Document wqwzJ8bz45veGOrkB0K9BMN7E

Chemical Manufacturers Association May 11,1998 Dear Vinyl Chloride Health Committee Members: Enclosed is a copy of the draft reproductive study from Huntingdon Life Sciences. Please review and send us comment on this draft study no later than COB Friday, May 29,1998. Huntingdon will then have thirty days to revise the study and respond to our comments. The final reproductive study is due to ATSDR by July 1998. If you have any questions, please call Wendy Sherman at 703/741-5639. Enclosure Sincerely, Burner Cynthia Barrett Senior Admin. Asst. Vinyl Chloride Health Committee \( 0-/YUZ-- finiM if : uiebiutinc ; 125 i TEARS ; Innovation, Technology and Responsible CarC' At Work nno Wilson Blvd.. Armncton, VA 22209 Thci'hone 703-741 -5000 Fax 70 3-741-6000 BFG 003270 * Responsible Care APubltcCommrtmerrt 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 BFG 003271 APPENDIX Y BFG 003272 Huntingdon Life Sciences Reproduction Study 96-4080 Pathology Report Table of Contents Page 1 Draft Final Report Appendix Y Adult Animals Incidence Summary ofMacroscopic Postmortem Observations Pi Generation.................................................................................................................. 3 P2 Generation.................................................................................................................. 7 Expanded Incidence Summary of Microscopic Postmortem Observations Pi Generation.................................................................................................................12 P2 Generation................................................................................................................ 21 Individual Animal Postmortem Findings Pi Generation................................................................................................................ 31 P2 Generation.............................................................................................................. 271 Pups Fi Pups Day 25 Weaning - External and Internal Examination.................................................. 510 Day 25 Weaning - External Examination......................................................................518 FaPups Day 21 Weaning - External and Internal Examination.................................................. 526 Day 21 Weaning - External Examination......................................................................534 BFG 003273 Huntingdon Life Sciences Reproduction Study 96-4080 Page 2 Draft Final Report Pathology Report Incidence Summary ofMacroscopic Postmortem Findings Preface Appendix Y Key to Abbreviations LN - Lymph Nodes GL, GLS = Glands TISS = Tissue FALOP T = Fallopian Tubes BFG 003274 TABLE INCLUDES: SEX-ALL;GROUP-ALL;WEEKS*ALL DEATH-T.A,D;SUBSET=T *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS OBSERVATIONS INCIDENCE SUMMARY PRINTED; 29-APR-98 PAGE: 3 STUOY NUMBER; 9640BO ___ N U M 6 E R - 0 F - A N 1 H A L S SEX: --MALE- -- -- --FEMALE- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND KEYVORD(S) OR PHRASE NUMBER: 30 30 30 30 30 30 30 30 ** TOP OF LIST ** ADRENAL GLANDS .............................................................................. ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 AORTA .................................................................................................. ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 BRAIN .................................................................................................. ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 FEMUR .................................................................................................. ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 FEMORAL MARROW .............................................................................. ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 EPIDIDYMIDES .................................................................................. ... NUMBER EXAMINED: 30 30 30 30 0 0 0 0 ESOPHAGUS ......................................................................................... ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 EYES .................................................................................................... .. . NUMBER EXAMINED: 30 30 30 30 30 30 30 30 OPACITY I 2 000000 HARDERIAN GLANDS .......................................................................... ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 LACRIMAL GLANDS ............................................................................ ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 HEART .................................................................................................. ... NUMBER EXAMINEO: 30 30 30 30 30 30 30 30 KIDNEYS .............................................................................................. . .. NUMBER EXAMINED: 30 30 30 30 30 30 30 30 IRREGULAR SHAPE 1 0000000 ENLARGED 0 1 000000 DILATATION 01 1 12121 CALCULUS(CALCULl) 00 1 00000 LIVER .................................................................................................. ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 NODULE(S)/MASS(ES) 0 1 00000 1 BFG 003275 LUNGS .................................................................................................. ... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 FLUID FILLED 00 00 1000 NOODLE(S)/MAS5{ES) 0000 1000 MESENTERIC LN ................................................................................ EXAMINEO: 30 30 30 30 30 30 30 30 BFG 003276 TABLE INCLUDES: SEX-ALL;GROUPsALL;WEEKSeALL OEATHT,A,D;SUBSET*T ORGAN AND KEYWORD(S) OR PHRASE MEDIASTINAL LN ................... OISCOLOREO MAMMARY GLANOS ................... NODULE(S)/MASS(ES) NERVE ....................................... NOSE/TURBINATES ................. OVIDUCTS/FALOP T ............... OVARIES ................................... DISCOLORED-FOCUS(FOCI) PANCREAS ................................. DISCOLORED PITUITARY GLAND .................. PROSTATE GLAND .................... DISCOLORED-AREA(S) SPINAL CORD .......................... SALIVARY GLANDS .................. SKIN ......................................... SCAB(S)/SORE(S) HAIR ABSENT/THIN SKELETAL MUSCLE ................. SPLEEN ..................................... STOMACH ................................... DISCOLORED-FOCUS(FOCI) DUODENUM *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS OBSERVATIONS INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 4 STUDY NUMBER: 964080 SEX: GROUP: -- HUM B E R - 0 F - A N I M A 1. S ----- MALE------ __ ___ -FEMALE-- 1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 30 30 30 30 30 30 30 30 NUMBER EXAMINED 30 30 30 30 30 30 30 30 000 1 0000 NUMBER EXAMINEO 30 30 30 30 30 30 30 30 000000 1 1 NUMBER EXAMINEO 30 30 30 30 30 30 30 30 NUMBER EXAMINED 30 30 30 30 30 30 30 30 NUMBER EXAMINED 0 0 0 0 30 30 30 30 NUMBER EXAMINED 0 0 0 0 30 30 30 30 00000001 NUMBER EXAMINED: 30 30 30 30 30 30 30 30 0000 1 000 NUMBER EXAMINED: 30 30 30 30 30 30 30 30 NUMBER EXAMINED: 30 30 30 30 0 0 0 0 000 1 0000 NUMBER EXAMINED 30 30 30 30 30 30 30 30 NUMBER EXAMINED 30 30 30 30 30 30 30 30 NUMBER EXAMINED 30 30 30 30 30 30 30 30 I 000 0000 0000 00 I 0 NUMBER EXAMINED 30 30 30 30 30 30 30 30 NUMBER EXAMINED 30 30 30 30 30 30 30 30 NUMBER EXAMINED 30 30 30 30 30 30 30 30 0000 00 1 1 NUMBER EXAMINED: 30 30 30 30 30 30 30 30 TABLE INCLUDES: SEXsALL;GROUP=ALL;WEEKS=ALL DEATHT,A.O;SUBSET=T ORGAN AND KEYWORO(S) OR PHRASE *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS OBSERVATIONS INCIDENCE SUMMARY PRINTED: 29-APR-9B PAGE: 5 STUDY NUMBER: 964030 ___ N U M 8 E R - 0 F - A N I M A L S SEX: -- HALE-- -- -- -FEMALE- GROUP: -1- -2- -3- -4- -I- -2- -3- -4- NUMBER: 30 30 30 30 30 30 30 30 -a- - s - JEJUNUM ............................................................ 30 30 30 30 30 30 30 30 ILEUM ................................................................ ....................................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 CECUM ................................................................ ....................................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 COLON ................................................................ ....................................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 LOW COLON/RECTUH ....................................... ....................................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 SEMINAL VESICLES ....................................... ....................................... NUMBER EXAMINED: 30 30 30 30 0 0 0 0 SMALL 0 1 000000 TESTES .............................................................. ....................................... NUMBER EXAMINED: 30 30 30 30 0 0 0 0 ENLARGED 0l 01 0000 SMALL 00 100000 THYROID GLAND .............................................. ....................................... NUM8ER EXAMINED: 30 30 30 30 30 30 30 30 PARATHYROID GLS .......................................... ....................................... NUM8ER EXAMINED: 30 30 30 30 30 30 30 30 THYMUS .............................................................. DISCOLORED 30 30 30 30 30 30 30 30 1 0002 0 00 TONGUE .............................................................. ....................................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 GINGIVA ........................................................... 30 30 30 30 30 30 30 30 TRACHEA ........................................................... ....................................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 FLUID 0000 1000 BFG 003277 LARYNX .............................................................. ....................................... NUMBER EXAMINED: 30 30 30 30 30 30 30 30 URINARY BLADDER .......................................... DISTENDED CALCULUS(CALCULI) 30 30 30 30 30 30 30 30 0 1 00000 0 00 I 000 00 TABLE INCLUDES: SEX=ALL;GROUP=ALL;UEEKS=ALL DEATH=T,A,D;SUB$ETT ORGAN AND KEYWORD(S) OR PHRASE *** PATH/TOX SYSTEH OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS OBSERVATIONS INCIDENCE SUMMARY PRINTED: 29-APR-9B PAGE: 6 STUDY NUMBER: 9640BO ___ N U M B E R - 0 F - A N I M A l S SEX: --MALE ---- ---- FEMALE- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- NUMBER: 30 30 30 30 30 30 30 30 ts - UTERUS ....................................................... IMPLANT SCARS - PRESENT IMPLANT SCARS - NOT PRESENT IMPLANT SITES NOT NOTED 0 0 0 0 30 30 30 30 0 0 0 0 27 27 22 27 0 000 3382 0 000 000 1 VAGINA ....................................................... .............................................. NUMBER EXAMINED: 0 0 0 0 30 30 30 30 ZYMBAL'S GLANDS ................................... .............................................. NUMBER EXAMINED: 30 30 30 30 30 30 30 30 ADIPOSE TISSUE ..................................... .............................................. NUMBER EXAMINED: 30 30 30 30 30 30 30 30 NODULE(S)/MAS S{E S) 0 l 0 0 000 0 EXTREMITY ................................................ .............................................. NUMBER EXAMINEO: 30 30 30 30 30 30 30 30 SWOLLEN 0 1 00 0000 HAIR ABSENT/THIN 0 l00001 0 EARS ........................................................... .............................................. NUMBER EXAMINED: 30 30 30 30 30 30 30 30 SWOLLEN 001 1 201 2 DISCOLORED 000 1 201 1 URETHRA .................................................... .............................................. NUMBER EXAMINED: 30 30 30 30 30 30 30 30 ** END OF LIST ** BFG 003278 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS OBSERVATIONS INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 7 STUDY NUMBER: 964O60A TABLE INCLUDES: SEX-ALL;GROUP-ALL;UEEKS-ALL DEATH-ALL;SU8SET-T -- NUMB E R -0 F -AN I MALS SEX: --MALE -- - --FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- TEDTM ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 30 30 30 30 30 29 ----------------------------------------------- --------------- - S - -S- -a- -a- -a - -a- ** TOP OF LIST ** ADRENAL GLANDS .............................................................................. ... NUMBER EXAMINEO: 30 30 30 30 30 29 30 30 *a - 30 30 AORTA ....................................................................................................................................................................................... 30 30 30 30 30 29 30 30 BRAIN NUMBER EXAMINEO: 30 30 30 30 30 29 30 30................................................................................................................................................................................... ... FEMUR NUMBER EXAMINED: 30 30 30 30 30 29 30 30....................................................................................................................................................................................... ... FEMORAL MARROW NUMBER EXAMINED: 30 30 30 30 30 29 30 30................................................................................................................................................. ... EPIDIDYMIDES NUMBER EXAMINEO: 30 30 30 30 0 0 0 0.......................................................................................................................................................... ... SMALL 1 00I 0000 ESOPHAGUS ......................................................................................... ... NUMBER EXAMINEO: 30 30 30 30 30 29 30 30 EYES .................................................................................................... ... NUMBER EXAMINEO: 30 30 30 30 30 29 30 30 OPACITY 00000 0 0 1 HARDERIAN GLANDS NUMBER EXAMINEO: 30 30 30 30 30 29 30 30.......................................................................................................................................... ... LACRIMAL GLANOS NUMBER EXAMINEO: 30 30 30 30 30 29 30 30............................................................................................................................................. ... HEART NUMBER EXAMINED: 30 30 30 30 30 29 30 30....................................................................................................................................................................................... ... KIDNEYS .............................................................................................................................................................................. DILATATION NOT EVIDENT DISCOLOREO-FOCUS(FOCI) 30 30 30 30 30 29 30 30 2 1000 I 1 1 1 0000000 0000 00 0 I LIVER .................................................................................................. ... NUMBER EXAMINEO: 30 30 30 30 30 29 30 30 DISCOLORED-FQCUS(FOCI) 0 I10 0001 BFG 003279 LUNGS .................................................................................................. 30 30 30 30 30 29 30 30 MESENTERIC LN ................................................................................ ... NUMBER EXAMINEO: 30 30 30 30 30 29 30 30 MEDIASTINAL LN .............................................................................. ... NUMBER EXAMINED: 30 30 30 30 30 29 30 30 MAMMARY GLANDS .............................................................................. ... NUMBER EXAHINED: 30 30 30 30 30 29 30 30 TABLE INCLUDES: SEX-ALL;GROUP=ALL;WEEKS=ALL DEATH-ALL; SUBSETS *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS OBSERVATIONS INCIDENCE SUMMARY PRINTED: 29-APR-96 PAGE: B STUDY NUMBER: 964080A --- N U M 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 AND KEYWORD(S) OR PHRASE NUMBER: 30 30 30 30 30 29 30 30 - II * --a- --a-- NERVE ........................................................................ NOSE/TURBINATES .............................................................................................. OVIDUCTS/FALOP T .......................................................................................... OVARIES ............................................................................................................................... PANCREAS ........................................................................................................................... PITUITARY GLAND .................................................. ENLARGED PROSTATE GLAND .................................................... SPINAL CORD ........................................................... SALIVARY GLANDS .................................................. SKIN .......................................................................... HAIR ABSENT/THIN SKELETAL MUSCLE .............................................................................................. SPLEEN .................................................................................................................................. STOMACH ............................................................................................................................... DUODENUM .......................................................................................................................... JEJUNUM ............................................................................................................................... ILEUM ........................................................................ CECUM ........................................................................ COLON ........................................................................ ................. NUMBER EXAMINED: 30 30 30 30 30 29 30 30 ................. NUMBER EXAMINEO: 30 30 30 30 30 29 30 30 ......... NUMBER EXAMINEO: 0 0 0 0 30 29 30 30 ......... NUMBER EXAMINEO: 0 0 0 0 30 29 30 30 ......... NUMBER EXAMINED: 30 30 30 30 30 29 30 30 ................. NUMBER EXAMINEO: 30 30 30 30 30 29 30 30 0 0 00 000 1 ......... NUMBER EXAMINEO: 30 30 30 30 0 0 0 0 ......... NUMBER EXAMINED: 30 30 30 30 30 29 30 30 ......... NUMBER EXAMINEO: 30 30 30 30 30 29 30 30 ................. NUMBER EXAMINED: 30 30 30 30 30 29 30 30 0000 1020 ................. NUMBER EXAMINED: 30 30 30 30 30 29 30 30 ................. NUMBER EXAMINED: 30 30 30 30 30 29 30 30 ................. NUMBER EXAMINED: 30 30 30 30 30 29 30 30 ................. NUMBER EXAMINED: 30 30 30 30 30 29 30 30 ................. NUMBER EXAMINEO: 30 30 30 30 30 29 30 30 ......... NUMBER EXAMINED: 30 30 30 30 30 29 30 30 ......... NUMBER EXAMINED: 30 30 30 30 30 29 30 30 ......... NUMBER EXAMINED: 30 30 30 30 30 29 30 30 BFG 003280 LOW COLON/RECTUM ................................................ ......... NUMBER EXAMINED: 30 30 30 30 30 29 30 30 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS OBSERVATIONS INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 9 STUDY NUMBER: 964060A TABLE INCLUDES: SEX-ALL;GROUP*ALL;WEEKS-ALL DEATH-ALL;SUBSET-T ORGAN AND KEYWORD(S) OR PHRASE NUMBER-0 F-AN I MALS SEX: --MALE-- -- -- --FEMALE- GROUP: -I- -2- -3- -4- -1- -2- -3- -4- NUMBER: 30 30 30 30 30 29 30 30 -- tt -- -as - SEMINAL VESICLES .................................................. ............................ NUMBER EXAMINED: 30 30 30 30 0 0 0 0 SMALL 1 000 0000 TESTES ........................................................................ ............................ NUMBER EXAMINEO: 30 30 30 30 0 0 0 0 SMALL 1 01 1 0000 ENLARGED 0 00 1 0000 SOFT 001 0 0000 THYROID GLAND ........................................................ ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 PARATHYROID GLS .................................................... ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 THYMUS ........................................................................ ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 TONGUE ........................................................................ ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 TRACHEA ...................................................................... ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 LARYNX ........................................................................ ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 URINARY BLAODER .................................................... ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 UTERUS ........................................................................ ............................ NUMBER EXAMINED: 0 0 0 0 30 29 30 30 IMPLANT SCARS - PRESENT 0 0 0 0 25 24 27 27 IMPLANT SCARS - NOT PRESENT 0000 5 533 VAGINA ........................................................................ ............................ NUMBER EXAMINED: 0 0 0 0 30 29 30 30 ZYMBAL'S GLANDS .................................................... ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 BFG 003281 LYMPH NODE ............................................................... ENLARGED EXAMINED: 30 30 30 30 30 29 30 30 1 0000000 ADIPOSE TISSUE ...................................................... ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 NODULE(S)/MASS(ES) 000I 0 1 00 EXTREMITY ................................................................. ............................ NUMBER EXAMINED: 30 30 30 30 30 29 30 30 HAIR ABSENT 0000 0010 ** CONTINUED ON NEXT PAGE ** BFG 003282 OS I * X <U) II t--U-KZUi I OX -- ziau<z C ' x --as t- ZI O I O. > t-- Lb /> O t/> uaj oos ^-I --> <> -- xu <t-- * * * * *PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS OBSERVATIONS INCIDENCE SUMMARY --* m ii xw as. Lrt O PRINTED: 29-APR-98 PAGE: 10 STUDY NUMBER: 964080A 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 U/ - Unilateral B/ = Bilateral FALOP T = Fallopian Tubes BFG 003283 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHIORIOE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY PRINTEO: 29-APR-98 PAGE: 12 STUDY NUMBER: 964060 TABLE INCLUDES: SEX-ALL;GROUP-ALL;SCREEN-ALL;WEEKS-ALL DEATH-T,A.D;FIND-ALL;SU6SET-T -- NUMBER-OF-ANIMALS-AFFECTED -- SEX: ------------MALE------------ ---------- FEMALE GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 30 30 30 -- St -- ** TOP OF LIST ** TRACHEA ..................................................................................................... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --MUCOSA: MUCOSAL 6LAN0S-DILATED 1> 2 0 0 0 0 0 0 0 TL> 2 0 0 0 0 0 0 0 LUNGS ......................................................................................................... NUMBER EXAMINED: 30 0 0 30 29 0 0 30 --CONGESTION 2> 1 0 0 0 0 0 0 0 Tl> 1 0 0 0 0 0 0 0 --PULMONARY VESSELS: MINERAL DEPOSIT(S) 1> 2 0 0 1 4 0 0 2 TL> 2 0 0 I 4 0 0 2 --LYMPHOID CELL INFILTRATE(S)/AGGREGATE(S) 1> 3 0 0 0 0 0 0 0 TL> 3 0 0 0 0 0 0 0 -- INTERSTITIUM: MINERAL DEPOSIT(S)/OSSEOUS METAPLASIA 1> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 --PERIVASCULAR: EDEMA 1> 0 0 0 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 TL> 0 0 0 0 2 0 0 0 --PERIBRONCHIAL: LYMPHOCYTIC HYPERPLASIA 2> 0 0 0 0 3 0 0 0 TL> 0 0 0 0 3 0 0 0 --PNEUMONITIS INTERSTITIAL SUBACUTE 2> 0 0 0 0 1 0 0 0 TL> 0 0 0 0 1 0 0 0 BFG 003284 --PERIVASCULAR/PERIBRONCHIAL LYMPHOID CELLS l> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 1 NOSE/TURBINATES ................................................................................... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 NOSE/TURB SEC 1 ................................................................................... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --VOMORONASAL ORGAN: FREE ERYTHROCYTES 1> 3 0 0 0 1 0 0 2 TL> 3 0 0 0 1 0 0 2 CONTINUED ON NEXT PAGE *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 13 STUDY NUMBER: 9640B0 TABLE INCLUDES: SEX-ALL;GROUP=ALL;SCREEN-ALL;WEEKS-ALL DEATH-T,A,D;FIND-ALL;SUBSET-T -- NUMB E R-0F-AN I MA LS SEX: ----- MALE--- -- --FEMALE- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED ** FROM PREVIOUS PAGE ** NUMBER: 30 30 30 30 30 30 30 30 -a- "=" NOSE/TURB SEC 1 ................................................................................... NUMBER EXAMINEO: 30 0 0 30 30 0 0 30 --NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES 1> 1 0 0 I 0 0 0 0 2> 1 0 0 0 0 0 0 0 TL> 2 0 0 1 0 0 0 0 --NASAL MUCOSA (RESPIRATORY): ACUTE/SUBACUTE INFLAMMATION 1> 1 0 0 0 0 0 0 0 Tl> 1 0 0 0 0 0 0 0 --ODONTOPATHY 1> 0 0 0 2 0 0 0 1 2> 1 0 0 0 0 0 0 0 TL> 1 0 0 2 0 0 0 1 --NASAL MUCOSA (RESPIRATORY): GOBLET CELL HYPERTROPHY/HYPERPLASIA 1> 0 0 0 0 0 0 0 3 2> 0 0 0 1 0 0 0 0 TL> 0 0 0 1 0 0 0 3 -NASOLACRIMAL DUCT(S): EOSINOPHILIC MATERIAL 1> 0 0 0 2 0 0 0 I TL> 0 0 0 2 0 0 0 1 --NASAL LUMEN: FREE ERYTHROCYTES 2> 0 0 0 0 1 0 0 0 TL> 0 0 0 0 1 0 0 0 --NASAL LUMEN: EXUDATE 1> 0 0 0 0 1 0 0 1 TL> 0 0 0 0 1 0 0 1 --NASAL MUCOSA (JUNCTION OF THE RESPIRATORY/OLFACTORY MUCOSA) 000000 0 1 GLANDS OILATEO TL> 0 0 0 0 0 0 0 1 --NASOLACRIMAL OUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION 2> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 l BFG 003285 -NASOLACRIMAL DUCT: EXUDATE l> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 1 NOSE/TURB SEC 2 .................................................................................. NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --NASAL LUMEN: FREE ERYTHROCYTES 1> 2 0 0 1 0 0 0 0 3> 0 0 0 0 1 0 0 0 TL> 2 0 0 1 1 0 0 0 ** CONTINUED ON NEXT PAGE ** *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS --- EXPANDED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 14 STUOY NUMBER: 964060 TABLE INCLUDES: SEX-ALL;GROUP=ALL;SCREEN-ALL;WEEKS-ALL DEATH-T,A,D;FIND-ALL;SUBSET*T -- NUMBER-0F-AN1MALS-AFFECTED -- 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 ** NOSE/TURB SEC 2 ............................................................................ ... NUMBER EXAMINEO: 30 0 0 30 30 0 0 30 -- NASOLACRIMAL DUCT(S): INFLAMMATORY CELLS/CELL DEBRIS 1> 2 0 0 4 3 0 0 2 TL> 2 0 0 4 3 0 0 2 -- NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION 1> 1 0 0 0 0 0 0 3 2 1 0 0 1 0 0 0 3 3> 2 0 0 0 1 0 0 0 TL> 4 0 0 1 1 0 0 6 --VOMORONASAL ORGAN: EOSINOPHILIC MATERIAL 1> 3 0 0 0 2 0 0 2 2> 1 0 0 0 0 0 0 0 TL> 4 0 0 0 2 0 0 2 --ODONTOPATHY 1> 0 0 0 2 0 0 0 1 2> 1 0 0 1 1 0 0 1 3> 2 0 0 1 0 0 0 0 TL> 3 0 0 4 1 0 0 2 -- VOMERONASAL ORGAN: FREE ERYTHROCYTES !> 1 0 0 0 3 0 0 3 TL> 1 0 0 0 3 0 0 3 -- NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES 1> 3 0 0 3 2 0 0 0 2> 2 0 0 0 3 0 0 0 TL 5 0 0 3 5 0 0 0 --NASOLACRIMAL DUCT: EXUDATE I> 0 0 0 0 0 0 0 1 2> 0 0 0 0 1 0 0 I TL> 0 0 0 0 1 0 0 2 BFG 003286 --NASAL LUMEN: INFLAMMATORY CELLS/CELL DEBRIS 1> 0 0 0 0 0 0 0 I TL> 0 0 0 0 0 0 0 1 --VOMERONASAL ORGAN: EXUDATE 1> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 1 NOSE/TURB SEC 3 ............................................................................ ... NUMBER EXAMINEO: 30 0 0 30 30 0 0 30 --NASAL MUCOSA (RESPIRATORY): EPITHELIUM-1NTRACYTOPLASMIC l> 1 0 0 1 4 0 0 0 EOSINOPHLIC MATERIAL TL> 1 0 0 1 4 0 0 0 ** CONTINUED ON NEXT PAGE * *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 15 STUDY NUMBER: 9640B0 TABLE INCLUDES: SEX=ALL;GROUPALL;SCREEN-ALL;WEEKS=ALL DEATH=T,A,0;FIND-ALL;SUBS ET-T -- NUMB E R- 0 F - AN I MA LS SEX: ----- MALE--- -- ---- FEMALE- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 30 30 30 -a-- -*-- a ** FROM PREVIOUS PAGE ** N0SE/TUR8 SEC 3 ................................................................................... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA 1> 10 0 0 2 8 0 0 5 2> 3 0 0 3 8 0 0 1 TL> 13 0 0 S 16 0 0 6 --NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE {CHRONIC ACTIVE)/ CHRONIC INFLAMMATION 1> 3 0 0 0 0 0 0 0 2> 2 0 0 0 0 0 0 0 TL> 5 0 0 0 0 0 0 0 --NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASM 1C EOSINOPHILIC MATERIAL 1> 7 0 0 12 13 0 0 6 2> 4 0 0 1 0 0 0 0 4> 0 0 0 1 0 0 0 0 TL> 11 0 0 14 13 0 0 6 --NASAL MUCOSA (OLFACTORY): EPITHELIUM DEGENERATION 1> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 --NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES 1> 0 0 0 2 2 0 0 0 2> 0 0 0 0 1 0 0 0 TL> 0 0 0 2 3 0 0 0 --NASAL LUMEN: FREE ERYTHROCYTES 1> 0 0 0 2 0 0 0 1 2> 0 0 0 0 1 0 0 0 3> 0 0 0 0 1 0 0 0 TL> 0 0 0 2 2 0 0 1 --NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL 1> 0 0 0 1 1000 TL> 0 0 0 1 1 0 0 0 --NASAL MUCOSA (RESPIRATORY): BASOPHILIC MATERIAL 1> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 BFG 003287 --NASAL LUMEN: INFLAMMATORY CELLS/CELL DEBRIS 1> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 1 PRINTED: 29-APR-98 PAGE: 16 STUDY NUMBER: 964080 EXPANDEO INCIDENCE SUMMARY REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS-- VINYL CHLORIDE COHBINEO INHALATION TWO-GENERATION UJ (*) _J I < oo>* -- Mmin oo so ooo ooo o o oo o o ooo o o o o a) o o oooo o e o o o O' ineQm ooo I .-H M II OO-M-* IO(OM --I --I -- -- O OJ (SI IsxOO 9)0 0 OO (SI O (si LUi mI _i < ooo oo oo o< x a. ui/ji oa * * * PATH/TOX SYSTEM OUTPUT * * * MICROSCOPIC FINDINGS uj x uj to aeej-- -i N --" a. u. moo UOJ (C0L <- Z<X n x< to i CO I mast<o o tOUOo --X--iI xa. o <-- to to <o a<a&----t _i -- to ct. < too (--_} <-- to to <o -- ts to BFG 003288 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANOEO INCIDENCE SUMMARY PRINTEO; 29-APR-98 PAGE: 17 STUDY NUMBER: 964080 TABLE INCLUDES: SEX-ALL;GROUP-ALL;SCREEN-ALL;WEEKS-ALL DEATH-T.A,D;FIND-ALL;SUBSET-T -- NUM8E R -0 F - AN I MA L S SEX: ----- MALE--- ---FEMALE- GROUP: -1- -2- -3- -4- -I- -2- -3- -4- ORGAN/TISSUE EXAMINED --------------- -------------------------------------------- - - - NUMBER: 30 30 30 30 30 30 30 30 -S - - S - -3- -- a - - 3 - - 3 - -3- - = - ** FROM PREVIOUS PAGE ** LIVER ....................................................................................................... . NUMBER EXAMINED: 30 30 30 30 30 30 30 30 --HEPATOCYTES: BASOPHILIC FOCUS 1> 0 0 0 l 0 0 0 0 TL> 0 0 0 l 0 0 0 0 --HEPATOCYTES CENTRILOBULAR: HYPERTROPHY 1> 0 0 15 30 0 2 26 30 TL> 0 0 15 30 0 2 26 30 --HEPATOCYTES: ACIDOPHILIC FOCUS 1> 0 0 0 1 0 0 0 0 TL> 0 0 0 1 0 0 0 0 -PELIOSIS HEPATIS 1> 0 0 2 0 0 0 0 0 TL> 0 0 2 0 0 0 0 0 --MICROGRANULOMA 1> 0 0 0 0 0 0 1 0 TL 0 0 0 0 0 0 I 0 KIDNEYS .................................................................................................. . NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --U: PYELITIS.SUBACUTE 1> 2 0 0 1 0 0 0 1 TL> 2 0 0 1 0 0 0 1 --CORTEX: INFILTRATES.SUBACUTE 1> 5 0 0 5 4 0 0 4 TL> 5 0 0 5 4 0 0 4 --DILATED TUBULES 1> l 0 0 1 1 0 0 1 TL> 1 0 0 1 1 0 0 1 -MEDULLA: CYST 1> I a 0 0 1 0 0 0 TL> 1 0 0 0 1 0 0 0 -- INTERSTITIAL NEPHRITIS SUBACUTE I> 0 0 0 2 1 0 0 0 TL> 0 0 0 2 I 0 0 0 BFG 003289 -- PELVIS DILATED ** CONTINUED ON NEXT PAGE ** l> 0 0 0 1 1 0 0 1 Z> 0 0 0 0 0 0 0 1 3> 0 0 0 1 0 0 0 0 4> 0 0 0 0 2 0 0 0 TL> 0 0 0 2 3 0 0 2 * * * PATH/TOX SYSTEM OUTPUT * * * VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION --REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS EXPANOEO INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 18 STUDY NUMBER: 964080 i -- <n n OMM MM 04 CSJ OOOO >o ooo ooooo ooo ooo ooooo oo o o OOO ooo OOI i o ooo ooooo >MM OO OO (^.MweM MM\J r^MM o tn -- o ^ m ui m m csi i m _j oo oo AA mj ac i--> oo oooo ooo ooo ooooo OO OOOO OOO OOO OOOOl A A AAA er, --j a n n -i lOO OOO OOO omOMlO AAA csi ro . O CSI__I O -- C\J n-i -- OI --1 1 o a. o -oioz. -ALVEOLAR LUMENS: CORPORA AMYLACIA/MIWERALIZED GRANULES Mm BFG 003290 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS --- EXPANDED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 19 STUDY NUMBER: 964080 TABLE INCLUDES: SEX*ALL;GROUPAlL;SCREEN=ALL;WEEKS-ALL DEATH=T,A,D;FI NO-ALL;SUBSET-T --- N U M 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 as- COAGULATING GL ............................................................................ ___ NUMBER EXAMINED: 30 0 0 30 0 0 0 0 OVARIES ........................................................................................... .... NUMBER EXAMINED: 0 0 0 0 30 0 0 30 0V1DUCTS/FAL0P T ........................................................................ 0 0 0 0 30 0 0 30 UTERUS .............................................................................................. .... NUMBER EXAMINED: 0 0 0 0 30 0 0 30 --ENDOMETRIUM: BROWN PIGMENT 1> 0 0 0 0 10 0 0 4 2> 0 0 0 0 1 0 0 0 TL> 0 0 0 0 11 0 0 4 --ENOOMETRIUM: HEMORRHAGE(S) 2> 0 0 0 0 1 0 0 0 TL> 0 0 0 0 I 0 0 0 --MYOMETRIUM: BROWN PIGMENT 1> 0 0 0 0 6 0 0 9 2> 0 0 0 0 6 0 0 12 3> 0 0 0 0 1 0 0 1 TL> 0 0 0 0 13 0 0 22 --ENDOMETRIUM: INFILTRATES SUBACUTE I> 0 0 0 0 1 0 0 0 TL> 0 0 0 0 1 0 0 0 --LUMEN: OILATED 1> 0 0 0 0 0 0 0 2 2> 0 0 0 0 0 0 0 2 TL> 0 0 0 0 0 0 0 4 BFG 003291 --ENDOMETRIUM: GLANDS 01LATEO/CYSTIC DILATION I> 0 0 0 0 0 0 0 2 TL> 0 0 0 0 0 0 0 2 VAGINA ............................................................................................. .... NUMBER EXAMINED: 0 0 0 0 30 0 0 30 --MUOCSA: HYERPKERAT0S1S (CORNIFIED) I> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 1 PITUITARY GLANO .......................................................................... ... . NUMBER EXAMINED: 30 0 0 30 30 0 0 30 -- PARS INTERMEDIA: CYST(S) 1> 0 0 0 0 1 0 0 0 2> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 1 0 0 0 CONTINUED ON NEXT PAGE ** *** PATH/TOX SYSTEM OUTPUT *** VINYL CHL0RI0E COMBINEO INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CO RATS MICROSCOPIC FINDINGS -- EXPANOED INCIDENCE SUMMARY PRINTEO: 29-APR-98 PAGE: 20 STUOY NUMBER: 964060 TABLE INCLUDES: SEX*ALL;GROUPALL;SCREENALL;WEEKS=ALL OEATH=T,A,D;FIND-ALL;SUBSET*! -- NUMBE R- 0 F-AN I MALS SEX: ----- MALE -- -- ---FEMALE- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 ~ - s-- ** FROM PREVIOUS PAGE ** PITUITARY GLAND ................................................................................... NUMBER EXAMINED: 30 0 0 -- PARS 0ISTAL1S: CYSTS I> 2 0 0 TL> 2 0 0 30 30 30 30 --*-- -- --- 30 30 0 0 3 100 3 100 30 30 1 1 MAMMARY GLANDS ..................................................................................... NUMBER EXAMINED: 28 0 0 25 30 0 0 30 --ADENOMA P> 0 0 0 0 0 0 0 I TL> 0 0 0 0 0 0 0 1 THYMUS ...................................................................................................... NUMBER EXAMINED: 1 0 0 0 2 0 0 0 --HEMORRHAGE(S) 1> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 --CONGESTION 1> 0 0 0 0 2 0 0 0 TL> 0 0 0 0 2 0 0 0 SKIN ........................................................................................................... NUMBER EXAMINED: I 0 0 0 0 0 0 0 -- ULCERATIVE DERMATITIS 3> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 MEDIASTINAL LN ..................................................................................... NUMBER EXAMINED: 0 0 0 I 0 0 0 0 --HEMORRHAGE(S) 2> 0 0 0 1 0 0 0 0 TL> 0 0 0 1 0 0 0 0 EYES ........................................................................................................... NUMBER EXAMINED: 1 0 0 0 0 0 0 0 EARS ........................................................................................................... NUMBER EXAMINED: 0 0 0 1 2 0 0 2 --SUBACUTE (CHRONIC ACT!VE)/CHRONIC INFLAMMATION 3> 0 0 0 1 2 0 0 1 4> 0 0 0 0 0 0 0 1 TL> 0 0 0 I 2 0 0 2 BFG 003292 --NECROSIS CARTILAGE l> 0 0 0 0 2 0 0 0 3> 0 0 0 1 0 0 0 2 TL> 0 0 0 I 2 0 0 2 PANCREAS .................................................................................................. NUMBER EXAMINED: 0 0 0 0 1 0 0 0 STOMACH .................................................................................................... NUMBER EXAMINED: 0 0 0 0 0 0 0 1 ** END OF LIST * * * * * * *PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION --REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS EXPANDED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 21 STUDY NUMBER: 964080A U1/1 Ko i O (D . --Zt iii ^ii OJ fO II -- rt II (/> i --tt--st lII okb < '--> b LiJ <z I okzU <oDi t ** b<as- I --I O O --C o ooo o o o o oo a o o 09 O OOO o oo oo -- tu --: o o -- ~ a. z -- -- oo oo -- to o o o o --H -- at oo oo o i tsj (*5 r,N O O -ACUTE/SUBACUTE INFLAMMATION BFG 003293 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS MICROSCOPIC FINDINGS --- EXPANDED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 22 STUDY NUMBER: 964080A TABLE INCLUDES: SEX=ALL;GROUPALL;SCREEN-ALL;WEEKS-ALL DEATH=ALL;F1ND*ALL;SUBSET*T NUMBER-0F -AN I MALS SEX: --MALE ---- ---- FEMALE- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- 1 u>o ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 29 30 30 ** FROM PREVIOUS PAGE ** LIVER ........................................................................................... ............. NUMBER EXAMINED: 30 30 30 30 30 29 30 30 --BASOPHILIC FOCUS 1> 0 0 0 6 0 0 1 11 TL> 0 0 0 8 0 0 1 11 --CLEAR CELL FOCUS 1> 0 0 0 5 0 0 0 0 TL> 0 0 0 5 0 0 0 0 --BILE DUCT/BILIARY EPITHELIUM: HYPERPLASIA 1> 0 0 0 1 0 0 0 0 TL> 0 0 0 1 0 0 0 0 --HEPATOCYTES CENTRILOBULAR: HYPERTROPHY 1> 0 0 19 30 0 6 30 30 TL> 0 0 19 30 0 6 30 30 --NECROSIS.COAGULATION 1> 0 0 0 0 0 1 0 0 1> 0 0 0 0 0 0 2 0 TL> 0 0 0 0 0 1 2 0 -- PEL IOS IS HEPATIS 1> 0 0 1 0 0 0 0 0 TL> 0 0 1 0 0 0 0 0 -- EXTRA MEDULLARY HEMATOPOIESIS 1> 0 0 0 0 0 0 2 0 TL> 0 0 0 0 0 0 2 0 --ANGIECTASIS 2> 0 0 0 0 0 0 2 0 TL> 0 0 0 0 0 0 2 0 KIDNEYS ....................................................................................... ........... NUMBER EXAMINEO: 30 0 0 30 30 0 0 30 --CORTEX: INFILTRATES SUBACUTE 1> 4 0 0 4 1 0 0 4 TL> 4 0 0 4 1 0 0 4 BFG 003294 -- TUBULES DILATED 1> 2 0 0 2 0 0 0 1 TL> 2 0 0 2 0 0 0 1 --PELVIS: INFLAMMATION SUBACUTE ** CONTINUED ON NEXT PAGE ** 1> 0 0 0 0 0 0 0 1 2> 1 0 0 0 0 0 0 0 3> 1 0 0 0 0 0 0 0 TL> 2 0 0 0 0 0 0 1 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANOED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 23 STUOY NUMBER: 964060A TABLE INCLUDES: SEXALL;GROUPALL;SCREENALL;WEEKSALL DEATH=ALL;FINOALL;SUBSETT NUMBE R- 0 F- AN I MALS SEX: ----- MALE-- -- ---FEMALE-- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 29 30 30 ** FROM PREVIOUS PAGE ** KIDNEYS ............................................................................ --PELVIS: EPITHELIAL HYPERPLASIA ... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 1> 1 0 0 0 0 0 0 1 2> 1 0 0 0 0 0 0 0 TL> 2 0 0 0 0 0 0 1 --PELVIS: MINERALIZED GRANULES 1> 2 0 0 0 0 0 0 0 TL 2 0 0 0 0 0 0 0 --PELVIS: DILATED 1> 1 0 0 1 0 0 0 3 TL> 1 0 0 i 0 0 0 3 --PYELONEPHRITIS 3> 1 0 0 0 0 0 0 0 Tl> 1 0 0 0 0 0 0 0 --MINERALIZED GRANULES I> 0 0 0 0 1 0 0 4 2> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 1 0 0 5 --PELVIS: FREE ERYTHROCYTES 1> 0 0 0 3 4 0 0 1 TL> 0 0 0 3 4 0 0 1 TESTES .............................................................................. --TUBULAR DEGENERATION ... NUMBER EXAMINED: 29 0 0 30 0 0 0 0 2> 1 0 0 0 0 0 0 0 3> 1 0 0 1 0 0 0 0 S> I 0 0 1 0 0 0 0 TL> 3 0 0 2 0 0 0 0 EPIDIDYMIDES ................................................................. --ASPERMIA . .. NUMBER EXAMINED: 29 0 0 30 0 0 0 0 5> 1 0 0 1 0 0 0 0 TL 1 0 0 1 0 0 0 0 BFG 003295 --HYPOSPERMIA 3> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 PROSTATE GLAND ............................................................. --EDEMA ** CONTINUED ON NEXT PAGE ** . . . NUM8ER EXAMINED: 30 0 0 30 0 0 0 0 1> 2 0 0 1 0 0 0 0 TL> 2 0 0 1 0 0 0 0 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 24 STUDY NUMBER: 964080A TABLE INCLUDES: SX"ALL;GROUP=ALL;SCREEN"ALL;WEEKS"ALL DEATH=ALL;FIND=ALL;SUBSET=T NUMBE R- 0 F -AN IMA LS SEX: --MALE -- -- -- --FEMALE- GROUP: -1- -2- -3- -4- -L- -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> 5 0 0 0 0 0 0 0 TL> 9 0 0 2 0 0 0 0 --ALVEOLAR LUMENS: CORPORA AMYLACIA/HINERALIZED GRANULES 1> 4 0 0 4 0 0 0 0 TL> 4 0 0 4 0 0 0 0 --ALVEOLAR LUMENS: EXUOATE 1> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 SEMINAL VESICLES ........................................................................ .. . NUMBER EXAMINED: 30 0 0 30 0 0 0 0 --INFLAMMATION, SUBACUTE 2> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 COAGULATING GL ............................................................................ . . . NUMBER EXAMINEO: 30 0 0 30 0 0 0 0 OVARIES ........................................................................................... . . . NUMBER EXAMINED: 0 0 0 0 30 0 0 30 OVIDUCTS/FALOP T ........................................................................ . . . NUMBER EXAMINED: 0 0 0 0 30 0 0 30 UTERUS ................................................................................................ . . . NUMBER EXAMINED: 0 0 0 0 30 0 0 30 --LUMEN: OILATEO 1> 0 0 0 0 4 0 0 5 2> 0 0 0 0 2 0 0 3 TL> 0 0 0 0 6 0 0 8 -- MYOMETRIUM: BROWN 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 13 BFG 003296 -- ENDOMETRIUM: BROWN PIGMENT 1> 0 0 0 0 1 0 0 12 TL> 0 0 0 0 1 0 0 12 -- ENDOMETRIUM: HYPERPLASIA 1> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 1 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANDEO INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 25 STUOY NUMBER: 964080A TABLE INCLUDES: SEX*ALL;GROUP*ALL;SCREEN=ALL;UEEKS=ALL DEATHALL;FIND-ALL;SUBSETT --- N U M 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 -------- ------------------------------------------------------------------------------ ------w---------------- -a- -a- -a- -a- -a- 29 30 30 -a- -a- VAGINA ......................................................................................... --MUCOSA: HYPERKERATOSIS (CORNIFIED) 0 0 0 0 26 0 0 30 1> 0 0 0 0 3 0 0 3 2> 0 0 0 0 1 0 0 0 TL> 0 0 0 0 4 0 0 3 PITUITARY GLAND ...................................................................... ........... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 -- PARS INTERMEDIA: CYST(S) 1> 1 0 0 2 0 0 0 0 TL> 1 0 0 2 0 0 0 0 --PARS D1STAL1S: CYSTS I> 0 0 0 1 0 0 0 0 TL> 0 0 0 1 0 0 0 0 --PARS DISTALIS: FOCAL HYPERPLASIA I> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 1 MAMMARY GLANDS ........................................................................ ........... NUMBER EXAMINED: 26 0 0 25 29 0 0 30 NOSE/TURBINATES ...................................................................... ........... NUMBER EXAMINED: 0 0 0 0 0 0 0 0 NOSE/TURB SEC 1 ...................................................................... ........... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 -- NASAL LUMEN: FREE ERYTHROCYTES I> 2 0 0 I 0 0 0 0 TL> 2 0 0 1 0 0 0 0 --NASAL MUCOSA (RESPIRATORY): ACUTE/SU8ACUTE INFLAMMATION 1 I 0 0 I 0 0 0 0 3> 0 0 0 0 1 0 0 0 TL> 1 0 0 I 1 0 0 0 --NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES I> 0 0 0 I 0 0 0 0 2> 0 0 0 0 0 0 D 2 TL> 0 0 0 I 0 0 0 2 BFG 003297 --NASOLACRIMAL OUCT(S): EOSINOPHILIC MATERIAL 1> 0 0 0 1 0 0 0 0 TL> 0 0 0 I 0 0 0 0 --VOMERONASAL ORGAN: FREE ERYTHROCYTES ** CONTINUED ON NEXT PAGE ** 1> 2 0 0 2 1 0 0 1 TL> 2 0 0 2 1 0 0 1 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CO RATS MICROSCOPIC FINDINGS --- EXPANDED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 26 STUDY NUMBER: 964080A TABLE INCLUDES: SEX*ALL;GROUP*ALL;SCREENALL;WEKSALL DEATH=ALL;FIND-ALL;SUBSET-T -- NUH BE R-0 F-AN 1 MALS SEX: --MALE ---- ---FEMALE- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 """ --a - "*" --a- ~ m ~~ ** FROM PREVIOUS PAGE ** NOSE/TURB SEC 1 ................................................................................... NUMBER EXAMINED: 30 0 0 30 30 --NASAL MUCOSA (RESPIRATORY): GOBLET CELL HYPERTROPHY/HYPERPLASIA 1> I 0 0 2 0 TL> 1 0 0 2 0 29 30 30 -a- --a- 0 0 30 000 000 -ODONTOPATHY 1> 1 0 0 1 1 0 0 0 TL 1 001 1000 --VOMERONASAL ORGAN: EOSINOPHILIC MATERIAL 1* 1 0 0 0 1 0 0 0 TL> 1 0 0 0 I 0 0 0 -NASOLACRIMAL DUCT: EXUDATE 2> 0 0 0 0 1 0 0 0 TL> 0 0 0 0 1 0 0 0 --NASAL LUMEN: EXUDATE 3> 0 0 0 0 I 0 0 0 TL> 0 0 0 0 1 0 0 0 --NASAL MUCOSA (VESTIBULAR): SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION 1> 0 0 0 1 0 0 0 0 TL> 0 0 0 1 0 0 0 0 NOSE/TURB SEC 2 ................................................................................... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 -NASAL LUMEN: FREE ERYTHROCYTES TL> 0 0 0 0 0 0 0 0 --NASOLACRIMAL OUCT(S): INFLAMMATORY CELLS/CELL DEBRIS 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 1> 0 0 0 4 0 0 0 1 4> 0 0 0 0 I 0 0 0 5> 0 0 0 0 I 0 0 0 TL> 0 0 0 4 2 0 0 1 BFG 003298 -ODONTOPATHY I> 2 0 0 2 1 0 0 0 2> 1 0 0 0 0 0 0 0 TL> 3 002 I00 0 -VOMERONASAL ORGAN: FREE ERYTHROCYTES ** CONTINUED ON NEXT PAGE ** 1> 2 0 0 3 0 0 0 0 TL> 2 0 0 3 0 0 0 0 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBIHEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS --- EXPANDED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 27 STUDY NUMBER: 964080A TABLE INCLUDES: SEX*ALL;GROUP"ALL;SCREENALL;WEEKSALL DEATH-ALL;FINO-ALL:SUBSET-T --- N U M B E R - 0 F - A N I H A 1L s SEX: ----- MALE--- -- ---FEMALE- GROUP: -1- -2- -3- -4- -I- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 29 30 30 ** FROM PREVIOUS PAGE ** NOSE/TURB SEC 2 .............................................................................. ... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES i> 2 0 0 2 2 0 0 2 2> 0 0 0 0 0 0 0 3 TL> 2 0 0 2 2 D 0 5 --VOMERONASAL ORGAN: EOSINOPHILIC MATERIAL i> 3 0 0 0 1 0 0 1 TL> 3 0 Q 0 1 0 0 1 --VOMERONASAL ORGAN: EXUDATE I> 0 0 0 0 0 0 0 1 TL> 0 0 0 0 0 0 0 1 -- NASOLACRIMAL DUCT: EXUDATE I> 0 0 0 1 0 0 0 0 3> 0 0 0 0 1 0 0 0 4> 0 0 0 0 1 0 0 0 TL> 0 0 0 I 2 0 0 0 NOSE/TURB SEC 3 ................................................................................. NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --NASAL LUMEN: FREE ERYTHROCYTES i> I 0 0 1 000 0 2> 0 0 0 0 l 0 0 1 3> 0 0 0 1 000 0 TL> 1 0 0 2 l 0 0 I --NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL --NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION t> 8 0 0 3 7 0 0 4 TL> 8 0 0 3 7 0 0 4 1> 2 0 0 0 1 0 0 0 Z> 0 0 0 0 1 0 0 0 4> 0 0 0 0 1 0 0 0 TL> 2 0 0 0 3 0 0 0 BFG 003299 --NASOLACRIMAL OUCT: LYMPHOID HYPERPLASIA 1> 13 0 0 8 8 0 0 8 2> 0 0 0 0 2 0 0 0 3> 0 0 0 0 1 0 0 0 TL> 13 0 0 8 11 0 0 8 --NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL ** CONTINUED ON NEXT PAGE ** l> 2 0 0 1 TL> 2 0 0 1 0000 00 0 0 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANOED INCIDENCE SUMMARY PRINTED: 29-APR-98 PAGE: 28 STUOY NUMBER: 964O60A TABLE INCLUDES: SEX=ALL;GROUP"ALL;SCREEN*ALL;WEEKSALL DEATH-ALL;FIND-ALL; SUBSETS -- N U M B E R - 0 F - A N I N A 1L S SEX: --MALE-- --FEMALE -- GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 29 30 30 --------------------------------------------------------- - - ------ - - ----------- --------------------- -s- - = - -s- - s - -= - -a- --E-- -s- ** FROM PREVIOUS PAGE ** NOSE/TURB SEC 3 ................................................................................... NUMBER EXAMINED: 30 0 0 30 30 0 0 30 --NASOLACRIMAL OUCT(S): FREE ERYTHROCYTES 1> 1 0 0 1 0 0 0 0 2> 0 0 0 0 0 0 0 1 TL> 1 0 0 1 0 0 0 1 --NASOLACRIMAL DUCT: EXUDATE 1> 0 0 0 0 1 0 0 0 3> 0 0 0 0 1 0 0 0 TL> 0 0 0 0 2 0 0 0 NOSE/TURB SEC 4 ................................................................................... --NASAL LUMEN: FREE ERYTHROCYTES NUMBER EXAMINED: 1> 2> 3> TL> 30 2 1 0 3 0 0 0 0 0 0 30 30 00 1 000 01 L 01 2 0 0 30 00 1 00 0 00 1 00 2 --NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL 1> 18 0 0 9 11 0 0 10 2> 1 0 0 1 3 0 0 0 TL> 19 0 0 10 14 0 0 10 --NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION TL> 0 0 0 0 0 0 0 0 --NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL l> 3 0 0 6 1 0 0 3 TL> 3 0 0 6 1 0 0 3 URETHRA .................................................................................................... NUMBER EXAMINED: 3 0 0 0 0 0 0 0 -- SEMINAL COAGULUM 1> 2 0 0 0 0 0 0 0 TL> 2 0 0 0 0 0 0 0 -- INFLAMMATION. SUBACUTE 2> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 BFG 003300 MESENTERIC LN ....................................................................................... NUMBER EXAMINED: 1 0 0 0 0 0 0 0 -- LYMPHOID HYPERPLASIA 2> 1 0 0 0 0 0 0 0 TL> I 0 0 0 0 0 0 0 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COHBINEO INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS MICROSCOPIC FINDINGS -- EXPANOED INCIDENCE SUMMARY PRINTEO: Z9-APR-98 PAGE: 29 STUDY NUMBER: 964O80A TABLE INCLUDES: SEX-ALL;GROUPAll;SCREEN-AIL;UEEKSALL DEATH-ALL;FIND-ALL;SUBSETT ___ N U M 6 E R - 0 F - A N I M A L S SEX: --MALE -- -- -- --FEMALE-- GROUP: -1- -Z- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 30 30 30 30 30 29 30 30 PREPUT/CLIT GL ............................................................................ --INFLAMMATION. SUBACUTE 1 0 000 000 l> 1 0 0 0 0 0 0 0 TL> 1 0 0 0 0 0 0 0 SKIN .................................................................................................. ... NUMBER EXAMINEO: 0 0 0 0 1 0 0 0 EXTREMITY ....................................................................................... ... NUMBER EXAMINED: 0 0 0 0 0 0 0 1 ADIPOSE TISSUE ............................................................................ ... NUMBER EXAMINEO: 0 0 0 1 0 0 0 0 -- ECTOPIC EPIDIDYMIS 3> a 0 a I Q 0 0 0 TL> 0 0 0 I 0 0 0 0 ** END OF LIST ** BFG 003301 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,(R) L,(L) w TE LN FALOP T = ASSOC = MFOC SUBA Unilateral Bilateral Right Left With Testes Lymph Node Fallopian Tubes Associated Multifocal Subacute Note Unless otherwise specified in a histopathology note, the organ/tissue examined was the required (routine) section. BFG 003302 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 31 STUOY NUMBER: 964080 ANIMAL NUMBER: 1001 OATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL 80DY WEIGHT: 458.3 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES LIVER . . MICRO: MICRO: N0SE/TUR8 SEC 2 MICRO: NQSE/TURB SEC 3 MICRO: NQSE/TUR8 SEC 4 MICRO: HISTOPATHOLOGICAL COMMENT: -MINIMAL. MULTI-FOCAL -MINIMAL, MULTI-FOCAL -MINIMAL. MULTI-FOCAL HISTOPATHOLOGICAL COMMENT: -MINIMAL. FOCAL -SLIGHT -SLIGHT >ONE PRESENT -EXTRAMEOULLARY HEMATOPOIESIS -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) INFLAMMATORY FOCI ASSOC W SINGLE CELL NECROSIS -NASAL LUMEN: FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL. EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: **M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. MI-" INVASIVE. HX-H OTHER BFG 003303 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 32 STUDY NUMBER: 964060 ANIMAL NUMBER: 1002 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: S39.4 GRAMS ORGAN NAME * * * PATHOLOG KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS GROSS/MICRO CORfi MICRO H1ST0PATH0L0GICAL COMMENT: >KIDNEY-L: IRREGULAR SHAPE/NMC KIONEYS GROSS -IRREGULAR SHAPE -LEFT LIVER MICRO -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS LUNGS MICRO -SLIGHT -CONGESTION NOSE/TURB SEC 4 MICRO -MINIMAL -NASAL MUCOSA (RESPIRATORY): BASOPHILIC MATERIAL TRACHEA MICRO: -MINIMAL, FOCAL -MUCOSA: MUCOSAL GLANDS-OILATEO 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: mM-m MALIGNANT, "B-" BENIGN. METASTATIC. "I-" INVASIVE. MX-" OTHER BFG 003304 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 33 STUDY NUMBER: 964080 ANIMAL NUMBER: 1003 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BOOT WEIGHT: 493.5 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWOROS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIOIOYMIDES . MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT LIVER . . . . MICRO: -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) NOSE/TURB SEC 2 MICRO: -MINIMAL, FOCAL -NASOLACRIMAL OUCT(S): INFLAMMATORY CELLS/CELL DEBRIS NOSE/TURB SEC 3 MICRO: -MINIMAL -NASAL MUCOSA (RESPIRATORY!1: EPITHELIUM-INTRACYT0PLASM1C EOS 1NOPHLIC MATERIAL -SLIGHT -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 MICRO: -SLIGHT -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL PROSTATE GLAND MICRO: -MINIMAL, FOCAL -LYMPHOID CELL INFILTRATE(S)/AGGREGATE(S) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL, EPIOIOYMIDES, KIDNEYS. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, PITUITARY GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "1-" INVASIVE, "X-" OTHER BFG 003305 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 34 STUDY NUMBER: 964080 ANIMAL NUMBER: 1004 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: S60.6 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIOYMIDES MICRO: GROSS/MICRO CORR MICRO: KIDNEYS MICRO: LIVER . . MICRO: LUNGS MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 3 MICRO: NOSE/TURB SEC 4 MICRO: THYMUS GROSS: MICRO: HISTOPATHOLOGICAL COMMENT: HISTOPATHOLOGICAL COMMENT: -MINIMAL, FOCAL -MINIMAL. MULTI-FOCAL -MINIMAL -MINIMAL. FOCAL -MODERATE -SLIGHT -MODERATE -SLIGHT -MINIMAL -SLIGHT -DISCOLORED -MINIMAL. MULTI-FOCAL >ONE PRESENT >THYMUS: OISCOLORED/HEMORRHAGE HFOC -U: PYELITIS,SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -PULMONARY VESSELS: MINERAL DEPOSIT(S) -NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION -VOMORONASAL ORGAN: EOSINOPHILIC MATERIAL -ODONTOPATHY -NASOLACRIMAL DUCT: LYMPHOIO HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -RED -HEMQRRHAGE(S) THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. MAMMARY GLANDS, NOSE/TURB SEC 1, PITUITARY GLAND, PROSTATE GLAND. SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003306 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 35 STUDY NUMBER: 964080 ANIMAL NUMBER: 1005 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 545.1 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F1N0INGS EPIDIDYMIDES KIDNEYS LIVER NOSE/TURB SEC I NOSE/TURB SEC 2 NOSE/TURB SEC 3 PROSTATE GLAND MICRO MICRO MICRO MICRO MICRO MICRO: MICRO: -MINIMAL, -MINIMAL -MINIMAL, -MINIMAL, -MINIMAL, -SLIGHT -MINIMAL, HISTOPATHOLOGICAL COMMENT; FOCAL FOCAL FOCAL FOCAL FOCAL >0N PRESENT -CORTEX: INFILTRATES,SUBACUTE -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -VOMORONASAL ORGAN: FREE"ERYTHROCYTES -NASAL LUMEN: FREE ERYTHROCYTES -VOMORONASAL ORGAN: EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -LYMPHOID CELL'INFiLTRATE(S)/AGGREGATE(S) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIQIOYMIDES. LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 4. PITUITARY GLAND. SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE. "X-M OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 36 STUDY NUMBER: 964060 ANIMAL NUMBER: 1006 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BOOY WEIGHT: 433.6 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIOYHIDES . MICRO: KIDNEYS . . . MICRO: LIVER . . . . MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 3 MICRO: HISTOPATKOLOGICAL COMMENT: -MINIMAL, FOCAL -MINIMAL, MULTI-FOCAL -MINIMAL -MODERATE -MODERATE -SLIGHT -SLIGHT >ONE PRESENT -DILATED TUBULES -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASOLACRIMAL OUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE}/ CHRONIC INFLAMMATION -ODONTOPATHY -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASOLACRIMAL OUCT{S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES. LUNGS. MAMMARY GLANOS. NOSE/TURB SEC 1. NOSE/TURB SEC 4, PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: '*H-" MALIGNANT. "8-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003308 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 37 STUDY NUMBER: 964080 ANIMAL NUMBER: 1007 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: l SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF OEATH: 16 TERMINAL BOOY WEIGHT: 447.9 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F1N0INGS 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-ZONAL) -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -MUCOSA: MUCOSAL GLANDS-OILATED *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL. EPIDIDYMIDES. KIDNEYS. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. PITUITARY GLAND. PROSTATE GLAND. SEMINAL VESICLES, TESTES KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, *'l-" INVASIVE, "X-" OTHER BFG 003309 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 38 STUDY NUMBER: 964080 ANIMAL NUMBER: 1008 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: SOI.1 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES ................................................................................................................................................................................................................................. MICRO: H1ST0PATH0L0GICAL COMMENT: >ONE PRESENT LIVER .............................................................................................................................................................................................................................................. MICRO: -MINIMAL, MULTI-FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) NOSE/TURB SEC 3 ......................................................................................................................................................................................................................... MICRO: -MINIMAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA NOSE/TURB SEC 4 ......................................................................................................................................................................................................................... MICRO: -SLIGHT -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYT0PLASM1C EOSINOPHILIC MATERIAL -MINIMAL -NASAL MUCOSA (RESPIRATORY): BASOPHILIC 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, NOSE/TURB SEC 2. PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER ou't'oo o ia *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 39 STUDY NUMBER: 964080 ANIMAL NUMBER: 1009 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 546.8 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS *** KEYWOROS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES . MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT KIDNEYS . . . MICRO:'-MINIMAL,'FOCAL.................................................... -CORTEX:' INFRTRATES j SUBACUTE LUNGS . . . . MlCROi'-MINIMAL, MULTI-FOCAL....................................... -LYMPH010 CELL INFIITRATE(S)/AGGREGATESj NOSE/TURB SEC 3 MICRO; -MINIMAL................................................................. -NASOLACRIMAL DUCT: LYMPHoio HYPERPLAsiA.................................. PROSTATE GLAND MICRO-.'-MINIMAL. MULTI-FOCAL....................................... -ALVEOLAR LUMENS': CORPORA AMYLACiA/MiNERALiZED GRANULES *** 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 GLAND, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-*' BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003311 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLOftIOE COMBINED INHALATION TUO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 40 STUDY NUMBER: 964080 ANIMAL NUMBER: 1010 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: 425.3 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES .................................................................................................................................................................................................................................. MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT EYES................................................................................................................................................................................................................................................... GROSS: -OPACITY -RIGHT LENS: FOCAL OPACITY GROSS/MICRO CORR ......................................................................................................................................................................................................................... MICRO: HISTOPATHOLOGICAL COMMENT: >SKIN: SORE VENTRAL CERVICAL/ULCERATIVE DERMATITIS EYE-R: OPACITY/NMC NOSE/TURB SEC 1 ......................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -VOMORONASAL ORGAN: FREE ERYTHROCYTES -MINIMAL. FOCAL -NASOLACRIMAL OUCT(S): FREE ERYTHROCYTES NOSE/TURB SEC 3 ............................................................................................................................................................................................................................. MICRO: -MINIMAL -NASOLACRIMAL OUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ......................................................................................................................................................................................................................... MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL SKIN................................................................................................................................................................................................................................................... GROSS: -SCAB(S)/SORE(S) -SORE. VENTRAL CERVICAL: TAN MICRO: -MODERATE, FOCAL -ULCERATIVE DERMATITIS THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIOIDYMIDES, EYES, KIDNEYS, LIVER. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 2, PITUITARY GLAND, PROSTATE GLAND. SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-m BENIGN, "S-" METASTATIC. "I-" INVASIVE. 'X-' OTHER BFG 003312 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 41 STUDY NUMBER: 964080 ANIMAL NUMBER: 1011 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOY WEIGHT: 426.2 6RAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FIN01NGS EPIDIDYMIDES MICRO HISTOPATHOLOGICAL COMMENT: >ONE PRESENT KIDNEYS MICRO -MINIMAL, FOCAL -CORTEX: INF!LTRATES,SUBACUTE LIVER MICRO: -MINIMAL, MULTI-FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) MAMMARY GLANDS MICRO: -TISSUE HISSING NOSE/TURB SEC 2 MICRO: -MINIMAL, FOCAL -VOMERONASAL ORGAN: FREE ERYTHROCYTES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIOIDYMIDES, LUNGS. NOSE/TURB SEC 1, NOSE/TURB SEC 3. NOSE/TURB SEC 4, PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-M OTHER BFG 003313 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 42 STUDY NUMBER: 964080 ANIMAL NUMBER: 1012 DATE OF DEATH: 04/29/97 SEX: HALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 113 STUDY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: 574.0 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWOROS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT LIVER . . MICRO: -MINIMAL. MULTI-FOCAL -EXTRAMEDULLARY HEMATOPOIESIS -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) NOSE/TURB SEC 3 MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPJTHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIOIOYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2, PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "8-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003314 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 43 STUOY NUMBER: 964080 ANIMAL NUMBER: 1013 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: 488.2 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES MICRO HISTOPATHOLOGICAL COMMENT: >ONE PRESENT LIVER MICRO -SLIGHT -HEPATOCYTES: CYTOPLASMIC VACUOLES {N0N-20NAL) NOSE/TURB SEC 4 MICRO -SLiGHT -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL PROSTATE GLAND MICRO: -MINIMAL, FOCAL -LYMPHOIO CELL INFILTRATE(S)/AGGREGATE(S) *** 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 2. NOSE/TURB SEC 3. PITUITARY GLANO. SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. *'S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003315 40 1 1 1 CD 1 1 1 11 O. 00 1 1 1 11 1 11 1 a to 1 (MO OJ 1 1 J CO 1 1 1 1 x1 1 au LkJ tJ 1-- ^ as 1 UJ 1 A 1 1 at 1 * J 1 M -- = 1 UJ <0 1 O1 1o 4 1 tn 1 z4 MM 4 >o4 1 lb 11 4 DC 1u 1 i 1 r 1 03 4 CO I 4 1 1 --1 * JX 1 i 1 <<3 1 1 Z MM 1 X4 H* < 11 1 1 Q_ J 1 OS 1 o 4 1 UJ ^ 1 1 1 1--0 1 CO ( 1 1 mm 4 eo 1 4o 1 X4 4 1 UJ ^ 1 4 111 1 3Z 1 * 4 tO 1 O -- 1 4 b< 3S QJ 4 UZ 1 * CO 4 4 Xas 1 1 O UJ 1 1 to u- UJ --o 1 1 1 vdx 1 11 1 CO 4 zo as z ix 1 1 UJ *- 1 K- 1o 1 Z UJ >- 1< l h- 11 1 -1 X 1 (JO i tO (A 1 UJ 1 u- ^ * o ^ UJ 1 UJ 1 1 3MU l CJ 1 i1 UJ 1 3 >- V) 1 Ik 1-- > as a. z -- 1 --< 1 lb 1 t-- o -- *: i OS UJ 1 at 1 ua CO 4 OH-< l < 1 UJ CO 4 C XQ 1 trt lx. 1 o 1 1 vi as l l 1 <9 l *-- x c 1 1o utZ-JZ l 1 UJ 1 UJ 1 l11 oz< l 1 X UJ UJ 1 MM^ 1 ' 4 Z Z_l l o 1 >- (-- >--. Q. * 1 3 "s-fiO Q 3 a.i-- I X _IQ i 5vi 1 z4 KOUJm l o 1 oo 4 1 D? & UJ -- l uoe i MM 4 4 ^u 1 X1 * a z 1 UJ 1 o CD 1 1 CO OJ 1 mm 1 Q Z o< 1 -- 1 xas i 0-4 1 l 1 -- tO mm w o 1 l X 1 <o 1 - 1 >- c_) ---o mo a Q_ w OS l UJ 1 >- 1 l14 l 1 Cl i l Lb 1 k DC 1 o 1 UJ i 1 > 4 1 UJ > 1 UJ 4 1 --1 1 to 4 l co 1 4 1X 1 m4 >- CO 1 1 --o 1 1 XX 1 o1 at 4 xl 1-- 1 1 V) CO 1 1 >- 4 1 1 UJ 4 111 l1 ' * -- z UJ UJ at 0_ UJ z o A ^ z UJ z <-> -J O mm o -- X o to * to > MM MM .1 < .2 SO UJ o 1 1 UJ O oe UJ X ID -X CO . UJ at lb X UJ .^ as (J h-J ( o CO * UJ o X CJ > & ^ > _> t CO UJ f-- .^ o u< a. . UJ z to ^ UJ >* DC o *Z X w Lb . MM CO *M o X o s C o CO UJ X o X CO 1 -c to z X ^^2 to o "-- H- ^ -oz Ilk oe <w --J v) as - s _> O Ik % ^ C MM z MM X | _J < MM MM X 1 oJ < X MM 2 MM X _J < Z MM Z MM X t CO - J DC a KJ MM UJ u _J > CO DC as --j UJ MM CO UJ Lu a _J X X ** z MM </> X 14 11 11 l r* 1 i o> 1 1 o1 l <9 csj 1 1 mm 1 1 OT 1 ^o < 11 l UJ -- 1 1 CD 1 1 X Ixl 1 xo i1 l u. 1 l --<o 1 11 1 ZMJ 1 1 MM -- 1 41 1 xo 1 1 ** o O o O i ac as as as at i <_> o > tJ CJ u 1 M MM MM MM MM Z X X X X 4 1M 1 1 _> _> bl 1 UJ o J) UJ i a z 1 M4 c 1 z 1> /> BB at as X i a > -- t ** bl i < o Jj Jj Jj (9 | CM o > /> o DC 1 Q- M 4W X zZ o o as ee CJ u MM MM X * z L9 >as UJ NMB -- CO ^o as Qk a. * o > as UJ to ImJ MM MM X as o SO CO CO as z <o X UJ *-- <o ItJ <o UJ <s> UJ z mm Ibl CO k o UJ mH CO as vi uj O CO m<c Q_ C0 CO --J U V) zo MM OX o X-- Q_ CO UJ UJ to -J UJ X 4 4 1 1 1 1 1 1 1X i |4 I% 1 UJ 1> 1 MM 1 CO 1 Z 1> 1z 1 1 MM 1 | 1^ 1 CO 1 h-- 11 i 1m 1 1 UJ |* 1z I IS 1 MM 1^ |J 1I 1z 1 to i l D. 1 UJ 1z 1 1 *-- 1 1 >" IX 1 1 1 1 1 1 4 BFG 003316 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 45 STUDY NUMBER: 964080 ANIMAL NUMBER: 1015 DATE OF DEATH: 04/Z8/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY OAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 493.0 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS . . . MICRO: -MINIMAL, FOCAL LIVER . . . . MICRO: -MINIMAL,'MULTI-FOCAL -SLIGHT LUNGS . . . . MICRO:'-MINIMAL,'FOCAL' MAMMARY GLANDS MICRO: -TISSUE MISSING NOSE/TURB SEC 1 MICRO: -SLIGHT^ FOCAL NOSE/TURB SEC 2 MICRO: -SLIGHT.......................... NOSE/TURB SEC 3 MICRO: -MINIMAL NOSE/TURB SEC 4 MICRO; -SLIGHT.......................... -U: PYELITIS,SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -INTERSTITIUM: MINERAL OEPOSIT(S)/OSSEOUS METAPLASIA -NASOLACRIMAL OUCT(S): FREE ERYTHROCYTES -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYT0PLASM1C EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "0-" BENIGN, "S-" METASTATIC, "1-" INVASIVE, "X-" OTHER BFG 003317 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 46 STUDY NUMBER: 964080 ANIMAL NUMBER: 1016 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: S70.9 GRAMS ORGAN NAME * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS, SEVERITY, DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER .......................................................................... MICRO: -MINIMAL, MULTI-FOCAL -SLIGHT NOSE/TURB SEC 2 ..................................................... MICRO: -MINIMAL NOSE/TURB SEC 3 ..................................................... MICRO: -MINIMAL -SLIGHT NOSE/TURB SEC 4 .................................................... MICRO: -SLIGHT -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -VOHORONASAL ORGAN: EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL. EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1, PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. BENIGN. "S-" METASTATIC, "I-'' INVASIVE, "X-" OTHER BFG 003318 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 47 STUDY NUMBER: 964080 ANIMAL NUMBER: 1017 OATE OF DEATH: 04/28/97 ORGAN NAME SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 535.2 GRAMS * * * PATHOLOGY OBSERVATIONS * * * KEYWORDS. SEVERITY. DISTRIBUTION GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . . . MICRO: -MINIMAL. MULTI-FOCAL -MINIMAL LUNGS .. .. micr6:"-hinihal,'focal' NOSE/TURB SEC 2 MICRO: -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -LYMPHOID CELL INFILTRATE(S)/AGGREGATE(S) -VOMORONASAL ORGAN: EOSINOPHILIC MATERIAL *** 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 3. NOSE/TURB SEC 4. PITUITARY GLAND, PROSTATE GLANO, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "8-'* BENIGN, METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003319 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 48 STUDY NUMBER: 9640B0 ANIMAL NUMBER: 1018 DATE OF DEATH; 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH; 112 STUDY WEEK OF DEATH: IB TERMINAL BODY WEIGHT: 486.2 GRAMS ORGAN NAME *** PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL, MULTI-FOCAL -SLIGHT LUNGS MICRO -MINIMAL, FOCAL NOSE/TURB SEC 3 MICRO -MINIMAL.FOCAL' NOSE/TURB SEC 4 MICRO '-SLIGHT.................... PITUITARY GLAND MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -PULMONARY VESSELS: MINERAL DEPOSIT(S) -NASALMUCOSA (OLFACTORYj:'EPITHCtiuH DEGENERATION' -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -PARS DISTALIS: CYSTS *** 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, PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. HX- OTHER BFG 003320 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 49 STUDY NUMBER: 964080 ANIMAL NUMBER: 1019 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 499.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ...................................................................... MICRO: -MINIMAL NOSE/TURB SEC 1 ............................................. 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-ZONAL) -NASAL MUCOSA (RESPIRATORY): ACUTE/SUBACUTE INFLAMMATION -NASOLACRIMAL OUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASM IC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -ALVEOLAR LUMENS: CORPORA AMYLACIA/MINERALIZED GRANULES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. KIDNEYS, LUNGS. MAMMARY GLANDS. PITUITARY GLANO. SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. *'I-** INVASIVE. "X-'* OTHER BFG 003321 ANIMAL NUMBER: 1020 DATE OF DEATH: 04/28/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INOIVIOUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 50 STUDY NUMBER: 964080 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEOULEO, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BOOY WEIGHT: 516.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION LIVER LUNGS NOSE/TURB SEC 2 NOSE/TURB SEC 3 NOSE/TURB SEC 4 MICRO: MICRO MICRO MICRO MICRO -MINIMAL -MINIMAL. FOCAL -SLiGHTi FOCAL -MINIMAL -MINIMAL PROSTATE GLAND MICRO: -MINIMAL, FOCAL OBSERVATIONS * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS -HEPATOCYTES: CYTOPLASMIC VACUOLES (NGN-ZONAL) -LYMPHOID CELL INFILTRATE(S)/AGGREGATE(S) -NASOLACRIMAL DUCT(Sj:'FREE ERYTHROCYTES' -NASOLACRIMAL DUCT: LYMPHOiD HYPERPLAsiA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL -LYMPHOIO CELL INFILTRATE(S)/AGGREGATE(S) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. KIDNEYS. MAMMARY GLANDS, NOSE/TURB SEC 1. PITUITARY GLAND. SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, MI-" INVASIVE, "X-" OTHER BFG 003322 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 51 STUDY NUMBER: 964080 ANIMAL NUMBER: 1021 OATE OF OEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 482.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL, MULTI-FOCAL NOSE/TURB SEC 1 ............................................................ MICRO: -SLIGHT, FOCAL NOSE/TURB SEC 2 ............................................................ MICRO: -SLIGHT NOSE/TURB SEC 3 ............................................................ MICRO: -MINIMAL -SLIGHT NOSE/TURB SEC 4 ............................................................ MICRO: -SLIGHT -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -ODONTOPATHY -ODONTOPATHY -NASOLACRIMAL OUCT: LYMPHOID HYPERPLASIA -NASOLACRIMAL DUCT{S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION -NASAL LUMEN: FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS. PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTHER BFG 003323 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 52 STUDY NUMBER: 964080 ANIMAL NUMBER: 1022 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUOY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 529.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL, MULTI-FOCAL -MINIMAL. FOCAL NOSE/TURB SEC 2 MICRO: -MINIMAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. KIDNEYS, LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 3, NOSE/TURB SEC 4, PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003324 ANIMAL NUMBER: 1023 DATE OF DEATH: 04/29/97 ORGAN NAME *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 53 STUOY NUMBER: 964080 SEX: HALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 451.8 GRAMS * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS MICRO: LIVER .............................. MICRO: NOSE/TURB SEC 4 MICRO: -MINIMAL -MINIMAL -MINIMAL HISTOPATHOLOGICAL COMMENT: >ONE PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (RESPIRATORY): BASOPHILIC MATERIAL ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIOIOYMIOES, KIONEYS. LUNGS. MAMMARY GLANDS. NOSE/TUR0 SEC 1. N0SE/TUR8 SEC 2, NOSE/TURB SEC 3. PITUITARY GLANO, PROSTATE GLAND, SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTHER BFG 003325 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 54 STUDY NUMBER: 964060 ANIMAL NUMBER: 1024 OATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 469.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: NOSE/TURB SEC 1 MICRO: NOSE/TURB SEC 3 MICRO: -SLI6HT -MINIMAL -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL PITUITARY GLAND MICRO: -MINIMAL, FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -VOMORONASAL ORGAN: FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY) : EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY) : EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -PARS OISTALIS: CYSTS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIDNEYS. LUNGS. MAMMARY GLANDS, N0SE/TUR8 SEC 2. PROSTATE GLAND, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-M METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003326 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 5S STUDY NUMBER: 964080 ANIMAL NUMBER- 1025 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUQY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 511.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . . . MICRO: -MINIMAL NOSE/TURB SEC 3 MICRO:'-MINIMAL,'FOCAL -MINIMAL NOSE/TURB SEC 4 .............................. MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYT0PLASM1C EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASM IC 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 SEC 2. PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE, "X-M OTHER BFG 00.1327 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-96 PAGE: 56 STUDY NUMBER: 964080 ANIMAL NUMBER: 1026 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY OAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 456.8 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ................................................................................................................................................................................................................................................................................ MICRO: -MINIMAL, MULTI-FOCAL -ACUTE/SUBACUTE INFLAMMATION -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) NOSE/TURB SEC 2 ....................................................................................................................................................................................................................................................... MICRO: -SLIGHT -NASOLACRIMAL OUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION -MINIMAL -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES NOSE/TURB SEC 3 ....................................................................................................................................................................................................................................................... MICRO: -MINIMAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA NOSE/TURB SEC 4 ....................................................................................................................................................................................................................................................... MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-1NTRACYT0PLASMIC EOSINOPHILIC MATERIAL PROSTATE GLAND .................................................. MICRO: -MINIMAL. FOCAL -LYMPHOID CELL INFILTRATE(S)/AGGREGATE(S) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIONEYS, LUNGS. MAMMARY GLANDS, N0SE/TUR8 SEC 1, PITUITARY GLAND. SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-M OTHER BFG 003328 *** PATH/TOX SVSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 57 STUOY NUMBER: 964060 ANIMAL NUMBER: 1027 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 4S4.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES MICRO KIDNEYS . . MICRO LIVER . . . MICRO: NOSE/TUR0 SEC 4 MICRO: -MINIMAL. -MINIMAL -MINIMAL HISTOPATHOLOGICAL COMMENT: FOCAL >ONE PRESENT -CORTEX: INFILTRATES.SUBACUTE -HEPATOCYTES: CYTOPLASMIC VACUOLES'(NON-ZONAL) -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1, NOSE/TURB SEC 2. NOSE/TURB SEC 3. PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, **l-" INVASIVE. "X-" OTHER BFG 003329 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 56 STUDY NUMBER: 964080 ANIMAL NUMBER: 1028 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 496.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS LIVER . . . . MICRO: -MINIMAL, MULTI-FOCAL -MINIMAL NOSE/TURB SEC 3 MICRO:"-MINIMAL -MINIMAL. FOCAL NOSE/TURB SEC 4 MICRO: -SLIGHT................................... -MINIMAL. FOCAL PROSTATE GLAND MICRO: -MODERATE] MULTI-FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (RESPIRATORY): BASOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL -LYMPHOID CELL INF ILTRATE(S)/AGGREGATE(S) *** 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 2. PITUITARY GLAND. SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003330 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 59 STUDY NUMBER: 964080 ANIMAL NUMBER: 1029 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 489.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . . . NOSE/TURB SEC 3 NOSE/TURB SEC 4 MICRO: MICRO: MICRO: -MINIMAL. -MINIMAL -MINIMAL -SLIGHT MULTI-FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORYj: EP1THELIUM-INTRACYT0PLASMIC 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 SEC 2, PITUITARY GLAND. PROSTATE GLAND. SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, MB-'* BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003331 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IK CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 60 STUDY NUMBER: 964060 ANIMAL NUMBER: 1030 DATE OF OEATH: 04/29/97 ORGAN NAME SEX: MALE OOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: 4B0.9 GRAMS * * * PATHOLOGY KEYWOROS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS . . . MICRO: LIVER . . . . MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 3 MICRO: NOSE/TURB SEC 4 MICRO: MINIMAL, -MINIMAL, -MINIMAL -MINIMAL -MINIMAL -SLIGHT FOCAL MULTI-FOCAL -HEOULLA: CYST -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -NASOLACRIMAL OUCT: LYMPHOIO HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. PITUITARY GLAND. PROSTATE GLANO. SEMINAL VESICLES , TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "8-'' BENIGN. `V METASTATIC. "I-" INVASIVE, "X-`* OTHER BFG 003332 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 61 STUDY NUMBER: 964080 ANIMAL NUMBER: 2001 DATE OF DEATH: 04/26/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF OEATH: 16 TERMINAL BODY WEIGHT: 543.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS *** GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER .......................................................................... MICRO: -MINIMAL. FOCAL -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-* ' MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-H OTHER BFG 003333 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHL0RI0E CQNBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-90 PAGE: 62 STUDY NUMBER: 964080 ANIMAL NUMBER: 2002 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL 600Y WEIGHT: 451.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ................................................................................................................................................................................................................ MICRO: -MINIMAL, FOCAL -EXTRAMEOULLARY HEMATOPOIESIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-' * MALIGNANT, "B-" BENIGN. "S-M METASTATIC. "I-" INVASIVE, "X-" OTHER B F G 003334 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 63 STUOY NUMBER: 964080 ANIMAL NUMBER: 2003 DATE OF DEATH; 04/28/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 536.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO; -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT. "8-" BENIGN, METASTATIC, Ml-" INVASIVE, "X-" OTHER BFG 003335 * * * PATH/TOX SYSTEM OUTPUT * * * VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS PRINTED: 29-APR-98 PAGE: 64 19 hj r*. t--_> <T> Ik -- CO -- e o Q09 UJ --I -- o3 --z <-- tsi to oa < tn Ik o (SI > UJ -- CJ o-- Cu X O <si t--c--*J: z o. UJ O X I>-->- o o > uj o zo CoO oas (SI Csl Oo ----I X =s UJ I-- l/l c/1 z o I X tn < tSI (3 m eo <C t9 in Z C/1 < Q. O o BFG 003336 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 65 STUOY NUMBER: 964030 ANIMAL NUMBER: 2005 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY OAY OF DEATH: 112 STUOY WEEK OF DEATH; 16 TERMINAL BODY WEIGHT: 495.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL, FOCAL -MINIMAL -EXTRAMEDULLARY HEMATOPOIESIS -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. MS-M METASTATIC. "1-" INVASIVE, "X-" OTHER BFG 003337 a> O) os o. 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I 1 1 1 4 1 i 4 1 1 r u? 1. o Lk. 1 --J < -X MM 1 1 1M -X 1 o QS 09 MM .X 1 1 4 4 4 1QC UJ > 1 1 14 l1 11111111411111 < 4 4 14111111 4 141111111 4 41 14 1111141 a l i 1i i i11 i 4 1141 141 14 41 1411 <1 a a a i a i i i i a a < a a i i i i i i i i i i i i i i t4 a a a i 411 111 11 1 a ai a I * a LU > ee LU a o LU H bU. U < X z o a c o ee o < X _l < X z < 11 4 ( 4 11( J 4 1411 1114 i as 1 UJ iz 4U 14 O t 1111 1 UJ > 4 OO >< 4 Iz 11 41 J MM 411 tu to ( a-- i< i^ 111 CO < ^ 1 UJ IX i i 1 CO 4 14 |J t t9 4Z 1 UJ 1 CD 1t j J1 4 OS 1 4 1u 1 4-- 1Z l< i C9 1I U X 1X 11i i 4X J1 4 VO iX 14 CO < 4 _J 4^ 4O 14 UJ z I 1o 4 4-- 4 4 >4 UJ 4 4 44 1 1 1 11 1 1 1 1 1 1 4 1 1 1 BFG 003338 ANIMAL NUMBER: 2007 DATE OF DEATH: 04/28/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: B7 STUDY NUMBER: 964080 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 549.6 GRAMS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003339 BFG 003340 KX (iJ -- 004 44 ao: o*- X => UJ -- 4/1 (O l/l PO oo --- * * * * * *PATH/TOX SYSTEM OUTPUT VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS <-- </! K --4 ec lu uo 4 4/1 u. o <z--t --3I a --o Li- (0 PRINTEO: 29-APR -96 PAGE: 68 <s Ol Z o_ c 1 919 CM <0 O o ^ (O 0) au uj(9 --c Z CL. -- z a. z uj o Z 3 z >o -- M V> ft-- S zz --o - u zz UJ -- UJ X (3 Q 1 3K O ft-- UJ S in uj -ft-- Z - u-l Q. Z ^ t-- o <-> < -- CJ 1-- O ft-- " < 4X0 ZJQ u<h_; -- z X U1Z-IZ -- v> >-- z z X UJ UJ oz z -- t-- o. s . 3 ZZ --J ft-- O uj " < a. uj a a * o z ~a-- az o t _j zz oo _J ^ >- UJ Z3 o ^o a a UJ fif 1 1 1 1 1 1 e/S Z 4 ae o UJ (0 u --m U.<*5 -m ae u < v* .. ft-- -JZ " UJ z ae UJ >1-0 -o o UJ _l --i <e z a" uj z zz CJ UJ VI ft-- *. V) f* UJ o "z U. ft-- --< Z UJ cj a < VI u. o X UJ UJ z CSI > o o- ft-- V) O z UJ V> M o --< O" z ft-- UJ o u. o UJ >--X Xo z > a x UJftC/> VI ru 4 1 1 to 1O 1 2E 1 MM 1a 1 jp 1 MM U. 4 J c_> t ro io t .4 i0 iX i 4-- i< i a. iO i n* i (A M iX i i i i i 4 * </) i i i UJ i a) X X Zo io io i i - X i UJ i 1 < UJ i UJ i > QC r Urn r ac i to i UJ to iO 4 to Q i0 i0 4 1O i i i i >i i to iZ i oo i i i0 i oo 4 MM i x ac 4 ** { K- to l MM ( 0 1 1& 4 >- 1 4 1 1 1 1 mm Q UJ > UJ J# 1 1 1 to to 1a 1a 1o 13 1 1 UJ 1X 1 1 1 1 1 f CT> <n cm O-u* cm e l 1 1 1 1 zz UJI-- o<t XUI o X Lu -- O < Xu z< <o 1 1 ( 1 1 t 1 1 1 1 1 4 1 faj z < < 0 a o i i t 1 1 1 1 J r i i i i -j <e i I ae -- Z i i -J o u. i i UJ z z o <J - ft-- u. UJ r i i i >1 i i i i i i i t i i i li ft-- ft-- u < a. i i i i v> in a z i i i 1 i i I i i t i 4 1 1 1 1 1 1 ( 1 1 1 l 1 1 1 1 1 1 1 4 1 t 1 t 1 1 1 1 1 1 1 1 4 1 1 t 1 1 1 1 4 * 1 4 1 1 1 1 1 1 4 1 4 1 1 1 1 4 l 1 1 1 4 1 4 l 1 1 4 4 1 4 1 1 1 1 1 1 1 1 4 1 1 1 1 4 1 1 1 1 4 1 1 1 1 1 1 1 1 4 4 4 1 1 1 1 ri 1 1 i1 4 1 V) 1 UJ 1 >- 1 UJ i 1 1 4 i4 o UJ as UJ to cfi a to UJ MM 4-- MM mJ < X ac o 2E CD O a. 0 u to o z CJ X o to < X c X * * BFG 003341 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 70 STUDY NUMBER: 964060 ANIMAL NUMBER: 2010 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 441.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS LIVER . . MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 00334 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 71 STUOY NUMBER: 964080 ANIMAL NUMBER: 2011 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUOY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 437.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ................................................................................................................................................................................................................ MICRO: -MINIMAL. FOCAL -EXTRAMEOULLARY HEMATOPOIESIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-' * MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, 'X-" OTHER BFG 003343 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 72 STUDY NUMBER: 964060 ANIMAL NUMBER: 2012 DATE OF DEATH: 04/29/97 SEX: MALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: NOT ENTERED ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL. FOCAL -MINIMAL -EXTRAMEDULLARY HEMATOPOIESIS -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-M BENIGN. "S-" METASTATIC. "I-'* INVASIVE. "X-" OTHER BFG 003344 ANIMAL NUMBER: 2013 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 PRINTED: 29-APR-98 PAGE: 73 STUDY NUMBER: 964080 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 483.9 GRAMS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003345 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 74 STUDY NUMBER: 964080 ANIMAL NUMBER: 2014 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEOULEO, TERMINAL SACRIFICE STUOY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 495.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, MS-M METASTATIC. "I-" INVASIVE, "X-" OTHER BFG 003346 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 75 STUDY NUMBER: 964080 ANIMAL NUMBER: 2015 DATE OF DEATH: 04/28/97 SEX: MALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 471.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . , MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, ''B-'' BENIGN, "S-" METASTATIC. "I-" INVASIVE, **X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 76 STUDY NUMBER: 964080 ANIMAL NUMBER: 2016 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: SIX.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS AOIPOSE TISSUE LIVER . . . GROSS: -NODULE(S)/HASS(ES) MICRO: -MINIMAL, FOCAL -MINIMAL -NODULE, ABDOMINAL: 0.2 X 0.4 CM, TAN, FIRM -EXTRAMEDULLARY HEMATOPOIESIS -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) KEY TO NEOPLASMS: ,,M-m MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. HX-M OTHER BFG 003348 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE CON8INED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 77 STUDY NUMBER: 964080 ANIMAL NUMBER: 2017 DATE OF DEATH: 04/28/97 SEX; MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 535.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EYES........................................ GROSS: -OPACITY LIVER ................................... MICRO: -MINIMAL -LEFT CORNEA: FOCAL, MINIMAL -HEPATOCYTES; CYTOPLASMIC VACUOLES (NON-ZONAL) KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. MS-" METASTATIC. "I-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 78 STUDY NUMBER: 964080 ANIMAL NUMBER: 2018 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF OEATH: 16 TERMINAL BOOY WEIGHT: 588.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZQNAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. MS-M METASTATIC, "I-" INVASIVE, "X-" OTHER 003350 ANIMAL NUMBER: 2019 OATE OF DEATH: 04/28/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 79 STUDY NUMBER: 964080 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BOOY WEIGHT: S3B.7 GRAMS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 80 STUDY NUMBER: 964080 ANIMAL NUMBER: 2020 DATE OF DEATH: 04/29/9T SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF DEATH: 113 STUDY WEEK OF OEATH: 17 TERMINAL BOOT WEIGHT: 526.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS *** ANIMAL HAS NO GROSS ABNORMALITIES <OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-M OTHER B FG 003352 00 CT1 z CL_ 4 i cn -- CNJ CO . . au UJ(j t--4 Z O. -- z a. o 9 O 4 co e> z UJ CO X a z >A a co co Hc z ae a ~ CJ H- o 4 O' Z UJ -- z UJ ca a i a*-- Oi-u 3 co uj -(-- x a - co a. z H-a--4 a -- u>-- OH--< <xo ZJO LJ4 H- _1 1--Z 4 mx-iZ -- 4 -- CO -- z a Z4 X UJ UJ Oz X -l >---0.4 -^eo o a XX-IO HO UJ -- <U^> a. uj -- uj O O *a z M O-- zz O4 zz (_! O X* _J " 0> u z --o >o X a. uu Of CO z 4 z to UJ o c_> *- CO u_ o MIA z u 4 CO -- --IZ 4 (a ---- -- UJ X3 z UJ >H~ Q O a a UJ _i -J 4 az o --. UJ z zz o uj CO H- co a t-- 4 -- 40 CO UJ u ---z U.H--4 Z UJ oo 4 CO u. a UJ UJ 3 CM X o a o_ >~ a co o z CJ UJ CO CM -- a-- z i-- 4 UJ a u_ a UJ . --14 4a Z >a xa UJ H CO CO 1 1 | 1 1 1 1 1 1 1 1 1 CO 1 CD 1z 01 1 1 1 mm 1 u. 1 to t XX 1o 1o 1 1o 1x 1 1 1& 1o 1 1 CO 1 mm 1X J 14 1 14 % t 4 40 1 -- 1 SB UJ 1 to x 1X J ZO 1o 1o 1 1 X 1 yj 1 h-- ^ 1i 1 < UJ l UJ t >x 1 u_ 1 or 1 v) t UJ ui 1O 1 40 X 1 CD 10 1 JO t 1 1 1 >1 1 cd 1z 1 oo 1 1 -- t0 t O0 1 XX 1 Xx 1 1 h- tO 1 mm 1 <o 1 1 Q_ % 1 >1 1 XX 14 X 1 UJ 1 > 1 UJ 1 4 CO 1 1 l CO 1o 1X 1o 1 11 UJ 1X 1 t 1 1 1 1 1 1 1 1 1 1 1 X 1 1 1 1 1 1 1 * 1 J 1 1 1 1 1 1 1 1 1 l * 1 1 1 t 1 1 1 I 1 t i t 1 < 1 i i i * j i 1 1 I 1 1 1 1 I I 1 1 1 1 I I i i i ( 1 1 j I 1 i \ I 1 1 1 1 1 1 1 1 t 1 1 I u 'X UJ 0 o _J *u o < t/l co < X UJ -J X *0 O ee UJ > M ^ A ^ *Z UJ *X X o (-> --J *< o o O uJ *O X *w & o -- in % x< X H. a a -- CU 4(M eu a 1 1 1 1 11 1 1 1 1 I *O lz 1I o 1I X X l OB IO lO 4 a Xc/> U-- 4/1 a uj 4O z o UJ H- a4 oz _J UJ z >- z >- O ee co 4 LO --J UJ _J c_> a u a 4 UJ z >4 co Z CO H4 X Z UJ - 40 UJ i- -- CO --1 CO 4 4U z o U. -- - 40 uj 4 --J Z a -- az o-- zz 11 co e 40 Z .o w z-- -49 Z ^ Cu UJ .1 K-- >x o xJ 0 0UJ X . UJ in tn o X CD zz UJ H<S 4 Z UJ aa tl_ --J O 4 Z UJ -- HZ4 4a 1 1 1 1 1 1 1 1 1 1 1 1 1 lO 1UJ i ee Xu < 1X 1z i tn c 40 o Jo Q < z o l CD a: -- _J cO UJ hCO UJ h- i t t 1 l QC UJ X o * 1 x UJ > to Cf > t XX \ 1 XX . o h4 40 < UJ X i 40 - Z CD UJ 0 2 1 0 H< CD .J c X \* 1 X to X 40 xJ X o UJ z o > UJ 1 f BFG 003353 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 82 STUDY NUMBER: 964080 ANIMAL NUMBER: 2022 OATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 598.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL. FOCAL -EXTRAMEDULLARY HEMATOPOIESIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-'' MALIGNANT. "B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE, "X-" OTHER BFG 003354 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 63 STUDY NUMBER: 964060 ANIMAL NUMBER: 2023 DATE OF DEATH: 04/28/97 ORGAN NAME SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 523.2 GRAMS * * * PATHOLOGY KEYUOROS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -SLIGHT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-* ' MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "I-** INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INOIVIOUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 84 STUDY NUMBER: 964080 ANIMAL NUMBER: 2024 DATE OF DEATH: 04/26/97 SEX: MALE OOSE GROUP: 2 SACRIFICE STATUS: UNSCHEDULED (D) STUDY DAY OF OEATH: 110 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 405.3 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EXTREMITY . . KIDNEYS . . . URINARY BLADDER GROSS: GROSS: GROSS: -SWOLLEN. SLIGHT -ENLARGED, SLIGHT -DILATATION -DISTENDED, SEVERE -RIGHT HINDPAW -BOTH -RIGHT PELVIS: EXTREME; LEFT PELVIS: MODERATE -WITH THIN RED FLUID *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003356 00 BFG 003357 ANIMAL NUMBER: 2025 DATE OF DEATH: 0 4 /2 9 /9 7 SEX: HALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: S 2 1 .6 GRAMS *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-9B PAGE: 86 STUDY NUMBER: 964060 ANIMAL NUMBER: 2026 OATH OF OEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUOY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: 631.8 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL, FOCAL -SLIGHT -EXTRAMEDULLARY HEMATOPOIESIS -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-' ' MALIGNANT. "B-" BENIGN, "S-M METASTATIC. "I-" INVASIVE, "X-" OTHER BFG 003358 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 87 STUDY NUMBER: 964080 ANIMAL NUMBER: 2027 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEOULEO. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOY WEIGHT: 431.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EXTREMITY LIVER . . GROSS: -HAIR ABSENT/THIN, SLIGHT MICRO: -MINIMAL, FOCAL -HAIR ABSENT, BOTH FOREPAUS -EXTRAMEDULLARY HEMATOPOIESIS KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-*' INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 08 STUDY NUMBER: 964080 ANIMAL NUMBER: 2028 DATE OF DEATH: 04/29/97 SEX: HALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEOULEO, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 490.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL SEMINAL VESICLES . . . GROSS: -SHALL, MODERATE -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -LEFT HORN KEY TO NEOPLASMS: "M-" MALIGNANT, *'B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003360 ANIMAL NUMBER: 2029 DATE OF DEATH: 04/29/97 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 89 STUDY NUMBER: 964080 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF OEATH: 113 STUDY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: 439.2 GRAMS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 90 STUDY NUMBER: 964080 ANIMAL NUMBER: 2030 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: Z SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 113 STUOY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: S29.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ........................................................................................................................................................................................................................................................ MICRO: -MINIMAL. FOCAL -EXTRAMEDULLARY HEMATOPOIESIS -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-'* MALIGNANT, "B-" 8ENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER B F G 00.1362 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 91 STUDY NUMBER: 964080 ANIMAL NUMBER: 3001 DATE OF DEATH: 04/28/97 SEX: HALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 493.8 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: *'M-'" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. "I-'* INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TU0-6ENERATI0N REPRODUCTION AND OEVELOPHENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 92 STUOY NUMBER: 964080 ANIMAL NUMBER: 3002 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF DEATH: 112 STUDY WEEK OF OEATH: 16 TERMINAL BODY WEIGHT: 561.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ....................................................................................................................................................................................................................................................... MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-' ' MALIGNANT. MB-" BENIGN. "S-" METASTATIC, "I-" INVASIVE. "X-" OTHER BFG 003364 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINEO INHALATION TVO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 93 STUDY NUMBER: 964060 ANIMAL NUMBER: 3003 DATE OP DEATH: 04/28/97 SEX: MALE OOSE GROUP: 3 SACRIFICE STATUS:: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 515.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL. FOCAL -PELIOSIS HEPATIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-M METASTATIC, "I-M INVASIVE. "X-" OTHER BFG 003365 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 94 STUOY NUMBER: 964080 ANIMAL NUMBER: 30D4 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 531.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALI6NANT, "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003366 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRIHTEO: 29-APR-9B PAGE: 9S STUDY NUMBER: 964080 ANIMAL NUMBER: 3005 DATE OF OEATH: 04/28/97 SEX: HALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 552.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ..................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR; HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M- MALIGNANT, "B-" BENIGN, MS-M METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003367 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 95 STUOY NUMBER: 964060 ANIMAL NUMBER: 3006 DATE OF OEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 490.B GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS LIVER . . GROSS: -DILATATION. MOOERATE MICRO: -MINIMAL, FOCAL -RIGHT PELVIS -ACUTE/SUBACUTE INFLAMMATION KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "1-** INVASIVE. "X-" OTHER BFG 003368 *** PATH/TOX SYSTEM OUTPUT ** VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 97 STUOY NUMBER: 964080 ANIMAL NUMBER: 3007 DATE OF 0EA7H: 04/18/97 SEX: MALE OOSE GROUP: 3 SACRIFICE STATUS: SCHEOULEO, TERMINAL SACRIFICE SlUOt DAY OF DEATH: U2 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: S41.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, MS-M METASTATIC, "I-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 98 STUDY NUMBER: 964080 ANIMAL NUMBER: 3008 DATE OF DEATH: 04/28/97 SEX: HALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAT OF OEATH: 112 STUOT WEEK OF DEATH: 16 TERMINAL BOOT WEIGHT: 533.2 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F1NQINGS LIVER . . MICRO: MINIMAL. FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-** OTHER BFG 003370 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-6ENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PA6E: 99 STUDY NUMBER: 964080 ANIMAL NUMBER: 3009 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: 564.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F1N0INGS EARS LIVER GROSS: -SWOLLEN, MODERATE MICRO: -MINIMAL -MINIMAL -BOTH -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBUIAR: HYPERTROPHY KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "J-M INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 100 STUDY NUMBER: 964080 ANIMAL NUMBER: 3010 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 439.3 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRIL08ULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "1-" INVASIVE, "X-" OTHER B FG 003372 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 1D1 STUDY NUMBER: 964060 ANIMAL NUMBER: 3011 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 522.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER .......................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, BENIGN. "S-M METASTATIC. "I-" INVASIVE. "X-" OTHER PATH/TOX* * * SYSTEM OUTPUT * * * VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION PRINTED: 29-A P R -98 PA6E: 102 to at u a fr-UJ to uj Xo a (-- _l < 1 1 1 4 1 1 1 1 1 CO 1 X1 1 CO 1 at 1 a> <o 1 1 z> UJ OJ 1 ai u 1 -- u-> 1 Z1 M) u. o 1 hU) U_ 1 at u < to H JX <0 1 1 1 1 1 1 1 1 ot a> O1 i O1 Xi ^1 -- UJ 4 < x* a U( at 4 a i UJ ^ 4 t-- t--Q 4 CO 1 O1 x 1 m 4 Xi a UJ --1 i -IX =3 Z 1 O-- 1 UX to 1 xac 1 u uj < t-- 1 Z1 to -- 4 Ul 1 1 CO X 1 c o 1 z a i a 1 CJ 1 t-- 1 a i < 1 K * 1 --X I CO (0 1 UJ > 1 t-- t-- 1 UJ 4 11 u I UJ 1 X1 UJ > u. 1 > at --a l U- ( z uj 4 at > ua 4 to 1 < 1 UJ CO t to u 1 a o 1 in at i 4 < r ce UJ i UJ i o :* t l i o > i o i 3 i a. a 3 CO i 1 ' a 1 aa i at i CO i _jt-- i I ai UJ t on < to CSI i i O -- i XOt > ox 4 t-- 4 t-- to * 4 X 4 <a - 4 4 a. UJ 4 > a4 Ht 4 M| u. 4 at o4 UJ 4 i UJ - 1 Ul 1 _ja a X >- a X3 utt er) to 4* 1 4 t 1 r to 1 l CO 1 a at i OI 3i >- i i UJ 1 Xl i i i i r> i ai i ai (MM i --t i o^ 4 coo 1 1 1 1 1 1 .. _> x z a rtl 1 1 1 ^ ax z o- o at in -- uj at _IUJ - o o. a^ UX < at u --i _i xa tom co _J__1 - a. ex >-- *-- >- X U UJ (_> 1 4 4 ( I 1 1 1 4 cO cO UJ UJ -- i-- >- - u<-> - ao >-- -- -< x Q. O. - uj uj XX 1 1 1 l 4 4 4 1 4 4 I 4 1 1 1 1 4 _J _J 4 XX *zz *-J XX 11 1 4 o at O X 1 1 1 1 OCX UJt-- a X Ul ao U. -JO < X uj -- Xa <a 4 4 1 1 1 4 1 1 1 1 1 1 Ul 1 X < X < 1 UJ ai> at i a i _J 1 1 1 1 I 4 1 4 4 4 4 1 4 4 4 4 4 4 4 1 1 1 1 4 1 1 4 1 1 1 1 1 1 i I i 4 i i i 4 r 1 4 1 1 4 4 a 4 4 4 1 1 1 4 4 1 1 1 1 i 1 1 4 4 1 1 1 4 1 4 4 4 4 4 4 4 4 4 4 1 1 1 1 1 1 1 1 4 4 4 4 1 4 4 1 l 1 1 1 1 1 4 1 1 4 4 4 a 1 1 4 4 1 4 4 1 4 f 4 4 1 1 a 4 l 4 1 t 1 o UJ 3 at UJ 1/1 a o to Ul tu t-- --i X at z a to V) a at a a z to X _J rf X z < X UJ S o 1 K UJ M CA > as i i XX z * o mm h< CS> < UJ X s a LA s o z UJ ca i a ; 1-- z c O < X s 4 X /> X (A < -J X. o UJ X o -- UJ BFG 003374 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-GENERATJON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 103 STUDY NUMBER: 964080 ANIMAL NUMBER: 3013 DATE OF DEATH: 04/28/97 SEX: HALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY HEIGHT: 512.2 6RAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL. FOCAL -MINIMAL -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZGNAL) -PElIOSIS HEPATIS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-' ' MALIGNANT. M8-" BENIGN, "S-H METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003375 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBIMEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIKAL OATA SHEET PRINTED: 29-APR-98 PAGE: 104 STUDY NUMBER: 964080 ANIMAL NUMBER: 3014 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY OAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 542.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ..................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZQNAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: ''M-' ' MALIGNANT. "8-" BENIGN, "S-" METASTATIC, "I-*' INVASIVE, "X-" OTHER BFG 003376 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COM8INEO INHALATION TWO-GENERATION REPRODUCTION AHO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 10S STUDY NUMBER: 9640B0 ANIMAL NUMBER: 3015 OATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH; 212 STUDY WEEK OF DEATH: 16 TERMINAL BOOY WEIGHT: 501.4 GRANS ORGAN NAME "** PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL. FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "H-" MALIGNANT, "8-" BENIGN. "S-" METASTArfC, INVASIVE, "X-" OTHER BFG 003377 * * * PATH/TOX SYSTEM OUTPUT * * * VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS PRINTED: 29-A P R -98 PA6E: 106 1 1 1 1 1 I r i l cO i i XI i r i ae i tSl (9 1 UJ f t * i i X00 O z 1 U. *4 i a --i m i i ae i u. u u < \ a co * i 69 o a -- --J --IX t <(0 o Z a X-- a -- ui a XX a ae a UJ >- i-- i i i i i a-- < CL o LO a oi a >0 i ao i a UJ --J i z -JX i 3X i * a o-- i a wz i 60 a z ae i a-- 1 CJ UJ i a va a-- i UJ i iO X iX i co i as a3 a a-- i u> i a i 1-- i Hi MX 1 (/) CO i UJ i 4 1-- M 1 UJ 1 1 O 4 <UI 1 --z 4 UJ u. a-- 4 > oe 4 U. a oe uj 1 ae oo 4 to a< 1 Ul CO a ua U. 4 o e 4 co ae ! x 1 <9 m 1 UJ 4 1 UJ 4 o X4 1 l CO >- 1 o1 1 X 1 1 O-l-- 4 a 3 to 1 aO a oo > ae 1 < 1 --Ja-- 13 1 Ul a CD i to e<j i mm aO l i zae I I 1-- CO a 1 X l <o a a-- i i c i Q_ 1 UJ i - a Oi i a lj_ i ae a O i Ul i > 1 UJ >- i Ul I --'< x lX im 1 -o i t i i i CO cO O 1 X3 i uj a-- a v> 60 t i i t ae o X > 4 UJ 4X i i i i a r-. i a aa i |1 I co 4 a 0N a u x* a ov a co O i 4 i i a . a ae X 1 UJ K 1 < 1 X Ul i 3a aZ a U. a JO a< a x uj a" a z< a 40 < i I t 4 I r i 1 1 1 1 1 1 Ul X 4 Z 4 ae o | | | 4 4 f 1 1 >- 4 z a. o1 ae UJ o. X s z . o -- ae >-- 4 4 --I X3 X 40 --i--i IkM z ae - --u z ui ui a-- cj 3 OCO 4 uj * 3 *- co -- ihia-- u-4 3 0. UU 4Z a 1 1 > 1 4 1 1 1 1 1 1 4 1 1 1 1 1 1 1 _l 4 U o u. 1 1 --1 -J 44 XX .zz 1 1 XX 4 o ae u X 4 4 4 1 4 ae Ul 1 > _i 4 4 4 4 4 4 4 1 4 4 I 4 4 4 4 1 1 4 I 4 1 1 4 f 4 t 1 1 4 4 4 4 4 4 4 1 4 > 1 k 4 1 1 1 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 4 4 1 4 1 4 t 1 1 1 1 4 4 4 4 4 4 1 4 4 4 4 k 1 4 1 4 1 4 1 4 1 4 1 4 1 1 4 4 1 1 4 4 4 4 4 4 4 4 4 4 4 1 4 4 Q UJ P cc UJ A A O CO UJ mm < z ae < CA t/> O K o < z, < z MM < 1 1 1 4 4 1 4 4 4 4 4 4 1 4 1 1 1 1 1 4 ac 1 UJ 1Z 1 1O 1 | 11 4X 4 1 |V 1 UJ 1> 1M i co i< 4> 1Z 1 ** 1 1$ 4 m 45 4 4 |a 4O 1 IK i 1 4-- 1 CO l< l^ 1 UJ Iz 1 1s 4 1 (A 1; i l |a |2 10 |M 12 1 UJ 1 1 |s 41 1 Ifi I; 1 * i i t-- 12 fX 4Z > (0 4 mm r^ 4X (z 4 4 11 4Z 4: i 4 1 VO iz 4 4< 1^ I o. Io 1 UJ I2 io 1^ 1 1^ 1 UJ 1X 1 1 1 1 1 4 1 4 4 4 1 1 1 1 1 1 1 1 BFG 003378 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PA6E: 107 STUDY NUMBER: 964080 ANIMAL NUMBER: 3017 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 112 STUDY WEEK OF OEATH: 15 TERMINAL BODY WEIGHT: 525.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL, FOCAL -MINIMAL, FOCAL -MINIMAL -EXTRAMEOULLARY HEMATOPOIESIS -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-' 1 MALIGNANT, "B-M BENIGN, V" METASTATIC. "I-" INVASIVE, "X-" OTHER BFG 003379 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINEO INHALATION TW0-6ENERATI0N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: LOS STUDY NUMBER: 964080 ANIMAL NUMBER: 3018 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY OAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY HEIGHT: 562.4 GRANS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER .......................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBUIAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-' ' MALIGNANT. "B-"' BENIGN. "S-" METASTATIC, "1-" INVASIVE. "X-" OTHER BFG 003380 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE C0H8INE0 INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 109 STUDY NUMBER: 964060 ANIMAL NUMBER: 3019 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: S64.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILQBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** KEY TO NEOPLASMS: "M-" MALIGNANT. "B-** BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 110 STUDY NUMBER: 964080 ANIMAL NUMBER: 3020 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY OAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 473.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS *** GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: mM-' ' MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER B F G 003382 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 111 STUDY NUMBER: 9640B0 ANIMAL NUMBER: 3021 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY OAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 523.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER .......................................................................... MICRO: -MINIMAL, FOCAL SLIGHT -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** KEY TO NEOPLASMS: "K-`' MALIGNANT, "8-"' BENIGN, METASTATIC, "l-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 112 STUDY NUMBER: 964080 ANIMAL NUMBER: 3022 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY OAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: 453.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL. FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003384 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 113 STUDY NUMBER: 964080 ANIMAL NUMBER: 3023 DATE OF OEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 495.8 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE. "X-M OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 114 STUDY NUMBER: 964080 ANIMAL NUMBER: 3024 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 479.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL. FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES <OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. HS-M METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003386 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 115 STUDY NUMBER: 964080 ANIMAL NUMBER: 3025 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 521.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *'* KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 116 STUDY NUMBER: 964060 ANIMAL NUMBER: 3026 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 371.3 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS . , . GROSS: LIVER . . . . MICRO: URINARY BLADDER GROSS: -CALCULUS(CALCULI) -MINIMAL -CALCULUS(CALCULl) MODERATE SEVERE -BOTH PELVES -HEPATOCYTES CENTRiLOBULAR: HYPERTROPHY KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. "1-" INVASIVE. "X-" OTHER BFG 003388 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 117 STUDY NUMBER: 964080 ANIMAL NUMBER: 3027 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 489.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER .................................................................. MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-' ' MALIGNANT. "B-" BENIGN. "S-" METASTATIC, "1-" INVASIVE, "X-" OTHER z z < 1 CO w CM -- o go o *1(> OW U(9 i--< ZQ. -- ce Q_ Z 04 X 9 as Q 3 H to to t-- < ZZ O -- J-- C_J c ZZ UJ -- UJ > dQ 1 =11-- O -- UJ Si/uu t-- t-- X 9 >- CO &ChH-O--^ 9~ CJhOl--< <X X -- o W<K-I i-- X to z j x >- --< -- to -* OX< xuu O Z X --1 i-- -- a. < -. o X X --IQ t-OU -- t o s a. uj -- UJ o o z ---- z < Xz uo __1 -- >- U Z3 --i o O' z UJ CL 11 11 CO X < z Cfl LU CJ --. CO U. IO -- ^ Z _> CO .. -- --1 X t z-- K-> UJ Z3 z UJ >(-- o .to o UJ--J u< 9Z UZ xz U UJ CO >-- CO 9 a: 1-- CO X UJ o --X u_ >-- -- c as uj u < CO U. O UJ UJ 3 CO > 9 *-- 9 CO o z UJ CO CO -N --1 X -- < UJ o Ik o UJ >~1 < <o X > o X9 UJ -- CO CO r. EM CM o # CO O ! 1 f 4 1 1 1 1 1 1 4 4 1 i i 1 t i 1 1 1 i 1 1 i 1 1 i 1 1 1 1 t 1 1 1 ( 1 4 t t 1 i i i $ 1 < 1 i i i i 1 i 1 1 1 1 1 4 i 1 i 1 1 1 i i i i i i 1 i 1 1 i 1 1 1 1 1 1 1 4 i 1 1 1 i i i t 1 1 i i i 1 i i i 1 i 4 i j t 1 ( 1 l 1 1 1 1 t 1 1 1 1 1 1 1 1 1 1 J 1 1 1 1 1 1 r i t i i i i i i 4 4 1 1 1 1 1 4 4 1 1 1 t 1 1 1 1 1 1 1 1 1 4 1 * 1 1 1 1 1 i 4 1 4 1 1 1 1 1 4 1 1 1 1 1 1 r ( 4 1 i 1 1 1 > 1 1 1 1 i 1 i 4 4 1 4 4 1 i i ( i i i 4 1 1 1 1 1 zx UJ -- to < x uj 9 z U. --1 o c X uj -- 1-- z< < 1 1 1 1 i 4 1 4 1 1 1 1 1 1 1 1 1 1 l 4 1 4 4 1 r i i i UJ > z UJ to Oa UJ o as <o LkJ UJ </> CD uO _J </> < UJ X mm z o << ac Q u as z oo <o CO [/) o to z o CJ DC ts X oo as z to CO < < XX _J < <c ac X H z2 << * BFG 003390 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 119 STUDY NUMBER: 964080 ANIMAL NUMBER: 3029 OATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEOULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: 513.3 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS LIVER . MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION HEPA70CYTES: CY70PIASHIC VACUOLES (NON-ZONAL) *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "1-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 120 STUDY NUMBER: 964060 ANIMAL NUM8ER: 3030 DATE OF DEATH: 04/29/97 SEX: HALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOY WEIGHT: 513.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . TESTES . . MICRO: -MINIMAL. FOCAL -MINIMAL GROSS: -SMALL. MODERATE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -BOTH KEY TO NEOPLASMS: "M-" MALIGNANT, "e-" BENIGN, "S-" METASTATIC, "1-" INVASIVE, ''X-" OTHER BFG 003392 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-9B PAGE: 121 STUDY NUMBER: 964080 ANIMAL NUMBER: 4001 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 481.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES LIVER . . MICRO: H1STOPATHOLOGICAL COMMENT: >ONE PRESENT MICRO:'-MINIMAL.'FOCAL............................................................-ACUTE/SUBACUTE INFLAMMATION............................................................... -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY NOSE/TURB SEC 3 MICRO:'-MINIMAL ...................................................................... MISSAL'MUCOSA {OLFACTORYjEPITHELiuM-iNTRACYTOPLASMic NQSE/TURB SEC 4 MICRO: -SLIGHT EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIOYMIOES. KIONEYS, LUNGS. MAMMARY GLANOS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE. '*X-'` OTHER BFG 003393 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-96 PAGE: 122 STUDY NUMBER: 964080 ANIMAL NUMBER: 4002 DATE OF OEATH: 04/26/97 SEX: HALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF OEATH: 16 TERMINAL BODY WEIGHT: 568.3 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIOIOYMIDES KIDNEYS . . LIVER . . . MAMMARY GLANDS NOSE/TURB SEC 3 NOSE/TURB SEC 4 PROSTATE GLAND TESTES .... MICRO MICRO MICRO: MICRO: MICRO: MICRO: MICRO: MICRO: H1STOPATHOLOG1CAL COMMENT: -MINIMAL, FOCAL -MINIMAL, FOCAL -MINIMAL -TISSUE MISSING -MINIMAL -MINIMAL -MINIMAL, MULTI-FOCAL -MINIMAL. FOCAL HISTOPATHOLOGICAL COMMENT: >ONE PRESENT -CORTEX: INFILTRATES.SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EP1THELIUH-1NTRACYTOPLASHIC EOSINOPHILIC MATERIAL -LYMPHOID CELL INF ILTRATE(S)/AGGREGATE(S) -ALVEOLAR LUMENS: CORPORA AMYLACIA/MINERAL I ZED GRANULES >ONE PRESENT *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, LUNGS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, PITUITARY GLAND. SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, `V METASTATIC, ''I-'' INVASIVE. "X-" OTHER C * 6 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 123 STUDY NUMBER: 964080 ANIMAL NUMBER: 4003 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEOULEO, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL 80DY WEIGHT: 562.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIOIOYMIOES . MICRO KIDNEYS . . . MICRO: -MINIMAL LIVER . . . . MICRO: -MINIMAL -MINIMAL -MINIMAL NOSE/TURB SEC 3 MICRO: -MINIMAL NOSE/TURB SEC 4 .............................. MICRO: -MINIMAL HISTOPATHOLOGICAl COMMENT: >ONE PRESENT MULTI-FOCAL -INTERSTITIAL NEPHRITIS SUBACUTE FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1, NOSE/TURB SEC 2. PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE, "X-" OTHER BFG 003395 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 124 STUDY NUMBER: 9640B0 ANIMAL NUMBER: 4004 DATE OF DEATH: 04/28/97 ORGAN NAME SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 538.4 GRAMS * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES MICRO GROSS/MICRO CORR MICRO LIVER .... MICRO: MEDIASTINAL LN GROSS: MICRO: NOSE/TURB SEC 3 MICRO: NOSE/TURB SEC 4 MICRO: PROSTATE GLAND MICRO: TESTES .... MICRO: -TISSUE MISSING .............................. HisTOPATHOLOGiCAL -MINIMAL. FOCAL -MINIMAL -OISCOLORED -SLIGHT -MINIMAL -MINIMAL -MINIMAL -MINIMAL -MINIMAL. FOCAL -TISSUE'MisSING' COMMENT: >LN MEDIASTINAL: oisCOLORED/HEMORRHAGE' -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -RED -HEMORRHAGE(S) -NASOLACRIMAL DUCT: LYMPHOIO HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASOLACRIMAL OUCT(S): FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -LYMPHOID CELL INFILTRATE{S)/AGGREGATE(S) THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. KIONEYS. LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 2. PITUITARY GLANO. SEMINAL VESICLES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. MS-''* METASTATIC. ''I-" INVASIVE. "X-" OTHER BFG 003396 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: I2S STUDY NUMBER: 964080 ANIMAL NUMBER: 4005 OATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BOOY WEIGHT: 465.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES MICRO LIVER MICRO NOSE/TURB SEC 1 MICRO NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 3 MICRO: NOSE/TURB SEC 4 MICRO: PROSTATE GLAND MICRO: -MINIMAL -MINIMAL -SLIGHT -MINIMAL -SLIGHT -SLI6HT -MINIMAL, H1STOPATHOLOGICAL COMMENT: FOCAL >QNE PRESENT -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -ODONTOPATHY -NASAL MUCOSA (RESPIRATORY): GOBLET CELL HYPERTROPHY/HYPERPLASIA -ODONTOPATHY -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -ALVEOLAR LUMENS: CORPORA AMYLACIA/MINERALIZEO GRANULES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL, EPIDIOYMIOES, KIDNEYS. LUNGS, MAMMARY GLANOS. PITUITARY GLANO, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "I-'' INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 126 STUDY NUMBER: 964080 ANIMAL NUMBER: 4006 DATE OF DEATH: 04/26/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCKEOULEO. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 536.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES LIVER . . MAMMARY GLANDS MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT MICRO: -MINIMAL -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY MICRO: -TISSUE MISSING *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, KIDNEYS, LUNGS. NOSE/TURB SEC 1. NOSE/TURB SEC 2. NOSE/TURB SEC 3. NOSE/TURB SEC 4. PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. MB-" BENIGN. MS-M METASTATIC, "I-" INVASIVE, "X-H OTHER BFG 003398 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 127 STUDY NUMBER: 964060 ANIMAL NUMBER: 4007 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEOULEO, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 518.2 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EP1DI0YMI0ES KIDNEYS . . LIVER . . . N0SE/TUR6 SEC 1 NOSE/TURB SEC 2 NOSE/TURB SEC 3 NOSE/TURB SEC 4 PROSTATE GLANO TESTES . . . MICRO: MICRO: MICRO: MICRO: MICRO: MICRO: MICRO: MICRO: MICRO: -TISSUE MISSING -MINIMAL, FOCAL -CORTEX: INFILTRATES.SUBACUTE -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATQCYTES CENTRlLOBULAR: HYPERTROPHY -MINIMAL -OOONTOPATHY -MINIMAL -MINIMAL -NASOLACRIMAL DUCT(S): INFLAMMATORY CELLS/CCLL 0E6RIS -ODONTOPATHY -MINIMAL -MINIMAL -NASOLACRIMAL DUCT: LYMPHOIO HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPIASMIC EOSINOPHILIC MATERIAL -MINIMAL. FOCAL -ALVEOLAR LUMENS: CORPORA AMYLACIA/MINERAL I ZED GRANULES -TISSUE Miss ING....................................................................................................................... *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, LUNGS. MAMMARY GLANDS, PITUITARY GLAND. SEMINAL VESICLES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 128 STUDY NUMBER: 964080 ANIMAL NUMBER: 4008 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 530.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES ........................................................................................................................................................................................................................................ MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT GROSS/MICRO CORR ............................................................................................................................................................................................................................... MICRO: HISTOPATHOLOGICAL COMMENT: >TESTES-L: ENLARGED/TUBULAR DEGENERATION LIVER ........................................................................................................................................................................................................................................................ MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY LUNGS ........................................................................................................................................................................................................................................................................... MICRO: -MINIMAL. FOCAL -PULMONARY VESSELS: MINERAL OEPOSIT(S) N0SE/TUR8 SEC 4 .................................................................................................................................................................................................................................................. MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -MINIMAL -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL TESTES ........................................................................................................................................................................................................................................................................... GROSS: -ENLARGED, MODERATE -LEFT MICRO: -MODERATE -U: TUBULAR DEGENERATION -MODERATE -REDUCEO SPERMATOGENESIS 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 GLANO, PROSTATE GLAND. SEMINAL VESICLES, TRACHEA KEY TO NEOPLASMS: "M-M MALIGNANT, "B-" BENIGN. "$-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003400 *** PATK/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATJON REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 129 STUDY NUMBER: 964030 ANIMAL NUMBER: 4009 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULEO. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: 477.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ........................................................................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -EXTRAMEDULLARY HEMATOPOIESIS -MINIMAL, MULTI-FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRIL09ULAR: HYPERTROPHY NOSE/TURB SEC 3 .................................................................................................................................................................................................................................................. MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EP1THELIUM-INTRACYT0PLASMIC EOSINOPHILIC MATERIAL PITUITARY GLAND ............................................. MICRO: -MINIMAL, FOCAL -PARS DISTALIS: CYSTS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EP10IDYMIDES, KIDNEYS, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC I, NOSE/TURB SEC 2, NOSE/TURB SEC 4, PROSTATE GLAND, SEMINAL VESICLES, TESIES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "6~" BENIGN, "S-" METASTATIC, "I-" INVASIVE. 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TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 595.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES . MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT KIDNEYS . .. MICRO: '-MINIMAL.'FOCAL............................................................-ORATED `TUBULES.......................................................... LIVER .... MICRO: -SliGHTi MULTi-FOCAl.............................................-ACUTE/SUBACUTE INFLAMMATION............................ -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY NOSE/TURB SEC 4 MICRO: -MINIMAL -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2, NOSE/TURB SEC 3. PITUITARY GLAND. PROSTATE GLANO. SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "M-m MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "1-*' INVASIVE, "X-" OTHER BFG 00340.1 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 132 STUDY NUMBER: 964080 ANIMAL NUMBER: 4012 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP; 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT; 543-7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES . LIVER . . . . NOSE/TURB SEC 3 NOSE/TURB SEC 4 PROSTATE GLANO MICRO: MICRO: MICRO: MICRO: MICRO: HISTOPATH0LOGICAL COMMENT: -MINIMAL. FOCAL -MINIMAL -MINIMAL -MINIMAL -SLIGHT, MULTI-FOCAL >ONE PRESENT -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASM IC EOSINOPHILIC MATERIAL -LYMPHOID CELL INF ILTRATE(S)/AGGREGATE (S) *** 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. PITUITARY GLAND, SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-" INVASIVE, "X-M OTHER BFG 003404 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 133 STUDY NUMBER: 964080 ANIMAL NUMBER: 4013 DATE OF DEATH: 04/29/97 SEX: MALE OOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 566.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EP10I0YM1DES . MICRO: LIVER . . . . MICRO: -MINIMAL -MINIMAL NQSE/TURB SEC 3 MICRO: -MINIMAL PROSTATE GLAND MICRO:'-MINIMAL HISTOPATHOLOGICAL COMMENT: >ONE PRESENT FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL FOCAL -ACUTE/SUBACUTE INFLAMMATION *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. KIDNEYS, LUNGS. MAMMARY GLANDS, N0SE/TUR8 SEC 1, NOSE/TURB SEC 2, NOSE/TURB SEC 4, PITUITARY GLAND. SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: MALIGNANT. "fl-M BENIGN. "S-" METASTATIC, "I-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 134 STUDY NUMBER: 964080 ANIMAL NUMBER: 4014 DATE OF DEATH: 04/29/97 SEX; MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 505.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES ......................................................................................................................................................................................................................................................................................... MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT LIVER ........................................................................................................................................................................................................................................................................................................ MICRO: -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY NOSE/TURB SEC 4 ................................................................................................................................................................................................................................................................................ MICRO: -SLIGHT- -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL PROSTATE GLAND ..................................................................................................................................................................................................................................................................................... MICRO: -MINIMAL, FOCAL -ALVEOLAR LUMENS: CORPORA AMYLACIA/M1NERALIZED GRANULES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL, EPIDIDYMIDES, KIDNEYS. LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. NOSE/TURB SEC 3, PITUITARY GLAND, SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-M METASTATIC, "I-" INVASIVE, MX-M OTHER BFG 003406 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 135 STUDY NUMBER: 9640B0 ANIMAL NUMBER: 4015 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BQOY WEI6HT: 483.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER NOSE/TURB SEC 4 MICRO: MICRO: -MINIMAL. -MINIMAL -MINIMAL FOCAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL LUMEN: FREE ERYTHROCYTES THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING 6L. EPIDIDYMIDES, KIONEYS, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2. NOSE/TURB SEC 3. PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "H-" MALIGNANT, "B-'* BENIGN. "S-M METASTATIC. "I-" INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 136 STUDY NUMBER: 964060 ANIMAL NUMBER: 4016 DATE OF DEATH: 04/26/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 549.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS GROSS/MICRO CORR . . MICRO: HISTOPATHOLOGICAL COMMENT: >KIDNEYS: OILATATION/PELVIS OILATEO PROSTATE: DISCOLOREO/ACUTE/SUBA INFLAMMATION KIDNEYS ......................... GROSS: -DILATATION, MODERATE -BOTH PELVES MICRO: -MINIMAL, FOCAL -U: PYELITIS.SUBACUTE -MINIMAL, FOCAL -INTERSTITIAL NEPHRITIS SUBACUTE -MODERATE -PELVIS DILATED LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY MAMMARY GLANDS MICRO: -TISSUE MISSING NOSE/TURB SEC 2 ....................................................................................................................................................................................................................................................... MICRO: -SLIGHT -NASOLACRIMAL DUCT(S): MUCOSA-SUBACUTE (CHRONIC ACTIVE)/ CHRONIC INFLAMMATION -MODERATE -ODONTOPATHY PROSTATE GLAND .................... ............................................................................................................................................................... GROSS: -OISCOLORED-AREA(S), SLIGHT -0.3 X 0.6 CM, GREEN MICRO: -MODERATE. FOCAL -ACUTE/SUBACUTE INFLAMMATION THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, EPIDIDYMIDES, LUNGS. NOSE/TURB SEC 1. NOSE/TURB SEC 3. NOSE/TURB SEC 4. PITUITARY GLAND, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "I-** INVASIVE, X- OTHER BFG 003408 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-96 PAGE: 137 STUDY NUMBER: 964080 ANIMAL NUMBER: 4017 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 538.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYUOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIOIDYMIOES KIDNEYS LIVER NOSE/TURB SEC 2 NOSE/TURB SEC 3 MICRO: MICRO MICRO: MICRO: MICRO: -SLIGHT -MINIMAL. -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 -HEPATOCYTES CENTR1LOBULAR: HYPERTROPHY -NASOLACRIMAL OUCT(S): INFLAMMATORY CELLS/CELL DEBRIS -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASM1C EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -U: TUBULAR DEGENERATION -REDUCED SPERMATOGENESIS ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES, TRACHEA KEY TO NEOPLASMS; "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC. INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHL0RI0E COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 138 STUDY NUMBER: 964080 ANIMAL NUMBER: 4018 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY OAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 482.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS LIVER ...................................................................... MICRO: -MINIMAL. FOCAL -MINIMAL -MINIMAL MAMMARY GLANDS ................................................. MICRO: -TISSUE MISSING NOSE/TURB SEC 3 ............................................. MICRO: -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL. EPIDIDYMIDES. KIONEYS, LUNGS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. NOSE/TURB SEC 4, PITUITARY GLANO, PROSTATE GLANO, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S- METASTATIC. INVASIVE. "X-M OTHER BFG 003410 *** PATH/TDX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOT IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 136 STUDY NUMBER: 964080 ANIMAL NUMBER: 4018 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF OEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 482.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ..................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL MAMMARY GLANDS .................................................. MICRO: -TISSUE MISSING NOSE/TURB SEC 3 ............................................. MICRO: -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NOH-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIDNEYS. LUNGS. NOSE/TURB SEC 1. NOSE/TURB SEC 2, NOSE/TURB SEC 4. PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "1-" INVASIVE. "X-" OTHER BFG 003411 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED; 29-APR-98 PAGE; 139 STUOY NUMBER: 964080 ANIMAL NUMBER: 4019 DATE OF OEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH; 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 483.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER NOSE/TURB SEC 2 MICRO: MICRO: -MINIMAL, -MINIMAL -MINIMAL FOCAL -EXTRAMEDULLARY HEMATOPOIESIS -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -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 GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 3. NOSE/TURB SEC 4. PITUITARY GLAND. PROSTATE GLAND. SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-'` BENIGN. "S-" METASTATIC, "I-" INVASIVE. "X-" OTHER BFG 003412 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INOIVIOUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 140 STUDY NUMBER: 964080 ANIMAL NUMBER: 4020 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 112 STUDY WEEK OF DEATH; 16 TERMINAL BODY WEIGHT: 527.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS . . . LIVER . . . . NOSE/TURB SEC 2 NOSE/TURB SEC 4 PITUITARY GLANQ MICRO: MICRO: MICRO: MICRO: MICRO: -MINIMAL -MINIMAL, -MINIMAL -MINIMAL -MINIMAL -MINIMAL, FOCAL FOCAL -PELVIS OILATED -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASOLACRIMAL OUCT(S): INFLAMMATORY CELLS/CELL DEBRIS -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL -PARS OISTAUS: CYSTS *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVE!) '** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC l, NOSE/TURB SEC 3, PROSTATE GLAND. SEMINAL VESICLES , TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "8-" BENIGN, "S-`* HETASTATIC, "I-" INVASIVE, "X-M OTHER BFG 003413 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 141 STUDY NUMBER: 964080 ANIMAL NUMBER: 4021 DATE OF DEATH: 04/28/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: S25.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS EPIDIDYMIDES MICRO: -TISSUE MISSING LIVER . . . MICRO: -MINIMAL -MINIMAL. FOCAL -MINIMAL NOSE/TURB SEC 2 MICRO: -SLIGHT NOSE/TURB SEC 3 MICRO: -MINIMAL -MINIMAL NOSE/TURB SEC 4 MICRO: -SLIGHT TESTES . . . MICRO: -TISSUE MISSING -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NECROSIS.COAGULATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -ODONTOPATHY -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL LUMEN: FREE ERYTHROCYTES -NASAL LUMEN: FREE ERYTHROCYTES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL, KIDNEYS. LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. PITUITARY GLAND. PROSTATE GLAND. SEMINAL VESICLES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-M METASTATIC. "I-" INVASIVE, "X-" OTHER BFG 003414 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COHBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: Z9-APR-98 PAGE: 142 STUOY NUMBER: 964060 ANIMAL NUMBER: 4022 DATE OF DEATH: 04/2B/97 SEX: MALE OOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 112 STUDY WEEK OF DEATH: 16 TERMINAL BODY WEIGHT: 461.2 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS LIVER NOSE/TURB SEC 1 NOSE/TURB SEC 2 NOSE/TURB SEC 3 PROSTATE GLAND MICRO: MICRO: MICRO MICRO MICRO MICRO -MINIMAL, -MINIMAL, -MINIMAL -MINIMAL -MINIMAL -MINIMAL -MINIMAL. FOCAL MULTI-FOCAL FOCAL -CORTEX: CYST -NECROSIS,COAGULATION -HEPATOCYTES CENTRIL06ULAR: HYPERTROPHY -NASOLACRIMAL DUCT{S): FREE ERYTHROCYTES -NASAL LUMEN: FREE'ERYTHROCYTES -NASALLUMEN: FREE'ERYTHROCYTES -ALVEOLAR LUMENS: CORPORA AMYLACIA/MiNERALiZED 6RANULES *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED; COAGULATING GL. EPIDIDYMIDES, LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 4, PITUITARY GLAND, SEMINAL VESICLES. TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003415 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 143 STUDY NUMBER: 964080 ANIMAL NUMBER: 4023 DATE OF DEATH: 04/29/97 SEX: HALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUOY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 439.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . . . NOSE/TURB SEC 3 MICRO: MICRO: -MINIMAL. -MINIMAL -MINIMAL FOCAL -MINIMAL NOSE/TURB SEC 4 .............................. MICRO: -MINIMAL -MINIMAL -HEPATOCYTES: BASOPHILIC FOCUS -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASAL MUCOSA (RESPIRATORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHLIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES 08SERVE0 *** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. KIDNEYS. LUNGS. MAMMARY GLANOS. NOSE/TURB SEC 1. NOSE/TURB SEC 2. PITUITARY GLANO, PROSTATE GLAND. SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "8-" BENIGN. "S-" METASTATIC. "I-M INVASIVE. MX" OTHER BFG 003416 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 144 STUDY NUMBER: 964080 ANIMAL NUMBER: 4024 DATE OF DEATH: 04/29/37 ORGAN NAME SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOT WEIGHT: 430.1 GRAMS * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: NOSE/TURB SEC 2 MICRO: N0SE/TUR6 SEC 3 MICRO: -MINIMAL -MINIMAL -MINIMAL -MINIMAL NOSE/TURB SEC 4 MICRO: -MINIMAL PITUITARY GLAND MICRO: -MINIMAL, FOCAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACTTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -PARS OISTALIS: CYSTS THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVEO: COAGULATING GL, EPIDIOYMIOES, KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, PROSTATE GLAND. SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. *'B-m BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED; 29-APR-98 PA6E: 145 STUDY NUMBER: 964000 ANIMAL NUMBER: 4025 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 523.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ..................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL NOSE/TURB SEC 2 ............................................. MICRO: -MINIMAL NOSE/TURB SEC 4 ............................................. MICRO: -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY :NASOLACRIMAL DUCT(Sj: FREE ERYTHROCYTES* -NASAL MUCOSA (OLFACTORY): EPITHELIUM-1NTRACYT0PLASM1C 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 SEC 3, PITUITARY 6LAND, PROSTATE GLAND. SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003418 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 146 STUDY NUMBER: 964080 ANIMAL NUMBER: 4026 DATE OF DEATH: 04/29/97 SEX: MALE OOSE GROUP: A SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 5S9.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER NOSE/TURB SEC 3 MICRO: MICRO: -MINIMAL -MINIMAL -SLIGHT -MARKED NOSE/TURB SEC 4 .............................. MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASOLACRIMAL OUCT: LYMPHOIO HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-1NTRACYT0PLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPIASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIDNEYS, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, PITUITARY GLANO. PROSTATE GLAND. SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: **M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 147 STUDY NUMBER: 964080 ANIMAL NUMBER: 4027 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEOULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BOOY WEIGHT: 487.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS . . . MICRO; -MINIMAL LIVER .... MICRO:'-MINIMAL -MINIMAL NOSE/TURB SEC 1 MICRO:'-MINIMAL NOSE/TURB SEC 3 MICRO:'-SLIGHT' NOSE/TURB SEC 4 MICRO: -MINIMAL FOCAL FOCAL -CORTEX: INFILTRATES.SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASOLACRIMAL DUCT(S): EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVED *** THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 2, PITUITARY GLAND. PROSTATE GLAND, SEMINAL VESICLES . TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. ,,B-" BENIGN. METASTATIC, "I-" INVASIVE. "X-" OTHER BFG 003420 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 148 STUDY NUMBER: 964080 ANIMAL NUMBER: 4028 DATE OF DEATH; 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF OEATH: 17 TERMINAL BODY WEIGHT: 46S.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS **" GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ...................................................................... . MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL, FOCAL NOSE/TURB SEC 4 ............................................. MICRO: -MINIMAL PROSTATE GLAND .................................................. MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -HEPATOCYTES: ACIDOPHILIC FOCUS -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -LYMPHOID CELL INFILTRATE(S)/AGGREGATE(S) *** 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/TURB SEC 3, PITUITARY GLANO, SEMINAL VESICLES, TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. METASTATIC, "I-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-96 PAGE: 149 STUDY NUMBER: 964080 ANIMAL NUMBER: 4029 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 451.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYVOROS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EPIDIDYMIDES . MICRO: HISTOPATHOLOGICAL COMMENT: >ONE PRESENT LIVER .... MICRO:'-MINIMAL................................................................................. -HEPATOCYTES CENTRI LOBULAR: HYPERTROPHY MAMMARY GLANDS MICRO:`-TISSUE'HISSING................................................................................................................................................................................................................... NOSE/TURB SEC 3 MICRO: '-SLIGHT.......................................................................................:NASOLACRIMAL DUCT! LYMPHOiO HYPERPLASiA..................................... -MINIMAL -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES NOSE/TURB SEC 4 MICRO: -SLiGHT.......................................................................................:NASAL ' MUCOSA (OLFACTORY j: 'EPITHELiUM-INTRACYTOPLASMic EOSINOPHILIC MATERIAL *** ANIMAL HAS NO GROSS ABNORMALITIES OBSERVEO *** THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES. KIDNEYS. LUNGS. NOSE/TURB SEC l. NOSE/TURB SEC 2. PITUITARY GLAND. PROSTATE GLANO, SEMINAL VESICLES, TESTES, TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003422 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-6ENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: ISO STUDY NUMBER: 964960 ANIMAL NUMBER: 4030 DATE OF DEATH: 04/29/97 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 113 STUDY WEEK OF DEATH: 17 TERMINAL BODY WEIGHT: 492.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EARS GROSS: MICRO: GROSS/MICRO CDRR MICRO LIVER MICRO N0SE/TUR8 NDSE/TURB NOSE/TURB SEC 1 SEC 2 SEC 3 MICRO: MICRO: MICRO: NOSE/TURB SEC 4 MICRO 'SWOLLEN. MODERATE 'DISCOLORED -MODERATE -MODERATE HISTOPATHOLOGICAL COMMENT: -MINIMAL -MINIMAL -MINIMAL -MINIMAL -MINIMAL -MINIMAL -BOTH -BOTH: RED -SUBACUTE (CHRONIC ACTIVE)/CHRONIC -NECROSIS CARTILAGE INFLAMMATION >EARS: SWOLLEN,DISCOLORED/SUBA.CHRONIC INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZGNAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -NASOLACRIMAL DUCT(S): EOSINOPHILIC MATERIAL -NASOLACRIMAL OUCT(S): INFLAMMATORY CELLS/CELL DEBRIS -NASAL MUCOSA (OLFACTORY): EPITHEL1UM-INTRACYT0PLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHEL1UM-INTRACYT0PLASMIC EOSINOPHILIC MATERIAL THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: COAGULATING GL. EPIDIDYMIDES, KIDNEYS, LUNGS, MAMMARY GLANDS, PITUITARY GLAND, PROSTATE GLAND, SEMINAL VESICLES. TESTES. TRACHEA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. MI-" INVASIVE. "X-M OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 151 STUDY NUMBER: 964060 ANIMAL NUMBER: 1501 DATE OF OEATH: 05/27/97 SEX: FEMALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 310.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS GROSS/MICRO CORR ........................................................................................................................................................................................................... MICRO: H1STOPATHOLOGICAL COMMENT: >KIDNEY {R): DILATATION/PELVIS OILATED KIDNEYS ............................................................................................................................................................................................................................... GROSS: -DILATATION.SEVERE -RIGHT MICRO: -MARKED -PELVIS DILATED -MODERATE -PYELONEPHRITIS,SUBACUTE LIVER ...................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) LUNGS ...................................................................... MICRO: -MINIMAL,FOCAL -PULMONARY VESSELS: MINERAL DEPOSIT(S) NOSE/TURB SEC 3 .............................. MICRO: -MINIMAL -MINIMAL -NASOLACRIMAL OUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ....................................................................................................................................................................................................................................................... MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL -MINIMAL -NASAL MUCOSA (RESPIRATORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHLiC MATERIAL UTERUS GROSS: -IMPLANT SCARS - PRESENT -LEFT: 6; RIGHT: 0 THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, OVARIES, OVIOUCTS/FALOP T. PITUITARY GLANO. TRACHEA. UTERUS. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-'* INVASIVE, "X-` OTHER 03 a 003424 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 152 STUDY NUMBER: 964080 ANIMAL NUMBER: 1502 OATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY OAY OF OEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 262.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS NOSE/TURB SEC 3 ................................. MICRO: -MINIMAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -MINIMAL -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -SLIGHT -NASAL LUMEN: FREE ERYTHROCYTES NOSE/TURB SEC 4 ................................. MICRO: -SLIGHT -NASAL LUMEN: FREE ERYTHROCYTES -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL UTERUS ............................................................................................................................................................................................................................. GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 6; LEFT: 6 MICRO: -SLIGHT -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LIVER. LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, OVARIES, OVIDUCTS/FALOP T, PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003425 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 153 STUDY NUMBER: 964080 ANIMAL NUMBER: 1503 DATE OF OEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 297.8 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO NOSE/TURB SEC 3 MICRO NOSE/TURB SEC 4 MICRO -MINIMAL -slIght -MINIMAL PITUITARY GLAND MICRO: UTERUS GROSS: MICRO: -MINIMAL. FOCAL -IMPLANT SCARS -MINIMAL. FOCAL PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASOLACRIMAL DUCT: LYMPHOID`HYPERPLASiA* -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASM 1C EOSINOPHILIC MATERIAL -PARS INTERMEDIA: CYST(S) -RIGHT: 12; LEFT: 3 -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. OVARIES. OVIDUCTS/FALOP T, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003426 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INOIVIOUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 1S4 STUDY NUMBER: 964080 ANIMAL NUMBER: 1504 OATE OF OCATH: 05/28/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY OAY OF OEATH: 142 STUDY WEEK OF DEATH: ZI TERMINAL BODY MIGHT: 3Q5.9 GRAMS * * * PATHOLOGY KEYWOROS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS LIVER . . . . NOSE/TURB SEC 3 MICRO: MICRO: -MINIMAL, -MINIMAL FOCAL -MINIMAL NOSE/TURB SEC 4 ........................... MICRO: -SLIGHT UTERUS ....................................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL. FOCAL -ACUTE/SU8ACUTE INFLAMMATION -NASAL MUCOSA (RESPIRATORY): EPITHELIUM-INTRACYTOPLASMIC EOS1N0PHLIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -RIGHT: 6; LEFT: 7 -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNGS, MAMMARY GLAN05, NOSE/TURB SEC 1, NOSE/TURB SEC 2. OVARIES, OVIOUCTS/FALOP T. PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "M-*` MALIGNANT. "B-" BENIGN, METASTATIC, "1-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 155 STUDY NUMBER: 964080 ANIMAL NUMBER: 1505 DATE OF DEATH: 05/28/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCKEOULEO, TERMINAL SACRIFICE STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 284.7 GRAMS * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER ............................................................................ MICRO: -MINIMAL, FOCAL -MINIMAL -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NECROSIS,COAGULATION NOSE/TURB SEC 3 ................................................. MICRO: -MINIMAL -MINIMAL -MINIMAL -NASAL MUCOSA (RESPIRATORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHLIC MATERIAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ........................................................................................................................................................................................................................................................................ MICRO: -SLIGHT -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL UTERUS ............................................................................................................................................................................................................................. GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 9; LEFT: 5 MICRO: -MINIMAL, FOCAL -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: KIDNEYS, LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 2. OVARIES, OVIDUCTS/FALOP T. PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-'* MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-H INVASIVE. "X-" OTHER o 8ltfOO *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 156 STUDY NUMBER: 964080 ANIMAL NUMBER: IS06 DATE OF DEATH: 05/29/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 143 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 305.7 GRAMS ORGAN NAME * * * PATH0L06Y KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS MICRO: -MINIMAL, FOCAL LIVER MICRO -MINIMAL NOSE/TURB SEC 2 MICRO -MINIMAL NOSE/TURB SEC 3 MICRO -MINIMAL NOSE/TURB SEC 4 MICRO -MINIMAL UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -CORTEX: INFILTRATES,SUBACUTE -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASOLACRIMAL DUCT(S)INFLAMMATORY CELLS/CELL DEBRIS -NASOLACRIMAL DUCT: LYMPHoiDHYPERPLASW................................. -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYT0PLASH1C EOSINOPHILIC MATERIAL -RIGHT: 5; LEFT: 8 -ENDOMETRIUM: BROUN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, OVARIES. OVIOUCTS/FALOP T, PITUITARY GLAND, TRACHEA. VAGINA KEY TO NEOPLASMS: "M-`* MALIGNANT, "B-" BENIGN. *'S-" METASTATIC, "I-" INVASIVE. "X-" OTHER BFG 003429 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 157 STUDY NUMBER: 964080 ANIMAL NUMBER: 1507 OATE OF DEATH: 06/03/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 148 STUOY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: 298.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC F1N0INGS LIVER LUNGS NOSE/TURB SEC NOSE/TURB SEC MICRO: MICRO 3 MICRO 4 MICRO -MINIMAL -MINIMAL -SLiGHT* -MINIMAL UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZONAL) -PERIVASCULAR: EDEMA -NASOLACRIMAL DUCT: LYMPHoiOHYPERPLAsiA' -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASM IC EOSINOPHILIC MATERIAL -RIGHT: B; LEFT: 5 -ENDOMETRIUM: HEMORRHAGE(S) THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. MAMMARY GLANDS. NOSE/TURB SEC 1, NOSE/TURB SEC 2. OVARIES. OVIDUCTS/FALOP T, PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003430 ANIMAL NUMBER: 1508 DATE OF DEATH: 05/27/97 ORGAN NAME *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-QENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 158 STUDY NUMBER: 964080 SEX; FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 298.6 GRAMS * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER LUNGS .. .. MICRO: -MINIMAL, FOCAL .. .. MICRO:'-MINIMAL,'FOCAL NOSE/TURB SEC 3 MICRO: -MINIMAL -MINIMAL -MINIMAL, FOCAL NOSE/TURB SEC 4 MICRO: -MINIMAL UTERUS ....................................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -PULMONARY VESSELS: MINERAL DEPOSIT(S) -NASAL MUCOSA (RESPIRATORY): EPITHELIUM-INTRACYTOPLASMIC E0SIN0PHL1C MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUH-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): BASOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUH-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -RIGHT: B: LEFT: 7 -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, OVARIES. OVIDUCTS/FALOP T, PITUITARY GLANO, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, H0-M BENIGN, METASTATIC, ''I-'* INVASIVE, "X-' OTHER BFG 003431 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 159 STUDY NUMBER: 964080 ANIMAL NUMBER: 1509 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL 80DY WEIGHT: 309.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS ...................................................... LIVER MICRO: -MINIMAL ............................................................ MICRO: -MINIMAL NOSE/TUR0 SEC 3 -MINIMAL ................................. MICRO: -MINIMAL FOCAL FOCAL NOSE/TURB SEC 4 ........................... MICRO: -SLIGHT UTERUS GROSS: -IMPLANT SCARS - NOT PRESENT -CORTEX: INFILTRATES.SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2, OVARIES. OVIDUCTS/FALOP T, PITUITARY GLAND, TRACHEA. UTERUS, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTHER BFG 003432 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 160 STUDY NUMBER: 964080 ANIMAL NUMBER: 1510 DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BOOY WEIGHT: 277.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EARS .................................................................................... GROSS: -SWOLLEN, SLIGHT -DISCOLORED, SLIGHT MICRO: -MODERATE -MINIMAL, FOCAL GROSS/MICRO CORR MICRO:................................... HISTOPATHOLOGICAL COMMENT: -BOTH -BOTH: RED -SUBACUTE {CHRONIC ACTIVEJ/CHRONIC INFLAMMATION -NECROSIS CARTILAGE >EARS: SWOLLEN.OISCOLORED/INFLAMMATION SUBACUTE KIDNEYS ....................................................................................................................................................................................................................................................... MICRO: -MINIMAL, HULTI-FOCAl -CORTEX: INFILTRATES.SUBACUTE LIVER ...................................................................... MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) NOSE/TURB SEC 2 ............................................. MICRO: -MINIMAL. FOCAL -VOMERONASAL ORGAN: FREE ERYTHROCYTES NOSE/TURB SEC 3 ................................................................................................................................................................................................................ MICRO: -MINIMAL -NASOLACRIMAL DUCT: LYMPHOIO HYPERPLASIA UTERUS ........................................................................................................................................................................................................................................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 12; LEFT: 2 THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANOS, NOSE/TURB SEC 1. NOSE/TURB SEC 4, OVARIES, OVIDUCTS/FALOP T, PITUITARY GLAND. TRACHEA, UTERUS, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, METASTATIC. "I-" INVASIVE, "X-M OTHER BFG 003433 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 161 STUDY NUMBER: 964080 ANIMAL NUMBER: 1511 OATE OF DEATH: 06/03/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 146 STUDY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: 315.8 GRAMS * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (N0N-20NAL) NOSE/TURB SEC 3 MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ......................................................................................................................................................................................................................................................................... MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACVTOPLASM IC EOSINOPHILIC MATERIAL UTERUS ........................................................................................................................................................................................................................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 6; LEFT: 9 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 2. OVARIES, OVIOUCTS/FALOP T, PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003434 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 162 STUDY NUMBER: 9G40B0 ANIMAL NUMBER: 1512 OATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 276.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS GROSS/MICRO CORR ........................................................................................................................................................................................................................................................................................................ MICRO: HISTOPATHOLOGICAL COMMENT: >PANCREAS: DISCOLORED/NMC THYMUS: DISCOLORED/CONGESTION KIDNEYS .............................................................................................................................................................................................................................................................................................................................. MICRO: -MINIMAL, FOCAL -CORTEX: CYST NOSE/TURB SEC 3 ......................................................................................................................................................................................................................................................................................................... MICRO: -MINIMAL -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES PANCREAS .............................................................................................................................................................................................................................................................................................................................. GROSS: -DISCOLORED. SLIGHT -REO THYMUS ................................................................................................................................................................................................................................................................................................................................... GROSS: -DISCOLORED, SLIGHT -REO MICRO: -MINIMAL -CONGESTION UTERUS ................................................................................................................................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS -PRESENT -RIGHT: 4; LEFT: 11 MICRO: -MINIMAL. FOCAL -ENDOMETRIUM:BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LIVER, LUNGS, MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 2, NOSE/TURB SEC 4, OVARIES. OVIOUCTS/FALOP T, PANCREAS, PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-*' BENIGN, METASTATIC. "I-" INVASIVE. "X-H OTHER smoo oia *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COHBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 163 STUDY NUMBER: 964080 ANIMAL NUMBER: 1513 DATE OF DEATH: 05/28/9? SEX: FEMALE OOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 289.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS KIDNEYS ... MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 3 MICRO: UTERUS . . . . GROSS: MICRO: -MINIMAL. FOCAL -MINIMAL -MINIMAL -SLIGHT -IMPLANT SCARS -MINIMAL. FOCAL PRESENT -MEOULLA: CYST -PELVIS DILATED -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -NASOLACRIMAL DUCT: LYMPHOIO HYPERPLASIA -RIGHT: 4; LEFT: 0 -ENDOMETRIUM: BROWN 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 GLAND, TRACHEA. VAGINA KEY TO NEOPLASMS: "M-H MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X" OTHER BFG 003436 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-9B PAGE: 164 STUDY NUMBER: 964080 ANIMAL NUMBER: 1514 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF OEATH: 21 TERMINAL BODY WEIGHT: 306.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS . . . MICRO: -MINIMAL, MULTI-FOCAL LIVER .... MICRO: -MINIMAL, FOCAL...................... NOSE/TURB SEC 2 MICRO: -MINIMAL NOSE/TURB SEC 3 MICRO:'-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-INTRACYTOPLASMIC E0S1N0PHLIC MATERIAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (RESPIRATORY): BASOPHILIC MATERIAL -RIGHT: 7; LEFT: 6 -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: LUNGS. MAMMARY 6LAN0S. NOSE/TURB SEC 1, OVARIES. OVIDUCTS/FALOP T. PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003437 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 16S STUDY NUMBER: 964080 ANIMAL NUMBER: 1515 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 302.8 GRAMS ORGAN NAME *** PATHOLOGY KEYUOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS EARS GROSS: -SWOLLEN, MODERATE -BOTH -DISCOLOREO, MODERATE -BOTH: RED MICRO: -MODERATE -SUBACUTE (CHRONIC ACT!VE)/CHRGNIC INFLAMMATION -MINIMAL, FOCAL -NECROSIS CARTILAGE GROSS/MICRO CORR ................................................................................................................................................................................................................................................................... MICRO: HISTOPATHOLOGICAL COMMENT: >EARS: SWOLLEN,DISCOLORED/SUBA.CHRONIC INFLAMMATION LIVER MICRO: -MINIMAL. FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) NOSE/TURB SEC 3 ......................................................................................................................................................................................................................................................................... MICRO: -MINIMAL -NASOLACRIMAL DUCT; LYMPHOID HYPERPLASIA -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ......................................................................................................................................................................................................................................................................... MICRO: -SLIGHT -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYT0PLASM1C EOSINOPHILIC MATERIAL UTERUS .............................................................................................................................................................................................................................. GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 3; LEFT: 9 MICRO: -MINIMAL, FOCAL -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, OVARIES, OVIOUCTS/FALOP T, PITUITARY 6LAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-** INVASIVE, "X-" OTHER BFG 003438 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 166 STUDY NUMBER: 964080 ANIMAL NUMBER: 1516 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 144 STUDY WEEK OF OEATH: 21 TERMINAL BODY WEIGHT: 286.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO LUNGS MICRO N0SE/TUR8 SEC 3 MICRO -MINIMAL. FOCAL -TISSUE MISSING -MINIMAL NOSE/TURB SEC 4 MICRO: -SLIGHT UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL -ACUTE/SUBACUTE INFLAMMATION -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -RIGHT: 8; LEFT: 6 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, HAMMARY GLANOS. NOSE/TURB SEC 1. NOSE/TURB SEC 2, OVARIES, 0V1DUCTS/FAL0P T. PITUITARY GLANO. TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN, "S-" METASTATIC, "1-'' INVASIVE. "X-" OTHER BFG 003439 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 167 STUDY NUMBER: 964080 ANIMAL NUMBER: 1517 DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BOOT WEIGHT: 296.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COHMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . . . MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 3 MICRO: -MINIMAL, -MINIMAL, -SLIGHT -MINIMAL FOCAL FOCAL NOSE/TURB SEC 4 MICRO: -MINIMAL UTERUS .... GROSS:* - IMPLANT SCARS - PRESENT -ACUTE/SUBACUTE INFLAMMATION -VOMERONASAL'ORGAN: FREE'ERYTHROCYTES -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -RIGHT: 5; LEFT: 8 THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LUNGS, MAMMARY GLANOS, NOSE/TURB SEC 1, OVARIES, OVIDUCTS/FALOP T, PITUITARY GLAND, TRACHEA, UTERUS. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-M OTHER BFG 003440 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 168 STUOY NUMBER: 964080 ANIMAL NUMBER: 1516 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 284.8 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS NOSE/TURB SEC 2 ............................................. MICRO: -MINIMAL, FOCAL -VOMORONASAL ORGAN: EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ............................................. MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASHIC EOSINOPHILIC MATERIAL UTERUS ........................................................................................................................................................................................................................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 5; LEFT: 8 MICRO: -MINIMAL. FOCAL -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: KIDNEYS, LIVER. LUNGS, MAMMARY GLANDS. N0SE/TUR8 SEC 1, NOSE/TURB SEC 3, OVARIES, OVIDUCTS/FALOP T. PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "l-*' INVASIVE, "X-" OTHER BFG 003441 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 169 STUDY NUMBER: 964060 ANIMAL NUMBER: 1519 DATE OF DEATH: 05/23/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: UNSCHEDULED (A) STUDY DAY OF DEATH: 13? STUDY WEEK OF DEATH: 20 TERMINAL BODY WEIGHT: 320.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS GROSS/MICRO CORR MICRO:...................................... HISTOPATHOLOGicAL COMMENT: >TRACHEA; FLUID/NMC KIDNEYS ................................................................................................. MICRO: -MINIMAL, FOCAL LIVER LUNGS ....................................................................................................... MICRO: -MINIMAL. FOCAL ...................................................................................................... GROSS: -FLUIO FILLED. SLIGHT MICRO: -MINIMAL -MODERATE NOSE/TURB SEC 1 ............................................................................ MICRO: -MINIMAL -SLIGHT NOSE/TURB SEC 2 ............................................................................ MICRO: -MODERATE -MINIMAL -SLIGHT NOSE/TURB SEC 3 ............................................................................ MICRO: -MODERATE TRACHEA ................................................................................................. GROSS: -FLUID. SLIGHT UTERUS ....................................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL LUNGS: FLUID FIUEO/HEMORRHAGE ALVEOLAR -CORTEX: INFILTRATES,SUBACUTE -ACUTE/SUBACUTE INFLAMMATION -ALL LOBES -PERIVASCULAR: EDEMA -HEMORRHAGE ALVEOLAR -VQMORONASAL ORGAN: FREE ERYTHROCYTES -NASAL LUMEN: FREE ERYTHROCYTES -NASAL LUMEN: FREE ERYTHROCYTES -VOMERONASAL ORGAN: FREE ERYTHROCYTES -NASOLACRIMAL DUCT(S): FREE ERYTHROCYTES -NASAL LUMEN: FREE ERYTHROCYTES -LUMEN: WHITE. FROTHY -RIGHT: 8; LEFT: 9 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: MAMMARY GLANOS, NOSE/TURB SEC 4, OVARIES. OVIDUCTS/FALOP T, PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, ''B-'' BENIGN, MS-" METASTATIC, **!-" INVASIVE. "X-" OTHER BpG 003442 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE; 170 STUDY NUMBER; 964080 ANIMAL NUMBER: 1520 DATE OF DEATH: 05/27/97 ORGAN NAME SEX; FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 271.2 GRAMS * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS GROSS/MICRO CORR MICRO: NOSE/TURB SEC 3 MICRO: NOSE/TURB SEC 4 MICRO- PITUITARY GLAND MICRO: THYMUS .... GROSS; MICRO: UTERUS .... GROSS: -SLIGHT -MINIMAL H1STOPATHOLOGICAL COMMENT: -MINIMAL -DISCOLORED, SLIGHT -MINIMAL -IMPLANT SCARS - PRESENT >THYMUS: DISCOLORED/CONGESTION -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY}: EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -PARS OISTALIS: CYSTS -RED -CONGESTION -RIGHT: 5; LEFT: 6 THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LIVER, LUNGS, MAMMARY GLANOS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, OVARIES, OVIDUCTS/FALOP T, TRACHEA. UTERUS, VAGINA KEY TO NEOPLASMS; "M-" MALIGNANT, MB-" BENIGN, "S-" METASTATIC, "I-" INVASIVE. "X-" OTHER BFG 003443 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 171 STUDY NUMBER: 964060 ANIMAL NUMBER: 1521 DATE OF DEATH: 06/05/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 150 STUDY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: 279.3 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . . . MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 4 MICRO: -MINIMAL, -SLIGHT -MINIMAL FOCAL UTERUS GROSS: -IMPLANT SCARS PRESENT MICRO: -MINIMAL. FOCAL ACUTE/SUBACUTE INFLAMMATION -NASOLACRIMAL OUCT(Sj:'FREE ERYTHROCYTES' -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -RIGHT: 11; LEFT: 4 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIONEYS, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 3, OVARIES. OV[DUCTS/FALOP T, PITUITARY GLAND. TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003444 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COHBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 172 STUDY NUMBER: 964080 ANIMAL NUMBER: 1522 DATE OF DEATH: 05/27/97 SEX: FEMALE OOSE GROUP: 1 SACRIFICE STATUS: SCHEDULEO. TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 283.3 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREC-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . . . MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 3 MICRO: -MINIMAL, -MINIMAL -MINIMAL FOCAL NOSE/TURB SEC 4 ............................ MICRO: -SLIGHT UTERUS ....................................................................................................... GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL. FOCAL -ACUTE/SUBACUTE INFLAMMATION -NASOLACRIMAL OUCT(S): INFLAMMATORY CELLS/CELL DEBRIS -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -RIGHT: 5; LEFT: 9 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVEO: KIDNEYS, LUNGS. MAMMARY GLANDS. NOSE/TURB SEC 1. OVARIES. OVIDUCTS/FALOP T. PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, MS-" METASTATIC. "I-" INVASIVE, MX-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 173 STUDY NUMBER: 964080 ANIMAL NUMBER: 1523 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 358.2 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS KIDNEYS . . . MICRO: LIVER .... MICRO: NOSE/TURB SEC 2 MICRO: NOSE/TURB SEC 4 MICRO: -MINIMAL. -MINIMAL, -SLIGHT -MINIMAL MULTI FOCAL UTERUS GROSS: -IMPLANT SCARS MICRO: -MINIMAL, FOCAL -INTERSTITIAL NEPHRITIS SUBACUTE -ACUTE/SUBACLITE INFLAMMATION...................................................................... -NASOLACRIMAL DUCT(Sj:'FREE ERYTHROCYTES...................................... -.N....A..S...A...L.....M...U...C...O...S..A......(..O...L..F..A...C...T..O...R...Y......... EPITHELiuM-iNTRACYTOPLASMic' EOSINOPHILIC MATERIAL -NYQNETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 3, OVARIES, OVIDUCTS/FALOP T. PITUITARY GLAND. TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. METASTATIC. "I-" INVASIVE, "X-M OTHER BFG 003446 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE CQMB1NE0 INHALATION TWQ-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-9B PAGE: 174 STUDY NUMBER: 964080 ANIMAL NUMBER: 1524 DATE OF DEATH: 05/29/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 143 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 292.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER LUNGS UTERUS MICRO: -MINIMAL, FOCAL MICRO: -MINIMAL, FOCAL -SLIGHT -SLIGHT. FOCAL GROSS: -IMPLANT SCARS - PRESENT MICRO: -MOOERATE, FOCAL -ACUTE/SUBACUTE INFLAMMATION -PULMONARY VESSELS: MINERAL OEPOSIT(S) -HEMORRHAGE ALVEOLAR -PERIBRONCHIAL: LYMPHOCYTIC HYPERPLASIA -RIGHT: 5; LEFT: 8 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. MAMMARY GLANDS. N0SE/TUR8 SEC 1. NOSE/TURB SEC 2. NOSE/TURB SEC 3. NOSE/TURB SEC 4. OVARIES, OVIDUCTS/FALOP T . PITUITARY GLAND. TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "IINVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 175 STUDY NUMBER: 964080 ANIMAL NUMBER: 1525 DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULEO, TERMINAL SACRIFICE STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 294.3 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS MICRO: LUNGS MICRO NOSE/TURB SEC 2 MICRO N0SE/TUR8 SEC 4 MICRO -MINIMAL, FOCAL -SLIGHT. FOCAL -MINIMAL -MINIMAL UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -DILATED TUBULES -PERIBRONCHIAL: LYMPHOCYTIC HYPERPLASIA -NASOLACRIMAL DUCT(S): INFLAMMATORY CELLS/CELL 0E6RIS -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -RIGHT: 10; LEFT: 6 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: LIVER, MAMMARY GLANDS. NOSE/TURB SEC 1. NOSE/TURB SEC 3, OVARIES, OVIDUCTS/FALOP T. PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-** BENIGN. "S-" METASTATIC. "1-" INVASIVE. "X-" OTHER BFG 003448 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 176 STUDY NUMBER: 964060 ANIMAL NUMBER: 1526 DATE OF OEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 144 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 277.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . UTERUS . . MICRO: -MINIMAL, FOCAL -MINIMAL, FOCAL GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT, FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -RIGHT: 9; LEFT: 2 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVEO: KIDNEYS, LUNGS. MAMMARY GLANOS. NOSE/TURB SEC I, NOSE/TUR0 SEC 2. NDSE/TURB SEC 3. NOSE/TURB SEC 4. OVARIES, QVIOUCTS/FALOP T. PITUITARY GLAND. TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. METASTATIC. "I-" INVASIVE, "X-" OTHER ANIMAL NUMBER: 1527 DATE OF OEATH: 05/30/97 ORGAN NAME *** PATH/TQX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 177 STUDY NUMBER: 964080 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 273.5 GRAMS *** PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER MICRO: NOSE/TURB SEC 3 MICRO: -MINIMAL. -MINIMAL. -SLIGHT -MINIMAL FOCAL FOCAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL NOSE/TURB SEC 4 ................................. MICRO: -MINIMAL -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL UTERUS .............................................................................................................................................................................................................................................. GROSS: -IMPLANT SCARS - NOT PRESENT MICRO: -MINIMAL, FOCAL -MYOMETRIUM: BROWN PIGMENT -MINIMAL -ENOOMETRIUM: INFILTRATES SUBACUTE THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS, LUNGS. MAMMARY GLANDS, NOSE/TURB SEC 1. NOSE/TURB SEC 2. OVARIES. OVIDUCTS/FALOP T. PITUITARY GLAND, TRACHEA, VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003450 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 178 STUDY NUMBER: 964080 ANIMAL NUMBER: 1528 DATE OF OEATH: 06/04/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY OAY OF OEATH: 149 STUOY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: 299.8 GRAMS * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS f HISTOPATHOLOGIC FINDINGS GROSS/MICRO CORR .............................................................................................................................................................. MICRO: HIST0PATH0L0G1CAL COMMENT: >LUNGS: NODULES/NMC LUNGS .............................................................................................. GROSS: -NO0ULE(S)/MASS(ES) -NODULES. ALL LOBES: 0.1 - 0.3 CM DIA, TAN MICRO: -MINIMAL, FOCAL -PULMONARY VESSELS: MINERAL OEPOSIT(S) -MINIMAL -SLIGHT. FOCAL -PERIVASCULAR: EDEMA -PERIBRONCHIAL: LYMPHOCYTIC HYPERPLASIA NOSE/TURB SEC 1 ...................................................................... MICRO: -MINIMAL -NASAL LUMEN: EXUDATE NOSE/TURB SEC 2 ...................................................................... MICRO: -MOOERATE -NASOLACRIMAL DUCT(S):`MUCOSA-SUBACUTE`{CHRONIC ACTIVE)/ CHRONIC INFLAMMATION -SLIGHT -ODONTOPATHY -SLIGHT -NASOLACRIMAL DUCT: EXUDATE NOSE/TURB SEC 3 ...................................................................... MICRO: -SLIGHT -NASOLACRIMAL OUCT: LYMPHOIO HYPERPLASIA UTERUS .............................................................................................. GROSS: -IMPLANT SCARS - PRESENT MICRO: -SLIGHT. FOCAL -RIGHT: 3; LEFT: 6 -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. LIVER. MAMMARY GLANDS. NOSE/TURB SEC 4. OVARIES, OVIDUCTS/FALOP T, PITUITARY GLAND. TRACHEA. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003451 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 179 STUDY NUMBER: 964080 ANIMAL NUMBER: 1529 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: J SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY OAY OF OEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 276.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS GROSS/MICRO CORR . . MICRO: HISTOPATHOLOGICAL COMMENT: >KIDNEYS: DILATATION/PYELONEPHRITIS SUBA KIDNEYS ............................ GROSS: -DILATATION, MOOERATE -BOTH PELVES MICRO: -MARKED -PELVIS OILATED -MODERATE -PYELONEPHRITIS. SUBACUTE LIVER ................................. MICRO: -SLIGHT. FOCAL -ACUTE/SUBACUTE INFLAMMATION NOSE/TURB SEC 3 ................................................................................................................................................................................................................................... MICRO: -MINIMAL -NASOLACRIMAL DUCT: LYMPHOID HYPERPLASIA UTERUS.................................................................................................................................................................................................................... GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 8; LEFT: 4 MICRO: -SLIGHT, FOCAL -MYOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAO NO MICROSCOPIC ABNORMALITIES OBSERVED: LUNGS, MAMMARY GLANDS, NOSE/TURB SEC 1, NOSE/TURB SEC 2, NOSE/TURB SEC 4. OVARIES. OVIDUCTS/FALOP T, PITUITARY GLAND, TRACHEA. VAGINA KEY TO NEOPLASMS: "M-" MALIGNANT, "0-" BENIGN, "S-" METASTATIC, "1-" INVASIVE. "X-" OTHER BFG 003452 ANIMAL NUMBER: 1530 DATE OF DEATH: 05/29/97 ORGAN NAME *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 180 STUDY NUMBER: 964080 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF DEATH: 143 STUDY WEEK OF OEATH: 21 TERMINAL 800Y WEIGHT: 261.6 GRAMS * * * PATHOLOGY KEYWOROS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HIST0PATH0L06IC FINDINGS LIVER LUNGS NOSE/TURB NQSE/TUR8 NOSE/TURB SEC 2 SEC 3 SEC 4 MICRO: MICRO MICRO MICRO MICRO -MINIMAL, FOCAL -SLIGHT. FOCAL -MINIMAL, FOCAL -MINIMAL -MINIMAL UTERUS GROSS: -IMPLANT SCARS - PRESENT MICRO: -MINIMAL, FOCAL -ACUTE/SUBACUTE INFLAMMATION -PNEUMONITIS INTERSTITIAL SUBACUTE -VOHORONASAL ORGAN: EOSINOPHilic MATERIAL -NASOLACRIMAL OUCT: LYMPHOID HYPERPLASIA -NASAL MUCOSA (OLFACTORY): EPITHELIUM-INTRACYTOPLASMIC EOSINOPHILIC MATERIAL -RIGHT: 3; LEFT: 8 -ENDOMETRIUM: BROWN PIGMENT THE FOLLOWING TISSUES HAD NO MICROSCOPIC ABNORMALITIES OBSERVED: KIDNEYS. MAMMARY GLANDS. NOSE/TURB SEC 1. OVARIES, OYIOUCTS/FALOP T. PITUITARY GLAND, TRACHEA. VAGINA KEY TO NEOPLASMS: "N-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BFG 003453 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TVO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 181 STUDY NUMBER: 9640&0 ANIMAL NUMBER: 2501 DATE OF OEATH: 05/29/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF OEATH: 143 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 271.9 GRAMS * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS UTERUS . . GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 13; LEFT: 4 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003454 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INOIVIOUAl ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 182 STUDY NUMBER: 964080 ANIMAL NUMBER: 2S02 DATE OF DEATH: OS/27/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 273.8 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS LIVER UTERUS ...................................... MICRO: -MINIMAL, FOCAL -MINIMAL ................................ GROSS: -IMPLANT SCARS - NOT PRESENT -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZONAL) KEY TO NEOPLASMS: "M-" MALIGNANT, "B-m BENIGN. "S-" METASTATIC, "1-" INVASIVE, MX-*` OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-90 PAGE: 1B3 STUDY NUMBER: 964080 ANIMAL NUMBER: 2503 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 292.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) GROSS:'-Implant SCARS - PRESENT ...................................... -RiGHT: 7;'lEFT:'6....................................................................... KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003456 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE C0K6INE0 INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRIMED: Z9-APR-9B RAGE: 1B4 STUDY NUMBER: 964080 ANIMAL NUM8ER: 2504 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF DEATH: 144 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 314.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS UTERUS . . GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 6; LEFT: 4 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INOIVIOUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 18S STUDY NUMBER: 964060 ANIMAL NUMBER: 2505 DATE OF DEATH: 05/29/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 143 STUDY WEEK OF OEATH: 21 TERMINAL BODY WEIGHT: 280.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS UTERUS . . GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 10; LEFT: 3 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003458 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXtCITY STUDY IN CD RATS INDIVIDUAL AKIHAL DATA SHEET PRINTED: 29-APR-98 PAGE: 186 STUDY NUMBER: 964080 ANIMAL NUMBER: 2506 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULEO, TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 296.6 GRANS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . UTERUS . . MICRO: -MINIMAL, FOCAL GROSS: -IMPLANT SCARS - PRESENT -ACUTE/SUBACUTE INFLAMMATION -RIGHT: 5; LEFT: 8 KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN. MS-" METASTATIC, "l-" INVASIVE. "X-" OTHER ANIMAL NUMBER: 2507 OATE OF DEATH: 05/29/97 ORGAN NAME *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 187 STUOY NUMBER: 964080 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 143 STUDY WEEK OF DEATH: 21 TERMINAL BOOY WEIGHT: 290.7 GRAMS * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS MICRO: -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -RIGHT: 6; LEFT: 10 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER BPG 003460 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTEO: 29-APR-S6 PAGE: 186 STUDY NUMBER: 964080 ANIMAL NUMBER: 2508 DATE OF OEATH: 06/06/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 151 STUDY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: 282.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . UTERUS . . MICRO: -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZONAL) -RIGHT: 10; LEFT: 5 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-H BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COHBINEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 189 STUDY NUMBER: 964060 ANIMAL NUMBER: 2509 OATE OF DEATH: 05/29/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 143 STUOY WEEK OF DEATH: 21 TERMINAL BOOY WEI6HT: 319.1 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS *** GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOtNGS LIVER UTERUS ...................................... MICRO: -MINIMAL ...................................... GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -RIGHT: 9; LEFT: 4 KEY TO NEOPLASMS: MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "I-" INVASIVE. "X-" OTHER BFG 003462 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 190 STUDY NUM6ER: 964000 ANIMAL NUMBER: 2510 DATE OF DEATH: 0S/Z8/97 ORGAN NAME SEX: FEMALE DOSE GROUP; Z SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 281.0 GRAMS * * * PATHOLOGY KEYWOROS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS ..................................... MICRO: -MINIMAL ..................................... GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -RIGHT: 4; LEFT: 8 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003463 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 191 STUOY NUMBER: 964080 ANIMAL NUMBER: 2511 DATE OF OEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF OEATH: 141 STUDY WEEK OF OEATH: 21 TERMINAL BODY WEIGHT: 264.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS . MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) GROSS: -IMPLANT SCARS - PRESENT ...................................... -RIGHT: S: LEFT:* KEY TO NEOPLASMS: "H-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-H OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 192 STUDY NUMBER: 964080 ANIMAL NUMBER: 2512 DATE OF DEATH: 05/30/9? SEX: FEMALE DOSE GROUP: Z SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUOY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 273.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS KIDNEYS UTERUS . . GROSS: -DILATATION, SLIGHT GROSS: -IMPLANT SCARS - NOT PRESENT -RIGHT PELVIS *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVCO *** BFG 003464 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUOY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTEO: 29-APR-98 PAGE: 193 STUDY NUMBER: 9640B0 ANIMAL NUMBER: 2513 DATE OF DEATH: 05/30/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY OAY OF OEATH: 144 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 255.8 GRANS. * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS LIVER . . UTERUS . . MICRO: -MINIMAL. FOCAL GROSS: -IMPLANT SCARS - PRESENT -ACUTE/SUBACUTE INFLAMMATION -RIGHT: 8; LEFT: 8 KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003-465 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 194 STUOY NUMBER: 964080 ANIMAL NUMBER: 2514 DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH; 142 STUDY WEEK OF DEATH: 21 TERMINAL BOOY WEIGHT: 296.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS UTERUS .............................. GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 4; LEFT: 10 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 195 STUDY NUMBER: 964080 ANIMAL NUMBER: 2515 DATE OF OEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 325.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS .............................................................................................................................................................................................................................................................................. MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) ........................................................................................................................................................................................................................................................ GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 9; LEFT: 7 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE, "X-" OTHER BFG 003467 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL OATA SHEET PRINTED: 29-APR-98 PAGE: 196 STUOY NUMBER: 964060 ANIMAL NUMBER: 2516 DATE OF DEATH: 05/30/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF OEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BOOY WEIGHT: 304.6 GRAMS ORGAN NAME * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS MICRO: -MINIMAL, FOCAL -MINIMAL -ACUTE/SUBACUTE INFLAMMATION -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) GROSS: -iMPLANT SCARS - PRESENT ...................................... -RiGHT: 4;'LEFT:*...................................................................... KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC, ''I-*' INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-9B PAGE: 197 STUDY NUMBER: 964080 ANIMAL NUMBER: 2517 DATE OF DEATH: 05/27/97 ORGAN NAME SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 290.8 GRAMS * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS LIVER . . UTERUS . . MICRO: -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZONAL) -RI6HT: 12: LEFT: 5 KEY TO NEOPLASMS: "M-" MALIGNANT. HB-" BENIGN, "S-" METASTATIC, INVASIVE. "X-" OTHER BFG 003469 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 198 STUDY NUMBER: 964060 ANIMAL NUMBER: 2SLB DATE OF DEATH: 05/30/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY Of OEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 310.6 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . UTERUS . . MICRO: -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -RIGHT: 6; LEFT: 9 KEY TO NEOPLASMS: '*M-" MALIGNANT, "B-" BENIGN. 'V* METASTATIC. "1-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: Z9-APR-98 PAGE: 199 STUDY NUMBER: 964080 ANIMAL NUMBER: 2519 DATE OF DEATH: 05/29/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 143 STUOY WEEK OF DEATH: 21 TERMINAL BOOY WEIGHT: 303.3 6RAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS UTERUS . . GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 4; LEFT: 3 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVEO *** BFG 003471 H3H10 ,,-XM `3MSVANI '3UV1SV13H ,,-SM 'N9IN38 *iHVM9PVH ,,"Hm :$NSVld03N 01 A3X (TVH02-N0H) S31003VA OIHSVTdOlAO :S31A301Vd3H- iN3S3Hd ION - SHV3S IWVTdKf- SS0V9 TVHIMIH- :0U3IH S9NI0NIJ 3I90T0HiVd01SIH / S1N3MH03 lX3l-33Hi SS0H9 , * * S N0 1 1V U3 sa0 NouneuisiQ 'aiib3A3S 'sodonAax noioHivd , , , SHVH9 ZC62 :iH9I3A AOOS 1VNIHH31 12 :H1V3Q JO X33A AOfUS Ptt :H1V30 JO AVO AOrUS 33IJJH3VS IVNlWMi `Q3Tfl03HDS :SIUViS 331J1H3VS Z :dnOH9 3S00 3TVM3J :X3S 080*96 -M38WnN AOrUS 002 :39Vd 86-8dtf-62 :a31NlSd 133HS VIVO 1VHINV TWOIAIQNI SiVM 03 HI AQIUS A1131X01 1VXN3Hd013A30 ONV NOIi3nOOUd3M NOUVd3H39-Ofli N0UV1VHNJ 03NIBH03 aOIVOItO TANIA indino H31SAS XOl/HIVd ... 3HVH NV9H0 16/OC/SO :H1V30 JO 31V0 02S2 aagwnN tvhinv *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TU0-6ENERATI0N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-90 PAGE: 201 STUDY NUMBER: 964000 ANIMAL NUMBER: 2521 DATE OF DEATH: 05/2B/97 SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 142 STUDY WEEK OF OEATH: 21 TERMINAL BOOY WEIGHT: 256.2 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREC-TEXT COMMENTS f HISTOPATHOLOGIC FINDINGS LIVER . . UTERUS . . MICRO: -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -RIGHT: 10; LEFT: 6 KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. MX-M OTHER BFG 003473 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COM8INED INHALATION TWO-GENERATION REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 202 STUDY NUMBER: 964080 ANIMAL NUMBER: 2522 DATE OF DEATH: 05/27/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BOOT WEIGHT: 309.7 GRAMS * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION OBSERVATIONS * * * 6R0SS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS MICRO: -MINIMAL -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZQNAL) GROSS:'-iMPLANT SCARS - PRESENT ...................................... -RiGHT! ; LEFT: B...................................................................... KEY TO NEOPLASMS: "M-" MALIGNANT. '*B-" BENIGN, "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMB1NEO INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 203 STUDY NUMBER: 964080 ANIMAL NUMBER: 2S23 DATE OF OEATH: 05/27/97 ORGAN NAME SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 286.7 GRAMS * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS UTERUS . . GROSS: -IMPLANT SCARS - PRESENT -RIGHT: 8; LEFT: 7 *** ANIMAL HAS NO MICROSCOPIC ABNORMALITIES OBSERVED *** BFG 003475 *** PATH/TOX SYSTEM OUTPUT *** , VINYL CHLORIDE COMBINED INHALATION TWQ-6ENERAT10N REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PACE: 204 STUDY NUMBER: 964080 ANIMAL NUMBER: 2524 DATE OF OEATH: 05/29/97 ORGAN HAME SEX: FEMALE OOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF OEATH: 143 STUOY WEEK OF OEATH: 21 TERMINAL BOOY WEIGHT: 274.4 GRANS * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FRCE-TEXT COMHENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS ...................................... MICRO: -MINIMAL ...................................... GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQM-ZONAL) -RIGHT: 6; LEFT: 6 KEY TO NEOPLASMS: MM-*` MALIGNANT. "B-" BENIGN, MS-" METASTATIC, "1-** INVASIVE. "X-" OTHER * * * PATH/TOX SYSTEM OUTPUT * * * V IN Y L CHLORIDE COMBINED IN H A LA TIO N TW 0-6ENERATI0N REPRODUCTION AND DEVELOPMENTAL T O X IC IT Y STUDY IN CO RATS PRINTED: 29-A P R -98 PAGE: 205 1 1 1 o o 1 1 e1 1 to 4 o1 </) 1 z< 1 1 ae 1 to ( 1 Ui--4 1 to iz--- o O 1 "X1 1 bz kb 4 kb -- oj 1 ae 1 u u1 id xin * 1 1 to o 1 -IX 1 Q X to 1 X Z '1 t-- hUJ 1 X x 1 a. ae 4 O UJ > 1 -- h- o o 1 1 VHI S3 1 z a1 UJ --1 ( * -JX 1 3Z 1 * S >i 1 UZ 4 * V* xa 1 1-- O kbl 1 in h- 1 UJ -j X z o N z>- ox z--o-o- X in h wee _l Ul o a. 3^ CJX X ^ > ae ox -1 X3 me 1 i/l X 4X on 4 z o 3 4u bX 1 t o b i -- X XO a. o ae >- z U UJ ^ i UJ UJ *W 4 4 l O 1 X UJ --x 4 UJ v> u. >-- 4 ae -- X 4 lb ae uj uo 1 1 ae i/i x 1 UJ 1/1 in u. 1 o o 1 tnee 1 to < X1o ui k UJ 4 o 31 4 Ol >- 4 X o 3 41 > a. -- 1 to OM 4 o 4 oo ae to 4 1 --J>-- 13 UJ in 1 I O eb O 4 1 X K a - r I -- in i x XO i x l a. UJ a i i > -- I Lb i * ae UJ O i UJ --l i > X >- i UJ X c we Lb i i i >n - i in a i Q x o i ae UJ *-- i O gA 1/) I 5 i i UJ i u r t/ in UJ UJ -- *-- ^^ uu oo *-- t-- XX (kb. UJ UJ XX 1I U. UJ * CD * o ae i ^ --I XX Xb Xb Z b b* XX 11 ^ . X UJ */* UJ DC <L 1 (/) ae < u V4 Kjg- O. Mz * .. i r>> i et fu i/i eg 4 Nu~i *in> 1 1 No 4 o </) ae c*n o o oc X to 4 4 ae x 4 UJ^- 4 tu OX 4 X UJ 4 30 1 1 kb 1 --J o 1 c 1 X UJ 4 -- H- 1 XX i Xo i X z ae X to ae O UJ >-- _j 3 oe UJ S ae UJ z o 1 X $ 4 LU >MX C/> < > NX X 1 MX t CJ MX < -- /) <1-- UJ z s %A 5 * Z 1 u> 4Z k UJ *0 4 1s <1 4 CD t9 1 4 l 1^ 4< Iz 4O 1 MX 1^ 1< x 11 2 14 11 2z 1 1 i 1 C/1 iZ i </> i i _j l& 4O 1 UJ <Z Io 1 1-- 1 1 >l UJ i Le i i i i i i i i i i i i ii i i i i i BFG 003477 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 206 STUOY NUMBER: 964080 ANIMAL NUMBER: 2S26 DATE OF DEATH: 0S/2B/97 SEX: FEMALE DOSE 6R0UP: 2 SACRIFICE STATUS: SCHEOULEO. TERMINAL SACRIFICE STUOY DAY OF OEATH: 142 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 298.9 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS MICRO: -MINIMAL, MULTI-FOCAL -ACUTE/SUBACUTE INFLAMMATION GROSS:`-iMPLANT SCARS - PRESENT ................................... -RiGHT: 6;'LEFT:'&.................... KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" BENIGN. "$-" METASTATIC. ,,I-,` INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMfllNED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 207 STUDY NUMBER: 964060 ANIMAL NUMBER: 2527 DATE OF DEATH: 05/28/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 275.0 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINOINGS LIVER . . UTERUS . . MICRO: -MINIMAL GROSS: -IMPLANT SCARS - PRESENT KEPATOCYTES: CYTOPLASMIC VACUOLES (N0N-20NAL) -RIGHT: 6; LEFT: 8 KEY TO NEOPLASMS: "M-" MALIGNANT. "B-" 8ENIGN, "S-" METASTATIC, "I-" INVASIVE. "X- OTHER BFG 003479 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-9B PAGE: 208 STUDY NUMBER: 964080 ANIMAL NUMBER: 2528 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEOUIEO, TERMINAL SACRIFICE STUOr DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 273.7 GRANS ORGAN NAHE * * * PATHOLOGY KEYWORDS. SEVERITY, DISTRIBUTION 0 BSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS -. .. MICRO; MINIMAL 6R0SS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZONAL) -RIGHT: 3; LEFT: 10 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN , "S-M METASTATIC, "I-" INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TU0-6ENERATI0N REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 209 STUDY NUMBER: 964080 ANIMAL NUMBER: 2530 DATE OF DEATH: 05/27/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 141 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 279.4 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS MICRO: -MINIMAL -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY -RIGHT: 6; LEFT: 4 KEY TO NEOPLASMS: "H-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC, "1-" INVASIVE, "X-M OTHER BFG 003481 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 210 STUDY NUMBER: 964080 ANIMAL NUMBER: 2531 DATE OF DEATH: 06/05/97 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 150 STUOY WEEK OF DEATH: 22 TERMINAL BODY WEIGHT: 276.7 GRAMS ORGAN NAME * * * PATHOLOGY KEYWOROS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . UTERUS . . MICRO: -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NQN-ZONAL) -RIGHT: 10; LEFT: 4 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, "S-" METASTATIC. "I-*' INVASIVE, HX-M OTHER BFG 003482 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHL0RI0E COMBINED INHALATION TW0-6ENERATI0N REPRODUCTION ANO DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 211 STUDY NUMBER: 9640B0 ANIMAL NUMBER: 3501 DATE OF DEATH: OS/27/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF OEATH: 141 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 305.2 6RAMS ORGAN NAME * * * PATHOLOGY KEYWORDS. SEVERITY. DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS MICRO: -MINIMAL -MINIMAL GROSS: -IMPLANT SCARS - NOT PRESENT -HEPATOCYTES: CYTOPLASMIC VACUOLES (NON-ZONAL) -HEPATOCYTES CENTR1LOBULAR: HYPERTROPHY KEY TO NEOPLASMS: "M-M MALIGNANT. "B-" BENIGN. "S-" METASTATIC. "I-" INVASIVE. "X-" OTHER BFG 003483 *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 212 STUDY NUMBER: 9640B0 ANIMAL NUMBER: 3502 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUOY OAY OF DEATH; 144 STUOY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 2B2.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS .................................. MICRO: -MINIMAL. FOCAL -MINIMAL .................................. GROSS: -IMPLANT SCARS - PRESENT -ACUTE/SUBACUTE INFLAMMATION -KEPATOCITCS CENTRlLOBULAR: HYPERTROPHY -RIGHT: 4; LEFT: 11 KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN, METASTATIC. INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICtTY STUDY IN CO RATS INDIVIDUAL ANIMAL DATA SHEET PRINTED: 29-APR-98 PAGE: 213 STUDY NUMBER: 964080 ANIMAL NUMBER: 3503 DATE OK DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BOOY VEI6HT: 328.5 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY. DISTRIBUTION OBSERVATIONS * * * 6R0SS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER . . UTERUS . . MICRO: -MINIMAL GROSS: -IMPLANT SCARS - PRESENT -HEPATOCYTES CENTRIL08ULAR: HYPERTROPHY -RIGHT: 13; LEFT: 7 KEY TO NEOPLASMS: "M-" MALIGNANT, "8-m 8ENIGN. MS-" METASTATIC, ''I-" INVASIVE. "X-" OTHER BFG 003485 *** PATM/TOX SYSTEM OUTPUT *** VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS INOIVIOUAL ANIMAL DATA SHEET PRINTEO: 29-APR-98 PAGE: 214 STUDY NUMBER: 9B4060 ANIMAL NUMBER: 3504 DATE OF DEATH: 05/26/97 ORGAN NAME SEX: FEMALE DOSE 6R0UP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFICE STUDY DAY OF DEATH: 142 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 272.1 SRAMS * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS MICRO: -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY gross:'-Implant scars - present ................................... -right- 7;'left: b.................................................. KEY TO NEOPLASMS: "M-" MALIGNANT. "fl-" BENIGN, "S-" METASTATIC, "I-" INVASIVE, "X-" OTHER *** PATH/TOX SYSTEM OUTPUT *** VINYL CHLORIOE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS INDIVIDUAL ANIMAL DATA SHEET PRINTEO: 29-APR-9B PAGE: 215 STUOY NUMBER: 964080 ANIMAL NUMBER: 3505 DATE OF DEATH: 05/30/97 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE STUDY DAY OF DEATH: 144 STUDY WEEK OF DEATH: 21 TERMINAL BODY WEIGHT: 289.3 GRAMS ORGAN NAME * * * PATHOLOGY KEYWORDS, SEVERITY, DISTRIBUTION OBSERVATIONS * * * GROSS FREE-TEXT COMMENTS / HISTOPATHOLOGIC FINDINGS LIVER UTERUS MICRO: -MINIMAL -HEPATOCYTES CENTRILOBULAR: HYPERTROPHY GROSS: -iMPLANT SCARS : PRESENT................................... -RiGHT: 6;'LEFT:*7...................................................... KEY TO NEOPLASMS: "M-" MALIGNANT, "B-" BENIGN. "S-" METASTATIC. "I-** INVASIVE, "X-M OTHER BFG 003487