TDMS Study 88122-07 Pathology Tables
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 final#1/Mice Facility: Battelle Columbus Laboratory Chemical CAS #: 37319-17-8 Lock Date: 04/14/00 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: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 8 6 10 9 Moribund Sacrifice 4 5 3 7 Accidently Killed 1 Dosing Accident 1 Survivors Terminal Sacrifice 37 37 37 34 Natural Death 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (39) (40) (38) (38) Sarcoma, Metastatic, Uterus 1 (3%) Intestine Large, Cecum (41) (43) (44) (43) Leiomyoma 1 (2%) Intestine Small, Duodenum (41) (44) (42) (42) Polyp Adenomatous 2 (5%) 1 (2%) Intestine Small, Jejunum (43) (44) (42) (42) Carcinoma 1 (2%) Intestine Small, Ileum (42) (44) (42) (42) Liver (50) (49) (50) (49) Hemangiosarcoma 1 (2%) 1 (2%) 1 (2%) 4 (8%) Hepatocellular Carcinoma 3 (6%) 3 (6%) 5 (10%) 3 (6%) Hepatocellular Adenoma 6 (12%) 3 (6%) 2 (4%) 9 (18%) Hepatocellular Adenoma, Multiple 1 (2%) 2 (4%) 2 (4%) 6 (12%) Histiocytic Sarcoma 3 (6%) 1 (2%) 2 (4%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) 2 (4%) Sarcoma, Metastatic, Uterus 1 (2%) Mesentery (30) (34) (32) (42) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (3%) 1 (2%) Sarcoma 1 (3%) Sarcoma, Metastatic, Skin 1 (3%) 2 (6%) 2 (6%) 1 (2%) Sarcoma, Metastatic, Uterus 1 (3%) 1 (3%) Pancreas (46) (45) (46) (46) Page 2 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Sarcoma, Metastatic, Skin 1 (2%) Salivary Glands (49) (49) (50) (48) Stomach, Forestomach (47) (48) (49) (48) Sarcoma, Metastatic, Skin 1 (2%) Stomach, Glandular (46) (45) (44) (46) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Pericardium, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Pericardium, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (49) (49) (48) Histiocytic Sarcoma 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) 1 (2%) Subcapsular, Carcinoma 1 (2%) Adrenal Medulla (49) (49) (47) (47) Pheochromocytoma Benign 1 (2%) Pituitary Gland (48) (47) (45) (48) Pars Distalis, Adenoma 2 (4%) 3 (6%) 4 (9%) 2 (4%) Pars Intermedia, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) Sarcoma, Metastatic, Skin 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (47) (46) (47) (48) Cystadenoma 1 (2%) 1 (2%) 2 (4%) Hemangioma 2 (4%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) Luteoma 1 (2%) Page 3 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Sarcoma, Metastatic, Mesentery 1 (2%) Uterus (48) (49) (50) (50) Histiocytic Sarcoma 2 (4%) Polyp Stromal 3 (6%) 1 (2%) 2 (4%) 2 (4%) Sarcoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (48) (50) (49) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) 3 (6%) Lymph Node (6) (10) (5) (10) Bronchial, Histiocytic Sarcoma 2 (20%) Bronchial, Osteosarcoma, Metastatic, Uncertain Primary Site 1 (20%) Lumbar, Histiocytic Sarcoma 1 (10%) Mediastinal, Histiocytic Sarcoma 2 (20%) Mediastinal, Osteosarcoma, Metastatic, Uncertain Primary Site 1 (20%) Mediastinal, Sarcoma, Metastatic, Skin 1 (17%) Pancreatic, Sarcoma, Metastatic, Skin 1 (17%) Renal, Sarcoma, Metastatic, Skin 1 (10%) Lymph Node, Mandibular (33) (38) (37) (39) Histiocytic Sarcoma 1 (3%) Lymph Node, Mesenteric (47) (44) (42) (45) Histiocytic Sarcoma 1 (2%) 1 (2%) Sarcoma, Metastatic, Mesentery 1 (2%) Spleen (47) (48) (47) (46) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) Thymus (43) (38) (43) (36) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Sarcoma, Metastatic, Skin 1 (3%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Basal Cell Adenoma 1 (2%) Sarcoma, Metastatic, Uterus 1 (2%) Subcutaneous Tissue, Hemangioma 1 (2%) Page 4 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Liposarcoma 1 (2%) Subcutaneous Tissue, Myxoma 1 (2%) Subcutaneous Tissue, Sarcoma 3 (6%) 4 (8%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Carcinoma, Metastatic, Harderian Gland 1 (2%) Osteosarcoma 1 (2%) 1 (2%) Skeletal Muscle (2) (2) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (50%) Sarcoma, Metastatic, Uterus 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (50) (50) Histiocytic Sarcoma 2 (4%) Meningioma Malignant 1 (2%) Oligodendroglioma Benign 1 (2%) Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 2 (4%) 2 (4%) 2 (4%) 1 (2%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) 2 (4%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 2 (4%) 2 (4%) Histiocytic Sarcoma 3 (6%) 1 (2%) 2 (4%) Liposarcoma, Metastatic, Skin 1 (2%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Sarcoma 1 (2%) Sarcoma, Metastatic, Skin 3 (6%) 2 (4%) 1 (2%) Mediastinum, Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Page 5 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Nose (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Pleura (1) Sarcoma, Metastatic, Lung 1 (100%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (48) (41) (50) (46) Adenoma 3 (6%) 3 (7%) 4 (8%) 3 (7%) Carcinoma 2 (5%) 2 (4%) 2 (4%) Bilateral, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (49) (48) (46) Histiocytic Sarcoma 4 (8%) 1 (2%) 1 (2%) Sarcoma, Metastatic, Mesentery 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Transitional Epithelium, Carcinoma 1 (2%) Urinary Bladder (43) (46) (47) (46) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 4 (8%) 1 (2%) 3 (6%) Lymphoma Malignant 7 (14%) 8 (16%) 6 (12%) 16 (32%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 29 34 29 40 Total Primary Neoplasms 39 50 41 64 Total Animals with Benign Neoplasms 17 16 14 26 Total Benign Neoplasms 21 20 19 30 Total Animals with Malignant Neoplasms 17 22 19 28 Total Malignant Neoplasms 18 30 22 34 Total Animals with Metastatic Neoplasms 4 5 7 6 Total Metastatic Neoplasm 7 13 24 9 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 7 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 4 5 8 15 Moribund Sacrifice 7 4 4 3 Dosing Accident 1 2 Survivors Terminal Sacrifice 39 40 38 30 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (47) (47) (42) Sarcoma, Metastatic, Liver 1 (2%) Intestine Large, Cecum (49) (47) (46) (39) Carcinoma 1 (2%) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (2%) Intestine Small, Duodenum (47) (47) (44) (40) Carcinoma 1 (2%) Polyp Adenomatous 1 (3%) Intestine Small, Jejunum (47) (47) (44) (38) Carcinoma 4 (9%) 1 (2%) Polyp Adenomatous 1 (2%) Sarcoma, Metastatic, Liver 1 (2%) Liver (50) (50) (50) (50) Hemangiosarcoma 2 (4%) 4 (8%) 9 (18%) Hepatoblastoma 1 (2%) 1 (2%) Hepatocellular Carcinoma 7 (14%) 12 (24%) 11 (22%) 11 (22%) Hepatocellular Carcinoma, Multiple 4 (8%) 1 (2%) 4 (8%) 2 (4%) Hepatocellular Adenoma 10 (20%) 12 (24%) 10 (20%) 10 (20%) Hepatocellular Adenoma, Multiple 9 (18%) 3 (6%) 5 (10%) 10 (20%) Histiocytic Sarcoma 1 (2%) 2 (4%) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Mesentery (10) (4) (20) (10) Sarcoma 1 (5%) Pancreas (50) (50) (49) (50) Page 8 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Histiocytic Sarcoma 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Stomach, Forestomach (49) (50) (50) (50) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (2%) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 2 (4%) Stomach, Glandular (49) (49) (48) (46) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (2%) Sarcoma, Metastatic, Liver 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Hemangiosarcoma 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Sarcoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (49) Adenoma 1 (2%) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (2%) Subcapsular, Adenoma 2 (4%) Adrenal Medulla (50) (50) (50) (49) Pheochromocytoma Benign 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Islets, Pancreatic (50) (50) (49) (50) Adenoma 2 (4%) Pituitary Gland (47) (48) (49) (48) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (48) (49) (50) (49) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (49) (50) (49) (50) Hemangiosarcoma 1 (2%) Seminal Vesicle (50) (50) (50) (49) Sarcoma, Metastatic, Liver 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Testes (50) (50) (49) (50) Hemangiosarcoma 1 (2%) Interstitial Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) Hemangiosarcoma 2 (4%) 2 (4%) 1 (2%) Histiocytic Sarcoma 2 (4%) Mast Cell Tumor Malignant 1 (2%) Sarcoma 1 (2%) Lymph Node (1) (1) (1) (1) Mediastinal, Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (100%) Lymph Node, Mandibular (28) (29) (30) (30) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (3%) Lymph Node, Mesenteric (48) (46) (45) (41) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Sarcoma, Metastatic, Mesentery 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Spleen (49) (50) (49) (49) Hemangiosarcoma 1 (2%) 2 (4%) Histiocytic Sarcoma 1 (2%) Mast Cell Tumor Malignant, Metastatic, Bone Page 10 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Marrow 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (49) (50) (50) (50) Keratoacanthoma 1 (2%) Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) Subcutaneous Tissue, Melanoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Chondroma 1 (2%) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (2%) Skeletal Muscle (2) (1) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (100%) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (50%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Carcinoma, Metastatic, Harderian Gland 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 9 (18%) 3 (6%) 8 (16%) 5 (10%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Alveolar/Bronchiolar Carcinoma 4 (8%) 3 (6%) 5 (10%) 4 (8%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 7 (14%) 3 (6%) 10 (20%) 5 (10%) Histiocytic Sarcoma 1 (2%) Page 11 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Mediastinum, Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (2%) Nose (50) (50) (50) (47) Mast Cell Tumor Malignant, Metastatic, Bone Marrow 1 (2%) Pleura (1) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (100%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (49) (48) (49) (48) Adenoma 6 (12%) 9 (19%) 4 (8%) 6 (13%) Carcinoma 1 (2%) 2 (4%) Bilateral, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) Histiocytic Sarcoma 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Urinary Bladder (50) (49) (49) (49) Hemangiosarcoma 1 (2%) Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) 3 (6%) Lymphoma Malignant 3 (6%) 1 (2%) 2 (4%) 4 (8%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 12 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:05:34 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 38 32 41 42 Total Primary Neoplasms 69 52 71 75 Total Animals with Benign Neoplasms 29 24 29 27 Total Benign Neoplasms 38 29 36 34 Total Animals with Malignant Neoplasms 24 20 27 30 Total Malignant Neoplasms 31 23 35 41 Total Animals with Metastatic Neoplasms 8 5 11 6 Total Metastatic Neoplasm 12 25 12 8 Total Animals with Malignant Neoplasms 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 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------