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

References

• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Cortes D, Kjellberg EM, Breddam M, Thorup J. (2008). The true incidence of cryptorchidism in Denmark. J Urol 179:314–318.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar
• European Food Safety Authority (EFSA). Agence Nationale de Sécurité Sanitaire 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.
   Google Scholar
• Farquhar C, Vail A. (2006). Pitfalls in systematic reviews. Curr Opin Obstet Gynecol 18:433–439.
   PubMed Web of Science ®Google Scholar
• Fisch H, Hyun G, Hensle TW. (2010). Rising hypospadias rates: disproving a myth. J Pediatr Urol 6:37–39.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Gronseth GS. (2004). From evidence to action. NeuroRx 1:331–340.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Hill AB. (1965). The environment and disease: association or causation? Proc R Soc Med 58:295–300.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar
• Liggins GC. (1994). The role of cortisol in preparing the fetus for birth. Reprod Fertil Dev 6:141–150.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Matthews SG. (2000). Antenatal glucocorticoids and programming of the developing CNS. Pediatr Res 47:291–300.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• McQueen MJ. (2001). Overview of evidence-based medicine: challenges for evidence-based laboratory medicine. Clin Chem 47:1536–1546.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Ng PC. (2000). The fetal and neonatal hypothalamic-pituitary-adrenal axis. Arch Dis Child Fetal Neonatal Ed 82:F250–F254.
   Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Ricci S, Celani MG, Righetti E. (2006). Development of clinical guidelines: methodological and practical issues. Neurol Sci 27 Suppl 3:S228–S230.
   Google Scholar
• Sharpe RM. (2003). The ‘oestrogen hypothesis’- where do we stand now? Int J Androl 26:2–15.
   PubMed Web of Science ®Google Scholar
• Smyth RL. (2000). Evidence-based medicine. Paediatr Respir Rev 1:287–293.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Weed DL. (2005). Weight of evidence: a review of concept and methods. Risk Anal 25:1545–1557.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar