Monograph on the Potential Human Reproductive and ... - OEHHA

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Table of ConTenTs Preface..............................................................................................................................................v Abstract.......................................................................................................................................... vii Introduction.................................................................................................................................... ix NTP.Brief.on.Bisphenol.A...............................................................................................................1 What.is.Bisphenol.A?...........................................................................................................1 Are.People.Exposed.to.Bisphenol.A?...................................................................................1 Can.Bisphenol.A.Affect.Human.Development.or.Reproduction?........................................6 Are.Current.Exposures.Bisphenol.A.High.Enough.to.Cause.Concern?............................34 NTP.Conclusions................................................................................................................38 Appendix.A:.Interpretation.of.Blood.Monitoring.Studies..................................................40 References..........................................................................................................................45 Appendix.I..NTP-CERHR.Bisphenol.A.Expert.Panel..................................................................I-1. Appendix.II..Expert.Panel.Report.on.Bisphenol.A......................................................................II-1 Appendix.III:.Public.Comments.and.Peer.Review.Report.on.Bisphenol.A............................... III-1 iii
Page 1: National Toxicology Program U.S. De
Page 5 and 6: prefaCe The. National. Toxicology.
Page 7 and 8: absTraCT NTP-CERHR MONOGRAPH ON THE
Page 9 and 10: inTroduCTion Bisphenol.A.(CAS.RN:.8
Page 12 and 13: Table of ConTenTs What.is.Bisphenol
Page 14 and 15: nTp brief on bisphenol a WhaT is bi
Page 16 and 17: Population Bisphenol A µg/kg bw/da
Page 18 and 19: nTp brief Population Table 2. Urina
Page 20 and 21: nTp brief and.growth.of.offspring.e
Page 22 and 23: nTp brief A.related.to.neural.and.b
Page 24 and 25: nTp brief of.laboratory.expertise,.
Page 26 and 27: nTp brief to.be.quantified.in.the.b
Page 28 and 29: nTp brief use.of.a.positive.control
Page 30 and 31: nTp brief survival.and.growth.follo
Page 32 and 33: nTp brief behavior.(116, 122, 143).
Page 34 and 35: nTp brief (96).. In. brief,. estrad
Page 36 and 37: nTp brief With.the.exception.of.an.
Page 38 and 39: nTp brief treatment. was. not. sign
Page 40 and 41: nTp brief considered.“positive”
Page 42 and 43: nTp brief • Tyl.et al..(41).repor
Page 44 and 45: nTp brief total. cholesterol,. trig
Page 46 and 47: nTp brief Chromosome and Meiosis Ab
Page 48 and 49: nTp brief ing.sources.of.exposure.(
Page 50 and 51: nTp brief exPoSuRe ComPaRISoNS baSe
Page 52 and 53:
nTp brief women.to.bisphenol.A.will
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nTp brief 60%.of.breast.milk.sample
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nTp brief higher,.as.much.as.~3000.
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nTp brief referenCes 1.. Wilson. NK
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nTp brief cessing.Aids.and.Material
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nTp brief 53.. Murray.TJ,.Maffini.M
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nTp brief activities.of.androgen.re
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nTp brief 106..Hiroi.H,.Tsutsumi,.O
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nTp brief natal. rat. bisphenol. A.
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nTp brief 159..Funabashi. T,. Kawag
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nTp brief 186..Russo.J,.Gusterson.B
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nTp brief and.developmental.paramet
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nTp brief 240..Parry. EM,. Parry. J
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[This page inTenTionally lefT blank
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Published 2008 Wiley-Liss, Inc. w E
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cumyl)phenol; 2,3-dihydro-3-(4 0 -h
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BISPHENOL A 161 Table 2 Concentrati
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BISPHENOL A Table 4 Continued Bisph
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BISPHENOL A Table 6 Surveys of Bisp
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emain in solution up to 20 hr when
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BISPHENOL A Table 7 Blood Concentra
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Country Study population BISPHENOL
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BISPHENOL A Table 10 Bisphenol A Or
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BISPHENOL A 175 Table 12 Average Es
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BISPHENOL A Table 14 Summary of Foo
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BISPHENOL A 179 Table 16 TWA Measur
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BISPHENOL A Table 19 Maximum Report
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BISPHENOL A Table 21 Saliva and Uri
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isphenol A. Bisphenol A was detecte
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in each group were killed at 96 hr
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Table 26 Toxicokinetic Endpoints fo
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Endpoint BISPHENOL A Table 30 Toxic
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BISPHENOL A Table 32 Toxicokinetic
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BISPHENOL A Table 34 Distribution o
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oute of elimination for radioactivi
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BISPHENOL A Table 42 Toxicokinetic
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isphenol A glucuronide (41% of the
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Table 44 Excretion of Radioactivity
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BISPHENOL A 205 lactate dehydrogena
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The European Union (2003) noted lim
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weight] included decreased heart we
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BISPHENOL A Table 52 In Vitro Estro
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BISPHENOL A Table 52 Continued Endp
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Model and exposure Husbandry a Adul
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Model and exposure Husbandry a Imma
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BISPHENOL A Fig. 2. In vitro estrog
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element. Eight hr after i.p. inject
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adioimmunoassay (RIA). Statistical
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Ivett et al. (1989) a,b Tennant et
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0.002, 0.02, and 2 mg/kg bw/day for
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* individuals with the SULT1A1 2 en
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BISPHENOL A Table 62 Continued Mode
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glucuronidating bisphenol A, and po
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Most in vivo estrogenicity studies
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BISPHENOL A 237 Table 70 Maternal a
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litter as the unit. It is unclear w
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group, as well as 19 offspring from
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In testes from 3-day-old rats, RT-P
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significance of the changes. Weakne
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N-methylurea were killed on PND 180
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parameters were examined at Day 30,
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study authors noted that no histori
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orn to 1 dam in that group died by
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Strengths/Weaknesses: Strengths of
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Student or Welch’s t-test using v
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cycles. The study authors concluded
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postnatal rearing. Pups were weaned
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slightly higher than environmental
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edding and caging materials. The Ex
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BISPHENOL A Table 73 Effects of Pub
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that 44.4% of prostates contained i
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injected with the tocopherol-stripp
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determine whether the changes in sp
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involved in cyclic AMP breakdown, w
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processes. The study authors noted
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BISPHENOL A 279 Table 75 Maternal a
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with 28 dams each were given the to
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utero and were 10% higher than body
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BISPHENOL A Table 77 Table 78 Effec
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6.5-13.5 days post-coitum and 6.5 t
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the studies. In each study, ddY mic
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glands were also conducted. Data we
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Technology, examined the effect of
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killed on GD 18 (plug 5 GD 0) for d
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and each treatment group was 36, 57
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Utility (Adequacy) for CERHR Evalua
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Endpoint b BISPHENOL A 301 Table 80
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3.2.8 Mouse—parenteral exposure p
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were culled to 10 pups/litter on PN
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Utility (Adequacy) for CERHR Evalua
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Results were reported to be similar
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isphenol A exposure on the developm
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457 lg/L] bisphenol A and malformat
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were no significant effects reporte
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Strengths/Weaknesses: This study is
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100 nM [23 ng/L], and 1 mM [0.23 mg
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BISPHENOL A Table 82 Summary of Hig
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BISPHENOL A Table 83 Summary of Lim
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Birth Defects Research (Part B) 83:
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Table 86 Adult Body Weights of Offs
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consistent effects on the levels of
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Hiroi et al. (2004), supported by t
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is not known if the sample numbers
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deciduoma formation in pseudopregna
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and left ovary weight in the mid-do
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social investigation, huddling, and
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[0.23 mg/L]. Bisphenol A dimethylac
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Experiment 1 2 3 4 5 BISPHENOL A 34
Page 268 and 269:
Endpoint Relative organ weight Test
Page 270 and 271:
Table 91 Effects in Rats Given Bisp
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BISPHENOL A Table 92 Effects Observ
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concluded that the testicular toxic
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oth] was significantly decreased at
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production at all dose levels, and
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are a primary (or secondary) effect
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Target intakes were B0, 0.0009, 0.0
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BISPHENOL A Table 93 Treatment-Rela
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Endpoint BISPHENOL A 363 Table 95 E
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Table 98 Treatment-Related Effects
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6/24 10/20 13/20 732 [124] 546 [92.
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1988 mg/kg bw/day in females during
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the 1.8 ppm group was not considere
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eproductive success were only 7-fol
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Multigeneration CD rat (gavaged wit
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0.0002 0.011 0.0082 0.0069 0.0050 0
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BISPHENOL A Table 104 Estimates of
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There is sufficient evidence in rat
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developmental endpoints that may be
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fish exposed to xenobiotics under c
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Hiroi H, Tsutsumi O, Momoeda M, Tak
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commercial resin-based dental resto
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ased composites and sealants used i
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Steinmetz R, Mitchner NA, Grant A,
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to pentachlorophenol, bisphenol-A,
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