Document jjNEobyOw17JQJ26MDbB8Kq9
PFOA
|
11113399..00000011
Exhibit 1139 I3MM_MMNND011669900337700
Industrial 1B 810 -V FRTOENO STATGELa2bOoAraDtovies, Inc. NORT1H81B0ROFORKO.NITLALGIENORIOSAD 60062
NORTHBROOK. tLLINOIS 60062
RREEPPOORRTT TTOO 33MM CCOOMMPPAANNYY 2268--DDAAYY OORRAALL TTFOOCXX-II1CC4II3TTYY SSTTUUDDYY WWIITTHH IINN AALLFBBCII-NN1O4O3MMIICCEE IIBBTT NNOO.. 88553322--1100585555
11113399..00000022
3M_MND1620371
3M MN01690371
Induitial BIO TEST Lokoratorist, Jue.
)
RREEPPOORRTT TTOO 33MM CCOOEM~PPAANNYY 228--DDAAYY OORRAALL TTFOOCXX-II1CC4II3TTYY SSTTUUDDYY WWIITTHH iINN AALLFBBCII-NN1OO43IMMIICCE
IIBBTT NNOO.. 88553322--1100665555 II.. IInnttrroodduuccttiioonn
AA mmaatteerriiaall iiddeennttiiffiieedd 2ass FFCC--114433 ((TT--11774422CCOcCC,, LLoott NNoo.. Z26699)) wwaass oobbttaaiinneedd ffrroomm 33MM CCoommppaannyy ffoorr tthhee ppuurrppoossee ooff ccoonndduuccttiinnggaa 2288--ddaayy ppiilloott ffeeeeddiinngg ssttuuddyy iinn aallbbiinnoo mmiiccee ttoo eessttaabblliisshh ffeeeeddiinnEg lleevveellss ffoorr lloonnEg--tteerrmm ssttuuddiieess iinn tthhaatt ssppeecciieess.. TThhiiss rreeppoorrtt pprreesseennttss tthhee rreessuullttss ooff tthhee eexxppeerriimmeenntt..
11113399..00000033
33MM_MMNND011669900337722
Incishial BIO-TEST Lakoralorist, Ine.
2
) DTbT.. Summary Summary A 28-day oral toxicity study was conducted in which groups of albino A 28-day oral toxicity study was conducted in which groups of albino mice were fed dietary concentrations of 0, 30, 100, 300, 1,000, 3,000, 10,000, mice were fed dietary concentrations of 0, 30, 100, 300, 1,000, 3,000, I0,000, or 30,000 parts of FC-143 per million parts of diet or 30.000 parts of FC-143 per million parts of diet. The results obtained during the investigation revealed reduced body The results obtained during the investiga~on revealed reduced body wweeiigghhtt ggaaiinnss f~oolllloowweedd bbyy lloosssseess iinn bbooddyy wweeiigghhtt aammoonngg aallll tteesstt ggrroouupp aanniimmaallss ((3300,, I10000,, 330000 ppppmm)) tthhaatt wweerree ssaaccrri~fiicceedd aaf~tteerr 2288 ddaayyss oof tteessttiinngg.. AAnn iinnccrreeaassee iinn aavveerraaggee ffoooodd ccoonnssuummppttiioonn wwaass eexxhhiibbiitteedd bb7y aallll aanniimmaallss ffeedd FFCC--114433.. HHoowweevveerr,, eexxcceessssiivvee wwaassttaaggee ooff ffoooodd ffrroomm tthheeiirr ffeeeeddeerrss mmaakkeess iinntteerrpprreett3a.ttiioonn ooff tthhiiss ppaarraammeetteerr ddiiffffiiccuulltt.. AAllll mmaalleess aanndd ffeemmaalleess ffeedd 11,,000000 ppppmm oorr mmoorree ooff FFCC--114433 ddiieedd ~witthhiinn tthhee f~iirrsstt 99 ddaayyss oof tteessttiinngg.. AAllll TT--TITIT ((330000 ppppmm)) mmiiccee eexxcceepptt 1I mmaallee ddiieedd within 2266 ddaayyss ooff tteessttiinngg.. OOnnee aanniimmaall ddiieedd iinn eeaacchh ooff tthhee 3300 aanndd 1I0000 ppppmm tteesstt ggrroouuppss.. NNoo ootthheerr ddeeaatthhss ooccccuurrrreedd.. RReeaaccttiioonnss nnootteedd dduurriinnEg tthhee iinnvveesst~iggaattiioonn iinncclluuddeedd rroouugghheedd ffuurr aanndd mmuussccuullaarr wweeaakknneessss ffoorr aallll aanniimmaallss ffeedd 33,,000000 ppppmm oorr ggrreeaatteerr aafftteerr tthhee ffiirrsstt d4 ddaayyss ooff tteessttiinngg.]. AAnniimmaallss ffeedd 11,,000000 ppppmm ((TT--IIVV)) ooff FFCC--114433 eexxhhiibbiitteedd ssiimmiillaarr rreeaaccttiioonnss aanndd ssiiggnnss ooff ccyyaannoossiiss aafftteerr 66 ddaayyss ooff tteessttiinngg.. AAllll ooff tthheessee rreeaaccttiioonnss wweerree eevviiddeenntt iinn tthhee 330000 ppppmm ((TT--TUTDT)) ggrroouuppss aafftteerr tteesstt ddaayy 99.. SSoommee TT--TITI ((1i0000 ppppmm)) aanniimmaallss eexxhhiibbiitteedd sslliigghhtt ccyyaannoossiiss oonn ddaayyss 1100 aanndd 1Ii1 ooff tteessttiinngg,, bbuutt aappppeeaarreedd nnoorrmmaall ffoorr tthhee rreemmaaiinnddeerr ooff tthhee ssttuuddyy.. A,%l1l1 3300 ppppmm ((TT--II)} aanniimmaallss rreeaacctteedd ssiimmiillaarr ttoo tthhee ccoonnttrroollss dduurriin=gg tthhee Z288 ddaayyss ooff tteessttiinngg..
11113399..00000044
I3MM_MMNND011669900337733
Judustiol BIO TESTLoboralories,Inc.
3
Gross pathologic examination of all animals sacrificed after 28 days of
Gross pathologic examination of a~l animals sacrificed after 28 days of
testing revealed enlargement and/or discoloration of 1 or more liver lobules.
tes~:ing revealed erdargement and/or d~scoloration of 1 or more liver lobules.
Statistical analyses revealed significant increases in the absolute liver
Statistical analyses revealed significant increases in the absolute liver
weights from males and females of the remaining 30 ppm (T-D), and
weights from males and females of the remaining 30 ppm (T-I), and
100 ppm (T-II) test groups. Increases were also noted in the liver to
100 ppm (T-I!) test groups. Increases were also noted in the liver to
body weight ratios for these animals.
body weight ~'at~os for these animals.
Histopathologic examination of all sacrificed mice revealed treatment-related
Histopathologic examination of a]! sacrificed mice revealed treatment-related
liver findings in the males and females of all test groups examined, 30 ppm
liver findings in the males and females of all test groups examined, 30 ppm
((TT-DI)),, 1i0000 ppppmm ((TT-IID!)),, aanndd iinn ttwwoo i1,,000000 ppppmm ((TT--IIVV)) aanniimmaallss tthhaatt ddiieedd dduurriinngg
tthhee ssttuuddyy.. TThheessee ffiinnddiinnggss ccoonnssiisstteedd ooff ddiiffffuussee ccyyttooppllaassmmiicc eennllaarrggeemmeenntt ((hhyyppeerrttrroopphhyy)) ooff hheeppaattooccyytteess tthhrroouugghhoouutt tthhee eennttiirree lliivveerr lloobbuul!eess ((ppaannlloobbuullaarr)) aaccccoommppaanniieedd bbyy ffooccaall ttoo mmuullttiiffooccaall ccyyttooppllaassmmiicc lliippiidd vvaaccuuoolleess.. TThheerree wwaass aallssoo ddeeggeenneerraattiioonn aanndd//oorr nneeccrroossiiss ooff hheeppaattooccyytteess aanndd ffooccaall bbiillee dduucctt
pprroolliiffeerraattiioonn aammoonngg aanniimmaallss ooff aallll tteesstt ggrroouuppss..
J)
11113399..00000055
IM_MND1690374
3M MN01690374
Industrial BIO TEST Lokoraloriss, Inc.
4
The
The
oiher
other
Liver
liver
cchhaannggeess
oobbsseerrvveedd
wweerree
tthhoossee
ooff
nnaattuurraallllyy
ooccccuurrrriinngg
disease or related to the method of sacrifice.
disease or related to the method of sacrifice.
Respeciilly submitied,
INDUSTRIAL BIO-TEST LABORATORIES, INC.
INDUSTRIAL BIO-TEST LABORATORIES INC.
Report prepares vy. BomrinCMon Bke, Report prepared by: BABnooinrmnaaisel GCCrhuraoituseptrooTppehhceehrrnician
RAondiemanlt Tosicity Group Technician
Rodent Toxicity
bG~roAdupnuLdeJT ar .ndeM erse wt~g5.rSiiea~ . RGordoeunpt LTeoasdiecrity
Rodent Toxicity
RReeppoorrtt
approved
approved
bbyy::
Loe. ol,
0). Ladd
Acting DDeennnniiss SWWe.c. tAiAorrnnnooHlledda,,d,BB..TSSo..xicology
py Acting Section Head, . Toxicology
renee Kooe KotiKoTodb
-
Technical Manager ToxiPcho.lDo.gy
Technical Manager, Toxicology
BVBeiaercreeiieePreMWs.idPPehnitLlRiapnsd,
PRD
Ph.D.
VDiirceectPorresoifdeRnetseaanrdch
D~ector of Research
QDuaanlaitVyerAifsiweadrabnyce Unit
Quality Assurance Unit
Fo Assurance S&u~pervise
a
Q~lity Assurance Supervisor
11113399..00000066
S_MNotes037S
3M MN01690375
Industrial BIO TEST Laboraloriot, Inc.
5
o.Ud. PPrroocceedduurree
AA tt~ottaall ooff 8800 yyoouunngg ((4433 ddaayy oolldd)) CChhaarrlleess RRiivveerr CCDD aallbbiinnoo mmiiccee**,, 4400 of
each sex, was randomly divided into groups of 5 male and 5 female animals
each sex, was randomly divided int~ 8 groups of 5 male and 5 female animals
cach. The animals were allowed 3n 8 day pre-test period to adjust to the
each. The animals were allowed an 8 day pre-test period to adjust to the
caging system. Groups were fed 0 (Control, 30, 100, 300, 1,000, 3,000,
caging system. Groups were fed 0 (Control), 30, i00, 300, 1,0000 3,000,
10,000, ox 30,000 parts of FC-143 per million parts of diets.
i0,000, or 30,000 parts of FC-143 per million parts of diet~*.
Al animale were individually housed with food and water available sd
All animals were individually housed with food and water available ad
Mbitum. Daily observations for behavioral reactions or mortalities were made.
libit~m. Daffy observations for behavioral reactions or mortalities were made.
Animals were weighed and food consumption calculations were made weekly
Animals were weighed and food consumption calcu!ations were made weekly
for a 28-day period.
for a 28-day period.
At the final sacrifice, a complete gross pathologic examination was conducted
At the final sacri~ce, a complete gross pathologic examination was conducted
on al surviving mice. Animals that died during the investigation were also
on all su.rviving mice. Animals that died during the investigation were a!so
!
eexxaammiinneedd ggrroossssllyy.. AAtt tthhee ttiimmee ooff ggrroossss eexxaammiinnaattiioonn,, aa rreepprreesseennttaattiivvee sseett ooff
argans snd other sssues was removed and preserved in neutral buffered
organs and other tissues was removed and preserved in neutral bu~ered
ffoorrmmaalliinn ffoorr ffuuttuurree hhiisstwoppaatthhoollooggiicc eexxaammiinnaattiioonn.. TThhee wweeiigghhtt ooff tthhee lliivveerr ooff
each sucriiced mouse wis determined and liver to body weight ratios were
each sacrificed mouse was determined a~d liver to body weight ratios were
calculated.
calculated.
Microscopic
'Microscopic
eexxaammiinnaattiioonn
wwaass
ccoonndduucctteedd
oonn
tthhee
lliivveerrss
frroomm
al
sacrificed mice.
sacrificed mice.
AAllssoo aatt ssaaccrriiffiiccee,, 5 anld ooff ssooddiiuumm hheeppaarriinniizzeedd bblloooodd ((wwhheenn ppoossssiibbllee)) aanndd
10
I0
g
of
of
whole
whole
Liver
Liver
(pooled)
(pooled)
from
from
the
the
Control
Control
((00
ppppmm)),,
TT--I1
(3300
ppppmm)),,
aanndd
TIL
T-If
(100
(I00
ppm)
ppm)
groups
groups
wweerree
ccooll!leecctteedd
aanndd
qquuiicckk
ffrroozseenn..
TThhee ssaammpplleess wweerree
subaitied to 3 Company for analyses.
submittal ~o 3M Company for analyses.
+ Charles River Breeding Laboratories, Wilmington, Mass. * PSPCuuhtrrairiLlnnoeaausiRRsaaR,ttivMCCeirhhsoosBwwor,u,erei((d.ddirrnyyg,, Lppauubllovvreearrtiiozzreieedds.ddiieeWtti))l,,miRRnaaglltssottnoo,nn--M PPuuarrsiisnn.aa CCoommppaannyy,,
St. Louis, Missouri.
11113399..00000077
S_MNotes03TS
3M MN01690376
Inlushial BIO -TEST Lakorsioris, Inc.
6
\ IV. Results IV. Results A. Body Weights A. Body Weights M Meeaann mmaallee aanndd ffeemmaallee bbooddyy wweeiigghhtt ddaattaa ccoolllleecctteedd dduurriinngg tthhee iinnvveessttiiggaattiioonn aarree pprreesseenntteedd ii~n TTaabbllee II.. AAl1l1 tteesstt ggrroouupp aanniimmaallss lloosstt wweeiigghhtt.. AAnniimmaallss ffeedd 3300,, i10000,, oorr 330000 ppppmm ooff FFCC--114433 eexxhhiibbiitteedd rreedduuccttiioonnss iinn bbooddyy wweeiigghhtt ggaaiinnss ffoolllloowweedd bbyy lloosssseess iinn bbooddyy wweeiigghhtt dduuar-iinngg tthhee iinnvveessttiiggaattiioonn.. TThhee bbooddyy wweeiigghhttss wweezr-ee ddeepplr-eesssseedd iinn aa ddoossee--~r-eellaatteedd mmaannnneerr..
11113399..00000088
I3MM_MMNND011669900337777
Instastial BVO -TEST Lakonalovist, Inc
7
)
TTAABBLLEE I
TTEESSTT MMAATTEERRIIAALL:: FFCC--114433
2288--DDaayy OOrra~l! TTooxxiicciittyy SSttuuddyy -- AAllbbiinnoo M Miiccee
BBooddyy W Weeiigghhtt DDaattaa
SSuummmmaarryy ooff MMeeaann VVaalluueess
"Grou
~
and Group Dieatnadry
Body Weight
Tota44l--W WWeeeeeikkght
DLieevtaerly
Week: Body Weight
Change Total Weight
(ppm) Sex 0 1 2 3 4 Level
Week:
(ppm)
Sex
0
1
2
3
4
(g/mouse) Change
(~/mouse)
CoCnonttrrooll MFM233333 2304 2m 357 B235 424080
+v577
(0)
F 23 24
25
24
28
+ 5
aTT-I0I
FMM o 333 2333 33ou4 32m 2 na32e
"--12i
(30)
F 23 24
25
22
21"*
- 2
TT0-0nH)
MFM 2333333 222188*% 2gl5es*em*w 22L33e*wm* s125em*x*
--- 868
(I00)
F 23 Zl
18"* 16"* 17"*
- 6
TT-Imll (300)
MM 3333 F233
22a33m*me*
2 a23r*e*
22I1ra"em*
2200-*m*
1--133
(300)
F
23
17"*
17"*
17"
-
-
Tv a(l.T,0-OI0OV0O))
M3 ae
FMFo
le 33
21"*
23
14"*
--
-
--
-
Tv
Moo
=---
-
((33T.,-0000V00))
FMFoo
33
23
-
-
-
-
-
oTTo-IVmI) MFM223 333 .--
---
---
-
-
(I0,000)
F 23
-
-
-
GTTo-voVH)
FMM o 32333
= -
-
-
-
-
(30,000) F 23
SFatsteallsyignificant mtergroup difference at the 95percent (B< 0.05)
* cSotnatiisdtiecnaclelylesvigen.lificant intergroup difference at the 95 percent (P < 0.05)
=** SccStootaanntftfiiiissddtteieicncnaacclleellyylleessviivggeennlli.iffiiccaanntt iinntteerrggrroouupp ddiiffffeerreennccee aatt tthhee 9999 ppeerrcceenntt ((P2 << 00..0011))
J
- =cAolnlfidaneinmcaelslevdieel.d.
- = All animals died.
11113399..00000099
33MM_MMNND011669900337788
Inlustiol B10 ~TEST Laboralorias, Inc.
8
)
B. Food Consumption
B. Food, Consumption
Mean weekly food consumption data collected during the investigation
Mean weekly food consumption data col3ected du~'ing the investigation
are presented in Table I. All surviving test group animals exhibited an
are presented ~ Table H. ~ s~n~ test ~roup ~m~s e~bited ~
increase in the average food consumption when compared to controls.
~crease ~ ~e av~a~e f~d ons~p~on when compared to consols.
However, in each of the groups fed FC-143, excessive food wastage was
However, ~ ea~ o the ~oups fed FC-143, excessive ~ood w~taEe was
observed during the study.
observed d~g ~e s~dy.
J
11113399..00001100
33MM_MMNND011669900337799
Industrial BIO -TEST Laboratori, Ine.
9
GGarrnooduupp Dieatnadry DoLLieeemvtvae)erlly Sex
(ppm) Sex
CCoonnttrrooll MFM
(0)
F
TaT--n1I ONMF
(30)
F
T T-U ONM a(io00)) FF
TT-Imll MOM [(3E00N) F
aTTs-IvVm FMM
(I ,000) F
GTT0-V0V )
(3,000)
FMFou
0.TV-0V0II0 MFM
(I0,000)
F
T T -VlE l MM (00o,,o0o00o)) FFE
TTAABBLLEE H1 TTEESSTT MMAATTEERRIIAALL:: FFCC--114433 2288--DDaayy OOrraall TTooxxiiciitDy, SSttuuddyy -- AAllbbiinnoo MMiiccee FFoooodd CCoonnssuummppltiioonn DDaa~taa
FF(oogoo/ddmoCCuosonens/su7ummpdptatiyisoo)nn
1
(E/mouse/7
2Week: Week:
days)
3
4
I
2
3
4
AACvovenersraauggmeeptFFiooooondd ((sg//Cmmooonuusssueem//77ptiddoaanyyss))
NNNAAA 24400 1ii200 5s5e74
85680
NA
42
52
57
50
NNNAAA o88m4a 111s881 8899
"9977
NA
87
57
76
73
NNAA Na
566 a
113m 66 77766
8829
NA
63
77
77
7Z
NNAA NA
112210 1m
11493% 3mI0-1
11-2222
NA
133
96
-
-
NNNAA A.-.. -- . -- .--
NA
....
- ---
-
- ---
-
-- -- -- --
--
- ---
-
- ---
-
- = All animals died. N-A== DAaltl aanniomtaalsvaidliaebdl.e. Food consumption inadvertently collected as a NA = mDmeeaaatann nppoeetrragvgrraooiluuappbleffo.orr mmFaaolloeedss caaonnnddsuffmeempmatailoleenss ittnooaggdeettvhheeerrrt.e.ntly collected as a
11113399..00001111
I3MM_MMNND011669900338800
Indactial BIO TESTLaboratori,Ince
10
\
CC.. MMoorrttaalliittyy aanndd RReeaaccttiioonnss
AAlDl aanniimmaallss iinn tthhee TT--IIVV ((i1,,000000 ppppmm)),, TT--VV ((33,,000000 ppppmm)),, TT--VVII
((I100,,000000 ppppmm)),. sanndd TT--VVIIII ((3300,,000000 ppppmm)) ggrroouuppss ddiieedd wwiitth}dinn tthhee ffiirrsstt 99 ddaayyss
ooff tteessttiinngg..
AAllll
mmiiccee,,
bbuutt
11
TT--IIIIlI
((330000
ppppmm))
animal
animal
((mmaallee
NNoo..
3311)),,
ddiieedd
wwiitthhiinn
2266 ddaayyss ooff tteessttiinngg.. OOnnee aanniimmaall ddiieedd iinn eeaacchh ooff tthhee 3300 aanndd 110000 ppppmm tteesstt
ggrroouuppss dduurriinn~g tthhee 2288 ddaayy ffeeeeddiinngg ppeerriioodd.. NNoo ootthheerr ddeeaatthhss ooccccuurrrreedd dduurriinngg
tthhee ssttuuddyy..
RReeaaccttiioonnss nnootteedd dduurriinngg tthhee ssttuuddyy iinncclluuddeedd rroouugghheedd ffuurr aanndd mmuussccuullaarr
wweeaakknneessss ffoorr aallll aanniimmaallss ffeedd 33,,000000 ppppmm oorr mmoorree aafftteerr tthhee ffiirrsstt 44 ddaayyss oof
tteessttiinngR,. AAnniimmaallss ffeedd !1,,000000 ppppmm ((TT--IIVV)) ooff FFCC--114433 eexxhhiibbiitteedd ssiimmiillaarr rreeaaccttiioonnss
aanndd ssiigEnnss ooff ccyy~annoossiiss aafftteerr 66 ddaayyss ooff tteessttiinngg.. AAllll ooff tthheessee rreeaaccttiioonnss wweerree
eevviiddeenntt iinn tthhee 330000 ppppmm ((TT--IITIT)) gSrtoouupp aafftteerr 99 ddaayyss ooff tteessttiinngg.. SSoommee 110000 ppppmm
((TT-T+T)) aanniimmaallss eexxhhiibbiitteedd ssl]iigghhtt ssiiggnnss ooff ccyyaannoossiiss oonn ddaayyss 1100 aanndd i1i1,, bbuutt
aappppeeaarreedd nnoorrmmaall ffoorr tthhee rreemmaaiinnddeerr ooff tthhee sSttuuddyy.. AAllll 3300 ppppmm ((TT--II)) aanniimmaallss
aappppeeaarreedd ssiimmiillaarr ttoo tthhoossee ooff tthhee ccoonnttrroollss.. NNoo ootthheerr uunnuussuuaall bbeehhaavviioorraall
rreeaaccttiioonnss wweerree nnootteedd..
DD.. PPaatthhoollooggiicc SSttuuddiieess
1. Gross Pathologic Findings
i. Gross PatholoEic Findings
GGrroossss ppaatthhoollooggiicc eexxaammiinnaattiioonn ooff aanniimmaallss ssaaccrriiffiicceedd aafftteerr 2288 ddaayyss
ooff tteessttiinngg rreevveeaalleedd eennllaarrgEeemmeenntt aanndd//oorr ddi~ssccoolloorraatti[oonn ooff 11 oorr mmoorree lloobbeess ooff
tthhee lLiivveerrss ooff aallll tteesstt ggrroouupp mmaalleess aanndd ffeemmaalleess.. NNoo ootthheerr ggrroossss ppaatthhoollooggiicc
d,i~ffeerreenncceess bbeettwweeee-nn tthhee tteesstt aanndd ccoonnttrrooll aanniimmaallss wweerree nnootteedd..
11113399..00001122
33MM_MMNNO011669900338811
' Sdaatial BIO TESTLaboratonst, Su.
un
\
2. Liver Weight and Liver to Body Weight Ratio Data
2. Liver Weight and Liver to Body Weight Ra~io Data
The results of the statistical analyses conducted on the sbsalute
The results of the s~atisrical analyses conducted on the absolute
liver weights and liver to body weight ratios are summarized in Table II.
liver weights and liver to body weight ratios are summarized in Table LII.
Significant differences between a test group and a control group axe
Significant di/~erences betv~een a test group and a control group are
ddeessiiggnnaatteedd bbyy aasstteerriisskkss.. SSttaattiissttiiccaallllyy ssiiggnniiffiiccaanntt iinnccrreeaasseess wweerree nnootteedd iinn
the absolute liver weights among the males and females of the remaining test
the absolute liver weights among the males and females of the remaining test
groups (30 and 100 ppm). The increased liver to body weight ratios for
groups (30 and 100 ppm). The increased liver to body weight ratios for
these animals can be atributed to the reduced body weights after 26 days
these animals can be arn-ibuted to the reduced body weights after 28 days
of feeding.
of feeding.
J
11113399..00001133
W3M_MMNN001166090338822
Industrial BIO TESTLbosatontit,Joe.
!
ig 311: fi
(30% 1p: oiud iz, eo LEE
2
i i,
13s |
tii
i23.p1 ni. ss
STEERIREREL
CEs iioiE
ii:
wEEo ofi oLl iLte to.l igd
2 PE: R2 EEE| 2 EiE 3: iRo5 iE iIiF3 zog
EE
z
| i; PEREE IS
2g 32 ii2 : 0%
ii [iEI5E53E. 1{57574 320
E3NE 3aIE3F
133 2 F 2ijzE sz3E z%E|
i233i5ARiE
5
HI
i230
P| oflleBE. zzyiigE8d3 POE BIT Ijtipe
aW_MND1650383
3M MN01690383
11113399..00001144
Indistial BVO TESTLaboratories,Ine.
113B
)
3. Histopathologic Findings
3. Histopathologic Findings
Histopathologic examination was conducted on sections of livers
Histopathologic examination was conducted on sections of livers
taken from all mice sacrificed after 28 days of testing and from 2 T-IV.
taken from all mice sacr~ced after 28 days o~ testing and from Z T-IV
(1,000 ppm) animals that died during the investigation. Treatment-related
(l,000 ppm) animals that died during the investigation. Treatment-related
liver ndings were noted among the males and females from all test groups
liver ~ndings were noted amonE the males and females from all test groups
eexxaammiinneedd.. TThheessee fRinn~diinnggss aarree pprreesseenntteedd iinn TTaabbllee IIVV.. TThhee kkeeyy ffoorr tthhee
grading system and abbreviations used is shown below:
grading system and abbreviations used is shown below:
+= minimal in severity
+++ == mmiilndimian! sinevesreivteyrity
+++++ == m moidlderianteseivnersietvyerity
++4+:++t+F++.~
=== =
moderate in severity
fmoacrakled in severity marked in severity
MF == mfoulctailfocal
MD == dmiuffltuisfoeca/
D = diffuse
The pathologist's statement follows on the next page.
The pathologist=s statement follows on the next page.
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mrIBT No. 8532-106_55
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1144 June 9, 1977
bee cto Hepat smi of i int is I have completed a histopathological examination of H~E stained sections
of liver from control and test (Groups T-I, T-II, T-III) mice of IBT No.
ws. tn sean, ens o re vm sn smd tt $0 8532-i0655. In addition, sections of liver from two anima!s of test group te et toi se ty ae to eto, T-IV that died duxing the study were also examined.
ee ttnt rte Shs oo ort i sh mi Treatment-related morphologic changes were present among both male rt fete se oo oe 9 ns cont of on and female animals of all test groups. The lesions consisted of diffuse rem states Goma of 1 sparen arose ios cytoplasmic enlargement (hypertrophy) of the hepatocytes situated tlu~ughout
the entire liver lobules (panlobular) accompanied by focrl ro mulrifocal cytoplasmic lipid vacuoles of variable size which were random in distribution.
oes oo sn opr ton ste sen at en There was also degeneration and/or necrosis of hepatocTtes and focal bile rasan sors so 2 on duct proliferation among animals of all test groups.
stn ee en ser er tons of sti sin The other liver changes observed were lesions of natu.rally occurring tres or ett eae ot in 8 tr se nn diseases or related to the method o sacrifice. ALl findings are tabulated
in Table IV.
Lpca Vt 5. Arceo, "M.D.
Staff Pathologist
Reviewed and Approved:
Reviewed and Approved:
TDms: GtaadleTu C .
Ss
Donovan E. Gordon, D.V.M., Ph.D. Diplomate0 American College o
Veterinary Pathologists
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