Document gek0268qLJr9YRGkYxrkkNLa

Huntingdon STUDY NO. 96-4080 VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS Reproduction Study Unaudited Draft Final Report Volume III of III Submitted to: Chemical Manufacturers Association Chemstar Department 1300 Wilson Boulevard Arlington* Virginia 22209 Attn: Hasmukh C. Shah, Ph.D. Date: 5 May 1998 Page 1 BFG43139 BFG 003271 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Table of Contents Page I Draft Final Report Appendix Y Adult Animals Incidence Summary of Macroscopic Postmortem Observations Pi Generation............................................................................................................ 3 Pj Generation............................................................................................................ 7 Expanded Incidence Summary of Microscopic Postmortem Observations PA Generation..................... P2 Generation.................. 12 21 Individual Animal Postmortem Findings Pi Generation................. P2 Generation............... ................................................................. 31 271 Pupa Fi Pups Day 25 Weaning * External and internal Examination................................................510 Day 25 Weaning - External E vimjfui*on ............................................................ 518 F2 Pups Day 21 Weaning - External and Internal Examination.............,........... ,....... ,............ 526 Day 21 Weaning - External F .......................... ...............................534 BFG4314! BFG 003273 **'* PATk/1 OX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS OBSERVATIONS INCIDENCE SUMMARY $ TABLE INCLUDES: SEX-ALLiGRQUPtALliVEEKS-ALL DEATH-T.A.DiSUBSET-T ORGAN AND KEVWORD(S) OR PHRASE ----------- - *--*** ** TOP OF LIST ** ADRENAL GLANDS .............. AORTA ................................. BRAIN ................................. FEMUR ................................. FEMORAL HARROW .............. EPIDIDYMIDES ................... ESOPHAGUS ........ .............. NUHBER-0F - AN I MALS SEX: tT, ---MALE-GROUP: -1- . . _ -FFHAtF -* -------------- . 1. .___________N_U_M_B_E_R_ : 30 30 30 30 30 - w* -X- _ _ _ 30 _ 3. 0 3|( ........ NUMBER EXAMINED: 3D 30 30 30 3D 30 30 3 ........ NUMBER EXAMINED: 30 30 30 30 3D 30 30 3 30 30 30 30 30 30 30 3 ........ NUMBER EXAMINED: 30 30 30 30 30 30 30 3 ........ NUMBER EXAMINED; 30 30 30 30 30 30 30 3 ........ NUMBER EXAMINED: 30 30 30 30 0 0 0 ........ NUMBER EXAMINED: 30 30 30 30 30 34 30 3 EW fr O tfff EYES ................................... OPACITY HARDERIAN GLANDS .......... LACRIHAl GLANDS ............ ............... HEART ................................. ........ NUMBER EXAMINED: 30 30 30 30 30 30 30 3 1 2 00000 ........ NUMBER EXAMINED: 30 30 30 30 30 30 30 3 ........ NUMBER EXAMINED: 30 30 30 30 30 30 30 3 ........ NUMBER EXAMINED: 30 30 3D 30 30 30 30 3 KIDNEYS ............................. IRREGULAR SHAPE ENLARGED DILATATION CAlCUlUS(CALCULl) LIVER ................................. s NODUL(S)/HASS(ES) 2 LUNGS ................................. flUlD FILLED NOOULF(S)/MASS(FS) MtSfNTFRIC IN .............. ........ NUMBER fXAHINtO: 30 30 30 30 30 30 30 3 1 000 000 0i 00000 0i 11 212 00 I 0000 ........ NUMBER EXAMINED: 30 30 30 30 30 30 30 3 0 I 00000 ........ NUMBER EXAMIHEO: 30 30 30 30 30 30 30 3 a000 I 00 0000 1 00 ........ NUMBER FXAMINID: 30 30 30 so 30 .10 30 3 s$ 0A> S Cl o LJ --Jo "* PATH/TOX SYSTEM OUTPUT *"* VINYL CHLORIDE COMBINED INHALATION TYO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDr IN CO RATS - ^ - U-y ... TABLE INCLUDES: . .------------- - ----- - ----------- - ---- ---- ---- -----OB-S-E--R--V--A-T--I-O--N--S----IN--C- -IDENCE SUMMARY ... - -- - *___ ___ r-^. __ N U H B E R 0 F - A N I M A SEXsALL;GROUP=ALL;WEEKS*ALL OtATH-T,A,D;SU0SET-T SEX: GROUP* -l- -2-" -2- -4- -1- -2- -3- ORGAN AND KEYWOftD(S) OR PHRASE NUMBER: 30 30 30 30 30 30 30 jejunum ......................................................................................... .. NUMBER EXAMINED: 30 30 30 30 30 30 30 ILEUM ............................................................................................. .. NUMBER EXAMINED: 30 30 3D 30 30 30 30 CECUM ............................................................................................. , . NUMBER EXAMINED: 30 30 30 30 3D 30 30 COLON ................................................................... .......................... .. NUMBER EXAMINED: 30 30 30 30 30 30 30 LOW COLON/RECTUM ....................................................................... .. NUMBER EXAMINED: 30 30 30 30 30 30 3o SEMINAL VESICLES ..................................... SMALL NUMBER EXAMINED. 30 30 30 10 0 0 D 0 1 00000 TfSTFS ........................................................................................... .. NUMBER EXAMINFD; 30 30 30 30 0 0 0 ENLARGED 0 I 0] 000 SMALL 00 1 D000 THYROID GLAND ............................................................................ ., NUMBER EXAMINED: 30 30 30 30 30 30 30 PARATHYROID GLS .................................................................... .. , .. NUMBER EXAMINED: 30 30 30 30 30 30 30 THYMUS ........................................................................................... .. NUMBER EXAMINED: 30 30 30 30 30 30 30 DISCOLORED 1 000 200 TONGUE ........................................................................................... ., NUMBER EXAMINED: 30 30 30 30 30 30 30 GINGIVA ......................................................................................... NUMBER EXAMINED: 30 30 30 30 30 30 30 TRACHEA .................................................................................... .. number examined: 30 30 30 30 30 .10 30 FLUID 0000 1 00 larynx ........................................................................................... .. NUMBER EXAMINED: 30 30 30 30 30 30 30 URINARY RIADOFR ........................................................................ DISTENDED CAiCUl US (CALCULI) NUMBER EXAMINED: 30 30 30 30 10 30 30 0 I 00000 00 1 0000 PRINTED: Z9-APR-9S PAM: 7 STUDY NUMBER: 964060A PATH/TOX* * * SVSTEH. OUTPUT VINYL CHIOS IDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY 5TUDV IH CD RATS OBSERVATIONS INCIDENCE SUMMARY w ni e eo UJ *n <n fc in *! <vi tn m tn It fO tn <n o ea O 5X 5M *-- e q c? C> -- o -- m in fn in rt M P3 m mO * fli o ff) (T) rt f*J /n F) F) in rt n nj rt m fn a c so o-- om in tn en ? (=5 m 0tn 0rt 9in f*> OO no o ep) on cmj m f**i r*n F) peso OaaO v a; at 4U Lt/kJ mw-aOiot. Po<d-* stX Q * f N V) i/i a W _j j < W _j o _i a o Lb tfl *--<H =^ K o E se tn w 4 Z o _i I>- _^1 tn UJ tn a V) z 4 O 4 *- t-- to VS - ^ Cb < Ul UVi U< A 4 U a a p. t C1-- UXJ o * : 4M ae 4o 2 4 cr tx s z UU_J < Q-- 4Z PM tn U&J 4 aX. u in bj 4. 4/1 O u aLltJ a <m s ae 4 b-- CC 4LU X H4 UiO--i Kii M--c?ia*lv (v--oJi o:ipt--On (5 LU -- X FG43l47 BFG 003279 TABLE INCLUDES: SEX-ALL;GRQUPALL;UEEKS*ALl OEATH-ALLiSUBSET-T ORGAN AND KEYWORD(S) Oft PHRASE *** PAlH/TQX SYSTEM OUTPUT *** VINYL CHLOR1UE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS OBSERVATIONS INCIDENCE SUMMARY --- > U M B E I ' 0 F - J N I M A ' SEX; -MALE-- -- -FEMALE' GROUP: -l- 3- -4* -1- -2- -3- NUMBER: 30 30 30 30 30 29 30 BFG43249 SEMINAL VESICLES .......................................................... SMALL . NUMBER EXAMINED: 30 30 30 30 0 0 0 1 0000 00 TESTES ............................................................................... SMALL ENLARGED son . NUMBER EXAMINED: 30 30 30 30 0 0 0 l 01 1 0 00 0001 0 0 D 00l00 00 THYR010 GLAND ................................................................ ............ . NUMBER EXAMINED: 30 30 30 30 30 29 30 PARATHYROID GLS ............................................................ . NUMBER EXAMINED: 30 30 30 30 30 29 30 THYMUS ............................................................................... TONGUE ............................................................................... TRACHEA ............................................................................. LARYNX ............................................................................... URINARY BLADDER ............................................................ UTERUS ............................................................................... IMPLANT SCARS - PRESENT IMPLANT SCARS - NOT PRESENT VAGINA ............................................................................... 2YMBAL'S GLANDS ............................................................ 03 LYHPH NODE ...................................................................... ENLARGED Cl ADIPOSE TISSUE .............................................................. N0DULE(S)/HASS(ES) O EXIREMITY ........................................................................ ee a HAIR ABSENT CONTINUED ON NEXT PAGE . NUMBER EXAMINED: 30 30 30 3D 30 29 30 . NUMBER EXAMINED: 30 30 30 30 30 29 30 . NUMBER EXAMINED: 30 30 30 30 30 29 30 . HUMBER EXAMINED: 30 30 30 30 30 29 30 . NUMBER EXAMINED: 30 30 30 30 30 Z9 30 . NUMBER EXAMINED: 0 0 0 0 30 29 30 0 0 0 0 25 24 21 00005 5 . NUMBER EXAMINED: 0 0 0 0 30 29 30 . NUMBER EXAMINED: 30 30 30 30 .10 29 30 . NUMBER EXAMINED: 30 30 30 30 30 29 30 1 00D0 0 0 . NUMBER EXAMINED: 30 30 30 30 30 29 30 000I 0 l . HUMBER EXAMINED; Jfl 30 30 30 30 29 30 Huntingdon Life Sciences Reproduction Study 96-4080 Page 11 Draft Final Report Pathology Report Expanded Incidence Summary of Microscopic Postmortem Findings Preface Appendix Y Key to Abbreviations 1> = Minimal 2> Slight 3> = Moderate 4 > = Moderately Severe 5> = Severe TL> = Total P> = Present VI = Unilateral B/ - Bilateral FALOPT " Fallopian Tubes BFQ43 Ml BFG 003283 to C> Oj 93 * O K> 90 (A *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE CQM0INEO INHALATION TWO-GENERATION REPRODUCTION AND OEVELOPNENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY TABLE INCLUDES; SEX-ALL;6R0UPpAU;SCREEN*ALL;EEILS*ALL DtATH-T(A,D;FIND-ALLiSUBSET-T SEX: GROUP; -- HUH 6 E A - 0 f - A N I H A --MALE-- __ . . -female- 1- QRGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 30 30 ** FROM PREVIOUS PAGE ** NOSE/TURfi SEC 1 ............................................................................... NUMBER EXAMINED: 30 0 0 30 30 0 0 -NASOLACRIMAL DUCT(S>: FREE ERYTHROCYTES U1 0 0 1 D 0 0 i> \ D 0 0 0 0 0 TL> l 0 0 1 0 0 0 --NASAL MUCOSA (RESPIRATORY): ACUTE/SUBACUTE INFLAMMATION 1 I 0 0 0 0 0 0 U> I 0 0 0 D 0 0 --ODONTOPATHY 1> 0 0 0 2 0 0 0 ?> I 0 0 0 0 0 0 U* 1 0 0 i 0 0 0 --NASAL MUCOSA (RESPIRATORY): GOBLET CELL HYPERTROPHT/HYPERPLASIA I> 0 0 0 0 D 0 0 ?> 0 0 ft 1 0 0 0 Tl> 0 0 0 1 0 0 0 NASOLACRIMAL DUCT(S): EOSINOPHILIC MATERIAL 1 0 U> 0 0 0 0 0 l 2 0 0 0 0 0 0 -NASAL LUMEN; FREE ERYTHROCYTES 2 0 TL> 0 0 0 0 0 0 0 1 1 0 0 0 0 -NASAL LUMEN: EXUDATE l> TL> 0 0 0 0 0 0 0 0 1 1 0 0 00 --NASAL MUCOSA (JUNCTION OF THERESPIRATORY/OLFACTORY MUCOSA) GLANDS DILATEO -NASOLACRIMAL DUCT(S):HUCQSA-SUBACUTE (CHRONICACTIVE)/ CHRONIC INFLAMMATION -NASOLACRIMAL DUCT: EXUOATE 1> tL> 0 0 0 0 0 0 0 0 0 0 0 0 0 6 2s- 0 TL> D 0 0 0 0 0 0 0 0 0 0 D 0 Z> TL> 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NOSE/TURB SEC 2 ............................. ............. NASAL LUHFM: FftfF ERYTHROCYTES A N CONTINUED ON NEXT PAfif ........ NUMBER EXAMINED: 1> 3> TL 30 2 0 2 0 0 Q 0 0 30 30 0l0 00 l 01 1 0 0 0 0 0 0 0 0 $ APPENDIX Y BFG43140 BFG 0Q327i BFG43155 PATh/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY S TABLE INCLUDES: SEX-ALL;GROUPAll:SCREEN-ALL;WEEKS-ALL DEATH=T,A1D;FIND-ALL;SUBSET-T -- NUH B E R - 0 F - A N 1 M A SEX: . ---------- ---HALE**- .... 'FEMALE- GROUP: -1- -2- 3* -4- *1- -2- -3- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 30 3D ** FROM PREVIOUS PAGE ** NOSE/TURfi $EC 3 ............................................................................... NUMBER EXAMINED: 30 D 0 30 30 0 0 -'NASOLACRIMAL OUCT: LYMPHOID HYPERPLASIA 1> 10 0 0 2 3 0 0 ?> 3 0 0 3 B 0 0 TL* 13 Q 0 5 16 0 0 --NASOLACRIMAL DUCT(S); MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION --NASAL MUCOSA (OLFACTORY): EPIIHELIUM-JNTRACYIOPLASMIC E0SINGPH1I !C MATERIAL -- NASAL MUCOSA (OLFACTORY): EPITHELIUM DEGf NFRAT |0N 1> 3 0 P 0 0 0 0 2> 2 0 D 0 0 0 a Tl> 5 0 0 0 0 0 0 1> 7 D D l? 13 0 0 2* 4 0 0 1 0a0 4> 0 0 0 1 000 TL> 11 0 0 14 13 0 0 1> [ 0 0 0 0 0 0 TL> l 0 0 0 0 0 0 --NASOLACRIMAL DUCKS): FREE ERYTHROCYTES 0002 200 2> 0 0 0 0 \ 0 0 TL> 0 0 0 2 3 0 0 --NASAL LUMEN; FREE ERYTHROCYTES --NASAL HUCDSA (OLFACTORY); BASOPHILIC MATERIAL l> 0 0 0 2 0 0 0 2 0 0 0 0 1 Q 0 3> 0 0 0 0 1 0 0 TL> 0 0 0 2 2 0 0 1> 0 0 0 1 1 0 0 Tl > 0 0 0 1 1 0 0 -NASAL MUCOSA (RESPIRATORY): BASOPHILIC MATERIAL 03 - NASAL LUMEN: INFLAMMATORY CELLS/CELL 0EBRI5 2 l> 1 0 0 0 a a 0 TL> 1 0 0 0 0 0 0 1' 0 0 0 0 0 0 0 Tt > 0 0 0 D 0 0 D oo IhPJ CO -J Huntingdon Life Sciences Reproduction Study 96-4080 Page 2 Draft Final Report Pathology Report Incidence Summary of Macroscopic Postmortem Findings Preface Appendix Y Key to Abbreviations LN Lymph Nodes GL, GLS - Glands TISS = Tissue FALOP T = Fallopian Tubes BFG43142 BFG 0032 *** PATH/10X SYSTEM OUTPUT *** VINYL CHIOHIOE COMBINED INHALATION TUQ*GENERAT!ON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS --- EXPANDED INCIDENCE SUMMARY S TABLE INCLUDES: SEX-ALL;GROUP=ALL;SCREEN-ALL;WEEK?-ALL DEATH=T,A,0;FEND-ALL;SUBSET*T ___ NUN B R - 0 F - A N 1 M A L S SEX; ---- - ""MALE--- .... .-- -FEMALE-GROUP; '1- -2" 3- -4' *1- -2- -3- -4 ORGAN/TlSSLff EXAMINED NUMBER: 30 30 30 30 30 30 30 3 ** FRDM PRFVJOUS PAGE ** UVER ................................................................................................ . NUMBER EXAMINED: 30 30 30 30 30 30 30 2 --HEPATOCYTE5; BASOPHILIC FOCUS 1 0 0 0 I 0a0 TL> 0 0 0 1 0 0 0 -HEPATOCYTES CEHTRILOBULAR: HYPERTROPHY 1 0 D IS 30 0 2 26 3 TL> 0 0 IS 30 0 2 26 3 BFG43157 --HEPATOCYTES: ACIDOPHILIC FOCUS 0D0I 000 TL> 0 0 0 l 0 0 0 --PELIQSIS HEPATIS l> Q 0 7 0 0 0 0 TL> 0 0 2 0 D 0 0 -MICROGRANULOMA 1> 0 0 0 0 0 D 1 TL> 0 0 0 0 0 0 1 KIDNEYS ........................................................................................... , NUMBER EXAMINED: 30 0 0 30 30 0 0 3 -U: PYELITIS,SUBACUTE I> 2 a 0 1 0 0 0 TLs* 2 0 0 1 0 D 0 --CORTEX: INFILTRATES.SUBACUTE I> 5 0 0 5 4 0 0 Tl > S 0 0 5 4 0 0 -DILATED TUBULfS \> I D D 1 1 0 0 TL> l 0 0 1 1 0 0 -MEDULLA: CYST -INTERSTITIAL NEPHRITIS SUBACUTE Cfl fl o --PELVIS DILATED o FONT 1 NUf D ON NEXT PA(it ' t-j l> 1 0 0 0 I a 0 TL> 1 0 0 0 l 0 0 0002 1 00 TL> 0 0 0 2 1 0 0 l> 0 0 0 1 1 0 0 a 0 00 0 i> I) 0 a 1 0 0 0 0 0 00 2 a a Tl > a 0 0 2 3 0 0 TABLE INCLUDES: SEXALL;GROUP-ALl;WEKS-ALL DEATH-T.A.OiSUBSET-T ORGAN AND KEYWORD!S) OR PHRASE PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AHO DEVELOPMENTAL TOXICITY STUDY IN CO RATS OBSERVATIONS INCIDENCE SUMMARY STUD -- NUNBER-OF - AN I HALS- 5tX; -MALt..............................FEMALE- GROUP: -1- -2- -3- -4- *1- -2- -3- i NUMBER; 3D 30 30 30 30 30 30 30 BFG43144 MEDIASTINAL LN .................................................. DISCOLORED EXAMINED: 30 30 30 30 30 30 30 30 000 1 0000 MAMMARY GLANDS .................................................. NODULE(S)/HASS{ES) EXAMINED; 30 30 30 30 30 30 30 30 0000 001 1 NERVE ..................................................................... ........................... NUMBER EXAMINED; 30 30 30 30 30 30 30 30 HOSC/TUftBINATES ................................................ ........................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 DVIDUCTS/FALOP T .............................................. EXAMINED: 0 0 0 0 30 30 30 30 OVARIES ................................................................. ........................... number EXAMtNED: 0 0 0 0 30 30 30 30 DISCOLORED-FOCUS(FOCI) 0000 000 1 PANCREAS ............................................................ .. ........................... NUMBER EXAMINED; 30 DISCOLORED 0 30 0 30 0 30 0 30 1 30 Q 30 0 30 0 PITUITARY GLAND ................................................ EXAMINED; 30 30 30 30 30 30 30 30 PROSTATE GLAND .................................................. ............................. NUMBER EXAMINED; 30 3Q 30 30 0 0 0 0 OISCOLOREO*ARA($) 000 1 000 0 SPINAL CORD ........................................................ ............................. NUMBER EXAMINED: 30 30 30 30 30 30 30 30 SALIVARY GLANDS ................................................ EXAMINED: 30 30 30 30 30 30 30 30 SKIN ...................................................................... SCAB(S)/SORE(S) HAIR ABSENT/THIN EXAMINED: 30 3D 30 30 30 30 30 30 1 000 0D00 00000D1 0 W SKELETAL MUSCLE ................................................ ............................. NUMBER EXAMINED; 30 30 30 30 30 30 30 30 a spleen .................................................................. ............................. NUMBER EXAMINED; 30 30 30 30 30 30 30 30 oou* STOMACH ................................................................ ............................. NUMBER EXAMINED; 30 DISCOLORED-FOCUS(FOCI) 0 30 0 30 0 30 0 30 0 30 0 30 1 30 I DUODENUM .............................................................. ............................. NUMBER EXAMINED: 30 30 30 30 30 30 30 .TO *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY S TABLE INCLUDES: SEX*ALL;GRQUPALL;SCREENALL;WEEKS=ALL DEATH-T,A.D;FIND-ALL;SUBSET*T ORGAN/TISSUE EXAMINED . NUMDE R- 0 F - AN I HAL5 GROUP: -1- -z- -3- -4- -l- -z- -3- -4 NUMBER: 30 30 30 30 30 30 30 3 -a - COAGULATING GL ........................................................................... .. NUMBER EXAMINED: 30 0 0 30 0 0 0 OVARIES ......................................................................................... .. NUHBER EXAMINED; 0 0 0 0 30 0 0 3 OVIDUCTS/FALOP T ...................................................................... .. NUHBER EXAMINED: 0 0 0 0 30 0 0 3 BFG 43159 UTERUS ........................................................................................... .. NUHBER EXAMINED; 0 0 0 0 30 0 0 3 --ENDOMETRIUM: BROUN PIGMENT \> 0 0 0 0 10 0 0 2> 0 0 0 0 I 0 0 TL> 0 0 0 0 11 0 0 * ENDOMETRIUM: HEMORRHAGE(S) l> 0 0 0 0 1 0 0 U> 0 0 0 0 1 0 0 --MYOMETRIUM: BROUN PIGMENT 1 0 Q 0 0 6 0 0 2> 0 0 0 0 6 0 0 1 3> 0 0 0 0 1 0 0 TL 0 0 0 0 13 0 0 2 --ENDOMETRIUM: INFILTRATES SUBACUTE l> 0 0 0 0 1 0 0 Tl> 0 0 0 0 1 0 0 --LUMEN: DILATED 0000Q 0 0 2> 0 0 0 0 0 0 0 TL> 0 0 0 0 a 0 0 -ENDOMETRIUM: GLANDS OILATED/CYSUC DILATION l> 0 0 0 0 D 0 0 TL> 0 0 0 0 0 0 0 VAGINA .......................................... . .. NUMBER EXAMINED; 0 0 0 0 30 0 0 3 --MUQC5A: HYERPKERATOSIS (CORN 1F1EO) CD 1> 0 0 0 0 0 0 0 TL> 0 0 0 0 0 0 0 2 Cl PITUITARY GLAND ........................................................................ ,,. NUMBER EXAMINtU: 30 --PARS INTERMEDIA: CVST(S) 1> 0 2> 1 0 0 0 0 30 30 00 1 00 0 0 0 0 D3 0 ftft CONTINUED ON NEXT PAGE t* Tl> l 0 0 0 1 0 0 U-> TABLE tNCLUOES: SEX-ALL;GR0UP-ALL;WEEKS-ALL 0EATH*T,A,0;SUe$T"T ORGAN ANO KEYWORD^) OR PHRASE "* PATH/TOX SYSTEM OUTPUT *** VINYL CHLOR10E COMBINED INHALATION TWOGENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS OBSERVATIONS INCIDENCE SUMMARY STUD ... n g m B E R - a F - A N 1 M A L S - SEX: --MALE --..... - - - - -FEMALE- -- GROUP: -I- -2* -3- -A- I* -2- -3' -4- NUMBER: 30 30 30 30 30 30 30 30 UTFRMS ......................................................................... ....................... NUMBER EXAHtNEO: 0 Q 0 0 30 30 30 30 IMPLANT SCARS - PRESENT 0 0 0 0 27 27 22 27 IMPLANT SCARS - NDT PRESENT 00 0 033Ai IMPLANT SITES NOT NOTED 0 00 0 000 1 VAGINA .................................................. ....................... NUMBER EXAMINED: 0 0 0 0 30 30 30 30 ZYHBAL'S GLANDS ...................................................... ....................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 ADIPOSE TISSUE ........................................................ ....................... NUMBER EXAMINED: SO 30 30 30 30 30 30 30 NDDUIE(5)/HASM$) 01 000000 Ft TDFMITY SWOLLEN HAIR ABSENT/THIN . . NUMBER EXAMINED: 30 30 30 30 30 30 30 30 0I 00 0000 01 00001 SWOLLEN DISCOLORED ................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 00 1 I 201 2 000 1 1 11 URETHRA ....................................................................... ....................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 ** END OF LIST BFG43146 09 a o hJ o-4c *" PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- - EXPANDED INCIDENCE SUMMARY Si TABLE INCLUDES: SEXALI;GRQUPAIL;SCREEN*ALL;EEKSALL DEATH-ALL;FIND-ALL;SU8SCTT ... NUN B E R - 0 F - A N I H A l s SEX: .... --MALE--- __ -FEMALE- -r -- GROUP; -1- -2- -3- -4- -1* * 2- *3- -4 ORGAN/TISSUE EXAMINED ** TOP OF LIST ** TRACHEA .................. NUMBER: 30 30 30 30 30 29 30 3 --B-- NUMBER EXAMINED: 30 0 0 30 30 0 0 3 -'OSSEOUS METAPLASIA NUMBER EXAMINED: 30 0 0 30 30 0 0 3 U1 0 0 1 0 0 0 tl> 1 0 0 1 0 0 0 P| V 1 VAM 1)1 AO 11A 11 1 B A 11 V M>Ml ,, W 1 ? 0 0 0 0 0 0 11 > 1 0 0 0 0 0 0 V Ii I MAi. f; I uAA . ,i I (.hAUkl( im \ AA*A> | .i* hi. ,'t ) i 0 0 0 0 0 0 1k 1 0 0 0 0 0 0 BFG43161 INM RSI l >iAA^Ti i rA j* , ; *> , 4M*A' ,,m 1 4 0 0 l 0 0 0 Tl 4 0 0 l 0 0 0 --PULMONART VtSSILS NlMlAl DtPOSlIlS) I> l 0 0 .1 0 0 D TL> 1 0 0 3 0 0 0 --ALVEOLAR HEMORRHAGE \> i 0 0 0 0 0 0 Tl> i 0 0 0 0 0 0 -PERIBRONCHIAL; LYMPHOCYTIC HYPERPLASIA l> 0 0 0 1 1 0 0 TL> 0 0 0 1 1 0 0 --HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) NUMBER EXAMINED: 30 3D 30 30 30 29 30 3 1> 30 11 IS 26 29 IS 23 3 2> 0 2 0 1 1 0 0 TL> 30 13 IS 29 30 15 23 3 -ACUTE/SUBACUTE INFLAMMATION 0 --NECROSIS. SINGLE CELL Cl ACIUUPHRK FOCUS o O'jJ ** CONTINUED ON NEXT PAGE hi l> 19 7 19 13 IS 8 7 1 2> 2 0 0 0 0 0 0 Tl > 21 7 19 13 IS 8 7 1 1 1 0 0 0 1 0 0 fL> 1 0 0 0 1 D 0 ]> 1 0 4 5 0 D 0 Tl * 1 0 4 5 0 0 0 TABLE INCLUDES: SEX-ALL;GROUP-ALL;VEEKS-ALL OEAlH>ALL;SUBSET-T QRGAN AND KEYUORO(S) OR PHRASE *4* PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS OBSERVATIONS INCIDENCE SUMMARY STU -- - NUM8ER-OF-ANIMALS- SEX: -- --MALf--- -- FEMALE-' GROUP; -1* -2- -3- -4- 1- - -2- -3- 4- NUMBER: 30 30 30 30 30 29 30 30 BFG43148 NERVE NUMBER EXAMINED 30 30 30 30 30 29 30 30 NOSE/TURBINATES 0VIDUCT5/FAL0P T OVARIES ............... PANCREAS ............. PITUITARY GLAND ENLARGED number Examined 30 30 30 30 30 29 30 30 NUMBER EXAMINED 0 0 0 0 30 29 30 30 NUMBER EXAMINED 0 0 0 0 30 29 30 30 NUMBER EXAMINED 30 30 30 30 30 29 30 30 NUMBER EXAMINED 30 0 30 0 30 0 .10 0 30 29 00 30 0 30 1 PROSTATE GLAND SPINAL CORD ___ NUMBER EXAMINED 30 30 30 30 0 0 0 0 NUMBER EXAMINED 30 30 3D 30 30 29 30 10 salivary glands SKIN ............... HAIR ABSENT/TH IN NUMBER EXAMINED 30 30 30 30 30 29 30 30 NUMBER EXAMINED 30 30 0 30 0 30 0 30 1 29 0 30 2 30 0 SKELETAL MUSCLE ......................................................................... . . . NUMBER EXAMINED: 30 30 30 30 30 29 30 30 SPLEEN ........................................................................................... ... NUMBER EXAMINED; 30 30 30 30 30 29 30 30 STOMACH ......................................................................................... ... NUMBER EXAMINED: 30 30 30 30 20 29 30 30 DUODENUM ....................................................................................... ... NUMBER EXAMINED; 30 30 30 30 30 29 30 30 JEJUNUM ......................................................................................... ... NUMBER EXAMINED; 30 30 30 30 30 29 30 30 a ILEUM .............................................................................................. ... NUMBER EXAMINED; 30 30 30 30 30 29 30 30 Ci CECUM ............................................................................................. ... NUMBER EXAMINED; 30 30 30 30 30 29 30 30 COLON ............................................................................................. ,.. NUMBER EXAMINED; 30 30 20 30 30 29 30 30 o IOW cotON/RECIUM ................................................. ................... .,. NUMBER EXAMINED: 30 30 30 30 30 29 30 30 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS MICROSCOPIC FINDINGS --- EXPANDED INCIDENCE SUHMARY S TABLE INCLUDES: SEX-ALLiQROUP"ALL;SCREfN-ALl:WEEKS-ALL DEATH-ALL;FIND*ALL;SUBSET-T -- NUM0ER-OF-ANJMAL5 SEX; --MALE -- -- -FEMALE- GROUP; -1- -2- - 3- -4- -1- -Z- -3- -4 organ;tis$ue examined NUMBER: 30 30 30 30 30 29 30 - J----*---------------------------------------------------- ------ ----------------- ---------------------------- i--------- -M- - -X i .d. a . ** FROM PREVIOUS PAGE " KIDNEYS ................................................................................... .......... NUMBER EXAMINED: 30 0 0 30 30 0 0 -- PELVIS: EPITHELIAL HYPERPLASIA 1* 1 0 0 0 0 0 0 l> I 0 0 0 0 0 0 TL* l 0 0 0 0 0 0 BFG43163 --PELVIS: MINERALIZED GRANULES \> 2 0 0 0 0 0 0 !L> 2 0 0 0 0 0 a --PELVIS: DILATED 1 001 000 TL l 0 0 1 0 0 0 --PYELONEPHRITIS 3* l 0 0 0 D 0 0 TL> l 0 0 0 0 0 0 --MINERALIZED GRANULES 1* 0 0 0 0 1 0 0 Z> 0 0 0 p 0 a 0 TL 0 0 0 0 I a 0 --PELVIS: FREE ERYTHROCYTES 1> 0 0 0 3 4 0 0 TL 0 0 0 3 4 D 0 TESTES .................................................................................... .......... NUMBER EXAMINED; ?9 --TUBULAR DEGENERATION 1 0 0 0 30 00 0 0 D 0 0 0 35 1 0 0 I 0 0 0 S> I 0 0 1 0 0 0 TL* 3 0 0 2 0 0 0 b f g G03i95 EPIDIDYMIDES ........................................................................ .......... NUMBER EXAMINED: 29 -ASPfflMIA 5* 1 0 0 a 30 01 a 0 0 0 0 a TL 1 0 0 i a 0 0 --HYPOSPERMIA 3> 1 D 0 0 0 0 0 TL> 1 0 0 0 a 0 PROSTATE GlAND ............................... ............. .................. .......... NUMBER EXAMINED; 30 --EDEMA 1> 2 TL 2 0 0 0 0 30 0I 01 Q 0 0 0 0 ** CONTINUED DN NEXT PAGE *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COM0JNEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS OBSERVATIONS INCIDENCE SUMMARY STL TABLE INCLUDES: $EX-ALL;GROUPALl;VEEK$'ALl DEATH-ALL;SLeSET-T ORGAN AND KEYUORD(S) OR PHRASE N UMBE R -0 F -AN IMALS SEX: --MALE----------- ---FEMALE--------- GROUP; -i- -3- -4* -1- -2- -3- -4- NUMBER: 30 30 3Q 30 30 29 30 30 ** FROM PREVIOUS PAGE ** EXTREMITY .................................................................. ....................... NUMBER EXAMINED: 30 30 3D 30 30 29 30 30 HAIR THIN 0 Q00 000 1 ** END OF LIST * CO Tl o 4- L*J O wMB O a tww 00 to 3 A Lo p\ W -*3 O o e w -4 PATH/TOX SYSTEM OUTPUT *** VINYL CHIOS IOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY S TABLE INCLUDES: SEXALL:GROUPAU:SCREEN=ALL;WEEKSALL DEATH-ALL;FlNO-ALL;SUBSET-T -- NUMBER-OF - ANIMALS SEX: ----------- MALE-------- --- ----FEMALE-------GROUP: -i- -2- -3- -4- -1- -z- -3- -4 ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 29 30 3 VAGINA ..................................................................................... ......... NUMBER EXAMINED; 0 0 0 0 28 0 0 3 -MUCOSA: HYPERKERATOSIS (CORNIFIED) 1> 0 0 0 0 3 0 0 Z> 0 0 0 0 1 0 0 TL 0 0 0 0 A 0 0 PITUITARY GLAND .................................................................. ........ NUMBER EXAMINED: 30 0 0 30 30 0 0 3 - PARS INTERMEDIA: CYST(S) 1> l 0 0 2 0 0 D TL> 1 0 0 2 0 0 0 -PARS DISTAL 15: CYSTS l> 0 0 0 I 00D U> 0 0 0 1 0 0 0 --PARS DISTAL IS : FOCAL HYPFRPUSIA l> 0 0 0 0 0 0 0 IL > 0 0 0 0 0 0 0 HAMHAOV Ri AMDS ....................................... ........... NUMBER EXAMINED: 26 0 0 25 29 0 0 3 .......... NUMBER EXAMINED: 0 0 0 0 0 0 0 NOSE/TUR0 SEC l .................................................................. ........... NUMBER EXAMINED: --NA5AL LUMEN: FREE ERYTHROCYTES \> 30 2 0 0 0 30 30 Ql 0 0 0 03 0 TL> 2 0 0 1 0 0 0 '-NASAL MUCOSA (RESPIRATORY): ACUTE/SUBACUTE INFLAMMATION 1> 1 0 0 1 0 0 0 a> 0 0 0 0 1 0 0 TL> 1 0 0 1 1 0 0 --NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES --NA50LACRIMAL DUCT(S): EOSINOPHILIC MATERIAL 1> 0 0D1 000 0000 0D 0 TL> 0 0 0 I 0 0 0 0001 Tl > 0 0 0 1 00n 0D0 --VOMERONASAL ORGAN: TREE ERYIhrOCYTFS ** CONTINUED ON NEXT PAGE 11 ^ l> 2 0 0 z 1 0 0 TL> 2 0 0 2 1 0 0 u> K) 03 2 u 00 4^ *** PATH/TOX SYSTEM OUTPUT * YlNYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY ST TABLE INCLUDES: SEX-ALL;GROUP"AIl;SCREEN*All;WEEKS"ALL DEATH-T,A.D;FIND-ALLiSUBSET-T ... MIH 0 e R - 0 F - A N I H A L S SEX: --MALE ---- ---FEMALE- GROUP: -I- -2- -3- -A- '1- -2- -3- -4 - ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 3D 30 30 ** TOP OF LIST ** TRACHEA ..................................................................................... -'MUCOSA: MUCOSAL GlANDS-OILATEO 30 0 0 30 30 0 0 30 2 0 00 0000 Tl> 2 0 0 0 0 0 0 0 LUNGS .......................................................................................... ........ NUMBER EXAMINED; 30 0 0 30 29 0 0 3D --CONGESTION 1 00 0 0000 TL> 1 0 0 0 0 0 0 0 -PULMONARY VESSELS: MINERAL DEPOSlT(S) 1> 2 Q 0 1 4 0 0 2 TL> 2 0 0 ) 4 0 0 2 --LYMPHOID CELL 1NFIITRATE(S)/AGGREGATE(S) l> 3 0 0 0 0 0 0 0 TL> 3 0 0 0 0 0 0 0 -INTERSTITIUM: MINERAL DEPOSiTfS1/OSSFOUS MFTAPIASIA 1? 1 U> 1 000 D00 0 00 0 0 000 -- PERIVASCULAR: EOEHA 1> 0 0 D 0 3 0 0 0 TL> 0 0 0 0 3 0 0 0 --HEMORRHAGE ALVEOLAR 2> 0 0 0 0 1 0 0 0 3> 0 0 0 0 1 0 0 0 0 0 0 0 2 00 0 -PERIBRONCHIAL: LYMPHOCYTIC HYPERPIA5IA 2> 0 0 0 0 3 0 0 0 TL> 0 0 0 0 3 0 0 0 -PNEUMONITIS INTERSTITIAL SUBACUTE Z? 0 0 0 0 1 0 0 0 H* 0 0 D D 1 0 0 0 --PERIVASCULAR/PERIBRQNCHIAL LYMPHOID CELLS \> 0 0 0 0 0 0 0 1 H> 0 0 0 0 0 0 0 1 NOSE/TURBINAtES .................................................................... ........ NUMBER EXAMINED: 0 0 0 0 0 0 0 0 N0SE/TUR8 SEC l ...................................... ........................... ........ NUMBER EXAMINED: 30 0 D 3D 30 0 Q 30 -- VOMOfiONASAL ORGAN: TftEE fRYTHHOCYTES 1' 3 0 TL> 3 0 0 0 1 ** CONTINUED ON NEXT PAGE *' *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWQ-GENtRATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS MICROSCOPIC flNOlNfiS -- EXPANOED INCIDENCE SUMMARY TABLE INCLUDES; SEX-ALL;GROUP=ALL;SCREEN-ALL;WEEKS-ALL DEATH*ALL:FIND-ALL;SUBSET-T ORGAN/TISSUE EXAMINED ** FROM PREVIOUS PAGE ** NOSE/TURB SEC 2 ............................................................ `-NASOLACRIMAL DUCT S ; FREE ERYTHROCYTES -- NUN 8 E r - a F - A N J H A SEX: - -- MALE---________ - 'FEMALE- GROUP: -i- 2- -3- -4- -1- -2- -3- NUMBER: 30 30 30 30 30 29 30 ------- -------------- * * -- - - -- -- NUMBER EXAMINED: 30 0 0 30 30 0 0 )> 2 0 0 2 2 0 0 2* 0 0 0 0 0 0 0 U* 2 0 0 2 2 0 0 -VOMERONASAL ORGAN: EOSINOPHILIC MATERIAL 1> 3 0 0 0 1 0 0 TL> 3 0 0 0 l 0 0 BFG43I67 --VOMERONASAL ORGAN; EXUOATE 1> 0 0 0 0 0 0 0 TL> 0 0 0 0 D 0 0 -NASOLACRIMAL DUCT; EXUDATE I> 0 0 0 1 0 0 0 3> 0 0 0 0 1 0 0 4> 0 0 0 0 1 0 0 Tl 0 0 0 1 2 0 0 NOSE/TURB SEC 3 ....................................... . --NASAL LUMEN; FREE ERYTHROCYTES NUMBER EXAMINED; 30 0 0 30 30 0 0 1> 1 0 D 1 0 Q D 2> 0 0 0 0 I 0 0 3> 0 0 0 1 0 0 0 TL> 1 0 0 2 1 0 0 EOSINOPHILIC MATERIAL LMIC l> a 0 0 3 7 0 0 TL> a a a 3 7 0 0 CHRONIC INFLAMMATION FIVE)/ 1- 2 0 0 0 1 0 0 Z> 0 0 a 0 1 0 0 4> 0 0 0 0 1 0 0 TL 2 0 0 0 3 0 0 03 --NASOLACRIMAL OUCT: LYMPHOID HYPERPLA5IA 3 1> 13 0 0 0 H 0 0 2> 0 0 0 0 2 0 0 3> 0 0 0 0 I a 0 TL> 13 0 0 0 11 0 0 Vtoo'Ji -NASAL HI/COSA (OLFACTORY): BASOPHILIC MATERIAL CONTINUED ON NEXT PAGE " O I> 2 0 D J 0 (] 0 TL> 2 0 0 1 0 0 0 *** PATH/tOX SrSfEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINOINGS --- EXPANDED INCIDENCE SUMMARY STUI TABLE INCLUDES: $X*ALL;GROUP*ALL;SCREEM-ALL;VEEKS-All OEATH-T,A,D;PlND-ALl;SUBSET-T -- NUHBL R - 0 F - A N 1 M A L S SEX: ..... --HALE--__ _ _ __ --FEMALE-- V GROUP: -1- -2- -3- -4- -1- '2- *3- -4- BFG 43154 ORGAN/TISSUE EXAMINED NUMBER: 30 ** FROM PREVIOUS PAGE ** NOSE/TURB SEC 2 --NASOLACRIMAL DUCT(5): NUMBER EXAMINED: INFLAMMATORY CflLS/CELL DEBRIS 1 TL> 30 -"NASOLACRIMAL DUCT(S): MUCOSA-SURACUTE (CHROMIC ACTIVE)/ CHRONIC INFLAMMATION 1> 1 2* I 3> Z Tl 4 --VOMORONASAL ORGAN: COSINOPHlLlC MATERIAL 1> 3 2> 1 TL> 4 --ODONTOPATHY !> 0 1 3* 2 TL> 3 30 30 30 0 0 30 00Q 001 000 001 0 00 0 00 0 D0 0 02 001 0 0I 0 04 30 30 30 0 00 00 10 10 20 00 20 00 10 00 10 30 30 -- 0 30 03 03 00 00 02 00 02 01 01 00 02 -'VOMERONASAL ORGAN: FRFf ERYTHROCYTES l> 1 0 0 0 3 0 0 3 TL> I 0 0 0 3 0 0 3 --NASOLACRIMAL DUCTfS): FRFE ERYTHROCYTES 1> 3 0 0 3 2 0 0 0 2> 2 0 0 0 3 0 0 0 TL S 0 0 3 5 0 0 0 --NASOLACRIMAL DUCT: EXUOATE I> 0 2> 0 TL> 0 000 000 000 0 0 01 10 0 1 10 0 2 -NASAL LUMEN: INFLAMMATORY CEUS/CELL DEBRIS & O --VOMERONASAL ORGAN: EXUDATE 1> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 I l> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 1 t0'J0 NOSE/TURB SEC 3 .................................................... . NIJMUFR FXAMINED: --NASAL HUC05A (RESPIRATORY): EPITHELIUM-INTRACYIOPLASMIC 1> LOSINOPHl.lt MATERIAL TL ** CONTINUED ON NEXT PAGE ** 30 1 1 0 0 0 0 30 30 0 0 14 0 0 14 0 0 3D 00 00 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY $ TABLE INCLUDES: $ EX-ALL;GROUP-ALL;SCREEN-ALLjWEEKS-ALl OEATH`ALL;EINq*ALL;SUflseT-T ... HUH B E ft - 0 F * A N I N A SEX: ----- MALE----- ----FEMALE- GROUP; *1- *2- 3- -4- -1- -2- -3- ORGAN/TISSUE EXAMINED NUMBER; SO 30 30 30 30 29 30 PREPUT/CLIT GL .................................................. ................ -INFLAMMATION, SUBACUTE 1 000000 1 000 Q00 TL> I 0 0 0 0 0 0 SKIN ....................................................................................... 00001 Q0 EXTREMITY ........ .............................................................. ............ NUMBER EXAMINED: D 0 0 0 Q 0 0 ADIPOSE TISSUE .................................................................. ............ NUMBER EXAMINED: 0 0 0 1 0 0 0 -ECTOPIC EPID10YMIS 3> Q 0 0 l 0 Q 0 TL> 0 0 0 l 0 0 0 ** END DF LIST ** BFG43169 CO <r> o u-i o BFG43156 *** PATH/IOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY STUE TABLE INCLUDES: SEX-AU,`GROUP-ALL; SCREEN-ALL;WCEKS-ALL DEATH-T,A,D;F1NO-ALL;SUBSET-T ___ N U H fi f R - 0 F - A N I M A L S SEX: GROUP: -I- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 30 30 30 V- - -- NOSE/TURB SEC 4 ................................................................................................... NUMBER EXAMINED: 30 0 Q 30 30 0 0 30 'NASAL LUMEN: FREE ERYTHROCYTES 1> 0 0 0 I 0 0 0 0 2> 1 0 0 1 1 0 0 1 TL> I 0 0 2 1 0 0 1 -NASAL MUCOSA {OLFACTORY): EPITHELlUM-iNTRACYTQPLASMIC EOSINOPHILIC MATERIAL 1> 9 0 0 IS 16 0 0 12 Z> 13 0 0 5 6 0 0 3 TL> 22 0 0 20 22 0 0 15 --NASAL MUCOSA (RESPIRATORY): EPlTHUIUM-tN1RACYTOPLASHIC EOSIN0PHUC MATERIAL l> 0 0 0 a 1 0 0 0 TL> 0 D 0 0 1 0 D 0 --NASAL MUCOSA (RESPIRATORY): BASOPHILIC MATERIAL 1> 3 0 0 0 1 0 0 0 IL> 3 U 0 0 1 0 0 0 --NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL 1> l 0 0 4 0 0 0 0 TL> 1 0 0 4 0 0 0 0 LIVER ............................................................................................................................ NUMBER EXAMINED: 30 30 30 30 30 30 30 30 --EXTRAMEDULLARY HEMATOPOIESIS 4 15 1 2 0 0 0 0 TL> 4 15 1 2 0 0 0 0 --ACUTE/SUBACUTE INFLAMMATION l> 16 2> 0 2> 0 TL 16 2 21 17 19 001 1 0 00 0 2 21 18 20 s 10 18 00 0 00 1 5 10 19 -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) 0 -CONGESTION fi -NECROSIS,COAGULATION ** CONTINUED ON NEXT PAGE ** 1> 21 10 16 ?> 5 3 1 TL> 26 13 17 1> 0 0 0 TL> 0 0 0 l> 0 0 0 4> 0 0 0 TL- 0 0 0 9 11 zo 0 00 9 11 20 0 00 0 a0 l i0 0 00 Z i0 9 20 0l 9 21 10 I0 00 01 01 o to to O U> > i *** PATH/TOX SYSTEM OUTPUT **' VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 1001 DATE OF DEATH: 04/28/97 SEX; MALE DOSE GROUP; 1 SACRIFICE STATUS. SCHEDULED. TERMINAL St STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TCXT COMMENTS / HISTOPATHOLOC EPlDIbYHlDEs MICRO: HISTOPATHQLOGtCAl COMMENT: >0N PRESENT LIVER .......................................................................................................................................................................................................... MICRO: -MINIMAL. MULTI-FOCAL -EXTRAMEDULLARY HEMATOPOIESIS 'MINIMAL, HUm-FOCAL -MINIMAL. MULT 1-FOCAL -AtUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES {NON-ZOf NOSE/TuRD SIC ? w I f U II NDSE/TuRR Sff 1 H | i S .i mosi> infip `.*1 4 1 J l*l H. 1 i.H! J'l"' HISTOPATHOlOGICAL COHMENT: ^INFLAMMATORY FOCI ASSOC W SINGLE CELL NECl \ (j( it NAS At l IJMfN [ [RYIHROCYTLS HA', At Will 0`,A I0tAUORY ) EPI THELiuH-iNTRi 1 J', INOPmI l K HA 1 ( P | Al AA', Al HU< O',A IO( A[ 108T \ IPI iMfL1JM- 1 NTR< L OS I NOP HI i l( AMRIAL *** ANIMAl MAS Q (.AOSS AillOilUl J 1 11 > *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS. LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1, PITUITARY GLAND. PROSTI SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "1-" INVASIVE, "X-" 01 WMtl O u> 05 O U\ 00 00 a iujj O *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FlNOINGS -- EXPANDED INCIDENCE SUMMARY STUI TABLE INCLUDES; SEX-ALL ;GROUP-AU;SCREEN-AlL;WEEKSALL DEATH-T.A.O;FIND>ALL;SUBST>T --N UMB ER -0F -AN I MAL s SEX: GROUP; -MALE------- __ -- FEMALE -- -__ ORGAN/TtSSUE EXAMINED NUMBER; 30 30 30 30 30 30 30 30 ** FROM PREVIOUS PAGE ** KIDNEYS .......................................................................................... ... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --CORTEX; CYST 1 0 0 0 1 1 0 0 0 Tt> 0 0 0 l 1 0 0 0 --CALCIFIC GRANULES 1> 0 0 0 0 I 0 0 4 TL> 0 0 0 0 1 0 0 4 -PYELONEPHRITIS, SUBACUTE 3> 0 0 0 0 2 0 0 0 TL> 0 0 0 0 2 0 0 0 TESTES ............................................................................................ ... NUMBER EXAMINED: 30 a 0 27 0 0 0 0 --!) TUBULAR DEGENERATION Z* 0 0 0 1 0 0 0 0 3> 0 0 0 1 0 0 0 0 TL 0 0 0 2 0 0 0 0 -- REDUCED SPFRMAT0GEHFSI5 2> 0 0 0 l 0 0 0 0 3> 0 0 0 1 0 0 0 0 TL> 0 0 0 2 0 0 a 0 EPIDIDYMIDES ... --U; OLIGOSPERMIA ............................. ... NUMBER EXAMINED: 30 0 0 27 0 0 0 0 2* 0 0 0 1 0 0 a 0 TL> 0 0 D I 0 0 0 0 PROSTATE GLAND . ............................. .. ... NUMBER EXAMINEO; 30 a 0 30 0 0 0 0 -- LYMPHOID CELL INFILTRATE(S)/AGGREGATE(S) 50Q3 0000 t> 0 0 0 I 0 0 0 0 3> 1 0 0 0 0 0 0 0 TL* 6 0 0 4 0 D 0 0 --ALVEOLAR LUMENS; CORPORA ANYLACIA/MINERALIZED GRANULES l> 3 0 0 5 0 0 0 0 TL> 3 a a 5 0 0 0 0 -ACUTE/SUBACUTE INFLAMMATION l> 0 0 a 1 0 0 0 0 3> 0 0 0 I 0 0 0 0 TL 0 0 a 2 (1 0 0 0 SCMJNAL VESICLES ...................................................................... ... NUMBER EXAMINED; 30 0 0 30 0 0 0 0 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INOIVIQUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1D03 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH; 16 TERMINAL BODY WEIGHT: ORGAN NAME PATHOLOGY OBSERVATIONS " * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHDLOG EPIDIDYMIDES LIVER . , MICRO: HI5TQPATHOLOGICAL COMMENT: >ONE PRESENT MICRO: -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZON NOSE/TURB SEC 2 MICRO: -MINIMAL, FOCAL -NASOLACRIMAL QUCT(S): INFLAMMATORY CELLS/C NOSE/TURB SEC 3 MICRO: -MINIMAL -SLIGHT -NASAL MUCOSA (RESPIRATORY): EPITHLLIUM-1NI COS 1NOPHL1C MATERIAL -NASAL MUCOSA (01 FACTORY): EPlTHELtUM-INTRA EOSINOPHILIC MATERIAL NQSE/TURB SEC 4 MICRO: -SLIGHT -NASAL MUCOSA (OLFACTORY): EP1THELIUH-INTRA EOSINOPHILIC MATERIAL PROSTATE GLAND MICRO: -MINIMAL, FOCAL -LYMPHOID CELL INFILTRATE|S)/AGGREGATE(S) ** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO HICROSCOPtC ABNORMALITIES OBSERVED: COAGULATING Gl EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC I, PITUITARY GLAND, 5EMINA TESTES, TRACHEA KEY TO NEOPLASMS; "M-'' MALIGNANT. "B-" BENIGN, "5-" METASTATIC. '`I-" INVASIVE. "X-" OT BFG43173 w o o LUoLtJ/il *** PATH/TQX system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY $TU TABLE INCLUDES: SEX*All;GRQUP*ALL; SCREEN-ALL; WEEKS-ALL OEATH-T,A,D;FIND-ALL;SU6SET-T -- NUN B E R - 0 F - A N I M A L s SEX: ----'MALE'-- -__ -- FEMALE- GROUP: -1- 2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 30 30 30 - ** FROM PREVIOUS PAGE ** PITUITARY GLAND ..................................................................... . NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --PARS D1STAUS; CYSTS 1> 2 0 0 3 1 0 0 1 TL> 2 0 D 3 1 0 0 \ MAMMARY GLANDS ..................... --ADENOMA NuHBEfi EXAMINED: 26 0 0 2S 30 0 0 30 P> 0 0 n 0 0 0 0 1 11 - 0 0 n 0 n 0 0 1 ththi/s H| (S! 1 000 ?000 l 1 0 0 0 0 0 0 0 11 0 0 0 0 0 0 0 BFG43160 t ON<it S11 1 0 o 0 6 2 0 0 0 U' 0 0 0 0 2 0 0 0 SUN ... --ULCERATIVE OEftMAUTIS NUMBER LXAMlNLO: 1 0 0 0 Q 0 0 0 I 00 0 Q000 TL> 1 0 0 0 0 0 0 0 MEDIASTINAL LN .................................................................................................. . NUMfilR EXAMINED: 0 0 0 l 0 0 0 0 - HEMORRHAGE!S> 2> 0 0 0 1 000 0 TL> 0 0 0 1 0 0 0 0 ETES ............................................................................................................................. . NUMBER EXAMINED: I 0 0 0 0 0 0 Q EARS ............................................................................................................................ . NUMBER EXAMINED: 0 0 0 1 2 0 0 2 --SUBACUTE (CHRONIC ACTIVEJ/CHRONIC INFLAMMATION 3> 0 Q 0 1 2 a 0 I 4> 0 0 0 0 0 0 0 1 Tl> 0 0 0 1 2 a 0 2 --NECROSIS CARTILAGE \> 0 0 Q 0 2 0 D 0 3> 0 0 0 1 0 0 0 2 TL> 0 0 Q 1 2 0 0 2 PANCREAS ........................................................................................... . NUMBER EXAMINED: 0 0 0 0 1 n 0 0 STOMACH .............................................................................................. . NUMBER EXAMINED: 0 0 0 0 fl 0 0 l ** ENO OF LIST " BFG 00329 *** PAT H/1 OX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1QQ5 DATE OF DEATH: 04/26/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGT OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG EPIDIDYMIDES .............................................................................................................................................................................................. MICRO HlStOPATHOLOGlCAL COMMENT: >ONE PRESENT KIDNEYS . . . MICRO -MINIMAL, FOCAL -CORTEX: INFILTRATES.SUBACUTE LIVER . . . . MICRO "MINIMAL -HEPAlQCYltS: CrioPLASMIC VACUOLES'(NQN-ZON, NOSE/TURR SFC 1 MICRO -MINIMAL. FOCAL -VOMORONASAL ORGAN: FREE ERYTHROCYTES NQSF/TURR SEC ? MICRO -MINIMAL. FOCAL -NASAL LUMEN; FREE ERYTHROCYTES -MINIMAL. FOCAL -VOMORONASAL ORGAN; EOSINOPHILIC MATERIAL NQSE/TURB SEC 3 MICRO; -SLIGHT NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA PROSTATE GLAND MICRO: -MINIMAL. FOCAL -LYMPHOID ffll INF|L TRAT F(S)/AGGREGATE(S) *** ANIMAL HAS NO GROSS ABNORMAL!T IL5 O0SERVEU *' THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL, EPIDIDYMIDES, LUNGS, MAMMARY GLANDS, NDSE/TURB SEC 4, PITUITARY GLAND, SEMINAL VESICLE: TRACHEA BFG43175 KEY TO NEOPLASMS: "H-" MALIGNANT. "8-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTi BFG 003307 to $ a pY tj 0 n Cl o '** PATH/TOX SYSTEM OUIPUI *** VINTl CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS MICROSCOPIC FINDINGS -- EXPANDEO INCIDENCE SUMMARY STUt TABLE INCLUDES: $CXALL;GROUP-ALL:SCREEN-ALl:VCEkSALL DEATH-ALL;FlN0*ALL;SUOSET-T NUNBE R - 0 F - A N I M A L S SEX: ----- MALE--' --FFMAIF-- GROUP: -1- *3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED - - - t ----- - - ------ - - *------------------------- ,-------------- ------- ------------ NUMBER; ** FROM PREVIOUS PAGE ** LIVER .................................................................................................. NUMBER EXAMINED: --BASOPHILIC FOCUS ] TL* 3D 30 0 0 30 3D *w- 30 -a* 30 -v - _2s9_ 30 -a- 3D _a-- 30 30 30 3D 29 30 30 0 0 8 0 0 l 11 0 0 8 0 0 1 11 --CLEAR CELL FOCUS 1 0 0 0 S 0 0 0 0 TL> 0 0 0 5 0 0 a 0 --BILE OUCT/BILIARr EPITHELIUM: HYPERPLASIA 1> 0 0 0 1 0 0 0 D TL> 0 0 0 1 0 0 0 0 --HEPATOCYTES CENTR1LOBULAR: HYPERTROPHY --NECROSIS.COAGULATION l> 0 0 19 30 D 6 30 30 TL> 0 0 19 30 0 6 30 30 I* 0 0 0 0 0 1 0 0 2> 0 0 0 0 0 0 2 0 TL> 0 0 0 0 D 1 2 0 - - PEL 10515 HEPATlS --EXTRA MEDULLARY HEMATOPOIESIS --ANGIECTASIS 1> 0 0 1 0 0 0 0 0 TL> 0 0 1 0 0 0 0 0 I> 0 0 0 0 0 0 2 0 TL> 0 0 0 0 0 0 2 0 2> 0 0 Q 0 0 0 l 0 TL> 0 0 0 0 0 0 l a KIDNEYS ....................................................................................... .... NUMBER EXAMINED: 30 --CORTEX: INFILTRATES SUBACUTE 4 0 0 0 30 30 04 1 0 0 0 30 0A Tl> 4 0 0 4 1 0 0 4 --TUBULES OtLATED 1> 2 0 0 2 0 0 0 1 TL> 2 0 0 2 0 0 0 1 --PELVIS: INFLAMMATION SUBACUTE * 4 CONTINUED ON NEXT PAGE l> 0 0 0 0 0 0 0 1 l> 1 0 0 0 0 0 0 0 I 000 Q000 TL 2 0 0 0 0 D 0 1 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1007 OATE OF DEATH: 04/26/97 SEX: MALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER ....................................................................... MICRO: -MINIMAL, MULTI-FOCAL -MINIMAL NOSE/TURB SEC 3 .................................................. MICRO; -MINIMAL -SLIGHT NOSE/TURB SEC 4 .................................................. MICRO: -SLIGHT TRACHEA .................................................................. MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZON -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPI THELIUN* INTRA EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRA EOSINOPHILIC MATERIAL MUCOSA: MUCOSAL GLANQS-QILATEO *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED "** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL EPIDIDYMIDES, KIDNEYS. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, PITUIT PROSTATE GLAND, SEMINAL VESICLES, TESTES BFG43177 KEY TO NEOPLASMS: "M-" MALIGNANT, V* BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OT wbfg oo3~ *** PATH/TOX SYSTEM OUTPUT *" VINYL CHLORIDE COM61NEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TQXlCtTY STUDY IN CD RATS MICROSCOPIC FIHOINGS -- EXPANDED INCIDENCE SUMMARY 5TUI TABLE INCLUDES: SEX-ALL:CROUPALL;SCREEN-ALL;UEEK$ALL DEATH-ALL;FINDALL;SUBSET-T - HUM 8 E ft 0 F - AN I KU 5 - SEX: -------- HALE*---------- --------- FEMALE- --- -- GROUP: -1- -2- -s- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 29 30 30 ** FROM PREVIOUS PAGE ** PROSTATE GLAND ......................................................................... ... NUMBER EXAMINED: 30 0 0 30 0 0 0 0 -ACUTE/SUBACUTE INFLAMMATION 1> 4 0 0 2 0 0 0 0 2> S 0 0 0 0 0 0 0 TL> 9 0 0 2 0 0 0 0 BFG43164 --ALVEOLAR LUMENS; CORPORA ANYLACIA/M1NERAI IZEO GRANULES 1> 4 0 0 4 0 0 0 0 TL> 4 0 0 4 0 0 0 0 --ALVEOLAR LUMENS: EXUDATE SfMlNAI VFSin FS -INFLAMMATION, SUBACUTE 1 0 0 0 0000 TL> ! 0 0 D 0 0 0 0 ............ . .. NUMBER EXAMINED: SO 0 0 SO 0 0 0 0 1 00 0 0000 TL* 1 0 0 0 0 a 0 0 COAGULATING 6L ......................................................................... ... NUMBER EXAMINED; 30 0 0 3D 0 0 0 0 OVARIES ............................................................................................................. ... NUMBER EXAMINED: 0 0 0 0 30 0 0 so fwtfmrT*/FAl f>P T ......................................... .. .. 0 0 0 0 30 0 0 so -- LUMEN: DILATED ... NUMBER EXAMINED; 0 0 0 0 SO 0 0 30 1* 0 0 0 0 4 00 5 2> 0 D 0 0 2 00 3 TL* 0 0 0 0 6 0 0 6 --MYOMETRIUM: BROUN PIGMENT 1> 0 0 0 0 12 0 0 6 2 0 0 0 0 7 0 0 7 TL> 0 0 0 0 19 0 0 IS -- ENDOMETRIUM: BROUN PIGMENT 3 a -- ENDOMETRIUM: HYPERPLASIA l> 0 0 0 0 I 0 0 12 Tl> 0 0 0 0 1 0 D 12 1' 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 I <O2> *'O4 9 *** PATH/TDK 5YSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TW0-6ENERAT1DN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1009 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEOULED, TERMINAL SA STUOY DAY OF DEATH; 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG EPIDIDYMIDES MICRO: HISTOPATHOLOG1CAL COMMENT: *CNE PRESENT KIDNEYS . . MICRO: 'MINIMAL, FOCAL.................................................. -CORTtX:' INFiLTHATE5!5UBACUTE LUNGS MICRO: -MINIMAL, MULTI-FOCAL NOSE/TURB SEC 3 MICRO: -MINIMAL PROSTATE GLAND MICRO; -MINIMAL, MULTI-FOCAL LYMPHOID CELL INFILTRATE(S)/AGGREGATE(S NASOLACRIMAL DUCTi LYMPHOio HYPERPLASIA -ALVEOLAR LUMENS: CORPORA AMYLACiA/MiNE.RAL! ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL, EPIDIDYMIDES, LIVER, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, NOSE/TURB SEC 4 PITUITARY GLANO. SEMINAL VESICLES, TESTES, TRACHEA KEY TO HEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "T-" INVASIVE, "X-" OT BFG43179 3 ft *** PATH/TOX SYSTEM OUTPUT M4 VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY STUD TABLE INCLUDES: SEX-ALL;GAOUP-ALL;SCREEN-ALL;WEEKS-ALL OEATHcALL;FIND-ALL;SUBSET-T __ NUMB E R 0 F - A N I H A L S SEX: --HALE ... ..... .... -FEMALE- GROUP: -1- 2' - 3- -4- -1- -Z- -3- -4- QftGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 29 30 30 ** FROM PREVIOUS PAGE ** NOSE/TURB SEC 1 ......................................................................... EXAMINED: 30 0 0 30 30 0 0 30 -NASAL MUCOSA (RESPIRATORY); GOBLET CELL HYPERTROPHY/HYPERPLASIA 1> 1 0 0 2 0 0 0 0 TL> l 0 0 2 0 0 0 0 -OODNTOPATHY \> 1 0 0 i I 0 0 0 TL 1 0 0 1 1 0 0 0 -VOMERONASAL ORGAN: EOSINOPHILIC MATERIAL i> 1 0 0 0 1 0 0 0 Tl> 1 0 0 0 1 0 0 0 -- NASOLACRIMAL DUCT; EXUDATE 2> 0 0 0 0 1 0 Q 0 U 0 0 D 0 1 0 0 0 991 -NASAL LUMEN: EXUDATE 0000 1 000 \L> u 0 0 0 1 0 0 0 -NASAL MUCOSA (VESTIBULAR); SUBACUTt (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION \> 0 0 0 1 0 0 0 0 TL 0 0 0 I 0 0 0 0 NOSE/TURB SEC 2 ......................................................................... --NASAL LUMEN; FREE ERYTHROCYTES -NASOLACRIMAL OUCT{S): INFLAMMATORY CELLS/CELL DEBRIS EXAHINEO: 30 0 0 30 30 Q 0 30 TL> 0 0 0 a 0 0 0 0 1> 0 0 0 3 1 0 0 1 TL> 0 0 0 3 1 0 0 1 -NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION 0004 D00 I l> 0 0 0 0 I 0 0 0 $> 0 0 0 0 1 0 0 0 TL> 0 0 0 4 2 0 0 1 -ODONTOPATHY 1 2 0 0 2 1 0 0 0 2> 1 0 0 0 0 0 0 0 tLs 3 0 0 l l 0 0 0 -VOMERONASAL ORGAN: FREE ERYTHROCYTES ** CONTINUED ON NEXT PAGE *' N O<0b 1 2 0 0 3 0 0 D 0 TL> 2 0 0 .1 0 0 0 0 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COH6INED INHALATION TVO'GENfRATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD HATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1011 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL $A STUDY DAY OF DEATH: 113 STUOY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTgPATHQlQG EPIDIDYMIDES . MICRO:............................. HiSToPATHOlOGICAL COMMENT: >ONE PRESENT............................................................... KIDNEYS . , . MICRO:'-HININAL.'fOCAL.................................................. -CORTEX:'iNFiLTRATES.'sUBACUTE LIVER . , . . MICRO: '-MINIMAL, ' MULTIFOCAL..................................... :ACUTE/SUBACUTE IMF LAMI1ATI ON................................ MINIMAL -HFPAfOCY 7ES: CYTOPLASMIC VACUOLES (NON-ZON, mammary glands !( NO I I 'jSut N| v, |<K, NOS! / T iiA0 *fl i a H Mi mln4| * Hi*. 0| WON*'.*) ORGAN IRK IRYJHR0CYU5 * AN | HA i mA', HQ ij it).'. *'* THi lUuOhlig i I -...I 1*L> NO , .im 11 ipiuim*. IMIS OAS! Yt n lOAGwlAMNC M ! Al o OJ \ lunij'i NOSKIUBB Sit I. OSI/tyRB St C 3, NOSl/IuRB Sit 4. PIHHURT CLAN! PROSTAII litANCl SIHINAL VlSIUIS USUS. IftAOUA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "1 " INVASIVE, "X-"OTI % o & 00 93 O o o w O *** PATH/TOX system output a ** VINYL chloride COMBINED INHALATION TWO-GENERAT10N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOT IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY STUDY TABLE INCLUDES; S EX-ALL ;GR0UP*ALL SCREEN'*ALL ;UEEKS-All DEATH*ALCj FINO-ALL;SUflSET-T -- N tine E R - 0 F - A N ] H A L S SEX; -MALE ,___ GROUP; i- 2- - -FEMALE-2- OROAN/TISSUE EXAMINED NUMBER; 30 30 30 30 30 29 30 30 ** FROM PREVIOUS PAGE ** NOSf/TURB SEC 3 ............................................................ -NASOLACRIMAL DUCT (S); FREE ERYTHROCYTES EXAMINED: 30 0 0 30 30 0 O 30 1 1 0 0 1 O 0 0 0 2> 0 O 0 0 0 0 0 1 Tl> I 0 0 1 O 0 0 1 -NASOLACRIMAL DUCT: EXUDATE l> 0 O 0 0 1 0 0 0 3> 0 0 0 0 I 0 0 0 TL> 0 0 0 0 2 0 0 0 NOSE/TURB SEC 4 --NASAL LUMEN: FREE ERYTHROCYTES EXAMINED: 30 0 0 30 30 0 0 30 i> 2 0 0 0 1 Q 0 1 2> 1 0 0 0 0 0 0 0 3* D D 0 l 1 O 0 1 TL 3 O 0 I 2 0 0 2 -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL 1* 10 0 0 9 11 0 0 10 2> 1 0 0 1 3 0 0 0 ri> 19 0 0 10 14 0 0 JD NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION TL> 0 0 0 0 0 0 0 0 -NASAL MUCOSA (OLFACTORY); BASOPHU 1C MATERIAL 1> 3 0 0 6 t 0 0 3 TL> 3 0 0 6 1 0 0 3 URETHRA ............................. --SEMINAL COAGULUM EXAMtNED; 3 0 0 0 0 Q 0 0 l 0 0 0000 0 TL> 2 D 0 0 0 0 0 0 -INFLAMMATION. SUBACUTE MESENTERIC IN ......................... --LYMPHOIO HYPERPLASIA 2> I 0 0 0 0 0 0 0 1L> I 0 0 D 0 0 0 0 EXAMINED; l 0 0 0 0 0 0 0 2> ) 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLOftlbE COMBINED INHALATION TWO-GENERATIQN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET SI ANIMAL NUMBER: 1013 DATE OF DEATH: 04/29/d7 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA( STUOY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HIST0PATH0L0G1 EPIDIDYMIDES . LIVER MICRO: .. .. MICRO.'-SLiGHT HISTOPATHOIOGICAL COMMENT: >QNE PRESENT -HCPATOCYTES; CYTOPLASMIC VACU0lfS*(NON-ioN/ N0SE/TUR8 SEC 4 MICRO; -SLiGHT -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRAl EOSINOPHILIC MATERIAL PROSTATE GLANO MICRO: -MINIMAL. FOCAL -LTMPHQ10 CELL 1NFILTRATE(S)/AGGREGATE(S) *** ANIMAL HAS NO GROSS ABNORMAL]TIES OBSERVED "* THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMAL ITICS OBSERVED; COAGULATING GL. EPIOlOYMlDCS. KIDNEYS, I UNITS. MAMMARY GLANDS. NOSt/TURB SEC 1. NOSE/TURB SEC 2. NOSE/TI PITUITARY GLANO, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS; "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. "I*" INVASIVE, `V OTI BFG43183 5= C.) in Huntingdon Life Sciences Reproduction Study 96-4080 Page 30 Draft Final Report Individual Animal Postmortem Findings Preface Appendix Y Key to Abbreviations U/ B/ R.W ML) W TE LN FALOPT ASSOC MFOC SUBA Unilateral Bilateral Right Left With Testes Lymph Node Fallopian Tubes Associated Multifocal Subacute Note Unless otherwise specified in a required (routine) section. > gy note* the organ/tissue examined was the bfG4317q BFG 003302 BFG43185 ANIMAL NUMBER: LOIS DATE OF OEATH: 04/28/97 *" PATH/TOX SYSTEM OUTPUT "* VINYL CHLORtOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INOIVIOUAL ANIMAL DATA SHEET STI SEX: MALE DOSE GROUP; 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION KIDNEYS LIVER . . MICRO: 'MINIMAL, FOCAL MICRO: -MINIMAL, MULTI-FOCAL -SLIGHT LUNGS MICRO: -MINIMAL, FOCAl MANHARr GLANDS MICRO: -TISSUE MISSING NOSE/TURB SEC t MICRO: -SLiGMli FOCAL NOSE/TURB SEC 2 MICRO: -SLIGHT NOSE/TURB SEC 3 MICRO: 'MINIMAL NOSE/tURB SEC 4 MICRO: -SLIGHT OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTGPATHOLOGU -u: pyelitis,subacute -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAI -1NTERSTIT1UH; MINERAL DPOSIT(S)/OSSEOUS HE' -NASOLACRIMAL 0UCT(5): FREE CRYTHROCYTES -NASOlACRINAL DUCT(S j: FREE ERYTHROCYTES Nasolacrimal duci! lymphoio"hvperplasia -NASAL MUCOSA {OLFACTORY): EPITHELIUM-INTRAC' EOSINOPHILIC MATERIAL ANIMAL HAS NO GROSS ABNORMALITIES OBSFRVFO THE FOLLOWING I ISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL. EPIDIDYMIDES, PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "6-" BENIGN, "S-1' METASTATIC. "l-" INVASIVE, "X-" OTH a it* -i *" PATH/TOX SYSTEM OUTPUT **' VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 1002 DATE OF DEATH: 04/26/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRI STUDY DAY Of OEATH; 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 5 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TCXT COMMENTS / HISTOPATHOLOGIC GROSS/MICRO CORR .......................................................................................................................................................................................... MICRO: HISTOPATHOLOGICAL COMMENT: >K1DNEY-L; IRREGULAR SHAPE/NMC KIDNEYS ........................................................................................................................................................................................................... GROSS: -tRREGULAR SHAPE -LEFT LIVER ............................................................................................................................................................................................................... MICRO; -MINIMAL, FOCAL 'EXTRAMEPUlLARY HEMATOPOIESIS LUNGS ............................................................................................................................................................................................................... MICRO; -SLIGHT -CONGESTION NOSE/TURB SCO 4 .......................................................................................................................................................................................... MICRO: -MINIMAL -NASAL MUCOSA (RESPIRATORY): BASOPHILIC MATERI TRACHEA ........................................................................................................................................................................................................... MICRO; -MINIMAL, FOCAL -MUCOSA: MUCOSAL GLANDS-OILATED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. NOSE/TURB SEC 3, PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES. TESTES KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, METASTATIC. "I-** INVASIVE. "X-" OTHER BFG43172 S3 o 4* tCf 3 A U 00 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AnO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET & ANIMAL NUMBER: 1017 PATE Of DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE 51ATU5: 5CHLDULLD, TERMINAL SAi STUOY DAY Of DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER .......................................................................................................................................................................................................... MICRO: -MINIMAL, MULTI-FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-JON, LUNGS .......................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -LYMPHOID CELL 1NFILTRATE (S)/AGGREGATE(S) NOSE/TURB SCC 2 ..................................................................................................................................................................................... MICRO: -MINIMAL -VONORONASAL ORGAN: EOSINOPHILIC MATffilAl "" ANIMAL HAS NO GROSS ABNORMAL! 1 it5 OBSERVED THE FOLLOWINlj TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS. MAMMARY GLANDS, NOSE/TURB SEC I, NOSE/TURB SEC 3. NOSE/TURB SEC PITUITARY GLAND, PROSTATE GLANO, SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "6-" BENIGN, "S-*' METASTATIC, "I-** INVASIVE, "X-" OT 03 a CD La_l bo o5 U-t*) 4^ 03 a *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TVQ-GENERAT1QN REPRODUCTION AND DEVELOPMENTAL ToXJClTY STUDY tH CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 1004 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY OAT OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 5 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES . MICRO:............................. HiSTOPATHOLOGiCAL COMMENT: *ONE PRESENT................................................................... GROSS/MICRO CORR MICRO:'......................... HisTQPATHOLOeicAl COMMENT; *THYHUS; oi5CQL0RED/HEM0RRHAGE HFQC KIDNEYS . . . MICRO:'-MINIMAL. 'FOCAL.................................................. -U: PYE.LiT1S1SU0ACUT LIVER ... MICRO: `MINIMAL. HULT1-F0CAL..................................... :ACUTE/SUBACUT INFLAMMATION.................................... -MINIMAL -HEPAT0CYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) LUNGS .... MICR0:`-MIN|MAL.'FOCAL..................................................:PULMONARY'VESSELS: MINERAL DP05IT(5) NOSE/TURB SEC 2 MICRO; `-MOOERATF.............................................................. -NASOLACRIMAL OUCT(S); 'hUCOSA-SUDACUTE '(CHRQNI -SLIGHT -MODERATE CHRONIC INFLAMMATION -VOMORONASAL ORGAN: EOSINOPHILIC MATERIAL -ODONTOPATHY NOSE/TURB SEC 3 MICRO''-SliGHT.................................................................. 'NASOLACRIMAL DUCT: LYHPHOiD HYPERPlAsiA -MINIMAL `NASAL MUCOSA (OLFACTORY); EPITHELIUM*INTRACYT EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 MICRO* -SLIGHT.................................................................. -NASAl'muCOSA {OLFACTORY j :* E PITHEL i UM-i NTRACYT EOSINOPHILIC MATERIAL THYMUS ............................................................................................................................................. GROSS: -DISCOLORED -RED MICRO: -MINIMAL. MULTI-FOCAL -HEMORRHAGE(S) THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. MAMMARY GLANDS. NOSE/TURB SEC 1, PITUITARY GLAND. PROSTATE GLAND, SEMINAL V TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "(-"INVASIVE, "X-" OTHffl O PATH/TOX SYSTEM OUTPUT '*** VINYL CHLORIDE COMBINED INHALATION TVQ-GENERATIQR REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1019 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA< STUDY DAY OF DEATH: HZ STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREC-TEXI COMMENTS / HISIOPATHQLOG LIVER , . . , MICRO; -MINIMAL NOSC/TURB SEC I MICRO: -MINIMAL. FOCAL NOSE/TURB SEC 2 MICRO: -MINIMAL NOSE/TURB SEC 3 .......................................... MICRO: -MINIMAL. FOCAL NOSE/TURB SEC 4 ..................... MICRO: -SLIGHT PROSTATE GLAND ......................................... MICRO: -MINIMAL, FOCAL HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONi -NASAL MUCOSA (RESPIRATORY);'aCUTE/SUBACUTE -NASOLACRIMAL pUCT($j: MUCQSA-SUBACUTf (CR< CHRONIC INFLAMMATION :NASAl'MUCOSA (OLFAcioRY); fPITHELiuM-iNIfiA< EOSINOPHILIC MATERIAL :NASAL'mUCOSA (OLFACTORY); EPITHELiUM-iNTRAI EOSINOPHILIC MATERIAL -ALVEOLAR LUMENS; CORPORA AHYLAC IA/HIMCftALi; *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED "* THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPlOIOYMiDES, KIDNEYS. LUNGS. MAMMARY GLANDS, PITUITARY GLAND. SEMINAL VESICLES, TESTF! KEY TO NEOPLASMS: "M-H MALIGNANT, "B-" BENIGN. "S-" METASTATIC, INVASIVE. "X-" OTI a 3 oUt to cd rrt O p t--* O' ANIMAL NUMBER: 1006 DATE OF DEATH: 04/24/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLOAIQE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY |N CO RATS INDIVIDUAL ANIMAL DATA SHEET STUE $EX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH; 112 STUDY WEEK OF DEATH; 16 TERMINAL BOOT WEIGHT; i ORGAN NAME * * * PATHOLOGY 0 BSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TCXT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES . MICRO: KIDNEYS . , . MICRO: LIVER .... MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 3 MICRO: HISTOPATHQLOGICAL COMMENT: -MINIMAL, FOCAL -MINIMAL, MULTI-FOCAL -MINIMAL -MODERATE -MODERATE -SLlGHl -SLIGHT ONE PRESENT -DILATED TUBULES -ACUTE/SUBACUTE iMFLAMHATION -HEPATOCYTES: CYTOPLASMIC VACUOLtS (NUN-ZUNAL] NASOtACRIMAL DUCT(5j: MUCOSA-SUBACUTE (CHRONj CHRONIC INFLAMMATION -ODONTOPATHY -NASOLACRIMAL DUCT: LYHPHOio HYPtftPLASiA NASOtACRIMAL t)UCI(S): HUCOSA-SUBACUtE (CHRONI CHRONIC INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMAL 111ES OflSERVED "* THE FOLLOWING TlSSUCS HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EP101OYM1DS. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. HOSE/TURB SEC A, PITUITARY GLAND, PROSTATE GLAND. SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: MH-" MALIGNANT, MB-M BENIGN, "S-M METASTATIC, "I-" INVASIVE, OTHEf *1 o <swz> Ooc *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 1021 DATE OF DEATH; 04/29/97 SEX: HALE DOSE GROUP: I SACRIFICE STATUS SCHEDULED. TERMINAL SAI STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * KEYWORDS. SEVERITY. DISTRIBUTION 6R0SS FREE-TEXT COMMENTS / HISTOPATHOIQG LIVER . . MICRO; -MINIMAL. MULTI nose/turb sec 1 MICRO: -SLIGHT. FOCAL NOSE/TURB SEC 2 MICRO: -SLIGHT NOSE/TURB SIC 2 w MICRO MINIMAL Si IL.HI O NOSf/llllB Uf * Nil NO M "ININA. -ACUTE/SUBACUTE INFLAMMATION ODONTOPATHY................................. ODONTOPATHY................................. -NASOlACRTHAI DUCT; LYMPHOID HYPERPLASIA NASOLACRIMAL OllCr(s): HUCOSA-SU8ACUTE (CHR< < hRodIl InFiAmmAJIun NASAl l liM| N i R | ( (RtIhROLHES NA'jii Mu(0*i* (OlFACfOMtl CP|TM|iIUM-lNTRA< lOSINOPtill H 11 0|A| *** AHlHA( has NO ` S AfcN(i*A| I ' ' I \ *** THE FOLLOWING 1 IS GL>* S HAD NO rtICIOlLOPll AflNOAMAI | II [ S ORSERVLD: COAGULAtlNG GL. [P|0IDlMlOfS. KIDNEYS. LUNGS, MAMMARY GLANOS. PITUITARY GLAND. PRO5TATf GIAND. SEMINAL TESTES, IRACHLA KEY TO NEOPLASMS: "H-" MALIGNANT. V BENIGN. "S-" METASTATIC, "I-" INVASIVE. "X-" DTI 03 o Uu)i *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET STUI ANIMAL NUMBER: 1000 DATE OF DEATH: 04/20/97 SEX; MALE DOSE GROUP; 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACK STUOY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 10 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS 44 * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREt-TEXT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES . MICRO:............................. HiSTOPATHOLOGicAL COMMENT: >ONE`PRESENT................................................................... LIVER . , , . MICRO:`-MINIMAL,'MULTI-FOCAL..................................... -ACUTE/SUBACUTE INFLAMMATION..................................... -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NDN-ZONAL NQSE/TURB SEC 3 MICRO;'-MINIMAL .............................................................. :NA50LACRIMAL DUCT: LYMPHOID HYPERPLASiA N0SE/TUR6 SEC 4 MICRO '-SI [GHI.................................................................. -NASA! 'MUCOSA (OLFACTORY); ' EPITHELIUH-iNTRACY -MINIMAL EOSINOPHILIC MATERIAL -NASAL MUCOSA (RESPIRATORY); BASOPHILIC MATER 444 ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED 114 THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL EPIDIDYMIDES, MONEYS, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, PITUlTAR PROSTATE GLAND, SEMINAL VESICLES. TESTES, TRACHEA KrTD'NEOPLASMSr"",M-:;"HALtGNAhT' '-B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTHE BFG 4317S W *1 O oo o *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANINAL DATA SHEET ANIMAL NUMBER; 1023 DATE OF DEATH; 04/29/07 SEX; MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / H1STOPATHOIOG EPIDIDYMIDES . MICRO; LIVER . r . . MICRO: -MINIMAL NOSE/TURB SEC 4 MICRO:'-MINIMAL -MINIMAL HIST0PATH0L06ICAL COMMENT; >ONE PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-ZON -NASAL MUCOSA (OLFACTORY): EPITHEL1UM-INTRA EOSINOPHILIC MATERIAL -NASAL MUCOSA (RESPIRATORY); BASOPHILIC HAT *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING Gl, EPIDIDYMIDES, KIDNEYS. LUNGS. MAMMARY GLANDS, N05E/TURB SEC I. NOSE/TURB SEC 2, NOSE/T PITUITARY GLANO, PROSTATE GLAND. SEMINAL VESICLES. TESTES, TRACHEA BFG43193 KEY TO NEOPLASMS: "H-M MALIGNANT, "B-" BENIGN, "S*" METASTATIC, INVASIVE, "X-" OT b f g 003325 05 o & o PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD! ANIMAL NUMBER: 1010 DATE OF OEATH: 04/29/97 5X: HALE POSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRlf STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 42 ORGAN NAME * * * PATHOLOGY OBSERVATIONS "** KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC f EPIDIDYMIDES MICRO: EYES ... GROSS: GROSS/HICRO CORR MICRO: -OPACITY HJSTOPATHOLOGICAL histopathologicai NOSE/TURB SEC I Ml l SO nos|;tubb su > M 11 G HI III ML H1 ft 1HA i h : ft , m, ( Ol Al 1 0< A i .ft;M N0*t/ IiB sk * nh id HlkjHftt Sk| N GROSS: -SCAB(S)/SORE{S) MICRO: "HPPERATE, FOCAL `RIGHT LENS: FOCAL OPACITY >sklN;'S0RE VENTRAL CERvid EYF-R: OPAClTY/NMC vOmOBOnASAL ORGAN TREE erythrocytes A SOI AC 11MAl OUT f(S1 fH(f ERYTHROCYTES M'.oiA(fftHAt in* mi mucosa subacuif [chronic [ Hf on l( I H i mil I Ok *I\t< HlKOSA (Oil ftMO*T 1 | P | I H( 1 1 UN I NTRACVTC H HA 11 I A l NASAL MUCOSA {OLFACTORY] l PI I M| 1 | UM -1MIRACYT ( EOSINOPHILIC MATERIAL -SORE, VENTRAL CERVICAL: TAN -ULCERATIVE DERMATITIS THE FOLLOWING TISSUES HAQ NO MICROSCOPIC ABNORMALITIES OBSERVED: ,,,,_ _ _ _ _ ............ ,, COAGULATING GL, EPIDIDYMIDES, EYES, KIDNEYS, LIVER, LUNGS. MAMMARY GLANDS. N0SE/TUR8 SEC 2, PITUITARY GLAl PROSTATE GLAND, SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS; "H-" MALIGNANT, "B-" BENIGN, "$-* METASTATIC, "I- INVASIVE, X- OTHER 09 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET 3 ANIMAL NUMBER: 1025 DATE OF OEATH: 04/29/97 SEX; HALE DOSE GROUP: 1 SACRIFICE STATUS; SCHEDULED, TERMINAL 5A STUDY DAY OF DEATH; 1LS STUOT WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FRfE-TEXT COMMENTS / HISTQPATHOIQG LIVER .......................................................... MICRO; -MINIMAL N0SE/1URB SEC 3 ...................................... MICRO: -MINIMAL, FOCAL 'MINIMAL NGSE/TUR0 SEC 4 ..................................... MICRO; -MINIMAL -HePAtOCYTES; CYTOPLASMIC VACUOLES (NON-ZoN -NASOLACRIMAL OUCl(S): MUCOSA-SUBACUTE (CMC CHRONIC INFLAMMATION -NASAL MUCOSA (OLFACTORY); EPlTHELlUM-lNTRA EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLfAcTORY); EPITHELIUM INTRA EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMAL IT 1L5 OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMAL 1T|FS OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS. LUNGS. MAHMAOr GLANDS, NOSE/TlJRB SFC I. NOSf/TURB SEC Z. P1TUIT PROSTATE GLAND, SEMINAL VESICLES, TESTES. TRACHEA BFG43I95 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. METASTATIC, "l-" INVASIVE, "X-" 07 ANIMAL NUMBER: 10|Z DATE OF DEATH: 04/29/97 *** PATH/TOX SYSTEM OUTPUT *** VtNYL CHLORIDE COMBINED iNHAlAttON TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU SEX; MALE DOSE GROUP: 1 SACRIFICE STATUS; SCHEDULED, TERMINAL SACK STUDY DAY OF OEATH: 113 STUDY WEEK OF DEATH; 17 TERMINAL BODY HEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES LIVER . . MICRO: MISTOPATHOLOGICAL COMMENT: >ONE PRESENT MICROj'-MINIMAl/mULTI-FOCAL..................................... -EXTRAMEDULLARY HEMATOPOIESIS -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-Z0NAL N0SE/TUR8 SEC 3 MICRO: -MINIMAL..............................................................-NASAl MUCOSA (OLFACTORYj: EP1THELiuH*iNTRACY EOSINOPHIL 1C MATERIAL NOSt/TURB SEC 4 MICRO: -MINIMAL .............................................................. :HASAl'mUCOSA (OLFACTORY):'EP1ThELiUH-iNTRACY EOSINOPHILIC MATERIAL ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL, EPIDIDYMIDES. KIDNEYS. LUNGS. MAMMARY GLANDS, NOSE/lURB SEC I, NOSE/TURB SEC 2, PITUITAR PROSTATE GLANO, SEMINAL VESICLES, TESTES. TRACHEA BFG43182 KEY TO NEOPLASMS: "M-" MALIGNANT, *B-" BLNIGN, "S-" METASTATIC, "|-M INVASIVE, "X-" OTHE b f g 003314 M3H10 '3A1SVANI ,,-1.. '3I1V1SVI3W 'HSINJA `lHVN9nVN ,,-H,, MHSV1J03N 01 A3X V3H3V01 'S31531 'S]iqiS3A 1VNIH3S '(INVIS 31VlS0d 'qNtfl! ' 33S 0WU/3SON 'l 33S 0W1J/3S0N *1 33S 81M1/3S0N ` SDNV19 AbVHWVH 'S^Nfll '530lHAO]01d3 *39 S :Q3AM3S8Q S3IinVHUONQV OldOOSQMIH ON OVH S3H5SIJ Q3AH3S0O S3I1I1VHHON0V SS0H9 ON IVmiVH 3|l]Hd0NIS03 'jlWSVldOJADVHlNi-Wnl^Hil^ :(A'tJ01DVJ10) VS03I1H 1VSVN- IVHINIH- (1VMOZ-NON) $31Qfl3VA 3IHSV1J01A3 :S3H301Vd3H- 1VMINIH- :0N3IH 3lO3V0nS'S31VniiNl -X31U03- 1V30J `1VHIHIH- :Q3]H 1N359W 3NO< *1N3HM03 3V3|901OHiVd0iSIH iOMIM S9NIQNIJ OIDOTQHlVdOlSIH / S1N3HH09 1X31-33NJ SSOM9 NO110S1 HIS 10 'AimA3S 'SOHOAA3X , , S Nil | n M3 s g D MDlDNlVd , , * SNV96'>5> UH9I3N A008 1VNIHN31 ZT :H1V30 JO X33A AfllUS Cl I :H1V30 30 A0 AOfliS 3:iJI3V$ 1VNIHN31 '031003105 ^SniViS 331JIOTS 1 ^n09 3S0Q 31VH MIS Qfl0*96 : U3QM0N AQfUS ZS -3`jVd BG-UdV-6Z :Q3iMiyd 133HS VIVO 1VH1HV VfMIAIQHI SAVU 03 NI AOfUS A1131X0A lVAN3HdOl3A30 ONV NOtlOnOOMdSH H0UVM3N39-OA1 NOllVlVHNl O3N(0hO3 301H01H3 TANIA ... ifldlflQ H315AS XOl/HIVd Z6/6; . ANIMAL NUMBER: 1014 DATE OF OEATH: 04/28/9? *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWQ-GENERATtON REPRODUCTION AND DEVELOPMENTAL TOX(CITY STUDY (N CO RATS INDIVIDUAL ANIMAL DATA SHEET STU SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACfi STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS KEYWOROS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES . MICRO:.............................HiSTOPATHOLOGiCAL'COMMENT: >ONE*PRESMT.................................................................... KIDNEYS . . . MICRO:*-MINIMAL.'fOCAL.............................................. :COflfEX:' INFiLTRATESisUBACUTE.............................. LIVER . . . . MICRO: -MINIMAL .............................................................. -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL HOSE/TURB SEC 2 MICRO: -MINIMAL .............................................................. -NASOLACRIMAL DUCT(sj: INFLAMMATORY CELLS/CEL NOSE/TURB SEC 3 MICRO; -MINIMAL .............................................................. -NASOLACRIMAL DUCT(S):`MUCOSA SUBACUTE'(CHRON CHRONIC INFLAMMATION PITUITARY GLAND MICRO: -SLIGHT* FOCAL.................................................. -PARS jNTERMEOIA: CYST(S) PROSTATE GLAND MICRO: -MINIMAL, FOCAL.................................................. ^ALVEOLAR LUMENS: CORPORA AMYl AC M/MiNERAL IZE ** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, LUNGS, MAMMARY GIANOS, NOSE/TURB SEC L, NOSE/TURB SEC 4. SEMINAL VESICLES. TRACHEA BFG43184 KEY TO NEOPLASMS: "M-" MALIGNANT. **6-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTHE *** PATH/TOK SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET S' ANIMAL NUMBER: 1029 DATE OF DEATH: 04/29/07 SEX: MALE DOSE GROUP; l SACRIFICE STATUS; SCHEDULED, TERMINAL SAi STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH: 17 TERMINAL 800Y WEIGHT: ORGAN NAME *"* PATHOLOGY OBSERVATIONS * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HJSTOPATHQLQG LIVER , , - MICRO: -MINIMAL, MULTI-FOCAL -MINIMAL NOSE/TURB SEC 3 MICRO: -MINIMAL NQSE/TURB SEC 4 MICRO: -SLIGHT -ACUTE/SUBACUTE INFLAMMATION............................. -HCPATOCYTES: CYTOPLASMIC VACUOLES (NQN'ZON, NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL'MUCOSA (OLFACTORY):`EMTHELiUM-iNTRA eosinophilic material *** ANIMAL MAS NO GROSS ABNORMALtT IE.5 OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMAI(TILS OBSERVED; COAGULATING GL, EPIDfOrMIDES, KIDNEYS, LUNGS, MAMMARY GIANOS. NOSE/TURB SEC I, NOSE/TURB SEC Z. PHUIT PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-'' INVASIVE, MX-" OT BFG43J99 CO O ((wjJJ ** PATH/TDX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWQ-GENERATION reproduction and developmental TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUO ANIMAL NUMBER: 1016 DATE OF DEATH: 04/20/97 SEX: HALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: UZ STUOT MEEK OF OEATH: 16 TERMINAL 0OOY WEIGHT: S ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................ MICRO: -MINIMAL, MULTI-FOCAL -ACUTE/SUBACUTE iNFLAHMATION................................. -SLIGHT HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) NQSE/TURB SEC 2 .................................................. MICRO: -MINIMAL -VQMORONASAL ORGAN: EOS 1NOPHiljc'MATERIAL NOSE/TURfl SEC 3 .................................................. MICRO: -MINIMAL -NASOLACRIMAL OUCT: LYMPHOID HYPERPLASIA -SLIGHT -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRACYT EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 .......................................................................................................................................................................................... MICRO: -SLIGHT -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYT EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO; COAGULATING Gl, EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANOS, NOSE/TURB SEC 1, PITUITARY GLAND. PROSTATE SEMINAL VESICLES, TESTES, TRACHEA BFG43186 KEY TO NEOPLASMS: "H-M MALIGNANT, "8-" BENIGN, METASTATtC. "I-'* INVASIVE, MX-*' OTHER b f g 003318 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 2001 DATE OF OEATH; 04/20/97 SEX; HALE POSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL S/ STUDY OAY OF OEATH; 112 STUDY WEEK OF DEATH; ID TERMINAL BODY WEIGHT; ORGAN NAME **' PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COHMENTS / HISTOPATHOLOI LIVER MICRO; -MINIMAL, FOCAL -MINIMAL. FOCAL :EXTRAHe6(/LLARY HEHATOPOlfSIS -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMAL(TIES OBSERVED ** n O & ll< IQ HO^ H lAl 11,NAN T I MNIgn Nt rtblAMC INVASIVE. "X-" Ol u o 2 e w *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 1018 DATE OF OEATH: 04/28/97 SEX: MAI F DOSE GROUP: 1 SACRIFICE STATU.1;: SCHFDUIFO, TfRMfNAl SACR STUOY OAY OF DEATH: 112 STUOY WEEK OF DEATH: 16 TERMINAL 80DY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................... MICRO: -MINIMAL, MULTI-FOCAL -ACUTE/SUBACUTE INFLAMMATION -SLIGHT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZQNAl LUNGS ............................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -PULMONARY VESSELS: MINERAL DEPOSIT(S) NOSE/TURB SEC 3 .......................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM DEGENERi NOSE/TURB SEC 4 ........................................................................................................................................................................................... MICRO' -SLIGHT -NASAL HUCOSA (OLFACTORY): EPITHELIUM-INTRACY EOSINOPHILIC MATERIAL PtTUITARY GLANO .......................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -PARS DIStALtS: CYSTS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS, MAMMARY GLANDS, NOSE/TURB SEC I, NQSE/TURB SEC 2. PROSTATE GLANO, SEMINAL VESICLES, TESTES, TRACHEA BFG43188 KEYTO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, "h" INVASIVE. "X-H OTHE *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TONICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 2003 DATE OF DEATH: 04/28/97 SEX: HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL $A STUDY DAY OF OEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS fflft'TEXT COMMENTS / HISTOPATHOLOG LIVER .......................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NDN-ZON *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "M-" MALIGNANT, 'B-" BENIGN, "S-H METASTATIC. "1-" INVASIVE:, "X-'* OT BFG43203 09 C5 BFG 003322 03 o ANlHAL NUMBER: 1070 Date of death: 04/20/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COHBINEO INHALATION TU0-GNRAT10k REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU SEX: MALE DOSE GROUP: I SACRIFICE STATUS; SCHEPULEP, TERMINAL SACR STUDY DAY OF DEATH; 117 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION LIVER , , , , MICRO: MINIMAL lungs .... MICRO; MINIMAL, FOCAL NOSE/TURB SEC 2 MICRO: -SliGHT, FOCAL NOSE/TURB SEC 3 ................. MICRO MINIMAl NOSE/TURB SEC 4 Hh BO HINIHAl PAOsMtt (ji anU H|. BO H | h|HAi 1 in A. *** ANIMAL HA1, NO oftu', . ANNOHMAi .' .1. OBSERVATIONS * 4 GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC -HEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-ZONAL -LYMPHOID CELL JNFILTRATE(S)/AGGREGATE(Sj Nasolacrimal duct(s): free erythrocytes' -NASOLACRIMAL DUCT: LYMPHoiD HYPtRPLASiA` HAVAi MlJlOSA lOl^ACIOHY) tPi iHLluH-jNTRACY 1 OS laOPHl l 1C MAI (RIAL i 1 hPhO 10 (III In(IiIRAII(S] /AGGREGATE(S) T ME H)l l M | PNf I IS Sul S haO NO H|HaS\ UPH ABNU*"A| MILS OBSERVED. COAGULANT lil |PlDlDTmfl iICKin NAMMANr OLANOS, NOSE/TUftB SEC I, PITUITARY GLAND. SEMINAL VESICLE TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. *1-" INVASIVE. "X-" OTHE *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION IWO-gCnERATloN REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 2005 DATE OF DEATH: 04/20/97 SEX: HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: LIZ STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-UXT COMMENTS / HiSTOPATHDLOG LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -EXTRAMEDULLARY HEMATOPOIESIS -HEPATOCYTES: CYTOPLASMIC VACUOLES IHON-ZDN *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVE!! *** BFG43205 KEY TO NEOPLASMS: "M-" HALIGNANT. M0-" BENIGN, METASTATIC. "1-" INVASIVE, ''X*" OT b f g 003337 ANIMAL NUMBER: 1022 OATE OF OEATH: 04/29/97 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUC SEX; MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRl STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: J7 TERMINAL BODY WEIGHT; ` ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................... MICRO: -MINIMAL MULTI-FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL, FOCAL -HEPATQCYTES: CYTOPLASMIC VACUOLES (NQN-20NAL) NOSE/TURB SEC 2 .......................................................................................................................................................................................... MICRO; -MINIMAL -NASOLACRIMAL DUCT(S); FREE ERYTHROCYTES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS, LUNGS. MAMMARY GLANOS. NOSE/TURB SEC 1, NOSE/TURB SEC 3, NOSE/TURB PiTUllANY GLANO, PROSTAlE GLAND, SfcMINAL VESICLES, TESTES. TRACHEA KEY TD NEOPLASMS: "M-" MALIGNANT, "B-`* BENIGN, "S-" METASTATIC. "I-" INVASIVE, 'X- OTHER BFG43192 03 c! Uoot Ui to C? <* c> ^7 ANIMAL NUMBER: 2007 DATE OF DEATH: 04/20/97 *** PATH/TOX SYSTEM OUTPUT **'r VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IK CD RATS INDIVIDUAL ANIMAL DATA SHEET SEX: HALE DOSE GROUP; 2 SACRIFICE STATUS: SCHEDULED, TERMINAL S' STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: *** ANIHAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** ts c o O BFG43I94 *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER: 1024 DATE OF DEATH: 04729/97 SEX: HALE OQSE GROUP: l SACRIFICE STATUS; SCHEDULED, TERMINAL SACF STUDY DAY OF DEATH; 113 STUDY WEEK OF OEATN; 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PAtHQLOGY observations * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FfiEE-TCXT COMMENTS / HISTOPATHOLOGIC UVER ............................................................................................................................................................................................................... MICRO: -SLIGHT -HCPATOCYTES; CYTOPLASMIC VACUOLES (H0N-2OHAI N0SE/TUR8 SEC I .......................................................................................................................................................................................... MICRO: -MINIMAL -VOHORONASAl ORGAN; FREE ERYTHROCYTES NOSE/TURB SEC 3 ......................................................................................................................................................................................................... MICRO; -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELlUH-INTftACT EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACT EOSINOPHILIC MATERIAL PITUITARY GLAND MICRO: -MINIMAL, FOCAL -PARS DISTALIS: CYSTS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING Gl, EPIDIDYMIDES. MONEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 2, PROSTATE GLAND, SEMINAL V TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "0*" BfNlGN, **S-" METASTATIC, "I-" INVASIVE. "X-" OTHt CO 3ft Uwtpaosf *** PATH/TOX SYSTEM OUTPUT *" VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET ANIMAL NUMBER: 2000 DATE DP DEATH; 04/20/9; SEX: HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL S STUDY DAY Of DEATH: 113 STUDY WEEK OP DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATHQLO EYES GROSS: -OPACITY -LEFT CORNEA: FOCAL. HIMIHAL *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED **' BFG43209 CO 3 o w La *** PATH/TOX SYSTEM OUTPUT ##* VINYL CHLORIDE COMBINED INHALATION TVO-GENERAtION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 1020 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................ MICRO: -MINIMAL, MULTI-FOCAL -MINIMAL NOSE/TUR0 SEC 2 ...................................................... MICRO: -SLIGHT -MINIMAL NQSE/TURB SEC 3 ...................................................... MICRO: -MINIMAL NOSE/TURB SEC 4 ...................................................... MICRO: -MINIMAL PROSTATE GLAND .......................................................... MICRO: -MINIMAL, FOCAL -acute/subacuTe Inflammation -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL -NASOLACRIMAL DUCTfsj:'MUCOSA-SUBACUTE'(CHRON CHRONIC INFLAMMATION -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -NASOLACRIHAL DUCT; LYMPHOID HYPERPLASIA -NASALHUCOSA (OLFACTORY)lEPITHELlUM-iNTRACY EOSINOPHILIC MATERIAL *LVMPHOfD CfLi INFILTRATE(5)/AGGREGATE(S) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OflSERVEO: COAGULATING GL EPIOIOYMIOES. KIDNEYS, LUNGS. MAMMARY GLANOS, NOSC/TURB SEC 1, PITUITARY GLAND, SEMINAL TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "ft-" BENIGN, "S'" METASTATIC. INVASIVE. "X-" OTHE ** PATH/TOX SYSTEM OUTPUT *** VtNVI CHLORIDE COMBINED INHALATION TVO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 2011 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * ` * KEYWDROS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER ........................................................................................................................................................................................... MICRO: -MINIMAL. FDCAL -EXTRAMEDULLARY HEMATOPOIESIS irtv 9 ia ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** Iff T 0 fcf 0L ISM , 91 N I (ill. Ml 1 AS IA t K "l" INW AS 1 v. "X-" OT m m ms *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET $Tl ANIMAL NUMBER: 1028 DATE OF DEATH: 04/29/37 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACF STUDY DAY OF DEATH; 113 STUOY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER , . . . MICRO: NOSE/TURB SEC 3 MICRO: -MINIMAL,' multi-focal' -MINIMAL ...................... -MINIMAL -MINIMAL, FOCAL NOSE/TURB SEC 4 MICRO: -SliGHr' -MINIMAL, FOCAL PROSTATE GLAND MICRO: -MODERATE, MULTI-FOCAL -ACUTE/SUBACUTE jNFLAHMATION.................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAl -NASAL'hUCQSA (OLFACTORYj: EPITHELIUM-iNTRAri EOSINOPHILIC MATERIAL -NASAL MUCOSA (RESPIRATORY); BASOPHILIC HATES -NASAL MUCOSA (01 FACTORY); [PlTHELlUH-INTRAC1 EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY)! BASOPHILIC MATERIA -LYHPHGIO CELL IMFILFRATEfS)/AGGREGATE(S) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS. LUNGS. MAMMARY GLANDS, NQSE/TURR SFC 1. NOSE/IURB SEC 2, PITUITAI SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. MB-" BENIGN, "5-" METASTATIC, "I-" INVASIVE. "X-" OTHE BFG43198 09 o <P LtJ o ANIMAL NUMBER: cOJ3 DATE OF DEATH; 04/29/97 *** PAfH/TOX system output ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SEX: MALE DOSE GROUP; Z SACRIFICE STATUS: SCHEDULED. TERMINAL 5< STUOY DAY OF DEATH; 113 STUDY WEEK OP DEATH; J7 TERMINAL DQOY WEIGHT; ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *"* *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** ANIMAL NUMBER: 1030 DATE OF DEATH: 04/Z9/97 *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION IVO-GLNfcRATJON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR STUDY OAY OF OEATH: US STUDY WEEK OF DEATH: l? TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION KIDNEYS ........................................................................ MICRO: -MINIMAL, FOCAL LIVER ............................................................................ MICRO: -MINIMAL, MULTI-FOCAL NOSE/TURB SEC 2 -MINIMAL .................................................................... MICRO; -MINIMAL NOSE/TURB SEC 3 Hlf HO HlhIHAi NOSI/TURH Sf< 4 It BO `ill 1.11 OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC -MEDULLA: CYST ACUTE/SUBACUTE iflFLAMMATJON.................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL -NASOLACRIMAL OUCT(S);'FREE ERYTHROCYTES' NASOlA( 0 IHAl DUCT IYHPHOID HVPFRPl HA',AI HiKO.A (Ol F II T ORv | I PI THE LIUM -1NTRACY lUSIVOPHliK HAl EM 1AL AM [ HAl 1A\ l I ;* . HVlMtJ I Hi f Ol I OW I MS'.jIV 1*0 NO [( to-., i't l. ANNyiM i | T I ( \ 0 ^ t fl Vf 0 t, OAtiUi A T | NO 1*1 mOID'Hlon iu*<.S HAHHAll (,,.AiOS, iOSC/U>fl| SIC I. Pi Y U11 Aft t GLAND, PROSTATE GLAND. S , HUES IRACHtA BFG43200 KEY TO NEOPLASMS: '*M-" MALIGNANT, "8-" BENIGN, "S-" METASTATIC, **I>** INVASIVE. "X-" OTHEI CO nn O oj TO *** PATH/TOX SYSTEM OUTPUT **" VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 2015 DATE OF DEATH: 04/23/g7 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED. TERMINAL S/ STUDY DAY OF DEATH: 112 STUOY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY 0 bservations * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOC LIVER . . MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KLr TV NEOPLASMS: "M-" MALlONANT, "0-" BENIGN, "S'" METASTATIC, "1-" INVASIVE, **X-" 01 CO Cl e> o U* *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER; 2002 PMC OF DEATH: 04/28/97 SEX: MALE OOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SACR STUDY DAY Of DEATH: ||2 STUDY WEEK Of DEATH: 16 TERMINAL 600Y WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ........................... MICRO: MINIMAL,'FOCAL......................................................-EXTRAMEDULLARY HEMATOPojC51S *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED KEY TO NEOPLASMS MALIGNANT B-" BENIGN. "5-" METASTATIC `[-M INVASIVE, "X-" QTNE BFG43202 S3 o & *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET Si ANIMAL NUMBER: 2017 DATE OF DEATH: 0A/2B/97 SEX; HALE DOSE GROUP; 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH; 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HIST0PATH0L06I EYES.......................................................... GROSS; -OPACITY LIVER ...................................................... MICRO: -MINIMAL -LEFT CORNEA; FOCAL. MINIMAL HEPATOCYtES: CYTOPLASMIC VACUOLES {N0N-Z0N7 KEY TO NEOPLASMS: "H-" MALIGNANT, V* BENIGN. "S-" METASTATIC, "l-" INVASIVE, "X-" QTI BFG43217 b f g 003349 e | <n t ae a b < ^ a) o s | J | | Nd OV | | ey U 4^ ac LkJ X *. B ^< a 9 Kb X u rs ae X U b M0> b U. BB a wie trt <5 X 4-- a ^9 W. | | | | | | | | | A| 9 at -* u (rt <c IA >> b- u o _i | | E| | | 31 | | H_ UJ X; at UJb e_ O M- o| | _ t 1 trt t--o 9 trt UJ | i| ID 9 3t s | UJ--J > in <_i 4 _l 4 3Z 4 1/1 Dh `4fl> LlJ 1 1 LlJ E 4 trt > -- <_) 1 -C EB Ot-- 1 XB a UU l^H X D- X 1 LkJ 9 trt 4 --o t i-- i_ - X 4 --J \ C irt ED i Eb 1 O' E 9 O UJ o 4 UJ i-h b O Z< X 1-- N- 1 1 LkJ b b MM -^U t tS 9 * i 5 9 1-- UJ Jwtu ind bb w u u un i ^Ui CE 4 w trt 1 __1 UJ l 1 l 1 k-t- X a b trt B- E B*> 1-- a -- 3hUN a h- <XQ X --> O UJ < t- -J 1-- 3= - trt X ^ X ^9 VTW |-- -BX U. VH< at w u5 5e V)lb Q U W u UJ >X L. CC 4/) LlJ trt o trt tt 40 X 5t- - a >- UJ u -X9 3b - ae 4 1- b - K UJ - UJ X i 1 1 4 1 4 1 1 1 1 i 1 1 v> f-- 3 1 i MU W <m b 1 C>z X -I i-- -- 05 ZZ JO i-OUJ- uoa <o 4 z a -- 3 n_ i-- g t/i JB b iO lii V) N >- z fia -- _j ^ o oa t--t 1 1 1 \ l I 1 i t4 1* 4 Of Z o^ _d Oh a hb X ^ u> j* 1o X uo u *~ ^ LJ X9 --a >9 s a. s <a t-- ; b uj a ^9 b 4X a UJ 4> _^j -4 1 UJ i > i B i UJ * <n 1a iD t 1 un 1 UJ UJ UJ>- LU u V 4 4rt -e <a u X* b Irt * >B CO -rJ 1 1 N-t 1 ^B 1 13 1r X3 WN U> (A <- 1V 2 S - 9 4--j i9 1X i9 u --^ !< Id X trt 4 1I 1 trt 4 V) 4a O at i at 49 a `U 4 1a 9 X 1 1 'B. 1 trt 94- 44 PJO 1X 1 .. i. KX uJb s< Eb 30 ItJ x 9 1 bJ 1 1X 1 HI 1X I X b za 4 IdJ 1 1 -JO c Zb Is o> a e _J 1 4* 1 1 1 1 1 1 1 1 t 4 1 1 4 1 1 4 1 l J 4X 4 UJ 1X 1 4-- ia i ii 4X i* j 4 | 1U 1 i trt 1* 1 1Z | ^9 1 1* 11 MX 1 | l <mi l *--1 4U I< 4f trt 4< 1 4^ 4U 4Z 4 4i 11 1 trt 4Z 1 1 4* lX ' <5 i 1K 1U ia i it ii 1 4D 1V 1 1 1 1 iX 1< 1X 1 LS 1 _1 i< iX 1 tI 4X 4S 4 J trt iX 1 <rt i^ i .J b *e UJ 4X 4 o 4^ 4 4 >l UJ 4W i 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 BFG43204 BFG 003336 ANIMAL NUMBER: ZOIR DATE OF DEATH: 04/28/97 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal DATA SHEET S SEX: MALE DOSE GROUP: l SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: *** ANIMAL HAS NO CROSS ABNORMALITIES OBSERVED *** ft** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *" PATH/TOX SYSTEM OUTPUT *** VINYL CHLORJ0E COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 2006 PATE OF DEATH: 04/28/97 SEX: HALE POSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 112 STUOY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 4 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................ MICRO; -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** to KEY TO NEOPLASMS: "M-* ' MALIGNANT. "B-" BENIGN, "S-" METASTATIC. " !INVASIVE, "X-" OTHER o U) N> o o\ m **3 o 9 e u IjJ oe *** PATH/TOX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS TNOtVlOUAL ANIMAL DATA SHEET i ANIMAL NUMBER: 2021 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEOULFD. TERMINAL SJ STUDY DAY OF DEATH: 1)2 STUDY WEEK OF DEATH: 16 TERMINAL BOOT WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOt GROSS/MICRO CORR . . MICRO: HtSTOPATHOLOGICAl COMMENT: >LIVER: NODULE/MASS ACC LOBE/NMC LIVER ................................................................................................................................................................................................ GROSS: ND0UIE($)/NA5S(ES) MICRO; MINIMAL, FOCAL -MASS. ACCESSORY LODE: M CM 0|A -EXTRAMEDULLARY HEMATOPOIESIS TESTES ........................... GROSS INlARGfD, SUGHt -LEFT M * M) K! L fl * *Ai i .*i*: #1 " Mi J i.*l "*> ` Ml 1 AM Al 1C . "1" INVASIVE , "X-" 01 BFG43221 BFG 0D3353 ANIMAL NUMBER: 2008 DATE OF DEATH: 04/29/97 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COHSINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUI SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 113 STUDY MEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ! "* ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS MO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG432G8 bfg 003340 CD O UJ NJ K) UJ ANIMAL NUMBER: 2073 DATE OF DEATH: 04/20/97 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWQ-GfNfRATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET S SEX: MALE DOSE CROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SA STUDY DAY Of DEATH: 112 STUOY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLDGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS *** GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER ...................................................................................................................................................................................................................................... MICRO: -SLIGHT -HFPATOCYTFS: CYTOPIASMIC VACUOLES (NON-ZON *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "8-" BENIGN. "S-" METASTATIC. "l-H INVASIVE, "X-" OT cs C5 (jj w *" PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY JN CO RATS INDIVIDUAL ANIMAL DATA SHEET STM ANIHAL NUMBER: 2010 DATE OP DEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR1 STUDV DAY OF DEATH: 1)3 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ' ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL -MEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONALj *** ANIMAL HAS NO GROSS ABNORMALITIES 08SERVE0 *** KEY TO NEOPLASMS; "M-" MALIGNANT, "8 " BENIGN. HS-" METASTATIC, "I-" INVASIVE, "X-" OTHEl % % % S3 *13 a <z> o -t* cn B O a ro CO U\ *** PATH/TQX SY5TEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIHAL DATA SHEET ST ANIHAL NUMBER: 2025 DATE OP DEATH: 04/29/97 SEX: HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGI LIVER .......................................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (N0K-20NA *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED "* KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "1-" INVASIVE, ''X'*' OTH od O 9 uIJl *** PATH/TOX SYSTEM OUTPUT *** VIKU CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND OEVELOPHENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU AN[HAL NUMBER: 201? DATE OF DEATH: 04/29/97 SEX: HALE OOSE GROUP: 2 SACRIFICE STATUS. SCHEDULED. TERMINAL SACR STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: NO ORGAN NAME * * p PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -EXTRAMEDULLARY HEMATOPOIESIS -HEPATOCYTES: CYTOPLASMIC VACUOLES (NoN-ZONAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED "* KEY TO NEOPLASMS: V MALIGNANT, "0-" BENIGN. "S'" METASTATIC, "l-" INVASIVE, "X-" QTHEI BFG43212 bfg 003344 **' PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 2027 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY DAY OF DEATH: 113 STUDY WEEK Of DEATH: 17 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / M15TOPATMOLOGI EXTREMITY .................................................................................................................................................................................. GROSS: -HAIR ABSENT/THlN. SLIGHT -HAIR ABSENT. BOTH FOREPAWS LIVER ............................................................................................................................................... ............................................ MICRO: -MINIMAL. FOCAL -EXTRAMEDULLARY HEMATOPOIESIS KEY TO NEOPLASMS: "M-" MALIGNANT. "B*" BENIGN. "5-" METASTATIC. *1*" JNVA5IYE, "X-" OTH CO 3 o 4^ U> NJ BFG 003359 *** PATM/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER; 2014 DATE OF DEATH; 44/29/97 SEX; HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAY OF DEATH; L13 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ................................................................................................................................................................................................................................ MICRO; -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS BFG43 *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NFQPLASHS: "M-u MALIGNANT, "B-" BENIGN, "S-" METASTATIC, INVASIVE. MX-" OTHf ANIMAL NUMBER; 2029 DATE OF OEAtH: 04/29/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GEnERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET SEX; MALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SI STUDY DAY Of DEATH; 113 STUDY WEEK OF DEATH; 17 TERMINAL BOOT WEIGHT: ** ANIMAL HAS NO GRDSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** U) K) K> BFG 003361 *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER; 2016 DATE OF DEATH: 04/28/97 SEX: MALE DOSE CROUP; 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR1 STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BOOY WEIGHT: S ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC ADIPOSE TISSUE LIVER . - . GROSS: -NODULE(5)/MASS(ES) MICRO: -MINIMAL. FOCAL -MINIMAL -NODULE, ABDQHiNAL: 0^2 X 0^4 CM, tan' F|ftM -EXTRAMEDULLARY HEMAtOPoifSlS -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) KEY TO NEOPLASMS: MALIGNANT, "B-" BENIGN, "S-" METASTATIC, I- INVASIVE. X-" OTHEfl BFG43216 b f g 003348 ANIMAL NUMBER: 3001 DATE OF DEATH: 04/26/97 ORGAN NAME *** PATH/TOX system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET SEX: HALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL S STUOY DAY OF DEATH; 112 STUDY WEEK OF DEATH: |6 TERMINAL BODY WEIGHT: * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREEZE*! COMMENTS f HISTOPATMOLO LIVER MICRO; -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION............................ -HEPATOCYTCS: CYTOPLASMIC VACUOLES (NON-ZO ANIMAL HAS NO GROSS ABNORMAL IT US OBSERVED ** 1(1 !0 llll'i , Al |t>A' 0 e( N|uH Ht JAUAKC , "l ' INVAiUf, "X-" 0 BFG43231 b f g 003363 *** PATH/TOX SYSTEM OUTPUT *** VJNTL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUI ANIMAL NUMBER: 2018 DATE OF DEATH: 04/20/97 SEX: HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR] STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BOOT WEIGHT: ! ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREI-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ................................................................................................................................................................................................................................ MICRO: -MINIMAL -HEPATQCYTES: CYTOPLASMIC VACUOLES (NON-ZONAl *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED '** I I U) M! tjYi A\**S m Ml HIN[<>N " HflASIAIIC. "I-" INVASIVE, "X*" OTHEl BFG43218 09 5 o o 'J\ to O u> NJ U> PATH/TOX STSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIHAL DATA SHEET SI ANIMAL NUMBER; 3003 DATE OF DEATH; 04/ZB/97 SEX; HALE DOSE GROUP; 3 SACRIFICE STATUS; SCHEDULED. TERMINAL SAI STUDY DAY OF DEATH; HE STUDY NECK OF DEATH; Jfi TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS "** KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPAThOLoG LIVER ................................................................................................................................................................ MICRO; MINIMAL. FOCAL -PEL[OSf5 HERATIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "H-" MALIGNANT. "B-" BENIGN, "S-n METASTATIC. MI-H INVASIVE, OTI u w 8 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 2DZQ DATE OF DEATH; 04/29/97 SEX: HALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED. TERMINAL SACK] STUDY DAY OF DEATH: 113 STUDY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: 5 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERlTT. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................................................ MICRO; -MINIMAL, FDCAl -EXTRAMEDULLARY HEMATOPOIESIS *** ANIMAL HAS ND GROSS ABNORMALITIES OBSERVED *** KtY TO NEOPLASMS: "M-" MALIGNANT. "6-" BENIGN. "S-" NETASTATIC. "l`" INVASIVE, "X-" OTHER do 2 O 4^ U) N> K> O BFG 003352 "* PATM/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET Si ANIMAL NUMBER: 3QOS DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY DAT OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / H1STOPATHOLOG1 LIVER M1CR0:'-MINIMAL.'FOCAL MINIMAL -ACUTE/SUBACUTt INFLAMMATION HEPATOCYTES CENTRILOBULAR: HYPERTROPHY ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED ** KEY TO NEOPLASMS: "N-" MALIGNANT, "R-" BENIGN, "S-" METASTATIC, I- INVASIVE, on 03 O LO N> ho N> *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE CONBINEQ INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAt TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD' ANIMAL NUMBER: 2022 DATE OF DEATH: 04/20/97 SEX: MALE DOSE GROUP; 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRII STUDY DAY OF DEATH; II? STUDY UEEK OF OEATH: 16 TERMINAL BODY WEIGHT: 51 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I LIVER MICRO: -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY 10 NEOPLASMS: "M-*' HAllGNANT, "B-" BENIGN, "S-M METASTATIC, "I-" INVASIVE. "X-" OTHER W 3 o u> w se *** PATH/TOX SYSTEM OUTPUT ft* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S' ANIMAL NUMBER: 3007 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAI STUDY DAY OF DEATH: ljZ STUDY UEfK OF DEATH: )6 ttRHlNAL BODY VElGHt: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS f HISTOPATHOLOG LIVER MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION "** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO ffl KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, V" METASTATIC, 'I-' INVASIVE. X* OT o u> to 3 a o o O' *** PATH/TQK SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 2024 DATE OF DEATH: 04/26/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: UNSCHEDULED (D| $TUOY DAY OF DEATH: 110 STUDY WEEK OF DEATH; 16 TERMINAL ?ODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC EXTREMITY . . GROSS: -SWOLLEN, SLIGHT KIDNEYS . . . GROSS; -fNLARGfP, SUM -DILATATION URINARY BLADDER GROSS: -DISTENDED, SEVERE -RIGHT HI NOPAW -DOTH -RIGHT PELVIS: EXTREME; LEFT PELVIS: MODERATE -WITH THIN RED FLUID *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** td n O 4^ 10 -H- BFG 003356 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLGAIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 3009 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HIStOPATHOLOG EARS . . . LIVER . . GROSS; -SWOLLEN, MODERATE MICRO: -MINIMAL -MINIMAL -BOTH -HEPATOCYIES: CYTOPLASMIC VACUOLES (NON-Z0N -HEPAT0CYTE5 CENTRILOBULAR; HYPERTROPHY ------ Cd T! KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" DT *" PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWQ-GENERATlON REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CP RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 2026 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDUIFO. TERMINAL SACH STUOY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ................................................................................................................................................................................................................................ MICRO: 'MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS -SLIGHT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-20NAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *" KEY TO NEOPLASMS: "M-" MALIGNANT, "B*" BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-H OTHE 03 T1 O L>> to O' BFG 003358 *** PATH/TOX SYSTEM OUTPUT It ft ft VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET S ANIMAL NUMBER: 3011 DATE OF DEATH: 04/28/97 SEX: HALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEDULED. TERMINAL SA STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH; 16 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES DESERVED *** 4L f 10 MQAlASMS, HAL 1. I " BUliin, V" ML IA& TAT 1C. "1-" INVASIVE, "X-" OT ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GtNERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STl ANIMAL NUMBER: 2028 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACf STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * 1 KETWOROS, SEVERITY, DISTRIBUTION GROSS FRCE-TEXT COMMENTS / HlSTOPATHOLOGK LIVER ............................................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZONAl SEMINAL VESICLES * .................................................................................................................................................................................................... GROSS: -SMALL, MODERATE -LEFT HORN KEY TO NEOPLASMS: "M-" MALIGNANT, "fi-1' BENIGN, "S-" METASTATIC, INVASIVE, "A-" OTHf 03 o ft N> N> 00 BFG 003360 *** pmh/tqk system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IK CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 3013 DATE OF DEATH: 04/26/97 SEX: MALE DOSE GROUP; 3 SACRIFICE STATUS; SCHEDULED, TERMINAL SACK STUDY DAY OF DEATH: 112 STUDY WEEK OF OEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION DROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATQCYTES; CYTqPlASHIC VACUOLES (NON-Z0NAI -PELIOSIS HEPATIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE, "X-" OTH< BFG43243 03 *TJ a o r9jJ U-4> <J\ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COHBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL HUMBER; 2030 DATE OF DEATH; 04/29/97 SEX; HALE DOSE GROUP; 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRJ STUDY DAY OF DEATH; 113 STUDY WEEK Of DEATH: IT TERMINAL BODY WEIGHT: 5 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, OtStRlBUTtON GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO:'-MINIMAL.'FOCAL -MINIMAL :EXTRAHe6uLIARY HEMATOPOIESIS -HEPATOCYTfS: CYTOPLASMIC VACUOLES (NON-ZONAL) ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *"* KEY TO NEOPLASMS: "M*" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "|-" INVASIVE. "X-" OTHER w % o 4^ U) U> O BFG 003362 to 3 U) ro U\ *** PATH/TOX SV$TEH OUTPUT VINYL CHLORIDE COMBINED INHALATION TUO-GEHERATION REPRODUCTION AND DEVELOPMENTAL TOXtClTY STUDY IN CD RATS individual animal data sheet s ANIMAL NUMBER: 3015 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMtNAL S* STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTOPATHOLDC LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS ND GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN. 'V" METASTATIC, "!-" INVASIVE, "X-" 01 *1 Cl oo u> u *** path/tqx systeh output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 3002 DATE Of DEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR STUDY OAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL HEPATOCYTES: CYTOPLASMIC VACUOLES (NON'ZONAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, METASTATIC. "I-" INVASIVE. "X-" OTHEI *" PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 3017 DATE OF DEATH: 04/26/97 SEX.- MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL $A STUDY DAY OF DEATH: 1U STUDY WEEK OF DEATH: 16 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FftU-TEXT COMMENTS / HISTOPATHOLOG LIVER MICRO: -MINIMAL, FOCAL ^MINIMAL. FOCAL -MINIMAL -EXTRAMEDULLARY HEMATOPOIESIS -ACIITE/SUBACUTE INFLAMMATION -HEPATOCYTES CCNTRtLQBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** BFG KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "l-" INVASIVE, V" Ol ANIMAL NUMBER: 3004 DATE OF DEATH: 04/2B/97 *** path/rox system output *** VINYL CHLORIDE COMBINED INHALATION TwO-GEnERATioN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD SEX; MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACKI STUDY DAY OF DEATH: 11Z STUDY MEEK OF DEATH: U TERMINAL BODY HEIGHT; 5. ORGAN NAME * * * PATHOLOGY OBSERVATIONS * ` * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEUT COHHENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL, FOCAL -MINIMAL 'ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** key'To'SioPLisMS:""M-'^MALIGWAriT, "B-" BENIGN, "5-" METASTATIC, MI-" INVASIVE, OTHER ANIMAL HUMBER: 3019 DATE Of DEATH: 04/29/d? ** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SEX: HALE 00$E GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL Si STUDY DAY Of DEATH: 113 STUDY WEEK Of DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOl LIVER . . H1CR0: -MINIMAL -MINIMAL -HEPATOCYTES. CYTOPLASMIC VACUOLES (NON-ZOI -HEPAtQCYTES CENTRILOBULAR: HYPERTROPHY to 3 O a u> K) -fc. *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** tO NEOPLASMS: "M-" MALIGNANT, BENIGN, "S-" METASTATIC, "1-" INVASIVE. "X`" 0 BFG 003381 *** PATH/TO* SYSTEM OUTPUT *** VINYL CHLORIDE COMBIAEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET STUD' ANIHAL NUMBER; 3006 DATE OF DEATH; 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR1I STUDY DAY OF DEATH; 1L2 STUDY WEEK Of DEATH; 16 TERMINAL BODY WEIGHT; 4! ORGAN NAME * * PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS LIVER GROSS: -DILATATION. MODERATE micro:'-minimal,Vocal' -RIGHT PELVIS `ACUTE/SUBACUTE INFLAMMATION KEY TO NEOPLASMS; "M-" MALIGNANT, "B-`* BENIGN. `V METASTATIC. "I-" INVASIVE, "X-" OTHER Ctf *T\ o 93 3 N> <3n O & GO *** PATH/TOX SYSTEM OUTPUT *M VINYL CHLORIDE COMBINED INHALATION TWD-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SI ANIMAL NUMBER: 3021 DATE OF DEATH: 04/29/97 SEX: MALE DOSE 6R0UP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY DAY OF DEAtH: 113 StlitJY WEEK Of DEATH: 17 TERMINAL 80DY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * h KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE*TEXT COMMENTS / HISTOPATHOLOGl L l VCR MICRO:'-MINIMAL, FOCAL -SLIGHT -ACUTE/SUflACUTE INFLAMMATION............................... HEPATOCYTES: CYTOPLASMIC VACUOLES (N0N-20N7 "* ANIMAL HAS NO GROSS ABNORMAL MIfS OBSfRVfO *** 11 t 'It N| 5P| 4-.tr. h 4i | , mAn? 01 Ah-* HflASIAtJC, INVASIVE. "x-" on BFG43251 BFG 003383 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE CONBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUl ANIMAL NUMBER: 3008 DATE OF DEATH: 04/26/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACK STUOY DAY OF DEATH: |12 STUDY MEEK OF DEATH: 16 TERMINAL BOOT VEI6HT: ! ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO; -MINIMAL, FOCAL -MINIMAL ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NOM-ZONAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSEIVIO " <| 10 kl 0*, AS*\ ' hAl 1 l*AAllf I " {!(* Hi I AS t A tIC, "I " INVASIVE X-" OTHt % o & G oo 0 : 0 0 *** PAIM/TDX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENEftATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S' ANIMAL NUMBER: 3023 DATE OF DEATH: 04/29/97 SEX: MALE DDSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL 5*1 STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL 60DY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREC-TExT COMMENTS / HtSTQPATHOLoG LIVER ........................................................................................................................................................................................................................... MICRO: `MINIMAL -HEPAIOCntS CENIRILQBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "N-m MALIGNANT "B-" BENIGN "S - METASTATIC I-" INVASIVE, "X-" 0T| ** PATH/TOX SYSTEM OUTPUT *#* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION reproduction and developmental toxicity STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUt ANIMAL NUMBER; 3010 DATE OF DEATH; 04/29/97 SEX: MALE OQ$C GROUP; 3 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRl STUDY OAT OF DEATH; 113 STUDY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: ' ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORD5, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO; -MINIMAL, FOCAL -MINIMAL -ACUTC/SURACUTE INFLAMMATION -HEPATOCYTE5 CENTRILOBULAR; HYPERTROPHY '** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "l-H INVASIVE, "X-" OTHEI CD 3 TO u *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET $T ANIMAL NUMBER: 3025 DATE OF DEATH: 04/t3/*7 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY PAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGl LIVER .......................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SU8ACUTE INFLAMMATION MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -MINIMAL -HEPATOCYTES CENtAIlDftM.AR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED **' KEY 10 NEOPLASMS: "H-" MALIGNANT B-" BENIGN METASTATIC, "J-" INVASIVE, `'X"" OTH CO **1 a o w 00 -T "* PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND PEVELOPNENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUO Animal Number: jqiz DATE OF DEATH: 01/28/97 sea.- male dose group3 sacrifice status: scheouled, terminal sacRi STUDY DAY OF DEATH; 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY HEIGHT: 5 ORGAN NAME * * * pathology KEYWORDS, SEVERITY. DISTRIBUTION observations * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER .................................................. MICRO: -MINIMAL -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZOMAL) -HEPATOCYTES CENTRIL06ULAR: HYPERTROPHY *** ANIMAL HAS MO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "M-" MALIGNANT, "S-" BENIGN, "S*" METASTATIC. INVASIVE. V" OTHER BFG43242 W o LJ --1 -Lfc *** PATH/IOX SYSTEM OUTPUT "* VINYL CHIQPIDE COMBINED INHALATION TWO-GENftATION REPRODUCTION And DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 3027 DATE OF DEATH: 04/Z9/97 SEX; MALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FRfE-TEXT COMMENTS / HISTOPATHOLOGI LIVER .......................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -MINIMAL -HEPATOCYTES CENTRllOBULAR: HYPERTROPHY BFG43257 ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. "l-" INVASIVE, "X-" OTH *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STl ANIMAL NUMBER: 3014 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACK STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOY HEIGHT: ORGAN NAME * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL -MINIMAL -HEPATOCYTES CENTRUOBUIAR: HYPERTROPHY "* ANIMAL MAS NO GROSS ABNORMALITIES OBSERVED ** KEY TO NEOPLASMS: MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTHE to td >TJ 0 U) to 01 so PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION tWQ-GENCRATlQN REPRODUCTION AND DEVELOPMENTAL TOXICITT STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 309 DATE OF DEATH; 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUOY DAT OF DEATH: 1U STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: ORGAN NAME * 4 * PATHOLOGY OBSERVATIONS 4 ` 4 KEYWORDS. SEVERITY. DISTRIBUTION GROSS FftEE-TEXT COMMENTS / HISTOPATH0L0GI LIVER MICRO: `MINIMAL, FOCAL -MINIMAL ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: cytoplasmic VACUOLES (NON-ZONA *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVE0 "* KEY TO NEOPLASMS; "H" MAI IGNANI. "B-" BENIGN. "S-" METASTATIC. *'l-" INVASIVE, "X-MOlh CD ft O 8 *** PAtH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUI ANIMAL HUMBER: 3016 DATE OF DEATH: M/Zfl/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR! STUDY DAY OF DEATH: 112 STUDY WEEK OF OEATH: 16 TERMINAL BODY WEIGHT: 1 ORGAN NAME * * * PATHDLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL. FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CINTRILOBULAR: HYPERTROPHY ANIMAL MAS NO GROSS ABNORMALITIES OBSERVED KEY TO NEOPLASMS: "H*" MALIGNANT, "fl-** BENIGN, "S-" METASTATIC, 'l**' INVASIVE, "X-" OTHEi tx> O VJ* N) ON BFG 00337^ *** PAYH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $T ANIMAL NUMBER: 4001 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY DAY OF DEATH: 1|Z STUDY WEEK OF DEATH: IB TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS 444 KEYWORDS. SEVERITY. DISTRIBUTION 6RQSS FREE-TEXT COMMENTS / HISTOPATHOLOGI EPIDIDYMIDES . LIVER . . . . NOSE/TURB SEC 3 NOSE/IlIRft Ml 4 MICRO: MICRO: MICRO H l( 40 -MINIMAL, -MINIMAL -MINIMAL \l I |Hl HISTOPATHOLOGICAL FOCAL COMMENT: >ONE PRESENT -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRIL08ULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY); EPITHELIUM-1NTRAC EOSINOPHILIC MATERIAL HtuO'.* iftlUClOfir) fPI THEUUM- I NTRAC lOSlHOPHU K NAT(R|AL * * * In | hAi mas nO .* j . apndNma, | , dam 11: * *' Inf f Oi l I ISS. I s MO ; 0'. ot-1 AANOfHAi I HI S OBMAvlD (OAf.Ul Al (Au ul (P!OICniD<', tu(,S MAh*UR? OlANOi. NOSl/TUBB MI ), NUSf/IURft SIC 1, P1 TO 1 * A PROS I AM blANO MMlAAc IlilCUS HSUS IIACHlA KEY TO NEOPLASMS; "H-" MAI IGNANT. "S-*' BENIGN, METASTATIC. `'I-" INVASIVE. "X-" DTE BFG43261 a G V* *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION THD-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 3018 DATE OF OEATH: 04/26/97 $CX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR] STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: IB TERMINAL BODY WEIGHT: 5 ORGAN NAHE * * * PATHOLOGY OBSERVATIONS KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-tEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -ACUU/SUBACUTE INFLAMMATION -HEPATOCYTE5 CENTRILOBULAR: HYPERTROPHY "* ANIMAL has no GROSS ABNORMAL 1TIFS OBSERVED *** KM to *| or A'.H', " U| | l**Ml AINU.* S ' Ml IASI At IC INVASIVE. "X" OTHER BFG43248 o o V* ut oo sCO -{X U> ro Q\ U) *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 4003 DATE OF DEATH: 04/26/97 SEX: MALE DOSE CROUP: 4 SACRIFICE STATUS: SCHF01IIFD, TERMINAL SA STUDY OAY OF DEATH: IU STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME ** pathology OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG EPIOIOYMIDES ....................................................................................................... MICRO: HISTOPATHOLOG1CAL COMMENT KIDNEYS ................................................................................................................ MICRO: -MINIMAL, MULTI-FOCAL LIVER ........................ *.............................................................................................. MICRO: -MINIMAL. FOCAL -MINIMAL -MINIMAL NOSE/TURB SEC 3 MICRO: -MINIMAL NOSE/TURB SEC 4 .............................................................................................. MICRO; -MINIMAL >ONE PRESENT -INTERSTITIAL NEPHRITIS SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES {NON-ZON -HEPATQCYTE5 CCNTRtLOBULAR: HYPERTROPHY :NASAL`muc6sA (OLFACTORY): EPlTHEliuM-iNTRA EOSINOPHILIC MATERIAL NASAL MUCOSA jOLFACTORYj: FPITHELIUM-INtRA EOSINOPHILIC MATERIAL ANIMAL HAS NO GROSS ABNORMALITIES OBSCRVtO *** THE FOLLOWING TI5SUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2. PITUITARY GLANO PROSTATE GLAND. SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: V MALIGNANT, "B-*" BENIGN, "S-" METASTATIC, "I-- INVASIVE, "X-" QT B d o o Ui l+l "* PAlH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TwO-GENERAtlON reproduction ano developmental toxicity STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUI ANIMAL NUMBER: 3020 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEDULED, TERMINAL SACK STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXI COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL -MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES'(NOH-ZONAL 'HfPATOCYTES CfNTft)LOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "H-" MALIGNANT, "& " PENJGH, MS'" METASTATIC, MI-" INVASIVE, MX`" OTMEl 10 2 O u> K> o zsetoo M S *** PATH/TOX SYSTEM OUTPUT VINYL CHL0RI0E COMBINED INHALATION TWD-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIHAL DATA SHEET ANIMAL NUMBER: 4005 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULEO, TERMINAL S< STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: Lfi TERMINAL 800V WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHDLOI EPIOIDTMIOES . MICRO: Liver . . . . MICRO: 'MINIMAL NOSE/TURB SEC 1 MICRO.1 'MINIMAL SLIGHT NOSE/TURB SEC 2 MICRO: -MINIMAL NOSE/TURB SEC 3 MICRO: -SLIGHT NOSE/TURB SFC 4 MICRO: -SLIGHT PROSTATE GLAND MICRO: -MINIMAL, H1ST0PATHDL0GICAL COMMENT: FOCAL >ONE PRESENT -HEPATOCYTES CENTRilOBULAR: HYPERTROPHY -ODONTOPATHY -NASAL MUCOSA (RESPIRATORY); GOBLET CELL HI -ODONTOPATHY -NASAL MUCOSA (OLFACTORY): EPITHCLlUH-INTW EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): LPI THELlUM-[NTRJ EOSINOPHIL 1C MATERIAL ALVEOLAR l.UMFNS: CORPORA AMYLACIA/MINFRAL ANIMAL HAS NO GROSS ARNQRMAIIT1ES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS PITUITARY GLAND. SEMINAL VESICLES, TESTI KtY to NEOPLASMS: "M-" MALIGNANT. "B*" BENIGN, 'V METASTATIC, "I-" INVAStVE. "X-" 0 *** PATH/TQX SYSTEM OUTPUT VlNYU CHLORIDE COMBINED INHALATION TWO'GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY ]N CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER; 3022 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULEO, TERMINAL SACRIF STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT; 45 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F LIVER ............................................................... MICRO: 'MINIMAL, FOCAL `MINIMAL `ACUTE/5U6ACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: hH-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "l-" INVASIVE, "X-" OTHER td *T\ O t* 03 to to BFG 003384 '** PATH/TOX SYSTFM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 4007 DATE OF DEATH; Di/26/97 SEX; MALE DOSE GROUP: 4 SAGRIHCE STATUS; SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS fREE-TEXT COMMENTS / HIST0PATHOL0G EPIDIDYMIDES . MICRO; -TISSUE HISSING KIDNEYS . . . MICRO: -MINIMAL. FOCAL LIVER , . . . MICRO; -MINIMAL, FOCAL -MINIMAL NOSE/TURB SEC I MICRO; -MINIMAL NOSE/TURB SEC 2 CO MICRO: -MINIMAL -MINIMAL B NOSE/TURB SEC 3 O MICRO: -MINIMAL NOSE/TURB SEC 4 U MICRO; -MINIMAL ro ON PROSTATE GLAND MICRO; -MINIMAL, FOCAL TESTES MICRO: -TISSUE HISSING -CORTEX: INFILTRATES,SUBACUTE -ACUTE/SUfiACUTE iNFLAMMATION............................... -HEPATOCYTES CENTR1LOBULAR; HYPERTROPHY ODONTOPATHY.......................... -NASOLACRIMAL DuCTfS): INFLAMMATORY CELLS/C -ODONTOPATHY NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRA EOSINOPHILIC MATERIAL -ALVEOLAR LUMENS: CORPORA AHYLACIA/MINERALl *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING IlSSULS HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: ....................... iirt COAGULATING GL, LUNGS, MAMMARY GLANDS, PITUITARY GLANQ. SEMINAL VESICLES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "I-M INVASIVE, "X-" OT CD a > *** PAIH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $TU ANIMAL NUMBER: J0Z4 OATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY OAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ................................................................................................................................................................................................................................ MICRO: -MINIMAL, FOCAL -ACUfE/SUflACUTE INFLAMMATION MINIMAL -HEPATOCYTES. CYTOPLASMIC VACUOLES (NQN-ZQNAl *** ANIMAL MAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "8-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHEl CO JS o BFG 003386 *'* PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENEAATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INQIVIDUA! ANIMAL DATA SHEET SI ANIMAL NUMBER: 4009 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOlQGl LIVER ................................................................................. MICRO: -MINIMAL, FOCAL -MINIMAL, MULTI-FOCAL -MINIMAL NOSE/TURB SEC 3 ...................................................... MICRO: -MINIMAL PITUITARY GLAND ........................................................ MICRO: -MINIMAL, FOCAL. -EXTRAMEDULLARY HEMATOPOIESIS -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILO0ULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRAC EOSINOPHILIC MATERIAL -PARS OJSTALIS: CYSTS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL EPIDIDYMIDES, KIDNEYS. LUNGS, MAMMARY GLANDS. NOSE/TURB SEC I, NOSC/TURB SEC Z, NOSE/TL PROSTATE GLANO, SEMINAL VESICLES, TESTES. TRACHEA bfg KEY TO NFOPlASMS: "M-" MALIGNANT. "B-" BENIGN, "S'" METASTATIC, "l-" INVASIVE. "X-" 0TF **" PATH/TOX SYSTEM OUTPUT *** VINYL CHIOft IDE COMBINED INHALATION TWO-GENtRAIION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER: .1026 DATE OF DEATH: 04/29/97 SEX: MALE D05F GROUP: .1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUDY DAY OF DEATH: 113 STUDY MEEK OF DEATH: 17 TERMINAL BODY WEIGHT; 37 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYVOROS, SEVERITY, DISTRIBUTION GROSS FREf-TEXT COMMENTS / HISTOPATHOLOGIC f KIDNEYS ... GROSS: -CAICULUS(CALCULI). MODERATE LIVER . . . . MICRO:'-MINIMAL URINARY BLADDER GROSS:`-CALCULUS(CALCULI}, SEVERE -BOTH PELVES -HEPATOCYTESCENfRILOBULAR; HYPERTROPHY KEY TO NEOPLASMS: "H-" MALIGNANT, "0-" BENIGN. "S-" METASTATIC, **!-" INVASIVE. "X-" OTHER BFG 003388 03 *T\ G 4^ fO <JT O' PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RAlS INDIVIDUAL ANIMAL DATA SHEET $ ANIMAL NUMBER: 4011 DATE OF DEATH; 04/29/97 SEX: MALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SAi STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH: \7 TERMINAL BOOT WEIGHT: ORGAN NAME ** PATHOLOGY OBSERVATIONS * 4 * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-fEXT COMMENTS / HISTOPATHOLOG EPIDIDYMIDES . MICRO:............................... MiSTOPATHOLOGiCAL COMMENT; KIDNEYS , . . MICROi-HIMIHAL/fOCAL...................................................... LIVER . . . . MICRO: -SlUmt! MULTi-FOCAL -MINIMAL NOSF/TURB SFC 4 MICRO MiftiiMi nm*. >qne'present' -DILATED TUBULES -ACUTE/SUBACUTE INFLAMMATION............................... -HEPATOCYTtS CLNIRILOBULAR: HYPERTROPHY -NASAL MUCOSA (QlFACTORY); EPITHELIUH-INTRA< f OS I NOPm 11 If MATFOUL NASA: NU(0(. (01 FACTORY) BASOPHILIC MATER MlNAl HA', 0 ,Ai)V. AAN(,** I'M-, uA TML fdadwit', I V Hi,i *1.1 ' AMi>*Ai ) I it s OB'ilRlD COAGULATING til (FlUIUUMDH i uNVi A**H Ol AMDS, NOSWlORB SIC I, hOSt/Tijftft SM {. NQSF / T U**B SEC S PITUITARY GLAND PROsUtl Gi AND SI M|NAk VlSlClfS, TESTES. 1RACCA Kll JO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN METASTATIC. "I-" INVASIVE, "X-" 0T ANIMAL NUMBER: 3020 DATE OF DEATH: 04/79/97 *** PATH/tOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBtNEO INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRl STUOY OAT OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 4 *** ANIMAL HAS NO CROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG43258 05 o 0 0 >_*> 0 0 *** PaTH/TOx SYSTEM OUTPUT *** VINYL CHIOS IDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 4013 DATE DF DEATH; 04/29/97 ORGAN NAME $X: MALE DOSE GROUP: 4 SACRIFICE STATUS; SCHEDULED, TERMINAL $A STUDY DAY OF OEATH: 113 STUDY WEEK DF DEATH; 17 TERMINAL BOOY WEIGHT; * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HtSTOPATHOLOG EPIOIOYMIOES LIVER , . . N0SE/TUR8 SEC 3 PROSTATE GLAND MICRO: MICRO; MICRO: MICRO; -MINIMAL, -MINIMAL -MINIMAL -MINIMAL, HlSTOPATHOLOGlCAl COMMENT; FOCAL FOCAL ONE PRESENT -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRtLOBULAR: HYPERTROPHY 'NASAL MUCOSA (OLFACTORY): BASOPHILIC MATER -ACUTE/SU&ACU7E INFLAMMATION............................... *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL. EPIDIDYMIDES. KIDNEYS. LUNGS. MAMMARY GLANDS, NOSE/TURB SEC I, NOSt/lURB SEC 2, NOSE/T PITUITARY GLAND, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASHS: "M-" MALIGNANT, V' BENIGN, "S-" METASTATIC, INVASIVE, "X*" OT BFG43273 a o tji U (A *** path/tqx system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUC ANIMAL NUMBER; 3030 DATE OF DEATH; 04/29/97 SEX; MAIE DOSE GROUP; 3 SACRIFICE STATUS; SCHEDULED. TERMINAL SACR1 STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT; E ORGAN NAME * * * pathology observations * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER TESTES ............................................................................................................................................................................................................................... MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) ............................... ............................................................................................................................................................................................ GROSS; -SMALL, MODERATE -BOTH KEY TO NEOPLASMS; "H-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, I- INVASIVE, X- OTHER BFG43260 CD 3 o Q U* 'O hi ,.'X,, `3AISVANI 'DI1V1SV1JN 'N0IN19 ..-H,, 'iNVNOPVH ,,-H,, ^SWSVldOBN Ol A3* V3H3VM1 `SJlSJi 'S310I53A 1VNIW3S 'ONVHJ 31VlSOdd 'QNVI'I ' 33$ 9MfU/3SDN `l 03S BtJni/JSUM 'l 33$ 9Uf1i/3SUM 'SONV1D AdVHWVH `SONfH 'SA3NQJX 'saoiHAflHIIdS 1 lfl 5 Q3Aii],::ti() $3111"IVHNONBV 3 ldODSUMIH ON QVH S3fSSI 1 O3M3S0O $31inVHdDN0V SSOB9 ON S31A30dH]Ad3 33dJ ;N3Hnl 1V5VN- 1VHINIM- :fldOIH AHdOdid3dAH WHlBOUdlNSO S3lA30lVd3HNOIiVHHVUNI 3in3Vfln5/3inOV- 1VW1NIH1VOOJ 1VH1N1H* -0d3IH 59NI0N|3 3l9010HlVdUlSlH / S1N3HNOO 1X31-3303 5S0d9 NOliflfllUlSlO *Aild3A3S 'SOVQAAM , , S N 0 I IVAdlSBO HOlOHlVd , , , SHVM9 tee :1H913A AGOfi 1VNIMM31 91 :H1V3Q iO 33ff AOH1S Ztl -HiVJO 30 AVO AOlUS 33IJId3VS IVNINdBl `03ln03H3$ :5fUVlS 33I3MVS * -dn0d9 3SOO 31VH -X35 000*96 :d36WMJ AORiS sn :39Vd fiE-ddV-62 :Q31Nldd 133HS VIVO 1VMINV lVOOIAlONl SIVb 03 NI AOniS A1I3IX01 1ViN3NdOl3A3G QUi N0U3n00dd3d N0IiVa3N39-UM NO I J.V1VHN I O3NI0HO3 30Id01H3 IAN | A ... indinO N31SAS XQl/HiVd ... Z6/62 S ANIMAL NUMBER: 4002 DATE OF DEATH; 04/28/97 *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TUQ-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY &TUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SACK! STUDY DAY OF DEATH; 112 STUDY WEEK OF DEATH; 16 TERMINAL BODY WEIGHT: 5 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREC-TEXT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES . MICRO: KIDNEYS . , . H1ST0PATH0L0GICAL COMMENT: >ONE PRESENT MICRO: '-MINIMAL, 'FOCAL......................................................-CORTEX:' !NFiLTRATs!sUBACUT LIVER . . . . MICRO: 'MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION 'HEPA10CYTES CENTR1L0BULAR: HYPERTROPHY MAMMARY GLANDS MICRO: 'TISSUE HISSING NOSE/TURD SEC 3 MICRO: '-MINIMAL................................................................... ^NASAL MCOSA (OLFACmV j: EPI THUtUM- INTRACYT EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 MICRO-'-MINIMAL................................................................... -NASAl'mUCQSA (OLFACTORYj; CP1TNELIUH-1TACVT. eosinophilic material PROSTATE GLAND MICRO;' -MINIMAL, MliLT I - FOCAL........................................ -LYMPHOID CELL ' INFi LTRATE(S) /AGGREGATE|sj -MINIMAL. FOCAL -ALVtOLAA LUMENS: CORPORA AHYLACl A/HINERAUZED TESTES . . . . MICRO; HIStOPATHOLOGICAL COMMENT: >0NE PRESENT *** ANIMAL NAS NO GROSS ABNORMAL I TJtS OBSERVEO *" THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; _ A,, COAGULATING Gl. EPIDIDYMIDES. LUNGS, NOSE/TUR0 SEC 1, NOSE/TURB SEC 2. PITUITARY GLAND. SEMINAL VESICLES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, INVASIVE, "X'" 01 HER BFG43262 B* G O <2> UtjJ* BFG43277 *** PATH/tOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SI ANIMAL NUMBER: 4017 DATE OF DEATH: 04/?fl/87 ORGAN NAME SEX: Hale DOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED, TERMINAL &A< STUDY DAY OF DEATH: 11? STUDY WEEK OF OEATH: 16 TERMINAL BOOT WEIGHT: * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HJSTOPATHOLOGI EPIDIDYMIDES KIDNEYS . . LIVER . . NOSE/TURB SEC 2 NOSE/TURB SEC 3 MICRO; MICft6: MICRO: MICRO: MICRO; -SLIGHT -M|MMAl. -MINIMAL, -MINIMAL -MINIMAL -MINIMAL FOCAL FOCAL NOSE/TURB SEC 4 MICRO: -SLIGHT TESTES MICRO: -SLIGHT FOCAL -SLIGHT -U; OLIGOSPERMIA -CORTEX;`INfiLTRATEs!SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCTIES CENTRILOBULAR: HYPERTROPHY NASOLACRIMAL DUCT(S): INFLAMMATORY CELLS/Cl -NASAL MUCOSA (OLFACTORY}: EPITHELIUM-INTRAf EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHEUUM-INTRAt EOSINOPHILIC MATERIAL -U: TUBULAR DEGENERATION -REDUCED SPERMATOGENESIS ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAP NO MICROSCOPIC ABNORMAL IT1FS OBSFRVED: COAGULATING GL, LUNGS, MAMMART GLXNpS, NOSE/TURB SEC I, PITUITARY GLAND, PROSTATE GLAND. SEMINAL VESICI KEY TO NEOPLASMS; "H-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, "l-H INVASIVE, "X-" OTI S Cl o 1*1 'c PATH/TOX SYSTEM OUTPUT * I * VINYL CHLORIDE COMBINED INHALATION TUO-GENERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIKAL DATA SHEET 5TUD1 ANIMAL NUMBER! 4004 DATE OF DEATH; 04/26/97 SEX; MALE (JOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SAtRjf STUDY DAY OF DEATH: 112 STUDY MEEK OF DEATH; 16 TERMINAL BODY WEIGHT; 52 ORGAN NAME * * * PATHOLOGY ODSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC f EPIDIDYMIDES . MICRO; -TISSUE MUSING.................................................................................................................................... GROSS/MICRO CORR MICRO:............................. HiSTOPATHOLOGiCAL COMMENT: >LN MEDIASTINALDISCOLORED/HETORRHAGe' LIVER .... MICRO: -MINIMAL. FOCAL.................................................. -ACUTE/SUBACUTE INFLAMMATION........................ -MINIMAL -HERATQCYTES CENTRILQBULAR: HYPERTROPHY MEDIASTINAL LN GROSS; `-DISCOLORED............................................................... -RED MICRO: -SLIGHT 'HEMORRHAGES} NOSE/TURB SEC 3 MICRO;'-MINIMAL................................................................... -NASOLACRIMAL DUCT; LYMPHOID HYPERPLASU' -MINIMAL -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRACYTC EOSINOPHILIC MATERIAL -MINIMAL -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES NOSE/TURB SEC 4 ........................... MICRO: -HIN1HAI -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTC EOSINOPHILIC MATERIAL PROSTATE GLAND TESTES . . . MICRO: -MINIMAL, FOCAL MICRO:'-TISSUE*Hi$SIMG -LYHPHOIO CEUINFiLTRATE(S)/AGGREGATE(S) THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING Gl. KIDNEYS. LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1 TRACHEA NOSE/TURD SEC 2. PITUITARY GLAND, SEMINA! KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE. "X-" DTHER CO a CO <s> 9 o OJ (>> 4^ uj to ANIMAL NUMBER: 4oiS DATE OF DEATH: 04/20/97 *** PAlH/TOX SYSTEM DUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TQXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ' SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL 5i 5TU0Y DAY OF DEATH: 112 STUOY WEEK OF DEATH; |B TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATHOLOI LIVER .......................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NOH-ZOI -MINIMAL -HEPATOCYTES CENTRlLOBULAR: HYPERTROPHY MAMMARY GLANDS ........................................................................................................................................................................................................ MICRO; -TISSUE MISSING N0SE/TUR8 SEC 3 ................................................................................................................................................................................................... MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EP1THELIUM-1NTRI EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMAL IKES OBSERVED **' THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL, EPIDIDYMIDES, KIDNEYS. IUNGS. NOSf/IURB StC I, NOSf/TllRB SFC ?, NOSC/TURB SEC 4. PITU; PROSTATE GLAND. SEMINAL VESICLES, USUS. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. BENIGN, METASTATIC. INVASIVE. "X-" O' w n o 83H10 43AI5VANI !)] 1V J SV J 3W ..-S., 'NQlNlfl 'lNVN'Jl'lVH ..-W,. :$HSV14D3N 01 A V3H3VH1 `53l$3l 'S3UIS3A 1VNIH1S 'QNV19 31VlS0d 4Qw 33$ QWI/35QN ' 33S SHni/3SQN `2 03$ 0M1/3SQN '( 335 8VH1/3SOW 'S9Nm `SllNGl* 4S3dIHAO101d3 4i :Q3AH3S80 S311nVHM0N8V DldODSOUDlH ON OVH $305 ... 03AD3SBO 53]inVHdON0y SS0H9 QN1SSJN 3HSSU- :0H: AHdOWlMdAH :Vma011biN3D saiMHJiVdJH- 3VH1N1N- OVN02*N0N) S310n3V/l OlHSyidOU? ;S3AADOlVdBH;................................................................... 1VM1N1W-. :OH: 1N3S3HJ 3ND< :1N3HHQ3 IVDIOOIOHlVdOlSlH !0: S9NI0NIJ 3IS030HiVdOlSlH / S1M3HH03 1X31-23MJ SSOMO NOIinflltiiSIO `A11U3A3S `SOWUM SN011VAH3S80 H010H1H , , , SHVaO 6'9c? `iH9i3n iaofl ivn1h31 91 -NlV3d jo 33a Minis 2tl 'hivbO jo avo Mini? 33U1H3VS 1VNIHM1 '{mflOJHJS -SfUVlS 3DUIH3VS f -dflOHO 3S0Q 31VN :X3S 060X96 H39HnN AGOiS 921 :39Vd 8E-aJV-62 :<J3iHlHd 133HS viva lVHIttV lVnOtAIOMI 51VU 03 N1 AOniS 11131X01 3YlN3HdOl3A30 QNV HOllOnOOtfdH 8QWH3M39"P1 N0UV1VHHI 03819803 30(00183 1ANJA indino H31SAS XOl/HiVd a BFG4328] *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATtON REPRODUCTION AND DEVELOPMENTAL TOXIC1FY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 40Z0 DAtt OF DEATH: 04/28/57 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL 1 STUDY DAY OF DEATH: 112 STUDY WEEK Of DEATH: 16 TERMINAL BODY WEIGHT ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION CROSS TREE-TEXT COMMENTS / HISTOPATHQLI KIDNEYS ... MICRO: -MINIMAL LIVER ., ., MICRO:`-MINIMAL, fOCAL -MfNtMAL NOSC/TUR0 SEC Z MKRO: -MINIMAL NQSE/TURB SEC 4 MICRO: -MINIMAL PITUITARY GLAND MICRO: -MINIMAL.'FOCAL -PELVIS DILATED -ACUTE/SUBACUTE INFLAMMATION........................... -HEPATOCYTES CENTRUQBULAR: HYPERTROPHY -NASOLACRIMAL OUCT($j: JNfLAMMAtOAY CELLS; 'NASAL MUCOSA (OLFACTORY): BASOPHILIC MATI -PARS OISTALIS: CYSTS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED **" THE FOLLOWING TISSUES HAD MO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIOIOYMIOES. LUNGS, MAMMARY GLANDS. N05E/TUR8 SEC . testes, trachea NOSt/TURB SEC 3. PROSTATE GLANI KEy'tQ NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, METASTATIC, "I-" INVASIVE, "X-" < *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-"GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STI ANIMAL NUMBER: A008 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH; 1)3 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * pathology OBSERVATIONS KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGI EPIDIDYMIDES MICRO: GRGSS/HICRG CORK MICRO: LIVER . . MICRO: I LJNftS Nf)St / 1 OP ft Sit MICRO H|( 4 < -MINIMAL -MINIMA! PiN|NA| . l l 1 ** i HISTOPATHOLOGICAL COMMENT HISTOPATHOLOGICAL COMMENT I Hi Ai If Mf ]( 10 1 k|MA <*. ii ,< L> L's.l i* ' I MOOIAA11 >TESTES-L: ENLARGED/TUBULAR DEGENERATION -HEPATOCYTES: CYTOPLASMIC VACUOUS (N0N-20NA -HEPATOCYTES CEKTRI LOBULAR: HYPERTROPHY PULMONARY VESSELS' MINERAL DfPOSIT(S) I*1,*! m.i( O',A |ni 11( tORr ) LOSlHOMMli K HAHRIAt ASH Biji'a'.* IOiIACIOAt) fPITHfllUH iNTRACT BASOPHILIC MATER IA LU I U lUBULAR Dt (it HI RA1 ION -REDUCED SPfRMAIOGfN(SIS THE FOLLOWING (ISSUES KAO NO MIlAQSLOPlL ABNORMAL 11 IIS OBSERVED: COAGULATING GL EPIDIDYMIDES, KIDNEYS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC l. NOSE/TURB SEC ; PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES. TRACHEA KEY TO NEOPLASMS: "M*" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "1-" INVASIVE, "X-" QTH| BFG 003400 cd T! a p* L*> TO 0\ 00 *** PATN/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TONICITY 5TUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 4022 DATE OF OEATH: 04/23/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SA STUDY DAY OF DEATH; 112 STUDY WEEK OF DEATH; 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * pathology KEYWORDS, SEVERITY, DISTRIBUTION KIDNEYS . .. MICRO: -MINIMAL, focal' LIVER .. ,. HICRO:'-MINIMA[.HULTI-FOCAL -MINIMAL NOSE/TUfip SEC | MICRO NtNltUi NOSF/Tuflfl SEC 2 N|C Ml] HltlHtl hgsi /tufift si1: j H l ( 6 ) BUI**. pros Tail l>i amu OBSERVATIONS * * * GROSS FREE'TEXT COMMENTS / HISTOPATHOLOG CORTEX: CYST Necrosis.coagulation -HEPAT0CYTE5 CENTRILOBULAR: HYPERTROPHY NASOlACRIHAl DUCT(S): fREC FRYTHROCYTCS bAUi I uMf n inn t n Y THHOC Y TE5 A', *1 lOHl* FR|( IRtImROLYUS AlftOlAR l uMtftl (OBPORA A*Y l AC I A/M l N Ffl AL l, AbIHAl "ANO A8<)AbA, Mil', bl,1*1(0 IH[ FOLLOWING lissolv KAO *0 Ml lOSlOPIC ANORNAl|T|ES OBSERVED: COAGULATING 6L FPIOlOTNIOlS LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 4, PITUITARY GLAND, SEMINAL VESICLE: TRACHEA BFG43283 KEY TO NEOPLASMS; "H-" MALIGNANT, "D-" BFNJfiN. "S-" METASTAttC, "t-" INVASIVE. "X-" Oil *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXlCjTY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER! 4010 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 4 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES . MICRO: HISTDPATH0L0G1CAL COMMENT: >ONE PRESENT KIDNEYS . . . MICRO: -MINIMAL, FOCAL...................................................... ^CORTEX,-` JNFilTRATEs! SUBACUTE LIVER , , , , MlCRO: -MINIMAL, MULTI-FOCAL........................................ -ACUTE/SUflACUTE iNFLAMHATION -MINIMAL -HEPATOCYTES CfHTRILOflULAR. HYPERTROPHY NOSE/TURB SEC 4 MICRO;'-MINIMAL ................................................................. :NASAL'hUCQSA (OLFACTORYiEPITHELiUM-INTHACYT EOSINOPHILIC MATERIAL ** ANIHAl HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL. EPIDIDYMIDES, LUNGS. MAMMARY GLANDS, NOSE/TUR0 SEC 1, NOSE/TURB SEC 2. NOSE/TURB StC 3. PITUITARY GLAND, PROSTATE GIANO, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, *'B-" BENIGN, "S-" HETASTAUC. "I-" INVASIVE. `V OTHES BFG 00340. GtJ T1 O O * PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 4024 DATE OF DEATH: 04/29/97 SEX; MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FflfE-TEXT COMMENTS / HlSTQPATHOL LIVER . . . . MICRO: -MINIMAL 'MINIMAL NOSE/TURB SEC 2 MICRO:'-MINIMAL NOSE/TURB SEC 1 MICRO; -MINIMAL NOSf/TURB SEC 4 ........................... MICRO; -MINIMAL CD PITUITARY GLAND MICRO: -MINIMAL. FOCAL a 'HIPATOCYTES: CYTOPLASMIC VACUOLES (NON-Z -HEPATOCYTES CENTRIL08UIAR; HYPERTROPHY -NASOLACRIMAL OUCT(S):'FREE ERYTHROCYTES' :NASAL MUCOSA (OLFACTORY): EPITHELiUM-INT EOSINOPHILIC MATERIAL :NASAl MUCOSA (OLFACTORY): EPltHEliUM*INT EOSINOPHILIC MATERIAL -PARS DISTAL IS: CYSTS *** ANIMAL HAS NO GROSS ABNORMALItIES OBSERVED *** U) ro THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: 00 COAGULATING Gl, EPIDIDYMIDES. KIDNEYS. LUNGS. MAMMARY GLANDS. NOSE/TURB SEC ]r PROSTATE GLAND. SEMIN L/Y 1STS, TRACHEA KEY 10 NEOPLASMS: "M-" MALIGNANT, "B'H BfNIflN. NfMSTAFIC, "l-" INVASIVE, "X-" W C o fjj -U **" PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO^GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANINA1 DATA SHEET STtll ANIMAL NUMBER: 4012 DATE Of DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACK! STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: ! ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE'TEXT CQHHENTS / HISTOPATHOLOGIC EPIDIDYMIDES MICRO:............................... HiSTOPATHOLOGiCAL COMMENT: iOME PRESENT........................................................................ LIVER . . MICROi'-MINIMAL, FOCAL.............................................................. -ACUTF/SUHACUTE i NFl AMMATION............................................. -MINIMAL -HEPATOCYTES CEHTRILOBULAfl: HYPERTROPHY NOSE/TURB SEC 3 MICRO: -MINIMAL................................................................... -NASAL`mUCOSA (OLFACTORYj:'tPITHCLiUH-1WTHACT 1 EOSINOPHILIC MAtERtAL N0SE/TUR8 SEC 4 .............................................................. MICRO: -MINIMAL -NASAL MUCOSA jOLFACTORY): EPITHEliuM'lNTRACYl EOSINOPHILIC MATERIAL PROSTATE GLAND ................................................................... MICRO: -SLIGHT, HULTI-FOCAL -LYMPHOID CELL * INFt LTRAT5)/AGGREGATE(S j **" ANIMAL HAS NO GROSS ABNORMALITIES OBSERVFD *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIDNEYS. LUNGS, MAMMARY GLANDS. NOSE/TURB sec l. NOSE/TURB SEC Z, PITUITARY SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "a-" BENIGN, "S-N METASTATIC, "l-" INVASIVE, HX-" OTHEf BFG 003404 nn O ft to to *** PATH/TOX SYSTEM OUTPUT *" VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 4026 OATE of DEATH: 04/29/9? SEX; MALE DOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED, TERMINAL S STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT CONMENTS } HISTOPATHOLQ LIVER . . . . MICRO; -MINIMAL -HEPATQCYTES: CYTOPlASMtC VACUOUS (NON-W -MINIMAL -HEPATOCYTES CFNTRJLOBULAR: HYPERTROPHY NOSF/TURB SEC 3 MICRO: -SLiGHT -NASOLACRIMAL DUCT; iVhPHOID HYPERPLASiA -NARKEO -NASAL MUCOSA (OLFACTORY): EPITHELIUN-1NTR EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ................................................................................................................................................................................. MICRO; -MINIMAL -NASAL MUCOSA (OLFACTORY): LP1THEL1UM-INTR EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL, EPIDIDYMIDES, KIDNEYS. LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SC 2. PITUI PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA BFG43287 KEYTONEOPLASMS:" "N-" MALIGNANTi `V BENIGN, "S-" METASTATIC, 'I-" INVAS1VL. "X-" 0 b f g 003419 ANIMAL NUMBER: 4014 DATE OF DEATH; 04/29/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY SEX: HALE DOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRIF STUDY DAY qF DEATH; 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: SO ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F EPIDIDYMIDES MICRO; HTSTOPATHOLOGICAL COMMENT: >ONC PRESENT LIVER .................................................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY NOSE/TURfl SEC 4 .............................................................................................................................................................................................................. MICRO: -SLIGHT -NASAL MUCOSA (OLFACTORY); EP1THELlUM-INTRACYTO EOSINOPHILIC MATERIAL PROSTATE GLAND .................................................................................................................................................................................................................. MICRO; -MINIMAL, FOCAL -ALVEOLAR LUMENS; CORPORA AHYLACIA/M1NRAL12ED *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIONEYS, LUNGS. MAMMARY GLANDS, NOSE/TURfl SEC I, NOSE/TURB SEC 2, NQSE/TURB PITUITARY GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "8-" BENIGN, "S-" METASTATIC, "l-" INVASIVE. '`X-" OTHER BFG 003406 w n O a UJ to o & CO 3 o 00 MO *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENFRATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS (NOmOUAI ANIMAL DATA SHEET ANIMAL NUMBER: 402B DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL 600Y WEIGHT ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATHQl LIVER ............................................................... MICRO; -MINIMAL. FOCAL 'MINIMAL MINIMAL, FOCAL MOSE/TURB SEC 4 ........................................ MICRO; -MINIMAL PROSTATE GLAND ............................................. MICRO; -MINIMAL, FOCAL *** ANIMAL MAS NO GROSS ABNORMALITIES OBSFRVEO *** "ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRROBULAR: HYPERTROPHY -HEPATOCYTES: ACIDOPHILIC FOCUS :NASAL MUCOSA (OLFACTORYSEPITHELiUM-ikl EOSINOPHILIC MATERIAL -LYMPHOID CELL 1NFUTRATE(S)/AGGREGATE(S) THF Foil OWING TISSUES HAD NO HtCROSmPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. KlDNLYS. LUNGS. MAMMARY GIANDS. NOSE/TURR SEC 1, NOSE/TURB SEC 2, NOSE PITUITARY GLAND, SEMINAL VfSIClES, TfSTfS, TRACHEA KEY TO NE0PLASH5: "M-" MALIGNANT, "fl-" BENIGN, "5-'* METASTATIC, MI-" INVASIVE. "X-" 03 a*Ti 04 44. N ** PATH/TOX system output *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER; 4016 DATE OF OEATH: 04/26/97 SEX: HALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRlF STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 54 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F GROSS/HlCRO CORR MICRO:............................... HisTOPATHOLDGiCAL COMMENT: >fclDMYS; CUiATATIOn/PElVIS DILATED PROSTATE: DISC0L0RED/ACU1E/SUBA INFLAMMATION KIDNEYS ............................................................................................................................................................................................ GROSS: -DILATATION, MODERATE -BOTH PELVES MICRO: 'MINIMAL, FOCAL -U: PYELITIS.SUBACUTE -MINIMAL, FOCAL -INTERSTITIAL NEPHRITIS SUBACUTE -MODERATE -PELVIS DILATED LIVER HAMHARY ,. ,. GLANDS MICRO: MICRO; -MINIMAL. FOCAL -MINIMAL -TISSUE MISSING -ACITE/SU0ACIJTf i HFLAMhAT I ON -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY NQSE/TURB SEC 2 HICRO: -SLIGHT -HODERAtE 'NASOLACRIMAL DUCT(S): MUC05A-SUBACUTE (CHRONIC CHRONIC INFLAMMATION -OOONlOPAlHY PROSTATE GLANO .................................................................................. GROSS; -DISCOLORED-AREA(S). 5L1GHT HICRO; -MODERATE, FOCAL ^sYq'.BCM, GREEN..................................................... -ACUTE/SUBACUTE INFLAMMATION THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL EPIDIDYMIOES. LUNGS, NoSE/TURB SEC 1, NQSE/TURB SEC 3. NOSE/TURB SEC 4, PITUITARY GLANO. SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASHS;"":'H-,"*HALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER OS O3 o o Ui to & oo ON BFG43291 *** PAIH/TOX system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 4030 DATE OF OEATH; 04/29/97 SEX: HALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL Si STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT; ORGAN NAME " " * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HTSTOPATHQLQi EARS ........................................................................................................................................................................................................................... GROSS: 'SWOLLEN,MOOERATE -DISCOLORED MICRO: -MODERATE -BOTH -ROTH: RED -SUBACUTE (CHRONIC ACHVE)/CHR0NIC INFLAMM, -MODERATE -NECRDSlS CARTILAGE GROSS/MICRO CORK MICRO; HlSTOPATMOlOGicAL COMMENT: *EARS: 'SWOLLEN|DISCOLORCO/SUBA!CHRONjc INF LIVER , ,,, MICRO: -MINIMAL MINIMAL -HEPATOCYTES: CYT0PLA5MIC VACUOLES'(NON-ZOi -HEPATOCYTES CEKTRILOBULAR: HYPERTROPHY NOSE/TURB SEC I MICRO:`-MINIMAL -NASOLACRIMAL DUCI(S); tUSlNUPHJUC MATER]. NOSE/TURB SEC 2 MICRO; -MINIMAL NOSE/TURB SEC 3 MICRO; -MINIMAL -NASOLACRIMAL QUCT(S): INFLAMMATORY CELLS/' NASAL MUCOSA (OLFACTORYj;'EPITHELIUH-iNTR, EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ........................... MICRO; -MINIMAL -NASAL MUCOSA (OLFACTORY); EPITHELJUM-INTR EOSINOPHILIC HAIERlAl THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL. EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS. PITUITARY GLANO, PROSTATE GLAND. SEMINA TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "B*" BENIGN, METASTATIC. "1-" INVASIVE, "X-" 0 9 O o o *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUQ-GENERAT1QN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RAT$ INDIVIDUAL ANIMAL DATA SHEET STUD) ANIMAL NUMBER; 4018 DATE OF DEATH: 04/28/07 SEX; MALE DOSE GROUP: * SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUOY DAY OF DEATH; 112 STUDY WEEK OF DEATH; 16 TERMINAL BODY WEIGHT: At ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC f LIVER ............................................................................................................ ........................................................................................ MICRO: `MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HfPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZQNAL) -MINIMAL -MEPATOCYTES CENTRR08UIAR: HYPERTROPHY MAMMARY GLANDS ............................................................................................................................ ............................................................................................................ MICRO: -TISSUE HISSING N0SE/TUR6 SEC 3 ............................... ............................................................................................................................................................... MICRO' MINIMAL -NASAL MIMOSA (OirACTORY): EPITHELIUM-1 NTRACYTC EOSINOPHILIC MAHRlAl ANtMAl HAS HU (jftoVi I t /f , *" tH| Y 0: 1 Owl M>> f I v ( OAi.uk At nr, ,i PROS T * r f A0 * *' *. N. . : SI M ! AAi HMl.1, ' I , .,f . | * .1 i'B* Ml '.(* 1 *()'.( / MlAfl }. W)\f/Tt>B SIC 4. FHUlTARl AIT TO MIOPLASMS M MU gum. "*" 0LNIGN, "S-" MflASTAllC, iNUAMVt, "X-" OTHER BFG43278 U C ANIMAL NUMBER: 1&02 DATE OF OEATH: 05/30/9? ORGAN NAME *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWQ-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S SEX: FEMALE OOSE GROUP: 1 SACRIFICE STATUS; SCHEDULEO. TERMINAL SA STUDY DAY OF OEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: * * * p A T H 0 LOGY keywords. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HI5TOPATHOlUG nose/turb SEC 3 MICRO: minimal -MINIMAL NOSf/TUftB Sft * Mil S() -MINIMAL -SLIGHT '.l ll.Hl U|*|Ri| I11 f RllS 'Mi, ,\ P|l ; *>, AM ' \ [ pW% T ** bI -NASOLACRIMAL DUCT: LYMPHOIO HYPERPLASIA -NASAL MUCOSA (OLFACTORY); EP1THEllUM-INTRA EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT(5); FREE ERYTHROCYTES -NASAL LUMEN; FREE ERYTHROCYTES NASAL LLIHIN ffiFf ERYTHROCYTES M'.Ai MUCOSA (01F AC TORY ): EPITHEI HIM-1NTRA (O .UOPHU |{. MAtUlAl fll'.xt , lit! 1, iaiwn* him bsown pu.mini T ii( Uli0Wl*Hj MV,.ifS h*> <) *i, . i/ i *Ate,,h*Ai | M t S 00M *V| U UUfcln ilflfi tLrti^S MAMMA* I m UD\ ilL l. *OSI/IU*B SIC i, QVARIlS, OV t OtlC > S/f ALOP T. PI I RAC Hi A, VACUA 6 :ff9 jg KEY TO NfQPlASHS: "M-" MALIGNANT. "8-'* BENIGN, `V METASTATIC. "I-" INVASIVE, "X-" OT *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STl ANIMAL NUMBER: 4019 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC! STUDY DAY OF DEATH; HZ STUDY WEEK OF DEATH; )6 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................................... MICRO; -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS -MINIMAL -HEPATOCYTES CENTRIIOBULAR; HYPERTROPHY NOSE/TURB SEC 2 ......................................................................................................................................................................................................... MICRO; -MINIMAL -NASOLACRIMAL OUCT(S); FREE ERYTHROCYTES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIDNEYS. LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1, NOSE/TURB SEC 3. NOSE/TUI PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "8-" BENIGN, "s-" METASTATIC, "I-" INVASIVE, "X-" OTHI BFG 003412 tr hfl O TO 00 o CnO O a TO vO *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal data sheet ANIMAL NUMBER; 1504 DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP; 1 SACRIFICE STATUS; SCHEDULED. TERMINAL S, STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTQPATHOLOi LIVER ..................................................................................... MICRO: -MINIMAL. FOCAL NO5E/TUR0 SEC 3 ......................................................................... MICRO: -MINIMAL -MINIMAL NOSE/TURB SEC 4 ......................................................................... MICRO: -SLIGHT UTERUS ..................................................................................... GROSS; -IMPLANT SCARS - PRESENT MICRO; -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION.......................... -NASAL MUCOSA (RESPIRATORYj: EPITHElluM-IN LOS1N0PHLIC MATERIAL -NASAL MUCOSA (OLFACTORY); EPJTHELJUM-INTRi EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORYj; EPITHEliUH-iNTRJ EOSINOPHILIC MATERIAL -RIGHT: 6;* LEFT: 7................................................... -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS LUNGS MAMMARY GLANDS NOSE/TURB SEC 1. NOSE/TURB SEC 2. OVARIES, OVIDUCTS/FALOP T. PI TUI TAR TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "H-" flFNIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" 0 00 o 3 O --I *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER: 4021 DATE OF DEATH: 04/28/97 SEX: HALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEOULED. TERMINAL SACS STUDY OAY OF DEATH: 112 STUDY WEEK OF DEATH: 18 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC EPIDIOYMIOES LIVER , . MICRO: -TISSUE MISSING MICRO: -MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZONAt -MINIMAL, FOCAL -NECROSIS,COAGULATION NOSE/TURB SEC 2 -MINIMAL -HEPATOCYTES CENTRILPBULAR: HYPERTROPHY MICRO; -SLIGHT -ODONTOPATHY NOSE/TURB SEC 3 DO MICRO; -MINIMAL -NASAL MUCOSA lULTACTORY); EPITHELIUM-INTRACY EOSINOPHILIC MATERIAL TJ -MINIMAL -NASAL LUMEN: FREE FRTTHROCYTES O NOSE/TURfl SEC 4 4^ U) MICRO: -SLIGHT TESTES . . . . to MICRO: -TISSUE HISSING NASAL LUMEN: FREE ERYTHROCYTES oo ro ** ANIMAL HAS NQ GROSS ABNORMALITIES OBSERVED "* THE FOLLOWING TISSUES HAP NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL, KIDNEY?, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, PITUITARY GLAND, PROSTATE GLAND. SEMINA TRACHEA KEY TO NEOPLASMS: "N-M MALIGNANT. "B-M BENIGN, "S-** METASTATIC. "I-" INVASIVE, "X-" OTHf s o o I--* 4* *** PATH/TOX SYSIEM OUTPUT VlNYl THIDRIOE COHBINEO INHALATION TUO-QENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDtVIOUAl ANIMAL DATA SHEET ANIMAL NUMBER; 1506 DATE OF DEATH: OS/29/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS; SCHEDULED, TERMINAL 1 STUDY DAY OF DEATH; 143 STUDY WEEK OF DEATH; 21 TERMINAL BODY WEIGHT ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS fREC-TCXT COMMENTS / HlSTQPATHOLI KIDNEYS .................................................................................................................................................................................................................. MICRO: -MINIMAL, FOCAL -CORTEX; INFILTRATES,SUBACUTE LIVER ...................................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (N0N-2I GO NOSE/IURfl SEC 2 ................................................................................................................................................................................................ 3 O MICRO; 'MINIMAL -NASOLACRIMAL DUCT(S): INFLAMMATORY CELLS. NOSE/TURB SEC 3 ............................................................................................................................................................................................... MICRO: -MINIMAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA NOSE/TURB SEC 4 ............................................................................................................................................................................................... u> MICRO: -MINIMAL NJ -NASAL MUCOSA (OLFACTORY); EPI THELIUH-1NTI EOSINOPHILIC MATERIAL vO UTERUS ...................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 5; lFFT: A MICRO: -MINIMAL, FOCAL -ENDOMETRIUM; BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1. OVARIES. QVIDUCTS/FALOP T. PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, X- < w aCl Ah t-J *** PATH/TGX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO'GtNERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 4023 DATE OF DEATH: 04/29/97 SEX; MALE DOSE GROUP: 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH; 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN name * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / KlSTOPATHDLOG] LIVER ............................................................... MICRO; -MINIMAL, FOCAL -MINIMAL NOSC/TURfl SEC 3 ............................... MICRO: -MINIMAL -MINIMAL NO5E/TUR0 SEC 4 ........................................ MICRO; -MINIMAL -MINIMAL -HEPATQCYTES: BASOPHILIC focus -HEPATOCYTES CENTR1L0BULAR: HYPERTROPHY -NASAL MUCOSA (RESPIRATORY j; EPITHELIUM-ilYTR EOSINOPHLIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUH-INTRAC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY); EPITHEUUM-INTRAC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY); BASOPHILIC HATERl *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD MO MICROSCOPIC ABNORMAL I TIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1 N05E/TUR6 SEC 2, PITUITA PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA BFG43284 KEY TO NEOPLASMS: "M-" HALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-* INVASIVE, "X-" OTH BFG43299 *** PMH/TDX 5YSTEH OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS Individual animal data sheet ANIMAL NUMBER: 1508 DATE OP DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: l SACRIFICE STATUS: SCHEDULED, TERMINAL i STUDY DAY OF DEATH; 141 STUDY WEEK OF OEATH: 21 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION LIVER ..................................................................................... MICRO: -MINIMAL, FOCAL LUNGS ... ........................................................................ MICRO: -MINIMAL, FOCAL N05E/TURB SEC 3 ............................................................... MICRO: -MINIMAL -MINIMAL -MINIMAL. FOCAL NQSE/TURB SEC A ............................................................... MICRO: -MINIMAL UTERUS ..................................................................................... GROSS; -IMPLANT SCARS - PRFSfNT MICRO: -MINIMAL OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLt ACUTE/SUBACUTE INFLAMMATION -PULMONARY VESSELS; MINERAL DEPOSITS) -NASAL MUCOSA (RESPIRATORY!: EPlTH|.iUH-il EOSIHOPHLIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTI EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATE -NASAL MUCOSA (OLFACTORY)EPITHELIUH-iNTF EOS1NOPHH 1C MATERtAl RIGHT! 8; LEFT ; 7................................................. -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMAL I TIPS OBSfRVtt): KIDNEYS, MAMMARY GLANDS. NOSE/TURB SFC 1, N0SE/TUR6 SEC 2. OVARIES, OVlDUCTS/FAl.or T, PITUITARY GLANI VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-M INVASIVE. "X-" ( 5 <n o o 'Jj *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUI ANIMAL NUMBER; 402$ DATE OF DEATH: 04/29/07 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACK STUOY DAY OF DEATH: 113 STUOY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ................................................................................................................................................................................................................................ MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (HON-ZQNAL -MINIMAL -HEPATOCYTES CENTRILOBUIAR: HYPERTROPHY NOSE/TURB SEC l ......................................................................................................................................................................................................... MICRO: -MINIMAL -NASOLACRIMAL DUCT(S); FREE ERYTHROCYTES 4,,b NOSE/TURB SEC 4 ......................................................................................................................................................................................................... MICRO- -MINIMAL -NASAL MUCOSA (OLFACTORY); EPITHELIUM'INtRAtY EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING fit. EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, HOSE/TUR0 StC 1. NUSt/TURB SEC 3. PITUItAR PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "N-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. "I-M INVASIVE. OTHE 98 E > 0 ;fa s ffi O 0 U w BFG43301 '** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GEN[RAT|ON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ' ANIMAL NUMBER; 1510 DATE OF DEATH: QS/28/97 SEX; FEMALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SJ STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * pathology OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREC-TEXT COMMENTS / HISTOPATHOLDI EARS . ......................................................................................................................................................................................................................... GROSS: -SWOLLEN. SLIGHT -DISCOLORED. SLIGHT -BOTH -BOTH: RED MICRO: -MODERATE -SUBACUTE (CHRONIC ACTIVEl/CHRONIC INfLAHMI -MINIMAL. FOCAL -NECROSIS CARTILAGE GROSS/MICRO CQRR ................................................................................................................................................................................................... MICRO: HtSTOPATHOLOGICAL COMMENT; >ARS: SWOLLEN.DISCDLORED/INFlAMMATION SUB! KIDNEYS ................................................................................................................................................................................................................. MICRO: -MINIMAL. MULII-FOCAL -CORTEX: INFfLTHATtS,SlffiACHTf IIVER ..................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES: CYIOPLA5MIC VACUOLES (NON-JO! NQSE/TURB SEC 2 ................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -VOMERONA5AL ORGAN; FREE ERYTHROCYTES NOSE/TIIRB SFC 3 ................................................................................................................................................................................................... MICRO; -MINIMAL -NASOLACRIMAL DUCl: LYMPHOID HYPERPLASIA UTERUS ............................................................................................................................................................ ..................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 1Z; LEFT: 2 THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1. NQSE/IURB SEC 4. OVARIES. OV1DOCTS/FALOP T, PITUITARY GLAND. 1 VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, METASTATIC, "1-M INVASIVE, "X-" O' 93 Ci 'j.* PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET STU1 ANIMAL NUMBER: 4027 DATE OF DEATH: 04/Z9/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAY QF DEATH; 113 STUDY WEEK OF DEATH: |7 TERMINAL BODY WEIGHT: < ORGAN NAME *** PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * 4 GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS LIVER MICRO: -MINIMAL, FOCAL MICRO: -MINIMAL, FOCAL -MINIMAL NOSE/TURB SEC I MICRO- -MINIMAL NOSE/TURB SEC T M1 C 80 Si ll^Mt NOM / t St i 4 11. iO TO 00 cc ** immi h*. m; ..trw ***.:,** ' ,t ***i. *" -CORTEX:'iNfiLTRATEs!SUBACUTE -ACUTE/SUBACUTE idFLAMMATlON................................... -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASOLACRIMAL DUCT| S); 'EOSINOPHUIC MATERIAL* nASOlAI'D 1 HAL DUCT LVHPHOIO HYPERPLASIA NASAi Mot 0 j* lOl'At IORT) f f* 11 H( HUM- 1NTRACY1 ( Oi IVOPM!( It MA11 8 1 A| t n( lUuMIhij 1 l Hi^ no p | i tOA(.UlAI*li M IPlDtOTHlOn n*tS . TESTES. TRACHIA i lNt 4l 0 HlHHAlT GtANDS. NOSf/tURB StC 2, PITUITARY GlANO, PROSTATE Gl AND, SI KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "l-M INVASIVE, "X-" OTMEI *** PATH/TOK 5Y$TEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION ACPAOOUCTI ON AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1512 DATE OP DEATH: OS/27/97 SEX: FEMALE DOSE GROUP: ] SACRIFICE STATUS; SCHEDULED TERMINAL SA STUDY DAY OF DEATH; 141 STUDY WEEK OF DEATH; 21 TERMINAL 0OOY HEIGHT: ORGAN NAME * 4 PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOFATHOLOG GROSS/MICRO CORR MICRO; KIDNEYS . . . MICRO; NOSE/TURB SEC 3 MICRO PANCREAS IjllU'.S J HfNl.lS uMi: . , MU MO IJTIRUV ,H * ; i ii HISTOPATHOLOGICAL COMMENT: -MINIMAL. FOCAL -MINI HA L u null dmm j i.m 1 .Ml mik;hi. < M i i ii > 1 > *1 ' >PANCRAS: DISCOLORED/NMC THYMUS: DISCOLORED/CONGESTION -CORTEX: CYST -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES Rf Cl mo ( 0* ,< , 1 1 OH I'.hI 4 . ||M 11 {MQOAirtllJN CSOVM PluHfNl INI fOllOWlN'i l IV.ol K*p MO M|| ot* it I I I E S OBSERVED LITER LUNGS HAWM*' GLAHDS NOSE/s/.C I. nOSE/IuAB SEC 2. HOSL/IUHB SEC 4, OVARIES. OVIOUCTS/FAL PITUITARY GLAND. TRACHEA. VAGINA fO i'i't-D jg KEY TO NEOPLASMS: "M-" MALIGNANT, "B'" BENIGN. "S-" METASTATIC, "l-" INVASIVE, "X-" OT *** PATH/TQX SYSTEM OUTPUT *** V)NYl CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $TI ANIMAL NUMBER; 4029 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACI STUDY OAY OF OEATH: 113 STUOY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / M5TOPATHOLOGII EPIDIDYMIDES . MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT LIVER . . . . MICRO: -MINIMAL.......................................................... -HEPATOCYTESCENTRUOBUUR: HYPERTROPHY MAMMARY GLANDS MICRO; -fISSUE HISS NOSE/TURB SEC 3 MICRO: -SliGHT........................................................................ -NASOLACRIMAL DUCT; LYMPHOID HYPERPLAsiA* -HlNlHAL NASOLACRIMAL OUCT(S): FREE ERYTHROCYTES NOSE/TURB SEC 4 MICRO' -SliGHT........................................................................ -NASAL MUCOSA (OLFAC WRY j; LKl TrtEliuH-iNTRAC' EOSINOPHILIC MATERIAL ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES 08SERVE0: CQAGUIAIING GL. EPIOIDYMIOES, KIDNEYS. LUNGS, NOSE/TURB SEC l. NOSE/TURB SEC 2, PITUITARY GLAND. PROSTA SEMINAL VESICLES. TESTES, TRACHEA BFG43290 KEY TO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "t-" OTHI BFG43305 *** PAIH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: tSM DATE OF DEATH: Q5/Z7/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL S STUOY DAY OF DEATH: 141 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEKT COMMENTS / HISTOPATNOLO KIDNEYS . . LIVER . . . NOSE/TURB SEC NOSE/TURB SEC MICRO: MICRO: 2 .. MICRO; 3 ,, MICRO: -MINIMAL, MULTI-FOCAL -MINIMAL, focal' -MINIMAL -MINIMAL -SLIGHT -MINIMAL -SLIGHT NOSE/TURB SEC 4 ............................................................... MICRO: -MINIMAL UTERUS -MINIMAL. FOCAL ..................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -CALCIFIC GRANULES -ACUTE/SUBACUTE INFLAMMATION NASOLACRIMAL OUCT(S): FREE ERYTHROCYTES -NASAL MUCOSA (RESPIRATORY): EPITHEliuM-INl EOSINOPHLIC MATERIAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPJTHELJUH-INTR/ EOSINOPHILIC MATERIAL -NASOLACRIMAL OUCT(S); FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY); EPJTHELilJH-iNTRI EOSINOPHILIC MATERIAL -NASAL MUCOSA (RESPIRATORY): BASOPHILIC HAl -R(GHI: 7; LEFl : 6 -ENDOMETRIUM: BROWN PIGMENT THt FOLLOWING 1 ISSUES HAD MO MICROSCOPIC ABNORMALITIES OBSERVED; u.,Ii(. LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1. OVARIES, OV1 DUCTS/FALOP T. PITUITARY GLAND. TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, V BENIGN, **S-" METASTATIC, "I-" INVASIVE. "X-" 01 03 O o o -J *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-&CNEflAT|ON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $TI ANIMAL NUMBER: 1501 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: Ml STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGII GR0SS/N1CR0 CORR KIDNEYS MICRO: GROSS; MICRO; LIVER MICRO: LUNGS MICRO: NOSE/TUR0 SfC 3 MICRO: NOSE/TUR0 5EC A MICRO: UTERUS GROSS: HISTOPATHOLOGICAL COMMENT: -DILATATION, SEVERE -HARKED -MODERATE -MINIMAL, FOCAL -MINIMAL -HINIMAL. FOCAL -MINIMAL -MINIMAL -MINIMAL -MINIMAL -IMPLANT SCARS - PRESENT >KIDNEY (R): DlLATATlON/PELVIS DILATED -RIGHT -PELVIS 01LATC0 -PYELONEPHRITIS, SUBACUTE -ACUTL/SUBACUTC INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (N0N-20NAI -PULMONARY VESSELS; MINERAL DEPOSlt(S) -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA NASAL MUCOSA (OLFACTORY): EP!THtLlUH-INTRAC EOSINOPHILIC MATERIAL - NASAL MUC05A (OLFACTORY): EPITHELIUM-INtRAC EOSINOPHILIC HATFRIAL -NASAL MUCOSA (RFSP(RAfORY): EPJTHELIUN-INTR COSINOPHLIC MATERIAL -LEFT; 6; RIGHT: 0 THE FOLLOWING TISSUES HAD NO HICROSC0P1C ABNORMALITIES OBSERVED: MAMMARY GIANOS. NOSE/TURB SEC 1, NQSE/TURB SEC 2. OVARIES, OVIDUCTS/FALOP Y, PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT. "0-'` BENIGN. "S-" METASTATIC. "1-" INVASIVE, "X-" OTH BFG43292 03 Ci % t** u *** PATH/TOX SYSTEM OUTPUT "* VINYL CHLOMOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CP RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 1516 DATE OF DEATH: 05/30/97 SEX; FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDUlED, TFRMINAl < STUOY DAY OF DEATH: 144 STUOT WEEK OF DEATH: 21 TERMINAL BODY WEIGHT ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * 4 KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATHQLT LIVER , . , , MICRO: MINIMAL, FOCAL LUNGS . . . . HICRO: -TISSUE HISSING N05E/TURB SEC 3 HICRO: -MINIMAL NOSE/TURfl SEC 4 ............................................................... MICRO: -SLIGHT UTERUS ..................................................................................... GROSS; -IMPLANT SCARS - PRESENT MICRO: 'SLIGHT, FOCAL -ACUiE/SUBACUTE jNFLANHATION' -NASAL'MUCOSA (OLFACTORY); EPITHELluH-INTI EOSINOPHILIC MATERIAL NASAL'mUCOSA (OLFACTORY j; EPITHELJUM-iNTI EOSINOPHILIC MATERIAL -RIGHT; 8; LEFT: 6 -MYUMfcIHlUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, MAMMARY GLANDS, NOSE/TURB SEC 1, NQSE/TURB SEC 2. OVARIES, OVJOUCTS/FALOP T, PITUITARY GLANI VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, METASTATIC, "l-" INVASIVE, "X-" I BFG43307 03 -fl ft O o i*. L*J SO *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-GtNERAT|ON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOV IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST! ANIMAL NUMBER: 1503 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE CROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHQLOGI! LIVER ........................................................................................................................................................................................................................... .... MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAI NOSE/TUR0 SEC 3 ..................................................................................................................................................................................................... .... MICRO: -SLIGHT -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA NOSE/TURB SEC 4 ............................................................................................................................................................................. MICRO' -MINIMAL -NASAL MUCOSA (OLFACTORY): EPtTHELlUM-INTRACl EOSINOPHILIC MATERIAL PITUITARY GLANO ....................................................................................................... ......................................................................................... MICRO; -MINIMAL, TOCAL PARS INTERMEDIA; CYST(S) UTERUS ........................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS PRESENT -RIGHT: IZ; LEFT: 3 MICRO: -MINIMAL, FOCAL -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNOHMALlI1ES OBSERVED: KIDNEYS, LUNGS, MAMMART GLANOS. NOSE/TURB SEC 1, NOSE/TURB SEC 2. OVARIES, QVIDUCTS/FALQP T. TRACHEA, V/ BFG43294 KEY TO NEOPLASMS: "H-" MALIGNANT, *B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE. "X-" QTH| *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1518 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEOULEO. TERMINAL S STUDY DAY OF DEATH; 144 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME *** pathology observations * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE'TEXT COMMENTS / HISTOPATHOLO' NOSE/TURB SEC 2 ........................................................... MICRO: -MINIMAL. FOCAL NOSE/TURB SEC 4 ........................................................... MICRO: 'MINIMAL UTERUS ............................................................................... GROSS; -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -VOMORONASM ORGAN EOStNOPHi LICMA f ERIAL -NASAL MUCOSA {OLFACTORY): EFITHELIUM-jHTR EOSINOPHILIC MATERIAL RIGHT; 5; LEFT; B............................................. -MYOMETRIUM: BROWN PIGMENT U> THE FOLLOWING TjSSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: Co KIDNEYS LIVER. LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 3, OVARIES. OVIOUCTS/FALOP T. P o TRACHEA, VAGINA KEY TO NEOPLASMS: "N-" MAllGNANl, "6-" fitNlUN, "S-" METASTATIC, "l-" INVASIVE, "X-" 0 99 3 o o ANIMAL NUMBER: ISOS DATE OF DEATH: 05/28/97 *** PATH/TQX SYSTEM OUTPUI *** VI NYt r.H| OR TOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $TI SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: 14? STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLDGII LIVER ...................................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL. FOCAL NOSE/TURB SFC 3 ........................................................................ MICRO: -MINIMAL -MINIMAL MINIMAL NOSE/TUR0 SEC 4 ............................................................... MICRO; -SLIGHT UTERUS ..................................................................................... GROSS: -IMPLANT SCARS * PRESENT MICRO: -MINIMAL, FOCAL -acute/subacute inflammation -HEPATQCYTES: CYTOPLASMIC VACUOLES (NON-ZONA| -NECROSIS,COAGULATION -NASALHUCOSA (RESPIRATORY): CPfTHELtUH-iNTRJ EOSINOPHLIC MATERIAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHEIIUH-IMTRACY EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY!. EPITHELIUM-jNTRAC> EOSINOPHILIC MATERIAL RiGHT: 9; LEFT :.......................................................... -ENODHETRlUM: BROWN PIGMENT IHt FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: KIDNEYS, LUNGS, HAHHARY GLANDS. NOSE/TURB SEC I, NOSE/TURB SEC 2, OVARIFS. OVIDUCTS/FAI OP T. PITUITARY ( TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE, V OTH( BFG43296 bFG <> O 4k Fi *** PATH/TOX STSTtH OUTPUT '** VINYL CHLOAIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: IS20 OATE OF OEATH; 55/Z7/9? SEX: FEMALE DOSE GROUP; I SACRIFICE STATUS: SCMFOUUO, TERMINAL SA STUDY DAY OF DEATH; 141 STUDY WEEK OF DEATH; 21 TERMINAL BODY WClGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS # * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HJSTOPATHOLOO GROSS/MICRO CORK MICRO; NQ5E/TURB SEC 3 MICRO: NOSE/TUR8 SEC 4 MICRO: PITUITARY GLAND MICRO: THYMUS . , , , GROSS; MICRO: UTERUS .... GROSS: fUSTOPATHOLOGlCAl COMMENT; THYMUS: OlSCOLORED/COMGESTION -SLIGHT...................................................................... -NASOLACRIMAL DUCT: {.YMPHoift HYPERPLASiA -MINIMAL................................................................... '-NASAL MUCOSA (DLFACTDRY):' EPITHEliuN' INTRA EOSINOPHILIC MATERIAL -MINIHA .................................................................. -PARS OISTALis: CYSTS -DISCOLORED! SliGHT -MINIMAL -RED -CONGESTION -IMPLANT SCARS * PRESENT -RIGHT: 5; LEFT: 6 THE FOLLOWING TISSUES MAD HQ MICROSCOPIC ABNORMAL!IICS OBSERVED; KIDNEYS, LIVER, LUMGS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2, OVARIES. OVlOUCTS/FALQP T. Tfl VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "0*`` BENIGN, METASTATIC, "1-" INVASIVE, "X-" OT BFG43311 0 O O o u> jt u *** PATH/TOX SYSTEM OUTPUT *" VINYL CHLORIDE COMBINED INHALATION TVO-GENERAIION REPRODUCTION AND DEVELOPHCNTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUI ANIMAL NUMBER: 1507 DATE OF DEATH: 06/03/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERHINAL SACRI STUDY DAT OF DEATH: 140 STUDY WEEK OF DEATH; ll TERMINAL BODY WEIGHT; i ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL LUNGS . . . MICRO; -MINIMAL NOSE/TURB SEC a . . MICRO: -SLIGHT nose/turb SEC 4 . . micro M|N|MAl u r fug i,fi 0 , nil >0 l nr a* i , I i.r' INI' -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZDNAL] -PERIVASCULAR; EDEMA NASOLACRIMAL DUCT: LYMPHOID HYPFRPlASIA NASAl MUCOSA (OLFACTORY): EPITHELIUM-TNTRACY1 tOSINIlPHll If MATERIA! N|i,Ml A |{M *j I I 1 lM H| HONNMAIiI ( ) f Ji ((>:. ' /' , IlLlUtT^ HAMAS* w, Am-. VAMM * ir * .M>A . l M | , I,A', t |( D ' l, j ntj.ti'oU sic t )ilir>, 0 J DvJL * %/< Ai Of I. PllulTARl GLAND, If KLY to UtOPLASMS M-" HAIIGNANI, "fl-" BENIGN, "S-" MEIASIATIC, "1-" INVASIVE, "X-" OTHEI o m o o o J fl 03 Tl O & C>> CO td 3 O *** PATH/TflX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1522 PATE OF PEATH: Q5/Z?W SEX; FEMALE DOSE GROUP; 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA> STUPY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLDG LIVER . , MICRO: -MINIMAL, FOCAL NOSE/TURB SEC 2 MICRO: -MINIMAL NOSE/TUfiB SEC 3 MICRO: -MINIMAL NOSf/TUNB Mi 4 MM HO li.nl uHRi>S uto pH AO i mv **' m , ikIMAi < ui i mi , i m -ACUTE/'SUeACUTE INFLAMMATION 'NASOLACRIMAL DUCT(S); INFLAMMATORY CELLS/C -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRAi EOSINOPHILIC MATERIAL -KA'iAL MIMOSA (OlfACTORY): fP|THFL|UM -1NTRAI fOSlNOPHl/ 1C MAMRIM ! I,H I S III I < fOmiHHffl BROWN PK.N(I 1 Hi LDliOWIRi, M'.Sul. pAO BO i. #0 V uM l AMoNaAi M i t > ONHHulO * i qqi T `j iuBuS NAHPAtf oiARDS now HlHB Ml J. OtARIfS, 0* L PUL 15/f AL OP I, MHjHARt Gl AND, 1RACWA, ' Kl Y 10 NEOPLASMS; "M-" MALIGNANT. "6-" BENIGN, V* MLTaSTATIC, 'V' INVASIVE, 'V OTl 03 Cl a LA *** PATH/TOX 5YSTEM OUTPUT *** VINYL CHI.ORI0E CQMBlNEQ INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RaTs INDIVIDUAL ANIMAL DATA SHEET 5TU ANIMAL NUMBER: 1509 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEOULEO, TERMINAL SACK STUDY DAY OF DEATH; 144 STUDY WEEK OF DEATH; 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS LIVER MICRO; MICRO: NOSE/TURB SEC 3 MICRO: -MINIMAL, `MINIMAL, -MINIMAL -MINIMAL FOCAL FOCAL NOSE/TURB SEC 4 MICRO: -SLIGHT UTERUS GROSS: -IMPLANT SCARS NOT PRESENT `CORTEX: INFILTRATES,SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (N0N-20MAL -NASAL HUCOSA (OLFACTORY): EPITHELIUM INTRACY EOSINOPHILIC MATERIAL -NASAL MLJCOSA (OLFACTORY); EP1 THELIUH-1NTRACV EOSINOPHILIC MATERIAL THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO; LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. OVARIES. OVIOUCTS/FALOP T, PITUITARY GLAND, TRAi VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, METASTATIC. "l-M INVASIVE, "X-'* OTHEl BFG 003432 tfl O Ui o o *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1H4 DATE Dp DEATH: 05/29/97 SEX: FEMALE DOSE GROUP; I SACRIFICE STATUS: SCHEDULED, TERMINAL S STUDY DAY OF DEATH: 143 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS TREE-TEXT COMMENTS / HISTOPATHOLO LIVER LUNGS UTERUS ...................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION ...................................................................................................................................................................................................................... MICRO: 'MtNINAL, FOCAL -PULMONARY VESSELS: MINERAL DEPO$|T(S) -SLIGHT -HEMORRHAGE ALVEOLAR -SLIGHT. FOCAL -PERIBRONCHIAL: LYMPHOCYTIC HYPERPLASIA ...................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT; 5; LEFT: B HICRO; -MODERATE, FOCAL -MYOMETRIUM; BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED; KIDNEYS. MAMMARY GLANDS. NOSE/TURfl SEC I, NOSE/TURB SEC 2, NOSE/TUftB SEC 3. NOSE/TUflB SEC 4, OVAfttES, . PITUITARY GLAND. IRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, 'V METASTATIC, "I-" INVASIVE, "X-" 0 BFG43315 W o o ijj it. *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST1 ANIMAL NUMBER: 1S11 OATE OF DEATH; 06/03/97 SEX: FEMALE DOSE GROUP; I SACRIFICE STATUS; SCHEDULED. TERMINAL SACI STUDY DAY OF DEATH: 148 STUDY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: ORGAN NAME PATHOLOGY OBSERVATIONS * * * KEYUORO$, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOtOGIl LIVER MICRO: -MINIMAL. FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-Z0NAJ NOSE/TURB SEC 3 ......................................... MICRO; -MINIMAL :NASALHUCOSA (OLFACTORY); EPITHEliUH-iNTRAC1 EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ......................................... MICRO: -MINIMAL -NASAL'MUCOSA (OLFACTORY); EPITHELIUM^iNTRAC' EOSINOPHILIC MATERIAL UTERUS ................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 6; LEF1: 9 HJCRO; -SLIGHT. MULTI-FOCAL -MYOMETRIUM; BROUN PIGMENT THE. FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMAL 11! ES OBSERVED: MONEYS, LUNGS, MAMMARY GLANDS. NOSE/fURB SEC 1, NOSE/TURB SEC 7, OVARIES. OVlOUCTS/fALOP T. PITUITARY I TRACHEA, VAGINA BFG43302 KEY TO NEOPLASMS: "M-" MALIGNANT, "B"" BENIGN. "S-" METASTATIC, "l-" INVASIVE. "X-" OTHI b f g 003434 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1526 DATE QF DEATH; 05/30/97 SEX: FEMALE DOSE GROUP; 1 SACRIFICE STATUS: SCHEDULED. TERMINAL STUDY OAY OF OEAth: 144 STUDY WEEK OF DEATH; 21 TERMINAL BODY WEIGT ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTQPATHC LIVER UTERUS MICRO: -MINIMAL. FOCAL...................................................... -ACUTE/SUBACUTE INFLAMMATION' -MINIMAL. FOCAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NON- GROSS: -iMPLANT SCARS - PRESENT ............................... -RIGHT: 9; LEFT:................................................. MICRO: -SLIGHT, FOCAL -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMAL 111E5 OBSERVED; KIDNEYS. LUNGS, MAMMARY GLANDS, NOSC/TUR0 SEC 1. NOSE/TURB SEC Z, NOSE/TURB SEC 3. NOSE/TURB SEC 4. QVTDUCT5/FAL0P T. PITUITARY GLAND. TRACHEA, VAGINA KEY TO NEOPLASMS; "H-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-'' INVASIVE, "X-' BFG43317 03 2 Ci *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER; 15(3 DATE OF DEATH: 05/28/97 SEX; FEMALE POSE GROUP; 1 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT; 2 ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS ... MICRO: NOSE/TURB sec l MICRO; NOSE/TURB SEC 3 MICRO: UTERUS . . . . GROSS: 'MINIMAL, FOCAL -MINIMAL -MINIMAL -SLIGHT - IMPLANT SCARS 1 PRESENT MICRO: -MINIMAL, FOCAL -MEDULLA: CYST -PELVIS DILATED -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -RIGHT: 4; LEFT: 0................................................... -ENDOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LIVER LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 4. OVARIES. OVIDUCTS/FALOP T, PITUITARY GLAN VAGINA BFG43304 KEY TO NEOPLASMS: "H*" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "1*" INVASIVE, "X-'* OTHER BFG 003436 BFG43319 *** PAfH/lOX SYSTtM OUTPUT *Mt VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIHAL NUMBER: 1528 DATE OF DEATH: 06/04/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL S STUDY DAY OF DEATH: 149 STUDY WEEK OF DEATH: 2? TERMINAL BODY WEIGHT: ORGAN NAME "** PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-tEXT COMMENTS / H1ST0PATH0L0 GROSS/MICRO CORR .................................................................................................. MICRO: HISTOPATHOLOGICAL COMMENT: LUNGS ........................................................................................................................ GROSS: -NOOULE(S)/HAS$(ES) MICRO: -MINIMAL. FOCAL MINIMAL SLIGHT, FOCAL NOSE/TURB SEC 1 ................................................................................................... MICRO: -MINIMAL NOSE/TURB SEC ? ................................................................................................................. MICRO: "MOOERATE SLIGHT -SLIGHT NOSE/TURB SEC 3 .................................................................................................. MICRO: -SLIGHT UTERUS ........................................................................................................................ GROSS: -1MPLAN1 SCARS - PRESENT MICRO: -SLIGHT, FQCAI >LUNG$; NOOULES/NMC NODULES, ALL LOBES: 0.1 - 0.3 CM DtA. TAN -PULMONARY VFSJEIS: MINERAI DEPOSITS) -PERIVASCULAR: EOEMA -PERIBRONCHIAL: LYMPHOCYTIC HYPERPLASIA -NASAL LUMEN: EXUDATE -NASOLACRIMAL OlfCr(S): KUCOSA-SUBACUfE'(CH CHRONIC INFLAMMATION -ODONTOPATHY -NASOLACRIMAL OUCT; EXUDATE -NASOLACRIMAL DllCT: LYMPHOID HYPERPLASIA -RIGHT: 3; LFFT: 6 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. HVfH. MAMMARY GLANDS, NOSE/TURB SEC 4. OYARtES, OVIDUCTS/FALOP T, PITUITARY GLAND, TRACHEA, KEY TO NEOPLASMS: "M-m MALIGNANT, "B-" BENtGN, "S-** METASTATIC, "l-" INVASIVE, X- 0 w O O 1*4 Jl ANIMAL NUMBER: 151S DATE QF DEATH: 05/30/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUI SEX; FEMALE DOSE GROUP; I SACRIFICE STATUS: SCHEDULED. TERMINAL SACK STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT; i ORGAN NAME * * Pathology Observations * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC EARS................................................................................. GAUSS; -SWOLLEN, MODERATE -DISCOLORED, MODERATE MICRO; -MODERATE -BOTH -BOTH: RED -SUBACUTE (CHRONIC ACTIVE)/CHRONIC INFLAMMATIl -MINIMAL, FacAl GROSS/MICRO CORR .......................................................... -NECROSIS CARTHAGE LIVER MICRO: H1STOPA1HOLOGICAL COMMENT: >EARS: SWOLLEN.DISCOLORED/SUBA,CHRONIC INFLAHI ................................................................................................... MICRO; -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION.................................... -MINIMAL NOSE/TURB SEC 3 ............................................................................ MICRO; -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONALl -NASOLACRIMAL OUCT; LYMPHoioHYPERPLASiA' -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUH-INTRACYl EOSINOPHILIC MATERIAL NO5E/1UR0 5EC 4 ............................................................................ MICRO: -SLIGHT -NASAL MUCOSA (OLFACTORY): EPITHELIUH-INTRACYl EOSINOPHILIC MATERIAL UTERUS GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 3; LEFT: 9 MICRO: -MINIMAL, FOCAL -ENDOMETRIUM; BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KlOHEtS. LUNGS. MAMMARY GLANDS, NOSE/TURB SEC \. NOSE/TURB SEC l, OYAR1FS. DVIOUCTS/FALOP T, PITUITARY Gl TRACHEA, VAGINA BFG43306 KEY TO NEOPLASMS; mM-" MALIGNANT, BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-1' OTHER BFG 003438 MH10 -X., '3MSVAM1 M-\u '3im$luaM 'NSlMfl M-B,, *lNVM9nVM M-N,, :SMSVUQ3N 01 A3* VN19VA 'mmi '0NV1Q imiruld `i dOWJ/SlOflOlAO 'S3WA0 `l 335 MM/3SQH 'S0NV1O JLWHtm :03AU3Sfl0 SSimVNWNBV OldDSSOtmM ON QVH S3HS5I1 iH3N9td WlHOtfS tmntlMQQNJ9 : 1J31 !E :1H91M' 1V30J '1VWINIH- WSIM lN3S3d * SMVDS lNVldMt- 'SSG09 1VIN31VH 3niMd0NlS03 OtHSVl<>0U3VlNI-Hnil3HU43 :(AUOI3V^10) VS03M 1$VN' 1VH1NIH- OB31H VJSVldUJdAM OIOHdMAl :i3fNJ 1VMMI3V10SVN' 1VWIMIM-/0N3IH iviU31VM 0 MIHdQNIS03 NttttO 1VSVN0U0H0A; 1V30J `lVHININ* !0U3lH ainoyens lvmisMiiii siiinwiisiw; HOUVMHVldNI 31fl3VanS/3in3V- lvood ;iHsnv :Qa31M lVOOd 'IVHINIH- :<N3IH S9N10MIJ 3!9010HlVd01S!H / SXN3HN03 IU1-39U SSOM9 NOIMQlUUia `Aint3A3S *$0WlfU , * , SHliVUHH A 9 0 3 0 H 1 V d SHVM9 9-182 :1HDI3A AQOi 1VNIHM31 (2 ;N1V30 JO *33* AQMS ttl H1V30 30 AV0 AMIS 33Idmv$ WUlMSi 'tmnoBHOS `-SAIVIS 33U1MVS \ :MQV9 3500 31VM33 'X35 0BDM6 :WBMnN AdfliS 091 -39d 06-HdX'52 :Q31Nlt)d A33HS ViVO lvMINV lVMlAIQN! S1VI do KI Addis AlOixOl 1VlN3hd013A30 QHV NOliyiOOd3 M0UW1N39-M1 N011V1VHH1 03N19W03 3Q1301H3 11NIA *,* indirtO H31SAS XOl/HIVd 26/62 0 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 1517 DATE OF DEATH: 0S/2B/97 SEX: FEMALE OOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY, DISTRIBUTION GROSS TREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER . . . . MICRO: -MINIMAL, FOCAL NOSE/TURB SEC 2 MICRO: -MINIMAL, FOCAL NOSE/TURD SEC 3 MICRO: -SLIGHT -MlNlHAt NOSE/Time sic 4 li on t ) 1 MA, uiirus i.su\, Ah ' ,, A* . * *( ,| hi -ACUTE/SUBACUTE INFLAMMATION -VOMERONASAL ORGAN: FREE`ERYTHROCYTES -NASOLACRIMAL OUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYT IOSIHOPHlLIC HAT ERI At .**; Wilin',* (miAllORY) E R l T HE L IUM - INTRACYT1 IOS iftOPHll )t MAIfBMl |t,Nl S L1 F 1 0 FH| FOtiOwHU. T | S S S ABWOA4i tUl S OB\l**f0 KlDMtrS IU4jS lUMtAUr (.1*hOi fruhl.ltAB bit 1 OvAR Hi, 0 IDUC t 5/1 AlOP I. P|lU|lAT (.LAND. TRACHLA. Ul t KEY TO NEOPLASMS: "H-" MALIGNANT, "8-" BENIGN, "S'" METASTATIC, "l-" INVASIVE, "X-" OTHER BFG43308 03 S o o Ui A* 9 ANIMAL NUMBER: 2502 DATE DF DEATH: 05/27/97 path/tox system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET S SEX: FEMALE DOSE eWUP: 2 " SACRIFICE STATUS: SCHEDULED, TERMINAL SAl STUDY DAY OF DEATH: 141 STUOY MEEK OF DEATH: 21 TERMINAL BODY WEIGHT; organ name * * * PATHOLOGY rwords, severity, distribution OBSERVATIONS * * * dross free-text comments / histopatholdg LIVER UTERUS MICRO: -MINIMAL, FOCAl' -MINIMAL .......................................... -ACUTE/SUBACUTE iNFLAHMATTON..................... -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZON GROSS: -iMPLAMT SCARS NOT PRESENT KEY TO NEOPLASMS: **M-H MALIGNANT, BENIGN, "S-" METASTATIC, "1-" INVASIVE, "X-" OT BFG43323 BFG 003455 BFG43310 PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHUT ST' ANIMAL NUMBER: 1519 GATE OF DEATH: 0S/C3/9? SEX: FEMALE OOSE GROUP: 1 SACRIFICE STATUS: UNSCHEDULED (A) STUDY DAY DF DEATH: 137 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS TREE-TEXT COMMENTS / HISTOPATHULOGIl GROSS/MICRO CORA , . MICRO: HISTOPATHOLOGICAL KtONtrs MICRO: -MINIMAL, FOCAL LIVER ..................................................................................... MICRO: -MINIMAL. FOCAL LUNGS ..................................................................................... gross: -fluid filled, slight MICRO: -MINIMAL -MODERATE ND5E/TURB SEC 1 ............................................................... MICRO: -MINIMAL SIIGHT NOSE/TURB SEC 2 ............................................................... MICRO; -MODERATE -MINIMAL -SLIGHT NOSE/TURB SC 3 ............................................................... MICRO: -MODERATE TRACHEA ................................................................................. GROSS; -FLUID, SLIGHT UTERUS ..................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO; -SLIGHT, FOCAL COMMENT: `TRACHEA; FLUIO/NMC LUNGS: FLUID FILLED/HEHORRHAGE ALVEOLAR -CORTEX: INFILTRATES,SUBACUTE -acute/subacute Inflammation' -ALL LOBES........................................ -PERIVASCULAR: EDEMA -HEMORRHAGE AI.VEOIAR -VQMQRONASAl ORGAN: FREE ERYTHROCYTES -NASAL LUMEN: FREE ERYTHROCYTES -NASAL LUMEN: FREE ERYTHROCYTES -VOMERONASAL ORGAN; FREE ERYTHROCYTES -NASOLACRIMAL OuClISJ: FREE ERYTHROCYTES -nasal'lumen- fruckythrqcytes -LUMEN: WHITE, FROTHY -RIGHT: fl: LEFT; 9 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: MAMMARY GLANDS, NOSE/TURB SEC 4. OVARIES. QVIOUCTS/FALQP T. PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS; HM'" MALIGNANT, "B-" BENIGN, "S-`r METASTATIC, "!" INVASIVE, "X-" OTHI 3 U N PATH/TQX SYSTEM OUTPUT *" VINYL CHLORIDE COHBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET 5 ANIMAL NUMBER: 2504 DATE OF DEATH: 0S/30/9? SEX; FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERHINAL SJ STUOY DAV OF DEATH: 144 STUDV WtfK OF DEATH: 21 TERMINAL BODY WEIGHT; ORGAN NAME * * * pathology OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREI-TCXT COMMENTS / HlSTOPATHOKK UTERUS . . GROSS; -IMPLANT SCARS - PRESENT -RIGHT; 6; LEFT: 4 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED to to G 4^ U LO *** FAIH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUl ANIMAL NUMBER: l52l DATE OF DEATH: 06/05/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR; STUDY DAY OF DEATH: 150 STUDY WEEK OF DEATH- 22 TERMINAL BODY WEIGHT: ! ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWOROS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER HICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION NOSE/TURB SEC 2 MICRO; -SLiOHT........................................................................ -NASOLACRIMAL QUCT( S)FREE ERYTHROCYTES ' NOSE/TURB SEC 4 ......................................................................................................................................................................................................... MICRO; -MINIMAL -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRACY' EOSINOPHILIC MATERIAL UtRUS ................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT; 11: LEFT: A MICRO: -MINIMAL, FOCAL -MYOMETRIUM; BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; KIDNEYS LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 3. OVARIES. OVlOUCTS/FALOP T, PITUITARY Gl TRACHEA, VAGINA KEY TO NEOPLASMS: ''M*" MALIGNANT. "B-" BENIGN. "S*" METASTATIC. "I-" INVASIVE, **X-M OIHEI 09 O u U 4- *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ! ANIMAL NUMBER; 2506 DATE OF DEATH: 05/27/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL S/ STUDY DAV OF DEATH; 141 STUDY WEEK OF DEATH: 21 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS TREE-TEXT COMMENTS / HI$TQPATHOLO< LIVER UTERUS MICRO: -MINIMAL, FOCAL..............................................................-ACUTE/SUBACUTE INFLAMMATION................................... GROSS:'-IMPLANT SCARS - PRESENT ........................... -RIGHT: 5: LEFT: 8 KEY TO NEOPLASMS; "M-'* MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "l-** INVASIVE. HX-" O' BFG43327 DO 3 o SO *** PATH/TQX system OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER: 1523 DATE OF DEATH: 05/30/97 SEX; FEMALE DOSE GROUP: 1 SACRIFICE STATUS; SCHEDULED. TERMINAL SACf STUDY DAY OF DEATH; 144 STUDY WEEK OF OEATH; Z\ TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS " * " KEYUOROS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATHOLOGH KIDNEYS , . . MICRO; -MINIMAL, HUIJI-FOCAL -INTERSTITIAL NEPHRITIS SUBACUTE LIVER .... MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION NOSE/TURB SEC 2 MICRO: 'SLifiHT....................... -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES' NOSE/TURB SEC 4 MICRO;1-MINIMAL :NA5AL MUCOSA (OLFACTORY):*EPITHEliuM-iNTBACY EOSINOPHILIC MATERIAL UTERUS ................................................................................................................................................................................... GROSS: -IMPLANT SCARS - NOT PRESENT MICRO: -MINIMAL. FOCAL -MYOMETRIUM; BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1, NOSE/TURB SEC 3, OVARIES, 0V1QUCTS/FA10P T, PITUITARY GLAND. TRJ BFG43314 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. US-*' MEIAS1ATIC. "l-" INVASIVE. "X-" OTHI BFG 003446 *** PATH/TQK system output *** VINYL CHLORIDE COMBINED INHALATION TVD-GENERAT]ON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $ ANIMAL NUMBER: 2506 DATE OF DEATH: 06/06/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL $A 5TU0Y OAY OF DEATH: 151 STUDY WEEK OF DEATH: 22 TERMINAL BOOT HEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTDPATHOLOfl LIVER UTERUS JfJCftQ; -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-CON GROSS: -INPLANT SCARS 1 PRESENT ............................. -RIGHT: ioi LEFT; 5 .............................................. KEY TO NiOPLASMS MALIGNANT, V` BENt&M. "S-" METASTATIC, "I*" INVASIVE, "X-" OT BFG43329 " FG 3461 *** PATH/TOX SYSTEM OUTPUT * VINYL CHLORIDE COMBINED INHALATION TVQ-GENERAlION REPRODUCTION AND DEVELOPMENTAL TDXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 152$ OATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUOY DAY OF DEATH: 142 STUDY UEEK OF DEATH: 21 TERMINAL BODY WEIGHT: Z ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS . . . MICRO -MINIMAL. FOCAL -DILATED TUBULES LUNGS .... MICRO -SLIGHT] FOCAL -PERiBRONCHIAL: LYMPHOCYTIC HYPERPLASIA NOSE/TURfl SEC 2 MICRO NOSE/TURB SEC 4 MICRO -MINIMAL -MINIMAL -NASOLACRIMAL DUr.T(sj INFLAMMATORY CfLLS/CELL -NASAL MUCOSA (OLFACTORY): EPITHEL1 UN-INFRACT I EOSINOPHILIC MATERIAL UTERUS CD GROSS: -IMPLANT SCARS - PRESENT n MICRO: -MINIMAL. FOCAL -RIGHT: JO; LEFT: G -MYOMETRIUM: BROWN PIGMENT a THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMAL!TIES OBSERVED: LIVER. MAMMARY GLANDS, NOSE/TUR8 SEC I, NOSF/TURB SEC 3. OVARIES, QVIDUCTS/FALOP T. PITUITARY GLAND, TRACI KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER 03 *n O 9 9 -F. Jj. 00 *** PMH/TOX SYSTEM OUtPUt *** VINYL CHLORIDE COMBINED INHALATION TWHSENEMT/M REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 2510 DATE OF DEATH; DS/Zfl/9? SEX; FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL 5A STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 2) TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER . . UTERUS . . MICRO: -MINIMAL GROSS: -IMPLANT $CARS - PRESENT -HEPATOmtS: CYTOPLASMIC VACUOLES (NON-ZON -RIGHT: 4; LEFT: 6 KEY TO NEOPLASMS; "H-" MALIGNANT, "B-" BENIGN, "5-" METASTATIC, "I-" INVASIVE. "X-" 01 O 4- 00 "* PATH/TOX SYSTEM OUTPUT " VINYL CHLORIDE COMBINED INHALATION TWO-GENEftATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUO' ANIMAL NUMBER; 1527 DATE OF DEATH: 05/30/97 $CX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRII STUDY DAY OF DEATH; 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEKT COMMENTS / HISTOPATHOLOGIC I LIVER . . . NOSE/TURB SEC MICRO; -MINIMAL, FOCAL -MINIMAL, FOCAL MICRO; -SLIGHT 'MINIMAL NOSE/TURB SFC 4 MI f #0 Ml* 1 HA Ull ftm (,ftO: |( *0 11# 4* hi* (Hi I* lift , 11 i ii I ftfcr ( *t -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES; CYTOPLASMIC VACUOLES (NQN-ZQNAl) -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA 'NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTl EOSINOPHILIC MATERIAL MASAI MUCOSA (01 FACTORY): EPI(HELIUM-INTRACYTl tOSIMOPMU H NAlUMAt m<ixi I ft 1 iiM AHCw* P|(*UN1 mOOMMUUH lMl IIAM S SUBACUH 1SS.M s HAD *0 A I ON f YS IUMuS UMilf fclAMOS IRACHLA. VAGINA ftQlf/TUM StL I. *OSi / '17*0 StC l. OVARIES, OVIDUCI S/Ml OP 1, FUUHARr GL< KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-H HtlASlAllC. "1-" INVASIVE, "X-" OTHER 09 **5 C o o Ui 9 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHlOftlQE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 2S|l OATC OF DEATH: 05/3D/RT ORGAN NANE SEX: FEMALE OOSE GROUP: % SACRIFICE STATUS: SCHEDULED, TERMINAL S/ STUDY DAY OF DEATH: 144 STUDY HECK OF DEATH: 21 TERMINAL 8Q0Y HEIGHT; * * p ATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOI KIDNEYS . . UTERUS . . . GROSS: -DILATATION, SLIGHT GROSS; -IMPLANT SCARS - NOT PRESENT -RIGHT PELVIS #** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** **** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GEHERATION REPRODUCTION AND DEVELOPMENTAL TOXICITT STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET SH ANIMAL NUMBER: 1529 DATE OF OEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMTNAL SACfl STUDY DAY OF DEATH; 144 STUDY WEEK OF DEATH: Zl TERMINAL BODY WEIGHT: ORGAN NAME * * * pathology OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC GROSS/MICRO CORR ................................................................................................... MICRO: HISTOPATHOLOGtcAL COMMENT: KIDNEYS ..................................................................................................................... GROSS: -DILATATION, MODERATE MICRO; -MARKED MODERATE LIVER ............................................................... MICRO: -SLIGHT, FOCAL NOSE/TURB SEC 3 ........................................ MICRO: 'MINIMAL UTERUS ..................................................................................... GROSS: `IMPLANT SCARS - PRESENT MICRO: -SLIGHT, FOCAL 'Kidneys! dilatation/pyelonephritis susa -BOTH PELVES PELVIS DILATED -PYELONEPHRITIS, SUBACUTE 'ACUTE/SUBACUTE iNFLAHMATION -NASOLACRIMAL DUCT; LYMPHOID HYPERPLASIA -RIGHT: 8; LEFT: 4 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANOS. NOSE/TURfl SEC 1. NOSE/TURB 5EC 2, NOSE/TURB SEC 4. OVARIES, OVIDUCTS/fALOP T. PIT TRACHEA, VAGINA KEy'tQ NEOPLASMS: ,`N-H MALIGNANT, "fl'" BENIGN, METASTATIC, "l-" INVASIVE. "X-" OTHI BFG43320 m C3i .u LA K1 to 3 U> Lo U> O) *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-6ENERATI0N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 25M DATE OF DEATH: 05/26/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE StATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. OISTRIDUTION GROSS FREE-TEX7 COMNENTS / H1STOPATHOLOG uterus . . GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 4; LEFT: 10 ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED "* S3 `sj o it* 4i $ *** PATH/TOX SYSTEM OUTPUT *#* VINYL CHLORIDE COHBINEO INHALATION TVO-GENERATIQN REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUI ANIMAL NUMBER; 2501 DATE OF DEATH: 05/29/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR STUOY DAY OF OEATH: 143 STUOY MEEK OF DEATH: 21 TERMINAL ROOT HEIGHT: i ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE'TEXT COMMENTS / HISTOPATHOLOGIC UTERUS . . GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 13; LEFT: 4 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG43322 bfg 003454 ** PATN/TOX SYSTEM OUTPUT *** VIHTl CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY 5TUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET Si ANIMAL NUMBER; 2510 DATE OF DEATH: 05/30/91 SEX; FEMALE DOSE GROUP; l SACRIFICE STATUS; SCHEDULED, TERMINAL $A< STUDY DAY QF DEATH: 144 STUDY WEEK OF OfATH: El TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHDLOO: LIVER UTERUS MICROj -MINIHAL. FOCAL...................................................... -ACUTE/SUBACUTE INFLAMMATION MINIMAL -HEPATOCVTES: CYTOPLASMIC VACUOLES (hON-ZONJ GROSS:*-IMPLANT SCARS - PRESENT ............................. -RIGHT: 4;*LEFT;*9.................................................. KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "1-" INVASIVE, "X-" OT1 BFG43337 W Cl o 8 *** FATH/TOX SYSTEM OUTPUT *" VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 25o3 DATE OF DEATH: 05/27/S7 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS ..................................................................................................................... .......................................................................................................... MICRO: -MINIMAL -HEPATOCYtES: CYTOPLASMIC VACUOLES (RON-ZONAL) ................................................................................................................................................................................................................................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 7; LEFT: 6 KEY 10 NEOPLASMS "M " MAUGHAM!. "B" BENIGN, "S-" METASTATIC, "l-" INVASIVE, "X-" QTHEI to 8 Oj u> 09 J n o Ah ** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 2$l6 DATE OF DEATH: 05/30/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED. TERMINAL SA STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY. DISTRIBUTION GROSS TREE-TEXT COMMENTS / HlSTOPATHOLOG LIVER UTERUS MICRO: -MINIMAL GROSS; -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZON Bright! b;'icft:`9................................................. KIT 10 NEOPLASMS "M-** MALIGNANT, HB-H BENIGN, "S-" METASTATIC, "l-" INVASIVE, "X-" OT CO ~n O -tUJ OJ VO 2 0 o s *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED 1NHAUT10N TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER; 2505 PATE OF DEATH; 05/Z9/N7 SEX; FEMALE DOSE GROUP: l SACRIFICE STATUS; SCHEDULED, TERMINAL SACR STUDY DAY OF DEATH: 143 STUDY WEEK OF DEATH; 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC UTERUS . . GROSS: IMPLANT SCARS - PRESENT -RIGHT; 10; LEFT: 3 ** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG43326 b f g oomss ANIHAL NUMBER: 2S20 DATE OF DEATH: 0S/30/0T ORGAN NAME PATH/TOM SYSTEM OUTPUT *M VINYL CHLORIDE COHNlNfQ INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIHAL OATA SHEET Si SEX: FEMALE DOSE GROUP: Z SACRIFICE STATUS: SCHEDULED, TERMINAL SA( STUOY OAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT; * * PATHOLOGY OBSERVATIONS **" KEYWORDS, SEVERITY. DISTRIBUTION GROSS FftiC-TCXT COMMENTS / HISTDPATH0L061 UVER UTERUS .... HlCRO: -MINIMAL................................................................... -HEPATOCYTES; CYTOPLASMIC VACUOLES'(NON-ZONJ ............................................................................................................................................................ .......................................................... GROSS; -IMPLANT SCARS - NOT PRESENT KEY TD NEOPLASMS M-h MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE. "X-" OTI BFG43341 o a u t-j ANIMAL NUMBER: 2507 DATE OF DEATH: 0S/29/07 *** PATH/TOX system output *** Vim CHLORIDE COMINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPHENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIHAL DATA SHEET STUD SEX: FEMALE DOSE GROUP; 2 SACRIFICE StATlJS: SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: M3 STUDY WEEK OF DEATH: El TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZONAL) 6R0SS:-iMPLANT SCARS - PRESENT ............................. -RIGHT: 6;LEFT;'l6 KEY TO NEOPLASMS: "M-" MALIGNANT. "6-" BEH16N, "S-* METASTATIC, H|-" INVASIVE, "X-'' OTHER *** PATH/TOX system output *** VINYL CHLORIDE COMBINED INHALATION TUO-6ENERATI0N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 2522 DATE OF DEATH: 05/27/07 $EX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SA STUDY DAY OF DEATH; 141 STUDY WEEK. OF OEATH: 21 TERMINAL DOOY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREC-TEXT COMMENTS / HlSTOPATHOlOG LIVER UTERUS MICRO: -MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZON GROSS; -iMPLANT SCARS - PRESENT ............................. -IUgHT: 8j*LEFT:B.................................................. KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, V METASTATIC. MI-" INVASIVE. "X-M OT U) BFG 003474 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-GENERATtON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STI ANIMAL NUMBER: 2509 DATE OF DEATH: 05/29/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH; 143 STUOY WEEK OF OEATH; 21 TERMINAL BODY WEIGHT: ORGAN NAME PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / H1ST0PATH010GH LIVER . . UTERUS . , MICRO: -MINIMAL GROSS: 'IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (HON-joNAI -RIGHT: 9; LEFT: 4 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, -V" METASTATIC, "l-** INVASIVE, "X-" OTHI to O & Lt* L>> O BFG 003462 *** PAfH/TOX SV5TEH OUTPUT *** VINYL CHLOftlOE COMBINED INHALATION TV0-6ENERATI0N REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS imoividual animal data sheet s ANIMAL NUMBER: 2524 DATE OF OEATH: 05/29/97 SEX: FEMALE DOSE GROUP: l SACRIFICE STATUS: SCHEDULED, TERMINAL $* STUDY DAY OF DEATH: 143 STUDY WEEK OF DEATH: 2| TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS *"* KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOti LIVER UTERUS MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZOP GROSS: -iHPLANT SCARS - PRESENT..................................*rUhT: G; LEFT:'6................................................... KEY TO NEOPLASMS: ,*M-'* MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" 01 S K tto u a ANIMAL NUMBER; 2511 DATE OF DEATH; OS/27/97 ** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUl SX: FEMALE OOSE GROUP; 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH; 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY MEIGHt; i ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * ` KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TCXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO; -MINIMAL -HCPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZONAL! gross; -Implant scars - present ............................. -rIght* 5;`left; 10 KEy"tO NEOPLASMs"';`M-'" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. V INVASIVE. "X-" OTHEI *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET S ANIMAL NUMBER; 2S2 DATE OF DEATH: OS/ZB/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SA STUDY DAY OF DEATH; 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER . . UTERUS . , MICRO: -MINIMAL. MULTIFOCAL GROSS: -IMPLANT SCARS - PRESENT -ACUTE/SUBACUTE INFLAMMATION -RIGHT; 8; LEFT: S -- ...................... KEY TO NEOPLASMS: "N-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE. "X-" 01 BFG43347 BFG 003478 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORtDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AMD DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 2513 DATE OF DEATH: 05/30/92 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACK STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BOOT WEI6HT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FAEE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS ................................................................................................................................................................................................. MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION ............................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT: $; LEFT: fl KEY 10 NEOPLASMS "N-" HAL |GNANT, V" BENIGN. "S-" METASTATIC. "l-" INVASIVE, "X-" OTHE o BFG 003465 ANIMAL NUMBER: 2526 DATE OF DEATH: 05/30/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA 5MEET SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL $1 STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: Zl TERMINAL BODY WEIGHT; ORGAN NAME * * PATHOLOGY OBSERVATIONS * * * KEYWOROS, SEVERITY, DISTRIBUTION GROSS FREE-TEKT COMMENTS / HISTQPATHOUK LIVER UTERUS MICRO: 'MINIMAL .............................................................. -HPATOCtTtS: CYTOPLASMIC VACUOLEs'(NON-ZOl GROSS: -ihPLANT SCARS : PRESENT........................... -RX6HT: j/lEFTjlO......................................... KEY TO NEOPLASMS "n" MALIGNANT, "I-" BENIGN, *`S-" METASTATIC, INVASIVE, "X-" 0 CD Lo U> fc. BFG IW348LI ANIMAL NUMBER; 2&15 DATE OF DEATH; 05/27/97 *** PATH/TOX system OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUI SEX; FEMALE DOSE GROUP; 2 SACRIFICE STATUS; SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: L41 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ................................................................................................................................................................................................................................ MICRO; -MINIMAL -HEFATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAl UTERUS......................... ........................................................................................................... .......................................... .... GROSS: -IMPLANT SCARS - PRESENT -RIGHT; 9; LEFT; 7 KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BCN|6N, METASTATIC. "I-" INVASIVE, "X*" 0THE1 % O S lP lP O' BFG 003467 *** PATH/TOX SYSTEM OUTPUT *" VJHYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 2531 OATE OF DEATH: 06/05/9? SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUOY DAY OF DEATH: ISO STUOY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HtSTOPATHDLOG LIVER . . UTERUS . . MICRO; -MINIMAL GROSS; -IMPLANT SCARS - PRESENT -HEPAtOCYTES: CYTOPLASMIC VACUOLES (NOH-ZOR -RIGHT: 10; LEFT: 4 KEY TO NEOPLASMS: "M-" MALIGNANT, "0-" BENIGN, "S'" NETASTAT|C, "I-" INVASIVE, "A-" 01 BFG43351 b f g 0034*2 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TW0-6ENERAI10N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL HUMBER: 2517 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL $ACR STUDY DAY OF DEATH: 141 STUDY UCEK OF OEATH: 21 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FNEE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL -HEFATOCYTES: CYTOPLASMIC VACUOLES (N0N-20NAL GROSS: -iMPLANT SCARS - PRESENT............................. -RffiNT: tS; LEFT-' 5 KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN, *VM METASTATIC, "1-" INVASIVE, "X-M OTHE ti O & a 00 003469 tec? s U> u> *** path/tox system output *** VINYL CHLORIDE COMBINED INHALATION TUO'GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 3502 DATE OF DEATH; 05/30/97 SEX: FEMALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH; 144 STUDY WEEK OF OEATH: Zl TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATHOlOG LIVER UTERUS MICRO; -MINIMAL, FOCAL................................................. -ACUTE/SUBACUTE INFLAMMATION........................ 'MINIMAL -HEPATOCYTES CENTRI LOBULAR: HYPERTROPHY SROSS: `jMPLANT SCARS - PRESENT ..................... -RIGHT; 4: LEFT; li KEY TO NEOPLASMS; "H-" MALIGNANT. "B-" BENIGN, "S*" METASTATIC, "I-" INVASIVE, "X-" OT e 9 4k *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLOftlOE COMBINED INHALATION TW0-6ENERAT10N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUOl ANIMAL NUMBER: 2S19 DATE OF DEATH: 05/29/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRII STUDY OAT OF DEATH: 143 STUDY WEEK OF OEATH: 21 TERMINAL BODY WEIGHT; 3( ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC 1 UTERUS . . GROSS: -INPLANT SCARS - PRESENT -RIGHT: 4; LEFT; 3 ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** *Tl O <>> O BFG 003471 ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET ANIMAL NUMBER; 350* DATE OF DEATH: 05/28/07 SEX; FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL S< STUDY DAY OF DEATH: HZ STUDY WEEK Of DEATH: 2t TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOI LIVER UTERUS MICRO; -MINIMAL -HEPATOCYtES CENTRILOBUIAR: HYPERTROPHY GROSS:''IMPLANT SCARS - PRESENT............................. -RIGHT1: 7:lEFT:B................................ $ y y KEY TO NFOPIASMS: "M-" MALIGNANT, *B-~ BENIGN, "S-" METASTATIC* "I-" INVASIVE, "X-" Ol OS *51 Cl S **. 00 Os "** PATH/TOX SYSTEM OUTPUT *** VINYL CHltyltOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INPIVIOUAI ANIMAL DATA SHEET STUDY AMI HAL NUMBER: Z5Z1 DATE OF DEATH: 05/28/37 SEX: FEMALE DOSE MOW; Z SACRIFICE STATUS: SCHEOULEO, TERMINAL SACK IF STUOT DAY OF DEATH: L42 STUDY WEEK OF DEATH! 21 TERMINAL BODY WEIGHT; 25 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F LIVER UTERUS ' MICRO; `MINIMAL GROSS:`-iHPLAHt SCARS : PRESENT -HEPATOCYTES; CYTOPLASMIC VACUOLESINON-ZOHAL) -RIGHT: 10; LEFT: 6 KEY TO NEOPUSHS: "H-h MALIGNANT, "B-" BENIGN, "S-" METASTATIC, Ml-H INVASIVE, "X-" OTHER BFG43342 CO O o 9OJ 4k. cJ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 3506 DATE OF DEATH: 05/30/97 SEX: FEMALE Q05E GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SI STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 22 TERMINAL BODY HEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * 1 KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLW LIVER UTERUS MICRO; -MINIMAL -HtPATOCYTES CENTMLQBDLAR; HYPERTROPHY GROSS:'-IMPLANT SCARS - PRESENT ............................. -RIGHT: 11; LEFT: 3 W KEY 10 NEOPLASMS 'V MALIGNANT. "B-" BENIGN. "5-" METASTATIC. INVASIVE. "X-" Q1 ............................................... .............................................................................. - - .............. . a & w U\ m 2 A o cUl GO oe ** PATH/TOX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANtMAl NUMBER: 2S2S DATE OF DEATH: 05/27/97 SEX; FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRlF STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: Zl TERMINAL BODY WEIGHT: 26 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F UTERUS ................................................................................................................................ ,................................................. ,........................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 8; LEFT: 7 ft* ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED ft** *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 3508 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL $i STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * PATH0L06T OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FRCC-TEXT COMMENTS ! KISTQPATHOLOl LIVER STOMACH UTERUS MICRO: -MINIMAL -HtNlMAl GROSS: -DISCOLORED*FOCUS(FOCI) GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES'(MON-ZOI HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -GLANDULAR MUCOSA: OJ CM DIA, RED -RIGHT: 10; LEFT; $ w a KEY TO NEOPLASMS: "M-" MALIGNANT. MB-rt BENIGN. >,5-H METASTATIC. "1-" INVASIVE, 0 Ui UT VO s o <+* ji. *** PATH/TOX SYSTEM OUTPUT ** V1NYI CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET STUDI ANIMAL NUMBER: *525 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE 6R0UP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR1I STUDY DAY OF DEATH: 141 STUOY WEEK OF DEATH: 21 TERMINAL 600V WEIGHT: 23 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FIEE-TEXT COMMENTS / HISTOPATHOLOGIC i LIVER . UTERUS . . MICRO: -MINIMAL -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -RIGHT: 6: LEFT: 4 KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, "l-" INVASIVE, "X-" OTHER BFG43346 3 U ANIMAL NUMBER: 3510' ' OATE OF DEATH: 06/03/9F *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S SEX: FEMALE DOSE GROUP-'s............. SACR1FICE STATUS: SCHEDULED. TERMINAL^' STUDY DAY OF DEATH: 148 STUDY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: ORGAN NAME " * PATH0L06T OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHQLD( LIVER UTERUS ............................................................................................................................................................................................ MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES INON-ZQI -MINIMAL -HEPATOCYTES CENTR1lOBULAfl; HYPERTROPHY ...................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - NOT PRESENT KEY TO NEOPLASMS: "M-" MALIGNANT, "6-" BENIGN, "S-" METASTATIC, "1-" INVASIVE. "X-" 0 BFG43361 *T c *** PAlH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AMO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD1 ANIMAL NUMBER; 2527 DATE OF DEATH: OS/Zfl/97 SEX: FEMALE DOSE GROUP; t SACRIFICE STATUS: SCHEDULED. TERMINAL SACR1I STUDY DAY OF DEATH: 14Z STUDY WEEK QF DEATH; 21 TERMINAL BODY WEIGHT: 2] ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS l HISTOPATHOLOGIC 1 LIVER . . UTERUS . . MICRO; -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -RIGHT: 6: LEFT: 0 KEY TO NEOPLASMS; "H-" MALIGNANT, "B-" BENIGN. "S-M METASTATIC. `V* INVASIVE. "X-" OTHER % o fi 00 BFG 003479 *** PATH/TOX SYSTCH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPAOOUCTIOH AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: J5U DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE 6ROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SI STUDY OAT OF DEATH: 142 STUDY WEEK OF DEATH: Z1 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FRfE-TfXT COMMENTS / HISTOPATHOLM LIVER UTERUS ......................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION ......................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 11; LEFT: 4 KEY TO NEOPLASMS; '*H-" MALIGNANT. "B-* BENIGN, HS-M METASTATIC, "l-" INVASIVE, "X-" 01 BFG43363 b f g <k494 *** PATH/T0X SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVQ-GENERATIQN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER: 2530 OATE OF DEATH: OS/27/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACK STUDY MY OF DEATH; 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ................................................... .. Vi T HO LOGY OBSERVATIONS * * * ORGAN NAME KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL -MINIMAL 6R0SS: -IMPLANT SCARS - PRESENT -HEPAT0CYTE5: CYTOPLASMIC VACUOLES (NON-ZONAl -HEPATOCYTES CENTRlLDGUlAR: HYPERTROPHY -RIGHT: 6; LEFT: 4 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE, HX-H OtMl ttf a 4^ u> UT B F G 003481 MJH10 '3AISVAMI ,,-lM '311Y1SVUW ..-S,, `N9IN3B ' 1NVN9HVH ;SM5VUQ3N 01 AS (IVNDZ'NON) S3100WA 3lNSVld0iA3 :S31A30iV<UH' N011VHHV1JNI 3103VBflS/3in3V' lN3S3Hd iON - $MV3S INVIdMI- :$SOll 1VMINIH1V30J "IVHINIH- 'Otni ssnionu oiBoiomvdoisiH / sinihhm im-saw ssoud noumiuisjo 'aiimms `sowu . , , SNOI JVH3M0 A 9 0 3 0 H 1 d , , , $HY9 V'992 ^H9l3ft AOOfl 3tHlM3l U :HiV30 JO X3Jfl AQfllS ZH :H1V30 JO AVO A001S 33UIM3YS 1VNIHM31 '033003435 :tf)iYlS 33IJIH3VS E 'dflO9 3500 31VN3J :X35 QBOfrSG :W3BHnH AGfUS m -3DVd S6-adV-6| ;03IHlttd 133HS viva 1VHINV 1V0GIAI0NI SiVM do Ml AQMS AllDtXOl 1VlN3MdOl3A3d OMV MOU3flOOMd3tJ U011VH3N39'OM NOUVlVHNl 03N19WO3 30130143 IAN IA *, lOdlOO 4315AS XQl/HIVd *,* 16/ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-SENEHATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STIR ANIMAL NUMBER: 3S01 OATE OF DEATH: 05/27/97 SEX: FEMALE OOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR] STUOY DAY OF OEATH: 141 STUDY WEEK Of OCATH: 21 TERMINAL ROOY HEIGHT: ORGAN NAME * * PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL -MINIMAL GROSS: -IMPLANT SCARS - NOT PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL! -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY KEy'tO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "l-" INVASIVE. "X-" OTHEl 3 o u> LP U\ to BFG 003483 ANIMAL NUMBER; 3516 DATE OF DEATH; OS/27/97 "* PATH/TOX SYSTEM OUTPUT VINYL CHLQRIQE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET 5 SEX: FEMALE DOSE GROUP; 3 SACRIFICE STATUS; SCHEDULED. TERMINAL it STUDY OAY OF DEATH: HI STUDY WEEK OF DEATH: 21 TERMINAL BOOT WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HJSTDPATHOLOC LIVER UTERUS MICRO; -MINIMAL GROSS; -IMPLANT SCARS - PRESENT -HEPATOCYTES CENfRllOflULAR: HYPERTROPHY -RIGHT; A-, LEFT; 3 KEY TO NEOPLASMS: ,,N-h MALIGNANT, "fi-" BENIGN. `V METASTATIC. "I-" INVASIVE, "X-" 01 CD C) f* Uj CO 2fi 3 w go *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SUN ANIMAL NUMBER; 3503 DATE Of- DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FftEE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL .......................................................... -HEPATOCYTESCENTRiLOBULARi HYPERTROPHY GROSS: -IMPLANT SCARS - PRESENT ................................. -RifiHT: 13i LEFT: 7 KEY TO NEOPLASMS: "H-" MALIGNANT. "0'" BENIGN. "S-" METASTATIC. "l-" INVASIVE. "X-" OTHEl % lP O' BFG 003485 *** PATH/TOX 5T5TEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal data sheet s ANIMAL NUMBER: 3518 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDV DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / H1STOPATHOLQG LIVER UTERUS ........................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL `ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTE5: CrTOPLASMIC VACUOLES (NQN-ZON, -MINIMAL -HEPATOCYTES CEHTRItOBULAR: HYPERTROPHY .......................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 3; LEFT: 12 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. 'V METASTATIC. "I-" INVASIVE. "X-" OT, BFG43369 os * C OJ U1 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUl ANIMAL NUMBER; 3505 OATC OF OCATH: 05/30/97 SEX; FEMALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEDULED, TERMINAL SAC* STUDY DAY OF OEATN: 144 STUQY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMHENtS / HISTOPATHOLOGIC tlVER UTERUS ..................................................................................................................................................................................... MICRO: -MINIMAL -HEPATXYTI5 CENTRI LOBULAR: HYPERTROPHY . . .......................................................... .... ....................................................................... .... .............................................................. GROSS: -IMPLANT SCARS - PRESENT -RIGHT; 6; LEFT: 7 KET TO BIOPLASMS "N-" MALIGNANT. "B*" BENIGN, METASTATIC. "l-" INVASIVE, "X-" OTHE BFG 005487 a UJ ON *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION reproduction and developmental toxicity study in co rats INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 3520 DATE OF DEATH: 05/30/97 ORGAN NAME SEX; FEMALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH; |44 STUPY WEEK OF DEATH; 21 TERMINAL BODY WEIGHT; * ft ft P A T H 0 LOGY KEYWORDS, SEVERITY, DISTRIBUTION observations * * * GROSS FREE-TEXT COMMENTS / HlSTOPATHOLOGl LIVER . . UTERUS , , MICRO: -MINIMAL GROSS: -implant scars - NOT PRESENT -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY KEY TO NEOPLASMS: "M-" MALIGNANT, "ft-" BENIGN, "S-" METASTATIC. "l-" INVASIVE. *'X-" OTH BFG43371 b f g 003502 *** PATH/tOK SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY 5TUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STl ANIMAL NUMBER: 3507 DATE OF DEATH: 05/30/9P SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC! STUDY DAY OF DEATH: 144 STUOT WEEK OF DEATH; 21 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OISERVAT ioNS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FftEC-TCXT COMMENTS / HlSTOPATHOLOGli LIVER'''7 .77 7*77! * 7 . ", . .7. . 7 . .7.......................................... MICRO; -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION UTERUS ......................... ............................................................................................................................................................................. GROSS: -IMPLANT SCARS - PRESENT -RIGHT; 13; LEFT; 3 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-** METASTATIC, "I-" INVASIVE, "A-" OTH *** PA7H/T0X SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-GtNRATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 3522 PATE of DEATH: o%mm SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY DAY OF DEATH: 141 sruor MEEK Of DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOtOSV OBSERVATIONS *** KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE'TEXT COMMENTS / HISTOPATHOLOGI LIVER . . UTERUS . . MICRO: 'MINIMAL -MINIMAL GROSS: -IMPLANT SCARS - NOT PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES {NON-ftTHA -HEPATOCYTES CENTR1LOQULAR: HYPERTROPHY KEY TO NEOPLASMS: "M-" MALIGNANT, "B*" BENIGN. "S-*' METASTATIC, Mr-" INVASIVE. "X'" oth BFG43373 n UJ u\ H3H10 ,,-XM `3ALSVANI 'allViSVia* "NOIMSQ ,,"0h `iNVWHVW ..'H,, ^SHSVIdQJH 01 A3* 11331 '01 jiN9lltAHdOBiaidAH ^VinMliai33 S31AMld3H` 1N3S3M - SUMS INVldMl- :0M9 IWlMjM-/OMOJM SOMONId 3}901QHiVd01$ 1H / SJ.N3HM03 4.X3i*33llJ $0V9 NOUMtHlSlO `A1IM3A3S 'SOHOMA3X , . , StlDl lmisto 1 9 0 1 0 H 1 V d SHVM9 a1a6iZjims: 1Hiv91N3AimAaQiOf^l o1sVhNvIHh1hIo31s :sfuvisUaoHu1Vu3o0vsJO X33 M lf'UdSno9 a2sotol :H130 3iyiJO AVO AOftlS -m 000*96 MJflHAN AOfUS 612 :3Wd 06-MdV-62 :031NI8d 133HS ViVQ iVHtNV 'WnOtAtONl SiW 03 HI 1001S UniXOi 1V1N3HJ013A30 QHV HOliOAOOWia HOUVH3H39-OA1 NOUV1VHHI 03HlflM03 30IH01H3 1AN1A *** mdlfio H3ms X01/H1VJ 16/0 *** PATH/TOX SYSTEM OUTPUT "* VINYL CHLORI0E COMBINED INHALATION TV0-6ENERATI0N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 3524 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL S, STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * 6 KEYWORDS, SEVERITY. DISTRIBUTION GROSS FHEE-TEXT COMMENTS / HtSTOPATHOLO EXTREMITY LIVER SKIN . . UTERUS GROSS: -HAIR ABSENT/THIN, MODERATE MICRO:'`MINIMAL -MINIMAL GROSS:''HAIR ABSENT/ThiN^ SLIGHT' GROSS: -iMPLAMT SCARS - PRESENT `HAIR THIN, RIGHT HINDLEGS -HEPATOCYTES: CYTOPLASMIC VACUOLES*(NON-ZQ -HEPAT0CVTE5 CENTRI LOBULAR: HYPERTROPHY -HAIR ThiN, ABDOMINAL -R}GHT: 10; LEFT: 9 BFG43375 KEY TO NEOPLASMS: "Mj" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, INVASIVE, "I-*' 0 BFG 003506 ANIMAL NUMBER: 3511 DATE OF OEATH: 0S/2A/07 *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY 5TUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STL SEX: FEMALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEOULEO, TERMINAL SAC* STUDY DAY OF DEATH: 143 STUDY WEEK OF DEATH: 21 TERHtMAl. ROOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................... MICRO: `MINIMAL -HEPATOCYTES CENTft)LOBULAR: HYPERTROPHY UTERUS..................... .... ............................ .... .................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 9; LEFT: 1 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" DEHI6N, METASTATIC, "l-" INVASIVE. "X-" OTHi 00 nn o U4 u> 0\ 6FG 003493 *** PATH/TQX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TUO-GEhERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL HUMBER; 3526 OATE OF DEATH; 05/27/97 SEX; FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SA STUDY DAY OF DEATH: Ml STUDY WEEK OF OEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTDPATHOlOfi KIDNEYS .............................................................................................................................................................................................. GROSS: -DILATATION -RIGHT; MODERATE; LEFT: SLIGHT LIVER ......................... ........................................................................................................................................................................ HtCRO: 'MINIMAL -HEPATQCYtES CENTRlLOBULAR: HYPERTROPHY UTERUS.............................................................................................................................................*.................... ............................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 11; LEFT: 4 MY 10 NlOPlASMS '* " Ul IWIAAI . "e " BENIGN. S-" MLlASTAl|C INVASIVE, "X-" 01 BFG43379 W ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CP NATS INDIVIDUAL ANIMAL DATA SHEET STl ANIMAL NUMBER: 3513 DATE OF DEATH: 05/29/97 SEX: FEMALE DOSE 6R0UP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACO STUDY PAT OF DEATH: 143 STUDY WEEK OF DEATH: 21 TERNtNAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS ................................................................................................................................................................................................. MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTC INFLAMMATION -MINIMAL, FOCAL -CONGESTION ................................................................................................................................................................................................. GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 6; LEFT: 5 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENJ6N. "S-" METASTATIC, "1-" INVASIVE. "X-" OTHI u> 3 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUPY |N cp HATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 3530 PATE OF DEATH: 05/29/97 SEX; FEMALE DOSt GROUP: 3 SACRIFICE STATUS; SCHEDULED, TERMINAL SA STUDY OAV OF DFATH; 14.1 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREC-TEXT COMMENTS / HISTOPATHOLOG KIDNEYS LIVER UTERUS GROSSr'-biLATATlOH! MODERATE..................................... -BOTH PELVES......................................................... MICROj -HIHIMAL.............................................................. ^EPATOCYTES CENTRiLOeilLAR: HYPERTROPHY GROSS;`-IMPLANT SCARS - NOT PRESENT KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "1'" INVASIVE. "X-" OT PATH/TOX SrSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANQ DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 3515 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS * ........................................................................................................................................................................................................... MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-IONAL -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY ............................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT; 7; LEFT: 6 KEY 10 QPtA**S V" AAilWAiiT. V" bEnIGh. METASTATIC, "l-" INVASIVE. V" OTHE BFG 003497 w o 4* LtJ U1 G\ On *** PATH/TOX SYSTEM OUTPUT M* VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD NATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 450? DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH; 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS PREE-TfXT COMMENTS / HISTOPATHOLOG LIVER MICRO: -MINIMAL. FOCAL -MINIMAL NQSE/TURB SEC 2 MICRO: -MINIMAL, FOCAL UTERUS GROSS: IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -ACUtE/SUftACuTE ImPlAmMaTIOn -HEPAtOCYtES CENtRKODULAR: HYPERTROPHY -NASAL LUMEN: INFLAMMATORY CELLS/CELL DEBRI `RIGHT: 2; LEFT: 6 -ENDOMETRIUM: BROWN PIGMENT THE FOILOUING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; KIDNEYS. LUNGS, MAMMARY GLANDS, NOSE/TUR0 SEC 1, NOSE/TURB SEC 3, NOSE/TURB SEC 4, OVARIES, QVIDUCTS/F PITUITARY GLAND. TRACHEA, VAGINA BFG43 KEY TO NEOPLASMS: "H-" MALIGNANT, '0-*' BCNlGN, "S-" METASTATIC, "l INVASIVE. X* OT *** PATH/TQX SYSTEM OUTPUT *** VINYL CHL0R10E COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD' ANIMAL HUMBER: 3517 DATE OF DEATH; OS/27/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEDULED. TERMINAL SACRU STUDY DAY OF DEATH: 141 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 21 ORGAN NAME * * * PATHDLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I LIVER UTERUS ..................... ............................................................................................................................................................................. MICRO: -MINIMAL -HEPATOCYTES CENTRlLOBULAR: HYPERTROPHY ................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 6: LEFT: 8 KEY TO NEOPLASMS: "N-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003499 td O & ON CO *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TONICITY STUDY IN CO RATS INDIVIDUAL ANtHAL DATA SHEET ANIMAL NUMBER: 4504 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL S STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLO KIDNEYS ......................................* . . . MICRO: "MINIMAL, FOCAL LIVER ......................... ................................. MICRO: -MINIMAL. FOCAL "MINIMAL -MINIMAL NOSE/TURB SEC l ...................................... MICRO: -MINIMAL, FOCAL NOSE/TURB SEC 2 ...................................... MICRO: -SLIGHT -SLIGHT. FOCAL 'MINIMAL, FOCAL NOSE/TURB SEC 3 ...................................... MICRO; -SLIGHT NOSE/TURB SEC 4 ...................................... MICRO; -MINIMAL UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -CORTEX:'INFILTRATES SUBACUTE -ACUre/SUfiACUTE INFLAMMATION HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-Z0 -HEPATOCYTES CENTRILOflULAR: HYPERTROPHY ODONTOPATHY -NASOLACRIMAL DUCT($); MUCOSA-SUBACUTE (CH CHRONIC INFLAMMATION -ODDNIOPATHY -VOMERONASAL ORGAN; EXUDATE -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY):'EPITHELIUM-iNTfl EOSINOPHILIC MATERIAL -RIGHT; 4; LEFT: S -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVE!): LUNGS. MAMMARY GLANDS. OVARtES. 0V1DUCTS/FAL0P T. PITUITARY GLAND. TRACHEA. VAGINA BFG43385 KEY TO NEOPLASMS:'"m-" MALIGNANT, "B-** BENIGN, METASTATIC, "1-" INVASIVE. "X-" 0 *** path/tox system output *** VINYU CHL0R10E COMBINED INHALATION TUO-GENCRATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal data sheet stu ANIMAL NUMBER; 3519 DATE OF DEATH: 05/29/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR STUDY DAY OF DEATH: 143 STUOY WEEK OF DEATH; 21 TERMINAL BODY WEIGHT: ORGAN NAME * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -HINIMAL. FOCAL......................................................... :ACUTE/SUBACUTE iHFLAMMATI ........................... -MINIMAL -HEPATOCYTCS CENTRILOBULAR: HYPERTROPHY GROSS: -IMPLANT SCARS - PRESENT ................................. -RieHT; Tj'lCFTs's............................................... KEY TO NEOPLASMS: "M-" MALIGNANT, "fl-" BENIGN. 'V" METASTATIC. "I-" INVASIVE. V OtHE CD 2 o A o BFG 003501 *** PATh/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER! 4506 DATE OF DEATH: 05/20/97 $X: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL STUDY OAT OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTOPATHOL KIDNEYS ........................................................................... MICRO: -MINIMAL. MULTI-FOCAL LIVER ............................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL NOSE/TURB SEC 3 ........................................................... MICRO; -MINIMAL NOSE/TURB SEC 4 .......................................................... MICRO: -MINIMAL UTERUS ............................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO; -SLIGHT. FOCAL -CALCIFIC GRANULES -ACUt/$UBACUTE INFLAMMATION......................... -HEPAT0CYTE5 CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORYjEPllHEL1UH-iNT EOSINOPHILIC MATERIAL -NASAL MUCDSA (OLFACTORY): EPI THELIUM-1NT EOSINOPHILIC MATERIAL -RioHT: 8; LEFT: 7............................................. -MYOMETRIUM; BROUN PfGHFNT THE MJLLUtflNG TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1, NOSE/TURB SEC 2. OVARIES. OVIOUCTS/FALOP T. PITUITARY GLANO, BFG43387 KEY TO NEOPLASMS: "M-" MALIGNANT. "&" BENIGN S-" METASTATIC. "I-" INVASIVE. "X-' *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLOftlOC COMBINED INHALATION TWO-GEHERATJON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 3521 DATE OF DEATH: 05/20/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUOY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY HEIGHT: X * * * PATHOLOGY OBSERVATIONS * * * KEYHOROS, SEVERITY, DISTRIBUTION GROSS FREE-lEXT COMMENTS / HISTOPATHOLOGIC UYfR UTERUS ................................................................................................................................................................................................................ MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HIN1HAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY ................................................................................................................................................................................................................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 7; LEFT: 6 KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. MX-" OTHER DO 33 o U) (jj -j to BFG 003503 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD NATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 4500 DATE OP DEATH; 05/27/97 SEX; FEMALE Dost GROUP; 4 SACRIFICE STATUS; SCHEDULED, TERMINAL ! STUDY DAY OF DEATH; 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT; ORGAN NAME * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FRtE-TEXT COMMENTS / HlSTOPATHOK LIVER . MICRO; -MINIMAL MO$E/TURB SEC I MICRO: -MINIMAL' NOSE/TURB SEC 2 MICRO; -MINIMAL NOSE/TUAB SEC 3 MICRO UTERUS OIOSS MICRO iNpiAir i(**s UIW<f ftXhl N|SMI -HCPATOCYTES CENTRILOBULAR; HYPERTROPHY -NASOLACRIMAL DUCT(S): EOSiNOPHILIC MATER] NASOLACRIMAL DUCT(si;' INFLAMMATORY CELLS) -NASAL Ll/MCN; INFLAMMATORY chii/CELL DEBT AlGMl 5. l(ri 6 -MIOME IRURt MOWN PIGMENT TH( fouowmw US Sul s HAD *0 PIllOsfQ'jr AANONhal 111( S 0*S[IV(0 M OMITS, UMGS MA^MT MOSIluA* S|< 4 OVARIES, 0 lOOC t S/I AiOP I, PITUITARY GIAKO, TRACHEA BFG43389 <T To HOPiaShS NILIWRAIl BIIIGN, METASTATIC. "1" INVASIVE. X- *** PATH/TQX SYSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 3523 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULEO, TERMINAL SACRI STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATHOLOGY OBSERVATIONS 4 * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER . . UTERUS . . MICRO: -MINIMAL GROSS:'-IMPLANT SCARS - PRESENT -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY Bright: 5;'left;'a......................................... KEY TO NEOPLASMS: "M-H MALIGNANT, "B-" BENIGN, "S-- METASTATIC, "1-" INVASIVE, "X-" OTHER BFG 003505 CD 3 o A '-J 4*. *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY pi CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 4510 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL $A STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * pathology OBSERVATIONS * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXt COMMENTS / HISTQPATHOLOG KIDNEYS MICRO: -MINIMAL, FOCAL UVER MICRO: -MINIMAL, FOCAL -MINIMAL LUNGS MICRO; -MINIMAL, FOCAL NOSC/TURfi SEC | MICRO: -MINIMAL, FOCAL UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT, FOCAL DILATED TUBULES -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRI LOBULAR: HYPERTROPHY -PULMONARY VESSELS; MINERAL OEPO$IT(S) -NASAlMUCOSA (RESPIRATORY): GOBLET CELL HY -RIGHT: 5; LEFT: 4 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: MAMMARY GLANOS, NOSE/TURB SEC 2. NOSE/TURB SEC 3, NOSE/TURB SEC 4, OVARIES, OVIOUCTS/FALOP T. PITIMTAR TRACHEA. VAGINA KEY TO NEOPLASMS: HM-" MALIGNANT, "B-" BENI6N, `V` METASTATIC, "I-" INVASIVE, X- OT BFG43391 CO S Cs rvj ANIMAL NUMBER: 3527 DAtE OF DEATH: OS/24/97 ORGAN NAME *M PATH/70X SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUC SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BOOV WEIGHT: 2 * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC EARS............................................................................................................................................. GROSS: -SWOLLEN. SLIGHT -RIGHT -DISCOLORED. SLIGHT -RIGHT: RED LIVER ............................. ........................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEFATOCYTES CENTR1LOBULAR; HYPERTROPHY UTERUS .................................... GROSS |HP<Anr tCAAl PtfSINf -RIGHT: 6; 'liFTiV M f 10 ( oPi " nil IbAAiil 6 61 RIGA. NtUSMHC, "t-" INVASIVE. "X-" OTHER &\ rtv t a03 O ' $> V ' .y,t k % w 60 it '00 H3U10 ..-X,, '3AJSVANI '311V1SV13W 'N91N18 ,.-0,. '1NVK9I1VH ,.-WH SHSVd03N 01 A3 VMI `0HV39 AWiMUd 'i dOlJ/51DM)lA0 'SiJlHVAO 'l 33S 9WU/1S0M *t 31S 0nJ/3SON 'S0NV19 1MVMNVH *sy Q3AM3590 SJIHlYMlKINflY 3U0DS08D1M ON OVH 53nS$ 03JV1JO ;N3HnilN3W91d 11*0(10 -MnniUMOIN- l ' 1J31 1M9J1SlYJOJ 'lVHlMJM- :oaoi iM3S3d - SUVDS iMVldHl- ;SSO 1VJH3IVW 3|llHd0Nl?03 OIHSVldOUOVHlNl-HfimHltdS :(AM13W10) VSMnH 1VSVN- IH9J1S- -0M01 vtsvidU^jtH ommi uano ivmimviosvh; iwjiiin- ;onoi AHdOtflM3UH iV1nOOin)lM33 S3W301Vd3H(lVNOZ-NOM) sSIOflOVA OlHSvldOlAi :S3iA30iYd3H- lVUlMtWlVHIMkh -00I S9H10N1J lQ010HiV<<015IH / S1N3HM03 1X31-33M SS019 NOIinSUIlSIO 'A1IH3A3S 'S08WA3* , , , S NO I mu 3 SH A9010H1V4 * * * SUMS Z'99* :1H9I3* AQOB 1VN1HV31 12 iHlVJO JO X33A AMIS fry l ;H1V30 JO AVO AO(U$ 3Dljl3VS IVNiNUSl `031003(05 -SIUVIS 30Idltt3VS t :>tn09 3$00 31VH3J -X3S 060*96 ^aewriN aqius 2S2 :39Yd B6-ad-6Z :Q31NlHd 131HS V1VQ 1VMINV WMlAiaNI Siva 00 Nl AOIUS 11131X01 1ViN3Md013A30 QNV NOflttMtfdail N0UV3N39'0A1 NOllYlVHHl 03M9H03 301U01H0 1AM1A lfldino M31SAS XOi/HIVd * Hi ** PATH/TOX system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RMS INDIVIDUAL ANIMAL DATA SHEET $U ANIMAL NUMBER: 35Z9 DATE OF DEATH; 05730/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACS STUDY DAY OF DEATH; 144 STUOV WEEK OF DEATH: 21 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS 444 KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS . MICRO: -MINIMAL -MINIMAL, FOCAL GROSS: -IMPLANT SCARS - NOT PRESENT -HEPATOCYTESCENTRiLOBULAR: HYPERTROPHY -MICROGRANULOMA KEY TO NEOPLASMS: "M-" MALIGNANT. "8-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "t-" OTHI B F G (JU3511 3 o 5 lP 06 O *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY |H CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBED; 4514 DATE OF DEATH: 05/Z7/9? ORGAN NAME SEX; FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL S STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: * * * P A T H 0 LOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE'HXT COMMENTS / HISTOPATHOLO LIVER ............................. MICRO; -MINIMAL 'MINIMAL NOSE/TURB SEC 2 . MICRO: -MINIMAL -MINIMAL NOSE/TURB SEC 4 . , MICRO: -MINIMAL UTERUS ......................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL f ft ft -HEPATOCYTES: CTTOPLASMIC VACUOLES (N0N-Z0 -HEPATOCTTES CENTRILOBULAR: HYPERTROPHY -NASOtACRIHAl DUCT(S); INFLAMMATORY CELLS/ -NASOLACRIMAL DUCT(S); MUCOSA-SUBACUTE (CH CHRONIC INFLAMMATION -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTR EOSINOPHILIC MATERIAL -RIGHT; 7j LEFT: 8 -MYOMETRIUM; BROWN PIGMENT THE FOLLOWING TISSUES HAD HO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC I. NOSE/TURN SEC 3, OVARIES, OVlOUCTS/FALQP T. PITUITAR TRACHEA. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "0-" BEHI6N, "S'" METASTATIC, "I-" INVASIVE, "X-" 0 BFG43395 a00 0 cn m \ ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY |N CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 4501 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: Zl TERMINAL BODY WEIGHT: 3 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. 0I5TRI8UTI0N GROSS TREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER . . . MICRO: 'MINIMAL, FOCAL -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL UTERUS ............................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL -ACUTE/SUBACUTE INFLAMMATION................................. -HEPAT0CYTE5 CENTA1L0BULAR: HYPERTROPHY -NASAL'MUCOSA {OLFACTORY): EP1THELil)M-jNTRACYT EOSINOPHILIC MATERIAL -RIGHT: II; LEFT: 2 -MYOMETRIUM: GROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 2, NOSE/TIIR0 SEC 3, OVARIES, OVIOUCTS/FALQ PITUITARY GLAND, TRACHEA, VAGINA Z s t> D d s KEY TO NEOPLASMS: "H-" MALIGNANT, V" BENIGN. METASTATIC, "I-" INVASIVE, "X-" OTHER "* PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATJON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 4516 DATE OF DEATH: 06/06/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS; SCHEOUlEO, TERMINAL S STUDY OAY OF DEATH; 15l STUDY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLO GR05S/HICRO CORR ................................................................................................................................................................................. MICRO: HISTOPATHDLOGICAl COMMENT; OVARJES: DlSCOLQRED/NHC LIVER ...................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZO MINIMAL -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY NOSE/TURB SEC 4 ................................................................................................................................................................................. MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTR EOSINOPHILIC MATERIAL OVARIES .................................................................................................................................................................................................. GROSS: -DISCOLORED-FOCUS(FOC|), MODERATE -LEFT; 0.2 CM DlA. WHITE UTERUS ...................................................................................................................................................................................................... GROSS: -IMPLANT SCARS PRESENT -LEFT: 9j RIGHT; 8 MICRO: -SLIGHT.MULTI-FOCAL -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NoSE/TURB SEC l, NOSE/TURB SEC 3, OVARIES. DVIOUCTS/ PITUITARY GLANO, TRACHEA, VAGINA BFG43397 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l" INVASIVE. "X-" 0 **" PATH/TOX SYSTEM OUTPUT "** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AHO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 4503 DATE OF DEATH: 05/29/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: M3 S1U0Y WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * 4 4 PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY. DISTRIBUTION GR0S5 FREE-TEXT COMMENTS / HISTOPATHOLOGI KIDNEYS MICRO: -MINIMAL, FOCAL LIVER MICRO: -MINIMAL, FOCAL -MINIMAL NOSE/TURB SEC 2 MICRO: -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL 'CORTEX: INFILTRATES,SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -VQMORONASAL ORGAN; EOSINOPHILIC MATERIAL -NASAL MUCOSA (OlFACTORT); EP!THLIUM-|NTRAC EOSINOPHILIC MATERIAL -RIGHT: 1; LEFt: 6 -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANDS, NOSE/TURB SEC I, NOSE/tURA SEC 3. OVARIES, OVIPUCTS/FALOP T. PITUITARY OLANP, TR HEY TO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN, "S-" METASTAtlC, INVASIVE, NX-" OTH BFG43384 03 o u* til Lit BFG43399 *** PATH/TOX SYSTEM OUTPUT *" VINYL CHLORIDE COMBINED INHALATION TVO-GENtRATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS individual animal data sheet < ANIMAL NUMBER: 4S18 DATE OF DEATH; OS/Z7/R? SEX: FEMALE DOSE GROUP: SACRIFICE STATUS: SCHEDULED, TERMINAL S3 STUDY DAY OF DEATH: 141 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATNOLOC GROSS/MICRO CORR.......................................... .... . , . ....................................................................................................................... MICRO: HISTOPATHOIOGICAL COMMENT: ^KIONEY(L): 01LATAT10N/PELVIS DILATED KIDNEYS GROSS: -DILATATION. SLIGHT *LEfT PELVIS MICRO: -MINIMAL -PELVIS DILATED LIVER , , MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION MIRIMAt -HEPATOCYtES: CYTOPLASMIC VACUOLES (NON-ZO) H||HAt - HE PA 1OC Y1CS CfMRIlOBULAfl: HYPERTROPHY UURUS 4*01 V MICRO iviiil VC41} Pt(WT Si IfcMt "W M >(X*I RIGHT J UM t MTOMCItllM MOWN MCMIN! IhC fouoviMi iiuvti nao no ton one mnoniuiihis otsttuO ll***. MMNiAtr 44AN0). NOi|/?u*A Ml t ROSEMU*! MC 2. MS4/IUR* IK 3 P| 1(J|1 AAV AlAMO , HUCNfA. VA4HU HOM/IUM SCC 4, OVARIES, 0) RET TO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN, `V METASTATIC, "I-" INVASIVE. "X-" 01 BFG 003530 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPROOUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 4SOB DATE OF OEATH: OS/ZD/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACAJ STUDY DAY OF DEATH: 143 STUDY WEEK OF DEATH; ?1 TERMINAL BODY WEIGHT: Z ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS ............................................................................................................................................................................................................ MICRO: ^MINIMAL -U: PYELITIS,SUBACUTE -SLIGHT -PELVIS DILATED LIVER ..................... .......................................................................................................................................................................................... MICRO: -MINIMAL, MULTI-FOCAL -ACUTE/SUBACUTE INFLAMMATION MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -MINIMAL -HEPATOCYTES CENTfilLOBULAR: HYPERTROPHY NOSE/TUR6 SEC 2 ........................................................................................................................................................................................... MICRO; -MINIMAL -VOMORONASAL ORGAN: EOSINOPHILIC MATERIAL PITUITARY GLANO .............................................................................................................................................................. ......................... MICRO: -MINIMAL. fOCAL -PARS DISTALlS: CYSTS UTERUS ............................................................................................................................................................................................................... GROSS: -IMPLANT SCARS -PRESENT -RIGHT: ID: LEFT: 3 MICRO: -MODERATE, FOCAL -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TUR0 SEC 3. NQSE/TUftB SEC 4, OVARIES. OVIDUCTS/FALOP T, TRAC KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "s-" METASTATIC, "I-" INVASIVE, "X-" OTHCH BFG43386 s03 a lh -4 BFG43401 ANIMAL NUMBER: 4S20 OATC OF DEATH: 08/06/97 *** PAfH/IQX SYSTEM OUTPUT *** VINYL CHIORIDE COMBINED INHALATION TWO-GENERATION reproduction AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL S/ STUDY DAY OF DEATH: 161 STUDY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHQLOt EARS GROSS: -SWOLLEN -DISCOLORED. SLIGHT MICRO: -MARKEO -MODERATE -BOTH -BOTH: RED -SUBACUTE (CHRONIC ACTIVE)/CHRORIC INfLAHH/ -NECROSIS CARTILAGE GROSS/MICRO CORR MICRO; HISTOPATHOIQGICAL COMMENT; EARS; SWOLLEN.015COLOREO/IHFLAMMATION SUB4 LIVER MICRO: 'MINIMAL -MINIMAL -HtPATOCYTES: CYTOPLASMIC VACUOLES (NON-EM -HEPATDCYTES CENTRILOBULAR: HYPERTROPHY NOSE/TURB SEC 1 MICRO: -MINIMAL. FOCAL -NASAL MUCOSA (JUNCTION OF THE RE5PIRAI0RT/ GLANDS OILATEO NOSE/TURB SEC 2 MICRO: -MINIMAL -NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHf CHRONIC INFLAMMATION NOSE/TURB SEC 3 MICRO: -MINIMAL -minimal -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTR/ EOSINOPHIUC MATERIAL NOSE/TURB SEC 4 MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPIfHEUUM-INTJM EOSINOPHILIC MATERIAL UTERUS............................................... *......................................................................................................................................................... GROSS: -IMPLANT SITES NOT NOTED MICRO: -MINIMAL. MULTI-FOCAL -MYOMETRIUM: BROWN PIGMENT -SLIGHT -LUMEN: DILATED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNGS, MAMMARY GLANDS. OVARIES. OVIOUCTS/FAtOP T. PITUITARY GLAND, TRACHEA. VAGINA BO KEY TO NEOPLASMS: "M-" MALIGNANT, "U-" BENIGN. "S-" METASTATIC, "I-" INVASIVE. 'V 01 3 UJ tji t-j BFG43388 *** path/iox system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANINAL DATA SHEET STI ANIMAL NUMBER; 4507 DATE OF DEATH: 05/29/97 SEX; FEMALE 00$E GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACl STUDY DAY OF DEATH: 143 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGN LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL NQSE/TURB SEC l .......................................................... MICRO: -MINIMAL NOSE/TURB SfC ? MICRO NIMIMAI NOSC/TURB SIC ) PlCQ NOSE/IUAi Sir 4 M|(IQ Mltinit ufiaus (pAOSl IMflARl HANS PNiSIRI M|(IO MINIMAL fKM -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES iKON-ZONAl -HEPATOCYTES CENTRUOBULAft; HYPERTROPHY -VOMORONASAL'ORGAN: FREE ERYTHROCYTES -VOMERONASAL ORGAN: FREE ERYTHROCYTES NASAl MUCOSA (OLFACtORY): EPITHELIUM-INTRAC roSlNOPMUK M FfRfAt MASAI MJfOlA | Oi F AC TORY) [P| iHCl IUN> INTRAC (OSIBOTMIUC MAItRIAL RJtMt 2. LEFT ID EMDOMCTIIIUM; MOWN P|6M(Nl THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS. OVARIES. OVIDUCTS/FAL0P T, PITUITARY GLAND, TRACHEA. VAGINA KEY TO NEOPLASMS: HM-" MALIGNANT, hB-h BENIGN, "S-*' METASTATIC, "I-" INVASIVE, "X-" OTH Lht lit *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMbtHEO INHALATION 7W-GENRAT10!t REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal data sheet sti ANIMAL NUMBER: 4SZ2 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACi STUDY OAT OF DEATH: 144 STUDY WEEK OF DEATH; 21 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIi LIVER UTERUS ......................... MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL ......................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT, MULTI-FOCAL -MINIMAL -MINIMAL ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -HEPATOCYTES CENTRlLOBUlAR: HYPERTROPHY -RIGHT: 8; LEFT: 10 -MYOMETRIUM: BROUN PIGMENT -LUMEN; DILATED 'FNDOHE1R1UM; GLANDS DIIATEO/CYSTIC ORATION THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMAL I TIES G0SFWD; KIDNEYS, LUNGS, MAMMARY GLANDS. NQSE/TURB SEC 1. NOSE/TURB SEC Z, NQSE/IURB SEC 3, NOSE/luRB SEC 4, OVA OVIOUCTS/fAlOP T, PITUITARY GLANO, TRACHEA, VAGINA BFG43403 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S'" HEIASTAIK, "I*" INVASIVE, "X-" OTH *4* path/tdx SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL ToXlClfY STUDY JM CO RATS INDIVIDUAL ANIHAL DATA SHEET $TUI ANIMAL NUMBER: 4509 DATE OF DEATH: 05/26/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACK STUDY DAY OF DEATH; M2 STUOY WEEK OF DEATH: 2! TERMINAL BODY WEIGHT: i ORGAN NAME * * * PATHOLOGY OBSERVATIONS *** KEYWOROS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVfR . . . MICRO: 'MINIMAL, FQCAL -MINIMAL NOSE/TURB SEC 1 ........................................... MICRO: -MINIMAL NOSE/TURB SEC 2 ............................ MICRO; -MINIMAL NOSE/TURB SEC 3 ........................................... MICRO: -MINIMAL NOSE/TURfl SEC 4 ........................ HtCRO: -SLIGHT UTERUS ............................................................. ........................ GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL -ACUTC/SU0ACUTE INFLAMMATION -HEPATOCYTES CENTRRDBUIAR: HYPERTROPHY -VOMORONASAL ORGAN: FREE ERYTHROCYTES -VOHERDNASAL ORGAN: FREE ERYTHROCYTES :NASAl'mUCOSA (OLFACTORY):'EPlTHEliuH-iNTRACY EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY}: EPITHELIUM-INTRACY EOSINOPHILIC HaTERIAI -RIGHT: |3: LEFT: 1 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANOS, OVARIES, OVIDUCTS/FAlOP I. PITUITARY GLAND, TRACHEA, VAGJHA BFG43390 KEY TO NEOPLASMS: "H-" MALIGNANT, "fl-" BENIGN. "S-" METASTATIC. "l-" INVASIVE. "X-" OTHEl BFG 003531 HtfiO ,.-X,, '3AISVAMI 'OIIVISVIS# 'M9IH3B `INVNSnVW ,,'N,, :5WSVlil03N 01 A3* 'S3INVA0 VNlOVA 'V3H3VM1 `0NV19 ABViMlId 'l dOH 33$ 9VfU/3$0N 'C 33$ WU/3$QN '2 33$ flUni/3$0N *1 335 8HM/3S0N `S0MV19 ABVHHVH *SOMI -o3Aas$ao sjunvHBONflv suoosomin on ovh %imi lN3U9]d NAOMfl :HniNi3N0AHl :ld11 -L :iH3lU- lV30d~UinH "IWINIH- WHH IN3S3M - SV3S iNVldNj- -SSOttO AHdOHiN3dAH WlftMllVlMO S3lA301Vd3HNOIJVHHVUNt 3in3Y8n$/31A?V- WHININ' 1V30J 'IVWININ' /0V3IH SSNIONIJ DIOtnOHlVdOlSlH / $iN3WH03 U3i-33MJ SS0a5 . . * SNQI1VAB3S0O HOIinBlHlSIO 'UIM3A3S 'SOBOttASA ADOlOHIVd , , , SHVB9 0 SIC :lH013fl AOQfl 1VN1HN31 U 'HiV3d 30 X33A AOfUS >l =HlV30 JO AVO AQfUS 33I31M3VS 1VNIHB31 *03in03M3S :SMV1S 33131B3VS t tdAOMQ 3500 31VM3J :*3$ 080>96 'U3BHnN AflMS m -md 86-BdV-62 :03iNJBd 133HS VIVO 1VH1NV WnQJAlaNt 51VB 03 N( AflfUS AU31X01 WlMWdOUASO AM JKlIi3naOKd3tf NOUVUN39-OA1 NOllVlWNl Q3N18H0D 3Q1B01H3 1AN{A indino N3i$A$ XQl/HlVd 16/0 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVQ-GENERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 4511 DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SAcfi STUDY DAT OF DEATH: 142 STUDY WEEK DF DEATH: 21 TFRH1NAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC GROSS/NICRO CORA ................................................................................. LIVER MICRO: HISTOPATH0106ICAI ........................................................................................................ GROSS: -NODULE(S)/MASS(ES) MICRO: -MODERATE, MULTI-FOCAL -MINIMAL -HARKED, FOCAL N05E/TURB SEC 3 -MINIMAL MICRO: -MINIMAL -MINIMAL UTERUS . . . . GROSS: -IMPLANT SCARS - PRESENT MICRO: 'MINIMAL, FOCAL COMMENT: >LIVR; NODULE/NECROSIS COAGULATION -NODULE, LEFT LOBE: 0.2 CM OIA, TAN, FIRM ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-'ZONAL NECROSIS,COAGULATION -HEPATOCYTES CENTRILQBULAR: HYPERTROPHY -NASOLACRIMAL bUCti LYMPHOID HYPERPlAMA -NASAL LUHEN: FREE ERYTHROCYTES -RIGHT: 7; LEFT: 9 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: MONEYS, LUNGS, MAMMARY GLANDS, MOSE/TURB SEC 1, NOSE/TURD SEC 2, NOSE/TURfl SEC A, OVARIES, OVIOUCTS/FAL PITUITARY GLANO, TRACHEA, VAGlNA BFG43392 KEY TO NEOPLASMS: "H-M MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE. "K-" OTHE 003523 to 3 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY lN CD RATS individual ANIMAL data sheet 5 ANIMAL NUMBER: 4526 DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SP STUDY DAY OF DEATH: lZ STUDT week OF DEATH: ?1 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HtSTOPAtHQLOd EARS GROSS: -SWOLLEN, MODERATE MICRO: -MODERATE -MODERATE GROSS/MICRO CORR MICRO: HIStoPATHOLOGICAL COMHENT; LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL LUNGS MICRO:'-MINIMAL, FOCAL' MOSE/TURB SEC 3 MICRO: -MINIMAL NOSt/IURB SEC 4 MICRO: -SLIGHT UTERUS GROSS: -IMPLANT SCARS - PRESENT -BOTH -SUBACUTE (CHRONIC ACTIVEl/CHRONIC 1NFLAHHA -NECROSIS CARTHAGE >EARS: SWOLLEN/INFLAHHATION,CHRONIC ACTIVE -ACUTE/SUBACUTE iNFLAMMATION................................. -HEPATDCYTES: CYTOPLASMIC VACUOLES (NON-ZOH -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY -PERIVASCULAR/PERI BRONCHIAL LYMPHOID CELLS :NASAL'MUCOSA (OLFACTORY) I'fPlTHUiuM-iNTRI EOSINOPHILIC MATERIAL -NASAL'MUCOSA (OLFACTORY): EPlTHUiuM-INTR^ EOSINOPHILIC MATERIAL -RIGHT: 3; LEFT: 0 THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. MAMMARY GLANDS, NOSE/TURB SEC l, NOSE/TUR6 SEC 2. OVARIES, OVIOUCTS/FALOP T, PITUITARY GLAND, UTERUS, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, ,,B-" BENIGN, "S-" METASTATIC. HI-H INVASIVE. "X-*' 0: *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GtNERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUI ANIMAL NUMBER: 4515 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAY OF DEATH: 141 STUOT WEEK OF DEATH: n TERMINAL BODY WEIGHT: \ ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWOROS, SEVERITY, DISTRIBUTION GROSS FrEE-JEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL -MINIMAL GROSS: -iMPLANT SCARS - PRESENT MICRO: -MINIMAL, MULTI-FOCAL HEPATOCYTES: CYTOPLASMIC VACUOLES*(NON-ZONAL -HEPATOCvm CENTR1 LOBULAR: HYPERTROPHY -RIGHT: 7; LEFT:6 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TUHB SfC I. NOSE/TURB SEC 2. NoSE/TURB SEC 3. NOSE/TURB SEC 4, OVAR OVIPUCTS/FALOP T, PITUITARY GLAND, TRACHEA. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "l-M INVASIVE. "X-" OTHEI *** path/tox system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET AN (HAL NUMBER; 4529 DATE OF DEATH; 05/30/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS; SCHEDULED. TERMINAL S< STUDY DAY OF DEATH; 144 STUDY WEEK OF DEATH; 21 TERMINAL BODY WEIGHT: ORGAN NAME ** PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOlOi KIDNEYS LIVER r . uterus . VAGINA . . MICRO: -MINIMAL, FOCAL MICRO: -MINIMAL -MINIMAL qross: - Implant scars * present MICRO MINIMAL -CORTEX: INFIlTRATES,SUOACUT% -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZOI -HEPATOCYTES CENTSlLOBULAR: HYPERTROPHY -right: 6; left: n > -HUOCSA- HYERPKERAT0S1S (CORNIFIED) THf fOUOWlUG MUU(\ h40 aO MKROUOPK AMORMAl I MIS l)(S(*V[D IIMGV HAMMAIT friiNOS bOSf/fu| i(( 1 *ti',f,ru* iff t MSI y I use SIC 1. MOSE/TVAB SCC 4, OVARIES, O' MtlHIAtV GiAfcO t(Afw|A ul*m BFG43409 All 10 (ORlAW " ' H4IIWII. "i " MtlA*tAI|, "1-" IAwASIVE. "l-*0 *** path/tqx system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET I $TUOY ANIMAL NUMBER: 4517 DATE OF DEATH: 05/2B/9? SEX; FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 30! ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION LIVER ........................................... .... . MICRO: -MINIMAL -MINIMAL NOSE/TURB SEC 3 ............................. HICRO: -MINIMAL MINIMAL NO5E/TUR0 SfL 4 MICRO MINIMA! UTERUS IMAiAfc) \tlt\ PRISim n I ( RO Mill u [ ml! HMH OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRtLOBULAR: HYPERTROPHY -NASOLACRIMAL DUCT: LYMPHOio HYPERPlAsiA -NASAL MUCOSA (OLFACTORY); EPITHELlUM-INTRACYTOI EOSINOPHILIC MATERIAL :MASAl MUCOSA (OLFAcioRV): EPITHELiuM-iMTRACTTOI fOSlNOPHUIC MATERIAL l<jn! 1. Lff I 5 M0N(1R|UM MOM PIGMENT tm I&IIMIM I mun A0 *4 HK*oxor|( it*0R**l | r l( 4 Qt[iv(9 ft | (Ml VI tu*\ MAIMAAI friAMH mlMuM \K I. MHI/MAI ItC I, OVARIES. 0 10UCI&/I ALOP I. PIlUltARY GlAI I RACHE A VAGINA KEY TO NEOPLASMS; "M-" MALIGNANT, "6-" BENIGN, "S-" METASTATIC, "1-" INVASIVE, "X-" OTHER O & oo a03 003529 *** PATH/YOX system OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS tNOtV|DUAL ANIMAL OATA SHEET S ANIMAL NUMBER: 4530 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEOUlED, TERMINAL $ STUDY DAY OF DEATH: Ml STUDY WEEK OF DEATH: 21 TERMINAL BOOT HEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHQIOG LIVER . . . , MICRO: -MINIMAL NOSE/TuRB SEC 1 -MINIMAL MICRO: -MINIMAL NOSE/TURB SEC 2 MICRO. -MINIMAL NOSE/TURB SEC 4 MICRO:`-SliGHT* -MINIMAL UTERUS GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLESfNOM-ZON -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASALMUCOSA (RESPIRATORY): GOBLET CELL NT -ODONTOPATHY...................................................................... NASAL LUMEN: FREE ERYTHRDCYIES -NASAL MUCOSA (OLFACTORY): tPI THELIUH-1NTRA EOSINOPHILIC MATERIAL -RIGHT: 6; LEFT: 5 THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLAHOS, NOSE/TURB SEC 3, OVARIES, QVJDUCTS/FALOP T. PITUITARY GLAND, TRACHEA. BFG434II KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN, METASTATIC. "1-" INVASIVF, "X-" 01 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION tt/O-GENCRATIQN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER: 4521 DATE DF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACfl STUDY DAY OF DEATH; HZ STUDY WEEK QF DEATH; 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION observations * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIONEYS .............................................................. MICRO: 'MINIMAL LIVER ................................................................... MICRO; 'MINIMAL, FOCAL MINIMAL -MINIMAL NOSE/TURB SEC 1 ........................................... MICRO: -SLIGHT -SLIGHT NOSE/TURB SEC Z .......................................... MICRO: -SLIGHT UTERUS -MINIMAL ......................................................................... GROSS: -JMPLANT SCARS - PRESENT MICRO: `SLIGHT, MULTI-FOCAL -CALCIFIC GRANULES -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL -HEPATOCYTCS CENTRllOBULAR: HYPERTROPHY -NASOLACRIMAL OUCT(S): MUCOSA-SUBACUTE (CHRON CHRONIC INFLAMMATION NASOLACRIMAL DUCT: EXUDATE -NASOLACRIMAL OUCtjsj: MUCOSA-SUBACUTE (CHRON CHRONIC INFLAMMATION -NASOLACRIMAL DUCT: EXUDATE -RIGHT: 5; lCFT:B MYOMETRIUM; BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: .............................................................. .. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 3, NOSE/TURB SEC 4, OVARIES, OVtDUCIS/FALOP T, PITUITARY GLAND. TRA BFG43402 KEY TO NEOPLASMS! MALIGNANT. "B-" BENIGN, "S-" METASTATIC. INVASIVE. **X-" OTHC ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1032 DATE OF DEATH: 09/15/97 $CX: HALE OOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUOY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG CP101DYH1DES . MICRO LIVER . . . . MICRO: -MINIMAL HOSE/TUR0 SEC 3 MICRO: -MINIMAL NDSE/TURB SEC 4 MICRO: -MINIMAL -MINIMAL 'MINIMAL HIST0PATH0L0G1CAL COMMENT: >0N PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZON -HASAL'mUCOSA (OLFACTORY):'tPlTHELiUM-iNTRA EOSINOPHILIC MATERIAL 'NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTQftr); BASOPHILIC MATER -NASAL MUCOSA {OLFACTORYjBASOPHILIC MATfl " ANIMAL HAS NO GROSS ABNORMALITIES OBSERVE!) "* THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EP1DIDYMIOES, KIDNEYS, LUNGS. MAMMART GLANOS, NOSE/TURB SEC 1, NOSE/TUftB SEC 2, PlTUlT PROSTATE GLANO. SEMINAL VESICLES. TESItS, TRACHEA KEY TO NEOPLASMS: "H'" MALIGNANT. `'B-*' BENIGN, "S-" METASTATIC, **!-** INYA5IVE, "X'" 01 CO a 003544 *** PATH/TOX system output *** VIHYL CHLORIDE COMBINED INHALATION TVO-GENERATIQN REPRODUCTION AND DEVElOPHENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 4*23 DATE OF DEATH: 05/29/97 SEX: FEMALE pOSE GROUP: 4 SACRIFICE STATUS: SCHEOULEO, TERMINAL SAC STUDY DAY QF DEATH: 143 STUDY HECK OF DEATH: 21 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * 4 KEYWOROS, SEVERITY. DISTRIBUTION GROSS TREE-TEXT COMMENTS / HTSTOPATHOIOGI KIDNEYS LIVER LUNGS UTERUS .................................................................................................................................................................................................................................. MICRO: -MINIMAL. FOCAL -CALCIFIC GRANULES ....................................................................................................................................................................................................................................... MICRO: `SLIGHT -HfPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -MINIMAL -HEPATOCYTES CENTRILOBULAR:HYPERTROPHY ....................................................................................................................................................................................................................................... MICRO: -MINIMAL. FOCAL -PULMONARY VESSELS: MINERAL DEPOS1T(S) ....................................................................................................................................................................................................................................... GROSS: -IMPLANTSCARS - PRESENT -RIGHT: 12; LEFT: 3 MICRO: -SLIGHT, FOCAL -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: MAMMARY GLANDS, NOSE/TURB SEC 1. N0SC/TUR6 SEC t. NOSE/TURB SEC 3, NOSE/TUAB SEC 4, OVARIES, OVIDUCTS/F PITUITARY GLAND, TRACHEA. VAGINA BFG43404 KEY TO NEOPLASMS: "M-" HALI6NANT, "6-" BENIGN. "S-" METASTATIC, "1-" INVASIVE, "X-" OTH *** PATH/TOX STStfM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TW0-6ENERATIQN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS IN01VI0UAL ANIHAL DATA SHEET ANIHAL NUMBER: 1035 DATE OF DEATH: 00/1S/9? SEX: HALE DOSE CROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL S/ STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS FREE-TEXT COMMENTS f histqpatholo< EPIDIDYMIDES KIDNEYS , . LIVER LUNGS NOSE/TURB SEC 3 NOSE/TURB SEC 4 PROSTATE GLAND MtCfta MICRO MICRO MICRO: MICRO: MICRO: MICRO: -MINIMAL. -HtNtMAl -MtNlMAL, -MINIMAL. -MINIMAL. -MINIMAL -MINIMAL -MINIMAL -SLIGHT `MINIMAL HISTOPATHOLOGICAL COMMENT: FOCAL FOCAL FOCAL FOCAL >ONE PRESENT -CORTEX; INFILTRATES SUBACUTE 'HEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZO* -ACUTE/SUQACUTE INFLAMMATION -NECROSIS. SINGLE CELL -PERIVASCULAR: INFILTRATES SUBACUTE -NASAL MUCOSA (OLFACTORY): EPITHCLlUM-INTR/ EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT: LYMPKOIO HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTR/ EOSINOPHILIC MATERIAL -ACUTE/SUBACUTE INFLAMMATION -ALVEOLAR LUMENS: CORPORA AHYLACIA/MINERAL I ANIHAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING &L, EPIDIDYMIDES, MAMMARY GLANDS, NOSE/TURB SEC l. NOSE/TURB SEC TESTES. TRACHEA , .................. PITUITARY GLAND, SEMI! KEY TO NEOPLASMS; *`M-'` MALIGNANT. "0-" BENIGN, "s-" METASTATIC, "l-" INVASIVE. "X-" 01 BFG 003546 % Q s* <>> *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD1 ANIMAL NUMBER; 4525 DATE OF DEATH: 05/29/97 SEX; FEMALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRJI STUDY DAY OF DEATH: 143 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 2< ORGAN NAME * " * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION 6R0SS FREC-TEXT COMMENTS / HISTOPATHOLOGIC I KIDNEYS , . , MICRO: -MINIMAL LIVER . . . . MICRO: -MINIMAL `MINIMAL NOSE/TURB SEC 2 MICRO; -MINIMAL FOCAL UTERUS GROSS: -iMPLANT SCARS - PRESENT MICRO; -SLIGHT. FDCAL -CORTEX: INFILTRATES,SUBACUTE -HEPATOCYTES: CYTOPLASMIC VACUOLES (NOH-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASOLACRIMAL DUCT(S); HUCQSA-SUBACUTE'(CHRQNIl CHRONIC INFLAMMATION -RIGHT: 3; LEFT: 7................................................................. MYOMETRIUM; BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TUftB SEC 3. NOSE/TURB SEC 4. OVARIES, DV|DUCTS/FALOP T TRACHEA, VAGINA PITUI KEY TO NEOPLASMS: "M-" MALIGNANT. `*0-` BENIGN, "s-H METASTATIC, "l-" INVASIVE. "X-" OTHER BFG43406 3 l/t Ul '* PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1039 DATE OF DEATH: 09/1 S/97 SfX: MALE OOSC GROUP: i SACRIFICE STATUS: SCHEDULED, TERMINAL $A STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY 0 BSERVATIQNS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TCXT COMMENTS / HI5TOPATHOLOG epididymides' , MICRO: LIVER . , .. MICRO: NOSE/TURB SEC l MICRO: NOSE/TURB SEC 3 MICRO; -SEVERE -MINIMAL -MINIMAL, -MINIMAL -MINIMAL HIST0PATH0L0G1CAL COMMENT: FOCAL NOSE/TURB SEC 4 ............................. MICRO: -MINIMAL PROSTATE GLAND TESTES . . . MICRO: -MINIMAL, HULTI-FOCAL MICRO;`-SEVERE............................. -ASPERMIA >ONE PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZON -ACUTE/SUBACUTE INFLAMMATION -VOMERONASAL ORGAN: EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY); EP|THElIUM-InTRA EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUK-lNTRA EOSINOPHILIC HATER1AL -ACUTE/SU8ACUTE INFLAMMATION -TUBULAR DEGENERATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *" THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. PITUITARY GLAND. SEMINAL VESICLES. TR KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-* MEIASIAUC. "I*" INVASIVE. "X-" OT B F G 003548 CO n O Sr* cc *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY |N CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 4527 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRli STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 3i ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC i GROSS/MICRO CORR .................................................................................................................................................................................................................... MICRO: K1&TDPATHOLOGICAI COMMENT: STOMACH: DISCOLOREO/NMC LIVER . . , . ................................................................................................................................................... *................................................................. MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTC INFLAMMATION -MINIMAL -HEPATOCmS: CYJOPtA$M|C VACUDLES (NON-ZDNAl) -MINIMAL -HEPATOCYTES CENTRILOOULAR: HYPERTROPHY STOMACH ....................................................................................................................................................................................................................................... GROSS -OISCOlORtO-FftUStrOCU -GLANDULAR MUCOSA: <0.1 CM DlA. RED UTERUS .............................................................................................. GROSS |HP<ANT MARS HlUkl MICRO MMUMAl IUM(N 011A i D minimal fnOOMCIRIk* GlANOS OUAtCO/CVSTtC DILATION IHf foiiowiwj nssufs hai> io HKAounni *no***i i'IM ORSOvfO l I (Ml tS itAmAlT m)S( i1 :)4| S(( l *OM/1UR SU t. MOSI7IURI S(C S OVlDUCfS/TilOP ( AI I U| I A? Gl AM S&"A(.H I1A(H<A. VA*|IIA AOU/lUR* SEC 4. OVARI RET TO MfpflASHV MALIGNANT, "D-'4 BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1043 DATE OF DEATH: Q9/1S/97 SEX: HALE DOSE GROUP: ] SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUOY OAT OF DEATH: 119 STUDY VEER OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREC-TEXT COMMENTS f HJSTOPATHOLOG EPIDIDYMIDES . MICRO:................................. HiSTOPATHOLOGiCAL COMHENri iONE PRESENT KIDNEYS . . . MICRO: -MINIMAL, FOCAL -TUBULES DILATED LIVER . . . . MICRO: -MINIMAL -HEPATOCYTfS: CYTOPLASMIC VACUOLES (NOM-ZQN MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION LUNGS ,... MICRO:`-MINIMAL,'FOCAL......................................................... -VISCERAL PLEURA/CAPSULE : SUBACUTE' (CHRONIC NOSE/TURB SEC 3 MICRO: -MINIMAL -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL CHRONIC INFLAMMATION -NASAL LUMEN; FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRAi EOSINOPHILIC MATERIAL NASALMUCOSA (OLFACTORY):EPlTHELfUM-iNTRA EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, MAMMARY GLANDS, HOSE/TORB SEC I. NOSE/TURB SEC 2. PITUITARY 6LAN0, PflOST SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "8-" BENIGN. "S-" METASTATIC, "l-" INVASIVE, "X-" OT BFG 003550 td pa o -p* -Pa so BFG43410 *** PAYH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CQ RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 4529 DATE OE DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAT OF DEATH: 141 STOTT WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE'TEXT COMMENTS / HISTOPATHOLOGIC GROSS/MICRO COftR LIVER . . MICRO; MICRO: MAMMARY GLANDS GROSS: HICRO; NOSE/TURB SEC 1 HICRO: NOSE/TURB SEC 4 HICRO: UTERUS GROSS: HICRO: HISTQPATHOLOGICAL COMMENT: -MINIMAL, FOCAL -MINIMAL -MINIMAL -NODULE(S)/HASS(ES) -PRESENT -MINIMAL -MINIMAL -IMPLANT SCARS - PRESENT -MINIMAL. MULTI-FOCAL 'MAMMARY GLAND; NODULE/ADENOMA -ACUTE/SUBACUTE inflammation -HEPATOCYTES: CYTOPLASMIC VACUOLES (NOn-ZONAl -HEPATOCYTCS CENTRI106UIAR; HYPERTROPHY -MASS. RIGHT AXILLARY: 2-0 CM OlA, TAN, FIRM -ADENOMA -NASAL MUCOSA {RESPIRATORY): GOBLET CELL HYPE `NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTBACV EOSINOPHILIC MATERIAL -RIGHT; 4; LEFT; 9 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, NOSE/luRB SEC 2, NOSE/TURB SEC 3, OVARIES. OVIOUCTS/FALOP T, PITUITARY GLAND, TRACHEA, V KEY TO NEOPLASMS: "M*-" MALIGNANT, "fl-" BENIGN, "S-44 METASTATIC, "l*" INVASIVE, "X-" OTHE 05 3 jh ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TW0*GENERATIOH REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $ ANIMAL NUMBER.- 1047 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SAi STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH; 19 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FRCE'TEXT COMMENTS / HlSTOPATHOLOG EPIDIDYMIDES . MICRO: LIVER . . .. MICRO:*-MINIMAL HISTOPAThOlOGICAL COMMENT: >0M PRESENT ...................................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-ZONi LUNGS -MINIMAL. FOCAL -ACUTE/SUDACUTE INFLAMMATION .... HICr6/-HTNIHAL/F0CAL.........................................................:PULMQNARy'vESSELS; mineral DEPOSIT(S)' NDSE/TURB SEC 2 MICRO:' -SLIGHT........................................................................... -ODONTOPATHY.......................................................................... NOSE/TORB SEC 3 MICRO:' -MINIMAL.......................................................................-NASOLACRIMAL DUCT: LYMPl'lOio'llYPERPLASiA' NOSC/TURB SEC 4 MICRO:'-MINIMAL...................................................................... :NASAI`hUCOSA (OLFACTORY j/EPITHELIUM- ifiTRAl EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIQIOYMIOES. KIDNEYS. MAMMARY GLANDS. NOSE/TURB SEC I. PITUITARY GLAND. PROSTATE GIAN1 SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "6-" BENIGN. METASTATIC, "I-" INVASIVE. "R-* OT BFG 003552 w a*n to BFG43412 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER; 1031 DATE OF DEATH: 09/IS/97 SEX: MALE DOSE GROUP; 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRII STUDY PAY OF DEATH: 119 STUDY WEEK OF DEATH: If TERMINAL BOOT WEIGHT; 5J ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS **' GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I EPIDIDYMIDES KIDNEYS . MICRO: HISTOPATHOIOGICAL COMMENT: >ONE PRESENT MICRO:'-MINIMAL, FOCAL.........................................................-CORTEX: INFiLTRATES SUBACUTE LIVER . . NQSE/TURB SEC 3 MICRO: MICRO: -MINIMAL -MINIMAL, `MINIMAL FOCAL -MINIMAL N0SE/TUR6 SEC 4 ................................................................... MICRO: -MINIMAL -MINIMAL PROSTATE GLAND MICRO:'-MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -ACUTE/SUBACUTE INFLAMMATION -NASAL MUCOSA {OLFACTORY): EPITHELIUM-INTRACYTt EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTt EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL -EDEMA ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: iv _ ^ ........................ ......... COAGULATING GL. EPIDIDYMIDES, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, PITUITARY GLAND, SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "5-" METASTATIC, "1-" INVASIVE. "X-" OTHER 09 u> E U> ANIMAL NUMBER; 1050 DATE Of DEATH: 05/28/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SEX; MALE DOSE GROUP; 1 SACRIFICE STATUS; UNSCHEDULED (D) STUDY DAY OF DEATH: 0 STUDY WEEK OF DEATH: Z TERMINAL BODY WEIGH!: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS FREE-TEXT COMMENTS / HISTOPATHOLO EPIOIDYHIDES .... MICRO: GROSS/HICRO corr , r MICRO: KIDNEYS ........................ MICRO: LIVER MICRO -TISSUE HISSING ,. HisiOPATHOLOGlCAL'COMMENT -HOQERMf -SLIGHT MINIMAL *AWAIT tLAAOi HlflO nOSIMuM Stl NOSI/luM U( \ mu o / icto NQSE/IURB SEC 4 MICRO. >ILWT * Mill U| MIRJNRl -MINIMAL -MINIMAL PROSTATE GLAND MICRO: -SLIGHT SEMINAL VESICLES GROSS: -SHALL, SEVERE MICRO: -SLIGHT TESTES MICRO: -TISSUE HISSING URETHRA MICRO: -SLIGHT' -PELVIS: INFLAMMATION SUBACUTE PELVIS: EPITHELIAL HYPERPLASIA HfMtQCYUS CYtOPtASMlC VACUOLES (HON-ZO AtUH/lUACUt( INFLAMMATION 0M(R0ft*Ml QlLAN (OSiNOPMUiC MATERIAL VOMdONASAl ORGAN tOSINOPHIllC MATERIAL -NASAL LUMEN; FACE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY); EPITHELIUM- l*4Tfl EOSINOPHILIC MATERIAL -ACUTE/SUBACUTE INFLAMMATION -INFLAMMATION, subacute -INFLAMMATION, SUBACUTE THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED, COAGULATING fiL, LUNGS, NOSE/TURB SEC 3. PITUITARY GIANO, TRACHEA 00 8 KEY TO NEOPLASMS: "M-" MALIGNANT. "0-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" I BFG43423 Ol U *** PATH/1QX SYSTEM OUTPUT **" VINYL CHLORIDE COMBINED INHALATION TUQ-GENERATtON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUt ANIMAL NUMBER; 1033 OATE OF OEATH: 09/15/9? SEX: HALE DOSE GROUP: 1 SACRIFICE STATUS; SCHEDULED, TERMINAL SACR1 STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: )7 TERMINAL BODY WEIGHT; ! ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION 6R0SS FflEE-TEXT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES LIVER . . MICRO; MICRO: LUNGS MICRO: NOSE/TURB SEC 4 MICRO: URETHRA MICRO: -MINIMAL -MINIMAL, -MINIMAL. -MINIMAL -MINIMAL HISTOPATHOLQGICAL COMMENT; FOCAL FOCAL >QNE PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-EONAL] -ACUTE/SUBACUTE INFLAMMATION OSSEOUS METAPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACY1 EOSINOPHILIC MATERIAL -SEMINAL COAGUlUN ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED ** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; , _____ ,,,, _ COAGULATING GL, EPIDIDYMIDES, KIDNEYS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC t, NOSE/TURB SEC 3, PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES. TESTES, TRACHEA Y TO NEOPLASMS: "H-" MALIGNANT, '"B*" BENIGN, "S-" METASTATIC, I- INVASIVE, X' OTHEI ANIMAL NUMBER: 1054 DATE OF DEATH: 09^16/ft7 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET SEX: MALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL S STUDY OAT OF OEATH: 120 STUDY WEEK OF DEATH: 10 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTOPATHOLO LIVER . . . . MICRO: 'MINIMAL ' MINIMAL, FOCAL LUNGS . , . , MICRO: -MINIMAL, MULTI-FOCAL nose/iurb SEC 4 MICRO; 'MINIMAL PROSTATE GLAND ............................... MICRO; -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-IO ACUTE/SUBACUTE INFLAMMATION -INTERSTITIUM: subacute/chrontc inflahmati NASAL MUCOSA (OLFACTORY); EP1TMEUUM-INTR EOSINOPHILIC MATERIAL ACUTE/SUBACUTE INFLAMMATION ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL, EPIDIDYMIDES, KIDNEYS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, NOSE/TURB SE PITUITARY GLAND, SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS; '*M-" MALIGNANT, *'8'" BENIGN, "S-" METASTATIC. "!" INVASIVE, "K-" 0 BFG43425 ANIMAL NUMBER: 1037 DATE OF DEATH: 09/1 S/9? *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD SEX; HALE DOSE GROUP; t ' SACRIFICE STATUS: SCHEDULED, TERMINAL 5ACRU STUDY DAY OF DEATH: 119 STUOY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 4 ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COHHENTS / HISTOPATHOLOGIC LIVER ................................................ ...................................................................... ..................................................................................................................... MICRO: -MINIMAL -MINIMAL, FOCAL -HEPATQCYTES; CYTOPLASMIC VACUOLES (RON-ZONAL) -ACUTF/SUBACUTE INFLAMMATION MAMMARY GLANDS ............................................... MICRO: -TISSUE HjSSjNG NOSE/TURB SEC 2 ........................................... MICRO: -MINIMAL -ODONTOPATHY PROSTATE GLAND ............................................... MICRO: -SLIGHT, FOCAL -ACUTE/5U6ACUTE INFLAMMATION -MINIMAL. FOCAL ALVEOLAR LUMENS: EXUDATE *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDlQYMlDES, KIDNEYS, LUNGS. NOSE/TURB SEC 1. NOSE/TURB SEC 3, NOSE/TURD SEC 4, PITUITAR' SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "M-*' MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER -n CD O n O X* t--* o O' u E *** PMH/TOX SYSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IK CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1057 DATE OF DEATH: 09/1B/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SI STUDY DAY OF DEATH: 120 STUOY WEEK OF DEATH: IS TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS 4 GROSS FREE'TEXT COMMENTS / HISTOPATHOLOf liver MICRO: -MINIMAL -slight, multi-focal HOSE/TURB SEC 1 MICRO: -MINIMAL NOSE/TURB SEC 3 MICRO: -MINIMAL -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL PROSTATE GLAND MICRO: -MINIMAL -HtPATOCTTES: CYtQPlASNlC VACUOLES (NON-ZD! -acute/subacute inflammation -NASAL LUMEN: FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPlTHELlUM-JNTR/ EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATEI -NASAL MUCOSA (OLFACTORY): EPUHUIUM-INTRJ EOSINOPHILIC MATERIAL -EOfMA *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HaO NO MICROSCOPIC ABNORMALITIES OBSERVE!!: COAGULATING GL. EPIDIDYMIDES, KIDNEYS, LUNGS, HAHHARY GLANDS. NOSE/TURB SEC 2, PITUITARY GLAND. SEHINi TESTES. TRACHEA KEY TO NEOPLASMS; **N-" MALIGNANT, V BENIGN, 'V METASTATIC. "l-" BFG43427 DO ANIMAL NUMBER: 1041 DATE OF DEATH: 09/15/97 *** PATH/TOX SYSTEM OUTPUT *** VlNYl CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TONICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD SEX; MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: 119 STUDY MEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 4 ORGAN NAME * * * PATHOLOGY KEYUOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER . - - . MICRO: N0SE/TUR6 SEC 3 MICRO: NOSE/TURB SEC 4 HICRO: -MINIMAL -minimal MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAli -nasolacrimal DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYT EOSINOPHILIC MATERIAL *** ANIMAL HAS NO G>0*1 ABNORMAL IT11 S OBMMIO *" THE FOLLOWING MAO NO M|(*OUO*I( AtNOtHAUMCS 0flWi(0 COAtOtAtllMj (,i LMOipraiBu |ON|n 1UNNS nAmk$1 6LU0S. iOH/tUM StC 1. NOSE/TUNR StC t. PITUITARY PROSTATE GliNO KHINAi vClICtd Td T| \ ?*( HE A 1(1 IQ N|0PV\"S H NAl INUNI . " ' BfNlftA. "S'" MtlASUIIC. "l-" |NA$|(, "X-** OlMCfl BFG43418 U- ** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S' ANIMAL NUMBER: 1060 DATE OF DEATH: 09/15/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL &AI STUDY DAY OF DEATH: 119 STUDY VEER Of DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TCXT COMMENTS / HISTDPATHOLOGI GftOsS/HlCfto CORN.................................................................. ,, , . , MICRO: HISTOFATHOLOGICAL COMMENT: 'KIDNEY-ft: OILATATION/PELVIS DILATED KIDNEYS ....................... ................................................................................................................................................................................... GROSS: -DILATATION. SLIGHT -RIGHT PELVIS -NOT EVIDENT -LEFT MICRO: -MINIMAL -PELVIS: MINERALISED GRANULES -MINIMAL -PELVIS: DILATED -MODERATE -PYELONEPHRITIS H1STOPATHOLOGICAL COMMENT: >ONE PRESENT LIVER - . . . MICRO: -MINIMAL -MEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZON, LUNGS .... MICR0:-MINIMAL. FOCAL -INTERSTiTIUM: SUBACUTE/CHRONtC iNFLAHMATIO NOSE/TURD SEC 3 MICRO: -MINIMAL ' -NASOLACRIMAL DUCT: LYNPHoio HYPERPLASIA' PROSTATE GLAND MICRO:'-MINIMAL -ALVEOLAR LUMENS: CORPORA AHVLACtA/Ni1 THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES. MAMMARY GLANDS, NOSE/TURB SEC 1 SEMINAL VESICLES. TESTES. TRACHEA NQSE/TURfi SEC 2. N05E/TURB SEC 4. PITUI KEY TO NEOPLASMS: "M-" MALIGNANT. *'0-" BENIGN. "S-" METASTATIC, "I-" INVASIVE, **X-H DT 53 c? to c? -b. U> -ti N> V 003560 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMGINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 1045 DATE OF DEATH: 09/16/97 SEX: HALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI, STUDY DAT OF DEATH: 1Z0 STUDY WEEK OF DEATH: 18 TERMINAL BODY WEIGHT: 4! ORGAN NAME * * * pathology KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC EPIDIOYMIOES MICRO; HISTQPATHQIDGICAL COMMENT: >ONE PRESENT KIDNEYS MICRO: -MINIMAL, FOCAL -TUBULES DILATED LIVER MICRO: -MINIMAL -SLIGHT, MULTI-FOCAL -HEPATOCYTtS; CYTOPLASMIC VACUOLES (NON-ZONAl) -ACUTE/SUBACUTE INFLAMMATION LUNGS MICRO: -MINIMAL, MULTl-fOCAL -INTERSTITIUM; 5U0ACUTE/CHROHIC INFLAMMATION NOSE/TURB SEC 2 MICRO: -MINIMAL -VOMERONASAL ORGAN: FREE`ERYTHROCYTES NOSE/TURB SEC 3 MICRO: -MINIMAL -NASOLACRIMAL DUCT(S); MUCOSA-SUBACUTE (CHftONl! CHRONIC INFLAMMATION -MINIMAL NASOLACRIMAL OUCT: LYMPHOID HYPERPLASIA PROSTATE GLAND MICRO: -SLIGHT, HULTI-FOCAL -ACUTE/SUBACUIE INFLAHMATION URETHRA MICRO: -MINIMAL -SEMINAL COAGULUH ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDTM1DES, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 4, PITUITARY GLAND, SEMINAL TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. "I-M INVASIVE. "X-" OTHER BFG 003551 0$ n O uj to ------1--*----------*--* ANIMAL NUMBER: DATE OF DEATH: -k - -Ip 1062 09/1S/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TH0-6ENERATI0N REPRODUCTION AN0 DEVELOPMENTAL TfWlCITY STUDY |N CO RATS INDIVIDUAL ANIMAL DATA SHEET L-J----------- wvv^vtv* W* WWW -- v --vtaaiiftaamiBfaa SI SEX: MALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED. TERMINAL SA< STUDY DAY OF DEATH: 119 STUOY WEEK OF DEATH: IT TERMINAL BODY HEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HlSTOPATHQLOG LIVER . . . . MICRO: -MINIMAL LUNGS MICRO: -MINIMAL, FOCAL NOSE/TUftB SEC 3 MICRO: -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL -HEPATOCYTCS: CYTOPLASMIC VACUOLES (NOM-ZPMJ -INTEASTmUN: SUBACUTE/CHRONIC tMF'L.AHHAT 101 -NASOLACRIMAL DUCT; LYMPHOIO HYPERPLASiA :NASAL MUCOSA (OLFACTORYj: BASOPHILIC HATER ** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIDNEYS. MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 2. PITUITARY GlAi PROSTATE GLAND. SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, taS-" METASYATjC. "1-" INVASIVE. 'A-4' OT 03 CO s3 O 4^ U> OJ z w ib o *** PATH/TOX SYSTEM OUTPUT M* VINYL CHLORIDE COMBINED INHALATION TVO-GCNCRATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUt ANIMAL NUMBER: 1063 DATE OF DEATH; 09/15/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STAtUS: SCHEDULED, TERMINAL SACR] STUDY DAY OF DEATH: 119 STUDY WEEK OF OEATH; 17 TERMINAL 600Y HEIGHT; i ORGAN NAME * * * PATH0106Y OBSERVATIONS * * * REWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS LIVER LUNGS PROSTATE GLAND MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT MICRO: -MINIMAL -HCPAT0CYTE5: CYTOPLASMIC VACUOLES (RON-ZONAL! HISTOPATHOLOGICAL COMMENT: >DNE LOBE PRESENT MICRO: -MINIMAL. FOCAL -VISCERAL PLEURA/CAPSULE: SUBACUTE (CHRONIC A! CHRONIC INFLAMMATION HISTOPATHOLOGICAL COMMENT: >ONE LOBE PRESENT MICRO: -MINIMAL -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -ALVEOLAR LUMENS: CORPORA AHYUCIA/HINENALIZEI *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED "* THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL. EPIDIDYMIDES, KIDNEYS, MAMMARY GLANOS, NOSE/TURB SEC 1. NOSE/IURB SEC Z, NOSE/TURB SEC 3 NOSE/TURB SEC 4, PITUITARY GLAND, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-* MALIGNANT. **B-" BENIGN, METASTATIC, INVASIVE, "X-" OTHE BFG 003563 to S S OJ U) *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE C0H61NE0 INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL T0X1C1TT STUOV IN CO RATS lHOtVIOUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1064 OATE OF DEATH: 09/15/97 SEX; MALE DOSE GROUP; 1 SACRIFICE STATUS; SCHEDULED, TERMINAL U STUDY DAY OF DEATH: U9 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOUK MONEYS LIVER . .. MICRO: HJSTOPMHOLOGlCAL COMMENT: >ONE PRESENT , ,, . MICRO: -MINIMAL ................................. * ............................. -NEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-Z0 LUNGS HISTOPATHOLOGICAI COMMENT; >QHE LOBE MISSING ,, , ...............................................NilTORATMOlOGiCAl'COMMENT: ONE LOBE PRESENT NOSC/TUA* SEC 4 MU.IO MINIMAL -RASAL MUCOSA {OLFACTORY): EP)WliUM-iHTR/ (OSIMPHU tC MAYtl(At *** AN|HAl MA^ AO l M ( > Af^UlD * " \*l FOUDUIAO TUSvIS HAD AO flidOvOMl AABOAHA^mn OGKIVid CDAUULAMM> u t'lOIDYMiftCl IIOAHS iUK.1 MAMIAiT tLABOl. AOSlMuM Sit I. M)(/?URG SEC 2. NOSE/ PI lull Ail tLAMO. PROSrAlt fciAB S(N|Mt filtUll, HSUS. TRACHEA XtY TO NEOPLASMS; *M-" MALIGNANT, "D-" BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-" 0 w CO o n o La> 003564 *" PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal DATA SHEET STI ANIMAL NUMBER: 1066 DATE OF DEATH: 09/15/97 SEX: HALE OOSE GROUP: I SACRIFICE STATUS: SCHEOULEO. TERMINAL SACI STUDY DAY OF DEATH: 119 STUDY VEER OF OEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS "** KEYWORDS, SCVERITr. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGJI KIDNEYS . . . MICRO: H1STOPATHOLOGICAL COMtCNT: >ONE PRESENT LIVER ,,.. MICRO: 'MINIMAL ....................................................................... ~HPATQCYTE$; CYTOPLASMIC VACu6ies`<N0N-Z0NAi -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION HISTOPATHOLOGICAl COMMENT: >ONE LOBE PRESENT LUNGS . . . . ..........................................HisTOPATHOLOGicALCOHMENT: >ONE LOBE PRESENT NOSE/TURB SEC 3 MICRO: -MINIMAL....................................................................... -NASAi'huCOSA (OLFACTORYj:*EP1 THELiuH-iKTRAC EOSINOPHILIC MATERIAL N0SC/TUR6 SEC 4 MICRO; -MINIMAL ....................................................................... -NASAL MUCOSA (OLFACTORY); EPITHELtUM-iNTRAC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES. KIDNEYS. LUNGS, MAMMARY GLANDS. NOSE/TURB SEC I PROSTATE GLAND, SEMINAL VESICLES. TESTES. TRACHEA NOSE/TURB SEC 2, PITUJTA KEY TO NEOPLASMS: "M-H MALIGNANT, "B-" BENIGN. `V" METASTATIC, "I-* INVASIVE, OTF W ta 3 a 2 4^ 003565 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COHBWEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1066 DATE OF DEATH; 09/16/97 SEA; MALE DOSE GROUP; I SACRIFICE STATUS; SCHEDULED, TERMINAL Si STUDY DAY OF DEATH: 1Z0 STUDY WEEK OF DEATH: IB TERMINAL SOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS *** KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COHHCNTS / HISTOPATHQLG' EPIDIDYMIDES KIDNEYS . , LIVER MICRO MICRO MICRO; 'MINIMAL LUNGS NOSE/TU&fi SEC 4 MICRO; -SLIGHT HISTOPATHOLOGICAL COMMENT: >ONE PRESENT HISroPATHDLOOICAL COMMENT: >ONt PRESENT -NEPATQCYTES: CYTOPLASMIC VACUOLES {NON-JO HISTOPATHOLOGICAL COMMENT: >DNE LOBE MISSING HISIOPATHOLOGICAL COMMENT; ?ONf LOBE PRESENT NASAL'LUMN: FREE*ERYTHROCYTES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES. KIDNEYS, LUNGS, MAMMARY GLANDS, HDSE/TUR0 SEC 1, NOSf/TUflB SEC 2, NOSE/ PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. INVASIVE. V 0 sCO w *( O u*> 003566 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET Si ANIMAL NUMBER; 1070 DATE OF DEATH; 09/1G/97 SEX: MALE OOSE GROUP; I SACRIFICE STATUS; SCHEDULED, TERMINAL SA< STUOY DAY OF DEATH: 1Z0 STUDY WEEK OF DEATH: 10 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HIST0PATHOLQG1 KIDNEYS LIVER LUNGS TESTES MICRO: MICRO: -MINIMAL MICRO SL14*1 HiST0PATH0L0G1CAL COMMENT: >ONf PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZdNJ HISTOPATHOLOGICAL COMMENT: >0NE LODE PRESENT M|SIOPATHOLOGICAL COMMENT: QNE LOBE PRESENT -!ULHA D(GENERATION mISTDPAInOlOgICai CO>i!NT *ONlY ONI IE AFFECTED W OLGtNRAlION ANlNAi Al *0 GIOU AGNOtMAi I I lU OBKMIR THE FOLLOWING I ISSUES HAD NO mtflQUOPIC ARMMMAll M(1 ODSIAVIO COAGULATING GL f'lQIR'MfM} LUPGS, WlT GtAMDS, N0SI/1UM L(C l. NOSt/TUM SEC J, NOSC/Tl NOSC/TM SU P|TU|!MT GLAND, PDOSIATf GLAM. SEMINAL VESICLES. TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OH B F G 003567 *-n O & 5 0V ** PATH/TOX SYSTEM OUTPUT **# VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1071 DATE OF DEATH: 09/16/07 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS; SCHEDULED. TERMINAL S STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: IS TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATWQLQ EPID10YHI0ES MICRO: HISTOPATHOLOGICAl COMMENT: >ONC PRESENT GROSS/MICRO CORR MICRO:................................. HiSTOPAfHOLOGiCAL COMMENT* >LN MESENTERIC: ENLARGEO/lYMPHQID HYPCRPLA KIDNEYS . . . ............................................... HistOPATHOLOGiCAL'COMMENT: >ONE PRESENT................................................................... LIVER .... MICRO: -MINIMAL -HEPATQCYTES: CYTOPLASMIC VACUOLES (NON-ZO HISTOPATHOLOGICAL COMMENT: >ONE LOBE PRESENT LUNGS .... MICRO: -MINIMAL, FOCAL -PERIVASCULAR: INFILTRATES SUBACUTE HISTOPATHOLOGICAL COMMENT: >ONE LOBE PRESENT LYMPH NOOE . . GROSS; -ENLARGEO, SLIGHT -MESENTERIC MESENTERIC IN MICRO; -SliGHT................... -LYMPHOID HYPERPLASIA NOSE/TURB SEC 2 MICRO: -MINIMAL -QOONTOPATHT................... THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 3. NOSE/TURB SE PITUITARY GLAND, PROSTATE GLAND. SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: **M-" MALIGNANT, "B-" BENIGN, "S-* METASTATIC. *1-" INVASIVE. "X-" 0 BFG 00356# sto u> -k Co *M PATH/TOX SYSTEM OUTPUT ** VINYL CMLOftlOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 1072 DATE OF DEATH: OS/16/97 SEX: HALE DO&E GROUP; 1 SACRIFICE STATUS: SCHEOULEO, TERMINAL SAC STUDY DAY OF DEATH; 120 STUDY WEEK OF DEATH: 1 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE*TEXT COMMENTS / HXStOPAfHOLOGl' KIDNEYS . . . MICRO: HISTOPATHOLOfitCAL COMMENT: >ONE PRESENT LIVER . . . . MICRO: -MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZONA -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION HISTOPATHOLOGICAL COMMENT: >ONE LOBE PRE5ENT Lungs . . . . HISTOPATHOIOGICAL COMMENT: >ONE LOBE PRESENT NOSE/TURB SEC 1 MICRO:'-MINIMAL ....................................................................... -NASAL MUCOSA (RESPIRATORY): ACUTE/SUBACUTE -MINIMAL -ODONTOPATHY NOSE/TURB SEC 4 MICRO:'-MINIMAL ....................................................................... -HASH'nuCOSA (OLFACTORY)EPITHELIUM-iwTRAC PREPUT/CL IT GL MICRO: -MINIMAL, FOCAL EOSINOPHILIC HATER ML -INFLAMMATION, SUBACUTE ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY BLANDS. N0SE/TUR6 SIC 2, NOSE/TURB SEC 3, PlTUITA PROSTATE GLAND. SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-M OTP BFG 003569 Cd 5! O 4^ LO 4* uj 00 *#* PATH/TOX SYSTEM OUTPUT ** VIHYL CHLORIDE C0N6INE0 INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1074 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP; \ SACRIFICE STATUS: SCHEDULED, TERMINAL S STUOY DAY OF DEATH: 120 STUDY VEER OF DEATH; IB TERNINAL BODY WEIGHT: ORGAN NAME ** PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FtlE-TEXT COMMENTS / H1ST0PATH0L0 epididymides KIDNEYS . LIVER . . MICRO MICRO MICRO -MINIMAL -MINIMAL. LUNGS NOSE/TURB SEC l MICRO; -MINIMAL KOSE/TURB SEC 2 MICRO: -MINIMAL NOSC/TURfl SEC 3 MICRO: -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL PROSTATE GLAND MICRO: -MINIMAL HISTOPATHDLOGICAL COMMENT; HiSTOPATHOLOGICAL'COMMENT: FOCAL HISTOPATHOLOGICAL COMMENT: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT >OWE'PRESENT' -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZO -ACtlTE/SUBACUTE INFLAMMATION >ONE LOBE PRESENT *ONE LOBE PRESENT -NASAL MUCOSA (RESPIRATORY): GOBLEt CELL H -NASOLACRIMAL OUCT(S); FREE ERYTHROCYTES' -NASAL MUCOSA (OLFACTORY): CPITMELtUM-lNTfi EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPlTHELlUM-INTH EOSINOPHILIC MATERIAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES. KIDNEYS, LUNGS, MAMMARY GLANDS, PITUITARY GLAND, SEMINAL VESICLES. TES1 KEY TO NEOPLASMS: "M-" MALIGNANT, *B-'k BENIGN, "S-n METASTATIC. "J-" INVASIVE, "X-" ( BFG 003570 Cd 53 o LO A *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 1070 DATE OF OEATH; 00/10/97 SEX: MALE DOSE GROUP: I SACRIFICE STATUS; SCHEDULED, TERMINAL SAC 5TUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: IS TERMINAL BODY WEIGHT: ORGAN NAME * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS TREE-TEXT COMMENTS / HI$T0PATH0L06I< KIDNEYS .................................................................................................................................... *......................................................................................... MICRO: LIVER , . . . HJSTDPATHOLOGJCAl COMMENT; >ONE PRESENT MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -MINIMAL. FOCAL 'ACUTE/SUBACUTE INFLAMMATION LUNGS , , . , HIST0PATH0LO61CAL COMMENT; >ONE LOBE ONLY PRESENT MICRO: -MINIMAL, MULTI-FOCAL -ALVEOLAR HEMORRHAGE HISTOPATHOLOGICAL COMMENT: >OHE LOBE PRESENT MAMMARY GLANDS MICRO -TISSUE MISSING NOSE/TURB SEC 1 PROSTATE GLAND MICRO MICRO: -MINIMAL -SLIGHT -VOMERONASAL ORGAN: FREE ERYTHROCYTES -ACUTE/SUBACUTE INFLAMMATION ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING 6L, EPIDIOYMIOES. KIDNEYS, NOSE/TURB SEC 2. NOSE/TURB SEC l, NOSE/TURB SEC A, PITUITARY SLA SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. ,4X-4` OTN BFG 003571 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERAtION reproduction AMO DEVELOPMENTAL TOXICITY STUDY IN CO NATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 10TB DATE OF DEATH: 09/16/97 SEX: MALE DOSE fiROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY OAY OF DEATH: IZO STUDY MEEK OF DEATH: IB TERMINAL BOOT WEIGHT; ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG EPIDIDYMIDES KIDNEYS . . LIVER MICRO MICRO MICRO: LUNGS . , NOSE/TUM SEC 3 MICRO; N05E/TUR6 SEC A MICRO: PITUITARY GLAND MICRO: PROSTATE GLAND MICRO: -MINIMAL -MINIMAL, -MINIMAL -MINIMAL 'MINIMAL 'MINIMAL, HlSTOPATHOlOfilCAL COMMENT: HIST0PATH0L061CAL COMMENT: FOCAL HISTOPAtHoLOgICAL COMMENT: HisTOPATHOLOGiCALCOMHENT: FOCAL >ONE PRESENT >ONE PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-TON 'ACUTE/SUBACUIE INFLAMMATION >ONLY ONE LOBE PRESENT >0N LOBE PRESENT ............................................. 'NASOLACRIMAL DUCT; LYMPHOID HYPERPLASIA 'NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTHJ EOSINOPHILIC MATERIAL `PARS INTERMEDIA: CYST(S) -ALVEOLAR LUMENS: CORPORA AHYLACIA/MINERALI *** ANIMAL HAS NO 6R0SS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING 6L, EPIOIOYMIOES, KIDNEYS. LUNGS, MAMMARY BLANDS, NOSE/TUR0 SEC 1, NOSE/TURB SEC Zt SENINJ TESTES, TRACHEA KEY TO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN, METASTATIC. "I-" INVASIVE, "t-'` 0 B F G 0113572 51 A t4^ PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER; ZOSl DATE OF DEATH: 09/1S/97 SlK: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACA STUDY DAY OF DEATH: 119 STUDY MEEK OF DEATH: 17 TERMINAL BOOY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE'TEXT COMMENTS / HISTOPATHOLOGIC m mm m m m m mmm mm w-m m m m m r -w m Ttrmmmmmi-wwm w-- * -- ri- - - * < i- *r m m m m m m m m w * m m m m m m mm w*- --------"w-w--- ------**- LIVER ............................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SU9ACUTE INFLAMMATION ** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED "** KEY TO NEOPLASMS: "M-" MALIGNANT. "8-" BENIGN, "S-'* METAStAtlC, "l-w INVASIVE. pX-" OTHI W BFG43442 ANIMAL NUMBER; 2033 DATE OF DEATH: 09/15/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVQ-GENERATIQN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD NATS INDIVIDUAL ANIMAL DATA SHEET ! SEX: MALE DOSE CROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SI STUDY DAY OF DEATH: 119 STUOY WEEK OF DEATH: 17 TERMINAL BODY HEIGHT: *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003574 w 3 O Lh) ANIMAL NUMBER; 2034 OATE OF DEATH: 09/15/97 ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY tN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULEO. TERMINAL SACRI STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 1? TERMINAL BOOT WEIGHT: 4 *** ANIHAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIHAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** CO *5 BFG43444 ANIMAL NUMBER: 2036 DATE OF DEATH: 09/IS/9? *** PATH/tOK SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION IVO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S SEX: HALE DOSE GROUP: Z SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 119 STUDY VECM OF DEATH; 17 TERMINAL BODY WEIGHT: *"* ANIMAL HAS NO GROSS ABNdAmALJTIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVEO *** cd 2 3O LO Ui U03576 ANIMAL NUMBER: 2037 DATE OF DEATH: 09/15/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD SEX: MALE DOSE GROUP: 2 SACRIFICE 5TATUS: SCHEDULED, TERMINAL SACRI STUOY OAY OF DEATH: 119 STUOY WEEK OF DEATH: 17 TERMINAL BOOT VCI6MT; $ *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003577 03 51 O ANIMAL NUMBER; 2030 DATE OF DEATH: D9/1S/97 *** PATH/fOx SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S SEX; MALE DOSE CROUP: 2 SACRIFICE STATUS; SCHEDULED. TERMINAL SA STUDY DAY OF DEATH: 119 STUDY WEEK OF OEATH; 17 TERMINAL BODY HEIGHT: *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** 03 "El a BFG 003578 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AMO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD1 ANIMAL NUMBER: 2040 SEX; HALE DOSE GROUP: t SACRIFICE STATUS: SCHEDULED, TERMINAL SACAH DATE OF DEATH: 09/15/97 STUDY DAY OF DEATH: )10 STUDY WEEK OF DEATH: 17 TERMINAL 9DDY WEIGHT: 4l mmuMMM a a x _r aa aaaaaaaxaaaaavv-- aawt*`*-*vvfr-'<a,wv+*4> aa.aaa.LiaaaaTTxaaaaaxaaaa aaaai.x-iaaa.f-ix. ORGAN NAME * # * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I LIVER ............................................................................................................................................................................................................................................ MICRO: -MINIMAL -HCPAToCYTES: CYTOPLASMIC VACUOLES (N0N-ZOMAL) "* ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "H-" MALIGNANT, "6-" BENIGN. "S-" METASTATIC, ''l-H INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION m DEVELOPMENTAL TOXICITY STUDY in CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 2042 DATE DF DEATH: 09/13/97 SEX; HALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SA STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH; 18 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOO LIVER . MICRO: -MINIMAL -hEPAtOcYTES: CYTOPLASMIC VACUOLES (NON-ZON *" ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *" KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, V" METASTATIC, "1-" INVASIVE. "X-n OT BFG 0035#U 3 o $ ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION reproduction and developmental toxicity study in co rats INDIVIDUAL ANIMAL DATA SHEET Pf STUDY 1 ANIMAL NUMBER*. 2044 DATE OF DEATH: 00/16/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRlfU STUDY DAY OF OEATH; 120 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 464 ORGAN NAME ** PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREC-TEXT COMMENTS / HISTOPATHOLOGIC FI! KIDNEYS LIVER . . GROSS: -DILATATION, SLIGHT MICRO: -MINIMAL -LEFT PELVIS -HEPATQCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) KEY TO NEOPLASMS: "M-" MALIGNANT. "G-" BENIGN. "S-* METASTATIC, "I-" INVASIVE, "X'** OTHER tiHiO ,.-K '3AISVAMI ,,!,, 'D11V1SV13H W-S,, 'N91N38 iHmnVH.cN,, 'SHSV1d03N Oi A3X OVMOZ-KOH) SllpftOVA 3lH$VldOU3 :S3lA301Vd3H3AIHA '3 CO X 6*0 3S01 NVlOJH' IVHtNIH- ^OMiH 31VB3QOH ' UOQdiWOQi-QMlOmQ- :SSO9 OWN/Q3W100S10 'S(TCQ;I b3Ml< ilNSMHOO 1V3J9010Hid01SIH -0H31M SDHIOWtj 319010HIVJ01SJH / SJN3WHQ3 1X3133HJ S50M NOUMmSIQ *A1I3A3S 'SOHOMa* , # , SH0J1VAD3SB0 IHlOHiVd , , . SHVU9 OOtS :1H913A AOOfl IVNlHMi 81 'H1V30 JO 3A AOfliS 021 *HiV3fl JO AW AOfUS 3DJ3JB3VS 1VMJMH31 'MlflOaHOS Sfl^lS 331JIU0VS 2 :jnOX9 3S0O 31VM ' X3S VO0OH6 AOms OIC :39Xd oe-ddv-ez -031NUM 133MS WW 1VHINV 1W0MIQNI %m 03 HI AOfUS AiH 1X01 IVUtiMJOiaAJO ONV 0U3n00d3W HO!lVWN39-OfU kOliVIWM QlHliHOO 30MO1H3 1AM1A ,* injioo hjisas xoi/tuvj Ml ANIMAL NUMBER: 2048 DATE OF DEATH: 09/16/97 ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD' SEX: MALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRII STUDY DAY OF OEATH; 120 STUDY WEEK OF DEATH: ID TERMINAL BODY WEIGHT: 5; ** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *" ANIMAL HAS no MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003583 & \>> *** PATH/TOX SYSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CQ RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: ZOSO DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: Z SACRIFICE STATUS: SCHEDULED. TERMINAL 5 STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: }B TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLO LIVER MICRO: -MINIMAL HEPATOCYTES: CYTqPlASHIC VACUOLES (NON-20 *** ANIHAl HAS NO GROSS ABNORMAL IT ICS OBSERVED *** l(T 1Q MGPlASMs n HiUGAANt ItNl&fl. Ml I ALTAI IC INVASIVE Qo GO aS L>J 4^ LJi U) UU3584 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUO ANIMAL NUMBER: 2052 DATE OF DEATH: 09/16/97 SEX: HALE DOSE GROUP; 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACft] STUDY DAY OF DEATH: 120 STUDY MEEK OF DEATH: IB TERMINAL flOOY WEIGHT: 3 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FRCE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................... MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION AHIHAL HAS HQ GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "1-" INVASIVE. "XTM" OTHER ANIMAL NUMBER: 2054 DATE OF DEATH; 09/16/97 *** PATH/TOX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWQ-6ENERATI0N REPRODUCTION AND DEVELOPMENTAL TOXlCltY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET SEX: MALE DOSE GROUP: Z SACRIFICE STATUS: SCHEDULEO.'teRMINAL Si STUDY DAY OF OEATH: 120 STUDY VEEN OF DEATH: ID TERMINAL BODY HEIGHT: *"* ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** ANINAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED "* BFG 003586 tX7 3 S u> L>1 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal data sheet stud ANIMAL NUMBER: 2056 DATE OF DEATH: M/16/87 ORGAN NAME SEX: HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACI1 STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH*. 16 TERHtNAl DOQY WEIGHT: E * * * p ATHOLDGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-HXT COMMENTS / HISTOPATHOLOGIC LIVER , . MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OB5EWO *** 10 fetOflAW IfafcAkT . "| " DlllW. i` N(1A$TA1tC. "1-" INVASIVE. OTHEI BFG43456 Os oe "* PATH/IOX SYSTEM OUTPUT *** VINYL CHlOftlOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL HUMBER: 20S6 DATE OF DEATH; 09/IS/97 SEX'. HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL $A STUDY DAY OF OEATH: 119 STUDY WEEK Of DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HlSTOPATHOlOG LIVER ...................................................................................................................................................................................................................................... MICRO: -SLIGHT -HEPATOCYTCS: CYTOPLASMIC VACUOLES (NON-ZON *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN, MS-H METASTATIC. "I-" INVASIVE. "X-" OT D3 rrt O U\ fts s e o n *** PATH/TOX SYSTEM OUTPUT *" VINYL CHLORIDE COMBINED INHALATION TVO-GEHERAT1QH REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU! ANIMAL NUMBER: 2060 DATE OF DEATH: 09/15/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULEO. TERMINAL SACR STUOY DAY OF DEATH: 119 STUDY MEEK OF DEATH: 17 TERMINAL BODY WEIGHT; * ORGAN NAHE LIVER . . * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS PREE-TEXT COMMENTS / HISTOPATHOLOGIC MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO 6R0SS ABNORMALITIES OBSERVED **" KEY TO NEOPLASMS: "N-" MALIGNANT. "B-" BENIGN. V" HETASIATIC, "I-" INVASIVE, "X-" OTHE *** MTH/TOX SVSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION 1H0'GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER! 2062 DATE OF DEATH: 09/15/97 SX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SAI STUDY DAY OF DEATH: 119 STUOY MEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYVOROS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / H1STQPATHOL0G LIVER MICRO; 'MINIMAL -HCPATOCYTES; CYTOPLASMIC VACUOLES (NDN-20Mi **" ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *" KEY TO NEOPLASMS: *N-4` MALIGNANT. "B-" BENIGN, 'V4 METASTATIC. "I-" INVASIVE. "X-" OT BFG 003590 to 2 O 4^ U> Ui VO *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIOE COMBINED INHALATION TVO-6ENERATI0N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET Stt ANIMAL NUMBER: 2064 DATE OF DEATH: OS/15/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACf STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL 900Y HEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS *** KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................................................ MICRO: 'SLIGHT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZOHAI *" ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT. V" BENIGN. **S-" METASTATIC. "l-" INVASIVE. "X-" OTHl oj *n O SO 3 s 003591 M3H10 ,rXM *3AlSVAHf `3iiVl$Y13H ,,-$H 'N91H39 ,,-fl,, `lNVNOllVH ..-M.. :SMSVlif03N Oi A3X 03AM3SB0 S3IinN80MBV $SDfl9 0> (ivnoz-non) SHtxrcVA aifriSVlJOlAO :S31AW1VJ3H* 1VMINIM- -0H3h S9N1QHU 3l9010HiVd01S1M / S1N3W03 1X31-33UJ S50H9 , SN011VA93590 Nounomsia 'aumass 'sawfUSH A9010H iV d , * , SNV09 6 tT> 4H913A AOOfl 1VNIHU31 l\ :H1V30 JO *3Jfl lOniS 11 iHIVIO JO AW JMM15 93MNPVS IVNIHtfl 7031n03H3S 'SfUVlS SOliiMVS Z -'dftOVB 3500 31VM :X3$ V0B0W6 WMM AMIS 02C :39Vd 06'MdV-62 :031NIUd 133HS VIVO 1VMINV IVOQUIQlU SAW 03 N1 AOIUS AiniXOl 1V1H3NJ013A30 ONV NOUDMOticIH KOUVH3N3S-Ofli N0UV1VHNI Q3H19HQ3 aqilJOlHa lANlft ... AMMO M31SAS Wl/HlVd /6/< H3H10 '3AISVAMI ,,-I(1 '31iVlSi3M ,,SM 'N9MJ8 M-8H `1NVH9I1VH tl-H,, SMSV1dQ3N 01 13* * 0?Atf3$W $?U!1VUMHBV SSDU9 OM uonmnnui sinavans/sinav(3VH07-NON) S31QA3VA 3IHSV'ld01A3 `SaiAOOiVdaH; iymm "ivhihin* IVNINIH- J0a3|H S9N10NIJ SIOOIOHiVdOlSlH / S1N3HM03 1X31-3383 SS0V9 MOUMltflSlO 'AltbiAJS 4S010flA3X , , , SNOI1VAB3SQO A 9 0 1 0 H i V d . , , SHVB9 `S6t :1H913A 1008 1VKIWU31 41 =H1V30 dO M33A AOfUS 611 :H1V3Q dO AV(I AOniS 33IJ1WVS lVNlHttl *a3W(l3H3$ `SMV1S 30IJU3VS Z :dflOOT 3S0Q 31VH :*3$ V080V96 :8l8HnN AOfUS 12C :j9Vd 66-adV-ez :oaiNiad I33H* VIVQ 1VMWV iVMlAlONl siva os ni ignis nnixoi lviHjwoiaAja onv NoiiandoadSa NOllVaaNaO-Mi NOUVIVHNI 03N16M3 301V01H3 1AN1A *** indino hu$a$ xoi/HiVd AAV* <6/6 *** PATH/TOX SYSTEM OUTPUT *" VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBERJ 2068 DATE OF DEATH: 09/15/97 SEX; HALE DOSE GROUP; 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 119 STUDY HECK OF DEATH: 17 TERMINAL BODY VE16HT: ORGAN NAME * * * PATHOlOflY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HiSTOPATHOLOC LIVER MICRO: -MINIMAL -MINIMAL, FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NOH-ZOF -ACUTE/SUDACUTE INFLAMMATION *** ANtHAL HAS NO GROSS ABNORMAL ITItS OBSERVED *** t(i (0 k( U B( MltAStAlIC l" INVASIVE. "X*" 01 BFG 003594 ta *n U) ON ANIMAL NUMBER; 2070 DATE Of DEATH: DB/1S/D7 PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-6CNCRATI0N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET $Tl SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACl STUDY DAT Of DEATH: 119 STUDY MEEK Of DEATH: 17 TERHtNAL BODY WEIGHT; *+* ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** *** ANIMAL HAS ND MICROSCOPIC ABNORMALITIES OBSERVED BFG 003595 Gd n O L*> 4^ ANIMAL NUMBER: 2072 DATE OF DEATH: 09/16/97 *** PAtH/rox ststem output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL AHIHAL DATA SHEET SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL Si STUOY DAY OF DEATH: 120 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: '** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL NAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** CO BFG43465 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $TU ANIMAL NUMBER: 2073 DATE Of DEATH: 09/16/97 SEX: MALE DOSE GROUP: t SACRIFICE STATUS: SCHEDULED. TERMINAL SACR STUDY DAY Of DEATH: 120 STUDY WEEK OF DEATH: IB TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS f HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................................................ HICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (N0N-20NAL -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION *'* ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED Kfv to ilQMw h " ML l^ur |' "S " HE I AS IA T 1C . "I" INVASIVE. "X-" DTHC B f,G 003597 to m o LP 4^ O O' ANIMAL NUMBER: 2074 OATE OF DEATH: 09/16/97 *** PATH/TOX SYSTEM OUTPUT *** VtNYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SI SEX: MALE DOSE GROUP' 2 SACRIFICE STATUS: SCHEDULED. TERMINAL $AI STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: IB TERMINAL BOOY WEIGHT: ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003598 a L>) ANIMAL NUMBER: 3075 DATE OF DEATH: 09/16/97 *'* PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STI SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: 120 STUOY WEEK OF DEATH: IB TERMINAL BODY WEIGHT: "* ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED **" *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG43468 SO ANIMAL HUMBER: 2076 DATE OF OEATH: 09/16/97 *** PA7H/T0X SYSTEM OUTPUT *** VINYL CHLORIOC COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY tN CD RATS INDIVIDUAL ANIMAL DATA SHEET S SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF OEAfK; 120 STUDY WEEK OF DEATH: IB TERMINAL BODY WEIGHT; *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *"* BFG 003600 cb T1 o *** PATH/TQX SYSTEM OUTPUT *** VJHYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET &TI ANIMAL NUMBER: 2077 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: UO STUDY WEEK OF OEATH: 16 TERMINAL BOOT WEIGHT: ORGAN NAME * * * pathology KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS f HISTOPATHOLOGIC LIVER MICRO:T-MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA! *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "8-" BENIGN, "S-" METASTATIC. "l-" INVASIVE. "*-H OTMI a Q p* -J o 003601 ANIMAL NUMBER: 207ft DATE OF DEATH: 09/16/97 *** PAlH/TOX system output *** VINYL CHLORIDE COHBINEQ INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $ SEX: HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: IB TERMINAL ftOOV WEIGHT: *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED "* *** ANIHAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** 09 BFG43471 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INOIVIOUAL ANIMAL DATA SHEET STUI ANIMAL NUMBER: 3031 DATE OF DEATH: 09/15/97 ORGAN NAME SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACK STUDY DAY OF DEATH: 119 STUOY WEEK OF DEATH: 17 TERMINAL BOOY WEIGHT: * * * PATHOLOG KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS TREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: "MINIMAL -MINIMAL, FOCAL -HEPAIOCYTES; CYTOPLASMIC VACUOLES (MON-ZONAL ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED "* KEY TO NEOPLASMS: HM-" MALIGNANT, "8-" BENIGN, "S*" METASTATIC. "I-" INVASIVE, "X-" QTHEI BFG 003603 o "* PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO'GENERaTION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET < ANIMAL NUMBER; 3032 DATE OF OEATH; W/I5/97 SEX: HALE DOSE CROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL 5/ STUDY DAY OF DEATH; 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME *"* PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTOPATHOlOC LIVER MICRO; -MINIMAL -MINIMAL, FOCAL -HEPATOCTTES: CYTOPLASMIC VACUOLES (NON-ZO* -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED **" i[t ?0 IMOPlAM*1. M HAt | ijBAlll * " (N|GN H( USIATIC, "l INVASIVE a BFG43473 *** PATH/TOX SYSTEM OUTPUT "* V|HTl CHLORIDE. COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY 5TU0Y IN CD RATS INDIVIDUAL ANIMAL OATA SHEET STU ANIMAL NUMBER: 3033 DATE OF DEATH: 09/15/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEOULEO, TERMINAL SACR STUDY DAY OF DEATH: 119 STUDY WEEK OF OEATH: 17 TERMINAL 0OOY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL -HEPATOCYTES CENTR1L0BULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "M-" MALIGNANT. "0-" BENIGN. "S-" METASTATIC, "l'*' INVASIVE, V" OTHEI BFG 003605 ANIMAL NUMBER: 3034 DATE OF DEATH; 09/15/97 PATH/TQX SYSTEM OUTPUT *n VINYL CHLORIDE COMBINED INHALATION TWO-GCHENATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S SEX: MALE 00$E GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL S/ STUDY OAT OF DEATH: 119 STUDY WEEK OF OCATH: 27 TERMINAL BODY WEIGHT: *** ANIMAL HAS NO gross abnormalities OBSERVED *** *** ANIMAL HAS HO MICROSCOPIC ABNORMALITIES OBSERVED *** *** PATN/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL AH1HAL DATA SHEET STUD ANIMAL NUMBER: 3035 DATE OF DEATH: 09/15/97 SEX: HALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: 119 STUDY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: A ORGAN NAME * * * PATHOLOGY KEYVOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................................................ MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** AM fO NIQPlASM* " MAM MAN I "I " BlNlm, 'S " Ml t ASIA NC . " I " INVASIVE. "X-" OTHER BFG 003607 03 a & Cr *** PATM/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ano developmental toxicity study IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 3037 DATE OF OEATH: 09/15/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SAi STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER .............................................................................................................................................................. MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; `V MALIGNANT, "B-" BENIGN, "S-" HETAStAtlC, "I-" INVASIVE, "X-" OTI BFG 003608 11 4^ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 3039 DATE OF DEATH: 09/15/87 StX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRl STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 4 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TExT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL -MINIMAL, FOCAL -MINIMAL, FOCAL -HCPATOCYTES: CYTOPLASMIC VACUOLES (NON-Z0NAL) -ACUTE/SUBACUTE INFLAMMATION -ACIDOPHILIC FOCUS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN, ,lS-" METASTATIC, "l " INVASIVE. "X-" OTHER BFG 003609 W 51 o P- 00 *** path/tdx system output *** VINYL CHLORIDE COMBINED INHALATION TVO'GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 3041 DATE OP DEATH: 09/15/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUOY DAY OF DEATH: U9 STUDY WEEK OF DEATH: 17 TERMINAL BOOY WEIGHT: organ name * * * PATHOLOGY 0 BSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHDLOGI LIVfR . . MICRO: `MINIMAL, FOCAL............................. -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, METASTATIC, "I-** INVASIVE. "X-M OTH *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ARP DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 3042 DATE OF DEATH: 09/16/97 ORGAN NAME SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 120 STUDY WEEK OF OEATH: IB TERMINAL BOOY WEIGHT: 4 * * * PATHOLOGY 0 B SERVAT |0N$ * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS l HISTOPATHOLOGIC LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRtLOBULAR: HYPERTROPHY ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-`* METASTATIC. "1-" INVASIVE, "X-" OTHER BFG 003611 o -> 4* 0 O *** PATH/10X SYSTEM OUTPUT '** VINYL CHLORIDE COh&InCD INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET % ANIMAL NUMBER: 9043 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SA( STUDY DAY OF DEATH: 120 STUDY WEEK OF OEATH: 16 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HlSTOPATHOlDG LIVER MICRO: -MINIMAL -MINIMAL -MINIMAL, FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZOft -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY PELIOSIS HEPATIS ANIMAL HAS NO GROSS ABNORMALITIES QBSERVEO *** KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" MEIASUTIC, "I-" INVASIVE. "X-" OTI BFG 003612 00 o 4*. CC ANIMAL NUMBER: 3045 DATE OF DEATH: 09/16/97 ORGAN NAME *** PATH/TGX SYSTEM OUTPUT **1' VIKYI chloride combined inhalation TU0-6ENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIHAL DATA SHEET STUD SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 4 * * * PATHOLOGY OBSERVATIONS *** KEYWOROS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC MICRO: 'MINIMAL `MINIMAL HEPATDCYTES: CYTOPLASMIC VACUOLES (N0H-20NAL) HEPATOCYTES CENTRlLOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT. V BENIGN. "S-" METASTATIC, 'V INVASIVE, "X-'* OTHER BFG 003613 o 4^ oo to **> PATH/TQX SYSTEM OUTPUT *** VINYL CHIORIOE CDHBtNEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 3048 OATE OF DEATH: 09/16/9? SEX; MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL Si STUDY DAY OP DEATH; 120 STUDY WEEK OF DEATH: 18 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATH0L06Y OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS fREE-TEXT COMMENTS / HIStOPATHQKH UVEA MICRO: -MINIMAL. FOCAL -MINIMAL ACUTE/SUBACUTE INFLAMMATION HfPATPCYTES EENTRJLOBULAfi: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** l|f IQ N(OflSl m - nAi IiiMAkl . "I " {!(*, "S " NEIASIATIC. "1-" INVASIVE, "X-" O' BFG 003614 to s A u A. 00 Oj *** PATH/TOX SYSUH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUE ANIMAL NUMBER: 3047 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GW; 3 SACRIFICE STATUS; SCHEDULED, TERMINAL $ACR1 STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: lfi TERMINAL OODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION 6RQSS FHEE-UXT COMMENTS / HISTOPATHOLOGIC LIVER ................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL -minimal -HEPATQCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL] -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY ** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED '** 'V"KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. METASTATIC, "l-" INVASIVE. "X-" OTHER BFG 003615 w 3J o pfc poo 4^ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S AIUHAL NUMBER; 3048 DATE OF DEATH: 09/lfi/R? SEX: MALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED. TERMINAL $A STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: 18 TERMINAL BODY WEIGHT: ORGAN NAME * * * pathology KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HtSTOpATHOLOG LIVER MICRO: -MINIMAL -MINIMAL, -MINIMAL, -MINIMAL FOCAL FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZOH -acute/subacute inflammation -ACIDOPHILIC FOCUS -HEPATOCYTES CEHTRIIOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSEftVEO ** KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, 'V* METASTATIC. "l-" INVASIVE, "1-" 01 PATH/TGX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUB ANIMAL NUMBER: 3049 DATE OF DEATH: 09/16/9/ SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEOULEO. TERMINAL SACRI STUDY OAT OF DEATH: 120 STUDY WEEK Of DEATH: IB TERMINAL BODY WEIGHT: 9 ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREC-TEXT COMMENTS ( HISTOPATHOLOGIC LIVER MICRO: 'MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -hepatocttes centrilogular: hypertrophy ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** MY 10 ~M * nAt IGAAR ( . i ' M T AS Y A11C , "1" INVASIVE, "X-" OTHER BFG 003617 O & fe & PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUQY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 3050 DATE OF DEATH: 09/15/9? SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SA STUDY DAY OF DEATH: 110 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * pathology KEYWORDS. SEVERITY, DISTRIBUTION observations * * * GROSS FREE'TEXT COMMENTS / HISTOPATHOLQG LIVER ...................................... ................................................................................................................................................................................................ MICRO; 'MINIMAL -HEPATOCYtES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "M-" MALIGNANT, "0-" BENIGN. "S-" METASTATIC, "i-" INVASIVE, nX-" OT ta 3 o 4^ U> 4^ 00 003618 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS individual animal DATA SHEET STUD ANIMAL NUMBER: 3051 DATE OF DEATH; 09/15/97 SEX: MALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH; 1/ TERMINAL BOOY WEIGHT: 4 ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-tExT COMMENTS / HISTOPATHOLOGIC LIVER ........................................................... MICRO: `MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATDCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS; "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "1-" INVASIVE. "X-" OTHEN aW a a o 4^ U> oo 00 003619 *** PATH/TDX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANINAL DATA SHEET 5 ANIMAL NUMBER; 3052 DATE OF OEATH: 09/15/9/ SEX; MALE DOSE GROUP; 3 SACRIFICE STATUS; 5CHE0ULED. TERMINAL 5A< STUDY DAY OF DEATH; 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER MICRO: -MINIMAL 'MINIMAL, FOCAL MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZON -ACIDOPHILIC FOCUS -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS HQ GROSS ABNORMALITIES OBSERVED KEY TO NEOPLASMS: "N-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, ")" INVASIVE, "X-" OT BFG 003620 05 O oo \Q *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 3055 DATE OF DEATH; OB/15/97 ORGAN NAME SEX: MALE OOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT; * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER MICRO: -MINIMAL -MINIMAL, FOCAL -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (RON-ZONAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILQDULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED ** KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTHEI BFG 00362 J ta *n O O *** PAlH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET ST ANIMAL NUMBER; 3057 DATE OF DEATH; 09/15/97 SEX; MALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH; 119 STUDY WEEK. OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS *'* GROSS FREE-TEXT COMMENTS f HISTDPATH0L06! LIVER ......................................................................................................................................... ............................................................................................. MICRO; `MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MAIIGNAHT. "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE, "X-" OTH BFG 003622 to 3 2 VO *** PATH/TOX SYSTEM OUTPUT **# VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER; 3058 DATE OF DEATH: 09/15/97 ORGAN NAME SIX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: LL9 STUDY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: 4 * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................................................ MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -MINIMAL -HEPATOCYTES CENTRI LOBULAR: HYPERTROPHY *** ANIHAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "H-" MALIGNANT, '"B-" BENIGN, "S-- METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003623 03 G p- "* PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWD-GENERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 3059 DATE OF DEATH: 09/15/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL 5/ STUDY OAV OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BOOY WEIGHT: ORGAN NAME *** p ATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOL LIVER ............................. MICRO: -HlNfMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTR1LO0ULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** L[1 TO BIOPLASMS "N " NAlMttAAl It IGl, "S " NlUStAllC, "I " INVASIVE, "X-" 01 BFG 003624 03 ^Tl o & vD U (71 i #> T*n IV Ifl u tg X5 A i-- ao O** *2 uw UJ >f* IlaSiin^2Ouycj x 9 ^ n o""5 KO UI--i5! ^ _l Q"K< XSUKJ XUJ -l <-- -- a. X ix-- zS ^0ujai7-- <u>> f ^ca -- * S3 55 _i ^ vice uj Si itS 5S vxi it zo < x 4^ * f VI u (A C m 03 foflaO si u>^ 5 90 dk BFG43494 BFG 00362S *** PATH/TgX system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXtCtlY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 3063 DATE OF DEATH: 09/16/97 SEX: HALE ROSE GROUP: 3 SACRIFICE STATUS: SCHEOULEO, TERMINAL S STUDY DAY OF DEATH: 170 STUDY WEEK OF DEATH: IB TERMINAL BODY HEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTOPATHQLQ LIVER MICRO: -MINIMAL -MINIMAL, FOCAL -HEPATOCVTCS: CYTOPLASMIC VACUOLES (HON-ZO -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "H-" MALIGNANT, V" BENIGN, "S-" METASTATIC, "l-" INYAStVE, "X-" 0 BFG 003626 03 3J o 4^ UJ Lft %* PATH/TOX SYSTEM OUTPUT *** VINYL CHLORI0E COMBINED INHALATION TW0*$MflATION REPRODUCTION and DEVELOPMENTAL toxicity STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD' ANIMAL NUMBER: 3064 OATE OF DEATH: 09/16/97 SEX; HALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRII STUDY DAY OF DEATH: 120 STUDY WEEK OF OEATH: IB TERMINAL BOOT WEIGHT: 5< ORGAN NAME tut PATHOLOGY ICEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I LIVER MICRO: -MINIMAL, FOCAL -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION ACIDOPHILIC fOCUS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** kit ro aio'iMi*! h ` MAtiMiANi. * ' Malta, "i " aiiAiiaiir "I " invasive OTHER BFG 003627 03 *Tl o U) 4^ <> ON 4`* PATH/TQX SYSTEM OUTPUT *" VINYL CHLORIDE COMRIHEO INHALATION TWO-GENERATION REPRODUCTION AHO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET ANIMAL NUMBER: 3065 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEDULED, TERMINAL $ STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: 10 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLO LIVER MICRO: `MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. MI-" INVASIVE, "X-" Q BFG 003628 03 O 4^ 4^ *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TV0-6ENERATI0N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY |H CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 3066 DATE OP OfATH: 09/16/9? SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY OAY OF DEATH: 120 STUDY WEEK OF DEATH: IB TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYVOROS, SEVERITY, DISTRIBUTION observations * * * GROSS FREE-TEXT COMMENTS / H1ST0PATM0L0G1 LIVER . . GROSS: -OISCOLOREO-FOCUS{FQCI) MICRO; -MINIMAL -MINIMAL -MEDIAN LOBE: 0.1 CM DIA. TAN, AT CLEFT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZOMA -HEPATOCYTES CEnTRRoBULAA r HYPERTROPHY KEY TO NEOPLASMS: "M-" MALIGNANT. "B-m BENIGN. "S-H METASTATIC, "l-" INVASIVE. "X-" OTH BFG 00362 td *T\ O 4^ 00 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET SI ANIMAL NUMBER: 306? ATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: LB TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTDPATHQL061 LtVfft TESTES MICRO: -MINIMAL, FOCAL -MINIMAL GROSS: -SMALL, SLIGHT -SOFT. SLIGHT acute/subacute inflammation -HEPATQCYTES CENTRILOBULAR: HYPERTROPHY -LEFT -LEFT KEY TO NEOPLASMS: "M-" MALIGNANT. "6-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTL BFG 003630 CO >n O VO VO "* PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STl ANIMAL NUMBER: 3069 DATE OF DEATH: 09/26/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACl STUDY DAY OF DEATH: 220 STUDY WEEK OF OEATH: 18 TERMINAL BODY WEIGHT: ORGAN NAME *** pathology KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HJSTQPATHOLOGH LIVER .............................................................................................................................................................................................................................. MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE iNfLAHMAUON -MINIMAL -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMAL 111 IS OBSfRYL'D *** 11 l pf l,uB. "s m I A', IA 1|( "l " INVASIVE. "X-" OlHl BFG tt) o -t- O OJ o o04 Ov O *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GEHEAATION REPRODUCTION AND DEVELOPMENTAL TOXICITY $TUOr IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 3070 DATE OP DEATH: 09/16/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEOULEO. TERMINAL SA STUDY DAY OF DEATH: 120 STUDY WEEK DF DEATH; IS TERMINAL BODY WEIGHT: ORGAN NAME * * 4 PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS 444 GROSS FREE-TEXT COMMENTS / H1ST0PATH010G UVER ............................................................................................................................................................................................................................. MICRO: -MINIMAL HEPATOCYTES CENTRILOBULAR: HYPERTROPHY 444 ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: *'M-" MALIGNANT, "B-" BtNlGN, "S-" METASTATIC. *'l-" INVASIVE, "X-" OT W n O W LA o BFG 003632 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXlClTY STUDY IN CD RATS 1N0IVI0UAL ANIMAL OATA SHEET ST ANIMAL NUMBER: 4031 DATE OF DEATH: 09/15/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL 8Q0Y WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FrEE-TEXT COMMENTS / HISTOPATHOLOSI EPIDIDYMIDES ............................................................................................................. MICRO: HISTOPATHOLOGICAL COMMENT LIVER ............................................................................................................................ MICRO: -MINIMAL -MINIMAL, focal -MINIMAL. FOCAL -MINIMAL MAMMARY GLANDS ........................................................................................................ micro: 'Tissue missing NOSE/TURB SEC t .................................................................................................... MICRO: -MINIMAL NOSE/TURB SEC 3 .................................................................................................... MICRO; -MINIMAL NOSE/TURB SEC 4 .................................................................................................... MICRO; -MINIMAL -MINIMAL >QNE PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES {NON-ZONA -ACUTC/SUBACUTE INFLAMMATION -Basophilic focus -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (RESPIBATORY); GOBLET CELL HYP -NASAL MUCOSA (OLFACTORY); BASOPHILIC MATERI -NASAL MUCOSA {OLFACTORY ) EPITHEl iuN-intflAC EOSINOPHILIC MATERIAL -NASAL MUCOSA {OLFACTORY),- BASOPHILIC MATERI *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING Gt, EPIDIDYMIDES. KIDNEYS, LUNGS, NOSE/TURB SEC 2. PITUITARY GLAND, PROSTATE GLAND TESTES, TRACHEA SEMINAL KEY TO NEOPLASMS; "M-H MALIGNANT, "a-" BENIGN, "5-" METASTATIC. "I-" INVASIVE. "X-- OTF BFG 00363: cd Tl a p* Ui O N> ANIMAL NUMBER: 4033 OATE OF DEATH: 09/15/97 ORGAN NAME *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-GENLRATIQN REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SJ STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: * * * PATHOLOGY o e S t R V A T I 0 N S * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOC EPIDIDYMIDES KIDNEYS . . LIVER , . . NOM/lUdR Mt OWMiiNB Mi NOM/UlNB MICRO: MICRO; HICRO: ? f* 1 All I Mi l; ttu o -MINIMAL -MINIMA1 -MlNlHAl. H 1 R|HA| * | N 1 HA i m, fe ; Hi. *|RH* HHIST0PA1H0L0G1CAL COMMENT: rocAi >ONE PRESENT `PELVIS:"OILATEO* -HEPATOCYTfS: CYTOPLASMIC VACUOLES (NON-ZOA -ACUTC/SUBACUTE INFLAMMATION HtPAIOCYTfS CENTRllOBULAR: HYPERTROPHY *', ); imM(S) MUCOSA-SUBACUTE (CHF l hiouK in i amha) t UR AA\I)| A( | HAl PU( I UUOATf RAM l HiN Os A |0( f AT TO#M {P r TMf L(UN-|MIRA tOSlNOPHll 1C MAKRUl NASAL MUCOSA (OLFACTORY). IP11 HE LIUH-1MIRA EOSINOPHILIC MATERIAL *** ANIMAL has no gross abnormalities observed THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING Gl EPIDIDYMIDES LUNGS. MAMMARY GLAN05. NOSE/TURB SEC I, PITUITARY GLAND, PROSTATE GLAND, , TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-- METASTATIC. "I-M INVASIVE, X- 01 99 BFG43503 ANIMAL NUMBER: 403S DATE OF DEATH: 09/15/97 *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TVD-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST SEX: HALE DOSE GROUP: 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: 119 STUDY WEEK OP DEATH: 17 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITT, DISTRIBUTION GROSS FREC-TEXT COMMENTS / HISTOPATHOLOGII EPIDIDYMIDES KIDNEYS . . LIVER LUNGS .... MAMMARY GLANDS MICRO: MICRO: -MINIMAL HISTOPATHOLOGICAL COMMENT: MICRO: -MINIMAL -MINIMAL, FOCAL -MINIMAL MICRO: -MINIMAL. FOCAL micro:'-Tissue missing >ONE PRESENT -PELVIS; FREE ERYTHROCYTES -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAI -BASOPHILIC FOCUS -HEPATOCYTES CENTRlLOGULAR; HYPERTROPHY -PULMONARY VESSELS: MINERAL DEPOSIT(S) N05E/TUR6 SEC 1 MICRO: -MINIMAL N0SE/TUR8 SEC 4 MICRO; '-SlieMT' -VOMERONASAL ORGAN; FREE ERTTHROCYTES -NASAL MUCOSA {OLFACTORY): EPUHEL |UM- INTRAC EOSINOPHILIC MATERIAL r* ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSFRVED: COAGULATING GL EPIDIDYMIDES, NOSE/TURB SEC 2, NOSE/TURB SEC 3, PITUITARY GLAND. PROSTATE GLANO, SEHINAI TESTES, TRACHEA KEY TO NEOPLASMS: "H-'* MALIGNANT, "B-" BENIGN, **S-" METASTATIC. "I-" INVASIVE. X- OTHl BFG 003635 03 nrt a LP o *** PAIH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RAfS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUHBER: 4037 DAlE OF DEATH; 09/JS/97 SEX; MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL S| STUDY DAY OF DEATH; )19 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION observations * * * GROSS fREE'TEXT COMMENTS / HISTOPAIHOlOc EPIDIDYMIOES ........................................................................................................................................................................................................................ MICRO: HlSTOPATHQLQGlCAl COMMENT; ?OHE PRESENT KIDNEYS ................................................................................................................................................................................................................................. MICRO; -MINIMAL, FOCAL -TUBULES DILATED LIVER ...................................................................................................................................................................................................................................... MICRO; -MINIMAL -HEPATOtYIES; CYTOPLASMIC VACUOLES (NON-ZOfc MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION MINIMAL -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY LUNGS ...................................................................................................................................................................................................................................... MICRO; -MINIMAL -PERIBRONCHIAL: LYMPHOCYTIC HYPERPLASIA NOSE/TURB SEC 4 ............................................................................................................................................. ................................................................ MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTR7 EOSINOPHILIC MATERIAL PITUITARY GIANO .............................................................................................................................................................................................................. MICRO; -HINtMAL. FOCAL -PARS INTERMEDIA: CYST(S) -MINIMAL. FOCAL -PARS DISTALIS: CYSTS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *" THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING Gi., EPIDIDYMIDES, MAMMARY GLANDS, NOSE/fURB SEC 1, NOSE/TURB SEC 2, NOSE/TURB SEC 3. PROSl SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: hM-m MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE, 01 BFG 003636 W-n O L/Y O L/i *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUQ-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET Si ANIMAL NUMBER: 4039 DATE OF DEATH: 09/15/97 SEX: HALE DOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH; 119 STUDY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLDGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGI EPIDIDYMIDES KIDNEYS LIVER . . MICRO MICRO MICRO NOSE/TURB SEC 4 . . MICRO: PROSTATE GLAND , . . MICRO: HisTOPATHOlOGicAL COMMENT: >ONE PRESENT MINIMAL....................................................................... -PELVIS: FREE ERYTHROCYTES.......................................... -MINIMAL ....................................................................... :HEPAT6cYTE5` CYTOPLASMIC VACUOLES (NON-ZONA -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -MINIMAL ....................................................................... -NASALMUCOSA (OLFACTORY): EPITHELIUM-THTHAC EOSINOPHILIC MATERIAL -MINIMAL,'FOCAL .................................................... -ALVEOLAR LUMENS: CORPORA AMYLAC IA/MiNCAAt1Z *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL EPIDIDYMIDES, LUNGS, NAMHARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2 PITUITARY GLAND. SEMINAL VESICLES, TESTES. TRACHEA NOSE/TURB SEC 3. KEY TO NEOPLASMS: "M-" HAUGNANT, "B-" BENIGN, "S-*' METASTATIC, "l-" INVASIVE. "X-" OTF BFG43506 O' ^i *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: <041 DATE OF DEATH: 09/15/a? SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL S STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / H1ST0PATH0L0 EPIDIOYMIDES .................................................................................................................................................................................................................... MICRO: H1ST0PATH0L06ICAL COMMENT: >ONE PRESENT LIVER .................................................................................................................................................................................................................................. MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZO -MINIMAL NOSF/tURB SEC 1 .................................. MICRO: 'MINIMAL -HEPATOCYTES CENTRILOBUIAR: HYPERTROPHY -NASAL MUCOSA (VESTIBULAR); SUBACUTE (CHRO CHRONIC INFLAMMATION NOSE/TURB SEC 2 ................................. MICRO: -MINIMAL -NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CH CHRONIC INFLAMMATION -MINIMAL -OOONTOPATHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES MAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, FPlDlDYHtOES. MONEYS, LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 3, NOSE/TURB SEC 4, PITU1 PROSTATE GLANO, SEMINAL VESICLES. tESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASTAUC, 1-" INVASIVE, 0 BFG43507 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWQ-GENEftATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RAIS INDIVIDUAL ANIMAL OATA SHEET STL ANIMAL NUMBER; 4043 DATE OF DEATH: 09/15/97 SEX: KALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACF STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT: organ name * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS FHfE'IfJCT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES LIVER , . , LUNGS .... MAMMARY GLANDS NOSE/TUKB SEC t HOSE/TURB StC 4 PROSTATE GLAND MICRO: MICRO: MICRO MICRO MICRO MICRO MICRO: HI5T0PATH0L0GICAL COMMENT: 'MINIMAL -MINIMAL, FOCAL MINIMAL -MINIMAL, FOCAL -TISSUE MISS IMG -MINIMAL -MINIMAL -MINIMAL -MINIMAL, FOCAL >0NE PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NGN-20NAI -BASOPHILIC FOCUS HEPATOCYTES CENTRlLOBULAfi; HYPERTROPHY 'PULMONARY VESSELS: MINERAL DEPQSIT(S) -NASOLACRIMAL DUCT(S): INFLAMMATORY CELLS/CEI -NASAL MUCOSA (OLFACTORY): EP1THFIIUH-INTRAC' EOSINOPHILIC MAIERIAL -NASAL MUC05A (OLFACTORY): BASOPHILIC HATERL -ALVEOLAR LUMENS; CORPORA AHYLAC1 A./MINEPALIZ '** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED **' THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING 6L. EPiOIOYMlOES. KIDNEYS, NGSE/TUR6 SEC 1. NOSC/TURfi SEC 3, PITUITARY GLAND, SEMINAL VESIC TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, INVASIVE, "X-" OTH BFG 003639 Cd O U\ O oo *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET < ANIMAL NUMBER' 4045 DATE OF DEATH: 09/15/97 SEXi MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SI STUDY OAT OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAHE * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLO( EPIDIDYMIDES GROSS: MICRO: GROSS/HJCRO CORR MICRO; -SNAIL, -SEVERE SLIGHT Hl&TOPATHOLOGICAL COMMENT: KIDNEYS MICRO: -MINIMAL, FOCAL LIVER MICRO; -MINIMAL -MINIMAL, FOCAL -MINIMAL, FOCAI, -MINIMAL LUNGS MICRO: -MINIMAL, FOCAL MAMMARY GLANDS MICRO: -TISSUE MISSING NOSE/TURB SEC 3 MICRO: -MINIMAL TESTES GROSS: -SHALL, SLIGHT MICRO: -SEVERE BOTH ASPERMJA TESTES: SMALI/TUBULAR DEGENERATION EPID1DYM10ES: SMALL/ASPERMIA TUBULES DILATED HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZOI ACUTE/SUBACUTE INFLAMMATION AClOOPMll1C FOCUS HEPATOCYTES CENTRROBULAR: HYPERTROPHY PULMONARY VESSELS; MINERAL DEPOSIT(S) NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA BOTH TUBULAR DEGENERATION THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, NOSE/TURB SEC 1, N0SC/TUR6 SEC 2, NOSC/ftfRfi SEC 4, PITUITARY GLAND, PftOSTAlE GLAND. 5! TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. **B-M BENIGN, "S-" METASTATIC. "[" INVASIVE, "X-" 01 BFG 003640 03 o 4^ U) L/i O *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION tWQ-GtNERATION REPRODUCTION and developmental toxicity study IN CO RATS INDIVIDUAL ANIMAL DATA SHEET $Tl ANIMAL NUMBER; 4046 DATE OF DEATH: 09/16/97 SEX; HALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERHINAL SACf STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH; IS TERMINAL BODY WIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS TREE-TEXT COMMENTS / HI510PATH0LDGK EPIDIDYMIDES KIDNEYS . . MICRO: HIST0PATH0L0G1CAL COMMENT; >ONE PRESENT MICRO: -MINIMAL, FOCAL......................................................... -CORTEX;'INFILTRATES SUBACUTE LIVER MICRO: -HtNlHAl -minimal, focal MINIMI NOSE / HJRfi Sf f l It RO NQM/tl'Rfl Ml I It no ; N ( "4 , 'HEPATOcyTES: CYTOPLASMIC VACUOLES (NON-ZONAl -BASOPHILIC FOCUS -HEPATOCYTES CENTR|LOBULAR: HYPERTROPHY MASAI IUH(N f Rf F (RYlHROCYTCS NA^OiAlRlMi DtK 1 11MPHOIO HYPERPLASIA MlNAi mA`i (] **.#*, P / *1 I n( (OimwINL M'.s.a1! Nti (OAGUlA11 m, U I'ijMMP.ji', -t- j > . 0*MiID itwiH iuANQV NOSE/lURB SIC l, NOU/tURB Ml 4. PITUMARY GLANQ. PIOSUU GLAND. *j|*1 RAF HMLlIS l|Uh, IRACHtA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-'* BENIGN. "S-" HElASlAlIC. "I-" INVASIVE, HX-" OTHI *** PAIh/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-6ENftATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 4047 DATE OF DEATH; 09/16/97 SEX: MALE OQSE GROUP: 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SAi STUDY DAY OF DEATH: 120 STUDY WEEK OP DEATH: IB TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS TREE-TEXT COMMENTS / HISTQPATHOIOG EPIDIDYMIDES ........................................................................................................................................................................................................................ MICRO: HISIOPATHOLQGICAL COMMENT: 'ONE PRESENT LEVER ...................................................................................................................................................................................................................................... MICRO; -MINIMAL -HCPATOCYTCS; CYTOPLASMIC VACUOLES (NON-ZQN. -MINIMAL, FOCAL -ACUTE/SUBACUTE IHFLAMHATIOM -MINIMAL, FOCAL -ACIDOPHILIC FOCUS -MINIMAL -HCPATOCYTES CENTR!LOBULAR; HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAO HQ MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING G| r EPIDlOYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, N0SE/TUR8 SEC 1. NOSE/TURB SEC 2, NdSf/TI NOSE/TURB SEC 4, PITUITARY GlAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN, METASTATIC. "I-" INVASIVE, "X-" OTI BFG 003642 W o path/tox srsTtn output *** VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION ANQ DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER: 4049 DATE OF DEATH: 09/16/97 SEX: HALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACfl StUOY DAY Of DEATH: 120 STUDY WEEK OF OEATH: IB TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS *** KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TCKT COMMENTS / HISTOPATHOLOGIC EPIDIDYMIDES .............................................................. ............................................................................................................................................................ MICRO: H1STOPATHOLOGICAL COMMENT: >ONE PRESENT LIVER ............................................................................................................................................................................................................................................ MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL -MINIMAL, FOCAL -MINIMAL -CLEAR CELL FOCUS -HEPATOCYTES CENTRIL06ULAR; HYPERTROPHY NOSE/TURD SEC 3 .................................................................................................................................................................................................................... MICRO; -MINIMAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA *** ANIHAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. KIDNEYS. LUNGS. HAHNARY GLANDS, NOSE/TURB SEC 1, NQSE/TURfi SEC ?, NOSF/TUR PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "ft-" BENIGN, "5-" METASTATIC, "l-" INVASIVE. "X-" OTHE BFG 003643 % O & a so 1 1 CTl j 1 1 1 4' 1 bL a a. 4 11 41 l 1 * i ru a ^ 11 1J l 1 tfl r- id 44 l rt 0> 41 i rt 1 l l aw B 5 ! WlS w b1 w <. ab e! S1 I 4 WW*> ! VI f (0 4 24 4 1 1 1 1 1 i W1 b u 1 1* u.o_ in 1 1 w 4 u. 1 a 11 3b 1 U1 4 - _J ww 1 1 t/> 1 is 4 i to 4 S1 1 1 s4 ae EE ^5 1 UJ kX 1 Vv w 1O w <s X-- -- UJ zs Of yj X we o e 1 1 1 1 1 1 1 1 1 1 1 .j 1 oi X1 4-- 4 <i 0. 4 1 4 Irt 4 1 X1 1 i t * M z t z: VI tW S u X u X 4- CE Uj 1/1 1 E 11 1X > 1 kJ 1 UJ 1 UJ i/ 1 B* yj _i t 1i . t_l z 1< cA W 4 z ts O _> f 1 3X * 1 O-- J 1 UJ z t * trt I SB * ^ UJ > 1 1 (A W W1 4z 5 O -- w *l-t < VXI Xf O' < _l C=D 3 < 2p j i E 1-- u* 1 l a 11 k --1 --a t-- u v\ X 1 i 1 X1 *A x 1 ' WW ` u. u. Q w -- 1 1 tt X w-- ww * <j> a * i 5n CIHUJ a t-- s <-- MB w ! KJ t 4-- 1 1 4 1r 1 1 1 1 1 1 1 i 4-- Qzvia >- w ^ w > IJ z >uugw W W kJ 3 (A a <_> tA <_) i -- k H-- < 4) ac VI lOU t--*- X 3 S- A AfKh M* O wB 3 _ UlOh-^B <xa x we Ui 1-- _J i-x < V1E->X > >">B -- X ww OttXi-l i-- -- a. B kJ 4 < Ui -- 3= 4 u1 U. W 4 ^ ae 1 - 4 t la 1 Q W 4 ke 1 oe i lA i B I U V) I 4rt kb a1 e -g 41 u 4 Ul 4 w X ^ *~S 4 1 1 1 1 1 1 I 1 : M V) UJ ' C* a. i UJ E .A W -- UJ w e w *-- . J- S -- iUtrtZU S 'vfi- o w uj a w - we< o, ^ --CL lUIJUW r << t III ^ X M D 1^-1 4 0w *1 * ---- r? w BJ Bj A U <-- -- B 3^ < ** UJ E 4 v> Z US' . LaJ a ".EDO 3 a. -- 1 49 4 i x _>o (-- OHi- 4(J>> a. yj -- LifiO +e z 9 uh e BC e Ui 1K 1 oo 1 1 1 b-- 1 1 lA i 4 1 ; 1 M ' ^ s 'M V- M j rt " -to - M - * -- . w < --a -- (a e 1 1 ,t - * ae x S2 1 Ice 1 ' 4 4 . - * OB 4 1 wJ k ,: w> i ^ vl 4 a <* XS u 14 X 4 < 4 14 X *U ^ r a w _i M __14-- 4& -4 4a u 4 >- o -- X b- 0 o4 1 4 U mm 1 V7 V. --^a cv> Li. 1 9 1 *M 4 UJ 4 X W --1 5 '' a. uJ w^ 11 * > w 4 i < * kJ Z _i< 4 * 1i . aa V-- ---- j' -- .. -- rj f 2 1 1 *- 1 1 1 4rt 4 kb U. * ft -- 44 4 " 1 j O 1 ;4 1 aeO 1 * 4 .J JJ V C 4 4 ^ 1 fl B* w^ 1 Lft V> | 1 S< 4 4* X XX V z _ z * ..: a *- *XKX A _> 4 M4 4-- t--f 4--ft ^ bua 4 rTr -* 1 4' zzzz 4 .T3 P | 41I i --4 %4 1 ." k w 1 1 * * 473 m s 4 4 aK sz O ot 1 | (0 1 1 *U *u i *X X -- " X 1m '4 -- _ A -- 1 ** 1 A 4 a 1 i 4 < 4 TM "-- - lT < .' TM * a E a 4 XX Ui -- S ao 4 4 l 4 4 4 1 4 bQ 1W UJ 1 | 4X 4^ 4 z -4 4 > --- 4 j _ -- E - J1 D f 4 '* *- 0 OO -- ac 4 w w fc Z u. 1 we 4 b1 i s a_ >fid i ae w X w z A Z UJ 4 4 UJ X i 10 < z u3 _i 2 4 K * nA s v* 4 a ^1 4 u W 1 B4 1 4a 4 BFG43513 BFG 003644 *** PATH/TDX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STI ANIMAL NUMBER: 4052 DATE OF DEATH; 09/16/97 SEX; MALE DOSE GROUP: 4 SACRIFICE STATUS: SCMEOULEO, TERMINAL SAC! STUDY DAY OF DEATH: 120 STUDY MEEK OF DEATH: IB TERMINAL BOOT WEIGHT: ORGAN NAME "** PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREMEXT COMMENTS / HISTOPATHOLOGII EPIDIDYMIDES ......................................................................................................................................................................................................................... MICRO; HISTOPATHOLOGlCAl COMMENT: >QNE PRESENT GROSS/MICRO CORR .................................................................................................................................................................................................................... MICRO: HISTOPATHOLOGlCAl COMMENT: *TSTES; ENLARGED/TUBULAR DEGENERATION LIVER ........................................................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAl 'Minimal, focal -acute/subacute inflammation -MINIMAL, FOCAL -BASOPHILIC FOCUS -MINIMAL -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY NOSE/TURB SEC 3 .................................................................................................................................................................................................................... MICRO: -MINIMAL -NASOLACRIMAL DUCT: LYHPHOIO HYPERPLASIA PROSTATE GLAND ........................................................................................................................................................................................................................ MICRO; -MINIMAL. FOCAL -ALVEOLAR LUMENS: CORPORA AHYLAClA/NlNERAU2< TESTES ............................................................. .......................................................................................................................................................................... GROSS: -ENLARGED, SLIGHT -RIGHT MICRO: -MODERATE -TUBULAR DEGENERATION THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL. EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, NOSE/TUf PITUITARY GLAND, SEMINAL VESICLES. TRACHEA KEY TO NEOPLASMS; "H-" MALIGNANT, BENIGN, HS-" METASTATIC. "I-" INVASIVE, "X-" OTMI BFG 003645 CO o 4^ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 4054 QATE OF DEATH: 09/16/97 SEX; MALE OOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SJ STUDY DAY Of DEATH: 120 STUDY WEEK Of DEATH: IB TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOl EPIDIDYMIDES ................................................................................................................................................................................................................... MICRO; HJSTOPATHOLOGICAL COMMENT; >ONE PRESENT LIVER ................................................................................................................................................................................................................................. MICRD: -MINIMAL -HEPATQCttCS: CYTOPLASMIC VACUOLES (NON-ZOI MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL. FOCAL -CLEAR CELL FOCUS -MINIMAL -HEPATOCYTES CENTRIIDBUIAR; HYPERTROPHY "* ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL. EPIdIDYMIDeS. KIDNEYS, LUNGS, HAMMARY GLANDS. NOSE/TIJRB SFC 1, NDSF/TURB SEC 2. NOSE/' NOSE/TURB SEC 4. PITUITARY GLANO, PROSTATE GLAND. SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE, "X-" 0 BFG 003646 Cd o -p* LO LA t--1 LA *** PATH/TOX SYSTEM OUTPUT *** VINtl CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET STUD ANIMAL NUMBER: 4056 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: UQ STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 4 ORGAN NAME * * * patholdgy keywords. Severity, distribution observations * * * GROSS TREE-TEXT COHMENTS / HISTOPATHOLOGIC EPIDIDYMIDES KIDNEYS LIVER . . NQSE/TURB SEC 1 NQSE/tURB SEC 4 PROSTATE GLAND MICRO: MICRO: MICRO: MICRO: MICRO: MICRO: -MINIMAL, -MINIMAL -MINIMAL. -MINIMAL, -MINIMAL -MINIMAL, -MINIMAL, 'MINIMAL HISTGPATHQIGGICAL COMMENT: MINE PRESENT FOCAL......................................................-CORTEX: INFiLTRATES'SUBACUTE FOCAL FOCAL FOCAL FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-iONAL) "ACUTE/SUBACUTE inflammation -BASOPHILIC FOCUS ttEPArOCYTCS CINJRU09ULAR: HYPERTROPHY NASAL MUCOSA (RESPIRATORY); ACUTE/SUBACUTE IN -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYT EOSINOPHILIC MATERIAL -EDEMA *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO HlCftoSCOPJC ABNORMALITIES OBSERVED: COAGULATING 6L, EPIDIDYMIDES. LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 2, NOSE/TURB SEC 3. PITUITARY GLAND. SEMINAL VESICLES, TESTES, TRACHEA KET 10 NEOPLASMS; "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, INVASIVE. "X-" OTHtl BFG 003647 ttf a o -p* U) Os *** PA1H/10X SYSTEM OUTPUT *** VIMTL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 4058 DATE Of DEATH: 09/15/97 SEX: HALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL 5. STUDY DAY OF DEATH: 119 STUDY WEEK Of DEATH: 17 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOar OBSERVATIONS * * * KEYWOROS, SEVERITY. DISTRIBUTION GROSS fREE-TEXT COMMENTS / HlSTOPATHOLQi LIVER . . . , LUNGS . , . . HOSF/TURB SEC 1 NUSE/TURB SEC 4 MICRO: MICRO: MICRO: MICRO: -SLIGHT -MINIMAL. -MINIMAL -MINIMAL. -MINIMAL -MINIMAL. FOCAL FOCAL FOCAL 'HEPAtOCYTES: CYTOPLASHIC VACUOLES (NON-ZOI -BASOPHILIC FOCUS -HEPATOCYTES CENTRILQBULAR: HYPERTROPHY INTERSTITIUM: 5UBACUTE/CHR0NIC (NFLAHMATH NASOLACRIMAL DUCT(S); FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPITHELIUH-INTR, EOSINOPHILIC MATERIAL *** ANIMAL MAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES MAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. MONEYS, MAMMARY GLANDS. NOSE/TURd SEC 2. NOSE/TURB SEC 3. PITUITARY GL PROSTATE GLAND. SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, **!-" INVASIVE. "X-" 0 BFG 003648 W U> *** PATH/TOX SYSTEM OUTPUT "** VINYL CHLOftIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STI ANIMAL NUMBER: 1060 DATE OF DEATH: 09/15/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: ORGAN NAME * * * pathology KEYWOROS, SEVERITY, DISTRIBUTION observations * * * 6R0SS FREE-TEXT COMMENTS f HISTOPATHOLOGK LIVER ................................................................... MICRO: -MINIMAL `MINIMAL, FOCAL -MINIMAL NOSE/TURB SEC 1 ........................................... MICRO: -MINIMAL NOSE/TURB sec 2 ........................................... MICRO: -HIHIHAL -MINIMAL PROSTATE GLAND ................................................ MICRO: 'MINIMAL, FOCAL ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED "* -HEPATOCYTES; CYTOPLASMIC VACUOLES (N0N-20NAI -ACIDOPHILIC FOCUS -HEPATOCYTES CENTRI LOBULAR: HYPERTROPHY -NASOLACRIMAL DUCT(S): EOSINOPHILIC MATERIAL :NASOLACRIHAL OUCTtsj; INFLAMMATORY CELLS/CEl -NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHRQI CHRONIC INFLAMMATION -AtUTE/SuBACUTE INFLAMMATION THE FOLLOWING TISSUES HAD HO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING 61. EPIDIDYMIDES, KIDNEYS. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 3. NOSE/TURB SEC A. P1TUITAI SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE, "X-" OTH BFG 003649 % o LP oo ANIMAL NUMBER: 4062 DATE OF DEATH: 09/15/97 ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST SEX; MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY OAY OF DEATH: 119 STUDY WEEK Of DEATH: |7 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATMOLOGI JtK ............................................... ..... .......................................................................................................................................... ............................................................. MICRO: -MINIMAL -HEPATQCYTES: CYTDPIASMIC VACUOLES (NON-ZONA -MINIMAL -HEPATOCYTES CENTRUOBULAR: HYPERTROPHY ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD No MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2. NOSE/TL NOSE/TURB SEC 4, PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESlClFS. TESTES. TRACHEA KEY 10 NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "5-" METASTATIC, INVASIVE. "X-- OTH BFG 003650 cd *T\ o *** PATH/TQX SYSTEM OUTPUT *** V|NY\. CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXlClTr STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER; 4064 OATE OF DEATH: 09/15/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACfi STUDY DAY OF DEATH: 119 STUOY WEEK OF OEATH: L7 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC ADIPOSE TISSUE GROSS: MICRO: GROSS/MICRO CORR . . MICRO: LIVER NIC AO l I!N(jS NOS!,1Uft VI ( N 1. * I - > -NODULE(S)/MASS{ES) -MODERATE, FOCAL HJJTOPAfHOLUGiCAL hHiIsStToOpPaAttHhOoLlOoGgilCcaAlL MINIH4I m ilhai l;H A, mi:hii .> A, COMMENT: -MASS: PERITONEAL CAVITY. 1.0 CM DIA, WHITE. -ECTOPIC EPIDIDYMIS 'ADIPOSE TISSUE; NODULE/ECTOPIC EPIDIDYMIS HFPATOCYTfS CYTOPLASMIC VACUOLES INON-ZONAl Ai Ul I / SUMCUl ( I NT L AHHAT ION M|PAOOtfS (miRHOBULAR HYPERTROPHY 0`,M Qy*) NJ 'AH AMR NASA: mrtOSA (QMAUufl!) AASOPHllIC NAHA|) !H< FOt(UW|!*U M > .i<( V h*c *0 M|, u .1. uf ; i AMoMMA, MIC COAGULAl (NO <( (PlDID'MUMS t|C4HT. NAMUR! UARDS. NOSl/lURBSl PITUITARY GLAND. PIOSfAII GlANO. SIHLNAl WESIClES. TESTES. TRACHEA KEY TO NEOPLASMS: "M'" MALIGNANT. BENIGN, "S-" METASTATIC. MJ-" INVASIVE, "XH OTHI BFG 00365 CO n a f- Lyi to O * * * PATH/TQX SYSTEM OUTPUT * * * VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITT STUDY IN CO U T S INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 380 STUDY NUMBER: 9G40SOA i i * in X x uj u b. o < VI 1 b-- -J X z-- UJ ^ *-a .s a UJ -_l ^4 2* e-- UJ x IB UlS>UUJ- ,, in 4 *- VI *> T--1 UJ U -- a; u,,^ --4 S t_a UaJ 4 trt Ll, O 14 UJ UJ 3 V >a a a. a <n a a a u lOS>'O*i 0*4 I z 1-- 4 u a u. a iw>> _J 4 5 ..a >o UilGrt P*. A VI u> -- 35 4o x li.il-> m c X ui ao u. JO 4 Ziu >- *53 I j i 1 lA l r i V\ &1 *i Urn 1 4 u> i i ' J * Ii -- 4 XJ &: bi vw* tf 3: *1 Sa | *1 J * v* r I-- 1 X1 (X) 1 ; XO (J e t-- X UJ >- h-1 1 < i 1 1 1 4 LU 1 M' af i U- 1 <n UJ i/* 1 1 l OI (AS 1 01 09 *^ < s -Xi 1 5(O. Xi 4 l3A (fl W J s K i-- IE U 5 a? 4k * > 0 ---K u^4 z-- 4is-J to # m -4.4 0 ^ .J Ckk-- O : tE z ><_>ujuj 4 <_) a IAIJVI ' Uj 4 uj J-- 03 1-- *UlAU o^e k> LUi-- 4 i-4 a. 3 a. lUUJJ t43I 1 1 iLac. 1U 4 ' a -i-- O -a nz_ V J 1- (_] 3 -a --< 4 X -- &r U * ^ 0 tn <4 4 '1 0 1 1 x- 1 t t0 1 e ! ^ JN- 3 c? | 1 * 1 XX 1 N- 1 1-- Vi H1 a 1 1 B. v 1 ^J ^1 * cz1 1 UJ 1 WI M1 1 V? 1 O1 3! 2: Ui 1 *1 _l 4 U 0 Lh -- ^ ^ _j >424c4x -4 -e U. -- < -4E C kx >z EEZ -Z iii 1 1 j j ac i u 1 1 E r 1 i 1 J j Ui > X1 < Xt 1 z 1s X 1w f> C 1 -- O O 4 v Z r 0 UJ i/> 0 a a r* w in O a 4 + LkJ 0E UJ VI a3 O U*( UJ -- _i tXt 0 X C Vi VI AC 0 0 t*rt X X & * 4 4 u UJ lA cp ac a -*-- Ui c/t E^S z N U UJ V) A 3 u v"> 0 A k k--1 u UJ i/1 a Of 2 *-- UJ 4 t/1 UJ t=>3: a0 4 >ee aa ujX X Ul oe uj UJ 19 t-- vrt tr) 0 ^ UJ 1 tth- 4 - WSlA ^ 4 UJ k-- I --J r-i LI ClAlA E 19 UJ tf X 09 * --1 n4 4 >4 wl M U> >- X m UJ LM 00 CJ" (AUp OZ *4 (JW7.J -- U (S za _ ui Btu *. ?- 4 {JiO--lA *ii VY W Ui a 'Q -rJ as VA 15 H tp -- >* ^ CE --10 3 J<OO -- U- I_1 0- LU X k- 1 f f > ] * 1 1 1 1 1 r I 1^ 1 j 1 1 1 f u/ 1 M- 11 l *1 * f I fa UJ 1^ 1 1* 1^ <i yXa sf - ( tl l 1 jm (J t N- 1< < # t/1 1* 1 - J UJ 1f 1 f* (1 < VI 11 i 1 1 1x 1 i *44 'z I Ui ^ A ^a I4 1 CO 1 1 1 ja 1 t-- I 1\ x< X r l3 f ^4 t j 1C X j T 11 X I 1 1 V* ix 1 tjfl * 1 _J 1 '1 B&- LkJ l1 X 1 1 -* r 1 uj < 1 1 1 1t r I l J 1 1 11 i I 1 s ! BFG43521 BFG 003652 *** PATH/TOX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STI ANIMAL NUMBER: 400 DATE OP DEATH; 09/15/97 SEX; MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACJ STUOY OAY OF DEATH; 119 STUDY WEEK Of DEATH: 1? TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FAEE-TEXT COMMENTS / HISToPATHOLOGlI KIDNEYS . . . MICRO; LIVER . . . . MICRO: -MINIMAL -MINIMAL LUNGS . . . . NQSE/TURB SEC 3 MICRO: -MINIMAL HJSTOPATHOLOGICAL COMMENT: ONE PRESENT 'HEPATOCyTES: CYTdPiASMIC VACUOLES (NON-ZONAI -HEPATOCYTCS CENTRILOBULAR: HYPERTROPHY HISIOPATHOLOGICAL COMMENT: >ONC LOBE PRESENT HISTOPATHOL0GICAI COMMENT: >ONE LOBE PRESENT -NASAL MUCOSA (OLFACTORY): tPlTHEUUM-INTRAC' EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAO MO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL, EPIDIDYMIDES, KIDNEYS, LUNGS. MAMMARY GLANOS. NOSE/TURB SEC 1, NOSE/TUftB SEC 2, NOSE/TUI PITUITARY GLAND, PROSTATE GLAND. SEMINAL VESlCUS, TESTES. TRACHEA KEYTONE0PLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "1-" INVASIVE. 4`X-H OTW ta 3 rti G -pu> Lr\ to to 003653 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY [N CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 4070 DATE OF DEATH: 09/15/97 SEX; MALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED. TERMINAL S' STUDY DAY OF DEATH; 119 STUDY WEEK OF DEATH; 17 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GRDSS PREE-TEXT COMMENTS / HlSTOPATHQLOl KIDNEYS LIVER I UNUS POOS T A f Ul NN.l MICRO; -MINIMAL, FOCAL........................................................ -CORTEX: '1NFRTRATES' SUBACUTE HISTOPATHOLDQICAL COMMENT: ONE PRESENT MICRO; -MINIMAL -MINIMAL, M1M|HAI FOCAL MI % r0PA I HQ( Oli | ( A( ronMf NT `HEPATOCYTES: CYTOPLASMIC VACUOLES (HON-ZOI -ACUTE/SUBACUTE INFLAMMATION -MfPATOCYTfS CENTRILOBULAR: HYPERTROPHY -ONF LOPF PRESENT | I U P * I HO i 0 I I *. < O* I N I -0l l06 E PRESENT N| . HI | N I *1, 1 ,] 1 A l V | f) l A l ijAINS (OfiPORA ANTI ACI A/MINtRAL *** ANINAi HA1, AO 0,-, UAK'iJ'lli **' inf louONlku IlssulS MAO NO 11 10i Uf I (. A6N0*AllUES OBSERVED COaCOL A ( jnu fci. (PIDIDTMIDES. UMfcS. mamkaRv UAnOS, NQSE/IURB SfC 1. NOSE/TURB SEC 2. NOSE/TURB SEC NOSE/TURB SEC 4. PITUITARY GLANO. SEMINAL VESICLES. TESTES, TRACKLA KEY TO NEOPLASMS; MALIGNANT, "0-" BENIGN. "S-M METASTATIC, "I-" INVASIVE. "X-" 0 BFG 003654 to 3 Q L/1 TO **" PATH/TOK SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS individual animal data sheet stu ANIMAL NUMBER: 4071 DATE OF DEATH: 09/25797 ORGAN NAME SEX: MALE DOSE 6A0UP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR STUDY DAT OF DEATH: 119 STUDY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS TREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS ....................................................................................................................................................................................................................................... LIVER MICRO: HISTOPATHOLDGICAL COMMENT: >0N PRESENT ........................................................................................................................................................................................................... -........................... MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMICVACUOLES (NOR-ZONAL -MINIMAL, FOCAL -ACIOQPHILIC FOCUS -MINIMAL. MULTI-FOCAL -BASOPHILIC FOCUS -MINIMAL -HEPATOCYTES CENTRILOBULAR;HYPERTROPHY HISTOPAtHOLOGICAL COMMENT: >ONE LOBE PRESENT IUNGS ..................................................... HisfoPATHOLOGiCALCOHMENT: ONE LOBE PRESENT NOSE/TURB SEC Z ............................. MICRO: `HINIHAl -VOMERONASAL ORGAN: FREE ERYTHROCYTES NOSE/TURB SEC 3 ............................. MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY):'EPITHtliuM-iHTRACY EOSINOPHILIC MATERIAL pituitary gland ........................................... MICRO: -MINIMAL, FOCAL -PARS iNTERMEOU: CYST(S) "** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: iifwir ,Tiinn r,,, * .nnct.Tt COAGULATING 6L. EPIDIDYMIDES. KIDNEYS. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 4, PROSTATE SEMINAL VESICLES, TESTES, TRACHEA KEV TO NEOPLASMS: "M-" MALIGNANT, BENIGN, *V" METASTATIC, "1-'* INVASIVE, "X-M OTHE PATH/TOX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED JNHALATJON TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET ANIMAL NUMBER: 4072 DATE OF DEATH: 09/16/97 SEX; MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL Si STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HlSTOPATHOLOl SIDNEYS LIVER MICRO: MICRO: -MINIMAL `MINIMAL LUNGS .................................................... NOSE/TURB SEC 2 ............................ MICRO: -MINIMAL HjsTOPATHOLOGiCAL COMMENT: >ONE PRESENT -HtPATOCYTES: CYTOPLASMIC VACUOLES (NflN-ZOI -HEPATOCYTES CfNTRlLDBULAR; HYPERTROPHY HISTOPATHOLOGICAL COMMENT: 'ONE LOSE PRESENT HiSTOPAiHOLOGiCAL COMMENT: 'ONE LOBE PRESENT -NASOLACRIMAL DUCT(5j: FREE ERYTHROCYTES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1 PITUITARY GLAND, PROSTATE GLAND. SEMINAL VESICLES, TESTES. TRACHEA NOSE/TURB SEC 3, NOSE/ KEY TO NEOPLASMS: "H-" MALJGNANl, "fl-" BlNJGN, "S'" METASTATIC. "l-" INVASIVE, "X-" 0 BFG 003656 % O U-J O' O' *** PATH/TOX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND developmental TOXICITY STUDY IN CD RAYS INDIVIDUAL ANIMAL DATA SHEET STU[ ANIMAL NUMBER: 40/3 DATE OF OEATH: 09/16/9? SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRl STUDY DAY DF DEATH: 120 STUOY WEEK OF DEATH: IB TERMINAL BODY WEIGHT: ! ORGAN NAME - * PATHOLOGY OBSERVATIONS * * * REWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC MONEYS . , , MICRO: H1ST0PATH0L0G1CAL COMMENT; >ONE PRESENT LIVER .. ,,. MICRO: -MINIMAL ....................................................................... -HEPATQCYTES: CYTOPLASMIC VACUOLES'(NON-ZONAL] LUNGS -MINIMAL -HEPATOCYTES CENIRUOBULAR: HYPERTROPHY HIST0PATH0L0G1CAL COMMENT: >QKE LOBE PRESENT ., .. ................................................HisTOPATHOLOGICAL COMMENT; >ONE LOBE PRESENT NOSE/TURB SEC L MICRO; -MINIMAL -VOMERONASAL ORGAN: PREC ERYTHROCYTES NOSE/TUR0 SEC Z MICRO: -MINIMAL ....................................................................... -VOMERONASAL ORGAN- FREE ERYTHROCYTES NOSE/TURB SEC 3 MtCRO: -MOOERAtE....................................................................... :NASAL'LUMEN: FREE ERYTHROCYTES NOSE/TURB SEC 4 MICRO; -MODERATE -MINIMAL -MINIMAL. FOCAL -NASAL LUMEN: FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACY1 EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERlAl *" ANIMAL HAS NO GROSS ABNORMALITIES 06SERVE0 "* THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING Gl, EPlOtOYMlDES. KIDNEYS, LUNGS, MAMMARY GLANDS. PITUITARY GLAND, PROSTATE GLAND, SEMINAL VI TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. `'B-" BENIGN, HSH METASTATIC, "l-M INVASIVE, "X-" OTHfF CO o cd n O g6 u\ to s| Ov *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWQ-GENFRAT|0H REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 4Q/4 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL 5 STUDY DAY OF DEATH: 120 STUOY WEEK OF DEATH: Ifl TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / MSTOPATHOLO KIDNEYS , . . MICRO: -MINIMAL -PELVIS: FREE ERYTHROCYTES HISTOPATHOLDGICAL COMMENT: >QNE PRESENT LIVER . . , . MICRO: -MINIMAL ...................................................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZO LUNGS . NOSE/TURB ... SEC 3 MtCftO; -MINIMAL, -MINIMAL -MINIMAL, FOCAL -CLFAR CELL FOCUS -HEPATOCYTES CtNTRlLO&ULAR:HYPERTROPHY HISTOPATHOIOGICAL COMMENT; >ONE LOBE PRESENT MISTOPATHOLOGICAL COMMENT; >ONE LOBE PRESENT FOCAL.........................................................-NASOLACRIMAL DUCT^ LYMPHOID HYPERPLASiA -MINIMAL. FOCAL -NASOLACRIMAL DUCl(S): FREE ERYTHROCYTES NOSE/TURB SEC 4 MICRO:'-MINIMAL, FOCAL........................................................ -NASALMUCOSA (OLFACTORY):`BASOPHILIC MATE *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING 61, EPIDIDYMIDES. LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 2, PITUITARY GLAN PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "1-" INVASIVE. "'X-" 0 CO 3 Cl 2 o La> TO <1 003658 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLOfitOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 4076 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: IS TERMINAL BOOT WEIGHT: A ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS MICRO: HISTOPATHOLOGICAL COMMENT: LIVER MICRO: -MINIMAL -MINIMAL, FOCAL -MINIMAL HISTOPATHOLOGICAL COMMENT: LUNGS .... ............................................... HisioPAiHOLOGiCAL comment! nose/turb SEC 2 PROSTATE ALAMO MICRO: MICRO; -MINIMAL -MINIMAL. FOCAL >ONE PRESENT HEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZONAL) -BILE DUCT/BILIARY EPITHELIUM; HYPERPLASIA -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY >ONE LOBE PRESENT iONE LOBE PRESENT -NASOLACRIMAL DUCUS); ` INFLAMMATORY CELLVCELL -ACUTE/SUBAtUTE iNrLAHHATI ON...................................... *** ANIMAL MAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMAL 1TIES OBSERVED: COAGULATING GL EPIDIDYMIDES KIDNEYS. LUNGS. MAMMARY GLANDS. NOSE/TURB SEC l. NOSE/TURB SEC 3. NOSE/TURB PITUITARY GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY 70 NEOPLASMS: HM-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE, "X-" OTHER BFG 003659 CD UJ Ui K) OO *** PATH/TOX SYSTEM OUTPUT *** VINYL CNL0RI0E COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET ANIMAL NUMBER: 4077 DATE OF DEATH: D9/IB/97 SEX: HALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL S STUDY PAY OF DEATH: 120 STUDY WEEK OF DEATH: IB TERMINAL BOOY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * 4 4 GROSS TREE-TEXT COMMENTS f HISTOPATHOLO' KIDNEYS .. MICRO: H]STGPATH0L0G1CAL COMMENT: 'ONE PRESENT LIVER .. .. MICRO: -MINIMAL, FOCAL' * -CLEARCElL FOCUS LUNGS -MINIMAL -HEPATOCYTES CENTR1L0BULAR: HYPERTROPHY HISTOPATHDLOGICAL COMMENT: >ONE LOBE PRESENT ., , , .............................................HiSTOPATHQLOGiCAL COMMENT: 'ONEIQBE PRESENT NQSE/TURB SEC 2 MICRO:'-HINIMAL ...................................................................... -VOMERONASAL ORGAN: FREE ERYTHROCYtfS -MINIMAL -NASOLACRIMAL DUCKS): FREE ERYTHROCYTES N0SE/TUR8 SEC 3 MICRO:'-MINIMAL ................................................................... -NASOLACRIMAL DUCT: LYMPHQID HYPERPLASiA NOSE/TURB StC 4 MICRO: -MINIHAL ...................................................................... -MASAI 'MUCOSA (OLFACTORYj; EPITHEllUM-INTR EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMAL IT1ES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING Gl , EPIDIDYMIDES, KIDNEYS. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, PITUITARY GLAND, PRQST SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE, "X-" 0 BFG 003660 cd o *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENCRATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STl ANIMAL NUMBER: 4079 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACl STUDY DAY OF DEATH: 120 STUDY WEEK OF DEATH: 18 TERMINAL BODY HEIGHT: ORGAN NAME **" PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTOPATKOLOGK KIDNEYS LIVER 1 UNGS NOSE / T l.i B 0 Mi MOSi/luftA Vi MICRO: -MINIMAL. FOCAL -CORTEX: INFILTRATES SUBACUTE HISTOPATHOLOGICAL COMMENT: >ONE PRESENT MICRO: 'MINIMAL -MINIMAL. -MINIMAL FOCAL HmoPAiHoinGirAi -HEPATOCYTES: CYTOPLASMICVACUOLES (NON-ZONAI -CLEAR CELL FOCUS -HEPATOCYTES CENTR|LOBULAR;HYPERTROPHY comment: >onf lobe Present \ 11 Li i H|'. Ill lIu'i l**0 01,11 *;*i***i >i UMMU1 Mint l OBI POE St N F ............ MV.KHNINM 0W.1 l TMPhOID nrp[pLA5IA M'.*J Hixns* [ Ot F A( TORT) BASOPHIL 1C MATERU AH|HA| has HOi.Bii.', ANNINA, i t . o8\t**U THE TOLL (MMG F | SSsM \ "*0 NO BKIOSLliAll AMOMAl I 1 I ( S QO'jIRUD COAGULATING GL IPIOIDYMIDIS LUNGS NAMMART GLANDS. NOSC/lURB SEC I, NOSE/IUHfl SIC 2. PIlUHARY GLAND PROSTATE GLANO. SEMINAL VESICLES, IESIES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT. "8-" BENIGN, "S-" METASTATIC, "l-'* INVASIVE. "X-" OTHI CD O CO m O o o w UJ O' O' UJ O *" PATH/TOX SYSTEM OUTPUT " VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TONICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET 5 ANIMAL NUMBER: 4061 DATE OF DEATH: 09/16/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF OEATH: 120 STUDY WEEK OF DEATH: 18 TERMINAL BOOT WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHQLOG KIDNEYS . . . MICRO: LIVER . . . . MICRO: LUNGS .... NOSE/TURB SEC 1 MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 3 MICRO: -MINIMAL -MINIMAL -HINTMAI -MINIMAL, -MINIMAL -MINIMAL -MINIMAL HisTOPATHOLOGICAL COMMENT: HtSTOPATHOLOGlCAL COMMENT: H[S HlpAiHtiLUtj 1 (-At COMMENT: FOCAL >ONE PRESENT NEPATQCYTES: CYTOPLASMIC VACUOLES (N0H-2CH -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY ONE LOBE PRESENT >ONE LOBE PRESENT :NA5AL MUCOSA (RESPIRATORY): GOBLET CELL'hY. -DOONTOPATHY -NASOLACRIMAL OUCT(Sj: MUCOSA-SUBACUTE'(CHRi CHRONIC INFLAMMATION -odontopathy NASAL LUMEN: FREE ERYTHROCYTES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING Gl, EPIDJOYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 4, PlTUITARy GLAND, PROSTA SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S'" METASTATIC. INVASIVE, "X-" OT BFG 003662 3 O 5 u\ Lp *** PAtH/fOX SYSTEM OUTPUT *** vinyl chloride cmewed inhalation M-GEHmUOH REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $Ti ANIMAL NUMBER; 1531 DATE OF DEATH: 10/01/9/ SEX: FEMALE OD$E GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: 135 STUDY WEEK OF OEATH: 20 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HlSTOPATHOLOGU LIVER . . . . MICRO; -MINIMAL NOSE/TURB SEC 2 MICRO: -MINIMAL NOSE/TURB SEC 3 MICRO:'-SLIGHT* -MINIMAL N05F/TURB SEC 4 ............................ MICRO: -MODERATE -SLIGHT UTERUS .......................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -NASOLACRIMAL OUCT(S): FREE ERYTHROCYTES -NASAL LUMEN; FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPITHEUUH-1NTRAC EOSINOPHILIC MATERIAL -NASAL LUMEN: FRtE LRtlHftOCYTES -NASAL MUCOSA (OLFACTORY): tPIIHELIUM-IHTRAC EOSINOPHILIC MATERIAL -RIGHTrS; LEFT:/ -LUMEN: DILATED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNQS, MAMMARY GLANDS. NOSE/TURB SEC 1, OVARIES, OVJDUCTS/FAIQP T. PITUITARY GLAND, TRACHEA. V KEY TO NEOPIASHS: "H-" MALIGNANT, "B-" BENIGN, HS-" METASTATIC, "1-" INVASIVE. 'X-" OTM BFG 003663 CD 3j o U) ro *' PATH/TO* SYSTEM OUTPUT *** VI MTU CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1533 DATE OF DEATH: 10/02/97 SEX; female dose GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL Si STUDY OAY OF DEATH; 136 STUDY WEEK OF DEATH: ?0 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOL0I LIVER . . . UTERUS . . . MICRO: -MINIMAL minimal, focal GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZOI -ACUTE/SUBACUTE INFLAMMATION -RIGHT:?; LEFT:9 THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMAL IT IFS OBSERVED: KIONCYS. JUNGS. MAmMABV UANOS. MSl/lUflB SI C I, NUSf/TU0 SEC 2. NOSE/lURB SEC 3, NOSE/TURB SEC 4. O' OVIOUCTS/MIOP I PMUllAlr Ul A*D 1 NA[ hi A uUlUV VAGINA i|T I .,*1**|I ft ft | i> lUH \ " Ml I A', 1AI It. . "] " lAVASIVE, "K-'`0: BFG 003664 to O -Pi u> Lh Oj U> *** PATH/TGX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 153S DATE OF DEATH: 10/02/97 SX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUOY OAY OF DEATH: 135 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * h PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTOPATHOLOGl LIVER . . . LUNGS . . . NOSE/TURB SEC NOSE/TURB SEC NOSE/TURB SEC . MICRO; -MINIMAL -MINIMAL, , MICRO: -MINIMAL I MICRO: -MINIMAL 2 MICRO: -SEVERE' -MODERATE 3 ............................. micro: -Marked -MODERATE -MODERATE FOCAL HISTOPATHOLOGICAL COMMENT: -HEPATQCYTIS: CYTOPLASMIC VACUOLES (HON-ONA -ACUTE/SUBACUTE INFLAMMATION -PERIBRONCHIAL: LYMPHOCYTIC HYPERPLASIA -odontopathy...................................................................... -NASOLACRIMAL DUCT(S): MUCQ5A-SU8ACUTE (CHRQl CHRONIC INFLAMMATION -NASOLACRIMAL OUCT; EXUDATE >BACTERIAL COLONIES IN DUCT -NASQIACRIHAI DIJCT(S): HUCOSA-SUBACUTE (CHRQl CHRONIC INFLAMMATION -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASOLACRIMAL DUCT; EXUOATE VAGINA GROSS; -IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL MICRO: -SLIGHT RIGHT:5; LEFT :3 -MYOMETRIUM: BROUN PIGMENT MUCOSA: HYPERKERATOSIS (CORNIFIEO) THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, MAMMARY GLANDS, NOSE/TURB SEC 4, OVARIES. OVIDUCTS/FALOP T. PITUITARY GLAND. TRACHEA KEy'tO~NEOFIAsHs""',,H-'' MALIGNANT. BENIGN. "S-* METASTATIC, "I-" INVASIVE. "X-*' OTH BFG43534 *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1537 DATE OF DEATH: 10/04/97 SEX: FEMALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED. TERMINAL S STUDY DAY OF DEATH; 130 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT; Organ name * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GftOSS FReE-TEXT COMMENTS / HISTOPATHOLO KIDNEYS . . , LIVER . , , . NOSE/1URB SEC 1 MICRO: MICRO: MICRO- MINIMAL. FOCAL -MINIMAL 'MODERATE.................. -CORTEX; INFILTRATES SUBACUTE -NEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZO -NASAL MUCOSA (RESPIRATORY): ACUTE/SUBACUT -SLIGHT -NASOLACRIMAL DUCT: EXUDATE -MODERATE -NASAL LUMEN: EXUDATE NOSE/TUR0 SEC l MICRO-'-MARKED........................................................................... -NASOLACRIMAL DUCT(S); HUCOSA-SUBACUtE'(CH -MARKED CHRONIC INFLAMMATION -NASOLACRIMAL DUCT: EXUDATE NOSE/TURB SEC 4 MICRO: -MINIMAL.......................................................................-NASAL MUCOSA (OLFACTORY): BASOPHILIC. MATf UTERUS . . . . GROSS: IMPLANT SCARS - PRESENT -RiGHT:3; LEFT:5 THE FOLLOWING TISSUES HAD ND MICROSCOPIC ABNORMALITIES OBSERVE0: LUNGS, MAMMARY GLANDS, NQSE/TUR6 SEC 3. OVARIES, OVIDUCTS/FALOP T. PITUITARY GLAND, TRACHEA, UTtRUS, KEY TO NEOPLASMS: "H-" MALIGNANT, "B" BENIGN. METASTATIC. "J-" INVA5IVE, "X-" 0 BFG 003666 oa a ft *** PATH/TOx SYSTEM OUTPUT VlHYl CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET 5TUC ANIMAL NUMBER: 1530 DATE OF DEATH; 09/Z9/9? ORGAN NAME SEX; FEMALE DOSE GROUP; I SACRIFICE STATUS: SCHEDULED. TERMINAL SACftl STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BODY WEIGHT: 3 * A It PATHO LOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS 1 HISTOPATHOLOGIC LIVER . . UTERUS . . VAGINA . . MICRO; 'MINIMAL GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL MICRO: -TISSUE HISSING -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAl) -RIGHT:4; LEFT :9 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS, NQSE/TURB SEC 1, NQSE/TURB SEC 2. NOSE/TURB SEC 3, NDSE/TURB SEC 4, OVARI OVIDUCTS/FALOP T, PITUITARY GLANO. TRACHEA KEY TO NEOPLASMS; "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "l-" INVASIVE, "X-" QTHEf BFG 003667 tti T) Q On *** path/tox system output "** VINYL CHLORIDE COMBINED INHALATION 1W0-GENERATIDN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1539 DATE OF DEATH; 10/02/97 SEX: FFMAIF DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL S STUDY DAY OF DEATH; 136 STUDY WEEK Of DEATH; 20 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHQLO UVER . . . , NOSE/TURB SEC 3 UTERUS .... VAGINA . , . . MICRO: MICRO: GROSS: MICRO: -MINIMAL -SLIGHT -IMPLANT SCARS -MINIMAL PRESENT -HEPATOCYIES: CYTOPLASMIC VACUOLES (NON-Z0 -NASOLACRIMAL DUCT: LYMPHOiDHYPERPLAsiA -RIGHT:4; LFT;6......................................................... -MUCOSA: HYPERKERATOSIS (CORNIFIEO) THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2 NOSE/TURB SEC A. OVARIES. OVIDUCTS/ PITUITARY GLAND. TRACHEA, UTERUS KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. `V" METASTATIC. "I-" INVASIVE, "X-" 0 BFG 003668 3 o S i_f\ u> W3H10 '3JIISVAII] ,,-l,, `3UV1SV12W ,,-S,, 'NDIN38 ` INVMQ11VW ,,*W.. JSHSVldOlN 01 A `0NV19 AWVlimid *1 dOIVJ/SlOfiaiAO 'SJUVAO VN l 33$ Mfli/JSON `T 33S 8tini/350N 'SONV19 ANVWHVH `S 03AH3S90 S3 I i 11VWH0N9V OldODSObOlH ON OVH S3flS 1N3H91d NftOUfl :wn]M13H0AHS:A331 ?6!iH9lb- 1V3QJ '1H9MS- :OW: lH353Hd - SMV3S INVldUl- = S$C IVIM31VH 3lllMd0Nl$03 DlHSVld01A3VUlNl-MniiaHl 1d3 i(AHOIDVJ'IO) VSOMUMVSVN- VISVldUBdJkH OlOHdMAl ;13na lVHlfl3yiO$VN` OVN02-N0N) S31003VA 3lH$V1dOiA3 :$JU30iVd3H- 1VH1N1H- :qm; 3VHINIW- :0; IVWINIH- `w: S9NJ0NJJ 3|SD10HiVd0i$lH / S1N3HH03 1X31-33M3 SSDH0 NOIindldlSlQ *A11V3A3S 'SQUMAft S N D 1 i V A N 3 S 80 A 9 0 1 0 1 V d * SHVH9 11H2 !1H9I3A AOOfl 1VNIHM31 61 'HIV30 30 Hmmvs lVNIMHJi '03in03H3S :snivis 331JIU3VS AttUS CCI 'Hi.V30 30 AVO AMIS T :dn0U9 3500 31VN3J ^X35 VOBOV98 :3WM AOfUS LSI :]9Vd B6'bdV-62 :03iNlbd 133HS VIVO lVNtNV lVnOUIONl Siva 03 Ml AOIUS AU3IX01 lViN3Hd013A30 onv NomnoQMd3S N0UVM3N39-QA1 N0UV1VHNI O3H10HO3 3Q|QlH3 lANlA ifid 100 H31SAS XOl/HIVd . It *** path/tox system output *** VINYL CHLORIDE COMBINED INHALATION TvO-GENtftATlON REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 1541 DATE OF OtAlH: 10/01/97 SX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS; SCHEDULED, TERMINAL S' STUDY DAY OF DEATH: 135 STUDY WEEK OF DEATH; 20 TERMINAL BOOY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HJSTOPATHOIOI KIDNEYS ... HICR0;'-MINIMAL,'fDCAL LIVER --,MICRO:'`MINIMAL -MINIMAL, FOCAL NQSE/TURB SEC 3 MICRO: -MINIMAL N0SE/TUR8 SEC 4 ................................ MICRO: -MINIMAL UTERUS VAGINA ............................................................................................................ GROSS: -IMPLANT SCARS - NOT PRESENT ............................................................................................................ MICRO: -TISSUE MISSING HiNERALiZED GRANULES -HEPATOCYTES: CYTOPLASMIC VACUOLES (N0N-20I -ACUTE/SUBACUTE INFLAMMATION -NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE'{CMI CHRONIC INFLAMMATION -NASAL MUCOSA (OLFACTORY}i EPITHELIUM-1NTW EOSINOPHILIC MATERIAL THE FOLLOWING TISSUES HAQ NQ MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS, NOSE/TURR SEC 1. NOSE/TURB SEC l, OVARIES. OVIDUCTS/FALOP T. PIIUMARY GLAND. 1 KEY TO NEOPLASMS: "M-" MALIGNANT. "fl-" BENIGN, "S-" METASTATIC, 'I-" INVASIVE, "X- 01 BFG 003670 a) O ft L/ \D *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-GENERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER; 1542 DATE OF DEATH: 10/03/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIf STUDY DAY OF DEATH: 137 STUDY WEEK OF DEATH: 20 TERMINAL BOQY WEIGHT; 2? ORGAN NAME * * * pathology KEYWOAOS. SEVERITY. DISTRIBUTION observations * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC f LIVER ........................ ........................................................................................................................................................................................................................ MICRO: -MINIMAL HtPATOCTTES; CTTOPlASMIC VACUOUS (NUN-ZONAL) -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION NOSE/TURB SEC 3 ............................. MICRO: -MINIMAL -NASAL MUCDSA (OLFACTORY): EPlTHELiuM-INTRACYTC EOSINOPHILIC HATFRIAI. UTERUS GROSS -|NP|AT SCARS PRIM NT - RIGHT:10;"LEFT: VAGINA Nil SO HCRIHA. NULQSA M?P|RMHAIOSIS (l6rn|F|ED) t HI ou OwlNij 1 I V.wl \ f'A- *IUR|s iuN-jV bawmih P | lull art <h I Mi H t .. ,1*' : IIM'.'H*, : lir, ;fl .< Rf > nu.i i st'. l nu'.l/luNB Sit .1(1 / NOsi/IuRO Sit 4. 0 v AM IE S, OV|OUC1S/FALOF it * iu opi ni, ft BtNIGN. `S-" HflASTAUC, '* I -INVASIVE, "X-" OlHfR w S o W u> L/1 4^ O O o O' --J *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET $1 ANIMAL NUMBER: 1543 DATE OF DEATH: 10/01/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEOULEO, TERMINAL SAC STUDY DAY OF DEATH: 135 STUDY WEEK OF DEATH: 20 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREC-TEXT COMMENTS / HI5T0PATH0L0G! liven .................................................................................................................................................. ........................................................ MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-Z0N7 -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION NOSE/TURB SEC 2 ............................................................................................................................................................................................................... MICRO: -MINIMAL -VOMERONASAL ORGAN: EOSINOPHILIC MATERIAL NOSE/TURB SEC 3 ............................................................................................................................................................................................................... MICRO; -MINIMAL -NASOLACRIMAL DUCt; LYMPHOID HYPERPLASIA UTERUS ....................................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESfNT -RIGHT:6; LtFT:10 MICRO; -MINIMAL, FOCAL -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMAL ITIFS OBSERVED: KIDNEYS. LUNGS, MAMMARY GIANDS, NOSE/TURB SEC l, NOSE/TURB SEC 4. OVARIES, OV1DUCTS/FALOP T, PITUITARY TRACHEA. VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT. "6-" BENIGN, **$-" METASTATIC, "l-" INVASIVE, "X-" OIL CD *3 BFG43541 *** PATH/IOX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED INHALATION tVO-GENERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 1545 DATE OF DEATH; 10/03/97 SEX: FCHALZ OOSE CROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAY OF DEATH; 137 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS ' - * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC UVER ............................... MICRO: NOSE/TURB SEC 3 MICRO; NOSE/TURB SEC * MICRO: -MINIMAL -MINIMAL. FOCAL -MINIMAL ................................. -MINIMAL ................................. UTERUS ............................. GROSS; -IMPLANT SCARS PRESENT MICRO: MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (MOM-ZONAL -ACUTE/SUBACUTE inflammation -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA :HASAL MUCOSA (OLFActoRYj; CPITHCliUM-INTRACY EOSINOPHILIC MATERIAL -rIgHT:9: LEFT;5 -LUMEN: DILATED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC Z, OVARIES. OVIDUCTS/FAIQP T. PITUITARY G TRACHEA. VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "s-" METASTATIC, "I-" INVASIVE, "X-H OTHE BFG 00367: td O u> LA M *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 1547 DATE OF DEATH: 10/04/97 ORGAN NAME SEX; FEMALE DOSE GROUP; 1 SACRIFICE STATUS; SCHEDULED, TERMINAL S, STUDY DAY OF DEATH: 13B STUDY WEEK OF DEATH; ZO TERMINAL BOOT WEIGHT: * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS TREE-TEXT COMMENTS / HISTOPATHQLQ LIVER MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC YACUOLES (NON-ZO -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION NOSE/TURB SEC 1 .......................................................................................................................................................................................................... MICRO* -MINIMAL -VOMERONASAL ORGAN; FREE ERYTHROCYTES UTERUS ............................................................................................................................................................................................. GROSS -IMPUNT SEARS NOT PRESENT MICRO NlNtmi I 0( 4i -MYOMETRIUM; BROWN PIGMENT lm[ r- o11 Ow iM<., t r,,\ >*; *n k l OK (VS UfktjS At*Al(T i.i*kM P|IUI<A*Y (il k,j o*' n a'N'|1"*a> i i u , onsi Ml D Mr, I I'.kH li t' HUST/TuB Y # L l. kUM/IUBft SIC 4, OVARIES, OVIDUCTS/ ( I i : o m , t . Ai i i,kAk r A (Mkluk. H( 1 A S 1 A I 11 INVASIVE. 0 BFG 003674 CO S o Lh UJ PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TwO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: IS49 DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: 130 STUDY WEEK OF PfATH; 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HIST0PATH0L06I GROSS/HIC/W CO*R MICRO: LIVER .... MICRO: NOSE/TURB SEC 3 MICRO: -MINIMAL MINIMAL HISTOPATHOLOGICAL NOSE/TURB SEC 4 -MINIMAL MICRO: -MINIMAL SKIN................... GROSS; -HAIR ABSENT/THIN. SLIGHT U1ER0S .......................................................................................... GROSS: -IMPLANT SCARS PRESENT MICRO: -SLIGHT -MINIMAL. FOCAL COMMENT; >SK|N: HAIR ABSENT/NHC -HfPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INtRAC EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRAC EOSINOPHILIC MATERIAL -HAIR THIN: VENTRAL SURFACE -RIGHT:5; LEFT:6 -LUMEN: DILATED -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: . _______ _ KIDNEYS, LUNGS, MAMMARY GLANDS. NOSE/TURB SEC I, NOSE/TURB SEC 2. OVARIES. OVIOUCTS/FAl.DP T. PITUITARY TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "8-" BENIGN. 'V" METASTATIC, "h" INVASIVE. "X-" OTH BFG 003675 a lP L/1 PATH/TOX 5Y5IEH OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 1551 DATE OF DEATH; 10/01/97 SEX: FEMALE OOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 135 STUDY WEEK OF OEAlH: 20 TERMINAL BODY WEIGH!: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HlStOPATHQlQG LIVER . . MICRO: -MINIMAL KOSE/TURB SEC A MICRO: -MINIMAL UTERUS GROSS; -IHPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -HCPAV0CYTE3: CYTOPLASMIC VACUOLES (NON-ZON -NASAL MUCOSA (OLFACTORY): EPJTHELIUN-lNTRA EOSINOPHILIC MATERIAL -RIGHT;8; LEFT:9 -MYOMETRIUM: BROWN PIGMENT THE FOLLOUING TISSUES HAD NO MICROSCOPIC ABNORMALITIES 08SERVFD: KIDNEYS LUNGS, MAMMARY GIANDS, NQSF/TURfi SEC 1. NOSE/IURB SEC 2, NOSE/TUR0 SEC 3. OVARIES. OVIOUCTS/F PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BtNlGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OT BFG43545 Ui 0\ <t Ov *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-6EHERAtlON REPRODUCTION AND developmental toxicity study IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 1553 DATE OF DEATH: 09/30/97 SfX: FEMALE DOSE GROUP; 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY OAT OF DEATH: 134 STUDY WEEK OF DEATH1. 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGT OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOBJ LIVER .. .. MICRO: -MINIMAL ................................. NOSE/TURB SEC 2 MICRO:'-MINIMAL ....................................................................... NOSE/TURB SEC 3 MICRO; -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL ................................................................... UTERUS VAGINA .. . . GROSS: 'IMPLANT SCARS - PRESENT MICRO: -SLIGHT .. .. MICRO: -MINIMAL ......................................................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -NASOLACRIMAL 6UCT{$j: FREE ERYTHROCYTES` -NASAL MUCOSA (OLFACTORY): EPITHEltUM-INTRAC EOSINOPHILIC MATERIAL -NASAL'MUCOSA (OLFACTORYj: EPITHELIUM-INTRAC EQSlWPHlUC MATERIAL 'RlGHl:9i LEFT: -LUMEN: DILATED :MUCOSA:'HYPERKERATOSIS (CORNIFIEO) THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1, OVARIES. OVIOUCTS/FALOP T. PITUITARY GLAND, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, HB-" BENIGN, "S-" METASTATIC, "l-" INVASIVE, "X-" OfH BJrG 003677 03 o 5 O' **" PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RAtS INDIVIDUAL ANIMAL OATA SHEET ! ANIMAL HUMBER: 1555 BATE Of DEATH: 09/30/97 SEX: FEMALE DOSE GROUP; 1 SACRIFICE STATUS: SCHEDULED. TERMINAL Si STUDY DAY OF DEATH; 134 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOl KIDNEYS . . . MICRO -MINIMAL -PELVIS: FREE ERYTHROCYTES LIVER , ,,. MICRO -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-ZOI NOSE/TURB &EC 3 MICRO -MINIMAL :NMAL'mUCO$A (OLFACTORY):' EPltHELTUH- INTRJ EOSINOPHILIC MATERIAL MOSE/tURB SEC 4 ............................. MICRO: -MINIMAL -NASAL LUMEN; FREE ERYTHROCYTES -SLIGHT -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRj EOSINOPHILIC MATERIAL UTERUS ................................................................................................................................................................................................................................. GROSS; -IMPLANT SCAR5 - NOT PRESENT MICRO: -MINIMAL, FOCAL -MYOMETRIUM; BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; LUNGS, MAMHARY G1AN0S. NOSE/TURB SEC 1, NOSE/TURB SEC 2P OVARIES. OVIDUCTS/FALOP T. PITUITARY GLAND. KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" 0 BFG 003678 "V O *** PATH/TOX SYSTEM OUTPUT *** vinyl chloride combined inhalation two-generatjoh REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 1557 DATE OF DEATH: 10/01/97 SEX: FEMALE DOSE CROUP; 1 SACRIFICE STATUS; SCHEDULED, TERMINAL SACR STUDY OAY OF DEATH: 135 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ............................................................................................................................................................................................................................................ MICRO; -MINIMAL -MINIMAL, FOCAL -HEPATQCYTES; CYTOPLASMIC VACUOLES (NQN-ZONAL -ACUTE/SUBACUTE INFLAMMATION NQSE/TURB SEC 4 .................................................................................................................................................................................................................... MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACY EOSINOPHILIC MATERIAL uterus ............................................................................................................................................................................................................................................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT:5; ICFT:6 MICRO: -MINIMAL. FOCAL -MYOMETRIUM; DROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIONEYS, LUNGS, MAMMARY GLANDS. NOSE/TIJRB SfC 1, NOSf/TURB SEC 2, NOSE/TURB SEC 3, OVARIES. OVJDUCTS/FAL PITUITARY GIAND. TRACHEA, VAGINA KEY 10 NEOPLASMS: "M-" MALIGNANT , "B-" BENIGN, 4V" ME IAS I Al 1C. "I-" INVASIVE. "X-1* OTHE 6Lm o M a o u> LA P00 *** PATH/1OX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 1556 DATE OF DEATH: 09/29/9? SEX; FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEOULE0. TERMINAL SA STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BQQY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * ' GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG LIVER . . . . MICRO MAMMARY GLANDS MICRO NOSE/TURfl SEC 3 MICRO -MINIMAL -TlSSUEMisSINfi -MINIMAL NOSE/TURfl SEC 4 MICRO; -MINIMAL UTERUS GROSS; -IMPLANT SCARS - PRESENT MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZON -nasal mucosa (olfactory): epitmelium-intrai EOSINOPHILIC MATERIAL NASAL MUCOSA (OLFACTORY): EPITHELIUM-(NTRAi EOSINOPHILIC HATERIAL -RIGHT:3; LEFT:5 -LUMEN: DILATED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, N0SE/TUR6 SEC 1. NOSE/TURB SEC Z. OVARIES. OVIDUCT5/FAIOP T, PITUITARY GLAND. TRACHEA, KEY TO NEOPLASMS: "M*" MALIGNANT, "B-" BENIGN, METASTATIC, Hl-" INVASIVE, "*" OTI BFG 003680 03 O e S *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET 51 ANIMAL NUMBER; 1S59 DATE OF DEATH: (0/04/97 SEX: FEMALE DOSE GROUP; I SACRIFICE STATUS; SCHEDULED, TERMINAL SAC $Wpr DAY OF DEATH: 136 STUDY WEE* OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FftEE-fEXT COMMENTS / HISTOPATHOLOGI LIVER MICRO; -MINIMAL MINIMAL, FOCAL NQSE/TUHB SEC 2 ........................................... MICRO: -MINIMAL MOSE/TURB 5EC 3 MICRO SkIGNT Most /1 (ifto SI H ! , ,) Si I /"1 m; *, 1 .h ' uURll'. i.nci . HIUIO [Kfiiiii it H | B | Hii . V'AI .41 ,n' -HEPATOCYTES; CYTDPLASHlC VACUOLES (NON-ZONA -ACUTE/SUBACUTE INFLAMMATION -NASOLACRIMAL PUCT(S): INFLAMMATORY CELLS/CE Nasolacrimal uunisj:'mucosa-subacute'(chro CHRONIC INFIAHMATION N A S 01 AC RI MAI 0UC1 LYMPHOID HYPERPLASIA hASOi ACt |MAl OUCT UUOATE h AA i Hu(D'.4 IihIaLIMt) ( P| IHl IUH- INIRAC IUMAOPhU U HAfdlAl i|(in> 9 kin i htomiirimm *RQWft Pft*'ttl THE FOLLOWING IlSSUtS HAD *0 MK.IOSCQPK ABNORMALITIES OBSERVED: KIDNEYS. LUNGS, MAMMARY GLANDS, NOSF/TURB SEC 1. OVARIES, OVIDUCTS/FALOP T. PITUITARY GLANO. TRACHEA. V KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE, X- OTH ANIMAL NUMBER: 1561 DATE OF DEATH: 10/02/97 *** PAtH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL S, STUDY DAY OF DEATH: 136 STUDY WEEK OF OEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGT OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLO* KIDNEYS ............................................................................................................................................................................................................................. MICRO: -MINIMAL -PELVIS; FREE ERYTHROCYTES LIVER ................................................................................................................................................................................................................................. MICRO: 'MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZOI NOSE/TURB SEC I ......................................................................................................................................................................................................... MICRO: -MINIMAL -VOMERONASAL ORGAN: EOSINOPHILIC MATCH IAL NOSE/TURB SEC 3 ............................................................................................................................................................................................................................ MICRO: -MINIMAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA NOSE/TURB SEC 4 ............................................................................................................................................................................................................................ MICRO: -MINIMAL -NASAL HUCDSA (OLFACTORY): EPUHEllUM-INTRJ eosinophilic MATERIAL UTERUS ................................................................................................................................................................................................................................. GROSS: -IMPLANT SCARS - PRESENT -RIGHT;6; LEFT:S MICRO: -MINIMAL. FOCAL 'MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TtSSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS. NOSE/TURB SEC Z. OVARIES, OVlDUCTS/fALOP T. PITUITARY GLAND. TRACHEA, VAGINA KEY TO NEOPLASMS: **M-" MALIGNANT. "B-" BENIGN. "S-M METASTATIC. "l-M INVASIVE, 0 BFG 003682 Hi O X* LP LA *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND OEVELOPHENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 1563 DATE OF DEATH: 09/Z9/9? SEX: FEMALE OOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE'TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS . . . MICRO: -MINIMAL LIVER ..,. MICRO:'-MINIMAL NQSE/TURB SEC 3 MICRO: -MINIMAL -MINIHAl NOSE/TURfl SEC 4 MICRO:'-MINIMAL UTERUS ................................................................................................... GROSS: -IMPLANT SCARS - NOT PRESENT MICRO: -MINIMAL, FOCAL -PELVIS:'FREE ERYTHROCYTES.......................................... -HEPATOCYTES; CrioPLASNIC VACUOLES (NON-ZONAL -NASAL MUCOSA (OLFACTORY); EPITHELIUM-IHTRACV EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT; LYMPHOID HYPERPLASIA -nasal MUCOSA (OLFACTORY): CPIthcliuh-intracy EOSINOPHILIC MATERIAL -MYOMETRIUM; BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; LUNGS, MAMMARY GLANDS, NQSE/TURB SEC 1, NOSE/TURB SEC Z, OVARIES, OVIDUCTS/FALOP 7. PITUITARY GLAND, TRA KEY'io'NEOPLASHS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, *'I-H INVASIVE, "X-1* OTHE BFG 003683 ad aTri 4^ L-A U\ N> ANIMAL NUMBER: 1S6S DATE OF OEATH: 10/04/97 ORGAN NAME "* PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS individual animal data $HUt SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SA STUDY DAY OF OEATH: 138 STUDY WEEK OF DEATH; ZO TERMINAL BODY WEIGHT; * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREC-TEXT COMMENTS / HISTOPATHOLOG LIVER ...................................................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZON -MINIMAL, FOCAL 'MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -NECROSIS, SINGLE CELL NOSE/TURB SEC 3 ............................................................................................................................................................................................................... MICRO: -HIHIMAI -NASOLACRIMAL DUCT; LYMPHOIDHYPERPLASIA NOSE/TURB 5Et 4 MICRO MINIMAL ............................................................................................................................................................. -NASAL MUCOSA (OLFACTORY): EPI THELTUN-1NTHA (OMNOfrtll li MATERIAL tllliUS M J ( 10 JHP4*** kfAkv || M*i 0(*l Al`,ln RUiHi H ml J MTOHtlAllMI ............................................... PIGMIMI THi fOllDkltl) 1 I S HiD y i lONItS luA'.L MA**AH biANDS I RAC H|A. VAblhA UM < AAMukNt. I 1 11 S OA. I X t D SK I WSI/lUM ML t. 0AI|(S. PYlOuUVfALOP t, PilUllART KEY TO NEOPLASMS; "M-" MALIGNANT, "B-" BENIGN, *'S-" METASTATIC, "I-" INVASIVE. "X-H 01 BFG 003684 03 Tl O L-A Ln UJ *" PATH/TGX SYSTEM OUTPUT *** VINYL CHLORtDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUI ANIMAL NUMBfR: 1566 DATE OF DEATH: 10/01/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL $ACR STUOY DAY OF DEATH: 135 STUDY WEEK OF DEATH; 20 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS .......................................................................................... MICRO: -MINIMAL -MINIMAL. FOCAL ............................................... *..................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL -ACUTE/SU6ACUTE INFLAMMATION -RIGHT:Z: LEFT:B............................................................. -MYOMETRIUM; BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; KIDNEYS, LUNGS. MAMMARY GLANDS. N05E/TURB SEC 1. NOSE/TUfiB SEC 2. NQSE/TURB SEC 3. NOSE/tURB SEC 4. OVAR OVIOUCTS/FALOP T, PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "N-" MALIGNANT, "6-" BENIGN. METASTATIC, "I-" INVASIVE, "X-" QTHtl BFG43554 *** PATH^TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-SENERAlION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: iSBfl DATE DP DEATH; Q9/Z9/9? SEX: FEMALE DOSE GROUP; I SACRIFICE STATUS: SCHEDULED, TERMINAL SAi STUDY DAY Of DEATH: 133 STUDY WEEK OF OEATH: 19 TERMINAL DOPY WEIGHT; ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS FREE-TEXT COMMENTS / HISTOPATHOIOG KIDNEYS LIVER UTERUS MICRO: -MINIMAL MICRO; -MINIMAL GROSS; `IMPLANT SCARS - NOT PRESENT MICRO: -MINIMAL, FOCAL `PELVIS: FREE ERYTHROCYTES -HEPATQCYTES: CYTOPLASMIC VACUOLES (NON-ZONl -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED; LUNGS, MAMMARY GLANDS, NUSE/TURB SEC 1, NOSE/TURB 5EC ?, NOSE/TURB SEC 3, NOSE/TURB SEC 4. OVARIES, OV PITUITARY GLAND, TRACHEA. VAGINA KEY TO NEOPLASMS: "M-`` MALIGNANT. "B-" BENIGN. 'V" ML IASTAT |C. "I-" INVASIVE, "X-'* 071 BFG 003685 CD o L>J Lf\ LAI L/l *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET STUt ANIMAL NUMBER: 1570 DATE OF DEATH: 10/04/97 SEX: FEMALE POSE GROUP; 1 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRl STUDY DAY OF DEATH: 139 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER . . . . MICRO: -MINIMAL `MINIMAL, FOCAL NOSE/TURB SEC 3 MICRO; '-MINIMAL UTERUS , . . . GROSS: 'iMPLANT SCARS - PRESENT MICRO: -SLIGHT, FOCAL -HEPATOCYTES; CYTOPLASMIC VACUOLE$*(NQN'ZONAL] -ACUTE/SUBACUTE INFLAMMATION -NASOLACRIMAL DUCf: LYMPHOID HYPEftPLASM *RI(iHT:8; LEFT;5 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TtSSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNGS. MAMMARY GLANDS, NOSE/TURB Sff 1, N05F/TURB SEC 2, NOSE/TURB SEC 4, OVARIES, OVIDUCTS/FAU PITUITARY GLANO, TRACHEA. VAGINA KEY TO NEOPLASMS: "h-" MALIGNANT, "B*" BENIGN, "5-"' METASTATIC, "t-" INVASIVE, "X-" OTHET BFG 003686 CD 2? 2 Ui Lai GTS *** PAIH/TQX SYSTEM OUTPUT *'* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal data sheet ANIMAL NUMBER: 1572 DATE OF DEATH: 10/04/97 SEX: FEMALE OOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SA STUDY DAY OF DEATH: 138 STUDY WEEK OF DEATH: ZD TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOIOG LIVER . . MICRO: 'MINIMAL NOSE/TURB SEC 2 MICRO: -MINIMAL UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-JON -ODONTOPATHY....................................................................... -RIGHT;7; LEFT;9 -MYOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, HAMHARY GLANDS, NOSE/TURB SEC I, NOSE/TURB SEC 3. N05E/1URB SEC 4, OVARIES. OVIDUCTS/F PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT, HB-" BENIGN, "S-'' METASTATIC. "1'" INVASIVE. "X-" OT *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER; 1574 DATE OF DEATH: 00/29/97 SEX: FEMALE DOSE CROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR1 STUDY DAY QF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * GROSS FACE-TEXT COMMENTS / histopathologic LIVER UTERUS MICRO; -MINIMAL `MINIMAL, FOCAL GROSS: `IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NON`ZQNAL) -ACUTE/SUBACUTE INFLAMMATION -RIGHT:0; LEFT: -MYOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1, NOSE/TURB SEC 2, NOSE/TURB SEC 3. NQSE/TURB SEC <, OVARI OVIDUCTS/FALOP T, PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN, "S-" METASTAIIC, "l-" INVASIVE. "X-" OTHER CO O W L* LA 00 3 o90G flJHJO ,,-X,, `3MSVANI ,,-I,, `31iViSV13H 'N91K3A ,,*fl,, 'lNVNOHVH ,,-H.. SNSVldOJK Oi A3X VNI9VA *V3H3V#i '0NV19 ANVilfUId '1 JOlV `S31HVAO > 33$ 0ni/3SON `E D3S 8HIU/3SON `Z 33$ SMni/3SON '1 33$ BMfU/lSQN 'SONVIS AHVNNVH `SONn 'Q3A03$flO SlIlIlVWdONdV OldOOSOlfJlH ON OVH SJflSSll Q31V110 -N3Hms:u3i ;s:iH9i8' TVHININ- ^OltfJN in|$31w ; snyos ANyidH|- :ssoyo N0I1VHHVUNJ 3inDVanS/3inDV- 1V30J mvhinih- ()VN02-NON) $non3VA 31HSVW01A3 ;S31A301VJ3H`..............................................................1VNIN1N- :ON3|M SDN 1 ON IJ 3l9Q3WUVd01SIH / S1N3HH03 IWi-JJNJ SS0M9 MMinBIUlSlO `A11MA3S 1 SOlJDAAJX SHOI iVA]SBO ADOlDMlVd * sum 0S62 -1H9I3H AOOS 1VN1WW1 02 :H1V3Q JO 3IS AOlUS 331J183VS 1VN1HH31 *<mnQ3H3$ >SniVA$ 33U1S3V5 I SEl 'M1V30 dO AYO AMIS 3SO0 33YH3J -X3S VO0Ot96 'M3flHflN AOIUS Sit *3QV<J 86-Hd"6Z '031NIMJ A33HS VIVO 1VH1NV lVOOIMONl SiVM 03 Nl AOOiS A1I31X01 1VlM3Wd033A3(J QNV NDU3naod3ll N0UVH3N39-QJU N0UV1VMK1 QINIflWQO MldOlKO IAN IA ,,, ifldiflO H3J.SAS XOi/HIVd 26/10 9 *** PATH/TOX SYSTEM OtJTPUT **" VINYL CHLORIDE COMBINED INHALATION TWO*GENERAT|ON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUI ANIHALNUMBtR: 1578.........................SEx''fEMALE DOSE GROUP: l SACRIFICE STATUS: SCHEDULED. TERMINAL SACK! PATE Of DEATH: 09/29/97 STUDY DAY OF OEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BOOT WEIGHT: i ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-tEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO- -SLIGHT.......................................................................... :HEPATOCYTEs! CYTOPLASMIC VACUOLES'(KON-ZONAL: `MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION GROSS:'-IMPLANT SCARS - PRESENT ' MICRO; -SLIGHT. FOCAl -RIGHT;9; LEFT;6 -MYOMETRIUM: BROWN PIGMENT THE FOIL OWING T | SSUf S HAD NO N| lOS< UMf AANFiOmAI 111 f S OBSEUVEO; KIPNITS. UiNtiS nahhar v (ji ANOS N()\l,uhB Ui l NOSE/lURB Sf( i. NOSI/IURB SEC 1. NOSE/TURB SEC 4, DVAR OviOuC t Wf AlOP I Flftil'A** l*i A*tl 'Al h A V Ai. | N A l| T 10 n OKI HA. , ..MAN 1 6 At NIU s Ht Ia-jIAT u INVASIYE, OlHfl 00 00 3 Cl n o 4^ TjJ <3 Ln iti a\ 0\ 9 ANIMAL NUMBER: 1580 DATE OF DEATH: 10/02/97 ORGAN NAME *** PATH/TQX SYSTEM output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION reproduction and developmental toxicity study in cd rats INDIVIDUAL ANIMAL DATA SHEET S SEX: FEMALE DOSE GROUP; 1 SACRIFICE STATUS; SCHEDULED, TERMINAL SA STUDY DAY OF OEATH; 130 STUD* WEEK OF DEATH; 20 TERMINAL ROOT WEIGHT: * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS *** GROSS FREE-TEXT COMMENTS / HlSTOPATHOLOG LIVER UTERUS ................................................................................................................................................................................................................... .... ' i ' MICRO; -MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NQN-ZON ...................................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT:?; LEFT:3 MICRO; -MINIMAL, FOCAL -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMAL!11ES OBSERVED; KIDNEYS LUNGS MAMMARY GLANDS, NOSE/TURR SFC I, NOSF/TURB SEC ?, NOSE/IURB SEC 3. NQSE/TURB SEC 4. OV OV1DUCTS/FAL0P T, PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: ''H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "1'" INVASIVE, "X-" OT BFG43561 *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUO' ANIMAL NUMBER: 2532 DATE OF OEATH: 09/30/97 SEX: FEMALE DOSE GROUP; 2 SACRIFICE STATUS: SCHEDUI.EI), TERHINAl SACRII STUDY DAY OF DEATH: 13* STUOT WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 2! ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I UTERUS .......................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT:7; LEFT:6 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003692 03 O LP O' t-> *** PATrt/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWQ-GFNERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY |N CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 2533 OATE OF DEATH: 10/01/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SAi STUDY DAY OF DEATH: L35 STUDY WEEK OF DEATH: 20 TERMINAL BODY UETGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HI$TQpATHQLOS LIVER UTERUS MICRO; -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZON, GROSS:'-iMPLANT SCARS - PRESENT ............................... -RiGHT:5; LEFT:4.......................................................... KEY TO NEOPLASMS; "M-" MALIGNANT. "B-" BENIGN, `V" METASTATIC, "I-" INVASIVE. hX-h OT; BFG 003693 ft o & O' <T> PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATtON REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUOY ANIMAL NUMBER; 2534 DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRIF STUDY DAY OF DEATH: 136 STUDY WEEK Of OEATH: 20 TERMINAL BODY WEIGHT; 32 ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F UTERUS .......................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT;!!; LEFT;? *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *#* BFG 003694 Si O P* O ANIMAL NUMBER: 2536 DATE OF DEATH: 09/30/97 ORGAN NAME *** PATH/TOX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET S SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SAi STUDY DAY OF DEATH: 134 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG UTERUS ................................................................................................... GROSS; -IMPLANT $CARS - NOT PRESENT ** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GEKERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD' ANIMAL NUMBER: 253B DATE OF DEATH; 09/Z9/9? SEX; FEMALE DOSE GROUP; Z SACRIFICE STATUS; SCHEDULED, TERMINAL SACRJl STUDY DAY OF DEATH: 133 STUOY WEEK OF DEATH: 19 TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREC-TEXT COMMENTS / HISTOPATHOLOGIC UTERUS .......................................................................................................................................................................... GROSS; -IMPLANT SCARS - PRESENT -RIGHT.il; LEFT;6 *** ANIMAL HAS NO MICROSCOPIC ABNORMAL I TIES OBSERVED *** *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 2540 DATE OF DEATH: 09/29/9? SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEpUlEQ, TERMINAL SA STUDY OAT OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERHIHAL BODY WEIGHT; ORGAN NAME * * * pathology KEYWORDS, SEVERITY, DISTRIBUTION observations *** GROSS FREE-TEXT COMMENTS / HlSTOPATHOLOG LIVER UTERUS MICRO;`-MINIMAL ...................................................................... -HEPATOCYTES; CYTOPLASMIC VACUOLES {NON-ZON -MINIMAL, FOCAL -ACUTE/SUSACUTE INFLAMMATION GROSS: -iMPLANT SCARS - NOT PRESENT KEY TO NEOPLASMS: "M-h MALIGNANT. `'B " BENIGN. 'V METASTATIC, "l-H INVASIVE, "X-" OT L69 M O jg $ O t^r\ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD! ANIMAL NUMBER: 2541 DATE OF DEATH; 10/02/97 SEX: FEMALE DOSE GROUP; 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRM STUDY DAY OF DEATH: 136 STUDY WEEK OF OEATH; 20 TERMINAL BODY WEIGHT: 21 ORGAN NAME * * * pathology KEYWORDS , SEVERITY DISTRIBUTION observations * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC 1 LIVER , , . UTERUS , . . MICRO: -MINIMAL GROSS; -IMPLANT !SCARS - PRESENT -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -RIGHT:?; LEFT:fl KEY TO NEOPLASMS ; "H-" MALIGNANT, "8-'' BENIGN. "S-" METASTATIC, "I*" INVASIVE, *`X-" OTHER BFG 003698 B) O 4^ U\ O' oo as St cx a. 141 U) <7l ht (u e aj Q W tp e> Su UJ o k-- < X Q. l-H ac B. a: UJ 0 X 0 e > O = O 40 Vi <C Z0 K >-<e ^ (-9 2* UJ -- zr UJ > da i 91 U. 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SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F LIVER UTERUS MICRO: -MINIMAL 'MINIMAL, FOCAL GROSS: -IMPLANT SCARS - PRESENT -HEPAT0CYTE5: CYTOPLASMIC VACUOLES (NON-ZONAL) `ACUTE/SUBACUTE INFLAMMATION -RIGHT:4; LEFT:6 KfY 10 NfOPlASHS N MAlIGNANt. "R-" BfNJGN. "S-" METASTATIC l-" INVASIVE. "X-" OTHER BFG 003700 03 T) O U\ o PATM/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWQ-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 2546 DATE OF DEATH: 10/01/97 SEX: FEMALE DOSE GROUP: t SACRIFICE STATUS: SCHEDULED, TERMINAL 5. STUDY DAY OF DEATH: 135 STUDY WEEK OF DEATH: ZQ TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHDLOI LIVER UTERUS ...................................................................................................................................................................................................... MICRO: 'MINIMAL -HEPATOCYTE5; CYTOPLASMIC VACUOLES (NON-ZOI ................................................................................................................................................................................................................................. GROSS: -IMPLANT SCARS * PRFSFNT -RIGHT:B; LEFT :9 MY 10 N10PIASN5 " hM I ('.NANI , "B-" BFNIGN. 5-" METASTATIC, "l-" INVASIVE, "X-" 0 iQ ie o o d j a OS o *** PATH/TOX SYSTEM OUtPUl *** VINYL CHLORIDE COMBINE!) INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET I STUDY ANIMAL NUMBER; 2548 DATE OF DEATH: 10/01/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH; t0 TERMINAL BODY WEIGHT: V ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F LIVER UTERUS MICRO: -MINIMAL GROSS; "IMPLANT SCARS - PRESENT -HEPATOCYTES CENTRlLOBULAR: HYPERTROPHY 'IMGHT:6; LEFT;1.................................................... KEY TO NEOPLASMS: "H-'* MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003702 td n o 4^ \J\ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER; 2550 DATE OF OEATH: 09/30/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL S STUDY DAY OF DEATH: 134 STUDY WEEK OF OEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLO LIVER UTERUS .................................................................................................................................................................................................................................. MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (N0N-20 .................................................................................................................................................................................................................................. GROSS: -IMPLANT SCARS - PRESENT -RIGHT:6; LEFT:7 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-m BENIGN. "5-" METASTATIC, "I-" INVASIVE, "X-" 0 BFG 003703 td O 4* LA B3H1Q ,,-X,, '3AI5VANI '3UV1SV13H 'N9IW38 ,,-0.. 'INWPIIVW :SWSY1d03N 01 1 1-1J31 `9'1M31W- NOnV1O9YO3'SIS033H(1VN0Z-N0N) S310H3YA DlHSVldOlAO :S31A301V<13H- iN3$3d - SBV3S INVldMl- *$$0 1VD0J 3VMINIW1YHIHIH- :0B3 S3NIQNIJ DlOCnOHiVdOlSlH / S1H3HH03 1X31-33BJ SS0M9 * S N0 I 1VH3 S 80 MOIiMtUiSIO *AiIU3AJS 'S0B0AA3)| nOlOHIV j . . GHV9 5'892 '1H0I3A 1000 1YNIWB31 02 H1V30 iO *33* AOniS Vl H1V30 JO AVQ lOfllS JDIJJMVS 1VNINB31 *a3lfl03H35 -snivis laiJlBDVS Z :dnoBO 3S00 31VH3J :X35 -mmvobo^6 aqois ECt> T39Vd B6*dV-Gd :gjlN|Hd hjhs vivo ivhihy ivooiaiohi S1VU 03 Nl lonis 11131X01 1V1N3IMD13A30 ONV NOU3fiaOMd3 N0llVB3N30'0nl N0UV1VHNI 03NI9H03 301H01H3 11NU ... iftdinO W31SAS XOi/HiVd ... 16 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL data SHEET ANIMAL NUMBER: 2553 DATE OF DEATH: 00/30/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SJ STUDY DAY OF DEATH: 134 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-IEXT COMMENTS / HlSTOPATHOLOC LIVER . UTERUS . MICRO: 'MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZO* GftDjS: -jMPLANT SCARS - PRESENT................................. -RIGHT:7 * LEFT8................................................................. KEY TO NEOPLASMS: "H*" MALIGNANT. "B-" BENIGN. "S-- METASTATIC, "l-" INVASIVE. "X-" 01 BFG 00370S CO Hi O L>> UY o L/T PATH/TQX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY tN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUG ANIHAL NUMBER: 2554 DATE OF DEATH: 09/30/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 134 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL 'MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES`(NON-ZONAL) -HEPATOCYTES CENT(MLOBULAR: HYPERTROPHY -ftiGHT:8; LEFT:6 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l" INVASIVE, "X-" OTHER BFG 003706 to % G Os PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COM&fMFO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 2555 DATE OF DEATH: 10/03/9? SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACK STUDY DAY OF DEATH; 13/ study WEEK OF DEATH: 20 TERMINAL BODY WEIGHT; ORGAN NAME * * * pathology OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS ........................... MICRO: -MINIMAL. FOCAL ........................... GROSS; -iNPLANT SCARS - PRESENT ACUTE/SUBACUTE INFLAMMATION -R1GHT:8: LEFT;8 KEY TO NEDPIASMS: "M-m MALIGNANT, mB-" BENIGN, "S-" METASTATIC. "I-" INVASIVE, "X-" OTHE BFG 003707 W T1 O P L-h *** path/tox system dutput *** VINYL CHLORIDE COMBINES INHALATION TWO-GENERAT1QN REPRODUCTION AND DEVELOPMENTAL TOXICITY StUOY IN CO NATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 2556 DATE OF DEATH: 10/01/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY DAY OF DEATH: US STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 3 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FfltE-TtxT COMMENTS / HISTOPATHOLOGIC UVEfi UTERUS ` MICRO: -MINIMAL.>OCAL.........................................................-ACUTt/SUBACUTE iNFLAMMATlON........................... 'MINIMAL -HEPATOCYTES CEHTRUQBULAR: HYPERTROPHY ' 6R0SS:'-iMPLANT SCARS - PRESENT................................. -RiGHT:9; LEFT :8 KEY TO NEOPLASMS: "H-" MALIGNANT, "6-" BENIGN, "S-" METASTATIC. MI-" INVASIVE, "A-" OTHER BFG 00370. W T1 o -pi U) Ui -J OO f *** PATH/TQX SYSTEM OUTPUT *'* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 2557 DATE OF DEATH; 10/02/97 sex: Female DOSE GROUP: Z SACRIFICE STATUS: SCHEDULED, TERMINAL SACfi STUDY DAY Of DEATH: 136 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LtVER UTERUS ............................. MICRO: -MINIMAL, FOCAL ............................. GROSS: -IMPLANT SCARS - NOT PRESENT -ACUTE/SUBACUTE INFLAMMATION KEY TO NEOPLASMS; *`H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-** INVASIVE. "X-" OTHE CO Tl U\ \Q 003709 ANIMAL NUMBER: 2558 DATE OF OEATH: 09/29/97 '** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWQ-GENERATIQN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUDY OAY OF DEATH: 133 STUDY MEEK OF DEATH: 19 TERMINAL BODY WEIGHT: ZB ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F ADIPOSE TISSUE LIVER . t - , UTERUS GROSS MICRO GROSS: -NQOULE(S)/MA$S(CS) -MINIMAL, FOCAL -IMPLANT SCARS - NOT PRESENT -NODULE: PERITONEAL CAVITY, 1.5 X 1.0 CM, TAM, -ACUTE/SUBACUTE INFLAMMATION...................................... K(Y 1C dlOPtASMS NAI I GUAM I B " BINIGN. "S " METASTATIC. "J-" INVASIVE, "X-" OTHER to 33 e U) o Ui 00 --1 O *** PATH/TOX SVSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET 5' ANIMAL NUMBER; 2559 DATE OP DEATH: 10/04/97 ORGAN NAME SEX; FEMALE DOSE GROUP: ? SACRIFICE STATUS; SCHEDULEO, TERMINAL SAI STUOY DAY OF DEATH: 130 STUDY WEEK OF DEATH; ZO TERMINAL BOOT WEIGHT: * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION observations * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOG UTERUS . . GROSS: -IMPLANT SCARS - PRESENT -RIGHT:8; LEFT:6 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003711 cd T1 O 4^ oo *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER: 2561 DATE OF DEATH; 10/02/9? SEX; FEMALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRIF STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH; 20 TERMINAL BODY WEIGHT; 24 ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F LIVER . . UTERUS . . MICRO: -MINIMAL GROSS: -iHPLANT SCARS - NOT PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-IONAl) KEY TO NEOPLASMS: V MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "1'" INVASIVE. "X-" OTHER BFG 003712 w a 4^ LA 00 to *** PAtH/tUX SYSTEM OUTPUT *** VINYL CHLORIDE COHBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 2563 DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTOPATllOLOGI' UTERUS ............................................................................................................................................................................. GROSS: -IMPLANT SCARS - PRESENT 'RIGHT:6; LEFTilO *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003713 03 m o U) U\ oo Uj *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION and developmental toxicity study IN CO RATS lNOIVIOUAL ANIMAL OATA SHEET STUD1 ANIMAL NUMBER: 2566 DATE OF DEATH: 10/01/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRII STUDY DAY OF DEATH: US STUDY WEEK DF DEATH: 2Q TERMINAL BODY WEIGHT: 21 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GRO$$ FREE-TEXT COMNENTS / HISTOPATHOLOGIC I LIVER UTERUS .................................................................................................................... .... . . ............................................................................................................... MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZONAL) -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION ...................................................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT:?; LEFT:6 KEY TO NEOPLASMS: "N-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" tNVASlVE, "X-" OTHER BFG 003714 <T\ o t UT 00 Jr^ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHL0RI0E COMBINED INHALATION TUQ-GENERATlON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal data sheet stu ANIMAL NUMBER: 2567 DATE OF DEATH: 10/01/97 ORGAN NAME SEX: FEMALE DOSE GROUP: Z SACRIFICE STATUS', SCHEDULED, TERMINAL SACR STUDT DAY OF DEATH: 135 STUDY WEEK OF OEATH: 20 TERMINAL BODY WEIGHT; * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FRfE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS LIVER UTERUS GROSS: -DILATATION. SLIGHT MICRO: -MINIMAL GROSS:'-IMPLANT SCARS : PRESENT RIGHT PELVIS -HEPATOCYTES: CYTOPLASMIC VACUOLES`(NON-ZONAL -RIGHT:6; LtfT:7 KEY TO NEOPLASMS: "M-" MALIGNANT, HB-" BENIGN. "S-" METASTATIC, "I-" INVASIVE. "X-" OTH BFG 003715 to TJ O 4^ Ui L/y 00 Or *** PAIH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER: 2569 DATE OF DEATH: 00/30/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUDY DAY OF DEATH: 134 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 27 ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FftEE'TEXT COMMENTS / HISTOPATHOLOGIC f LIVER Uterus MICRO: -MINIMAL -MINIMAL, FOCAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -ACUTE/SUBACUTE INFLAMMATION -RIGHT:8; LEFT:0 KEY TO NEOPLASMS: **H-M MALIGNANT. "B-" BENIGN* 'V" METASTATIC, "I-" INVASIVE, "X-" OTHER w 31 Co O *aj a 4^ LA 00 ON w "4 & *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER: 2571 DATE OF DEATH: 10/01797 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAY OF DEATH: 135 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL ..................................................................... -HEPATOCYTESCENTfiiLOBULAR: HYPERTROPHY GROSS:'-iMPLANT SCARS - PRESENT................................ -RiGHT:7; LEFT'S...................................................... KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASIATlC, "1-" INVASIVE, "X-" OTHE BFG 003717 tX) o -pu> u\ oo *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE C0H61NED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUC ANIMAL NUMBER: 2573 DATE OP DEATH: 10/02/07 ORGAN NAME SEX: FEMALE 00$E GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY Of OEATH: J36 STUDY WEEK OF OEATH: 20 TERMINAL BODY WEIGHT; J * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HlSTOPATHOlDGJC UTERUS . . GROSS: -implant scars - present 'RIGHTS: LEFT;? *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003718 8 O L/ CO CO *** PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL tOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 2575 OATE OF DEATH: 09/29/07 SEX: FEMALE DOSE GROUP: l SACRIFICE STATUS; SCHEDULED. TERMINAL SAC STUOY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREC-HXT COMMENTS / HISTOPATHOLOGI LIVER UTERUS MICRO: -MINIMAL -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY GROSS:'-IMPLANT SCARS 1 PRESENT.................................. -fii6HT:iO;1 LEFT;5........................................................ KEY to NEOPLASMS: "M-" MALIGNANT. 'V" BENIGN. "S-" HETASTATlC. *1-" INVASIVE. "X-" OTH *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TMO-fiENfRATlON REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET P STUDY ANIMAL NUMBER; 2577 DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE GROUP; 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI STUDY DAY OF DEATH: U6 STUDY UEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 27S ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC Fl LIVER UTERUS . . MICRO: -MINIMAL GROSS: -iHPlANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (KON-ZONAL) -RIGHT:11: LEFT:G KEY TO NEOPLASMS; "H-" HALIGNANT. M0-M BENIGN, V" METASTATIC, "l-" INVASIVE, HX-" OTHER BFG 003720 nn a U\ c> +* PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TW0*GENERAT10N HFPRQOUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STI ANIMAL NUMBER; 3531 DATE OF OEATH; 10/02/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACl STUDY DAY OF DEATH: 136 STUDY WEEK OF OEATH: 20 TERMINAL BODY WEIGHT: ** * pathology KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHQLQGH EXTREMITY .... ............................................................... GROSS: -HAIR ABSENT, SLIGHT LIVER ............................................................................................ MICRO: -MINIMAL -MINIMAL. FOCAL -MINIMAL UTERUS ............................................................................................ GROSS: -IMPLANT SCARS - PRESENT -BOTH FOREPAUS -NEPATOCYTES: CYTOPLASMIC VACUOLE?'(H0H-20HA -ACUTE/SUBACUTE INFLAMMATION -HCPATOCYTES CENTRILO0ULAR; HYPERTROPHY -IUGHT:fl; LEFT ;8................... in io mopi m HAi 1 I BIHlbW, "S " MITASTATIC. "l" INVASIVE. HX-" OTH BFG td O O LA --I ANIMAL NUMBER: 3532 ' DATE OF DEATH; 10/02/07 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO NATS INDIVIDUAL ANIMAL DATA SHEET STUD SEX: FEMALE DOSE GROUP; 3 SACRIFICE STATUS; SCHEDULED. TERMINAL SACRI STUOY DAY OF DEATH; 136 STUOY WEEK OF DEATH: 20 TERMINAL BODY WEI6HT: l ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL. FOCAL GROSS: -IMPLANT SCARS - PRESENT -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOOULAR; HYPERTROPHY -EXTRA MEDULLARY HEMATOPOIESIS -RIGHT:5: LEFT:10 KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, "l-" INVASIVE, "X-" OTHER BFG 003722 o p* TO ANIMAL NUMBER: 3533 DATE OF DEATH: 10/02/97 ORGAN NAME *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWQ-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS individual animal data sheet ST SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATHQLQGl UTERUS MICRO: -MINIMAL -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES*(NON-ZONA -HEPATOCYTES CENIRILOflULAR: HYPERTROPHY ........................................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT;; LEFT:9 KEY TO NEOPLASMS: 4<M-" MALIGNANT, "B-" BENIGN, V METASTATIC, "I-" INVASIVE. HX-" OTH BFG 003723 % a & U3 & *** PATH/TQX SYSTEM OUtPUT *'* VINYL CHLORIDE COMBINED INHALATION TWQ-OENftAT|ON REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU01 ANIMAL NUMBER: 3534 DATE OF DEATH: 09/29/9/ SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRII STUDY DAY OF DEATH: 133 STUDY WEEK Of DEATH: 19 TERMINAL BODY WEIGHT: V ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I LIVER UTERUS MICRO: -MINIMAL -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATQCVfES; CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBUIAR: HYPERTROPHY LFT:8 KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "1-" INVASIVE, "X-" OTHER BFG 003724 CD S u> 'O PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBtNED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST! ANIMAL NUMBER: 3535 DATE OF DEATH: 09/30/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: 134 STUOY WEEK OF DEATH: ZO TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FftEE-TEXT COMMENTS / HIST0PATH0L0G1I KIDNEYS LIVER UTERUS GROSS; -DILATATION, MODERATE -LEFT MICRO: -MINIMAL -MINIMAL, -MINIMAL, -MINIMAL FOCAL FOCAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NQN-ZONAI -ACUTE/SUBACUTE INFLAMMATION -BASOPHILIC FOCUS -HEPATOCYTES CENTKlLOBULAR: HYPERTROPHY GROSS: -jHPLANT SCARS - PRESENT..................................-RiGMT:6; LEFT:9 KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, 'V METASTATIC, *'I-H INVASIVE, "X-" OTHI BFG 003725 & o & *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER: 3536 DATE OF DEATH: 09/29/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRtF STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH; 19 TERMINAL BOOT WEIGHT: 27! ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-tCxT COMMENTS / HISTOPATHOLOGIC F LIVER UTERUS MICRO: -MINIMAL ........................................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES (NDN-ZONAL) -MINIMAL -HEPATOCYTES CENTR1LOBULAR: HYPERTROPHY GROSS: `IMPLANT SCARS - PRESENT `RJGHT;6; LEFT;7 KEY TO NEOPLASMS: "H-" MALIGNANT, "fl-" BENIGN, "S-M METASTATIC, "1-" INVASIVE. HX-M OTHER BFG 003726 3 O 5 O' *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOMClTV STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET SI ANIMAL NUMBER: 3537 OATE OF DEATH: IO/OZ/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY DAY OF DEATH; I3B STUDY WEEK OF DEATH: 20 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HJSTOPATHOLOGJ LIVER UTERUS ............................................................................................................................................................................................................................... MICRO; -MINIMAL -MINIMAL -HEPAT0CYTC5: CYTOPLASMIC VACUOLES (NON-ZON/ -IIEPATOCYTES CENTRILOBULAR: HYPERTROPHY ............................................................................................................................................................................................................................... GROSS; -IMPLANT SCARS - PRESENT -RIGHT:10; LEFT:3 KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" HETASTAUC. "I-" INVASIVE. "X-" Oil 3 o BFG 003727 *** path/tox system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD' ANIMAL NUMBER: 3536 DATE OF DEATH: ID/02/97 SEX: FEMALE DO$ CROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRil STUDY DAY OF DEATH; 136 STUDY WEEK OF DEATH: 2D TERMINAL BODY WEIGHT: 2` ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYUOROS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I LIVER UTERUS ..................................................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZQNAL) MINIMAL 'HEPATOCYHS CENTRIlOBULAR: HYPERTROPHY ..................................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT:; LEFT:7 KEY TO NEOPLASMS: "M-" MALIGNANT, "fl-" BENIGN, V" METASTATIC. ''I-" INVASIVE. "X-" OTHER RZiCHfl f)ja to 3 o -fc* UJ L/i oo *** PATH/TOK SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU ANIMAL NUMBER; 3539 DATE OF DEATH: 10/02/97 SEX; FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACK STUDY DAY OF DEATH: 136 STUOT WEEK OF DEATH; ?Q TERMINAL BODY HEIGHT: ORGAN NAME * * * pathology OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXY COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL -HEPAT0CYTE5 CENTRILOBULAR: HYPERTROPHY -RIGHT:; LEFT;5 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. MS-" METASTATIC, "l-" INVASIVE, "X-" OTHE *** PATH/TOX system output *** V(NYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET STUDY ANIHAL NUMBER: 3541 DATE OF DEATH: 10/01/97 ORGAN NAME SEX: FEMALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACfiJF STUDY DAY OF DEATH; 13$ STUDY WEEK OF DEATH: 20 TERMINAL BOOT WEIGHT: 264 " * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FRIE-TEXT COMMENTS / HISTOPATHOLOGIC F LIVER SMN UTERUS MICRO; -MINIMAL -MINIMAL GROSS; -HAIR A85ENT/THIN, MODERATE dross: -Implant ScArS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES*(NQN-ZONAL) -HEPATOCYTES CENTRlLOBULAR; HYPERTROPHY -HAIR THIN; BOTH FQftEPAWS -RIGHT-6; LEFT10 KIT 10 N10PlASM*k M MAI HikANT (I " BINION. "S`H NfTASTATlC. "I-" INVASIVE, "X-" DTHER D3 W T1 oO L>> & O O *** PATM/TOK SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER: 3543 DATE DP DEATH: 09/29/37 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACf STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH; 19 TERMINAL BODY WEIGHT: ORGAN NAHE * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATHQLQGH LIVER UTERUS MICRO:'-MINIMAL .................................................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-ZONAI -MINIMAL -HEPATOCTTES CENTRIL06ULAR: HYPERTROPHY GROSS; -IMPLANT SCARS - PRESENT -AIGHT:10; LEFT;10 KEY TO NEOPLASMS; "M-" MALIGNANT, "B*` BENIGN. "S-" METASTATIC, MI-" INVASIVE, 'V* DTHI GO 3a itie o o ** PATH/TOX $f$rCH OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 3S45 DATE OF DEATH: 10/04/97 SEX: FEMALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED* TERMINAL SACRU STUDY DAY OF OEATH: 138 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWOROS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC ' LIVER UTERUS ............................................................................................................................ ........................................................................................................ MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (RON-ZONAL) -MINIMAL, FOCAL -ACUTt/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY ................................................................................... ............................................................................................................................................. GROSS: -IMPUNT SCARS - PRESENT -RIGHT17; LEFT:9 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-* BENIGN. "S-" NETASTATIC, "I-" INVASIVE, "X-" OTHER CO T1 ee o *3 C o\ o G TO ez fjJ -J to *** PATH/TOK SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 3547 DATE OF DEATH; 10704/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEOULEO, TERMINAL SAC STUDY DAY OF DEATH: ISO STUDY WEEK OF DEATH: 20 TERMINAL DODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FRCE-TEXT COMMENTS / HI5T0PATHQL0GI LIVER UTERUS MICRO; -MINIMAL -MINIMAL gross; '-Implant scars - present -HEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZONA -HEPATOCYTES CEHTftllOSULAR: HYPERTROPHY -rIght^; lefti7 KEY TO NEOPLASMS; "H*`` MALIGNANT, V" BENIGN, METASTATIC, "1-" INVASIVE, "X-" OTH ANIMAL NUMBER: 3S49 DATE OF DEATH: 10/02/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIF STUDY DAY DF DEATH; 136 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 27 ORGAN nahe * * * PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COHHCNTS / HISTOPATHOLOGIC F LIVER SKIN . UTERUS MICRO; -MINIMAL 'MINIMAL -SLIGHT, FOCAL -SLIGHT, FOCAL GROSS: 'HAIR ABSENT/THIN. MODERATE GROSS; -iMPlANT SCARS - PRESENT 'HCPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CEHTRILOBULAR: HYPERTROPHY -NECROSIS.COAGULATION -ANGIECTASIS -HAIR THIN: LEFT LOWER VENTRAL -ftioMT:4; LEFT:10 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, *$-" METASTATIC, "l-*1 INVASIVE, "X-" OTHER BFG 003734 03 nn O & O' o FATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 3550 DATE OF DEATH: 10/02/97 SEX; FEMALE DOSE GROUP; 3 SACRIFICE STATUS; SCHEDULED. TERMINAL SA STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH: ZQ TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTDPATHOLDG LIVER . . UTERUS . . MICRO: -MINIMAL .................................................................... -NEPATQCYTES: CYTOPLASMIC VACUOLES (NON'ZON -MINIMAL -HEPATOCYTES CENTRIlOBULAR: HYPERTROPHY GROSS: -IMPLANT SCARS - PRESENT -RIGHT:6; LEfT:9 KEY TO NEOPLASMS; "H-" MALIGNANT, "t-" BENIGN, "S-" METASTATIC. "1-" INVASIVE. "X-" OT BFG 003735 a LP O' o O' *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 3551 DATE OF DEATH: 10/03/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI STUDY DAY OF OEATH: 137 STUDY WEEK OF QEATH: 20 TERMINAL BODY WEIGHT: 2 ORGAN NAME * * * PATH0L06Y OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREI-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS ............................................................*................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTtS CEMtRtLOBULAR: HYPERTROPHY -MINIMAL* FOCAL -EXTRA MEDULLARY HEMATOPOIESIS .................................................................................................................................................................................................... ............................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT:7: LEFT:? KEY TO NEOPLASMS: "M-" MALIGNANT. "B-** BENIGN. "S-" METASTATIC, "I-" INVASIVE, V' OTHEF C3 5o o=- O' *** PATH/TOX SYSTEM OUTPUT **" VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER: 3553 DATE OF DEATH: 10/03/9? SEX: FEMALE OOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAi STUDY DAY OF DEATH: 137 STUDY WEEK OF DEATH: ZO TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / H15TQPATH0L0G LIVER UTERUS ............................................................................................................................................................................................................................... MICRO: `MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION MINIMAL -HEPATOCYTES CEHTRILOBULAR: HYPERTROPHY ............................................................................................................................................................................................................................... GROSS; -IMPLANT SCARS - NOT PRESENT KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "l-" INVASIVE, "X-" OT BFG 003737 O & o *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER: 3S54 DATE OF DEATH: 10/04/97 SEX: FEMALE DOSE GROUP: l SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIF STUDY DAY OF DEATH: 138 STUDY WEEK OF DEATH: ZO TERMINAL BOOT WEIGHT: 32 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F LIVER UTERUS ......................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTE5 CENTRILOBULAR: HYPERTROPHY ......................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT:6; LEFT:? KEY TO NEOPLASMS: "M-H MALIGNANT, BENIGN. "S-" METASTATIC. HI-" INVASIVE, "X-" OTHER BFG43608 O o w 00 ** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANQ DEVELOPMENTAL TOXtCITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET Si ANIMAL NUMBER: 3S$S DATE OF DEATH: 09/30/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY DAY OF DEATH; 134 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HIST0PATH0L0G1 LIVER UTERUS MICRO; -MINIMAL, FOCAL.......................................................-ACUTE/SUMCUTE INFLAMMATION -MINIMAL -HEPAT0CYTE5 CEHTRILOBUIAR; HYPERTROPHY GROSS:"-IMPLANT SCARS - PRESENT ................................ -RIGHT:9; LEFT:7 KEY TO NEOPLASMS; mM-m MALIGNANT, "B-" BENIGN, **S-" METASTATIC, MI-" INVASIVE, "X-M OTt *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER: 3556 DATE OF DEATH: 09/30/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED* TERMINAL SACRlf STUDY OAY OF DEATH; 134 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: U * * * PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I LIVER UTERUS MICRO; MINIMAL, FOCAL -MINIMAL GROSS; -IMPLANT SCARS - PRESENT -HEPAT0CYTE5: CYTOPLASMIC VACUOLES (NON-ZONAL) "HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -RIGHT:5; LEFT:6 KEY TO RtOPlAW "H" HAt IGnAMT. "B-" BENIGN. "S-" METASTATIC, HI-M INVASIVE. "X-" OTHER B F G UU3740 3 o S O' *** PATH/TDX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET SI ANIMAL NUMBER: 3557 PATE OF DEATH: 09/29/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEOULEO, TERMINAL SAC STUDY DAY OF DEATH: 133 StUpY WEEK OF DEATH; 19 TERMINAL ROPY WEIGHT; ORGAN NAME * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGI LIVER UTERUS MICRO: -MINIMAL -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (HON-ZON/ -HEPAT0CYTE5 CENTRtLOBULAR: HYPERTROPHY -RIGHT:6; LEFT;A KEY TO NEOPtASMS NAUGNANT. "6-" BENIGN, V" METASTATIC, "I-** INVASIVE, "X-" OTI BFG 003741 o *** PATH/TOX SYSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD' ANIMAL NUMBER: 3SS8 DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRII STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 3: ORGAN NAME aaaw.aaaaaaaaaavaaaaa * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION a a aa a W w ^ w m -- + w -------- ^ LIVER UTERUS . . MICRO: 'MINIMAL 'MINIMAL, FOCAL -MINIMAL GROSS: -IMPLANT SCARS - NOT PRESENT OBSERVATIONS * 4 * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I _ _a aaaaaawT-svv-v--vaT----- t----------w ------- - *r-------------------------------------- -HCPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -ACUTE/SUDACVTE INFLAMMATION -HEPATOCYTES CENTRHOBUIAR: HYPERTROPHY KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER `3AISVANI `DllViSVlBW ,,-3,, *H9lN3fl ,,-8,, `lNYMSHYH ,r*,, -SMSVld03N 01 I I'ii31 MomnnwSu1'SsVis1t3w3Ia9NiNV-- iHdomajdAH ; avinaon IM1N30 s3u:jdiV43H- 1N3S3BJ * SHWS INVldHl- :SSt ivaoj 'iMgns- 1V30J 'IHSnS1WIN1H- :o: 59NI0HU 3I301QHlVd0i$2H / S1N3HHQ3 AX31-33HJ SS0W9 NOllMniiSIQ 'A1IM3A3S 'SQHWW]* , SHOIiVAU3S0O ABOTOHIVd , * SHVM9 Z'63E HH9I3H AOoO 1VMIMM31 61 `H1V3Q JO ^33ft AOMS SCI -MiV3<] 30 AVO AONIS 35I4IWV$ 3VNINM31 *O3ln03H3S :SfliVlS JOIdlttW t :<inOW 3S0Q 31YH34 X3S VOGOF96 :B30Mf1N AOHiS lit 1W4 fifi-BdV-6Z :Q3iNlUd X33MS VIVO 1VNIKV lVnatAKJHI Siva 03 HI AOOIS Alt3lXQi lYiN3Hd013A30 ONV NOll?nOQW3tf M>]jyWJ9-MJ JWJJVIVHNJ 03HIBH03 301H01H3 1AN1A ** IfldinO H3ISAS XOJi/HLVd *** /' *** PATtyTOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATIQN REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STtJDl ANIMAL HUMBER: 3560 DATE OF DEATH: 09/E9/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRlf STUDY OAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BODY HEIGHT: 3i ORGAN NAME * * * PATHOLOGY OBSERVATIONS *** KEYVOROS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I LIVER UTERUS MICR6:'-M1NIHAI ..................................................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-ZONAL) -MINIMAL -HEPATOCYTES CENTRILOBUIAR: HYPERTROPHY GROSS:''IMPLANT SCARS - PRESENT................................-RIGHT:3; LEFT: 10 KEY TO NEOPLASMS: "M-" MALIGNANT, 'B-" BENIGN, "S-" METASTATIC, "i-" INVASIVE, "X-" OTHER cc *r c o mem *" PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STL ANIMAL NUMBER: 356? DATE OF DEATH; 09/Z9/S7 SEX: FEMALE DOSE GROUP: 3 SACRIFICE StAtUS: SCHEDULED. TERMINAL $ACI STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOSY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGK LIVER UTERUS MICRO;'-MINIMAL .................................................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES*(NON-ZONAi -MINIMAL -HEPATOCVTES CENTAILOBULAR: HYPERTROPHY GROSS: -iMPLANT SCARS - NOT PRESENT KZY W NCOPMSMS; **M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTHI *** PATH/TDX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUW ANIMAL NUMBER; 3564 DATE OF DEATH; 09/29/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRII STUDY DAY OF DEATH; 133 STUDY WEEK OF DEATH: 19 TERMINAL BOOY WEIGHT; 31 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TCXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY -RIGHT:?; LEFT:7 KEY TO NEOPLASMS: "M-" MALIGNANT, `V BENIGN, MS-" METASTATIC. "I-H INVASIVE. "X-" OTHER *** paTH/tox system output *** VtkYL CHLORIDE CONBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY ]N CO RATS INDIVIDUAL ANIMAL DATA SHEET STI ANIMAL NUMBER; 3565 DATE OF DEATH: 10/04/07 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEDULED. TERMINAL SACI STUOY DAY OF DEATH: I3fl STUDY WEEK DF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * ` * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHQLOGtl LIVER UTERUS . MICRO: -MINIMAL .............................................. ..... -HEPATOCYTES CENTR1LOBULAR: HYPERTROPHY GROsSj-iMPLANT SCARS - PRESENT ................................ -R1GH:9; LPT KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, "1*" INVASIVE, nt-' OTHi B fX i 003747 O & L>J O' ANIMAL NUMBER: 3568 DATE Of DEATH: 10/0Z/9? ORGAN NAME *** PATH/TAX &VST EM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATIQN REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUD! SEX: FEMALE OQ$E GROUP; 3 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRII STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 2, * * * PATH0106Y OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I L IVn UTERUS ...........................................................,......................................................................................................................................... -............................................. <............................ . MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) "MINIMAL -HCPATOCYTES CENTRlLOBULAR: HYPERTROPHY .................................................................................................................................................................................................................................... GROSS: "IMPLANT SCARS - PRESENT -RIGHT:9; LEFT-.fl ....................................KEY TO NEOPLASMS; "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "l-" INVASIVE, "X-" OTHER a *T to a3 O 4^ CJ\ oo s t^rn o *** PATH/TOX system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST! ANIMAL NUMBER: 356? DATE OF DEATH: 10/03/97 SEX: FEMALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: 137 STUDY WEEK OF DEATH; 20 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FftEE-TExT COMMENTS / HI5T0PATH0L0G1 LIVER UTERUS MICRO: -MINIMAL -MINIMAL -HEPATQCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -HEPATOCYTES CENTRllOBULAR: HYPERTROPHY GROSS: -iMPLANT SCARS - PRESENT................................ -RisHT:7; LEFT:5.............................................................. KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, METASTATIC, "l-" INVASIVE. "X-" OTH BFG 003749 OS o & 'O *** PATH/TOK SYSTEM OUTPUT *** vinyl Chloride combined inhalation twq-seneratiqn REPRODUCTION AND DEVELOPNENTAL TOXICITY STUDY tN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 3566 DATE OF DEATH: 10/03/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 137 STUDY WEEK OF DEATH: 20 TERMINAL BODY HEIGHT; 2 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER UTERUS MICRO: -MINIMAL ................................ -minimal ` 6R0SS;`-IMPLANT SCARS - PRESENT -HEPATGCYTES: CYTOPLASMIC VACUOLES'(NON-ZONAL) 'HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -RIGHT:3; LEFT:S KEY TO NFOPlASNS "N-" MALIGNANT BENIGN, "S-" METASTATIC. "I-" INVASIVE, **X-M OTHER BFG43620 'J\ O B3HJ0 ,,-X,, 'JAlfVMtl .1. . 5. '*91*11 .. _ 1 ***>! '* 'rfo i* Oi j *i doivj/siDhoiACi '$310**0 sis wi/kw rm*A >h3i 0* t sis iwn/)f&* i sjs Mm/no* aivwmvw < 0]A)$0 mmVMM9V SltfOHOlSI* Q* 0th MO 1N3H9M NrtOdfl HniHi3HOaN3>:U3l 5:iH9la- 1V30J lVMlNlH' 0; A3S3tld ' SBV3S INVldHl- =SS( VlSlTMftdAH QlOHdHAl -1300 1VHIU3V10SVN- 1VH1M1H- :Ott AHdOaMdAH 0^lnflOMaiN33 S3U3<UVd3H(1VN02-N0NJ S31Qf13VA 3IWSVldOW3 'S3iA3(Ul3H; 1VH1NIHIVHINIH- :0#; S9MI0NM 3I9010HiVdQiSIH / S1K3HH03 1X31*3383 SS089 NOUnBlKlSIO 'A1IH3A3S 'SBU0AA3X , . , SH0I1VA03S80 HOlOHUil , . , SHVU9 I'SOC :iH9!3M AflOB IVMJHMi OZ :HlV3fl JO K33A AOAiS SCI `HlV30 do AVd AOlUS 3DIJIX3VS iVlllMttl 'a3ln03H3? JSfUViS 33U1MDVS * -dMHI9 3S00 31VM33 `KJt V080*96 *tt38HnN AOfUS Ofl> '39Vd 86-dV-6l '03iNlti4 133HS VIVO 1VHINV lVnQIMQNI SiVB 03 Nl AOniS AU31XQ1 lVlN3Hd0n3A30 QNV HQtl3n<JQtfd3H NQ[|W3N39-Ofli NOUVlVHNl Q3NIBH03 30WQ1H3 1AN1A ,,* indino H31SAS XOi/MIVd ... 0 ANIMAL NUMBER: 4531 DATE OF DEATH: 10/03/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVQ-GENERAT|ON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACK! STUDY DAY OF DEATH: 137 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 3 ORGAN KANE * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS LIVER UTERUS . MICRO: -MINIMAL, FOCAL.................. .................................... -PELVIS; ' FREE ERYTHROCYTES............................................. MICRO:'-MINIMAL .................................................................... -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -MINIMAL -HEPATOCYTES CENTRILOBULAR:HYPERTROPHY GROSS; MMPLANT SCARS - PRESENT................................ -RIGHT;8; LEFT:*................................................................... MICRO: -SLIGHT -SLIGHT, FOCAL -LUMEN: DILATED -MYOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURfi SEC 2. H05E/TURB SEC 3, HOSE/TURB SEC 4. OVARIES, QVlDl PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "0-*' BENIGN, "S-" METASTATIC, "1-** INVASIVE, "X-" OTHEF cd O t* *e U) c ON to to Z&100 *** PATH/TQX SYSTEM OUTPUT *** V1NTL CHLORIDE COMBtHEO INHALATION TVO-GCNEfiAflON REPRODUCTION AMO DEVELOPMENTAL TOXICITY STUQY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 4535 DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED. TERMINAL 5AC STUDY DAY OF DEATH: 136 STUDY WEEK OF OEATH: 20 TERMINAL BODY HEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTQPATHOLQSt KIDNEYS .................................................................................. MICRO: -MINIMAL, MULTI-FOCAL LIVER ....................................................................................... MICRO: 'MINIMAL -MINIMAL, FOCAL -MINIMAL, FOCAL -minimal NOSE/TURB SEC 3 ................................................................ MICRO: -MINIMAL UTERUS ...................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT, FOCAL -MINERALIZED GRANULES -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONA -ACUTE/SUBACUTE INFLAMMATION -ACIDOPHILIC FOCUS -HEPATOCYTES CEHTRILOBULAR; HYPERTROPHY -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -RIGHT:G; LEFT:6 'MYOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES MAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 2. NOSE/TURB SEC 4, OVARIES. OVIOUCTS/FALOP T, PI TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-h BENIGN, "S-" METASTATIC. "I-" INVASIVE, "X-" OTF BFG 003753 to 3 u> ON ro BFG 003754 *** PATH/TOX SrSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER; 4$3D DATE OP OEATH: 00/30/07 SEX: FEMALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC STUDY DAY DP DEATH: 134 STUDY WEEK OP DEATH; 20 TERMINAL BODY WEIGHT; ORGAN NAME ** PATHOLOGY OBSERVATIONS KETWOROS, SEVERITY. DISTRIBUTION DROSS FREE-TEXT COMMENTS l H1ST0PATH0L0G1 KIDNEYS MICRO: -SLIGHT, MULT I-FOCAL LIVER MICRO: -MINIMAL -MINIMAL NOSE/TURB SEC Z MICRO; -MINIMAL NOSE/TURB SEC 3 MICRO: -MINIMAL UTERUS GROSS: -IMPLANT SCAR5 - PRESENT MICRO: -MINIMAL. FOCAL -MINERALIZED GRANULES -HEPATOCYTES: CYTOPLASMIC VACUOLES (MQN-ZONA -HEPATOCYTCS CENTRILOBULAR: HYPERTROPHY -VOMERONASAL ORGAN: EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT: LYHPHoio HYPERPIAsIa' -RIGHT:5; LEFT:10 -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1, NOSE/TURB SEC 4, OVARIES, OYIDUCTS/FAlOP T, PITUITARY GLAND, TR KEY TO NEOPLASMS; "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "l-`` INVASIVE. "X-" QTH ANIMAL NUMBER: 4540 DATE OF DEATH: 10/04/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $TUd SEX; FEMALE* DOSE GROUP:T'""sACRIfICE STATUS: SCHEDULED, TERMINAl'sACJU STUDY OAY OF DEATH: 130 STUDY NECK OF DEATH; ?0 TERMINAL BODY HEIGHT: 3 ORGAN NAME * * * pathology observations * * * KEYWORDS. 5EVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER .................................................................................................................................................................................................................................... MICRO: 'MINIMAL -HEPATOCTTES: CYTOPLASMIC VACUOLES (NON-EONAL) -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION 'MINIMAL, MULTI-FOCAL -ACIDOPHILIC FOCUS -MINIMAL -HEPATOCVTES CENTRILOBULAR: HYPERTROPHY NOSE/TURB SEC 3 MICRO: -MINIMAL .................................................................... -NASOLACRIMAL DUCT; LYMPHOiD HYPERPLASIA' UTERUS .................................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - NOT PRESENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC I, NOSE/TURB SEC 2. NOSE/TURB SfC 4. OVARIES, OVIDUCTS/FAL( PITUITARY GLAND, TRACHEA, UTERUS, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-H METASTATIC, "1-" INVASIVE, "X-" OTHEI OS *T o L>J On N> O' q s ie o rt *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE C0HB1E0 INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 4542 DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS *"* KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOB! LIVER ....................................................................................... MICRO: -MINIMAL -MINIMAL, FOCAL -MINIMAL, FOCAL -MINIMAL NOSE/TURB SEC 2 ....................................................... MICRO; -SLIGHT NOSE/TURB SEC 3 ................................................................ MICRO: -MINIMAL UTERUS........................................................... *...................... GROSS; -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -HEPATOCVTES; CYTOPLASMIC VACUOLES (NON-ZONA -ACIDOPHILIC FOCUS -BASOPHILIC FOCUS -HEPATOCVTES CENTR1LOBULAR: HYPERTROPHY -NASOLACRIMAL OUCT(sj; FREE ERYTHROCYTES -NASOLACRIMAL OUCT: LYMPHOID HYPERPlASU ~RlGNti4; LEFT ;3.................................................. -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: KIDNEYS. LUNGS. MAMMART GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 4 OVARIES, 0V1DUCTS/FAL0P T, PITUITARY TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, BENIGN, "S-" METASTATIC. "I-'' INVASIVE, "X-" OTI BPG 00375 *T\ a p* L>> Oto' -J *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLOftlDf COMBINED INHALATION tW0-6ENERATl0N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STU01 ANIMAL NUMBER: 4545 DATE OF DEATH: 10/01/97 SEX: FEMALE OOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRII STUDY DAY OF OEATH: 135 STUDY MEEK OF DEATH: 20 TERMINAL BODY HEIGHT; 22 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC I GROSS/MICRO CORR ...................................................................................................................................................................................... MICRO: HISTOPATHOLOGICAl COMMENT; SIDNEYS; D1LATATI0N/PELVIS DILATED KIDNEYS ......................................................................................................................................................................................................... GROSS: -DILATATION. MODERATE -BOTH PELVIS MICRO; -MINIMAL -PELVIS: 01LATED LIVER ....................................................................................... MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ioNAL) -MINIMAL, FOCAL -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -Dicnpuii if* rnrut MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY UTERUS ....................................................................................... GROSS; -IMPLANT SCARS - PRESENT -RIGHT;7; LEFT;S MICRO; -MINIMAL, FOCAL -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS. NO5E/TUR0 SEC 1. NOSE/TURB SEC 2. NOSE/TURB SEC 3. NOSE/TURB SEC 4, OVARIES. OVfOUl PITUITARY GLAND. TRACHEA, VAGINA KEY TO NEOPLASMS; "N-" MALIGNANT, "B-" BENIGN, "S*K METASTATIC, -I-" INVASIVE, **X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VtNYl CHLOAlOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET Si ANIMAL NUMBERi 4546 DATE OF DEATH: 09/30/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SAt STUDY DAY OF DEATH: 134 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION DROSS FRfE-TEXt COMMENTS- / HISTOPATHOtOGI EXTREMITY .................................................................................................................. GROSS: -HAIR THIN, MODERATE GROSS/MICRO CORR . , . , MICRO: .............................................................................. HISTOPATHOLOGICAL COMMENT; LIVER ......................................................................... ................................................. MICRO: -MINIMAL MINIMAL. FOCAL MINIMAL NOSE/TURB SEC 4 .................................................................................................... MICRO: -MINIMAL UTERUS ........................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT, FOCAL -RIGHT H1NDPAW EXTREMITY: HAIR THlM/NHC -HEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-ZON/ -tcurt/smcoil INFLAMMATION -HEPATOCYTES CENTRILOBUIAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY); EPITHELiuH-INTRM EOSINOPHILIC MATERIAL -RIGHT:10; LEFT:* -MYOMETRIUM; BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OflSERVEO; EXTREMITY. MONEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2. N0SE/TUR6 SEC 3. OVARIES, , PITUITARY GLANO. TRACHEA. VAGINA KEY TO NEOPLASMS: "N-" MALIGNANT. "B-** BENIGN. "S-* METASTATIC. "l-M INVAStvE. "A-* OT BFG 003759 o P* \D *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET 5TUI ANIMAL NUMBER: 4548 DATE OF DEATH: 10/02/97 SEX; FEMALE DOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRl STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH; 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC LIVER ....................................................................................... MICRO; -MINIMAL -H1NIMAL, FOCAL -MINIMAL, FOCAL -MINIMAL NOSE/TURB SEC 3 ................................................................ MICRO: -MINIMAL NOSE/TURB SEC 4 MICRO -MINIMAL DTE ftUS GAOS S 1 l*Pi AH i l A A S M|C0 -MINIMI S v r M 41 -HEPAIOCYTES: CYTOPLASMIC VACUOLES (NON-IQNAI -ACIDOPHILIC FOCUS -BASOPHILIC FOCUS -HEPATOCYTES CENTR1L0BULAR: HYPERTROPHY -NASOLACRIMAL OUCT: LYMPHOIO HYPERPLASIA NASAL MUCOSA (OLFACTORYBASOPHIL 1C MATERIA! l|f,Hl . 1(TT 6 1UN(R PIL AI f D MTOMdllUM BIOVM Pi GHENT ;hL I Ol L Ov I N<i MUuC. *Al> NO "IliOUO'K t*NO*Mi 11 [{ S OtSIRYlQ MDMlTS. lyNUS. maaaAAi AMDS MOW/tuRB SIC 1. NOSt/TURI SEC 2, OVARIES. OVlQUtlS/FALOP T, PITUITARY 6 I*ACh(A. VAGINA KEY TO NEOPLASMS; "M-" MALIGNANT, "8-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-'OTHE cc a l>0 Os O B W 0U376U **" PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBER; 4549 DATE OF DEATH: 10/01/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SA> STUDY DAY OF DEATH: 135 STUDY WEEK OF OEATH; 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS.SEVERITY.DISTRIBUTION GROSS FREE-TEXT COMMENTS / H1STDPATH0L0G LIVER LUNGS UTERUS .............................................................................................................................................................................................................................. MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (HON-ZON -MINIMAL. MULTIFOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL. FOCAL -BASOPHILIC FOCUS 'MINIMAL -HEPATOCYTES CENTftilO&UlAR; HYPERTROPHY ........................................................................................................................................................................................................................................... MICRO; -MINIMAL. FOCAL -OSSEOUS METAPLASIA ... CROSS IMPiturSCARS PM(T ............................................................................................................................... -RIGHT; 4; LEFT:6 MICRO Ml HI Ml ro(Al -MTOHETRIUM: BROWN PIGMENT THE FOllO* H6 llSSUtS HAD *0 N U AOS( ON C 0*)(RV(0 UMpl aammait NO\|MuM 1U I. NOIC/TPM >(C i, MOM/lull SIC J, MOS'/IURB SIC 4, OVARIES. , HTUllART t|A5 IRAIHIA A(il*A if? 10 if ORt ASMS M MAiIWURT "| " |(NlG. `S " METASTATIC, "I-" INVASIVE. "R-" Of BFG43631 -4 O' *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND PEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER: 4551 DATE OF DEATH: 10/02/97 SEX: FEMALE OOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIF STUDY OAY OF DEATH: 136 STUDY WEEN OF DEATH: 20 TERMINAL BODY WEIGHT: 32 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC f LIVER UTERUS ....................................................................................... MICRO: -MINIMAL `MINIMAL, FOCAL -NIN1NAL .................................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: `SLIGHT, FOCAL `HEPATOCYTES: CYTdPlASHtC VACUOLES (NON-ZOHAL) -BASOPHILIC FOCUS -HEPAT0CYTE5 CENtNlLOBULAR: HYPERTROPHY -RIGHTS; LEFT:? -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC Z, NQSt/TURB SEC 3, N0SE/TUR6 SEC 4, OVARII OVIOUCTS/FALQP T, PITUITARY GLANO, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "l-M INVASIVE. "X-** OTHER BFG 003762 w 33 O 4^ U) OS LO to *"* PATH/TQK SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CQ RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 4552 DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE GROUP: SACRIFICE STATUS; SCHEDULED, TERMINAL SAC STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HI5T0PATHQL0G1 LIVER . . . . MICRO: -MINIMAL -MINIMAL NOSE/TURB SEC 2 MICRO: -MINIMAL UTERUS . . . . GROSS: 'IMPLANT SCARS - PRESENT MICRO: -SLIGHT, FOCAL -HIPAT0CYTE5: CYTOPLASMIC VACUOLES (NON-ZONA -HEPATOCYTES CENTRtLOBULAR: HYPERTROPHY -vomeronasal organ! exudate -RIGHT;j LEFT:7.................. -MYOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS. HOSE/TURB SEC 1, NOSE/TURB SEC 3, NOSE/TURB SEC 4, OVARIES, OVIDUCTS/FJ PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, INVASIVE, "X-" 0T> BFG 003763 bd 3 a os U) UJ PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-SENEftATIOK REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER: 4554 DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE 6A0UP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACAIF STUDY DAY OF DEATH: ISO STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 27 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC f LIVER , . . . MICRO: -MINIMAL -MINIMAL HOSE/TURB SEC 4 MICRO: -MINIMAL UTERUS ....................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRI LOBULAR: HYPERTROPHY -NASAL HUCOSA (OLFACTORY): 'EPtTHEliUM-INTRACYTC EOSINOPHILIC MATERIAL -RjGHT;2: LEFT-B....................................................... `ENDOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NQ MICROSCOPIC ABNORMALITIES OBSERVED: MONEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. NOSE/TURB SEC 3, OVARIES, OVIQUCTS/FAlflf PITUITARY GLAND, TRACHEA. VAGINA KEY TO NEOPLASMS: "n~` MALIGNANT, BENIGN, "5-" METASTATIC I-" INVASIVE, "X'** OTHER to 00 to aO A 4^ OS * Ui U* 4 8 *** PAfH/TOX system OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $TI ANIMAL NUMBER; 4555 DATE OF OEATH: 09/29/97 SEX; FEMALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEPULCO, TERMINAL SACI STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlSTOPATHOlOGH LIVER ........................................................................... MICRO: -MINIMAL -MINIMAL, FOCAL -MINIMAL NOSE/TURB SEC l .......................................................................... MICRO: 'MINIMAL NOSE/TURB SEC 4 ................................................................. MICRO; -MINIMAL UTERUS -MINIMAL. FOCAL ....................................................................................... GROSS; -IMPLANT SCARS - PRESENT MICRO; -MINIMAL, FOCAL -HCPATOCYTES: CYTOPLASMIC VACUOLES (HOH-ZQNA -BASOPHILIC FOCUS -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY NASOLACRIMAL OUCT(S): INFLAMMATORY CElLS/CE1 -NASAL MUCOSA (OLFACTORY): EPITHEllUM-INTftAC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY); BASOPHILIC H4TERI -RIGHT!?! LEFT!?........................................................... -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 3, OVARIES, OVIDUCTS/FALQP T, PITUITARY TRACHEA, VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. '*!-*' INVASIVE, "X-" OTH BFG 003765 cd 3 O Os u-> ^J\ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TwO-GEnERaTtON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 4556 DATE OF DEATH: 09/29/97 SEX: FEMALE DOSE 6R0UP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR1 STUOY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BOOT WEIGHT; i ORGAN NAME * * PATHOLOGY OBSERVATIONS * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIDNEYS LIVER LUNGS MICRO: -MINIMAL, FOCAL MICRO: -MINIMAL -MINIMAL, FOCAL -MINIMAL MICRO: -MINIMAL, FOCAL 'CORTEX: INFILTRATES SUBACUTE -HEPATOCYTES; CYTOPLASMIC VACUOLES (RON-ZONAL) -BASOPHILIC FOCUS -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY -VISCERAL PLEURA/CAPSULE: SUBACUTE (CHRONIC At CHRONIC INFLAMMATION NOSE/TURD SEC 4 MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACY1 EOSINOPHILIC MATERIAL OVIOUCTS/FALOP T MICRO; HIST0PATHQL0G1CAL COMMENT: >ONE PRESENT UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -RIGHT:8; LEFT:B -ENDOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: * ............ .. , MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, NOSE/TURB SEC 3. OVARIES, QVIDUCTS/FALOP T. PITUITARY ( TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "8-M BENIGN, "S-" METASTATIC. "1-" INVASIVE. "X-" OTHEI BFG43636 si o-v 0\ ?mtrox system output *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUMBER: 4557 DATE OF DEATH: 09/28/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE StATuS: SCHEDULED. TERMINAL SAC STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGI KIDNEYS ......................................................................... .... ............................................................................................................................................ LIVER MICRO: -MINIMAL. FOCAL -MINERALIZED GRANULES ................................................................ ,,....................................................................................................................................................... MICRO: -MINIMAL -HEPATDCYTES: CYTOPLASMIC VACUOLES (NON-ZONF -MINIMAL, FOCAL -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -ACIDOPHILIC FOCUS -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY NOSE/TURB SEC 2 .................................................................................................................................................................................................... MICRO; -MINIMAL -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES NQSE/TUftB SEC 3 ......................................................................................................................................................................................................... MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRAC EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ......................................................................................................................................................................................................... MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUH-lNTRAt EOSINOPHILIC MATERIAL UTERUS ........................................................................................................................................................................................................ ................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT:4; LEFT:9 MICRO; -MINIMAL, FOCAL -ENDOMETRIUM; BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, OVARIES, OVlDUCTS/FALOP T. PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "H-*' MALIGNANT, "B-" BENIGN, "5-" METASTATIC. *>" INVASIVE, "X-" OTI BFG 003767 00 53 o & <7\ *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET STUDY ANIMAL NUMBER: 4$S8 DATE OF DEATH: 09/30/97 SEX; FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRlf STUDY DAY OF DEATH: 134 STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: ti ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREC-TEXT COMMENTS / HISTOPATHOLOGIC f LIVER ................................................................ MICRO; -MINIMAL -MINIMAL, FOCAL `MINIMAL NOSE/TURB SEC 4 ......................................... MICRO; -MINIMAL uterus ................................................................................................ GROSS: -IMPLANT SCARS - NOT PRESENT MICRO: -MINIMAL, FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (MOM-ZONAL) ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYK EOSINOPHILIC MATERIAL ENDOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2. NOSE/TURB SEC 3. OVARIES, OVIOUCTS/FALOI PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "H-" MALIGNANT, V" BENIGN, 'V* METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003768 W o 0's o-> oo *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION reproduction and developmental toxicity STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET SI ANIMAL NUMBER; 4S80 DATE OF DEATH; 09/29/97 SEX; FEMALE DOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED. TERMINAL SAC STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEX1 COMMENTS / HIST0PATH0L06] GROSS/MICRO CORR MICRO: H1ST0PATH0L0GICAL COMMENT; LIVER GROSS: -D1SCOLORED-FOCUS(FOC1) HtCROi -MINIMAL NOSE/TURB SEC 1 -MINIMAL MICRO; -SLIGHT NOSE/tURB SEC i MICRO; -SLIGHT NOSE/TURB SEC 3 MICRO; -MINIMAL NOSE/TURB SEC 4 MICRO: -M1NIHAL PITUITARY GLAND GROSS: -ENLARGED, SLIGHT UTERUS GROSS: -INPUNT SCARS - NOT PRESENT MICRO: -MINIMAL -MINIMAL >t)VER: DJSCOLORED/NHC PITUITARY: ENLARGED/NNC ^-MEDIAN LODE: 0.1 CM OJA, TAN. AT CLEFT -HEPATOCYTfS: CYTOPLASMIC VACUOLES (NON-TQNJ -HEPATOCYTlS CENTRtLOBULAR: HYPERTROPHY -NASOLACRIMAL DUCT(5); FREE ERYTHROCYTES -NASOLACRIMAL OUCT($j: FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY); EPITHELIUM-INTRAI EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPtTHELlUM-lNTRAl EOSINOPHILIC MATERIAL -LUMEN: DILATED -ENDOMETRIUM: HYPERPLASIA the following tissues had no microscopic abnormalities OBSERVED: KIDNEYS. LUNGS, MAMMARY GLANDS, OVARIES. 0V1DUCTS/FALDP T. PITUITARY GLAND, TRACHEA. VAGINA KEY TO NEOPLASNS: "H-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, '*1-" INVASIVE, '`X-,T OT BFG43639 s0 o o !>J vj *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STUD ANIMAL NUMBER: 4567 DATE OF DEATH: 10/01/97 SEX: FEMALE DOSE GROUP; 4 SACRIFICE STATUS; SCHEDULED, TERMINAL SACftl STUDY DAY OF DEATH: 155 STUDY WEEK OF DEATH; 70 TERMINAL BODY WEIGHT: 7 ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC KIONEYS LIVER NICRO: `MINIMAL. FOCAL MICRO; -MINIMAL -MINIMAL, -MINIMAL, MINIMAL FOCAL FOCAL NOSE/TURB SEC 4 MICRO: -MODERATE UTERUS . . . . GROSS: -iMPLANT SCARS MICRO: -MINIMAL -MINIMAL, FOCAL PRESENT -CORTEX: INFILTRATES SUBACUTE -HEPATOCTTES: CYTOPLASMIC VACUOLES'(NON-ZONAL) -ACUTE/SUBACUTE INFLAMMATION -BASOPHILIC FOCUS -HEPATOCTTES CENTRILOBULAR; HYPERTROPHY -NASAL LUMEN: FREE ERYTHROCYTES -R1GHT:8; LEFT:B -LUMEN: DILATED -ENDOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. HAMMART GLANDS, NOSC/TURfl SEC t. NOSE/TURB SEC 2, NOSE/TURB SEC 3, OVARIES, OVIQUCTS/FAlOP T PITU TRACHEA, VAGINA r TO NEOPLASMS: "M-" MALIGNANT, "D-" BENIGN, "S-" METASTATIC. "I-" INVASIVE, '`X-** OTHER BFG 003770 Sf to & *** PATH/TOX SYSTEM OUTPUT "* VINYL CHLORIDE COMBINED INHALATION TWJ-etNERATION REPRODUCTION AMO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET S ANIMAL NUMBER: 4503 OATC OF OEATK: 09/29/97 SEX: FEMALE DOSE ORDUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 133 STUDY WEEK OF DEATH: 19 TERMINAL BOOT WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS *** KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HI5T0PATH0L0G KIDNEYS .................................................................................. MICRO: 'MINIMAL, FOCAL LIVER * *.................................... , , *...................... MICRO: -MINIMAL -MINIMAL, FOCAL MINIMAL NOSE/TURB SEC 3 ................................................................ MICRO: -MINIMAL UTERUS ...................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL -Minimal -MINERALIZED GRANULES -HEPAIOCYTIS: CYTOPLASMIC VACUOLES*(NOM-ZON -BASOPHILIC FOCUS -HEPATOCYTES CENTRltOfiULAR: HYPERTROPHY -NASOLACRIMAL DUCT: LYHPHOID HYPERPLASIA -RIGHT:*; LEFT:6 -LUMEN: DILATED -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMAL 111E5 OBSERVED: LUNGS, MAMMARY GLANDS. NQSE/TURB SEC I. NOSE/IURB SEC l. NOSf/TuHfl SC 4. OVARIES. QYlDUCTS/FALOP T, f TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, BENIGN, "5-" HETASTaUC. "l-" INVASIVE, "X-" 01 BFG 003771 D O' ANIMAL NUMBER: 4564 DATE OF DEATH; 10/02/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TM-6ENCRATI0N REPRODUCTION AND DEVELOPMENTAL TOXICITY SWOT IN CO RATS INDIVIDUAL ANIMAL DATA SHEET S SEX: FEMALE DOSE CROUP: 4 SACRIFICE STATUS: SCHDUL0, TERMINAL SA STUDY DAY OF DEATH; 136 STUDY WEEK OF DEATH; 20 TERMINAL BODY WEIGHT; ORGAN NAME KIDNEYS LIVER UTERUS ** PATHOLOGY OBSERVATIONS ' * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXI COMMENTS / KJST0PATH0L06 MICRO; -MINIMAL. FOCAL....................................................... 'CORTEX: INFILTRATES SUDACUTE MICRO; -MINIMAL -MINIMAL, FOCAL MINIMAL gross: -Implant scars- present 'HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-EON -ACUTE/SUSACUTE INFLAMMATION -HEPATOCYTES CENlRlLOBULAR: HYPERTROPHY -right.-io; leftii THE FOLLOWING TISSUES MAO NO MICROSCOPIC ABNORMAL MIES OBSEKVEO: LUNGS. MAMHART GLANOS. NQSf/TURB SEC 1, NOSC/TUftB SEC 2. NOSE/TURB SEC 3, NOSE/TURB SEC 4, OVARIES, OV PITUITARY GLAND, TRACHEA. UTERUS, VAGINA r To NEOPIASHS: "H " MALIGNANT, "G-" BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-" 01 B p G 003772 do *2 2 K> *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY JN CD RAtS iNOlVtOUAL ANIMAL DATA SHEET Si AN1HAL NUMBER: 4566 DATE OF OEAIH; 00/30/97 SEX: FEMALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SA< STUDY DAY OP DEATH: 134 STUDY WEEK OF DEATH: 70 TERMINAL BODY WEIGHT; ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS fREE-TEMT COMMENTS / HISTOFATHQLOG! LIVER UTERUS VAGINA MICRO: `MINIMAL -MINIMAL -HEPAlOCYTES: CYTOPLASMIC VACUOLES (NON-ZON, -HEPATOCYTES CEHTR1LOBULAR: HYPERTROPHY GROSS; -iMPLANT SCARS - PRESENT................................ -RIGHTitflzi.............................................................. MICRO; -MINIMAL MINIMAL, FOCAL -LUMEN: DILATED -MYOMETRIUM; DROWN PIGMENT MICRO MINIMA! -MUCOSA: HYPERKERATOSIS (CORNIFIED) IHE FOU0UIH Nllull HAO M) HICROVCOPK aRmOMAl 11 ||l OlURVID AIpNfTl, (WMAi. miumAtl tiAfeRS IRC I. 1(C I. MSE/TUM SEC J. NOSf/fUM SEC 4, OV. OVlDllC IS/FAlOP I PllwllAt* fct Mi 1AAC*A AIT 1 HRPiA>m "M * A*4|AMT, *R * MAIM. "S " NCUSlATtt. "I " llVAIUt. "X * Ot BFG43643 Ui 'J *4* payh/tok SYSTEM output 4*4 VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET ST ANIMAL NUNBEN: 4SM DATE OF DEATH: 10/01/07 SEX; FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC STUDY DAY OF DEATH: 135 STUDY WEEK OF DEATH: ZO TERMINAL BODY WEIGHT: 0R6AN NAME * * * PATHOLOGY OBSERVATIONS KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HlStOPATHOLOGI KIDNEYS ... micn6:'-minimal/fdcai LIVER . . . . MICRO: -MINIMAL HOSE/TWB SEC 3 -MINIMAL, FOCAL -MINIMAL MICRO: -MINIMAL -MINIMAL NQSE/TUA0 SEC 4 MICRO: 'MINIMAL PITUITARY GLAND ....................... MICRO: -MINIMAL. TOCAl UTERUS ...................................................... .................. gross: -implant scars - present MICRO: -MINIMAL, FOCAL -MINERALIZED GRANULES -MEPATOCYTES: CYTOPLASMIC VACu6lE$'(nON-ZONA -ACIDOPHILIC FOCUS -MEPATOCYTES CENTRIiOBULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORYj: EPITHELIUM-(NTRAC EOSINOPHILIC MATERIAL "NASOLACRIMAL PVCT: LYMPH0JD HYPERPLASIA NASAL MUCOSA (OLFACTORY): EPlTHELiUM-INTRAC EOSINOPHILIC MATERIAL -PARS DISTAliS: FOCAL HYPERPLASIA -RIGHT:?; LEFTla........................................................... MYOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAO HO MICROSCOPIC ABHORHAllTlCS OBSERVED: LUNGS, NAHNARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. OVARIES. 0V1DUCTS/FALOP T, TRACHEA. VAGINA KEY TO NEOPLASMS; MAlJfiMAMT. ftfHJGM, METASTATIC, *J-* INVASIVE, "X-" OTH CO a00 *n -fl o 4^ W o On o u> *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 45/0 DATE Of DEATH: 10/02/47 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SA STUDY DAY OF DEATH: 13C STUDY WEEK OF OEATH; 20 TERMINAL BODY WEIGHT; ORGAN MANE ** PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS TREE-TEXT COMMENTS / histopatholog KIDNEYS MICRO: -MINIMAL LIVER . . MICRO: -MINIMAL -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL, FOCAL UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -PELVIS: DILATED -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZON -HEPAT0CYTE5 CENTRILOBULAJt: HYPERTROPHY -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATER -RIGHT;/; LEFT;0 -MYOHETRlUH: DROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2. NOSC/TURB SEC 3, OVARIES. OVIOUCTS/FALOP T, P TRACHEA, VAGINA KET TO NEOPLASMS: "N-m MALIGNANT. "B-`` BENIGN, *V" METASTATIC, INVASIVE, "XM 0? BFG43645 -I 141 PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET STi ANIMAL NUMBER: 457? DATE OF DEATH: IO/OZ/S7 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SAC/ STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH: SO TERMINAL BODY HEIGHT: ORGAN NAME PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMtCNTS / HtSTOpATMLOGH LIVER . . .. MICRO: -MINIMAL -MINIMAL, FOCAL 'MINIMAL NOSE/TURB SEC 1 MICRO: -MINIMAL NOsE/TURS sec ? MICRO: -SLIGHT UTERUS . . . . GROSS: -iHPLANT SCARS - PRESENT VAGINA MICRO: -SLIGHT . . .. MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (K0N-20NAI -ACUTE/SOflACUTE INFLAMMATION -HEPATOCYTES CENTR1L08ULAR: HYPERTROPHY -VOMERONASAL ORGAN: FREE ERYTHROCYTES -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -RIGHT:9; LEFT:/.................................................. -LUMEN: ORAtfD -MUCOSA: HYPERKERATOSIS (COfiNlHEO) THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNGS. NAHMARY GLANDS. NOSE/TURB SEC 3. NOSE/TURB SEC 4. OVARIES. OV1DUCTS/FALOP T, PITUITARY TRACHEA KY TO NEOPLASMS: "H-* MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I" INVASIVE. "X-" OTH BFG 003776 go a o O' "* PATM/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET S ANIMAL NUMBED: 4574 DATE OF DEATH: 09/30/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SJ STUDY DAY OF DEATH: 134 STUDY MEEK OF OEATH: 20 TERMINAL BOOT HEIGHT: ORGAN NAME * * PATHOLOGY OBSERVATIONS * * * KEWOROS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COHHENTS / HlSTOPATHQLQC GROSS/MICRO CORR . . MICRO HISTOPATHOLOGICAL COMMENT: SIDNEYS: OISCDlORED/NMC KIDNEYS 6R0SS -D1SCOLOftE0-FOCUS(FOCI), SLIGHT -LEFT: 0.3 CM DIA. RED LIVER MICRO -MINIMAL -MINIMAL -HEPATOCmS: CYTOPLASMIC VACUOLES {NON-ZOI -HEPATQCTTES CENTRILOBULAR: HYPERTROPHY UTERUS GROSS; -IMPLANT SCARS - PRESENT -NIGHT:6; LEFT:5 THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED; KIDNEYS, LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1, NOSE/TURB SEC J. NOSE/TURS SEC 3, NOSE/TURB SEC 4, 0* 0VIDUCT5/FAL0P T. PITUITARY GLAND, TRACHEA, UTERUS. VAGINA KEY TO NEOPLASMS; "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-M INVASIVE, "K-" 01 BFG43647 -4 *** FATH/TOX SYSTEM OUTPUT *" VJNYI CHLORIDE CONSINEO INHALATION TWO-GENERATION REPRODUCTION ANO DfVtlOPNtNtAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET $Tl ANIMAL HUMBER: 4$7$ DATE OF DEATH: 10/02/97 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SAP STUOY DAY OF DEATH: 136 STUOY WEEK OF DEATH: 20 TERMIRAL BODY WEIGHT: ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREC-TEXT COMMENTS / HISTOPATHOLOGH LIVER UTERUS VAGINA ....................................................................................... MICRO: -MINIMAL `MINIMAL. FOCAL -MINIMAL ....................................................................................... GROSS: -IMPLANT SCARS PRESENT MICRO: `SLIGHT MINIMAL. fQCM MICRO MINIMA; -HIPATOCYTES: CYTOPLASMIC VACUOltS (N0N-20NA -BASOPHILIC FOCUS -HEPATOCYTCS CENTRlLOBULARi HYPERTROPHY -RIGHT:IQ; LEFT-3 'LUHEN: QHATCO -ENOOMETRIUM: GROWN PIGMENT MUCOSA HlPEUflAtOSIS (CMNIFICOj Tn( TQuOWING 1 USUIS AO NO M|(O0UOPl AOMOMMA* |l|h OBSIRWI0 klDNlTS. LUNAS NMMUat GLAUM NOlM** SU I MSI/lMt SIC I. IQVL/lUtl SIC i. MSC/tUlB SEC 4. OVA OVlBUEU/IAlGP I, FIIWIIMt ALAMO IAACA at TO (PLASMS 'M . KNIM. "S ' MttASTAIIC, "l*" INVASIVE. " OTH BFG 003778 to o oe *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD NATS INDIVIDUAL ANIMAL DATA SHEET ANIMAL NUMBER: 4577 DATE OF DEATH: 09/29/9/ SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL S STUDY DAY OF DEATH; 193 STUDY WEEK Of QCATH: 19 TERMINAL BODY HEIGHT: 0R6AN NAME ** PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TtXY COMMENTS / mISTOPAThOlO EYES r . . - GROSS: -OPACITY, SLIGHT KIDNEYS . . MICRO: -MINIMAL. FOCAL -MINIMAL. FOCAL LIVER .,. MICRO: -MINIMAL -MINIMAL, FOCAL -MINIMAL NOSE/TURD SEC 2 .............................................. MICRO; MINIMAL UTERUS . . , -MINIHAt GROSS: -iNPlANT SCARS - PRESENT MICRO; -MINIMAL. FOCAL -BOTH LENS -CORTEX; INFILTRATES SUBACUTE -TUBULES DILATED -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-/D -BASOPHILIC FOCUS -HEPATOCYTES CENTRLLOGULAR: HYPERTROPHY -NASOLACRIMAL DUCTIS): MUCOSA-SUBACUTE (CH CHRONIC INFLAMMATION -NASOLACRIMAL DUCT(S); FREE ERYTHROCYTES -RiGHT:*; LEFT:ft...................................................... -ENDONEtAIUMc BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS, NOSE/TURD SEC 1, NOSE/TUAfi SEC 3, N05E/TUR0 SEC 4. OVARIES, 0V|DUCT$/FALOP T, TRACHEA, VAGINA KEY TO NEOPLASMS: `'N-*4 MALIGNANT, "B-" BENIGN. "S-" METASTATIC. V INVASIVE, "X'" 0 BFG 003779 00 3J os -p* *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLDRIQE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET $Tl ANIMAL NUMBER: 4579 DATE Of DEATH: IQ/02/37 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACI STUDY DAY OF DEATH: 136 STUDY WEEK OF DEATH: 20 TERMINAL BODY HEIGHT; ORGAN NAME * * * PATHOLOGY ODSCRYATIOHS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS flE-TEXT COMMENTS / H1ST0PATH0L06H LIVER .............................................................................. MICRO: -MINIMAL 'MINIMAL, FOCAL -MINIMAL, MULT 1-FOCAL -MINIMAL HOSE/TURB SCC 3 ....................................................... MICRO: -SLIGHT KOSE/TURB SEC 4 ...................................... MICRO: -MINIMAL -MINIMAL UTERUS ....................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT, FOCAL -HEPATOCTTES: CYTOPLASMIC VACUOLES (NON-ZOHAl -ACUTE/SUBACUTE INFLAMMATION -ACIDOPHILIC FOCUS -HEPATOCTTES CENTRI LOBULAR: HYPERTROPHY -NASAL LUMEN: FREE ERYTHROCYTES -NASAL LUMEN: FREE ERYTHROCYTES NASAL MUCOSA (OLFACTORY): EPITHELIUM-1NTRAC' EOSINOPHILIC MATERIAL -RIGHTS LEFT:5 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS. MAMMARY GLANDS, N0SE/TUR6 SEC 1, NOSE/TURB SEC 2, OVARIES, OVIDUCTS/FALOP T, PITUITARY 4 TRACHEA. VAGINA KEY TO BIOPLASMS: "M-* MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-M INVASIVE, "N-" OTHI BFG 003780 00 3 o 4^ ON o Huntingdon Life Sciences Reproduction Study 96*4080 Page 510 Draft-Final Reoqrt Pathology Report Individual Animal Postmortem Findings FI Pups Day 25 Weaning Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dam Pup Internal Number Number Sex Macroscopic Observations: Group t * 0 ppm 1501 2 3 1502 4 1503 10 13 1504 3 7 1506 4 7 1506 2 13 1507 5 1508 3 7 1510 3 10 1511 fi 1512 1 11 1513 4 1514 7 14 1515 1 d M Within Normal Limits F Within Normal Limits F Head: hair moderately thin F Within Normal Limits M Within Norma! Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Norma? Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal limits F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits BFG43651 BFG 003781 Huntingdon Life Sciences Reproduction Study 96'4Q80 Page 511 praft Final Report Pathology Report individual Animal Postmortem Findings FI Pups Pay 25 Weaning Appendix V EXTERNAL AND INTERNAL EXAMINATION Dam Pvp Internal Number Number Sex Macroscopic Observation* Group 1 0 ppm 1516 2 12 M Within Normal Limits F Within Normal Limits 1517 1518 1515 1520 3 10 3 11 i 9 2 9 M Within Normal Limits P Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limns F Within Normal Limits M Within Normal Limits F Within Normal Limns 1521 15ZZ 1524 1525 1 26 1528 1529 1530 8 14 3 9 7 8 3 14 4 10 2 5 5 7 5 11 M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Norma* Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limns M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limns BFG43652 BFG 003782 Huntingdon Life Sciences Reproduction Stutjy 96-4080 Page 512 Draft Final Report Pathology Report individual Animal Postmortem Findings FI Pups - Day 25 Weaning Appendix V EXTERNAL AND INTERNAL EXAMINATION Dam Pup Internal Number Number Sex Macroicopic Observation* Group ll -10 ppm 2503 4 6 2504 2 9 2505 2506 2507 2508 2509 2510 2511 2512 2513 2614 2515 5 9 9 10 2 6 6 12 10 11 1 10 3 7 12 5 10 3 14 11 13 M Within Normal limits F Within Normal limit* M Within Normal limit* F Tail; part musmp, moderately swollen Ovaries: moderately small M Within Normal limits F Within Normal limits M Wtthin Normal limits F Within Normal Limits M Within Normal Lends F Right Eye ooehtheimic M Within Normal Lands F Within Normal lands M Within Normal LmdS F Within Normal Lanra M Witf*n Norm bmti F Within Normal LVWt* M Witftn Normal Lx**ti F Withm Normal lim.li F Wuhm Normal Lmiti M Witten Normal l*nd* F Wittm Normal M WitlNn Normal L mus F Within Normal L-mts M Within Normal L^tt F Within Normal Limns BFG43653 BFG 003783 Huntingdon Life Sciences Reproduction Study 96-4080 Page 513 Diafl-Einfll Report Pathology Report Individual Animal Postmortem Findings FI Pups - Day 25 Weaning Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dam Pup Internal Sax Number Numbar Macroscopic Observation*: Group II - 10 ppm 2516 2 6 2517 3 7 2516 3 6 2519 3 12 2521 1 7 2522 12 13 2523 4 12 2524 2 7 2525 3 11 2527 4 6 2526 6 8 2530 5 13 2531 12 7 M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Wcthin Normal Limits F Within Normal Limits M Within Normal Limits t Within Normal Limits M Within Normal Limits f Within Normal limits M Within Normal Limits F Within Normal Limits M Lungs, Diaphragmatic Lobe: rad foe), 0.3 cm die F Within Normal limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Liver. Mrt'jn Lobe: tan focus, 0.1 cm dia F Within Normal limns M Within Normal Limits F Within Normal Limits M No observable abnormalities recorded at the time of necropsy F Right Kidney Extremely Dilated F Both Kidneys: cysts, <0.1 cm die, clear, slight, embedded M Within Normal Limits BFG43654 BFG 003784 Huntingdon Life Sciences RaBT.QductiDQJStudv 9$-4090 Page 514 Draft Fin^l Report Pathology Report Individual Animal Postmortem Findings FI Pups iDay 25 Weaning Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dm Pup imsmai Sex Number Number Macroscopic Observations: Group III - 100 ppm 3502 1 14 3504 3 11 3505 5 8 3506 2 13 3507 3508 2 10 a 14 3509 6 10 3511 1 8 3512 4 7 3513 6 8 3515 1 9 3516 3 10 3517 3 11 M Within Normal limits F Within Normal Limits M Within Normal limits F Within Normal Limits M Within Normal limits F Within Normal Limits M Within Normal limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F ' Within Normal Limits M Within Normal Limits F Within Normal Limits BFG43655 BFG 003785 Huntingdon Life Sciences Reproduction Study 96-4080 -- Page 615 PTMft pinal Pathology Report Individual Animal Postmortem Findings FI Pups - Dav 25 Weanino Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dam Pup Internal Sax Numb* Numb* Macroscopic Obtarvationt: Group III - 100 ppm 3S18 2 14 3519 5 7 3521 7 8 3523 5 9 3524 2 8 3625 3 8 3528 7 13 M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limit* M Within Normal Limit* F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits BFG43656 BFG 003786 Huntingdon Life Sciences Reproduction Study 96-4080 Page Si6 Draft Finai Report Pathology Report Individual Animal Postmortem findings FI Puds - Day 25 Weanina Appendix V EXTERNAL AND INTERNAL EXAMINATION Dam Pup Internal See Number Number Macroscopic Observations: Group IV * 1100 ppm 4501 2 7 4502 4503 2 14 2 3 9 4504 4505 2 8 4 12 4506 4507 9 12 3 11 4508 11 4509 3 13 4510 2 5 4611 5 7 45U 2 S 4514 4 7 4615 2 12 M F M F M M F M F M F M F M F F M F M F M F M F M F M F Within Normal Limits Within Normal Limits Within Normal Limits Right Kidney: moderate dilated pelvis Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits b?G43657 BFG 003787 Huntingdon Life Sciences 96-4080 Page 517 Pathology Report Individual Animal Postmortem Findings FI Puds * Dev 25 Weanino EXTERNAL AND INTERNAL EXAMINATION Aooendix Y Dim Pup Internal Sex Number Number Macroscopic Observations; Group IV -1100 ppm 4816 2 10 M F Within Normal Unit* Wthin Normal Umts 4517 2 6 M Wthin Normal Limits F Within Norma* Limits 4518 6 7 M Within Normei Units F Within Norm* Units 4519 5 13 M Within Normal UmtS F Within Normei Units 4520 1 16 M No o*ar>a*e obnormalities recorded at the time o< necropsy F Within Normal L^nrts 4521 4 7 M Within Norma* Limns F Within Normal UfetS 4522 1 13 M Witftn Normal Limits F Witfwi Normal LmrtS 4524 1 12 M Withm Normal Limits f Withm Normal Un** 4525 5 13 M Withm Normal urmtt F Within Normal 4528 2 8 M Nomai laki F WttWi Normal LrMI 4528 4530 3 8 9 5 M Both fteh small F WThm Normal l-mits F Wttf*n Normal L-rrutS M WitNn Norm at L/rvlf 4544 9 F Wttr^n Nprmai L/mns BFG43658 BFG 003788 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report individual Animal Postmortem Findings FI Pups - Day 25 Weaning EXTERNAL EXAMINATION Dam Pup External Numb* Number Sax Macroscopic Observations: Group I 0 ppm 1501 4 1502 2 5 1503 6 5 150* 5 12 1505 3 12 1506 6 16 1507 2 1508 3 1510 3 9 1511 2 4 5 7 1512 2 13 1513 1 151* 4 9 1515 4 12 F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal limits M Within Normal Limits F Withm Norma1 Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits Page 518 Draft Final Report Appendix y bg^659 BFG 003789 Huntingdon Life Sciences Reproduction-Study 96-4030 Pathology Report Individual Animal Postmortem Findings FI Pups * Day 25 Weaning EXTERNAL EXAMINATION Dam Number Pup External Numbor Sox Macroscopic Observations: Group t - 0 ppm 1516 2 8 1517 3 10 isia 5 7 1519 1520 3 IT 2 9 1521 1522 5 15 2 7 1524 1 12 1525 2 10 1526 5 8 1526 n 15 1529 3 11 1530 4 9 M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Umits F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits Rage 519 Draft .Eifial. Report Appendix Y BFG43660 BFG 003790 Huntingdon Life Sciences fi8PWtitffitigQ.5*Udr. , 96-4030 Pathology Report individual Animal Postmortem Findings FI Pups - Day 25 Weaning EXTERNAL EXAMINATION Dam Number Pup Number Extern* Sex Macroscopic Qbssrvetioos; Group II 10 ppm 2503 2 11 2504 4 $ 6 2505 3 11 2506 8 11 2507 2 6 2508 5 10 2509 1 6 S 2510 7 11 2511 4 11 2513 6 12 2514 1 9 2515 1 5 7 M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limit* F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limns F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits Page 520 Draft Fine) Repoq Appendix Y BFG43661 BFG 003791 Huntingdon Life Sciences Reproduction Study ------ 96-4080 Pathology Report Individual Animal Postmortem Findings FI Pups - Day 25 Weaning EXTERNAL EXAMINATION Dam Number Pud External Number Sai Macroscopic Observations: Group II' 10 ppm 2516 1 11 2517 2 11 2518 1 9 2519 1 8 2521 9 2522 4 2523 7 10 2524 1 12 2625 1 9 2527 1 9 2528 5 12 2530 2 8 2531 4 10 M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limns F Withm Normal Limits M Within Normal Limits F Within Normal Limits M Withm Normal Limits F Within Normal Limits Page 521 Draft Final Report Appendix Y BFG43662 BFG 003792 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Individual Animal Postmortem Findings FI Pups - Day 25 Weaning EXTERNAL EXAMINATION Dam Number Pup Numb* External Sex Macroscopic Observations: Group HI - 100 ppm 3502 5 10 3506 3 11 3507 3508 3509 6 12 4 13 1 2 3511 5 10 3512 6 11 3513 2 n 3515 3 6 11 3516 6 7 3517 1 14 M With<n Normal Umiti F Within Normal limit* M Within Normal Umits F Within Normal Umiti M Within Normal Umit* F Within Normal Limits M With*n Normal Limits F Within Normal Umits M Within Normal Limits F Withm Normal Umits M Withm Norm* Umtt F W>trw> Norm* Umits M Withm Norm* Umits F Withm Norm* Umrts M Withm Norm* Unto F W'tnm Norm* F Within Norm* L*wtS F Withm Norm* Um*l F Wthm Norm* Um*tS M W*tf*n Norm* (jmitS F Wilt'll Norm* Limits M WitNn Num* Umif* F Witrnr> No*ma* Limit* Page 522 praft Final Report Appendix V BfG43663 BFG 003793 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Individual Animal Postmortem Findings FI Puds - Day 25 Weanino Dam Number Pup Number EXTERNAL EXAMINATION External Sea Macroscopic Observations! Group III - 100 ppm 3519 4 8 3513 2 3 6 3521 2 9 3523 8 10 3624 4 12 3525 1 e 3528 8 10 M Within Normal Limits F Wthin Normal Limits M Wthin Normal Limits M Within Normal Limits M Wthin Normal Limits M Wthin Normal Limits F Wthin Normal Limits M Wthin Normal Limits F Within Normal Limits M Wthin Normal Limits F Wthin Normal Limits M Within Normal Limits F Wthin Normal Limits M Wthin Normal Limits F Wthin Normal Limits Page 523 Draft Final Report Appendix Y BFG43664 BFG 003794 Huntingdon Life Sciences 96-4080 Pathology Report Individual Animal Postmortem Findings FI Pups - Day 25 Weanina EXTERNAL EXAMINATION 0am Number Pup Number Extemel Sex Macroscopic Observations: Group IV - 1100 ppm 4501 1 8 4502 3 8 4503 5 11 4504 5 6 4505 6 10 4506 7 13 4507 5 9 4508 2 8 4509 4 11 4511 4 11 4512 1 4514 3 6 4515 4 11 M Within Norm*! Limits F Within Norma) Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits f Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits Page 524 Appendix Y BFG43665 BFG 003795 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Individual Animal Postmortem Findings FI Pups * Day 25 Weaning EXTERNAJ- EXAMINATION Dam Number Pup Number External Sex Macroscopic Observations roup IV * 1100 ppm 4516 6 17 4317 5 4518 3 11 4519 1 15 4520 5 11 4521 4522 3 9 4 16 4524 3 14 4525 2 9 4528 4529 4530 4 10 n 6 10 M Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits Page 525 Draft Final Report Appendix Y BFG43666 BFG 003796 Huntingdon Life Sciences 96-4080 Page 526 Reproduction StudyDraft Final Report Pathology Report Individual Animal Postmortem findings F2 Puds - Dev 21 Weaning EXTERNAL AND INTERNAL EXAMINATION Dam Number Pup Number Internal $ex Macroscopic Observations Group 1 0 ppm 1531 5 11 1533 7 15 1535 1537 1538 1539 1540 1542 5 9 4 9 5 10 1 15 2 7 7 14 1543 1545 1549 4 8 13 4 6 1 7 1550 1 7 1551 3 16 1553 6 14 1558 2 6 M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Norma! Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Norma! Limits F Within Normal Limits M Within Norma! Limits F Within Normal Limits M a Male. F m Female Appendix V BFG43667 BFG 003797 Huntingdon Life Sciences Reproduction Study 96-4080 Page 527 Draft Final Recor^ Pathology Report Individual Animal Postmortem Findings F2 Pups - Day 21 Weaning Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dam Pup Numb* Number Group 1 0 ppm 1561 1 14 1565 1566 3 12 S 11 1570 5 14 1572 7 11 1574 3 9 1576 3 13 1578 3 10 1580 1 4 Internal Sex Macroscopic Observation* M Within Normal Units F Within Normal Units M Within Normal Units F Within Normal Units M Within Normal Unit* F Within Normal Unit* M Witftn Normal Units F WitNn Normal Units M WtNn Normal Units F Withm Normal Units M Withm Norma* Unit* F Witftol Normal Unit* M Witton Norm* UlMS F Witte> Norm* Un*S M Wrtte' Norm* l>hHJ F Witte* Norm* LrM* M WHte Norm* UMs F W'ttw> Norm* Limits M * Male, F - Female BFG43668 BFG 003798 Huntingdon Life Sciences Reproduction Study 96-4080 Page 528 Draft Final Report Pathology Report Individual Animal Postmortem Findings F2 Pupa - Day 21 Weaning Appendix V EXTERNAL AND INTERNAL EXAMINATION Dam Number Pup Number internai Sea Macroscopic Observations Croup U - 10 ppm 2932 3 8 2533 1 3 12 2534 1 8 2S3S 8 IS 5 2539 15 8 5 2541 1 15 2543 5 17 2544 8 10 2545 1 14 2548 7 10 2550 7 10 2552 1 11 2553 5 12 M Within Normal Limits F ftiQht Kidney; pelvis moderate dilated M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limns M Within Normal Limits F Within Normal Limits M Within Normal Limns F Within Normal limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Male, F 9 Female BFG43669 BFG 003799 Huntingdon Life Sciences Reproduction Study 96*4080 Page 529 Draft Final Rgpgrt; Pathology Report Individual Animal Postmortem Findings F2 Pups - Dev 21 Weaning Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dam hip Numb* Numb* Group H - 10 ppm 2554 3 12 2555 6 15 2555 8 16 2559 2 8 2563 3 12 2566 2567 4 7 a 9 12 2569 5 7 2571 2 5 2573 2575 10 13 3 11 2577 3 5 10 toitamal Sox Macroscopic Observation* M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limit* F Right Kidney: pelvis slightly dilated M Within Normal Limits F Within Normal Limits M Within Norm*! Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Wthin Normal Limits M Within Normal Limits F Within Normal Limits M No observable abnormalities recorded at the time of necropsy F No observable abnormalities recorded at the time of necropsy M Wthin Normal Limits F Wthin Normal Limits M Wthin Normal Limits F Within Normal limit* F Wthin Normal Limits M * Male, F - Female BFG43670 BFG qO.1800 Huntingdon Life Sciences Reproduction Study 96-4080 Page 530 Draft Final Report Pathology Report individual Animal Postmortem Findings F2 Pups - Day 21 Weaning Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dam Number Pup Numb* Internal Sex Macroscopic Observations Group III * 100 ppm 3531 2 4 M F 3532 1 11 12 M F P 3533 2 13 M F 3534 2 8 M F 3535 1 10 M F 3536 2 7 M F 3537 1 9 M F 3538 1 2 3 M M F 3539 4 14 M F 3541 6 14 11 M F F 3543 2 4 M F 3545 2 3 10 M M F 3547 1 10 M P 354$ 7 9 M - Mato, F - Femato M F Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Norma) Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Skint hair moderately thin, upper ventral surface Within Normal Limits Within Normal Limiis Within Normal Limits No observable abnormalities recorded St the time of necropsy Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits No observable abnormalities recorded at the time of necropsy Within Normal Limits Right Kidney; pelvis extreme dilated Within Normal Limits No observable abnormalities recorded at the time of necropsy Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits B-PG43671 BFG 003801 Huntingdon Life Sciences Reproduction Study, __ 96-4080 Page 53T Draft Pipe) Report Pathology Report Individual Animal Postmortem Findings F2 Pups Day 21 Weaning Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dam Pup internal Number Number Sax Macroscopic Observations Croup UJ - 100 ppm 3550 6 9 13 3551 1 6 3554 2 7 M Within Normal Limits F Within Normal limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits 3555 3556 3557 3559 3560 3564 3565 3666 3567 3568 5 13 5 8 1 7 6 U 3 10 2 13 5 11 4 14 5 13 4 6 M Within Normal Limits F No observable abnormalities recorded at the time of necropsy M Wthin Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M No observable abnormalities recorded at the time of necropsy F No observable abnormalities recorded at the time of necropsy M Within Normal Limits F Within Normal Limns M Within Normal Limits F Both Kidneys: moderately dilated M Wthin Normal L/miis F Right Kidney: pelvis moderately dilated M Within Normal Limits F Within Normal Limits M Withm Normal Limits F Right Kidney: pelvis slightly dilated M Within Normal Limits F Wtthin Normal Limits BFG43672 M - Male, F Female BFG 003802 Huntingdon Life Sciences Reproduction $tu<W 96-4080 Page 532 Draft Final Report Pathology Report Individual Animal Postmortem Findings F2 Pup* - Dev 21 Weaning Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dam Number Pup Number Internal Sex Macroscopic Observation* Group IV 1100 ppm 4531 7 9 4533 3 7 4535 2 10 4538 4542 3 12 7 9 4546 4548 5 12 1 9 4543 2 4551 9 11 4552 2 11 M F M F M F M F M F M F M F F M F M F 4554 4555 4556 1 2 6 3 5 13 1 12 M M F M M F M F M * Male, F * Female Within Normal Limns Within Normal limits Within Normal Lunts Within Normal Limits Within Normal Limits Within Normal LamtS Within Normal Lxroti Within Normal Units Left K^ney peNra moderettjuftigted With* Normal Uf*t *' ^'7 ' * Within Normal Units Witrwi Normal Limits Witfen Normal LafWtS Within Normal UmtS WitTfen Norm* Umts Wttvn Normal Uh*t* W'th* Normal LrMl Uaig* * <oo* taphOir fluid filled, white, frothy U*g*. *e tobM INN red Trachea wrute frothy fluid liXv* P obet **gnoy fluid filled, white, frothy lungs ooet tafft red Tracne* *h*e frothy fluid Within Norm*, With* Normal L-m,t* Within Normal Lights WitNn Normal UhitS No ot>ser>atn acv^malitles recorded at the time of necropsy Within Normal Limits Within Normal Limits Within Normal Limits BFG43673 BFG 003803 Huntingdon Life Sciences Reproduction Study 96-4080 Page 533 Draft Final Report Pathology Report Individual Animal Postmortem Findings F2 Pups - Day 21 Weaning Appendix Y EXTERNAL AND INTERNAL EXAMINATION Dam Number Fup Number Internet Sx Mecroscopic Observations Group IV - 1 100 ppm 4557 5 12 4562 6 8 4653 5 7 9 4554 6 12 4566 8 12 4563 4570 2 7 4 6 4572 7 13 4574 2 10 11 4575 4 9 4577 6 11 4579 3 11 M Within Normal Limits F Within Normal Limits M Withirr Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal limit* M No observable abnormalities recorded at the time of necropsy F Within Normal Limits M Within Normal Limits F Within Normal limit? M Within Normal limits F Within Normal limit? M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limns F Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal limits M Right Kidney: pelvis slight dilatation F Within Normal limits M Within Normal Limits F No observable abnormalities recorded et the time of necropsy M * Male, F *= Female BFG43674 BFG 003804 Huntingdon Life Sciences Reproduction Stu<jy 96-4080 Pathology Report Individual Animal Postmortem Findings F2 Pups - Day 21 Weanino EXTERNAL EXAMINATION Dam Pup Number Number External Sex Macroscopic Observation*: Group 1 0 ppm 1531 1 2 4 7 9 10 1533 1 4 5 9 14 16 1535 2 3 7 10 14 15 1637 2 5 13 1538 1 2 3 6 8 11 M Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limit* F Within Normal Limits F Wthin Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Wthin Normal Limits F Wthin Normal Limit* F Wthin Normal Limits F Wthin Normal Limits M Wthin Normal Limits M Wthin Normal Limits F Within Normal Limits M Wthin Normal Limits M Wthin Normal Limits M Wthin Normal Limits F Wthin Normal Limits F Within Normal Limits F Wthin Normal Limits Page 534 Draft Final Report Appendix Y M = Male, F - Female BFG43675 BFG 003805 Huntingdon Life Sciences Reproduction Study 96'4030 Pathology Report individual Animal Postmortem Findings F2 Pups - Day 21 Weaning EXTERNAL EXAMINATION Page 535 Draft Final Report Appendix Y Dam Pup Number Number Group 1 - 0 ppm 1539 2 3 6 8 9 10 1540 1 * 6 8 n 15*2 2 4 9 11 13 16 1543 1545 2 3 5 9 12 15 1 6 7 10 11 13 External $e* Macroscopic Observations: M Within Normal limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M - Male, F = Female BFG43676 BFG 003806 Huntingdon Life Sciences Repfoduction.Studv _ 96-4080 Pathology Report Individual Animal Postmortem Findings F2 Pups - Day 21 Weaning EXTERNAL EXAMINATION Page 536 Draft Final Report Appendix Y Pam Pup External Numb* Number Sax Macroscopic Observations: Group I - 0 ppm 1549 3 5 6 8 9 10 1551 4 8 9 13 15 17 1553 2 3 4 9 18 17 1558 1 3 4 5 7 8 1580 1 3 5 7 11 12 13 14 M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Norma) Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal limits F Wthin Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits f Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M - Male. F - Female BfG43677 BFG 003807 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Individual Animal Postmortem Findings _______ F2 Pups - Day 21 Weaning EXTERNAL EXAMINATION Page 537 Draft Final Report Appendix Y Dam Pup External Numb* Numb* $* M*cro*Of)J Ob**v*0ons: Group I * 1565 1565 1570 1572 1574 5 6 11 13 14 15 3 4 7 e 9 12 2 4 6 7 11 12 1 5 6 12 13 15 7 11 13 14 M Within Norm* Limits M Within Norm* Limits M Within Norm* Limit* F Within Norm* Limits F Within Norm* Limits F Within Norm* Limits M WitNn Norm* Umt M Within Norm* Lxmtt M WitNn Norm* Limit* F WitNn Norm* bmrti F WitNn Norm* Umtf F Witfvn Norm* urn** M WltNn Norm* ImU M Wirtsn Norm* LMtS M WittSO Norm* Lm*S F WVtrsn Norm* Um*i F WittV> Norm* UmitS F WitNn Norm* UwtS M W*tf*n Nqrm* L*"** M WitNn Norm* UmK* M Wrtfwl Norm* l#nKS F WitNh Norm* Lmtl F Wittw Norm* LmitS F Wrtnn Norm* irvtt* F WiTtv> Norm* L**Xt F WitNn Norm* F WittW' Norm* Lights F Within Norm* im** M Male, F = Female BFG43678 BFG 003808 Huntingdon Life Sciences Reproduction Styjflv 96-4080 Pathology Report Individual Animal Postmortem Findings F2 Pups - Day 21 Weaning EXTERNAL EXAMINATION Page 538 Draft Final Report Appendix Y Pam PP Number Number Group 1 0 ppm 1576 1 2 5 11 12 16 1578 1 6 7 13 14 IS 1680 2 3 6 7 8 9 External 5 Macroscopic Observations: M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal limit* F Within Normal Limits F Within Normal Limit* F Within Normal Limits F Within Normal Limits F Within Normal limits F Within Normal Limits M Within Normal Limits M * Male, P = Female BFG43679 BFG 003809 Huntingdon Life Sciences R e production Study_____ 96-4080 ---------------------------n Pathology Report Individual Animal Postmortem Findings F2 Puos - Day 21 weanina EXTERNAL EXAMINATION Page 539 praft Final Req<?r^ Appendix Y Dam Pup Number Number External Sea Macroscopic Observation*: Group II - 10 ppm 2532 1 4 7 12 13 14 2533 2 6 7 10 13 2534 2538 2541 2543 2 5 6 11 12 1$ 1 7 9 12 13 3 8 9 10 11 W 1 2 4 7 8 11 M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal limit* M Within Normal Limit* F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limit* F Within Normal Limits F Within Normal Limit* M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Umit* F Within Normal Limit* F Within Normal Limits M - Male. F Female BFG43680 BFG 003810 Huntingdon Life Sciences Rcpcoductiflo. Study 96-4080 Pathology Report Individual Animal Postmortem Findings P2 Pups - Day 21 Weaning EXTERNAL EXAMINATION Page 540 Draft Final Report Appendix Y Dam Pup Numb* Numb* Group ||. 10 ppm 3544 1 2 3 4 11 12 2546 4 5 8 9 11 2548 2850 2 4 5 8 9 11 1 6 8 11 12 13 Extamal $*JL Macroscopic Observations: M Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M - Mate, F - Female BFG43681 BFG 003811 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Individual Animal Postmortem Findings F2 Pups * Dav 1 Weaning EXTERNAL EXAMINATION Rage 541 Draft Final Report Appendix V Dam Pup Number Number Group ll 10 ppm 2552 2 3 6 5 9 12 2553 1 2 4 B 11 16 2554 1 2 4 7 11 13 2555 2 3 4 6 9 16 2556 7 9 11 13 14 16 2559 1 3 4 9 10 11 External Sex Macroscopic Observed M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limit* M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M - Mate, F - Female BFG43682 BFG 003812 Huntingdon Life Sciences RftpfQduction Study 96-4030 Pathology Report individual Animal Postmortem Findings F2 Pups - Day 21 Weaning EXTERNAL EXAMINATION Page 542 Dfaft Final Report Appendix Y Dam Pup External Number Number Sex Macroscopic Obta#vtion*i Group H - 10 ppm 2569 2 5 9 11 13 14 2566 1 9 10 11 12 13 2567 3 5 6 10 11 2569 1 3 4 6 6 9 M Within Normal Limits M Within Normal Um*a M Within Normal Unit* F Within Normal bmns F Within Normal Limits F Within Normal UrmtS M Within Normal Ufflrtl M Within Normal Umrtt F Within htorm^ Unu F Within Normal Unts F Withm Normal UmtS F Within Normal L*ltl M Within Normal Lxtvts M Withm Normal Lm*ts M Withm Normal Lmvt* F WithmNormal f Witten Normutmwt* M Witten Normal Lmvta M Withm Normal L*n*S M Withm Normal Uvett M Withm Norm# L#m* F Wrtton Normal Lmota F WitNn Normal Lanti M Male, F Female BFG43683 BFG 003813 Huntingdon Life Sciences Reproduction Stutjy 96-4080 Pathology Report Individual Animal Postmortem Findings F2 Puos - Day 21 Weening EXTERNAL EXAMINATION Page 543 Draft Final Report Appendix V Dam Pi* Numb* Number External Sex Maoroecople Observation*: Group M - 10 ppm 2577 1 3 4 6 8 9 2573 3 5 9 11 12 14 2575 1 4 7 9 10 12 2577 2 4 6 13 15 M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limns M Within Normal Limits M - Mile, F - Female BFG436&4 BFG 003814 Huntingdon Life Sciences Reproduction. Study 96-4080 Pathology Report Individual Animal Postmortem Findings ?2 Pups * Day 21 Weaning EXTERNAL EXAMINATION Page 544 .Draft Final Report Appendix Y Dam Pt4> Numb* Numb* Extamal Sax Macroscopic Observations: Group 111 -100 ppm 3531 1 3 5 9 14 15 3632 6 8 10 14 15 3533 5 6 7 9 10 11 3534 1 3 7 10 11 13 353$ 2 4 5 8 9 12 3536 1 3 5 8 11 12 M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limit* M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M a Male, F - Female BFG43685 BFG 003815 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Individual Animal Postmortem Findings F2 Pupa * Day 21 Weaning EXTERNAL EXAMINATION Page 545 Draft Final Report Appendix Y Pam Pup External Number Number Sex Macroscopic Observations: Group III -100 ppm 3637 3 4 5 7 8 10 3538 4 5 7 8 11 3539 2 9 10 11 12 15 3541 1 4 8 12 15 M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M Male, F * Female BFG43686 BFG 003816 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Individual Animal Postmortem Findings F2 Puds - Dav 21 Weening EXTERNAL EXAMINATION Page 546 Draft Final Report Appendix Y Dam Pup Number Number Group IN - 100 ppm 3543 1 3 5 5 11 12 3545 3547 4 5 7 8 9 2 6 7 11 12 16 3549 3550 3551 2 4 6 8 11 13 2 4 7 10 14 4 5 7 8 10 13 External Sax Macroscopic Observations? M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Umits F Within Normal Limits F Within Normal Limits F Within Normal Limns M Within Normal Limits M Within Normal Umits M Within Normal Limits F Within Normal Limits F Within Normal Umits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Umits F Within Normal Umits F Within Normal Umits F Within Normal Limits M Within Normal Limits M Within Normal Umits M Within Normal Limits F Within Normal Umits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits M * Male, F - Female BFG43687 BFG 003817 Huntingdon Life Sciences ReoroductiorUStudy 96-4080 Pathology Report Individual Animal Postmortem Findings F2 Pups - Day 21 Weanino EXTERNAL EXAMINATION Page 547 Draft Final Report Appendix Y Dam Pup Number Number External Sex Macroscopic Observed Group III 100 ppm 3554 1 3 4 6 9 10 3555 4 7 a 10 u 14 3556 3 4 6 7 9 3557 3 4 6 6 10 3559 3 8 9 IS 16 17 3560 2 4 5 7 8 9 M Within Normal Limit* M Within Normal Limit* M Within Normal Limns F Within Normal Limit* F Within Norm** Limit* F Within Norma* Limit* M Within Normal Limit* M Within Norma* Lxrwts M Withm Normal Limit* F Within Normal UmrTS F Within Normal Limits F Within Norma* Limits M WitNn Normal Lxrvti M Withm Normal Unit* M Withm Normal Limits M Withm Normp Limits F Within Norma* limits M WitNn Norma* Lxnrts M Wtttvi Norma* lmts F Withm Normal Um** F W'tTtn Normal LmutS M Wiffwi Normal Lmwts M Witten Normal Lmwta M Wrmn Norm# Ljrrma M Withm Normal Lm*tS F Wifftn Norm# Limit* F Withm Norm# l#wt* F Witten Norm# imuts M Wttfen Norm# Lmfs M Wttw Normji invt* M Withm Norm# limit* F Withm Norm# Im-wt* F Wtf*n Norm# l.rmt* F Witl^n Norm# limit* M * Male, F - Female BFG43688 BFG 003818 Huntingdon Life Sciences Reproduction Sti^y 96*4080 Pathology Report Individual Animal Postmortem Findings F2 Pups - Dav 21 Weaning EXTERNAL EXAMINATION Page 543 Draft Final Report Appendix Y Dam Puo Extern Number Number Sex Macroscopic Observations: Group HI 100 ppm 3564 1 3 4 8 9 11 3565 1 4 8 9 10 14 3868 2 6 8 9 11 12 3567 2 3 4 7 9 11 3566 3 7 8 12 M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normsi Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limns M Within Normal Limit* M Within Normal Limits F Within Normal Limit* F Within Normal Limits M Male, F * Female BFG43689 BFG 003819 Huntingdon life Sciences Reproduction Study 96-4080 Pathology Report Individual Animal Postmortem Findings F2 Pups * Dav 21 Weaning EXTERNAL EXAMINATION Page 549 Draft Final Repprj Appendix Y Dam Run Extam* Number Number Sex Macroscopic Observations: Group IV - 1100 ppm 4531 2 4 5 6 8 10 4533 4 S 6 3 10 11 4-535 1 4 6 a 9 13 4538 1 2 6 11 13 1$ 4542 1 5 6 10 11 14 4546 4 6 8 11 13 14 M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M = Male, F * Female BFG43690 BFG 003820 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Individual Animal Postmortem Findings ______ F2 Pups - Day 21 Weaning EXTERNAL EXAMINATION Page 550 Draft Final Report Appendix Y Dam Pup Number Number External Sex Macroscopic Observations: Group IV 1100 ppm 4648 3 4 8 12 13 4549 3 4551 2 5 10 12 14 15 4552 3 5 6 8 9 13 4954 4 6 7 8 9 4555 6 7 10 11 14 4556 3 4 5 7 9 13 M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Wthin Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limns M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limns F Within Normal Limits F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limns F Within Normal Limits F Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits M a Male, f * Female BFG 003821 Huntingdon Life Sciences 96-4080 Reproduction Study____________________ __Pratt Final Report Pathology Report Individual Animal Postmortem Findings F2 Pups - Day 21 Weaning EXTERNAL EXAMINATION Page 551 Appendix Y Dam Pipi Ext*fn4 Number Number Sex Macroscopic Observation*; Group IV-1100 ppm 4557 1 4 5 10 11 13 M M M F F F 4562 1 2 S 7 9 10 M M M F F F 4563 1 4 Q 8 10 M M M F F 4564 1 4 8 11 14 15 M M M F F F 4566 1 3 7 9 10 11 M M M F F f 4566 1 4 5 9 12 13 M M M F F F 4570 1 2 3 5 M Male, F Female M M M F Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limns Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limns Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limit* Within Normal Limits Within Normal Limits Within Normal Limits Within Normal Limits BFG43692 BFG 003822 Huntingdon Life Sciences 96-4080 Reproduction Study __________________ _Draft Final Report Pathology Report Individual Animal Postmortem Findings F2 Pups - Day 21 Weaning EXTERNAL EXAMINATION Dam Pup External Number Number Sex Macroscopic Observation*: Group (V * 1100 ppm 4572 2 3 6 10 15 M Within Normal Limits M Within Normal Limits M Within Normal Limits F Within Normal Limits F Within Normal Limits F Within Normal Limits 4574 1 3 4 6 8 M Within Normal Limits M Within Normal Limits M Within Normal Limits M Within Normal Unto M Within Normal Limits 4575 4577 4579 2 3 7 8 10 12 2 4 7 9 12 1 5 7 8 9 12 M Within Normal Unto M Within Normal Limits F Within Normal un*ts F Within Normal lnw M Within Normal UnrtS F Withm Normal L^to M Witr*n Norm* Unto M Withm Normal Unto M Withm Norm* Unto F Withm Norm* Unto F Withm Norm* Unto M Withm Norm* Lm*S M Withm Nm* Unto M Withm Normal units M Witfwt Norm* L*nflt F With** No*m* Lints F WithHO Norm* Limit* Page 652 Appendix Y M Male, F * Female BFG43693 BFG 003823 APPENDIX Z BFG43694 BFG 003824