TDMS Study 05002-06 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
GAMMA-BUTYROLACTONE
NTP Experiment-Test: 05002-06 Report: PEIRPT03
Study Type: CHRONIC Date: 09/02/94
Route: GAVAGE Time: 19:42:04
Facility: Southern Research Institute
Chemical CAS #: 96-48-0
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: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund 8 11 9
Dead 4 5 3
Survivors
Terminal Sacrifice 38 34 38
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (47) (47)
Dilatation 1 (2%)
Inflammation, Chronic 3 (6%) 1 (2%)
Intestine Large, Cecum (48) (48)
Edema 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Ileum (48) (1) (49)
Hyperplasia, Lymphoid 1 (2%) 1 (100%) 2 (4%)
Intestine Small, Jejunum (49) (49)
Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50) (50)
Basophilic Focus 1 (2%)
Cyst 1 (2%)
Eosinophilic Focus 1 (2%)
Focal Cellular Change 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%)
Inflammation, Chronic 14 (28%) 7 (14%) 6 (12%)
Mineralization 1 (2%) 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 8 (16%) 2 (4%) 2 (4%)
Kupffer Cell, Hyperplasia 1 (2%) 8 (16%) 3 (6%)
Kupffer Cell, Pigmentation 1 (2%)
Lobules, Necrosis 1 (2%) 3 (6%) 3 (6%)
Mesentery (3) (5) (5)
Accessory Spleen 1 (33%)
Cyst 1 (20%)
Inflammation, Suppurative 1 (20%) 1 (20%)
Fat, Inflammation, Granulomatous 1 (33%)
Fat, Necrosis 2 (67%) 1 (20%) 1 (20%)
Pancreas (50) (50) (48)
Atrophy 1 (2%) 4 (8%)
Cyst 1 (2%) 1 (2%)
Hyperplasia, Nodular 1 (2%)
Inflammation, Chronic 7 (14%) 3 (6%) 5 (10%)
Necrosis 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Pigmentation 2 (4%)
Salivary Glands (50) (50)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic 7 (14%) 10 (20%)
Stomach, Forestomach (50) (49) (50)
Diverticulum 1 (2%) 1 (2%) 4 (8%)
Inflammation, Chronic 1 (2%)
Mucosa, Dysplasia 1 (2%)
Mucosa, Hyperplasia 10 (20%) 2 (4%) 7 (14%)
Stomach, Glandular (50) (50) (50)
Cyst 1 (2%) 1 (2%)
Dysplasia 1 (2%)
Erosion 1 (2%) 2 (4%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Mineralization 2 (4%) 3 (6%)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50)
Myocardium, Mineralization 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (1) (50)
Accessory Adrenal Cortical Nodule 1 (2%) 2 (4%)
Angiectasis 1 (100%)
Cyst 1 (2%)
Developmental Malformation 2 (4%)
Inflammation, Chronic 1 (2%)
Spindle Cell, Hyperplasia 43 (86%) 46 (92%)
Zona Fasciculata, Hyperplasia, Focal 1 (2%)
Adrenal Gland, Medulla (50) (49)
Hyperplasia 3 (6%) 1 (2%)
Islets, Pancreatic (50) (49) (47)
Amyloid Deposition 1 (2%)
Hyperplasia 5 (10%) 4 (8%) 6 (13%)
Inflammation, Chronic 1 (2%)
Parathyroid Gland (47) (47)
Cyst 1 (2%)
Pituitary Gland (48) (48) (43)
Pars Distalis, Angiectasis 4 (8%) 5 (10%) 2 (5%)
Pars Distalis, Cyst 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia 13 (27%) 12 (25%) 7 (16%)
Thyroid Gland (49) (48) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Cyst 2 (4%) 9 (19%) 1 (2%)
Inflammation, Chronic 3 (6%) 2 (4%) 1 (2%)
Follicular Cell, Hyperplasia 5 (10%) 7 (15%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (1)
Ectasia 1 (100%)
Inflammation, Chronic 1 (100%)
Ovary (48) (49) (46)
Cyst 11 (23%) 14 (29%) 14 (30%)
Hemorrhage 2 (4%) 5 (10%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Suppurative 6 (12%) 1 (2%)
Uterus (50) (41) (50)
Angiectasis 1 (2%)
Exudate 8 (16%) 14 (34%) 3 (6%)
Hemorrhage 2 (4%)
Hydrometra 9 (18%) 4 (10%) 5 (10%)
Hyperplasia, Cystic 46 (92%) 37 (90%) 48 (96%)
Hyperplasia, Glandular 2 (5%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Metaplasia, Squamous 1 (2%) 2 (5%) 2 (4%)
Serosa, Cyst 1 (2%)
Vagina (2) (1)
Granuloma 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (1) (1)
Anemia 1 (100%) 1 (100%)
Leukocytosis 1 (100%) 1 (100%)
Bone Marrow (50) (50) (50)
Myelofibrosis 41 (82%) 41 (82%) 42 (84%)
Necrosis 1 (2%)
Proliferation 1 (2%) 6 (12%) 2 (4%)
Lymph Node (50) (6) (49)
Iliac, Angiectasis 1 (2%)
Iliac, Hyperplasia, Lymphoid 1 (2%)
Iliac, Hyperplasia, Plasma Cell 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Iliac, Infiltration Cellular,
Polymorphonuclear 1 (2%)
Inguinal, Hyperplasia, Lymphoid 1 (2%)
Renal, Hyperplasia, Lymphoid 1 (2%)
Renal, Hyperplasia, Plasma Cell 1 (17%) 1 (2%)
Lymph Node, Mandibular (47) (1) (45)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mesenteric (49) (5) (43)
Ectasia 1 (20%)
Hemorrhage 2 (4%) 2 (5%)
Hyperplasia, Reticulum Cell 1 (20%)
Spleen (50) (14) (50)
Angiectasis 1 (2%)
Developmental Malformation 1 (2%)
Hematopoietic Cell Proliferation 6 (12%) 7 (50%) 8 (16%)
Hyperplasia, Lymphoid 3 (6%) 2 (14%) 5 (10%)
Lymphoid Follicle, Depletion Cellular 2 (4%) 1 (2%)
Red Pulp, Depletion Cellular 2 (4%)
Sinusoid, Hyperplasia 1 (2%)
Thymus (47) (2) (44)
Cyst 1 (2%)
Hyperplasia, Lymphoid 1 (50%) 2 (5%)
Epithelial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (48) (50)
Hyperplasia, Cystic 17 (34%) 19 (40%) 18 (36%)
Hyperplasia, Lobular 2 (4%) 2 (4%)
Infiltration Cellular, Histiocyte 1 (2%)
Inflammation, Chronic 1 (2%)
Skin (50) (47) (50)
Acanthosis 3 (6%) 1 (2%) 3 (6%)
Cyst Epithelial Inclusion 1 (2%)
Fibrosis 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Ulcer 1 (2%)
Sebaceous Gland, Hyperplasia 1 (2%)
Subcutaneous Tissue, Edema 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Coccygeal, Fibrosis 1 (2%)
Coccygeal, Hyperplasia 1 (2%)
Skeletal Muscle (1) (4)
Inflammation, Suppurative 1 (25%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Compression 2 (4%)
Hemorrhage 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 36 (72%) 28 (56%) 31 (62%)
Necrosis 1 (2%)
Pigmentation 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Spinal Cord (1)
Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Congestion 1 (2%) 2 (4%)
Hemorrhage 1 (2%) 1 (2%) 3 (6%)
Infiltration Cellular, Histiocyte 4 (8%) 3 (6%) 2 (4%)
Inflammation, Chronic 6 (12%) 10 (20%) 7 (14%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Mineralization 2 (4%) 1 (2%)
Thrombosis 2 (4%)
Alveolar Epithelium, Hyperplasia 2 (4%)
Mediastinum, Necrosis 2 (4%)
Nose (50) (50)
Exudate 2 (4%) 3 (6%)
Fungus 1 (2%)
Trachea (50) (50)
Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2)
Cataract 1 (100%) 1 (50%)
Exudate 1 (50%)
Cornea, Hyperplasia 1 (100%) 1 (50%)
Cornea, Inflammation, Chronic 1 (100%) 2 (100%)
Cornea, Mineralization 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Casts Protein 9 (18%) 15 (30%) 2 (4%)
Cyst 2 (4%) 2 (4%) 1 (2%)
Glomerulosclerosis 2 (4%) 1 (2%)
Infarct 2 (4%)
Inflammation, Chronic 28 (56%) 26 (52%) 24 (48%)
Metaplasia, Osseous 3 (6%) 1 (2%) 2 (4%)
Mineralization 1 (2%) 1 (2%) 2 (4%)
Renal Tubule, Atrophy 5 (10%) 3 (6%) 5 (10%)
Renal Tubule, Dilatation 1 (2%) 1 (2%)
Renal Tubule, Necrosis 2 (4%) 1 (2%) 1 (2%)
Renal Tubule, Regeneration 2 (4%) 3 (6%) 7 (14%)
Urinary Bladder (50) (1) (49)
Inflammation, Chronic 35 (70%) 29 (59%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund 13 8 23
Dead 2 12 12
Accident 1
Natural Death 1
Moribund Sacrifice 1
Survivors
Terminal Sacrifice 35 30 12
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (46) (50) (47)
Ulcer 1 (2%)
Gallbladder (42) (41) (43)
Ectopic Tissue 1 (2%)
Fibrosis 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%)
Intestine Large, Cecum (47) (42) (45)
Edema 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Mucosa, Hyperplasia 1 (2%)
Intestine Large, Rectum (49) (49) (47)
Inflammation, Suppurative 1 (2%)
Intestine Small, Duodenum (49) (49) (46)
Ulcer 1 (2%)
Intestine Small, Ileum (46) (44) (44)
Hyperplasia, Lymphoid 3 (7%)
Intestine Small, Jejunum (47) (45) (45)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%)
Liver (50) (50) (50)
Angiectasis 1 (2%)
Basophilic Focus 1 (2%) 1 (2%)
Clear Cell Focus 2 (4%)
Cyst 2 (4%)
Ectopic Tissue 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Inflammation, Chronic 4 (8%) 1 (2%)
Mineralization 4 (8%)
Hepatocyte, Anisokaryosis 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hepatocyte, Atrophy 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 1 (2%) 1 (2%) 1 (2%)
Kupffer Cell, Hyperplasia 1 (2%) 2 (4%) 1 (2%)
Kupffer Cell, Pigmentation 1 (2%)
Lobules, Necrosis 6 (12%) 6 (12%) 6 (12%)
Mesentery (3) (3) (7)
Artery, Hypertrophy 2 (29%)
Artery, Inflammation, Chronic Active 2 (67%) 1 (14%)
Fat, Hemorrhage 1 (33%)
Fat, Inflammation, Chronic 1 (14%)
Fat, Inflammation, Suppurative 1 (14%)
Fat, Mineralization 1 (33%)
Fat, Necrosis 2 (67%) 1 (33%) 2 (29%)
Pancreas (50) (49) (49)
Amyloid Deposition 1 (2%)
Atrophy 2 (4%) 1 (2%)
Cyst 1 (2%) 1 (2%)
Fibrosis 2 (4%)
Necrosis 1 (2%) 1 (2%)
Salivary Glands (48) (50) (48)
Atrophy 1 (2%)
Inflammation, Chronic 9 (19%) 9 (18%) 2 (4%)
Stomach, Forestomach (50) (49) (49)
Diverticulum 2 (4%) 4 (8%) 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%)
Mucosa, Hyperplasia 2 (4%) 5 (10%)
Stomach, Glandular (50) (49) (49)
Cyst 1 (2%) 2 (4%)
Erosion 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Mineralization 3 (6%) 2 (4%)
Ulcer 1 (2%)
Mucosa, Hyperplasia 1 (2%) 1 (2%)
Tongue (1) (2)
Necrosis 1 (50%)
Tooth (10) (5) (3)
Dysplasia 8 (80%) 4 (80%) 3 (100%)
Inflammation, Chronic 1 (33%)
Inflammation, Suppurative 2 (20%) 3 (60%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
Artery, Hypertrophy 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Myocardium, Degeneration 1 (2%)
Myocardium, Fibrosis 1 (2%)
Myocardium, Inflammation, Chronic 1 (2%) 1 (2%)
Myocardium, Karyomegaly 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (48) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%) 2 (4%)
Basophilic Focus 1 (2%)
Cyst 1 (2%)
Developmental Malformation 1 (2%) 2 (4%) 2 (4%)
Hyperplasia, Focal 1 (2%)
Hypertrophy, Focal 3 (6%) 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Spindle Cell, Hyperplasia 18 (38%) 10 (20%) 8 (16%)
Adrenal Gland, Medulla (48) (50) (50)
Cyst 1 (2%)
Hyperplasia 2 (4%) 9 (18%) 4 (8%)
Infiltration Cellular, Mononuclear Cell 1 (2%)
Islets, Pancreatic (50) (49) (48)
Hyperplasia 14 (28%) 8 (16%) 2 (4%)
Parathyroid Gland (45) (48) (43)
Cyst 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (43) (48) (43)
Pars Distalis, Cyst 3 (7%) 5 (10%) 2 (5%)
Pars Distalis, Hyperplasia 2 (5%)
Thyroid Gland (49) (50) (48)
Cyst 5 (10%) 3 (6%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 3 (6%) 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (49)
Atypia Cellular 1 (2%)
Ectasia 1 (2%)
Fibrosis 1 (2%)
Granuloma Sperm 2 (4%)
Inflammation, Chronic 1 (2%) 1 (2%)
Penis (1) (1) (2)
Inflammation, Chronic Active 1 (50%)
Preputial Gland (18) (20) (17)
Atrophy 1 (6%)
Ectasia 9 (50%) 9 (45%) 7 (41%)
Inflammation, Chronic 11 (61%) 16 (80%) 13 (76%)
Inflammation, Suppurative 4 (22%) 5 (25%) 6 (35%)
Prostate (49) (48) (48)
Fibrosis 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%) 5 (10%) 8 (17%)
Epithelium, Hyperplasia 1 (2%)
Seminal Vesicle (8) (5) (9)
Dilatation 1 (20%)
Fibrosis 2 (25%) 2 (40%) 4 (44%)
Inflammation, Chronic 2 (25%) 1 (11%)
Inflammation, Suppurative 1 (13%) 2 (40%)
Testes (50) (50) (50)
Fibrosis 1 (2%) 1 (2%) 1 (2%)
Granuloma Sperm 1 (2%)
Mineralization 5 (10%) 9 (18%) 5 (10%)
Spermatocele 1 (2%)
Seminiferous Tubule, Atrophy 4 (8%) 8 (16%) 4 (8%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (7) (2) (1)
Anemia 1 (14%) 1 (50%)
Bone Marrow (50) (50) (49)
Angiectasis 1 (2%) 1 (2%)
Hyperplasia, Reticulum Cell 1 (2%)
Myelofibrosis 1 (2%) 2 (4%)
Necrosis 1 (2%)
Proliferation 6 (12%) 12 (24%) 8 (16%)
Lymph Node (50) (50) (49)
Iliac, Hyperplasia, Lymphoid 1 (2%)
Iliac, Hyperplasia, Plasma Cell 2 (4%)
Inguinal, Hyperplasia, Histiocytic 4 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Inguinal, Hyperplasia, Lymphoid 5 (10%) 5 (10%)
Inguinal, Hyperplasia, Plasma Cell 4 (8%) 2 (4%)
Mediastinal, Hemorrhage 1 (2%)
Mediastinal, Inflammation, Suppurative 1 (2%)
Renal, Hyperplasia, Lymphoid 1 (2%)
Renal, Hyperplasia, Plasma Cell 1 (2%)
Lymph Node, Mandibular (45) (46) (46)
Depletion Cellular 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Lymphatic, Dilatation 1 (2%)
Lymph Node, Mesenteric (48) (46) (41)
Depletion Cellular 3 (7%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 11 (23%) 7 (15%) 5 (12%)
Hyperplasia, Lymphoid 3 (6%) 1 (2%)
Infiltration Cellular, Megakaryocyte 1 (2%)
Necrosis 1 (2%)
Spleen (50) (50) (48)
Erythrophagocytosis 1 (2%)
Hematopoietic Cell Proliferation 14 (28%) 12 (24%) 18 (38%)
Hyperplasia, Lymphoid 5 (10%) 2 (4%)
Hyperplasia, Re Cell 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Lymphoid Follicle, Depletion Cellular 2 (4%) 3 (6%) 8 (17%)
Red Pulp, Depletion Cellular 1 (2%) 1 (2%)
Thymus (42) (39) (38)
Cyst 2 (5%) 2 (5%) 1 (3%)
Depletion Cellular 5 (13%) 6 (16%)
Epithelial Cell, Hyperplasia 4 (10%) 4 (11%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50)
Acanthosis 12 (24%) 36 (72%) 39 (78%)
Cyst Epithelial Inclusion 1 (2%)
Dysplasia 1 (2%)
Exudate 1 (2%) 4 (8%) 5 (10%)
Fibrosis 1 (2%) 3 (6%)
Hemorrhage 2 (4%)
Hyperkeratosis 1 (2%)
Hyperplasia, Pseudoepitheliomatous 2 (4%) 2 (4%)
Inflammation, Chronic 4 (8%) 17 (34%) 19 (38%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Pigmentation 3 (6%) 12 (24%) 19 (38%)
Ulcer 4 (8%) 15 (30%) 17 (34%)
Hair Follicle, Atrophy 1 (2%) 11 (22%) 16 (32%)
Lymphatic, Dilatation 1 (2%)
Subcutaneous Tissue, Edema 3 (6%) 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Hyperostosis 1 (2%) 1 (2%) 2 (4%)
Inflammation, Chronic 1 (2%)
Coccygeal, Hyperplasia 6 (12%) 1 (2%)
Coccygeal, Inflammation, Chronic 3 (6%) 1 (2%)
Coccygeal, Inflammation, Suppurative 2 (4%)
Tarsal, Hyperplasia 1 (2%) 8 (16%)
Tarsal, Inflammation, Chronic 3 (6%)
Tarsal, Inflammation, Suppurative 1 (2%)
Skeletal Muscle (1) (4) (2)
Fibrosis 1 (50%)
Inflammation, Chronic 1 (25%)
Necrosis 2 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (49)
Congestion 3 (6%)
Cyst 1 (2%)
Mineralization 27 (54%) 25 (50%) 24 (49%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Congestion 1 (2%) 1 (2%) 4 (8%)
Hemorrhage 1 (2%) 7 (14%)
Infiltration Cellular, Histiocyte 3 (6%) 2 (4%) 1 (2%)
Inflammation, Chronic 4 (8%)
Inflammation, Suppurative 1 (2%)
Leukocytosis 1 (2%) 2 (4%) 5 (10%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%)
Perivascular, Edema 2 (4%)
Nose (50) (50) (49)
Exudate 4 (8%) 4 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Foreign Body 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (1)
Cataract 1 (33%)
Cornea, Hyperplasia 1 (33%)
Cornea, Inflammation, Chronic 1 (33%)
Cornea, Inflammation, Granulomatous 1 (33%)
Harderian Gland (9) (48)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Amyloid Deposition 1 (2%)
Bacterium 1 (2%)
Casts Protein 4 (8%) 3 (6%) 2 (4%)
Cyst 4 (8%) 10 (20%) 7 (14%)
Glomerulosclerosis 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hydronephrosis 2 (4%) 2 (4%)
Infarct 2 (4%)
Inflammation, Chronic 21 (42%) 14 (28%) 5 (10%)
Inflammation, Suppurative 1 (2%) 3 (6%) 2 (4%)
Metaplasia, Osseous 1 (2%) 2 (4%)
Mineralization 3 (6%) 5 (10%) 4 (8%)
Glomerulus, Hyperplasia 1 (2%)
Glomerulus, Necrosis 1 (2%)
Renal Tubule, Atrophy 3 (6%) 5 (10%) 8 (16%)
Renal Tubule, Dilatation 2 (4%) 3 (6%)
Renal Tubule, Dysplasia 1 (2%)
Renal Tubule, Necrosis 1 (2%) 1 (2%) 1 (2%)
Renal Tubule, Regeneration 25 (50%) 26 (52%) 24 (48%)
Renal Tubule, Vacuolization Cytoplasmic 2 (4%)
Urethra (1) (4) (3)
Concretion 1 (25%)
Hemorrhage 1 (100%)
Inflammation, Suppurative 3 (75%) 3 (100%)
Necrosis 1 (25%)
Bulbourethral Gland, Hyperplasia 1 (25%)
Mucosa, Hyperplasia 1 (25%) 1 (33%)
Urinary Bladder (50) (48) (48)
Congestion 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05002-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 19:42:04
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 262. 525.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Edema 1 (2%)
Inflammation, Chronic 2 (4%) 3 (6%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Mucosa, Hyperplasia 2 (4%) 1 (2%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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