Relevance of mouse lung tumors to human risk assessment

References

• ACGIH. 2019. TLVs® and BEIs®. ACGIH. www.acgih.org.
   Google Scholar
• Aiso, S., M. Take, T. Kasai, H. Senoh, Y. Umeda, M. Matsumoto, and S. Fukushima. 2014. Inhalation carcinogenicity of dichloromethane in rats and mice. Inhal. Toxicol. 26 (8):435–51. doi:10.3109/08958378.2014.905660.
   PubMed Web of Science ®Google Scholar
• Andersen, M. E., G. Cruzan, Black, M. B. Black, S. N. Pendse, D. Dodd, J. S. Bus, S. S. Sarang, M. I. Banton, R. Waites, et al. 2017. Assessing molecular initiating events (MIEs), key events (KEs) and modulating factors (MFs) for styrene responses in mouse lungs using whole genome gene expression profiling following 1-day and multi-week exposures. Toxicology and Applied Pharmacology 335:28–40. doi:10.1016/j.taap.2017.09.015.
   PubMed Web of Science ®Google Scholar
• Andersen, M. E., G. Gruzan, M. B. Black, S. N. Pendse, D. Dodd, J. S. Bus, S. S. Sarang, M. I. Banton, R. Waites, and P. D. McMullen. 2018. Strain-related differences in mouse lung gene expression over a two-year period of inhalation exposure to styrene: Relevance to human risk assessment. Regul. Toxicol. Pharmacol. 96:153–66. doi:10.1016/j.yrtph.2018.05.011.
   PubMed Web of Science ®Google Scholar
• Andersen, M. E., M. E. Meek, G. A. Boorman, D. J. Brusick, S. M. Cohen, Y. P. Dragan, C. B. Frederick, J. I. Goodman, G. C. Hard, E. J. O’Flaherty, et al. 2000. Lessons learned in applying the U.S. EPA proposed cancer guidelines to specific compounds. Toxicol. Sci. 53 (2):159–72. doi:10.1093/toxsci/53.2.159.
   PubMed Web of Science ®Google Scholar
• Bailey, L. A., M. A. Nascarella, L. E. Kerper, and L. R. Rhomberg. 2016. Hypothesis-based weight-of-evidence evaluation and risk assessment for naphthalene carcinogenesis. Crit. Rev. Toxicol. 46 (1):1–42. doi:10.3109/10408444.2015.1061477.
   PubMed Web of Science ®Google Scholar
• Baldwin, R. M., W. T. Jewell, M. V. Fanucchi, C. G. Plopper, and A. R. Buckpitt. 2004. Comparison of pulmonary/nasal Cyp2F expression levels in rodents and rhesus macaque. J. Pharmacol. Exp. Therapeut. 309 (1):127–36. doi:10.1124/jpet.103.062901.
   PubMed Web of Science ®Google Scholar
• Banton, M. I., J. S. Bus, E. Collins, H. P. Delzell, H. P. Gelbke, J. E. Kester, M. M. Moore, R. Waites, and S. S. Sarang. 2019. Evaluation of potential health effects associated with occupational and environmental exposure to styrene - an update. J. Toxicol. Environ. Health B 22 (1–4):1–130. doi:10.1080/10937404.2019.1633718.
   PubMed Web of Science ®Google Scholar
• Bartels, M. J., M. J. Hackett, M. W. Himmelstein, J. W. Green, C. Walker, C. Terry, R. Rasoulpour, M. Challender, and Z. J. Yan. 2020. Metabolic basis for nonlinearity in 1,3-dichloropropene toxicokinetics and use in setting a kinetically-derived maximum inhalation exposure concentration in mice. Toxicol. Sci. 174 (1):16–24. doi:10.1093/toxsci/kfz241.
   PubMed Web of Science ®Google Scholar
• Barton, H. A., T. P. Pastoor, K. Baetcke, J. E. Chambers, J. Diliberto, N. G. Doerrer, J. H. Driver, C. E. Hastings, S. Iyengar, R. Krieger, et al. 2006. The acquisition and application of absorption, distribution, metabolism, and excretion (ADME) data in agricultural chemical safety assessments. Crit. Rev. Toxicol. 36 (1):9–35. doi:10.1080/10408440500534362.
   PubMed Web of Science ®Google Scholar
• Becker, R., V. Dellarco, J. Seed, J. M. Kronenberg, B. Meek, J. Foreman, C. Palermo, I. Linkov, R. Schoeny, M. Dourson, et al. 2017. Quantitative weight of evidence to assess confidence in potential modes of action. Regul. Toxicol. Pharmacol. 86:205–20. doi:10.1016/j.yrtph.2017.02.017.
   PubMed Web of Science ®Google Scholar
• Bittar, H. E. T., and S. A. Yousem. 2020. Lungs. In Histology for pathologists, ed. S. E. Mills, 469–505. Philadelphia, PA: Wolters Kluwer.
   Google Scholar
• Boffetta, P., and V. Desai. 2018. Exposure to permethrin and cancer risk: A systematic review. Crit. Rev. Toxicol. 48 (6):433–42. doi:10.1080/10408444.2018.1439449.
   PubMed Web of Science ®Google Scholar
• Boobis, A. R., S. M. Cohen, N. G. Doerrer, S. M. Galloway, P. J. Haley, G. C. Hard, F. G. Hess, J. S. MacDonald, S. Thibault, D. C. Wolf, et al. 2009. A data-based assessment of alternative strategies of identification of potential human cancer hazards. Toxicol. Pathol. 37 (6):714–32. doi:10.1177/0192623309343779.
   PubMed Web of Science ®Google Scholar
• Boobis, A. R., S. M. Cohen, V. Dellarco, D. McGregor, M. E. Meek, C. Vickers, D. Wilcocks, and W. Farland. 2006. IPCS framework for analyzing the relevance of a cancer mode of action for humans. Crit. Rev. Toxicol. 36 (10):781–92. doi:10.1080/10408440600977677.
   PubMed Web of Science ®Google Scholar
• Boogaard, P. J., K. P. de Kloe, B. A. Wong, S. C. Sumner, W. P. Watson, and N. J. van Sittert. 2000. Quantification of DNA adducts formed in liver, lungs, and isolated lung cells of rats and mice exposed to (14)C-styrene by nose-only inhalation. Toxicol. Sci. 57 (2):203–16. doi:10.1093/toxsci/57.2.203.
   PubMed Web of Science ®Google Scholar
• Buckpitt, A., A. M. Chang, A. Weit, L. van Winkle, X. Duan, R. Philpot, and C. Plopper. 1995. Relationship of cytochrome P450 activity to Clara cell cytotoxicity. IV. Metabolism of naphthalene and naphthalene oxide in microdissected airways from mice, rats, and hamsters. Mol. Pharmacol. 47 (1):74–81.
   PubMed Web of Science ®Google Scholar
• Buckpitt, A., B. Boland, M. Isbell, D. Morin, M. Shultz, R. Baldwin, K. Chan, A. Karlsson, C. Lin, A. Taff, et al. 2002. Naphthalene-induced respiratory tract toxicity: Metabolic mechanisms of toxicity. Drug Metab. Rev. 34 (4):791–820. doi:10.1081/DMR-120015694.
   PubMed Web of Science ®Google Scholar
• Burek, J. D., K. D. Nischke, T. J. Bell, D. L. Wackerle, R. C. Childs, J. E. Beyer, D. A. Dittenber, L. W. Rampy, and M. J. McKenna. 1984. Methylene chloride: A two-year inhalation toxicity and oncogenicity study in rats and hamsters. Fundam. Appl. Toxicol. 4 (1):30–47. doi:10.1016/0272-0590(84)90217-3.
   PubMedGoogle Scholar
• Bus, J. S. 2017. “The dose makes the poison”: Key implications for mode of action (mechanistic) research in a 21st century toxicology paradigm. Curr. Opin. Toxicol. 3 (Supplement c):87–91. doi:10.1016/j.cotox.2017.06.013.
   Google Scholar
• Busnach, G., P. Piselli, E. Arbustini, U. Baccarani, P. Burra, M. P. Carrieri, F. Citterio, E. De Juli, S. Bellelli, C. Pradier, et al. 2006. Immunosuppression and Cancer Study Group. Immunosuppression and cancer: A comparison of risks in recipients of organ transplants and in HIV-positive individuals. Transplant. Proc. 38 (10):3533–35. doi:10.1016/j.transproceed.2006.10.144.
   PubMed Web of Science ®Google Scholar
• Carlson, G. 2004. Influence of selected inhibitors on the metabolism of the styrene metabolite 4-vinylphenol in wild-type and Cyp2E1 knockout mice. J. Toxicol. Environ. Health Part A 67 (12):905–09. doi:10.1080/15287390490443696.
   PubMed Web of Science ®Google Scholar
• Carlson, G. P. 2012. Modification of the metabolism and toxicity of styrene and styrene oxide in hepatic cytochrome P450 reductase deficient mice and Cyp2F2 deficient mice. Toxicology 294 (2–3):104–08. doi:10.1016/j.tox.2012.02.006.
   PubMed Web of Science ®Google Scholar
• Carmichael, N. G., H. A. Barton, A. R. Boobis, R. L. Cooper, V. L. Dellarco, N. G. Doerrer, P. A. Fenner-Crisp, J. E. Doe, J. C. Lamb, and T. P. Pastoor. 2006. Agricultural chemical safety assessment: A multisector approach to the modernization of human safety requirements. Crit. Rev. Toxicol. 36 (1):1–7. doi:10.1080/10408440500534354.
   PubMed Web of Science ®Google Scholar
• Chirieac, L. R., and R. L. Attanoos. 2018. Usual lung cancers. In Pulmonary pathology, eds. D. S. Zander, and C. F. Farver, 534–51. 2nd ed. Philadelphia: Elsevier.
   Google Scholar
• Clemmesen, J., and S. Hjalgrim-Jensen. 1979. Is isonicotinic acid hydrazide (INH) carcinogenic to man? A 24-year follow-up of 3371 tuberculosis cases. Ecotoxicol. Environ. Saf. 3 (4):439–50. doi:10.1016/0147-6513(79)90033-2.
   PubMed Web of Science ®Google Scholar
• Cohen, J. T., G. Carlson, G. Charnley, D. Coggon, E. Delzell, J. D. Graham, H. Greim, D. Krewski, M. Edinsky, R. Monson, et al. 2002. A comprehensive evaluation of the potential health risks associated with occupational and environmental exposure to styrene. J. Toxicol. Environ. Health B 5 (1–2):1–265. doi:10.1080/10937400252972162.
   PubMed Web of Science ®Google Scholar
• Cohen, S. M. 2004. Human carcinogenic risk evaluation: An alternative approach to the two-year rodent bioassay. Toxicol. Sci. 80 (2):225–29. doi:10.1093/toxsci/kfh159.
   PubMed Web of Science ®Google Scholar
• Cohen, S. M., A. R. Boobis, V. L. Dellarco, J. E. Doe, P. A. Fenner-Crisp, A. Moretto, T. P. Pastoor, R. S. Schoeny, J. G. Seed, and D. C. Wolf. 2019. Chemical carcinogenicity revisited 3: Risk assessment of carcinogenic potential based on the current state of knowledge of carcinogenesis in humans. Regul. Toxicol. Pharmacol. 103:100–05. doi:10.1016/j.yrtph.2019.01.017.
   PubMed Web of Science ®Google Scholar
• Cohen, S. M., and L. B. Ellwein. 1990. Cell proliferation in carcinogenesis. Science 249 (4972):1007–11. doi:10.1126/science.2204108.
   PubMed Web of Science ®Google Scholar
• Cohen, S. M., and L. B. Ellwein. 1991. Genetic errors, cell proliferation, and carcinogenesis. Cancer Res. 51 (24):6493–505.
   PubMed Web of Science ®Google Scholar
• Collins, J. J., and E. Delzell. 2018. A systematic review of epidemiologic studies of styrene and cancer. Crit. Rev. Toxicol. 48 (6):443–70. doi:10.1080/10408444.2018.1445700.
   PubMed Web of Science ®Google Scholar
• Collins, J. J., K. M. Bodner, and J. S. Bus. 2013. Cancer mortality of workers exposed to styrene in the U.S. reinforced plastics and composite industry. Epidemiology 24 (2):195–203. doi:10.1097/EDE.0b013e318281a30f.
   PubMed Web of Science ®Google Scholar
• Cooper, R. L., J. C. Lamb, S. M. Barlow, K. Bentley, A. M. Brady, N. G. Doerrer, P. A. Fenner-Crisp, G. Eisenbrandt, R. N. Hines, L. F. Irvine, et al. 2006. A tiered approach to life stages testing for agricultural chemical safety assessment. Crit. Rev. Toxicol. 36 (1):69–98. doi:10.1080/10408440500541367.
   PubMed Web of Science ®Google Scholar
• Corton, J. C., M. L. Cunningham, B. T. Hummer, C. Lau, B. Meek, J. M. Peters, J. A. Popp, L. Rhomberg, J. Seed, and J. E. Klaunig. 2014. Mode of action framework analysis for receptor-mediated toxicity: The peroxisome proliferator-activated receptor alpha (PPAR α) as a case study. Crit. Rev. Toxicol. 44 (1):1–49. doi:10.3109/10408444.2013.835784.
   PubMed Web of Science ®Google Scholar
• Costello, H. D., and D. E. Snider. 1980. The incidence of cancer among participants in controlled, randomized isoniazid preventive therapy trial. Am. J. Epidemiol. 111 (1):67–74. doi:10.1093/oxfordjournals.aje.a112875.
   PubMed Web of Science ®Google Scholar
• Criswell, K. A., J. C. Cook, Z. Wojcinski, D. Pegg, J. Herman, D. Wesche, J. Giddings, J. T. Brady, and T. Anderson. 2012. Mode of action associated with development of hemangiosarcoma in mice given pregabalin and assessment of human relevance. Toxicol. Sci. 128 (1):57–71. doi:10.1093/toxsci/kfs149.
   PubMed Web of Science ®Google Scholar
• Cruzan, G., G. P. Carlson, K. A. Johnson, L. S. Andrews, M. I. Banton, C. Bevan, and J. R. Cushman. 2002. Styrene respiratory tract toxicity and mouse lung tumors are mediated by Cyp2F-generated metabolites. Regul. Toxicol. Pharmacol. 35 (3):308–19. doi:10.1006/rtph.2002.1545.
   PubMed Web of Science ®Google Scholar
• Cruzan, G., J. Bus, J. Hotchkiss, J. Harkema, M. Banton, and S. Sarang. 2012. Cyp2F2-generated metabolites, not styrene oxide, are a key event mediating the mode of action of styrene-induced mouse lung tumors. Regul. Toxicol. Pharmacol. 62 (1):214–20. doi:10.1016/j.yrtph.2011.10.007.
   PubMed Web of Science ®Google Scholar
• Cruzan, G., J. Bus, J. Hotchkiss, R. Sura, C. Moore, G. Yost, M. Banton, and S. Sarang. 2013. Studies of styrene, styrene oxide and 4-hydroxystyrene toxicity in Cyp2F2 knockout and Cyp2F1 humanized mice support lack of human relevance for mouse lung tumors. Regul. Toxicol. Pharmacol. 66 (1):24–29. doi:10.1016/j.yrtph.2013.02.008.
   PubMed Web of Science ®Google Scholar
• Cruzan, G., J. Bus, M. Banton, R. Gingell, and G. Carlson. 2009. Mouse lung tumors from Cyp2F2-mediated cytotoxic metabolism: An endpoint/toxic response where data from multiple chemicals converge to support a mode of action. Regul. Toxicol. Pharmacol. 55 (2):205–18. doi:10.1016/j.yrtph.2009.07.002.
   PubMed Web of Science ®Google Scholar
• Cruzan, G., J. R. Cushman, L. S. Andrews, G. C. Granville, K. A. Johnson, C. Bevan, C. J. Hardy, D. W. Coombs, P. A. Mullins, and W. R. Brown. 2001. Chronic toxicity/oncogenicity study of styrene in CD-1 mice by inhalation exposure for 104 weeks. J. Appl. Toxicol. 21 (3):185–98. doi:10.1002/jat.737.
   PubMed Web of Science ®Google Scholar
• Cruzan, G., J. R. Cushman, L. S. Andrews, G. C. Granville, K. A. Johnson, C. J. Hardy, D. W. Coombs, P. A. Mullins, and W. R. Brown. 1998. Chronic toxicity/oncogenicity stud of styrene in CD rats by inhalation exposure for 104 weeks. Toxicol. Sci. 46 (2):266–81. doi:10.1093/toxsci/46.2.266.
   PubMed Web of Science ®Google Scholar
• Cruzan, G., J. S. Bus, M. E. Andersen, G. P. Carlson, M. I. Banton, S. S. Sarang, and R. Waites. 2018. Based on an analysis of mode of action, styrene-induced mouse lung tumors are not a human cancer concern. Regul. Toxicol. Pharmacol. 95:17–28. doi:10.1016/j.yrtph.2018.02.010.
   PubMed Web of Science ®Google Scholar
• Cruzan, G., J. S. Bus, M. I. Banton, S. S. Sarang, R. Waites, D. B. Layko, J. Raymond, D. Dodd, and M. E. Andersen. 2017. Editor’s highlight: Complete attenuation of mouse lung cell proliferation and tumorigenicity in Cyp2F2 knockout and Cyp2F1 humanized mice exposed to inhaled styrene for up to 2 years supports a lack of human relevance. Toxicol. Sci. 15 (2):413–21. doi:10.1093/toxsci/kfx141.
   Google Scholar
• Dell, L. D., K. A. Mundt, M. McDonald, J. P. Tritschler, and D. J. Mundt. 1999. Critical review of the epidemiology literature on the potential cancer risks of methylene chloride. Int. Arch. Occup. Environ. Health 72 (7):429–42. doi:10.1007/s004200050396.
   PubMed Web of Science ®Google Scholar
• Dixon, D., R. A. Herbert, G. E. Kissling, A. E. Brix, R. A. Miller, and R. R. Maronpot. 2008. Summary of chemically induced pulmonary lesions in the National Toxicology Program (NTP) toxicology and carcinogenesis studies. Toxicol. Pathol. 36 (3):428–39. doi:10.1177/0192623308315360.
   PubMed Web of Science ®Google Scholar
• Doe, J. E., A. R. Boobis, A. Blacker, V. Dellarco, N. G. Doerrer, C. Franklin, J. I. Goodman, J. M. Kronenberg, R. Lewis, E. E. McConnell, et al. 2006. A tiered approach to systemic toxicity testing for agricultural chemical safety assessment. Crit. Rev. Toxicol. 36 (1):37–68. doi:10.1080/10408440500534370.
   PubMed Web of Science ®Google Scholar
• ECETOC. 1987. The assessment of carcinogenic hazard for human beings exposed to methylene chloride. Technical Report No. 26, European Chemical Industry Ecology and Toxicology Centre, Brussels, Belgium.
   Google Scholar
• ECETOC (European Chemical Industry Ecology and Toxicology Centre). 1987. The assessment of carcinogenic hazard for human beings exposed to methylene chloride. Technical Report No. 26, January 1987. Brussels, Belgium.
   Google Scholar
• ECHA. 2017. Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance. Version 3.0.
   Google Scholar
• Elcombe, C. R., R. C. Peffer, D. C. Wolf, J. Bailey, R. Bars, D. Bell, R. C. Cattley, S. S. Ferguson, D. Geter, A. Goetz, et al. 2014. Mode of action and human relevance analysis for nuclear receptor-mediated liver toxicity: A case study with phenobarbital as a model constitutive androstane receptor (CAR) activator. Crit. Rev. Toxicol. 44 (1):64–82. doi:10.3109/10408444.2013.835786.
   PubMed Web of Science ®Google Scholar
• EPA. 1997. Registration Eligibility Decision (Red). Paraquat Dichloride. EPA 738-F-96-018, August 1997.
   Google Scholar
• EPA. 2005. In ed., EPA. Cancer Assessment Review Committee Evaluation of the Carcinogenic Potential of Flonicamid (PC Code 1280126).
   Google Scholar
• EPA. 2019. 1,3-Dichloropropene: Report of the cancer assessment review committee. In ed., H.E.D. Office of Chemical Safety and Pollution Prevention. Washington, D.C.: Environmental Protection Agency.
   Google Scholar
• FDA. 2001. Guidance for industry statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals. Washington, D.C: Food and Drug Administration.
   Google Scholar
• Flieder, D. B. 2018. Benign neoplasms of the lungs. In Pulmonary pathology, ed. D. S. Zander, and C. F. Farver, 617–41. 2nd ed. Philadelphia: Elsevier.
   Google Scholar
• Foran, J. A. 1997. Principles for the selection of doses in chronic rodent bioassays, ILSI risk science working group on dose selection. Environ. Health Perspect. 105 (1):18–20. doi:10.1289/ehp.105-1469843.
   PubMed Web of Science ®Google Scholar
• Foster, J. R., T. Green, L. L. Smith, R. W. Lewis, P. M. Hext, and I. Wyatt. 1992. Methylene chloride-an inhalation study to investigate pathological and biochemical events occurring in the lungs of mice over an exposure period of 90 days. Fundam. Appl. Toxicol. 18 (3):376–88. doi:10.1016/0272-0590(92)90136-6.
   PubMedGoogle Scholar
• Foster, J. R., T. Green, L. L. Smith, S. Tittensor, and I. Wyatt. 1994. Methylene chloride: An inhalation study to investigate toxicity in the mouse lung using morphological, biochemical and Clara cell culture techniques. Toxicology 91 (3):221–34. doi:10.1016/0300-483X(94)90011-6.
   PubMed Web of Science ®Google Scholar
• Fu, L., and N. M. Kettner. 2013. The circadian clock in cancer development and therapy. Prog. Mol. Biol. Transl. Sci. 119:221–82.
   PubMed Web of Science ®Google Scholar
• Gibbs, J. E., S. Beesley, J. Plumb, D. Singh, S. Farrow, D. W. Ray, and A. S. Loudon. 2009. Circadian timing in the lung; a specific role for bronchiolar epithelial cells. Endocrinology 150 (1):268–76. doi:10.1210/en.2008-0638.
   PubMed Web of Science ®Google Scholar
• Glassroth, J. L., M. C. White, and D. E. Snider. 1977. An assessment of the possible association of isoniazid with human cancer deaths. Am. Rev. Respir. Dis. 116 (6):1065–74. doi:10.1164/arrd.1977.116.6.1065.
   PubMedGoogle Scholar
• Gocke, E., and L. Muller. 2009. In vivo studies in the mouse to define a threshold for the genotoxicity of EMS and ENU. Mutat. Res. 678 (2):101–07. doi:10.1016/j.mrgentox.2009.04.005.
   PubMed Web of Science ®Google Scholar
• Golden, R., J. Bus, and E. Calabrese. 2019. An examination of the linear no-threshold hypothesis of cancer risk assessment: Introduction to a series of reviews documenting the lack of biological plausibility of LNT. Chem-Biol. Interact. 301:2–5. doi:10.1016/j.cbi.2019.01.038.
   PubMed Web of Science ®Google Scholar
• Gollapudi, B. B. 2017. An ongoing journey toward a risk-based testing in genetic toxicology. Curr. Opin. Toxicol. 3:71–74. doi:10.1016/j.cotox.2017.06.012.
   Google Scholar
• Gooderham, N. J., S. M. Cohen, G. Eisenbrand, S. Fukushima, F. P. Guengerich, S. S. Hecht, I. M. C. M. Rietjens, T. J. Rosol, M. Bastaki, M. J. Linman, et al. 2020. The safety evaluation of food flavoring substances: The role of genotoxicity studies. Crit. Rev. Toxicol. 50 (1):1–17. doi:10.1080/10408444.2020.1712589.
   PubMed Web of Science ®Google Scholar
• Green, T. 1997. Methylene chloride induced mouse liver and lung tumours: An overview of the role of mechanistic studies in human safety assessment. Human Exp. Toxicol. 16 (1):3–13. doi:10.1177/0960327197016001021.
   PubMed Web of Science ®Google Scholar
• Green, T., W. M. Provan, D. C. Collinge, and A. E. Guest. 1988. Macromolecular interactions of inhaled methylene chloride in rats and mice. Toxicol. Appl. Pharmacol. 93 (1):1–10. doi:10.1016/0041-008X(88)90020-8.
   PubMed Web of Science ®Google Scholar
• Grulich, A. E., M. T. van Leeuwen, M. O. Falster, and C. M. Vajdic. 2007. Incidence of cancers in people with HIV/AIDS compared with immunosuppressed transplant recipients: A meta-analysis. Lancet 370 (9581):59–67. doi:10.1016/S0140-6736(07)61050-2.
   PubMed Web of Science ®Google Scholar
• Haseman, J. K. 1983. A reexamination of false-positive rates for carcinogenesis studies. Fundam. Appl. Toxicol. 3 (4):334–39. doi:10.1016/S0272-0590(83)80148-1.
   PubMedGoogle Scholar
• Haseman, J. K. 2013. Evaluating consistency in the interpretation of NTP rodent cancer bioassays: An examination of moue lung tumor effects in the 4-MEI study. Regul. Toxicol. Pharmacol. 66 (1):109–15. doi:10.1016/j.yrtph.2013.03.009.
   PubMed Web of Science ®Google Scholar
• Heflich, R. H., G. E. Johnson, A. Zeller, F. Marchetti, G. R. Douglas, K. L. Witt, B. B. Gollapudi, and P. A. White. 2020. Mutation as a toxicological endpoint for regulatory decision-making. Environ. Mol. Mutagen. 61 (1):34–41. doi:10.1002/em.22338.
   PubMed Web of Science ®Google Scholar
• Hill, T., and R. B. Conolly. 2019. Development of a novel AOP for Cyp2F2-mediated lung cancer in mice. Toxicol. Sci. 172 (1):1–10. doi:10.1093/toxsci/kfz185.
   PubMed Web of Science ®Google Scholar
• Howe, G. R., J. Lindsay, E. Coppock, and A. B. Miller. 1979. Isoniazid exposure in relation to cancer incidence and mortality in a cohort of tuberculosis patients. Int. J. Epidemiol. 8 (4):305–12. doi:10.1093/ije/8.4.305.
   PubMed Web of Science ®Google Scholar
• IARC. 1974. Isonicotinic acid hydrazide. In IARC monographs on the evaluation of carcinogenic risks to humans. Some aromatic amines, hydrazine and related substances, N-Nitrosos compounds and miscellaneous alkylating agents, Vol. 4, pp. 159–712. Lyon, France: IARC.
   Google Scholar
• IARC. 1987. Isoniconic acid hydrazide. In IARC monographs on the evaluation of carcinogenic risks to humans. Supplement 7. Overall evaluation of carcinogenicity: An updating of IARC monographs, Vols. 1-42. Lyon, France: IARC.
   Google Scholar
• IARC. 2019. Isonicotinic acid hydrazide. In IARC monographs on the evaluation of carcinogenic risks to humans. Supplement 7. Overall evaluation of carcinogenicity: An updating of IARC monographs, Vols. 1-42. Lyon, France: IARC.
   Google Scholar
• IPCS (International Programme on Chemical Safety). 1984. Environmental health criteria 39. Paraquat and diquat. Geneva, Switzerland: World Health Organization.
   Google Scholar
• Jarabek, A. M., L. H. Pottenger, L. S. Andrews, D. Casciano, M. R. Embry, J. H. Kim, R. J. Preston, M. V. Reddy, R. Schoeny, D. Shuker, et al. 2009. Creating context for the use of DNA adduct data in cancer risk assessment. I. Data organization. Crit. Rev. Toxicol. 39 (8):659–78. doi:10.1080/10408440903164155.
   PubMed Web of Science ®Google Scholar
• Kawamoto, K., K. Ogata, H. Asano, K. Miyata, T. Sukata, T. Utsumi, S. M. Cohen, and T. Yamada. 2020. Cell proliferation analysis is a reliable predictor of lack of carcinogenicity: Case study using the pyrethroid imiprothrin on lung tumorigenesis in mice. Regul. Toxicol. Pharmacol. 113:104646. doi:10.1016/j.yrtph.2020.104646.
   PubMed Web of Science ®Google Scholar
• Kerr, K. M., and W. K. Funkhouse. 2018. Precursors of malignancy. In Pulmonary pathology, ed. D. S. Zander, and C. F. Farver, 598–616. 2nd ed. Philadelphia: Elsevier.
   Google Scholar
• Kim, H. P., S. W. Ryter, and A. M. Choi. 2006. Molecular components of the mammalian circadian clock. Hum Mol Genet. 46:411–449.
   Google Scholar
• Klapacz, J., and B. B. Gollapudi. 2020. Considerations for the use of mutation as a regulatory endpoint in risk assessment. Environ. Mol. Mutagen. 61 (1):84–93. doi:10.1002/em.22318.
   PubMed Web of Science ®Google Scholar
• Kondo, M., K. Miyata, H. Nagahori, K. Sumida, T. G. Osimitz, S. M. Cohen, B. G. Lake, and T. Yamada. 2019. Involvement of peroxisome proliferator-activated receptor-alpha in liver tumor production by permethrin in the female mouse. Toxicol. Sci. 168 (2):572–96. doi:10.1093/toxsci/kfz012.
   PubMed Web of Science ®Google Scholar
• Kovalchuk, N., Q. Y. Zhang, J. Kelty, L. van Winkle, and X. Ding. 2019. Toxicokinetic interaction between hepatic disposition and pulmonary bioactivation of inhaled naphthalene studied using Cyp2abfgs -null and CYP2A13/2F1-humanized mice with deficient hepatic cytochrome P450 activity. Drug Metab. Dispos. 47 (12):1469–78. doi:10.1124/dmd.119.088930.
   PubMed Web of Science ®Google Scholar
• Krynitz, B., G. Edgren, B. Lindelof, E. Baecklund, C. Brattstrom, H. Wilczek, and K. E. Smedby. 2013. Risk of skin cancer and other malignancies in kidney, liver, heart and lung transplant recipients 1970-2008-a Swedish population-based study. Int. J. Cancer 132 (6):1429–38. doi:10.1002/ijc.27765.
   PubMed Web of Science ®Google Scholar
• Lantuejoul, S., and E. Brambilla. 2018. Neuroendocrine neoplasms. In Pulmonary pathology, ed. D. S. Zander, and C. F. Farver, 552–66. 2nd ed. Philadelphia: Elsevier.
   Google Scholar
• Lewis, D. F. V., Y. Ito, and B. G. Lake. 2009. Molecular modelling of Cyp2F substrates: Comparison of naphthalene metabolism by human, rat and mouse Cyp2F subfamily enzymes. Drug Metab. Drug Interact. 20:229–57.
   Google Scholar
• Li, L., S. Carratt, M. Hartog, N. Kovalchuk, K. Jia, Y. Wang, Q. Y. Zhang, P. Edwards, L. V. Winkle, and X. Ding. 2017. Human Cyp2A13 and Cyp2F1 mediated naphthalene toxicity in the lung and nasal mucosa of Cyp2A13/2F1-humanized mice. Environ. Health Perspect. 125 (6):067004. doi:10.1289/EHP844.
   PubMed Web of Science ®Google Scholar
• Li, L., Y. Wei, L. van Winkle, Q. Y. Zhang, X. Zhou, J. Hu, F. Xie, K. Kluetzman, and X. Ding. 2011. Generation and characterization of a Cyp2f2 -null mouse and studies on the role of CYP2F2 in naphthalene-induced toxicity in the lung and nasal olfactory mucosa. J. Pharmacol. Exp. Ther. 339 (1):62–71. doi:10.1124/jpet.111.184671.
   PubMed Web of Science ®Google Scholar
• Manenti, G., F. Galbiati, S. Noci, and T. A. Dragani. 2003. Outbred CD-1 mice carry the susceptibility allele at the pulmonary adenoma susceptibility 1 (Pas1) locus. Carcinogenesis 24 (6):1143–48. doi:10.1093/carcin/bgg065.
   PubMed Web of Science ®Google Scholar
• Marty, M. S., B. H. Neal, C. L. Zablotney, B. L. Yano, A. K. Andrus, M. R. Woolhiser, D. R. Boverhof, S. A. Saghir, A. W. Perala, J. K. Passage, et al. 2013. An F1-extended one-generation reproductive toxicity study in Crl: CD(SD)rats with 2,4-dichlorophenoxyacetic acid. Toxicol. Sci. 136 (2):527–47. doi:10.1093/toxsci/kft213.
   PubMed Web of Science ®Google Scholar
• Meek, M. E., J. R. Bucher, S. M. Cohen, V. Dellarco, R. N. Hill, L. D. Lehman-McKeeman, D. G. Longfellow, T. Pastoor, J. Seed, and D. E. Patton. 2003. A frame work for human relevance analysis of information on carcinogenic modes of action. Crit. Rev. Toxicol. 33 (6):591–653. doi:10.1080/713608373.
   PubMed Web of Science ®Google Scholar
• Murer, B. U., Gruber-Mosenbacher, and H. H. Popper. 2018. Unusual primary malignant lung neoplasms. In Pulmonary pathology, ed. D. S. Zander, and C. F. Farver, 567–83. 2nd ed. Philadelphia: Elsevier.
   Google Scholar
• NCI. 1979. Bioassay of styrene for possible carcinogenicity. NCI Technical Report 185, Bethesda, MD.
   Google Scholar
• Nikitin, A. Y., A. Alcaraz, M. R. Anver, R. T. Bronson, R. D. Cardiff, D. Dixon, A. E. Fraire, E. W. Gabrielson, W. T. Gunning, D. C. Haines, et al. 2004. Classification of proliferative pulmonary lesions of the mouse: Recommendations of the mouse models of human cancers consortium. Cancer Res. 64 (7):2307–16. doi:10.1158/0008-5472.CAN-03-3376.
   PubMed Web of Science ®Google Scholar
• North, D. W., K. M. Abdo, J. M. Benson, A. R. Dahl, J. B. Morris, R. Renne, and H. Witschi. 2008. A review of whole animal bioassays of the carcinogenic potential of naphthalene. Regul. Toxicol. Pharmacol. 51 (2 Suppl):S6–S14. doi:10.1016/j.yrtph.2007.09.022.
   PubMed Web of Science ®Google Scholar
• NRC. 2014. Review of the styrene assessment in the National Toxicology Program 12th Report on Carcinogens.
   Google Scholar
• NTP. 1986. NTP technical report on toxicology and carcinogenesis studies of CI disperse blue 1 in F344/N rats and B6C3F1 mice. NIH Publication #86-2555.
   Google Scholar
• NTP. 2011. Report on carcinogens: Styrene. Twelfth edition. U.S. Department of Health and Human Services Public Health Service National Toxicology Program.
   Google Scholar
• OECD. 2010. OECD Guidance Document 116 on the design and conduct of chronic toxicity and carcinogenicity studies, supporting TG 451, 452, and 453, Section 4: Statistical and dose response analysis, including benchmark dose and linear extrapolation, NOAELS and NOELS, LOAELS and LOELS.
   Google Scholar
• OECD. 2011. OECD guideline for the testing of chemicals. Extended One-gener Reprod. Toxic. Study 443.
   Google Scholar
• OECD. 2012. OECD guidance document 116 on the conduct and design of chronic toxicity and carcinogenicity studies, supporting test guidelines. 451, 452, 453.
   Google Scholar
• Oesch, F., E. Fabian, and R. Landsiedel. 2019. Xenobiotica-metabolizing enzymes in the lung of experimental animals, man and in human lung models. Arch. Toxicol. 93:3419–89.
   PubMed Web of Science ®Google Scholar
• Pandiri, A. 2015. Comparative pathobiology of environmentally induced lung cancers in humans and rodents. Toxicol. Pathol. 43 (1):107–14. doi:10.1177/0192623314556516.
   PubMed Web of Science ®Google Scholar
• Pandiri, A. R., R. C. Sills, V. Ziglioli, T. V. Ton, H. H. Hong, S. A. Lahousse, K. E. Gerrish, S. S. Auerbach, K. R. Shockley, P. R. Bushel, et al. 2012. Differential transcriptomic analysis of spontaneous lung tumors in B6C3F1 mice: Comparison to human non-small cell lung cancer. Toxicol. Pathol. 40 (8):1141–59. doi:10.1177/0192623312447543.
   PubMed Web of Science ®Google Scholar
• Papagiannakopoulos, T., M. R. Bauer, S. M. Davidson, M. Heimann, L. Subbaraj, A. Bhutkar, J. Bartlebaugh, M. G. Vander Heiden, and T. Jacks. 2016. Circadian rhythm disruption promotes lung tumorigenesis. Cell Metab. 24 (2):324–31. doi:10.1016/j.cmet.2016.07.001.
   PubMed Web of Science ®Google Scholar
• Penn, I. 1988. Tumors of the immunocompromised patient. Ann. Rev. Med. 39:63–73. doi:10.1146/annurev.me.39.020188.000431.
   PubMed Web of Science ®Google Scholar
• Pottenger, L. H., and B. B. Gollapudi. 2009. A case for a new paradigm in genetic toxicology testing. Mutat. Res. 678 (2):148–1451. doi:10.1016/j.mrgentox.2009.07.003.
   PubMed Web of Science ®Google Scholar
• Pottenger, L. H., G. Boysen, K. Brown, J. Cadet, R. P. Fuchs, G. E. Johnson, and J. A. Swenberg. 2019. Understanding the importance of low-molecular weight (ethylene oxide-and propylene oxide-induced) DNA adducts and mutations in risk assessment: Insights from 15 years of research and collaborative discussions. Environ. Mol. Mutagen. 60 (2):100–21. doi:10.1002/em.22248.
   PubMed Web of Science ®Google Scholar
• Renne, R., A. Brix, J. Harkema, R. Herbert, B. Kittel, D. Lewis, T. March, K. Nagano, M. Pino, S. Rittinghausen, et al. 2009. Proliferative and nonproliferative lesions of the rat and mouse respiratory tract. Toxicol. Pathol. 37 (7 Suppl):5s–73s. doi:10.1177/0192623309353423.
   PubMed Web of Science ®Google Scholar
• Rusiecki, J. A., R. Patel, S. Koutros, L. Beane-Freeman, O. Landgren, M. R. Bonner, J. Coble, J. Lubin, A. Blair, J. A. Hoppin, et al. 2009. Cancer incidence among pesticide applicators exposed to permethrin in the agricultural health study. Environ. Health Perspect. 117 (4):581–86. doi:10.1289/ehp.11318.
   PubMed Web of Science ®Google Scholar
• Saghir, S. A. 2013. Life-stage-, sex-, and dose-dependent dietary toxicokinetics and relationship to toxicity of 2,4-dichlorophenoxyacetic acid (2,4-D) in rats: Implications for toxicity test dose selection, design, and interpretation. Toxicol. Sci. 136 (2):294–307. doi:10.1093/toxsci/kft212.
   PubMed Web of Science ®Google Scholar
• Saghir, S. A., M. J. Bartels, D. L. Rick, A. T. McCoy, R. J. Rasoulpour, R. G. Ellis-Hutchings, S. M. Marty, C. Terry, J. P. Bailey, R. Billington, et al. 2012. Assessment of diurnal systemic dose of agrochemicals in regulatory toxicity testing–an integrated approach without additional animal use. Regul. Toxicol. Pharmacol. 63 (2):321–32. doi:10.1016/j.yrtph.2012.03.004.
   PubMed Web of Science ®Google Scholar
• Shen, S., L. Li, X. Ding, and J. Cheng. 2014. Metabolism of styrene to styrene oxide and vinyl phenols in cytochrome P450 2F2- and P450 2E1-knockout mouse liver and lung microsomes. Chem. Res. Toxicol. 27 (1):27–33. doi:10.1021/tx400305w.
   PubMed Web of Science ®Google Scholar
• Shimkin, M. B., and G. D. Stoner. 1975. Lung tumors in mice: Application to carcinogenesis bioassay. Adv. Cancer Res. 21:1–58.
   Google Scholar
• Shultz, M. A., P. V. Choudary, and A. R. Buckpitt. 1999. Role of murine cytochrome p-450-2f2 in metabolic activation of naphthalene and metabolism of other xenobiotics. J Pharmacol Exp Ther. 290:281–288.
   PubMed Web of Science ®Google Scholar
• Slikker, W., M. E. Andersen, M. S. Bodganffy, J. S. Bus, S. D. Cohen, R. B. Conolly, R. M. David, N. G. Doerrer, D. C. Dorman, D. W. Gaylor, et al. 2004b. Case studies. Toxicol. Appl. Pharmacol. 201:203–25.
   PubMed Web of Science ®Google Scholar
• Slikker, W., M. E. Andersen, M. S. Bogdanffy, J. S. Bus, S. D. Cohen, R. B. Conolly, R. M. David, N. G. Doerrer, D. C. Dorman, D. W. Gaylor, et al. 2004a. Dose-dependent transitions in mechanisms of toxicity: Case studies. Toxicol. Appl. Pharmacol. 201:226–94.
   PubMed Web of Science ®Google Scholar
• Smith, C., T. Perfetti, and J. King. 2018. Bronchioloalveolar lung tumors induced in “mice only” by non-genotoxic chemicals are not useful for quantitative assessment of pulmonary adenocarcinoma risk in humans. Toxicol. Res. Appl. 2:1–24.
   Google Scholar
• Sonich-Mullin, C., R. Fielder, J. Wiltse, K. Baetcke, J. Dempsey, P. Fenner-Crisp, D. Grant, M. Hartley, A. Knaap, D. Kroese, et al. 2001. IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis. Regul. Toxicol. Pharmacol. 34 (2):146–52. doi:10.1006/rtph.2001.1493.
   PubMed Web of Science ®Google Scholar
• Stott, W. T., B. B. Gollapudi, and K. S. Rao. 2001. Mammalian toxicity of 1,3-Dichloropropene. In Reviews of environmental contamination and toxicology: Continuation of residue reviews, ed. G. W. Ware, 1–42. New York: Springer New York.
   Google Scholar
• Strupp, C., D. A. Banas, S. M. Cohen, E. B. Gordon, M. Jaeger, and K. Weber. 2012. Relationship of metabolism and cell proliferation to the mode of action of fluensulfone-induced mouse lung tumors: Analysis of their human relevance using the IPCS framework. Toxicol. Sci. 128 (1):284–94. doi:10.1093/toxsci/kfs127.
   PubMed Web of Science ®Google Scholar
• Strupp, C., W. Bomann, S. M. Cohen, and K. Weber. 2016. Relationship of metabolism and cell proliferation to the mode of action of fluensulfone-induced mouse lung tumors. II: Additional mechanistic studies. Toxicol. Sci. 154 (2):296–308. doi:10.1093/toxsci/kfw168.
   PubMed Web of Science ®Google Scholar
• Swenberg, J. A., K. Lu, B. C. Moeller, L. Gao, P. B. Upton, J. Nakamura, and T. B. Starr. 2011. Endogenous versus exogenous DNA adducts: Their role in carcinogenesis, epidemiology, and risk assessment. Toxicol. Sci. 120 (Suppl 1):S130–S145. doi:10.1093/toxsci/kfq371.
   PubMedGoogle Scholar
• Tomenson, J. A. 2011. Update of a cohort mortality study of workers exposed to methylene chloride employed at a plant producing cellulose triacetate film base. Int. Arch. Occup. Environ. Health 84 (8):889–97. doi:10.1007/s00420-011-0621-z.
   PubMed Web of Science ®Google Scholar
• Toth, B., and P. Shubik. 1966. Carcinogenesis in Swiss mice by isonicotinic acid hydrazide. Cancer Res. 26 (7):1473–75.
   PubMedGoogle Scholar
• Toth, B., and T. Toth. 1970. Investigation on the tumor producing effect of isonicotinic acid hydrazide in ASW-Sn mice and MRC rats. Tumori 56 (6):315–24. doi:10.1177/030089167005600601.
   PubMed Web of Science ®Google Scholar
• Trueman, R. W., and J. Ashby. 1987. Lack of UDS activity in the livers of mice and rats exposed to dichloromethane. Environ. Mol. Mutagen. 10 (2):189–95. doi:10.1002/em.2850100209.
   PubMed Web of Science ®Google Scholar
• Villeneuve, P. J., and Y. Mao. 1994. Lifetime probability of developing lung cancer, by smoking status, Canada. Can. J. Public Health 85 (6):385–88.
   PubMed Web of Science ®Google Scholar
• Wei, Y., H. Wu, L. Li, Z. Liu, X. Zhou, Q. Y. Zhang, Y. Weng, J. D’Agostino, G. Ling, X. Zhang, et al. 2012. Generation and characterization of a CYP2A13/2B6/2F1 -transgenic mouse model. Drug Metab. Dispos. 40 (6):1144–50. doi:10.1124/dmd.112.044826.
   PubMed Web of Science ®Google Scholar
• Yamada, T., H. Asano, K. Miyata, L. R. Rhomberg, J. K. Haseman, P. Greaves, H. Greim, C. Berry, and S. M. Cohen. 2019. Toxicological evaluation of carcinogenicity of the pyrethroid imiprothrin in rats and mice. Regul. Toxicol. Pharmacol. 105:1–14. doi:10.1016/j.yrtph.2019.03.012.
   PubMed Web of Science ®Google Scholar
• Yamada, T., M. Kondo, K. Miyata, K. Ogata, M. Kushida, K. Sumida, S. Kawamura, T. G. Osimitz, B. G. Lake, and S. M. Cohen. 2017. An evaluation of the human relevance of the lung tumors observed in female mice treated with permethrin based on mode of action. Toxicol Sci. 157 (2):465–486.
   PubMed Web of Science ®Google Scholar