A systematic approach for identifying and presenting mechanistic evidence in human health assessments

Regulatory Toxicology and Pharmacology

Volumn 67, Issue 2, 2013, Pages 266-277

  Kushman, Mary E ^a   Kraft, Andrew D ^b   Guyton, Kathryn Z ^b   Chiu, Weihsueh A ^b   Makris, Susan L ^b   Rusyn, Ivan ^a  

^a University of North Carolina at Chapel Hill   (United States)

^b U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

Author keywords

Di(2 ethylhexyl)phthalate; Hazard assessment; Mechanistic evidence; Systematic review

Indexed keywords

PHTHALIC ACID 2 ETHYLHEXYL MONOESTER; PHTHALIC ACID BIS(2 ETHYLHEXYL) ESTER;

ARTICLE; CANCER RISK; CARCINOGENICITY; CELL COMMUNICATION; GAP JUNCTION; HAZARD ASSESSMENT; HEALTH HAZARD; HUMAN; LIVER CANCER; LIVER TOXICITY; MEDICAL LITERATURE; MEDLINE; NONHUMAN; PRIORITY JOURNAL; PUBLICATION; SYSTEMATIC REVIEW; SYSTEMATIC REVIEW (TOPIC);

DI(2-ETHYLHEXYL)PHTHALATE; HAZARD ASSESSMENT; MECHANISTIC EVIDENCE; SYSTEMATIC REVIEW;

ANIMALS; CARCINOGENS; DATABASES, FACTUAL; DIETHYLHEXYL PHTHALATE; HUMANS; LITERATURE BASED DISCOVERY; NEOPLASMS; PUBMED; RISK ASSESSMENT;

EID: 84886589296     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2013.08.005     Document Type: Article

References (47)

1. Caldwell J.C. DEHP: genotoxicity and potential carcinogenic mechanisms-a review. Mutat. Res. 2012, 751:82-157.
2. David R.M., et al. Chronic peroxisome proliferation and hepatomegaly associated with the hepatocellular tumorigenesis of di(2-ethylhexyl)phthalate and the effects of recovery. Toxicol. Sci. 1999, 50:195-205.
3. DHHS, The Health Consequences of Smoking: A report of the Surgeon General. 2004.
4. Drummond M.B., et al. Inhaled corticosteroids in patients with stable chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA 2008, 300:2407-2416.
5. EPA, Guidelines for carcinogen risk assessment 2005.
6. Eveillard A., et al. Di-(2-ethylhexyl)-phthalate (DEHP) activates the constitutive androstane receptor (CAR): a novel signalling pathway sensitive to phthalates. Biochem. Pharmacol. 2009, 77:1735-1746.
7. Feige J.N., et al. The pollutant diethylhexyl phthalate regulates hepatic energy metabolism via species-specific PPARalpha-dependent mechanisms. Environ. Health Perspect. 2010, 118:234-241.
8. Gehlhaus M.W., et al. Approaches to cancer assessment in EPA's integrated risk information system. Toxicol. Appl. Pharmacol. 2011, 254:170-180.
9. Goll V., et al. Comparison of the effects of various peroxisome proliferators on peroxisomal enzyme activities, DNA synthesis, and apoptosis in rat and human hepatocyte cultures. Toxicol. Appl. Pharmacol. 1999, 160:21-32.
10. Grosse Y., et al. Carcinogenicity of chemicals in industrial and consumer products, food contaminants and flavourings, and water chlorination byproducts. Lancet Oncol. 2011, 12:328-329.
11. Guyatt G.H., et al. Experience with GRADE. J. Clin. Epidemiol. 2012, 65:1243-1244.
12. Guyatt G.H., et al. GRADE guidelines-an introduction to the 10th-13th articles in the series. J. Clin. Epidemiol. 2013, 66:121-123.
13. Guyatt G.H., et al. GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology. J. Clin. Epidemiol. 2011, 64:380-382.
14. Guyton K.Z., et al. Mode of action frameworks: a critical analysis. J. Toxicol. Environ. Health B: Crit. Rev. 2008, 11:16-31.
15. Guyton K.Z., et al. A reexamination of the PPAR-alpha activation mode of action as a basis for assessing human cancer risks of environmental contaminants. Environ. Health Perspect. 2009, 117:1664-1672.
16. Hinton R.H., et al. Effects of phthalic acid esters on the liver and thyroid. Environ. Health Perspect. 1986, 70:195-210.
17. IARC, Di(2-ethylhexyl) phthalate. Some industrial chemicals, Vol. 77, Lyon, France, 2000, pp. 41-148.
18. IARC, Di(2-ethylhexyl)phthalate. Some chemicals present in industrial and consumer products, food, and drinking-water, Vol. 101, Lyon, France, 2012, pp. 149-284.
19. IOM, Improving the presumptive disability decision-making process for veterans. Washington DC, 2008.
20. Isenberg J.S., et al. Reversibility and persistence of di-2-ethylhexyl phthalate (DEHP)- and phenobarbital-induced hepatocellular changes in rodents. Toxicol. Sci. 2001, 64:192-199.
21. Isenberg J.S., et al. Effects of di-2-ethylhexyl phthalate (DEHP) on gap-junctional intercellular communication (GJIC), DNA synthesis, and peroxisomal beta oxidation (PBOX) in rat, mouse, and hamster liver. Toxicol. Sci. 2000, 56:73-85.
22. Ito Y., et al. Plasticizers may activate human hepatic peroxisome proliferator-activated receptor alpha less than that of a mouse but may activate constitutive androstane receptor in liver. PPAR Res. 2012, 2012. 201284.
23. Ito Y., et al. Di(2-ethylhexyl)phthalate induces hepatic tumorigenesis through a peroxisome proliferator-activated receptor alpha-independent pathway. J. Occup. Health. 2007, 49:172-182.
24. Kamendulis L.M., et al. Comparative effects of phthalate monoesters on gap junctional intercellular communication and peroxisome proliferation in rodent and primate hepatocytes. J. Toxicol. Environ. Health A 2002, 65:569-588.
25. Klaunig J.E., et al. PPARalpha agonist-induced rodent tumors: modes of action and human relevance. Crit. Rev. Toxicol. 2003, 33:655-780.
26. Klaunig J.E., et al. Inhibition of mouse hepatocyte intercellular communication by phthalate monoesters. Cancer Lett. 1988, 43:65-71.
27. Kluwe W.M. Overview of phthalate ester pharmacokinetics in mammalian species. Environ. Health Perspect. 1982, 45:3-9.
28. Leibold E., et al. Inhibition of intercellular communication of rat hepatocytes by nafenopin: involvement of protein kinase C. Carcinogenesis 1994, 15:1265-1269.
29. Lorber M., et al. A simple pharmacokinetic model to characterize exposure of Americans to di-2-ethylhexyl phthalate. J. Expo. Sci. Environ. Epidemiol. 2010, 20:38-53.
30. Lorber M., et al. A critical evaluation of the creatinine correction approach: can it underestimate intakes of phthalates? A case study with di-2-ethylhexyl phthalate. J. Expo. Sci. Environ. Epidemiol. 2011, 21:576-586.
31. McKee R.H. The role of inhibition of gap junctional intercellular communication in rodent liver tumor induction by phthalates: review of data on selected phthalates and the potential relevance to man. Regul. Toxicol. Pharmacol. 2000, 32:51-55.
32. Melnick R.L. Is peroxisome proliferation an obligatory precursor step in the carcinogenicity of di(2-ethylhexyl)phthalate (DEHP)?. Environ. Health Perspect. 2001, 109:437-442.
33. Melnick R.L., et al. Studies by the National Toxicology Program on di(2-ethylhexyl)phthalate. Toxicol. Ind. Health 1987, 3:99-118.
34. NRC, Monitoring Human Tissues for Toxic Substances. Washington DC, 1991.
35. NRC, Science and Decisions: Advancing Risk Assessment. Washington DC, 2009, pp. 424.
36. NRC, 2010. Review of the Environmental Protection Agency's Draft IRIS Assessment of Tetrachloroethylene.
37. NRC, Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde. Washington DC, 2011.
38. Peters J.M., et al. Peroxisome proliferator-activated receptor-alpha and liver cancer: where do we stand?. J. Mol. Med. (Berl) 2005, 83:774-785.
39. Pugh G., et al. Effects of di-isononyl phthalate, di-2-ethylhexyl phthalate, and clofibrate in cynomolgus monkeys. Toxicol. Sci. 2000, 56:181-188.
40. Roberts R.A., et al. Role of the Kupffer cell in mediating hepatic toxicity and carcinogenesis. Toxicol. Sci. 2007, 96:2-15.
41. Rusyn I., Corton J.C. Mechanistic considerations for human relevance of cancer hazard of di(2-ethylhexyl) phthalate. Mutat. Res. 2012, 750:141-158.
42. Rusyn I., et al. Modes of action and species-specific effects of di-(2-ethylhexyl)phthalate in the liver. Crit. Rev. Toxicol. 2006, 36:459-479.
43. Stroup D.F., et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of observational studies in epidemiology (MOOSE) group. JAMA 2000, 283:2008-2012.
44. Svensson K., et al. Phthalate exposure associated with self-reported diabetes among Mexican women. Environ. Res. 2011, 111:792-796.
45. Teitelbaum S.L., et al. Associations between phthalate metabolite urinary concentrations and body size measures in New York City children. Environ. Res. 2012, 112:186-193.
46. van der Worp H.B., et al. Can animal models of disease reliably inform human studies?. PLoS Med. 2010, 7:e1000245.
47. Woodruff T.J., Sutton P. An evidence-based medicine methodology to bridge the gap between clinical and environmental health sciences. Health Aff. (Millwood) 2011, 30:931-937.