TDMS Study 89006-02 Pathology Tables
NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 CORE STUDY Facility: Southern Research Institute Chemical CAS #: 30516-871 Lock Date: 11/01/93 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: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 7 6 5 9 Moribund Sacrifice 7 8 11 12 Dosing Accident 3 2 2 4 Accidently Killed 2 Survivors Terminal Sacrifice 33 32 32 24 Missing 1 Animals Examined Microscopically 50 50 50 49 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (48) (47) (49) (48) Fibrosarcoma, Metastatic, Uterus 1 (2%) Intestine Large, Colon (50) (48) (50) (49) Leiomyoma 1 (2%) Intestine Small, Jejunum (50) (49) (49) (49) Histiocytic Sarcoma 1 (2%) Intestine Small, Ileum (49) (49) (46) (47) Liver (50) (50) (50) (49) Carcinoma, Metastatic, Uterus 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Fibrous Histiocytoma, Metastatic, Lymph Node, Mesenteric 1 (2%) Hemangiosarcoma 1 (2%) Hemangiosarcoma, Multiple 1 (2%) Hepatocellular Carcinoma 12 (24%) 2 (4%) 3 (6%) 6 (12%) Hepatocellular Carcinoma, Multiple 1 (2%) 2 (4%) 2 (4%) 4 (8%) Hepatocellular Adenoma 8 (16%) 14 (28%) 11 (22%) 11 (22%) Hepatocellular Adenoma, Multiple 3 (6%) 3 (6%) 3 (6%) 3 (6%) Histiocytic Sarcoma 2 (4%) 3 (6%) 1 (2%) Mesentery (10) (11) (9) (6) Carcinoma, Metastatic, Uterus 1 (11%) Fibrosarcoma 1 (11%) Hemangioma 1 (10%) Squamous Cell Carcinoma, Metastatic, Vagina 1 (17%) Pancreas (50) (50) (50) (49) Carcinoma, Metastatic, Uterus 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Histiocytic Sarcoma 1 (2%) Salivary Glands (50) (49) (49) (48) Stomach, Forestomach (50) (50) (50) (49) Page 2 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Carcinoma, Metastatic, Uterus 1 (2%) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) 1 (2%) Stomach, Glandular (50) (50) (50) (49) Carcinoma, Metastatic, Uterus 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (49) Heart (50) (50) (50) (49) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (50) (50) (49) Histiocytic Sarcoma 1 (2%) Capsule, Adenoma 1 (2%) Adrenal Medulla (49) (49) (49) (48) Pheochromocytoma Malignant 2 (4%) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (50) (50) (50) (49) Adenoma 1 (2%) Pituitary Gland (50) (47) (48) (47) Pars Distalis, Adenoma 7 (14%) 3 (6%) 4 (8%) 5 (11%) Pars Distalis, Carcinoma 1 (2%) Pars Intermedia, Adenoma 2 (4%) 1 (2%) Thyroid Gland (50) (50) (50) (49) Bilateral, Follicular Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (49) (49) (49) (49) Cystadenoma 4 (8%) 2 (4%) Fibrosarcoma, Metastatic, Uterus 1 (2%) Histiocytic Sarcoma 1 (2%) 2 (4%) 1 (2%) Luteoma 1 (2%) Uterus (50) (50) (50) (49) Page 3 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Fibrosarcoma 1 (2%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 2 (4%) 3 (6%) 1 (2%) Leiomyosarcoma 1 (2%) Endometrium, Carcinoma 1 (2%) 1 (2%) Endometrium, Polyp Stromal 4 (8%) 3 (6%) 2 (4%) Endometrium, Sarcoma Stromal 1 (2%) Vagina (49) (44) (48) (48) Leiomyosarcoma, Metastatic, Uterus 1 (2%) Squamous Cell Carcinoma 5 (10%) 6 (13%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (49) Histiocytic Sarcoma 1 (2%) Lymph Node (4) (8) (10) (10) Histiocytic Sarcoma 1 (13%) Iliac, Histiocytic Sarcoma 1 (13%) 1 (10%) Inguinal, Histiocytic Sarcoma 1 (13%) Inguinal, Squamous Cell Carcinoma, Metastatic, Vagina 1 (10%) Mediastinal, Fibrosarcoma, Metastatic, Mesentery 1 (10%) Mediastinal, Fibrous Histiocytoma, Metastatic, Lymph Node, Mesenteric 1 (10%) Mediastinal, Histiocytic Sarcoma 1 (13%) Renal, Histiocytic Sarcoma 1 (13%) 1 (10%) Lymph Node, Mandibular (49) (45) (46) (48) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (50) (47) (49) (49) Fibrous Histiocytoma 1 (2%) 1 (2%) Histiocytic Sarcoma 2 (4%) 1 (2%) Spleen (50) (50) (50) (49) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) 2 (4%) Thymus (47) (46) (46) (45) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Histiocytic Sarcoma 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (49) (50) (49) Carcinoma 1 (2%) Skin (49) (50) (50) (49) Squamous Cell Carcinoma, Metastatic, Vagina 1 (2%) Page 4 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Fibrosarcoma 1 (2%) 4 (8%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (49) (50) (50) (49) Osteosarcoma 1 (2%) 1 (2%) Skeletal Muscle (50) (50) (50) (49) Carcinoma, Metastatic, Uterus 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Fibrosarcoma, Metastatic, Uterus 1 (2%) Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (49) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Spinal Cord (2) (2) (7) (3) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (49) Alveolar/Bronchiolar Adenoma 1 (2%) 3 (6%) 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 2 (4%) 1 (2%) 1 (2%) Carcinoma, Metastatic, Uterus 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (2) (1) Adenoma 2 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) Histiocytic Sarcoma 2 (4%) Osteosarcoma, Metastatic, Bone 1 (2%) Squamous Cell Carcinoma, Metastatic, Vagina 1 (2%) Urinary Bladder (50) (50) (50) (49) Page 5 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(49) Histiocytic Sarcoma 3 (6%) 3 (6%) 1 (2%) Lymphoma Malignant 13 (26%) 8 (16%) 12 (24%) 11 (22%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 35 39 38 36 Total Primary Neoplasms 60 58 61 62 Total Animals with Benign Neoplasms 23 25 23 20 Total Benign Neoplasms 28 33 26 27 Total Animals with Malignant Neoplasms 23 23 28 28 Total Malignant Neoplasms 32 25 35 35 Total Animals with Metastatic Neoplasms 2 1 5 1 Total Metastatic Neoplasm 2 1 19 4 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 7 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 13 14 5 9 Natural Death 1 7 4 6 Dosing Accident 2 2 Accidently Killed 1 Survivors Terminal Sacrifice 36 27 38 35 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) Squamous Cell Papilloma 1 (2%) Intestine Small, Jejunum (50) (50) (48) (50) Carcinoma 1 (2%) Fibrous Histiocytoma, Metastatic, Lymph Node, Mesenteric 1 (2%) Intestine Small, Ileum (50) (48) (49) (50) Liver (50) (50) (50) (50) Carcinoid Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Cholangiocarcinoma 1 (2%) Fibrous Histiocytoma, Metastatic, Lymph Node, Mesenteric 1 (2%) Hemangiosarcoma 1 (2%) 2 (4%) 1 (2%) 1 (2%) Hemangiosarcoma, Multiple 2 (4%) 3 (6%) 3 (6%) 3 (6%) Hepatoblastoma 1 (2%) 1 (2%) 1 (2%) Hepatocellular Carcinoma 12 (24%) 13 (26%) 15 (30%) 9 (18%) Hepatocellular Carcinoma, Multiple 1 (2%) 7 (14%) 2 (4%) 5 (10%) Hepatocellular Adenoma 10 (20%) 12 (24%) 14 (28%) 14 (28%) Hepatocellular Adenoma, Multiple 6 (12%) 4 (8%) 5 (10%) 4 (8%) Histiocytic Sarcoma 2 (4%) 1 (2%) Ito Cell Tumor Benign 1 (2%) Sarcoma, Metastatic, Mesentery 1 (2%) Sarcoma, Metastatic, Skeletal Muscle 1 (2%) Mesentery (1) (2) (1) Cholangiocarcinoma, Metastatic, Liver 1 (50%) Sarcoma 1 (50%) Pancreas (50) (50) (50) (50) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Sarcoma, Metastatic, Mesentery 1 (2%) Page 8 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Sarcoma, Metastatic, Skeletal Muscle 1 (2%) Salivary Glands (50) (50) (50) (50) Stomach, Forestomach (50) (50) (50) (50) Sarcoma, Metastatic, Mesentery 1 (2%) Sarcoma, Metastatic, Skeletal Muscle 1 (2%) Squamous Cell Papilloma 1 (2%) 2 (4%) Stomach, Glandular (50) (50) (50) (50) Carcinoma 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Carcinoid Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) Sarcoma, Metastatic, Skeletal Muscle 1 (2%) Bilateral, Capsule, Adenoma 1 (2%) Capsule, Adenoma 2 (4%) Adrenal Medulla (50) (50) (50) (50) Pheochromocytoma Malignant 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 1 (2%) Pituitary Gland (48) (43) (48) (47) Pars Distalis, Adenoma 1 (2%) Pars Intermedia, Adenoma 1 (2%) Pars Intermedia, Carcinoma 1 (2%) Thyroid Gland (50) (50) (50) (49) Bilateral, Follicular Cell, Adenoma 1 (2%) Follicular Cell, Adenoma 3 (6%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Hemangiosarcoma 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Preputial Gland (48) (48) (50) (50) Carcinoma 1 (2%) Prostate (50) (50) (48) (50) Testes (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Interstitial Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hemangiosarcoma 1 (2%) 1 (2%) Lymph Node (5) (8) (5) (5) Iliac, Histiocytic Sarcoma 1 (20%) Inguinal, Histiocytic Sarcoma 1 (20%) Pancreatic, Fibrous Histiocytoma, Metastatic, Lymph Node, Mesenteric 1 (13%) Pancreatic, Sarcoma, Metastatic, Skeletal Muscle 1 (13%) Renal, Fibrous Histiocytoma, Metastatic, Lymph Node, Mesenteric 1 (20%) Renal, Histiocytic Sarcoma 1 (20%) 1 (13%) Lymph Node, Mandibular (46) (47) (49) (46) Carcinoma, Metastatic, Harderian Gland 1 (2%) Lymph Node, Mesenteric (50) (48) (50) (47) Fibrous Histiocytoma 1 (2%) 1 (2%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 2 (4%) 1 (2%) Sarcoma, Metastatic, Mesentery 1 (2%) Sarcoma, Metastatic, Skeletal Muscle 1 (2%) Spleen (50) (49) (49) (50) Fibrous Histiocytoma, Metastatic, Lymph Node, Mesenteric 1 (2%) Hemangiosarcoma 1 (2%) 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Thymus (45) (40) (42) (43) Fibrosarcoma 1 (2%) Fibrous Histiocytoma, Metastatic, Lymph Node, Mesenteric 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (3%) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Skeletal Muscle (50) (50) (50) (50) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (50) (50) (50) Alveolar/Bronchiolar Adenoma 7 (14%) 3 (6%) 7 (14%) 7 (14%) Alveolar/Bronchiolar Adenoma, Multiple 3 (6%) 1 (2%) 2 (4%) 1 (2%) Alveolar/Bronchiolar Carcinoma 4 (8%) 2 (4%) 6 (12%) 6 (12%) Alveolar/Bronchiolar Carcinoma, Multiple 2 (4%) 1 (2%) Carcinoid Tumor Malignant, Metastatic, Uncertain Primary Site 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Fibrous Histiocytoma, Metastatic, Lymph Node, Mesenteric 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 3 (6%) 2 (4%) 3 (6%) Histiocytic Sarcoma 1 (2%) 1 (2%) Sarcoma, Metastatic, Skeletal Muscle 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (3) (3) (1) (5) Adenoma 3 (100%) 3 (100%) 1 (100%) 2 (40%) Carcinoma 2 (40%) ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Renal Tubule, Adenoma 1 (2%) Urinary Bladder (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 2 (4%) 2 (4%) Lymphoma Malignant 7 (14%) 8 (16%) 5 (10%) 6 (12%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 12 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 09:09:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 40 41 42 47 Total Primary Neoplasms 72 72 69 75 Total Animals with Benign Neoplasms 26 20 26 30 Total Benign Neoplasms 36 25 33 36 Total Animals with Malignant Neoplasms 30 32 29 33 Total Malignant Neoplasms 36 47 36 39 Total Animals with Metastatic Neoplasms 4 8 2 5 Total Metastatic Neoplasm 4 23 2 13 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 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------