Can exposure characterization explain concurrence or discordance between toxicology and epidemiology?

Toxicological Sciences

Volumn 97, Issue 2, 2007, Pages 241-252

  Ritter, Leonard ^a   Arbuckle, Tye E ^b  

^a UNIVERSITY OF GUELPH   (Canada)

^b Environmental Health Center   (Canada)

Author keywords

Administered dose; Biological dose; Epidemiology; Exposure assessment; Pesticides; Phthalates; Risk assessment; Toxicology

Indexed keywords

BIOLOGICAL MARKER; PESTICIDE; PHTHALIC ACID DERIVATIVE;

ARTICLE; BIOLOGICAL MONITORING; ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL MONITORING; EXPERIMENTAL ANIMAL; EXPERIMENTAL STUDY; HEALTH HAZARD; HUMAN; HUMAN VERSUS ANIMAL COMPARISON; NONHUMAN; OBSERVATIONAL STUDY; RISK ASSESSMENT; TOXICOKINETICS;

ADULT; ANIMALS; ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL MONITORING; EPIDEMIOLOGY; FEMALE; HALF-LIFE; HUMANS; MALE; NEOPLASMS; OCCUPATIONAL EXPOSURE; PESTICIDES; PHTHALIC ACIDS; POPULATION; PREGNANCY; PRENATAL EXPOSURE DELAYED EFFECTS; RESEARCH DESIGN; TOXICITY TESTS; TOXICOLOGY;

ANIMALIA;

EID: 34447580124     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfm005     Document Type: Article

References (87)

1. Ablake, M., Itoh, M., Terayama, H., Hayashi, S., Shoji, S., Naito, M., Takahashi, K., Suna, S., and Jitsunari, F. (2004). Di-(2-ethylhexyl) phthalate induces severe aspermatogenesis in mice, however, subsequent antioxidant vitamins supplementation accelerates regeneration of the seminiferous epithelium. Int. J. Androl. 27, 274-281.
2. Adibi, J. J., Perera, F. P., Jedrychowski, W., Camann, D. E., Barr, D., Jacek, R., and Whyatt, R. M. (2003). Prenatal exposures to phthalates among women in New York City and Krakow, Poland. Environ. Health Perspect. 111, 1719-1722.
3. Alavanja, M. C. R., Sandler, D. P., McMaster, S. B., Hoar Zahm, S., McDonnell, C. J., Lynch, C. F., Pennybacker, M., Rothman, N., Dosemeci, M., Bond, A. E., and Blair, A. (1996). The Agricultural Health Study. Environ. Health Perspect. 104, 362-369.
4. Arbuckle, T. E., Cole, D. C., Ritter, L., and Ripley, B. D. (2004). Farm children's exposure to herbicides: Comparison of biomonitoring and questionnaire data. Epidemiology 15, 187-194.
5. Astill, B. (1989). Metabolism of DEHP: Effects of prefeeding and dose variation, and comparative studies in rodents and the cynomolgus monkey (CMA studies). Drug Metab. Rev. 21, 35-53.
6. Baris, D., Zahm, S. H., Cantor, K. P., and Blair, A. (1998). Agricultural use of DDT and risk of non-Hodgkin's lymphoma: Pooled analysis of three case-control studies in the United States. Occup. Environ. Med. 55, 522-527.
7. Barr, D. B., Silva, J. M., Kato, K., Reidy, J. A., Malek, N. A., Hurtz, D., Sadowski, M., Needham, L. L., and Calafat, A. M. (2003). Assessing human exposure to phthalates using monoesters and their oxidized metabolites as biomarkers. Environ. Health Perspect. 111, 1148-1151.
8. Barr, D. B., Wilder, L. C., Caudill, S. P., Gonzalez, A. J., Needham, L. L., and Pirkle, J. L. (2005). Urinary creatinine concentrations in the U.S. population: Implications for urinary biological monitoring measurements. Environ. Health Perspect. 113, 192-200.
9. Blair, A., Sandler, D., Lynch, C. F., Roland, A., Wintersteen, W., Steen, W. C., Samanic, C., Dosemeci, M., and Alavanja, M. C. R. (2002). Reliability of reporting on lifestyle and agricultural factors by a sample of participants in the agricultural health study from Iowa. Epidemiology 13, 94-99.
10. Calafat, A. M., Silva, M. J., Reidy, J. A., Gray, L. E., Samandar, E., Preau, J. L., Herbert, A. R., and Needham, L. L. (2006a). Mono-(3-carboxypropyl) phthalate, a metabolite of di-n-octyl phthalate. J. Toxicol. Environ. Health A 69, 215-227.
11. Calafat, A. M., Slakman, A. R., Silva, M. J., Herbert, A. R., and Needham, L. L. (2004). Automated solid phase extraction and quantitative analysis of human milk for 13 phthalate metabolites. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 805, 49-56.
12. Calafat, A. M., Ye, X., Silva, M. J., Kuklemyik, Z., and Needham, L. L. (2006b). Human exposure assessment to environmental chemicals using biomonitoring. Int. J. Androl. 29, 166-171.
13. Calderon, R. L. (2000). Measuring risks in humans: The promise and practice of epidemiology. Food Chem. Toxicol. 38, S59-S63.
14. Coble, J., Arbuckle, T., Lee, W., Alavanja, M., and Dosemeci, M. (2005). The validation of a pesticide exposure algorithm using biological monitoring results. J. Occup. Environ. Hyg. 2, 194-201.
15. Daniels, J. L., Olshan, A. F., and Savitz, D. A. (1997). Pesticides and childhood cancer. Environ. Health Perspect. 105, 1068-1077.
16. Dosemeci, M., Alavanja, M., Rowland, A., Mage, D., Zahm, S., Rothman, N., Lubin, J., Hoppin, J., Sandler, D., and Blair, A. (2002). A quantitative approach for estimating exposure to pesticides in the agricultural health study. Ann. Occup. Hyg. 46, 245-260.
17. Duty, S. M., Silva, M. J., Barr, D. B., Brock, J.W., Ryan, L., Chen, Z., Herrick, R. F., Christiani, D. C., and Hauser, R. (2003). Phthalate exposure and human semen parameters. Epidemiology 14, 269-277.
18. Elswick, B. A., Welsch, F., and Janszen, D. B. (2000). Effect of different sampling designs on outcome of endocrine disruptor studies. Reprod. Toxicol. 14, 359-367.
19. Ema, M., and Miyawaki, E. (2001). Adverse effects on development of the reproductive system in male offspring of rats given monobutyl phthalate, a metabolite of dibutyl phthalate, during late pregnancy. Reprod. Toxicol. 15, 189-194.
20. Fennell, T. R., Krol, W. L., Sumner, S. C., and Snyder, R. W. (2004). Pharmacokinetics of dibutylphthalate in pregnant rats. Toxicol. Sci. 82, 407-418.
21. Fisher, J. S., Macpherson, S., Marchetti, N., and Sharpe, R. M. (2003). Human testicular dysgenesis syndrome: A possible model based on in-utero exposure of the rat to dibutyl phthalate. Hum. Reprod. 18, 1383-1394.
22. Foster, P. M., Cattley, R. C., and Mylchreest, E. (2000). Effects of di-n-butyl phthalate (DBP) on male reproductive development in the rat: Implications for human risk assessment. Food Chem. Toxicol. 38 Suppl.), S97-S99.
23. Ginsberg, G., Hattis, D., Sonawane, B., Russ, A., Banati, P., Kozlak, M., Smolenski, S., and Goble, R. (2002). Evaluation of child/adult pharmacokinetic differences from a database derived from the therapeutic drug literature. Toxicol. Sci. 66, 185-200.
24. Grandjean, P., and Toppari, J. (2006). General discussion: Possible effects of phthalate exposure in doses relevant for humans. Int. J. Androl. 29, 181-185.
25. Gray, L. E., Jr, Ostby, J., Furr, J., Price, M., Veeramachaneni, D. N., and Parks, L. (2000). Perinatal exposure to the phthalates DEHP, BBP, and DINP, but not DEP, DMP, or DOTP, alters sexual differentiation of the male rat. Toxicol. Sci. 58, 350-365.
26. Gray, L. E., Jr, Wilson, V. S., Stoker, T., Lambright, C., Furr, J., Noriega, N., Howdeshell, K., Ankley, G. T., and Guillette, L. (2006). Adverse effects of environmental antiandrogens and androgens on reproductive development in mammals. Int. J. Androl. 29, 96-104.
27. Green, R., Hauser, R., Calafat, A. M., Weuve, J., Schettler, T., Ringer, S., Huttner, K., and Hu, H. (2005). Use of di(2-ethylhexyl) phthalate-containing medical products and urinary levels of mono(2-ethylhexyl) phthalate in neonatal intensive care unit infants. Environ. Health Perspect. 113, 1222-1225.
28. Hattis, D., Ginsberg, G., Sonawane, B., Smolenski, S., Russ, A., Kozlak, M., and Goble, R. (2003). Differences in pharmacokinetics between children and adults - II. Children's variability in drug elimination half-lives and in some parameters needed for physiologically-based pharmacokinetic modeling. Risk Anal. 23, 117-142.
29. Hauser, R., and Calafat, A. M. (2005). Phthalates and human health. Occup. Environ. Med. 62, 806-818.
30. Hauser, R., Meeker, J. D., Park, S., Silva, M. J., and Calafat, A. M. (2004). Temporal variability of urinary phthalate metabolite levels in men of reproductive age. Environ. Health Perspect. 112, 1734-1740.
31. Hauser, R., Williams, P., Altshud, L., and Calafat, A. M. (2005). Evidence of interaction between polychlorinated biphenyls and phthalates in relation to human sperm motility. Environ. Health Perspect. 113, 425-430.
32. Hill, A. B. (1965). The environment and disease: Association or causation. Proc. R. Soc. Med. 58, 295-300.
33. Hoppin, J. A., Brock, J. W., Davis, B. J., and Baird, D. D. (2002). Reproducibility of urinary phthalate metabolites in first morning urine samples. Environ. Health Perspect. 110, 515-518.
34. Hunt, P. A., Koechler, K. E., Susiarjo, M., Hodges, C. A., Ilagan, A., Voigt, R. C., Thomas, S., Thomas, B. F., and Hassold, T. J. (2003). Bisphenol A exposure causes meiotic aneuploidy in the female mouse. Curr. Biol. 13, 546-553.
35. Itoh, H., Yoshida, K., and Masunaga, S. (2005). Evaluation of the effect of government control of human exposure to two phthalates in Japan using a urinary biomarker approach. Int. J. Hyg. Environ. Health 208 237-245.
36. Jung-Koo, H., and Mu-Lee, B. (2005). Human monitoring of phthalates and risk assessment. J. Toxicol. Environ. Health A 68, 1379-1392.
37. Kato, K., Silva, M. J., Brock, J. W., Reidy, J. A., Malek, N. A., Hodge, C. C., Nakazawa, H., Needham, L. L., and Barr, D. B. (2003). Quantitative detection of nine phthalate metabolites in human serum using reversed-phase high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry. J. Anal. Toxicol. 27, 284-289.
38. Kato, K., Silva, M. J., Reidy, J. A., Hurtz, D., III, Malek, N. A., Needham, L. L., Nakazawa, H., Barr, D. B., and Calafat, A. M. (2004). Mono(2-ethyl-5-hydroxyhexyl) phthalate and mono-(2-ethyl-5-oxohexyl) phthalate as biomarkers for human exposure assessment to di-e(2-ethylhexyl) phthalate. Environ. Health Perspect. 112, 327-330.
39. Kessler, W., Numtip, W., Grote, K., Csanady, G., Chahoud, I., and Filser, J. (2004). Body burden of di(2-ethylhexyl) phthalate (DEHP) and its primary metabolite mono(2-ethylhexyl) phthalate (MEHP) in pregnant and non-pregnant rats and marmosets. Toxicol. Appl. Pharmacol. 195, 142-153.
40. Koch, H. M., Bolt, H. M., and Angerer, J. (2004). Bi(2-ethylhexyl) phthalate (DEHP) metabolites in human urine and serum after a single oral dose of deuterium-labeled DEHP. Arch. Toxicol. 78, 123-130.
41. Koch, H. M., Bolt, H. M., Preuss, R., and Angerer, J. (2005). New metabolites of di(2-ethylhexyl) phthalate (DEHP) in human urine and serum after single oral doses of deuterium-labelled DEHP. Arch. Toxicol. 79, 367-376.
42. Koch, H. M., Drexler, H., and Angerer, J. (2003b). An estimation of the daily intake of di(2-ethylhexyl) phthalate (DEHP) and other phthalates in the general population. Int. J. Hyg. Environ. Health 206, 77-83.
43. Koch, H. M., Preuss, R., and Angerer, J. (2006). Di(2-ethylhexyl)phthalate (DEHP): Human metabolism and internal exposure - An update and latest results. Int. J. Androl. 29, 155-165.
44. Koch, H. M., Rossbach, B., Drexler, H., and Angerer, J. (2003a). Internal exposure of the general population to DEHP and other phthalates - Determination of secondary and primary phthalate monoester metabolites in urine. Environ. Res. 93, 177-185.
45. Koo, J. W., Parham, F., Kohn, M. C.,Masten, S. A., Brock, J. W., Needham, L. L., and Portier, C. J. (2002). The association between biomarker-based exposure estimates for phthalates and demographic factors in a human reference population. Environ. Health Perspect. 110, 405-410.
46. Kremer, J. J., Williams, C. C., Parkinson, H. D., and Borghoff, S. J. (2005). Pharmacokinetics of monobutylphthalate, the active metabolite of di-nbutylphthalate in pregnant rats. Toxicol. Lett. 159, 144-153.
47. Kurata, Y., Makinodan, F., Okada, M., Kawasuso, T., David, R., Gans, G., Regnier, J., and Katoh, M. (2003). Blood concentration and tissue distribution of 14C-di(2-ethylhexyl) phthalate (DEHP) in juvenile and adult common marmoset. Toxicologist 72, 384-385.
48. Leiss, J. K., and Savitz, D. A. (1995). Home pesticide use and childhood cancer: A case-control study. Am. J. Public Health 85, 249-252.
49. Ljungvall, K., Tienpont, B., David, F., Magnusson, U., and Torneke, K. (2004). Kinetics of orally administered di(2-ethylhexyl) phthalate and its metabolite mono(2-ethylhexyl) phthalate in male pigs. Arch. Toxicol. 78, 384-389.
50. Lottrup, G., Andersson, A.-M., Leffers, H., Mortensen, G. K., Toppair, J., Skakkebaek, N. E., and Main, K. M. (2006). Possible impact of phthalates on infant reproductive health. Int. J. Androl. 29 172-180.
51. Main, K. M., Mortensen, G. K., Kaleva,M. M., Boisen, K. A., Damgaard, I. N., Chellakooty, M., Schmidt, I. M., Suomi, A.-M., Virtanen, H. E., Petersen, J. H., et al. (2006). Human breast milk contamination with phthalates and alterations of endogenous reproductive hormones in infants three months of age. Environ. Health Perspect. 114, 270-276.
52. Marsee, K., Woodruff, T. J., Axelrad, D. A., Calafat, A. M., and Swan, S. H. (2006). Estimated daily phthalate exposures in a population of mothers of male infants exhibiting reduced anogenital distance. Environ. Health Perspect. 114, 805-809.
53. McKee, R. H., Butala, J. H., David, R. M., and Gans, G. (2004). NTP center for the evaluation of risks to human reproduction reports on phthalates: Addressing the data gaps. Reprod. Toxicol. 18, 1-22.
54. McKee, R. H., El-Hawari, M., Stoltz, M., Pallas, F., and Lington, A. W. (2002). Absorption, disposition and metabolism of di-isononyl phthalate (DINP) in F-344 rats. J. Appl. Toxicol. 22, 293-302.
55. Mylchreest, E., Wallace, D. G., Cattley, R. C., and Foster, P. M. (2000). Dose-dependent alterations in androgen-regulated male reproductive development in rats exposed to Di(n-butyl) phthalate during late gestation. Toxicol. Sci. 55, 143-151.
56. National Research Council (1983). Risk Assessment in the Federal Government: Managing the Process. National Academy Press, Washington, DC.
57. Ontario College of Family Physicians (2004). Pesticides Literature Review. Available at: http://www.ocfp.on.ca/English/OCFP/ Communications/CurrentIssues/Pesticides/default.asp?s=1.
58. Parks, L. G., Ostby, J. S., Lambright, C. R., Abbott, B. D., Klinefelter, G. R., Barlow, N. J., and Gray, L. E., Jr. (2000). The plasticizer diethylhexyl phthalate induces malformations by decreasing fetal testosterone synthesis during sexual differentiation in the male rat. Toxicol. Sci. 58, 339-349.
59. Pest Management Regulatory Agency (PMRA) (2005). Re-Evaluation of the Lawn and Turf Uses of 2,4-D. PACR 2005-01. PMRA (2005) = USEPA (2005) = Available at: http://www.pmraarla.gc.ca/english/pdf/pacr/ pacr2005-01-e.pdf.
60. Pugh, G., Jr, Isenberg, J. S., Kamendulis, L. M., Ackley, D. C., Clare, L. J., Brown, R., Lington, A.W., Smith, J. H., and Klaunig, J. E. (2000). Effects of di-isononyl phthalate, di-2-ethylhexyl phthalate and clofibrate in cynomolgus monkeys. Toxicol. Sci. 56, 181-188.
61. Rhodes, C., Orton, T., Pratt, I., Batten, P., Bratt, H., Jackson, S. J., and Elcombe, C. R. (1986). Comparative pharmacokinetics and subacute toxicity of di(2-ethylhexyl) phthalate (DEHP) in rats and marmosets: Extrapolation of effects in rodents to man. Environ. Health Perspect. 65, 299-308.
62. Rice, D. C. (2004). The US EPA reference dose for methylmercury: Sources of uncertainty. Environ. Res. 95, 406-413.
63. Rice, D. C. (2005). Assessing the effects of environmental toxicant exposure in developmental epidemiological studies: Issues for risk assessment. Neurotoxicology 26, 483-489.
64. Ritter, L. (2002). Cancer and exposure characterization: Application of the risk assessment paradigm. In Proceedings of the 223rd National Meeting of the American Chemical Societ,April, 2002, Orlando, Florida.
65. Rothenberg, S. J., and Rothenberg, J. C. (2005). Testing the dose-response specifications in epidemiology: Public health and policy consequences for lead. Environ. Health Perspect. 113, 1190-1195.
66. Rothman, K. J. (1986). Modern Epidemiology. Little, Brown and Company, Boston, MA.
67. Sears, M., Walker, R. C., Van der Jagt, R. H. C., and Claman, P. (2006). Pesticide assessment: Protecting public health on the home turf. Paediatr. Child Health 11, 229-234.
68. Sharpe, R. M. (2005). Phthalate exposure during pregnancy and lower anogenital index in boys: Wider implications for the general population? Environ. Health Perspect. 113, A504-A505.
69. Sharpe, R. M., Turner, K. J., and Sumpter, J. P. (1998). Endocrine disruptors and testis development. Environ. Health Perspect. 106, A220.
70. Silva, M. J., Barr, D. B., Reidy, J. A., Kato, K., Malek, N. A., Hodge, C. C., Hurtz, D., III, Calafat, A. M., Needham, L. L., and Brock, J. W. (2003). Glucuronidation patterns of common urinary and serum monoester phthalate metabolites. Arch. Toxicol. 77, 561-567.
71. Silva, M. J., Barr, D. B., Reidy, J. A., Malek, N. A., Hodge, C. C., Caudill, S. P., Brock, J. W., Needham, L. L., and Calafat, A. M. (2004). Urinary levels of seven phthalate metabolites in the U.S. population from the National Health and Nutrition Examination Survey (NHANES) 1999-2000. Environ. Health Perspect. 112, 331-338.
72. Silva, M. J., Kato, K., Gray, E. L.,Wolf, C., Needham, L. L., and Calafat, A. M. (2005). Urinary metabolites of di-n-octyl phthalate in rats. Toxicology 210, 123-133.
73. Silva, M. J. Reidy, J, A., Preau, Jr. J. L., Needham, L. L., and Calafat, A. M. (2006). Oxidative metabolites of di-isononyl phthalate as biomarkers for human exposure assessment. Environ. Health Perspect. 114, 1158-1161.
74. Skakkeback, N. E. (2002). Endocrine disruptors and testicular dysgenesis syndrome. Horm. Res. 57(Suppl. 2), 43.
75. Stewart, P. A. (1999). Challenges to retrospective exposure assessment. Challenges to retrospective exposure assessment. Scand. J. Work Environ. Health 25, 505-510.
76. Swan, S. H., Main, K. M., Liu, F., Stewart, S. L., Kruse, R. L., Calafat, A. M., Mao, C. S., Redmon, J. B., Ternand, C. L., Sullivan, S., et al. (2005). Decrease in anogenital distance among male infants with prenatal phthalate exposure. Environ. Health Perspect. 113 1056-1061.
77. Tanaka, A., Matsumoto, A., and Yamaha, T. (1978). Biochemical studies on phthalic esters. III Metabolism of dibutyl phthalate (DBP) in animals. Toxicology 9, 109-123.
78. Thompson, C. J., Ross, S. M., and Gaido, K. W. (2004). Di(n-butyl) phthalate impairs cholesterol transport and steroidogenesis in the fetal rat testis through a rapid and reversible mechanism. Endocrinology 145, 1227-1237.
79. U.S. Environmental Protection Agency (USEPA) (1990). Integrated Risk Information System: Dibutyl PhtHalate. Available at: http://cfpub.epa.gov/iris/quickview.cfm?substance_nmbr=0038.
80. U.S. Environmental Protection Agency (USEPA) (1991). Integrated Risk Information System: Di(2-ethylhexyl)Phthalate (DEHP). Available at: http://cfpub.epa.gov/iris/quickview.cfm?substance_nmbr=0014.
81. U.S. Environmental Protection Agency (USEPA) (1993a). Integrated Risk Information System: DiethylphtHalate. Available at: http://cfpub.epa.gov/iris/quickview.cfm?substance_nmbr=0226.
82. U.S. Environmental Protection Agency (USEPA) (1993b). Integrated Risk Information System: Butyl Benzyl PhtHalate. Available at: http://cfpub.epa.gov/iris/quickview.cfm?substance_nmbr=0293.
83. U.S. Environmental Protection Agency (USEPA) (2005). Reregistration Eligibility Decision for 2,4-D. 738-R-05-002. USEPA (2005) = http://www.epa.gov/REDs/24d_red.pdf.
84. Voss, C., Zerban, H., Bannasch, P., and Berger,M. R. (2005). Lifelong exposure to di-(2-ethylhexyl) phthalate induces tumors in liver and testes of Sprague-Dawley rats. Toxicology 206, 359-371.
85. Wilson, V. S., Lambright, C., Furr, J., Ostby, J., Wood, C., Held, G., and Gray, L. E., Jr. (2004). Phthalate ester-induced gubernacular lesions are associated with reduced insl3 gene expression in the fetal rat testis. Toxicol. Lett. 146, 207-215.
86. Zahm, S. H., and Ward, M. H. (1998). Pesticides and childhood cancer. Environ. Health Perspect. 106(Suppl. 3), 893-908.
87. Zhang, Y., Jiang, X., and Chen, B. (2004). Reproductive and developmental toxicity in F1 Sprague-Dawley male rats exposed to di-n-butyl phthalate in utero and during lactation and determination of its NOAEL. Reprod. Toxicol. 18, 669-676.