An adjustment factor for mode-of-action uncertainty with dual-mode carcinogens: The case of naphthalene-induced nasal tumors in rats

Risk Analysis

Volumn 28, Issue 4, 2008, Pages 1033-1051

  Bogen, Kenneth T ^a  

^a EXPONENT INC   (United States)

Author keywords

Biologically based cancer risk models; Cytotoxic; Genotoxic; Metabolism; PBPK

Indexed keywords

ARSENIC COMPOUNDS; BIOASSAY; CARCINOGENS; CHLORINE COMPOUNDS; ENVIRONMENTAL ENGINEERING; ENVIRONMENTAL PROTECTION; ENVIRONMENTAL PROTECTION AGENCY; EXTRAPOLATION; KETONES; NAPHTHALENE; ONCOLOGY; RISK MANAGEMENT; RISK PERCEPTION; SAFETY ENGINEERING; TUMORS;

BIOLOGICALLY BASED CANCER RISK MODELS; CANCER RISK ASSESSMENTS; CANCER RISKS; CELL-KILLING; CHEMICAL-; CYTOTOXIC; CYTOTOXIC EFFECTS; DUAL MODES; GENOTOXIC; LINEAR EXTRAPOLATION; LOW-DOSE; MECHANISTIC MODELING; METABOLISM; MODE OF ACTION; NAPHTHOQUINONE; PBPK; SITE-SPECIFIC; TOXICOKINETIC; TOXICOKINETIC MODELS; TWO STAGES; U.S. ENVIRONMENTAL PROTECTION AGENCY;

RISK ASSESSMENT;

NAPHTHALENE;

CARCINOGEN; COMPARATIVE STUDY; GENOTOXICITY; METABOLISM; MODELING; NAPHTHALENE; RISK ASSESSMENT; RODENT; TUMOR; UNCERTAINTY ANALYSIS;

BIOASSAY; CANCER RISK; CARCINOGENESIS; CYTOTOXICITY; ENVIRONMENTAL EXPOSURE; EXPERIMENTAL RAT; GENOTOXICITY; NONHUMAN; NOSE TUMOR; REVIEW; RISK ASSESSMENT; TOXICOKINETICS;

ANIMALS; CARCINOGENS; NAPHTHALENES; NOSE NEOPLASMS; RATS; RISK ASSESSMENT; UNCERTAINTY;

RATTUS;

EID: 48349097649     PISSN: 02724332     EISSN: 15396924     Source Type: Journal    
DOI: 10.1111/j.1539-6924.2008.01066.x     Document Type: Review

References (138)

1. U.S. Environmental Protection Agency (USEPA) 2005). Guidelines for Carcinogen Risk Assessment. EPA/630/P-03/001F. USEPA Risk Assessment Forum, USEPA, Washington, DC.
2. Moolgavkar, S. H. (1983). Model for human carcinogenesis: Action of environmental agents. Environmental Health Perspectives, 50, 285 291.
3. Bogen, K. T. (1989). Cell proliferation kinetics and multistage cancer risk models. Journal of the National Cancer Institute, 81, 267 277.
4. 4. Cancer Research, 43, 188 191.
5. Brunius, G. (1987). Mitogenic activity of chloroform and carbon tetrachloride in serum-deficient or calcium-deficient cultures of human embryonic lung fibroblasts. Carcinogenesis, 8 (11 1645 1649.
6. Bogen, K. T. (1990). Risk extrapolation for chlorinated methanes as promoters vs initiators of multistage carcinogenesis. Fundamental and Applied Toxicology, 15, 536 557.
7. Columbano, A., Ledda-Columbano, G. M., Ennas, M. G., Curto, M., Chelo, A., & Pani P. (1990). Cell proliferation and promotion of rat liver carcinogenesis: Different effects of hepatic regeneration and mitogen induced hyperplasia on the development of enzyme altered foci. Carcinogenesis, 11, 771 776.
8. Kotsanis, N., & Metcalfe, C. D. (1991). Enhancement of hepatocarcinogenesis in rainbow trout with carbon tetrachloride. Bulletin of Environmental Contamination and Toxicology, 46, 879 886.
9. International Agency for Research on Cancer (IARC) 2003). Predictive Value of Rodent Forestomach and Gastric Neuroendocrine Tumors in Evaluating Carcinogenic Risks to Humans: Views and Expert Opinions of an IARC Working Group. IARC Technical Report No. 39. Lyon, France : World Health Organization, IARC.
10. Larson, J. L., Wolf, D. C., & Butterworth, B. E. (1994). Induced cytotoxicity and cell proliferation in the hepatocarcinogenicity of chloroform in female B6C3F1 mice: Comparison of administration by gavage in corn oil vs ad libitum in drinking water. Fundamental and Applied Toxicology, 22, 90 102.
11. Solnick, J. V., & Schauer, D. B. (2001). Emergence of diverse Helicobacter species in the pathogenesis of gastric and enterohepatic diseases. Clinical Microbiology Reviews, 14 (1 59 97.
12. Suerbaum, S., & Michetti P. (2002). Helicobacter pylori infection. New England Journal of Medicine, 347 (15 1175 1186.
13. Holmes, T. J., & Rainsford, K. D. (2001). Differential effects of non-genotoxic carcinogens and proliferating agents on cell growth, survival and apoptosis in hepatic cells in vitro. Life Science, 69 (25-26 2975 2992.
14. Dietrich, D. R., & Swenberg, J. A. (1991). Preneoplastic lesions in rodent kidney induced spontaneously or by non-genotoxic agents: Predictive nature and comparison to lesions induced by genotoxic carcinogens. Mutation Research, 248, 239 260.
15. U.S. Environmental Protection Agency (USEPA) 1991). Alpha2u-globulin: Association with Chemically Induced Renal Toxicity and Neoplasia in the Male Rat. USEPA Risk Assessment Forum, Washington, DC.
16. U.S. Environmental Protection Agency (USEPA) 2003). Proposed OPPTS Science Policy: PPARα-Mediated Hepatocarcinogenesis in Rodents and Relevance to Human Health Risk Assessments. USEPA Office of Prevention, Pesticides & Toxic Substances, Washington, DC.
17. Rodgers, I. S., & Baetcke, K. P. (1993). Interpretation of male rat renal tubule tumors. Environmental Health Perspective, 101 (Suppl. 6 45 52.
18. Cohen, S. M., & Ellwein L. B. (1990). Cell proliferation in carcinogenesis. Science, 249, 1007 1011.
19. Cohen, S. M., & Ellwein, L. B. (1991). Genetic errors, cell proliferation, and carcinogenesis. Cancer Research, 51, 6493 6505.
20. Melnick, R. L., Kohn, M. C., & Portier, C. J. (1996). Implications for risk assessment of suggested nongenotoxic mechanisms of chemical carcinogenesis. Environmental Health Perspectives, 104 (S1 123 134.
21. Ward, J. M., Uno, H., Kurata, Y., Weghorst, C. M., & Jang J-J. (1993). Cell proliferation not associated with carcinogenesis in rodents and humans. Environmental Health Perspectives, 101 (Suppl. 5 125 136.
22. Schulte-Hermann, R., Timmermann-Trosiener, I., & Schuppler, J. (1983) Promotion of spontaneous preneoplastic cells in rat liver as a possible explanation of tumor production by nonmutagenic compounds. Cancer Research, 43, 839 844.
23. 01 study. Toxicology and Applied Pharmacology, 104, 79 93.
24. Maeda, S., Kamata H, Luo, J.-L., Leffert, H., & Karin, M. (2005). IKKβ couples hepatocyte death to cytokine-driven compensatory proliferation that promotes chemical hepatocarcinogenesis. Cell, 121, 977 990.
25. Sakurai, T., Maeda, S., Chang, L., & Karin, M. (2006). Loss of hepatic NF-kB activity enhances chemical hepatocarcinogenesis through sustained c-Jun N-terminal kinase 1 activation. Proceedings of the National Academy of Science, 103 (28 10544 10551.
26. Naugler, W. E., Sakurai, T., Kim, S., Maeda, S., Kim, K., Elsharkawy, A. M., & Karin M. (2007). Gender disparity in liver cancer due to sex differences in MyD88-dependent IL-6 production. Science, 317 (5834 121 124.
27. Conolly, R. B., Kimbell, J. S., Janszen, D., Schlosser, P. M., Kalisak, D., Preston, J., & Miller, F. J. (2004). Human respiratory tract cancer risks of inhaled formaldehyde: Dose-response predictions derived from biologically-motivated computational modeling of a combined rodent and human dataset. Toxicological Sciences, 82 (1 279 296.
28. Ghanayem, B. I., Maronpot, R. R., & Matthews, H. B. (1986). Association of chemically induced forestomach cell proliferation and carcinogenesis. Cancer Letters, 32 (3 271 278.
29. Kligerman, A. D., Atwater, A. L., Bryant, M. F., Erexson, G. L., Kwanyuen, P., & Dearfield, K. L. (1991). Cytogenetic studies of ethyl acrylate using C57BL/6 mice. Mutagenesis, 6 (2 137 141.
30. Ciaccio, P. J., Gicquel, E., O'Neill, P. J., Scribner, H. E., & Vandenberghe, Y. L. (1998). Investigation of the positive response of ethyl acrylate in the mouse lymphoma genotoxicity assay. Toxicological Sciences, 46, 324 332.
31. Hengstler, J. G., Bogdanffy, M. S., Bolt, H. M., & Oesch F. (2003). Challenging dogma: Thresholds for genotoxic carcinogens? The case of vinyl acetate. Annual Review of Pharmacology and Toxicology, 43, 485 520.
32. Bucher, J. R., Huff, J. E., Jokinen, M. P., Haseman, J. K., Stedham, M., & Cholakis, J. M. (1991). Inhalation of tetranitromethane causes nasal passage irritation and pulmonary carcinogenesis in rodents. Cancer Letters, 57, 95 101.
33. Murata, M., Kurimoto, S., & Kawanishi, S. (2006). Tyrosine-dependent oxidative DNA damage induced by carcinogenic tetranitromethane. Chemical Research in Toxicology, 19 (10 1379 1385.
34. Tarín, J. J., Vendrell, F. J., Ten, J., Blanes, R., van Blerkom, J., & Cano, A. (1996). The oxidizing agent tertiary butyl hydroperoxide induces disturbances in spindle organization, c-meiosis, and aneuploidy in mouse oocytes. Molecular Human Reproduction, 2 (12 895 901.
35. Armstrong, M. J., Gara, J. P., Gealy, R. III., Greenwood, S. K., Hilliard, C. A., Laws, G. M., & Galloway, S. M. (2000). Induction of chromosome aberrations in vitro by phenolphthalein: Mechanistic studies. Mutation Research, 457 (1-2 15 30.
36. Sanchez-Perez, Y., Carrasco-Legleu, C., Garcia-Cuellar, C., Perez-Carreon, J., Hernandez-Garcia, S., Salcido-Neyoy, M., Aleman-Lazarini, L., & Villa-Trevino, S. (2005). Oxidative stress in carcinogenesis. Correlation between lipid peroxidation and induction of preneoplastic lesions in rat hepatocarcinogenesis. Cancer Letters, 217 (1 25 32.
37. D'Angiolella, V., Santarpia, C., & Grieco, D. (2007). Oxidative stress overrides the spindle checkpoint. Cell Cycle, 6 (5 576 579.
38. U.S. Environmental Protection Agency (USEPA) 2002). A Review of the Reference Dose and Reference Concentration Processes. EPA/630/P-02/002F. USEPA Risk Assessment Forum, Washington, DC.
39. U.S. Environmental Protection Agency (USEPA) 1998). Toxicological Review of Naphthalene (CAS No. 91-20-3) in Support of Summary Information on the Integrated Risk Information System (IRIS). US EPA Office of Research and Development, Washington, DC.
40. U.S. Environmental Protection Agency (USEPA) 1998). Toxicological Review of Naphthalene (CAS No. 91-20-3) in Support of Summary Information on the Integrated Risk Information System (IRIS). USEPA Office of Research and Development, Washington, DC.
41. Wolfram, S. (1999). The Mathematica Book, 4th ed. Cambridge, UK : Cambridge University Press.
42. Kup, W. (1978 Work-related origin of cancer in the nose, mouth, throat, and larynx Akademic der Wissenschaft, 2, 20 25 (original in German, cited in Reference 47 (below) and abstracted in Carcinogenesis Abstracts).
43. Wolf, O. (1976). Krebserkrankungen bei Chemiearbeitern einer ehemaligen Naphthalinreinigung. [Cancer diseases in chemical workers in a former naphthalene cleaning plant.] Deutsches Gesundheitswesen., 31, 996 999.
44. Wolf, O. (1978). Larynxcarzinome bei Naphthalinreini gern [Carcinoma of the larynx in workers engaged in the purification of naphthalene]. Zeitschrift für des gesamte Hygiene und ihre. Grenzgebiete, 24 (10 737 739.
45. Ajao, O. G., Adenuga, M. O., & Ladipo, J. K. (1988). Colorectal carcinoma in patients under the age of 30 years: A review of 11 cases. Journal of the Royal College of Surgeons of Edinburgh, 33, 277 279.
46. International Agency for Research on Cancer (IARC) 2002). Traditional Herbal Medicines, Some Mycotoxins, Naphthalene and Styrene. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 82. Lyon, France : World Health Organization, IARC.
47. National Toxicology Program (NTP) 1992). Toxicology and Carcinogenesis Studies of Naphthalene in B6C3F1 Mice (Inhalation Studies). Technical Report Series No. 410. NTP, Research Triangle Park, NC.
48. National Toxicology Program (NTP) 2000). Toxicology and Carcinogenesis Studies of Naphthalene (CAS No. 91-20-3) in F344/N Rats (Inhalation Studies). Technical Report Series No. 500. NTP, Research Triangle Park, NC.
49. Abdo, K. M., Eustis, S. L., McDonald, M., Jokinen, M. P., Adkins, B. Jr., & Haseman, J. K. (1992). Naphthalene: A respiratory tract toxicant and carcinogen for mice. Inhalation Toxicology, 4, 393 409.
50. National Toxicology Program (NTP) 2002). Report on Carcinogens Background Document for Naphthalene. NTP, Research Triangle Park, NC. Available at http://ntp-server.niehs.nih.gov/newhomeroc/roc11/NaphthalenePub.pdf.
51. Adkins, K. M., Van Stee, E. W., Simmons, J. E., & Eustis, S. L. (1986). Oncogenic response of strain A/J mice to inhaled chemicals. Journal of Toxicology and Environmental Health, 17, 311 322.
52. Abdo, K. M., Grumbein, S., Chou, B. J., & Herbert R. (2001). F344 rats following 2 years of whole-body exposure to naphthalene vapors. Inhalation Toxicology, 13, 931 950.
53. Long, P. H., Herbert, R. A., Peckham, J. C., Grumbein, S. L., Shackelford, C. C., & Adbo K. (2003). Morphology of nasal lesions in F344/N rats following chronic inhalation exposure to naphthalene vapors. Toxicologic Pathology, 31, 655 664.
54. Mahvi, D., Bank, H., & Harley, R. (1977). Morphology of naphthalene-induced bronchiolar lesion. American Journal of Pathology, 86, 559 566.
55. Tong, S. S., Hirokata, Y., Trush, M. A., Mimnaugh, E. G., Ginsburg, E., Lowe, M. C., & Gram, T. E. (1981). Clara cell damage and inhibition of pulmonary mixed-function oxidase activity by naphthalene. Biochemical and Biophysical Research Communications, 100 (3 944 950.
56. West, J. A., Pakehham, G., Morin, D., Fleschner, C. A., Buckpitt, A. R., & Plopper, C. G 2001). Inhaled naphthalene causes dose dependent Clara cell cytotoxicity in mice but not in rats. Toxicology and Applied Pharmacology, 173 (2 114 119.
57. Farber, E. (1984). The multistep nature of cancer development. Cancer Research, 44, 4217 4223.
58. Farber, E., & Cameron, R 1984). The sequential analysis of cancer development. Advances in Cancer Research, 31, 125 226.
59. Pitot, H. C., Hikita, H., Dragan, Y., Sargent, L., & Haas, M. (2000). The stages of gastrointestinal carcinogenesis - Application of rodent models to human disease. Alimentary Pharmacology & Therapeutics, 14 (Suppl. 1 153 160.
60. Buckpitt, A. R., & Franklin, R. B. (1989). Relationship of naphthalene and 2-methylnaphthalene metabolism to pulmonary bronchiolar epithelial cell necrosis. Pharmacology and Therapeutics, 41 (1-2 393 410.
61. Buckpitt, A., Boland, B., Isbell, M., Shultz, M., Baldwin, R., Chan, K., Karlsson, A., Lin, C., Taff, A., West, J., Fanucchi, M., Winkle, L. Van, & Plopper, C. (2002). Naphthalene-induced respiratory tract toxicity: Metabolic mechanisms of toxicity. Drug Metabolism Reviews, 34 (4 791 820.
62. Waidyanatha, S., Troester, M. A., Lindstrom, A. B., & Rappaport, S. M. (2002). Measurement of hemoglobin and albumin adducts of naphthalene-1,2- oxide, 1,2-naphthoquinone and 1,4-naphthoquinone after administration of naphthalene to F344 rats. Chemico-Biological Interactions, 141, 189 210.
63. Agency for Toxicological Substance Disease Registry (ATSDR) 2005). Toxicological Profile for Naphthalene, 1-Methylnaphthalene, and 2-Methylnaphthalene. August (2005). U.S. Department of Health and Human Services, Public Health Service, ATSDR, Atlanta, GA.
64. O'Brien, K. A. F., Smith, L. L., & Cohen, G. M. (1985). Differences in naphthalene-induced toxicity in the mouse and rat. Chemico-Biological Interactions, 55, 109 122.
65. Buckpitt, A. R., & Bahnson, L. S. (1986). Naphthalene metabolism by human lung microsomal enzymes. Toxicology, 41, 331 341.
66. Buckpitt, A., Buonarati, M., Avey, L. B., Chang, A. M., Morin, D., & Plopper, C. G 1992). Relationship of cytochrome P-450 activity to Clara cell cytotoxicity. II. Comparison of stereoselectivity of naphthalene epoxidation in lung and nasal mucosa of mouse, hamster, rat, and rhesus monkey. Journal of Pharmacology and Experimental Therapeutics, 261 (1 364 372.
67. Buckpitt, A., Chang, A. M., Weir, A., Winkle, L. Van, Duan, X., Philpot, R., & Plopper, C. (1995). Relationship of cytochrome P-450 activity to Clara cell cytotoxicity. IV. Metabolism of naphthalene and naphthalene oxide in microdissected airways from mice, rats, and hamsters. Molecular Pharmacology, 47 (1 74 81.
68. Baldwin, R. M., Jewell, W. T., Fanucchi, M. V., Plopper, C. G., & Buckpitt, A. R 2004). Comparison of pulmonary/nasal CYP2F expression levels in rodents and rhesus macaque. Journal of Pharmacology and Experimental Therapeutics, 309, 127 136.
69. Boland, B., Lin, C. Y., Morin, D., Miller, L., Plopper, C., & Buckpitt, A. (2004). Site-specific metabolism of naphthalene and 1-nitronaphthalene in dissected airways of rhesus macaques. Journal of Pharmacology and Experimental Therapeutics, 310 (2 546 554.
70. Thornton-Manning, J. R., & Dahl, A. R. (1997). Metabolic capacity of nasal tissue - Interspecies comparisons of xenobiotic-metabolizing enzymes. Mutation Research, 380, 43 59.
71. Buckpitt, A. R., & Warren, D. L. (1983). Evidence for hepatic formation, export and covalent binding of reactive naphthalene metabolites in extrahepatic tissues in vivo. Journal of Pharmacology and Experimental Therapeutics, 225, 8 16.
72. O'Brien, K. A., Suverkropp, C., Kanekal, S., Plopper, C. G., & Buckpitt, A. R. (1989). Tolerance to multiple doses of the pulmonary toxicant, naphthalene. Toxicology and Applied Pharmacology, 99 (3 487 500.
73. Plopper, C. G., Suverkropp, C., Morin, D., Nishio, S., & Buckpitt, A. (1992). Relationship of cytochrome P-450 activity to Clara cell cytotoxicity. I. Histopathologic comparison of the respiratory tract in mice, rats and hamsters after parenteral administration of naphthalene. Journal of Pharmacology and Experimental Therapeutics, 261 (1 353 363.
74. Warren, D. L., Brown, D. L., & Buckpit, A. R. (1982). Evidence for cytochrome P-450 mediated metabolism in the bronchiolar damage by naphthalene. Chemico-Biological Interactions, 40, 287 303.
75. West, J. A., Buckpitt, A. R., & Plopper, C. G. (2000). Elevated airway GSH resynthesis confers protection to Clara cells from naphthalene injury in mice made tolerant by repeated exposures. Journal of Pharmacology and Experimental Therapeutics, 294 (2 516 523.
76. West, J. A. A., Chichester, C. H., Buckpitt, A. R., Tykler, N. K., Brennan, P., Helton, C., & Plopper, C. G. (2000). Heterogeneity of Clara cell glutathione: A possible basis for differences in cellular responses to pulmonary cytotoxicants. American Journal of Respiratory Cell and Molecular Biology, 23, 27 36.
77. West, J. A. A., Van Winkle, L. S., Morin, D., Fleschner, C. A., Forman, H. J., & Plopper, C. G. (2003). Repeated inhalation exposures to the bioactivated cytotoxicant naphthalene (NA) produce airway-specific Clara cell tolerance in mice. Toxicological Sciences, 75, 161 168.
78. Plopper, C. G., Van Winkle, L. S., Fanucchi, M. V., Malburg, S. R. C., Nishio, S. J., Chang, A., & Buckpitt, A. R. (2001). Early events in naphthalene-induced acute Clara cell toxicity: 11. Comparison of glutathione depletion and histopathology by airway location. American Journal of Respiratory Cell and Molecular Biology, 24, 272 281.
79. Phimister, A. J., Lee, M. G., Morin, D., Buckpitt, A. R., & Plopper, C. G. (2004). Glutathione depletion is a major determinant of inhaled respiratory toxicity and naphthalene metabolism. Toxicological Sciences, 82, 268 278.
80. Duan, X., Plopper, C., Brennan, P., & Buckpitt, A. (1996). Rates of glutathione synthesis in lung subcompartments of mice and monkeys: Possible role in species and site selective injury. Journal of Pharmacology and Experimental Therapeutics, 277, 1402 1409.
81. Phimister, A. J., Williams, K. J., Van Winkle, L. S., & Plopper, C. G. (2005). Consequences of abrupt glutathione depletion in murine Clara cells: Ultrastructural and biochemical investigations into the role of glutathione loss in naphthalene cytotoxicity. Journal of Pharmacology and Experimental Therapeutics, 314, 506 513.
82. Chichester, C. H., Buckpitt, A. R., Chang, A., & Plopper, C. G. (1993). Metabolism and cytotoxicity of naphthalene and its metabolites in isolated murine Clara cells. Molecular Pharmacology, 45, 664 672.
83. Zheng, J., Cho, M., Jones, A. D., & Hammock, B. D 1997). Evidence of quinone metabolites of naphthalene covalently bound to sulfur nucleophiles of proteins of murine Clara cells after exposure to naphthalene. Chemical Research in Toxicology, 10 (9 1008 1014.
84. Kitteringham, N. R., Davis, C., Howard, N., Pirmohamed, M., & Park, B. K 1996). Interindividual and interspecies variation in hepatic microsomal epoxide hydrolase activity: Studies with cis-stilbene oxide, carbamazepine 10,11-epoxide and naphthalene. Journal of Pharmacology and Experimental Therapeutics, 278, 1018 1027.
85. Lanza, D. L., Code, E., Crespi, C. L., Gonzalez, F. J., & Yost, G. S. (1999). Specific dehydrogenation of 3-methylindole and epoxidation of naphthalene by recombinant human CYP2F1 expressed in lymphoblastoid cells. Drug Metabolism and Disposition, 27, 798 803.
86. Raunio, H., Hakkola, J., Hukkanen, J., Lassila, A., Paivarinta, K., Pelkonen, O., Anttila, S., Piipari, R., Boobis, A., & Edwards, R. J. (1999). Expression of xenobiotic-metabolizing CYPs in human pulmonary tissue. Experimental and Toxicologic Pathology, 51, 412 417.
87. Ding, X., & Kaminsky, L. S. (2003). Human extrahepatic cytochromes P450: Function in xenobiotic metabolism and tissue-selective chemical toxicity in the respiratory and gastrointestinal tracts. Annual Review of Pharmacology and Toxicology, 43, 149 173.
88. Cho, T. M., Rose, R. L., & Hodgson, E. (2006). In vitro metabolism of naphthalene by human liver microsomal cytochrome P450 enzymes. Drug Metabolism and Disposition, 34, 176 183.
89. Schreiner, C. A. (2003). Genetic toxicity of naphthalene: A review. Journal of Toxicology and Environmental Health Part B: Critical Reviews, 6 (2 161 183.
90. Arfsten, D. P., Davenport, R., & Schaeffer, D. J. (1994). Reversion of bioluminescent bacteria (MutatoxTM) to their luminescent state upon exposure to organic compounds, munitions, and metal salts. Biomedical and Environmental Sciences, 7, 144 149.
91. Flowers-Geary, L., Bleczinski, W., Harvey, R. G., & Penning, T. M. (1996). Cytotoxicity and mutagenicity of polycyclic aromatic hydrocarbon o-quinones produced by dihydrodiol dehydrogenase. Chemico-Biological Interactions, 99, 55 72.
92. Wilson, A. S., Tingle, M. D., Kelly, M. D., & Park, B. K. (1995). Evaluation of the generation of genotoxic and cytotoxic metabolites of benzo(a)pyrene, aflatoxin B, naphthalene and tamoxifen using human liver microsomes and human lymphocytes. Human & Experimental Toxicology, 14, 507 515.
93. Wilson, A. S., Davis, C. D., Williams, D. P., Buckpitt, A. R., Pirmohamed, M., & Park, B. K. (1996). Characterization of the toxic metabolite(s) of naphthalene. Toxicology, 114, 233 242.
94. Sasaki, J. C., Arey, J., Eastmond, D. A., Parks, K. K., & Grosovsky, A. J. (1997). Genotoxicity induced in human lymphoblasts by atmospheric reaction products of naphthalene and phenanthrene. Mutation Research, 393, 23 35.
95. Yu, D., Berlin, J. A., Penning, T. M., & Field, J. (2002). Reactive oxygen species generated by PAH o-quinones cause change-in-function mutations in p53. Chemical Research in Toxicology, 15, 832 842.
96. Carrol, R. J., & Ruppert, D. (1988). Transformation and Weighting in Regression. New York : Chapman and Hall.
97. Sanderson, B. J. S., Johnson, K. J., & Henner, D. (1991). Dose-dependent cytotoxic and mutagenic effects of antineoplastic alkylating agents on human lymphoblastoid cells. Environmental and Molecular Mutagenesis, 17, 238 243.
98. Stewart, R. D. (2001). Two-lesion kinetic model of double-strand break rejoining and cell killing. Radiation Research, 156, 365 378.
99. Sweeney, L. M., Shuler, M. L., Quick, D. J., & Babish, J. G. (1996). A preliminary physiologically based pharmacokinetic model for naphthalene and naphthalene oxide in mice and rats. Annals of Biomedical Engineering, 24, 305 320.
100. Quick, D. J., & Shuler, M. L. (1999). Use of in vitro data for construction of a physiologically based pharmacokinetic model for naphthalene in rats and mice to probe species differences. Biotechnology Progress, 15 (3 540 555.
101. Ghanem, A., & Shuler, M. L. (2000). Combining cell culture analogue reactor designs and PBPK models to probe mechanisms of naphthalene toxicity. Biotechnology Progress, 16 (3 334 345.
102. Willems, B. A. T., Melnick, R. L., Kohn, M. C., & Portier, C. J. (2001). A physiologically based pharmacokinetic model for inhalation and intravenous administration of naphthalene in rats and mice. Toxicology and Applied Pharmacology, 176 (2 81 91.
103. Kohn, M. C. (1997). The importance of anatomical realism for validation of physiological models of disposition of inhaled toxicants. Toxicology and Applied Pharmacology, 147, 448 458.
104. Kohn, M. C., & Melnick, R. L. (2000). The privileged access model of 1,3-butadiene disposition. Environmental Health Perspective Supplementary, 108 (S5 911 917.
105. Andersen, M., Sarangapani, R., Gentry, R., Clewell, H., Covington, T., & Frederick, C. B. (2000). Application of a hybrid CFD-PBPK nasal dosimetry model in an inhalation risk assessment: An example with acrylic acid. Toxicological Science, 57, 312 325.
106. Frederick, C. B., Lomax, L. G., Black, K. A., Finch, L., Scribner, H. E., Kimbell, J. S., Morgan, K. T., Subramaniam, R. P., & Marshall, J. B. (2002). A hybrid computational fluid dynamics and physiologically based inhalation model for interspecies dosimetry comparisons of ester vapors. Toxicology and Applied Pharmacology, Pharmacol., 183, 23 40.
107. Sarangapani, R., Teeguarden, J. G., Cruzan, G., Clewell, H. J., & Andersen, M. E. (2002). Physiologically based pharmacokinetic modeling of styrene and styrene oxide respiratory-tract dosimetry in rodents and humans. Inhalation Toxicology, 14 (8 789 834.
108. Sweeney, L. M., Andersen, M. E., & Gargas, M. L. (2004). Ethyl acrylate risk assessment with a hybrid computational fluid dynamics and physiologically based nasal dosimetry model. Toxicology Sciences 79, 394 403.
109. Moolgavkar, S. H., & Knudson, A. G. (1981). Mutation and cancer: A model for human carcinogenesis. Journal of the National Cancer Institute, 66, 1037 1052.
110. Ames, B. N., & Gold, L. S. (1990). Chemical carcinogenesis: Too many rodent carcinogens. Proceedings of the National Academy of Science, 87, 7772 7776.
111. Ames, B. N., Shigenaga, M. K., & Gold, L. S. (1993). DNA lesions, inducible DNA repair, and cell division: Three key factors in mutagenesis and carcinogenesis. Environmental Health Perspectives, 101, 35 44.
112. Hanahan, D., & Weinberg, R. A. (2000). The hallmarks of cancer. Cell, 100, 57 70.
113. Copely, M. (2000). Background document for the session: A consultation on the proposed health effects division classification of the human carcinogenic potential of malathion. Presented by Dr. Marion Copely, Health Effects Division, Office of Pesticides, U.S. Environmental Protection Agency, to the FIFRA Scientific Advisory Panel, 16-17 August 2000 Available at http://www.epa.gov/ oscpmont/sap/meetings/2000/august/committee.pdf.
114. National Toxicology Program (NTP) 2006). NTP Historical Controls Report: All Routes and Vehicles, Rats. June 2006.
115. Trainor, K. J., Wigmore, D. J., Chrysostomou, A., Dempsey, J. L., Seshadri, R., & Morley, A. A. (1984). Mutation frequency in human lymphocytes increases with age. Mechanisms of Ageing and Development, 27, 83 86.
116. King, C. M., Gillespie, E. S., McKenna, P. G., & Barnett, Y. A. (1994). An investigation of mutation as a function of age in humans. Mutation Research, 316, 79 90.
117. Mendelsohn, M. L. (1990). The somatic mutational component of human carcinogenesis. In S. H. Moolgavkar (Ed. Scientific Issues in Quantitative Cancer Risk Assessment. Boston : Kirkhäuser.
118. Robinson, D. R., Goodall, K., Albertini, R. J., O'Neill, J. P., Finette, B., Sala-Trepat, M., Moustacchi, E., Tates, A. D., Beare, D. M., Green, M. H. L., & Cole, J. (1994). An analysis of in vivo HPRT mutant frequency in circulating T-lymphocytes in the normal human population: A comparison of four datasets. Mutation Research, 313, 227 247.
119. Monticello, T. M., Morgan, K. T., & Hurrt, M. E. (1990). Unit length as marked goblet cell hyperplasia with mucus accumulation in the airways the denominator for quantitation of cell proliferation in nasal epithelia. Toxicology Pathology, 18, 24 31.
120. Monticello, T. M., Swenberg, J. A., Gross, E. A., Leininger, J. R., Kimbell, J. S., Seilkop, S., Starr, T. B., Gibson, J. E., & Morgan, K. T. (1996). Correlation of regional and nonlinear formaldehyde-induced nasal cancer with proliferating populations of cells. Cancer Research, 56, 1012 1022.
121. Hotchkiss, J. A., Harkema, J. R., & Johnson, N. F. (1997). Kinetics of nasal epithelial cell loss and proliferation in F344 rats following a single exposure to 0.5 ppm ozone. Toxicology and Applied Pharmacology, 143, 75 82.
122. Rotstein, J., Sarma, D. S. R., & Farber, E. (1986). Sequential alterations in growth control and cell dynamics of rat hepatocytes in early precancerous steps in hepatocarcinogenesis. Cancer Research, 46, 2377 2385.
123. Dragan, Y. P., Hully, J., Crow, R., Mass, M., & Pitot, H. C. (1994). Incorporation of bromodeoxyuridine in glutathione S-transferase-positive hepatocytes during rat multistage hepatocarcinogenesis. Carcinogenesis, 15, 1939 1947.
124. Zerban, H., Radig S., Kopp-Schneider, A., & Bannasch, P. (1994). Cell proliferation and cell death (apoptosis) in hepatic preneoplasia and neoplasia are closely related to phenotypic cellular diversity and instability. Carcinogenesis, 15, 2467 2473.
125. Coste, A., Rateau, J. G., Roudot-Thoraval, F., Chapelin, C., Gilain, L., Poron, F., Peynegre, R., Bernaudin, J. F., & Escudier, E. (1996). Increased epithelial cell proliferation in nasal polyps. Archives of Otolaryngology-Head & Neck Surgery, 122 (4 432 436.
126. Ogawa, T., Tsubakihara, M., Ichikawa, M., & Kanisawa, M. (1993). An autoradiographic study of the renewal of mouse bronchial epithelium following bromobenzene exposure. Toxicology Pathology, 21 (6 547 553.
127. Mahler, J. F., Price, H. C. Jr., O'Connor, R. W., Wilson, R. E., Eldridge, S. R., Moorman, M. P., & Morgan, D. L. (1999). Characterization of hepatocellular resistance and susceptibility to styrene toxicity in B6C3F1 mice. Toxicological Sciences, 48, 123 133.
128. Forkert, P. G., Parkinson, A., Thaete, L. G., & Malkinson, A. M. (1992). Resistance of murine lung tumors to xenobiotic-induced cytotoxicity. Cancer Research, 52, 6797 6803.
129. Maung, Z. T., Hogarth, L., Reid, M. M., Proctor, S. J., Hamilton, P. J., & Hall, A. G. (1994). Raised intracellular glutathione levels correlate with in vitro resistance to cytotoxic drugs in leukaemic cells from patients with acute lymphoblastic leukemia. Leukemia, 8 (9 1487 1491.
130. Forsberg, L., de Faire, U., & Morgenstern, R. (2001). Oxidative stress, human genetic variation, and disease. Archives of Biochemistry and Biophysics, 389 (1 84 93.
131. Zheng, Q. (1995). On the MVK stochastic carcinogenesis model with Erlang distributed cell life lengths. Risk Analysis, 15, 495 502.
132. Heidenreich, W. F., Luebeck, E. G., & Moolgavkar, S. H. (1997). Some properties of the hazard function of the two-mutation clonal expansion model. Risk Analysis, 17, 391 399.
133. Bogen, K. T., Benson, J. M., Yost, G. S., Morris, J. B., Dahl, A. R., Clewell, H. J., Krishnan, K., & Omiecinski, C. J. (2008). Naphthalene metabolism in relation to target tissue anatomy, physiology, cytotoxicity and tumorigenic mechanism of action. Regulatory Toxicology and Pharmacology in press).
134. Farooqui, M. Y. H., & Ahmed, A. E. (1984). Circadian periodicity of tissue glutathione and its relationship with lipid peroxidation in rats. Life Sciences, 34, 2413 2418.
135. Dass, P. D., Bermes, E. W. Jr., & Holmes, E. W. (1992). Renal and hepatic output of glutathione in plasma and whole blood. Biochimica et Biophysica Acta, 1156, 99 102.
136. Lohr, J. W., Willsky, G. R., & Acara, M. A. (1998). Renal drug metabolism. Pharmacology Review, 50, 107 141.
137. Lash, L. H. (2005). Role of glutathione transport processes in kidney function. Toxicology and Applied Pharmacology, 204, 329 342.
138. Estonius, M., Forsberg, L., Danilsson, O., Weinander, R., Kelner, M. J., & Morgenstern, R. (1999). Distribution of microsomal glutathione transferase 1 in mammalian tissues: A predominant alternate first exon in human tissues. European Journal of Biochemistry, 260, 409 413.