Application of the OECD Conceptual Framework for Assessing the Human Health and Ecological Effects of Endocrine Disrupters

Endocrine Disrupters: Hazard Testing and Assessment Methods

Volumn , Issue , 2013, Pages 341-372

  Hutchinson, Thomas H ^a   Odum, Jenny ^b   Gourmelon, Anne ^c  

^a CENTRE FOR ENVIRONMENT   (United Kingdom)

^b Regulatory Science Associates   (United Kingdom)

^c OECD   (France)

Author keywords

17 ethynylestradiol (EE2); Conceptual framework (CF); Ecological effects; Endocrine disrupting chemicals; Human health; Klimisch criteria; Organisation for Economic Cooperation and Development; Vinclozolin (VIN)

Indexed keywords

EID: 84886147951     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118355961.ch12     Document Type: Chapter

References (53)

1. Herbst, A. L., Ulfelder, H., Poskanzer, D. C. (1971). Adenocarcinoma of the vagina. Association of maternal stilbestrol therapy with tumor appearance in young women. New England Journal of Medicine 284: 878-881.
2. Gill,W. B., Schumacher, G. F. B., Bibbo, M., Straus, F. H., Schoenberg, H.W. (1979). Association of diethylstilbestrol exposure in utero with cryptorchidism, testicular hypoplasia and semen abnormalities. Journal of Urology 122: 36-39.
3. Cooke, A. S. (1973). Shell thinning in avian eggs by environmental pollutants. Journal of Environment and Pollution 4: 85-152.
4. Bryan, G. W., Gibbs, P. E., Hummerstone, L. G., Burt, G. R. (1986). The decline of the gastropod Nucella lapillus around south-west England: evidence for the effects from tributyltin from antifouling paints. Journal of the Marine Biological Association of the United Kingdom 66: 611-640.
5. Fenner-Crisp, P., Maciorowski, A. F., Timm, G. E. (2000). The endocrine disruptor screening program developed by the U.S. Environmental Protection Agency. Ecotoxicology 9: 85-91.
6. Japanese Ministry of Environment. (1998). Japanese Ministry of Environment Strategic Program on Environmental Endocrine Disruptors (SPEED '98). Available at: www.env.go.jp/en/chemi/ed/speed98/sp98.html.
7. Huet, M. C. (2000). OECD activity on endocrine disrupters test guidelines development. Ecotoxicology 9: 77-84.
8. Organisation for Economic Cooperation and Development. (2011). Draft Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption. Available at: www.oecd.org/document/12/0,3343,en_2649_34377_1898188_1_1_1_1,00.html.
9. Klimisch, H.-J., Andreae, M., Tillmann, U. (1997). A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regulatory Toxicology and Pharmacology 25: 1-5.
10. Kilkenny, C., Browne, W. J., Cuthill, I. C., Emerson, M., Altman, D. G. (2010). Improving bioscience research reporting: The ARRIVE guidelines for reporting animal research. PLoS Biology 8(6): e1000412. doi:10.1371/journal.pbio.1000412.
11. Caldwell, D. J., Mastrocco, F., Hutchinson, T. H., Länge, R., Heijerick, D., Janssen, C., Anderson, P. D., Sumpter, J. P. (2008). Derivation of an aquatic predicted no-effect concentration for the synthetic hormone, 17 alpha-ethinylestradiol. Environmental Science & Technology 42: 7046-7054.
12. Food and Drug Administration Center for Drug Evaluation and Research. (1998). Guidance for Industry-Environmental Assessment of Human Drugs and Biologics Applications, Revision 1. FDA-CDER, Rockville, MD.
13. Routledge, E. J., Sumpter, J. P. (1996). Estrogenic activity of surfactants and some of their degradation products assessed using a recombinant yeast screen. Environmental Toxicology and Chemistry 15: 241-248.
14. Blair, R. M., Fang, H., Branham, W. S., Hass, B. S., Dial, S. L., Moland, C. L., Tong, W., Shi, L., Perkins, R., Sheehan, D. M. (2000). The estrogen receptor relative binding affinities of 188 natural and xenochemicals: Structural diversity of ligands. Toxicological Sciences 54: 138-153.
15. Organisation for Economic Cooperation and Development. (2006). Pre-validation and interlaboratory validation for the stably transfected transactivation assay to detect estrogenic activity. Available at http://www.oecd.org/chemicalsafety/testingofchemicals/37504278.pdf.
16. Folmar, L. C., Hemmer, M. J., Denslow, N. D., Kroll, K., Chen, J., Cheek, A., Richman, H., Meredith, H., Grau, E. G. (2002). A comparison of the estrogenic potencies of estradiol, ethinylestradiol, diethylstilbestrol, nonylphenol and methoxychlor in vivo and in vitro. Aquatic Toxicology 60: 101-110.
17. Vinggaard, A. M., Niemela, J., Wedebye, E. B., Jensen, G. E. (2008). Screening of 397 chemicals and development of a quantitative structure-activity relationship model for androgen receptor antagonism. Chemical Research in Toxicology 21: 813-823.
18. Pelissero, C., Flouriot, G., Foucher, J. L., Bennetau, B., Dunogues, J., Le Gac, F., Sumpter, J. P. (1993).Vitellogenin synthesis in cultured hepatocytes; an in vitro test for the estrogenic potency of chemicals. Journal of Steroid Biochemistry and Molecular Biology 44: 263- 272.
19. Dinan, L., Bourne, P., Whiting, P., Dhadialla, T. S., Hutchinson, T. H. (2001). Screening of environmental contaminants for ecdysteroid agonist and antagonist activity using the Drosophila melanogaster B(II) cell in vitro assay. Environmental Toxicology and Chemistry 20: 2038-2046.
20. Kanno, J., Onyon, L., Haseman, J., Fenner-Crisp, P., Ashby, J., Owens, W. (2001). The OECD program to validate the rat uterotrophic bioassay to screen compounds for in vivo estrogenic responses: Phase 1. Environmental Health Perspectives 109: 785-794.
21. Yamasaki, K., Takeyoshi, M., Sawaki, M., Imatanaka, N., Shinoda, K., Takatsuki, M. (2003). Immature rat uterotrophic assay of 18 chemicals and Hershberger assay of 30 chemicals. Toxicology 183: 93-115.
22. Katsiadaki, I., Williams, T. D., Ball, J. S., Bean, T. P., Sanders, M. B., Wu, H., Santos, E. M., Brown, M. M., Baker, P., Ortega, F., Falciani, F., Craft, J. A., Tyler, C. R., Viant, M. R., Chipman, J. K. (2010). Hepatic transcriptomic and metabolomic responses in the stickleback (Gasterosteus aculeatus) exposed to ethinyl-estradiol. Aquatic Toxicology 97: 174-187.
23. Hutchinson, T. H., Ankley, G. T., Segner, H., Tyler, C. R. (2006). Screening and testing for endocrine disruption in fish-biomarkers as "signposts," not "traffic lights," in risk assessment. Environmental Health Perspectives 114: 106-114.
24. Andrews, P., Freyberger, A., Hartmann, E., Eiben, R., Loof, I., Schmidt, U., Temerowski, M., Folkerts, A., Stahl, B., Kayser, M. (2002). Sensitive detection of the endocrine effects of the estrogen analogue ethinylestradiol using a modified enhanced subacute rat study protocol (OECD Test Guideline no. 407). Archives of Toxicology 76:194-202.
25. U.S. Environmental Protection Agency. (2007). Integrated Summary Report for Validation of a Test Method for Assessment of Pubertal Development and Thyroid Function in Juvenile Female Rats as a Potential Screen in the Endocrine Disruptor Screening Program Tier-1 Battery. Available at: www.epa.gov/scipoly/oscpendo/pubs/female_isr_v4.1c.pdf/.
26. Van den Belt, K., Verheyen R., Witters, H. (2003). Effects of 17-ethynylestradiol in a partial life-cycle test with zebrafish (Danio rerio): Effects on growth, gonads and female reproductive success. Science of the Total Environment 309: 127-137.
27. National Toxicology Program, Department of Health and Human Services. (2011). Report on Carcinogens, 12th ed. Available at: http://ntp.niehs.nih.gov/ntp/roc/twelfth/profiles/EstrogensSteroidal.pdf.
28. Jobling, S., Casey, D., Rodgers-Gray, T., Oehlmann, J., Schulte-Oehlmann, U., Pawlowski, S., Braunbeck, T., Turner, A. P., Tyler, C. R. (2003). Comparative responses of molluscs and fish to environmental estrogens and an estrogenic effluent. Aquatic Toxicology 65: 205-220.
29. U.S. Environmental Protection Agency. (2000). Reregistration eligibility decision (RED)-Vinclozolin. Reference EPA 738-R-00-023. Available at: www.epa.gov/oppsrrd1/REDs/2740red.pdf.
30. Kelce, W. R., Monosson, E., Gamcsik, M. P., Laws, S. C., Gray, L. E. Jr. (1994). Environmental hormone disruptors: evidence that vinclozolin developmental toxicity is mediated by antiandrogenic metabolites. Toxicology and Applied Pharmacology 126: 276- 285.
31. Wilson, V. S., Bobseine, K., Lambright, C. R., Gray, L. E. Jr. (2002). A novel cell line, MDA-kb2, that stably expresses an androgen- and glucocorticoid-responsive reporter for the detection of hormone receptor agonists and antagonists. Toxicological Sciences 66: 69-81.
32. Hecker, M., Newsted, J. L., Murphy, M. B., Higley, E. B., Jones, P. D., Wu, R., Giesy, J. P. (2006). Human adrenocarcinoma (H295R) cells for rapid in vitro determination of effects on steroidogenesis: Hormone production. Toxicology and Applied Pharmacology 217: 114-124.
33. Jolly, C., Katsiadaki, I., Morris, S., Le Belle, N., Dufour, S., Mayer, I., Pottinger, T., Scott, A. P. (2009). Detection of the anti-androgenic effect of endocrine disrupting environmental contaminants using in vivo and in vitro assays in the three-spined stickleback. Aquatic Toxicology 92: 228-239.
34. Yamasaki, K., Sawaki, M., Ohta, R., Okuda, H., Katayama, S., Yamada, T., Ohta, T., Kosaka, T., Owens,W. (2003). OECD validation of the Hershberger assay in Japan: Phase 2 dose response of methyltestosterone, vinclozolin, and p,p-DDE. Environmental Health Perspectives 111: 1912-1919.
35. Shin, J. H., Moon, H. J., Kim, T. S., Kang, I. H., Ki, H. Y., Choi, K. S., Han, S. Y. (2006). Repeated 28-day oral toxicity study of vinclozolin in rats based on the draft protocol for the "Enhanced OECD Test Guideline No. 407" to detect endocrine effects. Archives of Toxicology 80: 547-554.
36. Monosson, E., Kelce, W. R., Lambright, C., Ostby, J., Gray, L. E. Jr. (1999). Peripubertal exposure to the antiandrogenic fungicide, vinclozolin, delays puberty, inhibits the development of androgen-dependent tissues, and alters androgen receptor function in the male rat. Toxicology & Industrial Health 15: 65-79.
37. Ducrot, V., Teixeira-Alves, M., Lopes, C., Delignette-Muller, M. L., Charles, S., Lagadic, L. (2010). Development of partial life-cycle experiments to assess the effects of endocrine disruptors on the freshwater gastropod Lymnaea stagnalis: A case-study with vinclozolin. Ecotoxicology 19: 1312-1321.
38. Matsuura, I., Saitoh, T., Ashina, M.,Wako, Y., Iwata, H., Toyota, N., Ishizuka, Y., Namiki, M., Hoshino, N., Tsuchitani, M. (2005). Evaluation of a two-generation reproduction toxicity study adding endpoints to detect endocrine disrupting activity using vinclozolin. Journal of Toxicological Sciences 30 (Spec. no.): 163-188.
39. European Centre for Ecotoxicology and Toxicology of Chemicals. (2007). Intelligent testing strategies in ecotoxicology: Mode of action approach for specifically acting chemicals. ECETOC Technical Report 102. 145 pp.
40. Bars, R., Broeckaert, F., Fegert I., Gross M., Hallmark N., Kedwards, T., Lewis, R., O'Hagan, S., Panter, G. H., Weltje, L., Weyers, A., Wheeler, J. R., Galay-Burgos, M. (2011). Science based guidance for the assessment of endocrine disrupting properties of chemicals. Regulatory Toxicology and Pharmacology 59: 37-46.
41. Hutchinson, T. H. (2007). Small is useful in endocrine disrupter assessment-Four key recommendations for aquatic invertebrate research. Ecotoxicology 16: 231-238.
42. Gourmelon, A., Ahtiainen, J. (2007). Developing test guidelines on invertebrate development and reproduction for the assessment of chemicals, including potential endocrine active substances-The OECD perspective. Ecotoxicology 16: 161-167.
43. Matthiessen, P. (2008). An assessment of endocrine disruption in mollusks and the potential for developing internationally standardized mollusk life cycle test guidelines. Integrated Environmental Assessment and Management 4: 274-284.
44. Sciencelab. (2011). Ethinyl Estradiol Material Safety Data Sheet. Available at: www.sciencelab.com/msds.php?msdsId=9923943.
45. National Toxicology Program. (2007). TR0547-NTP Technical report on the multigenerational reproductive toxicology study of ethinyl estradiol (CAS NO. 57-63-6) in Sprague-Dawley rats (feed studies).Available at: http://ntp.niehs.nih.gov/files/547_board_ web.pdf.
46. Gyllenhammer, I., Holm, L., Eklund, R., Berg, C. (2009). Reproductive toxicity in Xenopus tropicalis after developmental exposure to environmental concentrations of ethynylestradiol. Aquatic Toxicology 91: 171-178.
47. Goto T., Hiromi, J. (2003). Toxicity of 17alpha-ethynylestradiol and norethindrone, constituents of an oral contraceptive pill to the swimming and reproduction of cladoceran Daphnia magna, with special reference to their synergetic effect. Marine Pollution Bulletin 47: 139-142.
48. Länge, R., Hutchinson, T. H., Croudace, C. P., Siegmund, F., Schweinfurth, H., Hampe, P., Panter, G. H., Sumpter, J. P. (2001). Effects of the synthetic estrogen 17 alphaethinylestradiol on the life-cycle of the fathead minnow. Environmental Toxicology and Chemistry 20: 1216-1227.
49. Tomlin, C. D. S. (ed.). (2003). The Pesticide Manual-A World Compendium, 13th ed. British Crop Protection Council, Alton, UK. 1344 pp.
50. ESIS. (2011). European Chemical Substances Information System. Available at: http://esis.jrc.ec.europa.eu/index.php?PGM=cla.
51. Kiparissis, Y., Metcalfe, T. L., Balch, G. C., Metcalfe, C. D. (2003). Effects of the antiandrogens, vinclozolin and cyproterone acetate on gonadal development in the Japanese medaka. Aquatic Toxicology 63: 391-403.
52. Makynen, E. A., Kahl, M. D., Jensen, K. M., Tietge, J. E.,Wells, K. L., Van Der Kraak, G., Ankley, G. T. (2000). Effects of the mammalian antiandrogen vinclozolin on development and reproduction of the fathead minnow (Pimephales promelas). Aquatic Toxicology 48: 461-475.
53. Pawlowski, S., van Aerle, R., Tyler, C. R., Braunbeck, T. (2004). Effects of 17alphaethinylestradiol in a fathead minnow (Pimephales promelas) gonadal recrudescence assay. Ecotoxicology and Environmental Safety 57: 330-345.