TDMS Study 88032-05 Pathology Tables
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
CORE STUDY
Facility: Battelle Columbus Laboratory
Chemical CAS #: 434-07-01
Lock Date: 01/02/96
Cage Range: All
Reasons For Removal: 25018 Dosing Accident 25019 Moribund Sacrifice
25020 Natural Death 25026 Other
25021 Terminal Sacrifice
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: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 90 90 90 90
Early Deaths
Natural Death 15 10 9 8
Moribund Sacrifice 9 11 10 10
Dosing Accident 1 1 1
Survivors
Terminal Sacrifice 25 29 30 31
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (49)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%)
Ulcer 1 (2%)
Intestine Large, Colon (46) (46) (49) (48)
Parasite Metazoan 1 (2%) 3 (6%)
Intestine Large, Rectum (44) (47) (46) (50)
Parasite Metazoan 2 (5%) 5 (11%) 5 (11%) 10 (20%)
Intestine Small, Duodenum (47) (48) (49) (49)
Inflammation, Chronic Active 1 (2%)
Intestine Small, Jejunum (43) (45) (43) (44)
Inflammation, Chronic Active 1 (2%)
Intestine Small, Ileum (40) (44) (44) (46)
Inflammation, Chronic Active 1 (2%)
Liver (50) (50) (50) (49)
Basophilic Focus 37 (74%) 40 (80%) 37 (74%) 41 (84%)
Clear Cell Focus 5 (10%) 11 (22%) 6 (12%) 14 (29%)
Cyst 1 (2%)
Degeneration, Cystic 1 (2%) 3 (6%)
Eosinophilic Focus 8 (16%) 6 (12%) 3 (6%) 3 (6%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 1 (2%)
Hepatodiaphragmatic Nodule 12 (24%) 6 (12%) 4 (8%) 9 (18%)
Inflammation, Chronic Active 17 (34%) 13 (26%) 10 (20%) 5 (10%)
Mixed Cell Focus 2 (4%) 7 (14%) 9 (18%) 7 (14%)
Necrosis 1 (2%) 2 (4%) 1 (2%)
Regeneration 1 (2%) 2 (4%)
Vacuolization Cytoplasmic, Focal 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 1 (2%) 3 (6%) 6 (12%)
Centrilobular, Necrosis 1 (2%)
Centrilobular, Vacuolization Cytoplasmic 7 (14%) 8 (16%) 6 (12%) 3 (6%)
Mesentery (5) (3) (12) (10)
Mineralization 1 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Inflammation, Chronic Active 2 (40%) 3 (100%) 10 (83%) 10 (100%)
Fat, Mineralization 1 (20%) 3 (25%) 5 (50%)
Fat, Necrosis 2 (40%) 2 (17%) 1 (10%)
Pancreas (50) (49) (49) (49)
Atrophy 1 (2%)
Inflammation, Chronic Active 2 (4%)
Acinus, Atrophy 8 (16%) 7 (14%) 5 (10%) 3 (6%)
Salivary Glands (50) (49) (50) (49)
Inflammation, Chronic Active 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Hyperkeratosis 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Perforation 1 (2%)
Ulcer 2 (4%) 2 (4%) 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Stomach, Glandular (50) (50) (50) (50)
Erosion 1 (2%)
Mineralization 1 (2%) 1 (2%)
Ulcer 3 (6%)
Tongue (1) (1)
Angiectasis 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (49)
Thrombosis 1 (2%)
Epicardium, Inflammation, Chronic Active 2 (4%)
Myocardium, Degeneration, Chronic 29 (58%) 34 (68%) 40 (80%) 45 (92%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (49)
Accessory Adrenal Cortical Nodule 1 (2%)
Angiectasis 21 (42%) 26 (52%) 15 (30%) 3 (6%)
Hematopoietic Cell Proliferation 1 (2%)
Hypertrophy 5 (10%)
Metaplasia, Osseous 1 (2%)
Mineralization 1 (2%)
Necrosis 1 (2%) 1 (2%)
Pigmentation 2 (4%)
Vacuolization Cytoplasmic 4 (8%) 5 (10%) 21 (42%) 36 (73%)
Adrenal Medulla (50) (50) (50) (49)
Hyperplasia 5 (10%) 1 (2%) 3 (6%) 13 (27%)
Vacuolization Cytoplasmic 1 (2%)
Islets, Pancreatic (49) (49) (49) (49)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia 1 (2%)
Parathyroid Gland (47) (46) (42) (38)
Hyperplasia 2 (5%)
Pituitary Gland (50) (50) (49) (50)
Angiectasis 1 (2%)
Cyst 10 (20%) 9 (18%) 4 (8%) 1 (2%)
Hemorrhage 1 (2%) 2 (4%)
Hyperplasia 3 (6%) 2 (4%) 2 (4%) 1 (2%)
Mineralization 1 (2%) 1 (2%)
Pars Distalis, Angiectasis 1 (2%) 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia 1 (2%) 2 (4%) 2 (4%)
Pars Nervosa, Developmental Malformation 1 (2%) 1 (2%)
Thyroid Gland (50) (49) (50) (49)
Cyst 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
Ultimobranchial Cyst 2 (4%) 1 (2%) 2 (4%)
C-Cell, Hyperplasia 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (48) (50) (50)
Cyst 6 (12%) 6 (13%) 5 (10%) 2 (4%)
Inflammation 1 (2%)
Inflammation, Chronic Active 7 (14%) 8 (17%) 11 (22%) 18 (36%)
Ovary (50) (49) (50) (49)
DYSGENESIS 1 (2%) 43 (86%) 49 (100%)
Corpus Luteum, Cyst 1 (2%)
Follicle, Cyst 2 (4%) 1 (2%) 1 (2%)
Periovarian Tissue, Cyst 4 (8%) 4 (8%) 2 (4%)
Uterus (50) (50) (50) (50)
Hemorrhage 1 (2%) 1 (2%) 2 (4%)
Hydrometra 3 (6%) 4 (8%) 5 (10%) 6 (12%)
Inflammation, Chronic Active 1 (2%)
Cervix, Angiectasis 1 (2%)
Cervix, Cyst 1 (2%) 1 (2%)
Endometrium, Cyst 1 (2%) 1 (2%) 9 (18%) 3 (6%)
Endometrium, Hyperplasia, Cystic 1 (2%) 4 (8%) 3 (6%)
Endometrium, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (49) (49)
Hyperplasia 1 (2%)
Infiltration Cellular 1 (2%)
Myelofibrosis 2 (4%) 2 (4%)
Lymph Node (4) (1) (1) (1)
Ectasia 1 (25%)
Lymph Node, Mandibular (49) (48) (48) (48)
Congestion 2 (4%)
Ectasia 1 (2%) 1 (2%) 2 (4%)
Lymph Node, Mesenteric (50) (48) (49) (49)
Atrophy 1 (2%) 1 (2%)
Ectasia 1 (2%) 3 (6%) 4 (8%)
Hemorrhage 1 (2%)
Inflammation, Granulomatous 1 (2%)
Inflammation, Suppurative 1 (2%)
Spleen (50) (49) (50) (49)
Accessory Spleen 1 (2%) 1 (2%)
Angiectasis 1 (2%)
Congestion 1 (2%)
Fibrosis 1 (2%) 1 (2%) 3 (6%)
Hematopoietic Cell Proliferation 2 (4%) 6 (12%) 3 (6%)
Hyperplasia, Focal 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Capsule, Fibrosis 1 (2%)
Lymphoid Follicle, Depletion Cellular 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Thymus (45) (47) (44) (42)
Atrophy 3 (7%) 2 (4%) 7 (16%) 6 (14%)
Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49) (50)
Dilatation 27 (54%) 34 (68%) 13 (27%) 17 (34%)
Galactocele 2 (4%) 1 (2%) 3 (6%) 2 (4%)
Hyperplasia, Focal 3 (6%) 1 (2%) 1 (2%)
Lobular, Hyperplasia 1 (2%) 1 (2%)
Skin (50) (50) (50) (50)
Inflammation, Chronic Active 1 (2%)
Parakeratosis 1 (2%)
Ulcer 1 (2%)
Epidermis, Cyst 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (49) (50)
Osteosclerosis 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Thrombosis 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Spinal Cord (1) (1) (1) (2)
Hemorrhage 1 (50%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (49)
Congestion 1 (2%)
Cyst, Squamous 1 (2%)
Inflammation, Chronic Active 8 (16%) 12 (24%) 7 (14%) 17 (35%)
Mineralization 15 (30%) 23 (46%) 33 (66%) 33 (67%)
Necrosis 1 (2%)
Pigmentation 2 (4%) 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 4 (8%) 10 (20%) 4 (8%) 9 (18%)
Alveolar Epithelium, Metaplasia, Squamous 1 (2%)
Interstitium, Fibrosis 1 (2%)
Nose (49) (50) (49) (50)
Inflammation, Suppurative 1 (2%) 3 (6%)
Trachea (50) (50) (50) (49)
Inflammation, Chronic Active 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (1)
Lens, Mineralization 1 (50%) 1 (100%)
Retina, Degeneration 1 (50%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (49)
Congestion 1 (2%)
Cyst 1 (2%)
Developmental Malformation 1 (2%)
Hydronephrosis 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Metaplasia, Osseous 1 (2%)
Mineralization 27 (54%) 31 (62%) 35 (70%) 36 (73%)
Necrosis 1 (2%)
Nephropathy 32 (64%) 26 (52%) 38 (76%) 41 (84%)
Pigmentation, Hemosiderin 5 (10%) 7 (14%) 4 (8%) 3 (6%)
Urinary Bladder (50) (50) (49) (50)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 3 (6%) 1 (2%)
Transitional Epithelium, Hyperplasia 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 90 90 90 90
Early Deaths
Moribund Sacrifice 24 22 25 15
Natural Death 12 12 11 12
Dosing Accident 1 3
Survivors
Terminal Sacrifice 15 15 14 20
Other 1
Animals Examined Microscopically 51 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (49) (50) (49)
Periesophageal Tissue, Hemorrhage 1 (2%)
Intestine Large, Colon (48) (49) (46) (47)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%) 2 (4%)
Parasite Metazoan 3 (6%) 2 (4%) 3 (6%)
Intestine Large, Rectum (49) (47) (47) (46)
Parasite Metazoan 1 (2%) 3 (6%) 1 (2%) 1 (2%)
Intestine Large, Cecum (43) (40) (41) (44)
Inflammation, Granulomatous 1 (2%)
Intestine Small, Duodenum (48) (49) (49) (47)
Inflammation, Chronic Active 1 (2%)
Mineralization 2 (4%) 1 (2%)
Liver (51) (50) (50) (49)
Angiectasis 1 (2%) 2 (4%)
Basophilic Focus 23 (45%) 29 (58%) 41 (82%) 38 (78%)
Clear Cell Focus 2 (4%) 2 (4%) 6 (12%) 12 (24%)
Degeneration, Cystic 4 (8%)
Eosinophilic Focus 6 (12%) 4 (8%) 4 (8%) 2 (4%)
Fatty Change 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 7 (14%) 3 (6%) 2 (4%) 6 (12%)
Inflammation, Chronic Active 9 (18%) 4 (8%) 3 (6%) 1 (2%)
Mixed Cell Focus 2 (4%) 1 (2%) 4 (8%) 4 (8%)
Necrosis 3 (6%) 1 (2%) 1 (2%) 1 (2%)
Bile Duct, Fibrosis 1 (2%)
Bile Duct, Hyperplasia 29 (57%) 27 (54%) 24 (48%)
Centrilobular, Congestion 1 (2%) 1 (2%)
Centrilobular, Degeneration 1 (2%)
Centrilobular, Necrosis 1 (2%) 3 (6%) 1 (2%) 1 (2%)
Centrilobular, Vacuolization Cytoplasmic 9 (18%) 6 (12%) 10 (20%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (14) (6) (5) (3)
Fat, Inflammation, Chronic Active 10 (71%) 4 (67%) 5 (100%) 3 (100%)
Fat, Mineralization 5 (36%) 2 (33%) 3 (60%)
Fat, Necrosis 2 (14%) 2 (33%) 1 (20%)
Oral Mucosa (3) (1)
Hyperplasia 1 (33%)
Pancreas (49) (48) (50) (48)
Inflammation, Chronic Active 2 (4%)
Acinus, Atrophy 11 (22%) 7 (15%) 11 (22%) 4 (8%)
Salivary Glands (51) (49) (50) (49)
Atrophy 2 (4%)
Stomach, Forestomach (51) (50) (49) (48)
Edema 2 (4%)
Erosion 1 (2%) 1 (2%)
Hyperkeratosis 1 (2%) 2 (4%)
Inflammation, Chronic Active 3 (6%) 3 (6%) 9 (18%) 4 (8%)
Mineralization 1 (2%) 2 (4%) 2 (4%) 2 (4%)
Perforation 2 (4%)
Ulcer 6 (12%) 2 (4%) 4 (8%) 5 (10%)
Epithelium, Hyperplasia 2 (4%) 2 (4%)
Stomach, Glandular (51) (50) (49) (48)
Erosion 2 (4%) 1 (2%)
Hemorrhage 1 (2%)
Mineralization 6 (12%) 6 (12%) 7 (14%) 7 (15%)
Ulcer 1 (2%)
Tongue (1) (1) (1)
Vacuolization Cytoplasmic 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (51) (50) (50) (48)
Mineralization 3 (6%) 5 (10%) 6 (12%) 7 (15%)
Thrombosis 1 (2%)
Heart (51) (49) (50) (47)
Mineralization 3 (6%) 5 (10%) 8 (16%) 5 (11%)
Thrombosis 1 (2%) 2 (4%)
Myocardium, Degeneration, Chronic 43 (84%) 43 (88%) 48 (96%) 42 (89%)
Pericardium, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (51) (50) (50) (49)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 2 (4%)
Vacuolization Cytoplasmic 22 (43%) 23 (46%) 40 (80%) 33 (67%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Adrenal Medulla (51) (50) (50) (49)
Hyperplasia 15 (29%) 17 (34%) 20 (40%) 15 (31%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Islets, Pancreatic (49) (48) (50) (48)
Hyperplasia 1 (2%) 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Parathyroid Gland (46) (44) (48) (43)
Hyperplasia 10 (22%) 14 (32%) 17 (35%) 15 (35%)
Pituitary Gland (51) (50) (50) (49)
Angiectasis 1 (2%)
Cyst 2 (4%) 2 (4%) 3 (6%) 3 (6%)
Hyperplasia 2 (4%) 2 (4%) 1 (2%)
Mineralization 2 (4%) 1 (2%)
Necrosis 2 (4%)
Vacuolization Cytoplasmic 1 (2%)
Pars Distalis, Fibrosis 1 (2%)
Pars Distalis, Hyperplasia 1 (2%)
Pars Nervosa, Developmental Malformation 1 (2%) 1 (2%)
Thyroid Gland (51) (48) (50) (49)
Mineralization 1 (2%)
Ultimobranchial Cyst 1 (2%) 6 (13%) 3 (6%)
C-Cell, Hyperplasia 1 (2%)
Follicle, Cyst 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (51) (50) (50) (49)
Atypia Cellular 2 (4%) 1 (2%)
Degeneration 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Granulomatous 1 (2%)
Preputial Gland (51) (49) (50) (49)
Cyst 3 (6%) 2 (4%)
Hyperplasia 1 (2%) 1 (2%)
Inflammation, Chronic Active 45 (88%) 37 (76%) 42 (84%) 36 (73%)
Mineralization 2 (4%)
Prostate (51) (50) (50) (49)
Atrophy 1 (2%)
Inflammation, Chronic Active 10 (20%) 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Granulomatous 1 (2%)
Mineralization 1 (2%) 2 (4%)
Seminal Vesicle (51) (49) (50) (48)
Inflammation, Chronic Active 1 (2%)
Inflammation, Granulomatous 1 (2%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Testes (51) (50) (50) (49)
Cyst 1 (2%)
Degeneration 9 (18%) 9 (18%) 37 (74%) 28 (57%)
Mineralization 17 (33%) 10 (20%) 33 (66%) 19 (39%)
Necrosis 1 (2%)
Interstitial Cell, Hyperplasia 16 (31%) 22 (44%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (48) (49) (50) (49)
Myelofibrosis 1 (2%) 2 (4%)
Necrosis 1 (2%)
Lymph Node (4) (4) (2)
Ectasia 1 (25%) 2 (50%)
Hemorrhage 1 (25%)
Pigmentation, Hemosiderin 1 (25%)
Lymph Node, Mandibular (51) (47) (50) (49)
Amyloid Deposition 1 (2%)
Ectasia 2 (4%) 2 (4%) 2 (4%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Lymph Node, Mesenteric (50) (49) (49) (48)
Atrophy 1 (2%) 1 (2%) 1 (2%)
Congestion 1 (2%)
Ectasia 3 (6%) 5 (10%) 3 (6%) 5 (10%)
Necrosis 1 (2%)
Spleen (51) (50) (50) (48)
Accessory Spleen 1 (2%)
Angiectasis 1 (2%)
Congestion 2 (4%)
Fibrosis 7 (14%) 3 (6%) 2 (4%)
Hematopoietic Cell Proliferation 3 (6%) 3 (6%) 2 (4%) 3 (6%)
Necrosis 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Thrombosis 1 (2%)
Lymphoid Follicle, Depletion Cellular 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Thymus (42) (42) (38) (39)
Atrophy 6 (14%) 3 (7%) 7 (18%) 7 (18%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (51) (48) (49) (50)
Angiectasis 1 (2%)
Dilatation 31 (61%) 24 (50%) 23 (47%) 23 (46%)
Galactocele 1 (2%) 4 (8%) 1 (2%) 7 (14%)
Hyperplasia 1 (2%)
Hyperplasia, Focal 1 (2%) 1 (2%)
Mineralization 2 (4%) 4 (8%) 3 (6%) 2 (4%)
Pigmentation, Hemosiderin 1 (2%)
Lobular, Hyperplasia 4 (8%) 35 (70%)
Skin (51) (50) (49) (50)
Inflammation, Chronic Active 1 (2%)
Parakeratosis 1 (2%) 1 (2%) 1 (2%)
Ulcer 1 (2%)
Epidermis, Cyst 2 (4%) 1 (2%)
Hair Follicle, Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (51) (49) (50) (50)
Fibrous Osteodystrophy 2 (4%) 8 (16%) 13 (26%) 15 (30%)
Osteosclerosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (51) (50) (50) (50)
Hemorrhage 2 (4%)
Necrosis 2 (4%)
Meninges, Infiltration Cellular, Histiocyte 1 (2%)
Spinal Cord (5) (1) (4)
Demyelination 1 (25%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (51) (50) (50) (47)
Congestion 1 (2%) 1 (2%)
Edema 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 12 (24%) 13 (26%) 11 (22%) 14 (30%)
Mineralization 19 (37%) 25 (50%) 27 (54%) 28 (60%)
Necrosis 1 (2%) 1 (2%)
Proteinosis 1 (2%)
Vacuolization Cytoplasmic 6 (12%) 7 (14%) 7 (14%) 4 (9%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 3 (6%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
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NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:19:17
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FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
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RESPIRATORY SYSTEM - CONT
Interstitium, Fibrosis 1 (2%) 2 (4%)
Nose (50) (49) (50) (50)
Inflammation, Chronic Active 3 (6%) 2 (4%) 1 (2%)
Inflammation, Suppurative 4 (8%) 6 (12%) 3 (6%) 2 (4%)
Trachea (50) (49) (50) (49)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%) 1 (2%)
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SPECIAL SENSES SYSTEM
Eye (1) (2) (2) (3)
Degeneration 1 (50%)
Cornea, Inflammation, Suppurative 1 (50%)
Cornea, Mineralization 1 (50%)
Cornea, Necrosis 1 (50%)
Lens, Mineralization 1 (50%) 2 (67%)
Retina, Degeneration 1 (100%) 1 (50%) 2 (67%)
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URINARY SYSTEM
Kidney (51) (50) (50) (49)
Cyst 1 (2%) 7 (14%) 4 (8%) 6 (12%)
Degeneration 1 (2%)
Hyperplasia, Oncocytic 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 6 (12%) 6 (12%) 9 (18%) 25 (51%)
Nephropathy 43 (84%) 47 (94%) 50 (100%) 48 (98%)
Pigmentation, Hemosiderin 4 (8%) 4 (8%) 2 (4%) 4 (8%)
Renal Tubule, Accumulation, Hyaline Droplet 2 (4%)
Renal Tubule, Hyperplasia 3 (6%) 2 (4%) 3 (6%) 1 (2%)
Urinary Bladder (51) (50) (50) (49)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (4%)
Mineralization 1 (2%)
Muscularis, Inflammation, Suppurative 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
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