{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T15:53:46Z","timestamp":1790610826721,"version":"4.1.0"},"reference-count":91,"publisher":"The Endocrine Society","issue":"5","license":[{"start":{"date-parts":[[2019,11,6]],"date-time":"2019-11-06T00:00:00Z","timestamp":1572998400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U01 ES026140"],"award-info":[{"award-number":["U01 ES026140"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U01 ES020886"],"award-info":[{"award-number":["U01 ES020886"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["P30 ES027792"],"award-info":[{"award-number":["P30 ES027792"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U011ES020929"],"award-info":[{"award-number":["U011ES020929"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U01 ES020908"],"award-info":[{"award-number":["U01 ES020908"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100014525","name":"Cornell Douglas Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014525","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>For many endocrine-disrupting chemicals (EDCs) including Bisphenol A (BPA), animal studies show that environmentally relevant exposures cause harm; human studies are consistent with these findings. Yet, regulatory agencies charged with protecting public health continue to conclude that human exposures to these EDCs pose no risk. One reason for the disconnect between the scientific consensus on EDCs in the endocrinology community and the failure to act in the regulatory community is the dependence of the latter on so-called \u201cguideline studies\u201d to evaluate hazards, and the inability to incorporate independent scientific studies in risk assessment. The Consortium Linking Academic and Regulatory Insights on Toxicity (CLARITY) study was intended to bridge this gap, combining a \u201cguideline\u201d study with independent hypothesis-driven studies designed to be more appropriate to evaluate EDCs. Here we examined an aspect of \u201cguideline\u201d studies, the use of so-called \u201chistorical controls,\u201d which are essentially control data borrowed from prior studies to aid in the interpretation of current findings. The US Food and Drug Administration authors used historical controls to question the plausibility of statistically significant BPA-related effects in the CLARITY study. We examined the use of historical controls on 5 outcomes in the CLARITY \u201cguideline\u201d study: mammary neoplasms, pituitary neoplasms, kidney nephropathy, prostate inflammation and adenomas, and body weight. Using US Food and Drug Administration\u2013proposed historical control data, our evaluation revealed that endpoints used in \u201cguideline\u201d studies are not as reproducible as previously held. Combined with other data comparing the effects of ethinyl estradiol in 2 \u201cguideline\u201d studies including CLARITY-BPA, we conclude that near-exclusive reliance on \u201cguideline\u201d studies can result in scientifically invalid conclusions.<\/jats:p>","DOI":"10.1210\/endocr\/bqz014","type":"journal-article","created":{"date-parts":[[2019,11,6]],"date-time":"2019-11-06T01:07:22Z","timestamp":1573002442000},"source":"Crossref","is-referenced-by-count":27,"title":["The Use and Misuse of Historical Controls in Regulatory Toxicology: Lessons from the CLARITY-BPA Study"],"prefix":"10.1210","volume":"161","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6807-9136","authenticated-orcid":false,"given":"Laura N","family":"Vandenberg","sequence":"first","affiliation":[{"name":"Department of Environmental Health Sciences, School of Public Health and Health Sciences, University of Massachusetts\u2013Amherst, Amherst, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gail S","family":"Prins","sequence":"additional","affiliation":[{"name":"Department of Urology, School of Medicine; Division of Epidemiology & Biostatistics, School of Public Health University of Illinois at Chicago, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather B","family":"Patisaul","sequence":"additional","affiliation":[{"name":"Center for Human Health and the Environment, Department of Biological Sciences, North Carolina State University, Raleigh, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R Thomas","family":"Zoeller","sequence":"additional","affiliation":[{"name":"Department of Biology, University of Massachusetts\u2013Amherst, Amherst, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"80","published-online":{"date-parts":[[2019,11,6]]},"reference":[{"issue":"6","key":"2021121717531097400_CIT0001","doi-asserted-by":"crossref","first-page":"E1","DOI":"10.1210\/er.2015-1010","article-title":"EDC-2: the Endocrine Society\u2019s second scientific statement on endocrine-disrupting chemicals","volume":"36","author":"Gore","year":"2015","journal-title":"Endocr Rev."},{"issue":"1","key":"2021121717531097400_CIT0002","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1210\/er.2008-0021","article-title":"Bisphenol-A and the great divide: a review of controversies in the field of endocrine disruption","volume":"30","author":"Vandenberg","year":"2009","journal-title":"Endocr Rev."},{"issue":"5","key":"2021121717531097400_CIT0003","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1016\/j.ijheh.2011.04.005","article-title":"Are potential sources for human exposure to bisphenol-A overlooked?","volume":"214","author":"Geens","year":"2011","journal-title":"Int J Hyg Environ Health."},{"issue":"10","key":"2021121717531097400_CIT0004","doi-asserted-by":"crossref","first-page":"3725","DOI":"10.1016\/j.fct.2012.07.059","article-title":"A review of dietary and non-dietary exposure to bisphenol-A","volume":"50","author":"Geens","year":"2012","journal-title":"Food Chem Toxicol."},{"issue":"8","key":"2021121717531097400_CIT0005","doi-asserted-by":"crossref","first-page":"1055","DOI":"10.1289\/ehp.0901716","article-title":"Urine, serum and tissue biomonitoring studies indicate widespread exposure to bisphenol A","volume":"118","author":"Vandenberg","year":"2010","journal-title":"Environ Health Perspect."},{"key":"2021121717531097400_CIT0006","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1016\/j.reprotox.2013.08.008","article-title":"Bisphenol A and human health: a review of the literature","volume":"42","author":"Rochester","year":"2013","journal-title":"Reprod Toxicol."},{"key":"2021121717531097400_CIT0007","doi-asserted-by":"crossref","first-page":"e26490","DOI":"10.4161\/endo.26490","article-title":"Low dose effects of Bisphenol A: an integrated review of in vitro, laboratory animal and epidemiology studies","volume":"1","author":"Vandenberg","year":"2013","journal-title":"Endocr Disruptors (Austin)."},{"key":"2021121717531097400_CIT0008","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/j.reprotox.2016.10.001","article-title":"Metabolism disrupting chemicals and metabolic disorders","volume":"68","author":"Heindel","year":"2017","journal-title":"Reprod Toxicol."},{"issue":"8","key":"2021121717531097400_CIT0009","doi-asserted-by":"crossref","first-page":"775","DOI":"10.1289\/ehp.1307728","article-title":"Bisphenol A and reproductive health: update of experimental and human evidence, 2007-2013","volume":"122","author":"Peretz","year":"2014","journal-title":"Environ Health Perspect"},{"issue":"2","key":"2021121717531097400_CIT0010","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1016\/j.reprotox.2007.07.005","article-title":"Chapel Hill Bisphenol A Expert Panel consensus statement: integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure","volume":"24","author":"vom Saal","year":"2007","journal-title":"Reprod Toxicol."},{"key":"2021121717531097400_CIT0011","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1016\/j.jclepro.2015.01.071","article-title":"Plastic bodies in a plastic world: multi-disciplinary approaches to study endocrine disrupting chemicals","volume":"140","author":"Vandenberg","year":"2017","journal-title":"J Clean Prod."},{"issue":"7","key":"2021121717531097400_CIT0012","doi-asserted-by":"crossref","first-page":"643","DOI":"10.1289\/ehp.1408989","article-title":"Bisphenol S and F: a systematic review and comparison of the hormonal activity of bisphenol a substitutes","volume":"123","author":"Rochester","year":"2015","journal-title":"Environ Health Perspect."},{"key":"2021121717531097400_CIT0013","doi-asserted-by":"crossref","first-page":"92","DOI":"10.1016\/j.mce.2018.02.002","article-title":"Concerns related to ED-mediated effects of Bisphenol A and their regulatory consideration","volume":"475","author":"ANSES\u2019s Working Group on Endocrine Disruptors; ANSES\u2019s Expert Committee on Chemicals covered by the REACh and CLP Regulations;","year":"2018","journal-title":"Mol Cell Endocrinol."},{"key":"2021121717531097400_CIT0014","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1016\/j.mce.2018.02.001","article-title":"Regulatory identification of BPA as an endocrine disruptor: context and methodology","volume":"475","author":"Beausoleil","year":"2018","journal-title":"Mol Cell Endocrinol."},{"key":"2021121717531097400_CIT0015","article-title":"Food additives: health consequences of regulatory oversight failure.","volume-title":"Integrative Environmental Medicine","author":"Maffini","year":"2017"},{"key":"2021121717531097400_CIT0016","doi-asserted-by":"crossref","first-page":"S559","DOI":"10.2105\/AJPH.2008.159228","article-title":"The politics of plastics: the making and unmaking of bisphenol a \u201csafety\u201d","volume":"99(Suppl 3)","author":"Vogel","year":"2009","journal-title":"Am J Public Health."},{"key":"2021121717531097400_CIT0017","author":"US Food and Drug Administration"},{"key":"2021121717531097400_CIT0018","first-page":"1","article-title":"NTP research report on the CLARITY-BPA Core Study: a perinatal and chronic extended-dose-range study of Bisphenol A in rats. NTP RR 9","volume":"9","author":"National Toxicology Program","year":"2018","journal-title":"National Toxicology Program."},{"issue":"11","key":"2021121717531097400_CIT0019","doi-asserted-by":"crossref","first-page":"1652","DOI":"10.1289\/ehp.0900887","article-title":"A clash of old and new scientific concepts in toxicity, with important implications for public health","volume":"117","author":"Myers","year":"2009","journal-title":"Environ Health Perspect"},{"issue":"3","key":"2021121717531097400_CIT0020","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1289\/ehp.0800173","article-title":"Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A","volume":"117","author":"Myers","year":"2009","journal-title":"Environ Health Perspect."},{"key":"2021121717531097400_CIT0021","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1016\/j.coph.2014.08.005","article-title":"Bridging the gap between academic research and regulatory health risk assessment of endocrine disrupting chemicals","volume":"19","author":"Beronius","year":"2014","journal-title":"Curr Opin Pharmacol."},{"issue":"6","key":"2021121717531097400_CIT0022","doi-asserted-by":"crossref","first-page":"607","DOI":"10.1002\/jat.2991","article-title":"Facilitating the use of non-standard in vivo studies in health risk assessment of chemicals: a proposal to improve evaluation criteria and reporting","volume":"34","author":"Beronius","year":"2014","journal-title":"J Appl Toxicol."},{"issue":"11","key":"2021121717531097400_CIT0023","doi-asserted-by":"crossref","first-page":"1644","DOI":"10.1289\/ehp.0900893","article-title":"Basic exploratory research versus guideline-compliant studies used for hazard evaluation and risk assessment: Bisphenol A as a case study","volume":"117","author":"Tyl","year":"2009","journal-title":"Environ Health Perspect."},{"issue":"1","key":"2021121717531097400_CIT0024","doi-asserted-by":"crossref","first-page":"167","DOI":"10.1093\/toxsci\/kfq025","article-title":"Developmental neurotoxicity study of dietary Bisphenol A in Sprague-Dawley rats","volume":"115","author":"Stump","year":"2010","journal-title":"Toxicol Sci."},{"issue":"2","key":"2021121717531097400_CIT0025","doi-asserted-by":"crossref","first-page":"362","DOI":"10.1093\/toxsci\/kfn084","article-title":"Two-generation reproductive toxicity study of dietary Bisphenol A in CD-1 (Swiss) mice","volume":"104","author":"Tyl","year":"2008","journal-title":"Toxicol Sci."},{"issue":"1","key":"2021121717531097400_CIT0026","doi-asserted-by":"crossref","first-page":"121","DOI":"10.1093\/toxsci\/68.1.121","article-title":"Three-generation reproductive toxicity study of dietary Bisphenol A in CD Sprague-Dawley rats","volume":"68","author":"Tyl","year":"2002","journal-title":"Toxicol Sci."},{"issue":"2","key":"2021121717531097400_CIT0027","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1016\/j.reprotox.2007.06.004","article-title":"In vivo effects of Bisphenol A in laboratory rodent studies","volume":"24","author":"Richter","year":"2007","journal-title":"Reprod Toxicol."},{"issue":"2","key":"2021121717531097400_CIT0028","doi-asserted-by":"crossref","first-page":"225","DOI":"10.1016\/j.reprotox.2007.05.008","article-title":"An ecological assessment of Bisphenol-A: evidence from comparative biology","volume":"24","author":"Crain","year":"2007","journal-title":"Reprod Toxicol."},{"key":"2021121717531097400_CIT0029","doi-asserted-by":"crossref","first-page":"448","DOI":"10.1016\/j.reprotox.2016.06.020","article-title":"Assessment of recent developmental immunotoxicity studies with Bisphenol A in the context of the 2015 EFSA t-TDI","volume":"65","author":"Hessel","year":"2016","journal-title":"Reprod Toxicol"},{"issue":"1","key":"2021121717531097400_CIT0030","doi-asserted-by":"crossref","first-page":"130","DOI":"10.1016\/j.yrtph.2012.06.015","article-title":"Low-dose effects and nonmonotonic dose-responses of endocrine disrupting chemicals: has the case been made?","volume":"64","author":"Rhomberg","year":"2012","journal-title":"Regul Toxicol Pharmacol."},{"issue":"9","key":"2021121717531097400_CIT0031","doi-asserted-by":"crossref","first-page":"4097","DOI":"10.1210\/en.2012-1422","article-title":"Endocrine-disrupting chemicals and public health protection: a statement of principles from the Endocrine Society","volume":"153","author":"Zoeller","year":"2012","journal-title":"Endocrinology."},{"key":"2021121717531097400_CIT0032","doi-asserted-by":"crossref","first-page":"168","DOI":"10.1196\/annals.1371.077","article-title":"Collision of basic and applied approaches to risk assessment of thyroid toxicants","volume":"1076","author":"Zoeller","year":"2006","journal-title":"Ann N Y Acad Sci."},{"issue":"12","key":"2021121717531097400_CIT0033","doi-asserted-by":"crossref","first-page":"1640","DOI":"10.1289\/ehp.1205330","article-title":"Consortium-based science: the NIEHS\u2019s multipronged, collaborative approach to assessing the health effects of Bisphenol A","volume":"120","author":"Birnbaum","year":"2012","journal-title":"Environ Health Perspect."},{"key":"2021121717531097400_CIT0034","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1016\/j.reprotox.2013.05.010","article-title":"A new approach to synergize academic and guideline-compliant research: the CLARITY-BPA research program","volume":"40","author":"Schug","year":"2013","journal-title":"Reprod Toxicol."},{"key":"2021121717531097400_CIT0035","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1016\/j.reprotox.2015.07.075","article-title":"NIEHS\/FDA CLARITY-BPA research program update","volume":"58","author":"Heindel","year":"2015","journal-title":"Reprod Toxicol."},{"key":"2021121717531097400_CIT0036","doi-asserted-by":"crossref","first-page":"110728","DOI":"10.1016\/j.fct.2019.110728","article-title":"A two-year toxicology study of bisphenol A (BPA) in Sprague-Dawley rats: CLARITY-BPA core study results","volume":"132","author":"Camacho","year":"2019","journal-title":"Food Chem Toxicol."},{"issue":"6","key":"2021121717531097400_CIT0037","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1038\/s41574-019-0173-y","article-title":"Endocrine disruptors and the future of toxicology testing - lessons from CLARITY-BPA","volume":"15","author":"Vandenberg","year":"2019","journal-title":"Nat Rev Endocrinol."},{"key":"2021121717531097400_CIT0038","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1111\/bcpt.13125","article-title":"CLARITY-BPA academic laboratory studies identify consistent low-dose Bisphenol A effects on multiple organ systems","volume":"125(Suppl 3)","author":"Prins","year":"2019","journal-title":"Basic Clin Pharmacol Toxicol."},{"key":"2021121717531097400_CIT0039","doi-asserted-by":"crossref","first-page":"32","DOI":"10.1111\/bcpt.13195","article-title":"Flaws in design, execution and interpretation limit CLARITY-BPA\u2019s value for risk assessments of Bisphenol A","volume":"125(Suppl 3)","author":"Vom Saal","year":"2019","journal-title":"Basic Clin Pharmacol Toxicol."},{"issue":"3","key":"2021121717531097400_CIT0040","doi-asserted-by":"crossref","first-page":"1559325818798282","DOI":"10.1177\/1559325818798282","article-title":"Nonmonotonic dose-response curves occur in dose ranges that are relevant to regulatory decision-making","volume":"16","author":"Hill","year":"2018","journal-title":"Dose Response."},{"issue":"6","key":"2021121717531097400_CIT0041","doi-asserted-by":"crossref","first-page":"1727","DOI":"10.1210\/en.2016-1887","article-title":"Bisphenol A exposure, ovarian follicle numbers, and female sex steroid hormone levels: results from a CLARITY-BPA study","volume":"158","author":"Patel","year":"2017","journal-title":"Endocrinology."},{"key":"2021121717531097400_CIT0042","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1016\/j.tox.2018.01.004","article-title":"CLARITY-BPA: effects of chronic Bisphenol A exposure on the immune system: part 1\u2014Quantification of the relative number and proportion of leukocyte populations in the spleen and thymus","volume":"396-397","author":"Li","year":"2018","journal-title":"Toxicology."},{"key":"2021121717531097400_CIT0043","doi-asserted-by":"crossref","first-page":"54","DOI":"10.1016\/j.tox.2018.02.004","article-title":"CLARITY-BPA: effects of chronic Bisphenol A exposure on the immune system: part 2\u2014Characterization of lymphoproliferative and immune effector responses by splenic leukocytes","volume":"396-397","author":"Li","year":"2018","journal-title":"Toxicology."},{"key":"2021121717531097400_CIT0044","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1016\/j.toxlet.2017.05.011","article-title":"Effects of Bisphenol A on incidence and severity of cardiac lesions in the NCTR-Sprague-Dawley rat: a CLARITY-BPA study","volume":"275","author":"Gear","year":"2017","journal-title":"Toxicol Lett."},{"key":"2021121717531097400_CIT0045","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.taap.2018.03.021","article-title":"Effects of continuous Bisphenol A exposure from early gestation on 90\u202fday old rat testes function and sperm molecular profiles: a CLARITY-BPA Consortium Study","volume":"347","author":"Dere","year":"2018","journal-title":"Toxicol Appl Pharmacol."},{"key":"2021121717531097400_CIT0046","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1016\/j.yhbeh.2015.09.005","article-title":"Effects of developmental exposure to Bisphenol A on spatial navigational learning and memory in rats: a CLARITY-BPA study","volume":"80","author":"Johnson","year":"2016","journal-title":"Horm Behav."},{"key":"2021121717531097400_CIT0047","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1016\/j.neuro.2017.09.002","article-title":"Effects of perinatal Bisphenol A exposure on the volume of sexually-dimorphic nuclei of juvenile rats: a CLARITY-BPA Consortium Study","volume":"63","author":"Arambula","year":"2017","journal-title":"Neurotoxicology."},{"issue":"10","key":"2021121717531097400_CIT0048","doi-asserted-by":"crossref","first-page":"3856","DOI":"10.1210\/en.2016-1339","article-title":"Impact of low dose oral exposure to Bisphenol A (BPA) on the neonatal rat hypothalamic and hippocampal transcriptome: a CLARITY-BPA Consortium Study","volume":"157","author":"Arambula","year":"2016","journal-title":"Endocrinology."},{"issue":"2","key":"2021121717531097400_CIT0049","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1093\/toxsci\/kfv163","article-title":"Impact of low-dose oral exposure to Bisphenol A (BPA) on juvenile and adult rat exploratory and anxiety behavior: a CLARITY-BPA Consortium Study","volume":"148","author":"Rebuli","year":"2015","journal-title":"Toxicol Sci."},{"key":"2021121717531097400_CIT0050","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1016\/j.neuro.2017.10.005","article-title":"Prenatal Bisphenol A (BPA) exposure alters the transcriptome of the neonate rat amygdala in a sex-specific manner: a CLARITY-BPA Consortium Study","volume":"65","author":"Arambula","year":"2018","journal-title":"Neurotoxicology."},{"key":"2021121717531097400_CIT0051","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1016\/j.neuro.2019.06.007","article-title":"Perinatal Bisphenol A (BPA) exposure alters brain oxytocin receptor (OTR) expression in a sex- and region- specific manner: a CLARITY-BPA consortium follow-up study","volume":"74","author":"Witchey","year":"2019","journal-title":"Neurotoxicology."},{"issue":"8","key":"2021121717531097400_CIT0052","doi-asserted-by":"crossref","first-page":"1771","DOI":"10.1210\/en.2019-00121","article-title":"CLARITY-BPA: Bisphenol A or propylthiouracil on thyroid function and effects in the developing male and female rat brain","volume":"160","author":"Bansal","year":"2019","journal-title":"Endocrinology."},{"key":"2021121717531097400_CIT0053","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1016\/j.yrtph.2017.06.010","article-title":"Relevance and reliability of experimental data in human health risk assessment of pesticides","volume":"88","author":"Kaltenh\u00e4user","year":"2017","journal-title":"Regul Toxicol Pharmacol."},{"issue":"2","key":"2021121717531097400_CIT0054","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1093\/toxsci\/kfw056","article-title":"Does GLP enhance the quality of toxicological evidence for regulatory decisions?","volume":"151","author":"Borgert","year":"2016","journal-title":"Toxicol Sci."},{"issue":"2","key":"2021121717531097400_CIT0055","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1007\/BF00048063","article-title":"The significance of spontaneous and induced apoptosis in the gastrointestinal tract of mice","volume":"11","author":"Potten","year":"1992","journal-title":"Cancer Metastasis Rev."},{"issue":"1","key":"2021121717531097400_CIT0056","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1002\/pst.1589","article-title":"Use of historical control data for assessing treatment effects in clinical trials","volume":"13","author":"Viele","year":"2014","journal-title":"Pharm Stat."},{"issue":"7","key":"2021121717531097400_CIT0057","doi-asserted-by":"crossref","first-page":"546","DOI":"10.1016\/S0960-9822(03)00189-1","article-title":"Bisphenol A exposure causes meiotic aneuploidy in the female mouse","volume":"13","author":"Hunt","year":"2003","journal-title":"Curr Biol."},{"issue":"5","key":"2021121717531097400_CIT0058","doi-asserted-by":"crossref","first-page":"679","DOI":"10.1177\/0192623309336154","article-title":"Best practices for use of historical control data of proliferative rodent lesions","volume":"37","author":"Keenan","year":"2009","journal-title":"Toxicol Pathol."},{"issue":"1","key":"2021121717531097400_CIT0059","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1093\/toxsci\/kfu021","article-title":"Comparison of life-stage-dependent internal dosimetry for Bisphenol A, ethinyl estradiol, a reference estrogen, and endogenous estradiol to test an estrogenic mode of action in Sprague Dawley rats","volume":"139","author":"Churchwell","year":"2014","journal-title":"Toxicol Sci."},{"key":"2021121717531097400_CIT0060","author":"Bisphenol"},{"issue":"11 Pt 2","key":"2021121717531097400_CIT0061","first-page":"4054","article-title":"Prolactin and the development and progression of early neoplastic mammary gland lesions","volume":"38","author":"Welsch","year":"1978","journal-title":"Cancer Res."},{"issue":"7","key":"2021121717531097400_CIT0062","doi-asserted-by":"crossref","first-page":"077007","DOI":"10.1289\/EHP1050","article-title":"Prostate cancer risk and DNA methylation signatures in aging rats following developmental BPA exposure: a dose-response analysis","volume":"125","author":"Prins","year":"2017","journal-title":"Environ Health Perspect."},{"issue":"1","key":"2021121717531097400_CIT0063","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.reprotox.2010.09.009","article-title":"Serum Bisphenol A pharmacokinetics and prostate neoplastic responses following oral and subcutaneous exposures in neonatal Sprague-Dawley rats","volume":"31","author":"Prins","year":"2011","journal-title":"Reprod Toxicol."},{"issue":"2 Suppl","key":"2021121717531097400_CIT0064","doi-asserted-by":"crossref","first-page":"e41","DOI":"10.1016\/j.fertnstert.2007.12.023","article-title":"Developmental exposure to Bisphenol A increases prostate cancer susceptibility in adult rats: epigenetic mode of action is implicated","volume":"89","author":"Prins","year":"2008","journal-title":"Fertil Steril."},{"issue":"2","key":"2021121717531097400_CIT0065","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1111\/j.1742-7843.2007.00166.x","article-title":"Perinatal exposure to oestradiol and Bisphenol A alters the prostate epigenome and increases susceptibility to carcinogenesis","volume":"102","author":"Prins","year":"2008","journal-title":"Basic Clin Pharmacol Toxicol."},{"issue":"11","key":"2021121717531097400_CIT0066","doi-asserted-by":"crossref","first-page":"5624","DOI":"10.1158\/0008-5472.CAN-06-0516","article-title":"Developmental exposure to estradiol and Bisphenol A increases susceptibility to prostate carcinogenesis and epigenetically regulates phosphodiesterase type 4 variant 4","volume":"66","author":"Ho","year":"2006","journal-title":"Cancer Res."},{"issue":"6","key":"2021121717531097400_CIT0067","doi-asserted-by":"crossref","first-page":"1636","DOI":"10.1095\/biolreprod61.6.1636","article-title":"Prepubertal exposure to compounds that increase prolactin secretion in the male rat: effects on the adult prostate","volume":"61","author":"Stoker","year":"1999","journal-title":"Biol Reprod."},{"issue":"5","key":"2021121717531097400_CIT0068","doi-asserted-by":"crossref","first-page":"2046","DOI":"10.1210\/en.2002-0038","article-title":"The role of prolactin in the prostatic inflammatory response to neonatal estrogen","volume":"144","author":"Gilleran","year":"2003","journal-title":"Endocrinology."},{"issue":"3","key":"2021121717531097400_CIT0069","doi-asserted-by":"crossref","first-page":"378","DOI":"10.1210\/er.2011-1050","article-title":"Hormones and endocrine-disrupting chemicals: low-dose effects and nonmonotonic dose responses","volume":"33","author":"Vandenberg","year":"2012","journal-title":"Endocr Rev."},{"issue":"2","key":"2021121717531097400_CIT0070","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1002\/bdrc.20176","article-title":"In honor of the Teratology Society\u2019s 50th anniversary: the role of Teratology Society members in the development and evolution of in vivo developmental toxicity test guidelines","volume":"90","author":"Tyl","year":"2010","journal-title":"Birth Defects Res C Embryo Today."},{"issue":"1","key":"2021121717531097400_CIT0071","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1186\/1476-069X-13-46","article-title":"Should oral gavage be abandoned in toxicity testing of endocrine disruptors?","volume":"13","author":"Vandenberg","year":"2014","journal-title":"Environ Health."},{"issue":"11","key":"2021121717531097400_CIT0072","doi-asserted-by":"crossref","first-page":"117001","DOI":"10.1289\/EHP3953","article-title":"Evaluation of Bisphenol A (BPA) exposures on prostate stem cell homeostasis and prostate cancer risk in the NCTR-Sprague-Dawley rat: an NIEHS\/FDA CLARITY-BPA Consortium Study","volume":"126","author":"Prins","year":"2018","journal-title":"Environ Health Perspect."},{"issue":"2","key":"2021121717531097400_CIT0073","doi-asserted-by":"crossref","first-page":"612","DOI":"10.1093\/toxsci\/kfq048","article-title":"Flawed experimental design reveals the need for guidelines requiring appropriate positive controls in endocrine disruption research","volume":"115","author":"vom Saal","year":"2010","journal-title":"Toxicol Sci."},{"issue":"3","key":"2021121717531097400_CIT0074","doi-asserted-by":"crossref","first-page":"140","DOI":"10.1002\/bdra.20120","article-title":"The importance of appropriate controls, animal feed, and animal models in interpreting results from low-dose studies of Bisphenol A","volume":"73","author":"Vom Saal","year":"2005","journal-title":"Birth Defects Res A Clin Mol Teratol."},{"issue":"1","key":"2021121717531097400_CIT0075","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1016\/j.envres.2005.09.001","article-title":"Large effects from small exposures. II. The importance of positive controls in low-dose research on Bisphenol A","volume":"100","author":"vom Saal","year":"2006","journal-title":"Environ Res."},{"key":"2021121717531097400_CIT0076","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.reprotox.2013.02.002","article-title":"Regulatory decisions on endocrine disrupting chemicals should be based on the principles of endocrinology","volume":"38","author":"Vandenberg","year":"2013","journal-title":"Reprod Toxicol."},{"key":"2021121717531097400_CIT0077","first-page":"301","article-title":"Atrazine has been used safely for 50 years?","author":"Hayes","year":"2011"},{"issue":"548","key":"2021121717531097400_CIT0078","first-page":"1","article-title":"Toxicology and carcinogenesis study of ethinyl estradiol (CAS No. 57-63-6) in Sprague-Dawley rats (feed study)","author":"National Toxicology Program","year":"2010","journal-title":"Natl Toxicol Program Tech Rep Ser."},{"issue":"1","key":"2021121717531097400_CIT0079","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1093\/toxsci\/kft035","article-title":"Prenatal bisphenol A exposure alters sex-specific estrogen receptor expression in the neonatal rat hypothalamus and amygdala","volume":"133","author":"Cao","year":"2013","journal-title":"Toxicol Sci."},{"issue":"8","key":"2021121717531097400_CIT0080","doi-asserted-by":"crossref","first-page":"3681","DOI":"10.1210\/en.2006-0189","article-title":"Evidence of altered brain sexual differentiation in mice exposed perinatally to low, environmentally relevant levels of Bisphenol A","volume":"147","author":"Rubin","year":"2006","journal-title":"Endocrinology."},{"issue":"1","key":"2021121717531097400_CIT0081","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1016\/j.ntt.2005.11.004","article-title":"Neonatal genistein or Bisphenol-A exposure alters sexual differentiation of the AVPV","volume":"28","author":"Patisaul","year":"2006","journal-title":"Neurotoxicol Teratol."},{"issue":"1","key":"2021121717531097400_CIT0082","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1016\/j.neuro.2010.07.008","article-title":"The impact of neonatal Bisphenol-A exposure on sexually dimorphic hypothalamic nuclei in the female rat","volume":"32","author":"Adewale","year":"2011","journal-title":"Neurotoxicology."},{"issue":"1","key":"2021121717531097400_CIT0083","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1016\/j.neuro.2011.11.002","article-title":"Neonatal Bisphenol A exposure alters sexually dimorphic gene expression in the postnatal rat hypothalamus","volume":"33","author":"Cao","year":"2012","journal-title":"Neurotoxicology."},{"issue":"3","key":"2021121717531097400_CIT0084","first-page":"84","article-title":"Closing the gap: improving additives safety evaluation to reflect human health concerns","volume":"1","author":"Maffini","year":"2017","journal-title":"Environ Risk Assess Remediat."},{"issue":"4","key":"2021121717531097400_CIT0085","doi-asserted-by":"crossref","first-page":"594","DOI":"10.1111\/andr.12176","article-title":"Low-dose effect of developmental bisphenol A exposure on sperm count and behaviour in rats","volume":"4","author":"Hass","year":"2016","journal-title":"Andrology."},{"issue":"4","key":"2021121717531097400_CIT0086","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1111\/andr.12193","article-title":"Low-dose effects of Bisphenol A on mammary gland development in rats","volume":"4","author":"Mandrup","year":"2016","journal-title":"Andrology."},{"issue":"4","key":"2021121717531097400_CIT0087","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1111\/andr.12219","article-title":"Clarity in the face of confusion: new studies tip the scales on Bisphenol A (BPA)","volume":"4","author":"Vandenberg","year":"2016","journal-title":"Andrology."},{"key":"2021121717531097400_CIT0088","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1016\/j.reprotox.2019.07.014","article-title":"A critical evaluation of thyroid hormone measurements in OECD test guideline studies: is there any added value?","volume":"88","author":"Beekhuijzen","year":"2019","journal-title":"Reprod Toxicol."},{"issue":"3","key":"2021121717531097400_CIT0089","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1289\/ehp.10524","article-title":"Meeting report: batch-to-batch variability in estrogenic activity in commercial animal diets\u2014importance and approaches for laboratory animal research","volume":"116","author":"Heindel","year":"2008","journal-title":"Environ Health Perspect."},{"issue":"7","key":"2021121717531097400_CIT0090","doi-asserted-by":"crossref","first-page":"e0128429","DOI":"10.1371\/journal.pone.0128429","article-title":"Laboratory rodent diets contain toxic levels of environmental contaminants: implications for regulatory tests","volume":"10","author":"Mesnage","year":"2015","journal-title":"PloS One."},{"issue":"1","key":"2021121717531097400_CIT0091","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1017\/S2040174410000711","article-title":"Choice of animal feed can alter fetal steroid levels and mask developmental effects of endocrine disrupting chemicals","volume":"2","author":"Ruhlen","year":"2011","journal-title":"J Dev Orig Health Dis."}],"container-title":["Endocrinology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/endo\/advance-article-pdf\/doi\/10.1210\/endocr\/bqz014\/30419189\/bqz014.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/endo\/article-pdf\/161\/5\/bqz014\/41811701\/endo_161_5_bqz014.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/endo\/article-pdf\/161\/5\/bqz014\/41811701\/endo_161_5_bqz014.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,17]],"date-time":"2021-12-17T19:21:33Z","timestamp":1639768893000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/endo\/article\/doi\/10.1210\/endocr\/bqz014\/5613539"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,6]]},"references-count":91,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2020,5,1]]}},"URL":"https:\/\/doi.org\/10.1210\/endocr\/bqz014","relation":{},"ISSN":["0013-7227","1945-7170"],"issn-type":[{"value":"0013-7227","type":"print"},{"value":"1945-7170","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2020,5]]},"published":{"date-parts":[[2019,11,6]]},"article-number":"bqz014"}}