Document xdQ9d7E9VNV4ED0oRbeQZwYmE
Pathology and Toxicology RNcer Liboratoriea, Inc.
Building 270-3S -05. 3M C enter S t Paul, M innesota 5 5 1 44 -1 0 0 0
AR226-OV38
TWO YEAR ORAL (DIET) TOXICITY / CARCINOGENICITY STUDY OF FLUOROCHEMICAL FC-143 IN RATS
(RIKER Ex p e r i m e n t No . 0281CR0012)
Volume 2 o f 4
Co n d u c t e d Du r i n g Ap r i l , 1 9 8 1 - Ma y , 1 9 8 3
RIKER LABORATORIES, I n c . / 3M Company U.S.A.St . Pa u l , Mi n n e s o t a 5 5 1 4 4 - 1 0 0 0
000679
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4643 Sex: Feaale Group: ( 5) FC-143 300 ppc Fate: (Neek= 78) Sacrificed in extreais
Microscopic Observations (continued): Lung
Lyaph Node (aesenteric) Farathyroid Pituitary Spleen Uterus
-Vascular aineralization, aild Heacrrhage, diffuse, aarked -Not exaained, aissing -Not exaained, not in plane of section -Adenoaa -Heaossderosis, aoderate -Cystic glands, aild
The Following tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Marrow, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Ovary, Maaaary Gland, Trachea, Adrenal, Thyroid, Pancreas, Salivary Gland, Eye.
Aniaal Nuaber: 1R-4644 Sex: Feaale Group: ! 5) FC-143 300 ppa Fate: (Week: 103! Tenir,al Sacrifice
Macroscopic Observations: Maaaary Gland
Microscopic Observations: Adrenal Kidney Liver
Lung
Maaaary Gland Pancreas Urinary Bladder
-Lobular aass, 3 ca dia., right axilla.
-Sinusoidal ectasia, cortex, aild -Pelvic aineralization, ainiaal -Hepatocyte vacuolation, aultifocal, aild Hepatocyte alteration, vacuolated, focal, aild Hepatocyte alteration, basophilic, focal, ainiaal Hyperplastic nodule -Vascular aineralization, aild Alveolar aacrophages, aultifocal, aild -Fibroadenoaa -Not exaained, aissing -Not exaained, aissing
The following tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Harrow, Spleen, Heart, Stoaach, Saall Intestine, Large Intestine, Aorta, Uterus, Ovary, Pituitary, Trachea, Thyroid, Parathyroid, Esophagus, Lyaph Node (aesenteric), Salivary Gland, Eye.
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Page
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M
FC-143: To Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4645 Sex: Feaale Sroup: ( 5) FC-143 300 ppa Fate: Uieek= 105) Terainal Sacrifice
Macroscopic Observations: Maiaa-y Sland
Microscopic Observations: Adrenal Aorta Kidnev Liver
Lung
Lyaph Node (eesenteric! Masaary Sland Parathyroid Fituitary
-Large aass, 10 x 4 ca, right axilla; lobular
aass, 5.5 x 5 x 4 ca, le ft inguinal.
-Sinusoidal ectasia, cortex, Barked -Not exaained, aissing -Pelvic aineralication, aild -Portal acnonuclear cell in filtra te , aild Portal bile duct proliferation, aild -Alveolar aacrophages, aultifocal, aild Heaorrhage, local areas, aild -Heaorrhage, Barked -Fibroadenoaa -Not exaained, not in plane of section -Adenoaa
The fo llo n ing tissues nere found to be within noreal lia its : Brain, Spiral Cord, Bone Marrow, Spleen, Heart, Stomach, Siall Intestine, Large Intestine, Urinary Bladder, Uterus, Ovary, Trachea,i Thyroi d, Esophagus, Pancreas, Salivary 61and, Eye.
Aniaal Nuaber: 1R-4546 Sex: Feaale Sroup: ! 5) FC-143 300 ppa Fate: iNeek= 105! Terainal Sacrifice
Macroscopic Observations: Maaeary Sland
Microscopic Observations: Adrenal Heart
Kidney
Li ver Lung Maasary Eland
Ovary Pancreas Parathyroid
-Saall nodular aass, 1 ca dia., le ft axilla; nodular aass, 4 x 2.5 ca, right axilla.
-Sinusoidal ectasia, cortex, aoderate -Myocardial fibrosis, focal, ainiaal Myocarditis, chronic nonsuppurative, focal, ainiaal -Chronic progressive nephropathy, ainiaal Pelvic aineralization, earked -Portal aononuclear cell in filtra te , aild -Heaorrhage, local areas, aoderate -Adenocarcinoaa Fibroadenoaa -Tubular hyperplasia, aoderate -Acinar atrophy, ainiaal -Not exaained, not in plane of section
Species: Rat Project Nuaber: 02B1CR0012
293Suaaarized STAR Page! 129 C006S1
Suiaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuiber: 1R-4G46 Sex: Feiale Group: ( 5) FC-143 300 ppi Fate: (Week* 105) Terainal Sacrifice
Microscopic Observations (continued): Pituitary Salivary Bland Uterus
-Adenoia -Not exaained, lissing -Cystic glands, lild
The following tissues sere found to be within norial l i i i t s : Brain, Spinal Cord, Bone Marrow, Spleen, Stoeach, Seall Intestine, Large Intestine, Urinary Bladder, Aorta, Trachea, Thyroid, Esophagus, Lytph Node (lesenteric), Eye.
Ar.isal Nuiber: 1R-4647 Sex: Feeale Group*. ( 5) FC-143 300 ppi Fate*. (Week* 105) Teriinal Sacrifice
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Esophagus Kidney
Liver Lung Ovary Parathyroid Pituitary Thyroid Trachea Urinary Bladder
-Mass, 0.5 ci dia.
-Sinusoidal ectasia, cortex, larked -Not exaained, lissing -Chronic progressive nephropathy, ainiial Pelvic aineralization, ain iia l -Hepatocyte vacuolation, aultifocal, lild -Vascular aineralization, aoderate -Cyst, unilateral -Not exaained, lissing -Adenoia -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The following tissues were found to be within noria! l i i i t s : Brain, Spinal Cord, Bone Marrow, Spleen, Heart , Stonach, Siali Intestine, Large Intestine, Aorta, Uterus, Maiiary Gland, Lyiph Node (lesenteric), Pancreas, Salivary Gland, Eye.
Anieal Nuiber: 1R-4648 Sex: Feiale Group: ( 5) FC-143 300 ppa Fate: (Week* 88) Found Dead
Macroscopic Observations: Haiiary 61and
Microscopic Observations: Eye Kidney Large Intestine
-Large fira subcutaneous aass, 12 x 9 x 5 ca, on le ft side.
-Net exaained, aissing -Pelvic aineralization, aild -Not exaained, aissing
Species: Rat Project Nuiber: 0281CROOI2
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Suaaarized Single Tabulated Aniial Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FC-143: Tko Tear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4640 Sex: Feaale Group: ( 5) FC-143 300 ppa Fate: (Neel- 88) Found Dead
Hicroscopic Observations (continued): Lung
Lyaph Node (aesenteric) Haaaary 61and Parathyroid Skin Saal1 Intestine
-Vascular aineralization, aild Alveolar aacrophages, aultifocal, aild Perivascular aononudear in filtra te , aild -Not exaained, aissing -Not exaained, aissing -Not exaained, not in plane of section -Fibrosa -Not exaained, aissing
The folloning tissues Here found to be aithin noraal lia its : Brain, Spinal Cord, Bone Harron, Spleen, Liver, Heart, Stoaach, Urinary Bladder, Aorta, Uterus, Ovary, Pituitary, Trachea, Adrenal, Thyroid, Esophagus, Pancreas, Salivary Gland.
Aniial Nuaber: 1R-4649 Sex: Feaale Group: ( 5) FC-143 300 ppa Fate: (Meek= 105) Terainal Sacrifice
Hacroscopic Observations: Pituitary Naeaary Gland
Hicroscopic Observations: Adrenal Kidney Liver
Lung Haaaary Bland
Ovary Parathyroid Fituitary Salivary Gland
-Raised aass, 0.8 ca dia. -Saall aass, 1 ca dia., possibly inflaaaed
ailk cyst, perineal area.
-Cortical atrophy, bilateral, acderate -Chronic progressive nephropathy, aild -Portal aononudear cell in filtra te , aild Portal bile duct proliferation, aild -Perivascular aononudear in filtra te , ainiaal -Galactocele Fibroadenoaa -Tubular hyperplasia, bilateral, aoderate -Not exaained, not in plane of section -Adenoaa -Not exaained, aissing
The following tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Harroa, Spleen, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Trachea, Thyroid, Esophagus, Lyaph Node (aesenteric), Pancreas, Eye.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 131
295
G006S3
Suiianzed Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Tno Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nuaber: 1R-465 Sex: Feiale Broup! ( 5) FC-143 300 ppe Fate: IHeek= 104) Sacrificed in extreeis
Macroscopic Observations: Pituitary Skin
Haiiary 61and Microscopic Observations:
Adrenal
Kidney Li ver
Lung
Maaeary Bland Ovary Parathyroid Pituitary Skin
--
-Heaorrhagic aass, 0.1 ci dia. -Raised circular inflaiied lesion on le ft rear
footpad. -Round lass, 1 ci dia., in inguinal area.
-Sinusoidal ectasia, cortex, lild Medullary cell hyperplasia, unilateral, oderate Pheochroiccytoia, alignant, unilateral In filtra tio n of neoplastic tissue into surrounding connective tissue.
-Pelvic aineralication, aild -Portal ononudear cell in filtra te , iiId
Portal bile duct proliferation, ciId Hepatocyte vacuolation, aultifocal, aild -Vascular aineralization, aild Perivascular aononuclear in filtra te , ainiaal -Salactocele -Tubular hyperplasia, bilateral, aoderate -Not exaained, not in plane of section -Adenoaa -Pododeraatitis, ulcerative, hindleg, unilateral, larked
The foilouing tissues were found to be within ncrtal lia its : ' Brain, Spinal Cord, Bone Marrou, Spleen, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Trachea, Thyroid, Esophagus, Lyaph Node (aesenteric), Pancreas, Salivary Bland, Eye.
Aniial Nutber: 1R-4B5! Sex: Feaale Group: ( 5) FC-143 300 ppa Fate: IHeek= 96) Sacrificed in extreiis
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Esophagus Eye Large Intestine Liver
-Raised aass, 1.1 c i dia.
-Sinusoidal ectasia, cortex, aild -Not exaained, aissing -Not exaained, aissir.g -Not exaained, aissing -Hepatocyte alteration, vacuolated, focal, aild
Species: Rat Project Hueber: 0281CR0012
OQ/1 Smiarized STAR Page: 132 7 0
GO0634
Suaearized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieai Nutber: 1R-4651 Sex: Feaale Group: 1 5) FC-143 300 ppa Fate: (Week= %) Sacrificed in extreiis
Microscopic Observations (continued): Ovary Parathyroid Fituitary Salivary Bland Thyroid Urinary Bladder
-
-Mb diagnosis, inadequate section -Not exaained, aissing -Adenc-aa -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The following tissues were found to be within norea! l i i i t s : Brain, Spinal Cord, Gone Marrow, Spleen, Kidney , Heart, Lung, Stoaach, Snail Intestine, Aorta, Uterus, Maieary Gland, Lyaph Node (aesenteric), Pancreas, Trachea.
Anna! Nuaber: 1R-4653 Sex: Feaale Group: ( 5) FC-143 300 ppa Fate: !Week= 87) Sacrificed in extreeis
Macroscopic Observations: Pituitary Haaaary 61and Liver
Microscopic Observations: Adrenal Esophagus Kidney Liver
Lung
Mastery Gland
Pancreas Pituitary Spleen
-Heaorrhagic aass, 1 ce dia. -Milk cyst in right inguinal area. -Pale
-Sinusoidal ectasia, cortex, ai Id -Not exaained, aissing -Chronic progressive nephropathy, air.ii.al -Hepatocyte vacuolaticn, diffuse, aarked Mononuclear cell in filtra tio n , aultifocal, parenchyaal, aild -Pneuacnia, in te rs titia l, chronic, aultifocal, ainieal -Within noraal lia its
Milk cyst not included with section exaained. -Acinar atrophy, aild -Adenoaa -Heaosiderosis, aild
The following tissues were found to be within noraal. 1ia its: Brain, Spinal Cord, Bone Marrow, Heart, Stoaach,, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Trachea, Thyroid, Parathyroid, Lyaph Node (aesenteric), Salivary 61and, Eye.
Species: Rat Project Nuaber: 0281CR0012
Sueiarized STAR Page: 133 C . 7 !
C006S5
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nutber: 1R-4654 Sex: Fetale Group: ( 5) FC-143 300 ppa Fate: tWeek= 57) Found Dead
Macroscopic Observations: Mataary Gland
Microscopic Observations: Aorena! Esophagus Heart
Liver Lung Mattary Gland Pancreas
--
-Subcutaneous aass, 6 x 5 x 2 ca, in le ft a xilla. Hass was aultilobular and reddish pink.
-Sinusoidal ectasia, cortex, aoderate -Not exaained, tissing -Myocarditis, chronic nonsuppurative, focal, ainiaal -Portal bile duct proliferation, tild -Pneunonia, in te rs titia l, chronic, focal, aild -Fibroadenoaa -Pancreatitis, chronic, diffuse, aoderate
The following tissues were found to be within nortal l i t i ts: Brain, Spinal Cord, Bone Marrow, Spleen , Kidney, Stoaach, Stall Intestine, Large Intestine, urinary Bladder, Aorta, Uterus, Ovary, 1"itu ita ry, Trachea, Thyroid, Parathyroid, Lytph Node resenteric), Salivary Gland, Eye.
Aniaal Nutber: 1R-1657 Sex: Fetale 6roup: ( 5) FC-143 300 ppt Fate.' (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Mattary Gland
Microscopic Observations: Adrenal Eye Kidney
Liver
Mattary Gland Salivary Gland Spleen Urinary Bladder
-Lobular aass, 2 x 1.5 x 1 ca, in perineal area.
-Sinusoidal ectasia, cortex, aild -Not exaained, tissing -Chronic progressive nephropathy, aild Pelvic ainera!izatior,, aild -Portal aononudear cell in filtra te , tild Portal bile duct proliferation, aild Hepatocyte vacuolation, suiti fecal, aild -Fibroadenoaa -Sialadenitis, chronic, aoderate -Heaosiderosis, aild -Not exaained, aissing
The -following tissues ere found to be within noreal li* it s : Brain, Spinal Cord, Bone Harrow, Heart, Lung, Stoaach, Stall Intestine, Large Intestine, Aorta, Uterus, Ovary, Pituitary, Trachea, Thyroid, Parathyroid, Esophagus, Lytph Node (aesentenc), Pancreas.
Species: Rat Project Nutber: 02S1CR0012
Suaaarized STAR Page: 134 2 9 8
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuaber: 1R-4658 Sex: Feiale Sroup: ( 5) FC-143 300 ppa Fate: (Ueek= 105) Tereinal Sacrifice
Macroscopic Observations:
Mastary Gland
--
Microscopic Observations:
Adrenal
Esophagus
Heart
Kidney
Liver
Lyeph Node (eesenteric)
Maasary Eland Ovary Parathyroid Salivary 61and Spleen Thyroid Trachea
-
-Milk cyst in perineal area.
-Sinusoidal ectasia, cortex, larked -Not exaeined, aissing -Myocarditis, chronic nonsuppurative, u ltifo ca l, ai Id -Chronic progressive nephropathy, cild Pelvic aineraiizatior., ainiaal -Hepatocyte vacuolation, ultifocal, ai Id Megalocytosis, ainiaal -Heaorrhage, aoderate Pigaent, brown, aoderate -Fibrosis, aild -Cyst, unilateral -Not exaained, aissing -Net exaained, aissing -Heaosiderosis, aild -Not exaained, aissing -Not exaained, aissing
The following tissues were found to be within noreal lia its : Brain, Spinal Cord, Eone Harrow, Lung, Stoaach,, Snail Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Pituitary, Pancreas, Eye.
Ar.iaa! Nuaber: 1R-4E59 Sex'. Fenale Group: ! 3! FC-143 300 ppa Fate: (Keek= 1C5) Terainal Sacrifice
Macroscopic Observations: Mateary Eland
Microscopic Observations: Adrenal Aorta Esophagus Kidney
Liver
Lung
Maaaary 61and Pancreas
-Lobular 3 x 3 ca aass in throat area.
-Sinusoidal ectasia, cortex, aoderate -Not exaained, aissing -Not exaained, aissing -Chronic progressive nephropathy, aoderate Pelvic aineralization, ainiaal -Portal aononudear cell in filtra te , ainiaal Portal bile duct proliferation, aild -Vascular aineralization, cild Perivascular aononudear in filtra te , aild -Fibroadenoaa -Acinar atrophy, aild Islet ceil adenoaa
Species: Rat Project Nueber: 02B1CR0012
Suaaarized STAR Page:
?99
06S^
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N
FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4659 Sex: Feaale Broup: ( 5) FC-143 300 ppa Fate: (Week- 105) Terainal Sacrifice
Microscopic Observations (continued): Uterus
-Polyp
The folloaing tissues aere found to be aithin noraal lin t s : Brain, Spinal Cord, Bone Marroa, Spleen, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Ovary, Pituitary, Trachea, Thyroid, Parathyroid, Lyaph Node (aesenteric), Salivary Bland, Eye.
Animal Nuaber! 1R-466C Sex: Feaale 6roup: ( 5) FC-143 300 ppa Fate: Week* 105) Terainal Sacrifice
Macroscopic Observations: Pituitary Haaaary Gland
Microscopic Observations: Adrenal Esophagus Kidney
Large Intestine Liver
Lung Lyaph Node (aesenteric! Maaeary Gland
Fancreas Parathyroid Pituitary Spleen
-Mass, 0.6 ca dia. -Hass, 2.5 x 2 x 3 ca, le ft a xilla: aass, 4.4
x 4 x 2 ca, le ft inguinal.
-Sinusoidal ectasia, cortex, aarked -Not exaained, aissing -Chronic progressive nephropathy, ainiaal Pelvic aineralizatior., ainiaal -Neaatodiasis, colon -Portal aononudear cell in filtra te , aild Portal bile duct proliferation, aild Hepatocyte vacuclation, aultifocal, ainiaal Cy5tcid degeneration, focal, ainiaal -Alveolar tacrophages, focal, aild -Pigaent, broan, aild -Fibroadenona Fibroadenoaa -Is le t cell carcinosa -Not exaained, not in plane of section -Adenona -Heaosiderosis, ainiaal
The folloaing tissues aere found to be aithin noraal. U nits: Brain, Spinal Cord, Bone Narroa, Heart, Stcaach, Saall Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Trachea, Thyroid, Salivary Gland, Eye.
Species: Rat Project Nuaber: 0281CR0012
Suaaarized 5TAR Page: 136
300
C006S8
Suanarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4661 Sex: Feaale Group: ( 5) FC-143 300 ppt Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Esophagus Kidney Liver
Lung
Parathyroid
-No visible lesions.
-Not exaained, aissing -Chronic progressive nephropathy, ainiaal -Portal aononudear cell in filtra te , aild Hepatocyts vacuo!ation, aultifocal, aild -Vascular aineralization, aild Alveolar aacrophages, aultifocal, aild -Not exaained, not in plane of section
The follouing tissues Here found to be within noraal lia its : Brain, Spinal Cord, Bone Marron, Spleen, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Maaaary Bland, Pituitary, Trachea, Adrenal, Thyroid, Lyaph Node iaesenteric), Pancreas, Salivary Gland, Eye.
Aniaal Number: 1R-4662 Sex: Feaale Group: ( 5! FC-143 300 ppa Fate: (Heek= 105) Terainal Sacrifice
Macroscopic Observations: Maaaary Gland
Microscopic Observations: Adrenal Esophagus Kidney Liver Lung
Lyaph Node (aesenteric) Maaaary Gland Pituitary Spleen
-Ulcerated necrotic aass, 4 x 3 ca, in right inguinal area.
-Sinusoidal ectasia, cortex, narked -Not exaained, aissing -Chronic progressive nephropathy, aild -Porta! aononudear cell in filtra te , aild -Vascular aineralization, aild Heaorrhage, aultifocal, aild -Pigaent, broan, aoderate -Fibroadenoaa -Adenoaa -Heaatopoiesis, extraaedullary, increased, aarked
The following tissues aere found to be within noraal lia its : Brain, Spinal Cord, Bone Marroa, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Trachea, Thyroid, Parathyroid, Pancreas, Salivary Gland, Eye.
Species: Rat Project Nuaber: 0281CR0012
000683091Suaaanzed STAR Page: 137
Suaaarized Single Tabulated Anital Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M
FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4663 Sex: Feaale Broup: ( 5! FC-143 300 ppt Fate: (Week= 105) Terainal Sacrifice
Macroscopic Observations: Maaaary Bland Adrenal
Microscopic Observations: Adrenal
Hidney
Liver
Lung
Masaary Gland Parathyroid
-Mass, 3 x 2.5 ca, in the throat area. -Right adrenal appears saall.
-Sinusoidal ectasia, cortex, unilateral, oderate
-Chronic progressive nephropathy, aild Pelvic aineralization, aild
-Portal aononuclear cell in filtra te , aild Hepatocyte vacuolation, aultifocal, aild Hepatocyte alteration, vacuolated, focal, aild
-Alveolar aacrophages, local areas, aild Heaorrhage, aild -Fibroadenoaa -Not exaained, not in plane of section
The fcllcaing tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Name*, Spleen, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Pituitary, Trachea, Thyroid, Esophagus, Lyaph Node iaesenteric), Pancreas, Salivary Gland, Eye.
Aniaa! Nuaber: 1R-4665 Sex: Feaale Group: i 5) FC-143 300 ppi Fate: !Week= 94) Sacrificed in extreais
Macroscopic Observations: Pituitary Maaaary Bland
Microscopic Observations: Adrenal Esophagus kidney
Liver
Lung
Lyaph Node (aesenteric) Maaaary Gland Ovary Pituitary Spleen
-Raised red aass, 1.2 ca dia. -Saall ailk cyst present.
-Sinusoidal ectasia, cortex, aild -Not exaained, aissing -Chronic progressive nephropathy, ainiaal Pelvic aineralization, niniaal -Portal aononuclear cell in filtra te , aild Portal bile duct proliferation, aild -Vascular aine-alization, aild Heaorrhage, local areas, aild -Not exaained, aissing -Lobular hyperplasia, aoderate -Tubular hyperplasia, aoderate -Adenoaa -Heaosiderosis, aild
Species'. Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 138
302
000690
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4665 Sex! Feaale Group! ( 5) FC-143 300 ppc Fate: (Week= 94) Sacrificed ir, extreais
Microscopic Observations (continued):
Uterus
--
-Hydroaetra, Barked
The follouing tissues cere found to be within noraal lia its : Brain, Spinal Cord, Bone Marroa, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Trachea, Thyroid, Parathyroid, Pancreas, Salivary Bland, Eve.
Anisal Nusber: 1R-4S67 Sex! Feaale Group: ( 5) FC-143 300 ppc Fate: (Neek= 105) Tersiral Sacrifice
Macroscopic Observations: Pituitary Urinary Bladder
Microscopic Observations: Adrenal Esophagus kidney Liver
Lung
Maasar y Gland Ovary Parathyroid Pituitary Salivary Gland Urinary Bladder
-Raised aass, 1.2 ca dia. -Nall appears thickened.
-Cortical atrophy, bilateral, aoderate -Not exaained, aissing -Pelvic aineralication, aild -Portal aononuclear cell in filtra te , aild Porta! bile duct proliferation, aild Megalocytosis, aild -Vascular aineralization, aild Pneuaonia, in te rs titia l, chronic, aultifocal, aild Alveolar aacrophages, local areas, aoderate Heaorrhage, local areas, aoderate 6ranuloaa, aultiple -Not exaained, aissing -Tubular hyperplasia, aild -Not exaained, not in plane of section -Adenoaa -Not exaained, aissing -Epithelial hyperplasia, sicple, diffuse, aild Hypertrophy, auscularis, aild
The following tissues aere found to be Mithin noraal lia its : Brain, Spinal Cord, Bone Marroa, Spleen, Heart, Stoaach, Saall Intestine, Large Intestine, Aorta, Uterus, Trachea, Thyroid, Lyaph Node (aesenteric), Pancreas, Eye.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized 5TAR Page: 139 303 000691
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: lR-46a8 Sex: Feaale Group: ( 5) FC-143 300 ppa Fate: (eek- 81) Sacrificed in extreais
Macroscopic Observations:
Fituitarv
--
Microscopic Observations:
Adrenal
Liver
Lung
Haasary Gland Parathyroid Pituitary Spleen Thyroid Urinary Bladder
-Enlarged due to red aass, 1 x 0.8 ca.
-Sinusoidal ectasia, cortex, ai 1d -Hepatocyte vacillation, periportal, aoderate -Vascular aineralization, aild Heacrrhage, local areas, aild -Not exanined, aissing -Not exaained, aissing -Adenoaa -Heaosiderosis, aild -Not exaained, aissing -Not exaained, aissing
The Following tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Harroa, Kidney, Heart, Stoaach, Saall Intestine, Large Intestine, Aorta, Uterus, Ovary, Trachea, Esophagus, Lyeph Node (aesenteric), Pancreas, Salivary Bland, Eye.
Aniaal Nuaber: 1R-4670 Sex: Feaale Group! ( 5) FC-143 300 ppa Fate: (Neel* 92) Sacrificed in extreais
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal
Kidney
Liver Lung
Maatary Gland Pituitary Spleen
-Raised heaorrhagic aass, 1 ct dia.
-Sinusoidal ectasia, cortex, unilateral, aild Medullary-cell hyperplasia, aultifocal, aild -Chronic progressive nephropathy, aild Pelvic aineralization, aoderate -Pigaer.t, Kupfer cell, broan, aild
-Alveolar aacrophages, focal, aild Perivascular aononudear in filtra te , ainiaal -Not exaained, aissing
-Adenoaa -Heaosiderosis, aild
The fc l lowing tissues ere found to be within noraal lia its : Brain, Spinal Cord, Bone Harroa, Heart, Stoaach, Saall Intestine, Large Intestine Urinary Bladder, Aorta, Uterus, Ovary, Trachea, Thyroid, Parathyroid, Esophagus, Lyaph Node (aesenteric), Pancreas, Salivary Eland, Eye.
Species: Rat Project Nuaber: 0281CR0012
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000692
Suaaarized Single Tabulated Aniaal Report (continued! Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Tao Year Oral Toxicity-Qr.cogenicity Study iR Rats
Table: 2
Aniaal Nuaber: 1R-4672 Sex: Feaale Group: ( 5) FC-143 300 ppa Fate: (Week- 105) Terainal Sacrifice
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Esophagus Lung Lyaph Node (aesenteric! Ovary Parathyroid Pituitary Salivary Eland Thyroid Trachea
-
-Haorrhagic aass, 0.9 ca dia.
-Sinusoidal ectasia, cortex, ainiaal -Not exaained, Bissino -Heaorrhage, local areas, aoderate -Pigaent, brown, ainiaal -Tubular hyperplasia, unilateral, aoderate -Not exaained, aissing -Adenoaa -Sialadenitis, chronic, aoderate -Not exaained, aissing -Not exaained, aissing
The fo l1owing tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Marrow, Spleen, Liver, Kidney, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Haaaary Gland, Pancreas, Eye.
Aniaal Nuaber: 1R-4673 Sex: Feaale Group: ( 5) FC-143 300 ppa Fate: (Heek= 79) Sacrificed in extreais
Macroscopic Observations: Pituitary Skin
Microscopic Observations: Adrenal Liver
Lung Haaaary Gland
Parathyroid Pituitary Thyroid
-Large heaorrhagic aass, 1.5 x 1 ca dia. -Subcutaneous Basses, 1.5 x 1.5 x 1 ca, right
axilla; 3.5 x 3 x 2 ca le ft axilla.
-Sinusoidal ectasia, cortex, aild -Portal aononuclear cell in filtra te , aild Portal bile duct proliferation, aild -Vascular cineralization, aild -Adenocarcinoaa Galactocele Lobular hyperplasia, aoderate
One of the grossly described aasses was an area of galactocoels and lobular hyperplasia. -Not exaained, aissing -Adenoaa -Not exaained, aissing
The following tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Marrow, Spleen, Kidney, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus,, Ovary, Trachea, Esophagus, Lyaph Node (aesenteric), Pancreas, Salivary 61and, Eye.
Species: Rat Project Nuaber: 0281 CROC12
Suaaarized STAR Page: M l 3 0 5
000693
Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H
FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4675 Sex: Feaale Group: ( 5) FC-143 300 ppa Fate: (Neek= 105) Terainal Sacrifice
Hacroscopic Observations: Lung - Kidney
Hicroscopic Obser vatior,s: Adrenal
Esophagus Heart
Kidney Liver
Lung
Parathyroid Pituitary
-
-Apparent areas of consolidation. -5oaewhat pale and pitted.
-Sinusoidal ectasia, cortex, aoderate Cortical vacuolation, aild -Not exaained, aissing
-Hyocarditis, chronic nonsuppurative, local areas, aild
-Chronic progressive nephropathy, aoderate -Portal aononudear cell in filtra te , aild Hegalocytosis, ainiaal -Vascular aineralization, aild 6ranuloaa, diffuse, aarked
Large area of granuloaa with aany giant cells. Few fragaents of foreign aaterial present. -Not exaair.ed, not in plane of section -Adenoaa
The following tissues were found to be within noraal b a its : Brain, Spinal Cord, Bone Harrow, Spleen, StDcach, Saall Intestine, Large Intestine, 'urinary Bladder, Aorta, Uterus, Ovary, Haaaary Bland, Trachea, Thyroid, Lyaph Node (aesenteric), Pancreas, Salivary 61and, Eye.
Aninal Number: 1R-4677 Sex: Feaale 6roup: ( 5) FC-143 300 ppa Fate: (Heek= 105) Terainal Sacrifice
Hacoscopic Observations: Haaaary Bland
Hicroscopic Observations: Adrenal Esophagus Kidney Liver
Lung
-Hass, 2 x 1.5 ca, in le ft axilla: aultilobular aass, .5 x 5.5 x 2 ca, in perineal area.
-Cortical vacuolation, aild Sinusoidal ectasia, cortex, aild -Not exaained, aissing
-Pigaent, conv. tub. epitheliue, brown. ainiaal
-Portal aononudear cell in filtra te , aoderate Portal bile duct proliferation, aoderate Hegalocytosis, ainiaal -Vascular aineralization, aild
Species: Rat Project Nuaer: C2B1CR0012
306Suaaarized STAR Page: 142
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Suuarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nuiber: 1R-4677 Sex: Feiale Group: ( 5) FC-143 300 ppi Fate: (Week- 105! Teriina! Sacrifice
Microscopic Observations (continued): Lyiph Node tiesenterich Haisary Gland
Ovary Pituitary
-Sinusoidal ectasia, derate -Fibroadenoia
Fibroadenoaa -Tubular adenoia, unilateral -Adenoia
The following tissues were found to be within norial lin t s : Grain, Spinal Cord, Bone Marrow, Spleen, Heart, Stoiach, Stall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Trachea, Thyroid, Parathyroid, Pancreas, Salivary Gland, Eye.
Anita! Nuiber: 1R-4&7B Sex: Feiale 6roup! 1 5) FC-143 300 ppi Fate-. (Neek= 49! Sacrificed in extreiis
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Kidney Liver
Lung
Parathyroid Pituitary Spleen Urinary Bladder
-Enlarged due to lass, 1 x 0.7 ci.
-Sinusoidal ectasia, cortex, aild -Pelvic lineralization, aild -Portal tonDnucJear cell in filtra te , lild Hepatocyte vacuolation, local areas, tild -Vascular lineralization, aild Perivascular lononudear in filtra te , tild Hetorrhage, local areas, toderate -Not exaiined, not in plane of section -Adenoia -Heiosiderosis, iiId -Not exaiined, lissing
The following tissues were found to be within norial l i i i t s : Brain, Spinal Cord, Gone Marrow, Heart, Stoiach, Siall Intestine, Large Intestine, Aorta, Uterus, Ovary, Maiiary Gland, Trachea, Thyroid, Esophagus, Lyiph Node liesenteric), Pancreas, Salivary Gland, Eye.
Aniial Nuiber: 1R-4B79 Sex: Feiale Group: ( 5! .FC-143 300 pps Fate: (Neek= 105! Teriinal Sacrifice
Macroscopic Observations: Pituitary Maiiary Gland
-Raised heiorrhagic lass, 0.5 ci dia. -Nodular iass, 1 c i dia., in le ft axilla;
large iass, 5 x 5 ci, in right inguinal area.
Species: Rat Project Nuiber: 0281CR0012
Suiiarned STAR Fane: 143
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 311
FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4679 Sex: Fetale Group: ( 5! FC-143 300 ppa Fate: (Neek= 105) Terairal Sacrifice
Microscopi: Observations (continued): Adrenal
Esophagus Kidney Liver Lung
Haaaary Gland Ovary Pituitary Thyroid Uterus
-Cortical vacuolation, aoderate Sinusoidal ectasia, cortex, aoderate Nodular hyperplasia, cortex, focal, aoderate -Not exaained, aissing
-Chronic progressive nephropathy, aarked -Portal bile duct proliferation, aild -Pneutonia, in te rs titia l, chronic, focal, ainiaal Alveolar aacrophages, focal, aild Perivascular aononuclear in filtra te , aild Heaorrhage, local areas, aoderate -Fibroadenoaa -Tubular hyperplasia, bilateral, aild -Adenera -Ultiaobranchial cyst -Cystic glands, ainiaal
The folloaing tissue; ere found to be within norsal lia its : Grain, Spinal Cord, Gone Harrow, SplEen, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Trachea, Parathyroid, Lyaph Node (aesenteric), Pancreas, Salivary Gland, Eye.
Aniaal Nunber: 1R-4GB0 Sex: Feaale 6roup: ( 5) FC-143 300 ppa Fate: (Heek= 104) Found Dead
Hacroscopic Observations: Haaaary Gland
Pituitary Liver Microscopic Observations: Adrenal Eye Heart
Kidney Large Intestine Liver Lung Lyaph Node (aesenteric)
-Large aass, 9 x 9 x 3.5 ce, in le ft inguinal area. Hass had necrotic, heaorrhagic surface.
-Dark lesion, 0.4 ca dia. -Pale
-Sinusoidal ectasia, cortex, aild -Not exaained, aissing -Myocarditis, chronic nonsuppurative, local areas, aild -Pelvic aineralization, ainiaal -Not exaained, aissing -Necrosis, centrilobular, aarked -Vascular aineralization, aild -Not exaained, aissing
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 144
308
000696
Suaaarized Single Tabulated Anna! Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Vear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Amaal Nuaber: 1R-46B0 Sex: Feeale Group: ( 5) FC-143 300 ppi Fate: (Week= 104) Found Dead
Microscopic Observations (continued): Naeaary Bland
Ovary Parathyroid Pituitary Stall Intestine Uterus
Lyaphangiosarcoaa Large well differentiated tutor with nuaercus eoderate to large size spaces containing few lyaphocytes. -Tubular hyperplasia, aoderate -Rot exaained, not in plane of section -Adenoaa -Not exaained, aissing -Not exaained, aissing
The f cl lowing tissues were found to be within norcal lin t s : Brain, Spinal Cord, Bone Marrow, Spleen, Stoaach, Urinary Bladder, Aorta, Trachea, Thyoid, Esophagus, Pancreas, Salivary 61and.
finiaal Nuafcer: 1R-46B1 Sex: Fetale Group: ( 51 FC-143 300 ppi Fate: (i4eek= 97! Sacrificed in extreais
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Esophagus Kidney
Liver Lung
Ovary Pancreas Parathyroid Pituitary Spleen
-Heaorrhagic aass, 1.2 ca dia.
-Sinusoidal ectasia, cortex, aoderate -Not exaained, aissing -Pelvic aineralization, ainiaal Pyelitis, acute, unilateral, aoderate -Hepatocyte vacuolation, aultifocal, wild -Vascular aineralization, aild Alveolar aacrophages, focal, ainiaal Perivascular aononudear in filtra te , ainiaal Heaorrhage, focal, aild -Tubular hyperplasia, aoderate -Acinar atrophy, aild -Not exaained, not in plane of section -Adenoaa -Heaosiderosis, aild
The fclloMing tissues were found to be within noraal lia its : Brain, Spinal Cord, Gone Marrow, Heart, Stoaach, Stall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Hataary Gland, Trachea, Thyroid, Lyaph Node (aesenteric), Salivary Gland, Eye.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page|_145
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-46E2 Sex: Feaale Broup: < 5) FC-143 300 ppa Fate: (Meek- 94) Found Dead
Macroscopic Observations:
Haaaary Bland
--
Microscopic Observations: Adrenal Esophagus Eye Large Intestine Lung
Lysph Node (aesenteric) Canary Bland Ovary Pancreas Parathyroid Pituitary Salivary 61ar.d Seal 1 Intestine Stoaach Thyroid Urinary Bladder Uterus
--
-Large aultilobular aass, 1 1 x 9 * 6 ca, in le ft axilla.
-Sinusoidal ectasia, cortex, aarked -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Vascular aineralization, ai Id Alveolar aacrophages, a u ltifocal, aild -Not exaained, aissing -Fibroadenoaa -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Adenoaa -Not exaained, aissing -Not exaained, aissing . -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The fallowing tissues aere Found to be within noraal lia its : Brain, Spinal Cord, Bone Marrow, Spleen,, Liver, Kidney, Heart, Aorta, Trachea.
Aniaal Nuaber: 1R-46B3 Sex: Feaale Broup: ( 5) FC-143 300 ppa Fate: !Neek= 105) Terainal Sacrifice
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal
Esophagus Liver Lung
Ovary Parathyroid Pituitary
-Mass, 0.5 ca dia.
-Sinusoidal ectasia, cortex, aoderate Adenora, cortical, unilateral -Not exaained, aissing
-Portal aononuclear cell in fi 1trate, aild -6ranuloaa, a u ltifocal, aild
Foreign aaterial in soae granulosas. Heaorrhage, local areas, aild -Tubular hyperplasia, bilateral, aoderate -Not exaained, not in plane of section -Adenoaa
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR PagE! 146 ^ ]
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Suttarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anita! Nutber: 1R-46B3 Sex: Fetale Group: ( 5) FC-143 300 ppa Fate: (Week= 105) Tertinal Sacrifice
Microscopic Observations (continued):
The following tissues were found to be within nornal l i i i t s : Brain, Spinal Cord, Bone Marrow, Spleen, Kidney, Heart, Stoiach, Stall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Mataary Bland, Trachea, Thyroid, Lytph Mode iieser.teric), Pancreas, Salivary Bland, Eye.
Aniial Nutber: 1R-4684 Sex: Fetale Group: ( 5) FC-143 300 ppt Fate: (Week- 103! Found Dead
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Aorta Esophagus Lung Lytph Node (tesenteric) Mattary Bland Ovary Parathyroid Pituitary Salivary Bland Thyroid Trachea Unidentified Tissue
-Raised, hetorrhagic, 0.1 ct dia.
-Not exatined, tissing -Not exatined, tissing -Not exatined, tissing -Vascular tineralizaticn, tild -Not exatined, tissing -Not exatined, tissing -Tubular hyperplasia, toderate -Not exatined, tissing -Adenota -Not exatined, tissing -Not exatined, tissing -Not exatined, tissing -Lipota
Large necrotic tutor of adipose tissue. unspecified.
Site
The following tissues were found to be within nornal l i i i t s : Brain, Spinal Cord, Bone Marrow, Spleen, Liver, Kidney, Heart, Stotach, Stall Intestine, Large Intestine, Urinary Bladder, Uterus, Pancreas, Eye.
Anita! Nutber: 1R-46B5 Sex: Fetale Broup: ! 5) FC-143 300 ppt Fate: IHeek= 75) Sacrificed in extretis
Macroscopic Observations: Haiiary Bland
Adrenal Microscopic Observations:
Adrenal
-Large tass, 15 x 9 x 4 ct, sonewhat f i n and nultilobular.
-Both appeared enlarged with dark foci.
-Sinusoidal ectasia, cortex, toderate
Species: Rat Project Nutber: 02B1CR0012
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000699
Suttarized Single Tabulated Aniial Report (continued) Individual Hacroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Too Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
il Nutber: 1R-46B5 Sex: Feiale Group: ( 5) FC-143 300 ppc ; (Heek= 75) Sacrificed in extretis
Hicroscopic Observations (continued): Esophagus Kidney Liver
Lung
Haatary 61and Salivary Gland Spleen
-
-Not exaained, aissing -Pelvic iineralization, tanked -Necrosis, tultiFocal, tild Heaatcpoiesis, extraiedullary, toderate -Vascular Mineralization, tild Alveolar tacraphages, Focal, tin ita l Hetorrhage, local areas, toderate -Fibroadenota -Not exaained, aissing -Heaatopoiesis, extraiedullary, increased, tild
The following tissues were Found to be within noraal lin t s : Brain, Spinal Cord, Bore Narrow, Heart, 5toaach, Seal 1 Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Pituitary, Trachea, Thyroid, Parathyroid, Lyeph Rode (aesenteric), Pancreas, Eye.
Aniaal Nuaber: 1R-46S6 Sex! Feaale Group: ( 5) FC-143 300 ppa Fate: (Heek= 105) Terainal Sacrifice
Macroscopic Observation:;: Pituitary Rataary Gland
Liver Microscopic Observations:
Adrenal Esophagus Liver
Ramary P:tu:ta*
-Saall heaorrhagic aass, 0.3 ca dia. -Large aultilobular aass, 10 x 7 x 4 ca, in
right axilla. -Hass, 5 ir 3 ca, in right lateral lobe.
-Sinusoidal ectasia, cortex, n r i i -Rot exaained, aissing -Portal bile s *;i prcliFe-atior, tild Hepatccallular carcinota -Alveclar aacrophages, Focal, tile Perivascular aor.onuclear inFiltrate, tin ita l Hescrhage, local areas, aiid -Fibroader.oaa -Adenosa
The Following tissues we-e Found to be within nornal liitits : Brain, Spinal Cord, Bone Harrow, Spleen, Kidney, Heart, Stoaach, Stall Intestine, La'ge Intestine, Urinary Bladder, Aorta, Utems, Ovary, Trachea, Thyroid, Parathyroid, Lyaph Node iiesenteric), Pancreas, Salivary Gland, Eve.
Species: Rat Project Nutter; 02B1ZR0012
Suaianzed STAR Page: 14E 3 1 2
000700
5utaarized Single Tabulated Anita! Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tec Vear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Ani3 Nutter: 1R-46B3 Sex: Fetale Broup: ( 5) FC-143 300 ppe Fate: (week- 105! Tenir,al Sacrifice
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Heart
Kidney Large Intestine Massary Bland Ovary Pituitary Spleen
-Mass, 0.9 ci dia.
-Sinusoidal ectasia, cortex, l i Id -Myocarditis, chronic nonsuppurative, u ltifocal, aild -Ch'onic progressive nephropathy, aild -Neiatodiasis, colon -Not exaained, ai ssi ng -Tubular hyperplasia, derate -Adenona -Heiosiderosis, aild
The following tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Marrow, Liver, Lung, Stoaach, Saall Intestine, Urinary Bladder, Aorta, Uterus, Trachea, Thyroid, Parathyroid, Esophagus, Lyaph Node (aesenteric), Pancreas, Salivary Bland, Eye.
Aniaal Nuater: 1R-469 Sex! Feaale Broup: ( 5) FC-143 3C0 ppa Fate: (Week= 105) Terainal Sacrifice
Macroscopic Observations!
Microscopic Observations: Adrenal
Kidney Liver Lung
Lyaph Node (aesenteric) Parathyroid Thyroid
-No visible lesions.
-Sinusoidal ectasia, cortex, unilateral, aarked
-Chronic progressive nephropathy, aild -Hepatocyte vacuolation, aultifocal, aild -Vascular liners!ization, aild Pneuaonia, in te rs titia l, chronic, aultifocal, aild Alveolar aacrophages, local areas, aild -Pigaent, brown, aild -Not exaained, not in plane of section rUltieobranchial cyst
The following tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Narrow, Spleen, Heart, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Naaiary Gland, Pituitary, Trachea, Esophagus, Salivary 6!and, Eye, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 149 3 1 3
000701
Suaaarized Single Tabulated ftniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-I43: Two Year Oral Toxicity-Oncogenicity Study in Rats
fable: 2
Aniaal Nuiber: 1R-4691 Sex: Fetale Group: ( S) FC-143 300 ppt Fate: (kieek= 100) Sacrificed in extreais
Macroscopic Observations: Liver
Adrenal Microscopic Observations:
Adrenal
Heart
kidney
Liver Lung
Pancreas Spleen
Stotach Thyroid Urinary El adder
-Appear enlarged with ultiple pale foci in all lobes.
-Left adrenal appears enlarged.
-Cortical vacuolation, local areas, aild Sinusoidal ectasia, cortex, unilateral, tarked -Myocarditis, chronic nonsuppurative, ultiFocal, aild -Chronic progressive nephropathy, ainital Protein resorption droplets, tubular, larked -Malignant lyaphota, histiocytic
-Vascular aineralization, aild Malignant lyaphota, histiocytic Keaorrhage, local areas, tild -Edeaa, in te rs ititia l, acderate
-Heaatopoiesis, extraaedullary, increased, coderate -Edeaa, subaucosal, acderate
-Hyperplasia, C cell, focal, aild -Malignant lyaphoaa, histiocytic
The following tissues were found to be within noraal lia its : Brain, Spinal Cord, Bone Marrow, Saall Intestine, Large Intestine, Aorta, Uterus, Dvary, Massary Gland, Pituitary, Trachea, Parathyroid, Esophagus, Lyaph Node (aesenteric), Salivary Gland, Eye.
Aniaal Nutber: 1R-4693 Sex: Feaale Group: ( 5) FC-143 300 ppa Fate: (Heek= 105) Terainal Sacrifice
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Kidney Liver Lung
Pituitary
-Dark raised lesion, 0.3 ca dia.
-Sinusoidal ectasia, cortex, aarked -Pelvic aineralization, aild -Hepatocyte vacuolation, aultifocal, aild -Pneuaonia, in te rs titia l, chronic, local areas, aild Alveolar aacrophages, local areas, aild Perivascular aononuclear in filtra te , aild -Adenoaa
Species: Rat Project Nuaber: C2G1CR0012
Suaaarized STAR Page: 150 3 1 4
Suttarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Piker Laboratories, Inc. 3H FC-143: Tto Year Oral Toxicity-Oncogenicity Study ir. Rats
Table: 2
Aniial Nutber: 1R-4B93 Sex: Feiale Group: ( 5) FC-143 300 ppi Fate: (Keek= 105) Terminal Sacrifice
Microscopic Observations (continued):
The following tissues ere found to be within ncrital 1iAits: Brain, Spinal Cord, Bone Marrow, Spleen, Heart, Stoaach, Stall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Mattary Gland, Trachea, Thyroid, Parathyroid, Esophagus, Lytph NcdE (tesenteric), Pancreas, Salivary 61and, Eye.
Aniial Nutber: 1R-4694 Sex: Feiale Group: 1 5) FC-143 300 ppi Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Fituitary Maotary Gland
Microscopic Observations: Adrenal Kidney
Lung Mattary Gland Ovary Parathyroid Pituitary Spleen
-Raised tass, 1.2 ci dia. -Stall nodular lesion, 0.6 ci dia., in right
axilla; possible t ilk cyst.
-Sinusoidal ectasia, cortex, tarked -Chronic progressive nephropathy, tild Pelvic tineralization, tin ita l -Alveolar tacrophages, tu ltifo c a l, tild -Fibroadenota -Cyst, unilateral -Not exatined, not in plane of section -Adenota -Hetcsidercsis, loderate
The following tissues nere found tc be within norial l i i i t s : Brain, Spinal Cord, Bone Macon, Liver, Heart, Stoiach, Stall Intestine, Lange Intestine, Urinary Bladder, Aorta, Uterus, Trachea, Thyroid, Esophagus, Lytph Node (tesenteric), Pancreas, Salivary Gland, Eye.
Anital Nutber: 1R-4695 Sex: Fetale Group: ( 5) FC-143 300 ppt Fate: (Neek= 105) Tertinal Sacrifice
Macroscopic Observations: Pituitary Mattary Gland
Liver Microscopic Observations:
Adrenal
Kidney
-Hetorrhagic tass, 0.8 ci dia. -Lobular cystic tass, 4.5 x 3 x 2 ct, in le ft
axilla. -Hass, 3.5 x 3 x 2 cn, in tedian lobe.
-Sinusoidal ectasia, cortex, unilateral, tarked
-Chronic progressive nephropathy, tild Pelvic tineralization, t ild
Species: Rat Project Nuaber: 02B1CR0012
Suttarized STAR Page! 151 3 1
000703
Sueaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nueber: 1R-4695 Sex: Fetale Group: ( 5) FC-143 300 ppi Fate: (Neek= 105) Terainal Sacrifice
Microscopic Observations (continued): Liver
Maaaary Gland Pituitary Uterus
-Portal ononudear cell in filtra te , aild Hepatocyte vacuolation, aultifocal, aild Hyperplastic nodule Large lesion with extensive cystoid degeneration within nodule. -Perivascular aononuclear in filtra te , ainiaai
-Fibroadenoaa Adenocarcinoaa Adenocarcinoaa arises in fibroadenoaa. -Adenoca
-Cystic glands, aild
The following tissues were found to be within norcal lia its : Brain, Spinal Cord, Gone Marrow, Spleen, Heart, Stoaach, Stall Intestine, Large Intestine, Urinary Bladder, Aorta, Ovary, Trachea, Thyroid, Parathyroid, Esophagus, Lyaph Node (aesenteric), Pancreas, Salivary Eland, Eye.
Aniaal Nueber: 1R-4696 Sex: Fetale Group: ( 5) FC-143 300 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Maaaary 61and
Lyaph NGde (aesenteric) Microscopic Observations:
Adrenal kidney Liver
Lung
Lyaph Node (aesenteric) Maaaary 61and
-Lobular aass, 5.5 x 4.5 x 2.5 ca, le ft axilla; aultilobular aass, 5.5 x * x 2 ca, in perineal and le ft inguinal area.
-Large and cystic.
-Sinusoidal ectasia, cortex, aild -Chronic progressive nephropathy, aild -Hepatocyte alteration, vacuolated, local areas, aild Negaiocytosis, ainiaai Hepatocyte alteration, basophilic, focal, aild -Perivascular aononuclear in filtra te , ainiaai Heaorrhage, local areas, eild Granulosa, local areas, aild -Sinusoidal ectasia, aarked Granulosa, aesentery -Fibroadenoaa Adenocarcinoaa
Species: Rat Project Nueber: 0281CR0012
Suaaarized STAR Page: 152 3
C00704
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
An;al Nuaber: 1R-469A Sex: Fetale Group: ( S) FC-143 300 ppi Fate: (Week= 105! Terminal Sacrifice
Microscopic Observations (continued): Ovary Pituitary Siali Intestine Thyroid
-Cyst, unilateral -Adenoia -Grand oaa, eesentery -Hyperplasia, C cell, focal, iiId
The following tissues were found to be within noraal lin t s : Erain, Spinal Cord, Bone Marrow, Spleen, Heart, Stoeach, Large Intestine, Urinary Bladder, Aorta, Uterus, Trachea, Parathyroid, Esophagus, Pancreas, Salivary Gland, Eye.
Aniiai Husoer: 1R-4S97 Sex: Feeale Group: 5) FC-143 300 ppa Fate: (Weeks 105) Teriinal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Kidney Lung
Pituitary Thyroid Uterus
-No visible lesions.
-Sinusoidal ectasia, cortex, aoderate -Hydronephrosis, unilateral -Vascular aineralization, aild Perivascular aononudear in filtra te , cild -Adenoaa -Hyperplasia, C cell, focal, aild -Cystic glands, aoderate
The following tissues wer e found to be within noraal lin t s : Brain, Spinal Cord, Bone Marrow, Spleen, Live , Heart, Stosach, Snail Intestine, Large Intestine, Urinary Bladder, Aorta, Ovar ', Maasary Gland, Trachea, Parathyroid, Esophagus, Lyaph Node (aesenterid, Pancreas, Salivary G and, Eye.
Aniaal Nuaber: 1R-4A92 Sex: Feaale Group: ( 51 FC-143 300 ppa Fate: (Week= 105) Terainal Sacrifice
Macroscopic Observations: Pituitary Haaaary Bland
Microscopic Observations: Kidney
Liver
Lung
-Hass, 0.5 ca dia. -Mass, 4 x 3.5 x 3 ca, le ft inguinal.
-Chronic progressive nephropathy, aild Pelvic aineralization, aild
-Portal aononudear cell in filtra te , ainiial Hepatocyte vacuolation, aultifocal, aild Megalocytosis, ainiaal -Vascular aineralization, aild Perivascular aononudear in filtra te , aild
Species: Rat Project Nuaber: 0281CR0012
Suiaarized STAR Page: 153 3
000705
Suitarized Single Tabulated Anital Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nutber: 1R-4698 Sex: Feiaie Sroup: ( 5) FC-143 300 ppi Fate: (Meek1 105) Teriinal Sacrifice
Microscopic Observations (continued): Mattery Eland Ovary
Pituitary
-
-Flbroadenoia -Cyst, unilateral
Tubular hyperplasia, oberate -Adenota
The following tissues were found to be within noraa! l i i i t s : Brain, Spinal Ccrd, Bone Marrow, Spleen, Heart, Stoiach, Stall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Trachea, Adrena1, Thyroid, Parathyroid, Esophagus, Lytph Nose iieser.terici, Pancreas, Salivary Eland, Eye.
Anital Nusber: 1R-4700 Sex: Feoale Sroup: ( 5) FC-143 300 ppc Fate: (Neek= 96) Sacrificed in extreeis
Macroscopic Observations: Maeiary 61and Heart Adrenal Kidney
Microscopic Observations: Adrenal
Aorta Heart Kidney Lung
Lyaph Node (tesenteric! Maeiary 61and Ovary Parathyroid Stall Intestine Stoaach Thyroid
-Mass, 3 x 2 ct, in le ft axilla. -Appears possibly enlarged. -Right adrenal appears enlarged. -Pale and pitted.
-Sinusoidal ectasia, cortex, unilateral, tarked Cortical degeneration, unilateral , tarked Cortical atrophy, unilateral, icderate -Not examined, tissing
-Myocardial fibrosis, local areas, tild -Chronic progressive nephropathy, larked -Pneutonia, in te rs titia l, chronic, diffuse, tarked -Not exatined, tissing -Fibroadenota -Tubular hyperplasia, tarked -Not exatined, tissing -Edeta, latina propria , jejunut, tild -Ecesa, subtucosal, oberate -Not exatined, tissing
The following tissues were found to be within norial l i i i t s : Brain, Spinal Cord, Bone Marrow, Spleen, Liver, Large Intestine, Urinary Bladder, Uterus, Pituitary, Trachea, Esophagus, Pancreas, Salivary Bland, Eye.
Species: Rat Project Nuiber: 0281CR0012
Suttarized STAR Page: 154
3IO
C-00706
Sueearized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Teo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nusber: 1R-4701 Sex: Feeale Group: ( 5) FC-143 30C ppe Fate: (Heek= 105) Teriinal Sacrifice
Macroscopic Observations:
Pituitary
. ..
Microscopic Observations:
Adrenal
Liver
Lung
Parathyroid Pituitary
-Heeorrhagic eass, 0.5 ce dia.
-Sinusoidal ectasia, cortex, eiId -Hepatocyte vacuolaticn, eultifccal, einieal Megalocytosis, einieal -Pneueonia, in te rs titia l, chronic, focal, eiId Alveolar aacrophages, focal, eild -Net exaeined, not in plane of section -Adenoea
The following tissues were found to be within noreal U nits: Brain, Spinal Cord, Bone Harrow, Spleen, Kidney, Heart, Stceach, Seall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Maenary Gland, Trachea, Thyroid, Esophagus, Lyeph Node (tesenteric), Pancreas, Salivary Gland, Eye.
Anieal Nueber: 1R-4702 Sex: Fesale Group: ! 5) FC-143 300 ppe Fate: (Keek* 67) Sacrificed in extreeis
Macroscopic Observations: Pituitary Maaeary Gland
Liver Microscopic Observations:
Esophagus Heart
Kidney
Liver Lung
Haeeary Gland Ovary Pancreas Pituitary
-Reddish eass, 1.2 x 0.S ce. -Lobulated eass, 3 x 2 x 1 ce, in le ft
axillary region. -Mottled and slightly pale.
-Not exaeined, eissing -Myocarditis, chronic nonsuppurative, eultifocal, eild -Chronic progressive nephropathy, einieal Pelvic eineralization, einieal Pyelitis, acute, unilateral, eild -Hepatocyte vacuolation, periportal, eoderate -Vascular eineralizaticn, eild Heecrrhage, eultifocal, eild -Adenccarcinoea -Tubular hyperplasia, eoderate -Not exaeined, eissing -Adenoea
The following tissues Mere found to be within noreal lia its : Brain, Spinal Cord, Bone Harrow, Spleen, Stoeach, Seall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Trachea, Adrenal, Thyroid, Parathyroid, Lyeph Node (eesenteric), Salivary Gland, Eye.
Species: Rat Project Nueber: 02B1CR0012
Sueearized STAR Page: 155 3 19 00707
Suiaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4703 Sex: Feaale Group: ( 5! FC-143 300 ppa Fate: (Week= ICS) Teraina! Sacrifice
Macroscopic Observations: Maeaary Gland
Microscopic Observations: Adrenal Esophagus Heart
Kidney Liver
Lung
Maaaary Gland Pancreas Pituitary
-Lobular aass, 3 x 2 ca, in perineal area.
-Sinusoidal ectasia, cortex, aarked -Not exaained, aissing -Myocarditis, chronic nonsuppurative, aultifocal, aild -Chronic progressive nephropathy, aild -Hepatocyte vacuolation, aultifocal, ainiaal Hepatocyte alteration, vacuolated, aultifocal, aild -Pneuaonia, in te rs titia l, chronic, local areas, aild Alveolar aacrophages, local areas, aild -Lobular hyperplasia -Hyperplasia, is le t cell, aild -Adencaa
The following tissues were found to be withig noraal H alts: Brain, Spinal Cord, Bore Marrow, Spleen, Stoaach, Saall Intestine, Large Intestine, Urinary Bladder, Aorta, Uterus, Ovary, Trachea, Thyroid, Parathyroid, Lyeph Node iaesenteric), Salivary Gland, Eye.
Ar.iaal Nuaber: 1R-47C5 Sex: Feaale Group! ( 5) FC-143 300 ppa Fate: (Weeks 2) Found Dead
Macroscopic Observations: Pituitary
Microscopic Observations: Esophagus Eye Heart
Liver
Lung Salivary Gland Urinary Bladder
-Tao saall heaorrhagic lesions approxiaately 0.1 ca dia.
-Not exaained, aissing -Not exaained, aissing -Myocarditis, chronic nonsuppurative, aultifocal, aild -Hepatocyte vacuolation, aultifocal, aild Megalocytosis, ainiaal -Vascular raneraliration, aild -Not exaained, aissing -Not exaained, aissing
The following tissues aere found to be within noraal lia its : Spinal Cord, Bone Marrow, Stoaach, Stall Intestine, Large Intestine, Aorta, Uterus, Ovary, Maaaary Gland, Pituitary, Trachea, Adrenal, Thyroid, Parathyroid, Lyeph Node (aesenteric),
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Page: 156
320
000708
Summed Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tko Year Oral Toxicity-Oncogenicity Study in Rats
Aniial Nuiberl 1R-4705 Sex: Feiale Group: ( 5) FC-143 300 ppe Fate: (Ueek= 2) Found Dead
Microscopic Obser vations (continued): The follow!r.g tissues were found to be within nonal l i i i t s (continued): Pancreas, Brain, Spleen, Kidney.
Table: 2
Species: Rat Project Nuiber: 02B1CR0012
321Sunarized STAR Page: 157
000709
Suaaarized Single Tabulated Aniaal Report Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Tear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuiber: 1R-3646 Sex: Male Group: ( 6) FC-143 30 ppi Fate: (Week: 106) Terainal Sacrifice
Macroscopic Observations: Liver
Microscopic Observations: Hea-t
kidney Liver
Lung Pancreas Salivary Eland Thyroid
-Possibly pale, lottled.
-Myocardial fibrosis, ai 1d Myocarditis, chronic nonsuppur ative, ai Id
-Chronic progressive nephropathy, ai Id -Portal onor.uclear cell in filtra te , ai id Portal bile duct proliferation, aild Hepatocyte vacuolation, aultifocal, ainiial Hepatccyte alteration, vacuolated, focal, ild -Vascular aineralization, cild -Not exaained, aissing -Sialadenitis, chronic, aarked -Hyperplasia, C cell, focal, aild
The following tissues were found to be within noraal lia its : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Parathyroid, Trachea, Esophagus, Pituitary.
Aniaal Nuaber: 1R-3647 Sex: Male Group: ! 6) FC-143 30 ppa Fate: (Meek* 101) Sacrificed in extreais
Macroscopic Observations: Pituitary Skin
Stoaach Microscopic Observations:
Heart
Kidney
Liver Lung
Pituitary Skin Stoaach Testis/Epididyais
-Raised heaorrhagic aass, 0.6 ca dia. -Raised ulcerated lesions on both hind
footpads. -Possible area of ulceration in cardia.
-Myocarditis, chronic nonsuppurative, aultifocal, aild
-Chronic progressive nephropathy, acderate Pelvic aineralization, aild
-Portal acnonuclear cell in filtra te , aild -Vascular aineralization, aild Alveolar aacrophages, aultifocal, aild Heaorrhage, aultifocal, aild -Adenoaa -Pododeraatitis, ulcerative, bilateral, aarked -Ulcer, aarked -Tubule atrophy, asperaatogenesis, aild Vascular aineralization, cild
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Page: 158 3 2 2
000710
Suisarized Single Tabulated Anital Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anita! Nutber: 1R-3647 Sex: Male Group: ( 6) FC-143 30 ppe Fate! (Week= 101) Sacrificed in extreiis
Microscopic Observations (continued):
Urinary Bladder
-
-Epithelial hyperplasia, sitple, diffuse, tiled Epithelial hyperplasia, papillary, local areas, t i 1d Calculus
The following tissues were found to be within norcal l i t i t s : Spleen, Prostate, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Anita! Nutber: 1R-3648 Sex: Male 6roup: i 6! FC-143 30 ppt Fate: (Week* Sfc) Sacrificed in extretis
Macroscopic Observations: Thyius
Liver Spleen Lytph Node (abdetina!)
Microscopic Observations: Kidney
Liver Lung
Lytph Node (abdotinal! Pancreas Pituitary Sp! een Thytus
-Lobulated, light-green tass, 2.5 x 1 ct, in th/ius area.
-Possibly slightly pale. -Enlarged -Renal, internal ilia c lytph nodes slightly
enlarged and lig h t greenish in color.
-Leuketia, tyeloid Protein resorption droplets, tiId Extensive in filtra tio n of proliferating cells of early tyeloid series in hi 1us. -Leuketia, tyeloid
-Leuketia, tyeloid Heaorrhage, tu ltifo c a l, tiId -Leuketia, tyeloid -Not exatined, aissing -Not exatined, tissing -Leuketia, tyeloid -Leuketia, tyeloid
The following tissues were found to be within nortal l i t i t s : Heart, Testis/Epididyiis, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and.
Species: Rat Project Nutber: 02B1CR0012
Sutaarized STAR Page: 159 3 2 3 000711
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Tao Vear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3649 Sex: Hale Broup: ( FC-143 30 ppa Fate: (Keek: 106) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Kidney Lung Pancreas Pituitary Salivary Eland Thyroid
-No visible lesions.
-Medullary cell hyperplasia, aultifocal, wild -Chronic progressive nephropathy, ai Id -Vascular ainEralization, wild -Acinar atrophy, aild -Hyperplasia, aultifocal, pars distalis, aild -Sialadenitis, chronic, aoderate -Hyperplasia, C cell, aultifocal, aoderate Ultiacbranchial cyst
The feiloising tissues aere found to be within non il H alts: spleen, Liver, Heart, Testis/Epididyiis, Prostate, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus.
Aniaal Nuaber; 1P-26C0 Sex: Male Group: ( 6) FC-143 30 ppa Fate: (Hsek= 106) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal
Kidney Liver
Lung
Pancreas Salivary Sland
-No visible lesions.
-Cortical degeneration, focal, aoderate Pheochroaocytoas, aalignant, unilateral Neoplastic cells highly pleoeorphic. -Chronic progressive nephropathy, aoderate
-Portal aonanudear cell in filtra te , aild Necrosis, focal, ainiaal -Vascular aineralization, aild Alveolar aacrophages, aultifocal, aild -Acir.ar atrophy, aoderate
-Sialadenitis, chronic, aarked
The following tissues aere found to be within nornal lia its : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach,. Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Pituitary.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 160 3 2 4
C00712
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Annal Nueber: 1R-3651 Sex: Male Group: ( 1 FC-143 30 ppt Fate: (Keek: 106) Terminal Sacrifice
Macroscopic Observations: Kidney
Microscopic Observations: Adrenal
Esophagus Heart Kidney
Liver
Lung Pancreas Pituitary
-Multiple cysts in one area of right kidney.
-Cortical vacuolation, local areas, aild Sinusoidal ectasia, cortex, tild -Not examined, eissing
-Myocarditis, chronic nonsuppurative, ainisal -Chronic progressive nephropathy, oderate Pelvic aineralization, iin n a i Cyst, cortical, aultiple -Hepatocyte vacuolation, eultifccal, ai Id Hepatocyte alteration, vacuolated, focal, aild Megalocytosis, ainiaal -Vascular aineralization, aild -Not exasined, aissing -Hyperplasia, focal, pars distalis
The following tissues Mere found to be within- noraal lia its : Spleen, Testis/Epicii/ais, Prostate. Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Gland.
Aniaal Nueber: IP-3652 Sex: Male Group: ( 61 FC-143 30 ppa Fate: !Neek= 94) Sacrificed in extreais
Macroscopic Observations: Pituitary Stoaach
Microscopic Observations: Adrenal Kidney Liver
Lung
Pituitary Prostate Spleen Stoaach Thyroid Urinary Bladder
-Enlarged due to aass, 1.2 ca dia. -Lining appears thickened (eceaatous);
possible ulcer in cardia.
-Cortical vacuolation, eultifccal, aild -Vacuolation, conv. tub. epitheiua, ainiaal -Portal bile duct proliferation, aild Hepatocyte vacuolation, diffuse, aild -Vascular aineralization, aild Alveolar aacrcphages, aultifocal, aild -Adenoaa -Prostatitis, acute, aarked -Heaosiderosis, aild -Ulcer, aarked -Hyperplasia, C cell, aultifocal, tild -Epithelial hyperplasia, siaple, diffuse, aild
Species: Rat Project Nuaber: 0281CR0012
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000713
Suaaarized Single Tabulated Aniaal Report (continued) Individual Nacroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3652 Sex; Male Group: t 1 FC-143 39 ppa Fate: (Neek- 94) SacriFiced in extreais
Microscopic Observations (continued):
The Following tissues Here Found to be within noraal H alts: Heart, Testis/Epididvais, Parathyroid, Trachea, Esophagus, Salivary Eland, Pancreas.
Aniaal Nuaber: 1R-3653 Sex: Hals Group: ! 6) FC-143 39 ppa Fate: (WeeH 106) laminai Sacri Fi ce
Macroscopic Obse-vatiors: Testis,'Epididyais
Microscopi: Observations: Kidney Lung
Testis/Epi di dyais
-Right testis saall.
-Chronic progressive nephropathy, aild -Vascular aineralization, aild Heaorrhage, local areas, aoderate -Tubule atrophy, aspernatogenesis, unilateral, aarked
The Following tissues were Found to be within noraal Halts: Spleen, Liver, Heart, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pituitary, Pancreas.
Aniaal Nusbe'! 1R-3654 Sex: Male Group: ( 6) FC-143 39 ppa Fate: (Meefc= 106) Terainal SacriFice
Macroscopic Observations: Brain
Microscopic Observations: Adrenal Brain Heart Kidney Liver
Lung
-Dark area, possibly old heaorrhage, in anterior part oF right cerebral heaisphere.
-Sinusoidal ectasia, cortex, loderete Pheochroiocytoia, benign, bilateral -Astrocytoaa, benign Large neoplasia occupying auch cF cerebruc. -Myocarditis, chronic nonsuppurative, aultiFocal, aild -Chronic progressive nephropathy, aild Pelvic aineralization, andiate -Hepatccyte alteration, vacuolated, Focal, aild Megalocytasis, ain iia l
-Pneuacnia, in te rs titia l, chronic, aultiFocal, aild Alveolar aacrophages, aultiFocal, aild
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 162 326 C00714
Suaaarized Single Tabulated Anita! Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Arnaal Nuaber: 1R-3654 Sex: Male Group: ( 6) FC-143 30 ppi Fate: (Week* 106) Tertina! Sacrifice
Microscopi: Observations (continued):
Fsncreas
-
Parathyroid
-Acinar atrophy, toderate -Not exatined, not in plane oF section
The foilDNing tissues aere Found to be within norta! U nits: Spleen, Testis/Epididyiis, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland, Pituitary.
Anna! Nuiber: 1R-3655 Sex: Male 6roup: 6) FC-143 30 ppe Fate: (Neek= 106) Tereinal SacriFice
Macroscopic Observations: SoFt Tissues (neck) Testis.'Epididyeis
Microscopic Observations: fidr enal Kidney
Lung
Salivary SI and Testis/Epididyeis
-Mass, 4 x 2.5 x 2 ca, salivary gland area. -Right testis enlarged, pale yellowish 1.5 ci
dia. less.
-Cortical vacuolation, Focal, eild -Chronic progressive nephropathy, aoderate Pelvic aineralization, aild -Vascular aineralization, aild Alveolar aacrophages, local areas, aoderate -Sialadenitis, acute, aarted -Tubule atrophy, asperaatogenesis, unilateral, aoderate Leydig cell adenoaa, unilateral
The Following tissues were Found to be within noraal 1is its : Spleen, Liver, Heart, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Pituitary, Pancreas.
Amasi Nuaber: 1R-3656 Sex: Hale Group: ( 6) FC-143 30 ppa Fate: (Neek= 85) SacriFiced in extreais
Macroscopic Observations'. Pituitary
Microscopic Observations: Adrenal
Kidney Liver Lung
-Large aass, 1 x 0.7 ca dia.
-Cortical vacuolation, Focal, aild Sinusoidal ectasia, cortex, aild
-Chronic progressive nephropathy, ainiaal -Hepatocyte vacuolation, diFFuse, aoderate -Vascular aineralization, aild Heaorrhage, aultifocal, aild
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 163 327 CC0715
Suiiarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuiber: 1R-3656 Sex: Male 6roup: ( 6) FC-143 30 ppi Fate: (Week= 65! Sacrificed in extreiis
Microscopic Observations (continued): Parathyroid Pituitary Salivary Gland
-Mot exaeined, not in plane of section -Adenoea -Not exaeined, eissing
The following tissues were found to be within ncr eal lie its : Spleer., Heart, Testis/Epididysis, Prostate, Stosach, Urinary Bladder, Thyroid, Trachea, Esophagus, Pancreas.
Anna! Nuice-: 1R-3657 Sex: Male Group: ( 6) FC-143 30 ppc Pate: (Week: 65) Sacrificed in extreiis
Macroscopic Observations: Pituitary
Microscopic Observations: Heart
Liver Lun;
Pancreas Pituitary Salivary Gland
-Enlarged, 0.8 ci dia.
-Myocarditis, chronic nonsuppurative, focal, oderate
-Portal aononudear cell in filtra te , iild -Vascular aineralization, iild Alveolar aacrophages, aultifocal, iild Heeorrhage, local areas, iild -Acinar atrophy, lin iia l -Adenoaa -Not exanined, aissing
The following tissues were found to be within noraal lin t s : Spleen, Kidney, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus.
Ari aal Nuaber: 1R-3658 Sex: Male Group: ( 6) FC-143 30 pps Fate: (Week= 106) Terainal Sacrifice
Macroscopic Observations: Eye
Microscopic Observations: Eye Kidney Liver
Lung
-Right eye appears cloudy.
-Keratitis, chronic, unilateral, iild -Chronic progressive nephropathy, aild -Hepatocyte alteration, vacuolated, aultifocal, aild Regalocytosia, ainiaal -Vascular aineralization, aild Alveolar aacrophages, aultifocal, aild
Species: Rat Project Nuiber: 02B1CR0012
328Suiiarized STAR Page: 164 000716
Suaaarized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Tt*o Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuaber: 1R-365G Sex: Male Group: ( 6) FC-143 30 ppe Fate: (Meek= 106) Terainal Sacrifice
Microscopic Observations (continued):
Pituitary
-
Thyroid
'Cyst, pars distalis -Hyperplasia, C cell, focal, eoderate
The following tissues were found to be within noreal lie its : Spleen, Heart, Testis/Epididyeis, Prostate, Stoaach, Urinary Bladder, Adrenal, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Anieal Nueber: 1R-3659 Sex: Male Group: ( 6) FC-143 30 ppe Fate: (deefc= 96) Sacrificed in extreeis
Macroscopic Observations: Pituitary Liver
-Large heaorrhagic aass, 1.4 x 0.8 ce. -Pale and B o ttle d .
Adrenal
Kidney
Liver
Lung Parathyroid Pituitary Spleen Testis/Epid idyais
-Cortical vacuolation, diffuse, aild Sinusoidal ectasia, cortex, aild
-Chronic progressive nephropathy, aild Pelvic mineralization, aarked -Portal aononudear cell in filtra te , aild Portal bile duct proliferation, aild Hepatocyte vacuolation, periportal, aoderate -Vascular aineralization, aild -Not exaained, not in plane of section -Adenoaa -Heaosiderosis, aild -Vascular aine-alization, aild
The -following tissues aere found to be within noraal lia its : Heart, Prostate, Stomach, Urinary Eliidder, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Ariaal Nuaber: 1R-3660 Sex: Hale Group: ( 6) FC-143 30 ppi Fate: (Keek1 106) Terair.al Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Heart
Kidney Liver
-No visible lesions.
-Sinusoidal ectasia, cortex, aild -Myocarditis, chronic nonsuppurative, aultifocal, aild -Chronic progressive nephropathy, aild -Portal aononudear cell in filtra te , aild Portal bile duct proliferation, aild
Species: Rat Project Nuaber: 02B1CR0012
Suaiarized STAR Page: 165 3 2 9 000717
Suaaanzed Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Microscopic Observations
Rike*- Laboratories, Inc. 3H FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3660 Sex: Male Sroup: ( 6) FC-143 30 ppe Fate: ibieek= 106) Terainal Sacrifice
Microscopic Observations (continued): Lung
Parathyroid Thyroid
-
-Vascular aineralization, aild Pneuaonia, in te rs titia l, chronic, focal, aild Alveolar aacrophages, aultifocal, aild -Not exaimed, not in plane of section -C cell adenona, unilateral Ultiaobranchial cyst
The following tissues were found to be within noraal U nits: Spleen, Testis/Epididyais, P-ostate, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Gland, Pituitary, Pancreas.
Aniaal Nuaber: 1R-3661 Sex: Male 6roup: ( 6) FC-143 30 ppa Fate! (Neex= 106) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Heart
Kidney Lung Salivary Bland
-No visible lesions.
-Cortical vacuclation, focal, aild -Myocarditis, chronic nonsuppurative, aultifocal, aild -Chronic progressive nephropathy, aild -Vascular aineralization, aild -Sialadenitis, chronic, ni Id
The following tissues were found to be within noraal l i i i t s : Spleen, Liver, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Pituitary, Pancreas.
Aniaal Nuaber: 1R-3662 Sex: Male Group: ( 6) FC-143 30 ppa Fate: (Ueek= 94) Sacrificed in extreais
Hacroscopic Observations: Eye Lung
Spleen Liver Kidney Testis/Epididyais Microscopic Observations: Adrenal
-Bilateral opacities -Multiple white lesions, 0.2 ca dia., in le ft
lobe. -Slightly enlarged -Hass, 4.5 x 4 x 2 ca, le ft lateral lobe. -Both kidneys pale and enlarged. -Both testes very saall.
-Sinusoidal ectasia, cortex, aild
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Page: 166 330 000718
Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuiber: 1R-3462 Sex: Hale Group: ( 4) FC-143 30 ppa Fate: (Neek= 94) Sacrificed in extreais
Hicroscopic Observations (continued): Eye Heart Kidney
Liver
Lung
Parathyroid Pituitary Testis/Epididyais Thyroid Urinary Bladder
-
-Cataract, tiia te ra l -Hyocarditis, chronic nonsuppurative,
ultifocal, ni Id -Chronic progressive nephropathy, aarkej Pyelitis, acute, aild
Cyst, cortical, derate -Portal acnonudear cell in filtra te , aild
Portal bile duct proliferation, aild Hepatocyte alteration, vacuolated, focal, aild Hepatocellular carcinoaa
Large, poorly differentiated neopiasa. Trabecular and adenoid patterns. -Vascular aineralization, aild Alveolar aacrophages, multifocal, aild Heaorrhage, local areas, aild -Not exaaineb, not in plane of section -Cyst, pars distalis -Tubule atrophy, asperaatogenesis, bilateral, aild -Not exaained, not in plane of section -Epithelial hyperplasia, siaple, diffuse, aild Cystitis, chronic, diffuse, ainiaal
The following tissues were found to be within norr.a! 1in its : ' Spleen, Prostate, Stoiach, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3663 Sex: Hale Group: ( 4) FC-143 30 ppa Fate: (Week* I03 Teninal Sacrifice
Hacroscopic Observations: Kidney
Hicroscopic Observations: Kidney Liver
Lung
-Cyst, 4 ca dia.
-Chronic progressive nephropathy, acderate -Portal aononudear cell in filtra te , aild Portal bile duct proliferation, aild -Vascular aineralization, aild
The following tissues were found to be within noraal lia its : Spleen, Heart, Testis/Epididyais,, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pituitary, Pancreas.
Species: Rat Project Nuaber: 02B1CR002
331Suaaarized STAR Page: 167
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Suiiarired Single Tabulated Aniial Report (continued! Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Annal Nuiber: 1R-3664 Sex: Male Group: ( 61 FC-143 30 ppa Fate: (Heek= 106) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Heart
Liver Lung
-Mo'visible lesions.
-Myocarditis, chronic nonsuppurative, ultifocal, aild
-Hyperplasia, Kupffer cell, diffuse, aode'ate -Vascular aineralization, aild Heaorrhage, local areas, aild
The following tissues were found to be within norrsal lia its : Spleen, Kidney, Testis/Epididvais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pituitary, Pancreas.
Ani sal Nuiber: 1R-3665 Sex: Male Group! ! 6) FC-143 30 ppn Fate! (Week= 40) Sacrificed in extr esis
Macroscopic Observations: Li VET Spleen Maaaary Gland
Microscopic Observations: Liver
Parathyroid Skin
Spleen
-Slightly pale -Slightly enlarged -Mass with ulcerated heeorrhagic surface, 6.5
x 6 x 4.5 ci, in right axilla.
-Necrosis, centrilobular, lild Heiatopoiesis, extraeedullary, wild
-Not exaained, not in plane of section -Fibrosar coaa
Highly cellular neoplasi with lyiphatic invasion. Surface ulcerated. -Heiatopoiesis, extraiedullary, increased, arked
The following tissues were found to be within norial lia its : Kidney, Heart, Lung, Testis/Epididyiis, Prostate, Stoeach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Gland, Pituitary, Pancreas.
Aniial Nuiber: 1R-3666 Sex: Male Group: ( 6) FC-143 30 ppe Fate: !Neek= 106) Teriinal Sacrifice
Macroscopic Observations: Eye Skin
Pituitary
-Opacity, right eye. -Hair loss on liib s with scab foriationi
possible d e n a titis. -Raised dark lass, 0.B ci dia.
Species: Rat Project Nuiber: 02B1CR0012
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Suiiarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nuiber*. 1R-3666 Sex: Hale Broup: ( 6 ! FC-143 30 ppi Fate: (Naek= 106) Teriina! Sacrifice
Macroscopic Observations (continued):
kidney (continued! Microscopic Observations:
Adrenal Eye
Heart Kidney Live-
Lung
Pancreas Pituitary Saliva-y Gland Skin Testis-'Epididyiis
-Falei possibly soiewhat enlarged.
-Sinusoidal ectasia, cortex, loderate -Retinal atrophy, unilateral Cataract, unilateral -Myocardial fibrosis, focal, ai Id -Chronic progressive nephropathy, loderate -Portal ncnonudear cell in filtra te , ci Id Mononuclear cell in filtra tio n , lu ltifo c a l, ild -Vascular lineralization, tiId Hescrrhage, local areas, lild -Polyarteritis, nininal -Adenoia -Sialadenitis, chronic, noderate -Ulcer, larked -Polyarteritis, lild
The following tissues were found to be within norial l i i i t s : Spleen, Prostate, Stciach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus.
Anisal Nuiber: IP-3667 Sex: Hale Group:! ! 6) FC-143 30 ppi Fate: (Nsek= 106! Teriinal Sacrifice
Macroscopic Observations:
Microscopic Observations: Heart
Kidney
Liver
Lung Pancreas Pituitary Salivary Gland Thyroid Urinary Bladder
-No visible lesions.
-Myocarditis, chronic nonsuppurative, ultifccal, lild
-Chronic progressive nephropathy, iiId Pyelitis, acute, nild -Portal lononuclear cell in filtra te , iiId Portal bile duct proliferation, iiId -Vascular lineralization, lild -Acinar atrophy, lild -Adenoia -Sialadenitis, chronic, larked -Hyperplasia, C cell, focal, iiId -Nat exaiined, lissing
The following tissues were found to be within norial Units*. Spleen, Testis/Epid idyiis, Prostate, Stoiach, Adrenal, Parathyroid, Trachea, Esophagus.
Species: Rat Project Nuiber: 0261CR0012
333Suiiarized STAR Page: 169
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Suatarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Huaber: IK-3668 Sex: Male Fate: (Keek= 106) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Heart
Kidney Liver
Lung
Pituitary
Broup! ( 6) FC-143 30 pps
'
-No visible lesions.
-Sinusoidal ectasia, cortex, ai 1 d -Myocarditis, chronic nonsuppurative,
aultifocal, slid -Chronic progressive nephropathy, ainieal -Portal aononudear cell in filtra te , ai id Necrosis, focal, aild -Vascular aineralization, aild Heacrrhage, aultifocal, aild -Adencna
The foilDwing tissues aere found to be within noraal lia its : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary SI and, Pancreas.
Aniaal Nuaber! 1R-3669 Sex: Hale Sroup: ( 6) FC-143 30 ppa Fate: IHeek= 70) Sacrificed in extreais
Macroscopic Observations: Skin
Large Intestine
Liver Microscopic Observations!
Adrenal
Esophagus Lung
Parathyroid Salivary Bland Skin Thyroid Trachea
-Left side of scrotua ulcerated with rectal-scrotal abscess.
-Marked iipaction at terainal colon and dilatation of reaaining colon and ileua containing fecal aaterial.
-Pale
-Hithin noraal lia its One of pair present -Not exasined, aissing
-Alveolar aacrophages, aultifocal, aild Heaorrhage, aultifocal, aild -Not exaained, aissing
-Not exaained, aissing -Abscess, subcutaneous -Not exaained, aissing -Not exaained, aissing
The following tissues ere found to be within noraal lia its : Spleen, Liver, Kidney, Heart, Testis/Epididyais, Prostate, Stonach, Urinary Bladder, Pituitary, Saall Intestine, Large Intestine, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 170
00072
Suiiarized Single Tabulated flniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuiber: 1R-3670 Sex: Male Fate: ilieek= 106) Teriinal Sacrifice
Macroscopic Observations: Mesentery kidney
Microscopic Observations: Kidney Liver
Lung Pancreas
Pituitary Salivary Bland Testis/Epididyris
Broup: ( 6 ) FC-143 30 ppi
'
-Hass, 1.3 x 1.07 in area of pancreas. -Enlarged, pale and pitted.
-Chronic progressive nephropathy, larked -Portal lononudear cell in filtra te , lild Portal bile duct proliferation, ai Id -Vascular cineralization, lild -Adenocarcinosa
Nell differentiated, ductular pattern. Large aaount of fibrous stroaa. Acinar atrophy, lild Polyarteritis, derate -Adenoea -Sialadenitis, chronic, derate -Polyarteritis, derate
The following tissues nere found to be within norial l i l i t s : Spleen, Heart, Prostate, Stoeach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Lyiph Node (eesentericl.
Aniial Nuiber: 1R-3671 Sex: Male Broup: ( 6) FC-143 30 ppi Fate: (kieek= 106) Teriinal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Esophagus Kidney Liver Lung
Pancreas Parathyroid Salivary Bland Testis/Epididyiis Thyroid Trachea
-No visible lesions.
-Sinusoidal ectasia, cortex, lild -Not exaained, lissing -Chronic progressive nephropathy, arked -Portal lononudear cell in filtra te , lild -Vascular eineralization, lild Perivascular lononudear in filtra te , lild -Acinar atrophy, ai Id -Not exaained, lissing -Not exaained, lissing -Polyarteritis, derate -Not exaained, lissing -Not exaiined, lissing
The following tissues were found to be within nomai l i l i t s : Spleen, Heart, Prostate, Stoiach, Urinary Bladder, Pituitary.
Species: Rat Project Nuiber: 02B1CR0012
77 c Suiiarized STAR Page: 171 J 0 5
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Suaaarized Single Tabulated Aniaal Report (continued! Individual flacroscopic and Microscopic Observations
Riter Laboratories, Inc. 3M FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nueber: 1R-3672 Sex: Male Fate: !Week= 106) Terainal Sacrifice
Macroscopic Observations: Pituitary Testis/Epididyais
Microscopic Qbservatinns: Ki dney Liver
Lung Parathyroid Pituitary Testis/Epididyais
Thyroid
Group: ( 6) FC-143 30 ppa
-
-Dark a^ea -Left testis snail.
-Chronic progressive nephropathy, ainiaal -Portal aononudear cell in filtra te , a:ld Hepatocyte alteration, basophilic, focal, aild -Vascular aineralization, aild -Not exaained, not in plane of section -Adenoaa -Tubule atrophy, asperaatogenesis, unilateral, aarked -Cyst, colloid
The following tissues were found to be within noraal lia its : Spleen, Heart, Prostate, Stoaach, Urinary Bladder , Adrenal, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3673 Sex: Hale Group: ( 6! FC-143 30 ppa Fate: (Neek= 106! Terainal Sacrifice
Macroscopic Observations: Microscopic Observations:
Kidney Liver
Lung Pancreas Salivary Gland
-No visible lesions.
-Chronic progressive nephropathy, aild -Portal aononudear cell in filtra te , aild Hepatocyte alteration, vacuolated, aultifocal, aild Megalocytosis, ainiaal -Vascular aineralization, aild Perivascular aononudear in filtra te , aild -Hyperplasia, acinar cell, nodular, aild -Sialadenitis, chronic, aoderate
The following tissues uere found to be within noraal lia its : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Pituitary.
Species: Rat Project Nuaber: 0281CROC12
3 3 6Sueaarized STAR Page: 172
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Suaaarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3d FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: IP-3674 Sex: Male Fate: (Neek* 106) Teriinal Sacrifice
Macroscopic Observations: Microscopic Observations:
Heart
Kidney Liver
Lung Parathyroid
Group: ( 4) FC-143 30 ppe
"
-No visible lesions.
-Myocardial fibrosis, aultifocal, aild Myocarditis, chronic nonsuppurative, aultifocal, aild -Chronic progressive nephropathy, aild
-Portal aononuclear cell in filtra te , aild Cystoid degeneration, focal, aild Hepatocyte alteration, vacuolated, aultifocal, aild -Vascular aineralization, aild -Not exaained, not in plane of section
The following tissues were found to be within nornal lia its : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Glar.d, Pituitary, Pancreas.
Aniaal Nuaber: 1R-3675 Sex: Male Group: ( 4) FC-143 30 ppa Fate: (Neek= 94) Sacrificed in ex.treais
Macroscopic Observations: skin
Pituitary
Microscopic Observations: Heart Kidney Li ver Lung
Pancreas Pituitary Skin Testis/Epididyais
-Raised area of thickening, 1.5 ca dia., in neck area; possibly inflaaaation or tuaori. perineal lesion appears to be inflaaaed area of subcutaneous fat.
-Slightly enlarged due to heaorrhagic area, 0.4 ca dia.
-Myocarditis, chronic nonsuppurative, aild -Chronic progressive nephropathy, aild -Cystoid degeneration, aultifocal, aild -Vascular aineralization, aild Heaorrhage, local areas, aild -Hyperplasia, is le t cell, nodular, aild -Adenoaa -Fibr D5arcoaa, subcutaneous -Vascular aineralization, aild
The following tissues were found to be within noraa! lia its : Spleen, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Haiaary Gland.
Species: Rat Project Nuaber: 0281CR0012
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Suiaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: !
Aniaal Nuaber: 1R-3676 Sex: Male Group: ( 6) FC-143 30 ppa Fate! INeek= 106) Terainal Sacrifice
Macroscopic Observations', Soft Tissues (leg! Mesentery Kidney Lyaph Node iaesenteric)
Microscopic Observations: Adrenal
Ecne Heart Kidney Lung Mesentery Pancreas Pituitary Salivary Si and Spleen Testis/Epididysis
-
-Swollen right and le ft hind feet. -Vessels thickened -Pale, pitted, enlarged. -Enlarged
-Cortical vacuolation, local areas, ai 1c Medullary cell hyperplasia, aultifccal, aiid
-A rth ritis, synovitis! joints, aoderate -Myocardial fibrosis, local areas, aild -Chronic progressive nephropathy, earked -Vascular mineralizatior, eild -Polyar te ritis , Barked -Polyarteritis, aoderate -Cyst, pars distalis -Sialadenitis, chronic, aarked -Polyarteritis, aoderate -Tubule atrophy, asperaatogenesis, unilateral, aarked Polyarteritis, aarked
The following tissues aere found to be Mithin ncraal lim its: Liver, Prostate, Sto&ach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus.
Aniaal Nuaber: 1R-3677 Sex: Male Group: ( 6) FC-143 30 ppa Fate: (Week1 106! Terainal Sacrifice
Macroscopic Observations: Microscopic Observations:
Esophagus Kidney Liver
Lung
Parathyroid
-No visible lesions.
-Not exaained, aissing -Chronic progressive nephropathy, aild -Portal aononuclear cell in filtra te , aild Cystoid degeneration, focal, aild Hepatocyte attention, vacuolated, aultifocal, aild Megalocytosis, ainiaal Necrosis, aultifocal, aild -Vascular ainerali2 ation, aild Pneuaonia, in te rs titia l, chronic, aultifocal, aild -Not exaained, not in plane of section
Species: Rat Project Nuaber: 0281CR0I2
338Suaaarized STAR Page: 174
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Suttarized Single Tabulated Antal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anita! Nutber: 1R-3677 Sex: Hale Group: ( 6) FC-143 30 ppi Fate: (Keek= 106) Teninal Sacrifice
Microscopic Observations (continued): Tesiis/Epididytis
-Polyarteritis, tild Leydig cell adenota, unilateral
The following tissues were found to be within noraal lia its : Spleen, Heart, Prostate, Stoiach, Urinary Bladder, Adrenal, Thyroid, Trachea, Salivary Gland, Pituitary, Pancreas.
finisal Nutber: 1P-367B Sex: Male Group: ( 6) FC-143 30 ppi Fate*. (leek= 6?) Sacrificed in extreiis
Macroscopic Observations: Pituitary Liver
Microscopic Observations: kidney Liver
Lung
Pituitary Spleen Stoiach
-Hetorrhagic tass, 1 x 0.7 ct dia. -Possibly slightly pale.
-Chronic progressive nephropathy, tild -Porta! tononudear cell in filtra te , tild Portal bile duct proliferation, tild Hepatocyte vacuolation, diffuse, toderate -Vascular aineralization, tild Hetorrhage, aultifocal, tild -Adenota -Hetosiderosis, tild -Ulcer, tarked
The following tissues were found to be within nortal lin t s : Heart, Testis/Epididysis, Prostate, Urinary Bladoer, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Anital Nutber: 1R-367? Sex: Male Group: l 6) FC-143 30 ppi Fate: (Neek= 106) Ter tinal Sacrifice
Macroscopic Observations:
Microscopic Observations'. Heart Kidney
Lung
Pancreas
-No visible lesions.
-Myocardial fibrosis, tu ltifo c a l, tild -Chronic progressive nephropathy, tild -Vascular tineralization, tild Hetorrhage, local areas, toderate -Hyperplasia, acinar cell, nodular, toderate
The following tissues were found to be within nortal l i t i t s : Spleen, Liver, Testis/Epididyiis, Prostate, Stotach, Urinary Bladder, Adrenal, Thyroid,
Species: Rat Project Nutber: 0281CR0012
Suttarizad STAR Page: ITS
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Suaaarized Single Tabulated Armai Repent (conti: j.ed; Individual Hacroscopic and Microscopie. Observations
Riler Laboratories, I*.:. 3"!
FC-143: To Year Oral Toxi : : t y-D~.ccgEr.i ci t y Study ir Rats
Aniaal Nuaoe". jp-3i7; cE, HtiE Fate: !* (.= : It: Ter sira! Sacrific e
6r cup! ( 6) FC-143
(r;k- 2-'-r ic Observations {continued):
'
The fc:1}~k. - tissues re feund tc be ithin ne-ral lia it:
FiretS.roid, Traches, Esochsgue, Salivary Sia--d, Pituitary,
Table: 3
Lecer; 1--350 Se*: Hale Group: ( fc! FC-143 30 ppi sek* I t i) Tersine! Sacrifice
roseo?:: Otservations*. E?s Aiders: {interrai 1
Toscopic Otservations: Eye Kidney
Live-
i -U :-,
2s- J Vaf f i."d Scft Tissues iabdoaer)
-Opacity, le ft eye. -Soft fatty tusor, 3 x 3
Mli.
attached tc nigh
-Cataract, unilateral -Chronic progressive nephropathy, foderate Fyelitis, acute, aild -Portal acnsnudea' cell in filtra te , aild -Vascular ameraiization, aild -Sialadenitis, chronic, aa-xed -Fibrosa
"he following tissues *er e found to be within norial lia its : Spleen, Heart, Testis/Epid:dyis, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathy-Gid, Trachea, Esophagus, Pituitary, Pancreas.
nias! Nster: 1R-363! Sex: Hale Group: ! fc! FC-143 30 ppa Fate: (seek- 105' Tersinal Sacrifice
Hacroscopic Otservations: Skin
Pituitary Microscopic Otservations:
KidneyLiver Lung
Pituitary Prostate Skin
-Raised ulcerated inflaaaatory lesions, right and le ft hind footpads.
-Saal 1 raised heiorrhagic lesion, C.2 ci dia.
-Chronic progressive nephropathy, aild -Porta! aononudear cel! in filtra te , aild -Vascular aineraiization, aild Fneuioria, in te rs titia l, chronic, aultifccal, ild Perivascular aononuclear in filtra te , aild -Adenoaa -Prostatitis, acute, aild -Pododeraatitis, ulcerative, bilateral, hindleg, aarked
Species: Rat Project timber: 0281CR0012
Sutiarned STAR ?.j i : 17i 3 4 0
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BEST COPY AVAU ABLE
Sutaarized Single Tabulated Anita! Report (continued! Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: T*o Year Ora! Toxicity-Oncogenicity Study in Rats
Table: 2
Ar.ital Nutber: 1R-368I Sex: Male Broup: ( 6) FC-143 30 ppi Fate: !eek= 106) Terminal Sacrifice
Microscopic Observations (continued): Thyroid
-Follicular hyperplasia, cystic, unilateral, arked
The following tissues were found to be within noma! lim its: spleen, Heart, Testis/Epididysis, Stoiach, Urinary Bladder, Adrenal, Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Anisal Nutber: 1S-3682 Sex: Male Broup: ( 6) FC-143 30 ppi Fate: (Heek= 106! Tertinal Sacrifice
Macroscopic Observations: Liver
Microscopic Observations: Adrenal
Kidney
Liver
Lung
Testis/Epididytis Thyroid
-Mottled
-Cortical vacuolation, local areas, tild Nodular hyperplasia, cortex, focal, toderate
-Chronic progressive nephropathy, tild Calculus, pelvic
-Pcrtal tononuclear cell in filtra te , tild Portal bile duct proliferation, tild Cystoid degeneration, tu ltifo c a l, tild -Vascular mineralization, tild Alveolar tacrophages, local areas, toderate
-Leydig cell hyperplasia, tu ltifo c a l, tild -Hyperplasia, C cell, focal, tild
Follicular adenota
The following tissues were found tc be within noma! lim its: Spleen, Heart, Stoiach, Urinary Bladder, Parathyroid, Prostate, Trachea, Esophagus, Salivary Gland, Pituitary, Pancreas.
Animal Nutber: 1R-3663 Sex: Male Broup: ( 6) FC-143 30 ppi Fate: (Neek= 106) Tertinal Sacrifice
Macroscopic Observations:
Microscopic Observations: Kidney Liver
Lung
-No visible lesions.
-Chronic progressive nephropathy, tild -Hepatocyte alteration, vacuolated,
local areas, toderate Vascular tineralization, tild Alveolar tacrophages, tu ltifo c a l, tild
Species: Rat Project Nutber: 02B1CR0012
341Suuarized STAR Page: 177
BEST COPY AVAIIABLE Suasarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations Riker Laboratories, Inc. 3H FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Kuaber: 1R-3683 Sex: Male Group: ( 6) FC-143 30 ppi Fate: (Ueei= 106! Terainal Sacrifice
Microscopic Observations (continued): Parathyroid
'
-Not exaiined, not in plane of section
The following tissues were found to be within norsal h a lts : Spleen, Heart, Testis/Epididvais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Bland, Pituita-y, Fancreas.
Aniaal Kunber: 1R-36B4 Sex: Male Group: 1 6) FC-143 30 ppe Fate: (seek1 106! Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Heart Kidney
Liver
Lung
Salivary Bland
-No visible lesions.
-Sinusoidal ectasia, cortex, n ld -Endocarditis, chronic, diffuse, aar ked -Chronic progressive nephropathy, si Id Pelvic sineralization, ai 1d -Portal sononuclear cell in filtra te , sild Portal bile duct proliferation, si Id -Vascular sineralization, sild Alveolar sacrophages, ultifo c a l, sild -Sialadenitis, chronic, soderate
The -following tissues were found to be within norial lia its : Spleen, Testis/Epididyais, Prostate, Stosach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Pituitary, Pancreas.
Aniaal Nutber: 1R-36S5 Sex: Hale Group: ( 6) FC-143 30 pps Fate: (Week 104! Sacrificed in extreais
Macroscopic Observations: Skin Pituitary
Microscopic Observations: Kidney
Liver Lung Pituitary Prostate Salivary Gland Skin
-Raised ulcerated lesion on le ft hind footpad. -Seal 1 dark area.
-Chronic progr essive nephropathy, sinisal Pelvic nineralization, sild
-Portal sononuclear cel! in filtra te , sild -Vascular sinerahzation, sild -Adenosa -Prostatitis, acute, sild -Not exasined, sissing -Podcderaat: tis , ulcerative, sarked
Species: Rat Project Nusber: 0281CR0012
Suasarized STAR Page: 178 34
000730
M M COPY AVAiii Suaaariced Single Tabulated Aniaal Report (continued) iljdividual Macroscopic and Microscopic Observations Riker Laboratories, Inc. 3(1 FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuafaer: 1R-3BB5 Sex: dale Group: ( 6) FC-143 30 ppi Fate: (Week* 104) Sacrificed in extreeis
Microscopic Observations (continued): Testis/Epididyiis
-Tubule atrophy, asperaatcgenesis, unilateral, aarked
The fclloaing tissues ere found to be within noraal lia its : Heart, Stcaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Spleen, Pancreas.
Aniaal Nuaber: 1R-3A86 Sex: Male 6roup: ( 61 FC-143 30 ppa Fate: (Reek= 106) Terainal Sacrifice
Macroscopic Observations: Microscopic Observations:
Kidney Li ver
Pituitary Salivary Gland
-No visible lesions.
-Chronic progressive nephropathy, aild -Portal aononuclear cell in filtra te , aild Cystcid degeneration, focal, ainiaal Hepatccyte alteration, vacuolated, focal, aild -Cyst, pars interaedia -Nat exaained, aissing
Tne following tissues ere found to be within noraal lia its : Spleen, Heart, Lung, Testis'Epitiidyeis, Prostate, Stcaach, Urinary Bladder, Acrenal, Thyroid, Parathyroid, Trachea, Esophagus, Pancreas.
Aniaal Nuaber: 1R-36B7 Sex: Male 6rcup: ( 6) FC-143 30 ppi Fate: Reeks 93) Sacrificed in extreais
Macroscopic Observations: Thorax (internal) Heart Lung Liver Kidney Testis/Epididyais Mesentery
Microscopic Observations: Adrenal
Heart
-Filled with blood tinged flu id . -Appears enlarged -Possible areas of consolidation. -Mottled and possible congestion. -Pale and pitted. -One testis appears saall. -Nodular aesenteric blood vessels.
-Cortical vacuolation, local areas, aarked Sinusoidal ectasia, cortex, aoderate
-Myocardial fibrosis, aultifocal, aild Myocarditis, chronic nonsuppurative, aultifocal, aild
Species: Rat Project Nuaber: 02B1CR012
Suaiarized STAR Page: 179 343 000731
Summed Single Tabulated Aniaal Report (continued! Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Tonicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber'. 1R-3687 Sex! Male Group: ( 6) FC-143 30 ppa Fate: (Keek* 98) Sacrificed in extreais
Microscopic Observations (continued): kidney Liver
Lung
Mesentery Pancreas
Parathyroid
Prostate Testis/Epididyais
-Chronic progressive nephropathy, narked Pelvic aineralization, aild
-Portal aononuclear ceil in filtra te , aild Portal bile duct proliferation, aild Cystoid degeneration, focal, aild Hepatccyte vacuolation, diffuse, aild -Vascular aineralization, aild Alveolar aacrophages, aultifocal, aild Atelectasis, diffuse, acderate Pneueor.ia, in te rs titia l, acute, local areas aoderate -Polyarteritis, narked
-Not exaained, aissirg -Not exaained, not in plane of section -Not exaained, aissing -Tubule atrophy, aspercatogenesis, aoderate Polyarteritis, aoderate Leydig cell hyperplasia, focal, aoderate Sranuloaa, speraatic
The following tissues were found to be within noraal U nits: Spleen, Stoaach, Urnary Bladder, Thyroid, Trachea, Esophagus, Salivary Bland, Eye. Pituitary.
Aniaal Nuaber: 1P-34BS Sex: Male 6roup: ! i) FC-143 30 ppa Fate: (Week1 89) Sacrificed ir, extreais
Macroscopic Observations: Pituitary Thyroid Liver kidney Testis/Epididyais
Microscopic Observations: Adrenal Kidney Liver
Lung Parathyroid Pituitary Spleen
-Enlarged due to raised 1 ca dia. cass. -One thyroid appeared slightly enlarged. -Slightly pale -Pale and slightly enlarged. -Appear saall
-Sinusoidal ectasia, cortex, aild -Chronic progressive nephropathy, aoderate -Hepatccyte vacuolation, local areas, tild Necrosis, local areas, aoderate -Vascula'- aineralization, aild -Not exaained, not in plane of section -Adenoaa -Heaosiderosis, aild
Species: Rat Project Nuaber: 02B1CR0012
Suaaarned STAR Page: 1B0 3 4 4
000732
Suiiarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
BEST COPY AVAU ABLE Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table:
Aniial Nuiber: 1R-36B8 Sex: Male Broup: ( 6) FC-143 30 ppa Fate: (Keek- 89) Sacrificed in extreeis
Microscopic Observations (continued): Testis/Epididyiis
Thyroid
-Tubule atrophy, asperiatogenesis, bilateral, i Id
-Follicular hyperplasia, cystic, unilateral, arked Ultiiobranchial cyst
The iallowing tissues were found to be within norial l i i i t s : Heart, Prostate, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Bland, Pancreas.
Aniial Nusber: 1R-368R Sex: Male Broup: ( 6! FC-143 30 ppi Fate: <Heek= 104) Teriinal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal kidney Liver
Lung Parathyroid Pituitary Thyroid
-No visible lesions.
-Fheochroiocytoaa, benign, unilateral -Chronic progressive nephropathy, iiId -Portal lononuclear cell in filtra te , lild Portal bile duct proliferation, eiId -Vascular lineralization, iiId -Not exaiined, not in plane of section -Not exaiined, eissing -C cell adenoia
The following tissues were found to be within norial l i i i t s : Spleen, Heart, Testis/Epididyiis, Prostate, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Eland, Pancreas.
Anisal Nuiber: 1R-3690 Sex: Male Group: ( 6! FC-143 30 ppi Fate: (Week= 106! Teriinal Sacrifice
Macroscopic Observations: Testis/Ep:didyii5
Microscopic Observations: Adrenal Heart
Kidney Liver
Parathyroid
-Left testis soaewhat s ta ll.
-Sinusoidal ectasia, cortex, lin iia l -Myocarditis, chronic nonsuppurative, local areas, iiId -Chronic progressive nephropathy, lild -Portal lononuclear cell in filtra te , lild Hegalocytosis, a iniial -Not exaiined, not in plane of section
Species: Rat Project Nuiber: Q281CR0012
Suiiarized STAR Page: 181
^ -r
J 4J
000733
Suiiarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tec Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuiber: 1R-3690 Sex: Hale Group: ( 6) FC-143 30 ppi Fate: (Heek= 106) Teriinal Sacrifice
Hicroscopic Observations (continued): Pitu:tary Testis/Epididyiis
-Cyst, pars intereedia -Tubule atrophy, aspermatogenesis, unilateral,
arked
Tne follcuir.: tissues re found to be within ncrial lia its : Spleen, Lung, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
AninaI Nuaber: 1R-391 Sex: Hale 6roup: ( 6i FC-143 30 ppi Fate: Week* 106! Teriinal Sacrifice
Macroscopic Observations: Hatiary Si and
Hicroscopic Observations:
Heart
Kidney
Liver Lung Pancreas Parathyroid
Skir,
-Subcutaneous, aultiiobular lass, 5.5 x 4 x 5 , left.
-Myocardial fibrosis, local areas, liId Myocarditis, chronic nonsuppurative, aultifocal, lild -Chronic progressive nephropathy, lild Pelvic lineralization, lild -Portal lononudear cell in filtra te , lild -Vascular lineralization, lild -Acinar atrophy, lin iia l -Net exaeined, not in plane of section -Fibrosarcoia, subcutaneous
The fo il owing tissues were found to be within noreal lia its : Testis/Epidiesya:s, Prostate, Stciach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Gland, Pituitary, Spleen.
Aninal Nuiber: 1R-3692 Sex: Hale Group: I 6) FC-143 30 ppi Fate: (Week: 106) Teriinal Sacrifice
Macroscopic Observations:
Hicroscopic Observations: Kidney Liver Lung Pituitary
-No visible lesions.
-Chronic progressive nephropathy, ai Id -Portal lononudear cell in filtra te , lild -Vascular lineralization, iiId -Adenoea
The following tissues ere found to be within norial lia its : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid,
Species: Rat Project Nuiber: 0261CR0012
346Sunarized STAR Page: 182
000734
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3(1 FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nueber: 1R-3692 Sex: Male Group: ( 1 FC-143 30 ppa Fate: iileek= 106) Terainal Sacr ifice
Microscopic Observations (continued): The following tissues were Found to be within noreal h a its (continued): Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Aniaal Nusbsr: 1R-3693 Sex! Male Group: ( 6) FC-143 30 ppa Fate! <Week= 106) Terainal Sacrifice
Macroscopic Observations: Skin Liver
Microscopic Observations! Adrenal Hea-t Ki dney Liver
?t ^ n n
Pancreas Salivary Gland Skin
-Raised ulcerated inflaaaed le sicn, right hind footpad.
-Appears aottled
-Cortical degeneration, focal, aoderate Phecchroaocytcaa, benign, bilateral
-Myocarditis, chronic nonsuppurative, aultifocal, aild
-Chronic progressive nephropathy, aoderate Pelvic aineralization, aoderate
-Portal aononudear cell in filtra te , aild Portal bile duct proliferation, aild Cystoid degeneration, aultifocal, aild Hepatocyte alteration, vacuolated, focal, aild -Vascular aineralization, aild Alveolar aacrophages, aultifocal, aild Heacrrhage-, aultifocal, aild -Acinar atrophy, aild -Sialacenitis, chronic, aoderate -Pododeraatitis, ulcerative, aarked
The following tissues were found to be within noraal lia its : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Pituitary.
Aniaal Nueber: 1R-3694 Sex: Male Group! ( 6! FC-143 30 ppa Fate: (Keek* 106) Tereina! Sacrifice
Macroscopic Observations: Pituitary
Hicroscopic Observations: Adrenal Kidney
-Reddish aass, 0.5 ca dia.
-Pheochroaocytoaa, benign, unilateral -Chronic progressive nephropathy, aild
Species: Rat Project Nueber: 2B1CR0C12
Sumrized STAR Page: 1B3 3 4 1
000735
Suiaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riter Laboratories, Inc. 3M FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3694 Sex: Hale Sroup: ( 6) FC-143 30 ppa Fate: (Keek- 106) Terainal Sacrifice
Microscopic Observations (continued): Liver
Lung Pancreas Pituitary
-Portal aononudear cell in filtra te , aild Portal bile duct proliferation, aild -Alveolar aacrophages, aild -Hyperplasia, isle t cell, nodular, aild -Adenota
The fol 1Dating tissues were found tc be within noraal lia its : Spleen, Heart, Testis/Epididye:s, Prostate, Stowach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland.
Aniaal Nueber: 1R-3695 Sex: Male Group: ( 6) FC-143 30 ppa Fate: (Week= 106) Tereinal Sacrifice
Macroscopic Observations:
Hicroscppic Observations: Adrenal
Esophagus Heart
Liver Lung
Pituitary
-No visible lesions.
-Medullary cell hyperplasia, focal, aild * One of pair present
-Not exaained, aissing -Myocarditis, chronic nonsuppurative, aultifocal, aild -Portal aononudear cell in filtra te , aild -Vascular aineralization, aild Pneuaonia, in te rs titia l, chronic, focal, aild -Not exaained, aissing
The following tissues were found to be within noraal lia its : Spleen, Kidney, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Eland, Pancreas.
Aniaal Nuaber: lfi-4706 Sex: Feaale Group! ( 6) FC-143 30 ppa Fate: Reek1 72) Sacrificed in extreais
Macroscopic Observations: Maaaary Gland
Microscopic Observations: Adrenal Kidney Liver Lung
-Large ulcerated aass, 1.5 x 3.5 ca dia. in le ft inguinal area
-Sinusoidal ectasia, cortex, air.iaal -Chronic progressive nephropathy, ainiaal -Heaatopoiesis, extraaedullary, aild -Vascular aineralization, ainiaal
Species: Rat Project Nuaber: 0281CROO12
348Suaaarized STAR Page: 184
C00736
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Rifcer Laho'atories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nueber: 1R-470 Sex: Feiale 6roup: ( i) FC-143 30 ppi Fate: (Keek* 72) Sacrificed in extreais
Microscopic Observations (continued): Maneary Sland Pancreas Parathyroid Pituitary Spleen
-Adenocarcinoia -Acinar atrophy, ainiaal -Not exaainec, not in plane of section -Aderoaa -Heaatcpoiesis, extraeedullary, increased, arked
The following tissues were found to be within noreal lia its : Heart, Uterus, Ovary, Stoeach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Stand.
Aniaal Nueber: 1R-477 Sex: Feaale Group: ( 6) FC-143 30 ppi Fate! (Neek= 90) Found Dead
Macroscopic Observations: Haiaary Sland
Pituitary Microscopic Observations:
Adrenal kidney Maaaary Gland Ovary
Parathyroid Pituitary
-Large cystic aass, 8 x 4.5 x 2.S ca, fille d with blood, in perineal and right inguinal areas.
-Heaorrhagic lesion, 1.5 x 1 ca.
-Sinusoidal ectasia, cortex, aild -Chronic progressive nephropathy, aild -Adenocarcinoaa -Hithin noraal lia its One of pair present -Not exaained, not in plane of section -Adencaa
The fcilowirg tissues were found to be within ncreal lia its : Spleen, Liver, Heart, Lung, Uterus, Stoeach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Eland, Pancreas.
Animal NuebEr: 1R-4708 Sex: Feaale Group: ( 6) FC-143 30 ppe Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Pituitary Maaaary Gland
Microscopic Observations: Adrenal
-Raised aass, 0.5 ca dia. -Snail nodular aass, 1 ca dia., in le ft
axilla; large aass, 5 x 5 x 3 ca, in right inguinal area.
-Sinusoidal ectasia, cortex, noderate
Species: Rat Project Nueber: 0281CR0012
Suaaarized STAR Page: 1B5
000737
Sutaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FC-143: T*o Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4708 Sex: Feaale Group: ( G) FC-143 30 ppa Fate: (Week* 105! Tereina! Sacrifice
Hicroscopic Observations (continued): Haasary Eland Parathyroid Pituitary Uterus
-Fibroadenoaa -Not exaained, not in plane of section -Adenoea -Cystic glands, eoderate
The following tissues were found to be within noraal lia its : Spleen, Liver, Kidney, Heart, Lung, Ovary, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Si and, Pancreas.
Aniaal Nuaber: 1R-4709 Sex: Feaale Group'. ( 6) FC-143 30 pps Fate: (Heek= 99) Sacrificed in extreai s
Hacroscopic Observations: Pituitary Abdoeen (internal) Liver
Hicroscopic Observations'. Adrenal Kidney Liver
Lung Kaaaary Gland Pancreas Parathyroid Pituitary Spleen
-Enlarged, 0.7 ca dia. -Gastrointestinal tract distended with gas. -Yellowish focal lesion, 0.9 x 0.3 ca, in
fissure of aedian lobe; liver possibly slightly pale.
-Sinusoidal ectasia, cortex, aarked -Pelvic aineralization, aild -Portal aononudear cell in filtra te , aild Hepatocyte alteration, vacuolated, focal, aarked -Vascular aineralization, aild -Galactocele -Not exaained, aissing -Not exaained, not in plane of section -Adenoea -Heaatopoiesis, extraaedullary, increased, aild
The fcllowing tissues ere found to be within nornal lia its : Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland.
species: Rat Project Nuaber: 02B1CR0012
Suaaarjzed STAR Page: 18G
000738
Suaiarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4710 Sex: Feaale Group: ( 6) FC-143 30 ppa Fate: (Neek= 103) Terainal Sacrifice
Macroscopic Cbse-vations: Pituitary Macnary Eland
Microscopic Observations: Adrenal
Lung Maaaar y Eland
Ovary Parathyroid Pituitary Uterus
-
-Heacrrhagic aass, 0.6 ca dia. -Large aultilobular aass, 9 x 7.5 x 3 ca, in
le ft inguinal area.
-Sinusoidal ectasia, cortex, aarked Cortical degeneration, aoderate -Vascular aineralization, aild
-Fibroadenoaa Extensive necrosis of tuaor.
-Cyst -Not exaained, not in plane of section -Adenoaa -Cystic glands, aarked Leioayona
The -following tissues ere found to be within ncrr.al lin t s : Spleen, Liver, Kidney, Heart, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Eland, Pancreas, Thyroid.
Aniaal Nusber: 1R-4711 Sex: Feaale Group: ! 6) FC-143 30 ppa Fate: iWeek- 105! Tereinal Sacrifice
Macroscopic Observations: Manaary Gland
Microscopic Observations: Adrenal Kidney
Liver Lung Maaaary Eland Pituitary 5pleen
-Large aass, 10 x 10 x 4 ca, in right inguinal/perineal area.
-Cortical vacuolation, local areas, aild -Chronic progressive nephropathy, aild Pelvic aineralization, aild -Hepatocyte vacuolation, aultifocal, aild -Vascular aineralization, ainiaal -Fibroadenoaa -Adenoaa -Ueaatopoiesis, extraaedullary, increased, aoderate
The following tissues ere found to be within norral lia its : Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Page: 187 3 5
000739
Summarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4712 Sex: Feiale Group: < 6) FC-143 30 ppa Fate: (Heek= 94) Sacrificed in extreeis
Macroscopic Observations: Pituitary Mammary Bland
Pancreas Microscopic Observations:
Adrenal Heart
Kidney
Liver
Lung
Mammary Gland
Ovary Pancreas Pituitary Uterus
-
-Hemorrhagic aass, 1.3 x 1 cm. -Cystic aultilcbular mass, 5 x 5 x 3 cm,
le ft inguinal area, fille d with dark flu id ; saall cystic aass, 2 x 1 cb, in inguinal area. -Saall nodule, 0.3 ca dia.
-Sinusoidal ectasia, cortex, aoderate -Myocarditis, chronic nonsuppurative, aultifocal, aild -Chronic progressive nephropathy, ainiaal Pelvic aineralization, ainiaal -Portal aononudear cell in filtra te , aild Portal bile duct proliferation, aild -Vascular aineralization, aild Alveolar aacrophages, aultifocal, aild -Balactocele Adenocarcinoma -Cyst -Is le t cell adenoma -Adenoma -Cystic glands, aoderate
The following tissues nere Found to be within norial l i i i t s : Spleen, Stomach, Urinary Bladder, Thyroid, Parathyroid, Tracha, Esophagus, Salivary Bland.
Animal Nuaber: 1R-4713 Sex: Female Group: ( 6) FC-143 30 ppa Fate: (Ueek= 97) Found Dead
Macroscopic Observations: Liver Uterus
Microscopic Observations: Liver
Lung Lyaph Node Haaaary Bland
-Slightly pale -Lett uterine horn has saall dear spherical
aass, 0.5 ci dia.i right uterine .horn greatly enlarged and fille d with dark bloody flu id .
-Portal aononudear cell in filtra te , aild Necrosis, aultifocal, aild -Vascular mineralization, aild
-Hyperplasia, reactive, toderate -Not exaained, aissing
Species: Rat Project Nuaber: 0281CR0012
Summarized STAR Page: 18B
000740
SuaaarizEd Single Tabulated flniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Am ai Nuaber*. 1R-4713 Sex: Feaale Group: ( b) FC-143 30 ppa Fate: (Keek^ 97) Found Dead
Microscopic Observations (continued): Pituitary Spleen
Uterus
-Adenoaa * -Hesatopoiesis, extraaedullary,
mild -Cystic glands, aarked
Hesangiosa
increased,
The following tissues were found to be within nortal lia its : Kidney, Heart, Ovary, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
finina! Nusber: 1R-4714 Sex: Feaale Group: ( 6) FC-143 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Maaaary Gland
Lyaph Node (abdoainal) Microscopic Observations:
Adrenal
Heart
Kidney Liver Lung Maaaary Bland
Pancreas Spleen
Uterus
-Milk cyst, le ft axilla large nass, 6.5 x 7 x 4 ca, in le ft inguinal area.
-Renal lyaph nodes enlarged.
-Sinusoidal ectasia, cortex, aoderate Adenoaa, cortical Tuaor described as enlarged renal lyaph node at necropsy. -Myocarditis, chronic nonsuppurative, aultifocal., aild -Chronic progressive nephropathy, aild -Negalocytosis, ainiaa! -Vascular aineralization, aild -FibroadEnoaa Salatocele Adenocarcincaa -Not exaained, Hissing -Hesatopoiesis, extraaedullary, increased, aild -Polyp
The following tissues were found to be within ncraal U nits: Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pituitary.
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Pie:0^74.153
Sueaarized Single Tabulated Aniial Report (continued! Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4715 Sex: Feaale Group: ( 6) FC-143 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal
Heart
Kidney
Liver Lung Ovary Pancreas Parathyroid Pituitary Spleer
'
-No visible lesions.
-Sinusoidal ectasia, cortex, unilateral, narked
-Myocarditis, chronic nonsuppurative, aultifocal, aild -Pelvic aineralizatisn, Moderate Polyarteritis, ainiaal -Hepatocyte vacuslatior., aultifocal, ainiaal
-Vascular aineralization, aild -Cyst, unilateral -Polyarteritis, ainiaal -Net exaained, not in plane of section -Adenoaa -Heaosiderosis, aild
The fdloning tissues Mere found to be within noraal lia its : Uterus, Maaiary Gland, Stcaach, Urinary Bladder , Thyroid, Trachea, Esophagus, Salivary Gland.
Aniaal Nuaber: 1R-4716 Sex: Feaale Broup: ( 61 FC-143 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Skin
Microscopic Observations: Adrenal
Lung Ovary Pituitary
-Hair thinning on head.
-Sinusoidal ectasia, co'tex, narked Cortical degeneration, focal, aild -Vascular aineralization, ainiaal
-Cyst, unilateral -Cyst, pars interaedia
The fallowing tissues Mere found to be within noraal lia its : Spleen, Liver, Kidney, Heart, Uterus, Maaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas, Skin.
Species: Rat Project Nuaber: 0281CR0012
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Suasarized Single Titillated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: IR-4717 Sex: Feeale Broup: ( 6) FC-143 30 ppi Fate: (Week= 105) Tersina! Sacrifice
Macroscopic Observations: Pituitary Masaary Gland
Adrenal Microscopic Observations:
Adrenal
Kidney Liver Lung
Maaaary Gland
Pituitary Uterus
-Hsorrhagic aass, 1 ci dia. -Lobular aass, 4 x 3 x 2.5 ct, in le ft axilla!
cystic lobular aass, 2.5 x 2 x 1.2 ca, in perineal area. -Left adrenal enlarged.
-Sinusoidal ectasia, cortex, aarked Enlargeaent of le ft adrenal due to aassive sinusoidal ectasia.
-Chronic progressive nephropathy, ni ni sal Pelvic sineralization, aoderate -Hepatocyte vacuolation, aultifocal, ai Id -Vascular sineralization, cild Alveolar aacrophages, aultifocal, sild Hesorrhage, local areas, aoderate -Fibroadenosa Balactocele Adenocarcinosa -Adenoaa -Cystic glands, aild
The -following tissues sere found to be within noraal lia its : Spleen, Heart, Ovary, Stench, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, Pancreas.
Aniaal Nuaber: 1R-471B Sex: Fesale 6roup: ! i) FC-143 30 pps Fate! ieek= 94) Sacrificed in extreais
Macroscopic Observations: Pituitary Masra'-y Bland
Adrenal Kidney Microscopic Observations: Adrenal
Esophagus Kidney Lung
-Raised aass, 1.3 ci dia. -Cystic aass, 4 x 3 cs, le ft axilla! silk cyst
in the perineal area. -Right adrenal enlarged. -Possibly pale
-Sinusoidal ectasia, cortex, aarked Enlargeaent of right adrenal due to aassive sinusoidal ectasia.
-Not exaained, aissing -Chronic progressive nephropathy, siniaal -Hesorrhage, local areas, aild Pneuacnia, foreign body, local areas, aarked
Species: Rat Project Nusber: 02B1CR0012
Susaa n zed STAR Page: 191 3 5 5
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Suaaarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4718 Sex: Feiale Group: ( 6! FC-143 30 ppa Fate: (Week= 94) Sacrificed in extreais
Microscopic Observations (continued): Haiaar y Gland
Parathyroid Pituitary Uterus
-Fibroadenoaa Galactocele -Not exaained, not in plane of section -Adencaa -Cystic glands, aoderate
The follouing tissues were found to be within noraal lia its : Spleen, Liver, Heart, Ovary, Stoaach, Urinary Bladder, Thyroid, Trachea, Salivary Gland, Pancreas.
Aniaal Nuaber: IR-4719 Sex: Feaale Group: ( 6) FC-143 30 ppa Fate: !Week= 96) Sacrificed in extreais
Macroscopic Observations: Eye Pituitary Soft Tissues (neck)
Liver Kidney Microscopic Observations: Adrenal Eye Kidney Liver
Lung
Maaaary Gland Ovary Parathyroid Pituitary Salivary 61and Spleen
-Left eye dark, possible heaorrhage. -Sr,all heaorrhagic lesion. -Irregular cystic subcutaneous aass, 6 x 4 x 2
ca, in neck area, possibly aaaaary gland or salivary gland. -Slightly pale -Slightly pale and pitted.
-Cortical vacuolation, local areas, aoderate -Keratitis, acute, unilateral, narked -Chronic progressive nephropathy, aild -Hepatocyte vacuolation, diffuse, aild Hepatocyte alteration, basophilic, focal, aild -Heaorrhage, local areas, Barked Metastatic neoplasa -Adenocarcinoaa -Cyst, unilateral -Not exaained, not in plane of section -Adenoaa -Not exaained, aissing -Heacsiderosis, aoderate
The following tissues aere found to be within noraal lia its : Heart, Uterus, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 192
356
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Sueaarized Single Tabulated Annal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tmq Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
flnieal Nuaber: 1R-4720 Sex: Feaale 6roup: ( 6) FC-143 30 pps Fate: !Neek= 105) Terminal Sacrifice
Macroscopic Dbservations: Maaeary Bland
Microscopic Observations: Adrenal Kidney Liver
Lung
Maaeary Bland Pancreas Pituitary
-Mass in right inguinal area appears to be i nflasted ai Ik cyst.
-Sinusoidal ectasia, cortex, aarked -Pelvic ainerali: at ion, eiId -Hepatocyte vacuolation, eultifccal, ai Id Hepatocyte alteration, vacuolated, Focal, ni Id -Alveolar aacrophages, aultifocal, aild Perivascular aononudear in filtra te , aild -Adenocarcinoaa -Acinar atrophy, eoderate -Adenona
The following tissues Mere found to be within noria! lis its : Spleen, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea Esophagus, Salivary 61and.
Aniaal Nusber: 1R-4721 Sex: Feaale Group: ( 61 FC-143 30 ppa Fate: (heek= 95) Found Dead
Macroscopic Observations: Maiiary Gland
Uterus
Microscopic Observations: Adrenal
Liver Maaeary Gland
Ovary
Pancreas Parathyroid Pituitary Salivary Gland Spleen
-Mass, 6 x 7.5 x 3.5 ca, aultilcbular, right inguinal area; aultilcbular Bass in le ft inguinal area.
-Heaorrhagic lesion, 0.7 x 1 ca, le ft uterine horn.
-Sinusoidal ectasia, cortex, aoderate Heaatapoiesis, extraeedullary, cortical, aarked
-Keaatopoiesis, extraeedullary, ainiaal -Fibroadenoaa Aderocarcinoea -Within noreal lie its One of pair present -Not exaained, aissing -Not exaained, not in plane of section -Not exaained, aissing -Not exaained, aissing -Heaatopoiesis, extraeedullary, increased, aarked
Species: Rat Project Nuaber: 02B1CR0012
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Suuarized Single Tabulated Aniial Repo-t (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year 0-al Toxicity-Oncogenicity Study in Rats
Table: 2
Annal Nuiber: 1R-4721 Sex: Feiale Group: ( 6) FC-143 30 ppi Fate: (Neek= 95) Found Dead
Microscopic Observations (continued): Steiach Uterus
-Heccrrhage, focal, lucosal, iiId -Polyp
The following tissues were found to be within noria! lie its : Kidney, Heart, Lung, Urinary Bladder, 1'hyreid, Trachea, Esophagus.
Anna! Nusber: IR-4722 Sex: Feiale Group: ( 6) FC-143 30 ppi Fate: !KeEk- 33) Found Dead
Macroscopic Observations: Hassary Gland
Liver Pituitary Microscopic Observations: Adrenal Liver Lung
Masnar y Gland Pituitary Salivary Gland Skin Spleen
Uterus
-Large necrotic lass, 11 x B x 3.3 ci, le ft axillary region.
-Pale -Heiorrhagic lass, 0.5 ci dia.
-Sinusoidal ectasia, cortex, eoderate -Necrosis, eultifocal, larked -Vascular liberalization, lin n a l Alveola'' eacrophages, eultifocal, i i Id -Not exaiined, lissing -Adenoia -Not exaiined, lissing -Fibroia -Heiatopoiesis, extraiedullary, increased, oderate -Cystic glands, larked
The following tissues were found to be within norial l i i i t s : Kidney, Heart, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Pancreas.
Aniial Nuiber: 1R-4723 Sex! Feiale Group: ( 6) FC-143 30 ppi Fate: <lieek= 105) Teriinal Sacrifice
Macroscopic Observations: Haiiary Gland
Microscopic Observations: Adrenal Kidney
-Perineal lass appears to be inflaned silk cyst; large lass, 9 x 5 x 2 ci, in throat area.
-Sinusoidal ectasia, cortex, aoderate -Nephrosis, tubular, aoderate
Species: Rat Project Nuiber: 02B1CR0012
358Suuarized 5TAR Page: 194
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Suaaarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tmo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nuaber: 1R-4723 Sex: Feiale Broup: ( 6) FC-143 3C ppi Fate: (Week1 105? Teriinal Sacrifice
Microscopic Observations (continued): Lung Maasary Bland Ovary Pituitary Uterus
-Vascular aineralization, ainiaal -Adenocarcinoaa, papillary -Tubular hyperplasia, aoderate -Adenoaa -Cystic glands, aarked Hyperplasia, endoeetrial, papillary, aoderatE
The folloiing tissues Mere found to be Mithin noraal liaits: Spleen, Liver, Heart, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, Pancreas.
tl Nuaber: 1R-4724 Sex: Feiale Group: ( f>) FC-143 30 ppi (Week= 105; Teraina! Sacrifice
Macroscopic 0bser vati cos: Saall Intestine
Microscopic Observati DfiSl Adrenal
Kidney
Liver
Lung Lyaph Node Haatary 61and Ovary Parathyroid Saall Intestine
Urinary Bladder
-Ulcerated outpouching fille d with ingesta in * jejunua.
-Sinusoidal ectasia, cortex, aild Cortical degeneration, focal, aild
-Chronic progressive nephropathy, ainiaal Pelvic aineralization, ainiaal
-Portal aononudear cell in filtra te , aild Portal bile duct proliferation, aild -Vascular aineralization, ainiaal
-Hyperplasia, reactive, aoderate -Not exaained, aissing -Tubular hyperplasia, bilateral, aild -Not exaained, not in plane of section -Leioayosarcoaa, jejunua
Large in filtra tiv e tuaor with aucosal surface ulcerated. -Not exaained, aissing
The fo llo ttin g tissu e s Mere found to be M ith in noraal l i a i t s :
Spleen, Heart, Uterus, Stoaach, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas, Pituitary.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 195 3 5 9 COO747
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-14J: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4725 Sex: Feaale Group: ( 6) FC-143 30 ppa Fate: (Heek= 94! Sacrificed in extreais
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Kidney
Lung
Pituitary
-Raised red sass, 1 ca dia.
-Sinusoidal ectasia, cortex, ciId -Chronic progressive nephropathy, c i1d Pelvic aineralization, ainiaal -Vascular aineralization, aild Heaorrhage, aultifocal, aild -Adenoaa
The following tissues ere ^ound to be within noraal lia its : Spleen, Liver, Heart, Ovary, Kaasary Gland, Stoaach, Urinary Bladder, Uterus, Thyroid, Farathyroid, T-achea, Esophagus, Salivary Bland , Pancreas.
Aniaal Nucber: 1R-4726 Sex: Feaale Group: ( 6) FC-143 30 ppa Fate: (Meek1 105) Terainal Sacrifice
Hacroscopic Observations: Pituitary Haaaary 61and
Microscopic Observations: Adrenal
Kidney
Liver Lung
Parathyroid Pituitary Urinary Bladder
-Heaorrhagic aass, 0.6 ca dia. -Snail aass, appears to be ailk cyst, in
throat area.
-Sinusoidal ectasia, cortex, aoderate Nodular hyperplasia, cortex, aode-ate
-Chronic progressive nephropathy, ainiaalPelvic aineralization, ainiaal
-Portal aononudear cell in filtra te , ainiaal -Vascular aineralization, ainiaal Heaorrhage, local areas, aoderate -Not exaained, not in plane of section -Adenoaa -Not exaained, aissing
The following tissues were found to be within noraal lia its : Spleen, Heart, Uterus, Ovary, Maatary Gland, Stoaach, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nutber: 0281CR0012
Suaaarized STAR Page: 196 360 000748
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4727 Sex: Feaale Broup: ( b) FC-143 30 ppa Fate: (Week* 105) Terainal Sacrifice
Macroscopic Observations: Skin Pituitary Maaaary Bland
Micrcscopic Obse'vations: Adrenal Kidney Lung
Maaaary Bland Ovary Pancreas Pituitary Uterus
'
-Hair loss on head and neck. -Raised dark aass, 0.5 ca dia. -Hass, 4 x 3 ca, right axillary and throat
areas! aass, 3 ca dia., le ft side.
-Sinusoidal ectasia, cortex, aarked -Pelvic aineralizaticn, ainiaal -Vascular aineralizaticn, aild Heacrrhage, diffuse, aarked -Fibroadenoaa -Cyst -Acinar atrophy, ainiaal -Adenoea -Cystic glands, aarked
The fdlouing tissues ere found to be within nc-tal lim its: Spleen, Liver, Heart, Stosach, U-inary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Eye.
Aniaal Nunber: 1R-4728 Sex: Feaale Group: ( 6) FC-143 30 ppa "ate: (Week= 84) Sacrificed in extreais
Macroscopic Observations: Abdoaen (internal)
Microscopic Observations: Adrenal
Kidney
Liver Lung Mesentery Pancreas Pituitary Spleen
-Abdominal cavitv fille d with bloody fluid; aesentary and oaentua extensively involved with nodular, granular tissue, possibly tuacr or chronic inf 1 aaaation.
-Sinusoids! ectasia, cortex, aild Cortical degeneration, focal, aild Metastatic neoplasa -Chronic progressive nephropathy, aild Pelvic aineralizaticn, aild Metastatic neoplasa
-Hepatccyte validation, aultifocal, ainiaal Heaatopoiesis, extraaedullary, ainiaal -Vascular aineralizaticn, aild
-Hesotheliona, aalignant -Metastatic neoplasa -Adenoaa -Metastatic neoplasa
Species: Rat Project Nuaber: 02B1CR0012
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Summarized Single Tabulated Animal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nuiber: 1R-4728 Sex: Fesale Group: ( 6) FC-143 30 ppa Fate: (Meeks 04) Sacrificed in extremes
Microscopic Observations (continued): Stonach
Urinary Bladder Uterus
-Ulcer Metastatic neoplasm
-Metastatic neoplasa -Cystic glands, lild
The following tissues were found to be within noreal lie its : Heart, Ovary, Maaaary Gland, Thyroid, Parathyroid, Trachea, Esophagus, Salivary aland.
Aniaal Nueber: 1R-4729 Sex! Fetale Group: ( i) FC-143 30 ppa Fate: (Meek= 105> Terminal Sacrifice
Macroscopic Observations: Pituitary Hanary Gland
Microscopic Observations: Adrenal Kidney Liver Lung
Maaaary Gland Parathyroid Pituitary
-S iali raised dark aass, 1 ca dia. -Multilobular aass, 3.5 x 3 ca, in right
axilla; large aulti 1 obular aass, 9 x 6 x 3 ca, in throat area.
-Sinusoidal ectasia, cortex, aoderate Cortical degeneration, local areas, aoderate -Pelvic aineralization, ainiaal
-Portal aononudear cell in filtra te , ainiaal Hepatocyte vacuolation, aultifocal, ainiaal -Vascular aineralization, wild Pneuaonia, in te rs titia l, chronic, local areas, aild Heaorrhage, aultifocal, ainiaal 6ranuloda, aultifocal, aild -Fibroadenoma Fibroadenoaa
-Not exaained, not in plane of section -Adenoaa
The following tissues were found to be within noraal b a its : Spleen, Heart, Uterus, Ovary, Stomach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Number: 0281CR0012
Summarized STAR Page: 198
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Suuarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nuaber: 1R-4730 Sex: Feiale Broup: ( 6' FC-143 30 dpi Fate: (Ueek= 74) Found Dead
Macroscopic Observations! Maaiary Bland
Adrenal Microscopic Observations:
Adrenal Kidney
Liver Lung Manary Bland Pituitary Spleen Uterus
-Multilobular ulcerated subcutaneous lass, 4 x 3 x 2.5 ci, right a xilla: cystic aiiary gland, 1 . 2 ci dia ., tille d with ailky white Fluid, in le ft inguinal area.
-Right adrenal enlarged.
-Sinusoidal ectasia, cortex, larked Cortical degeneration, local areas, loderate
-Chronic progressive nephropathy, liId Mineralization, in te rs ititia l, cortical, oderate -Portal lononudear cell in filtra te , ci Id Necrosis, Sultifc c a l, tile -Vascular lineralization, lin ita l
-Adenocarcinoia Sslactocele -Adenona
-Heiatopoiesis, extraiedullary, increased, ci Id -Polyp
The following tissues were found to be within norial l i i i t s : Hsart. Ovary, Stoiach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esoohagus, Salivary Gland, Pancreas.
Aniial Nutter: 1R-4731 Sex: Feiale Group: ( 61 FC-143 30 ppi Fate: (Reek* 99! Sacrificed in extreiis
Macroscopic Observations: Mauary Bland Liver Stall Intestine
Microscopic Observations: Adrenal
Kidney Liver
Lung
-Circular lass, 3 ci dia., in right axilla. -Pale and slightly enlarged. -Area of ulceration with adhesions.
-Cortical vacuolation, diffuse, loderate Heiosiderosis, diffuse, cortical, lild
-Protein resorption droplets, larked -Hepatocyte vacuolation, diffuse, larked Malignant lyiphoia, histiocytic -Malignant lyiphoia, histiocytic Atelectasis, local areas, ciId
Species: Rat Project Nuiber: 02B1CR0012
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4731 Sex! Resale Group: ( 6 ) FC-143 30 ppa FatE! (Neek= 99) Sacri-ficed in extreais
Microscopic Observations (continued): Lyaph Node (thoracic) ' Mantary Eland Mesentery Ovary Pancreas
Salivary Gland Siall Intestine Spleen Stosach Urinary Bladder
-Malignant lysphoaa, histiocytic -Fibrcadenoia -Malignant lyaphoaa, histiocytic -Malignant lyaphoaa, histiocytic -Acinar atrophy, aarked Malignant lyaphoaa, histiocytic -Not exaained, aissing -Ulcer, aarked -Malignant lyaphosa, histiocytic -Ulcer, aultiFocal, aild -Malignant lyaphoaa, histiocytic
The Following tissues were found to be within norsal lia its : Uterus, Thyroid, Parathyroid, Trachea, Esophagus, Pituitary, Heart.
Aniaal Nuiber : 19-4732 Sex: Feaale Group: ! 6) FC-143 30 ppa Fate: (Wee*'= 99) Sacrificed in extreais
Macroscopic Observations: Fituitary Maasary 61and
Adrenal Liver Microscopic Observations: Adrenal
Kidney Liver
Lung
-Raised aass, 0.5 ca dia. -Cystic aass, 4 ca dia., possibly inflaaaed
ailk cyst, le ft inguinal area; fira cystic aass, 4 ca dia., possibly tuaor, in right inguinal area; large aass, 12 x 10 x 3 ca, le ft and right axilla. -Right adrenal enlarged; le ft adrenal pale aass, 0.7 ca dia. -Appears swollen and enlarged.
-Sinusoidal ectasia, cortex, aarked Cortical degeneration, aoderate Carcinoaa, cortical, unilateral -Pelvic aineralization, aarked Nephrosis, tubular, aarked -Cystcid degeneration, focal, aild Heaatopoiesis, extraaedullary, aild Necrosis, focal, ainiaal
-Vascular aineralization, ainiaal Alveolar aacrophages, aild Metastatic neoplass
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Page: 200
364
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Vear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4732 Sex: Feaale 6roup: ( 6) FC-143 30 ppa Fate: (Meek- 99! Sacrificed in extrenis
Microscopic Observations (continued): Haaaary Gland
Pituitary Spleen
Fibroadenoaa Fibroadenoaa Adenoaa Heiatopoiesis, extraaedullary, increased, aild
The following tissues ere found to be within noraal lia its : Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-473J Sex: Feaale Group: ( 6) FC-143 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Kidney Liver Lung
Pituitary
-No visible lesions.
-Sinusoidal ectasia, cortex, aoderate - -Pelvic aineralization, aild
-Hepatocyte vacuolation, aultifocal, aild -Vascular aineralization, ainiaal Alveolar aacrophages, aultifocal, aild -Adenoaa
The following tissues ere found to be within noraal lia its : Spleen, Heart, Uterus, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4734 Sex: Feaale Group: ( 61 FC-143 30 ppa Fate: (Meek1 95) Sacrificed in extreais
Macroscopic Observations: Pituitary Haaaary Gland
Liver Microscopic Observations:
Adrenal Liver Lung Haaaary Gland Pituitary
-Heaorrhagic aultilobular aass, 1.2 x C.S ca. -Cystic aass, 3 x 3 x 1.5 ca, in le ft inguinal
-area. -Possibly slightly pale.
-Sinusoidal ectasia, cortex, aoderate -Hepatocyte vacuolation, periportal, aoderate -Heaorrhage, aultifocal, aild -Lobular hyperplasia, cystic -Adenoaa
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 201
365
OC0753
Suaaarized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Tear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4734 Sex: Feaale Group: ( 6 ) FC-143 30 ppa Fate: (Neek= 95) Sacrificed in extreais
Microscopic Observations (continued): Spleen Stoaach
-Heeosiderosis, aarked -Ulcer, aultifocal, aild
The following tissues ere Found to be within noraal lia its : Kidney, Heart, Uterus, Ovary, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Eland, Pancreas.
Aniaal Nuaber: IP-4715 Sex: Feaale Broup: ( 6) FC-143 30 ppa Fate: (Keek= 50) Sacrificed in extreais
Macroscopic Ohse-vations: Maaaary Bland
Live' Microscopic Observations:
Adrenal
Liver Lang Parathyroid Skin
Spleen
-Large Fire aass, 9 x 6.5 x 4.5 ca, ulceated skin surface, right axilla, circular aass, 2.5 ca die., le ft axilla.
-Pale areas on a ll lobes.
-Cortical vacuolation, Focal, aild Sinusoidal ectasia, cortex, aild -Necrosis, centrilobular, aarked
-Vascular aineralization, .ainiaal -Not exaained, not in plane of section -Fibroaa Fib'osarcoaa -Heaatcpoiesis, extraaedullary, increased, ;ld
The -tollc:*iir,g tissues were Found to be within noraal U nits: Kidney, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Bland, Pituitary, Pancreas, Hanary Bland.
Aniial Nuaber: 1R-4736 Sex: Feiale Broup: ( 1 FC-143 30 ppa Fate: (Week= 105) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Liver
Parathyroid Pituitary Thyroid
-No visible lesions.
-Hepatocyte alteration, vacuolated, Focal, ainiaal -Not exaained, aissing -Adenoaa -Not exaained, aissing
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 202
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gganiMMIIi
Suiearized Single Tabulated Anieal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H F C -1 4 3 : Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: IR-4736 Sex: Feaale Group: ( 6) FC-143 30 ppa Fate: INeek= 105) Terainal Sacrifice
Hicroscopic Observations (continued):
-
The following tissues were found to be within noraal lia its : Spleen, Kidney, Heart, Lung, Uterus, Ovary, Haaaary Eland, Stoeach, Urinary Bladder, Adrenal, Trachea, Esophagus, Salivary Eland, Pancreas.
Aniaal Nuaber! 1R-4737 Sex: Feaale 6rcup: ( 6) FC-143 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Hacroscopic Observations: Pituitary Haaaary Gland
Hicroscopic Observations: Adrenal Kidney
Liver
Bast-ary Eland
Ovary
Pancreas *. * wcr j
JUW C . . Y 3 I J
Oi i ' U
L'ts'us
-Raised lass, 0.6 cs d:a. -Bass, 2 x 1.5 cs, in per;real area; cass, 3 x
4 " 1 cc, in -igh.t inguinal a-ea.
-Sinusoidal ectasia, cortex, code-ate -Chronic progressive nephropathy, cinita! Pelvic liReralization, aimsal -Hepatocyte vacudatior, periportal, slid -Vascular aineralizatior,, sinusal -Fibroadenosa Fibroader-osa -Tubular hyperplasia, bilateral, eoderate -Not examined, cissin; -Adenotia -Sialadenitis, chronic, slid -Not examned, cissir.g
Tha following tissues were found to be within no-sal lis its : Spleen, Hea-t, Stosach, Urinary Bladder, Thyrs:id, Pa-athyrcid, Tracha, Esophagus.
Anisal * usher: 1F.-A73B Ses: Fecale Group: ( t i FC-143 30 pps Fate: Otee* 101) Sacrificed in extreiis
Hacrcscopic Observations: Haaaary 3!and
Adrenal Hicroscopic Observations:
Adrenal
Kidney
-Large subcutaneous aass, 9 x 12 x 5 ce, in right axilla.
-Le: t ad-enal slightly enlarged.
-Cortical vacuolation, local areas, sodErate Sinusoidal ectasia, cortex, eoderate Nodular hyperplasia, cortex, focal, soderate -Pelvic Bineraiization, ni 1d
Species: Rat Project Nuaber: 02B1CRC012
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Sueaarized Single Tabulated Antal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nuiber: 1R-4738 Sex: Fetale Group: ( 4) FC-143 30 ppe Fate: (Heeks 101) Sacrificed in extretis
Microscopic Observations (continued): Liver
Lung Maatary Gland Pituitary Skin Stoaach Thyroid
-Hepatocyte alteration, basophilic, focal, eild -Vascular aineralization, aild
-Not exaained, aissing -No diagnosis, inadequate section -Fibroea -Necrosis, focal, aucosal, aild -Hyperplasia, C cell, focal, aild
The following tissues were found to be within noraal U nits: Spleen, Heart, Uterus, Ovary, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Anna! Muster! 1R-4739 Sex: Aeeale Group! ( 6) FC-143 30 ppa Fate: (keel1 105) Terimal Sacrifice
Macroscopic Observations: Maaaary Gland
Spleen Microscopic Observations:
Adrenal
Hear t Kidney
Liver Lung Maaaary Gland Skin
Spleen
-Very large aultilobular aass, 14.5 x 10 x 4.5 ca, in the axillary and lateral area.
-Enlarged
-Sinusoidal ectasia, cortex, acderate Keaatopoipsis, extraaedullary, cortical, aoderate -Myocarditis, chronic nonsuppurative, aultifocal, aild -Protein resorption droplets, tubular, aild Pigaent, conv. tub. epitheliua, aoderate Nephrosis, tubular, aild
-Heaatopoiesis, extraaedullary, aild -Vascular aineralization, aild Hyperplasia, septal cell, focal, aild -Not exaained, aissing -Fibrosarcoaa
Extensive necrosis and ulceration. No aaatary tissue ir tunor. -Heaatopoiesis, extraaedullary, increased, aarked
The following tissues were found to be within noraal lia its : Uterus, Ovary, Stcaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus,
Species: Rat Project Nuaber: 0281CR0012
ST" p,!,; ftoo
Summed Single Tabulated Anital Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nuaber: 1R-473S Sex: Feeale Broup: < 6) FC-143 30 ppe Fate: (Week: 105) Tereinal Sacrifice
Microscopic Observations (continued): The following tissues were found to be within noria! lie it s (continued): Salivary Bland, Pituitary, Pancreas.'
Ar.iaal Nuaber: 1R-474C Sex: Fenale Broup: ( 6) FC-143 30 ppe Fate: (Neek= 105) Teriinal Sacrifice
lt>u. __ 1
Macroscopic Observations: Haeeary Bland
Microscopic Observations: Adrenal
Kidney
Lung
Nanaary Bland Parathyroid Pituitary Thyroid
-Mass, 4 x 3 x 1 ce, in perineal area.
-Sinusoidal ectasia, cortex, aoderate Medullary cell hyperplasia, eultifocal, ai Id -Pelvic aineralization, eiId
-Hepatocyte alteration, vacuolated, aild Hepatocyte alteration, basophilic, aild -Vascular aineralization, ni Id Perivascular aononuclear in filtra te , aild -Lobular hyperplasia
-Not exaained, not in plane of section -Adenoea -Ultieobranchial cyst
The following tissues were found to be within nornal lie its : Spleen, Heart, Uterus, Ovary, Stoeach, Urinary Bladder, Trachea, Esophagus, Salivary Bland, Fanc-eas.
Aniial Nunber; 1R-474! Sex! Fecale Broup: ! 6) FC-143 30 ppe Fate: (Keek* 97) Sacrificed in extreeis
Macroscopic Observations: Pituitary Maneary Bland
Microscopic Observations: Adrenal Kidney Lung
Haeeary Eland Parathyroid Pituitary
-Raised dark eass, 1.3 ce dia. -Nodular lesion, 1 ce dia., in perineal area.
-Sinusoidal ectasia, cortex, aoderate -Chronic progressive nephropathy, aild -Vascular aineralization, ainiea! Heaorrhage, focal, aild -Lobular hyperplasia -Not exaained, not in plane of section -Adenoea
The following tissues were Found to be within noreal lie its : Spleen, Liver, Heart, Uterus, Ovary, Stoeach, Urinary Bladder, Thyroid, Trachea, Esophagus,
Species: Rat Project timber: 0281CR0012
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Suuarized Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3(1 FC-143: Two Year Oral Toxicity-Oncogenicity Study ir Rats
Table: 2
Aniial Nuiber: 1R-4741 Sex: Feiale Group: ! 6) FC-143 30 ppi Fate: (Meek= 97) Sacrificed ir, extreiis
Microscopic Cbse-vations (continued):
"
The following tissues were found to be within norsal lin t s
Salivary Bland, Pancreas.
(continued):
Aniial Nuater: 1R-4742 Sex'. Feiale Group: ( t! FC-143 30 ppe Fate: (Keek- 63) Found Dead
Macroscopic Observations: Maiaary Gland
Adrenal Pituitary Microscopic Observations: Adrenal Esophagus Kidney Liver
Lung Mataary Gland
Pancreas Parathyroid Pituitary Spleen Thyroid Trachea
-Large m ltilobular lass, 10 x 9 x 3 ci, in right axilla; necrotic aass, 4 x 3 ct, in le ft inguinal area.
-Possibly slightly enlarged. -Heicrrhagic lass, 0.5 ci dia.
-Sinusoidal ectasia, cortex, loderate -Not exalined, lissing -Pelvic sineralization, lild -Necrosis, aultifocal, eild Atrophy, hepatocytes, centrilobular, aoderate -Vascular eineralization, lild -Fibroadenoaa Fibroadenoia -Not exaained, lissing -Not exaiined, lissing -Adenona -Not exaiined, cissing -Not exaiined, lissing -Not exaiined, lissing
The following tissues were found to be within :norial l i i i t s : Heart, Uterus, Ovary, Stoaach, Urinary Bladder,, Salivary Gland.
Aniial Nuiber: IR-4743 Sex: Feiale Group: ( 6) FC-143 30 ppi Fate: (Meek1 97) Sacrificed in extreiis
Macroscopic Observations: Pituitary Mattary Gland Lung
Liver
-Raised heiorrhagic lass, 1 c i dia. -Circular lass, 2 ci dia, in perineal area. -Areas of consolidation in right anterior and
apical lobes. -Possibly Bottled
Species: Rat Project Nuiber: 02E1CR0012
Suuarized STAR Page: 2j
Suaaarized Single Tabulated Aniaal Report (continued) Individual Racroscopic and Ricrcscopic Observations
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nueber: 1R-4743 Sex: Feeale 6roup: ( 6) FC-143 30 ppe Fate: (Neek= 97) Sacrificed in extreeis
Ricrcscopic Observations (continued): Adrenal Kidney Liver
Lung
Haseary Bland Pancreas Pituitary Urinary Bladder Uterus
'
-Sinusoidal ectasia, cortex, eiId -Pelvic eineralizatior., earked -Hepatocyte vacuolation, periportal, derate Hepatocyte alteration, basophilic, focal, rild -Vascular eineralization, tild Pneusonia, acute exudative, local areas, eild Heeorrhage, ultifocal, ni Id -Fibroadenoaa -Acinar atrophy, eild -Adenoaa -Epithelial hyperplasia, siaple, diffuse, eild -Cystic glands, aarked
The following tissues were found to be within noreal lie its : Spleen, Heart, Ovary, Stoaach, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, Skin.
Ari aal Nueber: 1R-4744 Sex: Feeale Group*. ( 6) FC-143 30 ppe Fata: ikieek* 4B) Found Dead
Racroscopic Ofcse-vations: Haaeary Gland
Heart Lung
Ricrcscopic Observations: Kidney Lung Raaeary Gland
Pituitary Spleen
-Rass, 8.5 x 7.5 x 4.5 ci, hollow cavity fille d with brown aatter, in le ft inguinal area.
-Possibly slightly enlarged. -Rultiple grayish tar, raised nodules, 0.1 -
C.3 ca dia.i 2 nodules in le ft lobe, 3 nodules in right cardiac lobe! 2 nodules in right intermediate lobe; 3 nodules in right diaphragsatic lobe.
-Chronic progressive nephropathy, ainiaal -Retastatic necolast Heiorrhage, local areas, eild -Adenocarcinoia
Extensive necrosis in tucor; areas highly anaplastic. Locally invasive. Rultiple lung aetastases. -No diagnosis, inadequate section -Heaatcpoiesis, extraaedullary, increased, aoderate
Species: Rat Project Nueber: 02B1CR0012
....Smeari zed STAR Page: 207 37 \
&00759
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. JM FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4744 Sex: Feaale Group: ( 6) FC-143 30 ppe Fate: (Week- 4S! Found Dead
Microscopic Observations (continued):
The f cl Idling tissues were found to be within noraal lia its : Liver, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Eland, Pancreas.
Aniaal Nuaber: 1R-4745 Sex: Feaale Group: ( 6) FC-143 30 pp* Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Pituitary Hairary Sland
Microscopic Observations: Adrenal Esophagus Kidney
Lung
Haar,ary Sland Ovary
Pituitary
-Saall raised dark lass, 0.4 ca dia. -Hass, 5 x 4 x 2 ca, in perineal area.
-Sinusoidal ectasia, cortex, aoderate -Not exasined, aissing -Chronic progressive nephropathy, aild Pelvic aineralization, aild -Vascular aineralization, aild Fneuaonia, in te rs titia l, chrcnic, aultifocal, aild Alveolar aacrophages, aultifocal, aild -Fibroadenoaa -Tubular hyperplasia, unilateral, aoderate Granulosa cell tuaor, benign, unilateral -Adenora
The following tissues were found to be within noraal lia its : Spleen, Liver, Heart, Uterus, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4746 Sex: Feaale Group: I 6! FC-143 30 ppa Fate: (Neek= B7! Sacrificed in extresis
Hacroscopic Observations: Pituitary Haaaary Gland
Spleen Microscopic Observations:
Ad'enal Kidney Liver
-Enlarged with 0.7 ci dia. aass. -Multilobular aass, 11 x & x 3 ca, in le ft
inguinal area. -Slightly enlarged
-Sinusoidal ectasia, cortex, aild -Pelvic aineralization, ainiaal -Hepatocyte vacuolation, aultifocal, ainiaal Hepatocyte alteration, basophilic, aultifocal, aild Heaatopoiesis, extraaedullary, aultifocal, ainiaal
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Page: 20B
372
'07S0
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4746 Sex: Feaale Group: ( 6) FC-143 30 ppa Fate: (Week= S7) Sacrificed in extreais
Microscopic Observations (continued):
Lung
Maaaary Gland Pituitary
Spleen
-Vascular aineralization, ai Id -Adenocarcinoaa -Adenora -Keaatopoiesis, extraaedullary, increased,
aoderate
The -fallcwing tissues were found to be within noreal lim its: Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Anisal Nuaber: 1R-4/47 Sex: Feaale Group: ( fc) FC-143 30 ppa Fate: (Keek1 105'! Terminal Sacrifice
Macroscopic Observations: Maaaary Eland
Microscopic Observations: Adrenal
Liver
Lung
Maaaary Gland Ovary Pancreas Skin Spleen
-Lobular aass, 5 x 4 x 3 ca, in throat area: lobular aass, 5 x 2.6 x 1.5 ca, in le ft axilla; lobular aass, 7 x 4.5 x 3 ca, in right inguinal area.
-Sinusoidal ectasia, cortex, mild Medullary cell hyperplasia, multifocal, mi 1d -Portal aoncnuclear cell in filtra te , mild Porta! bile duct proliferation, mild Heaatopoiesis, extraaedullary, minimal Hepatocyte alteration, basophilic, multifocal, mild -Vascular aineralization, minimal Alveolar aacrophages, aild -Fibroadenosa Fibroadenoaa -Cyst, unilateral -Not examined, aissing -Fitroaa -Heaatopoiesis, extraaedullary, increased, aild
The following tissues were found to be within noraal lim its: Kidney, Heart, Uterus, Stoaach, Urinary Bladder, Thy-cid, Parathyroid, Trachea, Esophagus, Salivary Eland, Pituitary.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized STAR Page: 2^ - q .q
Suiiarized Single Tabulated flmaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FC-143: T*o Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Annal Nuaber: 1R-474B Sex: Fetale Broup: ( 6) FC-143 30 ppt Fate: !Neek= Bl! Sacrificed in extreeis
Macroscopic Observations: Pituitary Matiary Bland
Adrenal
Kidney
Microscopic Observations: Adrenal
Esophagus Kidney Liver
Lung
Mainary Bland
Parathyroid Pituitary Thyroid Trachea Urinary Bladder
-Enlarged due to red tass, 1.3 x 1.2 x 0.B ca. -Subcutaneous aass, 3.5 x 3 . ct, le ft
axillary; subcutaneous aass, 1.5 x 2 ca, le ft inguinal. -Right adrenal darkened and enlarged, 1.4 ci dia., fille d with reddish liquid. -Stall cyst, 0.4 cn dia., on surface of le ft kidney.
-Sinusoidal ectasia, cortex, larked Cortical degeneration, loderate -Not exaiined, ussing
-Chronic progressive nephropathy, aiId -Portal lononudear cell in filtra te , lild Hepatocyte alteration, basophilic, lu ltifo c a l, ild -Vascular lineralization, iiId Heaorrhage, local areas, Bild -Fibroadenota Adenocarcinoia Ealactccele -Not exaiined, ussing -Adenoia -Not exaiined, lissing -Not exaiined, lissing -Epithelial hyperplasia, siiple, local areas, ild
The fcIloNirg tissues ere found to be within norial I i i i t s : Spleen, Heart, Uterus, Ovary, Stoiach, Salivary Gland, Pancreas.
Aniial Nuiber: 1R-4749 Sex: Feiale Broup: ( 6) FC-143 30 ppi Fate: (Neelf= B2) Sacrificed in extreiis
Macroscopic Observations: Pituitary Maiiary Bland
Microscopic Observations: Adrenal Kidney
-Heaorrhagic lass, 1 x 0.5 ci dia. -Stall ilk cyst present.
-Sinusoidal ectasia, cortex, larked -Chronic progressive nephropathy, aiId Pelvic lineralization, lild
Species: Rat Project Nuiber: 02B1CR0012
Sunarized STAR Page: 210
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4749 Sex'. Feaale Group: ( 6) FC-143 30 ppa Fate: (Heek= 82) Sacrificed in extreais
Microscopic Observations (continued): Lung
Maaaary 61and Pituitary
-Vascular ainerslization, aild Heaorrhage, local areas, aild -Balactocele -Adenoaa
The following tissues aere found to be within noraal lia its : Spleen, Liver, Heart. Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 6!and, Pancreas, Eye, Skin.
Aniaal Nuaber: 1R-4750 Sex: Feaale Broup: < b) FC-143 30 ppa Fate: (Neex= 97) Found Dead
Macroscopic Observations: Kaaaary Eland
Pituitary Microscopic Observations:
Adrenal Harderiar, Bland
kidney Liver Lung Maaaary Bland
Parathyroid Pituitary Thyroid Uterus
-Multilobular aass, 0.3 x 2 ca, ir. right inguinal area; aultilobular aass, 8.5 x 5 x 4 ca, in right axilla.
-Enlarged, 0.9 ca dia.
-Sinusoidal ectasia, cortex, aild -Adenocarcinoaa
Not described at necropsy. Probably froa c lin ica lly described atrophic right eye. -Pelvic aineralization, aild -Hepatocyte vacuolation, aultifecal, aild -Edeaa, local areas, aild -Fibroadenoaa Balactocele Fibroadenoaa -Not exaained, aissing -Adenoaa -Not exaained, aissing -Cystic glands, aarked
The following tissues aere found to be within noraal lia its : Spleen, Heart, Ovary, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary 61ar.d, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
Suaaarized 5TAR Page: 211
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Sum m ed Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-4751 Sex: Feeale 6roup: ( 4) FC-143 30 ppt Fate: (Neek- 42) Found Dead
Macroscopic Observations: Hataary Bland
Microscopic Observations: Kidney Lung Skin Spleen
Stoaach
-Subcutaneous tass, B x 5.5 x 4.5 ca., right
axilla
-Pelvic fineralization, ainital -Vascular fineralization, ainital -Fibrota -Heeatopoiesis, extraaedullary, increased, federate -Ulcer
The following tissues were found to be within noreal l i f i t s : Liver, Heart, Uterus, Ovary, Mattary Bland, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pituitary, Pancreas.
Anital Nueber: IR-4752 Sex: Fetale Broup.' ( 6) FC-143 30 ppt Fate: lkleek= 105! Terainal Sacrifice
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal
Kidney
Lung Ovary
Pancreas Pituitary
-Raised beaorrhagic aass, 0.4 ci dia.
-Sinusoidal ectasia, cortex, foderate Nodular hyperplasia, cortex, foderate
-Chronic progressive nephropathy, c:Id Pelvic fineralization, tiniaal -Vascular fineralization, mild
-Cyst, bilateral Tubular hyperplasia, bilateral, foderate -Hyperplasia, is le t ce ll, eild -Adenofa
The following tissues were found to be within noreal l i f i t s : Spleen, Liver, Heart, Uterus, Haeeary Bland, Stoeach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland.
Anital Nueber: 1R-4753 Sex: Fetale 6roup: ( 6) FC-143 30 ppt Fate: (Week= 105) Terainal Sacrifice
Macroscopic Observations: Pituitary Skin Hataary 61and
-Enlarged with stall dark lesions, 0.2 ct dia. -Hair less on head. -Lobular tass, 4 x 3 x 2 ct, in perineal area.
Species: Rat Project Nueber: 0281CR0012
Suttarized STAR Page: 212
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Suiiarized Single Tabulated Anisal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nusber: 1R-4753 Sex: Fesale Group: ( 6) FC-143 30 pps Fate: iHeek= 105) Tersinal Sacrifice
Microscopic Observations (continued): Adrenal Kidney Liver
Lung Massary Gland Ovary Pituitary Spleen
'
-Sinusoidal ectasia, cortex, sild -Pelvic sineralization, unilateral, sarked -Porta! sononudear cell in filtra te , sild Portal bile duct proliferation, sild Hepatocyte vacuolation, sultifocal, sild Hepatocyte alteration, vacuolated, sild -Vascular sineralization, sild -Fibroadenosa -Tubular hyperplasia, bilateral, soderate -Adencsa -Not examined, sissing
The following tissues were found to be within norsal lis its : Heart, Uterus, Stosach, Urinary Bladder, Thyroid,, Parathyroid, Trachea, Esophagus, Salivary 61and, Pancreas.
fir, i sal Nster : 1R-4754 Sex! Resale 6roup: ( 6) FC-143 30 pps Fate: (Reek 105) Te-sinal Sacrifice
Macroscopic Observations: Massary SI and
Microscopic Observations: Ad'enal Kidney Liver
Lung
Massary Gland Ovary Pituitary Spleen
-Lobulated sass, B x & x 3 cs, in inguinal and perineal areas; sass is quite necrotic and cystic.
-Sinusoidal ectasia, cortex, soderate -Pigsent, conv. tub. epithelius, brown, soderate -Portal sononudear cell in filtra te , sild Portal bile duct proliferation, sild Hepatocyte vacuolation, sultifocal, sild Hepatocyte alteration, vacuolated, sild -Vascular sineralization, sild Pneusonia, in te rs titia l, chronic, sultifocal, sild Alveolar sacrophages, sultifocal, sild -Adenocarcinosa -Cyst, unilateral -Adenona -Hesatcpoiesis, extrasedullary, increased, soderate
The following tissues were found to be within norsal lis its : Heart, Uterus, Stosach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus,
Species: Rat Project Nusber: 0261CR0012
Sussarired STAR Page: 213
377
000765
Suiaar;zed Single Tabulated Aniial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3K FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Ar.iaa Nueber: 1R-4754 Sex! Feeale Group: ( 6) FC-143 30 ppi Fate: (Ueek= 1C5) Terainal Sacrifice
Microscopic Observations (continued):
-
The folloving tissues Mere found to be Mithin norial l i i i t s (continued):
Salivary Bland, Pancreas.
Aniial Nueber: 1R-4755 Sex: Feeale Group: ( 61 FC-143 30 ppi Fate: (Week= 105) Terminal Sacrifice
Macroscopic Observations: Pituitary
Microscopic Observations: Adrenal Esophagus Heart
Kidney
Liver
Lung Ovary Parathyroid Pituitary Thyroid Trachea
-Heiorrhagic uss, 0.7 ci dia.
-Sinusoidal ectasia, cortex, derate -Not exaiined, lissing -Myocarditis, chronic nonsuppurative, ultifocal, mild -Chronic progressive nephropathy, liniea! Pelvic lineralization, lild -Hepatocyte alteration, basophilic, focal, ild * -Alveolar lacrophages, focal, a iniial -Tubular hyperplasia, bilateral, derate -Not exaiined, aissing -Adenoia -Net exaiined, aissing -Not exaiined, aissing
The fclloeing tissues Mere found to be Mithin norial l i i i t s : Spleen, Uterus, Matiary Gland, Stoeach, Urinary Bladder, Salivary Gland, Pancreas, Skin.
Species: Rat Project Nuiber: 028ICR012
izedSueur STAR Page: 214 378
C00766
Tissus Inventory Table: 3
Riker Laboratories, Inc. 3N FC-143: Teo Year Oral Toxicity-Oncogenicity Study in Rats - One Year In te rii
Project Nueber: 0281CR0012 Species: Rat
Tissue Naae
Oose Sroup Naae: CONTROL 0 ppa
1111111111111111111111I 11 RRRRRR- RRRRRRRRRRRRRRRRRRR
Anieal Nuebers 333333333333333444444444 4 555555555555555555555666 6 1 1 222344 55567787B8BB9001 2 6 7 0 2 75 3 6 0 l98 0 5 0 8 25 B9 0 1 8 0 0
Sex N H N N N N MH H N H H K H n f F F F F F F F F F
Adrenal Aorta Bone Harrou Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyaph Node (aesenteric) Haeaary Eland Ovary Pancreas Parathyroid Pituitary
4+++444+44444444444444444
+ + ++ 4 4 4 4 +4 ++ 4 4 4 4 4 4 4 4 4 4 4 4 4
++4+44444+++44C4444444444
4++444444 ++ 44 44 44 44 4444 4
4+44444444+4444444444444
4 +44 4 4 +4 4 4 +4 4 44 4 4 4 4 4 4 4 4 4
4444+4+444444444444444444
4 4 4 4 +4 4 4 ++ 44 44 44 4 4 4 4 4 4 4 4 4
444444444 4+44 44c 444 44 444
444444444++4444444444444
4+++444++444444444444444
c +c + ++44444C444444C44
++-4
444 4444 444
4 4 4 4 4. 4 4 4 4 4
44444444+44444444 4444444
c c cc +c +4+44CC4CCc c 4C44+C4
4 +c +4 4 4 +44 44 4 4 4 4 4 44 4 44 4 4 4
Prostate
4 4 44 +4 44 ++44 4 4 4
Salivary 61and Snail Intestine Spinal Cord Spleen
+4++4444 +4444444444444444 +44444444444444444444444 +++ 44 44 444444c 4 44C44 4444 4 ++++4 ++4 + 44 4 4 4 44 4 4 4 44 44 4
Stoaach Testis/Epididyais Thyroid Trachea Urinary Bladder Uterus
+444++c 444444444444 44 444 4 4 4 4 +4 4 4 +4 4 4 44 4
cc+c4c 4444444444444444444 4+44+44444444444444444444
4+++4444 +4444444c4444444C 4444444444
--------------------------- jhe fo il ouing tissue(s) ere not required by protocol ---------
Nesentary
--------- - +
Skin - --------- -- -------- -- ----------------------
Ureter
............................................................
A + indicates that a diagnosis uas aade. A - indicates that no diagnosis or coaaent uas aade. A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 215
379
Tissue Inventory (continued)
Table: 3
Riker Laboratories, Inc. 3H
FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats - One Year Interie
Project Nueber: 0281CR0012 Species: Rat
Tissue Naae
Dose Broup Nane: CONTROL 0 ppa ! I 1 11 RRRRR'
Ani sal Nuebers 44444
66666 23334 9 0 12 0 Sex F F F F F
Adrenal Aorta Bone NarroM Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyiph Node (eesenteric) Nasiary Bland Ovary Pancreas
++444 c+444 ++444 +444 +444 ++444 ++444 ++444 ++444 4.4 4 4 4 44444 44C + + 4 44 4 4 4 44 4 4 4 44 + 4
Parathyroid Pituitary
C CC + C
4 44 44
Prostate
Salivary 61and
4 +4 + 4
Seall Intestine
4 44 4 4
Spinal Cord Spleen
4 44 44 4 44 4 4
Stoeach
4 44 4 4
Testis/Epididyais
Thyroid
4C+
Trachea
44444
Urinary Bladder Uterus
44C++
44444
The follouing tissue(s) Here not required by protocol
Hesentary
Skin
Ureter
A + indicates that a diagnosis uas aade. A - indicates that no diagnosis or coeeent eas sade. A c indicates only a nondiagnostic coeeent eas eade. Please reFer to the Single Tabulated Anieal Report.
Tissue Inventory Page: 216
380
CO0768
Tissue Inventory (continued) Table: 3
Riker Laboratories, Inc. 3H FC-H3: Two Year Oral Toxicity-Oncogenicity Study in Rats - One Year In te rii
Project Nuaber: 02B1CR0012 Species: Rat
Tissue Naee
Dose Eroup Naee: FC-1A3 300 ppt 1I111 11111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers-------------- ---------------- -- ------------------------------ -3333333333333334444444444 555556 6 6 6 6 i 6 i 6 6 6 t 6 6 6 i 6 i 6 6 0BB99O1 1 2 2 2 2 3 4 4 4 5 5 5 6 6 6 7 7 7 4892843702678232256469146
Sex H H H R N H H H H H H H H H H F F F F F F F F F F
Adrenal
4444444444444444444444444
Aorta
c +c ++c ++c ++++++++c +++++c +
Bone Harrow
4444444444444444444444444
Brain
++++++++++4 ++++++++++++++
Esophagus Eye
4444444444444444444444414 4444444444444444444444444
Heart
4444444444444444444444444
Kidney
4444444444444444444444444
Large Intestine
44444444444444444444444c*
Liver
4. 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Lung
4444444444444444444444444
Lyaph Node (aesenteric)
444444444444cc++++c+44444
Naeaary Bland
---------------------------- ----------- ( * ' 4 * c * * *
Ovary
- - - --------------------------- - - - - - - 4 4 4 4 4 4 4 4 4 4
Pancreas
4444444444444444444444444
Parathyroid
c+ccccc+cccc+cccc+++++cc+
Pituitary
4 444[ 4 44 4 * C * C * * M [ t 4(4444
Prostate
4 4 4 4 4 4 4 4 4 C + + C + + .............................. ........
Salivary Eland Stall Intestine
44444C +++++++++++++++++++
4444444444444444444444444
Spinal Cord
4444444444444444444444444
Spleen
4444444444444444444444444
Stoaach
4444444444444444444444444
Testis/Epididyais
4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 ---------------------------- ---- ---------------
Thyroid Trachea
4 4 C + + + 4 4 4 4 4 4 4 C + + + + + + ++ + + +
4444444444444444444444444
Urinary Bladder
444c44444444c+++++++++*++
Uterus
4444444444
--------------------------- 7he following tissue(s) were not required by protocol --------------------------
Hesentary
-------------------------------------------------- ----------------
Skin - - - --------- 4 ---------- -- ---------------------------------
Ureter
-------------- -------------------------------------- -- ----------
A 4 indicates that a diagnosis as aade. A - indicates that no diagnosis or coaaent as aade.
381
A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 217
000769
Tissue Inventory (continued)
Table: 3
Riker Laboratories, Inc. 3H
FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats - One Year Interie
Project Nuaber: 02S1CR0012 Species: Rat
Tissue Naae
Dose Group Naie: FC-143 300 ppt 1 1 1 1i RRRRR-
Aniaal Nuabers 44444 b6 6 b7 8 B9 9 0 79294
Sex F F F F F
Adrenal
4 4 44 4
Aorta Bone tlarroH Brain Esophagus Eye Heart Kidney Large Intestine
44444
++ ++ +++++ c 4 +++ + ++ + ++++ ++++* +++++
Liver
44444
Lung
44444
Lyaph Node (aeser.teric) Haeaary Gland
++c + c+4 ++
Ovary
44444
Pancreas
44444
Parathyroid
CCHt
Pituitary
44444
Prostate Salivary Gland
+++++
Saall Intestine Spinal Cord
44444
++ +++
Spleen Stoaach
44444
+++++
Testi s/Epi didyais
Thyroid Trachea Urinary Bladder
+c ++c ++* +
++++
Uterus
t ++
--------------------------- The f o ilOKing tissueCs) uere not required by protocol
Nesentary
------------
Skin ..............
Ureter .
+ - ------
382
A ind ic a te s that a diagnosis Has ia d e . A - ind ic a te s th a t no diagnosis or coeaent aas aade.
A c indicates only a nondiagnostic coaaent Has aade. Please refer to the Single Tabulated Aniaal Report.
C O 0 7 7 0Tissue Inventory Page: 218
Tissue Inventory
Riker Laboratories, Inc. 3N FC-143: To Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naae
Dose Group Nate: CONTROL 0 ppa 1111111111111111111111111 RRRRRR- RRRRRRRRRRRRRRRRRRR
Aniial Nuebers - -------------------------- - --------------- - -------------3333333333333333333333333
55555555555555555555 55555 1 i 2 2 2 2 2 n4. 2 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 B9 1 3 4 5 6 8 9 0 12 3 4 b7 B9 0 1 2 4 5 7 B Sex H H MN N H N H H N H H It H H H H H H H H H H N H
Adrenal Aorta Bone Marrox Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyaph Node (aesenteric)
4 + 44 +4 4 4 4 4 4+ 44+ 44 +4 +4 4 4 4 +4 4 4 4 4 + 4 4 + 4 + + 4 4 4 + 4 4 4 + + + + + 4 + 4 + 4 + 4 4 + 4 4 4 4 4 4 c4 4 4 4 4 4 4 + 4 4 + + + 4 4 4 4 +4 4 4 4 +4 4 4 +4 4 4 4 c 4 +4 +4 +4 +4 4 4 4 4 4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 +4 +4 4 4 c 4 +c 4 4 4 4 4 4 C + + 4 4 4 4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 +4 4 4 4 4 4 4 + 4 4 4 4 4 4 4 +4 4 4 4 4 4 4 4 +4 4 4 4 ++4 4 4 4 +4 4 +4 4 4 +++ 4 4 4 4 ++4 ++++++4 4 4 4 +4 4 +++ +4 4 4 4 4 +4 4 4 4 +4 4 4 4 4 4 4 4 4 4 4 4 4 +4 4 4 c 4 +4 4 4 4 +4 +4 c 4 4 4 4 4 4 4 4 4
Naaaary Gland
Ovary Pancreas Parathyroid Pituitary Prostate Salivary 61and Stall Intestine Spinal Cord
+4 4 +4 +4 4 4 4 4 4 4 4 4 c 4 4 4 4 4 4 4 4 4 c 4 c 4 c c 4 4 c 4 4 4 4 c 4 c c c 4 4 +c ++c ++ 4 4 4 4 + + 4 4 4 4 4 4 +4 4 4 4 4 4 4 4 4 4
+++4 4 4 +4 c 4 4 4 4 4 4 4 4 +c c 4 4 4 4 4 +4 +4 4 4 4 4 c 4 4 4 4 4 4 4 ++4 4 4 +++ +4 + 4 + + + 4 4 4 4 4 + 4 4 4 4 4 4 4 4 4 + ++
4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 c4 4 4 + + +
Spleen
4444+444++44+44+44 44 ++444
Stoaach Testis/Epididyais Thyroid Trachea Urinary Bladder
++44++444+4+44444++4 44444
4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 +c 4 4 4 4 4 c 4 4 4 4 4 4 4 4 4 +4 4 c 4 c 4 4 4 4 c + ++ +4 4 4 4 4 4 4 4 4 4 4 4 +4 +4 4 4 4 4 4 + + t +4 4 +4 4 4 4 4 4 4 4 4 4 cc 4 ++++
Uterus
--------------------------- Tl,e follouing tissue(s) ere not required by protocol
Bone --------- - + - - - ----------------
C litoral Gland Harderian 61and
------------ - ----------------------. . . . --------------- . . . . .
Lyeph Node
------------ . . . . . . . . . .
Lyeph Node (abdoainal)
------------- - - - - - - - - -
Lyeph Node (thoracic)
-------------------- -- ------------- --
Hesentary
-------------- ---------------- --------
A + indicates th at a diagnosis aas eade. A - in dicates th at no diagnosis or coaeent was Bade.
383
A c indicates only a nondiagnostic coaaent as Bade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 219
000771
Tissue Inventory (continued)
Riker Laboratories, Inc. 3M FC-143: To Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Eland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Consent
Dose 6roup Naae: CONTROL 0 ppa 1111 11111111111111111111 RRRRRR' RRRRRRRRRRRRRRRRRRR
Aniaal Nuabers 33333333.3 33333 33333333333 5555555555555555555555555 1122222223333333334444444 B9 13 4 5 b 6 9 0 12 3 4 6 7 8 9 0 1 2 4 5 7 B
Sex N H N N N N N H H N N N N N N H N H H K K R n N N
----------------------- - ---------------------------------+ - + + --------- + ................ + + - - - + - - +
------------------------------- - ------------------------------------- - --------- ------------------------------------------ -- ----------------------------------------------------------------- ------------------------------ -- ------------------------------ -- ---------------- -- --------------------------------------------- - - - ---------------- - ----------------- ---------- -- ----------------------------------- -- ------------------- ---------------------------------
A indicates that a diagnosis aas aade. A - indicates that no diagnosis or coaaent aas Bade.
384
A c indicates only a nondiagnostic coaaent aas aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 220
CC0772
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber! 02B1CR0012 Species: Rat
Table: 4
Tissue Naae
Dose Group Naae: CONTROL 0 ppe
1 1 1 1 I'1 1 1 1 1 1 1 1 1 I I 1 1 1 1 1 1 1 1 1
RRRRRR- RRRRRRRRRRRRRRRRRRR Aniaal Nuabers ------------------------- -- ---------------------------------- -
3333333333333333333333333 5555555555555555555555555 455555556 4i 6 i 6 i i i 77777777 9 2 3 4 5 &7 0 0 12 3 45 b7 9 123 4 6 7 8 9 Sex H N N N H N N N H N N N H N N N N N N N N N N N N
Adrenal
4 4 4 4 4 4 4 4 4 4 4 4 c4 4 4 4 44 4 4 4 4 4
Aorta Bone Marrov
44 4 4 4 4 4 4 4 4 4 44 c4 4 4 4 4 4 4 4 44 4 +4 4 4 4 4 4 4 4 C4 4 C4 4 4 4 4 4 4 4 4 4 4 4
Brain
4 444 4 4444 444 44 44 4444 44 4 44
Esophagus
444 4444444444C44 44 44 44444
Eye 4 4 C 4 4 4 4 4 4 4 4 4 4 c 4 4 4 4 4 4 4 4 4 4 4
Heart
4 4 4444 444 444 44 444 4 44 44 4 44
Kidney
4 44 44 4 444 444 44 4 44 44 4 4 4 4 44
Large Intestine
4 4 C4 4 4 4 4 4 4 4 4 4 C4 4 4 4 4 4 4 4 44 4
Liver
4 .4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Lung
44 4444 4 4 4 444 4444 44 44 44 44 4
Lyaph Node (aesenteric)
4 4 C4 4 4 4 4 4 4 4 4 4 C4 4 4 4 4 4 C4 4 4 4
Haasary Bland
Ovary Pancreas
+ + C + + + + + + + + + CC + + + + + + + + + + +
Parathyroid Pituitary Prostate
c c + c c c + c + CC + CCC + + C C C C C + + C ++++++++ + + 4 + +C + + +C + ++++ + + ++++++++ ++ + + +C ++ + ++++++++
Salivary Gland Saall Intestine Spinal Cord Spleen Stoaach Testis/Epididyais Thyroid Trachea
+ + C + + + + + + + C + CC+ + + + + + C + + + + + + C + + + + + ++ + + + C + + +++++++++ ++++++++ +C++C++++++++++++ ++++++++ +++++++++++++++++
4 + + + + + 4 + ++++++++++C++++++ + + + ++++++++++++++ ++++++++
C + + + + + + + + C + + + C+ + + + + + + + + + + + + + + + + ++ ++ ++ + C + + + ++++++++
Urinary Bladder
4 + 4 + 4 4 + + + + + + + C+ + + + 44 + C + + +
Uterus
--------------------------- The foiioaing tissue(s) sere not required by protocol ---------------------
Bone ----------- -- -------- --------------------------- -----------
C litoral Gland
---------------------------- ---------------------------------
Harderian Gland
----------- -- ------------------------ -- -------- -----------
Lyaph Node
------------ -- ------------- ------------------------ --------
Lyaph Node (abdoainal)
-------------- -------- -- ------------- -- ------------ - -
Lyaph Node (thoracic)
--------------------------------------------------------------
Hesentary
-------------- ------------------------------ + -----------
A + indicates that a diagnosis aas aade. A - indicates that no diagnosis or consent uas aade. A c indicates only a nondiagnostic consent aas aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 221
CC0773
385
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: To Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Tibie: 4
Tissue Nate
Preputial Bland Skin Soft Tissues (abdoien) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coeeent
Dose Group Nate: CONTROL 0 ppa 1 1 1 1 I'll 1 1 1 1 1 I 1 1 1 1 1 1 1 1 1 l 1 1 RRRRRRKRRRRRRRRRRRRRRRRRR
Ani sal Nuabers------ -- ------------------------- -- ------------- -- ----------3333333333333333333333333 5555555535555555555555555 4555555566666666677777777 9234567801234567912346789
Sex H n H H H H H N H H H f l H H H H H H H H H H H H M
----------------------- - -------------------- - --------------.............................. ------ -- -------- -- ------------------------ ------------------- --------------------- -- ---------------- -- ------------------------------------------------ ------------- -- ------------------- -- ----------------------- -- ------------- -- ------------------------------------------------------------------ ---------------- - - ----------------------- -- ------------------- * ------------- * ' ------------------------------------------ -- ------------------- -- r ----------------- -- -------------------------------------- --
A indicates that a diagnosis as aade. A - indicates that no diagnosis or coaaent as aide.
386
A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 222
000774
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Tea Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table1. 4
Tissue Naae
Dose Broup Naae: CONTROL 0 ppa
1111111111111111111111111 RRRRRR- RRRRRRRRRRRRRRRRRRR Aniaal Nuabers 4444444444444444444444444 5555555555555555556666666 77788BB8B9999999990000000 4790 1 3 46 7 123456789 0 2 3456 7 Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal Aorta Bone Narron Brain
++4 4 4 4 + 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4+4c444444 44 c4 444444 4c444
44+4444444444444444444444 444444 +4444444444444 44444
Esophagus
+ + 4 c4 4 4 44 4 4 4 4 4 44 4 4 4 4 4 C 4 4 c
Eye + 4 4 4 4 + 4 4 + 4 4 4 4 4 4 4 4 c c c 4 4 4 4 4
Heart Kidney Large Intestine
4+444++4+4444444444444444 44444++4444444444444444
4+ 4 + 4 + 4 4 4 4 4 44 4 4 4 4 44 4c44 4
Liver Lung
4+444444444444444444444 ++4++444+4444444444444444
Lyaph Node (sesenteric) Naaaary Gland Ovary Pancreas
4 ccc4 + + 4cc4 c4 cC 4 4 44 4 4 44 4
++44+44444444444444444444
4 + 4 4 4 4 4c4 4 44 44 4 4 4 4 4 4 4 4 +C 4 4 +4 44 4 +4 4 4 4 c4 4 4 4 4 4 4 4 4 4 4 4
Parathyroid
4 +ccccccccCcccccccccccCCC
Pituitary
4+44++444444444444444444
Prostate
Salivary Gland Saall Intestine Spinal Cord Spleen Stoaach
c+4 4 4 +4 c44 4 4 4 C 4 4 4 4 4 44 4 4 c f4 4 4 4 4 4 4 4 4 4 4 c4 44 4 4 4 4 4 4 44 4 4 4 4 4 4 4 ++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 +4 4 4 + 4 + 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Testi s/Epididyais Thyroid Trachea Urinary Bladder Uterus
4 4 4 4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 +4 +4 +4 4 4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 ++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
The follouing tissue(s) nere not required by protocol
Bone
C litoral Gland
Harderian Bland
Lyaph Node
Lyaph Node (abdoainal)
Lyaph Node (thoracic)
Nesentary
A + indicates that a diagnosis uas aade. A - indicates that no diagnosis or consent as aade.
387
A c indicates only a nondiagnostic consent mbs aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 223
000775
Tissue Inventory (continued)
Riker Laboratories, Inc. 311 FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaberl 0281CR0012 Species: Rat
Tibie: 4
Tissue Naae
Preputial Gland Skin Soft Tissues labdoaeni Soft Tissues (head) Soft Tissues (leg! Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Group Naae: CONTROL 0 ppe 1111111111111111111111111 R R R R R R'R R R R R R R R R R R R R R R R R R R
Anieal Nuabers ------------------------------------------------- - - - - - 4444444444444444444444444 55555555555555555566 6 6 6 6 6 7778888889999999990000000 6790134671234567890234567
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
------------------------- ----------------------------------------- - + .............. + .................................... ----------------- -- ---------------------* - - * ---------------------------- ------------- -------- -- ------------------------------------------------------------------------ - ------ - ------------------------------------------------------------------------ -- ---------- ---------------------------------------- -- ------------------------------ - - - - - ------------------------- ---------- -------------------------------------------------------------------- -- ---------- -------------
388
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent aas aade. A c indicates only a nondiagnostic coaaent aas aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 224
000776
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC--143: Tno Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuiber: 0261CR0012 Species: Rat
Table: 4
Tissue Nase
Dose Sroup Nane: CONTROL 0 ppe lllll-llllllllllllllllllll RRRRRR- RRRRRRRRRRRRRRRRRRR
Aniaal Nuebers ----------------- -- -----------. . . . -----------. . . . .
4444444444444444444444444 6666 666666 AA66 AAAA666AA6A 0111111111222222223333333 91234567B9123456783456789 Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal
4444444444444444444444444
Aorta
44 444C44 44 4[ 44 444 4C H H 4 (
Bone Harrou
4444444444444444444444444
Brain
4444444444444444444444444
Esophagus
4 4 4 C 4 4 4 4 C C C + C + C + + CCCC + + C +
Eye 4 4 C + + + + 4 + C 4 4 4 4 C + + + 4 4 C + + 4 4
Heart
4444444444444444444444444
Kidney
4444444444444444444444444
Large Intestine
C4 4 t *4 M 4 H M M M 4 t H I M
Liver
4444444444444444444444444
Lung
4444444444444444444444444
Lyaph Node (aesenteric)
4444444444444444444444444
Naaaary Eland
4 4 4444 CCC + + + + + + + + + + + 444C +
Ovary-
4444444444444444444444444
Pancreas
4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4444
Parathyroid
CCCCCCCCCCCC + CCCCCCCCC4 C4
Pituitary
4444444C + +4C44444444C + +C+
Prostate
Salivary 61and
444444444444444444C4C 444C
Saall Intestine
4444444444444444444444444
Spinal Cord
4444C + + 4 4 4 4 4 4 4 4 C 4 4 4 4 4 4 4 4 4
Spleen
4444444444444444444444444
Stoaach
4444444444444444444444444
Testis/Epididyais
Thyroid
4444444444444444444444444
Trachea
4444444444444444444444444
Urinary Bladder
4444 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Uterus
4444444444444444444444444
--------------------------- The folloing tissue(s) ere not required by protocol --------------------------
Bone
Clitoral Bland
Harderian 61and
Lyaph Node
Lyaph Node (abdoainall
Lyaph Node (thoracic)
Hesentary
389
A 4 indicates that a diagnosis as aade. A - indicates that no diagnosis or coaaent as aade. A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report.
0 0 0 7 7 7Tissue Inventory Page: 225
Tissue Inventory (continued)
filter Laboratories! Inc. 3H FC-143: To Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuiber: 0281CR0012 Species: Rat
Table: 4
Tissue Naie
Preputial Bland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue Beneral Coaaent
Dose Broup Naoe: CONTROL 0 ppi
11111-11111111111111111111
RRRRRR- RRRRRRRRRRRRRRRRRRR Aniaal N u ib e rs------ . . . . . . . ---------- . . . ----------------------
4444444444444444444444444 A6 AAA4 6 A6 AAAA6 A4 AAAAAAAAA 0111111111222222223333333 9 123 45 4 7 8 9 123 4 5 4 78 3 4 5 4 7 B9 Sex F F F F F F F F F F F F F F F F F F F F F F F F F
- - - - ----------- ---------------------........................+ - - + -----------+ ---------------------------- - -----------------------. . . . . . . ------------. . . . . . . . --------------------------------------------- -- ------------------------ -- -------- -- ------------------------
----------------------- -- . . . . . . ------------ ------------- . . . . . . --------------- . . . . .
390
A + indicates that a diagnosis as aade. A - indicates that no diagnosis or coaaent as aade. A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 224
000778
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuiber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Dose 6roup Naie: FC-143 300 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers - - - --------- -- -- - - ----------------------------
3333333333333333333333333 555555555555556 6 6 6 6 6 6 6 6 6 6 BB8B8B999999990000000001 1 123567013456790123567B901 Sex n N N N H H N H K H H H I l H N N H I l H H H H n N R
Adrenal Aorta Bone Harroe Brain Esophagus Eye Heart Kidney
444444 444444
444444
444444 444444
444444 444444 444444
4 4 4 4 4 4 4 4 4 4 4 4 4 444444 4 4 4 4 4 4 4 4 4 4 4 4 4 444444 + 4 44 c + C 4 + + 4 4 4 4 4 4 4 4 44 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 c 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 c 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 44 4 44 4 4 4 4 4 4 4 4 4 4 4 4
Large Intestine
4 4 4 4 4 4 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Liver
+. + + + + + 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Lung Lyaph Node (aesenteric)
4 4 4 4 4 4 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
4 4 4 4 4 4 4 4 44 4 44 4 4 4 4 4 4 4 4 4 4 4 4
Raasary Gland
Ovary
Pancreas
444444444444 4444444444444
Parathyroid
+ C + + + CC + CC + + + + + + + C + C4 + C + C
Pituitary
444444C + 4444 44C4444444444-
Prostate
444444444444 4444444444444
Salivary Gland
4C4444444444 4444444444444
Saall Intestine
444444444444 4444444444444
Spinal Cord
4 4 4 4 4 4 4 4 4 4 C 4 44C ++ + + + 4 4 4 4 4
Spleen
444444444444 4444444444444
Stoaach
444444444444 4444444444444
Testis/Epididyais
444444444444 4444444444444
Thyroid
+ C + + + 4C + + 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 c
Trachea
444444444444 444444444444c
Urinary Bladder
4444 44444444 4 4 4 4 4 4 4 4 4 4 4 4 4
Uterus
--------------------------- jhe follouing tissue(s) were not required by protocol
Bone --------- -- ---------------------------
Clitaral Gland
------ -- ------------------------------
Harderian Gland
---------------------------------------
Lyaph Node
----------------------- --------------
Lyaph Node (abdoainal)
------------ - --------------------
Lyaph Node (thoracic)
------ -- ----------------------- - -
Nesentary
- - - ------------- - - - - - -
391
A 4 indicates that a diagnosis aas aade. A - indicates that no diagnosis or coaaent uas aade.
A c indicates only a nondiagnostic coaaent aas aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 227
000779
Tissue Inventory (continued)
RiIter Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuiber: 0281CR0012 Species: Rat
Table: 4
Tissue Naee
Preputial Gland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Group Naae: FC-143 300 pp*
11111-11111111111111111111
RRRRRR- RRRRRRRRRRRRRRRRRRR Aniaal Nuabers-------------- -- ---------- ----------------------------------- -
3333333333333333333333333 5 5 5 5 5 5 555 5 55 5 5 6 &6 6 6 6 6 6 6 6 6 8 8 8 8 6 8 9 9 9 9 9 9 9 9 0 0 0 0 0 0 0 0 0 1,1 1 2 3 5 6 7 0 1 3 4 3 6 7 9 0 1 2 3 5 6 7 8 9 0* 1 Sex H N H K M M M H t l H H M H H H H H K H R N H H I l H
-
392
A indicates that a diagnosis as aade. A - indicates that no diagnosis or coaaent as aade.
A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report.
C 0 0 7 S OTissue Inventory Page: 228
^
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 02S1CR0012 Species: Rat
Table: 4
Tissue Nate
Dose Group Naae: FC-143 300 ppa
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 RRRRRRRRRRRRRRRRRRRRRRRRR Aniial Nuabers 3333333333333333333333333 b b b b b b b b b b b b b b b b b b b b b b bb b 1111112222223333333334444 2 4 5 6 B9 13 4 5 B9 0 12 3 4 5 6 7 9 0 14 5 Sex H H H H H H H H H H H H H H H H H H M H H H H H H
Adrenal Aorta Bone Harrow Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyaph Node (eesenteric)
4 + + 4+ + + + + + + + + + + + 4 + + + + + + + + ************************* ************************* ************************* ************************* ************************* ************************* ************************* *************************
*^* * * * * * * * * * * * * * * * * * * * * * * * ************************* *************************
Kaauary 61 and
Ovary
Pancreas
********************z****
Parathyroid
**z***z***z*****z***z****
Pituitary
4 4 4 4 4 4 4 C + ++ + C+ + + + + ++ ++ + ++
Prostate
+ C + + + + + + + ++ + + + + + + + + + + + + ++
Salivary 61and
+ + C+ C + + + ++ + + + + + + + +C+ + + + +
Stall Intestine
4444444444444444444444444
Spinal Cord
4444444444444444444444444
Spleen
4444444444444444444444444
Stoaach
4444444444444444444444444
Testis/Epididyais
4444444444444444444444444
Thyroid
4444444444444444444444444
Trachea
4444444444444444444444444
Urinary Bladder
4444444444444444444444444
Uterus
--------------------------- y(,e following tissue(s) were not required by protocol -----------
Bone -------------- -- ------------------------------ +
Clitoral Gland
--------- ------------------------ -- -------------
Harderian Gland
---------------
Lyaph Node
---------------------------- -- -------------------
Lyaph Node (abdoainal)
-------------------- - --------------------------
Lyaph Node (thoracic)
---------------------------------------------------
Hesentary
--------- - -------------------------------------
393
A * indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was Bade. A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 229
CC0781
Tissue Inventory (continued)
Hiker Laboratories, Inc. 311 FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber*. 02B1CR0012 Species: Rat
Table: 4
Tissue Naie
Preputial Gland Skin Soft Tissues (abdoeen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyeus Unidentified Tissue General Coiaent
Dose Broup Naie: FC-143 300 ppe 1 1 1 1 M 1 1 I 1 1 1 1 1 1 1 1 1 1 1 1 1 11 1 R R R R R R-R R R R R R R R R R R R R R R R R R R
Anisal Nuebers------ -- -------- -- ---------------- -- - - -------------------3333333333333333333333333
1111112222223333333334444 2454891345890123456790145 Sex H H H N H N N H H H N R M H H H M H M R R R H H I 1
394
A indicates that a diagnosis as aade. A - indicates that no diagnosis or coeient as eade. A c indicates only a nondiagnostic coaaent as eade. Please refer to the Single Tabulated Anieal Report.
Tissue Inventory Page: 230
000782
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: To Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuiber: 0281CR0012 Species: Rat
Tibie: 4
Dose 6roup Nate: FC-143 300 ppi 1 1 1 1 1-1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 11 1 1 1 RRRRRR- RRRRRRRRRRRRRRRRRRR
Aniial N u ib e rs------ -- ---------------- -- -------------------------------------4444444444444444444444444
Tissue Naie
4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 b i b b t> b 6 7 77 1 3 4 56 7 8 9 0 1 3 47 8 9 0 l 2 3 5 7 B 0 23 Sex F F F F F F F F F F F F F F F F F F F F F F F FF
Adrenal Aorta Bone Harro Brain
++++444+ 4 + 4 4 4 4 4 4 4 4 4 4 4 4 4 4 ++ c 44444 4 4 4 4 4 C + 4 4 4 4 4 4 4 4 +++++++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 ++++44444 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Esophagus Eye Heart Kidney Large Intestine Liver Lung
C C H c ++ C CC + C C C C C 4 C C + + C + 4 4 4 4 ++c + C + 4 C 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 + 44 4 4 4 4 4 4 4 4
4 4 4 4 +c++ C + 4 + 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 + 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 + 44 + + + + ++++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Lyiph Node iiesenteric) Hainary Gland OvaryPancreas
C + + ++c4 4 4 4 4 4 4 4 4 4 4 C 4 4 4 4 4 4 4 4 4 ++c ++ 4 + 4++4 4 4 4 4 4 C C C + C + + + ++++ C 4 4 4 4 4 4 4 4 4 4 4 4 4 4 + + C + +4++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Parathyroid Pituitary
+c +c c c c c C C 4 4 C + C C 4 C 4 C C + C c 4 4 4 4 + + + +44 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Prostate
Salivary Gland Stall Intestine
C + + + C + + C+ C + + + C+ + + + + + C + + + + 444444C + + 4444444444444444
Spinal Cord
4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 + 444
Spleen
+ + +++ + + + + + + + + + + + + + + + + + + + +
Stoiach
+ + +++ + + + + 4 + + + + 4 + 4 + + + + + + + +
Testis/Epididyiis
Thyroid
4 + +++ C + 4 + C + + + C + + + + + + + C + C C
Trachea
+ + +++ C + + + + + + + C + + + + + + + + + C +
Urinary Bladder
- + + C + + C + + + C + 4C + + + + + + + + C + + +
Uterus
+ 4 + + + + + + + + ++ + + + + + ++ + ++ ++ +
The fo llo iing tissue(s) were not required by protocol --------------------------
Bone
C litoral Gland
Harder!an Gland
Lyiph Node
Lyiph Node (abdoiinal)
Lyiph Node (thoracic)
Hesentary
395
A + indicates that a diagnosis as iade. A - indicates that no diagnosis or conent as lade. A c indicates only a nondiagnostic coiient as iade. Please refer to the Single Tabulated Aniial Report.
Tissue Inventory Page: 231
00783
Tissue Inventory (continued)
Riker Laboratories, Inc. 3N FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Eland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Broup Naie: FC-143 300 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers - - - - -------------------------------------------------------4444444444444444444444444 6 6 6 6 6 6 6 6 6 i fc 6 t 6 6 6 t t b 4444444455555556666666777 134567B901347890 123578023
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
------------------------------- - - + - + ------------------------------- - - - - ------ -- -------------
--------------------------------------- -- ---------------------------------------
396
A + indicates that a diagnosis as aade. A - indicates that no diagnosis or coaaent was aade. A c indicates only a nondiagnostic coaaent aas aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 232
CG0784
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-14J: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Dose Group Nate: FC-143 300 ppe 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Anieal Nuabers-------------- ------------- -------------------------------------4444444444444444444444444
Tissue Nate
7777BB8B8BB89999999900000 57 8 9 0 12 3 4 5 bS0 13 4 5 i 7 8 0 12 3 5 Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal Aorta Gone Harrow
++++++++c ++ +++ +++++++++ ++++++++c ++++++++++ c ++++ ++++++++++++ + +++++++++
Brain
+++ ++ +++++++++++ ++ ++++
Esophagus
c c +c c c c cc c ++++++++++cc c
Eye + + + + C + C + + + + + + + + + + + + + + c
Heart Kidney Large Intestine
++++ ++ + + + +++ ++++++++++ +++++++ + + ++ +++++++ ++++ ++++ C+ C+ + ++++++++ +++++++
Liver
+-+ + + + + + + + + + + + + + + + + + + + +
Lung + + + + + + + + + + + + + + + + + + + + + + +
Lytph Node (eesenteric)
++++c+c +c +* ++ +++++c++++
Hataary Gland
++++++++c ++c +++++++++++++
Ovary Pancreas
++++C+ + ++++++++ +++++++ ++++++C+ + + + ++++++++C+ +
Parathyroid
c c +cc c cc ++C+ + C + + ++cc +++
Pituitary
+++++++++ ++ + + ++++++++++
Prostate
Salivary Gland
+ + + + +-C + C C + + + + + + + + + + + + + + C
Stall Intestine
++++C+C+++++++++ ++ +++++++
Spinal Cord
+ + + + + + + + + ++ + + + + + + + + + + +
Spleen
++++++++++++++++++++++
Stoaach
++++++C++++++++++++++++++
Testis/Epididyais
Thyroid
+ + ++ + + C + C + + + + + + + + + + + C + + + +
Trachea
+ + + + +. + + + C + + + + + + + + + + + + + + + +
Urinary Bladder
+ + C+ + + C + + + + + + + + + + + + + + + + + C
Uterus
+ + ++ C+ C + + + + + + + + + + + + + + + + + +
The Polloaing tissue(5) were not required by protocol -------------------------------
Bone
Clitoral Gland
Harden an 61and
Lytph Node
Lytph Node (abdotinal)
Lytph Node (thoracic)
Hesentary
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or cotaent was Bade.
397
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Anital Report.
Tissue Inventory Page: 233
000785
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber! 0281CROC12 Species: Rat
Table: 4
Tissue Naae
Preputial Bland Skin Sott Tissues (abdoaen) Soit Tissues (head) Soit Tissues (leg) Soit Tissues (neck) Soit Tissues (thorax) Thyaus Unidentified Tissue Beneral Coaaent
Dose Sroup Naae: FC-143 300 ppa 1111111111111111111111111 RRRRRR- RRRRRRRRRRRRRRRRRRR
Aniaal Nuabers - - - - ------------------------- ---------------------4444444444444444444444444 66t i b6666i 6 bt b66h77777 7777B8888BBB9999999900000 S7 B9 0 12 3 4 5 bB0 13 4 5 6 7 B0 ! 2 3 5
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
------ - ------------
--------------- -------------- ----------------- -- -------------------------------- +
398
A + indicates that a diagnosis aas aade. A - indicates that no diagnosis or coaaent aas aade. A c indicates only a nondiagnostic coaaent aas aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 234
Tissue Inventory (continued)
Riker Laboratories, Inc. 3ft FC-143: Two Year Dral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Dose Sroup Naae.` FC-143 30 ppi 1111T11111I 11111111111111 RRRRRR- RRRRRRRRRRRRRRRRRRR
Aniaal Nuabers ------------ - ---------------------------------- - -----------3333333333333333333333333
Tissue Naae
4 4 4 4 5 5 5 5 55 5 5 5 5 6 b t> t> 6 6 6 b i i 7 6 7 B 9 0 1 2 3 45 6 7 6 9 0 1 2 3 4 5 6 7 B 9 0 Sex HIt ft N 11 II ft N H H H H H H H H ft ft N ft 11 N HH
Adrenal
4444444444444444444444*44
Aorta
----------- - * -------------- --------------------------- - -
Bone Harrow
---------------------------------------------------------------- --
Brain
------------ -- -------------------
Esophagus
+ + + + + C+ + + + + + + + + + + + + + + + + C+
Eye --------- -- ------------- - - + - - - * - - - 4 -------- --
Heart
4444444444444444444444444
Kidney
4444444444444444444444444
Large Intestine Liver
----------------- ------------------- -- ----------------------+ -
4. 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Lung
4444444444444444444444444
Lyaph Node (aesenteric)
+
ftaaaary SI and
--------------------------------------- -- ---------------- - - -
Ovary
-------------- --------------------------- -- ---------------- - -
Pancrea5
C+ C++C+++4++4444444444444
Parathyroid Pituitary
4 4 4 4 4 4 4 4 C + C44CC + C44C + 44C + 4 4 C + 4 4 4 4 4 4" 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Prostate
4444444444444444444444444
Salivary Sland
4 4 4 4 4 4 4 4 4 4 c c`+ 4 4 t 4 4 4 4 4 4 4 c 4
Stall Intestine
---------------------------- -- ------------------------------ + -
Spinal Cord Spleen
------------------------------------ -- ---------- ----------------
4444444444444444444444444
Stoaach
4444444444444444444444444
Testi s/Epididyai s
4444444444444444444444444
Thyroid
4444444444444H4t*44444C*
Trachea Urinary Bladder
44444444444444444444444C +
444444444444444444444^444
Uterus
..................................................................... ...
--------------------------- The following tissue(5 ) were not required by protocol
Bone Clitoral Gland
------ -- ---------- ---------- -------. . . . . -------------- -----------
Harderi an Sland
----------------- -------- - - - - -
Lyaph Node
--------- -- ---------------------------
Lyaph Node (abdoainall
-- 4 - ----------------------------------------------- ----
Lyaph Node (thoracic)
-------------------------- - ---------
Hesentary
------ -- ---------------- -- ----------
399
A 4 indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade. A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 235
CC07S7
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: To Year Oral Toxicity-Oncogenicity Study in Rats
Project Kuiber: 0281CR0012 Species: Rat
Table: 4
Tissue Naee
Preputial Bland Skin Soit Tissues (abdoeen) Soit Tissues (head) Soit Tissues (leg) Soit Tissues (neck) Soit Tissues (thorax) Thyeus Unidentified Tissue General Coeeent
Dose Broup Naae: FC-143 30 ppa 1 1 1 1 fl 1 1 1 1 l 1 1 1 1 1 1 1 1 1 1 1 1 1 1 RRRRRR' RRRRRRRRRRRRRRRRRRR
Aniial Nuebers-------------- ------------- . . . . ------------- ------------3333333333333333333333333 6666666666666666666666666 4444555555555546666666647 6 7 B0 1 2 3 4 5 6 7 B9 0 1 2 3 4 5 6 7 B9 0
Sex P H H Hfl H N H H K H N K MH H H R H N K H MK H
-------------------------- - ----------------- - --------------- ..................................................... --------- - ---------------------------- - --------------------------------------------------------------------------------- - ------ -- -------------------------------------- -- --------------------- -- ------------------------ -- ------------------- . . . . ----------------- -- ------------------- -- ---------------- -------- - ----------------- ------------- -- ------------------------------------------- - ------------ - --------------------------
--------- . . . . . ---------- -------------------
400
A indicates that a diagnosis as eade. A - indicates that no diagnosis or coiaent was aade. A c indicates only a nondiagnostic consent as aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 236
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naae
Do1se1 61ro1upl -Nlalae:1 F1C1-14131301 p1p1t 1 1 1 1 1 1 1 1 1 1
RRRRRR' RRRRRRRRRRRRRRRRRRR Aniial Nuabers - ----------------- -----------------------------------------------
3333333333333333333333333 bbbbbbbbbbbbbbbbbbbbbbbbb 7777777770888888888999999 1234567B901234567B90 12345
Sex
Adrenal
4444444444444444444444444
Aorta
Bone Barroa
Brain
Esophagus Eye
C+ + + + + C+ + + + + + + + + + + + + + + + + C
- -------------------- + -- -----------4 ----------------------
Heart
4444444444444444444444444
Kidney
4444444444444444444444444
Large Intestine liv e '-
+++++++++++++++++++++++++
Lung
4444444444444444444444444
Lyaph Node (aesenteric) Haaaary Bland
+
Ovary
Pancreas
4444444444444444C ++++++++
Parathyroid
CC + C + + C + + + + + C + + + C C C C C + + + +
Pituitary
4 4 4 4 4 4 4 4 4 4-4 4 4 4 4 4 4 4 C 4 4 4 4 4 C
Prostate
4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 C + + 4 + 4444
Salivary Gland
[ 444444 44444 44 [ [ H t H M H
Seal! Intestine
Spinal Cord
Spleen
44444444 44444444 444444444
Stoaach
44444444 44444444 444444444
Testi s/Epididyais
44444444 44444444 444444444
Thyroid
[ 4 44 44 44 44444444 444444444
Trachea
[ 44 444 44 44444444 444444444
Urinary Bladder
44444444 44444444 444444444
Uterus
--------------------------- The following tissue(s) ere not required by protocol --
Bone ------ - -
Clitoral Bland Harderian Bland
----------------------- - ----------------. . . . . . . --------------------------
Lyaph Node
--------- - ------------ -----------------
Lyaph Node (abdoainal)
------ -- ---------------- -- ----------------
Lyaph Node (thoracic)
-------------------- -- ----------------------
Hesentary
------------ 4 ---------- ---------------- 4
A 4 indicates that a diagnosis aas aade. A - indicates that no diagnosis or coaaent m s Bade.
401
A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 237
Tissue Inventory (continued)
Riker Laboratories, Inc. 3N FC-143: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Project Nutber: 02B1CROC12 Species: Rat
Table: 4
Tissue Naae
Preputial Bland Skin Soft Tissues (abdoeen) Soit Tissues (head) Soit Tissues (leg) Soit Tissues (neck) Soit Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Group Naae: FC-143 30 ppn 1 1 1 1 1' 1 1 ! 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 RRRRRR- RRRRRRRRRRRRRRRRRRR
Anieal Nuabers------ -- ------------- -- ------------------------------ -- -------3333333333333333333333333 6666666666666666666666666 7777777778888BBBB88999999 1234567890123456789012345
Sex N H N N H N N N N N H H N I I H H N N H H N N N N N
-------------------------------------* --------- + ................+ -------- ----------------- * - - - ---------------------------------- - - - ----------------------- '---------- * * --------- -- ---------------------------
------------------------------------------------------------------- -------------------------------. . . --------
A + in d ic a te s th a t a d ia g n o s is aas Bade. A - in d ic a te s th a t no d ia g n o s is o r coaaent as aade. A c indicates only a nondiagnostic coaaent aas aade. Please reier to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 238
402
000790
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Tno Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naie
Dose Group Naie: FC-143 30 ppa 11111-11111111111111111111 RRRRRR- RRRRRRRRRRRRRRRRRRR
flnieal Nuebers-------------------- -- ---------- ------------------- -- ---------4444444444444444444444444 7777777777777777777777777
0000111111111122222222223 6 7 B9 0 12 3 4 5 6 7 8 9 0 123 45 6 7 6 9 0 Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal
4444444444444444444444444
Aorta
Gone Harro
Brain
Escphagus Eye
444444444444:444444444444
. . . ---- . . . -------+
+ -----
Heart
4444444444444444444444444
Kidney Large Intestine
4444444444444444444444444
Liver Lung
4444444444444444444444444 4444444444444444444444444
Lyiph Node (aesenteric) Naeaary Gland
4444444:44444444:4:444444
Ovary Pancreas Parathyroid Pituitary
4444444444444444444444444 444C+ + + + C+ + + + + + C + 44 4444 44 C C C C C + + + + C + + CC + C + + C + C + + C4 444444444444444:444444444
Prostite
Salivary Gland
4444444444444C4CC44444444
Stall Intestine
----------------------------------------------------------------- 4 - - ---------------
Spinal Cord
Spleen
4444444444444444444444444
Stoiach
4444444444444444444444444
Testi s/Epidi dyais Thyroid
4444444444444444444444444
Trachea Urinary Bladder
4 4 4 4 4 4 4 4 4 4 4 *4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 H * 4 4 4 44 4 4 4 4 4 4 C4 [ 4 4 4 4
Uterus Bone
4444444444444444444444444
The following tissue(s) ere not required by protocol ----------------------------------------------------------- -- ------------------- --
Clitoral Gland Harderian Gland Lyaph Node
------------------------------------- - ----------------- ----------------- -- -------------------------------------- -
+ --------------------------+ -----------
Lyaph Node (abdoainal) Lyaph Node (thoracic)
----------------- ------------- -- ---------------------------------------------------------------- - - - - - - - -
Hesentary
--------- - --------------------------------------------- +
403
A 4 indicates that a diagnosis uas aade. A - indicates that no diagnosis or coaaent as aade. A c indicates only a nondiagnostic couent as aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 239
000791
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Project Nusber: 02S10R0012 Species: Rat
Table: 4
Tissue Naie
Preputial Gland Skin Soft Tissues (abdoeen) So-ft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyiu s Unidentified Tissue General Coiient
Dose 6roup Naie: FC-143 30 ppi 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Anieal Nuebers ------------------------------------------------------------------4444444444444444444444444 7777777777777777777777777 0000111111111122222222223 6 7 8 9 0 12 3 4 5 6 7 B9 0 12 3 4 5 6 7 B9 0
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
- -------------------------- - ------------------------------------ + - - -------- ----------------------- - ------------ - ----------------------- -- ----------------------------------------- . . . . . ------------------------ - -------------------------------------. . . . . . . . . . . -------------------------------------------------- -- ------------- - - - - - - - ---------------------------------------------
404
A indicates that a diagnosis as aade. A - indicates that no diagnosis or coaaent as aide. A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 240
0C0792
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Hueber: 02B1CR0012 Species: Rat
Tifale: 4
Tissue Naee
Dose 6roup Naie: FC-143 30 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Amsal Nuebers---------------------------- -- ---------- ------------- -- -------4444444444444444444444444 7777777777777777777777777 3333333334444444444555555 123456 78 90 1234 56 7B90 12345
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal
+ + + + + + + + + + + + + + + + 4 +
Aorta Bone Harro
Brain
Esophagus Eye Heart Kidney Large Intestine Liver Lung
4 4 4 + + + + 4 4 4 4 C + + C + + C+ + + + + + C
. . . -----------
- - ------------ 4 - - - -----------
4444444444444444444444444
4444444444444444444444444
4444444444444444444444444 4444444444444444444444444
Lyeph Node (eesenteric)
Naasary 61and
Ovary
+ + + + + + + CC + + + + + + + + + + + + + + + + 4444444444444444444444444
Pancreas Parathyroid P it u it a ry
+ 4 4 4 4 4 C + + + + C + + + + C + + + + ++ ++ + + + + CC ++ + C CC + + + + + C + C + + + + C 4444444c H M t c M M * M ( H (
Prostate S a liv a ry Gland
---------------------------------------------------------------------------- - - - - -
C4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
S ta ll Intestine Spinal Cord Spleen Stoeach
+ - ----------------------------------------------------------------------------------- -- ------------- ------------------------------------------------ - - - - - ---------------44444444444044444444440 ++ 44 + + + + + 4 4 4 + 4 4 4 4 4 4 4 + + + 4 + + +
T e s tis /E p id id y e is
Thyroid Trachea Urinary Bladder
-------------------------------------- - ---------------------------------- - --------------
+44 + +c + + + + + c+ + + + +c+ c + + + +c
4 4 4 4 4 + 4 4 + + + C+ + + + + C ++ + + + +C 4 4 + 44 + 44 + ++ 4 4 + + + + + ++ + + + + +
Uterus
4 4 4 + ++ C + + + + ++ + + + ++ ++ + + + ++
---------------------------------------- The Following tissu e (s) ere not required by protocol --------------------------------------
Bone
------------------------- --- ---------------------------- --- ------------------------------------
C lit o r a l Gland Hardeman Gland Lyeph Node Lyaph Node (abdoeinal)
------------------------- --- ---------------------------------------------------- --------------------------------------------- ---------------------------------------------+ - - - - ----------------------------------------- --- --------------- ------------------------ --------------------------------------------------------------------------------------------------------------
Lyeph Node (thoracic) Hesentary
+ ------------------------------------------------------------ ----------------------------------- ---------------------------------------------------------- -------------------------------- ---
405
A + indicates that a diagnosis eas aade. A - indicates that no diagnosis or concent as cade. A c indicates only a nondiagnostic consent as aade. Please reFer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 241
-00793
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FC-143: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Bland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Broup Naie: FC-143 30 ppe 111111111 1111111 11I1 11111 RRRRRR- RRRRRRRRRRRRRRRRRRR
Aniaal Nuabers------ -- ------------- -------------------------------------------4444444444444444444444444 7777777777777777777777777 3333333334444444444555555 12345678901234567B9012345
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
-------------------- -- ------------------- ----------------------
--------- + - + - +
+
-------------------- -- ---------------- -- ---------------- --------
------------------------- --------------------------- -- -----------
---------------------------- --------------------------------------
-------------------------------------------------- ----------------
---------------------------- ------------- ------------------------------------------------ -- ------------------- -- ----------------
------------------------- -------- -- ---------------- -------------
-------------- -- ------------------------ -- ----------------------
406
A indicates that a diagnosis uas aade. A - indicates that no diagnosis or coaaent uas aade. A c indicates only a nondiagnostic coaaent uas aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 242
fC0794
APPENDIX ITEM E STATISTICAL METHODS ]. For memo dated February 11, 1985; see Tables 12-18 2. For memo dated September 24, 1985; see Tables 19 and 20
407
000795
Internal Correspondence
Appendix Item E
To: Chuck F. Chesney - Riker Path and Tox - 270-3S-05 From Sally E. McCarville - Riker Res Data Ops - 270-3A-01 Subject: Statistical Analysis for FC-143 in Rats Date: February 11, 1985
The laboratory values and organ weight data for the study of fluoro carbon FC-143 in rats have been analyzed, and the results are presented in the attached tables. The statistical methods used to analyze the data are described in the following paragraphs.
Statistical Methods The means and standard deviations for percent organ weight to body weight ratios, organ weight to brain weight ratios, and labora tory data were determined separately for each sex and dose group. These data were analyzed using Bartlett's test for homogeneity of variance. If this test was not significant at a = 0.001, the data were further analyzed by comparing each treated group to the control group using a two-tailed Dunnett's test at the a = 0.05 significance level. The results of Dunnett's test have been indicated by asterisks on the mean tables. If Bartlett's test was significant at a = 0.001, the data were ranked and a two-tailed Dunnett's test was performed on the ranks. These results have been indicated by the pound sign (#) on the mean tables.
References Bartlett's Test
Anderson, V.L. and McLean, R.A. (1974), Design of Experiments: A Realistic Approach, New York: Marcel Dekker, Inc., 16-22.
Dunnett's Test Winer, B.J. (1971), Statistical Principles in Experimental Design, New York, McGraw-Hill Book Company, 201-204.
408
Appendix Item E
Page 2 Statistical Analysis for FC-143 in Rats SEMremr 02/11/85
Rank Transformations Conover, W.J., and Iman, R.L. (1981), "Rank Transformations as a Bridge Between Parametric and Nonparametric Statistics", The American Statistician, Vol.35, No. 3, 124-129. If you have any questions regarding the analyses, please let me know. SEM :emr Att. c: Cathy E. Ludemann
Len JT Slblnski
MEE/RWH
4U9 000797
Internal Correspondence
APPENDIX ITEM E
To: From: Subject: Date:
L. J. Sibinskt - Riker Path and Tox - 270-3S-05 <
S. E. McCarville - Riker Res Data Ops - 270-3A-01
Statistical Analysis of Microscopic Findings for FC-143 in Rats September 24, 1985
The major microscopic findings of the Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FC-143 in Rats were statistically analyzed. For each organ/lesion classifica tion the sexes were analyzed separately using a two-tailed Fisher's Exact Test comparing each treated group to the
controls. An <*= o.05 significance level with Bonferroni's
adjustment for multiple comparisons was used within each organ/lesion/sex category. If the expected value of each
cell was greater than 20,-then Yates' corrected Chi-Square test was used. An asterisk on the summary tables indicates a significant difference between the controls and the treated group.
References
Fisher's Exact Test:
Conover, W. J., (1971), Practical Nonparametric Statistics, New York, John Wiley and Sons Inc., 162-164.
Yates' Corrected Chi-Square:
Fleiss, Joseph L., (1973), Statistical Methods for Rates and Porportions, New York, John Wiley and Sons Inc., 14-15, 19-20.
J .I <7H* Cs~Jbk S. E. McCarville :mjm
c: MEE/RWH
410 C00798
APPENDIX ITEM F
GROUP MEAN BODY WEIGHTS, INDIVIDUAL BODY WEIGHTS AND FEED JAR WEIGHTS OF MALE
RATS RECEIVING F1UOROCHEMICAL FC-143 IN DIET FOR TWO YEARS
NOTES:
Code 1 indicates a control group rat weight Code 2 indicates a FC-143 - 300 ppm group rat weight Code 3 indicates a FC-143 - 30 ppm group rat weight Codes 11, 12, 13 indicates the total feed jar weight for
the previous rat All weights are in grams
4 000799
APPENDIX ITEM F
Two Year Oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon FC-143 in Rats
Group Mean Body Weights (g) _+ Standard Deviation
Males
Study Week
0 2 4 6 8 10
12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52
Control - 0 ppm Mean BW + SD (N)
165.3 + 270.9 + 334.0 + 390.7 T 429.2 + 456.2 +
475.5 493.2 + 502.9 + 515.3 + 526.8 + 542.3 + 550.4 + 561.0 + 567.5 + 576.3 + 580.6 + 582.9 + 591.0 + 599.4 + 608.4 + 612.9 + 619.8 + 623.5 + 626.1 + 639.2 + 638.6 +
10.5 16.4 25.1 31.0 37.3 42.7 43.4 47.7 48.9 48.7 49.5 52.1 53.0 54.3 55.0 56.7 57.4 62.5 59.7 59.4 61.6 61.2 62.3 64.3 63.4 67.0 70.1
(65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (65) (64) (64) (64) (64) (64) (64) (64) (64) (64)
300 ppo Mean BW + SD
(N)
162.1 + *234.3 + *276.7 + *308.6 + *353.2 + *380.1 +
*398.0 + *412.8 + *425.4 + *436.0 + *447.4 + *456.1 + *464.2 + *475.0 + *484.9 + *497.2 + *505.7 + *511.8 + *514.2 + *524.8 + *535.2 + *540.9 + *550.8 + *552.0 T *558.5 + *566.7 + *570.1 +
11.0 21.7 31.8 38.6 39.7 44.9
46.7 47.4 47.5 48.4 48.7 48.9 49.4 49.4 51.4 51.8 52.5 52.5 53.1 53.2 56.0 57.9 58.0 61.2 64.0 64.7 66.2
(65) (65) (65) (65) (65) (65)
(65) (65) (65) (65) (64) (64) (64) (64) (63) (63) (63) (63) (63) (63) (63) (63) (63) (63) (63) (63) (63)
30 ppm Mean BW + SD
(N)
167.0 + 271.0 + 328.5 + *369.4 + *410.3 + 441.5 +
458.1 + 475.4 + 487.9 +
498.5 + 512.1 + *519.4 + *526.3 + 538.9 + 546.2 + 558.6 + 566.4 + 571.3 + 575.4 + 584.0 + 592.5 + 600.5 + 610.4 + 612.1 + 618.9 + 627.1 + 633.6 +
9.8 14.7 22.9 30.8 37.1 44.2
47.5 48.6 52.5 52.8 53.6 54.7 56.7 59.7 61.8 61.3 62.3 63.3 64.6 65.6 69.0 69.1 69.7 71.0 72.3 74.2 76.2
(50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (50) (49) (49) (49) (49) (49) (49) (49)
--a Number of animals weighed * Significant difference from Control at the 5% level (Dunnett's t Test; a - 0.05)
412 C008G0
APPENDIX ITEM P
Two Year Oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon FC-143 in Rats
Group Mean Body Weights (g) _+ Standard Deviation
Males
Study Week
54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 88 90 92 94 96 98 100 102 104
Control - 0 ppm Mean BW + SD (N)
300 ppm Mean BW _+ SD
(N)
654.3 + 75.3 661.6 + 73.3 668.0 + 76.4 673.2 + 75.4 674.4 + 77.4 664.5 + 77.6 650.8 + 78.1 656.6 + 82.9 661.9 + 84.7 658.3 + 86.3 660.8 + 81.7 667.7 + 84.9 668.8 + 83.8 670.6 + 85.2 663.1 + 85.5 668.1 + 88.8 675.6 + 86.8 678.9 + 86.4
690.0 + 93.9
686.0 + 91.6
678.3 + 90.3
677.5 + 95.1
675.7 + 98.6 671.1 + 94.4
665.9 + 101.2 642.0 + 99.5
(49) (48) (48) (48) (48) (47) (47) (47) (47) (47) (46) (46) (46) (46) (46) (45) (42) (41) (41) (40) (40) (38) (38) (37) (36) (35)
-
*577.6 + *583.1 + *587.9 + *590.8 + *593.2 + *596.8 + *598.2 + *604.9 + *608.2 +
*608.5 + *601.1 + *605.4 + *604.6 + *611.8 + *610.0 + *617.5 + *617.4 + *614.7 +
*624.6 +
*621.8 + *627.6 + *621.0 +
627.2 + 625.5 +
629.4 + 613.3 +
69.8 71.2 73.9 75.9 74.9 80.8 80.8 83.0 79.9 76.5 76.5 76.6 77.5 76.7 77.1 79.1 78.8 83.0
87.3 85.6 80.8 84.6 80.8 87.5 88.0 88.1
(48) (48) (48) (48) (48) (48) (48) (48) (48) (46) (46) (46) (46) (46) (46) (46) (46) (46) (45) (45) (45) (45) (45) (44) (44) (44)
30 ppm Mean BW +_ SD
(N)
641.9 + 76.9 646.4 + 78.6 652.7 + 78.2 656.8 + 79.5 655.7 + 82.1 658.3 + 84.7 662.5 + 82.0 666.5 + 84.0 666.2 + 86.8 664.4 + 86.3 659.2 + 83.9 663.8 + 86.0 661.7 + 89.3 669.2 + 88.0 666.9 + 87.0 662.3 + 92.6 664.5 + 95.7 654.7 + 102.3
662.4 + 100.5 652.9 + 103.5 660.0 + 86.1 653.4 + 87.0
659.7 + 88.8
660.0 + 94.8
664.0 + 93.2
650.8 + 95.0
(49) (49) (49) (49) (49) (49) (47) (47) (45) (45) (45) (45) (45) (45) (45)
(45) (44) (44) (43) (43) (40)
(39) (38) (38) (37) (36)
-- Number of animals weighed * Significant difference from Control at the 5% level (Dunnett's t Test; a - 0.05)
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TWO VEftR O R A L D IE T > TOX-ONC STUDY OF FM -3924 & FC -143 IN RATS EXP. # 0261CR0012
TECHNICIAN IN IT IA L S S MH TODAY'S DATE: S 4 /2 8 /8 1 SEX OF RATS: S MALE ROOM NUMBER:S D -3 4 0 WEIGHT OF FULL FOOD JA R : S 500GRAMS
WEEK 1
1R03516 01S 010000218. 7Q FOODJAR U S 010100338. 90 1R03517 01S 010200216. 6Q
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1R03551 01S 017000183. 2Q FOODJRR U S 017100374. 2Q
1R03552 01S 017200216. 10
FOODJRR U S 017200336. 9Q 1R02553 01S 017400228. 3Q
FOODJRR U S 017500234. 7Q
1R02554 01S 017600192. 60 FOODJRR U S 017700257. 40
1R02555 01S 017800204. 8Q
FOODJRR U S 017900254. 4Q
1R03556 01S 018000226. 6Q FOODJRR U S 018100339. IQ 1R03557 01S 018200233. 2Q
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1R03561 01S 19000212. 60
FOODJRR U S 019100338. 0Q 1R02562 01S 019200192. 6Q FOODJRR U S 019300270. 0Q
1R02563 01S 019400237. 6Q FOODJRR U S 019500238. 7Q 1R83564 01S 019600197. 8Q
FOODJRR U S 019700362. 5Q 1R03565 01S 019800227. IQ FOODJRR U S 019900351. IQ 1R03566 01S 020000205. 3Q FOODJRR U S 020100356. 8Q 1R03567 01S 020200221. 30 FOODJRR U S 020300340. 8Q 1R02568 01S 020400247. IQ
FOODJRR U S 020500228. 7Q
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BEST COPY AVAILABLE
336. 8
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BEST COPY AVAILABLE
361. 4
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216. 5
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FOOD-JAR 12S 014400355. 60
1R03608 02S 014500199 00
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1R03609 02S 014780186. 30
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1R03610 02S 814900226. 90
FOODJAR 12S 015000350. 40
33611 02S 015100210. 3G
FOODJAR 12S 015200371. 60
1R03612 02S '015300206- 00
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1R03625 02S 017800185. 80
FOODJAR 12S 017900375. 40 1B03626 02S 018000218. 8Q FOODJAR 12S 018100374. 10 1R03627 02S 018200221. 7Q FOODJAR 12S 018300359. 5Q 1R0362S 02S 018400203. 7Q
FOODJAR 12S 018500362. 00 1R03629 02S 018600193. IQ FOODJAR 12S 018700366. 3Q
1R03630 02S 018800178. 9G FOODJAR 12S 018900407. 20
1R03631 02S 019000211. 9Q
FOODJAR 12S 019100349. 9Q
1R03632 02S 019200197. 6Q FOODJAR 12S 019300361. 9Q 1R03633 02S 019400200. 8Q FOODJAR 12S 019500373. 6Q 1R03634 02S 019600158. 7Q FOODJAR 12S 019700388. 90 1R03635 02S 019800162. IQ FOODJAR 12S 019900391. 7Q
:03636 02S 020000197. 3Q FOODJAR 12S 820100369. 5Q
1R03637 02S 020200195. 9Q FOODJAR 12S 020300359. 2Q 1R03638 02S 020400186. 3Q FOODJAR 12S 020500358. 7Q 1R03639 02S 020600180. 7Q FOODJAR 12S 020700368. 2Q
12 2 12 2 12 2 12 2 12 ' 2 12 2 12 2
12 2 12 2
12 2 12 2 12 2 12 2 12 2 12 '2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12
355. 6 199 349. 3 186. 3
355. 5 226. 9 350. 4 210. 3 371. 6 206 359 220. 7 350.-4
208.:3
334 194. 7 349. 6 191
362. 3 187. 4 364. 3
195. 1 354. 5 177. 1 370. 4 184. 9 357. 8 163. 1 400. 4176. 3 385. 7 200. 8 356. 9 174. 8 372. 6 185. 8
- 375. 4 218. 8 374. 1 221. 7 359. 5 203. 7
362 193. 1 366. 3 178. 9 407. 2 211. 9 349. 9 197. 6
361. 9 200. 8 373. 6
158. 7 388. 9 162. 1 391. 7 197. 3 369. 5 195. 9 359. 2 186. 3 358. 7 180. 7 368. 2
J
s COPY AVAILABLE
423
000811
1R03648 02S 020800158. IQ
FOOD.IftF: 128 020900396. 8Q
1F:03641 02S 021000201. 3Q FOODJfiR 12S 021100365. 8Q 1RQ3642 02S 021200174. 8Q FOODJfiR 12S 021300293. 26 1R03643 02S 021400188. 8Q
ODJfiR 12S 021500377. 46 _.-i03644 02S 021600189. 26 FOODJftR 12S 021700374. 16 1R03645 02S 021800187. 26 FOODJftR 12S 021900362. 46
1R03646 03'S 022000198. 46 FOODJftR 128 022100353. 36 1R03647 02S 022200228. 16
FOODJftR 12S 022300336. 76 1R03648 02S 022400226. 26 FOODJftR 12S 022500326. 3Q
1R03649 03S 022600212. 26 FOODJfiR 13S 022700346. 16 1R03650 03S 022800214. 96 FOODJftR 13S 022900349. IQ
1R03651 02S 023000208. 0Q FOODJfiR 13S 023100344. 7Q 1R03652 02S 023200224. 46 FOODJftR 12S 023300345. 06 1R03653 02S 023400221. 66 FOODJftR 12S 023500336. 66
1R03654 03S 023600222. 48 FOODJfiR 138 023700340. 96 1R03655 03S 023800221. 9Q
FOODJFIR 13S 023900334. 4Q
dR03656 02S 024000219. 76 ODJfiR 12S 024100328. 56
1R03657 03S 024200218. 56 FOODJftR 12S 024300349. 16 1R03658 02S 024400210. 96
FOODJftR 12S 024500340. 86 1R02659 02S 024600237. 96
FOODJftR 13S 024700330. 0Q
1R03660 02S 824800207. 2Q FOODJftR 13S 024900352. 2Q 1R03661 03S 025000225. 7Q
FOODJftR 12S 025100343. 6Q 1R03662 03S 025200283. 8Q FOODJfiR 12S 025300357. 8Q
1R03663 038 025400233. 36 FOODJftR 13S 025500323. 86 1R03664 03S 025600219. 26
FOODJfiR 13S 025700337. 6Q
1R03665 03S 025800230. 66 FOODJfiR 13S 025900337. 46 1R03666 03S 026000243. 7Q FOODJfiR 13S 026100323. 5Q
1R03667 03S 026200206. 76
FOODJfiR 13S 026300358. 6Q 1R03668 03S 026400198. 4Q FOODJfiR 12S 026500361. 56
03669 03S 026600212. 0Q . -ODJfiR 13S 026708334. 7Q 1R03670 03S 026800227. 8Q FOODJftR 13S 026900333. IQ 1R03671 02S 027000221. 56 FOODJfiR 12S 027100345. 06 1R03672 03S 027200231. 6Q FOODJfiR 12S 027300326. 3Q
2
12
2
12 2 12 2 12 2 12 2 12 3 13 3 13 3 13
3 13 3 13 3 13 3
13 3 13 3 13 "3
13
3
13 3 13 3
13 3 13 3 13 3
13 3 13
3 13 3 13 3
13 3 13
3 13 3
13 3 13 3 13 3 13 3 13
158. 1
296 8
201. 3 265. 8 174. 8 293. 2 188. 8 377. 4 189. 2 374. 1 187. 2 362. 4 198. 4 353. 3 238. 1 336. 7 226. 2 326. 3
213. 2 346. 1 214. 9 349. 1 208 344. 7 224. 4 345 221. 6 336. 6 222. 4 340. 9221. 9 334. 4
219. 7 328. 5 218. 5 349. 1 210. 9 340 237. 9 330 207. 2 352. 2 225. 7 343. 6 203. 8 357. 8 233. 3 323. 8 219. 2 337. 6 230. 6 337. 4 243. 7 323. 5 206. 7 358. 6 198. 4
r BEST COPY AVAILABLE
227. 8 333. 1 221. 5 345 231. 8 326. 3
00081422 4
1R0367j: 02S .037400230 40 FOOD,THF! 13S 027500342.' 10 1R02674 03027600202. 3C:ic.
FOODJRR 13 S 027700341. 70
1R03675 03 S 027880225. 30 F'XiDJRR l"?^ 027900333. IQ
03676 03S 028000244. 00
FOODJRR 13 S 028100324. 50
1R03677 03S 028200229. 3Q
FOODJFlR 13 S 028300327. 50
1R03678 03 S 028400227. 9Q
FOODJFlR 13 S 028500335. 4Q
1R03679 03S 028600216. 40
FOODJRR 13S 028700332. 40
1R036S0 03S 028800204. 50
FOODJRR 13S 028900337. 20
1R036S1 03S 029008231. 80
FOODJRR 12S 0291003-30. 80
1R03682 03S 029200216. 00
FOODJRR 13S 029300353. 60
1R036S3 03S 029400206. 80
FOODJRR 13S 029500350. 00
1R03684 03S 029600222. 7Q FOODJRR l^c; 029700339. 7Q
1R02685 03S 029800227. 6Q
FOODJRR 13S 029900350. 10
1R03686 03S 030000288. 40
FOODJRR 17c. 030100345. 9Q
1R03687 03S 030200229. 90
FOODJRR 13S 030300330. 9Q
1R03688 03 030400230. 00
ODJRR 13S 030500337. 50
u.,<03689 03S 030600211. 9Q
FOODJRR 13S 030700349. 2Q
1R03690 02S 030800214. 50
FOODJRR 13S 030900338. 6Q
1R03691 03S 031000223. 40
FOODJRR 13S 031100345. 30
1R03692 03S 031200212. 00
FOODJRR 13S 031300348. 1G
1R03692 03S 031400223. 4Q
FOODJRR 13S 031500328. 9Q
1R03694 03S 031600234. 9Q
FOODJRR 13S 031700334. 4Q
1R03695 03S 031800236. 4Q
FOODJRR 13S 031900320. 20
9999999999
99
3
13 3
12 3 12 3 13 3 13 3 13 3 13 3 12 2 13 2 12 3 13 3 12 3 13 2 13 3 13 3
13 3 13 3 13 3 13 3 13 3 13 3 12 3 13 0
238. 4 342. 1
203..3
341. 7 225. 3 333. 1 244 324. 5 229. 3 327. 5 227. 9 225. 4 216. 4 232. 4 204. 5 337. 2 231. 8 220. 8 216 353. 6206. 8 350 222. 7 339. 7 227. 6 350. 1 208. 4 345. 9 ' 229. 9 330. 9 230 337. 5 211. 9 349. 2 214. 5 328. 6 223. 4 345. 3 212 348. 1 223. 4 328. 9 234. 9 234. 4 236. 4 320. 2
BEST COPY AVAILABLE
425
000813
TWO YEAR O R A L <DIET) TOX-ONC STUDY OF FM-3924 , FC-143 IN ROTS EXP. # 0281CR0012
TECHNICIAN INITIALS:S MH TODAY'S D A T E :S 5/5/81 SEX OF R A T S :S MALE ROOM NUMBER.S 0-240/0-228 WEIGHT OF FULL FOOD J A R :S 500GRAMS
WEEK 2
1R03516 01S 007100284. 0Q FOODJAR 11S 007200332. 60 1R03517 01S 007300270. 00
FOODJAR IIS 007400341. 50 1R0251S 01S .07500267. 60 FOODJAR 11S 007600342. 00 1R03519 01S .7700293. 7Q FOODJAR 11S 007800325. 2Q 1RO3520 01S 0079. 0280. 60 FOODJAR. 11S 010000322. 30 1R03521 01S 010100255. 60 FOODJAR IIS 010200249. 90 1R03522 01S 010308273. 60
FOODJAR 11S 010400338. 60 1R03522 01S .10500281. 90 FOODJAR 11S 010600346. 4Q
1R03524 01S 018700250. 2Q POODJAR IIS 010800362. 7Q
.02525 01S 010900258. 50 FOODJAR 11S 011000352. 00 1R03526 01S 011100268. 20 FOODJAR U S 011200329. 6Q
1R03527 01S 011/00266, 20 FOODJAR 11S 011400345. 2Q 1R03528 IS .11500276. 60
FOODJAR IIS 011600337. 0Q 1R03529 G1S 011700266. 80
FOODJAR IIS 011800312. 5Q
1R03520 01S 011900290. 3Q FOODJAR 11S 012000339. 7Q 1R03531 01S 012100268. 80 FOODJAR 11S 012200336. 9Q 1R03532 01S 012/00271. 00 FOODJAR 11S 012400337. 5Q 1R02533 01S .12500294. 50 FOODJAR 11S 012600320. 6Q 1R03524 01S 012700284. 6Q
FOODJAR 11S 012800327. 40
1R02535 eis 012900244. 6Q
FOODJAR 11S 013000362. 5Q 1R02536 01S 813100250. 50 FOODJAR U S 013200356. 60 1R03537 01S 013300266. 5Q
ODJAR IIS 013400338. 4Q XK03538 01S 013500283. 00 FOODJAR 11S 013600332. IQ 1R03539 01S 013780247. 50 FOODJAR 11S 013808358. 6Q 1R03540 01S .13900249. 2Q FOODJAR 11S 014000344. 80 1R03541 01S 014100286. 3Q
1 11 1
11 1 11 1
11 1 11 1
11 1
11 1 .11
1 11 1
11 1 11 1 11 1
11 1 11
1 11 1
11 1
11 1 11 1
11 1 11 1 11 1
11 1 11 1 11 1 11 1
284
232. 6 270 341. 5 267. 6 242 293. 7
325. 3 280. 6 332. 3 '
255. 6 249. 9 273. 6
338. 6 281. 9 346. 4'
250. 2 362. 7 258. 5
352 268. 2 229. 6 266 245. 2 276. 6 337 266. 8 312. 5
290. 2 239. 7 268. 8
336. 9 271 237. 5 294. 5 320. 6 284. 6
327. 4 244. 6 362. 5
250. 5 356. 6 266. 5
i ; BEST COPY AVAILABLE
247. 5 358. 6 249. 2 344. 8 286. 3
426 000814
FOODJRR 118 014200339. 50 1R03542 eis 014300274. 80 FOODJRR 118 0144O0331. 30
1R03543 01S 014500290 40 FOODJRR 118 014600316. 20 1R03544 01S 0147. 0275. 60 FOODJRR IIS 014300330. 50
03545 01S 014900286. 30 F-OOD JRR 118 015000330. 90 1R03546 01S .015100269. 60 FOODJRR 11 015200337. 40 1R03547 01S 015300266. 60 FOODJRR 118 815400321. 00 1R03548 IS 015500300. 40 FOODJRR 118 015600327. 40 1R03549 018 .15700270. 60 FOODJRR! 118 015800354. 60 1R03550 01S 015900278. 60 FOOD'JRR! 118 016000345. 70
1R83551 018 016100216. 00 FOODJRR 118 016200375. 90 1R03552 018 016300275. 60
FOODJRR 118 016400320. 60 1R03553 018 016500289. 60 FOODJRR: 118 016600326. 60 1R03554 01S 016700239. 70 FOOD1JRR: 118 0068003:51. 50 1R03555 018 .16900255. 70
FOODJRR 118 017000351. 80 1R03556 018 017100264. 3Q FOODJRR 118 017200320. 30 1R03557 018 017300287. 00 '"-IODJRR 118 017400336. 10
. .03558 018 .17500252. 00
FOODJRR 118 017600359. 10 1R03559 018 017700280. 10 FOODJRR: 118 017800342. IQ
1R03560 01S 017900278. 70 FOODJRR 118 013000350. 10
1R03561 018 .18100287. 70 FOODJRR 118 018200316. IQ 1R03562 018 .18300239. 90 FOODJRR 118 018400360. 2Q 1R03563 018 018500284. 60 FOODJRR 118 018608337. 80 1R03564 018 018700243. 80 FOODJRR 118 018800358. 40 1R03565 01S 018900280. 6Q FOODJRR 11S 019000341. 80
1R03566 01S 019100263. 9Q FOODJRR 11S 019200338. 7Q
1R03567 01S 019306280. 50
FOODJRR U S 019400337. 3Q 1R03568 018 019500303. 70 FOODJRR IIS 019600330. 2Q 1R03569 01S .19700277. 7Q FOODJRR 118 019800336. 50 1R03570 018 019900266. 7Q
ODJRR 118 020000317. 70 1R03571 018 020100283. 70 FOODJRR 118 020200320. 90 1R03572 01S 020300268. 4Q FOODJRR 118 820400342. 80 1R03573 018 .20500291. 30 FOODJRR 11S 020600334. 70 1R02574 01S .20700265. 4Q
11 1
11 1
11 1
11 1 11 . 1
11 1 11 1 11
1 11 1 11
1 11 1 11 1 11 1 11 1
11 1 '11 1 11 1
11 1 11
1 11 1 11 1
11 1 11 1
11 1
11
1 11 1
11 1
11
1 11 1
11 1 11 1 11 1 11 1
339 5 274. 8 331. j: 290. 4 316. 2 275. 6 330. 5
286. 3
330. 9
269. 6 337. 4 266. 6
321 300. 4 327. 4
270. 6 354. 6 270. 6 345. 7
216 375. 9 275. 6 320. 6 289. 6 326. 6 239. 7 351. 5 255. 7
351. 8 264. 3 320. 3
287 336. 1 252
359. 1 280. 1
342. 1 278. 7
350. 1 287. 7
316. 1 239. 9
360. 2
284. 6 337. 8 243. 8 358. 4 280. 6
341. 8
263. 9 338. 7 280. 5
337. 3 303. 7
330. 2 277. 7 336. 5 266. 7 317. 7 283. 7 320. 9 268. 4 342. 8
291. 3 334. 7 265. 4
BEST COPY AVAILABLE
427
000815
FOODJflR 1 1 020800315 10
1R03575 01S .0900263. 30
FOODJflR l i s 021000339. 40 1R03576 018 .21180268. 40 FOODJflR 118 021208340. 00 1R03577 01S 021200283. 80
FOODJflR l i s 021400330. 6Q i35 7*S 01S 021500261. 60
r o D J h R l i s 021600350. 10 1P02579 ers .021700258. 80 FOODJflR 11S 021800344.' 10 1R03580 01S 21900261. 20 FOODJflR l i s 022000229. 00 1R03581 02S .07100248. 70 FOODJflR 12S 007200343. 10 1R03582 02S 007300245. 00 FOODJflR 12S 007400337. 20 1R03583 02S 007/00189. 30
FOQDJftR 12S 007600266. 80 1R03584 02S 0077. 0233. 40 FOODJflR 12S 007800350. 7Q 1R03585 02S 007900236. 0Q
FOODJflR 12S 018800327. 60 1R03586 02S 010100252. 20
FOODJflR 12S 018200321. 50 1R035S7 02S 010300209. 60 FOODJflR 12S 010400370. 50 1R03588 02S 810500236. 1Q
FOODJflR 12S 010600353. 7Q 1R03589 02S 010700224. 3Q FOODJflR 12S 010808332. 4Q
1R03590 02S 010900274. 20 FOODJflR 12S 011000319. 20
.02591 02S .11100213. 2Q
FOODJflR 12S 011200251. 10 1R02592 02S 011300242. 7Q FOODJflR 12S 011488340. 10
1P03593 02S 011500239. 7Q FOODJflR 12S 011600346. 80 1R02594 02S 011700251. 80 FOODJflR 12S 011800318. 7Q 1R02595 02S 011900237. 60
FOODJflR 12S 812000332. 60 1R03596 02S 012/00232. 6Q FOODJflR 12S 012200324. 7Q 1R03597 02S 012300244. 4Q
FOODJflR 12S 012400329. 9Q 1R02598 02S 012500274. 3Q
FOODJflR 12S 012600325. 5Q 1R03599 02S 012700225. 60 FOODJflR 12S 012800237. 1Q 1R03600 02S 012900220. 9Q
FOODJflR 12S 013000341. 80 1R03601 02S .13100254. 7Q
FOODJflR 12S 813200328. 80 1R03602 02S .13300220. 70 FOODJflR 12S 013400355. 3Q 1R03603 02S .13500249. 40
'ODJflR 12S 012680340. 6Q J.P03604 02S .13700221. 1Q FOODJflR 12S 013800354. 30
1R03605 02S 013900247. 2Q FOODJflR 12S 014000342. 7Q 1R02606 02S .14100224. 90 FOODJflR 12S 014200361. 7Q 1R03607 02S .14300261. 1Q
11
1
11
1
11 1
11
1 11
1
11 1
11
2 12
2
12 2
12
2
12
2
12 2
12
2
12
2
12 2
-12
2
12
2
12
2
12
2
12
2
12
2
12
2
12
2
12
2
12
2
12
2
12
2 12 2
12
2
12
2
12
2
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2 12 2
315. 1
263. 3
339. 4 268. 4
340 283. 8 330. 6 261. 6 350. 1 258. 8 344. 1 261. 3 339 248. 7 343. 1 245 337. 2 189. 3 366. 8 233. 4 350. 7 236 327. 6 252. 2 321. 5
209. 6 370. 5 236. 1 353. 7 224. 3
332. 4
274. 2 319. 3 213. 2
351. 1 242. 7 340. 1
239. 7 346. 8 251. 8
318. 7 237. 6
332. 6
232. 6 324. 7 244. 4
339. 9 274. 3
325. 5 235. 6 337. 1
220. 9
341. 8 254. 7
328. 8 220. 7 355. 3 249. 4 340. 6 221. 1 354. 3 247. 2 342. 7 224. 9
361. 7 261. 1
428
000816
FOODJRR 12S 014400329. 2Q i r o j -608 62S 014500246 60 FOODJflR 12S 014600325 70 1R03609 02S 814700217. 00 FOODJRR 12S 014800338. 20 1R03610 02S .14900277. 90 FOODJRR 12S 015000343. 40
03611 02S .15100252. 50 FOODJRR 12S 015200322. 00 1R03612 02 0153002*8. 20
FOODJRR 12S 015400334. 10 1R03613 02S 015500. 70. 80
FOODJRR 12S 015600325. 30 1R03614 02S .15700241. 80 FOODJRR 12S 015800321. 30 1R03615 02S 015900225. 80 FOODJRR 125 016000332. 7Q 1R03616 025 016100234. 90 FOODJflR 125 016200338. 3Q 1R02617 025 016300226. 5Q FOODJRR l2> 016400342. 6Q 1R03618 025 016500244. 60 FOODJRR 125 016600323. 00 1R03619 025 016700206. 20 FOODJRR 125 016800335. 80 1R03620 025 .16900225. 50 FOODJRR 12S 017000338. 00 1R03621 025 0171002. 0. 50
FOODJRR 125 017200362. 70 '"-03622 025 .17300218. 2Q
jODJRR 125 017400352. 7Q 1R03622 025 017500237. 9Q FOODJRR 125 817600329. 70 1R02624 025 01/700212. 60 FOODJRR 125 017800340. 50 1R03625 025 017900201. IQ FOODJRR 125 018000364. 30 1R03626 025 018100263. 00 FOODJRR 125 018200231. 3Q 1R03627 025 818300261. 60 FOODJRR 125 018400344. 6Q 1R03628 02S 0/8500248. 4Q FOODJRR 12S 018600339. 7Q 1R03629 025 .18700237. 80 FOODJRR 12S 018800239. 2Q 1R83630 025 018900211. 8Q FOODJRR 12S 019000364. IQ 1R03631 02S 019100264. 40 FOODJRR 125 019200342. 60 1R03632 025 019300239. 80 FOODJRR 12S 019400345. 50 1R03633 025 .19500249. 10 FOODJRR 125 019600319. 7Q 1R02634 825 019700177. 4Q FOODJRR 125 019800370. 0Q
02635 02S 01990. 187. 5Q FOODJRR 12S 820000354. 2Q 1R03636 02S .20180240. 9Q FOODJRR 125 020200347. 7Q 3R03637 025 .20388225. 0Q FOODJRR 12S 020400352. 7Q 1R03628 025 828500223. 2Q FOODJRR 125 020600332. 8Q
12 2 12 2 12 2 12 2 12 2
12 2
12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2
12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12 2 12
329. 2 246. 6 325 7 217 338. 2 277. 9 342. 4 252. 5 332
248.2
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270.8
325. 3 241. 8 321. 3 235. 8 332. 7 234. 9 338. 3 226. 5 342. 6 244. 6 323 206. 2 335. 8 225. 5 338
200.5 -
362. 7 218. 2 352. 7 237. 9 329. 7 212. 6 340. 5 201. 1 364. 3 263 331. 3 261. 6 344. 6 248. 4 339. 7 237. 8 339. 2 211. 8 364. 1 264. 4 342. 6 239. 8 345. 5 249. 1 319. 7 177. 4 370 187. 5 354. 2 240. 9 347. 7 225 352. 7 223. 2 332. 8
K S T COPY AVAILABLE
429
000S17
1R03639 0'b 020700221. 60
FOODJRR 1 020800352. 60 1R03640 02S 020900185. 40 FOODJRR 12S 021000361. 10 1R03641 02S .21100251. 10 FOODJRR 12S 021200239. 6Q 1R03642 02S .21300218. 2Q
00 JRR 12S 021400347. 50 J.R03643 02S .21500239. 50 FOOD-JftR 12S 021600342. 20 1R03644 028 021700229: 90 FOODJRR 12S 021800337. 20 1R03645 028 021900234. 60 FOODJRR 128 022000341. 60 1R03646 03S 022100245. 10 FOODJRR 138 022200353. 70 1R83647 03S 022300284. 40 FOODJRR 138 022400331. 50 1R03648 03S 022500274. 30
FOODJRR 138 022600322. 7Q 1R03649 03S 022700255. 2Q FOODJRR 13S 022800342. 0Q
1R03650 03S .22900260. 7Q FOODJRR 128 023000349. 40 1R03651 03S 023100261. 80 FOODJRR 138 023200336. 2G 1R02652 028 023300276. 0Q FOODJRR 138 023400344. 2Q
1R03653 028 .23500275. 9Q FOODJRR 12-S 023600335. 3Q 1R03654 02S .23700278. 0Q
FOODJRR 138 823800326. 90 "R03655 03 S 023900276. 90
.iODJRR 138 024080320. 5Q
1R03656 038 024100275. 80 FOODJRR 13S 024200326. 5Q 1R03657 03S .24300266. 10
FOODJRR 12S 024400345. 3Q
1R03658 038 .24500266. 30 FOODJRR 13 S 024600342. 70 1R03659 03S 024700286. 50 FOODRR 13S 024800328. 0Q 1R03660 03S 024900266. 0Q
FOODJRR 138 825800336. 20 1R03661 028 025100272. 0Q
FOODJRR 138 025200340. 3Q
1R03662 028 025300242. 2Q FOODJRR 13S 025400354. 8Q 1R02663 03S 025500290. 30 FOODJRR 13S 825600314. 10 1R02664 03S 025700274. 8Q BFOODJRR 13S 025800227. 0Q
1R03665 035 025900289. 2Q FOODJRR 13S 026000332. 0Q 1R03666 03S 026100284. 3Q FOODJRR 13S 026200340. IQ 1R03667 03S 026300229. 7Q FOODJRR 138 026400367. 5Q
':03668 025 026500232. 5Q ruODJRR 13S 026600362. 4Q 1R03669 02S 026700272. 00 FOODJRR 135 026300323. 60 1R02670 02S 026900272. 7Q FOODJRR 135 027000317. 60 1R03671 03S 027100273. 00 FOODJRR 135 027200331. IQ
2
12
2
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430
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TWO YEAR ORAL(DIET > TOX-ONC STUDY OF FM-2924 & FC-142 IN RATS' EXP. # 02810*0012
TECHNICIAN IN1TIALS:S MH TODAY DATE : 5.'12/81 SEX OF RATS:S MALE ROOM N U M B E R : D-346D-328 WEIGHT.OF FULL FOOD J A R : 500GRAMS
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1R02622 02S 019200284. 30
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1R83<622 025 019500305. 70
FOODJAR 125 019600325. 40
1R03634 025 019700208. 90
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1R03635 02S 19900206. 10
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259. 5
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441
000829
1R02640 025 020900158 60 FOODJRR 1 2 S 021000283. 90 1P02641 02S 021100206. 00
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1F.'02646 02 S 02210O288. 40 FOODJRR 135 022200366. 60 1R03647 03 S 02220032S. 00 FOODJRR 12S 022400358. 80 1R02648 02S 022500354. 10 FOODJRR 13S 022600313. 10
1R02649 03S 022788322. 10 FOODJRR 125 022800346. 00 1R03650 03S 02290O308. 00 FOODJRR 12S 023000266. 70 1R02651 02S 023100325. 80 FOODJRR 12S 023200355. 10
1R02652 02S 022300327. 30 FOODJRR 135 022'40G36O. 60 1R03-652 03^* 823500220. 50
FOODJRR 135 O23600357. 20 1R03654 03S 023700249. 00 FOODJRR 13S 023800341. 80 1R02655 025 02390G325. 10 FOODJRR 135 024000228. 00 1R02656 025 024100332. 10 FOODJRR 125 02420025G. 10 1R03657 03S 02430O224. 20 FOODJRR 135 024400359. 60 1R02658 025 02450O228. 90 FOODJRR 135 024600260. 20 1R03C-551 035 024700331. 10
FOODJRR 12S 02480O249. 70 1R03660 02S 02490O325. 00 FOODJRR 125 025000252. 20
1R02661 02S 025100336. 50 FOODJRR 125 025200249. 00 1R02662 025 025300277. 60
FOODJRR 135 025400388. 20
1R02662 02S 025500262. 20 FOODJRR 135 02560O214. 50 1R02664 03S 025700326. IQ FOODJRR 125 025800257. 20 1RG3665 035 025900228. 00 FOODJRR 13S 026000252. 70
1R03666 03S 026100339. 40 FOODJRR 13S 026200349. 10
1R03667 03S 026300264. 30 FOODJRR 135 026400388. 60 1R02668 03S G26500268. 70 FOODJRR 12S 026600279. 70 k 3 6 6 9 02S 026700330. 40
FOODJRR 125 026800338. 50 1R83670 025 026908239. 60 FOODJRR 135 027000317. 30 1R02671 03S 027100225. 80
FOODJRR 125 027200225. 70 1R03672 035 027300329. 5Q FOOD-TAR 12S 027400346. 80
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325. 7
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1R83673 02 027500317. 80
FOODJflR 12S 027600264. 00
1R03674 03S 027700319. 00
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1R03675 02S 027900351. 80
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1R02679 03S 028700328. 90
FOODJflR 12S 028800240. 80
1R03680 03S 828900240. 00
FOODJflR 13S 129000323. 70
1R03681 03 029100245. 00
FOODJflR 135 029200236. 70
1R3682 02S 029200210. 40
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1R03690 02 020900225. 00
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FOODJflR 135 031200261. 30
1R03692 03 021300287. 60
FOODJflR 13 031400384. 60
1R02693 03 031500272. 20
FOODJflR 13 031600318. 50
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BEST COPY AVAILABLE
443
000831
TWO YEAR O R A L 'D I E T > TOX-ONC STUDY OF FM-2924 & FC-142 IN RFiTS EXP. # 0281CR0012
TECHNICIAN INITIALS:S MH TODAY'S D A T E :S 5/26/81 SEX OF R A T S :S MALE ROOM N U M B E R :S D-240, D-338 . WEIGHT OF FULL FOOD J A R :S 550GRAMS
WEEK. 5
1R02516 01S 007000388. 6Q FOODJAR IIS 007100358. 0Q 1R03517 01S 007200257. 20
FOODJAR U S 007300386. 8G
1R0251S 01S 007400355. 7Q FOODJAR 11S 007500389. 60 1R02519 01S 007600389. 80 FOODJAR IIS 007700361. 80 1R03520 01S 007800382. 50 FOODJAR U S 007900364. 20 1R03521 01S 010000345. 90 FOODJAR U S 010100235. 70 1R03522 01S 010200254. 90
FOODJAR U S 010300394. 2Q 1R03523 01S 010400388. 70 FOODJAR U S 010500377. 40 1R03524 01S 010600340. 90 FC--IDJAR U S 010700385. 8Q 1 3525 01S 010800257. 6Q
FOODJAR U S 010900277. 30 1R03526 01S 011000353. 50 FOODJAR U S 011100383. 60 1R03527 01S 11200361. 70 FOODJAR U S 011200389. 90 1R02528 01S 011400379. 20
FOODJAR U S 011500278. 70 1R03529 01S 011600265. 60 FOODJAR U S 011700376. 10 1R03520 01S 011800277. 3Q FOODJAR U S 011900377. 00 1R03531 01S 012000253. 80
FOODJAR U S 012100392. 40 1R03532 01S 012200363. 80 FOODJAR U S 012300363. 7Q 1R03533 01S 012400370. 4Q FOODJAR U S 012500282. 20 1R03534 01S 012600396. 90
FOODJAR 11S 012700360. IQ 1R03535 01S 012800320. 00 FOODJAR U S 012900350. 7Q 1R03536 01S 013000339. 20 FOODJAR U S 012100398. 80 1R02537 01S 013200325. 7Q F DJAR U S 013200369. 80 1R03538 01S 013400286. 40 FOODJAR U S 013500375. 20 1R03539 01S 012600295. 80 FOODJAR U S 013700407. 0Q 1R03540 01S 013800339. 20 FOODJAR U S 013900384. 50 1R03541 01S 014000369. 7Q
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S 2 BEST COPY AVAILABLE
384. 5 369. 7
444
000832
h i-JUL1.1HR 11S 0 14 10038,-. 10
1R82542 01S 014200368. 70 FOOD1JAR U S 01430O370. 00 1R02543 01S 01440O402. 70 FOODJAP 11S 014500335. 60 1R03544 01S 014600357. 20 FOOD JAR 11S 014700384. 30 1 3545 01 014800391. 60 F>. jD JAR IIS 014900370. 90 1R03546 01S 015000382.- 50 FOODJAR l l s 015100372. 60 1R03547 01S 015200273. 70 FOODJAR 11S 015300353. 50 1R03548 01S 015400406. 30 FOODJAR 11S 015500366. 30
1R03549 01S 015600349. 90 FOODJAR 11S 015700383. 50 1R03550 01S 915800347. 10 FOODJAR IIS 015900383. 00
1R03551 01S 016000280. 60 FOODJAR 11S 016108417. 70 1R03552 01S 016200361. 40
FOODJAR IIS 0163 00349. 90 1R02553 01s 016400406. 00 FOODJAR 11S 016500355. 10 1R02554 01S 016600306. 30 FOODJAR U S 016700401. 40 1R03555 01S 016800346. 00
FOODJAR 11S 016900390. 90
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1R02557 01S 017200347. 40 FOOD*JAR 11S 017200408. 00 1 "iFISR: 01S 017400308. 50
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FOODJAR IIS 018100348. 60 1R03562 01S 018200308. 20 FOODJAR 11S 018300402. 90
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FOODJAR 11S 018700372. 0Q 1R03565 01S 018800371. 20 FOODJAR 11S 018900375. 10 1R03566 01S 019000345. 5Q FOODJAR 11S 019100383. 40 1R03567 01S 019200390. 20 FOODJAR 11S 019300359. 10 1R02563 01S 019400375. 2Q FOODJAR 11S 019500394. 70 1R03569 015 019600377. 40 FOODJAR U S 019700373. 30 1R03570 eis 019800378. 70 F -DJAR 115 019900329. 6Q 1.J3571 015 020000386. 5Q FOODJAR 11S 020100357. 50
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SSS BEST COPY AVAILABLE
357. 5 362. 4 373. 1 373. 7 386. 3 410. 9
445
000833
MJUDJHK 118 OtOi 0088 /'. 7U 1R02*}75 01S 020800324. 00
FOODJftR lis 020900382. 0Q 1R03576 01S 021000364. 90 FOODJftR lis 021100276. 70 1R03577 01S 021200371. 20 FOODJftR lis 021300369. 20 i 2578 01S 021400349. 30 FuODJflR lis 021500366. 10 1R02579 01S 021600345. 70 FOODJftR lis 021700386. 00 1R03580 01S 021800241. 6Q FOODJftR lis 021900267. 30 1R02581 02S 007100334. 30 FOODJftR 12S 00?200270. 70 1R03582 02S 007300271. 50 FOODJftR 12S 007400406. 90 1R03583 02S 007500234. 9Q FOODJftR 12 S 007600407. 1Q 1R02584 02S 007700201. 20 FOODJftR 12S 007800393. 9Q 1R03585 02S 007900297. 60
FOODJftR 12S 010000370. 50 1R03586 02S 010100220. 60 FOODJftR 12S 010200379. 70 1R03587 02S 010300268. 90 FOODJftR 12S 010400407. 10 1R02588 02S 010500303. 5Q
FOODJftR 12S 010600400. 50 1R03589 02S 010700282. 50 FOODJftR 12S 010800248. 50
1R03590 02S 010900378. 30 F'-'-'DJftR 12S 011000256. 40 1. ,3591 02S 011100254. 50
FOODJftR 12S 011200411. 9Q 1R03592 02S 011200325. 40 FOODJftR 12S 011400276. 00
1R03593 02S 011500224. 00 FOODJftR 12S 011600391. 50 1R03594 02S 011700333. 40
FOODJftR 12S 011880358. 2Q 1R02595 02S 011900292. 20 FOODJftR 12S 012000398. 80 1R03596 02S 012100319. 50 FOODJftR 12S 012200368. 7Q 1R03597 02S 012300289. 6Q FOODJftR 12S 012408407. 1Q 1R03598 02S 012500355. 7Q FOODJftR 12S 012600384. 20
1R03599 02S 012700314. 50 FOODJftR 12S 012800371. 0Q 1R03600 02S 012900260. 40 FOODJftR 12S 013000416. 60 1R03601 02S 013100238. 8Q FOODJftR 12S 013200262. 3Q 1R03602 02S 013300285. 00 FOODJftR 12S 013400405. 1Q 1R03603 02S 012500308. 0Q F DJfiR 12S 013600288. 9Q 1R03604 02S 012700268. 0Q FOODJftR 12S 012800414. 20 1R03605 02S 012900286. 5Q FOODJftR 12S 014000398 6Q 1R03606 02S 014100304. 30 FOODJftR 12S 014200297. 9Q 1R03607 02S 014300343. 6Q
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2 BEST COPY AVAILABLE
398. 6 304. 3 397. 9 343. 6
446
000834
FOODJAR 12 S 014400377. 00
1R0260S 02S 014500238. 60 FOODJAR 12S 014600255. 90
1R03609 02R 004600296. 40
FOODJAR 12S 014800271. 20 1R03610 02S 014900267. 70 FOODJAR 123 015000280. 40
r '6 02S 015100309. 70 F._ _,DJAR 12S 015200385. 90 1R03612 02S 015300318. 50
FOODJAR 123 015400394. 90 1R03613 023 015500276. 10 FOODJAR 123 015600367. 50
1R03614 023 015700308. 20 FOODJAR 123 015800274. 40
1R03615 023 015900297. 00 FOODJAR 123 016000378. 00 1R03616 023 016100306. 80 FOODJAR 123 016200287. 40
1R03617 023 016300306. 90 FOODJAR 123 816400387. 40
1R03618 023 016500327. 6Q
FOODJAR 123 O16600368. 7Q
1R03619 02S 016700251. 50 FOODJAR 123 016800403. 00
1R03620 023 016900287. 60
FOODJAR 123 017000274. 30 1R03621 023 017100255. 60
FOODJAR 123 017200423. 80 1R03622 023 017300280. 30 FOODJAR 12S 017408402. 7Q
1R03623 02S 017500282. 30 FOODJAR 12S 017600287. 90 1 3624 023 017700293. 80
FOODJAR 123 017800393. 10 1R03625 023 017900239. 70 FOODJAR 123 018000399. 50
1FI03626 023 018108318. 50 FOODJAR 123 018200389. 60 1R03627 023 018300317. 90
FOODJAR 123 018400399. 20 1R02628 023 018500301. 50 FOODJAR 123 018600407. 70
1R03629 023 018700320. 90 FOODJAR 123 018800282. 60 1R03630 023 018900265. 00
FOODJAR 123 019000414. 50
1R03631 023 019100247. 70
FOODJAR 12S 019200289. IQ
1R03632 02S 019300312. 9Q FOODJAR 12S 019400396. IQ 1R03633 02S 019500233. IQ FOODJAR 12S 019600381. 20 1R03634 02S 019700223. 10 FOODJAR 12S 019800407. 00
1R03635 02S 019900221. 70 FOODJAR 123 020000294. 90 1R03636 023 020100322. 30 F '-DJAR 123 020200379. 90 li-.03637 023 020300284. 50 FOODJAR 123 020400274. 60
1R03638 023 028500274. 20 FOODJAR 123 020600386. 4Q 1R03639 023 020700282. 80
FOODJAR 12S 020800395. 0Q 1R03640 023 020900211. 3Q
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B11 EST COPY AVAILABLE
282. 8
395
211. 3
447
000835
1-UODJAR 12S 021000414. 80 1R03641 02S 021100330. 80 FOODJAR 12S 021200381. 60 1R03642 02S 021300269. 30 FOODJAR 12S 0214003:86. 60 1R03643 02S 021500327. 60 FOODJAR 12S 021600375. 60 : 3644 02S 021700269. 60 FijODJAR 12S 021800351. 90 1R03645 02 S 021900331. 20 FOOD JAF: 12S 022000371. 80 1R03646 03S 022100312. 50 FOODJAR 13S 022200396. 30 1R03647 03S 022300365. 00 FOODJAR 13S 022400384. 80 1R03648 03S 022500393. 00 FOODJAR 13S 022600341. 20 1R03649 03 S 022700359. 8Q FOODJAR 13S 022800369. 40 1R03650 03S 022900333. 70 FOODJAR 13S 023:000393. 20 1R03651 03 S 023100354. 50 FOODJAR: 13S 023200375. 90 1R03652 03 S 823300353. 8Q FOODJAR 13 S 023400386. Q 1R03653 03S 023500341. 80 FOODJAR 13S 023600379. 3Q 1R03654 03S 023700373. 5Q
FOODJAR 13 023800377. 00 1R03655 03 S 023900370. 60 FOODJAR 13S 024000342. 40 1R03656 03S 024100358. 30 FOODJAR 13S 024200378. 00 1 3657 03 S 024300352. 90 FOODJAR 13S 024400388. 70 1R03658 03S 024500360. 30 FOODJAR 13S 024600385. 80 1R03659 03S 024700347. 30 FOODJAR 13S 024800379. 1Q 1R03660 03S 024900363. 80 FOODJAR 13S 025000369. 20 1R03661 03S 025100360. 20 FOODJAR 13S 025200379. 4Q 1R03662 03S 025300302. 40 FOODJAR 13S 025400396. 2Q 1R03663 03S 025500403. 60 FOODJAR 13S 025600343. 4Q 1R03664 03S 025700347. 60 FOODJAR 13S 025800386. 4Q 1R03665 03S 025900359. 7Q FOODJAR 13S 026000379. 0Q 1R03666 02S 026100364. 8P
1R03667 02S 026300279. 00 FOODJAR 13S 026400414. 4Q 1R03668 03S 026500281. 90 FOODJAR 13S 026600409. 7Q 1R03669 03S 026700355. 3Q F DJAR 13S 026800374. 1Q lk*s3670 03S 026900365. 50 FOODJAR 12S 027000360. 8Q 1R03671 03S 027100350. 90 FOODJAR 13S 027200377. 5Q 1R03672 03S 027300358. 6Q FOODJAR 13S 827400366. 60 1R03673 03S 027500339. 6Q
12 2
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377. 5 358. 6 366. 6 339. 6
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1R03674 02S 02771110343. 00 FOODJRR 13 S 027800382. 80 1R03675 03S 027900378. 70 FOODJRR 12S 028008362. 40 1R83676 02S 028100404. IQ FOODJRR 128 028200358. 10 i ' 3677 038 0283010362. 20 Fi-j OJRR 138 028400361. 40 1R02678 02:8 028500367. 60 FOODJRR 128 028600378. 60 1R03679 039 028700371. 50 FOODJRR 138 028800366. 60 lRti3iSS0 028 028900373. 90 FOODJRR 138 029000361. 5Q
1R03681 03S 029100376. 10 FOODJRR 128 0292010362. 70 1R03682 03S 029300321. 00 FOODJRR 138 029400405. 50
1R036S3 038 029500382. 2Q FOODJRR 12S 029600359. 30 1R03684 028 029700366. 80
FOODJRR 128 029800352. 20 1R036S5 028 029900341. 70 FOODJRR 138 030000380. 30
1R0286 03S 030100339. 7Q FOODJRR 128 03:0200390. 70 1R03687 02S 030300341. 90
FOODJRR 138 030400371. 20 1R03<S88 038
FOODJAR 1R03689 038 030700321. IQ FOODJRR 12S 030800391. 30 1 3690 038 030900371. 8P FOODJRR 138 31000357. 40 1R03691 028 031100341. 5Q FOODJRR 138 031200386. 10 1R03692 038 031300300. 60 FOODJRR 138 031400413. 2Q 1R02693 03S 031500402. 7Q FOODJRR 13S 031600348. 80 1R03694 03S 031700256. 2Q FOODJRR 12S 031800362. 7Q 1R02695 03S 021900376. 40 FOODJRR 138 032000380. 3Q
99
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BEST COPY AVAILABLE
449
000837
TWO YEAR ORAL<DIET> TOX-ONC STUDY OF FM-2924 6. FC-143 IN RATS EXP. 0281CR0012
TECHNICIAN INITIALS:S MH TODAY S D A T E :S 6/2/81 SEX OF R A T S :S MALE ROOM N U M B E R :S D-340, D-238 WEIGHT OF FULL FOOD J A R :S 550GRAMS
WEEK 6
1R03516 01S 000000421. ;<Q FOODJAR 11S 000100252. 6Q 1R03517 01S 000200387. 8G! FOODJAR 11S 000200265. 90
1R0351S 01S 000400385. 70 FOODJAR 11S 000500369. 80 1R03519 01S 000600421. 00 FOODJAR IIS 000700358. 20 1R03520 01S 000800410. 10 FOODJ AF: U S 000900360. 40
1R62521 01S 001000376. 30 FOODJAR IIS 001100272. 60 1R02522 eis 001200275. 90
FOODJAR n s 001200292. 80 1R03523 01S 001400426. 30 FOODJAR n s 001500318. 60
1R03524 01S 001600363. 90 FOODJAR IIS 001700385. 30 1 2525 01S 001800401. 10 FuoDJAR IIS 001900352. 10 1R02526 01S 002800384. 80 FOODJAR IIS 002100363. 50 1R03527 01S 002200389. 80 FOODJAR 11S 002300378. 90 1R03528 01S 002480414. 50 FOODJAR 15 002500360. 00 1R03529 01S 002600389. 10 FOODJAR IIS 002700329. 20
1R0353O 01S 002800396. 30 FOODJAR IIS 002900372. 20 1R03531 01S 003000386. 90
FOODJAR IIS 003100371. 20 1R03522 01S 002200390. 00 FOODJAR 11S 003300365. 70
1R03533 01S 003400409. 00 FOODJAR 11S 002500276. 60 1R03534 01S 003600432. 80
FOODJAR 11S 003700347. 70 1R03535 01S 803800241. 20 FOODJAR 11S 003900393. IQ 1R03536 01S 004000370. 70 FOODJAR 11S 004100286. IQ 1R03537 01S 004200350. 2Q FOODJAR IIS 004300366. 30 1 2538 01S 004400425. 60 FOODJAR 11S 004500350. 10 1R03529 01S 004600323. 9Q FOODJAR 11S 004700392. 60 1R03540 81S 04800364. 60 FOODJAR U S 004908375. 2Q 1R03541 01S 005000412. 50
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387. 8
365. 9
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410. 1
360. 4
376. 2
372. 6
375. 9
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426. 3
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384. 8
363. 5
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432. 8
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341. 2
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270. 7
386. 1
350. 2
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425. 6
350. 323. 392.
1
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BEST COPY
AVAILABLE
364. 6
375. 2
412. 5
450
COO838
FOODJAR 119 003100228. 50 1R02542 013 005200397. 20 FOODJAR 11S 005300265. 20 1R03543 015 005400443. 80 FOODJAR 115 005500325. 20 1R03544 015 00560O384. 60 FOODJAR IIS 005700367. 00 1. 3545 01S 005800422. 10 FOODJAR U S 005900259. 60 1R02546 015 006O00420. 20 FOODJAR 115 006100371. 10 1R03547 015 6106200407. 10 FOOD JAR 115 006300247. 00 1R0354S 015 006400441. 10 FOODJAR 115 006500359. 4Q 1R02549 015 006600371. 00 FOODJAR 115 006700282. 3Q 1R03550 015 006800282. 10 FOODJAR 115 006900279. 70
1R03551 015 007000201. 10 FOODJAR 11S 0O7100408. SO 1R03552 015 007200403. 20 FOODJAR IIS 0073:00363. 90 1R02553 015 007400442. 70 FOODJAR 115 807500348. 90
1R02554 015 007600329. 80 FOODJAR 115 007700385. 00 1R03555 015 007800374. 00
FOODJAR 115 007900385. 90 1R03556 01S 008000421. 00 FOODJAR 115 008100380. 00 1R02557 015 008200382. 50 F DJAR 115 008300392. 70 1k 02558 015 008400326. 90 FOODJAR 115 1R02559 015 008600409. 10 FOODJAR 115 008700372. 40 1R02560 015 008800374. 20 FNMDJ0R 00R 008900279. 60 1R02561 015 009000435. 80 FOODJAR 115 09100248. 30 1R02562 015 009200329. 70 FOODJAR: 115 009300297. 20 1R:02563 015 009400368. 90 FOODJAR 115 009500385. 60 1R03564 015 009600364. 70 FOODJAR 115 009700374. 00 1R03565 01S 009800398. 70 FOODJAR 11S 009900346. 8Q
1R03566 01S 010000361. 3Q FOODJAR 115
1R03567 FOODJAR 11S 010300358. IQ 1R03568 015 010400404. 90 FOODJAR 11S 010500388. 70 1R02569 01S 010600409. 0Q FOODJAR 115 010700362. 20 3D03570 015 010800414. 2Q 1 JDJAR 11S 010900319. 00 1R03571 015 011000424. 6Q FOODJAR 115 011100340. 00 1R02572 015 011200396. 7Q FOODJAR 115 011300350. 9Q 1R03573 015 011400298. 50 FOODJAR IIS 811500368. IQ 1R03574 015 011600407. 4Q
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410. 1 409. 1 372. 4 274. 2 279. 6 425. 8 348. 3 229. 7 297. 3 368. 9 385. 6 364. 7 274 298. 7 246. 8
361. 3 397. 2
427. 0 358. 1 404. 9 388. 7
409 362. 2 414. 2 319 424. 6 340
296. 7 350. 9 298. 5 368. 1 407. 4
S I COPY AVAILABLE
45 000839
M JIJL'.'IIK H i - 011/00317. 8 0
1R03575 015 011800358 30
FOOC'JRF: 115 011900250 10 1R03576 015 012000387. 40
FOOC'JRF: 115 012100272. 40 1R02577 015 012200405. 10 FOOC'JRF: 115 012300361. 50 J ''02578 015 012400276. 40 1 .tC'JRF: 115 012500252. 20 1R03579 015 012600372. 70 FO O L1J HR 115 012700374. 10 0F:O35S0 0 1 5 0128003-66. 30 FOOC'JRF: 115 012900368. 30 1R03581 025 007100365. 30 FOOC'JRF: 125 007200360. 0 0 1R035S2 025 007300279. 40 FOOC'JRF: 125 00'7400422. 20 1R03583 025 00 7500242. 30 FOOC'JRF: 125 007600421. 20
1R03584 025 007700310. 50 FOOC'JRF: 12S 007800413. 0 0 1R03585 025 007900308. 90 FOOL'Th F: 125 010000388. 30 1R03586 025 010100333. 90
FOOL-'-JRF: 125 010200400. 80
1R035S7 025 010300281. 7 0 FOODJRR 125 010400434. 10 1R03588 025 010500328. 30
FOOC'JRF: 125 010600399. 80 1R03589 025 018700289. 20 FOOC'JRF: 125 010800382. 30 1R0359O 025 010900391. SO FOOC'JRF: 125 011000387. 2Q J 3591 025 011100269. 50
FuJDJRR 125 011200417. 10 1R03592 025 011300332. 60 FOOC'JRF: 125 011400392. 80
1R03593 025 011500338. 60 FOOC'JRF: 125 011600396. 30 1R03594 025 011700320. 40 FOOC'JRF: 125 011800406. 40 1R83595 025 011900300. 40 FOOC'JRF: 125 012000409. 80
1R03596 025 01210032-6. 40 FOOC'JRF: 125 012200397. 20 1P.03597 025 012300296. 20
FOOC'JRF: 125 012400426. 50 1R03598 025 012500350. 0 0 FOODJRR 125 012600432. 90 1R03599 025 012700308. 3Q FOODJRR 125 012800425. 40 1F;03600 025 012900263. 60 FOODJRR 125 013000440. 3Q 1R03601 025 012100348. 60 FOODJRR 125 013200398. 20 1R03602 025 013300292. 50 FOODJRR 12S 013400414. 60 1R03603 025 013500325. 30 Ff"-'C'JRR 125 013600403. 0 0 1 3604 025 013700278. 10 FOND JFIR 125 013800420. 0 0 1R03605 025 013900295. 80 FOODJRR 125 014008411. 90 1R03606 25 014100315. 30 FOODJRR 125 014200414. 40 1R03607 025 014300352. IQ
11
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358. 3
350. 1 387. 4
373. 4 405. 1
261. 5 376. 4 352. 3 372. 7 374. 1 366. 3 368. 3 365. 3 368 279. 4
422. 3 242. 2 421. 2
310. 5 413 308. 9
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281. 7 434. 1 328. 3
299. 8 289. 2 382. 3 391. 8 387. 2
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308. 3 425. 4 263. 6 440. 3 348. 6 398. 2
292. 5 414. 6
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403 278. 1 420
295. 8 411. 9 315. 3
414. 4 352. 1
T COPY AVAILABLE
452
000840
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1R03619 023 016700263. 70
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FOODJFlR 123 016800413. 70
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1R03620 023 016900302. 20
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1R03621 023 017100269. 40
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FOODJFlR 123 017200436. 70
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1F;03623 023 017500288. 10
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1R03628 023 018500306. 60
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FOODJFlR 123 018600431. 10
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1R.03631 02S 819100227. 70
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FOODJflR 123 019200439. 30
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1R03632 02S 019300226. 00
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FOODJflR 12S 019600411. 40
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FOODJflR 123 019800415. 80
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1R02637 02S 020300286. 00
2
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FOODJflR 123 020400407. 30 1R03638 023 020500262. 00 FOODJflR 123 020600419. 70
12 2 12
407. 3 284. 3
BEST COPY AVAILABLE
419. 7
1R03639 023 020700306. 00
2
306
FOODJflR 12S 020800403. 80
12
403. 8
1R03640 023 020900233. 2Q
2
233. 2
453
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MJUD-JHK X26 0 2 1 0 0 0 4 1 , - ' . U
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FOODJRR 133 022400293. 20
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FOODJRR 133 022600358. 80
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1R03650 023 02290O350. 30
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FOODJRR 123 023000394. 50
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FOODJRR 133 023200374. 90
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1R03652 033 022200365. 00
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FOODJRR 123 023400385. 00
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FOOD JRF: 133 023600280. 80
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1R03654 023- 023708402. 60
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FOODJRR 133 023800374. 90
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1R03655 033 023900384. 20
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384. 3
FOODJRR: 133 024800372. 10
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1R03656 023 024100395. 20
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FOODJRR 123 024200272. 30
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1R03658 023 024500270. 80
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FOODJRR 133 025200402. 60
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1R03662 023 025300314. 20
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FOODJRR 123 025400417. 20
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FOODJRR 133 025608371. 90
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FOODJRR 13S 025800391. 20
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1R03666 023 026100380. 20
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FOODJRR 13S 026200384. 60
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1R03667 023 026300292. 9Q
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FOODJRR 133 026400420. 50
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1R03668 02S 026500289. 90
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FOODJRR 133 026600421. 10
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FO-DJRR 133 026800289. IQ
13
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1. 3670 033 026908375. 00 FOODJRR 123 027080383. 60 1R03671 033 027100369. 10
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383. 6 369. 1
BEST COPY AVAILABLE
FONDJ0R 123 027200377. 60
13
377. 6
1R02672 023 027308378. 80
3
378. 8
FOODJRR: 133 027400390. 90
13
390. 9
1R03673 02S 027500336. 8Q
3
336. 8
454
000842
M JU D JH K l i i . U2i t > 0 0 4 2 y . in 1R02674 03 S 027700266. 0Q FOODJflR 12R 026800291. 3Q 1R02675 02S 027900391. 8Q FOOD-JAR 13 028000372. 3Q 1R02676 03S 028100434. 6Q FOODJAR 13 028200364. 3Q 1. 677 03S 0283003-57. 60 FOOD-JAR 135 028400403. 60 1R0267S 035 028500384. 70
FOODJAR 135 028600391. 90 1R03679 035 028700396. 20 FOOD-JAR 13 028800288. 80 1R03680 03 028900390. 70 FOOD-JAR 13 029000374. 40 1R02681 03 029100382. 10 FOODJAR 13 029200389. 00 1R03682 03 029300337. 70 FOODJAR 13 029400415. 20
1R03683 03S 029500399. 80 FOODJAR 12 029600376. 60 1R03684 03 829700277. 90
FOODJAR 13 029800371. 50 1R03685 03S 029900351. 9Q FOODJAR 13S 030000299. 00
1 R0 3 6 St* OS -- 03:0100355. 50 FOODJAR 13S 030200394. 60 1R03687 03 020300357. 90 FOODJAR 13 020400384. 50 1R03688 02 030500266. 60 FOODJ0R 02R 020600282. 8F'i
1R03689
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319.9 412.2
280. 3 370. 9 257. 1 392. 5 207. 4 431. 6 420. 4 379. 1 382. 9 382. 9 390. 8 390. 9
BEST COPY AVAILABLE
455
000843
TWO YEAR U R A L D I E T > TOX-ONC STUDV OF FM-2924 6. FC-143 IN RATS EXP. # 0281CR0012
TECHNICIAN INITIALS:S MH TODAY'S D A T E :S 6/9/81 SEX OF R A T S :S MALE ROOM NUMBER :S D-340, 0.-228 WEIGHT OF FULL FOOD J A R :S 550GRAMS
WEEK
1R02516 01S 00 7100434. 70 FOOD JAR 11S 007200346. 80 1R02517 01S 0073:00400. 00 FOODJAR 11S 887400361. 20
1R02518 01S 007500399. 60 FOODJAR 11S 007600347. 50 1R03519 01S 00 7700434. 70
FOODJAR 11S 007800353. 60 1R02520 01S 007900420. 20. FOODJAR IIS 010000348. 30
1R02521 01S 010100280. 80 FOODJAR IIS 010200376. 00 1R03522 01S 0103<00392. 00
FOODJAR 11S 010400278. 60 1R02523 01S 010500442. 10 FOODJAR 11S 010600330. 20
1R02524 01S 010780382. 60 FOODJAR 11S 010800371. 40 1 3525 01S 010900378. 00
FOODJAR 11S 011000315. 80 1R03526 01S 011100399. 20 FOODJAR 11S 011200331. 20 1R02527 01S 011200401. 90 FOODJAR IIS 011400378. 10 1R03528 01S 011500424. 70 FOODJAR 11S 811600334. 00 1R03529 01S 011700399. 80 FOODJAR IIS 011800368. 30
1R03530 01S 011980413. 60 FOODJAR 11S 012000356. 70 1R03521 eis 012100402. 0Q
FOODJAR 11S 012200363. 80 1R02532 01S 012300411. 20 FOODJAR IIS 012400263, 2Q
1R03533 01S 012500427. 90 FOODJAR 11S 012600362. 5Q 1R03534 01S 012700445. 80
FOODJAR 11S 012800243. 30 1R02535 01S 012900356. 0Q FOODJAR 11S 012000392. 50 1R03536 01S 012100375. 00 FOODJAR 11S 012200293. 2Q 1R03537 01S 013200360. 30 F`- -DJAR IIS 013400369. 50 1.-2538 01S 012500447. 20 FOODJAR 11S 013600352. 70 1R02535 01S 013700342. 90 FOODJAR 11S 012800384. 9 0 1R03540 01S 013900280. 30 FOODJAR 11S 014000371. 80 1R03541 01S 014100428. 30 FOODJAR 11S 0 1 4 2 0 0 3 6 0 . 6Q
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BEST COPY AVAILABLE
428. 3
360. 6
456
000844
1R03542 01S 014300408 00
FUOD JFtF' IIS 014400360. 90 1R62542 01S 014500453. 20 FOODJflR n s 014600226. 40 1R03544 01S 014700402. 20 FOODJFlR IIS 014800362. 70 lr 2545 01S 014900422. 50 F.. _.DJflR lis 015000356. 30 1R07546 01S 015100434. 90 FOOD JflR n s 015200370. 00 1R02547 01S 015300426. 50 FOODJFlR lis 015400313. 60
1R02548 01S 015500457. 60 FOODJFlR lis 015600328. 30 1R03549 01S 015700384. 00
FOOD JRF' lis 015800388. 30 1R03550 01S 015900399. 00 FOODJFlR; lis 016000366. 70
1R02551 01S 016100312. 20
FOODJFlR lis 016200408. 50 1R03552 01S 016300416. 20 FOODJFlR lis 016400355. 30 1R02553 01S 016500456. 90 FOODJFlR lis 016600317. 40
1R03554 01S 016700333. 90 FOODJFlR lis 016800352. 80 1R03555 01S 016900390. 20
FOODJFlR lis 017000355. 90 1R03556 01S 017100427. 30 FOODJFlR lis 117200313. 60 1R02557 01S 017300397. 40 FOODJFlR lis 017400384. 60 1 2558 01S 017500338. 70
FOOD JflR; lis 017600368. 10 1R03559 01S 017700422. 40 FOODJFlR lis 017800373. 60
1R0256O 01S 017900380. 40 FOODJflR lis 018000377. 60 1R03561 01S 018100452. 90
FOODJFlR lis 018200327. 40 1R03562 01S 0183-00343. 90 FOODJflR lis 018400389. 50
1R03563 01S 018500379. 10 FOODJFlR lis 018600382. 00 1R03564 01S 018700373. 90
FOODJFlR lis 018800351. 1Q 1R03565 01S 018900412. 00 FOODJFlR lis 019000373. 7Q
1R03566 01S 019100373. 20 FOODJFlR lis 019200375. 70 1R03567 01S 019300434. 30
FOODJFlR lis 019400353. 8Q 1R03568 01S 019500428. 40 FOODJFlR lis 019600361. 90 1R03569 01S 019700421. 30 FOODJFlR lis 019800354. 20 1R03570 01S 019900432. 2Q
F"-DJflR lis 020000325. 60 1, ...2571 01S 020100445. 50 FOODJFlR lis 020200342. 00 1R03572 01S 020300414. 80 FOODJFlR lis 020400353. 10 1R03573 01S 020500421. 50
FOODJFlR lis 020680361. 30 1R03574 01S 020700417. 9Q FOODJFlR lis 020800313. 30
1
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355. 9 427. 3 313. 6 397. 4 384. 6 338. 7 368. 1 422. 4 373:. 6 380. 4 377. 6 452. 9 327. 4 343. 9 389. 5 379. 1 382 373. 9 351. 1 412 373. 7 373. 2 375. 7 434. 3 353. 8 428. 4 361. 9 421. 3 354. 2 432. 2 325. 6 445. 5 342
B S T copy available
421. 5 361. 3 417. 9 313. 3
457
000845
1R02575 01 S G20900275. 70 FOGDJflR IIS 021000334. 00 1R03576 01S 021100399 80 FOGDJflR 11 s 021200331. 70 1R02577 GIS 021300423. 50 FuODJflR H'S 0214G0350. 10 lr '578 01S 021500384. 60 F_-DJflF: IIS 021600354. 90 1RG2579 01S 021700387 60 FGOL* JflF: IIS 021800362.. 50 IF'G7580 01S 021900379. 30 FGOD JAR: IIS 022000369. 90 1R02581 02S 007100387. 30 FOODJAR 12S 007200355. 70 1R03582 02S 00730294. 40 FOGDJflR 12S 00"'400399. 70 IF:GI-582 02S 007500258. 00 FOGDJflR 12S 007600405. 20 1R02584 028 00 7700328. 90
FOGDJflR' 12S 007800377. 80 1R02585 02S 007'900325. 30
FOGDJflR 12S 010000381. 20 1R035S6 G2S 010100348. 20 FOGDJflR 12S 010200385. 40
1R02587 02S 01G300297. 70 FOODJAR 128 .18400411. 20 1R035S8 028 010500246. 20
FOGDJflR 128 010600383. 00 1R03589 028 010700305. 60 FOGDJflR 128 010800258. 10 1803590 028 010900407. 10 FOGDJflR 128 011000370. 80 1 2591 028 011100277. 10 FOGDJflR 128 011200400. 60 1ft0259c- 028 011300365. 30 FOODJflR 128 011400379. 00 1R02592 028 011500354. 20 FOGDJflR 128 011600381. 20 1R03594 028 0117003561. 90 FOODJflR 128 @113610377. 20 1R03595 028 011900310. 80 FOGDJflR 129 012000393. 80
1R03596 028 012100359. 20 FOGDJflR 128 012200363. 60 1R03597 028 012300318. 70
FOGDJflR: 128 012400392. 10 1R03598 028 012500378. 80 FOODJRR 128 012600363. 60 1R02599 028 012780339. 60 FOODJflR 12S 012800361. 3Q 1R026O0 02S 012900285. 50
FOODJflR 125 013000407. 0Q 1R03601 02S 013100365. 30 FOODJflR 12S 013200373. 00
1R03602 02S 013300315. 10 FOODJflR 12S 013400406. 90 1R03603 028 013500345. 00 F '" "OJflR: 128 013600380. 60 li -3604 028 013700288. 90 FOGDJflR 128 013800416. IQ 1R:03605 02S 013900304. 70 FOODJflR 128 014000400. 50 1R02606 028 014100327. 50
FOGDJflR 128 014200407. 60 1R02607 02S 014300354. 7Q FOODJflR 12S 014400396. 50
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416. 1 304. 7 400. 5
BEST COPY AVAILABLE
327. 5
407. 6
354. 7
396. 5
458
000846
1R02 608
014500376. 20
FOODJAR 128 014600363. 00
1R03609 02S 014700323. 2 0
FOODJAF: 1 2 S 014800378. 30
1R03 610 2S 014900388. 00
FuOD JflF: 12S 015000385. 20
lr "2611 02S 015100322. 40
F._ ..L'Jh F 1 2 S 015200384. 60
IF:2 612 0 2 ? 115200246. 10
FOODJAF' 1 2 S 0154 00287. 00
1R02612 0 2 ? 015500410. 50
FOOD JflF' 128 015600285. 40
1R02614 0 2 ? 15700355. IQ
FOODJAR 1 2 S 015800362. IQ
1R02615 0 2 ? 015900323. 10
FOODJAR 1 2 S 016000368. 80
1R03616 02S 016100231. 20
FOODJHR 1 2 S 016200390. 20
1R03617 0 2 S 816300316. 80
FOOD JflF: 1 2 S 016400314. 10
1R03618 0 2 ? 016500378. 30
FOOD JflF: 12S @1?*SQ@5:70. 8 Q
1R03619 0 2 ? 816700288. 50
FOOD JflF: 12S 016800401. 10
1R82620 02S Q1 if:h 0 m 327. 7Q,
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FOOD JflF: 12S 017200405. 70
1R03622 028 017300302. 70
FOOD JflF: 128 017400410. 60
1R03622 0 2 S 017500317. 00
FOODJAR 12S 017600375. 50
1 3624 0 2 ? 017700321. 50
FOODJAR 12S 017800392. 90
1R03625 0 2 S 017900244. 10
FOODJAR 12S 018000396. 60
IF:02626 0 2 ? 018100351. 50
FOOD JflF' 1 2 S 018200291. 70
1R03627 0 2 ? 018300344. 20
FOODJAR 129 018400388. 60
1R03628 0 2 ? 018500333. 50
FOOD JflF: 1 2 S 018600393. 70
1R02629 029 018700357. 50
FOODJAR 129 018800382. 10
1R02'630 029 018900275. 60
FOODJAR 129 019000434. 00
1R03631 029 019100379. 7Q
FOODJAR 129 019200346. 7Q
1R03632 029 019200345. 7Q
FOODJAR 129 819400383. 10
1R03633 0 2 S .19500375. 90
FOODJAR 129 019600361. 60
1R03634 0 2 S 019700262. 90
FOODJAR 1 2 S 019800400. 80
1R03635 029 019900255. 90
FOODJAR 129 020000385. 60
1R02636 029 20100360. 50
F" -'DJAR 129 020200382. 00
1.-337 0 2 ? 020300213. 70
FOODJAR 129 020400378. 10
1R03638 029 020500303. 30
FOODJAR 129 020600391. 7Q
1R03639 029 020700228. 40
FOODJAR 129 020800387. 50
1R0364O 029 020900246. 20
FOODJAR 129 021000409. 20
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255. 9 385. 6 360. 5
382 313. 7 378. 1
303. 3 391. 7 328. 4 387. 5 246. 2 409. 2
BEST COPY AVAILABLE
459
000847
1R03641 023 02110O359 80
FU D JftR 1 2 121200395. 50
1R03642 0 2 S 021300290. 40
FOODJHR 1 2 S 0214O0422. 20
IF:03 8 43 02S 0215O0350. 10
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1R03645 CCS C21?CiCC82. 2Q
FOODJHR 12S 022000358!. 1 0
1R03646 CCS 022100335. 80
FOODJAR 13 022200397. 60
1R03647 CCS Ci222-0CC'92. 80
FOODJHR 138 022400379. 80
1R03648 03S 022500438. 10
FOOD-JAR 13 022600374. 90
1R03649 03 022700391. 30
FOODJHR 12S 022800367. 20
1R03650 03 S 0225*00368. 20
FOOD JftR 13 S 023000392. 50
1R03651 03 S 023100387. 40
FOODJHR 13S 023200388. 90
1RCC652 03 S 023300375. 60
FOODJHR 13 S 823400362. 40
1R@3*S53 3 S 023500385. 90
FOODJAR 13S 023600382. 00
1R03654 03S 02370O422. 80
FOODJAR 13S 023800364. 80
1R03655 03 S 023900405. 50
FOOD1JHR 13S 024000341. 70
1R03656 03S 024100408. 30
FOODJHR 13S 824200367. 90
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FOODJHR 13S 024400355. 9Q.
1R03658
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FOODJHR: 13S 024800384. 10
1R03680 03S 824900410. 00
FOODJHR 13S 025000371. 70
1R03681 03S 025100389. 30
FUODJAR 13 025200374. 80
1R.03662 03 S 025300320. 50
FOODJHR 135 025400406. 60
1R03883 CC-S 025500445. 00
FOODJHR
025680369. 9Q
1R03664 03 025700379. 80
FOODJHR 13S 025800385. 70
1R03865 03S 025900398. 50
FOODJHR 13S 026000373. 90
1FI03666 03S 026100389. 4Q
FOODJHR 13S 026200377. 60
1R03667 03S .26300308. 80
FOODJHR 13S 026400401. 7Q
1R03668 03S 026500308. 70
FOODJHR 13S 026600406. 20
1R03669 03 .26700368. 50
F''DJHR 13S 026800380. 7Q
li --3670 03S 026900385. 70
FOODJHR 13 027000374. 20
1R03671 03 S 027100368. 90
FOODJHR 135 027200376. 50
1R03672 035 027300392. 90
FOODJHR 135 027400380. 60
1R03873 03S 027500350. 60
FOODJHR 13S 027600390. 6 Q
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BEST COPY AVAILABLE
374 2
368. 9
376. 5
392. 9
380. 6
350. 6
390. 6
460 C00848
1R03674 0 3 0i 7 70028:7. 00
FOODJRR
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FOODJRR 13S 028200255. 10
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FOOt> JRR 12 028800375. 50
1R03688 03 028900407. 20
FOODJAR
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FOODJRR 12 029100366. 50
1R03682 02 029200348. 90
FOODJRR 12 029300407. 50
1R03683 02 029400423. 40
FOODJRR 12 029500359. 20
1R03684 02 029600401. 50
FOODJRR 13 029700371. 50
1R03685 02 029800367. 80
FOODJRR 13 029900380. 80
1R03686 02 .20000368. 60
FOODJRR 12 030100403. 10
1R03687 02 020200375. 60
FOODJRR 13S 030300365. 70
1R03688 02 030400385. 20
FOODJRR 12 030500376. 20
1R03689 02 030600325. 10
FOODJRR 12 030700403. 30
1 3690 03 020800389. 00
FOODJRR 13S 020900290. 30
1R03691 02 021000357. 20
FOODJRR 13S 021100364. 20
1R03692 03 021200312. 10
FOODJRR 13 021300372. 50
1R02693 02S 031400428. 00
FOODJRR 13 S 021500358. 50
1R03694 03S 021600400. 80
FOODJRR 13S 021700266. 90
1R03695 03S 031800412. 30
FOODJRR 13S 021900281. 50
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BEST COPY AVAILABLE
461
C00849
TWO YEAR O R AL<D I ET> TOX-ONC STUDV OF FM-2924 & FC-143 IN RATS EXR. # 0281CRO812
TECHNICIAN INITIALS: MH TODA Y-'S DATE -.S 6/16X61 SEX OF R A T S :S MALE ROOM N U M B E R :S D-240, D-228 WEIGHT OF FULL FOOD JAR::S 550GRAMS
WEEK 8
1R02516 01S 00?100462. 90 FOOD JAR 11S 00?200358. 00 1R0351? 01S 00 7200426. 2G! FOODJAR 11S 007400276. 20 1R02518 01S 007500419. 00 FOOD JAR 11S 007600366. 90 1R03519 01S 0O7700455. 60 FOOD JAR: 11S 007800272. 40 1R02520 01S 007900437. 90 FOODJAR 11S 010000280. 20 1R02521 01S 010100400. 80 FOODJAR 11S 010200274 30 1R02522 01S 010300408. 20
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TWO YEAR O P A L D I E T T O X - O N C STUDY OF FM-2924 S, FC-143 IN RATS EXP. # 0281CR0012
TECHNICIAN INITIALS:S MH TODAY S D A T E :S 6/22/81 SEX OF P A T S :S MALE ROOM N U M B E R :S D-240, D-238 WEIGHT OF FULL FOOD J A R :S 550GRAMS
WEEK 9
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TWH VEAR ORAL-: DIET/ TOX-ONC STUDV OF FM-3924 & FC-143 IN RATS EXP. # 0281CR6012
TECHNICIAN INITIALS:S MH TOC-'AV S DATE :S 6/30/81 SEX OF R A T S :S HALE ROOM N U M B E R :S D-340, D-33S WEIGHT OF FULL FOOD JAP.:S 550GRAMS
WEEK 10
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484 CC0S72
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FOODJRR 111. U14400408. 40
1R02542 011 014500528. 00
FUUL1JRF 111. `2146013336. 20
1R03544 `31i 0147 "3482. 50
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IFU2545 Oil 014800518. 8`3
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FC`C`DJRR 111 015*200281. 40!
1R02547 `311 `3152`3`3522. `0!
FOC`D JRR 118 015400356. 50
1R03548 Oil 015500535. 5
FDOC'JRR 112 015600285. 50.
1R03549 011 015700445. 70!
FODD JRR 118 015*800381. 20
1R03550 018 .15800458. 30!
FODDJ RR 118 016000287. 50
1R03551 l
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FOODJRR 118 016200416. 60
1R02552 `318 016200510. 80!
FOODJRR 118 `3164*30267. 50!
1R01552 Oil Olc.5oo551. 30
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1ROC 554 *312 `3167330289. 7Q
FOODJRR 118 016800286. 80!
1R02555 `318 016800458. 10!
FOOL*JRR 118 017000384. 80
1R02556 018 017100518. 40
FOODJRR 112 017200281. 40
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1R0255S `318 `317500386. 00!
FOODJRR 118 017600284. 70
1R03559 018 0177O0488. 70
FOODJRR 112 `3178010408. 20!
1R03560 `318 17800438. 50!
FOODJRR 118 `3180001286. 50
1R03561 012 013100527. 00
FOODJRR 118 `3182010346. 80
1R03562 018 118200349. 60
FOODJRR 118 018400421. 00
1R02563 018 018500432. 10
FOOt.1JRR 118 018600284. 80
1R02564 OHS OU8700455. 30
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1R02566 01S 018100435. 30
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501. , 282. 2 464. 6 408. 4
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1R02595 028 011700359. 40 POOL'JHP: 128 0 1 1 8 0 0 4 1 5 . 30
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1R0259S 02S 012200444. 20. FOODJHR 12S 012400281. 30 1R03599 02S O12500409. 80
FOODJHR 12S 01260280. 20
1R 0J600 02S 012700283. 30 FOOL'JHR 1 2 S 0128010389. 40
1 R 02 6 0 1 0 2 S 1129010424. 70 FOOL1JH R 1 2 8 11300101276. 1 0
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BEST COPY AVAUABIE
488
G00876
FyuDJhF j.j y Jm yu yJijL-i 2 u
lk6i2607 122 0141O041 &. 20
FuuD JHF: 12 014200380. 80
1R03608 028 0143-00460. 10
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FOOL1JFtF: 123 0152010138 7. 90
1R6'3612 0123' 015300496. 20
FOODJflR 128 0115401013.78. 20
1R03614 0'2S 01155010413. 40!
FOOD JflF: 128 015600277. 40
1R03615 0128 015700364. IQ
FOODJflR 128 01158010292. 80!
1R03616 0'28 011590104019. 50
FOODJflR 128 016000382. 50
1R03617 0'28' 611616101288. 86!
FOOD JflF: 128 0162004101. 60
1R03618 6128 016308454. 30
FOOD JflF: 128 0164001274. 50
1R03619 028 0165061355. 30
FOOC:'JflF: 128 01660101392. 10
1R03620 0i28' 0116761012901. 00
FOOC'JflR 128 816800379. 10
1R83621 028 01696i6i244. 50
FOODJflR 128 01170010419. 86!
1R03622 028 017100339. 10
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FOOD JflF: 128 017400422. 80
1R03624 02S 017500419. 10 F'OODJflF: 128 0176001368. 70
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1R03627 0i28 0181001394. 20
FOODJflR 128 018200395. 80
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1R03629 028 018500441. 40
FOOD1JflR 128 018600371. 90
1R03630 028 0187010339. 70
FOODJflR 128 018800406. 20
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1R03632 028 019100414. 70
FOODJflR 128 0192 0375. 40
1R03633 028 019300453. 60
FOODJflR 128 019400370. 60
1R03634 028 019500294. 60
FOODJflR 128 019600423. 70
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1R03637 0128 02016161385. 80 FGOD'JflR 128 0126120102-78. 80
1R03638 028 02030O370. 30 FOODJflR 128 01204001390. 90
1R03639 028 0201500387. 90
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370. 3
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1F:02646 02 4 O219O0392. 00
FOOL'JMR 126 022000247. 2Q
1R03647 02 S 022100482. 00
FOOL'JFlF: 12 6 0222002.75. 20
1R03648 02 4 02230525. 80
FOOL'JMF: 126 022400257. 60
1F:Z*2649 026 022500471. 90
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1R 0 3 6 5 0 02 S 022700413. 00
FODDJMR 126 022800248. OQ
1R02651 02 4 022900462. 90
FOOL'JMF: 126 0123000277. 50
1R02652 02 4 023100459. 20
FOOL'JMF 126 02220022-0. 80
1R02652 02 S 22300455. 90
FOOD JAR 126 023400377. 50
1R02654 02S 1122500503 .40
FODDJAR 125 Zi226Z'8292. 20
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FOOL'JMR 12 5 0238ZiZ*394. 50
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FOOD JMF: 135 024080375. 70
1R83657 024 024100469. 80
FOOL'JMF: 126 024200379. 60
1R 1*2658 02S 024300436. 3Q
F OODJhR 125 024400412. 50
1R02659 024 024500452. 20
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1R02660 02 2* 024700479. 90
FOOL'JMF: 125 024800276. 5*0
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1R02662 02 4 025100259. 20
FOOL'J MR 126 6252*30417. 90
1R03663 024 112520*3520. 10
F OOD Jm F; 125 325400264. 10
1R02664 02 S 025500417. 90
FOOL'JMR 135 325600404. 90
1R03665 025 025700446. 00
FOOL'JMR 125 025800414. 40
1R02666 025 025900452. 70
FOOL'JMR 125 026060375. 00
1R02667 024 026100338. 30
FOOL'JMR 125 3262*3*3434. 30
1R0266S 0 2S 32'6333359. 00
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FOOL'JMR 125 0 2 8 6 0 0 2 8 2 . OQ
1R02670 02S 326.700496. 2*2
FOOL'JMR 125 326.8Z10359. 20
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433. 1
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490
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BEST COPY AVAILABLE
491
G00879
TUO VEflR ORL<DIT> TOX-ONC STUDV OF FM-3924 & FC-143 IN RTS
/
EXP. # 0281CR0012
TECHNICIAN INITIALS :S-MH
TODAY'S DATE :S 7/21/81 .
SEX OF RfS:S MALE
ROOM NUMBER :S D-240, D-338
WEIGHT OF FULL FOOD J A R :S 550GRAMS
WEEK 13
1R03516 01S 007100523. 4Q
FOODJFtR 11S 007200376. 4Q
1R03517 01S 007300477. 4Q
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1R03518 01S 007500464. 50
FOODJR U S 0076O0387. 30
1R03519 01S 007700524. 20
FOODJFiR U S 007800363. 10
1R03520 01S 00 7900499. 30
FOODJR lis 010000378. 90
1R03521 01S 010100458. 00
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FOODJR lis 010400390. 80
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FOODJR lis 010800379. 6Q
1R03525 01S 010900480. 30
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FOODJR lis 011200379. 10
1R03527 01S 011300464. 5Q
FOODJR lis 011400387. 90
1R02528 01S 011500524. 7Q
FOODJR lis 011600362. 00
1R03529 01S 011700485. 90
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1R03530 01S 011900507. 00
FOODJR lis 012800384. 5Q
1R03531 01S 012100493. 8Q
FOODJR lis 012200340. 5Q
1R03532 01S 012300480. 6Q
FOODJR lis 012400383. 40
1R03533 01S 012500528. 2Q
FOODJR U S 012600364. 7Q
1R03534 01S 012700546. 9Q
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1R03535 01S 012900428. 8Q
FOODJR U S 013000398. 20
1R03536 01S '013100440. 6Q
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1R03537 OIS 013300408. 4Q
FOODJR U S 012400390. 6Q
1R03538 01S 13500561. 7Q
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1R03539 01S 013700409. 0Q
FOODJR lis 013800387. 30
1R03540 01S 013900450. 3Q
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BEST COPY AVAILABLE
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1 YEAR RfiL D 1ET > TOX-ONC STUDY OF FM-3924 & FC-143 IN RRTS EXP. # 0281CR0012
TECHNIC1RN INITIRLSiS MH TODRY'S DRTE : 8/4/81 SEX OF RRTS ;S MftLE ROOM NUMBER :S D --34.- D--338 WEIGHT OF FULL FOOD J R R :S 550GRRMS
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000964
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WEEK 30
1R03516 0 1 S 007100642. 1 G FOODJAR I I S 00?200370. 2 G 1R03517 0 1 S 00 7-300574. 3G
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361. 2 570. 9 346. 6
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FOODJftR 12S 010900373. 50
12
1R02595 02S 011000454. 20
2
FOODJftR 12S 011100296. 60
12
1R03596 02S . 11200582. 60
2
FOODJftR 12S 011200362. 70
12
1R02597 02S 011400464. 80
2
FODDJftR 12S 011500405. 90 1R0359S 02S 011600514. 90
12 2
FOODJftR 12S 011700382. 00
12
1R02599 02S 011800500. 70
2
FOODJftR 12S 011900374. 60
12
1R02600 02S 012000505. 90
2
FOODJftR. 12S 01210 0377. 90
12
iLF!0 j-60iL 02S . 12200551. 20
2
FOODJftR 12S 012200279. 50
12
1 3602 02S . 12400524. 90
2
FOODJftR 12S 0 1250 0374. 60
12
1R03602 02S . 12600537. 20!
FOODJftR; 12S 012700386. 40
12
1R02604 02S . 12800485. 50
2
FOODJftR 12S 012900298. 80
12
1R03605 02S 013000482. 60
2
FOOt* JftR; 12S 01310 0386. 30
12
369 522. 9 317. 8 521. 1 253. 4 547. 7
378. 7 574. 5 377. 8
561. 5 358. 2 581. 6 267. 8 549 372. 1 583. 6 271. 1 413. 4 295. 5 425. 2 288. 1 475. 7 385. 7
5 1 2 .5 363. 6 537. 8 284. 1
446. 8
402. 9 563. 3
382. 9 482. 8 373. 9 0 NOT ON STUDV 0 393. 1 . 381. 9 561. 4 372. 8 494. 1 386. 2 548. 8 373. 5 454. 3
296. 6 582. 6 263. 7 464. 8 405. 9 514. 9
500. 7 374. 6
505. 9 377. 9 551. 2 379. 5 524. 9 174. 6 527. 2 386. 4 485. 5 398. 8 482. 6 286. 3
BEST COPY AVAILABLE
591
000979
lR0_;.60t. 022. 01^10 0 4 4 0. 20
FOODJflR 122. *011300418 00 i f 026 o r 02S 13400042. 5*0 FOODJflR 122. 012000377. 80
1R03608 02 S 013 600575. 80
FOOD JmF: 122 0 1 3 .0 0 3 6 4 . 80
12 12 3
12
1r 2O? 022 013800482. 10
F'_ ..0 JmF: 122 01380*3377. 40 1P.03610 022 *314*30*3585. 10 FOOD JmF: 122 14100375. .30
12 12
1R03611 022 . 14200524. 20 FOOD JRF: 122 0142*3*33 72. 50
12
1R03612 022 *3144*30526. 80
2
FOODJflR 122 *31450*3378. 20
12
1R03613 022 014600612. 80
.*
FOODJ hF: 122 *314700378. 0
12
1R03614 022 *31480*3483. 70 FOOD JmF: 122 0148*30275. 50
12
1R02615 022 *3150*30488. 10 FOODJ mF: 122 0151*30375. 80
2 12
1R02616 022 0152O0522. 10
2
FOODJflR 122 81530 0372. 20
12
1R03617 022 0115400505. 80
2
FOODJflR 122 01550*3282. 70
12
1R03618 022 *315601*3601. 00
cl'
FOODJflR 122 015700365. 60
12
1R02619 022 *315801*3453. 80
FOODJflR 122 015880286. 60
12
1R03620 22 016*300542. 40
2
FOODJflR 122 *3161*30366. 20
12
1R02621 022 . 162*30433. 60
2
FOODJflR 122 016300412. 20
12
104622 02S O1640O426. 50
2
FOODJflR 122 *3165*30286. 20
12
1R03622 022 *3166*301503. 20 FOODJflR 122 *3167*3*3377. 40
2 12
1R02624 022 *316.8*3*3550. 60
2
FOODJflR 122 011680*3268. 40
12
IF :03628 022 0170*30*3*3*3. 00
2
RAT #
1R03625 2S 017000000. 00
FOODJflR 122 01710*3000. 0
12
1R02626 022 017200543. 00
2
FOODJflR 122 `31730*3377. 40
12
1R03627 022 0174*30518. 70
2
FOODJflR 122 017500282. 80
12
1R02628 022 017600502. 20
2
FOODJflR 122 *317700385. 20
12
1R03629 022 017800567. 50
2
FOODJflR 122 017800373. 30
12
1R03638 022 *318000452. 10 FOODJflR 122 018100286. 60
2 12
1R03631 022 . 18200562. 00
2
FOODJflR 122 018300273. 80 1R03632 022 018400504. 70
12 2
FOODJflR 122 1185*30387. 30
12
1R03633 022 0186*30587. 50
2
FOODJflR 122 31870*3364. 70
12
703634 22 *318800408. 00
2
. JODJflR 122 0188*30285. 50 1R03635 022 18000443. 20
12 2
FOODJflR 12 *318100402. 20
12
1R03636 022 018200/40. 80
2
FOODJflR 122 018300378. 10
1R03637 022 018408512. 80
ForiD TFlfc1 1 Fv1
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12
2 1P
440. 2
418
542. 8 377 8 575' 8 364. 8
482. 1
377. 4
585. 1 75. 3
534. 2
372. 5
52. 8
378. 2
612. 8
378
483. 7
375. 5
488. 1
375. 8
522. 1
372. 2
585. 8
382. 7
601
365. 6
453. 8
386. 6
542. 4
366. 2
433. 6
413. 2
4 2 6 .5
386. 2
5*33. 2
377. 4
550. 6
368. 4
0
NOT ON STUDV
0
543
377. 4
519. 7
382. 9
503. 2
95. 2
567. 5
373. 3
452. 1
396. 6
562
373. 9 504. 7
87. S
587. 5 364. 7
BEST COPY AVAILABLE
408
385. 5 443. 2
402. 2
5 4 0 .8
378. 1 512. 8 77ft ft
592
C009S0
1R02628 IV--- 0186610482. 70-! FOODJRR 12 8 01870 0292. 90 1R o 2 2 y 022. 018800466. 40 FOODJRR: 125 01980 0292. 40 1RG3640 025 01010001284. 10 FOODJ RR 125 02010 0421. 00
1R83641 029 02020 0508. 70 :ODJRR 125 028200287. 90
1R82642 1025 020400471. 90 F'OODJRR 125 820500285. .80 1RGG642 '25 82068 0543. 20 FOOC1JRR 125 020700388. 30 1R02644 025 . 28800475. 80 FOODJRR 125 0209010375. SO 1R82645 025 021008554. 70 FOODJRR 125 02110 0272. 00 1R03646 025 021200581. 70 FOODJRR 125 02120 0290. 20 1R02-647 023 01140O515. 10 FOOC' JRF: 125 021508358. 70 1R03648 025 02168. 675. 20 FOOC'JftR 125 021700348. 30 IF: 02 64 8 025 021880586. 60 FOODJRR 125 021900267. 60
IF:02-650 025 022808580. 50
FOODJFlR 125 02210 0386. 70 1R02651 025 022208596. 90 FOOD1JFlR 125 J-0367. 6Q
1R02652 25 822400597. 80 FOODJFlR 125 022580363. 40 1R02652 025 0226001574. 60 FOOD'JRF: 125 02270 8374. 50 1R2654 05 S . 228006G6. 10 FOODJRF; 125 02290 0369. 60
1R82655 025 . 23008575. 90 FOOD'JRR 125 022100378. 20 1R02656 025 02320 0599. 40. FOOD1JRR 125 023208377. 30
1R02657 025 022480573. SO FOOD'JRR 125 022580281. 20
1R02658 025 6122600511. 80 FOOD'JRR 125 82270 0296. 80 1R02659 025 023800611. 70 FOOD JRF; 125 0239610364. 60
1RI02660 025 024808594. 10
FOOD'JRF: 125 02410 8381. 20
1R03661 025 024208584. 70 FOODHRR 12S 02420 0266. 60
1R613662 025 82440 0420. 80 FOOD'JRR 13S 02458 8404. 60 1R02663 035 024600689. 50 FOODJRR 13S 02470 0371. 30
1R02664 025 024800492. 10 FOODJRR 135 02490 0394. 80
1R03665 02 S 02500 0517. 7Q FOODJRR 135 02510 8390. 80 1R02666 025 025208579. 70 FOODJRR 125 02520 0364. 70
1 2667 025 025480456. 20 FOOD'JRR 125 82558 0482. 60 1R03668 025 825608467. 10 FGODJRR 125 82570 0399. 20 1R0J668 025 025888599. 80 FOODJRR 135 0259610377. 10 1R02670 025 6126000613. 4? Fl IDD.TRR 1 " 5 ft 2 61 lift" : 71 4 0
12 l! 12 2 12 eZ 12 2 12 cZ 12 eZ 12
m
12 3 13 3 13 3 13 3 13 3 13 3 13 3 13 3 13 3 13
13
13 3 13 3 13 3 13 3 13 3 13 3 13 3 13 3 13 3
13 2 13
3 13 3 13 3 13 3 13
482. 7 292. 9 466. 4
392. 4 384. 1 421
5CiS. 7 287. 9 471. 9
285. 8 543. 2 388. 3 475. 8 375. 8 554. 7
372 501. 7 390. 2 515. 1 358. 7 675. 3 348. 3 586. 6 267. 6
508. 5 386. 7 596. 9 267. 6 597 363. 4 574. 6 374. 5 606. 1 369. 6
378. 2
599. 4
. 377. 2
573. 8
281. 2
511. 8
296. 8
611. 7
364. 6
594. 1
281. 2
584. 7
266. 6
428. 8
404. 6
689. 5
371. 2
492. 1
394. 8
517. 7
390. 8
579. 7
364. 7 BEST COPY AVAILABLE
456. 2
482. 6
467. 1
399. 2
599. e
377. 1
613. 4
371 4
593
GCC9S1
Oli 0 2620 8539. 80
FOODJAR 3_- 00 >0010202-. 8Q
CC5 0 .`100580. 7*0
FOOD JAF: 12 0 7200374. 20 1R82672 13S 6. T'3-00528. 10
FOODJAR 2 5 0O ?4002S>4. 00
1' 1674 02-S . O''00622. 20
F.-_'DJAR 12 00 ?600274. 80
1R82675 03 O0 7700588. 70
FOODJAR 12 S . 0 7800371. 70
1R03676
00 7800651. 90
FOODJflR 13S 818800263. 80
1R03677 03 010108580. 80
FOODJAR 12 010200381. 40
1R0167S 05 01030 0550. 30
FOODJAR 13 01040 0395. 30 1R03679 02S 010508678. 70
FuODJAR 13 01 600239. 50
1RO1680 3 8 1878 8688. 50
F0 UDJhF: 3 01080359. 50
1R826S1 02S 01090561. 60
FOODJAR 13 011000368. 40
1R82632 03 011180463. 00 FOODJAR 12 011200401. 30
1R03682 02:5 01130 0642. 00
FOODJAR 12 811400344. 50
1R836S4 G2S . 11500640. 70
FOODJAR 12 011600353. 70
1R82685 02 011700532. 10 FOODJAR 12 011800384. 40
1R02686
. 119010590. 50
FOODJAR 12 612254. 5Q
1R03687 025 012100604. 00
FOODJAR 13 01220 0269. 30
1R03688 02*5 01230 0 5 9 4 . 00
FOODJAR 12 012400276. 70
1R03689 02 012500430. 30
FOODJAR 13 0112600393. 20
1R03698 02 012700564. 70
FOODJAR 13S 012808372. 10
1R03691 02S 8129O0488. 00
FOODJAR 12 S 013000391. 00
1R03692 03S 012180466. 20
FOODJAR 1 1 013280394. 40
1R03692 01S 013300654. 10
FOODJAR 12S 0 1240 0270. 30
1R02694 02S 013508575. 70
FOODJAR 12 S 013608366. 50
1R03695 02 012700620. 20
FOODJAR 13 01280 0259. 40 99
13
.
12 -i12
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13
2
13 3 13 3 13
13 3 13 3 13
13 3 12 3 13 3 13
13 3 13 3 12
12 3 12
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13 3 13 3 13
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13 3 13 3 13 0
539. 8 383. S SSO. T J -74. .' 528. 1 294 623. 2 374. 8 598. 7 371. 7 651. 9 362 588 381. 4 550. 3 295. 3 679. 7 239. 5 680. 5 359. 5 561. 6 368. 4 462 401. 3 642 344. 5 648. 7 352. 7 533. 1 284. 4 590. 5 254. 5 684 369. 3 594 376. 7 430. 3 293. 2 564. 7 13 i ' cL. 488 291 466. 2 394. 4 654. 1 370. 3 575. 7 366. 5 628. 2 359. 4
BEST COPY AVAILABLE
594
C009S2
BISTCOPYAVAUABLE
1H O V E H k O RH L `.L*1E T > T O X -O N C - S T U O V O F FI-1-2 9 2 4 * F C - 1 4 3 IN R R T S EXP. * 0281CRO012
T E C H N IC IR N I N I T I A L S :S MH TO L'RV 5 L'H TE : 1 2 / 1 5 . '8 1 S E X OF. R R T 5 :S I1RLE KOOt'i N U I'lt E R . S D - 2 4 0 . D - 2 2 8 W EIG H T OF F U L L FO O D JH R : 5 5 5 0 G R 8 M S
WEEK 24
1R:00516 03 L1007'_l0 0639. 8 Q FOOL-1JHP 115 00 72:00282. 20 1F:0i3 517 1'. 00 5 0015 5. 5 u FOODJHR 115 00V400279. 0 1R0O51S @1 o 500553. 70 FOOL 1HP. H i 0?600i297. 0
1R02519 v. 00 ?7`00592. 9Q FOOL' JHP l . o 0i - 8010i2 7`9. 10
1R005201 0x3 00 ?900533. 6Q FOOD JHR 1 1 S 010000391. 701
1R0O 5 s l OX- OlOlOOOiili*. ILL! FOOL-JHR 13 01 *J3003 53. SQ 1R0O522 01S F0 0 L' THP l l s 011014010287. 50! 1R02522 013 01000033-3. 5*0 FOODJHR: 113 0106083S3. 3-Q 1R62524 0115 011O7 0101575. 60
FOOL-JHR 115 010800274. 80 1R0G525 0115 011090101584. 4Q FOODJHR 115 011000279. 40
1R0O526 013 0111001033. 4Q FOOL1JHP I l l - 0110'0i284. 80 1RG2527 013 0113005*55. 2Q FOOL1JHR l l s - 0>li.40i0i290. 80
1R020SS 015 01150101880. 70 FOOL1JHR 115 011600269. 90 1R0O529 18 011170101598. 70 FOOL'JHR 115 011800292. 40
1 R0102 '0 015 119010542. 90 FOOL' JHR 115 012000392. 40 1R02531 013 011100533. 50 FOOD-JHR 115 0122001388. 60
1R03522 IS 012200591. 80 FOuC'JHR 15 012400383. 90
1R02533 015- 0112500608. 90 FOODJHR 115 012600384. SQ 1R03534 015 012700672. 40 FOODJHR 115 01280 0359. 80
1R03535 015 01129010532. 70 FOOC'JhR 115 01130010'279. 80 1R:02526 015 01131010496. 16
r `'OL1JHR: 115 012200418. 00 _ -*3*--0 S \ IS 0il220i0i504. 2 0 FOODJHR 115 013400298. 70
IP:I3-52S 013* 0x3500 3?6. 7*0 FuOC'J HP 115 1312.600262. 40 1R02529 013 013-700509. 70 FUODJHR 111 0 1 j-800387. 60 IF:03 040 615 013900538. 60 FOOL' JHR: 115 014000393. 30
1 11 1 11 1 11 1 11 1 11 1 11 1 11 1
11 1 11 1 11 1 11 1
11 1 11 1 11 1 11 1 11 1 11 1
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11 1 11 1 11 1 11 1 11
6x9. 8 2- 8 2 . 3 590. 5 x-79. 1 563. 7 3-37. 2 592. 9 279. 1 593. 6 391. 7 529. 1 356. 8 567.3 387. 5
39. 9
3-S3. 3575. 6 374. 8 564. 4 279. 4 598. 4 284. 8 565. 2 296. 8 660. 7 369. 9 596. 7 392. 4 542. 9 392. 4 598. 5 288. 6 591. 8 283. 9 60S. 9 384. 8 6*t-' d 4 359. 8 532. 7 379. 8 496. 1 418 504. 3 298. 7 676. 7 263. 4 509. 7 387. 6 528. 6 393. 3
595 00983
IF'.'.. O'11 ' j l i I.u-l 1 0 0 * 0 0 40
FOOL-1j HF l i b Ui 4 _HtJ_ 71 70
IF'Oil 0 - 1 2 Jli- 014
80
F00[ 'JRF: 116 0 -t 'H.i0'2S4. 0 0
IF: 01 042 016 014 -00*80 1 0
FOUL1JHR 116 0x4 *0 0 1 1 * . 4 0 .
IF U_ 044 O i l 014 r 0 0 *4 6 8 U
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J r't-L 04 0 u l6 014 r"J0*19.
r UL`L' 1HF 118 O i l >0003 71. s o .
1R 0_ 04 0 0 1 6 t ' l 0 1 lu*0 7 . 0 0
b 0 0 L1JhF: 116 J l'j
8 *. IQ
ik o _ 047 u l 6 0 1 0 2 0100.71. 3*Q
FOOL' .1HF: 116 0 1 0 400271. IQ
1 F02 048 0X6 0 1 0 '500669. 9Q
FOOL' THF: 116 0 1 0 *003-67. 60
J>01 042 016 0 1 0 70014O. 9Q
FOOL' JRF: 116 0 1 0 8003 97. 7Q
1R03 OOO 015
FOOL' JRF: U S 016 000404. 9Q
1P03 0 0 1 018 O i l 1001427. 2.0. FOODJRF: 116 016 201014x0. 6 Q
iF:o_ 0 0 2 016 O i l 2-00652. 0 0 .
FOOL' JRF: 115 016 40O318. 8 Q
1 R02 c~t~ 015 lj_l6 50O663-. 5Q
FijOL1JRF: 115 0 1 * 6003-67. H-W
xF 02- 004 O i l 0 J.6 n0457. IQ
FOOL' JRF: 115 0 1 * 601014101. 9Q IF. 02 fc*crrr( 015 0 1 . .1 8 0 1 0 1 0 8 1 70
FOOL'JRF: 115 017 0003 83. 8 Q
1R:03- 006 015 017 1 0 1 0 1 6 6 1 . 40
FOOL' JRF: 115 1F:02 E;r-(-7 015
017 200275. 1 0 017 2010044. 60
FOOL' j HR: 115 0x7 4010140101. 60 1.P03 (Tc-,V 015 017 500503. 6 0 .
FOOL' JRF: 115 017 *0 0 3 88. 6 0 . 1F-02-ir SC* 015 017 7 00560. 2 0 .
FOOD .'HR 115 017 80C*3 91. 40
1F02 060 015 017 96043 9. IQ
FOOL' JRF: 115 6 1 8 000506. 3Q
O i l R 0 2 OIS 016 1 0 0 1 6 8 1 . 70
FOOL' JRF: 115 018 200252. 1 0
IRC12 062 015 0 1 S2010014. 80
FOODJRF: 115 018 40101267. 1 0
IF '02 062 015 016 060018. 1 0
FOOL1JRF: 118 0 lS 600266. 1 0
xPU2 064 018 016 700072. 3-Q
FOOL'JRF: 115 016 6001272. 0 0
1F:02 065 015 018 900640. 40
FOOL' JRF: 118 018000271. 1 0
IF '02 566 018 0181001486. 70
FOODJRF: 118 018 100410. IQ
IF'02 567 018 018 300687. 2 0
FOODJRF: 118 0118400564. 50!
1F:02 56S 018 018 000626. 2 0
FOOL' JRF: 118 018600262. 0 0 .
IF: 02
018 O I S O0667. 70
FOOL' JRF 115 018 6002-57. 2 0
0 2 576 018 118800508. 60 t .jOL' JRF 115 0 '2 0 0 1 0 1 015 101. 40
IF: 02 071 618 O l'O1 0 1 0 1 6 2 0 1 9Q
FOOL' JRF 1 1 6 *
100369. 0 0
i r,03 072 015 03`U200574. so
FOOL' j HR: 115 0 1 0 40101260. 60
IF:02 072 0 x5 010 -001627. 0Q
FOOL*JRF 118 0i2 60*0127 1 . 70
1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11
1 11
BEST COPY AVAHM
60 4 271. 1* 90 6 S .
264
680. 1 3:3'6. 4 648. 8
201
618. 6 J- I-' 3. 8 607 3;8`6. 2 671. 5 271. 2 669. 9 367. 6 040. 8 287. I*-
524. 404.
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427. V
410. 6
652. 5
228. 8 663. Cj
367. 4
457. z* 410. 9
581. 7
282. 8
661. 4
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544. 6
4010. 6
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6
560. 2
393. 4 428. 31
506. 3
691. i*' 252. i 514. 8
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518. 1
286. 1
57 3. 2
272 640. 4
371. 1
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410. 2 687. 2 364. 5 638. 2 362 667. 7 257. 2 558. 6 310. 4 630. 9
268 074. 8 385. 6 637 271. ?
596
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FuuL'JRR l 0 x 1 1 0 0 2 9 1 . 80
'0 1 5 7 7 0 2 2 *J_:22 0 0 0 6 0 . 5 0
..OL1J h R 1 2 0 x 1 4 0 0 3 7 3 . 6 0
j. PGC l_<,>: 0l -. I . i x l ' '0 0 3 l'iH 4 0
FOODJRF 222. -0 6 l*U j> 5 .8 . 0
1 R 0 Z 5 7 ;* 0 2 . 0 2 2 >o 0 6 6. ? 0
F OOL'JRR 1 1 3 U xx8 0 O 2 63. 2 Q
l R y x 58L> 0 1 3 0 x 1 9 0 .0 5 4 4 . 1 0
FOOL1JRR 1 1 3 0 2 2 0 0 0 2 7 7 . 2Q
IF : j 5 8 1 01X3 010' :`X 0 0 5 9 6 . 7 0
FOOL'Jh R 1 x S 0O Vx 010 3 7 5 . 2 0
1 R 0 2 58 2 02S 00 ;2 0422. 10
FOOL'JRF: 1 2 3 00 P 4 0 0 2 9 4 . 5 0 1 F :0 3 5 8 2 02S 00?" 0447. 0
FOODJ HR 2 2 6 0 O >6 0 O2-8 2. 4 0
1 R 0 2 5 8 4 0 2 6 OO > 7 0 0 4 8 2 . 4 0
FOuD JRF: 2 2 S 0 0 ? 8 8 2 8 i. 5 0
1 R 0 2 5 8 5 0 2 3 0 0 ?9 01G5 2 3 . 0
FOOL* JRF: 1 2 3 0 X 000I 373. 0 0
F:02 5 8 6 0 2 6 0 2 0 2 0 0 0 4 6 . 7 0
FOOL'Jh R 2 2 5 0J.O 2O 0276. 7 0
1R 0356? 026 O202OO448. 50
FOODJRF 1 2 3 0 1 4 0 0 4 0 9 . 0
1R02588 023 01050515. 20
FOOL'Jh R 1 2 3 0 1 0 6 0 0 3 8 5 . 4 0
1R02588 623 010700492. 10
FOODJFiR 1 2 3 0 1 0 8 0 0 3 7 1 . 0 0
1 R 0 3 5 9 0 0 2 S 0 x 6 0 OOO0. 0 0
RRT #
2 R 5 !r*O 02s
FOOD JRF: 123' 011101000100. 00
1R02591 023 o iil0 0 3 9 9 . 60
FOOL1JRF: 2 2 8 0 2 2 2 O O4 O0. 20
1R62592 0X3 011300572. 20
FOOL' Jh R 1 x 3 01140101376. 6 0
1 R 0 3 5 9 3 0' 2 3 ii5 i0 4 9 2 . 0 0
FOOL'Jh R 1 2 3 0 1 x 6 0 0 3 7 8 . 2 0
IF :0 2 5 9 ' 1 0123 0 x 1 7 8 0 5 5 6 . 6 0
FOOL'JhR 1 2 3 0118001367. 4 0
1R 02593 023 011904601. 70
FOOD JRF: 2 2 8 0 2 2 0 0 685*. 4 0
1R03596 023 012100601. 00
FOOD JRF: 1 2 3
1R02597 023
FOODJRR 1 2 3 0 1 2 4 0 0 4 0 7 . 9 0
1R02598 023 012500526. 40
FOODJRR. 1 2 3 0 1 2 6 0 0 2 7 8 . 6 0
1R03599 023 012700504. 60
FOODJRR 1 2S 0 1 2 8 0 0 2 8 0 . 0 0
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