP) and sodium orthophenylphenate (SOPP) on the urinary tract of male F344 rats. Toxicol. Appl. Pharmacol. 73:345-349. Reitz, R.H., A.L. Mendrala, R.A. Corley, J.F. Quast, M.L. Gargas, M.E. Andersen, D.A. Staats, and R. B. Conolly. 1990. Estimating the risk of liver cancer associated with human exposures to chloroform using physiologically-based pharmacokinetic modeling. Toxicol. Appl. Pharmacol. 105:443-459. Reuzel, P.G., H.C. Dreef-van der Meulen, V.M. Hollanders, C.F. Kuper, V.J. Feron, and C.A. van der Heijden. 1991. Chronic inhalation toxicity and carcinogenicity study of methyl bromide in Wistar rats. Food Chem. Toxicol. 29:31-39. Rieth, J.P., and T.B. Starr. 1989a. Chronic bioassays: Relevance to quantitative risk assessment of carcinogens. Regul. Toxicol. Pharmacol. 10:160-173. Rieth, J.P., and T.B. Starr. 1989b. Experimental design constraints on carcinogenic potency estimates. J. Toxicol. Environ. Health 27:287-296. Roe, F.J.C. 1988. How do hormones cause cancer? Pp. 259-272 in Theories of Carcinogenesis, O.H. Iversen, ed. New York: Hemisphere Publishing Corporation. Sabourin, P.J., J.D. Sun, J.T. MacGregor, C.M. Wehr, L.S. Birnbaum, G.W. Lucier, and R.F. Henderson. 1990. Effect of repeated benzene inhalation exposures on benzene metabolism, binding to hemoglobin, and induction of micronuclei. Toxicol. Appl. Pharmacol. 103:452-462. Safe, S. 1986. Comparative toxicology and mechanism of action of polychlorinated dibenzo-p-dioxins and dibenzofurans. Annu. Rev.

OCR for page 76
Issues in Risk Assessment Pharmacol. Toxicol. 26:371-399. Sawyer, C., R. Peto, L. Bernstein, and M.C. Pike. 1984. Calculation of carcinogenic potency from long-term animal carcinogenesis experiments. Biometrics 40:27-40. Scott, B.R. 1988. Early and Continuing Effects of Combined Alpha and Beta Irradiation of the Lung: Phase II Report. Division of Regulatory Applications, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, D.C. Scott, B.R., F.F. Hahn, M.B. Snipes. G.J. Newton, A.F. Eidson, J.L. Mauderly, and B.B. Boecker. 1990. Predicted and observed eraly effects of combined alpha and beta lung irradiation. Health Phys. 59:791-805. Shubik, P., ed. 1978. Special Problems with Carcinogenicity Protocols. Toxicology Forum. Sipes, I.G., and A.J. Gandolfi. 1991. Biotransformation of toxicants. Pp. 88-126 in Caserett and Doull's Toxicology, M.O. Amdur, J. Doull, and C.D. Klaassen, eds. 4th ed. New York: Pergamon Press. Sontag, J.M., N.P. Page, and U. Saffiotti. 1976. Guidelines for Carcinogen Bioassay in Small Rodents. Carcinog. Tech. Rep. Series 1. DHEW Publication (NIH 76-801). Bethesda, Maryland.: National Cancer Institute. Stephenson, R.P. 1956. A modification of receptor theory. Brit. J. Pharmacol. 11:379-. Tennant, R.W., M.R. Elwell, J.W. Spalding, and R.A. Griesemer. 1991. Evidence that toxic injury is not always associated with induction of chemical carcinogenesis. Mol. Carcinogen. 4:420-440. Tischler, A.S., R.A. Delellis, G. Nunnemacher, and H.J. Wolfe. 1988. Acute stimulation of chromaffin cell proliferation in the adult rat adrenal medulla. Lab. Invest. 58:733-735. Tischler, A.S., L.A. Ruzicka, S.R. Donahue, and R.A. Delellis. 1989. Chromaffin cell proliferation in the adult rat adrenal medulla. Int. J. Devel. Neurosci. 7:439-448. Tischler, A.S., R.M. McClain, H. Childers, and J. Downing. 1991. Neurogenic signals regulate chromaffin cell proliferation and mediate the mitogenic effects of reserpine in the rat adrenal medulla. Lab. Invest. 65:374-376. Turnbull, G.J., P.N. Lee, and F.J.C. Roe. 1985. Relationship of body

OCR for page 77
Issues in Risk Assessment weight to longevity and to risk of development of nephropathy and neoplasia in Sprague-Dawley Rats. Food Chem. Toxicol. 23:355-362. Umbreit, T.H., and M.A. Gallo. 1988. Physiological implications of estrogen receptor modulation by 2,3,7,8-tetrachlorodibenzo-p-dioxin. Toxicol. Lett. 42:5-14. Wada, S., M. Hirose, S. Takahashi, S. Okazaki, and N. Ito. 1990. Para-methoxyphenol strongly stimulates cell proliferation in the rat forestomach but is not a promoter of rat forestomach carcinogenesis. Carcinogenesis 11:1891-1894. Ward, J.M., N. Konishi, and B.A. Diwan. 1990. Renal tubular cell or hepatocyte hyperplasia is not associated with tumor promotion by di(2-ethylhexyl)phthalate in B6C3F1 mice after transplacental initiation with N-nitrosoethylurea. Exp. Pathol. 40:125-138. Whitlock, J.P. 1986. The regulation of cytochrome P-450 expression. Annu. Rev. Pharmacol. Toxicol. 26:333-369. Williams, G.M., ed. 1988. Sweeteners: Health Effects. Princeton, N.J.: Princeton Scientific Publishing Co., Inc. Zeise, L., R. Wilson, and E. Crouch. 1984. Use of acute toxicity to estimate carcinogenic risk. Risk Anal. 4(3):187-199. Zeise, L., E.A.C. Crouch, and R. Wilson. 1985. Reply to comments: On the relationship of toxicity and carcinogenicity. Risk Anal. 5(4):265-270. Zeise, L., E.A.C. Crouch, and R. Wilson. 1986. A possible relationship between toxicity and carcinogenicity. J. Amer. Coll. Toxicol. 5(2):137-151.

OCR for page 78
Issues in Risk Assessment This page in the original is blank.