ASSESSING ENDOCRINE DISRUPTING SUBSTANCES FEDERAL ...

FEDERAL INSTITUTE FOR RISK ASSESSMENT

ASSESSING ENDOCRINE DISRUPTING SUBSTANCES

Handling of risk assessment under different regulations

Andreas Hensel

How EDs may act - sexual hormones as an example

Hypothalamus

(Releasing factors)

Hypophysis

(Gonadotrophic hormons FSH, LH)

Feed back mechanisms

Gonads

(Estrogenes gestagenes androgenes)

Hormone biosynthesis

Phase I/-II

enzymes

ED

SHBG

Binding to transport proteins

Excretion Hormone metabolism

Target tissue

ER / AR

Receptor binding

(Agonist/antagonist)

Signal transduction

Andreas Hensel, 47 AF-Meeting, Assessing endocrine disrupting substances 6-7 March 2013, Dublin

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What is an Endocrine Disruptor?

...the world of known chemicals

Endocrine active substances (EAS)

effects on the endocrine system

!

Endocrine disruptors (EDs)

effects on the endocrine system

induce adverse health effects

Andreas Hensel, 47 AF-Meeting, Assessing endocrine disrupting substances 6-7 March 2013, Dublin

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Definition of ,,Endocrine Disruptors"

WHO/IPCS 2002 definition

An Endocrine Disruptor is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub) populations.

in vitro or in vivo methods in vivo methods

Definition of "adversity" (WHO/IPCS 2004)

"A change in morphology, physiology, growth, reproduction, development or lifespan of an organism which results in impairment of functional capacity or impairment of capacity to compensate for additional stress or increased susceptibility to the harmful effects of other environmental influences."

Andreas Hensel, 47 AF-Meeting, Assessing endocrine disrupting substances 6-7 March 2013, Dublin

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...One substance ? one toxicological assessment!

PPlalannt tPProrotetecctitoionn PProrodduucctsts

(E(ECC11110077/2/2000099) )

Biocides

FFooooddaadddditiitviveess

(98/8/EC; 528/2012) (E(ECC11333333/2/2000088))

RREEAACCHH (E(ECC11990077/2/2000066) )

PPlalasstitcicsswwitihth fofoooddccoonntatacct t (E(EUU1100/2/2001111) )

CCoossmmeetitcicss (E(ECC11222233/2/2000099) )

FFooooddaannddooththeersrs

AArereddaatatarereqquueesstetedduunnddeerrththeereregguulalatitoionnssuufffifcicieiennt tfoforridideenntitfiifcicaatitoionn??

(( ))

ddeeppeennddininggoonn pprorodduucctiotionnvovolulummee

(( ))

ddeeppeennddininggoonn mmigimgrmaraataittoeitonerinrafiralforlomm

(( ))

ddeeppeennddininggoonn inintetennddeedduussee

frfuoruosmsmuuamalmlayllanynnunoufoafpacprctourtoduredurerucsrctstfsofpsorpertechtichefiiecfaicatuotutoxhtxihociorcoirtoliioteliogesgiscaiacavalvadlaildaailatabatblaele

WWhhaat taarereththeepprirninccipiplele(s(s))oof freregguulalatitoionn??

AApppprorovvaal lpprorocceedduurere

AApppprorovvaal l (E(EUUlisliststsoof faapppprorovveedd aadddditiitvievess: :AAIII/II/IIII)I)

RReeggisistrtaratiotionn, , AAuuththoorirziazatitoionn

RRisikskaasssseesssmsmeennt t++RRisikskaasssseesssmsmeennt t

aauuththoorirziazatiotionn

++aadddditiiotionntotolisliststsoof f

(asE(asuuEuUubthUbtsholstiaosrltiiasntrzintcoezecoefdesfds) )

psprsuorubohbshisbtiatbitanietncedcedess(A(AIII)I) ssuubbsstatanncceesswwitihth reresstrtircictitoionnss(A(AIIIII)I)

aallollowweeddssuubbsstatanncecess

(A(AIVIV, ,VV, ,VVI)I)

RRisikskaasssseesssmsmeenntsts GGeenneeraral pl prorovivsisioionnss

AAvvooididininggddisisppaarirtiiteiessininththeeaasssseessssmmeennttoofftotoxxicicoolologgicicaal lpproroppeertriteiessbbeetwtweeeennththeeddififfefererennttreregguulalatitoionnss PPrereddicictatabbiliiltiyty, ,eefffifcicieiennccyy, ,ccoonnssisistetennccyy

Andreas Hensel, 47 AF-Meeting, Assessing endocrine disrupting substances 6-7 March 2013, Dublin

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