TDMS Study 88122-07 Pathology Tables
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
FINAL/MICE
Facility: Battelle Columbus Laboratory
Chemical CAS #: 37319-17-8
Lock Date: 04/14/00
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: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 8 6 10 9
Moribund Sacrifice 4 5 3 7
Accidently Killed 1
Dosing Accident 1
Survivors
Terminal Sacrifice 37 37 37 34
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (49)
Inflammation, Chronic Active 1 (2%)
Necrosis 1 (2%)
Gallbladder (39) (40) (38) (38)
Cyst 2 (5%) 1 (3%) 1 (3%)
Degeneration, Hyaline 1 (3%) 1 (3%) 3 (8%) 2 (5%)
Intestine Large, Colon (45) (44) (44) (46)
Necrosis 1 (2%)
Intestine Large, Rectum (45) (45) (44) (46)
Infiltration Cellular, Histiocyte 2 (5%) 10 (22%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 2 (5%) 32 (70%)
Metaplasia, Squamous 1 (2%) 26 (57%)
Myxomatous Change 3 (7%) 21 (48%) 31 (67%)
Necrosis 1 (2%) 24 (52%)
Intestine Large, Cecum (41) (43) (44) (43)
Inflammation, Granulomatous 1 (2%)
Necrosis 1 (2%)
Ulcer 1 (2%)
Intestine Small, Jejunum (43) (44) (42) (42)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%)
Intestine Small, Ileum (42) (44) (42) (42)
Infiltration Cellular, Mixed Cell 1 (2%)
Liver (50) (49) (50) (49)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Basophilic Focus 5 (10%) 6 (12%) 8 (16%) 12 (24%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Clear Cell Focus 4 (8%) 1 (2%) 21 (43%)
Cyst 1 (2%) 1 (2%)
Eosinophilic Focus 10 (20%) 6 (12%) 7 (14%) 15 (31%)
Fatty Change 4 (8%) 2 (4%) 1 (2%) 12 (24%)
Hematopoietic Cell Proliferation 3 (6%) 7 (14%) 5 (10%) 7 (14%)
Infarct 1 (2%)
Inflammation, Chronic 40 (80%) 37 (76%) 40 (80%) 38 (78%)
Mineralization 1 (2%) 1 (2%)
Tension Lipidosis 2 (4%) 1 (2%)
Bile Duct, Hyperplasia 1 (2%)
Centrilobular, Degeneration 1 (2%) 1 (2%)
Centrilobular, Necrosis 1 (2%)
Mesentery (30) (34) (32) (42)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (3%)
Thrombosis 1 (2%)
Artery, Inflammation, Chronic Active 1 (3%)
Fat, Necrosis 29 (97%) 33 (97%) 31 (97%) 41 (98%)
Pancreas (46) (45) (46) (46)
Atrophy 1 (2%) 1 (2%)
Basophilic Focus 2 (4%) 1 (2%)
Inflammation, Acute 1 (2%)
Lipomatosis 1 (2%)
Artery, Inflammation 1 (2%)
Salivary Glands (49) (49) (50) (48)
Atrophy 1 (2%)
Basophilic Focus 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 2 (4%)
Stomach, Forestomach (47) (48) (49) (48)
Hyperplasia, Squamous 2 (4%) 2 (4%) 2 (4%)
Inflammation, Acute 1 (2%)
Ulcer 3 (6%)
Artery, Inflammation, Chronic Active 1 (2%)
Stomach, Glandular (46) (45) (44) (46)
Hyperplasia 1 (2%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (2)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Aorta, Mineralization 1 (50%)
Heart (50) (50) (50) (50)
Cardiomyopathy 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 2 (4%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%) 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (49) (49) (48)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia 5 (10%) 3 (6%) 2 (4%) 2 (4%)
Hypertrophy 1 (2%) 3 (6%) 3 (6%) 12 (25%)
Necrosis 1 (2%)
Pituitary Gland (48) (47) (45) (48)
Hyperplasia 1 (2%)
Pars Distalis, Hyperplasia 11 (23%) 8 (17%) 10 (22%) 11 (23%)
Pars Intermedia, Hypertrophy 1 (2%)
Thyroid Gland (46) (47) (49) (46)
Necrosis 1 (2%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (39) (44) (42) (35)
Cyst 1 (2%)
Inflammation, Chronic Active 1 (3%) 1 (2%)
Ovary (47) (46) (47) (48)
Angiectasis 1 (2%) 2 (4%)
Cyst 10 (21%) 12 (26%) 8 (17%) 7 (15%)
Thrombosis 1 (2%)
Uterus (48) (49) (50) (50)
Angiectasis 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Hydrometra 27 (56%) 21 (43%) 25 (50%) 20 (40%)
Hyperplasia, Cystic 8 (17%) 9 (18%) 8 (16%) 10 (20%)
Inflammation, Suppurative 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (48) (50) (49)
Atrophy 1 (2%)
Necrosis 1 (2%)
Lymph Node (6) (10) (5) (10)
Bronchial, Hyperplasia, Lymphoid 1 (10%)
Mediastinal, Hyperplasia, Lymphoid 1 (10%) 1 (20%)
Pancreatic, Hyperplasia, Lymphoid 1 (10%)
Renal, Hyperplasia, Lymphoid 1 (10%)
Lymph Node, Mandibular (33) (38) (37) (39)
Hyperplasia, Lymphoid 1 (3%) 1 (3%) 3 (8%)
Infiltration Cellular, Plasma Cell 1 (3%) 1 (3%) 2 (5%)
Infiltration Cellular, Histiocyte 3 (8%)
Lymph Node, Mesenteric (47) (44) (42) (45)
Hemorrhage 1 (2%) 3 (7%)
Hyperplasia, Lymphoid 3 (6%) 1 (2%) 3 (7%)
Infiltration Cellular, Plasma Cell 1 (2%) 1 (2%) 2 (4%)
Infiltration Cellular, Histiocyte 23 (52%) 35 (83%) 25 (56%)
Spleen (47) (48) (47) (46)
Congestion 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 10 (21%) 19 (40%) 15 (32%) 18 (39%)
Hyperplasia, Lymphoid 1 (2%) 3 (6%)
Infiltration Cellular, Histiocyte 3 (6%) 12 (26%) 28 (61%)
Metaplasia, Osseous 2 (4%)
Thymus (43) (38) (43) (36)
Hyperplasia, Lymphoid 1 (2%)
Necrosis 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Edema 1 (2%)
Inflammation, Chronic Active 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Subcutaneous Tissue, Necrosis, Fatty 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Fibrous Osteodystrophy 4 (8%) 1 (2%) 5 (10%) 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM - CONT
Skeletal Muscle (2) (2)
Degeneration 1 (50%)
Mineralization 1 (50%)
Artery, Inflammation, Chronic Active 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49) (50) (50)
Artery, Inflammation, Chronic Active 1 (2%)
Meninges, Infiltration Cellular, Mononuclear
Cell 1 (2%)
Meninges, Inflammation, Chronic 1 (2%)
Peripheral Nerve (1)
Infiltration Cellular, Mast Cell 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Thrombosis 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 5 (10%) 3 (6%) 1 (2%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 2 (4%) 2 (4%)
Mediastinum, Inflammation, Acute 1 (2%)
Nose (50) (50) (50) (50)
Inflammation, Suppurative 2 (4%) 2 (4%) 2 (4%)
Olfactory Epithelium, Atrophy 1 (2%) 1 (2%) 1 (2%)
Olfactory Epithelium, Metaplasia 2 (4%) 1 (2%)
Trachea (46) (48) (46) (48)
Metaplasia, Squamous 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2)
Degeneration 1 (100%)
Cornea, Inflammation, Acute 1 (50%)
Cornea, Inflammation, Chronic 1 (50%)
Harderian Gland (48) (41) (50) (46)
Atrophy 1 (2%) 1 (2%)
Hyperplasia 3 (6%) 3 (7%) 2 (4%) 4 (9%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (49) (48) (46)
Cyst 1 (2%)
Hydronephrosis 1 (2%)
Infarct 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Metaplasia, Osseous 3 (7%)
Mineralization 3 (6%) 2 (4%) 1 (2%) 1 (2%)
Nephropathy 19 (40%) 17 (35%) 22 (46%) 27 (59%)
Artery, Inflammation, Chronic Active 1 (2%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%)
Renal Tubule, Vacuolization Cytoplasmic 1 (2%)
Urinary Bladder (43) (46) (47) (46)
Artery, Inflammation, Chronic Active 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 4 5 8 15
Moribund Sacrifice 7 4 4 3
Dosing Accident 1 2
Survivors
Terminal Sacrifice 39 40 38 30
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50)
Hyperplasia, Squamous 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%)
Gallbladder (40) (38) (39) (34)
Cyst 1 (3%) 1 (3%)
Degeneration, Hyaline 3 (8%) 1 (3%) 1 (3%)
Inflammation, Chronic Active 1 (3%)
Epithelium, Hyperplasia 1 (3%)
Intestine Large, Colon (50) (47) (47) (42)
Necrosis 1 (2%)
Intestine Large, Rectum (49) (47) (46) (44)
Infiltration Cellular, Histiocyte 6 (14%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%) 8 (18%)
Metaplasia, Squamous 5 (11%)
Myxomatous Change 13 (30%)
Necrosis 5 (11%)
Intestine Large, Cecum (49) (47) (46) (39)
Inflammation, Chronic Active 2 (5%)
Necrosis 1 (3%)
Intestine Small, Jejunum (47) (47) (44) (38)
Hyperplasia, Lymphoid 1 (3%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Intestine Small, Ileum (46) (47) (43) (38)
Inflammation, Acute 1 (3%)
Liver (50) (50) (50) (50)
Basophilic Focus 14 (28%) 10 (20%) 5 (10%) 10 (20%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Clear Cell Focus 21 (42%) 23 (46%) 19 (38%) 15 (30%)
Eosinophilic Focus 13 (26%) 11 (22%) 9 (18%) 12 (24%)
Fatty Change 9 (18%) 12 (24%) 8 (16%) 13 (26%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Infarct 1 (2%)
Inflammation, Chronic 11 (22%) 15 (30%) 23 (46%) 33 (66%)
Mineralization 1 (2%)
Necrosis 2 (4%) 2 (4%) 2 (4%) 5 (10%)
Tension Lipidosis 2 (4%) 2 (4%) 2 (4%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Bile Duct, Cyst 1 (2%)
Centrilobular, Degeneration 1 (2%) 3 (6%) 4 (8%)
Mesentery (10) (4) (20) (10)
Mineralization 1 (10%)
Fat, Necrosis 10 (100%) 3 (75%) 19 (95%) 10 (100%)
Pancreas (50) (50) (49) (50)
Atrophy 1 (2%) 1 (2%) 1 (2%)
Cyst 1 (2%)
Artery, Inflammation 1 (2%)
Stomach, Forestomach (49) (50) (50) (50)
Hyperplasia, Squamous 6 (12%) 2 (4%) 3 (6%)
Inflammation, Acute 1 (2%) 1 (2%)
Ulcer 1 (2%) 1 (2%)
Stomach, Glandular (49) (49) (48) (46)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%)
Necrosis 1 (2%) 1 (2%)
Tooth (33) (27) (30) (23)
Inflammation, Chronic Active 6 (18%) 6 (22%) 5 (17%) 6 (26%)
Malformation 29 (88%) 22 (81%) 27 (90%) 20 (87%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1)
Angiectasis 1 (100%)
Thrombosis 1 (100%)
Heart (50) (50) (50) (50)
Cardiomyopathy 3 (6%) 1 (2%) 2 (4%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%) 1 (2%) 2 (4%)
Artery, Inflammation, Chronic Active 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (49)
Hyperplasia 5 (10%) 8 (16%) 8 (16%) 13 (27%)
Hypertrophy 27 (54%) 27 (54%) 23 (46%) 15 (31%)
Adrenal Medulla (50) (50) (50) (49)
Hyperplasia 3 (6%) 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Pituitary Gland (47) (48) (49) (48)
Pars Distalis, Hyperplasia 3 (6%) 2 (4%)
Thyroid Gland (48) (49) (50) (49)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (49) (50) (49) (50)
Ectasia 3 (6%) 3 (6%) 5 (10%) 3 (6%)
Infiltration Cellular, Histiocyte 1 (2%)
Inflammation, Chronic Active 1 (2%) 2 (4%) 2 (4%) 3 (6%)
Prostate, NOS (50) (49) (50) (50)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Seminal Vesicle (50) (50) (50) (49)
Congestion 1 (2%)
Dilatation 5 (10%)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Inflammation, Suppurative 1 (2%)
Testes (50) (50) (49) (50)
Atrophy 1 (2%)
Germinal Epithelium, Degeneration 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (49) (50)
Angiectasis 1 (2%) 1 (2%)
Lymph Node (1) (1) (1) (1)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mediastinal, Infiltration Cellular,
Histiocyte 1 (100%)
Lymph Node, Mesenteric (48) (46) (45) (41)
Angiectasis 3 (6%) 3 (7%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%)
Infiltration Cellular, Histiocyte 15 (33%) 34 (76%) 37 (90%)
Spleen (49) (50) (49) (49)
Amyloid Deposition 1 (2%)
Hematopoietic Cell Proliferation 10 (20%) 8 (16%) 15 (31%) 15 (31%)
Infiltration Cellular, Mast Cell 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 23 (47%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (49) (50) (50) (50)
Inflammation, Chronic Active 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Mineralization 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (6%) 7 (14%) 4 (8%) 4 (8%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 2 (4%)
Mediastinum, Hemorrhage 1 (2%)
Mediastinum, Inflammation, Acute 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ELMIRON Date: 09/26/01
Route: GAVAGE Time: 14:40:32
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Nose (50) (50) (50) (47)
Inflammation, Suppurative 5 (10%) 11 (22%) 2 (4%)
Polyp, Inflammatory 1 (2%)
Glands, Degeneration, Hyaline 1 (2%)
Olfactory Epithelium, Atrophy 3 (6%) 1 (2%)
Olfactory Epithelium, Hyperplasia 1 (2%)
Olfactory Epithelium, Metaplasia 3 (6%) 1 (2%) 1 (2%)
Sinus, Inflammation, Chronic Active 1 (2%)
Trachea (50) (50) (49) (50)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (1)
Cornea, Inflammation, Chronic 1 (100%) 2 (100%)
Harderian Gland (49) (48) (49) (48)
Atrophy 1 (2%) 1 (2%)
Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (49)
Cyst 3 (6%) 1 (2%)
Hydronephrosis 1 (2%) 1 (2%)
Infarct 1 (2%) 3 (6%) 4 (8%)
Infiltration Cellular, Mast Cell 1 (2%)
Inflammation, Suppurative 3 (6%) 3 (6%) 1 (2%)
Metaplasia, Osseous 1 (2%) 1 (2%)
Mineralization 1 (2%)
Nephropathy 43 (86%) 41 (82%) 47 (94%) 41 (84%)
Papilla, Necrosis 1 (2%)
Renal Tubule, Hyperplasia 2 (4%)
Urinary Bladder (50) (49) (49) (49)
Artery, Inflammation, Chronic Active 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
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