ZENECA CENTRAL TOXICOLOGY LABORATORY ALDERLEY P,ARK ... · · received zeneca central toxicology laboratory alderley p,ark macclesfield cheshire uk category b report (confidential)

, · RECEIVEDZENECA CENTRAL TOXICOLOGY LABORATORY

ALDERLEY P,ARK MACCLESFIELDCHESHIRE UK

CATEGORY B REPORT (CONFIDENTIAL) Sponsor:Not to be Copied Except by aReports Centre Sponsor Ref:

CTL Ref:CTL Study Nos:

Copy No: 5

REPORT NO: CTL/P/4097

PERCHLOROETHYLENE: MULTIGENERATIONINHALATION STUDY IN THE RAT

INDIVIDUAL ANIMAL DATA SUPPLEMENT

VOLUME IV OF IV

Approved for Issue: G A Wickramaratne Date of Issue:O 3 NOV 1994 Product Toxicologist

Ill/ '71995

CTL/P/4097 - 1368'

PERCHLOROETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT


CONTENTS

Page No VOLUME IV

APPENDIX 25A: Microscopic Pathology Cross Reference - F1 Generation 1370-1381

APPENDIX 258: Pathology - F1 Generation 1382-1591

APPENDIX 26A: Pathology - F2A Pups 1592-1948

APPENDIX 268: Pathology - F28 Pups 1949-2067

APPENDIX 26C: Pathology - F2C Pups 2068-2116

APPENDIX 27 : Corpora Lutea and Implantation Site Counts - F1 Females 2117-2120

CTL/P/4097 - 1369

)

)

( )

Halogenated Solvents Industry Allianc~

PERCHLOROETHYLENE: MULTIGENERATION

INHALATION STUDY IN THE RAT


VOLUME IV OF IV

Data Requirement - Guideline Ref. 83-4

Study Completion Date ,z.., .ltl\1\ 1995

Performing Laboratory .. Zeneca Central Toxicology LaboratoryAlderley Park, Macclesfield,

Cheshire, UK

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

RR0580/Fl

CTL/P/4097 - 1368

ZENECA CENTRAL TOXICOLOGY LABORATORY

ALDERLEY PARK MACCLESFIELD

CHESHIRE UK

CATEGORY B REPORT (CONFIDENTIAL) Sponsor: Halogenated Solvents Not to be Copied Except by a Industry Alliance Reports Centre Sponsor Ref: HSIA/90/D002

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

RR0580/FlCopy No:

REPORT NO: CTL/P/4097



VOLUME IV OF IV

'I

Approved for Issue: G +-

A Wickramaratne 9'

Date of Issue: 2 7 JUN 1995Product Toxicologist

CTL/P/4097 - 1368



APPENDIX 25A

MICROSCOPIC PATHOLOGY CROSS REFERENCE - Fl GENERATION

CTL/P/4097 - 1370

PAC910-04/02

PERCHI..OBDE'll!YLENE: MULTIGENERATION INHALATION STUDY lN THE RAT

INDIVIIXTAL ANlM!\L DATA SUPPLEl1ENT

APPENDIX 25A

MICROSCOPIC PATHOLOGY CROSS REFEREN::E - l'1. GENERATION

REM>V.AL REASON: INTERCURRENT

OOSE LEVEL: 0 SEX: FEMALE ppn 3

3

CERVIX................................................... N

KIJ:NEY ................................................... +

Chronic progressive glarerulanephropathy • • . • . • • • • • • • • • • Intratubular microlithiasis •••••••••••••••.••.•••••••••

1 1

LIVER.................................................... N

MAM1AR.Y GLAND .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. • .. .. .. • .. +

Diffuse hyperplasia .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 2

NASAL CAVITY .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. • + Trauma (macroscopic observation) •••.••••••..•.••••••••. X

OVP.P:Y • • • • • • • • .. • • • • • • • • • • .. • • • • • • • • • • • • • • • • • • • • • • • • • .. • • • N

T.JTERIJS • • • • • • • • • • • •••• • •••• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • N

VAGlNA ............................... , • • • • • • • • • • • • • • • • • • • N

KEY: MJRPHOLOGY SE.VERITY NOT RECORDED 1 minlmal

N N.A.D. 2 slight0 MISSIN:; 3 m:xlilrate + MJRPHOLOGY PRESENT 4 marked X NO SEVERITY

(""")

-1 r ...... ...... """ ... 0 V.AL

PAC910-04/ 02

PERCHLOROE'l'HYLENE: MIJLTIGENERAT.ION INHALATION STUDY ill THE RAT

JNDIVIOOAL ANlMAL DATA SUPPLEMENT

APPENDIX 25A

MICROSCOPIC PATHor..cx:;y CROSS REI!EREla - F1. GENERATION

REMJVAL REASON: INl'ERCllRRENT

IXJSE LEVEL: 300 ppn

SEX: FEMALE 111

2 2 4

2 3 1

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

KJI:!'lEY • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Intratubular microlithiasis •••.••...•.•.••.•...........

+ N + 2 • 1

MAt-MARY GLAND •••••••••••••••••••••••••••• • • • • • • • • • ••••••• Diffuse hyperplasia ••..•••..•••.••.•..•••.•....•.•.•.•.

+NN 2 ..

OV};ff:[ •••••••••••••••••••••••••••••••.••••••••••••....• • • • NON

UTEBilS ••••••••••••••••••••••••••••••••••••••••••••••••••• Lt.IIrirtal. dilatation. .................................... . Endaretritis ••..••...•.•..••••••..•...•....•....•...... Placental tissue in llmm ••.••••..•.•......••..••....•• Dystocia (diagnosis based an macroscopic observations) .

+++4 ••

4 ••

. . X

. XX

VAGINA ••••••••••••••••••••••••••••••••••••••••••••••••••• • 0 •

KEY: MlRPHOr..cx:;y SEVERITY' N:lT REJ:ORilED 1 minimal

N N.A.D. 2 slight

0 MISSIN:; 3 rroderate

+ MJRPHQr..cx:;y PRESENT 4 nmked

X ID SEVERITY'

("") ...... r...... -c ...... ol>o 0 \0 ......

w -...... N

'

PAC910-04/02

PERCHLOROE'I'Hi'LENE: MULTIGENERATION INHALATION STUDY lN THE RAT

lNDIVIIXIAL ANlli\1 ll'ITA SUPPLEMENT

.APPENDIX 25A

MICROSCOPIC PATHOLOGY CROSS REFERl!!a F1. GENERATION

REMJVIIL REASON: INTERCURRENT

OOSE LEVEL: 1000 SEX: FE!1.'.LE ppn

1 1 1 8 8 8 3 4 5

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

KIIlNEY .................................................. . Tubular vacuolation. ................................... . Glomerular mineralisation ••••••.•••••••••••••••••••••••

N++ • 2 • • . 1

LIVER ................................................... . Extramedullary haemopoiesis .•••••••••••••••••••.••••••• Hepatocyte necrosis centrilobular ••••..•.••••.••••••• Hepatocyte necrosis .................................. ..

N++

. . 1 . . 1• 3 •

MIIM1I\RY GLAND .......................................... .. NN.

r:NAK:l .................................................... N N •

UTERUS .................................................. . Placental tissue in lumen ••••••••••••••••••••.•••••.••• Dystocia (diagnosis based on rracroscopic observations) •

++.

. X . XX.

VAGlNA ................................................... N N.

KEY: illRPHOLOGY SEVERITY OOT RECORDED 1 minimal

N N.A.D. 2 slight 0 MISSlNG 3 JrO

PAC910-04/02

PERalLOROE1'HYLENE: MULTIGENERATION lNHAlATION STUDY IN THE AAT

INDIVIIXIAL IINlMAL Jl.\IA SUPPLEMENT

APPENDIX 25A

MICROSCOPIC PATHOLOGY CROSS REFEREN::E - Fl. GENERATION

REMWAL REASON: TERMINAL

!XlSE LEVEL: ppn

0 SEX: MALE 111111111122222

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

EPIDIDYMrS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N . . . . . . . . . • . . . N . . . . N . . lC[I)lllEY ........ 0 ••••••• 0 •• 0 0 •••• 0 ••••• 0 0 • 0 0 0 • 0 • 0 • 0 0 0 • 0 •••••

Uhilateral hyrlronephrosis •.••.•••.•....•.•.....•.•...•.

Bilateral hydronephrosis •••••.••.....••.•...•.•........

Chronic pro~~si':'= glooerulanephropathy •..••••.•..••..

Pelvic urohth.iasH •..••••.•••••.•.•...•.•.•.•.•.•.•...Transitional epithelial hyperplasia .•.••••.•..•..•...•.

+N++++++++++N+++++++++++ . . 2 . . 0 • 0 • • • 0 0 • 0 • 0 • • 0 0 0 • • • 0 • • • • • 0 • • • 0 0 • 0 2 0 • • 0 0 • • 0 2.1211211112.12211112112 • • 1 • • . • • • • • • • . • 2 • • • • • • • • .. 1 .• 1 ••...•... 2 ..•.••••

LIVE:R. .................................................... .

Hepatitis •.•••.••••......•..•.••••..•.••.•.....•.•.....

++++N+NN+++++++NN+++++++ 1 1 1 1 . 1 • . 1 1 1 2 1 2 1 . . 1 1 1 1 2 1 1

PROSTATE ~ ••• •• • • •• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •Prostatitis ........................................... .

.N .•••••.•••.•• +. • .. +

. 1 0 0 • • 1 .

~ 'VESIClE •.•••••..••.•.••..••.••••.•.•..••.•.•...•. N..........•.. N .... N

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

-I '"' r ...... -o ...... 0 .;..

1.0 ......

w -...... .;..

KEY: M)RPHOLOGY SEVERITY OOT RECORDED 1 min.imal

N N.A.D. 2 slight0 MISSIN; 3 m:xlerate + M)RPHOLOGY PRESENI' 4 nm:ked X 00 SEVERITY

-~

~ -._../ '-' v

PAC9l0-04/02

PERCHLOROEI'HYLENE: MULTIGENERATION INHALA1'ION STUDY IN THE RAT

INDIVIlXJAL ANIMAL llATA SUPPLEMENT

APPENDIX 25A

MICROSCOPIC PATHOLCGY CROSS REFEBENCE - TI GENERATION

REMJVAL REASON: TERMINAL

OOSE LEVEL: 0 SEX: FEMALE ppn 2 2 2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4

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

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

KIJ:X>lEY ••••••••••••••••••••••••••••••••••••••••••••••••••• +++++++++++++++++++++++ Chronic progressive glCJJErulonephropathy ••••.•.•••••••• . . • . • . . • l.l.l ..• ll ..... IntratubUlar microlithiasis •••.•.......••••..•........• 2l3ll2ll222ll2l23lll234 Tubular basophilia ••.••.••...•...•.•••......•....•..... . . . . . . . . . . . . . . . . 1 • . . . Interstitial rrononuclear cell infiltration ..•.•.•...... . . . . . . • . . . . . . . . . . . . . . . 1 Granulanatous reaction around micrcliths ........•.•..•. l • • • • • • • • • . . . • • • 3 • • • . . .

LIVER •••••••••••••••••••••••••••••••••••••••••••••••••••• NNNN+NNNNN+N+NNNNNNNNNN Hepatitis ...••..•.•.••..••.•.•.•.•...•.••.••.•...•.•..• . . . . . . l . l . Extramedullary haemopoiesis •••........••.••...•.•..•..• l

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

OVARY • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • N •

UTERIJS • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • + . Luminal dilatation . . • . • . • . . . • . . • . . . • • . . • . . • . • . . . . . . . • . . 2 • Involution. implantation site/s •.•..•.••.•..••..•...••• X.

V.AGINA ••••••••••••••••••••• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • + • Luminal dilatation . • . • • . . . • . . • • . • . • . . • . . . . . . . . . . . . . . . . . 4 .

("'") -! r ........

"0 ........

0""' 0.0 .....

,_. w ..... U1

KEY: MJBPHOLOGY SEVERITY NJT RECORDED l mi.niiml

N N.A.D. 2 slight 0 MISSJN:; 3 IIJJderate + MJRPHOLCGY PRESENT 4 marked X NJ SEVERITY

PAC910-04/02

-I ""' ........

"'0 ...........

0

......

.....

"'

w ...... ""

PEROll.OROETHYLENE: 11JLTIGENERATION IN!lALATION STUDY IN THE RAT

INDIVI!XlliL .ANlMAL DATA SUPPLEMENT

APPENDlX 25A

MICROSCOPIC PATHOLOGY CROSS l1EFERE!a - Fl. GENERATION


OOSE LEVEL: 100 SEX: MALE ppn 5 5 6 6

2 6 3 4

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

KII:NEY • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • .. • • .. Chronic progressive glanerulonephropathy • • • • • • • • • • • • • • •

+ . 1 .

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

+ • 1 .

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

+ + N N 1 1 . .

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

TESTIS ••••••••••••••••••••••••••••••••••••••••••••••••••• NNNN

KEY: MJRPHOLOGY SEVERITY NOT RECOJIDED 1 mJnima1

N N.A.D. 2 slight0 MISSOO 3 m:xlerate + MJRPHOLOGY PRESENT 4 marked X ID SEVERITY

''--'

.~

~ ~

PAC910-04/02

PEilCHLOBDETIM..ENE: MIJLTIGENERATION INHAI.JITION STUDY IN TBE RAT

INDlVIIJIJl\L /INII1AL JlliTA SUPPLEMENT

APPENDIX 25A

MICROSCOPIC PATHOI..OOY CROSS RE:FERilOCE - F1 GENERATION


OOSE LEVEL: 100 SEX: E'.EMALE ppn 8

0

CERVIX................................................... N M/>M1IIRY GLAND .. • .. .. • .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. N

OVN.ri .................................................... N

UTERUS................................................... N V.IIGINA • • • • • • • • • • • .. • • • • • • • • • • • .. • • • .. • • • • • • • .. • • • • • • • • • • • N

(""") ~ r ........., ....... ""' 0 \0.....,

..... w....., .....,

KEY: MJRPHOI..OOY SEVERITY NJT RElXlRDED 1 m:iltimal

N N.A.D. 2 slight0 MISSOO 3 mxlerate + MJRPHOI..OOY PRESENT 4 nw:ked X NJ SEVERITY

roSE LEVEL: 300 SEX: MALE 111111111111111111111 Jl!lll 9 9 9 0 0 0 0 0 0 0 0 0 0 1 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 6 7 8 9 0

EPIDIDOOS .••••...••••...•••••••..••••.•••.•.••••.•...••• N •.•.••••.. N •.•• N .•..••• Ia.Il-tEY • 0 ••• 0 0 0 • 0 •• 0 • 0 0 ••••••••• 0 0 0 •• 0 • 0 • 0 ••• 0 0 0 0 0 •.•• 0 ••••

Unilateral hydronephrosis ............................. .Chronic progressive glaretulanephropathy .•.•.•.....••..l-2seJ:lC11yiiE1. tmrur .••....••.••••••.••••...•.•••••••.•••

++++++N+++++++++++++N+++ • 0 0 1 . . 0 • • • 0 • • 0 • • 0 • • • • • • 2 111211.1112111111111.111 • • X • • . . . • . . • . . • • • • . . • • • .

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

N+NN+N+++NN++N+++NNN++N+ .1 •• 1.121 .. 11.111 .•. 11.1

PROSTATE GLAND .......................................... . N. • N • • N • ~ VESICLE . • • . • • • • . . . • • . • . • • • • • . • . • • • . • • • . • • . • • . • • • • N • • N • • N •

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

PAC910-04/02

PERCHLOROETilYLENE: MDLTIGENERATION INHAIJillON STUDY IN THE RAT

INDIVIOOAL ANIMAL lli\TA SUPPLEMENT

APPENDIX 25A

MICROSCOPIC PATHOLOGY CROSS REFEREN:::E - Fl. GENERATION

REMJVAL REASON: 'l'EBMrnAL

("") -< ....... ' -o .........,. 0 1.0 .....

.....

....."" CXl

KEY: MJRPHOLOGY SEVERITY I'm RECORDED 1 miniinll

N N.A.D. 2 slight0 MISSJN:; 3 m:xlerate + MJRPHOLOGY PRESENT 4 DBrl

PAC910-04/02

PERCHI.OROETIIYLENE: MULTIGENERATION INHAI..ATION STUDY IN THE RAT

INDIVIOOAL ANIMAL DATA SUPPLEMENT

APPENDIX 25A

MICROSCOPIC PATHOLOGY CROSS REFERE!K:E - F1. GENERATION


DJSE LEVEL: 300 SEX: FThiALE 111111111111111111111 ppn 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4

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

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

ICII:NEY .................................................. . +++++++++++++++++++++ Chronic progressive glCJJerulanephropathy ••••••.•••••••. • 1 ... 1.1 ...• 11 ..•. 1 •• IntratubUlai microlithiasis .•.••.........•...•.•.•...•. 111211121221112111111 1\Jbular basophilia .................................... . 1 . Granul011atous reaction around microliths ......•..•...•. • 2 . 1

M.AM1ARY GU\ND ............................................ . N .

fNNIT ..................... . 0 . • • • .. • • • • • • • • • • • • .. • • • • • • • • • • • •

UTERUS .................................................. . . 0 .

VAGINA .................................................. . . 0 .

C""') -1 r .......

"'0 ....... ..,. 0 'D ......

..... w ...... 'D

KEY: MJRP!IOLOGY SEVERITY NOT RECORDED 1 mirUmal

N N.A.D. 2 slight 0 MISSING 3 m:xlerate + MJRPHOLOGY PRESENT 4 tmrked X N:J SEVERITY

PAC910-04/02

PERCHLORDETHYLENE: MULTIGENERATION INHALATION STUDY IN '!'BE RAT

INDIVIDUAL ANIMAL Jl.\TA SUPPLE!1ENT

APPENDIX 25A

MICROSCOPIC PATHOLCGY CROSS ~ - F1. GENERATION


IOSE LEVEL: 1000 ppn

SEX: MALE 11111111111111111111111 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 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 4 5 6 7 8

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

KIDNEY ••••••••••••••••••••••••••••••••••••••••••••••••••• Chronic progressive glCllErulanephropathy ....•••.•...•.• IntratubUlai microlithiasis ••..•••...•....•••.......•.•Increase in nuclear plecmorphism ••••••••.•.•••••.••..••

+++++++++++++++++++++++ 11122121111111111.11111 . . . . . . . . . . . 1 . . . . . . . . . 1 . 11111111111111111111111

LIVE:R. •••••••••••••••••••••••••••••••••••••••••••••••••••• Hepatitis •.••..•.••••...•...••.. • ..•• · • · • • · • · • • · • · · · • · ·

NN+NNNNN+NNN+NNN+NN+NNN .2 ..... 1 ... 1 ... 1 .. 1 .

PROSTATE GUND •••••••••••••• • • • • ••••••• • • • • • • • • • • • • • • • • • • Prostatitis .••••••.•.••..••..•••..•.. · · · • · • · • • · · • · • • · • ·

.+ ••• +N+ ••• N ••• NN.

.1 ... 1.1 ..........

SEMrNliL VESICLE • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • L~,dj.latation •••.•.•••.•••.....•...••...•...•..•.• VesJ.culitis ......................................... · •.

N ••• +N+ ••• N ••• NN. • 4 • 4 • • • • •

. 2 . 2 . . . . . . . . . .

TESTIS ........................... 0 ,0 • 0 ••• 0 ••••••••••••••• .N ••• NNN ••• N ••• NN.

P.AC910-04/02

PERCHLOROETHYLENE: MULTIGENERATION lNHM..ATION STUDY IN TilE RAT

INDIVIDUAL AN:lMIIL Jlo\TA SUPPI..EMEm

APPENDIX 25A

MICROSCOPIC PATHOLOGY CROSS ~ - F1. GENERATION REMlVAL REASON: TEllMINAL

IXJSE LEVEL: 1000 SEX: FEMALE ll111lllllll11111111lJll2Il 6 7 7 7 7 7 7 7 7 7 7 8 8 8 8 8 8 8 9 9 9

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

CERVIX ....................................................... 0 •••• NO ••••• 0 ••••

Jai:NE:Y ................................................. .. +++++N++++NN+++++++++Chronic progressive glarerulonephropathy •........•..... 1211 ... 1.1 .. 1.1.1.1 ..IntratubUlar microlithiasis ......•...........••••...... 1 . 1 1 1 . 1 . 1 1 . . . 1 . 1 1 1 1 . 1Interstitial nononuclear cell infiltration ...•...•...•. . . . . . . . . . . . . . . . . . . . 1 .LIVER ......... • ••• • • • • • • • •.. • • • • • • • • • • • • • • • •·"' • •·'' ·' ·' NNNNNNNNNNN+NNNN+NNNNEXtramedullary haemopoiesis ...•.•....••........•.•...•. . .. 1 .... 1 .

MAM:1ARY GLAND ........................................... . + .... N .. . .. N . Diffuse hyperplasia ................................... . 1 OVAP.Y ................................................... . 0 .... NO ..... 0UTERUS .................................................. . 0 . . . N 0 .. . 0V/IGINA ••••••••••••••••••••••• • • • • • • • • .. • • • • • • • • • • • • • • • • • • .0 .... NO. . 0

("") -! r -...., ........,. 0....., ""

....w OJ ....

KEY': MlRPHOLOGY SEVERITY

OOT RECORDED 1 Jl1inlnW

N N.A.D. 2 slight

0 MISSim 3 lll:lderate

+ MJRPHOLOGY PRESENT 4 marked

X 00 SEVERITY

)

)

)

( )



APPENDIX 258

PATHOLOGY - Fl GENERATION

Key:

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

CTL/P/4097 - 1382

(

( )

("")-!...........'"0

0

......... 1.0....,

.....wcow

PAC900-05/ 02

PERCHLORDET!lYLENE: MULTIGENERATION lNHALATION STUDY IN THE RAT

INDIVI!XJAL ANIMAL IliiTA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - F1. GENERATIONANIMAL ID: 1 SEX: M DJSE: 0 ppn ON STUDY: 238 days (34 wks) TERMINAL

MACROPATHOLOGY Killed by Fluothane

THE FOILOWINJ TISSUES WERE SUEMI:Tl'ED

EPIDIDYMIS ; KirnEY ; LIVER ; PITUITARY GLIIND ; PROSTATE GLIIND ; SEMINAL VESICLE ; TESTIS ID ABIDllMALITIES WERE SEEN IN THE ANIMAL

MICROPATHOLOGY

TISSUE CHECK: TOTAL EXAMINED IDT EXAM MISSING NAD PRDTOOOL REX{UIRED 2 2 0 0 01m PROTOCOL (SUEMI:Tl'EDl 5 1 4 0 1(lm SUEMI:Tl'ED) 0 0 0 0 0

THE FOILOWINJ TISSUES WERE MARKED NAD

TESTIS

THE FOWJWIN::; MICROSCOPIC OBSERVATIONS WERE MADE

KirnEYChronic progressive glarerulanephropathy : (slight)LIVERHepatitis : (minimall

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

PAC900-05/02

PERCHLOROE'I'HYLENE: MULTIGENERATION INHALATION S'l'tJDY IN THE RAT

INDIVII:UAL ANIMAL DATA SUPPLEMENT

APPENDIX 25B


ANIMAL 00: 2 SEX: M OOSE: 0 Jl!lll ON S'l'tJDY: 235 days (34 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOI..LCJ~IDK; TISSUES VIEBE SUEMITTED

EPIDIDYMIS ; JGI:tlEY ; LIVER ; PITUITARY GU\ND ; PROSTATE GU\ND ; SEMINAL VESIClE ; TESTIS

NJ ABIDllMALITIES WERE SEEN IN THE ANIMAL

MJ:CROPATHOLOGY

('") --1 r........, ...... ""'0 ..... "' TISSUE alECK: TOTAL EXAMINED roT EXAM MJ:ss:rn:; Ni\1)

PROTOCOL REQUIRED roT PROTOCOL (SUEMITTED)

(roT SUEMITTED)

2 5 0

2 1 0

0 4 0

0 0 0

1 1 0

..... w CXl

""' THE FOI..LCJ~IDK; TISSUES VIEBE MARKED Ni\D

JGI:tlEY ; TESTIS

THE FOI..LCJ~IDK; MJ:CROSOOPIC OBSERVATIONS WERE MADE

LIVER Hepa ~ t'ti's . • (minimal) ------------------------------------------------------END OF ANIMAL---------------------------------------------------------------

·~ - .. \....-· '

P.AC900-05/02

PERCHLORDE:J'HYLENE: MIJLTIGENERATION INHAlATION S'IUDY IN THE RAT

INDIVIDUAL ANIMIIL JlliTA SUPPLEMENT

.IIPPENDlX 25B

PAT!fow:;y - F1 GENERATION

ANIM11L 00: 3 SEX: M !XlSE: 0 ppn ON S'IUDY: 236 days (34

("")

.......r...;

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

0

......

,_.

""

wCX>

"'

/

\_....

PAC900-05/02

PERCHLORDETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIOOAL ANIMAL J:IIITA SUPPLEMENT APPENDIX 25B

ANIMAL PATHOLOOY - Fl. GENERATIONN:l: 3 SEX: M OOSE: 0 ppn ON STUDY: 236 days (34 Wks) TERMINAL

MICRDPATHOLOOY

CONTINtiATION - THE FOLI.OWIN; MICROSCOPIC OBSERVATIONS WERE MADE

KII:NEYPelvic urolithiasis : (minimal ; unilateral)

LIVERHepatitis : (minimal)

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

-

PAC900-05/02

PERCHLORDET!!YLENE: MJLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIIXli\L ANlMAL JliiTA SUPPI..EMENT

APPENDIX 25B

PATHOLCGY - F1 GENERATION ANlMAL NO: 4 SEX: M OOSE: 0 ppn ON STUDY: 232 days (34 wksl TEilMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FO!..I..OWlN; TISSUES WERE SUEMlTTED

EPIDIDYMIS : I

P11C900-05/ 02

PERCHLOBDE'l'HYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIOOAL .1\NlMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOJ..(X;Y - Fl GENERATION

.1\NlMAL NO : 5 SEX: M DJSE: 0 ppn ON STUDY: 228 days (33 wks) TERMINAL

MACROPATHOJ..(X;Y

Killed by Fluothane

THE FOLLOWING TISSUES 'WERE SUEMI'l'l'ED

EPIDIDYMIS ; KII:mY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

NO ABNOllMALITIES 'WERE SEEN IN THE .1\NlMAL

MICRDPATHOJ..(X;Y

(""') -I,... ...... '"C ........,. 0 u::> ..... TISSUE CHECK: TOTAL EXAMINED NOT ElW1 MISSTil; NAD

PROTOCOL REl:1UIRED NOT PROTOCOL (SUEMI'!'l'ED)

(NOT .SUEMI'l'l'EDl

2 5 0

2 1 0

0 4 0

0 0 0

1

00 w -co co

THE FOLLOWING TISSUES 'WERE MARKED NAD

LIVER

THE FOLLOWING MICROSCOPIC OBSERVATIONS 'WERE MI\DE

KII:mY

Chronic progressive glarerulonephropathy : (mirUmal)

TESTIS

Unilateral tubular degeneration : (mirUmal ; focal)

-------------------------------------------------------END OF 1\NlMAL---------------------------------------------------------------

-. '-..../"---'

PAC900-05/02

PEBCHLOBDETHYLENE: M!JLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIIXJAL AN1MAL IliiTA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - Fl GENERATION AN1MAL 00: 6 SEX: M OOSE: 0 PJ:Ill ON STUDY: 239 days (35 wksl TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUEMITIED

EPIDIDYMIS ; KilllEY ; LIVER ; PITUITARY GLAND ; PBDSTATE GLAND ; SEMINAL VESICLE ; TESTIS

00 ABOORMALITIES WERE SEEN IN THE AN1MAL

MICROPATHOLOGY

("") -1 ..... ....... '"'0 ....... ""' 0

P.AC900-0S/02

PERCHLORDEI'IIYLENE: MULTIGENERATION lNHALATION STUDY' IN THE RAT

lNDIVIIXJAL iiNlMAL !lATA stJPPLl!MENT

APPENDlX 25B

PATHOLOGY - fl GENERATION iiNlMAL ID: 7 SEll:: M OOSE: 0 ppn ON STUDY': 238 days (34 M

PAC900-05/02


INDIVI!XlAL ANlMAL DATA SUPPLEMENT

APPENDIX 2SB

PA'lllOLOGY - Ji1. GENERATION

ANlM!IL NO: 8 SEX: M IXJSE: 0 ppn ON STUDY: 239 days (35 'MlEY ; LIVER ; PITUITARY GLAND : PRDSTATE GLAND : SEMINAL VESICLE : TESTIS

NO .ABNORMALITIES WERE SEEN IN THE ANlM!IL

MICROPA'lllOLOGY

(") -!........ ...... "" 0""' ...... '"" TISSUE CHECK: TOTAL EXAMINED NOT EXAM Missm:; NAD

PRDTOOOL REQUIRED NOT PRDTOOOL (SUFMITTED)

(NOT SUFMITTED)

2 5 0

2 1 0

0 4 0

0 0 0

1 l 0...... w

...... THE FOI.LOWIN; TISSUES WERE M!\RKEIJ NAD

LIVER ; TESTIS

THE FO!.LQWIN; MICROSOOPIC OBSERVATIONS WERE MllllE

KII't>lEY Chronic progressive glarerulanephropathy : (minimall

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

'""

PAC900-05/02

PERCHLOllDE'I'HYLENE' M!JLTIGENERATION IN!!AIATION STUDY IN mE RAT

INDIVIDUAL liNlMAL 11

-\

("") ......-..,-.....

0 v:> .....

..... w v:> w

PAC900-0S/02

PERCHLOROETHYLENE: MULTIGENE:RATION INHALATION STUDY IN THE RAT

INDI.VIOOAL ANIMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOI..CX;Y - fl GENERATION

ANIMAL NJ: 10 SEX: M DJSE: 0 ppn ON STUDY: 237 days (34 wks) Tm1INAL

MACROPATHOI..CX;Y

Killed by Fluothane

THE FOu.owm:: TISSUES WERE SUFMf.Tl'ED

EPIDIDYMIS ; :rarnE'l ; LIVER ; PI11JITARY GLAND ; PROSTATE GLAND : SEMINAL VESICLE ; TESTIS

NJ AB!!:lRMALITIES WERE SEEN IN THE ANIMAL

MICROPATHOI..CX;Y

TISSUE CHECK: TOTAL EX8MINED NJT EXAM MISSING NAD

PROTOCOL REQUIRED 2 2 0 0 0 NJT PROTOCOL (SUIMITl'EDl

(NJT SUIMITJ.'ED) s 0

1 0

4 0

0 0

1 0

THE FOu.owm:: TISSUES WERE MARKED NAD

TESTIS

THE FOu.owm:: MICROSCOPIC OBSERVATIONS WERE MIIDE

:rarnE'{ Chronic progressive glc:merulanephropathy : (lllin.imall

LIVER Hepatitis : (lllin.imal)

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

PAC900-05/ 02

PERCHLOROE'I'HYLENE: MIJLTIGENERATION INHALATION ST!JDY IN THE RAT

INDIVIWAL ANJMAL 1:>\TA SlJPPLEMENT

APPENDIX 2SB

PATHOLOGY - Fl. GENERATION ANJMAL NJ: ll SEX: M D:lSE: 0 ppn ON ST!JDY: 217 days (31 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE rou.owm:; TISSUES WERE SUJMI:'I'I'ED

EPIDIDYMIS ; KJ:J:m:Y' ; LIVER ; PITUITARY GLAND ; PROSTA'IE GLI\NlJ ; SEMINAL VESICLE ; '!ESTIS

NJ ABNJRMALITIES WERE SEEN IN THE ANJMAL

MICRDPATHOLOGY

("")

'""' r ....... ""0 .......

""' 0 "'...., TISSUE CHECK: TOTAL EXM1INED NOT EXAM MlSSlN3 NAD

PROTOCOL REQUIRED NOT PROTOCOL (SlllMI:'I'I'ED)

(NOT SUJMI:'I'I'ED)

2 5 0

2 1 0

0 4 0

0 0 0

0 1 0

..... w "' ""'

THE rou.owm:; TISSUES WERE MARKED NAD

'!ESTIS

THE rou.owm:; MlCRDSCOPIC OBSERVATIONS WERE MADE

KJ:J:m:Y' Chronic progressive glaiErulcmephropathy : (minimal)

LIVER Hepatitis : (minimal)

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

\.._.

·~ ~

PAC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION JNHAIATION STUDY IN THE RAT

INO:rvmJAL ANIMAL DATA SUPPLEMENT

APPENDIX 25B

PATHO!..CGY - F1. GENERATION

ANIMAL ID: 12 SEX: M !XlSE: 0 ppn ON STUDY: 238 days (34 wks) TERMINAL

MACROPATHO!..CGY

Killed by Fluothane

THE FOI..LOWIN:; TISSUES WERE SUEMI'ITED

EPIDIDYMIS : KIIX

PAC900-05/0Z

PERCHLOROET!M.J!NE: MULTIGENERATION INHALATION STUDY IN THE RAT

INDIVIWAL ANJMAL Jl.\TA SUPPLEMENT Al'PENDIX 25B

ANJMAL PATHOLCGY - F1 GENERATIONNO: 1.3 SEX: M lXJSE: 0 JllDl ON STUDY: 218 days (32 >ks) TERMINAL

MIICROPATHOLCGY

Killed by Fluothane

THE FOILCJWIN:; TISSUES WERE SUJM[TJE)

EPIDIDYMIS ; JCIJ:mY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SElilllAL VESICLE ; TAIL ; TESTIS

THE FOILCJWIN:; MIICROSOOPIC OBSERVATIONS WERE MADE

TAILKinked

NO AllroRMALITIES WERE SEEN IN THE REMAINING TISSUES

MICROPATHOLCGY

'""' .-i ...... "'0 ......... 0

..... ""

..... w 0'1

TISSUE CHECK: TOTAL EXAMINED NOT EXM1 MISS]}K; NAD

PROTOCOL REQUIRED NOT PROTOCOL (SUEM!TrED)

2 6

2 1

0 5

0 0

1 0

(NOT SUJM[TrED) 0 0 0 0 0

""

THE FOILCJWIN:; TISSUES WERE J.WU\ED NAD

JCIJ:mY

THE FOILCJWIN:; MICROSOOPIC OBSERVATIONS WERE MADE

LIVER

Hepatitis : (min:imll)

TESTIS

Unilateral tubular degeneration : (min:imll ; focal)

-------------------------------------------------------END OF ANJMAL-~--------------------------------------------------------------"

'-' ·

PAC900-05/02


INDIVIIXIAL liNlMIIL !lATA SUPPLEMENT

APPENDIX 25B

PATHOLOOY - F1. GENERATION

liNlMIIL NO: 14 SEX: M !XJSE: 0 ppn ON STUDY: 217 days (31 M

PAC900-05/02

PERCHLORDETHYLENE: MllLTIGENERATION INHAI..A1'ION STUDY IN THE RAT

INDIVIIXlAL .ANIMAL DATA SUPPLEMENT

.APPENDIX 25B

PATHOLCGY - Fl GENERATION

.ANIMAL NO: 15 SEX: M OOSE: 0 ppn ON STUDY: 230 days (33 wks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FQILCJWIN; TISSUES WERE SlJ!M['fTED

EPIDIDYMIS ; :KIIM:Y ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES WERE SEEN IN THE .ANIMAL

MICROPATHOLCGY

('") -i

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

TISSUE CHECK: TOTAL EXAMINED NOT EliAM MISSING NAD

PROTOCOL I1EQUIRED NOT PROTOCOL (SlJ!M['fTED)

(NOT SlJ!M['fTED)

2 5 0

2 1 0

0 40

0 0 0

01 0

.... w \0 co

THE FOILCJWIN; TISSUES WERE MARKED NAD

TESTIS

THE FOILCJWIN; MICROSCOPIC OBSERVATIONS WERE MI\DE

IaJl'.lEY

Chronic progressive glaJErulanephropathy : (slight)

LIVER

Hepatitis : (m:in:imal)

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

-~

'

P.AC900-05! 02

PERCHLOROETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIIXTAL ANIMAL DATA SUPPLEMENT

APPENDIX ZSB


ANIMAL N:l: 16 SEX: M IXJSE: 0 Jlllll ON STUDY: 256 days (34 hl

P.AC900-05/02

PERC!lLORDETHYLENE: MULTIGENERATION 1NHALATION STUDY IN THE RAT

INDIVIDUAL .ANn1\L DATA SUPPLEMENT

APPENDlX 25B

PA'l'HOL(X;Y - Fl. GENERATION .ANn1\L 00: 16 SEX: M OOSE: 0 ppn ON STUDY: 236 days (34 Wks) TEilMlNAL

MICROPA'l'HOL(X;Y

CONTINUATION - THE FO!..L(JW]N; MICROSCOPIC OBSERVATIONS WERE MADE

~ Pelvic urolithiasis : {slight ; unilateral)

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------("")

-

PAC900-05/02

PERCHLOROEI'HYLENE: MULTIGENERATION INHAUTION STUDY IN THE RAT

INDIVIIXIAL ANlM\L !lATA SUPPLEMENT

APPENDIX 25B

PATHou:x;y - Fl. GENERATION

ANlM\L 00: 17 SEX: M OOSE: 0 ppn ON STUDY: 229 days (33 wks) TERMINAL

MIICROPATHOu:x;y

Killed by Fluothane ; No live pups recorded at day 1 follcw.ing mating for C litter.

THE FOLLOWING TISSUES VlERE SUEMITI'ED

EPIDIDYMIS ; lClll>lEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

THE FOLLOWING MACROSCOPIC OBSERVATIONS WERE MADE

IarnEYPelvic dilatation : (slight)

00 AB!'KlllMALITIES VlERE SEEN IN THE REMAINING TISSUES

MICROPATHOu:x;y

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

PAC900-05/02

PERCHLORDETI:!YLENE: MIJLTIGENERATION INHAUTION STUDY IN THE RAT

INDIVIJX!AL ANIMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - F1 GENERATION

ANIMAL NO: 18 SEX: M OOSE: 0 Jl!ll1 ON STUDY: 234 days (34 ""-

PAC900-05/ 02

PERCHLOROEI'HYLENE: MIJLTIGENERATION lNHALATION STUDY IN TilE RAT

INDIVIDJAL AN1MAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLCX;Y - F1 GENERATION

AN1MAL 00: 19 SEX: M IXlSE: 0 ppn ON STUDY: 239 days (35 wks) TERMINAL

MIICROPATHOLffiY

Killed by Fluothane

TilE FQLLCJW]}K; TISSUES WERE SUOOTI'ED

EPIDIDYMIS ; ICI:LNEY : LIVER ; PITUITARY GLIIND ; PROSTATE GLIIND : SEMINAL VESICLE ; TESTIS

00 ABNORMALITIES WERE SEEN IN TilE AN1MAL

MICROPATHOLffiY

n -I,.... ........., .........,. 0 ...., "" TISSUE CHECK: TOTAL EXPMlNEil OOT EXAM MISSING NAD

PRD'IOCOL REQUIRED 2 2 0 0 0 NJT PRD'IOCOL (SUOOTI'EDl

(NJT SUOOTI'ED) 5 0

1 0

4 0

0 0

10

,_. ..,. 0 w

TilE FOLLCJW]}K; TISSUES WERE MARKED NAD

TESTIS

TilE FOLLCJW]}K; MICROSCOPIC OBSERVATIONS WERE MADE

ICI:LNEY Chronic progressive glarerulanephropathy : (min.inal.l

LIVER

Hepatitis : (min.inal.)

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

P.i\C900-05/02

PERCHLOROETIJYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

OOIVIOOAL ANlMAL DATA SUPPLEMENT

APPENDIX 25B


ANlMAL ID: 20 SEK: M OOSE: 0 ppn ON STUDY: 241 days (35 M

PAC900-05/02

PERCHLOROETIJYLENE: MIJLTIGENERATION lNHAI.ATION STUDY :rn THE RAT

INDIVIIXJAL AN.lMiiL IWrA SUPPLEMENT

APPENDIX 25B


AN.lMiiL NO: 2l SEX: M OOSE: 0 ppn ON STUDY: 240 days (35 wksJ TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FCJll.OW]}K; TISSUES WERE SUEMITTED

EPIDIDYMIS : ICI:I:NEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND : SEMrNAL VESICLE ; TESTIS

NO ABNORM.'\LITIES WERE SEEN :rn THE AN.lMiiL

MICROPATHOLOGY

("') ......'"0 --... 0 ...... "" TISSUE CHECK: TOTAL EXAMINED NOT EXM1 MISSJN:; NAD

PROTOCOL REQUIRED NOT PROTOCOL (SUEMITTED)

(NOT SUEMITTED)

2 5 0

2 1 0

0 4 0

0 0 0

0 1 0 ........

0 (.11

THE FCJll.OW]}K; TISSUES WERE MARKED NAD

TESTIS

THE FCJll.OW]}K; MICROSCOPIC OBSERVATIONS WERE MADE

ICI:I:NEY

Chronic progressive glarerulonephropathy : (slight)

LIVER

Hepatitis : (minirral)

-------------------------------------------------------END OF AN.IMIIL---------------------------------------------------------------

("")

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

.........,.0...,""

..,..... 0

"'

'~

'

PAC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION INil'AIMION STUDY IN THE RAT

INDIVIOOAL .ANlMiiL DI\TA SUPPLEMENT

.APPENDIX 25B

PATHOLOGY - fl GENERATION.ANlMiiL NO: 22 SEX: M OOSE: 0 ppn ON STUDY: 230 days (33 wks) TEFMINAL

MACROPATHOLOGY

Killed by Fluothane ; No live pups recorded at day 1 foll

PAC900-05/ 02

PERCHLORDETHYLENE: MULTIGENERATION IN!!AIMION STUDY IN THE RAT

INDIVIDUAL AN.IMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - Fl. GENERATION AN.IMAL NO: 23 SEX: M DJSE: 0 Jlllll ON STUDY: 240 days (35 M

PAC900-05/OZ

PERCHLORDE'IHYLENE: MJLTIGENERATION INI!t\LATION STUDY IN THE RAT


APPENDIX 25B

PATHOLOGY - Fl GENERATIONANIMAL NJ: 24 SEX: M IXlSE: 0 ppn ON STUDY: 231 days (33 wks) TEFMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOWJWIN:; TISSUES WERE SUBMITTED

EPIDIDJ:MIS ; KII:tlEY ; LIVER ; PITUITARY GUJID ; PROSTATE GUJID ; SEMINAL VESICLE ; TESTIS NJ .ABNJRMIILITIES WERE SEEN IN THE ANIMAL---------------------------------------

MICROPATHOLOGY

(""') -; r .......

"0 .......... 0

......"" TISSUE CHECK: TOTAL EXAMINED NJT EXAM MISSOO NAD PRDTCXXJL REQUIRED

NJT PRDTCXXJL (SUBMITTED)(NJT SUBMITTED)

2 5 0

2 1 0

0 4 0

0 0 0

010

..... ... 0 0:>

THE FOWJWIN:; TISSUES WERE MARKED NAD

TESTIS

THE FOWJWIN:; MICROSCOPIC OBSERVATIONS WERE MADE

KII:tlEY

Chronic progressive glcnerulanephropathy : (slight)

LIVER

Hepatitis : (minimal)

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

~

'

--------------

PAC900-05/ 02

PERCHLOROETI!YLENE: 11l.JLTIGENERATION lN!IALATION STUDY IN THE RAT


APPENDIX 25B

PATHOI..CGY - F1 GENERATION

ANIMAL 00: 25 SEX: F IXlSE: 0 ppn ON STUDY: 250 days (36 wks) TERMINAL

l1'!:ROPATHOI..CGY

Killed by Fluothane ; Failed to produce F2B litter.

THE FOWJWIN:; TISSUES WERE SUEMITTED

CERVIX ; KIDNEY ; LIVER ; M&MARY GLI\ND : CNAP:f ; PITUITARY GLI\ND ; UTERlJS : VAGINA

THE FOWJWIN:; l1'!:ROSOOPIC OBSERVATIONS WERE MIIDE

CERVIXDistended : l2mm diameter.

UTERlJS Implantation site/s present

NO ABNJBMALITIES WERE SEEN IN THE REMAINJN:; TISSUES

MICROPATHOI..CGY

C'"') ..... r..._ ..._" 0 ""' 1.0 .....

-0""' 1.0

TISSUE CHECK: TOTAL EXAMINED OOT EXAM MISSIN:; NAD

PRal'COJ~OOT PRal'COJL ( TTEDl (OOT SUEMITTED)

2 6 0

2 5 0

0 1 0

0 0 0

13 0

THE FQWJWIN:; TISSUES WERE MARKED NAD

CERVIX : See vagina for gross abnonmlity. : LIVER ; M&MARY GLI\ND ; OVAP:f

THE FQWJWIN:; MICROSOOPIC OBSERVATIONS WERE MIIDE

KIDNEY

Intratubular microlithiasis : (slight)

P.AC900-05/02


INDIVIIXIAL ANlMAL Jl.\TA SUPPLEMENT

APPENDIX 25B

PATHOLWY - fl GENERATION

ANlMAL NO: 25 SEll:: F DJSE: 0 ppn ON STUDY: 250 days (36 wks) TEFMINAL

MICRDPATHOLWY

CONTINUATION - THE FO:r..towm:; MICROSCOPIC OBSERVATIONS WERE MADE

KII:mY Granulanatous reaction around microliths : Cmin.inal)

1JTERIJS

Luminal dilatation : (slight ; tmilateral) Involution, :irrplantation site/s : (unilateral)

VAGINA

Luminal dilatation : (Ill9.tked)

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

n --1 ..... ..._ -o ..._ .1:> 0 \0 ......

-,_. .1:> 0

.~.

~·

PAC900-05I02

PERCHLORDETHYLENE: MULTIGENERATION INHAlATION STUDY IN THE RAT

INOIVIOOAL ANIMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - F1. GENERATION

ANIMAL 00: 26 SEX: F DJSE: 0 PJlll ON STUDY: 231 days (33 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUEMITI'ED

CERVIX ; lCill'lEY ; LIVER ; WM1ARY G!..AND ; OVAP:i ; PITUITARY G!..AND ; UTERUS ; VAGINA

THE FOLLOWING MACROSOOPIC OBSERVATIONS WERE MADE

UTERUS Inplantation site/s present

00 ABNORMALITIES WERE SEEN IN THE REMIIININ:; TISSUES

MICROPATHOLOGY

('")

-i,... .......

""0 .......... 0

l?AC900-0S/02

PEilCHLORDETHYLENE: MULTIGENERATION lNHAIATION STUDY IN THE RAT

INDIVIDUAL ANIMilL DATA SUPPLEMENT

APPENDIX 25B


ANIMilL 00: 27 SEX: F IXlSE: 0 ppn ON STUDY: 229 days (33 >k:s) TERI1INAL

MIICRDPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUEMI:TTED

CERVIX ; IGrnEY ; LIVER ; !1.AM1ARY G!.JIND ; OVPJ>.Y ; PITUITARY G!.JIND ; UTERUS ; VAGINA

THE FOLLOWING MIICRDSCOPIC OBSERVATIONS WERE MADE

UTERUS Implantation site/s present

00 ABOORMALITIES WERE SEEN IN THE REMAINING TISSUES

MICROPATHOLOGY

r; -l r.......

'"0 .......

.;. 0 \0...,

.....

.;. TISSUE CHECK: 'lDTAL EKAI1INED NOT EKAM MISSIN:; NAD

PROTOCOL llEQUIRED NOT PROTOCOL (SlJEMI:TTED)

2 6

2 0

0 6

0 0

10

(NOT SUEMI:TTED) 0 0 0 0 0

-"" THE FOLLOWING TISSUES WERE MIIRKED NAil

LIVER

THE FOLLOWING MICROSCOPIC OBSERVATIONS WERE MADE

IGrnEY Intratubular microlithiasis : (JJDdarate)

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

~ "'--•

PAC900-0S I02

PERCHI..OROEl.'HYLENE: MULTIGENERATION INHAlATION STUDY IN THE RAT

INDIVIW\L AN1M!IL lliiTA SUPPLEMENT

APPENDIX 25B

PATHOLCGY - F1 GENERATION

AN1M!IL NO: 28 SEX: F DJSE: 0 Jlllll ON STUDY: 229 days (33 wks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FOWJWING TISSUES WERE SUEMITI'ED

CERVIX ; KII:NEY ; LIVER : MliM1ARY GLAND ; OVARY : PITUITARY GLAND ; UI'ERIJS ; VAGINA

THE FOWJWING MACROSOOPIC OBSERVATIONS WERE MADE

UTERlJS Implantation site/s present

NO ABNORMALITIES WERE SEEN IN THE ~ TISSUES

MICROPATHOLCGY

('") -i r-'"0 -..,.-0 ....., ""

.......,. ..... TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NADPROTOCOL REQUIRED 2 2 0 0 1

NOT PROTOCOL (SUEMITI'EDl 6 0 6 0 0 (NOT SUEMITI'EDl 0 0 0 0 0

w

THE FOWJWING TISSUES WERE MARKED NAD

LIVER

THE FOWJWING MICROSOOPIC OBSERVATIONS WERE MADE

KII:NEY Intratubular microlithiasis : (minimal)

-------------------------------------------------------END OF ANlM!IL---------------------------------------------------------------

PIIC900-05/02

PERCHLOROET!IYLENE: MULTIGENERATION :INHALATION STUDY JN '!HE RAT

OOIVIJJUAL ANJMAL DATA SUPPLEMENT

APPENDIX 25B


ANIMAL NO: 29 SEX: F OOSE: 0 Jl!lll ON STUDY: 258 days (37 wks) TEFMlNAL

MACROPATHOLOGY

Killed by Fluothane

THE FO!.l.OWING TISSUES WERE SUE'MITI'ED

CERVIX ; KirnEY ; LIVER ; l1AM1ARY GLAND ; OVAPS ; PITUITARY GLAND ; UTERlJS ; VAGINA

'!HE FO!.l.OWING MI\CROSOOPIC OBSERVATIONS WERE MADE

UTERlJS ------------------------------------------------Implantation site/s present

NO ABNORMALITIES WERE SEEN JN '!HE REMAININ:; TISSUES

MICROPATHOLOGY

('"') .....,... ......., ...... 0 .... \0....,

.... .... .... TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NADPROTOCOL REQUIRED 2 2 0 0 0

NOT PROTOCOL (SUEMITI'ED) 6 0 6 0 0 (NOT Sill'MITI'ED) 0 0 0 0 0

....

THE FO!.l.OWING MICROSOOPIC OBSERVATIONS WERE M!1DE

KIJ:NEY Intratubular microlithiasis : !minimal)

LIVER

Ex:tranedullary haempoiesis : (minimal)

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

~

PAC900-05 I02.

PERCHLOIJDETHYLENE: MULTIGENERATION INHAlATION STUDY IN THE RAT

INDIVI!XlAL i1NI11!1L ll

PAC900-05I02

PERCHI..OROE'I'HYLENE: MULTIGENERATION INHALATION STUDY IN TilE RAT

INDIVIOOAL ANlMAL Jl.\TA SUPPLEMENT APPENDIX 25B

ANlMAL PATHOLCGY - F1 GENERATIONNO: 31 SEX: F roSE: 0 ppn ON STUDY: 225 days (33 wks) 'l'EFMINI\L

MACRDPATHOLCGY

Killed by Fluothane

TilE FOU1JW:rn:; TISSUES WERE SUJM[TTED

CERVIX ; KrOOEY ; LIVER ; !1Al4!i\RY GlAND ; r:NAPCI ; PITUITARY GlAND ; UI'ERlJS ; VIIGINA

TilE FOU1JW:rn:; MACROSCOPIC OBSERVATIONS WERE MADE

UI'ERlJS Implantation site{s present

NO ABNORMALITIES WERE SEEN IN TilE BEMAINJN3 TISSUES

MICROPATHOLCGY

('"') --!, ........

-c ..........,. 0 ...., ""

..,. -0'1

TISSUE CHECK: TOTAL EXAMINED N:lT EXAM MISSJN:; NAil

PROTOCOL REQUIRED N:lT PROTOCOL (SUBMiTTED)

(N:lT SUJM[TTED)

2 6 0

2 0 0

0 6 0

0 0 0

1 0 0

-TilE FOU1JW:rn:; TISSUES WERE MARKED NAil

LIVER

TilE FOU1JW:rn:; MICROSCOPIC OBSERVATIONS WERE 11!\DE

KrOOEY Intratubular microlithiasis : (minimal)

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

---,

~·

PAC900-05I02

PERCHLORDETHYLENE: MllLTIGENERl\TION INHAI..ATION STUDY IN THE RAT

INDIVIIXJAL ANIMAL J:l.\TA SUPPLEJ:1ENT APPENDIX 25B

ANIMAL PATilOLCGY - Fl GENER!\TIONNO: 32 SEX: F OOSE: 0 ppn ON STUDY: 230 days (33 Wks) TERMINAL

MACROPATilOLCGY

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUE!1ITI'ED

CERVIX ; I

("")-!,.........."'0........,.0....,""

.......,.

.....(X)

~~~

~

PAC900-0S/02

PERC!lLORDETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDJAL ANIMAL Jl.\TA SUPPLEMENT

APPENDIX 25B

PATHOLCGY - F1. GENERATIONANlMAL NO: 33 SEX: F DOSE: 0 ppn ON STUDY: 233 days (34 »ks) INl'ERCtlRRENT

!1\CROPATHOLCGY Killed by Fluothane ; Failed to produce F2A or F2B litter.

THE FOLJ..OloiOO TISSUES "WERE SUEMI'ITED

CERVlX ; KimEY ; LIVER ; l1t'M1

PAC900-05/02

PERCHLORDETI!YLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INOlVIDUAL ANIMIIL Il'\TA SUPPLEMENT APPENDIX 25B

ANIMIIL 00: PATIIO!JXY - Fl. GENERATION 33 SEX: F toSE: 0 ppn ON STUDY: 233 days (34 'M

PAC900-05/ 02

PERCHLORDE'I'HYLENE: MULTIGENERATION INHAIJmON STUDY IN THE RAT

INDIVIlXfAL ANIMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - Fl. GENERATION ANIMAL NO: 34 SEX: F !XlSE: 0 ppn ON STUDY: 227 days {33 M

P.AC9oo-os!02

PERCHLORDE'l.HYLENE: MULTIGENERATION INHALATION STUDY JN THE RAT

JNDIVI!JUAL ANIMAL WA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - Fl. GENERATION

ANIMAL 00: 35 SEX: F IXlSE: 0 ppn ON STUDY: 226 days (33 wks) TERMINAL

Ml\CRDPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES VlERE SUEMITI'ED

CERVIX ; KIDNEY ; LIVER ; MA!4!AAY GLAND : OVAFC! ; PITUITARY GLAND ; UTERUS ; Vl\GJNA

THE FOLLOWING Ml\CRDSCOPIC OBSERVATIONS VlERE I1ADE

UTERUS Inplantatian site/s present

00 ABOORMALITIES VlERE SEEN JN THE REMAINING TISSUES

MICROPATHOLOGY

(")

-I r .......

-c .......

""' 0

P.IIC900-05/ 02

PERC!lLOROE'I'HYLENE: MDLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDJAL ANil1AL MTA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - F1 GENERATIONANil1AL NJ: 36 SEX: F DJSE: 0 ppn ON STUDY: 247 days (36 M

PAC900-05I02

PERCHLORDEl'HYLENE: MULTIGENERATION INHAlATION STUDY IN THE RAT

INDIVID.IAL ANIMIIL DATA SUPPLEMENT iiPPENDIX 25B

PATHOLCGY - Fl. GENERATION

ANIMIIL 00: 37 SEX: F IXJSE: 0 Pflll ON STUDY: 221 days (32 ""=sl TERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FOLLOWIN; TISSUES WERE SUEMITI'ED

CERVIX ; KilX'lEY ; LIVER ; M.AM1!IRY GLAND ; OVAAY ; PITUITARY GLAND ; UTERUS ; VAGINA

THE FOLLOWIN; MACROSCOPIC OBSERVATIONS WERE MADE

UTERUSInplantation site/s present

00 ABOOBMALITIES WERE SEEN IN THE llEMAINING TISSUES

MICRDPATHOLCGY

("") .... r -.. "'C -...., 0 1.0 .....

,......, N TISSUE CHECK: TOTAL EXAMINED OOT EXAM Missm:; NAD

PROTOCOL REQUIRED 2 2 0 0 1 OOT PROTOCOL (SUPMITI'EDl

(OOT SUEMITI'ED) 6 0

0 0

6 0

0 0

0 0

w

THE FOLLOWIN; TISSUES WERE MIIRKED NAD

LIVER

THE FOLLOWIN; MICROSCOPIC OBSERVATIONS WERE MADE

KilX'lEY

Intratubular microlithiasis : (IIrinimll)

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

PAC900-05/02

PEBCHLORDETHYLENE: MULTIGENERATION J1lHAIMION STUDY IN THE RAT

INDIVIOOAL IINlMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLCGY - Fl. GENERATIONIINlMAL 00: 38 SEX: F lXlSE: 0 ppn ON STUDY: 208 days (30 wks) TERMINAL

MACROPATI!OLCGY

Killed by Fluothane

THE FO!l.OWIN3 TISSUES WERE SUEMITTED

CERVIX ; KIIM:Y ; LIVER ; Ml\t11ARY GLAND ; CNAJIT ; PITUITARY GLAND ; llTERIJS ; Vl\GINA

THE FO!l.OWIN3 MACROSCOPIC OBSERVATIONS WERE MADE

llTERIJS Implantation site/ s present

00 ABNORMALITIES WERE SEEN IN THE REMAlNIJ>K; TISSUES

MICROPATI!OLCGY

("") ...., r......., .......,. 0 ....., ""

.....,. N.,. TISSUE CHECK: TOTAL EX/>MINED OOT EXAM Missm:; NAD

PROTOCOL REQUIRED roT PROTOCOL (Sl.JEMtTTED)

(roT SUEMITTED)

2 6 0

2 0 0

0 6 0

0 0 0

000

THE FO!l.OWIN3 MICROSCOPIC OBSERVATIONS WERE MADE

KIIM:Y

Ommic progressive glmerulonephropathy : {rnl.ninal ; unilateral)

IntratubUlar microlithiasis : (inin.ilnal)

LIVER

Hepatitis : (lllinimll)

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

~/~

'-....>

PAC900-05/02

PERCHLORDErrlYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INOIVIIXIAL .ANlMI\L DA.TA SUPPLEMENT

APPENDIX 25B


.ANlMI\L NJ: 39 SEX: F DJSE: 0 ppn ON STUDY: 223 days (32 mcs) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWIN3 TISSUES WERE SUEMITI'ED

CERVIX ; KII:NEY ; LIVER ; M.AM1ARY GLtillD ; OV!IRY ; PITUITARY GLtillD ; UTERUS ; VAGINA

THE FOLLOWIN:; MI\CROSOOPIC OBSERVATIONS WERE MADE

UTERUSImplantation site/s present

NJ ABNJBMIILITIES WERE SEEN IN THE REMAI:N:liD TISSUES

MI:CRDPATHOLOGY

n -1 ..... -... -o -...

""" 0

PAC900-05/02

PERC!ll..OROETHYLENE: MULTIGENERATION lNHAJ.ATION STUDY IN THE RAT

OOIVIOOAL ANIMAL DATA SUPPLEMENT

APPENDIX 25B

P.ATHOLOGY - F1. GENERATIONANIMAL 00: 40 SEX: F IXJSE: 0 ppn ON STUDY: 222 days (32 'Wks) TERMINAL

MACROP.ATHOLOGY

Killed by Fluothane

THE FOWJWlNG TISSUES WERE SUOOTI'ED

CERVIX ; KIJ::tlEY ; LIVER ; ~ GLAND ; OVN!Y ; PITUITARY GLAND ; UTERUS ; VAGINA

THE FOWJWlNG MACROSCOPIC OBSERVATIONS WERE MADE


00 1\BOORMI\LITIES WERE SEEN IN THE REMAIN:nK; TISSUES

MICROP.ATHOLOGY

('"') ......-........., .........,. 0 \D .....

..,. -N 0'1

TISSUE C!JEXX: TOTAL EXAMINED OOT EXAM MISSING NAD

PROTCCOL REQUIRED OOT PROTCCOL (SUJM[TI'ED)

(OOT SUOOTI'ED)

2 6 0

2 0 0

0 6 0

0 0 0

l00

THE FOWJWlNG TISSUES WERE MARKED NAD

LIVER

THE FOWJWlNG MICROSCOPIC OBSERVATIONS WERE MADE

KIJ::tlEY Intratubular microlithiasis : (min.imal)

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

·~

PAC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION INHA!.IITION STUDY IN THE RAT

INDIVIru\1 ANIMAL DATA SUPPLEMENT APPENDIX 25B

ANIMAL PATHOLCX;Y - Fl GENERATION00: 41 SEX: F IXJSE: 0 Pfiil ON STUDY: 209 days (30 w!cs) TEilMlNAL

WICROPATHOLCX;Y

Killed by Fluothane

THE FOlLOWit'K; TISSUES VlERE SUEMITI'ED

CERVIX ; ICII:NEY" ; LIVER ; MllM1iiRY GLAND ; CNAP:Y ; PITUITARY GLAND ; UTERilS ; VAGINA

THE FOlLOWit'K; WICROSCOPIC OBSERVATIONS VlERE M\JJE

UTERilSIrrplantatian site/s present

00 ABNOFM\LITIES VlERE SEEN IN THE REl1!UN:rn:; TISSUES

MICRDPATHOLCX;Y

~ " r ........, .......

0 """ ...... ""

-N""" TISSUE CHECK: TOTAL EX/>MINED NOT EXAM MISSING NAD

PROTCCOL REX{lJIRED

OOT PROTCCOL (SUEMITI'ED)

2 6

2 0

0 6

0 0

1 0

(NOT SUEMITI'ED) 0 0 0 0 0

......

THE FOlLOWit'K; TISSUES VlERE M!IRKED NAD

LIVER

THE FOlLOWit'K; MICROSCOPIC OBSERVATIONS VlERE M\JJE

J.

PAC900-0S /02

PERCHLOROETHYLENE: MDLTIGENERATION INHALATION STtlDY IN THE RAT

INDIVIru\L ANlMAL IlA.TA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - fl GENERATIONANlMAL Ill: 42 SEX: F OOSE: 0 ppn ON STtlDY: 225 days (33 wks) TEilMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOlLOWJNG TISSUES WERE SUEMIITED

CERVIX ; I

P.i\C900-05/02

PERCI[.()ROETHYLENE: MOLTIGENERATION INHALliTION STUDY IN THE RAT

lNDIVIJXIAL ANJMAL Il!I.TA SUPPLEMENT

APPENDIX Z5B

PATHOLCX;Y - F1 GENERATION ANJMAL NO: 43 SEX: F OOSE: 0 ppn ON STUDY: 218 days (32 wks) TERMINAL

MIICROPATHOLCX;Y

Killed by Fluothane

THE FOu.QWm; TISSUES WERE SUFMITJED

CERVIX ; ICIINEY ; LIVER ; MAM1ARY GLAND ; OVAirf ; PITUITARY GLAND ; UTERUS ; VAGINA.

THE FOu.QWm; MIICROSOOPIC OBSERVATIONS WERE MIIDE


NO llllNOJJMALITIES WERE SEEN IN THE REMAINING TISSUES

MICROPATHOLCX;Y

(") -l

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

.... ""' N TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSIN:; NAD

PROTCCOL REQUIRED: NOT PROTCCOL (SUEMiTJEDl:

(NOT SUFMITrED) :

2 6 0

2 0 0

0 6 0

0 0 0

1 0 0

""

THE FOil.Qlolm; TISSUES WERE MABKED NAD

LIVER

THE FOu.QWm; MICROSCOPIC OBSERVATIONS WERE MIIDE

ICIINEY Chronic progressive glc:nerulonephropathy : (rnininal ; tmilaterall

IntratubUlar microlithiasis : (inln.liiE.l)

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

P.AC900-05/02

PERCHLOROETHYLENE: MULTIGENEBATION INHALATION STUDY IN THE RAT

INDIVIDUAL ANIMAL DATA SUPPLEMENT APPENDIX 25B

ANIMAL PATHOLCGY - Fl GENEBATIONNO: 44 SEX: F J:OSE: 0 pp;n ON STUDY: 232 days (34 wks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FOILOWIN:; TISSUES WERE SUFMI'l'l'Ell

CERVIX ; J.CirnEY ; LIVER ; MtiM1ARY GLAND ; OVPJ!.Y ; PITUITARY GLAND ; UTERlJS ; VAGINA

THE FOILOWIN:; MACROSOOPIC OBSERVATIONS WERE MADE

UTERlJSImplantation site/s present

NO ABNORMALITIES WERE SEEN IN THE REMAINING TISSUES

MICROPATHOLCGY

("") -;.-.... '""0 -.... 2:> \0 ......

......., w TISSUE CHECK: TOTAL EXAMINED NOT EKAM MISSliD NAD

PROTOC.OL REQUIRED NOT PROTOC.OL (SUFMI'l'l'Ell)

2 6

2 0

0 6

0 0

1 0

(NOT SUFMI'l'l'Ell) 0 0 0 0 0

0

THE FOILOWIN:; TISSUES WERE MARKED NAD

LIVER

THE FOILOWIN:; MICROSOOPIC OBSERVATIONS WERE MADE

KIJ:NEY Tubular basClph4lia : (minimal ; nultifocal)

Intratubular microlithiasis : (minimal)

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

.__

http:PROTOC.OLhttp:PROTOC.OL

P.AC900-05/ 02

PERCHLORDETHYLENE: MDLTIGENERATION INHALATION STUDY ill' THE RAT

lNDIVIlX!liL ANlWIL DATA SUPPLEMENT

APPENDIX 25B

PliTHOLCGY - Fl GENERATION

ANlM!IL !Kl: 45 SEX: F OOSE: 0 ppn ON STUDY: 210 days (30 wks) TERMINI\1

MACROPliTHOLCGY

Killed by Fluothane

THE FOILOWIN:; TISSUES WERE SUEMITI'ED

CERVIX ; KII:NEY ; LIVER ; MA!11ARY GLAND ; OVAPCI ; PITUITARY GLAND ; UTERIJS ; VAGINA

THE FOILOWIN:; MACROSCOPIC OBSERVATIONS WERE MADE


!Kl AB!KlllWILITIES WERE SEEN ill' THE ~ TISSUES

MICRDPliTHOLCGY

" -;........, ........, 0

...... "'

......, w TISSUE CHECK: EXPMINED !KlT EXAM MISSING NAD

PR01)JC()L REQUIRED !KlT PR01)JC()L (SIJ!'MLTI'ED)

(!KlT SUEMITI'ED)

2 6 0

2 0 0

0 6 0

0 0 0

1 0 0

rom ....

THE FOILOWIN:; TISSUES WERE M'IRKED NAD

LIVER

THE FOILOWIN:; MICROSCOPIC OBSERVATIONS WERE MADE

l

PAC900-0S/02

PERCHI.OROETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INDIVIIXJAL ANIMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - Fl GENERATION ANIMAL 00: 46 SEX: F DJSE: 0 ppn ON STUDY: 252 days (36 >

PIIC900-05/02

PERCHLOROETHYLENE: MULTIGENERATION INHAlATION STUDY. IN TilE RAT

INDIVIWAL ANIMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - Fl. GENERATIONANIMAL N:l: 47 SEX: F IDSE: 0 P1ID ON STUDY: 254 days (37 wksi TEFMINAL

MIICRDPATHOLOGY

Killed by Fluothane

TilE FOLLOWING TISSUES WERE SUEMITI'ED

CERVIX ; KII:NEY ; LIVER ; M.AM1ARY GUIND ; OVPJJY ; PITUITARY GUIND ; TAIL ; UTERilS : VAGINA

TilE FOLLOWING MIICRDSCOPIC OBSERVATIONS WERE MI\DE

TAIL Kinked

UTERilS Implantation site/s present

N:l ABNJRMALITIES WERE SEEN IN TilE REMAI:Nm; TISSUES

MICRDPATHOLOGY

n -< r..._ "'0 ..._.., 0 1.0.....,

......., w w

TISSUE CHECK: TOTAL EXAMINED NJT EXAM MISSm3 NAil

PROTOCOL REQUIRED 2 2 0 0 1 NOT PROTOCOL (SUPMlTI'ED) 7 0 7 0 0

(NOT SUEMITI'EDl 0 0 0 0 0

TilE FOLLOWING TISSUES WERE MARKED NAil

LIVER

TilE FOLLOWING MICROSCOPIC OBSERVATIONS WERE MI\DE

KII:NEY Intratubular microlithiasis : (rrrxlerate)

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

PAC900-05/02

PERCHLOROETHYLENE: M!JLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIlXJAL ANlMAL DATA SlJPPLEMENT .APPENDIX 25B

ANlMAL P.ATHOLCGY - Fl GENERATIONNO: 48 SEX: F OOSE: 0 ppn ON STUDY: 219 days (32 wks) TEFMINAL

MACBDP.ATHOLCGY

Killed by Fluothane

THE FOLLOWIN:; TISSUES WERE SUEMITI'ED

CERVIX ; KIJ:NEY ; LIVER ; M.AM1ARY GLAND ; CNPK'f ; PITUITARY GLAND ; tJ'I'ERIJS ; VAGINA

THE FOLLOWIN:; MACBDSCOPIC OBSERVATIONS WERE MADE

tJ'I'ERIJSImplantation site/s present

NO ABNORMALITIES WERE SEEN IN THE REMAINm:; TISSUES

MICROP.ATHOLCGY

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

...... '""

........, w TISSUE CHECK: TOTAL EXAMINED NOT EXAM MISSING NAD

PROTCCOL REQUIRED 2 2 0 0 1 NOT PROTCCOL CSUOOTI'ED)

(NOT SUEMITI'ED) 6 0

0 0

6 0

0 0

0 0

..,

THE FOLLOWIN:; TISSUES WERE MARKED NAD

LIVER

THE FOLLOWIN:; MICROSCOPIC OBSERVATIONS WERE MADE

KIJ:NEY Interstitial IIDrlOrl1lClear cell :infiltration : (m:inim9.1 ; focal ; unilateral)

Intratubular microlithiasis : (marked)

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

~.

"----'

P.AC900-05/02

PERCHLORDETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

OOIVIIXlAL AN"lMi\L !lATA SUPPLEMENT

APPENDIX 25B

PATHOLCGY - Fl GENERATION AN"lMi\L NJ: 49 SEX: M DJSE: 100 ppn ON STUDY: 224 days (32 wks) TERMINAL

M'\CRDPATHOLCGY

Killed by Fluothane

THE FQLJ..OWm:; TISSUES WERE SUEMITI'ED

EPIDIDYMIS ; KII:NEY ; LIVER ; PITUITARY G!.AND ; PROSTATE G!.AND : SEMINAL VESICLE ; TESTIS

NJ IIBNJRMALITIES WERE SEEN IN THE AN"lMi\L

-------------------------------------------------------END OF AN"lM!\L---------------------------------------------------------------

("') -l r-.. '"0 ...... ""' 0

----

PAC900-05/ 02

PERCffi..ORDEI'!IYLENE: MJLTIGENERATION INHAlATION STUDY IN THE RAT

INDIVIOOAL .ANIMi\L DATA SUPPI..EMENT

APPENDIX 25B

PATHOLOGY - Fl GENERATION .ANIMi\L NO: 50 SEX: M OOSE: 100 PJlll ON STUDY: 238 days (34 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOll.OWm; TISSUES WERE SUJMI'ITED

EPIDIDYMIS ; KJ::OOEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES WERE SEEN IN THE .ANIMi\L

-------------------------------------------------------END OF .ANIMI\L---------------------------------------------------------------

n -I

'....._ -c....._.., 0 1.0 ......

-.., w ""

-~

-~

PAC900-05/02


INDIVIOOAL ANIMAL DATA SUPPLEMENT APPENDIX 25B

ANIMAL PATHOLCGY - fl GENERATIONNO: 51 SEX: M OOSE: 100 ppn ON STUDY: 233 days (34 ""s) TERMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FOLLOWIN:; TISSUES WERE SU!'MITTED

EPIDIDYMIS ; I

---

l?AC900-05/02

l?ERCHLOROETHYLENE: MtlLTIGENERATION INIIALATION STUDY IN THE RAT

INDIVIIIUAL ANlMAL lliiTA SUPJ?LEMENT

APPENDIX 25B

l?.ATHOLOGY - F1 GENERATION

ANlMAL NO: 52 SEX: M !XlSE: 100 ppn ON STUDY: 218 days (32 wks) TERtilllAL

MACRDP.ATHOLOGY

Killed by Fluothane ; No live pups recorded at day 1 following mating for A litter.

THE FQu.owm; TISSUES 'WERE SUPMITTED

EPIDIDYMIS ; KII:NEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES 'WERE SEEN IN THE ANlMAL

MICROP.ATHOLOGY

("") .....,... ...... "'0 ...... ... 0 -------------...... "' TISSUE CHEX::K: TOTAL EXAMINED NOT EXAM MISSING NAD

PRO'l'(XX)L REQUIRED NOT PRO'l'(XX)L (SUPMITTED)

(NOT SUPMITTED)

0 7 0

0 6 0

0 1 0

0 0 0

0 30

..... a ex:>

THE FQu.owm; TISSUES 'WERE MARKED NAD

EPIDIDYMIS ; SEMINAL VESICLE ; TESTIS

THE FQu.owm; MICROSCOPIC OBSERVATIONS 'WERE MADE

KII:NEY

Chronic progressive glCIJErulanephropathy : (lllirilinal)

LIVER

Hepatitis : (lllirilinal)

PROSTATE GLAND

Prostatitis : !lllirilinal)

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

PAC900-05/02


INDIVIIXIAL ANlMliL Il!\TA SUPPLEMENT

APPENDIX 25B

P.ATrlOLOGY - Fl GENERATION

ANlMliL NO: 53 SEX: M OOSE: 100 ppn ON STUDY: 236 days (34 wksl TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWIN:; TISSUES WERE SUBMIITED

EPIDIDYMIS ; KirNEY ; LIVER ; PITUITl\RY GLIIND ; PROSTATE GLIIND ; SEMrniiL VESICLE ; TESTIS

NO ABNORM\LITIES WERE SEEN IN THE ANlMliL

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

(""')

.-1 ...... ......'"" .., 0 u::>.....,

......., w ""

PAC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE MT

INDIVIDUAL ANlMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOOY - Fl. GENERATION .ANlM!\L 00 : 54 SEX: M roSE: 100 pjDl ON STUDY: 239 days (35 wks) TERMINAL

MACROP.t\THOLOOY

Killed by Fluothane

THE FOLLOWING TISSUES WERE S!JI'MITTED

EPIDIDYMIS ; :KilM:Y ; LIVER ; PITUITARY GI..liND ; PROSTATE GI..liND ; SEMINAL VESICLE : TESTIS

THE FOLLOWING MACROSOOPIC OBSERVATIONS WERE MADE

:KilM:Y

Pelvic dilatation : (slight ; right)

00 ABOORMALITIES WERE SEEN IN THE REM11INING TISSUES

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

("")

.-i ........

'"tl ..........,. 0

....."'

.......,...,. 0

~

·.'-"

PIIC900-05/02.

PERCHLORDETHYLENE: MDLTIGENERATION INHALATION STUDY IN THE RAT

INDIVIIX!AL ANIMI\.L IWrA SUPPLEMENT

APPENDIX 2SB

Plll'HOLCGY - F1. GENERATIONANIMI\.L 00: 55 SEX: M !XlSE: 100 Jllill ON STUDY: 236 days (34 wksl 'l'EPMINAL

MACRDPlll'HOLCGY

Killed by Fluothane

THE rou.owm:; TISSUES WERE SUEMI'ITED

EPIDIDYMIS ; :KirnEY : LIVER : PITIJITJ\RY GLliNil ; PROSTATE GLliNil : SEMINAL VESICLE : 'IESTIS

00 ABOORMIILITIES WERE SEEN IN THE ANIMI\.L

-------------------------------------------------------END OF ANIMI\.L---------------------------------------------------------------

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

I

P.AC900-05/02

PERCHLOROETHYLENE: MULTIGENERATION INHAlATION STUDY ru THE RAT

INDIVIIX!AL ANlli\L lJ.A.TA SUPPLEMENT

APPENDIX 25B

ANlli\L PATHCJLCGY - F1 GENERATION00: 56 SEX: M IXlSE: 100 ppn ON STUDY: 240 days (35 Vlks) TERMINAL

MACROPATHOLCGY

Killed by Fluothane ; No live pups recorded at day 1 followJng mating for A litter.

THE FOlLOWING TISSUES 'WERE SUEMITI'ED

EPIDIDIMIS ; KJ:Il'lEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

00 ABNJRMALITIES 'WERE SEEN ru THE ANlli\L

MICROPATHOLCGY

C""l --t r -... "'C-.....,. 0 ....., "" TISSUE CBECK: TOTAL EXAMINED OOT EXAM MISSruG NAD

PRO'fOC,QL REQUIRED 0 0 0 0 0 l!m PRDTOOOL (SUEMITI'ED)

(l!m .SUEMITI'ED) 7 0

4 0

3 0

0 0

3 0

.... ..,. ..,. N

THE FOlLOWING TISSUES 'WERE MARKED NAD

EPIDIDYMIS ; SEMINAL VESICLE ; TESTIS

THE FOlLOWING MICROSCOPIC OBSERVATIONS 'WERE l1'IDE

_____PROSTATE ::::::~s______ . (minimal) ~-------------------------------------END OF ANlli\L---------------------------------------------------------------

. '

'--

P.AC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION IN!lAUTION STUDY IN THE RAT

OOIVIDJAL 1INIMI\L JlliTA SUPPLEMENT

APPENDIX 25B


1INIMI\L ID: 57 SEX: M OOSE: 100 ppn ON STUDY: 240 days (35 wks) TERMINAL

WICROPATHOLOGY

Killed by Fluothane

THE FQI..LOWIN:; TISSUES "WERE SU!!MITI'ED

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

THE FQI..LOWIN:; WICROSOOPIC OBSERVATIONS "WERE MADE

KIDNEY Pelvic dilatation : (slight)

ID ABIDRMIILITIES "WERE SEEN IN THE REMA:INm:; TISSUES

-------------------------------------------------------END OF IINIMI\L---------------------------------------------------------------

n -i, .......

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

..... ""

.......,.., w

PAC900-0SI02

PERCHLOROETHYLENE: MDLTIGENERATION INHALATION STUDY IN THE RAT

INDIVI!Xfi\L ANIMAL DATA SUPPLEMENT APPENDIX 2SB

ANIMAL PATHOLOGY - Fl. GENERATIONNO: 58 SEX: M DJSE: 100 ppn ON STUDY: 15 days (3 wks) INTERCl1RRENT

MACROPATHOLOGY

Found dead

THE FOLLOWING TISSUES WERE SUEMI'ITED

EPIDIDIMIS ; KJ:JM:Y ; LIVER ; LlJI'l; ; PITUITARY GLliND ; PROSTATE GLliND ; SEMINAL VESICLE ; TESTIS THE FOLLOWING MACROSCOPIC OBSERVATIONS WERE MADE

LlJI'l;IJaJ:k

NO ABNOFMALITIES WERE SEEN IN THE REMAIN:lN3 TISSUES

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

("") .... ..... ...... "'0 ......... 0

.....""

.............

-~ .~-, -~

~

PAC900-05/02

PERCHLOBDETHYLENE: MULTIGENERATION INHALATION STUDY Til THE RAT

INDIVIOOAL ANlMAL Jl.\TA SUPPLEMENT

APPENDIX 25B


ANlMAL 00: 59 SEX: M DJSE: 100 ppn ON STUDY: 238 days (34 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOlLOWlN:> TISSUES WERE S!JEM[T'l'EO

EPIDIDYMIS ; KirnEY ; LIVER ; PITUITARY GLAND ; PBDSTATE GLAND ; SEMINAL VESICLE : TESTIS

00 ABOORMI\LITIES WERE SEEN Til THE ANlMAL

-------------------------------------------------------END OF ANIMAL---------------------------------------------------------------....'"' ........,' .........,. 0 .....,"'

.......,...,. t.T1

I

PAC900-05/ 02

PERCBLOROETHYLENE o MULTIGENERATION INHAU\TION STUDY IN THE RAT

INDIVIOOAL ANM\L DATA SUPPLEMENT

APPENDIX 25B

ANM\L PATHOLOOY - F1. GENERATION00• 60 SEX: M IOSEo 100 ppn ON STUDY: 235 days (34 wks) TERMINAL

MACROPATHOLOOY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUEMITTED

EPIDIDYMIS ; KII:m:Y ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

00 .ABOORMALITIES WERE SEEN IN THE ANM\L

-------------------------------------------------------END OF ANM\L---------------------------------------------------------------

('"')

.......r-1

.,.........,. 0

PAC900-05/ 02

PERCHI..OROE'l'HYLENE: MULTIGENERATION INHA!.JITION STUDY IN THE RAT

INDIVIIXIAL liNlMI\L Il!\TA SUPPLEMENT

APPENDIX 25B


liNlMI\L NO: 61 SEX: M toSE: 100 ppn ON STUDY: 240 days (35 ~s) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOILCJWIN:; TISSUES WERE SUEMITI'ED

EPIDID'iMIS ; KICNEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEM!NI\L VESICLE : TESTIS

NO ABNOBMALITIES WERE SEEN IN THE liNlMI\L

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

(""") -i r---o ...... 0 """ lO .....

...... """ ....."""

L

P.AC900-05/ 02

PERCH!.ORDET!IYLENE: MIJLTIGENERATION JNHAIATION STUDY IN THE RAT

INDIVIIX.TAL ANn1AL DATA SUPPLEMENT

APPENDlX 25B

PATHOLOGY - Fl. GENERATIONANn1AL NO: 62 SEX: M I:OSE: 100 ppn ON STUDY: 218 days (32 wks) TERMINAL

MIICRDPATHOLOGY

Killed by Fluothane

THE FOILOWIN; TISSUES WERE SUEMITTED

EPIDIDYMIS ; KirnEY ; LIVER ; PITUITARY GLAND ; PROSTATE GLAND ; SEMrNAL VESICLE ; TESTIS

NO .ABNORMALITIES WERE SEEN IN THE liNlM8L

-------------------------------------------------------END OF 11N.!M8L---------------------------------------------------------------

("") ..............,....... ~......"'

........i!i;

-~ ~-~

PIIC900-05/02

PERCHLOROETHYLENE: MIJLTIGENERATION INHALATION STUDY IN THE RAT

lliDIVIIXJAL ANJMAL DATA SUPPLEMENT APPENDIX 25B

PATHOLOGY - F1. GENERATION ANJMAL NO: 63 SEX: M !XlSE: 100 ppn ON STUDY: 239 days (35 wks) TERMINAL

MACROPATHOLOGY

Killed by Fluothane ; No live pups recorded an day 1 follcwing mating for A litter.

THE FOlLOWING TISSUES WERE SUEMlTTED

EPIDIDYMIS ; KIJ::NEY : LIVER ; PITUITARY GUIND ; PROSTATE GUIND ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES WERE SEEN IN THE ANJMAL

MICROPATHOLOGY

("") .............. "'C ........,. 0

,_

P.AC900-05/ 02


INDIVIOOAL ANIMAL 11 01.0 -------------.... TISSUE C!EK: TOTAL EXAMINED NOT EXAM MISSIN; NAD

PRDTCCOL REQUIRED 0 0 0 0 0NOT PRDTCCOL (SUBMITTED) 7 4 3 0 4(NOT SUBMITTED) 0 0 0 0 0..... .1'> t.l'l0

THE FOu.owm:; TISSUES WERE MARKED NAD

EPIDIDYMIS ; PROSTATE GLAND ; SEMINAL VESICLE ; TESTIS

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

---,

PAC900-05/02

PERCHLORDETHYLENE: MULTIGENERATION INHALtiTION STUDY IN THE RAT

INDIVIDUAL ANIMAL JliiTA SUPPLEMENT l\PPENDIX 25B

PATHOI..CGY - Fl GENERATIONANIMAL 00: 65 SEX: M IXJSE: 100 Jl!lll ON STUDY: 35 days (5 wksl IN'l'ERCURRENT

MIICROPATHOI..CGY

Killed by Fluothane

THE FOWJWING TISSUES WERE SUEMITI'ED

EPIDIDYMIS ; EYE ; I

---

L_

PJ\C900-05/02

PERC!ll.OROEI'HYLENE: MULTIGENERATION INHALATION STUDY IN TilE RAT

INDIVIIlUAL ANlMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - Fl GENERATION~NO: 66 SEX: M IXJSE: 100 ppn ON STUDY: 240 days (35 wks) TERMilW..

MACROPATHOLOG'l Killed by Fluothane

TilE FOll.OW:IOO TISSUES WERE SUPMI'l'I'ED EPIDIDYMIS ; KilllE'l ; LIVER ; PITUITARY' GLIIND ; PROSTATE GLliND ; SEMINAL VESICLE ; TESTIS NO ABNORMALITIES WERE SEEN IN TilE ANlMAL

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

('") -i,......"'0...... ..,01.0......

.......,tJ1

"'

~

PAC900-05/02

PERCHLO!lDETHYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

OOIVIDUAL ANJMAL DATA SUPPLEMENT

APPENDIX 25B

ANJMAL PATHOLCGY - F1 GENERATION

NO: 67 SEX: M OOSE: 100 ppn ON STUDY: 239 days (35 wks) TERMINAL

MI\CROPATHOLCGY

Killed by Fluothane

THE FOLI..OWIN:; TISSUES WERE SUEMI:'ITED

EPIDIDYMIS : ~ ; LIVER ; PITUITARY GLAND ; PllDSTA'IE GLAND : SElm!AL VESICLE : TESTIS

NO ABIDllMIILITIES WERE SEEN IN THE ANJMAL

-------------------------------------------------------END OF ANJMAL---------------------------------------------------------------"-i ' ...... -o ...... 0""'

P.i\C900-0SI02

PERCHLOB!lE'l.'llYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INDIVIIXIAL ANlMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOOY - Fl. GENERATIONANlMAL NO: 68 SEX: M OOSE: 100 P!Xfl ON STUDY: 235 days (34 wks) TERMINAL

MACRDPATHOLOOY Killed by Fluothane

THE FOWJWIN:; TISSUES WERE SUEMITI'ED

EPIDIDYMIS ; KII:NEY ; LIVER ; PI'IUITARY GUND ; PBDSTATE GUND ; SEMINAL VESICLE ; TESTIS NO ABNOBMALITIES WERE SEEN IN THE ANlMAL

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

~.......r

.::::.""'0!:8

....

t.T1""'""'

'

PAC900-05/02

PERCHLOBDETHYLENE: MULTIGENERATION INHALATION STUDY JN THE RAT

JNDIVIIXJAL ANlMAL ll'ITA SUPPLEMENT APPENDlX 25B

PATHOLCGY - E1. GENERATION ANlM8L 00: 69 SEX: M DJSE: 100 ppn ON STUDY: 226 days (33 ~s) TEBMINAL

MACROPATHOLCGY

Killed by Fluothane

THE FOILOW'lN3 TISSUES "WERE SUEMITI'ED

EPIDIDYMIS ; KIOOEY ; LIVER ; PITUITARY GLAND ; PBDSTATE GLAND : SEMINAL VESIClE : TESTIS

00 .ABNJBMALITIES "WERE SEEN JN THE ANlM8L

-------------------------------------------------------ENO OF ANlMAL---------------------------------------------------------------

(")

-.. -i

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

-t.n """ t.n

PAC900-05/02.


INDIVIJXlAL ANIMAL DATA SUPPLEMENT

APPENDIX 25B

PATHOLOGY - F1. GENERATIONANIMAL NO: 70 SEX: M IXlSE: 100 IJilll ON STUDY: 2.41 days (35 wks} TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOLLOWING TISSUES WERE SUEMI:Tl'ED

EPIDIDYMIS ; JCII:NEY ; LIVER ; PITUITARY GUIND ; PROSTATE GUIND ; SEMINAL VESICLE ; TESTIS

NO ABNORMALITIES WERE SEEN IN THE ANIMAL

-------------------------------------------------------END OF ANIMAL--------------------------------------------------------------- .......r n-1

"'tl....... .j:>0.._,""

....

.j:>01

"'

~·

PAC900-05/02

PERCHLORDETHYLENE: MULTIGENERATION INH&.ATION STUDY lli THE RAT

lliDIVIlXIAL ANlMIIL !lt\.TA SUPPLEMENT

APPENDIX 25B

PK!'HO!.CGY - F1. GENERATION

ANlMIIL ID: 71 SEX: M DJSE: 100 ppn ON STUDY: 218 days (32 >ksl TERMINAL

MACROPK!'HO!.CGY

Killed by Fluothane

THE FO!l.OWm:; TISSUES WERE SUEMITI'ED

EPIDIDYMIS l I

P.AC900-05/ 02

PERCHLOROE'I'HYLENE: MULTIGENERATION INHAl..ATION STUDY IN THE RAT

INDIVIIXIAL ANJMAL DATA SUPPLEMENT

APPENDIX 25B

ANJMAL PATHOLOGY - F1 GENERATIONNJ: 72 SEX: M IXlSE: 100 ppn ON STUDY: 239 days (35 M

'-

PAC900-05/02

PERCHLORDEI'HYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INDIVIDUAL .ANlli\L DATA SUPPLEMENT

.APPENDlX Z5B


.ANlli\L NO: 73 SEX: F !XlSE: 100 P!lll ON STUDY: 228 days (33 M

PAC900-05/02

PERCHLOROE'I'HYLENE: MULTIGENERATION INHALATION STUDY IN THE RAT

INDIVmlAL ANIMAL DATA SUPPLEMENT APPENDIX 25B

ANIMAL PATHOLOGY - F1. GENERATIONNO: 74 SEX: F OOSE: 100 ppn ON STUDY: 230 days (33 ""'s) TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FQJ..L(JW]N; TISSUES WERE SUEMI'l'I'ED

CERVIX ; KII:NEY ; LIVER ; M.AM1IIRY ruND ; OVNJY ; PITUITARY ruND ; UTERUS ; VAGINA THE FOJ..L(JW]N; MACROSCOPIC OBSERVATIONS WERE MADE


NO ABNOllMALITIES WERE SEEN IN THE REMAINING TISSUES

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

("") -1 r "0 --0""' .....

.....

"'

""' 0"'

~

'--'

P.I\C900-05/02


JNDIVIDJAL ANn1IIL DII1A SUPPLlliENT

APPENDlX 25B

PKI'HOLCGY - F1. GENERATION

ANn1IIL NO: 75 SEX: F OOSE: 100 P!lll ON STUDY: 230 days (33 wks) TERMINAL

11'\CRDPKI'HOLCGY

Killed by Fluothane

THE FOWJWJN:; TISSUES WERE SUEMITIED

CERVIX : KJJ:M:Y ; LIVER : Mli!11ARY Gl.

PAC900-05/02

PERCHLOROETHYLENE: MULTIGENERATION INHAlATION STUDY IN THE RAT

INDIVIlXTAL ANIMAL ll'.TA SUPPLEMENT APPENDIX 25B

ANIMAL PATHOLCX:;Y - Fl GENERATIONNJ: 76 SEX: F IXJSE: 100 ppn ON STUDY: 229 days (33 -.ks) TERMINAL

MACROPATHOLCX:;Y

Killed by Fluothane

THE FOlLOWING TISSUES WERE SUEMITIED

CERVIX ; KliNE¥ ; LIVER ; MAM1ARY GLAND ; OVARY ; PITUITARY GLAND ; UTERlJS ; VAGINA

THE FOlLOWING MACROSOOPIC OBSERVATIONS WERE MADE


NJ .ABNORMALITIES WERE SEEN IN THE REMAINING TISSUES

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

(""') -i r .......

"0 .......

0 ""' 1.0 ......

...... en ""' N

~.

'-'

PAC900-05/02

PERCHLORDETHYLENE: MULTIGENERATION INHALATION STUDY m THE RA:r INDIVIIX.!AL ANlMAL DATA SUPPLEMENT

APPENDIX 25B

ANlMAL PATHOLOGY - F1. GENERATION NJ: 77 SEX: F IXJSE: 100 ppn ON STUDY: 228 days (33 wksl TERMINAL

MACROPATHOLOGY

Killed by Fluothane

THE FOu.ow:m:: TISSUES WERE SUFMITTED

CERVIX ; KII:NEY ; LIVER ; l1A!11ARY GLIINIJ ; CNAE! ; PITUITARY GLIINIJ : Ul'ERlJS ; VAGINA

THE FOu.ow:m:: MACROSCOPIC OBSERVATIONS WERE MADE


NJ ABNJBMALITIES WERE SEEN m THE REMAINING TISSUES

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

("") -i,... ...... "0 ........,. 0

"" "

.......,. CTI

""'

PAC900-05/02

PERCH!.OROETHYLENE: MOLTIGENERAT.ION INHAlATION STUDY IN THE RAT

INDIVIDJAL ANIMAL DATA SUPPLEMENT APPENDIX 25B

ANIMAL PATHOLOGY - Fl GENERAT.IONNO: 78 SEX: F DJSE: 100 ppn ON STUDY: 230 days (33 wks) TEBMINAL

MACROPATHO!..OOY

Killed by Fluothane

THE FOLI..OWm:; TISSUES WERE SUEMI'ITEO

CERVIX ; KII:NEY ; LIVER ; MAM1I\RY GLAND ; rN.AAY ; PITUITARY GLAND ; UTERUS ; VAGINA

THE FOlLOWING MACROSCOPIC OBSERVATIONS WERE MADE

UTERUSImplantation site is present

NO ABNORMALITIES WERE SEEN IN THE REMAINlNG TISSUES

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

("") ..... r ...... -c ........,. 0

...... ""

,_...,. Ol..,.

.~ .~

PAC900-05/02

PERCHLORDETHYLENE: MIJLTIGENERATION INHAUTION STUDY IN 1HE RAT

INDIVIlXIAL ANIMAL D."-TA SUPPLEMENT APPENDIX 25B


ANlMIIL J:Kl: 79 SEX: F lXJSE: 100 P!lll ON STUDY: 36 days (6 wks) IN'l'ERCURBENT

MACROPATHOLOGY

Killed by Fluot.hane

1HE FOWJWING TISSUES WERE SUIMITTED

CERVIX ; EYE ; :Kil:X'lEY : LIVER : M.AM18RY GLAND ; NASAL CAVITY ; INNJY ; PITUITARY GLAND ; UTERUS ; VAGJNA

1HE FOWJWING MACRDSOOPIC OBSERVATIONS WERE M8DE

Documents

ZENECA CENTRAL TOXICOLOGY LABORATORY ALDERLEY P,ARK ... · · received zeneca central toxicology laboratory alderley p,ark macclesfield cheshire uk category b report (confidential)