Physiologically based pharmacokinetic modeling of 1,4-dioxane in rats, mice, and humans

Toxicological Sciences

Volumn 101, Issue 1, 2008, Pages 32-50

  Sweeney, Lisa M ^a   Thrall, Karla D ^b   Poet, Torka S ^b   Corley, Richard A ^b   Weber, Thomas J ^b   Locey, Betty J ^c   Clarkson, Jacquelyn ^c   Sager, Shawn ^c   Gargas, Michael L ^a  

^a Sapphire Group   (United States)

^b BATTELLE MEMORIAL INSTITUTE   (United States)

^c ARCADIS   (United States)

Author keywords

Agents; Biological modeling; Biotransformation and toxicokinetics; Hepatocytes; In vitro and alternatives; Physiologically based pharmacokinetics; Risk assessment; Toxicokinetics; Volatile organic compounds

Indexed keywords

ACETIC ACID DERIVATIVE; DIOXANE; DRINKING WATER;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; AREA UNDER THE CURVE; ARTICLE; BIOASSAY; BLOOD LEVEL; CANCER RISK; CONTROLLED STUDY; EXPERIMENTAL MODEL; FLUORESCENCE MICROSCOPY; GAS CHROMATOGRAPHY; HUMAN; HUMAN CELL; IN VITRO STUDY; LIVER TOXICITY; LUNG TOXICITY; MALE; MASS SPECTROMETRY; MOUSE; NEPHROTOXICITY; NONHUMAN; OCCUPATIONAL EXPOSURE; PARTITION COEFFICIENT; PREDICTION; RAT; RISK ASSESSMENT; SPECIES DIFFERENCE; TIME; TISSUE DISTRIBUTION; TOXICOKINETICS;

ALGORITHMS; ANIMALS; CHEMISTRY, PHYSICAL; CHROMATOGRAPHY, GAS; DIOXANES; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; HEPATOCYTES; HUMANS; MALE; MICE; MICE, INBRED STRAINS; MICROSCOPY, FLUORESCENCE; MODELS, STATISTICAL; OCCUPATIONAL EXPOSURE; RATS; RATS, SPRAGUE-DAWLEY; REPRODUCIBILITY OF RESULTS; SOFTWARE;

MUS; RATTUS;

EID: 36949030749     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfm251     Document Type: Article

References (26)

1. Agency for Toxic Substances and Disease Registry (ATSDR). (2006). Toxicological Profile for 1,4-Dioxane. U.S. Department of Health and Human Services. Public Health Service, Atlanta, GA.
2. Arias, I. M., Popper, H., Schacher, D., and Shafritz, D. A. (1982). In: The Liver: Biology and Pathobiology. Raven Press, New York.
3. Braun, W. H., and Young, J. D. (1977). Identification of b-hydroxyethoxyacetic acid as the major urinary metabolite of 1,4-dioxane in the rat. Toxicol. Appl. Pharmacol. 39, 33-38.
4. Brown, R. P., Delp, M. D., Lindstedt, S. L., Rhomberg, L. R., and Beliles, R. P. (1997). Physiological parameter values for physiologically based pharmacokinetic models. Toxicol. Ind. Health 13, 407-484.
5. Carlile, D. J., Zomorodi, K., and Houston, J. B. (1997). Scaling factors to relate drug metabolic clearance in hepatic microsomes, isolated hepatocytes, and the intact liver: Studies with induced livers involving diazepam. Drug Metab. Dispos. 25, 903-911.
6. De Rosa, C. T., Wilbur, S., Holler, J., Richter, P., and Stevens, Y. W. (1996). Health evaluation of 1,4-dioxane. Toxicol. Ind. Health 12, 1-43.
7. Gargas, M. L., Burgess, R. J., Voisard, D. E., Cason, G. H., and. Andersen, M. E. (1999). Partition coefficients of low-molecular-weight volatile chemicals in various liquids and tissues. Toxicol. Appl. Pharmacol. 98, 87-99.
8. Goldsworthy, T. L., Monticello, T. M., Morgan, K. T., Bermudez, E., Wilson, D. M., Jackh, R., and Butterworth, B. E. (1991). Examination of potential mechanisms of carcinogenicity of 1,4-dioxane in rat nasal epithelial cells and hepatocytes.. Arch. Toxicol. 65, 1-9.
9. Kociba, R. J., McCollister, S. B., Park, C. N., Torkelson, T., R., and Gehring, P. J. (1974). 1,4-Dioxane. I. Results of a 2-year ingestion study in rats. Toxicol. Appl. Pharmacol. 30, 275-286.
10. Leung, H. W., and Paustenbach, D. J. (1990). Cancer risk assessment for dioxane based upon a physiologically-based pharmacokinetic approach. Toxicol. Lett. 51, 147-162.
11. Mikheev, M. I., Gorlinskaya, Ye.P., and Solovyova, T. V. (1990). The body distribution and biological action of xenobiotics. J. Hyg. Epidemiol. Microbiol. Immunol. 34, 329-336.
12. Nannelli, A., De Rubertis, A., Longo, V., and Gervasi, P. G. (2005). Effects of dioxane on cytochrome P450 enzymes in liver, kidney, lung and nasal mucosa of rat. Arch. Toxicol.79, 74-82.
13. National Cancer Institute (NCI). (1978). Bioassay of 1,4-dioxane for possible carcinogenicity. Technical Report Series No. 80, NCI-CG-TR-80. U.S. Department of Health, Education and Welfare. NIH, Washington, DC.
14. Price, P. S., Conolly, R. B., Chaisson, C. F., Gross, E. A., Young, J. S., Mathis, E. T., and Tedder, D. R. (2003). Modeling interindividual variation in physiological factors used in PBPK models of humans. Crit. Rev. Toxicol. 33, 469-503.
15. Reitz, R. H., McCroskey, P. S., Park, C. N., Andersen, M. E., and Gargas, M. L. (1990). Development of a physiologically based pharmacokinetic model for risk assessment with 1,4-dioxane. Toxicol. Appl. Pharmacol. 105, 37-54.
16. Royal Society of Chemistry. (1989). 1,4-Dioxane. Solvents in common use: Health risk to workers. EUR, 11553. 105- 134; (Cited in ATSDR, 2006).
17. Seglen, P. O. (1976). Preparation of isolated liver cells. Methods Cell Biol. 13, 29-83.
18. Stickney, J. A., Sager, S. L., Clarkson, J. R., Smith, L. A., Locey, B. J., Bock, M. J., Hartung, R., and Olp, S. F. (2003). An updated evaluation of the carcinogenic potential of 1,4-dioxane. Regul. Toxicol. Pharmacol. 38, 183-195.
19. Torkelson, T. R., Leong, B. K. J., Kociba, R. J., Richter, W. A., and Gehring, P. J. (1974). 1,4-Dioxane, II. Results of a two year inhalations study in rats. Toxicol. Appl. Pharmacol. 30, 287-298.
20. U.S. EPA. (1990). 1,4-Dioxane (CASRN 123-91-1). Carcinogenicity assessment for lifetime exposure. Available at: http://www.epa.gov/iris/ substl/0326.htm. Accessed July 3-1, 2006.
21. Wala-Jerzykiewicz, A., and Szymanowski, J. (1998). Headspace gas chromatography analysis of toxic contaminants in ethoxylated alcohols and alkylamines. Chromatographia 48, 299-304.
22. Woo, Y.-T., Arcos, J. C., Argus, M. F., Griffin, G. W., and Nishiyama, K. (1977). Structural identification of p-dioxane-2-one as the major urinary metabolite of p-dioxane. Arch. Pharmacol. 299, 283-287.
23. Yamazaki, K., Ohno; H., Asakura, M., Narumi, A., Ohbayashi, H., Fujita, H., Ohnishi, M., Katagiri, T., Senoh, H., Yamanouchi, K., et al. (1994). Two-year toxicological and carcinogenesis studies of 1,4-dioxane in F344 rats and BDF1 mice. Drinking Studies. Proceedings of the 2nd Asia-Pacific Symposium on Environmental and Occupational Health Environmental and Occupational Hazards (2), pp. 193-198. Kobe University, Kobe, Japan.
24. Young, J. D., Braun, W. H., and Gehring, P. J. (1978). Dose-dependent fate of 1,4-dioxane in rats. J. Toxicol. Environ. Health 4, 709-726.
25. Young, J. D., Braun, W. H., Gehring, P. J., Horvath, B. S., and Daniel, R. L. (1976). 1,4-Dioxane and beta-hydroxyethoxyacetic acid excretion in urine of humans exposed to dioxane vapors. Toxicol. Appl. Pharmacol. 38, 643-646.
26. Young, J. D., Braun, W. H., Rampy, L. W., Chenoweth, M. B., and Blau, G. E. (1977). Pharmacokinetics of 1,4-dioxane in humans. J. Toxicol. Environ. Health 3, 507-520.