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

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nTp C<strong>on</strong>Clusi<strong>on</strong>s<br />

The.NTP.reached.<strong>the</strong>.following.c<strong>on</strong>clusi<strong>on</strong>s.<strong>on</strong>.<br />

<strong>the</strong>.possible.effects.of.exposure.to.bisphenol.A.<br />

<strong>on</strong>.human.development.<strong>and</strong>.reproducti<strong>on</strong>..Note.<br />

that.<strong>the</strong>.possible.levels.of.c<strong>on</strong>cern,.from.lowest.to.<br />

highest,.are.negligible.c<strong>on</strong>cern,.minimal.c<strong>on</strong>cern,.<br />

some.c<strong>on</strong>cern,.c<strong>on</strong>cern,.<strong>and</strong>.serious.c<strong>on</strong>cern.<br />

The NTP has some c<strong>on</strong>cern for effects <strong>on</strong> <strong>the</strong><br />

brain, behavior, <strong>and</strong> prostate gl<strong>and</strong> in fetuses,<br />

infants, <strong>and</strong> children at current human exposures<br />

to bisphenol A.<br />

The.NTP.c<strong>on</strong>curs.with.<strong>the</strong>.c<strong>on</strong>clusi<strong>on</strong>.of.<strong>the</strong>.<br />

CERHR.Expert.Panel.<strong>on</strong>.Bisphenol.A.that.<strong>the</strong>.<br />

scientific. evidence. supports. a. c<strong>on</strong>clusi<strong>on</strong>. of.<br />

some c<strong>on</strong>cern.for.exposures.in.fetuses,.infants,.<br />

<strong>and</strong>.children.based.<strong>on</strong>.a.number.of.laboratory.<br />

animal.studies.reporting.that.“low”.level.exposure.<br />

to. bisphenol.A. during. development. can.<br />

cause.changes.in.<strong>the</strong>.brain.<strong>and</strong>.behavior..In.additi<strong>on</strong>,.<strong>the</strong>.NTP.has.some<br />

c<strong>on</strong>cern.for.exposures.<br />

to. <strong>the</strong>se. populati<strong>on</strong>s. based. <strong>on</strong>. effects. <strong>on</strong>. <strong>the</strong>.<br />

prostate.gl<strong>and</strong>.observed.in.laboratory.animals..<br />

This.level.of.c<strong>on</strong>cern.for.effects.<strong>on</strong>.<strong>the</strong>.prostate.<br />

gl<strong>and</strong>.is.higher.than.that.expressed.by.<strong>the</strong>.Expert.<br />

Panel.<strong>and</strong>.is.based.primarily.<strong>on</strong>.new.supportive.<br />

data.related.to.(1).<strong>the</strong>.interpretati<strong>on</strong>.of.studies.<br />

that.use.a.n<strong>on</strong>-oral.route.of.administrati<strong>on</strong>.in.<br />

ne<strong>on</strong>atal.rodents,.<strong>and</strong>.(2).an.additi<strong>on</strong>al.publicati<strong>on</strong>.reporting.subtle.cellular.changes.in.<strong>the</strong>.<br />

prostate.gl<strong>and</strong>..These.reports.were.not.published.<br />

when.<strong>the</strong>.Expert.Panel.completed.its.deliberati<strong>on</strong>s..These.studies.in.laboratory.animals.provide.<strong>on</strong>ly.limited.evidence.for.adverse.effects.<br />

<strong>on</strong>.development.<strong>and</strong>.more.research.is.needed.to.<br />

better.underst<strong>and</strong>.<strong>the</strong>ir.implicati<strong>on</strong>s.for.human.<br />

health..However,.because.<strong>the</strong>se.effects.in.animals.<br />

occur.at.bisphenol.A.exposure.levels.similar.to.<br />

those.experienced.by.humans,.<strong>the</strong>.possibility.<br />

that.bisphenol.A.may.alter.human.development.<br />

cannot.be.dismissed.<br />

38<br />

The NTP has minimal c<strong>on</strong>cern for effects <strong>on</strong> <strong>the</strong><br />

mammary gl<strong>and</strong> <strong>and</strong> an earlier age for puberty<br />

for females in fetuses, infants, <strong>and</strong> children at<br />

current human exposures to bisphenol A.<br />

The.NTP.c<strong>on</strong>curs.with.<strong>the</strong>.c<strong>on</strong>clusi<strong>on</strong>.of.<strong>the</strong>.<br />

CERHR. Expert. Panel. <strong>on</strong>. Bisphenol. A. that.<br />

<strong>the</strong>.scientific.evidence.supports.a.c<strong>on</strong>clusi<strong>on</strong>.<br />

of.minimal c<strong>on</strong>cern.for.exposures.in.fetuses,.<br />

infants,. <strong>and</strong>. children. based. <strong>on</strong>. a. number. of.<br />

laboratory.animal.studies.reporting.that.“low”.<br />

level.exposure.to.bisphenol.A.during.development.can.alter.<strong>the</strong>.timing.of.events.related.to.<br />

sexual.maturati<strong>on</strong>.in.females..In.additi<strong>on</strong>,.<strong>the</strong>.<br />

NTP.has.minimal c<strong>on</strong>cern.for.exposures.to.<strong>the</strong>se.<br />

populati<strong>on</strong>s.based.<strong>on</strong>.effects.<strong>on</strong>.<strong>the</strong>.mammary.<br />

gl<strong>and</strong>. observed. in. laboratory. animals.. This.<br />

level.of.c<strong>on</strong>cern.for.effects.<strong>on</strong>.<strong>the</strong>.mammary.<br />

gl<strong>and</strong>.is.higher.than.that.expressed.by.<strong>the</strong>.Expert.<br />

Panel.<strong>and</strong>.is.based.primarily.<strong>on</strong>.(1).informati<strong>on</strong>.<br />

received. through. public. comments. <strong>and</strong>. (2). a.<br />

new.supportive.study.reporting.subtle.changes.<br />

in.<strong>the</strong>.undifferentiated.structures.of.<strong>the</strong>.mammary.gl<strong>and</strong>..These.studies.in.laboratory.animals.<br />

provide.<strong>on</strong>ly.limited.evidence.for.adverse.effects.<br />

<strong>on</strong>.development.<strong>and</strong>.more.research.is.needed.to.<br />

better.underst<strong>and</strong>.<strong>the</strong>ir.implicati<strong>on</strong>s.for.human.<br />

health..However,.because.<strong>the</strong>se.effects.in.animals.<br />

occur.at.bisphenol.A.exposure.levels.similar.to.<br />

those.experienced.by.humans,.<strong>the</strong>.possibility.<br />

that.bisphenol.A.may.alter.human.development.<br />

cannot.be.dismissed.<br />

The NTP has negligible c<strong>on</strong>cern that exposure of<br />

pregnant women to bisphenol A will result in fetal<br />

or ne<strong>on</strong>atal mortality, birth defects, or reduced<br />

birth weight <strong>and</strong> growth in <strong>the</strong>ir offspring.<br />

The.NTP.c<strong>on</strong>curs.with.<strong>the</strong>.c<strong>on</strong>clusi<strong>on</strong>.of.<strong>the</strong>.<br />

CERHR.Expert.Panel.<strong>on</strong>.Bisphenol.A.that.<strong>the</strong>re.<br />

is.negligible c<strong>on</strong>cern.that.exposure.of.pregnant.<br />

nTp brief

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