Revised assessment of cancer risk to dichloromethane: Part I Bayesian PBPK and dose-response modeling in mice

Regulatory Toxicology and Pharmacology

Volumn 45, Issue 1, 2006, Pages 44-54

  Marino, Dale J ^a   Clewell, Harvey J ^b   Gentry, P Robinan ^c   Covington, Tammie R ^c   Hack, C Eric ^d   David, Raymond M ^a   Morgott, David A ^a  

^a EASTMAN KODAK COMPANY   (United States)

^b CIIT CENTERS FOR HEALTH RESEARCH   (United States)

^c ENVIRON Health Sciences Institute   (United States)

^d Toxicology Excellence for Risk Assessment   (United States)

Author keywords

Bayesian modeling; Dose response modeling; PBPK modeling

Indexed keywords

DICHLOROMETHANE;

ARTICLE; BAYES THEOREM; BIOASSAY; CALIBRATION; CANCER RISK; COMPUTER PROGRAM; DOSE RESPONSE; DOSIMETRY; LIVER; LUNG; MATHEMATICAL MODEL; MONTE CARLO METHOD; POPULATION MODEL; PRIORITY JOURNAL; PROBABILITY; QUANTITATIVE ANALYSIS; RISK ASSESSMENT; SIMULATION; UNCERTAINTY;

ANIMALS; BAYES THEOREM; CARCINOGENS; DOSE-RESPONSE RELATIONSHIP, DRUG; INHALATION EXPOSURE; MARKOV CHAINS; METHYLENE CHLORIDE; MICE; MODELS, BIOLOGICAL; MONTE CARLO METHOD; NEOPLASMS; RISK ASSESSMENT;

EID: 33646092056     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2005.12.007     Document Type: Article

References (32)

1. Ahmed A.E., and Anders M.W. Metabolism of dihalomethanes to formaldehyde and inorganic halide. I. In vitro studies. Drug Metab. Dispos. 4 (1978) 357-361
2. Andersen M.E., Clewell H.J., Gargas M.L., Smith F.A., and Reitz R.H. Physiologically based pharmacokinetics and the risk assessment for methylene chloride. Toxicol. Appl. Pharmacol. 87 (1987) 185-205
3. Angelo M.J., Bischoff K.B., Pritchard A.B., and Presser M.A. A physiological model for the pharmacokinetics of methylene chloride in B6C3F1 mice following i.v. administration. J. Pharmacokinet. Biopharm. 12 (1984) 413-436
4. Bernillon P., and Bois F.Y. Statistical issues in toxicokinetic modeling: A Bayesian perspective. Environ. Health Perspect. 108 5 (2000) 883-893
5. Bois F. Analysis of PBPK models for risk characterization. Ann. N. Y. Acad. Sci. 895 (1999) 317-337
6. Bois F. Statistical analysis of Clewell et al. PBPK model of trichloroethylene kinetics. Environ. Health Perspect. 108 2 (2000) 307-316
7. Bois, F., Maszle, D., Revzan, K., Tillier, S., Yuan, Z., 2002. MCSim Version 5 beta 2. .
8. Burek J., Nitschke K., Bell T., Wackerle D., Childs R., Beyer J., Dittenber D., Rampy L., and McKenna M. Methylene chloride: a two-year inhalation toxicity and oncogenicity study in rats and hamsters. Fundam. Appl. Toxicol. 4 (1984) 30-47
9. Carlin B.P., and Louis T.A. Bayes and Empirical Bayes Methods for Data Analysis. second ed. (2000), CRC Press LLC, Boca Raton
10. Clewell, H.J., Gearhart, J.M., Andersen, M.E., 1993. analysis of the metabolism of methylene chloride in the B6C3F1 mouse and its implications for human carcinogenic risk. Submission to OSHA Docket #H-071, Exhibit #96.
11. Clewell H.J. The use of physiologically based pharmacokinetic modeling in risk assessment: a case study with methylene chloride. In: Olin S., Farland W., Park C., Rhomberg L., Scheuplein R., Starr T., and Wilson J. (Eds). Low-Dose Extrapolation of Cancer Risks: Issues and Perspectives (1995), ILSI Press, Washington, DC 199-221
12. David, R.M., Clewell, H.J., Gentry, P.R., Covington, T., Morgott, D.A., Marino, D.J., 2005. Revised assessment of cancer risk to cichloromethane using improved human metabolic parameters and bayesian statistics. Reg. Pharmacol. Toxicol Submitted.
13. El-Masri H.A., Bell D.A., and Portier C.J. Effects of glutathione transferase theta polymorphism on the risk estimates of dichloromethane to humans. Toxicol. Appl. Pharmacol. 158 (1999) 221-230
14. Gelman A. Inference and monitoring convergence. In: Gilks W.R., Richardson S., and Spiegelhalter D.J. (Eds). Markov Chain Monte Carlo in Practice (1996), Chapman and Hall/CRC, Boca Raton, FL 131-143
15. Gelman A., Bois F., and Jiang J. Physiological pharmacokinetic analysis using population modeling and informative prior distributions. J. Am. Stat. Assoc. 91 436 (1996) 1400-1412
16. Gilks W.R., Richardson S., and Spiegelhalter D.J. Markov Chain Monte Carlo in Practice (1996), Chapman and Hall/CRC, Boca Raton, FL
17. Holbrook M.T. Methylene chloride. In: Kroschwitz J.I. (Ed). Kirk-Othmer Encyclopedia of Chemical Technology. fourth ed. vol. 5 (1993), John Wiley, New York, NY 1041-1050
18. Jonsson, F., 2001. Physiologically based pharmacokinetic modeling in risk assessment: development of Bayesian population methods. National Institute for Working Life. Stockholm, Sweden. .
19. Jonsson F., and Johanson G. A Bayesian analysis of the influence of GSTT1 polymorphism on the cancer risk estimate for dichloromethane. Toxicol. Appl. Pharmacol. 174 (2001) 99-112
20. Jonsson F., and Johanson G. The Bayesian population approach to physiological toxicokinetic-toxicodynamic models-an example using the MCSim software. Toxicol. Lett. 138 8 (2003) 143-150
21. National Coffee Association, 1982. Twenty-four month chronic toxicity and oncogenicity study of methylene chloride in rats. Unpublished report, Hazleton Laboratories America, Inc., Vienna VA, as cited in NTP (1986).
22. National Coffee Association, 1983. Twenty-four month chronic toxicity and oncogenicity study of methylene chloride in mice. Final report, Hazleton Laboratories America, Inc., Vienna VA, as cited in NTP (1986).
23. National Toxicology Program (NTP), 1986. Toxicology and carcinogenesis studies of dichloromethane (methylene chloride) (CAS No. 75-09-2) in F344/N rats and B6C3F1 mice (inhalation studies). NTP-TR-306.
24. Nitschke K.D., Burek J.D., Bell TJ., Kociba R.J., Rampy L.W., and McKenna M.J. Methylene chloride: a 2-year inhalation toxicity and oncogenicity study in rats. Fundam. Appl. Toxicol. 11 (1988) 48-59
25. Occupational Safety and Health Administration (OSHA), 1997. Occupational Exposure to Methylene Chloride. Fed. Reg. vol. 62, No. 7, pp 1493-1619.
26. Serota D.G., Thakur A.K., Ulland B.M., Kirschman J.C., Brown N.M., Coots R.H., and Morgareidge K. A two-year drinking water study of dichloromethane in rodents. I. Rats. Food Chem. Toxicol. 24 (1986) 951-958
27. Serota D.G., Thakur A.K., Ulland B.M., Kirschman J.C., Brown N.M., Coots R.H., and Morgareidge K. A two-year drinking water study of dichloromethane in rodents. I. Mice. Food Chem. Toxicol. 24 (1986) 959
28. Slikker Jr. W., Andersen M.E., Bogdanffy M.S., Bus J.S., Cohen S.D., Conolly R.B., David R.M., Doerrer N.G., Dorman D.C., Gaylor D.W., Hattis D., Rogers J.M., Setzer R.W., Swenberg J.A., and Wallace K. Dose-dependent transitions in mechanisms of toxicity: case studies. Toxicol. Appl. Pharmacol. 201 3 (2004) 226-294
29. Sweeney L.M., Kirman C.R., Morgott D.A., and Gargas M.L. Development of a refined physiologically based pharmacokinetic model for dichloromethane and application to estimation of interindividual variation in oxidative metabolism in human volunteers. Toxicol. Lett. 154 (2004) 201-216
30. Thomas R.S., Lytle W.E., Keefe T.J., Constan A.A., and Yang R.S. Incorporating Monte Carlo simulation into physiologically based pharmacokinetic models using advanced continuous simulation language (ACSL): a computational method. Fundam. Appl. Toxicol. 31 1 (1996) 19-28
31. United States Environmental Protection Agency (USEPA), 1987. Technical Analysis of New Methods and Data Regarding Dichloromethane Hazard Assessments Office of Health and Environmental Assessment. EPA/600/8-87/029A. June 1987.
32. United States Environmental Protection Agency (USEPA), 2004. Integrated Risk Information System: Dichloromethane. .