Addressing nonlinearity in the exposure-response relationship for a genotoxic carcinogen: Cancer potency estimates for ethylene oxide

Risk Analysis

Volumn 24, Issue 5, 2004, Pages 1165-1183

  Kirman, C R ^a,f   Sweeney, L M ^b   Teta, M J ^c   Sielken, R L ^d   Valdez Flores, C ^d   Albertini, R J ^e   Gargas, M L ^b  

^a The Sapphire Group Inc   (United States)

^b Sapphire Group   (United States)

^c EXPONENT INC   (United States)

^d Sielken & Associates Inc   (United States)

^e UNIVERSITY OF VERMONT   (United States)

^f NONE   (United States)

Author keywords

Cancer risk assessment; Dose response; Ethylene oxide; Leukemia

Indexed keywords

CARCINOGENS; CONCENTRATION (PROCESS); DISEASE CONTROL; DRUG DOSAGE; HEALTH CARE; HEALTH RISKS; MOLECULAR STRUCTURE; RISK ASSESSMENT; TOXICITY; TUMORS;

CANCER MORTALITY; CARCINOGENICITY; GENOTOXICITY; LEUKEMIA; MOLECULAR LEVEL;

GENES;

ETHYLENE OXIDE;

CARCINOGEN;

ARTICLE; CANCER RISK; DOSE RESPONSE; GENOTOXICITY; HUMAN; LEUKEMIA; LEUKEMOGENESIS; NONLINEAR SYSTEM; RISK ASSESSMENT;

ANIMALS; CARCINOGENS; DOSE-RESPONSE RELATIONSHIP, DRUG; ETHYLENE OXIDE; FEMALE; HUMANS; LEUKEMIA; MALE; MICE; MODELS, BIOLOGICAL; MUTAGENS; NEOPLASMS; NONLINEAR DYNAMICS; RATS; RISK ASSESSMENT;

EID: 8844224127     PISSN: 02724332     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.0272-4332.2004.00517.x     Document Type: Article

References (78)

1. Abrahams, R. H. (1980). Recent studies with workers exposed to ethylene oxide. In J. F. Jorkasky (Ed.), Safe Use of Ethylene Oxide. Proceedings of the Educational Seminar. Washington, DC: Health Industries Manufacturers Association.
2. Caldwell, D. J. (1999). Review of mononuclear cell leukemia in F-344 rat bioassays and its significance to human cancer risk: A case study using alkyl phthalates. Regulatory Toxicology and Pharmacology, 30, 45-53.
3. CALEPA. (2002). Technical support document for describing available cancer potency factors. In Air Toxics Hot Spots Program Risk Assessment Guidelines. Part II, California Environmental Protection Agency.
4. Csanady, G. A., Denk, B., Putz, C., Kreuzer, P. E., Kessler, W., Baur, C., Gargas, M. L., & Filser, J. G. (2000). A physiological toxicokinetic model for exogenous and endogenous ethylene and ethylene oxide in rat, mouse, and human: Formation of 2-hydroxyethyl adducts with hemoglobin and DNA. Toxicology and Applied Pharmacology, 165(1), 1-26.
5. Embree, J. W., & Hine, C. H. (1975). Mutagenicity of ethylene oxide. Toxicology and Applied Pharmacology, 33, 172-173.
6. Faderl, S., Talpaz, M., Estrov, Z., Öbrien, S., Kurzrock, R., & Kantarjian, H. (1999). The biology of chronic myeloid leukemia. New England Journal of Medicine, 341(3), 164-172.
7. Fennell, T. R., & Brown, C. D. (2001). A physiologically based pharmacokinetic model for ethylene oxide in mouse, rat, and human. Toxicology and Applied Pharmacology, 173(3), 161-175.
8. French, J. E., & Dieter, M. P. (1983). Journal of Cell Biochemistry (Suppl 7B), 47.
9. Furmanski, P., & Rich, M. A. (1987). Neoplasms of the hematopoietic system. In J. D. Foster et al. (Eds.), The Mousein Biomedical Research (pp. 351-371). New York: Academic Press.
10. Generoso, W. M., Cain, K. T, Cornett, C. V., Cacheiro, N. L., & Hughes, L. A. (1990). Concentration-response curves for ethylene-oxide-induced heritable translocations and dominant lethal mutations. Environmental and Molecular Mutagenesis, 16(2), 126-31.
11. Greaves, M. (2003). Biological models for leukaemia and lymphoma. In IARC Workshop on Mechanistic Considerations in the Design and Interpretation of Molecular Epidemiologic Studies of Cancer.
12. Greife, A. L., Hornung, R. W., Slayner, L. G., & Steenland, K. N. (1988). Development of a model for use in estimating exposure to ethylene oxide in a retrospective cohort mortality study. Scandinavian Journal of Work Environment and Health, 14, 29-30.
13. Health Canada. (1999). Priority substance list assessment report: Etylene oxide. In Draft for Public Comments. Environment Canada.
14. Hogstedt, C., Rohlen, O., Berndtsson, B. S., Axelson, O., & Ehrenberg, L. (1979). A cohort study of mortality and cancer incidence in ethylene oxide production workers. British Journal of Industrial Medicne, 36, 276-280.
15. Hornung, R. W., Greife, A. L., Slayner, L. T., Steenland, N. K., Herrick, R. F., Elliott, L. J., Ringenburg, V. L., & Morawetz, J. (1994). Statistical model for prediction of retrospective exposure to ethylene oxide in an occupational mortality study. American Journal of Industrial Medicine, 25, 825-836.
16. Huebner, K., Isobe, M., Croce, C., Golde, D., Kaufman, S., & Gasson, J. (1985). The human gene encoding GM-CSF is at 5q21-q32, the chromosome region deleted in the 5q-anomaly. Science, 230, 1282-1285.
17. IRIS. (2002). Integrated Risk Information System, Online Database. Washington, DC: U.S. Environmental Protection Agency.
18. Kantarjian, H. M., & Keating, M. J. (1987). Therapy-related leukemia and myelodysplastic syndrome. Cancer, 40, 435-443.
19. Karelova, J., Jablonicka, A., & Vargova, M. (1987). Results of cytogenetic testing of workers exposed to ethylene oxide. Journal of Hygiene, Epidemiology, Microbiology, and Immunology, 31, 119-126.
20. Kligerman, A. D., Erexson, G. L., Phelps, M. E., & Wilmer, J. L. (1983). Sister-chromatid exchange induction in peripheral blood lymphocytes of rats exposed to ethylene oxide by inhalation. Mutation Research, 120, 37-44.
21. Lemieux, N., Zhang, X. X., Dufort, D., & Nepveu, A. (1994). Assignment of the human homologue of the Drosophila Cut homeobox gene (CUTL1) to band 7q22 by fluorescence in situ hybridization. Genomics, 24, 191-193.
22. Lerda, D., & Rizzi, R. (1992). Cytogenetic study of persons occupationally exposed to ethylene oxide. Mutation Resarch, 281, 31-37.
23. Levine, E. G., & Bloomfield, C. D. (1992). Leukemias and myelodysplastic syndromes secondary to drug, radiation, and environmental exposure. Seminars in Oncology, 19, 47-84.
24. Logan, C., Willard, H. R., Rommens, J. M., & Joyner, A. L. (1989). Chromosomal localization of the human homeo box-containing genes, EN1 and EN2. Genomics, 4, 206-209.
25. Look, A. T. (1997). Oncogenic transcription factors in human acute leukemia. Science, 278, 1059-1064.
26. Lynch, D. W., Lewis, T. R., Moorman. W. J., Burg, J. R., Groth, D. H., Khan, A., Ackerman, L. J., & Cockrell, B. Y. (1984a). Carcinogenic and toxicologic effects of inhaled ethylene oxide and propylene oxide in F344 rats. Toxicology and Applied Pharmacology, 76, 69-84.
27. Lynch, D. W., Lewis, T. R., Moorman, W. J., Burg, J. R., Gulati, D. K., Kaur, P., & Sabharwal, P S. (1984b). Sister-chromatid exchanges and chromosome aberrations in lymphocytes from monkeys exposed to ethylene oxide and propylene oxide by inhalation. Toxicology and Applied Pharmacology, 76, 85-95.
28. Major, J., Jakab, M. G., & Tompa, A. (1996). Genotoxicological investigation of hospital nurses occupationally exposed to ethylene-oxide: I. Chromosome aberrations, sister-chromatid exchanges, cell cycle kinetics, and UV-induced DNA synthesis in peripheral blood lymphocytes. Environmental and Molecular Mutagenesis, 27, 84-92.
29. Major, J., Jakab, M. G., & Tompa, A. (1999). The frequency of induced premature centromere division in human populations occupationally exposed to genotoxic chemicals. Mutation Resarch, 445, 241-249.
30. Mrozek, K., & Bloomfield, C. D. (1998). Major cytogenetic findings in non-Hodgkins lymphoma. In G. P. Canellos, T. A. Lister, & J. L. Sklar (Eds.), The Lyomphomas Canellos (pp. 107-128). Philadelphia: W B Saunders.
31. Neubauer, A., Dodge, R. K., George, S. L., Davey, F. R., Silver, R. T., Schiffer, C. A., Mayer, R. J., Ball, E. D., Wurster-Hill, D., & Bloomfield, C. D. et al. (1994). Prognostic importance of mutations in the ras proto-oncogenes in de novo acute myeloid leukemia. Blood, 83, 1603-1611.
32. NTP Working Group. (1987). Toxicology and carcinogenesis studies of ethylene oxide in B6C3F1 mice inhalation studies. National Toxicology Program Technical Report Series, 326, 114.
33. Offit, K., Louie, D. C., Parsa, N. Z., Noy, A., & Chaganti, R. S. (1995). Del (7)(q32) is associated with a subset of small lymphocytic lymphoma with plasmacytoid features. Blood, 86, 2365-2370.
34. Pedersen-Bjergaard, J., Pedersen, M., Roulston, D., & Philip, P. (1995). Different genetic pathways in leukemogenesis for patients presenting with therapy-related myelodysplasia and therapy-related acute myeloid leukemia. Blood, 86, 3542-3552.
35. Pedersen-Bjergaard, J., & Philip, P. (1991). Two different classes of therapy-related and de novo acute myeloid leukemia? Cancer Genetics and Cytogenetics, 55, 119-124.
36. Pedersen-Bjergaard, J., Phillip, P., Larsen, S. O., Anderson, M., Daugaard, G., Ersbill, J., Hansen, S.W., Hou-Jensen, K., Nielson, D., Sigsgaard, T. C., Specht, L., & Osterlind, K. (1993). Therapy-related myelodysplasia and acute myeloid leukemia, Cytogenetic characteristics of 115 consecutive cases and risk in seven cohorts of patients treated intensively for malignant diseases in the Copenhagen series. Leukemia, 7, 1975-1986.
37. Pedersen-Bjergaard, J., & Rowley, J. D. (1994). The balanced and the unbalanced chromosome aberrations of acute myeloid leukemia may develop in different ways and may contribute differently to malignant transformation. Blood, 83, 2780-2786.
38. Pero, R. W., Widegren, B., Hogstedt, B., & Mitelman, F. (1981). In vivo and in vitro ethylene oxide exposure of human lymphocytes assessed by chemical stimulation of unscheduled DNA synthesis. Mutation Research, 83, 271-289.
39. Pettenati, M., LeBeau, M., Lemons, R., Shima, E., Kawasaki, E., Larson, R., Sherr, C., Diaz, M., & Rowley, J. (1987). Assignment of CSF-1 to 5q33.1: Evidence for clustering of genes regulating hematopoiesis and for their involvement in the deletion of the long arm of chromosome 5 in myeloid disorders. Proceedings of the National Academy of Sciences of the USA, 84, 2970-2974.
40. Preston, R. J. (1999a). Chromosomal Changes. IARC Scientific Publication No. 146.
41. Preston, R. J. (1999b). Cytogenetic effects of ethylene oxide, with an emphasis on population monitoring. Critical Reviews in Toxicology, 29, 263-282.
42. Preston, R. J. (2003). Personal communication.
43. Preston, R. J., Fennell, T. R., Leber, A. P., Sielken, R. L., & Swenberg, J. A. (1995). Reconsideration of the genetic risk assessment for ethylene oxide. Environmental and Molecular Mutagenesis, 26, 189-202.
44. Rabbitts, T. H. (1994). Chromosomal translocations in human cancer. Nature, 372, 143-149.
45. Ribeiro, L. R., Rabello-Gay, M. N., Salvadori, D. M., Pereira, C. A., & Becak, W. (1987). Cytogenetic effects of inhaled ethylene oxide in somatic and germ cells of mice. Archives of Toxicology, 59, 332-335.
46. Ribeiro, L. R., Salvadori, D. M., Pereira, C. A., & Becak, W. (1987). Activity of ethylene oxide in the mouse sperm morphology test. Archives of Toxicology, 60, 331-333.
47. Ribeiro, L. R., Salvadori, D. M., Rios, A. C., Costa, S. L., Tates, A. D., Tornqvist, M., & Natarajan, A. T. (1994). Biological monitoring of workers occupationally exposed to ethylene oxide. Mutation Research, 313, 81-87.
48. Richmond, G. W., Abrahams, R. H., Nemenzo, J. H., & Hine, C. H. (1985). An evaluation of possible effects on health following exposure to ethylene oxide. Archives of Environmental Health, 40, 20-25.
49. Rowley, J. D. (1998). The critical role of chromosome translocations in human leukemias. Annual Review of Genetics, 32, 495-519.
50. Sarto, F., Cominato, I., Pinton, A. M., Brovedani, P. G., Faccioli, C. M., Bianchi, V., & Levis, A. G. (1984). Cytogenetic damage in workers exposed to ethylene oxide. Mutation Research, 138, 185-195.
51. Shore, R. E., Gardner, M. J., & Pannett, B. (1993). Ethylene oxide: An assessment of the epidemiological evidence on carcinogenicity. British Journal Industrial Medicine, 50, 971-997.
52. Simeone, A., Acampora, D., Pannese, M., D'Esposito, M., Stornaiuolo, A., Gulisano, M., Mallamaci, A., Kastury, K., Druck, T., & Huebner, K. et al. (1994). Cloning and characterization of two members of the vertebrate D1x gene family. Proceedings of the National Academy of Sciences of the USA, 91, 2250-2254.
53. Sisk, S. C., Pluta, L. J., Meyer, K. G., Wong, B. C., & Recio, L. (1997). Assessment of the in vivo mutagenicity of ethylene oxide in the tissues of B6C3F1 lacI transgenic mice following inhalation exposure. Mutation Research, 391, 153-164.
54. Snellings, W. M., Weil, C. S., & Maronpot, R. R. (1984). A two-year inhalation study of the carcinogenic potential of ethylene oxide in Fischer 344 rats. Toxicology and Applied Pharmacology, 75, 105-117.
55. Stayner, L., Steenland, K., Greife, A., Hornung, R., Hayes, R. B., Nowlin, S., Morawetz, J., Ringenburg, V., Elliot, L., & Halperin, W. (1993). Exposure-response analysis of cancer mortality in a cohort of workers exposed to ethylene oxide. American Journal of Epidemiology, 138, 787-798.
56. Steenland, K., Stayner, L., Greife, E., Halperin, W., Hayes, R., Hornung, R., & Nowlin, S. (1991). Mortality among workers exposed to ethylene oxide. New England Journal of Medicine, 324(20), 1402-1407.
57. Stefanski, S. A., Elwell, M. R., & Stronmberg, P. C. (1990). Spleen, lymph nodes, and thymus. In G. A. Boorman et al. (Eds.), Pathology of the Fischer Rat. San Diego, CA: Academic Press.
58. Stolley, P. D., Soper, K. A., Galloway, S. M., Nichols, W. W., Norman, S. A., & Wolman, S. R. (1984). Sister-chromatid exchanges in association with occupational exposure to ethylene oxide. Mutation Research, 129, 89-102.
59. Stromberg, P. C. (1985). Large granul lymphocyte leukemia in F344 rats: Model for human T lymphoma, malignant histiocytosis and T-cell chromic lymphocytic leukemia. American Journal of Pathology, 119, 517-519.
60. Swaen, G. J. W., & Van Heerde, P. (1987). Tumors of the hematopoeitic system. In V. S. Turusov (Ed.), Pathology of Tumors in Laboratory Animals. Vol 1. Tumors of the Rats. Lyon, France: International Agency for Research on Cancer.
61. Sweeney, L. M., Gargas, M. L., Strother, D. E., & Kedderis, G. L. (2003). Physiologically based pharmacokinetic model parameter estimation and sensitivity and variability analyses for acrylonitrate disposition in humans. Toxicological Sciences, 71, 27-40.
62. Tales, A. D., Grummt, T., Tornqvist, M., Farmer, P. B., van Dam, F. J., van Mossel, H., Schoemaker, H. M., Osterman-Golkar, S., Uebel, C., & Tang, Y. S. et al. (1991). Biological and chemical monitoring of occupational exposure to ethylene oxide. Mutation Research, 250, 483-497.
63. Teta, M. J., Benson, L. O., & Vitale, J. N. (1993). Mortality study of ethylene oxide workers in chemical manufacturing: A 10 year update. British Journal Industrial Medicine, 50, 704-709.
64. Teta, M. J., Sielken Jr., R. L., & Valdez-Flores, C. (1999). Ethylene oxide cancer risk assessment based on epidemiological data: Application of revised regulatory guidelines. Risk Analysis, 19, 1135-1155.
65. Thiess, A. M., Schwegler, H., & Fleig, I. et al. (1981). Mutagenicity study on workers exposed to alkene oxides (ethylene oxide/propylene oxide) and derivatives. Journal of Occupational Medicine, 23, 343-347.
66. USEPA. (1985). Health Assessment Document for Ethylene Oxide. EPA 600/8-84-009F. Research Triangle Park, NC: U.S. Environmental Protection Agency.
67. USEPA. (1997a). Health Effects Assessment Summary Tables. Washington, DC: U.S. Environmental Protection Agency.
68. USEPA. (1997b). Chemical And Radiation Leukemogenesis in Humans and Rodents and the Value of Rodent Models for Assessment Risks of Lymphohematopoietic Cancers. EPA/600/R-97/090. 1997. Washington, DC: United States Environmental Protection Agency.
69. USEPA. (1998). Integrated Risk Information System for Arsenic. Downloaded October, 2002. Available at: http://www.epa.gov/iris/subst/0278.htm.
70. USEPA. (1999). Proposed Guidelines for Carcinogen Risk Assessment. Draft. Washington, DC: U.S. Environmental Protection Agency.
71. USEPA. (2003). Draft Final Guidelines for Carcinogen Risk Assessment. Washington, DC: U.S. Environmental Protection Agency.
72. van Sitten, N. J., Boogaard, P. J., Natarajan, A. T., Tales, A. D., Ehrenberg, L. Q, & Tornqvist, M. A. (2000). Formation of DNA adducts and induction of mutagenic effects in rats following 4 weeks inhalation exposure to ethylene oxide as a basis for cancer risk assessment. Mutation Research, 447(1), 27-48.
73. van Sitten, N. J., de Jong, G., Clare, M. G., Davies, R., Dean, B. J., Wren, L. J., & Wright, A. S. (1985). Cytogenetic, immunological, and haematological effects in workers in an ethylene oxide manufacturing plant. British Journal of Industrial Medicine, 42, 19-26.
74. Walker, V. E., Fennell, T. R., Upton, P. B., Skopek, T. R., Prevost, V, Shuker, D. E., & Swenberg, J. A. (1992). Molecular dosimetry of ethylene oxide: formation and persistence of 7-(2-hydroxyethyl) guanine in DNA following repeated exposures of rats and mice. Cancer Research, 52, 4328-4334.
75. Walker, V. E., Wu, K. Y., Upton, P. B., Ranasinghe, A., Scheller, N., Cho, M. H., Vergnes, J. S., Skopek, T. R., & Swenberg, J.A. (2000). Biomarkers of exposure and effect as indicators of potential carcinogenic risk arising from in vivo metabolism of ethylene to ethylene oxide. Carcinogenesis, 21(9), 1661-1669.
76. Ward, J. M., Rehm. S., & Reynolds. C.W. (1990). Pathology of tumors in laboratory animals. In Tumors of the Rat. Tumors of the Haematopoietic System. IARC Sci Pub. 125-157. Lyon, France.
77. Willman, C. L., Sever, C. E., Pallavicini, M. G., Harada, H., Tanaka, N., Slovak, M. L., Yamamoto, H., Harada, K., Meeker, T. C., List, A. F., & Taniguchi, T. (1993). Deletion of IRF-1, mapping to chromosome 5q31.1, in human leukemia and preleukemic myelodysplasia. Science, 259, 968-970.
78. Yunis, J. J., Boot, A. J., Mayer, M. G., & Bos, J. L. (1989). Mechanisms of ras mutation in myelodysplastic syndrome. Oncogene, 4, 609-614.