PERCHLOROETHYLENE: MULTIGENERATION INHALATION … · 6/27/1995 · INDIVIDUAL ANIMAL DATA...

Halogenated Solvents Industry Alliance;

PERCHLOROETHYLENE: MULTIGENERATIONINHALATION STUDY IN THE RAT

INDIVIDUAL ANIMAL DATA SUPPLEMENT

VOLUME II OF IV

Data Requirement - Guideline Ref. 83-4

Study Completion Date 2 7 JUN 1995

Performing LaboratorJL - Zeneca Central Toxicology LaboratoryAlderley Park, Macclesfield,

Cheshire, UK

Laboratory Project ID - Report No CTL/P/4097Study Nos RR0580/FO

RR0580/Fl

CTL/P/4097 - 499

ZENECA CENTRAL TOXICOLOGY LABORATORY

ALDERLEY PARK MACCLESFIELD

CHESHIRE UK

CATEGORY B REPORT (CONFIDENTIAL) Sponsor: Halogenated SolventsNot to be Copied Except by a Industry AllianceReports Centre Sponsor Ref: HSIA/90/0002

CTL Ref: Y00207/005CTL Study Nos: RR0580/FO

RR0580/FlCopy No:

REPORT NO: CTL/P/4097

PERCHLOROETHYLENE: MULTIGENERATIONINHALATION STUDY IN THE RAT


VOLUME II OF IV

Approved for Issue: -+-~G A Wickramaratne Date of Issue: 2 7 JUN 1995Product Toxicologist

II

'

CTL/P/4097 - 499

PERCHLOROETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT


CONTENTS

Page No VOLUME II

APPENDIX 12A: Pathology Cross Reference - FO Generation 501-513

APPENDIX 12B: Pathology - FO Generation 514-731

APPENDIX 13 : Pathology - F1A Pups 732-989

CTL/P/4097 - 500



APPENDIX 12A

MICROSCOPIC PATHOLOGY CROSS REFERENCE - FO GENERATION

CTL/PI 4097 - 501

--

PAC910-04/0Z

PERCHLORDETHYLENE: M!JLTIGENERATION INHALATION STUDY IN TilE RAT


APPENDIX 1ZA

MICROSCOPIC PATHOLCX;Y CROSS REFERENCE - FO GENERATION

REMJVAL REASON: INl'ERCURRENT

OOSE LEVEL: 0 SEX: MALE

ppn 1

8

KIDNEY ••••••••••.•••••••••••••••••••••..•••.•••••.•••.••• Unilateral hydronephrosis ...•..........................

+ z

LIVER ••••••••••••••••••••••••••.••.••••.•••••••••.•••••.• N

ORAL CAVITY • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • + Malocclusi~ (macroscopic observation).················· Palatine f~stula (macroscopic observat~on) •••..•..•••..

X X

~ ~ -a

+> C) ~ ~

U1 C) N

KEY: MJRPHOLCX;Y SEVERITY NOT RECORDED 1 minimal

N N.A.D. 2 slight 0 MISSING 3 mxlerate + MJRPHOLCX;Y PRESENT 4 marked

X NO SEVERITY

PAC910-04/02

PERCHLORDETHYLENE: MDLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANJMAL DATA SUPPLEMENT

APPENDIX 12A


REMJVAL REASON: INTERCURRENT

DOSE LEVEL: 100 SEX: FEMALE

HE 7

3

KIDNEY • • • • . • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • . • • +

Intratubular microlithiasis ......•......••.........•... 1

Pelvic urolithiasis . . . . • . . . . . . . . . . . . . . . . . . . . . . . . . . . . • • . 1

("")........_r.,..._ 0""' "ID

U"10w

KEY: MJRPHOLOGY SEVERITY

NOT RECORDED 1 minimal

N N.A.D. 2 slight

0 MISSING 3 IIXlderate

+ MJRPHOLOGY PRESENT 4 marked

X NO SEVERITY

-

PAC910-04/02

PERCHLOROETHYLENE: MllLTIGENERATION INHAlATION STUDY IN TilE RAT

INOIVIDUAL ANIMAL DATA SUPPLEW:NT

APPENDIX l2A

MICROSOOPIC PATHOLOGY CROSS REFERENCE - FO GENERATION

REMJVAL REIISON: INTERCURRENT

DOSE LEVEL: 300 SEX: MALE 1 ~ 1

6

KIDNEY................................................... N

" --; r-""C -..,. 0 "" ......

PAC910-04/02

PERCHLOROETHYLENE: M!JLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL AN1MAL DATA SUPPLEMENT

APPENDIX 12A

MICROSCOPIC PATHOLOOY CROSS REFERENCE - FO GENERATION

REMJVAL REASON: INTERCURRENT

rosE LEVEL, 1ooo SEX: FEMALE ll ppn 7 7

4 5

CERVIX • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • N •

IG:DNEY • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • + + Intratubular microlithiasis .•.••••.......•.........•.•. 21

LIVER ••.•••••••••••••••••••••••••••••.••••••••••••••••.•• ++Hepatocyte necrosis . • . . • . . . • . . . • . . . . • • . . • • • • • • . • . • • • . . . 2 3

M.AM1ARY GLAND • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • N N

OVPJrf • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • N N

UJ'ERlJS • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • + +

Dystocia (diagnosis based on 1113.croscopic observations) . X X

VAGINA • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • N N

::::j C: "0 :;;; 0 ~

~ U1

KEY: M)RPHOLOOY SEVERITY NOT RECORDED 1 l11i.n.iiMl

N N.A.D. 2 slight o MISsm; 3 m:xlerate + M)RPHOLOOY PRESENT 4 1113.rked X NO SEVERITY

--

PAC910-04I02.

PERCHLOROETHYLENE: MULTIGENERATION INHAlATION STUDY IN THE RAT

INDIVIDUAL ANlMAL DATA SUPPLEMENT

APPENDIX 12A

MICROSCOPIC PATHOLCX;Y CROSS REFERENCE - FO GENERATION

REMJVAL REASON: TERMINAL

lXJSE LEVEL: 0 SEX: MALE IJlill 1 1 1 1 1 1 1 1 1 2 2 2 2. 2

1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 9 0 1 2 3 4

EPIDIDYMIS •.•••••••••••••••.•.•••••••.••••.•••••••••••••• . . N ....... N.N.N.N .. N .. .

KIDNEY ••••••••••••••••••••••••••••••••••••••••••••••••••• +++++NN++N+++++++++++++ Unilateral hydronephrosis ..................•........... . . 32. 2..222.22.. 22. Chronic progre~si~ glamerulonephropathy .............. . . 1 .... 1. 111 1 11 Pelvic urol~thias~s ....................•............... . . . . 2 Transitional e~ithelial hyperplasia ..•.•••...•...••.••. 2 . . • . . • . . . . . 1 Tubular basophilia •..•.•....................•••........ 1. 1. 11 .1 Interstitial mononuclear cell infiltration ...•..•...... 1 1 .

LIVER •••••••••••••••••••••••••••••••••••..••••••••..••.•• NN++NNNNNNNNNN+N+NNN+N+ Hepatitis ..•.............•....•...........•............ . 11 .......... 1.1 ... 1.1

PROSTATE~ •...••...........•......................... . N. .N.+.N.N .. +. Prostauus ........•.•..........•................•..... 1 ...... 1 .

SEMINAL VESICLE •.••••••••••••••••••••••••••••.•••••.••••• N. .N.N.N.N .. N.

TESTIS ••••••••••••••••••••••••••••••••••••••••••••••••••• + . . + . N . N . N . . + Unilateral tubular degeneration .•...................... 1 . . ........ 1 Tubular distension ....................••..•..•.•....... 3

" -i r ---o ..,. 0

PAC910-04/02



APPENDIX 12A



!XJSE LEVEL: 0 SEX: F.EMALE ppn 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4

5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8

CElWIX • • • • • • • • • • • .. • • • • .. • • • • • • • • • • • • • • • • • • • • • • .. .. • • • • • • • • N •••••••••••••••••••••

KIDNEY ••••••••••••••••••••••••••••••••••••••••••••••••••• Unilateral hydronephrosis •••......•.•......•......•..•• Bilateral hydronephrosis .•......••.•.....•••.......•.•• Iotratubular microlithiasis ....••.........•.....•......

Transitiooal epithelial hyperplasia .........••.........

Papillitis .........••..••..•.....•••......•....•......•

Nephroblastana •........•.•••.•.....••.•..•••.......••.•

Sui-face depression ..•.•••••....•.•••.........•.........

Dilatation collectiog ducts .......••......•.....•.•.•..

++++++++++++++++++++++++ • .• 2 3 •.•...•....•..•••.. • ••••.••••••••• 2 ••••••••

2 2 2 3 2 3 2 2 2 2 2 3 1 2 2 3 3 3 1 2 2 2 3 3

l 2 x .

. 2

1 2

LIVER.................................................... Hepatitis . . . . . . . . . . . . . . • . • • • . . . . . . . . • • . . . . . • . . . . . . . . . . .

N N N N N N N N N N N N N N N N N N N N + N N N . . . . . . . . . • . . . . . . . . . • 1

MIIM1ARY GLAND ........................................... . .N OVAP:f .................................................... , N

UTERUS ................................................... • N

VAGINA................................................... . N,

n --l r ..._ '"0 ..._..,. 0 \0 ....,

t.n 0....,

KEY: MlRPHOLOGY SEVERITY • NOT RECORDED 1 mioimal N N.A.D. 2 slight0 MISSING 3 JJXJC1erate + MJRPHOLOGY PRESENT 4 IMrked X NO SEVERITY

PAC910-04/02



APPENDIX 12A

MICROSCOPIC PATHOl.(X;'{ CROSS REFERENCE - FO GENERATION


DOSE LEVEL: 100 SEX: MALE ppn 4 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6 7 7 7

9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2

EPIDIDYMIS • • .. • • • • .. • .. • . • • • • • • • .. • • • .. .. • • • • • • .. • .. .. • • • , • N , • N • N •..• N .•• N • N N ••••

KIDNEY ................................................. ..

lhlilateral hydronephrosis ...........••.••••••.•.•......

Bilateral hydronepnrosis ••.•••.........•.•.......•.....

~c pro~ressi~ glomerulonephropathy •.••...•.....•. Pelnc urolithiasl.s ................................... .Transitional e~ithelial hyperplasia .....•...•..........

Tubular basophilia ................................... ..

Tubular dilatation ................................... ..

+++++++++NN+++++++++++++

. 1212.. 3 2332 2

• , . 2 . , , , 1.111 • ..1 ... 1.11

1 .. . 1

1 . 2 ... , . . . , , 1 . ,

1 1 1 . 1 1 . 1 1 1 . 1

1

PROSTATE~ .......................................... .

Prostatl.tis ........................................... .

N .. N. N, • N. .N.N+ • , 2

SEMINAL VESIClE ......................................... . N .. N. N, • N • • N • N N

TESTIS .................................................. . N .. N.N. • N • . N.NN

n -1 r -... -o-... .., 0

..... "'

lT1 0 OJ

KEY: MJRPHOl.(X;'{ SEVERITY NOT RECORDED 1 mi.niira1

N N.A.D. 2 slight0 MISSING 3 !!1Jd8rate + MJRPHOl.(X;'{ PRESENT 4 marked X NO SEVERITY

PAC910-04/02

PERC!ll..ORDETHYLENE: l1IJLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANIMAL DATA SUPPLEJ.IENT

APPENDIX l2A

MICROSCOPIC PATHOLCGY CROSS REFERENCE - FO GENERATION

REMJVAL REASON: TEBMINAL

DOSE LEVEL: 100 P!lll

SEX: FEMALE 7 7 7 7 7 7 8 8 8 8 8 8 8 8 8 8 9 9 9 9 9 9 9

4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6

CERVIX .................................................... N •••• O ••••.•.•.•••••••

KIJJNEY ••••••••••••••••••••••••••••••••••••••••••••••••••• Unilateral hydronephrosis •••••••.•••........•..•.•...•• Bilateral hydronephrOsis ••••••.....•..........•......•. Chronic progressive glrnerulonephropathy ..••........... Intratublllar microlithiasis ••••.••..•...•....•.••.•.... Tubular basophilia ...........•..•••.•...•...••......... Interstitial m:monuclear cell infiltration .•.......••..

+++++++++++++++++++++++ ... 1 ..... 2 ... 1 ... 1 ...... . ' .. ' ...... ' • 1 .. ' . 2 ' .. . ........ 1 ' .. 1 ...... 1 . 1

1 1 2 3 2 1 2 2 2 1 3 1 2 1 1 3 2 1 2 1 1 1 3

1 1 ' 1 1 1 1 . . . . . . 1 . . • ' 1

1

MAM1ARY GLAND •••••••••••••••••• • • • • ••••••••• • •••• • • ••••• • N • • N

OVJ>;EI •••••••••••••••••••••••••••••••••••••••••••••••••••• • N • .N

UTERlJS ••••••••••••••••••••••••••••••••••••••••••••••••••• Placental tissue in 11Jl1Erl •.•...•....••••....•.•....•... Foetal death in utero (nacroscopic observation) .•••...•

N. ' + X

X

VN;INA ................ • • • • .. • • • • .. • • • • • • • • • • • • • • • .. • • • • • • N •••• N

,..., __, ,.... -., -... 0 ..._, ""

(,J1 0

""

KEY: !oDRPHOLCGY SEVERITY • NOT RECORDED 1 Illininal

N N.A.D. 2 slight

0 MISSING 3 rroderate

+ !oDRPHOLCGY PRESENT 4 narked

X NO SEVERITY

~-

PAC910-04/02

PERCIHJJRDETHYLENE: M!JLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANlMI\L DATA SUPPLEMENT

APPENDIX 12A

MICROSCOPIC PATHOLCGY CROSS REFERENCE - FO GENERATION


DOSE LEVEL: 300 SEX: MALE 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

ppn 9 9 9 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 2

7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 7 8 9 0

EPIDIDYMIS ............................................... NN.N •• N •.•• NN •••. N.NN ••

KIDNEY .................................................. . ++++NN++++++++++++N++++

Unilateral hydronephrosis ..•.•......................... Bilateral hydronepnrosis .•.•.•.......•.••••.••..•...... Chronic,progressive ~lomerulonephropathy .•...••........ Trans1t1onal e~ithelLal hyperplasLa ................... . Tubular basophilia .................................... .

2.21 .. 22. '.212.232 ... 31

. .. 1 . . .

. 1 1 . . . . . . 1 1 ..... 1

. . 1 2 ... 1 . 1 ..

1 . . 1 1 1 . 1 . 1 . 1 1 1 .

PROSTATE GLAND ...................... • ...... • • .. • • .. • • • .. • Prostatitis ........................................... .

+N.N .. N. 1 .. . . . .NN. . ... .N.NN . . . .

SEMINAL VESICLE ......................................... . NN.N .. N. .NN. .N.NN

TESTIS ................................................. .. NN.N .. N. • N N. .N.NN

n -l r ...... ""0 ......... 0 '-0 ....,

,_."' 0

KEY: MJRPHOLCGY SEVERITY

IDTRECORDED l mi.nirnal

N N.A.D. 2 slight

0 MISS:IN3 3 rn:xlerate + M:JRPHOLCGY PRESENT 4 nmked

X ID SEVERITY

PAC910-04/02

PERCHLOROETHYLENE: Ml.JLTIGENERATION INHAlATION STUDY IN THE RAT


APPENDIX 12A

MICROSOOPIC PATHOLCGY CROSS REFERENCE - FO GENERATION


DOSE LEVEL: 300 SEX: FE1'll: 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

ppn 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4

1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4

CERVIX ................................................... N. N +. .+ N L1.li!rinal dilatation . . . . . . . . . . • . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 • • 4

KIDNEY ••••••.••••••••.••••. • • • • • • • • • • • • • • • • • • • • • • • • • • • ++++++++++++++++++++++++ · • •Unilateral hydronephrosis •....•...........••.•...... : . . 3 •...... ' ' ' . ' . 1 ... 3 ' . ' ' . Bilateral hydronephrosis .•..........•............•..... ' ' •••• ' ' .• 2 .••• ' ••• ' ' ••• Chrooic progressive glomerulonephropathy ....••••....... • •. 1 • ' •••• ' ' •. 1 ' • 11 •• ' •• Intratublllar microlithiasis .................••......•.. 1 1 3 1 3 3 1 1 3 1 3 3 1 1 1 1 1 2 1 1 1 2 1 3 Tubular basophilia .......................•..•....•..... 1 . ' . 1 ' .... ' .. ' . ' ' .... 1 Interstitial mononuclear cell infiltration ..•......•••. 1 ...... 1

Cyst/s ••....•••........•••••••••••••••••....... · · • • · · · · .x

l1i'l-MABY GLAND • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •• N. • N. • N • • N • N

ov~ ................................................... . N. , N. • N • • N • N • UTERUS ••••••••••••••••••••••••••••••••••••••••••••••••••• N. • N. . +. . . +. + .

L1.li!rinal dilatation ..••.•.....•.....•.•.•.......•.•.•.•. 4 . ' 4 • 3

VAGINA •••••••••••••••••• • •• • • • • • • •• • • • • • • • • • • • • • • • • • • • • • • N. • N. • N • • N. N.

" ..... r--" -0 """ lO

"

U"1 I-'

I-'

KEY: MlRPHOLCGY SEVERITY NOT RECORDED 1 lllin:lJml.

N N.A.D. 2 slight 0 MISSING 3 rnxlerate + MlRPHOLCGY PRESENT 4 nmked X NO SEVERITY

.--,

-

PAC910-04/02

PERCHLOROETIIYLENE: MI.JLTIGENERATION INHALATION STUDY ill THE RAT

OOIVIDUAL ANJMAL DATA SUPPLEMENT

APPENDIX 12A



DOSE LEVEL: 1000 Pfill

SEX: MALE 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6

5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8

EPIDIDYMIS ................................................ NN ...... N ... , .... NN. N ..

KIDNEY .................................................. .

Unilateral hydronephrosis ............................. .

Bilateral hydronephrosis .............................. .

Chrome ,Progressive glaTErulonep~athy .............. .

Transit~onal epithelial hyperplas~ ................... .

Tubular basophilia .................................... .

Interstitial nephritis ............................... ..

Increase in nuclear pleomorphism ...................... .

++++++++++++++++++++++++ .. 223 ... 2 .3.2 ... 2 ... 3 2

. 2 .1 1 1 1 1 . 1 1 . . 1 1 1 . 1 1 . 1 1

2 •..•.•.• . 1 ...... .

• •••••••••• 2 ••••••••.. 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

LIVER ................................................... .

Mononuclear cell infiltration ......................... .

Hepatitis ............................................. .

N+NNNNNNNNNNNNNN+N+NNNNN . . . . . . . . . . . . . . . . . . 1 . . 2 ............•. 1

PROSTATE GLAND .......................................... .

Prostatitis ........................................... .

NN. + 1

NN.N.

SEMrnAL VESICLE .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. • N N • N NN.N.

TESTIS ................................................... . N N, N NN.N.

n...., r -o

PAC910-04/02

PERCHLORDETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX 12A



!XJSE LEVEL: 1000 SEX: FEMALE ppn

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 6 7 7 7 7 7 7 7 7 8 8 8 8 8 8 8 8 8 8 9 9 9 9 0 1 2 3 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2

CERVIX •••• •• • •• .... •• • •• •• •••• •••• •••••• ....... •• .. •• • ••• • •••••••••••••••••• 0 ••

KIDNEY ••••••••••••••••••••••••••••••••••••••••••••••••••• Unilateral hydronephrosis •••.•••.•••••••••••••.••••..•• Chronic progressive glarerulonephropathy .............. . Intratubillar microlithiasis ...•.....•....••..••..•.....Pelvic urolithiasis ...•••....•...........•.•..•.•.•....

Tubular basophilia ........................•............

Increase in nuclear pleomorphism .........•.....•......•

++++++++++N+++++++++++ 2 • 2 •••• 2 . • ••••.• 2 •••

. ... 1 . 1 ............ .

1 1 . 1 1 1 1 1 1 1 . 2 1 1 2 2 1 1 1 1 1 1 1 . . . . . . ............. . . ............. 1 1 . 1 ... . 1 1 1 1 1 . • 1 . 1 • 1 • 1 1 • . . 1 • 1 .

LIVER •••••••••••••••••.••••••••.•••••••••••••••.•••••••..Subcapsular fibrosis and inflammation ................. .

NNNNNNNNN+NNNNNNNNNNNN 2

Mili'MARY GLAND •••••••••••••••••••••••••••••••••••••••••••• . N.

OVAP::I •••••••••••••••••••••••.••.••••.••••••••••.••••••••• • N •

UTERUS ••••••••••••••••••••••••••••••••••••••••••••••••••• Placental tissue in lUOE01 .........•.....•........•..... Foetuses in lumen (macroscopic observation) .•.•..•.•...

. +. • X. . X.

VAGINA •..••.••.•.•••••.••••••••.••••••••••..•••••••••••.• . 0.

n -< r .._ -o .._.., 0 1.0 .....,

U1 ..... w

KEY: M:JRPHOLOGY SEVERITY NOT RECORDED 1 m:inlJn3l

N N.A.D. 2 slight0 MISSING 3 IJDderate + MJRPHOLOGY PRESENT 4 marked X NO SEVERITY

~.



APPENDIX 12B

PATHOLOGY - FO GENERATION

Key:

NO = number M = male F = female wks = weeks EXAM = examined NAD = no abnormality detected

CTL/P/4097 - 514

PAC900-05/02



APPENDIX 12B


ANIMAL NO: 1 SEX: M IDSE: 0 ppn ON STUDY: 129 days (19 wks l TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOliiNG TISSUES WERE SUEMITTED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES WERE SEEN IN THE ANIMAL

MICROPATHOLOGY

"-l r ...... -o ...... 0""' .._,"' TISSUE CHECK: TOTAL EXliMINED NOT EXAM MISSING NAil

PROTOCOL REQUIRED 2 2 0 0 1 NOT PROTOCOL (SUEMITTED) 5 0 5 0 0

(NOT SUEMITTED) 0 0 0 0 0 (J"t ...... (J"t

THE FOLLOliiNG TISSUES WERE MARKED NAil

LIVER

THE FOLLOliiNG MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY

Transitional eJ?it±!elial ,hyperplasia : (sli~t ; tmilaterall Tubular basophilla : {llll11.i!ml ; focal : tmilateral)

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

PAC900-05/02



APPENDIX 12B

PATHOLOGY - FO ANJMAL GENERATIONNO: 2 SEX: M lXJSE: 0 ppn ON STUDY: 129 days (19 ;..ks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES VlERE SU!'MITTEO

EPIDIDYMIS ; lGlJNEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLANO ; SEMJ:NIIL VESICLE : TESTIS

NO ABNORMALITIES VlERE SEEN IN THE ANJMAL

MICROPATHOLOGY

n -i r....._ "'0....._.,. 0

PAC900-05/02

PERCffi..ORDETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANTI1AL D.t;TA SUPPLEMENT

APPENDIX 12B


ANTI1AL NO: 3 SEX: M D:JSE: 0 P!lJl ON STUDY: 129 days (19 wks J TERMINAL

MACROPATHOLOGY

Killed by Fluothane ; No live pups recorded at day 1 follCMing any trating.

THE FOlLOWING TISSUES WERE SUEMITTEO

EPIDIDYMIS ; KIDNEY ; LIVER : PITUITARY GLAND ; PROSTATE GLAND : SEMINAL VESICLE : TESTIS

THE FOLLO\rrNG MACROSCOPIC OBSERVATIONS WERE MADE

KIDNEYPelvic dilatation : (right : rnx!erate)

NO ABNORMALITIES WERE SEEN IN THE REMAINING TISSUES

MICRDPATHOLOGY

n -; r--. -o--..,. 0

....., "'

U1 ..... ....., TISSUE CHECK: TOTAL Elii'MINED NOT EXAM MISSING NtiD

PROTOCOL REQ!JIRED:

NOT PROTOCOL (SUEMITTEOl :

(NOT SUEMITTEOl :

2 5 0

2 4 0

0 1 0

0 0 0

0 3 0

THE FOLLOWING TISSUES WERE MARKED NtiD

EPIDIDYMIS ; PROSTATE GLAND ; SEMINAL VESICLE

THE FOlLOWING MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY Unilateral hydronephrosis : (nnderate)

LIVER Hepatitis : (min.inal. : focal)

PAC900-05/02

PERCHLORDETHYLENE: MIJLTIGENERATION INHAlATION STUDY IN THE RAT


APPENDIX 12B PATHOLOGY - FO GENERATION

ANJMAL NO: 3 SEX: M IXlSE: 0 ppn ON STUDY: 129 days (19 wks) TERMINAL

MICROPATHOLOGY

CONTINUATION - THE FDLLOWING MICROSCOPIC OBSERVATIONS WERE l'.ADE

TESTIS

Unilateral tubular degeneration : {minimal)

-------------------------------------------------------END OF ANJMi\1---------------------------------------------------------------n -l r.......

-o .........,. 0

PAC900-05/02

PERCHLORDETHYLENE: M!JLTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX l2B

PATHOLOGY - FO GENERATION ANIMAL NO: 4 SEX: M J:OSE: 0 Pfill ON STUDY: 129 days (19 wks l TERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FDLLO\o/ING TISSUES \oiERE SUPMITI'ED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TAIL ; TESTIS

THE FDLLOi>IING MACROSCOPIC OBSERVATIONS \oiERE MADE

TAILKinked : 50mm fran tip.

NO ABNO!IMALITIES wERE SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

n --l r -.. -.."" 0""'

PAC900-05/02

PERCHLOROETHYLENE: MULTIGENEAATION INHALATION STUDY IN THE RAT

INDlVIDUAL AN1MAL DATA SUPPLEMENT

APPENDIX 12B

PATHoux:;y - FO GENEAATION AN1MAL NO: 5 SEX: M DJSE: 0 ppn ON STUDY: 130 days (19 ""s) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUBMITTED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE : TESTIS

NO ABNOBMALITIES WERE SEEN IN THE AN1MAL

MICROPATH0!.1X}Y

n -1,....._ '"0....._ _, 0

""...., TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD PROTOOOL REQUIRED

NOT PROTOCOL (SUBMITTED)(NOT SUBMITTED)

2 5 0

2 0 0

0 5 0

0 0 0

1 0 0 ""'N

0

THE FOLLOWING TISSUES vlERE MARKED NAD

LIVER

THE FOLLOWING MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY Tubular basophilia : (nrinilml ; llllltifocal)

-------------------------------------------------------END OF AN1MAL---------------------------------------------------------------

~'

PAC900-05/02

PERCHLORDETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX l2B

PATHOLOGY - FO GENERATIONANIMAL NO: 6 SEX: M IXJSE: 0 Jll.Ill ON STUDY: 130 days (19 wks l TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOWJWING TISSUES WERE Slll'MITI'ED

EPIDIDYMIS : KIDNEY : LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS


MICROPATHOLOGY

n -1 r ...... -o ...... 0""' "' " TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD

PRD=L REQUIRED 2 2 0 0 2 NOT PRD=L (Slll'MITI'ED) 5 0 5 0 0

(NOT Slll'MITI'ED) 0 0 0 0 0 "'N ~

THE FOWJWING TISSUES WERE MARKED NAD

KIDNEY · LIVER -------~-----------------------------------------------END OF ANIMAL---------------------------------------------------------------

PAC900-05/02

PERCillllROETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX 12B


ANIMAL NO: 7 SEX: M DJSE: 0 ppn ON STUDY: 130 days (19 ,;ks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUEMITTED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; Sa-ITNAL VESICLE : TESTIS

NO ABNORMALITIES v1ERE SEEN IN THE ANIMAL

MICROPATHOLOGY

n ..... r._ ._'""' 0

PAC900-05/02

PERCffi.DRDETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANlli\L DATA SUPPLEMENT

APPENDIX 12B

PATHOLCX;Y - FO ANlli\L GENERATIONNO: 8 SEX: M IDSE: 0 IJFlll ON STUDY: 130 days ( 19 wks) TERMINAL

MACROPATHOL(X;Y

Killed by Fluothane

THE FOLLOWING TISSUES WERE SU!'MITTED

EPIDIDYMIS ; KIDNEY : LIVER : PITUITARY GLAND : PROSTATE GLAND : SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES WERE SEEN IN THE ANlli\L

MICRDPATHOLCX;Y

n -! r --" ..,. 0 -a....,

TISSUE CHECK: TOTAL EXII.MINED NOT EXAM MISSING NAD

PROTOCOL REQUIRED 2 2 0 0 1 NOT PROTOCOL (SU!'MITTEDl 5 0 5 0 0

(NOT SU!'MITTEDl 0 0 0 0 0U1 N w

THE FOLLOWING TISSUES WERE MARKED NAD

LIVER

THE FOLLOWING MICROSCOPIC OBSERVATIONS \o/ERE MADE

KilJNEY

Tubular basophilia : (minimal : rrultifocal l

-------------------------------------------------------00 OF ANlli\L---------------------------------------------------------------

PAC900-05/02

PERCHLOROETHYLENE: !-M..TIGENERATION INHALATION STUDY IN THE RAT


APPENDIX 12B

PATHOLOGY - FO GENERATION ANIMAL NO: 9 SEX: M IXlSE: 0 ppn ON STUDY: 131 days (19 t'1ks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOILOlill!G TISSUES WERE SUl'MITTED


NO .ABNORMALITIES WERE SEEN IN THE ANIMAL

MICROPATHOLOGY

n --; r....... -o ....... ""' 0 ""..._, TISSUE CHECK: TOTAL EXAMINED NOT EXf.M MISSING NAD

PROTOCOL BEQUIRED NOT PROTOCOL (SUl'MITTED)

2 5

2 0

0 5

0 0

1 0

CNOT SUl'MITTED) 0 0 0 0 0 tTl N

""' THE FOILOlill!G TISSUES WERE MARKED NAD

LIVER

THE FOILOlill!G MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY Tubular basophilia : (rrrlnirnal ; focal ; unilateral)

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

~

PAC900-05/02

PERCHI..OROE'IHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL AN.lMAL DATA SUPPLEMENT

APPENDIX 12B


AN.lMAL NO: 10 SEX: M DJSE: 0 ppn ON STUDY: 131 days (19 'Wks J TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOlLOWING TISSUES 'WERE SUEMITI'ED

EPIDIDYMIS : KIDNEY : LIVER : PITUITARY GLAND : PROSTATE GLAND : SEMINAL VESICLE : TESTIS

NO ABNORMALITIES 'WERE SEEN IN THE AN.lMAL

MICROPATHOLOGY

n -l r .......

....... " ... 0 '-0.....,

TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD

PROTOCOL REQUIRED 2 2 0 0 2 NOT PROTOCOL (SUEMITI'ED) 5 0 5 0 0

(NOT SUEMITI'ED) 0 0 0 0 0 N U1

U1

THE FOLLOWING TISSUES 'WERE MARKED NAD

~-~-~~-----------------------------------------END OF AN.IMAL---------------------------------------------------------------

PAC900-05/02


INDIVIDUAL ANIMAL DATA SUPPUMENT

APPENDIX 12B

PATHOLOGY - FO GENERATION ANIMAL NO: 11 SEX: M !XlSE: 0 Jlll1l ON STUDY: 131 days (19 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane ; No live pups recorded at day 1 following any mating.

THE FOLLOWING TISSUES WERE SUEMITTED

EPIDIDYMIS ; IGDNEY ; LIVER ; PITUITARY GLI\ND ; PROSTATE GLI\ND ; SEMINAL VESICLE ; TESTIS

THE FOLLOHING MACROSCOPIC OBSERVATIONS WERE MADE

TESTIS Enlarged : (left) xl.S •

NO ABNORMI\LITIES WERE SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

,-, ..... r ........, .......

""" 0 '"' "

tJl N 01 TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAil

PROTOCOL REQUIRED 2 2 0 0 1 NOT PROTOCOL (st.JEM1TTED) 5 4 1 0 3

(NOT SUEMITTED) 0 0 0 0 0

THE FOLLOWING TISSUES WERE MARKED NAil

EPIDIDYMIS ; LIVER ; PROSTATE GLI\ND ; SEMINAL VESICLE

THE FOLLOHING MICROSCOPIC OBSERVATIONS WERE MADE

1GDNEY Unilateral hydronephrosis : (slight)

TESTIS

Tubular distension : Cmxlerate ; unilateral)

-------------------------------------------------------~ OF ~---------------------------------------------------------------

PAC900-05/02


INDIVIDUAL AN.lMi\1 DATA SUPPLEMENT

APPENDIX 12B

AN.lMi\1 PATHOLOGY - FO GENERATIONNO: lZ SEX: M IXJSE: 0 ppn ON STUDY: 131 days (19 wksl TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOl.JING TISSUES vlERE SUBMITTED

EPIDIDYMIS ; KIDNEY : LIVER : PITUITARY GLt\NlJ : PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

NO ABNOBMALITIES V1ERE SEEN IN THE AN.lMi\1

MICROPATHOLOGY

n --i r"0 -.., -0

PAC900-05/02

PERCHLOROETHYLENE: M!JLTIGENERATION WHALATION STUDY IN THE RAT

INDIVIDUi\L ANJMAL DATA SUPPLEMENT

APPENDJX l2B

PATHOLCGY - FO GENERATION ANJMAL NO: 13 SEX: M OOSE: 0 ppn ON STUDY: 131 days ( 19 wks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane ; No live pups recorded at day 1 following any nating.

THE FOIJ.DWING TISSUES WERE SUPMITTED


THE FOlJ.DWING MACROSCOPIC OBSERVATIONS WERE MADE

KIDNEY Pelvic dilatation : (ri~t ; moderate)


MICROPATHOLCGY

n --;

' .......

"0 ..,-0

PAC900-05/0Z

PERCHLOROETHYLENE: Ml.JLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANIMAL DATA SUPPLEMENT APPENDIX 12B

ANIMAL NO: PATHOLOGY - FO GENERATION13 SEX: M J:OSE: 0 P!ID ON STUDY: 131 days (19 wks) 1'ERMINliL

MICROPATHOLOGY

CONTINUATION - THE l'OLLOWING MICROSCOPIC OBSERVATIONS \oiERE MADE

PROSTATE~. Prostat~t~s • ( -----------------END. rrllrtllnall -------------------------------------- OF ANIMAL---------------------------------------------------------------('") --< r -... -o-... 0""'

PAC900-05/02

PERCHLORDETHYLENE: MULTIGENERATION INHAlATION STUDY IN THE RAT


APPENDIX 12B

PATHOLOGY - FO GENERATION ANlMAL NO: 14 SEX: M roSE: 0 ppn ON STUDY: 131 days (19 wks) TERMINAL

MACRDPATHOLCGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SU!'Ml:TrED


THE FOLLOliDIG MACROSCOPIC OBSERVATIONS WERE MADE

KIDNEY Pelvic dilatation : (right ; nnderate)


MICROPATHOLOGY

n ..... r-

--.,..__., 0

"'....,

PAC900-05/02

PERCHLOROETHYLENE: MULTIGENERATION lNHALATION STIJDY IN THE RAT

INDIVIDUAL Atillf.AL DATA SUPPLEMENT

APPENDIX 12B PATHOLCGY - FO GENERATION

AN:lMi\L NO: 15 SEX: M lXlSE: 0 ppn ON STIJDY: 131 days (19 wks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane : No live pups recorded at day 1 following any mating.

THE ED!LOWING TISSUES WERE SUI'MITTED ------------------------------------EPIDIDYMIS : KIDNEY ; LIVER ; PITUITARY GLAND : PROSTATE GLAND ; SEMINAL VESICLE : TESTIS

NO ABNOilMALITIES WERE SEEN IN THE AN:lMi\L

MICROPATHOLCGY

n --l r.._ -o.._.., 0 -------------__,"" TISSUE CHECK: TOTAL EXAMINEO NOT EXAM MISSING NtiD

PROTOOOL REQUIRED 2 2 0 0 0 NOT PROTOOOL (SUI'MITTED)

(NOT SUl'MITTED) 5 0

4 0

10

0 0

4 0

U'1 w .....

THE ED!LOWING TISSUES WERE MARKED Nt1D

EPIDIDYMIS : PROSTATE GLAND : SEMINAL VESICLE ; TESTIS

THE ED!LOWING MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY C!J.::onic progressive glCI!Erulanephropathy : (minimal ; tmilateral) Unilateral hydranephrosJ.s : (slightl

LIVER

Hepatitis : (minimal : focal)

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

http:Atillf.AL

PAC900-05/02

PERCllLOROETHYLENE: MIJLTIGENERATION INHAlATION STUDY IN THE RAT


APPENDIX 12B

PATHOLCGY - FO GENERATIONANJMAL NO: 16 SEX: M OOSE: 0 PJlll ON STUDY: 131 days (19 wks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FOWJWING TISSUES WERE SUEMITTED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GLANO ; PROSTATE GLANO ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES WERE SEEN IN THE ANJMAL

MICROPATHOLCGY

-; " r..._ "0....._.., 0

PAC900-05/0Z



APPENDIX l2B

PATHOLOGY - FO GENERATION ANIMAL NO: 17 SEX: M DOSE: 0 P!lll ON STUDY: 131 days (19 wksl TERMINAL

MACROPATHOLOGY

Killed by Fluothane ; No live pups recorded at day 1 follaving any lll3.ting.

THE FQI..LOl{[NG TISSUES wERE SUEMITTED

EPIDIDYMIS ; KIDNEY : LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE : TESTIS


MICROPATHOLOGY

("")

--< r-" -0 """ co " TISSUE CHECK: TOTAL EXAMINED NOT EXliM MISSING NAD

PROTOCOL REQUIRED 2 z 0 0 0 NOT PROTOCOL (SUEMITTED) 5 4 1 0 4

(NOT SUEMITTEDl 0 0 0 0 0 U"1 w w

THE FOI..LOl{[NG TISSUES WERE MARRED NAD

EPIDIDYMIS ; PROSTATE GLAND : SEMINAL VESICLE ; TESTIS


KIDNEY Chronic progressive glCIIErulonephropathy : (minimall

Unilateral hydronephrosis : (slight)

LIVER

Hepatitis : (minimal ; nultifocal)

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

PAC900-05/02

PERCHI.OROETHYLENE: MllLTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX 12B


ANJMAL NO: 18 SEK: M !XlSE: 0 ppn ON STUDY: 95 days (14 wks) INTERCURRENT

MACROPATHOLOGY

Killed by Fluothane

THE FOILOIIDIG TISSUES WERE SUPM[T!'ED

EPIDIDYMIS ; KIDNEY ; LIVER ; ORAL CAVITY ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

THE FOILOIIDIG MACROSOOPIC OBSERVATIONS WEllE MADE

KIDNEYPelvic dilatation : cright ; DDderate)

ORAL CAVITYTeeth maloccluded Erosion/s : hole approximately 2mn cliam=ter, just above front DDlars of upper jaw.

NO ABNOBMALITIES WERE SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

n -I r..._., ..... ""' 0 co "

U1 w ""'


PROTOCOL REQUIRED 2 2 0 0 1 NOT PROTOOOL (SUPM[Tl'ED) 6 1 5 0 0

(NOT SUPM[T!'ED) 0 0 0 0 0

THE FOILOIIDIG TISSUES WERE MARRED NAD

LIVER

THE FOILOIIDIG MICROSOOPIG OBSERVATIONS WERE MADE

PAC900-05/02

PERCfiT..ORDETHYLENE: M!JLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANIMAL DATA SUPPLEMENTAPPENDIX l2B

ANIMAL NO: PATHOLffiY - FO GENERATION18 SEX: M IXJSE: 0 Pflll ON STUDY: 95 days (14 wks) INTERCURRENT

MICROPATHOLOGY

KIDNEYUnilateral hydronephrosis : (slight)

ORAL CAVITY

Malocclusion (macroscopic observation)

Palatine fistula (macroscopic observation)

FACTOR OONTRIBUI'ORY TO DEATH

ORAL CAVITY : Palatine fistula (macroscopic observation)

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

"--i...._ ..._" 0_, '-0.._,

U1wU1

PAC900-05/ 02


INOIVIDUAL ANIMAL DATA SUPPLEMENT

APPENDIX 12B

PATHOLCGY - FO GENERATION

ANIMAL NO: 19 SEX: M !DSE: 0 Pflll ON STUDY: 131 days (19 wks) TERMINAL

MACRDPATHOLCGY

Killed by Fluothane

THE FOllOWING TISSUES WERE stm1ITTED



MICROPATHOLCGY

n -l r .......

....... ""' ... 0 \D ..... TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD

PROTOOOL REQUIRED 2 2 0 0 1 NOT PROTOCOL (stm1ITTED)

(l\1JT stm1ITTED)5 0

0 0

5 0

0 0

00

U"1 w 0">

THE FOllOWING TISSUES WERE MARKED NAD

LIVER

THE FOllOWING MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY

Unilateral hydronephrosis : (slight)

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

,~

PAC900-05/02



APPENDIX l2B PATHOLOGY - FO GENERATION

AN1MAL NO: 20 SEX: M IDSE: 0 Jl!Ill ON STUDY: 131 days (19 wks l TEllMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOWJWING TISSUES WERE SUEMITTEO

EPIDIDYMIS : KIDNEY ; LIVER : PITUITARY GLAND : PROSTATE GLAND : SEMINAL VESICLE : TESTIS

NO ABNOllMi\LITIES 1-IE!lE SEEN IN THE AN1MAL

MICROPATHOLOGY

"..... r ...... "........,. 0 \.0

" TISSUE CHECK: TOTAL EXl\MINED NOT EXAM MISSING NAD PROTOCOL REQUillEO 2 2 0 0 1

NOT PROTOCOL (SUEMITTEO) 5 0 5 0 0(NOT SUEMITTEO) 0 0 0 0 0

U1 w "

THE FOLLOHING TISSUES 1-IE!lE I1AllliED NAD

LIVER

THE FOWJWING MICROSCOPIC OBSERVATIONS 1-IE!lE MADE

KIDNEY

Chronic progressive glarerulanephrcpathy : (mininal : unilateral)

-------------------------------------------------------END OF ANlMAL---------------------------------------------------------------

-----

PAC900-05/02



APPENDIX 12B


AN1MAL NO: 21 SEX: M J:OSE: 0 ppn ON STUDY: 131 days ( 19 M

PAC900-05/02

PERCHLOROETHYLENE: Ml.IT..TIGENERATION INHALATION STUDY IN THE RAT

INDIVIru\1 ANJMAL DATA SUPPill1ENT APPENDIX l2B

ANJMAL PATHOI..CX;Y - FO GENERATIONNO: 22 SEX: M lXJSE: 0 ppn ON STUDY: 131 days (19 wks l TERMINAL

MACROPATHOI..CX;Y

Killed by Fluothane

THE FOLJ..CJVIING TISSUES WERE SU!'MI'ITED

EPIDIDYMIS : KIDNEY ; LIVER ; PITUITARY GLAND : PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS


MICROPATHOI..CX;Y

n -l r.._ -o.._.., 0 '-0....,

TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING N.'\1)

PROTOCOL REQUIRED 2 2 0 0 0 NOT PROTOCOL (SU!'MI'ITEDl 5 0 5 0 0

(NOT SU!'MI'ITEDl 0 0 0 0 0 U1 w '-0

THE FOLJ..OVIING MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY Unilateral hydronephrosis : (slignt)Interstitial l!IJilO[lUClear cell infiltration : (minimal : rrultifocal l

LIVER Hepatitis ' (minimal ; focal)

-------------------------------------------------------END OF ANJMAL---------------------------------------------------------------

PAC900-05/02

PERCHLOROETHYLENE: MDLTIGENERATION INHALATION STUDY IN THE RAT

INDlVIJJUAL ANIMAL DATA SUPPLEMENT

APPENDIX 12B

PATHOLOGY - FO GENERATIONANIMAL NO: 23 SEX: M lXJSE: 0 ppn ON STUDY: 131 days (19 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane



THE FOLLOWING MACROSCOPIC OBSERVATIONS WERE MADE

KIDNEY Pelvic dilatation : (rignt ; slignt)


MICROPATHOLOGY

n --i r-...,-.. ""'0 "" "

(J1

""'0 TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD PROTOCOL REQUIRED

NOT PROTOCOL (SUEMITTED) (NOT SUEMITTED)

2 5 0

2 0 0

0 5 0

0 0 0

1 0 0


LIVER


KIDNEY ~c progressive glareruloneJ?ll!:opathy : (nrinimal ; unilateral)Unilateral !iydronephrosis : (slight)

Transitional epithelial hyperplasia : (nrinimal ; unilateral)

-

PAC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION INHAlATION STUDY IN THE RAT

INOIVIDUAL ANlMAL DATA SUPPLEMENT

APPENOIX 12B

PATHOLOGY - FO GENERATION ANlMAL NO: 23 SEX: M !XlSE: 0 Pfill ON STUDY: 131 days (19 wks) TERMINAL

MICROPATHOLOGY

CONTINUATION - THE FOLLOWING MICROSCOPIC OBSERVATIONS WERE MADE

~ Pelvic urolithiasis : (slight ; unilateral)

-------------------------------------------------------ENO OF ANJMAL---------------------------------------------------------------~ r

" " " ~ CJ uo '"

""'~-

PAC900-05/02

PERCHLORDETHYLENE: MULTIGENERATION IN!IAI.ATION STUDY IN THE RAT


APPENDIX 12B

ANJMAL PATHOI..OOY - FO GENERATIONNO: 24 SEX: M !XJSE: 0 ppn ON STUDY: 131 days (19 wks) TERMINAL

MACROPATHOI..OOY

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUEMITTEO



MICROPATHOI..OOY

"-i r '""0---.!'>---0

PAC900-05/02

PERCHI.DROETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX 12B

PATHOLCX;Y - FO GENERATION ANlMAL NO: 25 SEX: F !XJSE: 0 ppn ON STUDY: 134 days (20 wks) TERMINAL

M;\CROPATHOLCX;Y

Killed by Fluothane

THE FOLLOWING TISSUES 1>1ERE SUFMITTED

CERVIX ; KIDNEY ; LIVER ; l1AM1ARY GLAND ; OVAP..Y ; PITUITARY GLAND ; Ul'ERlJS : VAGINA

THE FOllOWING MACROSCOPIC OBSERVATIONS WERE MADE

KIDNEY Mass 1 : (right> l2mn d.ianEter, cranial pcle, pale, finn.

Ul'ERlJS Implantation site/s present : left 7, right 6.


MICROPATHOLCX;Y

n -i r-.. ""C-...., 0

PAC900-05/02

PERC!!LOROET!M..ENE: MULTIGENERATION INHAlATION STUDY IN THE RAT

INDIVIDUAL ANlMAL DATA SUPPLEMENT APPENDIX 12B

ANlMAL NO: PATHOLOOY - FO GENERATION 25 SEX: F !XlSE: 0 ppn ON STUDY: 134 days (20 wks} TERMINAL

MICROPATHOLOGY

CONTINUATION - THE FOLLO\'IING MICROSCOPIC OBSERVATIONS \'/ERE MADE

KIDNEY Nephroblastana : (NEOPLASTIC ; MALIGNANT ; PRJMARY}

-------------------------------------------------------END OF ANlMAL---------------------------------------------------------------~ r ....... "0 ....... ""' 0 '.0 ......

U"1

""' ""'

---

PAC900-05/02

PERCHLORDETHYLENE: M!JLTIGENERATION INHA!.ATION STUDY IN THE RAT

INDIVIIIUAL ANlMAL DATA SUPPLlliENT

APPENDIX lZB

PATHOLCGY - FO GENERATIONANlMAL NO: 26 SEX: F DOSE: 0 pp:n ON STUDY: 135 days (20 wks J 'I'ERt1INAL

MACROPATHOLOGY

Killed by Fluothane

THE FOWJ\o/ING TISSUES WERE SU!'MITTED

CERVIX ; KIDNEY ; LIVER ; MAt41ARY GLIIND ; OVA!IT ; PITUITARY GLIIND ; UI'ERUS ; VAGINA

THE FOLLOvliNG MACRDSOOPIC OBSERVATIONS l-IERE MADE

KIDNEYCepressed area/s : (right) capsular surface, 3mn cl.imreter, central on greater curvature •UI'ERUS Implantation site/s present : left 7. right 2.

NO ABNORMALITIES WERE SEEN IN THE REWIINING TISSUES

MICRDPATHOLOGY

n--<r-... .., -... 0""'

PAC900-05/ 02


INDIVI!JUAL 1\NlMAL DATA SUPPLEMENT

APPENDIX l2B


1\NlMAL NO: 26 SEX: F DOSE: 0 ppn ON STUDY: 135 days (20 \Oks) TERMINAL

MICROPATHOLOGY

OONTINUATION - THE FOlLOWING MICROSOOPIC OBSERVATIONS WERE MADE

KIDNEY

Surface depression ' (slight ; unilateral)

-------------------------------------------------------00 OF ANDl1~----------------------------------------------------------------("") -I........

'"t:f ........, 0

PAC900-05/02

PERC!llJ)ROETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANIMAL DATA SUPPLEMENT APPENDIX l2B

PATHOLOGY - FO ANIMAL GENERATION NO: 27 SEX: F DOSE: 0 Jllill ON STUDY: 134 days (20 wksl TERMINAL

MACROPATHOLOGY

Killed by Fluothane ; Failed to produce FlA litter.

THE FOLLOWING TISSUES WERE SUEMITI'ED

CERVIX : KIDNEY ; LIVER ; M/>.!-MARY GLAND ; OVAE! ; PITUITARY GLAND ; UTERUS ; VAGINA

THE FOLLOWING MACROSCOPIC OBSERVATIONS WERE ~'fADE

UTERUSImplantation site/s absent

NO ABNORMALITIES WERE SEEN IN THE REMiilliiNG TISSUES

MICROPATHOLOGY

n --! r-... -o -... """ 0

PAC900-05/02



PATHOLOGY - FO ANIMAL GENERATIONNO: 28 SEX: F l:XJSE: 0 ppn ON STUDY: 134 days (20 W!

PAC900-05/02



.APPENDIX 12B

PATHOLCX;¥ - FO GENERATION

ANIMAL NO: 29 SEX: F DOSE: 0 Pll" ON STUDY: 135 days ( 20 wks l TERMINAL

MACROPATHOLCX;¥

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUEMITIED

CERVIX ; IGJJNEY ; LIVER ; MAM1ARY GLAND ; OV.AP:I ; PITUIT.AP:I GLAND ; UTERUS ; VAGINA

THE FOILCJVIING MACROSCOPIC OBSERVATIONS WERE MI\DE

IGJJNEYPelvic dilatation : (right : rroderate)

UTERUSImplantation site/s present

NO ABNORMALITIES wERE SEEN IN THE REMAINING TISSUES

MICROPATHOLCX;¥

"--< r ---..., ---.. ..,. 0 co....,

U1..,. co


PROTOCOL REQUIBED: 2 2 0 0 1 NOT PROTOCOL (SUEMITIEDl: 6 0 6 0 0

(NOT SUEMITIEDl : 0 0 0 0 0

THE FOILOVIING TISSUES WERE Mi\BKED NAD

LIVER

THE FOILOVIING MICROSCOPIC OBSERVATIONS WERE MI\DE

lGJlNEY Unilateral hydronephrosis : (rroderate)

PAC900-05/02



APPENDIX 12B

ANIMAL PATHOLOGY - FO GENERATION NO: 29 SEX: F DOSE: 0 ppn ON STUDY: 135 days (20 wks) 1m1INAL

MICROPATHOLOGY

CONTINUATION - THE FOlLOWING MICROSCOPIC OBSERVATIONS "WERE MADE

KIDNEY Transitional eJ?ithelial hyperplasia : (mlnimal ; focal ; unilateral) Intratubular nucrolithiasis : cslight)

-------------------------------------------------------El

PAC900-05/02

PERCHLORDETHYLENE: MULTIGENERATION INHAlATION STUDY IN THE RAT



AN1MAL NO: 30 SEX: F DOSE: 0 PJlll ON STUDY: 136 days ( 20 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLO\i!NG TISSUES lo/ERE SUEMITTED

CERVIX ; KIDNEY : LIVER ; Mi'M1ARY GLAND : OVARY ; PITUITARY GLAND ; UTERUS ; VAGINA

THE FOlLOWING MACROSCOPIC OBSERVATIONS WERE MADE

UTERUSImplantation site/s present : left 1, right 2.

NO ABNORMALITIES vlERE SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

...... " r .._ .._ -o ..,. 0

"'....,

U1 U1,_. TISSUE CHECK: TOTAL EXFMINED NOT EXAM MISSING NAD

PROTOCOL REQUIBED 2 2 0 0 1 NOT PROTOCOL (SUEMITTEDl 6 0 6 0 0


THE FOlLOWING TISSUES WERE MARl

PAC900-05/02

PERC!ll..OllDETHYLENE: M!JLTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX 12B


ANlMAL NO: 31 SEX: F DOSE: 0 pji11 ON STUDY: 141 days (21 M

PAC900-05/0Z

PERCHLOROETHYLENE: MIJLTIGENERATION INHAlATION STIJDY IN THE RAT


APPENDIX 12B

PATHOLCX;Y - FO ANJMAL GENERATIONNO: 32 SEX: F DOSE: 0 ppn ON STIJDY: 135 days (20 wks J TERMINAL

MACROPATHOLCX;Y

Killed by Fluothane

THE FOLLOl-iiNG TISSUES WERE SUl'MITI'ED

CERVIX ; KIDNEY ; LIVER ; MAl11ARY GLAND ; OVAP:I ; PITUITARY GLAND ; UTERUS ; VAGINA

THE FOLLOl-iiNG MACROSCOPIC OBSERVATIONS WERE MADE

UTERUS-----------------------------------------------Implantation site/s present : left 6, right 5.


MICROPATHOLCX;Y

n -< r --.. --.." -"' 0

....,'"'

U1 U1 w TISSUE CHECK: TOTAL EXAMINED NOT EXM1 MISSING NAD

PROTOCOL REQUIRED NOT PROTOCOL (SUl'MITI'ED)

(NOT SUl'MITI'ED)

2 6 0

2 0 0

0 6 0

0 0 0

100

THE FOLLOl-iiNG TISSUES WERE MARKED NAD

LIVER

THE FOLLOl-iiNG MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY

Intratubular microlithiasis : (slight)

-------------------------------------------------------END OF ANJMAL---------------------------------------------------------------

PAC900-05/02



APPENDIX 12B

ANJMAL PATHOLOGY - FO GENERATIONNO: 33 SEX: F DOSE: 0 ppn ON STUDY: 134 days (20 wks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUBMITIED

CERVIX ; KIDNEY ; LIVER ; MAM1ARY GLAND ; OVPJ!..Y ; PITUITARY GLAND ; tiTERUS ; VAGINA

THE FOlLOWING MACROSCOPIC OBSERVATIONS WERE MADE

tiTERUS Implantation site/s present : left 5, right 5 .


MICROPATHOLOGY

n -I r...._ ., ...._ ""' 0

PAC900-05/02



APPENDIX 12B


ANlMAL NO: 34 SEX: F DOSE: 0 ppn ON STUDY: 134 days {20 wks J TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUEMITI'ED

CERVIX ; KIDNEY ; LIVER ; Ml\t11ARY GLAND : OVAP:i ; PITUITAP:i GLAND ; UTERUS ; VAGINA

THE FOlLOWING MI\CROSOOPIC OBSERVATIONS vlERE MADE


NO ABNOilMEILITIES WERE SEEN IN THE REMAINING TISSUES

MICROPATHOLCGY

n --;.-..... "-..... -"' 0

PAC900-05/02


INDIVIDUAL .IINJWIL DATA SUPPLEMENT APPENDIX 12B

PATHOLOGY - FO .IINJWIL GENERATIONNO: 35 SEX: F DJSE: 0 ppn ON STUDY: 151 days {22 vlks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUEMI'ITED

CERVIX ; KIIlNE\' ; LIVER ; Ml#1ARY GLAND ; OVM.Y ; PITUITM.Y GLAND ; UTERIJS ; VAGINA


TAIL : Damage recorded clinically not seen at necropsy.UTERUS

Implantation site/s present : left 7, right 5.


MICROPATHOLOGY

n -l r "'0 -_, -0 '"" .....

CJ1 CJ1

"' TISSUE CHECK: TOTAL EXI>MINED NOT EXAM MISSING NAil PROTOCOL REQUIRED 2 2 0 0 1

NOT PROTOCOL {S!JEMI'ITED) 6 0 6 0 0 (NOT SUEMI'ITED) 1 0 1 0 0

THE FOLLOWING TISSUES \-lEBE 11!\RKED NAil

LIVER


KIIlNE\' Iotratubular microlithiasis : (slight)

-------------------------------------------------------END OF .IINJWIL---------------------------------------------------------------

PAC900-05/02

PERCHLOROETHYLENE: MULTIGENERATION INHAlATION STUDY IN TilE RAT

OOIVIJJIJAL ANlMI\1 DATA SUPPLEMENT APPENDIX 12B

ANlMI\1 PATHOLCGY - FO GENERATION NO: 36 SEX: F DOSE: 0 ppn ON STUDY: 135 days ( 20 wks) TERMINAL

MACROPATHor..cx;y

Killed by Fluothane

TilE FOILO\ID!G TISSUES WERE SUPMITTEO

CERVIX : KIDNEY : LIVER ; l1llt-MI\RY GLANO ; OVARY ; PITOITARY GLAND : UTERUS ; VAGINA

TilE FOLLOWING MACROSCOPIC OBSERVATIONS WERE MADE

UTERUS Implantation site/s present : left 4, rigrrt 7 •


MICROPATHOLCGY

n --l r-....,-... ""' 0

PAC900-05/02

PERCHLOROETHYLENE: MULTIGENERATION lNHALATION STUDY IN THE RAT


PATHOLCGY - FO ANIMAL GENERATIONNO: 37 SEX: F lXJSE: 0 ppn ON STUDY: 152 days ( 22 wks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FOil..OWING TISSUES v/ERE SUOOTTED

CERVJX ; KIDNEY ; LIVER ; MA.M1ARY GLAND ; OVABY ; PITUITABY GLAND ; UTER!JS ; VAGINA

THE FOLLOWING MJ\CROSCOPIC OBSERVATIONS V1ERE MADE

UTER!JSImplantation site/s present : left 4, right 8.

NO ABNOllMALITIES V1ERE SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

n -< r -... "0 -..._,. 0 u;).._,

U"1 U"1 00 TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD

PROTOCOL REQUIRED 2 2 0 0 1 NOT PROTOCOL (SUOOTTED) 6 0 6 0 0

(NOT SUOOTTED) 0 0 0 0 0

THE FOil..OWING TISSUES V1ERE MARRED NAD

LIVER

THE FOLLOHING MICROSCOPIC OBSERVATIONS V1ERE MADE

KIDNEY

Intratubular microlithiasis : (minimal)

-------------------------------------------------------ENO OF ANIMAL---------------------------------------------------------------

-

PAC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX l2B

PATHOLQ:;Y - FO GENERATION ANIMAL NO: 38 SEX: F DOSE: 0 PJill ON STUDY: 135 days (20 wks) 'I'ERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUPMITTED

CERVIX ; KIDNEY ; LIVER ; LUNG ; M.AM1ARY GLI\ND : OVN!:i ; PITUITN!:i GLI\ND ; UTERlJS ; VAGINA

THE FO!LOHING MACROSOOPIC OBSERVATIONS HERE MADE

LUNG Red spot/s : nultiple, 1mn diarreter, all lobes all surfaces .



MICROPATHOL(X;Y

("") --;

.......' .,

.......

-"' 0 __,""

U1 U1

"" TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD

PROTOOOL REQUIRED NOT PROTOOOL (SUPMITTEDl

2 7

2 0

0 7

0 0

1 0

(NOT SUPMITTED) 0 0 0 0 0


LIVER

THE FOLLOWING MICROSOOPIC OBSERVATIONS WERE MADE

KIDNEY


-------------------------------------------------------EI

PAC900-05/02



APPENDIX 12B

PAT!IOLCGY - FO GENERATION AN1MAL NO: 39 SEX: F IXlSE: 0 ppn ON STUDY: 151 days (22 wks) TERMINAL

MACROPAT!IOLCGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE Slll'MITTED

CERVIX ; KIDNEY ; LIVER ; MIIM1ARY GLAND ; OVJ!JIT ; PITUITJ!JIT GLAND ; UTERUS ; VAGINA


KIDNEY Pelvic dilatation : (slight)

UTERUSImplantation site/s present ' left 6, right 7.


MICRDPAT!!OLCGY

n --< r--" -""'0 co "

U1 0"> 0

TISSUE CHECK: TOTAL EXII.MINED NOT EXAM MISSING Nt\D

PROTOCOL REQUIRED 2 2 0 0 1 NOT PROTOCOL (Slll'MITTED) 6 0 6 0 0

(NOT Slll'MITTED) 0 0 0 0 0

THE FOLL01YING TISSUES WERE MARKED Nt\D

LIVER


KIDNEY Intratubular microlithiasis : tslight)

-------------------------------------------------------END OF ANJMAL---------------------------------------------------------------

PAC900-05/02


INDIVIDUAL ANlMl\1 DATA SUPPLEMENT

APPENDIX l2B

PATHOLOGY - FO GENERATION AN1M!\L NO: 40 SEX: F DOSE: 0 ppn ON STUDY: 135 days (20 wks l TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES VIERE Slll'MITTED

CERVIX : KIDNEY ; LIVER ; MAM1ARY GLAND : OVPJri : PITUITPJri GLAND : UTERUS : VAGINA

THE FOLLOWING MACROSCOPIC OBSERVATIONS V1ERE MADE


NO ABNOBMALITIES V1ERE SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

n -< r -.. "0 -.. -"' 0 \0....,

U1

,_."" TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD PROTOCOL REQUIRED:

NOT PROTOCOL (Slll'MITTEDl : 2 6

2 0

0 6

0 0

1 0

(NOT Slll'MITTEDl : 0 0 0 0 0

THE FOLLO\o/ING TISSUES V1ERE MARKED NAD

LIVER

THE FOLLOWING MICROSCOPIC OBSERVATIONS V1ERE MADE

KIDNEY

Bilateral hydronephrosis : (slight)Intratubular microlithiasis : (moderate)

-------------------------------------------------------END OF ANlMl\1---------------------------------------------------------------

PAC9D0-05 I02


INDIVIDUAL AN1MAL DATA SUPPLEMENT APPENDIX l2B

FO GENERATIONAN1MAL PATHOLOGY -NO: 41 SEX: F DOSE: 0 ppn ON STUDY: 152 days (22 wks) TERMINAL

MIICROPATHOLOGY

Killed by Fluotrume

THE FOLLOWING TISSUES WERE Slll!MITTED

CERVIX ; KillNEY ; LIVER ; MAM'1ARY GLAND ; OVJ>JIT ; PITUITARY GLAND ; UTERUS ; VAGINA


liTERUS Implantation site/s present : left 7, right 4.


MICROPATHOLOGY

n -l r-"'0 --..,.--0

PAC900-05/02

PERCHLORDETHYLENE: HULTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANil1AL DATA SUPPLEMENT

APPENDIX 12B


ANil1AL NO: 42 SEX: F DOSE: 0 ppn ON STUDY: 141 days (21 wksl TERl1INAL

1:1ACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUJ'MITTEO

CERVIX ; KIDNEY ; LIVER ; t1AM1ARY GLAND ; OVPJJ.Y : PITUITARY GLAND : UTERUS ; VAGINA

THE FOlLOWING 1:1ACROSCOPIC OBSERVATIONS WERE MADE

UTERUS

Implantation site/s present : left 3, right 9.


HICRDPATHOLOGY

n -< r-"0 ----0""'

j_

PAC900-05/02

PEBCHLOROETHYLENE: MIJLTIGENERATION INHAlATION STUDY IN THE RAT

INDIVIDUAL ANJMAL JliiTA SUPPLEMENT

APPENDIX 12B

ANJMAL PATHOLC>:;Y - FO GENERATIONNO: 43 SEX: F DOSE: 0 ppn ON STUDY: 135 days (20 ""'s) TERMINAL

MACROPATHOLC>:;Y

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUBMI'l'l'ED

CERVIX ; KIDNEY ; LIVER ; MAl11ARY GLAND ; OVI!Jf:l ; PITUITARY GLAND ; UTERUS ; VAGINA

THE FOLLOVIING MACROSCOPIC OBSERVATIONS WERE M.'\DE

UTERUS Implantation site/s present : left 8, right 6.


MICROPATHOLC>:;Y

("") -; r ..._ ""0 .........,. 0

PAC900-05/02

PERCHLORDETIIYLENE: MIJLTIGENERATION INHAlATION STUDY IN THE RAT


APPENDIX 12B


ANIMAL NO: 44 SEX: F DOSE: 0 ppn ON STUDY: 141 days (21 hl

PAC900-05/02

PERCHLOROETHYLENE: Ml.JLTIGENERATION lliHALATION STUDY IN THE RAT



ANJMAL NO: 45 SEK: F DJSE: 0 ppn ON STUDY: 158 days (23 wks) TERl1INAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOHING TISSUES WERE SUBMITTED

CERVIX ; KIDNEY ; LIVER ; Mlll41ARY GlAND ; OVl\RY ; PITUITARY GlAND ; UTERlJS ; VAGINA

THE FOLLOliDlG MACROSCOPIC OBSERVATIONS WERE MADE

UTERlJSImplantation site/s present : left 9, rigrrt 3.


MICROPATHOLOGY

n ..... r ..._ ""0 ..._ 0 ""

PAC900-0S/02


INDIVIDUAL ANIMAL DATA SUPPLl'MENT APPENDIX 12B

PATHOLOGY - FO ANIMAL GENERATIONNO: 46 SEX: F DOSE: 0 P!ID ON STUDY: 136 days (20 wks l 'l'EllMINAL

MACROPATHOLOGY

Killed by Fluothane


CERVIX ; KIDNEY ; LIVER ; MAM1ARY GLAND ; OVAAY ; PITUITAAY GLAND ; UIER!JS ; VAGINA

THE FOLLOHING MACROSCOPIC OBSERVATIONS WERE MADE

UIER!JSImplantation site/s present ' left 9, right 3.

NO ABNORMALITIES HERE SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

n --< r--" ..,.-0 \0

"

U1

"' TISSUE CHECK: TOTAL EX/>111NED NOT EXAM MISSING NAil PROTOCOL REQUIRED

NOT PROTOCOL (SUEMITTED) 2 6

2 0

0 6

0 0

10


"

THE FOLLOHING TISSUES WERE MARKED NAil

LIVER

THE FOILOHING MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY


-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

PAC900-05/02

PERCHLORDETHYLENE: MIJLTIGENERATION INHALATION ST!JDY IN THE RAT

INDIVJJJUAL ANJl1AL DATA SUPPLEMENT

APPENDIX 12B


ANJl1AL NO: 47 SEX: F IXJSE: 0 Jlllil ON STODY: 134 days (20 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOlLOWING TISSUES \

CERVIX ; KIDNEY ; LIVER ; M&MARY GLAND ; OVAPCI ; PITUITAPCI GLAND ; UTERUS ; VAGINA

THE FOlLOWING MACROSCOPIC OBSERVATIONS \


NO ABNORMALITIES \

MICROPATHOLOGY

" --i r----o _.,.--0

---

PAC900-05/02


INDIVIDUAL ANIMAL DATA SUPPLEMENT APPENDIX lZB

PATHOLOGY - FO ANIMAL

GENERATIONNO: 48 SEX: F roSE: 0 ppn ON STUDY: 134 days (20 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUEMITI'ED

CERVIX ; KIDNEY ; LIVER ; MAM1ARY GLAND ; OVPEI ; PITUITARY GLAND ; UTERIJS ; VAGINA


UTERilS Implantation site/s present : left 5, right 4.


MICROPATI!OLOGY

n_, r -c ..,.---0

PAC900-05/02

PERCHLORDETHYLENE: MULTIGENERATION INHALATION STUDY lN THE RAT

INDIVIDUAL ANIMIIL DATA SUPPLEMENT

APPENDIX 12B


ANIMIIL NO: 49 SEX: M lXJSE: 100 Jllill ON STUDY: 129 days (19 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUEMITTEO

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GlAND ; PROSTATE GlAND ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES WERE SEEN lN THE ANIMIIL

MICROPATHOLOGY

n .... r...._ ..,...._ 0""' co....,

TISSUE CHECK: TOTAL EX/>MINED NOT EX/>M MISSJNG NAD

PROTOCOL REQUIRED: NOT PROTOCOL (SUEMITTED) :

(NOT SUEMITTEO) :

0 7 0

0 5 0

0 2 0

0 00

04 0

c..n ...., 0

No live pups follc:Ming any mating.

THE FOLLOHJNG TISSUES \.JERE MARKED NAD

EPIDIDYMIS ; PROSTATE GlAND ; SEMINAL VESICLE ; TESTIS

THE FOLLOWING MICROSOOPIC OBSERVATIONS WERE MADE

KIDNEY

Chronic progressive glCJIErulonephropathy : (nllnimal)

-------------------------------------------------------END OF ANIMIIL---------------------------------------------------------------

PAC900-05/02



APPENDIX 1ZB

PATHOW3Y - FO GENERATION

ANIMAL NO: 50 SEX: M DJSE: 100 PJI1l ON STUDY: 129 days (19 wks J TERMINi\1

M!\CROPATHOW3Y

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUI'MITTED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GLAND : PROSTATE GLAND ; SEMINAL VESICLE : TESTIS


MICROPATHOW3Y

n_, r-....,-... -"' 0 ~ ...... TISSUE CHECK: TOTAL EXAMINED NOT EXm MISSING NAD

PROTOCOL REQUIRED 0 0 0 0 0 NOT PROTOCOL (SUI'MITTEDl

(NOT SUI'MITTEDl 7 0

1 0

6 0

0 0

0 0U1 ...... -

THE FOLLO\mlG MICROSCOPIC OBSERVATIONS WERE WIDE

KIDNEY Unilateral hydronephrosis : (minimal)

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

PAC900-05/02

PERC!ILOROETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT


PATHOLCGY - FO GENERATIONANIMAL NO: 51 SEX: M OOSE: 100 Jlllll ON STUDY: 129 days (19 >lks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane ; No live pups recorded at day 1 following any mting.

THE FOLLOWTh'G TISSUES WERE SUEMITTEO


THE FOLLOWTh'G MACROSCOPIC OBSERVATIONS WERE MADE

KIDNEYPelvic dilatation : cslight ; right)


MICROPATHOLOGY

....,

..... r ..._ "0 ..._..,. 0

PAC900-05/02

PERCHLORDETHYLENE: HIJLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIIJUAL ANJMAJ.. DATA SUPPLEMENT

APPENDIX 12B


ANJ}f.AL NO: 52 SEX: M !XlSE: 100 ppn ON STUDY: 129 days (19 wksl TERMINAL

MACRDPATHOLCGY

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUEMITI'ED

EPIDIDYMIS : KIDNEY : LIVER ; PITUITARY GLAND : PROSTATE GLAND : SEMINAL VESICLE : TESTIS

NO ABNOR!'ALITIES WERE SEEN IN THE ANIMAL

MICROPATHOLOGY

n --

PAC900-05/0Z


INDIVIDUAL ANIMAL DATA SUPPLEMENT APPENDJX 12B

PATHOLCGY - FO GENERATION ANIMAL NO: 53 SEX: M !XlSE: 100 ppn ON STUDY: 130 days (19 toks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane




KIDNEYPelvic dilatation : (right ; slight)


MICROPATHOLCGY

n -< r----o --0 ""' u;).._,

U"1 ....., ""' TISSUE CHECK: TOTAL EXAMINED NOT EX!

PAC900-05/02


INOI.VIDUi\L ANIMAL DATA SUPPLEMENT


ANIMAL NO: 54 SEX: M IXJSE: 100 ppn ON STUDY: 130 days (19 M/ING MACROSCOPIC OBSERVATIONS ~ MADE

lGJlNEY Pelvic dilatation : (left ; slight ; right ; l!Dderate)

NO ABNORMALITIES ~ SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

n --

PAC900-05/02

PERCHLOROET!M..ENE: MULTIGENERATION INHALATION STUDY IN THE RAT


ANIMAL NO: PATHOLCGY - FO GENERATION55 SEX: M OOSE: 100 ppn ON STUDY: 130 days (19 >.ks) TERMINAL

11'\.CROPATHOLCGY

Killed by Fluothane



NO ABNORMALITIES WERE SEEN IN THE AN1MAL

MICROPATHOLCGY

n ..... .._ .., ' .._ ... 0

"' " TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD PROTOCOL REQUIRED 0 0 0 0 0

NOT PROTOCOL (SUEMITTED) (NOT SUEMITTED)

7 0

1 0

6 0

0 0

00

U"l

"Cj) THE FOLLOWING MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY

Pelvic urolithiasis : (nrinimal ; unilateral)

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

-·~

PAC900-05/02

PERCHLORDETHYLENE: ~lULTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX 12B


ANlMAL NO: 56 SEX: M DOSE: 100 ppn ON STUDY: 130 days (19 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane : No live pups recorded on day 1 follow:lng any mating.

THE FOLLOWING TISSUES WERE SUPMITTEO

EPIDIDYMIS : KIDNEY ; LIVER : PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES WERE SEEN IN THE ANlMAL

MICROPATHOLOGY

(""')

--< r-.. ""0-...,. 0

---

PAC900-05/ 02

PERCIILORDETHYLENE: MJJLTIGENERATION INHAlATION STUDY IN THE RAT


APPENDIX 12B


ANIMAL NO: 57 SEX: M OOSE: 100 ppn ON STUDY: 130 days (19 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUJM[TI'ED


00 ABNOllMALITIES WERE SEEN IN THE ANIMAL

MICROPATHOLOGY

n -< r"'0 --0 """

' -

PAC900-05/02

PERCHLOROETHYLENE: MULTIGENERATION INfWATION STUDY IN THE RAT

INDIVIIJUAL ANIMAL DATA SUPPLEMENT

APPENDIX l2B

PATHOLOGY - FO GENERATION ANIMAL NO: 58 SEX: M IXJSE: 100 ppn ON STUDY: DO days (19 wks J TERMINAL

MIICROPATHOLOGY

Killed by Fluothane

THE FOLLO\-IING TISSUES WERE SUEMITTED

EPIDIDYMIS ; IGJJNEY ; LIVER ; PITUITARY GLAND : PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS


MICROPATHOLOGY

n --; r.._ ., ...... -"' 0

"'...... TISSUE CHECK: TOTAL EXAMrNED NOT EXAM MISSING NAD PROTcx::OL REQUIRED

NOT PRDTcx::OL (SUEMITTEDl (NOT SUEMITTEDl

0 7 0

0 1 0

0 6 0

0 0 0

0 1 0 U"1 ......

"' THE FOLLOillNG TISSUES WERE MARKED NAD

IGJJNEY ------------------------------------------------------ENQ OF ANIMAL---------------------------------------------------------------

PAC900-05/02

l?ERCHLDROETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANIMAL DATA SUPPLEM:NT

APPENDIX 12B

PATHOLCGY - FO GENERATION ANIMAL NO: 59 SEX: M D:JSE: 100 ppn ON STUDY: 131 days (19 'Mcs) TERMINAL

M.J\CROPATHOLCGY

Killed by Fluothane

THE FDWJWING TISSUES vlERE SUEMITI'ED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GlAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES VlERE SEEN IN THE ANIMAL

MICROPATHOLCGY

n__, '-... "-...... 0 lO .....,


PROTCCOL REQUIRED NOT PROTCCOL (SUEMITI'ED)

(NOT SUEMITI'ED)

0 7 0

0 1 0

0 6 0

0 0 0

0 1 0

U"1 co 0

THE FDWJWING TISSUES VlERE MARKED NAD

~-------------------------------------------------END OF ANIMAL---------------------------------------------------------------

~ ~

PAC900-05/02

PERCHLORDETHYLENE: MIJLTIGENERATION INHAlATION STUDY IN THE RAT


APPENDIX l2B

ANIMAL PATHOLOGY - FO GENERATIONNO: 60 SEX: M DOSE: 100 PJ::m ON STUDY: 131 days (19 Vlks l TERMil'W..

M

PAC900-05/02


INDIVIDUAL ANlNAL DATA SUPPLEMENT

APPENDIX 12B

PATHOLCGY - FO GENERATION ANlNAL NO: 61 SEX: M DOSE: 100 Jlj:JJ1 ON STUDY: 131 days (19 wks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane : No live pups recorded on day 1 follCM.ing any nating.

THE FOlLOWING TISSUES WERE SUFMITTED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND : SEMINAL VESICLE : TAIL ; TESTIS


TAIL Kinked


MICROPATHOLOGY

n -< r .......

-o .......

""' 0 ~ ....,

co "' N TISSUE CHECK: TOTAL EXJI.MINEO NOT EXAM MISSING NAil

PROTOCOL REQUIRED

NOT PROTOCOL (SUIMITTED)

0 8

0 5

0 3

0 0

0 4

(NOT SUFMITTED) 0 0 0 0 0

THE FOUDioJING TISSUES 1IDlE MARI

PAC900-05/0Z



APPENDIX 12B

PATHOLOGY - FO GENERATION ANlMAL NO: 62 SEX: M !XJSE: 100 P!Ill ON STUDY: 131 days (19 wksl TERMINAL

MACROPATHOLOGY

Killed by Fluothane



NO ABNORMALITIES WERE SEEN IN THE ANlMAL

MICRDPATHOLOGY

" -i r..._ "...__,. 0

""..._, TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSlliG NAD PROTOCCL REQUIRED

NOT PRDTOCCL (SUEMITTEDl(NOT SUEMITTED)

0 7 0

0 1 0

0 6 0

0 0 0

0 0 0

U1 co w

THE FOILOHlliG MICROSCOPIC OBSERVATIONS WERE MADE

KIDNEY Tubular basophilia : (Il1in.iJml ; focal ; un.il.aterall

-------------------------------------------------------END OF Af011AL---------------------------------------------------------------

PAC900-05/02

PERC!ll.DRDETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT


APPENDIX 12B

PATHOLOGY - FO ANJMAL GENERATIONNO: 63 SEX: M I:OSE: 100 Jl!lll ON STUDY: 131 days Cl9 M

PAC900-05/02

PERC!ll.DROETHYLENE: MULTIGENERATION INHAlATION STUDY IN THE RAT

INDI\IIJJUAL ANIMAL DATA SUPPLEMENT APPENDIX 12B

PATHOLOGY - FO ANIMAL GENERATIONNO: 64 SEX: M IXlSE: 100 P!lll ON STUDY: 131 days (19 wksl TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUl'MITI'ED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TAIL ; TESTIS

THE FOLLOWING MACROSCOPIC OBSERVATIONS viERE MADE

KIDNEY Pelvic dilatation : (right ; lefti

TAIL Fracture : near tip.


MICROPATHOLOGY

n --! r .......

....... -"" " 0

PAC900-05/02


INDIVIDUAL ANlMAL DATA SUPPLEMENT APPENDIX l2B

ANlMAL PATHOLOGY - FO GENERATION NO: 65 SEX: M IXJSE: 100 ppn ON STUDY: 131 days (19 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane ; No live pups recorded on day 1 follcw:ing any mating.

THE FO~ TISSUES WERE SUEMITTED


THE FO~ MACROSCOPIC OBSERVATIONS WERE M'illE

KIDNEY Pelvic dilatation : (right ; !l'Dderate)

NO ABNORMAJ..ITIES WERE SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

n --< r..._ "..._ _,. 0

'·

PAC900-05/02


INDIVIDUAL ANIMAL DATA SUPPLEMENT APPENDlX l2B

PATHOLOGY - FO GENERATIONANIMAL NO: 66 SEX: M IXlSE: 100 ppn ON STUDY: 131 days (19 wks I TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES 'V/ERE SUEMITI'ED

EPIDIDYMIS ; IGDNEY ; LIVER : PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE : TESTIS

THE FOILO\f.rNG MACROSCOPIC OBSERVATIONS \oiERE MADE

lGDNEYPelvic dilatation : (right : ooderate)


MICROPATHOLOGY

n ...... r -... -o-....., 0

PAC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION IN!W.ATION STUDY IN THE RAT


APPENDIX 12B


ANJMAL NO: 67 SEX: M IXJSE: 100 ppn ON STUDY: 131 days (19 wks) 'l'ERMINAL

MACROPATHOLCGY

Killed by Fluothane ; No live pups recorded an day 1 follcw.ing any !!E.ting.

THE FOILOIID!G TISSUES WERE SOEMITTED

EPIDIDl:MIS ; KIDNEY ; LIVER ; PITUITARY GLANO ; PROSTATE GLANO ; SEMINAL VESICLE ; TESTIS


KIDNEY Pelvic dilatation : (right ; slight)

NO ABNORMALITIES WERE SEEN IN THE REM

PAC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION INHAlATION STUDY IN THE RAT


APPENDIX 12B


ANIMAL NO: 68 SEX: M DJSE: 100 ppn ON STUDY: 131 days (19 wksl TERMINAL

MACROPATHOLOGY

Killed by Fluothane ; No live pups recorded on day 1 folloo:ing any lll9.ting.


EPIDIDYMIS ; lGDNEY : LIVER ; PITUITARY GLAND : PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

NO ABNOBMALITIES WERE SEEN IN THE ANIMAL

MICROPATHOLOGY

n -l, -., -""'0 co " TISSUE CHECK: TOTAL EX!IMINED NOT EX!IM MISSING Nl\D

PROTOCOL REQUIRED 0 0 0 0 0 NOT PROTOCOL (SUEMITTEDl

(NOT SUEMITTEDl 7 0

5 0

2 0

0 0

3 0 tn co

co

THE FOLLOWING TISSUES WERE MARKED Nl\D

EPIDIDYMIS ; SEMINAL VESICLE ; TESTIS


lGDNEY

Tubular basophilia : (nrin:inal ; focal ; unilateral)

PROSTATE GLAND

Prostatitis : (slight)

-------------------------------------------------------00 OF ANIMAL---------------------------------------------------------------

PAC900-05/02

PERCHLORDETHYLENE: l1l.JLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANTI1AL DATA SUPPLEMENT

APPENDIX 12B

PATHOLOGY - FO GENERATION ANIMAL NO: 69 SEX: M OOSE: 100 PIJl1 ON STUDY: 131 days (19 >ks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane


EPIDIDYMIS ; KlllNEY ; LIVER ; PITUITARY Gl.AND ; PROSTATE Gl.AND ; SEMINAL VESICLE ; TESTIS


KIDNEYPelvic dilatation : (right ; rroderate)

NO ABNORMALITIES \-IERE SEEN IN THE REMAINING TISSUES

MICRDPATHOLOGY

("") -I r -... -a -... 0""' \0

"

U"1 \0 0 TISSUE CHECK: TOTAL EXl\MINED NOT EXAM MISSING NAD

PROTOCOL REQUIRED

NOT PROTOCOL (SUPMITTED)

(NOT SUEMITTED)

0 7 0

0 1 0

0 6 0

0 0 0

0 0 0


KlllNEY Chronic progressive glarerulone~athy : (min.irml)Unilateral hydronephrosis : (sl1ght,

-------------------------------------------------------END OF ANlli\L---------------------------------------------------------------

'

PAC900-05 I02



APPENOIX 12B


ANlMAL NO: 70 SEX: M IXJSE: 100 ppn ON STUDY: 131 days (19 ,,ics) 'l'ERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FOLLOWING TISSOES 'WERE SUI'MIITED

EPIDIDYMIS ; KIDNEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESIClE ; TESTIS

THE FOLLOI-IING MACROSCOPIC OBSERVATIONS 'WERE Mi\DE

KIDNEYPelvic dilatation : (right ; slight)

NO ABNORMALITIES 'WERE SEEN IN THE REMA1NING TISSOES

MICROPATHOLCGY

n --1 r--..., ........, 0 '-0....,

U1

""- TISSOE CHECK: TOTAL EXllMINEO NOT EXAM MISSING NAD PROTOCOL REQUIRED

NOT PROTOCOL (SUI'MIITEDl 0 7

0 1

0 6

0 0

0 0

(NOT SUI'MIITEDl 0 0 0 0 0

THE FOLLOl.JING MICROSCOPIC OBSERVATIONS

PERCHLOROETHYLENE: MULTIGENERATION INHALATION … · 6/27/1995 · INDIVIDUAL ANIMAL DATA...

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Transcript of PERCHLOROETHYLENE: MULTIGENERATION INHALATION … · 6/27/1995 · INDIVIDUAL ANIMAL DATA...