TDMS Study 05092-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) O-NITROANISOLE NTP Experiment-Test: 05092-01 Report: PEIRPT05 Study Type: CHRONIC Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 Facility: Southern Research Institute Chemical CAS #: 0091-23-6 Lock Date: None 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: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 10 50 10 50 10 Scheduled Sacrifice 10 10 10 Early Deaths Moribund Sacrifice 17 7 18 Natural Death 2 6 Survivors Terminal Sacrifice 33 41 26 Animals Examined Microscopically 50 10 50 10 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (10) (49) (46) Intestine Large, Colon (50) (10) (49) (46) Intestine Large, Rectum (50) (10) (49) (46) Intestine Small, Ileum (50) (10) (49) (46) Intestine Small, Jejunum (50) (10) (49) (47) Liver (50) (10) (50) (10) (50) (10) Sarcoma Stromal, Metastatic, Uterus 1 (2%) Mesentery (9) (1) (6) (2) (11) Hemangiosarcoma 1 (17%) Fat, Fibrosarcoma 1 (11%) Fat, Lipoma 1 (17%) Fat, Sarcoma Stromal, Metastatic, Uterus 1 (9%) Pancreas (50) (10) (50) (49) Pharynx (2) Palate, Squamous Cell Carcinoma 1 (50%) Stomach, Forestomach (50) (10) (50) (1) (50) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (10) (50) (1) (50) Tongue (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) (50) (50) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (10) (50) (50) Adenoma 1 (2%) 5 (10%) Adrenal Gland, Medulla (50) (10) (50) (50) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (50) (10) (50) (49) Adenoma 2 (4%) 1 (2%) 2 (4%) Carcinoma 1 (2%) Pituitary Gland (50) (10) (50) (3) (50) (1) Pars Distalis, Adenoma 28 (56%) 28 (56%) 2 (67%) 27 (54%) 1 (100%) Pars Distalis, Carcinoma 1 (2%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (10) (50) (50) (1) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 4 (8%) 3 (6%) 2 (4%) C-Cell, Adenoma, Multiple 1 (2%) C-Cell, Carcinoma 2 (4%) 2 (4%) 1 (2%) 1 (100%) Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (45) (10) (47) (10) (50) (10) Adenoma 3 (7%) 5 (11%) 3 (6%) 1 (10%) Carcinoma 4 (9%) 1 (2%) 2 (4%) Bilateral, Carcinoma 1 (2%) Ovary (50) (10) (50) (50) Thecoma Benign 1 (2%) Uterus (50) (10) (50) (10) (50) (10) Hemangioma 1 (2%) Leiomyosarcoma 1 (2%) Polyp Stromal 9 (18%) 3 (30%) 13 (26%) 8 (16%) Sarcoma Stromal 3 (6%) Cervix, Leiomyoma 1 (2%) Cervix, Leiomyosarcoma 1 (2%) Vagina (3) (1) Polyp 1 (100%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (10) (50) (50) Lymph Node (50) (10) (50) (50) Lymph Node, Mandibular (48) (10) (49) (50) Lymph Node, Mesenteric (48) (10) (50) (50) Spleen (50) (10) (50) (10) (50) (10) Sarcoma 1 (2%) Thymus (47) (10) (49) (47) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) (50) (50) Adenocarcinoma 2 (4%) 2 (4%) Adenoma 1 (2%) Fibroadenoma 17 (34%) 17 (34%) 12 (24%) Fibroadenoma, Multiple 1 (2%) 3 (6%) Skin (50) (10) (50) (50) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 2 (4%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) (50) (50) Maxilla, Squamous Cell Carcinoma, Metastatic, Nose 1 (2%) Skeletal Muscle (1) (1) Abdominal, Lipoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) (50) (50) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) (50) (50) (1) Alveolar/Bronchiolar Adenoma 2 (4%) 1 (100%) Nose (50) (10) (50) (3) (50) (6) Respiratory Epithelium, Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Pinna, Schwannoma Malignant 1 (100%) Zymbal's Gland (1) (1) Carcinoma 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) (50) (10) (50) (10) Myxosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(10) *(50) *(10) *(50) *(10) Leukemia Mononuclear 14 (28%) 11 (22%) 14 (28%) 1 (10%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 46 3 46 2 46 5 Total Primary Neoplasms 99 3 101 2 93 6 Total Animals with Benign Neoplasms 40 3 44 2 38 3 Total Benign Neoplasms 73 3 80 2 62 3 Total Animals with Malignant Neoplasms 21 18 27 3 Total Malignant Neoplasms 26 21 31 3 Total Animals with Metastatic Neoplasms 2 1 Total Metastatic Neoplasm 2 2 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 6 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 10 Scheduled Sacrifice 9 Early Deaths Moribund Sacrifice 14 1 Natural Death 3 Survivors Terminal Sacrifice 33 Animals Examined Microscopically 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (10) Intestine Small, Jejunum (48) (10) Liver (50) (10) Hepatocellular Adenoma 3 (6%) Mesentery (12) (4) Pancreas (50) (10) Acinar Cell, Adenoma 1 (2%) Acinar Cell, Adenoma, Multiple 1 (2%) Salivary Glands (50) (10) Stomach, Forestomach (50) (10) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (10) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (10) Adenoma 2 (4%) Adrenal Gland, Medulla (49) (10) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 1 (2%) Pituitary Gland (50) (10) Pars Distalis, Adenoma 19 (38%) Pars Distalis, Adenoma, Multiple 1 (10%) Thyroid Gland (50) (10) Page 7 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont C-Cell, Adenoma 3 (6%) 1 (10%) C-Cell, Carcinoma 1 (2%) 1 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (10) Adenoma 3 (6%) Carcinoma 2 (4%) Ovary (50) (10) Uterus (50) (10) Hemangiosarcoma 1 (2%) Leiomyoma 1 (2%) Polyp Stromal 8 (16%) 2 (20%) Polyp Stromal, Multiple 1 (2%) Sarcoma Stromal 1 (2%) Cervix, Adenocarcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (10) Lymph Node (50) (10) Lymph Node, Mandibular (50) (10) Lymph Node, Mesenteric (47) (10) Spleen (50) (10) Thymus (48) (10) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) Carcinoma 1 (2%) Fibroadenoma 8 (16%) Fibroadenoma, Multiple 1 (2%) Skin (50) (10) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) Alveolar/Bronchiolar Adenoma 3 (6%) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (5) Harderian Gland (2) Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) Urinary Bladder (50) (10) Transitional Epithelium, Carcinoma 1 (2%) Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(10) Leukemia Mononuclear 26 (52%) 1 (10%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 9 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 46 4 Total Primary Neoplasms 95 6 Total Animals with Benign Neoplasms 35 2 Total Benign Neoplasms 57 4 Total Animals with Malignant Neoplasms 32 2 Total Malignant Neoplasms 38 2 Total Animals with Metastatic Neoplasms Total Metastatic Neoplasm 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 10 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 10 50 10 50 10 Scheduled Sacrifice 10 10 10 Early Deaths Natural Death 2 3 2 Moribund Sacrifice 16 13 24 Survivors Terminal Sacrifice 32 34 24 Animals Examined Microscopically 50 10 50 10 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (48) (10) (48) (49) Intestine Large, Rectum (46) (10) (49) (50) Intestine Small, Duodenum (49) (10) (47) (50) Intestine Small, Ileum (48) (10) (47) (48) Intestine Small, Jejunum (48) (10) (47) (48) Liver (50) (10) (50) (10) (50) (10) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 3 (6%) 1 (2%) Mesentery (10) (2) (11) (2) (5) (2) Histiocytic Sarcoma 1 (10%) Pancreas (49) (10) (49) (50) (1) Histiocytic Sarcoma 1 (2%) Acinar Cell, Adenoma 5 (10%) 3 (6%) Pharynx (1) Palate, Squamous Cell Papilloma 1 (100%) Stomach, Forestomach (50) (10) (50) (50) (1) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (10) (49) (50) (1) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) (50) (1) (50) Schwannoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (48) (10) (50) (50) Adenoma 2 (4%) 1 (2%) Adrenal Gland, Medulla (49) (10) (50) (50) Ganglioneuroma 1 (10%) Pheochromocytoma Malignant 4 (8%) 3 (6%) 2 (4%) Pheochromocytoma Benign 7 (14%) 5 (10%) 8 (16%) Bilateral, Pheochromocytoma Malignant 2 (4%) Bilateral, Pheochromocytoma Benign 2 (4%) Islets, Pancreatic (49) (10) (49) (50) Adenoma 1 (2%) 3 (6%) 4 (8%) Adenoma, Multiple 1 (2%) Mixed Tumor Benign 2 (4%) Parathyroid Gland (47) (10) (46) (47) Adenoma 1 (2%) Pituitary Gland (50) (10) (50) (1) (49) Pars Distalis, Adenoma 14 (28%) 3 (30%) 11 (22%) 1 (100%) 9 (18%) Pars Distalis, Carcinoma 1 (2%) 1 (2%) Thyroid Gland (49) (10) (50) (50) C-Cell, Adenoma 1 (2%) 2 (4%) 2 (4%) C-Cell, Carcinoma 1 (2%) 2 (4%) Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (10) (50) (10) (50) (10) Preputial Gland (50) (10) (50) (10) (50) (9) Adenoma 3 (6%) 1 (2%) Carcinoma 6 (12%) 4 (8%) 1 (10%) 3 (6%) 1 (11%) Squamous Cell Carcinoma 2 (4%) Bilateral, Adenoma 1 (2%) Bilateral, Carcinoma 1 (2%) Prostate (50) (10) (50) (50) Sarcoma 1 (2%) Seminal Vesicle (50) (10) (50) (50) (1) Testes (50) (10) (50) (10) (50) (10) Bilateral, Interstitial Cell, Adenoma 40 (80%) 4 (40%) 38 (76%) 1 (10%) 36 (72%) 4 (40%) Interstitial Cell, Adenoma 8 (16%) 1 (10%) 7 (14%) 5 (50%) 9 (18%) 5 (50%) ____________________________________________________________________________________________________________________________________ Page 12 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (10) (50) (50) Lymph Node (50) (10) (50) (50) (1) Mediastinal, Histiocytic Sarcoma 1 (2%) Pancreatic, Histiocytic Sarcoma 1 (2%) Lymph Node, Mandibular (50) (10) (48) (50) Lymph Node, Mesenteric (49) (10) (48) (49) Histiocytic Sarcoma 1 (2%) Spleen (50) (10) (49) (10) (50) (10) Hemangiosarcoma 1 (2%) Thymus (45) (9) (48) (42) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (10) (49) (47) Adenoma 1 (2%) Fibroadenoma 3 (6%) 1 (2%) 2 (4%) Skin (50) (10) (50) (1) (50) Basal Cell Adenoma 1 (2%) Basosquamous Tumor Benign 1 (2%) Hemangioma 1 (2%) Keratoacanthoma 3 (6%) 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) Sebaceous Gland, Carcinoma 1 (2%) Subcutaneous Tissue, Basal Cell Carcinoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 3 (6%) 2 (4%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) Subcutaneous Tissue, Scrotum, Fibrosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) (50) (50) Cranium, Osteoma 1 (2%) Femur, Chondroma 1 (2%) Tibia, Chondroma 1 (2%) Skeletal Muscle (1) ____________________________________________________________________________________________________________________________________ Page 13 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) (50) (50) Astrocytoma Malignant 1 (2%) Glioma Malignant 1 (10%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) (50) (1) (50) Alveolar/Bronchiolar Adenoma 2 (4%) 2 (4%) 2 (4%) Alveolar/Bronchiolar Adenoma, Multiple 1 (10%) 1 (100%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Pheochromocytoma Malignant, Multiple, Metastatic, Adrenal Gland 1 (2%) Nose (50) (10) (50) (50) Lumen, Endothelium, Squamous Cell Carcinoma 1 (2%) Respiratory Epithelium, Squamous Cell Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Pinna, Schwannoma Malignant 1 (100%) Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (10) (50) (10) (50) (10) Renal Tubule, Adenoma 1 (2%) 1 (2%) Urinary Bladder (50) (10) (50) (10) (50) (10) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(10) *(50) *(10) *(50) *(10) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 26 (52%) 25 (50%) 1 (10%) 42 (84%) Mesothelioma Malignant 1 (2%) 1 (10%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 14 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 8 49 7 50 9 Total Primary Neoplasms 147 12 133 11 140 10 Total Animals with Benign Neoplasms 50 8 48 6 47 9 Total Benign Neoplasms 96 10 90 8 85 9 Total Animals with Malignant Neoplasms 35 2 33 2 45 1 Total Malignant Neoplasms 51 2 43 3 55 1 Total Animals with Metastatic Neoplasms 1 1 Total Metastatic Neoplasm 1 1 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 15 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 10 Scheduled Sacrifice 9 Early Deaths Moribund Sacrifice 35 1 Natural Death 6 Survivors Natural Death 1 Terminal Sacrifice 8 Animals Examined Microscopically 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (47) (10) Intestine Large, Colon (48) (10) Intestine Small, Duodenum (47) (10) Intestine Small, Ileum (46) (10) Intestine Small, Jejunum (48) (10) Adenocarcinoma 1 (2%) Liver (50) (10) Hepatocellular Adenoma 1 (2%) Hepatocellular Adenoma, Multiple 1 (2%) Mesentery (9) Pancreas (48) (10) Carcinoma, Metastatic 1 (2%) Acinar Cell, Adenoma 5 (10%) Stomach, Forestomach (50) (10) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (10) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (10) Adrenal Gland, Medulla (49) (10) Pheochromocytoma Benign 9 (18%) Bilateral, Pheochromocytoma Benign 1 (2%) Page 16 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Islets, Pancreatic (48) (10) Adenoma 2 (4%) Mixed Tumor Benign 1 (2%) Parathyroid Gland (48) (10) Adenoma 1 (2%) Pituitary Gland (49) (10) Pars Distalis, Adenoma 4 (8%) Thyroid Gland (50) (10) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (10) Preputial Gland (49) (10) Adenoma 1 (2%) Carcinoma 8 (16%) 1 (10%) Prostate (50) (10) Seminal Vesicle (50) (10) Testes (50) (10) Bilateral, Interstitial Cell, Adenoma 35 (70%) 4 (40%) Interstitial Cell, Adenoma 10 (20%) 3 (30%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (10) Lymph Node (50) (10) Lymph Node, Mandibular (50) (10) Lymph Node, Mesenteric (48) (10) Spleen (50) (10) Carcinoma, Metastatic, Harderian Gland 1 (2%) Hemangiosarcoma 2 (4%) Sarcoma 1 (2%) Thymus (47) (10) ____________________________________________________________________________________________________________________________________ Page 17 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) Fibroadenoma 1 (2%) Skin (50) (10) Basal Cell Carcinoma 1 (2%) Keratoacanthoma 2 (4%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Myxosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) Skeletal Muscle (2) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) Glioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) Nose (50) (10) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) Harderian Gland (2) Carcinoma 1 (50%) Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (10) Renal Tubule, Adenoma 1 (2%) Renal Tubule, Carcinoma 2 (4%) Urinary Bladder (50) (10) Page 18 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont Transitional Epithelium, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(10) Leukemia Mononuclear 34 (68%) 2 (20%) Mesothelioma Malignant 3 (6%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 19 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 8 Total Primary Neoplasms 137 10 Total Animals with Benign Neoplasms 48 7 Total Benign Neoplasms 78 7 Total Animals with Malignant Neoplasms 44 3 Total Malignant Neoplasms 59 3 Total Animals with Metastatic Neoplasms 2 Total Metastatic Neoplasm 2 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 20 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------