Document MobvvxJ7oYV4QZZ6Jbkpn9Brz
:
AR226-1919
H18636: Slide Reviewofpancreas lesions fram DuPont APFO Study
DateofReview: 28 November 2001-11-29
Reviewing Pathologists: Dr EE McConnell and DrIR Foster
Study No: HN-18636 SWyt1u4d,y6T4i3tl.e: Combined Chronic Toxicity/Oneogenicity Study with Linuron, C8 end Conclusionofthe review: th"eThierfoivnerdailnlgsc.onTclhuesiroenvoifewthceonrfeivrimeewod fthtehcetarwcoinsotguedniiecs ewfafesctthoaftAtPheFyOweirnethneotDiunPcoonnstisstteundty in awnads tchoensmiodsetreHdike0lbyeeaxdpelacnraetaisonedforstehensJiactkioffvointthyaencdoegveenleotpimceneftfoefctpofaAnPFcO raacietnhaaere3tfMfeiscttcsu,dy sctoumdbyisnheodwweidtthhaenfuulnldesrp-ercetprourmotnfgoAfPFthOe-iancdinuacrehdypaecripnlaarspiraotlhiafterwaatisonpsrefsrenotm. hyTpheerpDluasPioant tahsroaurgefhlteoctciaonrocfinionmaad.eqIutsahcoyuilndtbheenoorgtiendatlhtinttehrepcroetmamtieonnotfotnuesntuddyeburtrmeerepilsyonroretfiltenctitesnntdheged. . yefaacrtsthsatiknnotwhlcee3deMge,santdwdaiusscrriedmpionratytedi.onAoffhienaslecsuobtlne pfanciroerafttimicsalcesotinocnilsu,sohiaonsnadavwaanictesdaimnotrhee exteasive reviewofthe pancreas slides from the 3M study to be carried out by Dr McComnell.
Sum1m. aArlyloofftthhee nreeovpileaws:tic findings originally diagnosed on the DuPont stady were 2. Ecloenvfeirnmoefdt.he hyperplasiesoriginallydiagnosedin group IIontheDuPstoudynwetre 3. `Tdwoowongfrtahedehdyp5e0rp8lapsoitastoobreigrienpaolrlyteddiaagsnhoyspeedrpilnagsirao.u I on the DuPont stdy were 4. Adn ado ditiow nalston w2osnacog inarbhr eypreerpa polratseidd aaswheyre peerdpilad agnsoisaed in group II Gig the review 5. I`nprsopcietsesowfhithcehsewcehraenngoetsotrhiegionvaelrlyaldlicaognncolsuesdioansfosrukt.heDuPstadoyrenmaitned that 6. AFPolFlOowiinngthalisismtiutdeydhcaodmsbhionwend raecvaizecwinboygeDnrisceFfofsetecrt afordthFreammael,eorftathepanpcarnecarse.as slides fwreorme ecpopnrfoixrimmeadtienlyth3e03aMnsitmuadlsya(snedlecatletdhobuyghDralFroaftmhe)e,asneivmearlals awceirnearnohtypreervpileawsieadsthe i`npdreulciemdinianrcyrceoansceliunsaicoinnoefrthhyepleirmpiltaesidareovnitehwwea3sMtshtautdyt.heDedriMd capCpeaorntohnbaeesabnleeAlnPFOrequestedtoreviewallofthepancreas"fomthe 3M study.
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Introduction: ``oTnheAPpaFtOholwoagsyirneitviiaetewodbfecthaeuspeaincnretahse'3rMostmutdhye,wthwoicohncwoagsecnaircrtiyedsotuudtifeisrscto,tnhduecctoemdpion uthnedrat tahesmanoltecraart,csihnoogweendic&0ctlheaeproannccorgeeansiwcehfifleecitaotnhtehDeupPaonncrtesattuidcys,cwihniecrchavlise.s oTnhleyscloinddeircetveidewin wasrequestedtoconfirm orrefutethefindingsinthe pancreas'fromthe twostudies.
S`TihteeroefvRieevwi1e0w0:k place at DuPont Haskell Laboratories, New rk, Delewaorne 28% November 2001 Those Present: DDrrJRoahnndyHFarnsaemne~--HSetauddyofPPaathtohloolgoigsyt,, DDuuPPoonntt HHaasskkeellll LLaabboorraattoorriieess,, DDeellaawwaarree,, UUSSAA DDrrCG RKeEnlcnoemdbey~,HBeiaodchoefmTiocxailcoTlaxoigcyo,loDguiPsto,ntDuHnadskeeellUnLiavbeorrsaittoyr,ieUsK,.Delaware, USA. DDrr JJoohhnn RBuFtoesntheorf,f,ReTvoixeicwoilnoggPiast,ho3lMog,isMti,nnAesstortaaZ,enUeScAa Pharmaceuticals, Cheshire, UK DrE E McConnell,ReviewingPathologist, Pata.abs, NorthCaroling, USA
Conductof Review:
1.
The STP Pancreas
(G1u9i9de5l)winaesstfhoerbthaesdiiafgonrotshiesdoiafgPnorstoiclcriitfereLiearusieaodntsioinftvthheereeEvxioecwrpirnoecess.
2. Tpaongcertehaesr'wirtohmDrapFprraoxmiem,aotnel&yt3w0oahneiamdaelds rmiocmrotshceop3eM,DArPFFoOstesrtruedvyiwehwiecdhthinecluded
3. DwroMacnCiomnanlesflrlwomasthnoctoanbtlreolg0rreouvpieawntdhtehe3rMesmtauignydoenrthriosmoctchaestiopondboustehGaosupbe.en
givente slides from (report pending).
al
ofthe animalsonthisstudytoreview
in thenearfuture. 4
4. F'oErEMtheeC)rweevireewgoifvtehnesDuuPmonmt aAtParbFlyeOs Sotftuhyeotrhigrienvailedwiianggnpoestehso.logists (IRFand
.
5. D`r MwctChohenpnreeelsiernntcieaeollfyerietvhiereawceidntahrehpyapnecrrpelaassssl,idaedsefnroommaoonrlcyatrhcoisneogmraohuapdIbleaennimals
arneicmoardlesdf.roInmagdrdoiutipoInIh. eParnecvrieeaswesdlitdheesfparnocmrteahsegslrioduespf|coomnatloolafntihmeaplasifr-rfoemdtchoentrol
6.
D"rDuFPoosnttesrrtahdeyn
werenoreviewed. indepreevienweddtheesnametanlimaylsasDr
McConnell
from
group
IMcbCountnienllthheiandtecroensstisdoefretdisohno,owneldyprreovliifeewreadttivheosleesiaonnismaalnds/forrotmhogsreoudpeeImtehdatbDyrthe
7. sTthueddyipaagtnhoosliosgfisotmtobohatvheDsrhsoMwncCleosinonnsefalrnoldmFotsheteorrwigeirnaelirenpodrteofptheensrtdeudceyo.rndetdalnyd
-
8. t`hAennywdeisraegrceoemmpeanrtesd.betweenthereviewing pathologists were then reviewed together
oanddi2ttiwoon-alheraedvieedwmoifcrthoescsolpiedeas,ntdogeectohnesrewnistuhsargefreereednicentcoontshiedoerriagtiinoanodfiabgonotshitsh.e
i
//
"5. DrervsieMwcaCnodmweelrle, Fjoositneerd,lHataenrsbeynaDardsFErlacmomebteh,eaBumetsetnohdoiasfncfdusKstehnenfeidnyfdionrgasfoifnathle 10.1dewbraiseas.greedthatDr Framewoulddeaf asinglepagereportoftheproceedingsand cpiartchuolloagtiesitst,otahdeDatrtscFordianmgemaemnbdeHrasnsfeo ncwoomumldenstigsnethrewfhiniac!hvtehresiroenviaseawinnagccarsze represcationof heprocesdings.
3 /2
: "Table 1: SummoafJrRFy 's reviewofthe DuPont pancreas slides.
v
L am|r Di SE Consensus Disagree
| Poat
| "=| Diagnosis
eT) [Rooms [|TXX ] ow|]Toeisoose c|iKEereelmess|
[ To | 7|i on] i e ee eneeemtetn y[oAdeamm]] . byperplasia);| hyperplasia _|Hyperplasia (4) I I--Ia J P 7 illPI E =To [NADTX |Rava | Hyperplasia |Hyperplasia()]
Te 7 RaSHT62
"Adenoma
Hypperlpleas(i3)a
Te)
| E-- [ --TE en1n s eeens es ]he aawemen]
I=Bevr] llI
a)
I = a reviewed
Somp0n)
|[ereviemwed [Rese
em eno)
I = pe ls hn) ]
.
/3
} [ees
[[een m[rFewese[n Pee] d]
[1 J [ravasos|
NAD
|Hypemplsia(D)|
focus
[1 J T"Raoasis|
3
Basophiliciocus
|Hyperplasia(1)|
a I [TRemsi i
focus
Ew] [ [RT 4o6IL2| Hypeply sia |Hyperplasia(D)|
[ TrT eas [Naby|
Hyperplasia?
[ Twm1 aotese| Nab7 | |
--
TT
7"1
`Table 2: Comparison ofincidencesofproliferativelesionsintheacinarpancreasbetween
Grwp2 | Grows
[OrigimalDiaguoss|
|
1
[Acmerhyperplasia |
8
|
2%
|
[Acnaradenoms
|
1
|6
|
. [Acmarcarcinoma
|
0
1]
[Tow -------- T-- 0-- 13
|
rr 1
[Acinaradenome | T 1 g1]
[(Totar
7
11]
|
Ire
1* December 2001
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