TDMS Study 88122-06 Pathology Tables
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
FINAL/RATS
Facility: Battelle Columbus Laboratory
Chemical CAS #: 37319-17-8
Lock Date: 06/01/00
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: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 13 10 9 6
Moribund Sacrifice 6 8 11 11
Dosing Accident 1 2 5
Accidently Killed 1 1
Survivors
Natural Death 1
Terminal Sacrifice 30 31 28 26
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50)
Muscularis, Inflammation, Chronic 1 (2%)
Intestine Large, Colon (50) (50) (50) (50)
Parasite Metazoan 2 (4%) 3 (6%) 3 (6%) 3 (6%)
Intestine Large, Rectum (46) (43) (44) (42)
Infiltration Cellular, Histiocyte 18 (43%)
Inflammation, Acute, Focal 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Myxomatous Change 1 (2%) 12 (27%) 35 (83%)
Parasite Metazoan 2 (4%) 3 (7%) 1 (2%)
Intestine Small, Jejunum (50) (50) (50) (50)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Ileum (50) (50) (50) (50)
Parasite Metazoan 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 2 (4%) 1 (2%)
Basophilic Focus 39 (78%) 35 (70%) 40 (80%) 34 (68%)
Clear Cell Focus 8 (16%) 4 (8%) 8 (16%) 6 (12%)
Eosinophilic Focus 12 (24%) 12 (24%) 14 (28%) 10 (20%)
Fibrosis, Focal 1 (2%)
Hepatodiaphragmatic Nodule 9 (18%) 8 (16%) 11 (22%) 14 (28%)
Inflammation, Granulomatous 36 (72%) 31 (62%) 37 (74%) 39 (78%)
Mixed Cell Focus 19 (38%) 12 (24%) 10 (20%) 9 (18%)
Necrosis, Focal 1 (2%)
Regeneration 1 (2%) 1 (2%)
Tension Lipidosis 1 (2%)
Bile Duct, Hyperplasia 13 (26%) 14 (28%) 11 (22%) 14 (28%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Bile Duct, Inflammation 1 (2%)
Centrilobular, Fatty Change 1 (2%) 2 (4%)
Mesentery (8) (4) (6) (9)
Fat, Necrosis 7 (88%) 4 (100%) 6 (100%) 9 (100%)
Oral Mucosa (1) (1)
Cyst 1 (100%)
Pharyngeal, Hyperplasia, Squamous 1 (100%)
Pancreas (50) (50) (50) (50)
Acinus, Atrophy 7 (14%) 12 (24%) 11 (22%) 8 (16%)
Acinus, Hyperplasia, Focal 1 (2%) 1 (2%)
Salivary Glands (50) (50) (50) (50)
Parotid Gland, Atrophy, Diffuse 1 (2%)
Parotid Gland, Atrophy, Focal 2 (4%) 1 (2%)
Parotid Gland, Hyperplasia, Focal 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Inflammation, Acute 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Epithelium, Hyperplasia, Squamous 1 (2%)
Epithelium, Inflammation, Focal, Suppurative 1 (2%)
Stomach, Glandular (50) (50) (50) (50)
Inflammation, Chronic, Focal 1 (2%)
Mineralization 1 (2%) 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Ulcer 1 (2%) 3 (6%)
Epithelium, Ectasia 1 (2%)
Tongue (1)
Epithelium, Hyperplasia, Focal, Squamous 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (50)
Aorta, Inflammation, Chronic 1 (2%) 1 (2%)
Heart (50) (50) (50) (50)
Artery, Hyperplasia, Focal 1 (2%)
Atrium, Thrombosis 1 (2%)
Myocardium, Degeneration 38 (76%) 30 (60%) 31 (62%) 34 (68%)
Myocardium, Inflammation, Chronic, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia, Focal 20 (40%) 17 (34%) 17 (34%) 19 (38%)
Adrenal Medulla (50) (50) (50) (50)
Hyperplasia, Focal 5 (10%) 2 (4%) 4 (8%) 4 (8%)
Necrosis 1 (2%)
Islets, Pancreatic (50) (50) (50) (50)
Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (50) (50) (50) (50)
Angiectasis 1 (2%) 2 (4%) 2 (4%) 2 (4%)
Cyst 20 (40%) 21 (42%) 18 (36%) 22 (44%)
Hemorrhage 1 (2%)
Pars Distalis, Hyperplasia, Focal 16 (32%) 15 (30%) 10 (20%) 13 (26%)
Pars Distalis, Mineralization 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Hemorrhage 1 (2%) 1 (2%)
C-Cell, Hyperplasia 33 (66%) 38 (76%) 34 (68%) 31 (62%)
Follicle, Hyperplasia 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (50) (50) (49)
Cyst 4 (8%) 4 (8%) 4 (8%) 3 (6%)
Fibrosis 1 (2%)
Hyperplasia 1 (2%)
Hyperplasia, Focal 5 (10%) 3 (6%) 2 (4%) 3 (6%)
Inflammation, Chronic 7 (14%) 10 (20%) 11 (22%) 8 (16%)
Inflammation, Suppurative 1 (2%) 1 (2%) 2 (4%)
Ovary (50) (50) (50) (50)
Cyst 4 (8%) 5 (10%) 7 (14%) 5 (10%)
Inflammation, Granulomatous 1 (2%)
Oviduct (1)
Cyst 1 (100%)
Uterus (50) (50) (50) (50)
Inflammation, Suppurative 1 (2%)
Ulcer 1 (2%)
Cervix, Endometrium, Hyperplasia 1 (2%)
Endometrium, Hyperplasia, Cystic 4 (8%) 5 (10%) 3 (6%) 6 (12%)
Endometrium, Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Vagina (2) (2)
Hyperplasia 1 (50%)
Infiltration Cellular, Polymorphonuclear 1 (50%)
Epithelium, Vacuolization Cytoplasmic 1 (50%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Fibrosis 1 (2%) 1 (2%)
Lymph Node (7) (19) (14) (13)
Deep Cervical, Hemorrhage 1 (8%)
Deep Cervical, Hyperplasia, Lymphoid 1 (5%) 1 (8%)
Deep Cervical, Infiltration Cellular,
Histiocyte 1 (14%)
Mediastinal, Congestion 1 (8%)
Mediastinal, Ectasia 2 (11%) 3 (21%) 1 (8%)
Mediastinal, Hemorrhage 3 (16%) 2 (14%) 3 (23%)
Mediastinal, Hyperplasia, Lymphoid 2 (29%) 3 (16%) 3 (21%) 6 (46%)
Mediastinal, Infiltration Cellular, Mast Cell 1 (8%)
Mediastinal, Infiltration Cellular, Plasma
Cell 1 (14%) 1 (8%)
Mediastinal, Infiltration Cellular,
Histiocyte 1 (14%) 4 (29%)
Mediastinal, Necrosis, Lymphoid 1 (5%)
Pancreatic, Infiltration Cellular, Histiocyte 1 (8%)
Pancreatic, Pigmentation, Hemosiderin 1 (8%)
Lymph Node, Mandibular (3) (8) (3) (2)
Infiltration Cellular, Histiocyte 1 (13%)
Necrosis, Lymphoid 1 (13%)
Lymph Node, Mesenteric (50) (50) (50) (49)
Ectasia 1 (2%)
Hyperplasia, Lymphoid 2 (4%) 2 (4%)
Infiltration Cellular, Histiocyte 3 (6%) 27 (54%) 42 (86%)
Spleen (50) (50) (50) (50)
Hematopoietic Cell Proliferation 6 (12%) 2 (4%) 4 (8%) 5 (10%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphohistiocytic 1 (2%) 2 (4%) 4 (8%)
Necrosis, Focal 1 (2%)
Lymphoid Follicle, Atrophy 35 (70%) 32 (64%) 31 (62%) 28 (56%)
Lymphoid Follicle, Hyperplasia 1 (2%)
Thymus (45) (41) (46) (41)
Epithelial Cell, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Hyperplasia 2 (4%)
Hyperplasia, Focal 6 (12%) 3 (6%) 3 (6%) 2 (4%)
Duct, Dilatation 29 (58%) 15 (30%) 20 (40%) 23 (46%)
Skin (50) (50) (50) (50)
Ulcer 1 (2%)
Subcutaneous Tissue, Pigmentation,
Hemosiderin 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Osteopetrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hydrocephalus 8 (16%) 6 (12%) 8 (16%) 10 (20%)
Cerebrum, Degeneration, Focal 1 (2%)
Cerebrum, Gliosis, Focal 1 (2%)
Cerebrum, Necrosis, Focal 1 (2%)
Hypothalamus, Compression 5 (10%) 3 (6%) 5 (10%) 8 (16%)
Medulla, Compression 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 5 (10%) 3 (6%) 1 (2%)
Hemorrhage 2 (4%) 1 (2%) 1 (2%) 4 (8%)
Infiltration Cellular, Histiocyte 1 (2%)
Inflammation, Chronic Active, Focal 1 (2%)
Inflammation, Granulomatous, Multifocal 1 (2%)
Metaplasia, Osseous 2 (4%) 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 3 (6%) 4 (8%) 5 (10%) 3 (6%)
Alveolus, Emphysema, Focal 1 (2%)
Alveolus, Inflammation, Acute 1 (2%) 1 (2%)
Alveolus, Inflammation, Chronic Active, Focal 2 (4%) 25 (50%) 27 (54%) 34 (68%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Nose (50) (50) (50) (50)
Inflammation, Chronic 6 (12%) 3 (6%) 7 (14%) 5 (10%)
Trachea (50) (50) (50) (50)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%)
Peritracheal Tissue, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (1) (3)
Cataract 1 (33%) 1 (100%) 2 (67%)
Degeneration 2 (67%)
Cornea, Fibrosis 1 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Infarct 2 (4%) 1 (2%)
Inflammation, Focal, Suppurative 1 (2%)
Nephropathy 16 (32%) 13 (26%) 11 (22%) 16 (32%)
Pelvis, Inflammation, Suppurative 1 (2%)
Renal Tubule, Cyst 1 (2%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation, Lipofuscin 1 (2%)
Urinary Bladder (50) (50) (50) (50)
Hemorrhage 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 7 9 8 5
Moribund Sacrifice 15 10 17 12
Dosing Accident 2 2 5
Survivors
Terminal Sacrifice 26 29 25 28
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50)
Muscularis, Periesophageal Tissue,
Inflammation, Chronic 1 (2%)
Periesophageal Tissue, Hemorrhage 1 (2%) 1 (2%)
Intestine Large, Colon (50) (50) (50) (50)
Parasite Metazoan 4 (8%) 1 (2%) 3 (6%)
Intestine Large, Rectum (48) (48) (49) (45)
Erosion 2 (4%) 2 (4%)
Infiltration Cellular, Histiocyte 4 (9%)
Inflammation, Chronic 1 (2%) 1 (2%) 5 (11%)
Myxomatous Change 1 (2%) 3 (6%) 25 (56%)
Parasite Metazoan 5 (10%) 8 (17%) 4 (8%) 3 (7%)
Ulcer 1 (2%)
Intestine Small, Duodenum (50) (50) (50) (50)
Epithelium, Cyst 1 (2%)
Epithelium, Necrosis 1 (2%)
Intestine Small, Jejunum (50) (50) (50) (50)
Inflammation, Chronic, Focal 1 (2%)
Peyer's Patch, Hyperplasia 1 (2%)
Intestine Small, Ileum (50) (50) (50) (50)
Parasite Metazoan 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 1 (2%)
Basophilic Focus 27 (54%) 27 (54%) 22 (44%) 19 (38%)
Clear Cell Focus 18 (36%) 22 (44%) 23 (46%) 16 (32%)
Eosinophilic Focus 9 (18%) 12 (24%) 5 (10%) 4 (8%)
Fatty Change, Focal 1 (2%)
Fibrosis, Focal 1 (2%) 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 5 (10%) 5 (10%) 7 (14%) 9 (18%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Granulomatous 30 (60%) 26 (52%) 32 (64%) 27 (54%)
Mixed Cell Focus 8 (16%) 17 (34%) 13 (26%) 11 (22%)
Necrosis, Focal 1 (2%)
Artery, Hyperplasia, Focal 1 (2%)
Bile Duct, Hyperplasia 44 (88%) 41 (82%) 32 (64%) 39 (78%)
Centrilobular, Degeneration 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Centrilobular, Fatty Change 1 (2%) 1 (2%)
Centrilobular, Necrosis 1 (2%) 1 (2%) 2 (4%) 3 (6%)
Mesentery (9) (11) (9) (13)
Accessory Spleen 1 (8%)
Hemorrhage 1 (8%)
Fat, Inflammation, Granulomatous 2 (15%)
Fat, Necrosis 7 (78%) 10 (91%) 9 (100%) 8 (62%)
Pancreas (50) (50) (50) (50)
Fibrosis 1 (2%)
Acinus, Atrophy 12 (24%) 14 (28%) 14 (28%) 16 (32%)
Acinus, Hyperplasia, Focal 2 (4%) 1 (2%)
Duct, Necrosis 1 (2%)
Salivary Glands (50) (50) (49) (50)
Duct, Parotid Gland, Sublingual Gland,
Mineralization 1 (2%)
Parotid Gland, Atrophy, Focal 1 (2%) 1 (2%)
Sublingual Gland, Atrophy, Focal 1 (2%)
Sublingual Gland, Hypertrophy, Focal 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Edema 1 (2%)
Hyperplasia, Focal, Squamous 2 (4%) 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%)
Ulcer 1 (2%) 2 (4%) 4 (8%) 1 (2%)
Stomach, Glandular (50) (50) (50) (50)
Mineralization 2 (4%) 1 (2%) 1 (2%)
Ulcer 1 (2%) 3 (6%) 5 (10%) 2 (4%)
Epithelium, Hyperplasia, Focal 1 (2%) 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (50)
Aorta, Mineralization 1 (2%)
Heart (50) (50) (50) (50)
Atrium, Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Atrium, Thrombosis 2 (4%) 4 (8%) 1 (2%)
Myocardium, Degeneration 41 (82%) 41 (82%) 42 (84%) 41 (82%)
Myocardium, Necrosis, Focal 1 (2%)
Vein, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Hyperplasia 1 (2%)
Hyperplasia, Diffuse 1 (2%)
Hyperplasia, Focal 14 (28%) 16 (32%) 17 (34%) 17 (34%)
Necrosis, Acute 1 (2%)
Necrosis, Focal 1 (2%)
Adrenal Medulla (50) (50) (50) (50)
Fibrosis 3 (6%)
Hyperplasia, Diffuse 2 (4%)
Hyperplasia, Focal 10 (20%) 17 (34%) 12 (24%) 13 (26%)
Necrosis, Acute 1 (2%)
Necrosis, Focal 1 (2%)
Islets, Pancreatic (50) (50) (50) (50)
Hyperplasia 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Parathyroid Gland (46) (44) (45) (47)
Cyst, Multiple 1 (2%)
Pituitary Gland (50) (50) (50) (50)
Angiectasis 1 (2%) 1 (2%)
Cyst 3 (6%) 3 (6%) 5 (10%) 2 (4%)
Hyperplasia 2 (4%)
Necrosis, Focal 1 (2%)
Pars Distalis, Hyperplasia, Focal 12 (24%) 12 (24%) 17 (34%) 9 (18%)
Thyroid Gland (50) (50) (50) (50)
C-Cell, Hyperplasia 31 (62%) 36 (72%) 40 (80%) 35 (70%)
Follicle, Cyst 1 (2%)
Follicle, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (1)
Inflammation, Chronic 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1) (1)
Inflammation, Chronic 1 (100%)
Epididymis (50) (50) (50) (50)
Fibrosis 1 (2%)
Granuloma Sperm 1 (2%) 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Preputial Gland (50) (50) (50) (50)
Cyst 3 (6%) 2 (4%)
Hyperplasia 1 (2%) 2 (4%)
Inflammation, Chronic 35 (70%) 44 (88%) 42 (84%) 37 (74%)
Inflammation, Suppurative 1 (2%) 2 (4%) 1 (2%)
Prostate, NOS (50) (50) (50) (49)
Hyperplasia 1 (2%)
Hyperplasia, Focal 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 18 (36%) 16 (32%) 19 (38%) 18 (37%)
Seminal Vesicle (50) (50) (50) (49)
Atrophy 1 (2%) 1 (2%)
Fibrosis 1 (2%) 1 (2%)
Hyperplasia 4 (8%) 2 (4%) 2 (4%)
Testes (50) (50) (50) (50)
Cyst 2 (4%)
Artery, Necrosis 1 (2%)
Germinal Epithelium, Atrophy 3 (6%) 1 (2%) 1 (2%) 1 (2%)
Interstitial Cell, Hyperplasia 5 (10%) 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Fibrosis 2 (4%) 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Lymph Node (11) (17) (10) (13)
Deep Cervical, Angiectasis 1 (8%)
Deep Cervical, Hyperplasia, Lymphoid 1 (9%)
Mediastinal, Angiectasis 1 (8%)
Mediastinal, Ectasia 2 (12%) 2 (20%) 1 (8%)
Mediastinal, Hemorrhage 2 (18%) 1 (8%)
Mediastinal, Hyperplasia, Lymphoid 2 (18%) 7 (41%) 2 (20%) 1 (8%)
Mediastinal, Hyperplasia, Plasma Cell 1 (8%)
Mediastinal, Infiltration Cellular,
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Histiocyte 1 (10%)
Pancreatic, Ectasia 1 (6%)
Pancreatic, Hemorrhage 1 (6%)
Renal, Ectasia 1 (10%)
Renal, Infiltration Cellular, Plasma Cell 1 (10%)
Lymph Node, Mandibular (5) (5) (9) (2)
Ectasia 1 (11%) 1 (50%)
Infiltration Cellular, Plasma Cell 1 (20%)
Lymph Node, Mesenteric (50) (50) (50) (49)
Ectasia 2 (4%) 2 (4%)
Fibrosis 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 18 (36%) 39 (80%)
Inflammation, Granulomatous 3 (6%)
Necrosis, Lymphoid 1 (2%)
Endothelial Cell, Hyperplasia 1 (2%)
Spleen (50) (50) (50) (50)
Fibrosis, Focal 2 (4%) 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 3 (6%) 4 (8%)
Hyperplasia, Lymphohistiocytic 2 (4%) 2 (4%) 2 (4%) 8 (16%)
Necrosis, Focal 1 (2%)
Capsule, Fibrosis, Focal 1 (2%) 1 (2%)
Lymphoid Follicle, Atrophy 20 (40%) 25 (50%) 29 (58%) 25 (50%)
Lymphoid Follicle, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Lymphoid Follicle, Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (49) (50) (48)
Hyperplasia 25 (51%) 37 (76%) 31 (62%) 17 (35%)
Duct, Dilatation 12 (24%) 24 (49%) 27 (54%) 15 (31%)
Duct, Dilatation, Diffuse 1 (2%)
Skin (50) (50) (50) (50)
Metaplasia, Osseous 1 (2%)
Epidermis, Cyst, Squamous 1 (2%)
Epidermis, Epidermis, Cyst 1 (2%)
Sebaceous Gland, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
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MUSCULOSKELETAL SYSTEM - CONT
Bone (50) (50) (50) (50)
Cyst 2 (4%)
Femur, Hyperostosis 1 (2%)
Skeletal Muscle (1) (2)
Hemorrhage 1 (50%)
Inflammation, Acute 1 (50%)
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NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hydrocephalus 8 (16%) 7 (14%) 9 (18%) 6 (12%)
Cerebrum, Degeneration, Focal 1 (2%)
Hippocampus, Cerebrum, Degeneration 1 (2%)
Hypothalamus, Compression 6 (12%) 2 (4%) 5 (10%) 4 (8%)
Medulla, Degeneration, Focal 1 (2%)
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RESPIRATORY SYSTEM
Larynx (1)
Hemorrhage 1 (100%)
Lung (50) (50) (50) (50)
Emphysema, Focal 1 (2%)
Hemorrhage 2 (4%) 1 (2%) 1 (2%) 4 (8%)
Infiltration Cellular, Histiocyte 1 (2%)
Metaplasia, Osseous 3 (6%)
Myxomatous Change 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 6 (12%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 3 (6%) 4 (8%) 3 (6%) 3 (6%)
Alveolar Epithelium, Metaplasia, Squamous 2 (4%)
Alveolus, Emphysema, Focal 1 (2%) 1 (2%)
Alveolus, Inflammation, Acute 1 (2%) 1 (2%) 2 (4%)
Alveolus, Inflammation, Chronic Active, Focal 6 (12%) 11 (22%) 14 (28%)
Artery, Thrombosis 1 (2%)
Interstitium, Fibrosis, Focal 1 (2%)
Interstitium, Alveolus, Inflammation 1 (2%)
Mediastinum, Inflammation, Chronic 1 (2%)
Nose (50) (50) (50) (50)
Foreign Body 1 (2%)
Inflammation, Chronic 9 (18%) 7 (14%) 8 (16%) 9 (18%)
Thrombosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
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NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:32:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Ulcer 2 (4%) 1 (2%)
Trachea (50) (50) (50) (50)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%) 4 (8%)
Ulcer 1 (2%)
Epithelium, Metaplasia, Squamous 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1)
Cataract 1 (100%) 1 (100%)
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URINARY SYSTEM
Kidney (50) (50) (50) (50)
Glomerulosclerosis 1 (2%)
Hemorrhage 1 (2%)
Hydronephrosis 2 (4%)
Infarct 2 (4%) 2 (4%)
Nephropathy 40 (80%) 42 (84%) 41 (82%) 37 (74%)
Artery, Thrombosis 1 (2%)
Pelvis, Inflammation, Suppurative 1 (2%)
Renal Tubule, Necrosis, Focal 2 (4%) 1 (2%) 2 (4%)
Renal Tubule, Pigmentation, Lipofuscin 1 (2%) 3 (6%)
Vein, Inflammation, Chronic 1 (2%)
Urethra (1)
Inflammation, Suppurative 1 (100%)
Urinary Bladder (50) (50) (50) (49)
Hemorrhage 1 (2%)
Inflammation, Acute 1 (2%)
Mineralization 1 (2%)
Ulcer 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
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