TDMS Study 88032-05 Pathology Tables
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
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)
Fibrosarcoma 1 (2%)
Intestine Large, Colon (46) (46) (49) (48)
Leiomyoma 1 (2%)
Intestine Large, Rectum (44) (47) (46) (50)
Intestine Large, Cecum (38) (44) (42) (45)
Intestine Small, Duodenum (47) (48) (49) (49)
Intestine Small, Jejunum (43) (45) (43) (44)
Intestine Small, Ileum (40) (44) (44) (46)
Liver (50) (50) (50) (49)
Fibrosarcoma 1 (2%)
Hepatocellular Carcinoma 2 (4%)
Hepatocellular Adenoma 1 (2%) 1 (2%) 8 (16%)
Hepatocellular Adenoma, Multiple 1 (2%)
Mesentery (5) (3) (12) (10)
Fibrosarcoma 1 (20%)
Oral Mucosa (1)
Squamous Cell Carcinoma 1 (100%)
Pancreas (50) (49) (49) (49)
Salivary Glands (50) (49) (50) (49)
Stomach, Forestomach (50) (50) (50) (50)
Stomach, Glandular (50) (50) (50) (50)
Adenoma 1 (2%)
Tongue (1) (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (49)
Heart (50) (50) (50) (49)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (49)
Adrenal Medulla (50) (50) (50) (49)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 7 (14%) 4 (8%) 2 (4%) 6 (12%)
Bilateral, Pheochromocytoma Benign 4 (8%)
Islets, Pancreatic (49) (49) (49) (49)
Adenoma 1 (2%) 1 (2%)
Pituitary Gland (50) (50) (49) (50)
Pars Distalis, Adenoma 27 (54%) 26 (52%) 18 (37%) 14 (28%)
Thyroid Gland (50) (49) (50) (49)
C-Cell, Adenoma 5 (10%) 8 (16%) 7 (14%) 4 (8%)
Follicular Cell, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (1)
Fibrosarcoma, Metastatic, Uncertain Primary
Site 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (48) (50) (50)
Adenoma 4 (8%) 4 (8%) 2 (4%) 2 (4%)
Carcinoma 1 (2%) 3 (6%) 1 (2%) 3 (6%)
Squamous Cell Papilloma 2 (4%) 1 (2%)
Ovary (50) (49) (50) (49)
Uterus (50) (50) (50) (50)
Fibrosarcoma 1 (2%)
Hemangiosarcoma 1 (2%)
Polyp Stromal 4 (8%) 8 (16%) 2 (4%)
Sarcoma Stromal 1 (2%)
Cervix, Sarcoma Stromal 1 (2%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (49) (49)
Lymph Node (4) (1) (1) (1)
Lymph Node, Mandibular (49) (48) (48) (48)
Lymph Node, Mesenteric (50) (48) (49) (49)
Spleen (50) (49) (50) (49)
Thymus (45) (47) (44) (42)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49) (50)
Carcinoma 3 (6%)
Fibroadenoma 15 (30%) 11 (22%) 1 (2%) 4 (8%)
Fibroadenoma, Multiple 6 (12%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Keratoacanthoma 4 (8%)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 2 (4%)
Pinna, Melanoma Malignant 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
Sweat Gland, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (49) (50)
Sarcoma 1 (2%)
Skeletal Muscle (1)
Fibrosarcoma, Metastatic, Uncertain Primary
Site 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (49)
Alveolar/Bronchiolar Adenoma 6 (12%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Sarcoma, Metastatic, Bone 1 (2%)
Page 4
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Nose (49) (50) (49) (50)
Trachea (50) (50) (50) (49)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (49)
Mesenchymal Tumor Benign 1 (2%)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (50) (50) (49) (50)
Leiomyoma 1 (2%)
Transitional Epithelium, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 12 (24%) 11 (22%) 11 (22%) 5 (10%)
Lymphoma Malignant 2 (4%)
Mesothelioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 45 45 37 37
Total Primary Neoplasms 94 85 61 66
Total Animals with Benign Neoplasms 44 40 29 33
Total Benign Neoplasms 72 66 45 52
Total Animals with Malignant Neoplasms 17 18 16 12
Total Malignant Neoplasms 22 19 16 14
Total Animals with Metastatic Neoplasms 1 1
Total Metastatic Neoplasm 2 1
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 6
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
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
Intestine Large, Colon (48) (49) (46) (47)
Intestine Large, Rectum (49) (47) (47) (46)
Histiocytic Sarcoma 1 (2%)
Intestine Large, Cecum (43) (40) (41) (44)
Intestine Small, Duodenum (48) (49) (49) (47)
Liver (51) (50) (50) (49)
Hepatocellular Carcinoma 1 (2%)
Hepatocellular Adenoma 1 (2%) 1 (2%)
Hepatocellular Adenoma, Multiple 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mesentery (14) (6) (5) (3)
Oral Mucosa (3) (1)
Squamous Cell Papilloma 1 (33%) 1 (100%)
Pharyngeal, Squamous Cell Papilloma 1 (33%)
Pancreas (49) (48) (50) (48)
Acinus, Adenoma 1 (2%)
Stomach, Forestomach (51) (50) (49) (48)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Tongue (1) (1) (1)
Squamous Cell Papilloma 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (51) (50) (50) (48)
Heart (51) (49) (50) (47)
Myocardium, Schwannoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (51) (50) (50) (49)
Adrenal Medulla (51) (50) (50) (49)
Ganglioneuroma 1 (2%)
Pheochromocytoma Malignant 1 (2%) 1 (2%)
Pheochromocytoma Benign 16 (31%) 14 (28%) 12 (24%) 10 (20%)
Bilateral, Pheochromocytoma Benign 3 (6%) 11 (22%) 9 (18%) 19 (39%)
Islets, Pancreatic (49) (48) (50) (48)
Adenoma 4 (8%) 2 (4%) 2 (4%) 1 (2%)
Carcinoma 2 (4%)
Parathyroid Gland (46) (44) (48) (43)
Pituitary Gland (51) (50) (50) (49)
Pars Distalis, Adenoma 30 (59%) 32 (64%) 30 (60%) 19 (39%)
Thyroid Gland (51) (48) (50) (49)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 5 (10%) 3 (6%) 5 (10%) 4 (8%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (51) (50) (50) (49)
Preputial Gland (51) (49) (50) (49)
Adenoma 2 (4%) 2 (4%)
Carcinoma 3 (6%) 2 (4%) 1 (2%)
Prostate (51) (50) (50) (49)
Seminal Vesicle (51) (49) (50) (48)
Testes (51) (50) (50) (49)
Bilateral, Interstitial Cell, Adenoma 31 (61%) 9 (18%)
Interstitial Cell, Adenoma 2 (4%) 11 (22%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (48) (49) (50) (49)
Lymph Node (4) (4) (2)
Lymph Node, Mandibular (51) (47) (50) (49)
Rhabdomyosarcoma, Metastatic, Skeletal Muscle 1 (2%)
Lymph Node, Mesenteric (50) (49) (49) (48)
Spleen (51) (50) (50) (48)
Lipoma 1 (2%)
Page 8
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Thymus (42) (42) (38) (39)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (51) (48) (49) (50)
Carcinoma 1 (2%)
Fibroadenoma 4 (8%) 1 (2%) 1 (2%) 1 (2%)
Fibroadenoma, Multiple 1 (2%)
Histiocytic Sarcoma 1 (2%)
Skin (51) (50) (49) (50)
Basal Cell Carcinoma 1 (2%)
Keratoacanthoma 4 (8%) 1 (2%) 1 (2%) 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (2%)
Sebaceous Gland, Adenoma 1 (2%)
Subcutaneous Tissue, Fibroma 5 (10%) 2 (4%) 2 (4%)
Subcutaneous Tissue, Fibrosarcoma 2 (4%)
Subcutaneous Tissue, Lipoma 1 (2%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (51) (49) (50) (50)
Osteoma 1 (2%)
Skeletal Muscle (2) (1)
Histiocytic Sarcoma 1 (50%)
Rhabdomyosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (51) (50) (50) (50)
Astrocytoma Malignant 2 (4%)
Spinal Cord (5) (1) (4)
Schwannoma Malignant 1 (25%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (51) (50) (50) (47)
Alveolar/Bronchiolar Adenoma 4 (8%) 1 (2%) 3 (6%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Chordoma, Metastatic, Uncertain Primary Site 1 (2%)
Histiocytic Sarcoma 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Page 9
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Adrenal Medulla 1 (2%)
Nose (50) (49) (50) (50)
Squamous Cell Carcinoma 1 (2%)
Glands, Carcinoma 1 (2%)
Olfactory Epithelium, Neoplasm NOS 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (2) (3)
Lids, Squamous Cell Carcinoma 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (51) (50) (50) (49)
Renal Tubule, Adenoma 1 (2%) 2 (4%)
Renal Tubule, Oncocytoma Benign 1 (2%) 1 (2%)
Transitional Epithelium, Carcinoma 1 (2%)
Urinary Bladder (51) (50) (50) (49)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(51) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 21 (41%) 15 (30%) 7 (14%) 4 (8%)
Mesothelioma Benign 1 (2%)
Mesothelioma Malignant 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:24:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 51 48 44 40
Total Primary Neoplasms 139 125 89 74
Total Animals with Benign Neoplasms 50 45 40 39
Total Benign Neoplasms 108 102 70 67
Total Animals with Malignant Neoplasms 28 22 16 7
Total Malignant Neoplasms 31 23 18 7
Total Animals with Metastatic Neoplasms 1 2
Total Metastatic Neoplasm 1 2
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 1
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 11
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------