A critique of the European Commission Document, "State of the Art Assessment of Endocrine Disrupters"

Critical Reviews in Toxicology

Volumn 42, Issue 6, 2012, Pages 465-473

  Rhomberg, Lorenz R ^a   Goodman, Julie E ^a   Foster, Warren G ^b   Borgert, Christopher J ^c,d   Van Der Kraak, Glen ^e  

^a GRADIENT   (United States)

^b MCMASTER UNIVERSITY   (Canada)

^c Applied Pharmacology and Toxicology Inc   (United States)

^d University of Florida College of Veterinary Medicine   (United States)

^e UNIVERSITY OF GUELPH   (Canada)

Author keywords

Endocrine active; endocrine disruptor; state of science; weight of evidence; WHO IPCS

Indexed keywords

ENDOCRINE DISRUPTOR;

DRUG EXPOSURE; MEDICAL LITERATURE; REVIEW; RISK ASSESSMENT; WORLD HEALTH ORGANIZATION;

ANIMALS; ENDOCRINE DISRUPTORS; ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL POLLUTANTS; EUROPEAN UNION; HUMANS; POLICY MAKING;

EID: 84862192775     PISSN: 10408444     EISSN: 15476898     Source Type: Journal    
DOI: 10.3109/10408444.2012.690367     Document Type: Review

References (48)

1. Adami HO, Berry SC, Breckenridge CB, Smith LL, Swenberg JA, Trichopoulos D, Weiss NS, Pastoor TP. (2011). Toxicology and epidemiology: improving the science with a framework for combining toxicological and epidemiological evidence to establish causal inference. Toxicol Sci 122:223-234.
2. Ankley GT, Bennett RS, Erickson RJ, Hoff DJ, Hornung MW, Johnson RD, Mount DR, Nichols JW, Russom CL, Schmieder PK, Serrrano JA, Tietge JE, Villeneuve DL. (2010). Adverse outcome pathways: a conceptual framework to support ecotoxicology research and risk assessment. Environ Toxicol Chem 29:730-741.
3. Boobis AR, Gooderham NJ, Rich KJ, Zhao K, Edwards RJ, Murray BP, Lynch AM, Murray S, Davies DS. (1995). Enzymatic studies of the activation of heterocyclic food mutagens in man. Int Symp Princess Takamatsu Cancer Res Fund 23:134-144.
4. Boobis AR, Doe JE, Heinrich-Hirsch B, Meek ME, Munn S, Ruchirawat M, Schlatter J, Seed J, Vickers C. (2008). IPCS framework for analyzing the relevance of a noncancer mode of action for humans. Crit Rev Toxicol 38:87-96. (Pubitemid 351225507)
5. Borgert CJ, Mihaich EM, Ortego LS, Bentley KS, Holmes CM, Levine SL, Becker RA. (2011). Hypothesis-driven weight of evidence framework for evaluating data within the US EPA's Endocrine Disruptor Screening Program. Regul Toxicol Pharmacol 61:185-191.
6. Borgert CJ, Sargent EV, Casella G, Dietrich DR, McCarty LS, Golden RJ. (2012). The human relevant potency threshold: reducing uncertainty by human calibration of cumulative risk assessments. Regul Toxicol Pharmacol 62:313-328.
7. Brucker-Davis F, Wagner-Mahler K, Delattre I, Ducot B, Ferrari P, Bongain A, Kurzenne JY, Mas JC, Fénichel P; Cryptorchidism Study Group from Nice Area. (2008). Cryptorchidism at birth in Nice area (France) is associated with higher prenatal exposure to PCBs and DDE, as assessed by colostrum concentrations. Hum Reprod 23:1708-1718. (Pubitemid 352020015)
8. Cortes D, Kjellberg EM, Breddam M, Thorup J. (2008). The true incidence of cryptorchidism in Denmark. J Urol 179:314-318. (Pubitemid 350225694)
9. Doerge DR, Twaddle NC, Woodling KA, Fisher JW. (2010). Pharmacokinetics of bisphenol A in neonatal and adult rhesus monkeys. Toxicol Appl Pharmacol 248:1-11.
10. Doerge DR, Twaddle NC, Vanlandingham M, Fisher JW. (2011). Pharmacokinetics of bisphenol A in neonatal and adult CD-1 mice: inter-species comparisons with Sprague-Dawley rats and rhesus monkeys. Toxicol Lett 207:298-305.
11. European Commission Joint Research Centre. (2003). European Union risk assessment report for 4,4′-isopropylidenediphenol (Bisphenol-A) (CAS No. 80-05-7) (EINECS No. 201-245-8) (Final). Luxembourg: European Chemicals Bureau, Office for Official Publications of the European Communities. EUR 20843 EN, 3rd Priority List, Volume 37.
12. European Food Safety Authority (EFSA). Agence Nationale de SécuritéSanitaire de l'Alimentation, de l'Environnement et du Travail (ANSES). (2011). "Agreed Joint Report of EFSA and ANSES According to Article 30 of the Regulation (EC) No 178/2002 on Bisphenol A (BPA)." [Online] Available at: http://www.efsa.europa.eu/en/cefmsmeetings/docs/111107-m. pdf. Accessed on 12 December 2011.
13. Farquhar C, Vail A. (2006). Pitfalls in systematic reviews. Curr Opin Obstet Gynecol 18:433-439. (Pubitemid 43964772)
14. Fisch H, Hyun G, Hensle TW. (2010). Rising hypospadias rates: disproving a myth. J Pediatr Urol 6:37-39.
15. Fisher JW, Twaddle NC, Vanlandingham M, Doerge DR. (2011). Pharmacokinetic modeling: prediction and evaluation of route dependent dosimetry of bisphenol A in monkeys with extrapolation to humans. Toxicol Appl Pharmacol 257: 122-136.
16. Goodman JE, McConnell EE, Sipes IG, Witorsch RJ, Slayton TM, Yu CJ, Lewis AS, Rhomberg LR. (2006). An updated weight of the evidence evaluation of reproductive and developmental effects of low doses of bisphenol A. Crit Rev Toxicol 36:387-457.
17. Goodman JE, Witorsch RJ, McConnell EE, Sipes IG, Slayton TM, Yu CJ, Franz AM, Rhomberg LR. (2009). Weight-of-evidence evaluation of reproductive and developmental effects of low doses of bisphenol A. Crit Rev Toxicol 39:1-75.
18. Gronseth GS. (2004). From evidence to action. NeuroRx 1:331-340.
19. Guzelian PS, Victoroff MS, Halmes NC, James RC, Guzelian CP. (2005). Evidence-based toxicology: a comprehensive framework for causation. Hum Exp Toxicol 24:161-201. (Pubitemid 40778683)
20. Hengstler JG, Foth H, Gebel T, Kramer PJ, Lilienblum W, Schweinfurth H, Völkel W, Wollin KM, Gundert-Remy U. (2011). Critical evaluation of key evidence on the human health hazards of exposure to bisphenol A. Crit Rev Toxicol 41:263-291.
21. HILL AB. (1965). The environment and disease: association or causation? Proc R Soc Med 58:295-300.
22. Hosie S, Loff S, Witt K, Niessen K, Waag KL. (2000). Is there a correlation between organochlorine compounds and undescended testes? Eur J Pediatr Surg 10:304-309. (Pubitemid 32014824)
23. Jana NR, Sarkar S, Yonemoto J, Tohyama C, Sone H. (1998). Strain differences in cytochrome P4501A1 gene expression caused by 2,3,7,8- tetrachlorodibenzo-p-dioxin in the rat liver: role of the aryl hydrocarbon receptor and its nuclear translocator. Biochem Biophys Res Commun 248:554-558. (Pubitemid 28404459)
24. Klimisch HJ, Andreae M, Tillmann U. (1997). A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol 25:1-5. (Pubitemid 27117571)
25. Korkalainen M, Tuomisto J, Pohjanvirta R. (2001). The AH receptor of the most dioxin-sensitive species, guinea pig, is highly homologous to the human AH receptor. Biochem Biophys Res Commun 285:1121-1129. (Pubitemid 32916146)
26. Korkalainen M, Tuomisto J, Pohjanvirta R. (2004). Primary structure and inducibility by 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) of aryl hydrocarbon receptor repressor in a TCDD-sensitive and a TCDD-resistant rat strain. Biochem Biophys Res Commun 315:123-131. (Pubitemid 38175195)
27. Kortenkamp A, Martin O, Faust M, Evans R, McKinlay R, Orton F, Rosivatz E. (2011). State of the Art Assessment of Endocrine Disrupters. Final Report. [Online] Available at: http://ec.europa.eu/environment/endocrine/documents/4- SOTA%20EDC%20Final%20Report%20V3%206%20Feb%2012.pdf. Accessed on 12 March 2012.
28. Liggins GC. (1994). The role of cortisol in preparing the fetus for birth. Reprod Fertil Dev 6:141-150.
29. Martignoni M, Groothuis GM, de Kanter R. (2006). Species differences between mouse, rat, dog, monkey and human CYP-mediated drug metabolism, inhibition and induction. Expert Opin Drug Metab Toxicol 2:875-894. (Pubitemid 44911538)
30. Matthews SG. (2000). Antenatal glucocorticoids and programming of the developing CNS. Pediatr Res 47:291-300.
31. McGlynn KA, Guo X, Graubard BI, Brock JW, Klebanoff MA, Longnecker MP. (2009). Maternal pregnancy levels of polychlorinated biphenyls and risk of hypospadias and cryptorchidism in male offspring. Environ Health Perspect 117: 1472-1476.
32. McQueen MJ. (2001). Overview of evidence-based medicine: challenges for evidence-based laboratory medicine. Clin Chem 47: 1536-1546.
33. Mol NM, Sørensen N, Weihe P, Andersson AM, Jørgensen N, Skakkebaek NE, Keiding N, Grandjean P. (2002). Spermaturia and serum hormone concentrations at the age of puberty in boys prenatally exposed to polychlorinated biphenyls. Eur J Endocrinol 146: 357-363. (Pubitemid 34257646)
34. Ng PC. (2000). The fetal and neonatal hypothalamic-pituitary-adrenal axis. Arch Dis Child Fetal Neonatal Ed 82:F250-F254.
35. Oosterhuis WP, Bruns DE, Watine J, Sandberg S, Horvath AR. (2004). Evidence-based guidelines in laboratory medicine: principles and methods. Clin Chem 50:806-818.
36. Prueitt RL, Goodman JE, Bailey LA, Rhomberg LR. (2011). Hypothesis-based weight-of-evidence evaluation of the neurodevelopmental effects of chlorpyrifos. Crit Rev Toxicol 41:822-903.
37. Rhomberg LR, Bailey LA, Goodman JE. (2010). Hypothesis-based weight of evidence: a tool for evaluating and communicating uncertainties and inconsistencies in the large body of evidence in proposing a carcinogenic mode of action-naphthalene as an example. Crit Rev Toxicol 40:671-696.
38. Rhomberg LR, Bailey LA, Goodman JE, Hamade A, Mayfield D. (2011). Is exposure to formaldehyde in air causally associated with leukemia? - A hypothesis-based weight-of-evidence analysis. Crit Rev Toxicol 41:555-621.
39. Ricci S, Celani MG, Righetti E. (2006). Development of clinical guidelines: methodological and practical issues. Neurol Sci 27 Suppl 3:S228-S230. (Pubitemid 43834666)
40. Sharpe RM. (2003). The 'oestrogen hypothesis'- where do we stand now? Int J Androl 26:2-15.
41. Smyth RL. (2000). Evidence-based medicine. Paediatr Respir Rev 1: 287-293.
42. Teeguarden JG, Calafat AM, Ye X, Doerge DR, Churchwell MI, Gunawan R, Graham MK. (2011). Twenty-four hour human urine and serum profiles of bisphenol a during high-dietary exposure. Toxicol Sci 123:48-57.
43. Thorup J, McLachlan R, Cortes D, Nation TR, Balic A, Southwell BR, Hutson JM. (2010). What is new in cryptorchidism and hypospadias - a critical review on the testicular dysgenesis hypothesis. J Pediatr Surg 45:2074-2086.
44. Turpeinen M, Ghiciuc C, Opritoui M, Tursas L, Pelkonen O, Pasanen M. (2007). Predictive value of animal models for human cytochrome P450 (CYP)-mediated metabolism: a comparative study in vitro. Xenobiotica 37:1367-1377. (Pubitemid 350146687)
45. Weed DL. (2005). Weight of evidence: a review of concept and methods. Risk Anal 25:1545-1557.
46. Witorsch RJ. (2002). Low-dose in utero effects of xenoestrogens in mice and their relevance to humans: an analytical review of the literature. Food Chem Toxicol 40:905-912.
47. WHO (World Health Organization)/International Programme on Chemical Safety (IPCS). (2002). Global Assessment of the State-of- the-science of Endocrine Disruptors. [Online] Available at: http://www.who.int/ipcs/ publications/new-issues/endocrine-disruptors/en/. Accessed on 4 October 2002.
48. Zaza S, Wright-De Agüero LK, Briss PA, Truman BI, Hopkins DP, Hennessy MH, Sosin DM, Anderson L, Carande-Kulis VG, Teutsch SM, Pappaioanou M. (2000). Data collection instrument and procedure for systematic reviews in the Guide to Community Preventive Services. Task Force on Community Preventive Services. Am J Prev Med 18:44-74. (Pubitemid 30114234)