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

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NTP.will.transmit.the.NTP-CERHR.<strong>Monograph</strong>. on.Bisphenol.A.to.federal.and.state.agencies,. interested. parties,. and. the. public. and. make. it. available. in. electronic. PDF. format. on. the. CERHR. web. site. (http://cerhr.niehs.nih.gov) and.in.printed.text.or.CD.from.CERHR:. Dr..Michael.D..Shelby Director,.CERHR. NIEHS,.P.O..Box.12233,.MD.EC.-.32 Research.Triangle.Park,.NC.27709 919.-.541.-.3455.[phone] 919.-.316.-.4511.[fax]. shelby@niehs.nih.gov.[email] viii
inTroduCTion Bisphenol.A.(CAS.RN:.80.–.05.–.7).is.a.high.production.volume.chemical.used.primarily.in.the. production.of.polycarbonate.plastics.and.epoxy. resins..Polycarbonate.plastics.are.used.in.food. and.drink.packaging;.the.resins.are.used.as.lacquers.to.coat.metal.products.such.as.food.cans,. bottle.tops,.and.water.supply.pipes..To.a.lesser. extent.bisphenol.A.is.used.in.the.production.of. polyester.resins,.polysulfone.resins,.polyacrylate. resins,.and.flame.retardants..In.addition,.bisphenol.A. is. used. in. the. processing. of. polyvinyl. chloride.plastic.and.in.the.recycling.of.thermal. paper..Some.polymers.used.in.dental.sealants. and.tooth.coatings.contain.bisphenol.A. In.2007,.the.CERHR.Expert.Panel.on.Bisphenol. A.evaluated.bisphenol.A.for.reproductive.and. developmental.toxicity..Because.most.people.in. the.United.States.are.exposed.to.bisphenol.A. and.a.number.of.studies.have.reported.effects. on.reproduction.and.development.in.laboratory. animals,.there.is.considerable.interest.in.its.possible.health.effects.on.people..For.these.reasons,.the.CERHR.convened.an.expert.panel.to.conduct.an.evaluation.of.the.potential.reproductive. and.developmental.toxicities.of.bisphenol.A.. ix This.monograph.includes.the.NTP.Brief.on.Bisphenol.A,.a.list.of.the.expert.panel.members. (Appendix.I),.and.the.Expert.Panel.Report.on. bisphenol.A.(Appendix.II)..The.monograph.is. intended.to.serve.as.a.single,.collective.source. of.information.on.the.potential.for.bisphenol. A.to.adversely.affect.human.reproduction.or. development.. The.NTP.Brief.on.Bisphenol.A.presents.the. NTP’s.opinion.on.the.potential.for.exposure.to. bisphenol.A.to.cause.adverse.reproductive.or. developmental.effects.in.people..The.NTP.Brief. is.intended.to.provide.clear,.balanced,.scientifically.sound.information..It.is.based.on.information.about.bisphenol.A.provided.in.the.expert. panel.report,.public.comments,.comments.from. peer.reviewers. 3 .and.additional.scientific.information.available.since.the.expert.panel.meeting.. 3 Peer.review.of.this.brief.was.conducted.by.the.NTP. Board.of.Scientific.Counselors.(supplemented.with. eight. non-voting. ad hoc. reviewers). on. June. 11,. 2008..The.peer.report.is.available.at.http://cerhr. niehs.nih.gov/chemicals/bisphenol/bisphenol. html.
Page 1: National Toxicology Program U.S. De
Page 4 and 5: [This page inTenTionally lefT blank
Page 10: National Toxicology Program U.S. De
Page 15 and 16: nTp brief tainers.with.internal.epo
Page 17 and 18: Population Adult General. Populatio
Page 19 and 20: Table 3. Blood and Breast Milk Biom
Page 21 and 22: Figure 2b. The weight of evidence t
Page 23 and 24: in.considering.the.biological.plaus
Page 25 and 26: isphenol.A.as.efficiently.as.adult.
Page 27 and 28: isphenol.A..For.example,.this.raise
Page 29 and 30: laboRaToRy aNImal STudIeS In.contra
Page 31 and 32: of.normal.sex-based.differences.bet
Page 33 and 34: death.(168),.synaptic.plasticity.(1
Page 35 and 36: gland.carcinogen.or.that.bisphenol.
Page 37 and 38: understand.the.possible.long-term.c
Page 39 and 40: strategies.to.improve.the.sensitivi
Page 41 and 42: • • Howdeshell.et.al. (55).repo
Page 43 and 44: and.cystic.endometrial.hyperplasia.
Page 45 and 46: cutaneous. injection. 20 . vom. Saa
Page 47 and 48: are CurrenT exposures To bisphenol
Page 49 and 50: w/day;.95th.percentiles.0.289.-.0.2
Page 51 and 52: nTp ConClusions The.NTP.reached.the
Page 53 and 54: appendix a: inTerpreTaTion of blood
Page 55 and 56: µg/kg.bw/day.based.on.the.assumpti
Page 57 and 58: concentrations.from.maternal,.fetal
Page 59 and 60:
12.. Padmanabhan. V,. Siefert. K,.
Page 61 and 62:
In..Research.Triangle.Park,.NC:.RTI
Page 63 and 64:
65.. Alonso-Magdalena. P,. Laribi.
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91.. Calabrese.EJ,.Baldwin.LA.(2003
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Thyroid.Function.in.Juvenile.Female
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droxylase.immunoreactivity..76:423.
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stanceschimiques.gc.ca/challenge-de
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Watanabe.H,.Ohta.Y,.Iguchi.T.(2006)
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226..vom. Saal. FS,. Cooke. PS,. Bu
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solid.phase.extraction-high.perform
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appendix i. nTp-Cerhr bisphenol a e
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158 CHAPIN ET AL. the CERHR Core Co
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160 CHAPIN ET AL. referred to as 4,
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162 CHAPIN ET AL. concentrations in
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164 CHAPIN ET AL. Food (no. sampled
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166 CHAPIN ET AL. Table 6 Continued
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168 CHAPIN ET AL. comparison of the
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170 CHAPIN ET AL. Table 8 Urinary C
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172 CHAPIN ET AL. the blood of male
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174 CHAPIN ET AL. Table 11 Bispheno
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176 CHAPIN ET AL. Table 13 Summarie
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178 CHAPIN ET AL. Table 15 Estimate
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180 CHAPIN ET AL. Table 17 Maximum
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182 CHAPIN ET AL. 2.0 GENERAL TOXIC
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184 CHAPIN ET AL. fetuses (3.572.7
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186 CHAPIN ET AL. Secondary sources
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188 CHAPIN ET AL. Table 25 Maternal
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190 CHAPIN ET AL. Table 27 Bispheno
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192 CHAPIN ET AL. Table 31 Qualitat
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194 CHAPIN ET AL. Table 33 Toxicoki
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198 CHAPIN ET AL. appeared to occur
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200 CHAPIN ET AL. Table 43 Biliary
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202 CHAPIN ET AL. suggesting that 4
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204 CHAPIN ET AL. low following ora
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206 CHAPIN ET AL. scaling and speci
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208 CHAPIN ET AL. 60-100% in each d
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210 CHAPIN ET AL. related. No histo
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212 CHAPIN ET AL. Table 52 Continue
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214 CHAPIN ET AL. Model and exposur
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216 CHAPIN ET AL. Model and exposur
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218 Model and exposure Husbandry a
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220 CHAPIN ET AL. Table 54 Differen
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222 CHAPIN ET AL. Table 56 Anti-And
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224 Table 57 In Vitro Genetic Toxic
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226 CHAPIN ET AL. Table 58 In Vivo
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228 CHAPIN ET AL. Table 59 Developm
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232 CHAPIN ET AL. Table 64 Tissue R
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236 CHAPIN ET AL. treatment conditi
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238 CHAPIN ET AL. clinical signs, b
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240 CHAPIN ET AL. Table 71 Benchmar
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242 CHAPIN ET AL. group, 5 from 1 l
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244 CHAPIN ET AL. least significant
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246 CHAPIN ET AL. group was a reduc
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248 CHAPIN ET AL. 100-151 g for fem
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250 CHAPIN ET AL. 3.2.3.2 Developme
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252 CHAPIN ET AL. weights, bispheno
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254 CHAPIN ET AL. 120 mg/kg bw/day
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256 CHAPIN ET AL. comparisons condu
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258 CHAPIN ET AL. the findings of t
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260 CHAPIN ET AL. analyzed.] Anogen
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262 CHAPIN ET AL. purposeful confou
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264 CHAPIN ET AL. increased lordosi
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266 CHAPIN ET AL. that there was a
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268 CHAPIN ET AL. duration of adver
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270 CHAPIN ET AL. doses of potent e
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272 CHAPIN ET AL. Table 74 Effects
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274 CHAPIN ET AL. reproductive orga
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276 CHAPIN ET AL. tyrosine-hydroxly
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278 CHAPIN ET AL. include small sam
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280 CHAPIN ET AL. males/group. [It
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282 CHAPIN ET AL. termination, whic
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284 CHAPIN ET AL. provided a reliab
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286 CHAPIN ET AL. grooming, and out
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288 CHAPIN ET AL. method of oral do
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290 CHAPIN ET AL. reared by their d
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292 CHAPIN ET AL. has been informed
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294 CHAPIN ET AL. buffered paraform
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296 CHAPIN ET AL. unit. Further, th
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298 CHAPIN ET AL. PND 21 and housed
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300 CHAPIN ET AL. Tando et al. (200
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302 CHAPIN ET AL. Purina Certified
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304 CHAPIN ET AL. high-doses of bis
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306 CHAPIN ET AL. born to those dam
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308 CHAPIN ET AL. average weight we
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310 CHAPIN ET AL. study authors con
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312 CHAPIN ET AL. used for extracti
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314 CHAPIN ET AL. jar, and there we
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316 CHAPIN ET AL. of testes and com
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318 CHAPIN ET AL. differentiation o
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320 CHAPIN ET AL. Table 81 Summary
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322 CHAPIN ET AL. Table 82 Continue
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Page 249 and 250:
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328 CHAPIN ET AL. 600 mg/kg bw/day)
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330 CHAPIN ET AL. (Nagao et al., 19
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332 CHAPIN ET AL. antinuclear antib
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334 CHAPIN ET AL. least 6 animals.
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336 CHAPIN ET AL. Utility (Adequacy
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338 CHAPIN ET AL. stomach weight wa
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340 CHAPIN ET AL. Schirling et al.
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342 CHAPIN ET AL. Endpoint Table 88
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344 CHAPIN ET AL. different diets b
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346 CHAPIN ET AL. with 40 mg vitami
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348 CHAPIN ET AL. the bisphenol A v
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350 CHAPIN ET AL. and determining t
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352 CHAPIN ET AL. expression [to B6
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354 CHAPIN ET AL. indicated] at 0 (
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356 CHAPIN ET AL. concentrations us
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358 CHAPIN ET AL. animals were non-
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360 CHAPIN ET AL. following adjustm
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362 CHAPIN ET AL. Table 94 Treatmen
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364 CHAPIN ET AL. Table 97 Effects
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366 CHAPIN ET AL. Table 99 Treatmen
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368 CHAPIN ET AL. Therefore the NTP
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370 CHAPIN ET AL. weeks before mati
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374 Table 101 Summary of High Utili
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376 Table 102 Summary of Limited Ut
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380 CHAPIN ET AL. from other suppli
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382 CHAPIN ET AL. U.S. populations.
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384 CHAPIN ET AL. 10. Critical desi
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386 CHAPIN ET AL. Engel SM, Levy B,
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388 CHAPIN ET AL. alpha and beta ex
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390 CHAPIN ET AL. Murray TJ, Maffin
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392 CHAPIN ET AL. Ryan BC, Vandenbe
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394 CHAPIN ET AL. Thomas P, Dong J.
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appendix iii. publiC CommenTs and p
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