Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
권호 표지
DOI QR코드

DOI QR Code

Establishment of the Korean Tolerable Daily Intake of Bisphenol A Based on Risk Assessments by an Expert Committee

  • Choi, Chan-Woong (Risk Analysis & Research Division, Food Safety Evaluation Department, National Institute of Food and Drug Safety Evaluation) ;
  • Jeong, Ji-Yoon (Risk Analysis & Research Division, Food Safety Evaluation Department, National Institute of Food and Drug Safety Evaluation) ;
  • Hwang, Myung-Sil (Risk Analysis & Research Division, Food Safety Evaluation Department, National Institute of Food and Drug Safety Evaluation) ;
  • Jung, Ki-Kyung (Risk Analysis & Research Division, Food Safety Evaluation Department, National Institute of Food and Drug Safety Evaluation) ;
  • Lee, Kwang-Ho (Risk Analysis & Research Division, Food Safety Evaluation Department, National Institute of Food and Drug Safety Evaluation) ;
  • Lee, Hyo-Min (Risk Analysis & Research Division, Food Safety Evaluation Department, National Institute of Food and Drug Safety Evaluation)
  • Received : 2010.07.15
  • Accepted : 2010.08.25
  • Published : 2010.12.01
Download PDF
⟨ Previous Next ⟩

Abstract

Recently, reproductive and neurobehavioral effects of bisphenol A (BPA) have been documented, and thus a review was requested for BPA management direction by the government. Therefore, this study was performed to establish a Korean tolerable daily intake (TDI) for BPA. An expert committee, consisting of specialists in fields such as toxicology, medicine, pharmacology, and statistics, was asked to evaluate BPA health based guidance values (HbGVs). Although many toxicological studies were reviewed to select a point of departure (POD) for TDI, rat and mouse reproductive studies by Tyl et al. (2002, 2006), which were performed according to GLP standards and OECD guidelines, were selected. This POD was the lowest value determined from the most sensitive toxicological test. The POD, a NOAEL of 5 mg/kg bw/day, was selected based on its systemic toxicity as critical effects. An uncertainty factor of 100 including interspecies and intraspecies differences was applied to calculate the TDI. According to the evaluation results, a TDI of BPA for Korean was suggested at 0.05 mg/kg bw/day. In addition, the BPA exposure level based on food consumption by the Korean population was estimated as 1.509 ${\mu}g/kg$ bw/day, and the HI was evaluated at 0.03 when the TDI of 0.05 mg/kg bw/day was applied. This HI value of 0.03 indicated that hazardous effects would not be expected from BPA oral exposures. Although highly uncertain, further studies on low dose neurobehavioral effects of BPA should be performed. In addition, it is recommended that the 'as low as reasonably achievable' (ALARA) principle be applied for BPA exposure from food packaging materials in newborn infants and children.

Keywords

References

  1. ATSDR (2008). Toxicological profile for cadmium. Georgia, Agency for Toxic Substances and Disease Registry.
  2. Brotonx, J.A., Olea-Serrano, M.F., Villalobos, V.M., Pedraza, V. and Olea, N. (1995). Xenoestrogens released from lacquer coatings in food cans. Environ. Health Perspect., 103(6), 608-612. https://doi.org/10.2307/3432439
  3. Cagen, S.Z., Waechter, J.M., Dimond, S.S., Breslin, W.J., Butala, J.H., Jekat, F.W., Joiner, R.L., Shiotsuka, R., Veenstra, G.E. and Harris, L.R. (1999). Normal reproductive organ development in CF-1 mice following prenatal exposure to bisphenol A. Tox. Sci., 50, 36-44. https://doi.org/10.1093/toxsci/50.1.36
  4. Calvin, C.W., Gwendolyn, L.B. and Clifton, J.M. (2008). Derivation of a bisphenol A oral reference dose (RfD) and drinkingwater equivalent concentration. Journal of Toxicology and Environmental Health, Part B, 11, 69-146. https://doi.org/10.1080/10937400701724303
  5. Health Canada (2009). Government of canada acts to protect newborns and infants from bisphenol A in polycarbonate plastic baby bottles. Health Canada Press.
  6. Dodds, E.C. and Lawson, W. (1936). Synthetic estrogenic agents without the phenanthrene nucleus. Nature, 137, 996.
  7. EFSA (2006). Opinion of the scientific panel on food additives, flavourings, processing aids and materials in contact with food on a request from the commission related to 2,2-BIS(4-HYDROXYPHENYL)PROPANE (Bisphenol A). The EFSA Journal, 428.
  8. EFSA (2010). EFSA considers more than 800 studies on BPA, to finalise opinion in September. European Food Safety Authority Press.
  9. Ema, M., Fujii, S., Furukawa, M., Kiguchi, M., Ikka, T. and Harazono, A. (2001). Rat two-generation reproductive toxicity study of bisphenol A. Reprod. Toxicol., 15, 505-523. https://doi.org/10.1016/S0890-6238(01)00160-5
  10. Health Canada (2008). Health Risk Assessment of Bisphenol A from Food Packaging Applications. Ottawa, Health Canada.
  11. Kim, H.S., Han, S.Y., Kim, T.S., Kwack, S.J., Lee, R.D., Kim, I.Y., Seok, J.H., Lee, B.M., Yoo, S.D. and Park, K.L. (2002). No androgenic/anti-androgenic effects of bisphenol-A in Hershberger assay using immature castrated rats. Toxicol. Lett., 135(1-2), 111-123. https://doi.org/10.1016/S0378-4274(02)00130-3
  12. Kim, J.C., Shin, H.C., Cha, S.W., Koh, W.S., Chung, M.K. and Han, S.S. (2001). Evaluation of developmental toxicity in rats exposed to the environmental estrogen bisphenol A during pregnancy. Life Sci., 69(22), 2611-2625. https://doi.org/10.1016/S0024-3205(01)01341-8
  13. Kurebayashi, H., Betsui, H. and Ohno, Y. (2003). Disposition of a low dose of $^{14}C$-bisphenol A in male rats and its main biliary excretion as BPA glucuronide. Toxicol. Sci., 73, 17-25. https://doi.org/10.1093/toxsci/kfg040
  14. Kurebayashi, H., Nagatsuka, S., Nemoto, H., Noguchi, H. and Ohno, Y. (2005). Disposition of low doses of $^{14}C$-bisphenol A in male, female, pregnant, fetal, and neonatal rats. Arch. Toxicol., 79, 243-252. https://doi.org/10.1007/s00204-004-0628-2
  15. Lim, D.S., Kwack, S.J., Kim, K.B., Kim, H.S. and Lee, B.M. (2009). Risk assessment of bisphenol A migrated from canned foods in Korea. J. Toxicol. Environ. Health, 72(21-22), 1327-1335. https://doi.org/10.1080/15287390903212444
  16. Morrissey, R.E., George, J.D., Price, C.J., Tyl, R.W., Marr, M.C. and Kimmel, C.A. (1987). The developmental toxicity of bisphenol A in rats and mice. Fundamental and Applied Toxicol., 8, 571-582. https://doi.org/10.1016/0272-0590(87)90142-4
  17. Morrissey, R.E., Lamb, J.C., 4th, Morris, R.W., Chapin, R.E., Gulati, D.K. and Heindel, J.J. (1989). Results and evaluations of 48 continuous breeding reproduction studies conducted in mice. Fundam. Appl. Toxicol., 13, 747-777. https://doi.org/10.1016/0272-0590(89)90332-1
  18. Nagao, T., Saito, Y., Usumi, K., Yoshimura, S. and Ono, H. (2002). Low-dose bisphenol A does not affect reproductive organs in estrogen-sensitive C57BL/6N mice exposed at the sexually mature, juvenile, or embryonic stage. Reprod. Toxicol., 16(2), 123-130. https://doi.org/10.1016/S0890-6238(02)00003-5
  19. Nagel, S.C., vom Saal, F.S., Thayer, K.A., Dhar, M.G., Boechler, M. and Welshons, W.V. (1997). Relative binding affinity-serum modified access (RBA-SMA) assay predicts the relative in vivo bioactivity of the xenoestrogens bisphenol A and octylphenol. Environ. Health Perspect., 105, 70-76. https://doi.org/10.2307/3433065
  20. Nam, S.H., Seo, Y.M. and Kim, M.G. (2010). Bisphenol A migration from polycarbonate baby bottle with repeated use. Chemosphere., 79(9), 949-952. https://doi.org/10.1016/j.chemosphere.2010.02.049
  21. National Toxicology Program (1982). Carcinogenesis bioassay of bisphenol A in F344 rats and B6C3F1 mice (feed study). NTP Technical Report PB82184060.
  22. National Toxicology Program (2008). NTP-CERHR Monograph on the potential human reproductive and developmental effects of bisphenol A. NIH Publication No. 08-5994.
  23. Sakamoto, H., Yokota, H., Kibe, R., Sayama, Y. and Yuasa, A. (2002). Excretion of bisphenol A-glucuronide into the small intestine and deconjugation in the cecum of the rat. Biochim. Biophys. Acta, 1573, 171-176 https://doi.org/10.1016/S0304-4165(02)00418-X
  24. Schonfelder, G., Friedrich, K., Paul, M. and Chahoud, I. (2004). Developmental effects of prenatal exposure to bisphenol a on the uterus of rat offspring. Neoplasia., 6(5), 584-594. https://doi.org/10.1593/neo.04217
  25. Shimizu, M., Ohta, K., Matsumoto, Y., Fukuoka, M., Ohno, Y. and Ozawa, S. (2002). Sulfation of bisphenol A abolished its estrogenicity based on proliferation and gene expression in human breast cancer MCF-7 cells. Toxicol. In Vitro., 16, 549-556. https://doi.org/10.1016/S0887-2333(02)00055-3
  26. Stowell, C.L., Barvian, K.K., Young, P.C., Bigsby, R.M., Verdugo, D.E., Bertozzi, C.R. and Widlanski, T.S. (2006). A role for sulfation-desulfation in the uptake of bisphenol a into breast tumor cells. Chem. Biol., 13, 891-897. https://doi.org/10.1016/j.chembiol.2006.06.016
  27. Timms, B.G., Howdeshell, K.L., Barton, L., Bradley, S., Richter, C.A. and vom Saal, F.S. (2005). Estrogenic chemicals in plastic and oral contraceptives disrupt development of the fetal mouse prostate and urethra. Proc. Natl. Acad. Sci. USA, 102(19), 7014-7019. https://doi.org/10.1073/pnas.0502544102
  28. Tinwell, H., Haseman, J., Lefevre, P.A., Wallis, N. and Ashby, J. (2002). Normal sexual development of two strains of rat exposed in utero to low doses of bisphenol A. Toxicol. Sci., 68, 339-348. https://doi.org/10.1093/toxsci/68.2.339
  29. Tyl, R.W., Myers, C.B., Marr, M.C., Thomas, B.F., Keimowitz, A.R., Brine, D.R., Veselica, M.M., Fail, P.A., Chang, T.Y., Seely, J.C., Joiner, R.L., Butala, J.H., Dimond, S.S., Cagen, S.Z., Shiotsuka, R.N., Stropp, G.D. and Waechter, J.M. (2002). Three-generation reproductive toxicity study of dietary bisphenol A in CD Sprague-Dawley rats. Toxicol. Sci., 68, 121-146. https://doi.org/10.1093/toxsci/68.1.121
  30. Tyl, R.W., Myers, C.B. and Marr, M.C. (2006). Two-generation reproductive toxicity study of dietary bisphenol A in CD-1 (Swiss) mice. Toxicol. Sci., 104(2), 362-384. https://doi.org/10.1093/toxsci/kfn084
  31. U.S.EPA (2002). A Review of the reference dose and reference concentration process. Washington, DC, U.S. Environmental Protection Agency.
  32. Volkel, W., Bittner, N. and Dekant, W. (2005). Quantitation of bisphenol A and bisphenol A glucuronide in biological samples by HLPC-MS/MS. Drug Metab. Dispos., 33(11), 1748-1757. https://doi.org/10.1124/dmd.105.005454
  33. Volkel, W., Colnot, T., Csanady, G.A., Filser, J.G. and Dekant, W. (2002). Metabolism and kinetics of bisphenol a in humans at low doses following oral administration. Chem. Res. Toxicol., 15, 1281-1287. https://doi.org/10.1021/tx025548t
  34. vom Saal, F.S., Cooke, P.S., Buchanan, D.L., Palanza, P., Thayer, K.A., Nagel, S.C., Parmigiani, S. and Welshons, W.V. (1997). A physiologically based approach to the study of bisphenol A and other estrogenic chemicals on the size of reproductive organs, daily sperm counts and behaviour. Tox. Ind. Health, 14, 239-260.
  35. Wazeter, F.X. and Goldenthal, E.I. (1984a). Report on reproduction and ninety day oral toxicity study in rats. Report by the International Research and Development Corporation, Mattawan, MI (IRDC Report No. 313-078) for the General Electric Company. EPA/OTS; Doc. No. 40-8486013.
  36. Wazeter, F.X. and Goldenthal, E.I. (1984b). Report on reproduction and ninety day feeding study in rats. Report by the International Research and Development Corporation, Mattawan, MI (IRDC Report No. 313-112) for the General Electric Company. EPA/OTS; Doc. No. 40-8486013.
  37. WHO. IPCS (1994). Assessing human health risks of chemicals: Derivation of guidance values for health-based exposure limits. Environmental Health Criteria 170. World Health Organization.
  38. WHO (2010). Principles and methods for the risk assessment of chemicals in food. World Health Organization.
  39. Yang, M., Kim, S.Y., Chang, S.S., Lee, I.S. and Kawamoto, T. (2006). Urinary concentrations of bisphenol A in relation to biomarkers of sensitivity and effect and endocrine-related health effects. Environ. Mol. Mutagen., 47(8), 571-578. https://doi.org/10.1002/em.20230
  40. Yang, M., Kim, S.Y., Lee, S.M., Chang, S.S., Kawamoto, T., Jang, J.Y. and Ahn, Y.O. (2003). Biological monitoring of bisphenol a in a Korean population. Arch. Environ. Contam. Toxicol., 44(4), 546-551. https://doi.org/10.1007/s00244-002-2124-0
  41. Yuji, T., Ho, C.L., Shinya, K. and Koji, A. (2002). Release of bisphenol A from food can lining upon heating. J. Health Sci., 48(4), 331-334. https://doi.org/10.1248/jhs.48.331