TDMS Study 05002-05 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
GAMMA-BUTYROLACTONE
NTP Experiment-Test: 05002-05 Report: PEIRPT03
Study Type: CHRONIC Date: 09/02/94
Route: GAVAGE Time: 17:49:23
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: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund 19 16 14
Dead 3 7 6
Dosing Accident 2
Survivors
Terminal Sacrifice 28 26 28
Dead 1
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (24) (50)
Serosa, Inflammation, Chronic 1 (2%)
Intestine Large, Colon (48) (20) (49)
Infiltration Cellular, Lipocyte 1 (2%)
Parasite Metazoan 6 (13%) 2 (10%) 7 (14%)
Intestine Large, Rectum (48) (20) (43)
Parasite Metazoan 1 (2%)
Intestine Small, Ileum (47) (20) (45)
Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50) (50)
Angiectasis 1 (2%) 1 (2%)
Basophilic Focus 1 (2%) 1 (2%)
Basophilic Focus, Multiple 35 (70%) 40 (80%) 32 (64%)
Clear Cell Focus 2 (4%)
Cyst 1 (2%)
Eosinophilic Focus 1 (2%) 3 (6%) 1 (2%)
Eosinophilic Focus, Multiple 2 (4%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 1 (2%)
Hepatodiaphragmatic Nodule 4 (8%) 5 (10%) 6 (12%)
Hyperplasia, Nodular 4 (8%) 4 (8%) 3 (6%)
Inflammation, Granulomatous, Multiple 5 (10%) 9 (18%) 10 (20%)
Mixed Cell Focus 1 (2%) 2 (4%) 4 (8%)
Necrosis, Focal 1 (2%) 1 (2%)
Vacuolization Cytoplasmic 4 (8%) 2 (4%) 1 (2%)
Bile Duct, Dilatation 1 (2%)
Bile Duct, Hyperplasia 14 (28%) 15 (30%) 10 (20%)
Centrilobular, Necrosis, Multiple 1 (2%)
Serosa, Hemorrhage 1 (2%)
Serosa, Inflammation, Suppurative 1 (2%)
Mesentery (5) (3) (4)
Fat, Inflammation, Chronic 3 (60%) 1 (33%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Inflammation, Focal, Granulomatous 1 (25%)
Fat, Necrosis, Focal 4 (80%) 2 (67%) 2 (50%)
Pancreas (49) (24) (50)
Polyarteritis, Multiple 1 (4%)
Acinar Cell, Atrophy 5 (10%) 4 (17%) 6 (12%)
Acinar Cell, Hyperplasia 2 (4%) 5 (10%)
Acinar Cell, Hyperplasia, Multiple 1 (2%)
Duct, Cyst 1 (2%)
Stomach (49) (24) (50)
Forestomach, Edema 1 (2%) 2 (8%) 2 (4%)
Forestomach, Inflammation, Chronic 1 (2%) 1 (2%)
Forestomach, Ulcer 1 (2%) 2 (8%) 3 (6%)
Forestomach, Ulcer, Multiple 2 (4%)
Glandular, Cyst, Multiple 1 (2%)
Glandular, Mineralization 1 (4%) 4 (8%)
Glandular, Epithelium, Hyperplasia 1 (2%)
Tongue (1)
Hyperplasia, Squamous 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1)
Aorta, Media, Hypertrophy 1 (100%)
Heart (50) (25) (50)
Congestion 1 (2%)
Fibrosis, Focal 1 (4%)
Fibrosis, Multiple 1 (4%) 1 (2%)
Inflammation, Chronic 35 (70%) 13 (52%) 29 (58%)
Atrium, Congestion 1 (2%)
Atrium, Thrombosis 1 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (25) (50)
Accessory Adrenal Cortical Nodule 4 (8%) 4 (16%) 2 (4%)
Angiectasis 1 (2%)
Congestion 1 (2%)
Degeneration, Cystic 4 (8%) 2 (4%)
Hematopoietic Cell Proliferation 1 (2%)
Hypertrophy, Focal 3 (6%) 3 (12%) 6 (12%)
Vacuolization Cytoplasmic 5 (10%) 3 (12%) 3 (6%)
Adrenal Gland, Medulla (50) (25) (49)
Angiectasis 1 (2%)
Congestion 1 (2%)
Hyperplasia, Focal 4 (8%) 1 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pituitary Gland (49) (37) (48)
Cyst 1 (2%)
Cyst, Multiple 2 (4%)
Pars Distalis, Angiectasis 4 (8%) 9 (24%) 4 (8%)
Pars Distalis, Cyst 9 (18%) 6 (16%) 5 (10%)
Pars Distalis, Cyst, Multiple 16 (33%) 7 (19%) 6 (13%)
Pars Distalis, Hemorrhage 3 (8%)
Pars Distalis, Hyperplasia, Focal 7 (14%) 7 (19%) 6 (13%)
Pars Distalis, Inflammation, Focal,
Granulomatous 1 (2%)
Thyroid Gland (50) (27) (50)
Angiectasis 1 (4%)
Degeneration, Cystic 1 (4%)
Ultimobranchial Cyst 2 (4%)
C-Cell, Hyperplasia 10 (20%) 2 (7%) 3 (6%)
Follicle, Cyst 1 (2%)
Follicular Cell, Hyperplasia 1 (2%) 1 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (22) (46)
Atrophy 1 (5%) 1 (2%)
Fibrosis 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 2 (4%) 1 (5%)
Inflammation, Suppurative 4 (8%) 2 (9%) 3 (7%)
Metaplasia, Squamous 1 (2%)
Necrosis 1 (2%)
Duct, Cyst 19 (40%) 4 (18%) 11 (24%)
Ovary (50) (24) (50)
Cyst 5 (10%) 3 (6%)
Hyperplasia, Tubular 1 (2%)
Uterus (50) (32) (50)
Decidual Reaction 1 (2%) 1 (2%)
Dilatation 4 (8%) 1 (3%) 2 (4%)
Inflammation, Suppurative 1 (2%)
Cervix, Cyst 2 (4%) 1 (3%)
Endometrium, Fibrosis 1 (2%)
Endometrium, Fibrosis, Focal 1 (2%)
Endometrium, Hyperplasia, Cystic 6 (12%) 3 (9%) 7 (14%)
Endometrium, Hyperplasia, Glandular 1 (3%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Vagina (2) (4)
Cyst 1 (50%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (24) (50)
Hyperplasia, Reticulum Cell 2 (4%)
Myelofibrosis 3 (6%) 1 (2%)
Myeloid Cell, Hyperplasia 1 (2%) 1 (4%)
Lymph Node (50) (26) (50)
Mediastinal, Hyperplasia, Lymphoid 1 (4%)
Pancreatic, Inflammation, Granulomatous 1 (2%)
Lymph Node, Mandibular (49) (23) (50)
Hyperplasia, Lymphoid 1 (2%) 1 (4%) 1 (2%)
Lymph Node, Mesenteric (49) (24) (49)
Depletion Lymphoid 1 (2%) 1 (4%)
Hyperplasia, Lymphoid 1 (2%) 1 (4%)
Pigmentation 1 (2%) 1 (4%)
Spleen (48) (49) (50)
Atrophy 2 (4%) 1 (2%)
Fibrosis 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 3 (6%) 8 (16%) 3 (6%)
Necrosis 1 (2%)
Pigmentation 7 (15%) 9 (18%) 3 (6%)
Thymus (48) (21) (47)
Atrophy 1 (5%)
Cyst, Multiple 2 (4%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Mediastinum, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50)
Hyperplasia, Lobular 6 (12%) 7 (14%) 3 (6%)
Duct, Cyst 42 (84%) 35 (70%) 23 (46%)
Skin (50) (28) (50)
Cyst Epithelial Inclusion 1 (2%)
Hemorrhage 1 (2%)
Ulcer 1 (4%)
Subcutaneous Tissue, Thrombosis, Multiple 1 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (28) (50)
Calvarium, Hyperostosis 2 (4%) 4 (14%) 2 (4%)
Femur, Fracture 1 (2%)
Skeletal Muscle (2) (1)
Diaphragm, Inflammation, Chronic 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (24) (50)
Compression 5 (10%) 6 (25%) 1 (2%)
Hydrocephalus 1 (4%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (30) (50)
Congestion 2 (4%) 5 (17%) 6 (12%)
Hemorrhage 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (6%) 1 (2%)
Alveolus, Pigmentation 1 (3%) 2 (4%)
Bronchus, Foreign Body 1 (2%)
Lymphatic, Foreign Body 1 (2%) 2 (7%) 1 (2%)
Mediastinum, Edema 1 (2%)
Mediastinum, Foreign Body 1 (3%) 2 (4%)
Mediastinum, Hemorrhage 2 (4%)
Peribronchial, Infiltration Cellular,
Lymphocyte 1 (2%)
Nose (50) (24) (50)
Nasolacrimal Duct, Inflammation, Suppurative 2 (4%) 1 (2%)
Trachea (50) (24) (50)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (5)
Inflammation, Suppurative 1 (100%)
Eye (1) (1) (3)
Cataract 2 (67%)
Cataract, Multiple 1 (100%)
Cornea, Edema 1 (100%)
Retina, Degeneration 1 (100%) 1 (100%) 2 (67%)
Zymbal's Gland (2) (1)
Inflammation, Suppurative 1 (50%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (24) (49)
Fibrosis, Focal 1 (2%)
Infarct, Multiple 1 (2%)
Nephropathy, Chronic 23 (47%) 7 (29%) 19 (39%)
Cortex, Cyst 1 (2%)
Medulla, Cyst 1 (2%)
Renal Tubule, Degeneration 1 (4%)
Renal Tubule, Dilatation 1 (2%) 1 (2%)
Renal Tubule, Mineralization 10 (20%) 2 (8%) 19 (39%)
Renal Tubule, Pigmentation 4 (8%) 3 (6%)
Urinary Bladder (50) (24) (50)
Inflammation, Chronic, Focal 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Dead 6 7 3
Moribund 19 13 12
Dosing Accident 1 3 3
Survivors
Terminal Sacrifice 24 27 32
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (48) (17) (49)
Parasite Metazoan 1 (2%)
Intestine Large, Colon (47) (21) (50)
Fibrosis, Focal 1 (2%)
Parasite Metazoan 7 (15%) 1 (5%) 8 (16%)
Ulcer 1 (2%)
Intestine Large, Rectum (47) (19) (49)
Parasite Metazoan 2 (11%) 1 (2%)
Intestine Small, Ileum (46) (18) (49)
Hyperplasia, Lymphoid 2 (4%) 5 (10%)
Intestine Small, Jejunum (46) (17) (50)
Hyperplasia, Lymphoid 1 (2%)
Metaplasia, Osseous 1 (6%)
Liver (50) (50) (50)
Basophilic Focus 7 (14%) 2 (4%) 5 (10%)
Basophilic Focus, Multiple 13 (26%) 20 (40%) 18 (36%)
Clear Cell Focus 4 (8%) 2 (4%)
Clear Cell Focus, Multiple 3 (6%)
Congestion 1 (2%) 1 (2%)
Degeneration, Cystic 1 (2%) 1 (2%) 4 (8%)
Eosinophilic Focus 4 (8%) 1 (2%)
Eosinophilic Focus, Multiple 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 5 (10%) 4 (8%) 7 (14%)
Hyperplasia, Nodular 4 (8%) 4 (8%) 6 (12%)
Inflammation, Granulomatous, Multiple 1 (2%) 1 (2%) 3 (6%)
Mixed Cell Focus 3 (6%) 4 (8%)
Mixed Cell Focus, Multiple 1 (2%) 2 (4%)
Necrosis, Focal 1 (2%)
Vacuolization Cytoplasmic 6 (12%) 8 (16%) 11 (22%)
Bile Duct, Hyperplasia 45 (90%) 35 (70%) 38 (76%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Centrilobular, Degeneration 2 (4%) 1 (2%) 3 (6%)
Centrilobular, Necrosis 1 (2%) 1 (2%)
Mesentery (11) (10) (19)
Inflammation, Chronic 2 (20%)
Metaplasia, Osseous 1 (9%)
Polyarteritis 1 (5%)
Fat, Inflammation, Focal, Granulomatous 1 (10%) 2 (11%)
Fat, Mineralization, Focal 1 (9%) 1 (10%)
Fat, Necrosis, Focal 9 (82%) 9 (90%) 13 (68%)
Pancreas (50) (22) (50)
Polyarteritis 3 (6%) 6 (12%)
Acinar Cell, Atrophy 18 (36%) 7 (32%) 21 (42%)
Acinar Cell, Hyperplasia 2 (4%) 2 (9%) 4 (8%)
Acinar Cell, Hyperplasia, Multiple 1 (2%)
Pharynx (1)
Palate, Hyperplasia, Squamous 1 (100%)
Stomach (50) (29) (50)
Forestomach, Cyst 1 (3%)
Forestomach, Edema 1 (2%) 3 (10%) 1 (2%)
Forestomach, Fibrosis, Chronic 1 (3%)
Forestomach, Hyperkeratosis 1 (3%)
Forestomach, Inflammation, Chronic 2 (4%) 3 (10%) 1 (2%)
Forestomach, Mineralization 1 (2%)
Forestomach, Polyarteritis 1 (2%) 1 (2%)
Forestomach, Ulcer 1 (2%) 2 (7%) 1 (2%)
Forestomach, Epithelium, Hyperplasia 1 (2%) 3 (10%) 2 (4%)
Glandular, Mineralization 2 (4%)
Glandular, Polyarteritis 2 (4%)
Tongue (3) (4)
Hemorrhage, Focal 1 (25%)
Hyperkeratosis 1 (25%)
Inflammation, Focal 1 (33%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Mesenteric Artery, Polyarteritis 1 (100%)
Heart (50) (25) (50)
Congestion 1 (4%)
Fibrosis, Focal 1 (2%)
Inflammation, Chronic 46 (92%) 21 (84%) 43 (86%)
Mineralization 1 (4%)
Atrium, Congestion 1 (4%) 4 (8%)
Atrium, Fibrosis 1 (2%)
Atrium, Thrombosis 1 (4%) 4 (8%)
Valve, Bacterium 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Valve, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (48) (24) (49)
Accessory Adrenal Cortical Nodule 2 (4%)
Degeneration, Cystic 4 (8%)
Hyperplasia, Focal 5 (10%) 3 (6%)
Hypertrophy, Focal 2 (4%) 1 (4%)
Vacuolization Cytoplasmic 11 (23%) 5 (21%) 5 (10%)
Adrenal Gland, Medulla (48) (23) (49)
Hemorrhage 1 (4%)
Hyperplasia, Focal 5 (10%) 1 (4%) 1 (2%)
Hyperplasia, Focal, Multiple 2 (4%)
Mineralization 1 (2%)
Thrombosis 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Parathyroid Gland (46) (22) (48)
Hyperplasia 1 (2%) 1 (5%)
Pituitary Gland (48) (28) (49)
Pars Distalis, Angiectasis 3 (6%) 1 (4%) 2 (4%)
Pars Distalis, Cyst 4 (8%) 2 (7%) 1 (2%)
Pars Distalis, Cyst, Multiple 1 (2%) 1 (4%)
Pars Distalis, Hemorrhage 1 (4%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 8 (17%) 4 (14%) 3 (6%)
Pars Intermedia, Hemorrhage 1 (4%)
Thyroid Gland (50) (25) (50)
Hyperplasia, Cystic 1 (2%)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 9 (18%) 5 (20%) 13 (26%)
Follicle, Cyst 2 (4%) 1 (2%)
Follicle, Hyperplasia, Cystic 1 (2%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (23) (50)
Edema 1 (2%)
Preputial Gland (48) (24) (50)
Atrophy 12 (25%) 3 (13%) 13 (26%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Fibrosis 1 (2%) 2 (8%)
Hyperplasia 1 (4%) 1 (2%)
Inflammation, Chronic 4 (8%) 1 (2%)
Inflammation, Suppurative 8 (17%) 9 (38%) 2 (4%)
Necrosis 1 (2%)
Duct, Cyst 10 (21%) 5 (21%) 7 (14%)
Prostate (49) (24) (49)
Cyst 1 (4%)
Cyst, Multiple 2 (8%)
Fibrosis 1 (2%)
Inflammation, Chronic 2 (8%) 2 (4%)
Inflammation, Suppurative 16 (33%) 11 (46%) 17 (35%)
Epithelium, Hyperplasia 1 (2%)
Seminal Vesicle (50) (25) (50)
Atrophy 1 (4%)
Dilatation 2 (8%)
Inflammation, Chronic 1 (4%)
Epithelium, Hyperplasia 1 (4%)
Testes (50) (50) (50)
Atrophy 15 (30%) 19 (38%) 22 (44%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Bilateral, Atrophy 1 (2%)
Bilateral, Interstitial Cell, Hyperplasia 8 (16%) 2 (4%) 2 (4%)
Interstitial Cell, Atrophy 2 (4%)
Interstitial Cell, Hyperplasia 7 (14%) 8 (16%) 14 (28%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (2) (2)
Leukocytosis 1 (50%)
Bone Marrow (50) (23) (50)
Atrophy 1 (2%)
Myelofibrosis 1 (2%)
Myeloid Cell, Hyperplasia 1 (2%) 1 (4%) 1 (2%)
Lymph Node (50) (25) (50)
Axillary, Hyperplasia, Lymphoid 1 (2%)
Inguinal, Cyst 1 (4%)
Inguinal, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Mediastinal, Hemorrhage 2 (8%)
Mediastinal, Hyperplasia, Histiocytic 1 (4%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%) 1 (4%)
Mediastinal, Necrosis 1 (4%)
Mediastinal, Pigmentation 1 (2%)
Pancreatic, Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mandibular (48) (21) (49)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Cyst 1 (5%) 1 (2%)
Cyst, Multiple 2 (4%)
Hyperplasia, Lymphoid 5 (10%) 1 (5%) 2 (4%)
Lymphocyte, Necrosis 1 (2%)
Lymph Node, Mesenteric (48) (23) (50)
Angiectasis 1 (2%) 1 (4%)
Cyst, Multiple 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Lymphocyte, Necrosis 1 (2%)
Spleen (50) (45) (50)
Atrophy 1 (2%) 1 (2%)
Atrophy, Focal 1 (2%)
Congestion 1 (2%)
Developmental Malformation 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 2 (4%)
Necrosis 2 (4%)
Pigmentation 1 (2%)
Thymus (43) (20) (49)
Hyperplasia, Lymphoid 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (44) (23) (48)
Hyperplasia, Lobular 1 (2%) 1 (4%) 1 (2%)
Duct, Cyst 6 (14%) 8 (35%) 10 (21%)
Skin (50) (37) (50)
Cyst 1 (2%)
Cyst Epithelial Inclusion 1 (3%) 4 (8%)
Fibrosis 1 (2%) 1 (3%)
Ulcer 1 (2%)
Epidermis, Hyperplasia 1 (2%)
Epidermis, Hyperplasia, Focal 1 (2%) 3 (8%) 1 (2%)
Subcutaneous Tissue, Hemorrhage, Chronic 1 (2%)
Subcutaneous Tissue, Inflammation,
Granulomatous 1 (2%)
Subcutaneous Tissue, Necrosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (1) (3)
Abdominal, Metaplasia, Osseous 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (24) (50)
Compression 1 (2%) 2 (8%) 1 (2%)
Hemorrhage 5 (10%) 1 (4%) 1 (2%)
Hippocampus, Vacuolization Cytoplasmic 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (29) (50)
Congestion 6 (12%) 9 (31%) 5 (10%)
Edema 1 (2%)
Foreign Body 2 (4%)
Hemorrhage 1 (2%) 1 (3%) 2 (4%)
Inflammation, Granulomatous 1 (3%)
Inflammation, Suppurative 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (3%) 1 (2%)
Alveolus, Edema 1 (3%)
Alveolus, Foreign Body 1 (3%) 2 (4%)
Alveolus, Pigmentation 2 (7%)
Artery, Embolus Tumor 1 (2%)
Artery, Embolus Tumor, Multiple 1 (3%)
Artery, Mineralization, Multiple 1 (3%)
Lymphatic, Foreign Body 3 (10%) 3 (6%)
Perivascular, Foreign Body 1 (2%)
Subpleura, Hemorrhage 1 (2%)
Nose (50) (23) (49)
Lumen, Foreign Body 1 (2%)
Lumen, Fungus 7 (14%) 2 (9%) 9 (18%)
Lumen, Inflammation, Suppurative 8 (16%) 2 (9%) 8 (16%)
Nasolacrimal Duct, Inflammation, Suppurative 2 (4%) 3 (6%)
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SPECIAL SENSES SYSTEM
Eye (7) (5) (3)
Cataract 3 (43%) 3 (60%) 3 (100%)
Hemorrhage 1 (14%)
Inflammation, Suppurative 1 (14%)
Retina, Degeneration 4 (57%) 3 (100%)
Harderian Gland (1)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:49:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Pigmentation 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (23) (50)
Bacterium 1 (2%)
Hydronephrosis 2 (9%)
Hydronephrosis, Multiple 1 (4%)
Infarct 1 (2%)
Inflammation, Suppurative 1 (2%)
Nephropathy, Chronic 41 (82%) 15 (65%) 46 (92%)
Medulla, Necrosis 1 (4%)
Pelvis, Hemorrhage 1 (4%)
Pelvis, Necrosis 1 (4%)
Renal Tubule, Mineralization 1 (2%) 1 (4%) 2 (4%)
Renal Tubule, Pigmentation 1 (2%) 1 (4%) 4 (8%)
Urinary Bladder (48) (22) (50)
Inflammation, Chronic 1 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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