TDMS Study 89006-08 Pathology Tables
NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 Facility: Southern Research Institute Chemical CAS #: 76543-88-9 Lock Date: 09/03/93 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: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 13 13 9 11 Natural Death 12 5 15 8 Dosing Accident 1 Survivors Terminal Sacrifice 25 32 25 31 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (45) (50) (48) (49) Intestine Large, Colon (47) (50) (50) (49) Intestine Large, Cecum (48) (50) (50) (49) Liposarcoma, Metastatic, Mesentery 1 (2%) Intestine Small, Duodenum (47) (50) (49) (45) Intestine Small, Jejunum (47) (50) (49) (48) Histiocytic Sarcoma 1 (2%) Intestine Small, Ileum (47) (50) (49) (48) Histiocytic Sarcoma 1 (2%) Liver (49) (50) (50) (50) Carcinoma, Metastatic, Harderian Gland 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) Hemangiosarcoma, Multiple 1 (2%) 1 (2%) Hepatocellular Carcinoma 9 (18%) 10 (20%) 10 (20%) 12 (24%) Hepatocellular Carcinoma, Multiple 7 (14%) 2 (4%) 3 (6%) 6 (12%) Hepatocellular Adenoma 12 (24%) 16 (32%) 12 (24%) 13 (26%) Hepatocellular Adenoma, Multiple 12 (24%) 9 (18%) 10 (20%) 9 (18%) Hepatocholangiocarcinoma 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) Liposarcoma, Metastatic, Mesentery 1 (2%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Plasma Cell Tumor Malignant, Metastatic, Spleen 1 (2%) Mesentery (21) (21) (18) (16) Carcinoma, Metastatic, Harderian Gland 1 (5%) Fibrosarcoma 1 (6%) Fibrosarcoma, Metastatic, Skin 1 (5%) 1 (6%) Fibrosarcoma, Metastatic, Tissue NOS 1 (5%) Hemangiosarcoma 1 (6%) Page 2 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Hepatocellular Carcinoma, Metastatic, Liver 1 (5%) Histiocytic Sarcoma 1 (5%) 1 (5%) Liposarcoma 1 (5%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (6%) Pancreas (48) (50) (50) (50) Fibrosarcoma, Metastatic, Skin 1 (2%) Fibrosarcoma, Metastatic, Tissue NOS 1 (2%) Liposarcoma, Metastatic, Mesentery 1 (2%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Acinus, Adenoma 1 (2%) Salivary Glands (50) (50) (48) (49) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Stomach, Forestomach (48) (50) (50) (46) Liposarcoma, Metastatic, Mesentery 1 (2%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Squamous Cell Papilloma 2 (4%) Stomach, Glandular (48) (50) (50) (46) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Liposarcoma, Metastatic, Mesentery 1 (2%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Carcinoma, Metastatic, Harderian Gland 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (50) (49) Adenoma 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Capsule, Adenoma 1 (2%) Adrenal Medulla (50) (49) (50) (49) Pheochromocytoma Malignant 1 (2%) 1 (2%) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (48) (50) (50) (50) Adenoma 1 (2%) Pituitary Gland (46) (47) (44) (43) Pars Distalis, Adenoma 11 (24%) 8 (17%) 7 (16%) 5 (12%) Pars Intermedia, Adenoma 1 (2%) Page 3 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Thyroid Gland (50) (50) (49) (50) Carcinoma, Metastatic, Harderian Gland 1 (2%) Follicular Cell, Adenoma 5 (10%) 3 (6%) 2 (4%) 4 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (2) (1) Fibrosarcoma, Metastatic, Skin 1 (50%) Tissue NOS (1) (1) (2) Abdominal, Fibrosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (49) (47) (49) Hemangioma 1 (2%) Ovary (46) (48) (49) (48) Carcinoma, Metastatic, Harderian Gland 1 (2%) Cystadenoma 4 (9%) 2 (4%) 1 (2%) Granulosa Cell Tumor Benign 1 (2%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Liposarcoma, Metastatic, Mesentery 1 (2%) Teratoma Benign 1 (2%) 1 (2%) Uterus (50) (50) (50) (50) Hemangioma 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) Liposarcoma, Metastatic, Mesentery 1 (2%) Endometrium, Polyp Stromal 1 (2%) 1 (2%) 2 (4%) Endometrium, Sarcoma Stromal 1 (2%) Vagina (48) (50) (47) (46) Sarcoma 1 (2%) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Plasma Cell Tumor Malignant, Metastatic, Spleen 1 (2%) Lymph Node (12) (13) (9) (11) Bronchial, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (8%) Iliac, Histiocytic Sarcoma 1 (8%) 1 (8%) Inguinal, Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (11%) Page 4 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Mediastinal, Carcinoma, Metastatic, Harderian Gland 1 (8%) Mediastinal, Fibrosarcoma, Metastatic, Mesentery 1 (9%) Mediastinal, Fibrosarcoma, Metastatic, Skin 1 (8%) Mediastinal, Fibrosarcoma, Metastatic, Tissue NOS 1 (8%) Mediastinal, Hepatocellular Carcinoma, Metastatic, Liver 1 (8%) Mediastinal, Liposarcoma, Metastatic, Mesentery 1 (8%) Pancreatic, Histiocytic Sarcoma 1 (8%) Renal, Histiocytic Sarcoma 1 (8%) 1 (11%) Renal, Liposarcoma, Metastatic, Mesentery 1 (8%) Lymph Node, Mandibular (49) (49) (47) (48) Histiocytic Sarcoma 1 (2%) 1 (2%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Lymph Node, Mesenteric (45) (50) (50) (47) Histiocytic Sarcoma 2 (4%) 1 (2%) Liposarcoma, Metastatic, Mesentery 1 (2%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Spleen (47) (50) (50) (49) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Hemangiosarcoma 1 (2%) 1 (2%) 2 (4%) Histiocytic Sarcoma 1 (2%) 1 (2%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Plasma Cell Tumor Malignant 1 (2%) Thymus (41) (48) (48) (39) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (3%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Histiocytic Sarcoma 1 (2%) Liposarcoma, Metastatic, Mesentery 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (48) (50) (50) Carcinoma 1 (2%) Skin (50) (50) (50) (50) Basal Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) Page 5 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Carcinoma, Metastatic, Harderian Gland 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 2 (4%) 2 (4%) 2 (4%) Subcutaneous Tissue, Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Osteosarcoma 1 (2%) 1 (2%) Skeletal Muscle (50) (50) (50) (50) Carcinoma, Metastatic, Harderian Gland 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Fibrosarcoma, Metastatic, Tissue NOS 1 (2%) Liposarcoma, Metastatic, Mesentery 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (50) (50) Spinal Cord (2) (2) (4) (1) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 5 (10%) 4 (8%) 3 (6%) Alveolar/Bronchiolar Carcinoma 2 (4%) 4 (8%) 7 (14%) Basal Cell Carcinoma, Metastatic, Skin 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 2 (4%) 2 (4%) 3 (6%) 4 (8%) Histiocytic Sarcoma 1 (2%) 1 (2%) Liposarcoma, Metastatic, Mesentery 1 (2%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Mediastinum, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Mediastinum, Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Nose (50) (50) (50) (50) Carcinoma, Metastatic, Harderian Gland 1 (2%) Page 6 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (3) (8) (4) (3) Adenoma 2 (67%) 5 (63%) 3 (75%) 3 (100%) Carcinoma 1 (33%) 2 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (50) (49) (50) Carcinoma, Metastatic, Harderian Gland 1 (2%) Mast Cell Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Ureter (1) Fibrosarcoma, Metastatic, Skin 1 (100%) Urinary Bladder (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 2 (4%) 1 (2%) 2 (4%) 1 (2%) Lymphoma Malignant 11 (22%) 13 (26%) 11 (22%) 6 (12%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 7 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 48 48 44 44 Total Primary Neoplasms 96 92 72 84 Total Animals with Benign Neoplasms 34 32 33 31 Total Benign Neoplasms 53 52 42 43 Total Animals with Malignant Neoplasms 35 33 27 30 Total Malignant Neoplasms 43 40 30 41 Total Animals with Metastatic Neoplasms 7 6 4 7 Total Metastatic Neoplasm 36 12 17 12 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 8 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 10 15 11 13 Moribund Sacrifice 13 7 10 10 Dosing Accident 1 Survivors Terminal Sacrifice 27 28 28 27 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (45) (45) (48) (43) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Intestine Small, Duodenum (49) (47) (49) (50) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Polyp Adenomatous 1 (2%) Intestine Small, Jejunum (49) (47) (49) (50) Carcinoma 1 (2%) 1 (2%) 1 (2%) Hepatoblastoma, Metastatic, Liver 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Intestine Small, Ileum (49) (47) (49) (50) Fibrous Histiocytoma 1 (2%) Hepatoblastoma, Metastatic, Liver 1 (2%) Liver (50) (50) (50) (50) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Fibrous Histiocytoma 1 (2%) Hemangioma, Multiple 1 (2%) Hemangiosarcoma 1 (2%) 1 (2%) 2 (4%) 2 (4%) Hemangiosarcoma, Multiple 3 (6%) 3 (6%) 2 (4%) 2 (4%) Hepatoblastoma 2 (4%) 1 (2%) 1 (2%) 3 (6%) Hepatocellular Carcinoma 10 (20%) 17 (34%) 10 (20%) 13 (26%) Hepatocellular Carcinoma, Multiple 8 (16%) 6 (12%) 4 (8%) 6 (12%) Hepatocellular Adenoma 11 (22%) 10 (20%) 11 (22%) 14 (28%) Hepatocellular Adenoma, Multiple 3 (6%) 4 (8%) 5 (10%) 5 (10%) Hepatocholangiocarcinoma 1 (2%) 1 (2%) 2 (4%) Histiocytic Sarcoma 1 (2%) 1 (2%) Mesentery (7) (5) (6) (9) Fibrosarcoma 1 (17%) Fibrous Histiocytoma 1 (20%) 1 (17%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (14%) 1 (17%) 1 (11%) Histiocytic Sarcoma 1 (11%) Pancreas (49) (49) (49) (49) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Page 9 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Fibrous Histiocytoma, Metastatic, Mesentery 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) 1 (2%) 1 (2%) Salivary Glands (50) (50) (49) (50) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Stomach, Forestomach (50) (48) (49) (50) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (48) (49) (50) Adenoma 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Tooth (24) (14) (24) (20) Odontoma 1 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Hepatoblastoma, Metastatic, Liver 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (50) (49) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Hepatoblastoma, Metastatic, Liver 1 (2%) Bilateral, Capsule, Adenoma 1 (2%) Capsule, Adenoma 1 (2%) 1 (2%) 3 (6%) 3 (6%) Adrenal Medulla (49) (49) (50) (49) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Pheochromocytoma Benign 1 (2%) 1 (2%) Bilateral, Pheochromocytoma Benign 1 (2%) 1 (2%) Islets, Pancreatic (50) (48) (50) (50) Adenoma 1 (2%) Carcinoma 1 (2%) Thyroid Gland (50) (49) (50) (50) Follicular Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) Tissue NOS (1) (2) (1) (1) Hepatoblastoma, Metastatic, Liver 1 (100%) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Preputial Gland (50) (50) (50) (50) Adenoma 1 (2%) Prostate (49) (49) (50) (49) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Seminal Vesicle (50) (50) (50) (50) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Testes (50) (50) (50) (50) Sertoli Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hemangiosarcoma 2 (4%) Histiocytic Sarcoma 1 (2%) Lymph Node (3) (3) (6) (3) Iliac, Fibrous Histiocytoma 1 (33%) Mediastinal, Fibrosarcoma, Metastatic, Mesentery 1 (17%) Mediastinal, Fibrous Histiocytoma 1 (33%) Mediastinal, Fibrous Histiocytoma, Metastatic, Mesentery 1 (17%) Mediastinal, Hepatocholangiocarcinoma, Metastatic, Liver 1 (33%) 1 (17%) 1 (33%) Mediastinal, Histiocytic Sarcoma 1 (33%) Pancreatic, Hepatocholangiocarcinoma, Metastatic, Liver 1 (33%) Renal, Fibrous Histiocytoma 1 (33%) Lymph Node, Mandibular (47) (46) (45) (45) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (50) (48) (46) (50) Fibrous Histiocytoma, Metastatic, Mesentery 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) Spleen (49) (49) (49) (50) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Fibrous Histiocytoma 1 (2%) Hemangiosarcoma 5 (10%) 2 (4%) Histiocytic Sarcoma 1 (2%) 1 (2%) Thymus (38) (38) (35) (39) Fibrous Histiocytoma 1 (3%) ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (49) (50) (50) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Hemangioma 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Hepatoblastoma, Metastatic, Liver 1 (2%) Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (50) (50) (50) (50) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 8 (16%) 10 (20%) 8 (16%) 5 (10%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 4 (8%) 4 (8%) 3 (6%) 3 (6%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Fibrous Histiocytoma 1 (2%) Hepatoblastoma, Metastatic, Liver 1 (2%) 2 (4%) Hepatocellular Carcinoma, Metastatic, Liver 6 (12%) 10 (20%) 2 (4%) 7 (14%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) 1 (2%) 2 (4%) Histiocytic Sarcoma 1 (2%) 1 (2%) Mediastinum, Fibrosarcoma, Metastatic, Mesentery 1 (2%) Mediastinum, Fibrous Histiocytoma, Metastatic, Mesentery 1 (2%) Mediastinum, Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Nose (50) (50) (50) (50) Carcinoma, Metastatic, Harderian Gland 2 (4%) ____________________________________________________________________________________________________________________________________ Page 12 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (4) (6) (8) (4) Adenoma 2 (50%) 5 (83%) 4 (50%) 3 (75%) Carcinoma 2 (50%) 1 (17%) 1 (13%) 1 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (49) (49) (50) Fibrous Histiocytoma 1 (2%) Hemangioma 1 (2%) Hepatoblastoma, Metastatic, Liver 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Urinary Bladder (49) (49) (50) (50) Hemangioma 1 (2%) Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) 2 (4%) Lymphoma Malignant 4 (8%) 2 (4%) 5 (10%) 2 (4%) Mesothelioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 13 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:41 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 42 40 41 47 Total Primary Neoplasms 66 94 75 70 Total Animals with Benign Neoplasms 22 26 28 29 Total Benign Neoplasms 29 38 39 34 Total Animals with Malignant Neoplasms 32 30 25 30 Total Malignant Neoplasms 37 56 36 36 Total Animals with Metastatic Neoplasms 10 10 5 11 Total Metastatic Neoplasm 26 10 24 22 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 14 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------