An updated evaluation of the carcinogenic potential of 1,4-dioxane

Regulatory Toxicology and Pharmacology

Volumn 38, Issue 2, 2003, Pages 183-195

  Stickney, Julie A ^a   Sager, Shawn L ^b   Clarkson, Jacquelyn R ^a   Smith, Lee Ann ^c   Locey, Betty J ^d   Bock, Michael J ^a   Hartung, Rolf ^e   Olp, Steven F ^f  

^a ARCADIS   (United States)

^b ARCADIS   (United States)

^c ARCADIS   (United States)

^d ARCADIS US   (United States)

^e UNIVERSITY OF MICHIGAN   (United States)

^f Celanese America Corporation   (United States)

Author keywords

1,4 Dioxane; Carcinogenicity; Dose response assessment; Epidemiology; Genotoxicity; Liver; Mode of action; Nasal cavity; Pharmacokinetics; Physiologically based pharmacokinetic model

Indexed keywords

1,1,1 TRICHLOROETHANE; CARBON TETRACHLORIDE; CARCINOGEN; DIOXANE; DRINKING WATER; TETRACHLOROETHYLENE; TUMOR PROMOTER; VINYL CHLORIDE;

BIOASSAY; CANCER RISK; CARCINOGENESIS; CARCINOGENIC ACTIVITY; CARCINOMA; CELL PROLIFERATION; CHROMOSOME ABERRATION; COLON CANCER; DOSE RESPONSE; DRUG CLEARANCE; DRUG MEGADOSE; EXPERIMENTAL MODEL; EXPOSURE; GALLBLADDER CARCINOMA; GENETIC TOXICOLOGY; GENOTOXICITY; GERMANY; GLIOBLASTOMA; GLOMERULONEPHRITIS; HUMAN; KIDNEY CARCINOMA; LEUKEMIA; LIVER CELL; LIVER CELL CARCINOMA; LIVER TOXICITY; LIVER TUMOR; LUNG ALVEOLUS CELL CARCINOMA; LUNG CANCER; LYMPHOSARCOMA; MAXIMUM TOLERATED DOSE; MEDIASTINUM TUMOR; MORTALITY; MYELOFIBROSIS; NEOPLASM; NONHUMAN; NOSE CAVITY TUMOR; OCCUPATIONAL EXPOSURE; PRIORITY JOURNAL; REVIEW; SEX DIFFERENCE; SPECIES DIFFERENCE; SQUAMOUS CELL CARCINOMA; STOMACH CARCINOMA; STRAIN DIFFERENCE; TEXTILE INDUSTRY; TOXICOKINETICS; UNITED STATES;

EID: 0141726853     PISSN: 02732300     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0273-2300(03)00090-4     Document Type: Article

References (57)

1. Argus M.F., Arcos J.C., Hoch-Ligeti C. Studies on the carcinogenic activity of protein-denaturing agents: hepatocarcinogenicity of dioxane. J. Natl. Cancer Inst. 35:1965;949-958.
2. Argus M.F., Sohal R.S., Bryant G.M., Hoch-Ligeti C., Arcos J.C. Dose-response and ultrastructural alterations in dioxane carcinogenesis. Eur. J. Cancer. 9:1973;237-243.
3. Ashby J., Tennant R.W. Chemical structure, Salmonella mutagenicity and exent of carcinogenicity as indicators of genotoxic carcinogens among 222 chemicals tested in rodents by the U.S. NCI/NTP Mutat. Res. 204:1988;17-115.
4. Ashby J. Series: current issues in mutagenesis and carcinogenesis, No. 45 - The genotoxicity of 1,4-dioxane. Mutat. Res. 322(2):1994;141-150.
5. Braun W.H., Young J.D. Identification of β-hydroxyethoxyacetic acid as the major metabolite of 1,4-dioxane in the rat. Toxicol. Appl. Pharmacol. 39:1977;33-38.
6. Buffler P.A., Wood S.M., Suarez L., Kilian D.J. Mortality follow-up of workers exposed to 1,4-dioxane. J. Occup. Med. 20(4):1978;255-259.
7. Bull R.J., Robinson M., Laurie R.D. Association of carcinoma yield with early papilloma development in SENCAR mice. Environ. Health Perspect. 68:1986;11-17.
8. DeRosa C.T., Wilbur S., Holler J., Richter P., Stevens Y. Health evaluation of 1,4-dioxane. Toxicol. Ind. Health. 12(1):1996;1-43.
9. Galloway S.M., Armstrong M.J., Reuben C., Coleman S., Brown B., Cannon C., Bloom A.D., Nakamura F., Ahmed M., Duk S., Rimpo J., Margolin B.H., Resnick M.A., Anderson B., Zeiger E. Chromosome aberrations and sister chromatid exchanges in Chinese hamster ovary cells: evaluation of 108 chemicals. Environ. Mol. Mutag. 10(Suppl. 10):1987;1-175.
10. Goldsworthy T.L., Monticello T.M., Morgan K.T., Bermudez E., Wilson D.M., Jäckh R., Butterworth B.E. Examination of potential mechanisms of carcinogenicity of 1,4-dioxane in rat nasal epithelial cells and hepatocytes. Arch. Toxicol. 65(1):1991;1-9.
11. Hartung R. Health and Environmental Effects Assessment for 1, 4-Dioxane. 1989;Gelman Sciences, Inc. Ann Arbor, MI.
12. Haseman J.K., Hailey J.R. An update of the National Toxicology Program database on nasal carcinogens. Mutat. Res. 380:1997;3-11.
13. Haworth S., Lawlor T., Mortelmans K., Speck W., Zeiger E. Salmonella mutagenicity test results for 250 chemicals. Environ. Mutag. (Suppl. 1):1983;3-142.
14. Hoch-Ligeti, C., Argus, M.F., 1970. Effect of carcinogens on the lungs of guinea pigs. In: Nettesheim, P., Hanna Jr., M.G., Deatherage Jr., J.W. (Eds.), Morphology of Experimental Respiratory Carcinogenesis. Publication No. CONF-700401, pp. 267-279. Technical Information Service, U.S. Department of Commerce, Springfield, VA.
15. Hoch-Ligeti C., Argus M.F., Acros J.C. Induction of carcinomas in the nasal cavity of rats by dioxane. Br. J. Cancer. 24:1970;164-167.
16. IARC, 1999. 1,4-Dioxane. IARC Monogr. Eval. Carcinog. Risks Hum. 71(Pt. 2), 589-602.
17. Keenan R.E., Paustenbach D.J., Wenning R.J., Parsons A.J. Pathology reevaluation of the Kociba et al. (1978) bioassay of 2,3,7,8-TCDD: implications for risk assessment. J. Toxicol. Environ. Health. 34:1991;279-296.
18. King M.E., Shefner A.M., Bates R.R. Carcinogenesis bioassay of chlorinated dibenzodioxins and related chemicals. Environ. Health Perspect. 5:1973;163-170.
19. Kitchin K.T., Brown J.L. Is 1,4-dioxane a genotoxic carcinogen? Cancer Lett. 53(1):1990;67-71.
20. Kociba R.J., McCollister S.B., Park C., Torkelson T.R., Gehring P.J. 1,4-Dioxane. I. Results of a 2-year ingestion study in rats. Toxicol. Appl. Pharmacol. 30:1974;275-286.
21. Kociba, R.J., Torkelson, T.R., Young, J.D., Gehring, P.J., 1975. 1,4-Dioxane: correlation of the results of chronic ingestion and inhalation studies with its dose-dependent fate in rat. In: Proceedings of the 6th Annual Conference on Environmental Toxicology. October 21-23, Aerospace Medical Research Laboratory, Wright-Patterson Air Force Base, Ohio, pp. 345-354.
22. Kramer C.G., Ott, M.G., Fulkerson, J.E., Hicks, N., Imbus, H.R., 1978. Health of workers exposed to 1,1,1-trichloroethane: a matched-pair study. Arch. Environ. Health November/December, 331-342.
23. Krewski D., Withey J.R., Ku L., Andersen M.E. Applications of physiologic pharmacokinetic modeling in carcinogenic risk assessment. Environ. Health Perspect. 102(Suppl. 11):1994;37-50.
24. Leung H., Paustenbach D.J. Cancer risk assessment for dioxane based upon a physiologically based pharmacokinetic approach. Toxicol. Lett. 51(2):1990;147-162.
25. Lundberg I., Hogberg J., Kronevi T., Holmberg B. Three industrial solvents investigated for tumor promoting activity in the rat liver. Cancer Lett. 36:1987;29-33.
26. Maronpot R.R., Montgomery C.A. Jr., Boorman G.A., McConnell E.E. National Toxicology Program nomenclature for hepatoproliferative lesions of rats. Toxicol. Pathol. 14(2):1986;263-273.
27. Marzulli F.N., Anjo D.M., Maibach H.I. In vivo skin penetration studies of 2,4,-toluenediamine, 2,4-diaminoanisole, 2-nitro-p-phenylenediamine, p-dioxane, and N-nitrosodiethanolamine in cosmetics. Food Cosmet. Toxicol. 19:1981;743-747.
28. McFee A.F., Abbott M.G., Gulati D.K., Shelby M.D. Results of mouse bone marrow micronucleus studies on 1,4-dioxane. Mutat. Res. 322(2):1994;145-148.
29. Mirkova E.T. Activity of the rodent carcinogen 1,4-dioxane in the mouse bone marrow micronucleus assay. Mutat. Res. 322(2):1994;142-144.
30. Miyagawa M., Shirotori T., Tsuchitani M., Yoshikawa K. Repeat-assessment of 1,4-dioxane in a rat-hepatocyte replicative DNA synthesis (RDS) test: evidence for stimulus of hepatocyte proliferation. Exp. Toxicol. Pathol. 51:1999;555-558.
31. Moore J.A., Hardisty J.F., Banas D.A., Smith M.A. A comparison of liver tumor diagnoses from seven PCB studies in rats. Reg. Toxicol. Pharmacol. 20:1994;362-370.
32. Morita T. No clastogenicity of 1,4-dioxane as examined in the mouse peripheral blood micronucleus test. MMS Commun. 2:1994;7-8.
33. Morita T., Hayashi M. 1,4-Dioxane is not mutagenic in five in vitro assays and mouse peripheral blood micronucleus assay, but is in mouse liver micronucleus assay. Environ. Mol. Mutag. 32(3):1998;269-280.
34. Munoz E.R., Barnett B.M. The rodent carcinogens 1,4-dioxane and thiourea induce meiotic non-disjunction in Drosophila melanogaster females. Mutat. Res. 517:2002;231-238.
35. Neumann H.G., Thielmann H.W., Filser J.G., Gelbke H.P., GriemH H., Kappus H., Norpoth K.H., Reuter U., Vamvakas S., Wardenbach P., Wichmann H.E. Proposed changes in the classification of carcinogenic chemicals in the work area. Reg. Toxicol. Pharmacol. 26:1997;288-295.
36. NICNAS, 1998. 1, 4-Dioxane, Priority Existing Chemical No. 7, Full Public Report. National Industrial Chemicals Notification and Assessment Scheme. Commonwealth of Australia. June 1998.
37. NCI, 1978. Bioassay of 1,4-Dioxane for Possible Carcinogenicity. National Cancer Institute. U.S. Department of Health, Education, and Welfare. DHEW Publication No. 78-1330.
38. NCI, 1985. Monograph on Human Exposure to Chemicals in the Workplace: 1,4-Dioxane. National Cancer Institute. U.S. Department of Health, Education, and Welfare. Prepared by Center for Chemical Hazard Assessment, Syracuse Research Corporation for Division of Cancer Etiology, National Cancer Institute, Contract NO1-CP-26002-03, p. 6-1.
39. Netherlands, 1999. Risk Assessment: 1, 4-Dioxane. Netherlands Organization for Applied Scientific Research (TNO) and the National Institute of Public Health and the Environment (RIVM). Chemical Substances Bureau, Ministry of Housing, Spatial Planning and the Environment (VROM), Netherlands, Final Version, 5 November, EINECS-No.: 204-661-8.
40. Pawar S.S., Mungikar A.M. Dioxane-induced changes in mouse liver microsomal mixed function oxidase system. Bull. Environ. Contam. Toxicol. 15(16):1976;762-767.
41. Reitz R.H., McCroskey P.S., Park C.N., Andersen M.E., Gargas M.L. Development of a physiologically based pharmacokinetic model for risk assessment with 1,4-dioxane. Toxicol. Appl. Pharmacol. 105(1):1990;37-54.
42. Stott W.T., Quast J.F., Watanabe P.G. Differentiation of the mechanisms of oncogenicity of 1,4-dioxane and 1,3-hexachlorobutadiene in the rat. Toxicol. Appl. Pharmacol. 60(2):1981;287-300.
43. Thiess A.M., Tress E., Fleig I. Arbeitsmedizinische Untersuchungsergebuisse von Dioxan-exponierten Mitarbeitern. Arbeitsmedizin Sozialmedizin Praventivmedizin. ASP 2/76:1976;36-46.
44. Tinwell H., Ashby J. Activity of 1,4-dioxane in mouse bone marrow micronucleus assays. Mutat. Res. 322:1994;148-150.
45. Torkelson T.R., Leong B.K.J., Kociba R.J., Richter W.A., Gehring P.J. 1,4-Dioxane. II. Results of a 2-year inhalation study in rats. Toxicol. Appl. Pharmacol. 30:1974;287-298.
46. USEPA, 1988. Recommendations for and Documentation of Biological Values for Use in Risk Assessment. U.S. Environmental Protection Agency, Cincinnati, OH. PB88-179874. February.
47. USEPA., 1990. IRIS Summary for 1, 4-Dioxane. U.S. Environmental Protection Agency, Integrated Risk Information System, Last Revised September, 1990. Available from: < http://www.epa.gov/iris/subst/0326.htm >.
48. USEPA, 1994. Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry. Office of Research and Development. U.S. Environmental Protection Agency, Washington, DC. EPA/600/8-90/006F. October.
49. USEPA, 1999. Guidelines for Carcinogen Risk Assessment. Review Draft. U.S. Environmental Protection Agency, Washington, DC. NCEA-F-0644. July.
50. Willhite, C.C., Spirtas, R., Weisburger, E.K., 1997. Integrating epidemiologic, pharmacokinetic, and pharmacodynamic data to determine human health risk: The case of trichloroethylene and 1,4-dioxane. American Water Works Association, In: Proceedings of the 1997 Annual Conference, Water Research, vol. C, pp. 205-218. June 15-19.
51. Woo Y.T., Arcos J.C., Argus M.F., Griffen G.W., Nishiyama K. Structural identification of p-dioxane-2-one as the major urinary metabolite of p-dioxane. Naunyn-Schmiedeberg's Arch. Toxicol. 299:1977;283-287.
52. Woo Y.T., Argus M.F., Arcos J.C. Effect of mixed function oxidase modifiers on metabolism and toxicity of the oncogen dioxane. Cancer Res. 38:1978;1621-1625.
53. Yamazaki, K., Ohno, H., Asakura, M., Narumi, A., Ohbayashi, H., Fujita, H., Ohnishi, M., Katagiri, T., Senoh, H., Yamanouchi, K., Nakayama, E., Yamamoto, S., Noguchi, T., Nagano, K., Enomoto, M., Sakabe, H., 1994. Two-year toxicological and carcinogenesis studies of 1,4-dioxane in F344 ratts and BDF1 mice. Drinking studies. In: Proceedings on the Second Asia-Pacific Symposium on Environmental and Occupational Health, Environmental and Occupational Chemical Hazards (2), Kobe University, pp. 193-198.
54. Yoon J.S., Mason J.M., Valencia R., Woodruff R.C., Zimmering S. Chemical mutagenesis testing in Drosophila, Part IV, Results of 45 coded compounds tested for the National Toxicology Program. Environ. Mutagen. 7:1985;349-367.
55. Young J.D., Braun W.H., Gehring P.J., Horvath B.S., Daniel R.L. 1,4-Dioxane and beta-hydroxyethoxyacetic acid excretion in urine of humans exposed to dioxane vapors. Toxicol. Appl. Pharmacol. 38(12):1976;643-646.
56. Young J.D., Braun W.H., Rampy L.W., Chenoweth M.B., Blau G.E. Pharmacokinetics of 1,4-dioxane in humans. J. Toxicol. Environ. Health. 3:1977;507-520.
57. Young J.D., Braun W.H., Gehring P.J. The dose-dependent fate of 1,4-dioxane in rats. J. Toxicol. Environ. Health. 4:1978;709-726.