TDMS Study 05090-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
COUMARIN
NTP Experiment-Test: 05090-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/12/94
Route: GAVAGE Time: 03:12:33
Facility: American Biogenics Corp.
Chemical CAS #: 000091645
Lock Date: None
Cage Range: All
Reasons For Removal: All
Removal Date Range: All
Treatment Groups: Include All
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG 100MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund 14 7 7 14
Dead 5 4 2 6
Gavage Death 2 1 5
Survivors
Terminal Sacrifice 29 38 35 30
Dead 1
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (57) (48) (48) (58)
Ulcer 2 (3%)
Liver (60) (58) (58) (60)
Basophilic Focus 39 (65%) 33 (57%) 17 (29%) 21 (35%)
Clear Cell Focus 1 (2%) 3 (5%)
Cytologic Alterations 9 (15%)
Developmental Malformation 6 (10%) 4 (7%) 9 (16%) 6 (10%)
Eosinophilic Focus 1 (2%) 1 (2%) 2 (3%)
Fatty Change 5 (8%) 12 (21%) 17 (28%)
Fibrosis 1 (2%) 12 (20%)
Hematopoietic Cell Proliferation 1 (2%)
Inflammation, Chronic 19 (32%) 24 (41%) 21 (36%) 21 (35%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Mineralization 1 (2%)
Mixed Cell Focus 6 (10%) 1 (2%) 3 (5%)
Necrosis 1 (2%)
Necrosis, Coagulative 3 (5%) 3 (5%) 4 (7%) 15 (25%)
Bile Duct, Cyst 1 (2%)
Bile Duct, Hyperplasia 27 (45%) 30 (52%) 30 (52%) 23 (38%)
Hepatocyte, Cytologic Alterations 1 (2%)
Hepatocyte, Degeneration, Granular 11 (19%) 39 (65%)
Mesentery (3) (8) (10) (7)
Fat, Cyst 1 (13%)
Fat, Inflammation, Chronic 1 (13%) 2 (20%) 2 (29%)
Fat, Mineralization 2 (25%) 1 (10%)
Fat, Necrosis, Coagulative 3 (100%) 5 (63%) 6 (60%) 2 (29%)
Pancreas (59) (49) (48) (56)
Infiltration Cellular, Lymphocyte 1 (2%)
Acinus, Atrophy 6 (10%) 1 (2%) 4 (8%) 4 (7%)
Acinus, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG 100MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Salivary Glands (60) (50) (50) (60)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (58) (50) (50) (58)
Developmental Malformation 1 (2%)
Hyperkeratosis 2 (4%) 1 (2%) 1 (2%)
Hyperplasia, Squamous 2 (4%)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Ulcer 1 (2%) 1 (2%) 6 (12%) 9 (16%)
Stomach, Glandular (58) (50) (49) (57)
Mineralization 1 (2%)
Ulcer 4 (7%) 1 (2%) 7 (12%)
Tongue (1) (1)
Hyperkeratosis 1 (100%)
Hyperplasia 1 (100%)
Inflammation, Suppurative 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Polyarteritis, Chronic 1 (100%)
Heart (60) (50) (50) (60)
Cardiomyopathy 27 (45%) 20 (40%) 22 (44%) 23 (38%)
Fibrosis 2 (3%) 2 (4%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%) 2 (3%)
Thrombosis 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (60) (50) (48) (60)
Atrophy 1 (2%)
Clear Cell Focus 3 (5%) 1 (2%) 2 (4%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%)
Adrenal Gland, Medulla (60) (50) (48) (59)
Basophilic Focus 2 (3%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Parathyroid Gland (55) (47) (45) (57)
Hyperplasia 3 (7%) 1 (2%)
Pituitary Gland (58) (48) (48) (59)
Pars Distalis, Congestion 1 (2%)
Pars Distalis, Cyst 5 (9%) 8 (17%) 7 (15%) 6 (10%)
Pars Distalis, Pigmentation, Melanin 1 (2%)
Pars Intermedia, Congestion 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG 100MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Nervosa, Cyst Multilocular 1 (2%)
Thyroid Gland (59) (50) (49) (59)
C-Cell, Hyperplasia 6 (10%) 5 (10%) 6 (12%) 4 (7%)
Follicle, Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (58) (47) (49) (59)
Inflammation, Suppurative 4 (7%) 10 (21%) 7 (14%) 4 (7%)
Duct, Dilatation 2 (3%) 2 (4%) 4 (8%) 1 (2%)
Ovary (60) (50) (50) (59)
Corpus Luteum, Cyst 2 (3%) 1 (2%)
Follicle, Cyst 4 (7%) 3 (6%) 1 (2%) 2 (3%)
Uterus (60) (51) (52) (59)
Hydrometra 9 (15%) 5 (10%) 8 (15%) 12 (20%)
Hyperplasia, Cystic 3 (5%) 3 (6%) 1 (2%) 1 (2%)
Necrosis, Coagulative 1 (2%)
Cervix, Cyst 1 (2%)
Cervix, Inflammation, Suppurative 1 (2%)
Epithelium, Cytoplasmic Alteration 1 (2%)
Vagina (1) (1) (4)
Cyst 1 (100%)
Hyperkeratosis 1 (25%)
Inflammation, Suppurative 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (1) (1)
Anisocytosis 1 (100%)
Monocytosis 1 (100%)
Bone Marrow (60) (50) (49) (59)
Hyperplasia, Neutrophil 1 (2%)
Inflammation, Chronic 1 (2%)
Myelofibrosis 1 (2%)
Lymph Node (59) (50) (50) (59)
Mediastinal, Hyperplasia, Macrophage 1 (2%)
Pancreatic, Hemorrhage, Acute 1 (2%)
Pancreatic, Inflammation, Suppurative 1 (2%)
Lymph Node, Mandibular (59) (47) (48) (57)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG 100MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Macrophage 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Lymph Node, Mesenteric (57) (49) (49) (59)
Congestion 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Spleen (59) (51) (49) (59)
Congestion 2 (4%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Pigmentation, Hemosiderin 3 (6%) 1 (2%) 1 (2%)
Sinusoid, Dilatation 1 (2%)
Thymus (58) (48) (49) (56)
Congestion 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (59) (50) (50) (59)
Galactocele 6 (10%) 4 (8%) 3 (6%) 1 (2%)
Hyperplasia, Glandular 1 (2%)
Inflammation 1 (2%) 1 (2%)
Skin (60) (50) (51) (60)
Cyst Epithelial Inclusion 2 (4%) 2 (3%)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (50) (50) (60)
Fracture 1 (2%)
Osteopetrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (50) (50) (59)
Cerebrum, Atypia Cellular 1 (2%)
Cerebrum, Hemorrhage 1 (2%) 1 (2%)
Cerebrum, Mineralization 1 (2%)
Hypothalamus, Compression 1 (2%) 2 (4%) 3 (6%) 2 (3%)
Hypothalamus, Developmental Malformation 1 (2%)
Hypothalamus, Hemorrhage 2 (4%)
Meninges, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG 100MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (49) (50) (60)
Congestion 2 (4%) 1 (2%)
Edema 2 (3%)
Foreign Body 4 (8%)
Hemorrhage 1 (2%)
Inflammation 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Alveolus, Inflammation, Chronic 1 (2%)
Nose (60) (50) (50) (59)
Congestion 1 (2%)
Fungus 1 (2%) 1 (2%)
Inflammation, Suppurative 4 (7%) 2 (4%) 14 (24%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (4) (1) (1)
Anterior Chamber, Edema 1 (100%)
Cornea, Edema 1 (100%)
Lens, Cataract 1 (100%) 3 (75%)
Retina, Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (59) (58) (60) (59)
Inflammation, Suppurative 1 (2%)
Mineralization 2 (3%) 1 (2%) 1 (2%)
Nephropathy 38 (64%) 52 (90%) 54 (90%) 59 (100%)
Cortex, Cyst 1 (2%) 2 (3%)
Urinary Bladder (59) (49) (49) (57)
Inflammation, Suppurative 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0 MG/KG 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG
CONTROL 39 KILL 65 KILL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 20 10 60 60 60
Scheduled Sacrifice 10 17 7 10 9 10
Early Deaths
Moribund 14 31 33 31
Gavage Death 2 2 3 3 2 2
Dead 6 1 7 13 17
Moribund Sacrifice 1
Survivors
Terminal Sacrifice 28 9 2
Animals Examined Microscopically 59 20 10 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (59) (3) (10) (49) (51) (60)
Inflammation, Suppurative 1 (2%)
Periesophageal Tissue, Hemorrhage 1 (2%)
Intestine Large, Colon (55) (2) (10) (48) (42) (54)
Inflammation, Suppurative 1 (2%)
Intestine Small, Duodenum (56) (2) (9) (48) (48) (56)
Ulcer 1 (2%) 1 (2%) 2 (4%) 3 (5%)
Liver (59) (20) (10) (60) (60) (60)
Basophilic Focus 16 (27%) 1 (10%) 5 (8%) 2 (3%) 4 (7%)
Clear Cell Focus 5 (8%) 1 (5%) 1 (10%) 1 (2%)
Cyst 1 (2%)
Cytologic Alterations 28 (47%) 29 (48%)
Developmental Malformation 2 (3%) 1 (2%) 1 (2%) 4 (7%)
Eosinophilic Focus 5 (8%) 1 (2%) 3 (5%)
Fatty Change 4 (7%) 4 (20%) 2 (20%) 14 (23%) 15 (25%) 6 (10%)
Fibrosis 3 (5%) 41 (68%) 42 (70%)
Hemorrhage 3 (5%)
Hyperplasia 2 (3%) 2 (3%) 2 (3%)
Infiltration Cellular, Lymphocyte 3 (5%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (10%) 1 (2%)
Inflammation, Suppurative 3 (5%) 3 (5%) 2 (3%)
Mineralization 2 (3%)
Mixed Cell Focus 4 (7%) 1 (2%) 1 (2%)
Necrosis, Coagulative 1 (2%) 13 (22%) 38 (63%) 41 (68%)
Bile Duct, Hyperplasia 47 (80%) 7 (35%) 6 (60%) 49 (82%) 54 (90%) 56 (93%)
Hepatocyte, Degeneration, Granular 8 (13%) 8 (13%) 6 (10%)
Periductular, Fibrosis 1 (2%)
Mesentery (21) (1) (3) (12) (18) (7)
Ectopic Tissue 1 (6%)
Fat, Hemorrhage 1 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0 MG/KG 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG
CONTROL 39 KILL 65 KILL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Inflammation, Chronic 2 (10%) 1 (100%) 1 (33%) 1 (8%) 1 (6%) 1 (14%)
Fat, Inflammation, Suppurative 4 (33%) 2 (29%)
Fat, Necrosis, Coagulative 14 (67%) 2 (67%) 8 (67%) 16 (89%) 3 (43%)
Pancreas (57) (20) (9) (49) (50) (59)
Atrophy 4 (7%) 1 (5%) 7 (14%) 2 (4%) 1 (2%)
Fibrosis 2 (4%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Acinar Cell, Hyperplasia 1 (2%)
Acinus, Hyperplasia 2 (4%) 1 (2%)
Vein, Dilatation 1 (2%)
Salivary Glands (59) (3) (10) (49) (49) (60)
Inflammation, Suppurative 1 (2%)
Necrosis, Caseous 1 (2%)
Stomach, Forestomach (58) (20) (10) (51) (51) (60)
Hyperkeratosis 2 (3%) 3 (6%) 4 (8%)
Inflammation, Chronic 3 (6%) 5 (10%) 4 (7%)
Inflammation, Suppurative 3 (6%) 1 (2%) 3 (5%)
Mineralization 1 (2%)
Ulcer 7 (12%) 24 (47%) 35 (69%) 34 (57%)
Stomach, Glandular (57) (20) (10) (48) (49) (60)
Inflammation, Chronic 2 (4%) 3 (6%) 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Mineralization 4 (8%) 5 (10%) 5 (8%)
Ulcer 2 (4%) 5 (10%) 8 (16%) 7 (12%)
Tongue (1)
Necrosis, Zenkers 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (4) (2) (1)
Aorta, Mineralization 1 (25%) 1 (100%)
Mesenteric Artery, Arteriosclerosis 1 (25%)
Mesenteric Artery, Polyarteritis 2 (100%)
Mesenteric Artery, Thrombosis 1 (50%)
Heart (59) (20) (10) (49) (51) (60)
Cardiomyopathy 36 (61%) 11 (55%) 8 (80%) 34 (69%) 25 (49%) 23 (38%)
Inflammation, Suppurative 1 (2%)
Thrombosis 1 (2%)
Atrioventricular Valve, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0 MG/KG 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG
CONTROL 39 KILL 65 KILL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (59) (19) (10) (50) (50) (60)
Clear Cell Focus 1 (2%) 1 (2%) 2 (3%)
Cytoplasmic Alteration 1 (2%)
Hypertrophy 1 (2%)
Adrenal Gland, Medulla (59) (19) (10) (50) (50) (60)
Basophilic Focus 1 (2%) 1 (2%)
Congestion 1 (2%)
Hyperplasia 4 (8%)
Parathyroid Gland (51) (19) (10) (47) (49) (57)
Hyperplasia 3 (6%) 20 (43%) 31 (63%) 29 (51%)
Pituitary Gland (58) (20) (10) (48) (51) (60)
Pars Distalis, Cyst 1 (2%) 4 (8%) 3 (5%)
Pars Distalis, Hyperplasia 1 (5%) 1 (10%)
Pars Distalis, Hypertrophy 1 (10%) 1 (2%)
Pars Intermedia, Hemorrhage 1 (2%)
Thyroid Gland (57) (20) (10) (49) (49) (60)
C-Cell, Hyperplasia 6 (11%) 3 (6%) 1 (2%) 2 (3%)
Follicle, Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (2) (1) (1)
Inflammation, Chronic 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (55) (3) (10) (49) (50) (56)
Hyperplasia 1 (2%)
Inflammation, Chronic 1 (2%) 2 (4%) 1 (2%)
Inflammation, Suppurative 8 (15%) 1 (10%) 6 (12%) 3 (6%) 2 (4%)
Duct, Dilatation 3 (5%) 2 (4%) 3 (5%)
Prostate (55) (20) (10) (50) (50) (59)
Edema 1 (2%)
Hyperplasia 1 (2%) 2 (4%) 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 4 (7%) 7 (14%) 6 (12%) 5 (8%)
Seminal Vesicle (55) (20) (10) (50) (50) (59)
Atrophy 1 (5%)
Testes (55) (20) (10) (58) (54) (60)
Interstitial Cell, Hyperplasia 3 (5%) 9 (45%) 1 (10%) 2 (3%) 2 (4%) 2 (3%)
Seminiferous Tubule, Atrophy 3 (5%) 1 (5%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0 MG/KG 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG
CONTROL 39 KILL 65 KILL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (58) (3) (10) (50) (50) (60)
Hyperplasia, Mononuclear Cell 1 (2%)
Hyperplasia, Neutrophil 1 (2%)
Lymph Node (59) (20) (10) (50) (49) (58)
Lumbar, Hemorrhage 1 (2%) 1 (2%) 3 (5%)
Mediastinal, Hemorrhage 2 (4%) 1 (2%)
Mediastinal, Pigmentation 1 (2%)
Renal, Hemorrhage 1 (2%)
Lymph Node, Mandibular (57) (20) (10) (47) (48) (58)
Congestion 1 (2%)
Edema 1 (10%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%) 3 (6%) 5 (9%)
Hyperplasia, Plasma Cell 1 (2%) 2 (4%)
Infiltration Cellular, Histiocyte 1 (2%)
Lymph Node, Mesenteric (53) (4) (10) (50) (48) (60)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Spleen (58) (20) (10) (50) (51) (60)
Amyloid Deposition 1 (2%)
Congestion 2 (3%) 1 (2%) 1 (2%)
Developmental Malformation 2 (3%)
Ectopic Tissue 1 (10%)
Fibrosis 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Hypoplasia 1 (2%)
Infarct 2 (4%)
Inflammation, Suppurative 2 (4%) 2 (4%)
Necrosis, Coagulative 1 (2%)
Pigmentation, Hemosiderin 1 (2%) 1 (2%) 2 (3%)
Thrombosis 1 (2%)
Thymus (57) (3) (10) (48) (48) (56)
Ectopic Tissue 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (54) (2) (10) (46) (44) (54)
Galactocele 2 (4%) 2 (5%)
Skin (59) (4) (10) (50) (51) (60)
Acanthosis 1 (2%)
Cyst Epithelial Inclusion 3 (5%) 1 (10%) 1 (2%) 2 (4%)
Degeneration 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0 MG/KG 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG
CONTROL 39 KILL 65 KILL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Hemorrhage 1 (2%) 1 (2%)
Hyperkeratosis 1 (2%)
Inflammation, Chronic 2 (3%) 3 (6%)
Inflammation, Suppurative 1 (2%) 2 (4%)
Sebaceous Gland, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (59) (3) (10) (50) (51) (60)
Inflammation, Chronic 1 (2%)
Necrosis 1 (2%)
Cranium, Proliferation 1 (2%)
Skeletal Muscle (1) (2) (1)
Inflammation, Chronic 1 (50%)
Inflammation, Suppurative 1 (50%) 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (57) (20) (9) (50) (49) (59)
Cerebellum, Developmental Malformation 1 (2%)
Hypothalamus, Compression 1 (2%)
Meninges, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (1)
Hemorrhage 1 (100%)
Lung (59) (20) (10) (49) (51) (60)
Atelectasis 1 (2%)
Congestion 3 (15%)
Edema 2 (20%) 1 (2%)
Foreign Body 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Macrophage 2 (4%) 1 (2%)
Inflammation, Granulomatous 2 (10%)
Inflammation, Suppurative 1 (2%) 1 (2%) 2 (4%)
Mineralization 1 (2%)
Alveolar Epithelium, Hyperplasia 5 (8%) 1 (2%) 1 (2%) 1 (2%)
Nose (59) (2) (10) (50) (52) (60)
Congestion 1 (50%)
Fungus 4 (7%) 2 (4%) 4 (8%) 3 (5%)
Hemorrhage 1 (2%) 1 (2%)
Inflammation, Suppurative 15 (25%) 20 (40%) 28 (54%) 44 (73%)
Metaplasia, Squamous 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0 MG/KG 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG
CONTROL 39 KILL 65 KILL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Olfactory Epithelium, Degeneration 1 (2%)
Respiratory Epithelium, Hyperplasia 1 (2%)
Trachea (59) (3) (10) (49) (50) (60)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (4) (1)
Cataract 1 (25%) 1 (100%)
Pigmentation 1 (25%)
Cornea, Edema 1 (25%)
Retina, Degeneration 1 (100%)
Zymbal's Gland (2) (1) (1)
Inflammation, Suppurative 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (59) (19) (10) (60) (60) (60)
Congestion 1 (2%)
Nephropathy 58 (98%) 17 (89%) 9 (90%) 58 (97%) 59 (98%) 60 (100%)
Cortex, Cyst 1 (2%) 3 (5%) 2 (3%) 1 (2%)
Renal Tubule, Hyperplasia 1 (2%) 3 (5%)
Urinary Bladder (55) (20) (10) (49) (50) (59)
Hyperplasia 1 (2%)
Inflammation, Suppurative 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 100MG/KG 100MG/KG 100MG/KG 100MG/KG
39 STOP 65 KILL 65 STOP
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 20 20 10 20
Scheduled Sacrifice 18 10
Early Deaths
Gavage Death 2 1 3
Moribund 6 13
Dead 4 2
Survivors
Terminal Sacrifice 8 2
Dead 1
Animals Examined Microscopically 20 20 10 20
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (2) (18) (10) (20)
Inflammation, Suppurative 1 (5%)
Intestine Small, Jejunum (2) (17) (10) (20)
Necrosis, Coagulative 1 (5%)
Liver (20) (20) (10) (20)
Basophilic Focus 2 (10%) 1 (5%)
Clear Cell Focus 2 (10%)
Developmental Malformation 2 (10%)
Fatty Change 2 (10%) 9 (90%) 3 (15%)
Fibrosis 2 (10%)
Hyperplasia 1 (5%)
Inflammation, Chronic 1 (5%) 1 (5%)
Inflammation, Chronic, Focal 1 (5%)
Mixed Cell Focus 1 (5%)
Necrosis, Coagulative 11 (55%) 2 (10%) 2 (20%) 3 (15%)
Necrosis, Multifocal 6 (30%)
Bile Duct, Hyperplasia 17 (85%) 17 (85%) 10 (100%) 14 (70%)
Hepatocyte, Cytomegaly 18 (90%)
Hepatocyte, Degeneration, Granular 8 (80%) 1 (5%)
Periductular, Fibrosis 1 (5%)
Mesentery (1) (7) (1) (4)
Fat, Inflammation, Chronic 2 (29%)
Fat, Inflammation, Suppurative 1 (25%)
Fat, Necrosis, Coagulative 1 (100%) 2 (29%) 1 (100%) 3 (75%)
Pancreas (20) (19) (10) (20)
Atrophy 1 (5%) 2 (10%)
Hyperplasia 1 (5%)
Inflammation, Chronic 1 (10%)
Stomach, Forestomach (20) (19) (10) (19)
Cyst Epithelial Inclusion 1 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 100MG/KG 100MG/KG 100MG/KG 100MG/KG
39 STOP 65 KILL 65 STOP
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hyperkeratosis 2 (11%)
Hyperplasia 1 (5%) 1 (5%)
Inflammation, Chronic 3 (16%) 3 (16%)
Inflammation, Suppurative 1 (5%) 1 (5%)
Ulcer 3 (16%) 5 (26%)
Stomach, Glandular (20) (18) (10) (20)
Dilatation 1 (5%)
Inflammation, Chronic 1 (6%)
Mineralization 1 (6%) 2 (10%)
Ulcer 2 (10%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1)
Aorta, Mineralization 1 (100%) 1 (100%)
Mesenteric Artery, Mineralization 1 (100%)
Heart (20) (20) (10) (20)
Cardiomyopathy 9 (45%) 11 (55%) 4 (40%) 10 (50%)
Fibrosis 1 (5%)
Thrombosis 1 (5%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (20) (20) (10) (20)
Congestion 1 (5%)
Parathyroid Gland (20) (19) (10) (18)
Hyperplasia 4 (21%) 8 (44%)
Pituitary Gland (20) (20) (10) (20)
Pars Distalis, Congestion 1 (5%)
Pars Distalis, Cyst 1 (5%)
Pars Distalis, Hyperplasia 1 (5%)
Thyroid Gland (20) (20) (10) (20)
Follicular Cell, Cyst 1 (5%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 100MG/KG 100MG/KG 100MG/KG 100MG/KG
39 STOP 65 KILL 65 STOP
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (3) (19) (10) (20)
Dilatation 1 (5%)
Hemorrhage 1 (5%)
Inflammation, Suppurative 1 (5%) 2 (10%)
Prostate (20) (20) (10) (20)
Hemorrhage 1 (5%)
Hyperplasia 2 (10%) 1 (5%)
Inflammation, Chronic 1 (5%)
Testes (20) (20) (10) (20)
Atrophy 1 (5%) 1 (10%) 1 (5%)
Infarct 1 (5%)
Interstitial Cell, Hyperplasia 14 (70%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (2) (19) (10) (20)
Hyperplasia, Mononuclear Cell 1 (5%)
Lymph Node, Mandibular (20) (20) (9) (20)
Congestion 1 (5%)
Hyperplasia, Lymphoid 1 (5%)
Lymph Node, Mesenteric (3) (20) (10) (20)
Congestion 1 (5%)
Spleen (20) (19) (10) (20)
Developmental Malformation 1 (5%)
Fibrosis 1 (5%)
Necrosis 1 (5%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (2) (20) (10) (20)
Cyst Epithelial Inclusion 1 (5%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (20) (19) (10) (20)
Cerebellum, Hemorrhage 1 (5%)
Cerebrum, Hemorrhage 1 (5%)
Cerebrum, Infarct 1 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05090-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COUMARIN Date: 09/12/94
Route: GAVAGE Time: 03:12:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 100MG/KG 100MG/KG 100MG/KG 100MG/KG
39 STOP 65 KILL 65 STOP
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (20) (20) (10) (20)
Congestion 2 (10%)
Emphysema 1 (5%)
Fibrosis 1 (5%)
Foreign Body 3 (15%)
Hemorrhage 1 (5%) 1 (5%)
Inflammation, Suppurative 1 (5%)
Alveolar Epithelium, Hyperplasia 3 (15%) 1 (5%)
Nose (2) (20) (10) (20)
Fungus 1 (5%) 2 (10%)
Inflammation, Suppurative 3 (15%) 1 (10%) 3 (15%)
Metaplasia, Squamous 1 (5%)
Necrosis, Coagulative 1 (5%)
Nasolacrimal Duct, Inflammation 2 (100%)
Trachea (2) (20) (10) (20)
Metaplasia, Squamous 1 (5%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1)
Inflammation, Suppurative 1 (100%)
Posterior Chamber, Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (20) (20) (10) (20)
Hydronephrosis 1 (10%)
Nephropathy 19 (95%) 20 (100%) 10 (100%) 20 (100%)
Cortex, Cyst 1 (5%)
Renal Tubule, Hyperplasia 3 (15%)
Urinary Bladder (20) (20) (10) (20)
Calculus Gross Observation 2 (10%)
Inflammation, Suppurative 1 (5%)
Lumen, Hemorrhage 1 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
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