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 ---------- ------------------------------------------------------------