TR 388 Rat Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) ETHYLENETHIOUREA NTP Experiment-Test: 05076-01 Report: PEIRPT05 Study Type: CHRONIC Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 Facility: Battelle Columbus Laboratory Chemical CAS #: 96-45-7 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: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 50 50 Early Deaths Moribund Sacrifice 20 15 13 8 10 13 Natural Death 6 5 3 9 13 4 Survivors Moribund Sacrifice 2 1 Terminal Sacrifice 23 30 34 30 26 32 Natural Death 1 1 1 Animals Examined Microscopically 50 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (49) (50) (49) (50) Intestine Large, Colon (47) (47) (50) (45) (43) (47) Intestine Small, Duodenum (49) (49) (50) (48) (48) (49) Intestine Small, Ileum (45) (47) (48) (42) (42) (44) Jejunum, Sarcoma Stromal, Metastatic 1 (2%) Intestine Small, Jejunum (47) (47) (50) (44) (45) (48) Leiomyoma 1 (2%) Liver (50) (50) (50) (50) (50) (50) Adenocarcinoma, Metastatic, Uterus 1 (2%) Hepatocellular Adenoma 1 (2%) 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Neoplastic Nodule 1 (2%) Mesentery (3) (2) (2) (1) (4) (8) Adenocarcinoma, Metastatic, Uterus 1 (33%) Sarcoma Stromal, Metastatic, Uterus 1 (50%) Pancreas (50) (49) (50) (49) (49) (50) Adenocarcinoma, Metastatic, Uterus 1 (2%) Salivary Glands (50) (50) (50) (50) (50) (49) Stomach, Forestomach (49) (49) (50) (49) (48) (50) Glandular, Adenocarcinoma, Metastatic, Uterus 1 (2%) Stomach, Glandular (48) (49) (50) (48) (48) (50) Tongue (1) (1) (1) (1) (1) Squamous Cell Carcinoma 1 (100%) Squamous Cell Papilloma 1 (100%) 1 (100%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (49) (49) (48) (49) (50) Adenoma 2 (4%) 1 (2%) 6 (12%) 2 (4%) Capsule, Adenocarcinoma, Metastatic, Uterus 1 (2%) Adrenal Gland, Medulla (50) (49) (49) (49) (49) (50) Pheochromocytoma Malignant 2 (4%) Pheochromocytoma Benign 2 (4%) 8 (16%) 1 (2%) 1 (2%) 5 (10%) 7 (14%) Bilateral, Pheochromocytoma Benign 2 (4%) 1 (2%) 1 (2%) 3 (6%) Islets, Pancreatic (50) (49) (50) (50) (50) (50) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) Parathyroid Gland (46) (47) (48) (46) (46) (47) Adenoma 1 (2%) 2 (4%) 1 (2%) 1 (2%) Pituitary Gland (50) (50) (49) (49) (49) (49) Pars Distalis, Adenoma 24 (48%) 23 (46%) 26 (53%) 25 (51%) 20 (41%) 25 (51%) Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%) Pars Distalis, Carcinoma 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (50) (48) (49) (44) (46) (47) Bilateral, C-Cell, Adenoma 3 (6%) 2 (4%) Bilateral, Follicular Cell, Adenoma, Multiple 1 (2%) C-Cell, Adenoma 11 (22%) 10 (21%) 14 (29%) 12 (27%) 6 (13%) 6 (13%) C-Cell, Carcinoma 1 (2%) 3 (6%) 1 (2%) 1 (2%) 2 (4%) Follicular Cell, Adenocarcinoma 2 (4%) 1 (2%) 1 (2%) 1 (2%) 2 (4%) Follicular Cell, Adenoma 1 (2%) 5 (11%) 5 (11%) 7 (15%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (50) (49) (47) (49) (45) Adenoma 3 (6%) 1 (2%) 2 (4%) 1 (2%) Carcinoma 1 (2%) 1 (2%) 1 (2%) Ovary (50) (50) (50) (50) (50) (50) Adenocarcinoma, Metastatic, Uterus 1 (2%) Cystadenoma 1 (2%) Granulosa-Theca Tumor Malignant 1 (2%) Uterus (50) (50) (50) (50) (50) (50) Adenocarcinoma 1 (2%) Page 3 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Leiomyoma 1 (2%) 1 (2%) 1 (2%) Polyp Stromal 8 (16%) 6 (12%) 13 (26%) 15 (30%) 7 (14%) 6 (12%) Polyp Stromal, Multiple 1 (2%) Sarcoma Stromal 1 (2%) 1 (2%) Cervix, Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (10) (10) (16) (14) (18) (11) Bone Marrow (50) (50) (49) (50) (47) (50) Lymph Node (50) (49) (50) (50) (50) (50) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (2%) Lymph Node, Mesenteric (5) (8) (6) (14) (14) (6) Spleen (50) (50) (50) (50) (50) (50) Adenocarcinoma, Metastatic, Uterus 1 (2%) Fibrosarcoma 2 (4%) Hemangiosarcoma 1 (2%) Thymus (43) (46) (44) (44) (45) (42) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (47) (50) (50) (50) (50) Adenocarcinoma 1 (2%) 1 (2%) 2 (4%) Adenoma 1 (2%) 1 (2%) 2 (4%) Fibroadenoma 10 (20%) 11 (23%) 7 (14%) 11 (22%) 11 (22%) 9 (18%) Fibroadenoma, Multiple 3 (6%) 2 (4%) 1 (2%) 2 (4%) Mixed Tumor Malignant 1 (2%) Skin (50) (49) (50) (50) (50) (48) Basal Cell Adenoma 1 (2%) Basal Cell Carcinoma 1 (2%) Keratoacanthoma 1 (2%) 1 (2%) Squamous Cell Carcinoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Lip, Osteosarcoma, Metastatic, Bone 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (49) (50) (50) (50) (50) Chondrosarcoma 2 (4%) Mandible, Osteosarcoma 1 (2%) Skeletal Muscle (1) Page 4 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - cont Diaphragm, Sarcoma Stromal, Metastatic, Uterus 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) (50) Astrocytoma Malignant 1 (2%) 1 (2%) Carcinoma, Metastatic, Pituitary Gland 1 (2%) 1 (2%) Meningioma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (50) (50) Adenocarcinoma, Metastatic, Uterus 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Chordoma, Metastatic, Uncertain Primary Site 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Mixed Tumor Malignant, Metastatic, Mammary Gland 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (2%) Nose (50) (50) (49) (50) (49) (50) Trachea (50) (50) (49) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Fibrosarcoma 1 (100%) Harderian Gland (50) (50) (50) (50) (50) (50) Zymbal's Gland (1) (3) Adenoma 2 (67%) Carcinoma 1 (100%) 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (50) (50) (50) (50) Adenocarcinoma, Metastatic, Uterus 1 (2%) Lipoma 1 (2%) Mixed Tumor Benign 1 (2%) Renal Tubule, Adenoma 1 (2%) 1 (2%) Urinary Bladder (49) (48) (50) (47) (48) (50) Adenocarcinoma, Metastatic, Uterus 1 (2%) Page 5 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont Hemangioma 1 (2%) Sarcoma Stromal, Metastatic, Uterus 1 (2%) Transitional Epithelium, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 18 (36%) 18 (36%) 19 (38%) 22 (44%) 29 (58%) 23 (46%) Mesothelioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 48 46 46 46 46 47 Total Primary Neoplasms 95 95 107 112 102 109 Total Animals with Benign Neoplasms 40 38 39 39 40 38 Total Benign Neoplasms 68 69 80 81 65 74 Total Animals with Malignant Neoplasms 25 23 24 28 35 30 Total Malignant Neoplasms 27 26 27 31 37 35 Total Animals with Metastatic Neoplasms 3 2 1 2 1 2 Total Metastatic Neoplasm 12 5 1 2 1 2 Total Animals with Malignant Neoplasms 1 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: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 Early Deaths Moribund Sacrifice 26 30 Natural Death 4 6 Survivors Terminal Sacrifice 20 13 Natural Death 1 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (45) (49) Polyp Adenomatous 1 (2%) Intestine Small, Ileum (45) (50) Liver (50) (50) Hepatocellular Carcinoma 1 (2%) Pancreas (49) (50) Salivary Glands (50) (50) Stomach, Forestomach (50) (50) Stomach, Glandular (50) (50) Tongue (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) Adrenal Gland, Medulla (50) (50) Pheochromocytoma Benign 6 (12%) 4 (8%) Bilateral, Pheochromocytoma Benign 1 (2%) Pituitary Gland (50) (50) Pars Distalis, Adenoma 18 (36%) 24 (48%) Pars Distalis, Carcinoma 3 (6%) 2 (4%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (49) (50) Bilateral, C-Cell, Adenoma 1 (2%) 2 (4%) Page 8 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Bilateral, Follicular Cell, Adenocarcinoma 1 (2%) 4 (8%) Bilateral, Follicular Cell, Adenoma 6 (12%) 9 (18%) Bilateral, Follicular Cell, Adenoma, Multiple 7 (14%) 2 (4%) C-Cell, Adenoma 9 (18%) 6 (12%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenocarcinoma 7 (14%) 13 (26%) Follicular Cell, Adenoma 12 (24%) 11 (22%) Follicular Cell, Adenoma, Multiple 3 (6%) 7 (14%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (47) Adenoma 2 (4%) 2 (4%) Ovary (50) (50) Granulosa-Theca Tumor Benign 1 (2%) Uterus (50) (50) Polyp Stromal 7 (14%) 3 (6%) Sarcoma Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (22) (17) Bone Marrow (49) (50) Lymph Node (50) (50) Lymph Node, Mesenteric (3) (8) Spleen (50) (50) Thymus (41) (44) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) Adenocarcinoma 2 (4%) 2 (4%) Fibroadenoma 7 (14%) 9 (18%) Fibroadenoma, Multiple 1 (2%) Skin (49) (50) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) Carcinoma, Metastatic, Pituitary Gland 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) Carcinoma, Metastatic 1 (2%) Nose (50) (50) Nasolacrimal Duct, Squamous Cell Papilloma 1 (2%) Trachea (50) (50) Adenocarcinoma, Metastatic, Thyroid Gland 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (1) Squamous Cell Papilloma 1 (100%) Eye (12) (8) Harderian Gland (50) (50) Zymbal's Gland (2) (4) Carcinoma 2 (100%) 4 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) Urinary Bladder (49) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) Leukemia Mononuclear 27 (54%) 25 (50%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 50 Total Primary Neoplasms 129 136 Total Animals with Benign Neoplasms 44 42 Total Benign Neoplasms 84 84 Total Animals with Malignant Neoplasms 35 41 Total Malignant Neoplasms 45 52 Total Animals with Metastatic Neoplasms 3 3 Total Metastatic Neoplasm 3 3 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 11 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 50 50 Early Deaths Natural Death 10 5 8 7 7 10 Moribund Sacrifice 21 27 20 26 23 25 Survivors Terminal Sacrifice 18 15 17 15 18 14 Natural Death 1 1 3 1 1 Moribund Sacrifice 2 2 2 1 Animals Examined Microscopically 50 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (45) (47) (40) (44) (43) (43) Intestine Large, Colon (48) (49) (42) (45) (45) (50) Polyp Adenomatous 1 (2%) Intestine Large, Rectum (47) (46) (40) (43) (44) (45) Intestine Small, Duodenum (48) (49) (46) (47) (49) (49) Intestine Small, Ileum (45) (47) (42) (43) (45) (46) Intestine Small, Jejunum (48) (49) (44) (46) (47) (50) Leiomyoma 1 (2%) Liver (50) (50) (50) (50) (50) (50) Hepatocellular Adenoma 3 (6%) Hepatocellular Adenoma, Multiple 1 (2%) Mesentery (3) (5) (6) (2) (2) (3) Sarcoma 1 (33%) Pancreas (48) (50) (50) (50) (49) (50) Sarcoma, Metastatic, Mesentery 1 (2%) Pharynx (1) Palate, Squamous Cell Papilloma 1 (100%) Salivary Glands (50) (49) (50) (50) (50) (50) Adenoma 1 (2%) Stomach, Forestomach (49) (50) (47) (50) (48) (49) Stomach, Glandular (49) (50) (47) (49) (49) (49) Tongue (2) (1) Squamous Cell Papilloma 1 (50%) 1 (100%) Tooth (50) (50) (49) (50) (50) (50) Gingiva, Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 12 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) (50) (50) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) (49) (50) (49) (50) Adenoma 1 (2%) 1 (2%) 1 (2%) Adrenal Gland, Medulla (50) (50) (49) (49) (49) (50) Pheochromocytoma Malignant 2 (4%) 1 (2%) 1 (2%) 1 (2%) 4 (8%) 1 (2%) Pheochromocytoma Benign 16 (32%) 16 (32%) 18 (37%) 15 (31%) 13 (27%) 19 (38%) Bilateral, Pheochromocytoma Benign 6 (12%) 15 (30%) 6 (12%) 7 (14%) 11 (22%) 5 (10%) Islets, Pancreatic (48) (50) (50) (50) (49) (50) Adenoma 2 (4%) 2 (4%) 1 (2%) 1 (2%) 2 (4%) Carcinoma 1 (2%) 1 (2%) 2 (4%) 1 (2%) Parathyroid Gland (44) (46) (48) (45) (45) (47) Adenoma 1 (2%) 1 (2%) 2 (4%) 1 (2%) 1 (2%) Pituitary Gland (50) (50) (48) (47) (49) (49) Pars Distalis, Adenoma 19 (38%) 15 (30%) 10 (21%) 10 (21%) 13 (27%) 11 (22%) Pars Distalis, Adenoma, Multiple 1 (2%) Pars Distalis, Carcinoma 1 (2%) 1 (2%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (49) (49) (46) (46) (47) (50) Bilateral, C-Cell, Adenoma 2 (4%) 1 (2%) 1 (2%) 1 (2%) Bilateral, Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (2%) C-Cell, Adenoma 8 (16%) 10 (20%) 9 (20%) 12 (26%) 16 (34%) 12 (24%) C-Cell, Carcinoma 2 (4%) 1 (2%) 1 (2%) Follicular Cell, Adenocarcinoma 1 (2%) 3 (6%) 2 (4%) 3 (7%) 4 (9%) 6 (12%) Follicular Cell, Adenoma 1 (2%) 1 (2%) 8 (17%) 9 (19%) 7 (14%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) (49) (50) Sarcoma, Metastatic, Mesentery 1 (2%) Preputial Gland (49) (49) (49) (49) (46) (50) Adenoma 2 (4%) 4 (8%) 1 (2%) 1 (2%) Carcinoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) Bilateral, Adenoma 1 (2%) Prostate (50) (50) (50) (50) (50) (49) Page 13 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Seminal Vesicle (1) (1) (4) (1) Testes (50) (50) (50) (50) (50) (50) Sarcoma, Metastatic, Mesentery 1 (2%) Bilateral, Interstitial Cell, Adenoma 35 (70%) 34 (68%) 39 (78%) 36 (72%) 40 (80%) 40 (80%) Interstitial Cell, Adenoma 7 (14%) 11 (22%) 5 (10%) 4 (8%) 5 (10%) 8 (16%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (17) (25) (24) (21) (24) (26) Bone Marrow (50) (50) (50) (50) (49) (50) Lymph Node (50) (50) (50) (50) (48) (50) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (2%) Deep Cervical, Mediastinal, Mandibular, Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Lumbar, Fibrosarcoma, Metastatic, Skin 1 (2%) Mandibular, Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Mediastinal, Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (2%) Mediastinal, Sarcoma, Metastatic, Mesentery 1 (2%) Lymph Node, Mesenteric (2) (10) (14) (10) (9) (10) Hemangiosarcoma 1 (10%) Spleen (50) (50) (50) (50) (50) (50) Fibrosarcoma 1 (2%) 1 (2%) Hemangiosarcoma 1 (2%) Thymus (40) (39) (45) (42) (40) (38) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (42) (40) (42) (37) (45) (41) Adenocarcinoma 1 (2%) Adenoma 1 (3%) Fibroadenoma 1 (3%) 4 (10%) 2 (5%) 1 (2%) 1 (2%) Skin (50) (49) (50) (50) (49) (50) Basal Cell Adenoma, Multiple 1 (2%) Basosquamous Tumor Benign 1 (2%) 2 (4%) Basosquamous Tumor Benign, Multiple 1 (2%) Keratoacanthoma 1 (2%) 2 (4%) 1 (2%) 1 (2%) Lipoma 1 (2%) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) Trichoepithelioma 1 (2%) Subcutaneous Tissue, Fibroma 2 (4%) 3 (6%) 1 (2%) 8 (16%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) 2 (4%) 2 (4%) 1 (2%) 3 (6%) Page 14 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) Subcutaneous Tissue, Leiomyosarcoma 1 (2%) Subcutaneous Tissue, Neurofibrosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Osteosarcoma, Metastatic, Bone 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) (50) Squamous Cell Carcinoma, Metastatic, Skin 1 (2%) Cervical, Osteoma 1 (2%) Femur, Osteosarcoma 1 (2%) 1 (2%) Skeletal Muscle (1) (1) (1) Diaphragm, Sarcoma, Metastatic, Mesentery 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) (50) Carcinoma, Metastatic, Pituitary Gland 1 (2%) 1 (2%) Meningioma Benign 1 (2%) Oligodendroglioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 2 (4%) 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (2%) Schwannoma Malignant, Metastatic, Heart 1 (2%) Nose (50) (50) (50) (50) (49) (50) Squamous Cell Carcinoma, Metastatic, Skin 1 (2%) Trachea (50) (50) (50) (50) (50) (50) Adenocarcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ Page 15 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (2) (1) Squamous Cell Papilloma 1 (50%) Harderian Gland (48) (50) (49) (49) (50) (50) Zymbal's Gland (1) (1) (1) (3) (2) (2) Carcinoma 1 (100%) 1 (100%) 1 (100%) 3 (100%) 1 (50%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (49) (50) (50) (50) Cystadenocarcinoma 1 (2%) Myxoma 1 (2%) Nephroblastoma 1 (2%) Capsule, Sarcoma, Metastatic, Mesentery 1 (2%) Renal Tubule, Adenoma 1 (2%) 1 (2%) 4 (8%) 1 (2%) 1 (2%) Renal Tubule, Adenoma, Multiple 1 (2%) Renal Tubule, Carcinoma, Multiple 1 (2%) Urinary Bladder (49) (50) (48) (49) (48) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) *(50) *(50) Leukemia Monocytic 1 (2%) Leukemia Mononuclear 22 (44%) 32 (64%) 29 (58%) 25 (50%) 31 (62%) 34 (68%) Mesothelioma Malignant 2 (4%) 2 (4%) 1 (2%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 16 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 48 50 49 49 49 50 Total Primary Neoplasms 136 173 151 147 179 170 Total Animals with Benign Neoplasms 48 50 46 48 49 49 Total Benign Neoplasms 102 126 106 106 130 118 Total Animals with Malignant Neoplasms 26 40 36 37 39 40 Total Malignant Neoplasms 34 47 45 41 49 52 Total Animals with Metastatic Neoplasms 3 4 1 2 2 2 Total Metastatic Neoplasm 4 5 1 2 4 7 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 17 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 Early Deaths Moribund Sacrifice 23 30 Natural Death 8 14 Accidently Killed 5 Survivors Moribund Sacrifice 1 Natural Death 1 Terminal Sacrifice 14 4 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) Adenocarcinoma, Metastatic, Thyroid Gland 1 (2%) Intestine Small, Jejunum (42) (45) Adenocarcinoma 1 (2%) Liver (50) (50) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) 1 (2%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Mesentery (2) (3) Pancreas (49) (50) Salivary Glands (50) (49) Adenocarcinoma, Metastatic, Thyroid Gland 1 (2%) Stomach, Forestomach (49) (50) Stomach, Glandular (49) (49) Tongue (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Bilateral, Adenoma 1 (2%) Page 18 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Adrenal Gland, Medulla (50) (50) Pheochromocytoma Malignant 1 (2%) 2 (4%) Pheochromocytoma Benign 11 (22%) 15 (30%) Bilateral, Pheochromocytoma Benign 13 (26%) 7 (14%) Islets, Pancreatic (50) (50) Adenoma 2 (4%) Carcinoma 1 (2%) 1 (2%) Parathyroid Gland (33) (21) Adenoma 1 (3%) Pituitary Gland (50) (49) Pars Distalis, Adenoma 11 (22%) 11 (22%) Thyroid Gland (50) (50) Bilateral, Follicular Cell, Adenocarcinoma 11 (22%) 23 (46%) Bilateral, Follicular Cell, Adenocarcinoma, Multiple 1 (2%) 1 (2%) Bilateral, Follicular Cell, Adenoma 6 (12%) 2 (4%) Bilateral, Follicular Cell, Adenoma, Multiple 2 (4%) 4 (8%) C-Cell, Adenoma 9 (18%) 3 (6%) Follicular Cell, Adenocarcinoma 14 (28%) 20 (40%) Follicular Cell, Adenoma 11 (22%) 20 (40%) Follicular Cell, Adenoma, Multiple 4 (8%) 8 (16%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (50) Preputial Gland (49) (50) Adenoma 3 (6%) Carcinoma 1 (2%) Squamous Cell Carcinoma 1 (2%) Prostate (49) (50) Seminal Vesicle (2) Testes (50) (50) Bilateral, Interstitial Cell, Adenoma 30 (60%) 33 (66%) Interstitial Cell, Adenoma 10 (20%) 12 (24%) ____________________________________________________________________________________________________________________________________ Page 19 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (14) (22) Bone Marrow (49) (50) Femoral, Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Lymph Node (50) (49) Mediastinal, Adenocarcinoma, Metastatic, Thyroid Gland 1 (2%) Lymph Node, Mesenteric (14) (10) Spleen (50) (50) Thymus (43) (44) Thymoma Benign 2 (5%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (49) (49) Keratoacanthoma 1 (2%) 1 (2%) Subcutaneous Tissue, Adenocarcinoma, Metastatic, Thyroid Gland 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (5) (2) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) Adenocarcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (2%) Nose (50) (50) Nasolacrimal Duct, Squamous Cell Carcinoma 1 (2%) Trachea (50) (50) Adenocarcinoma, Metastatic, Thyroid Gland 2 (4%) Page 20 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (49) (50) Zymbal's Gland (3) (5) Adenoma 1 (33%) Carcinoma 2 (67%) 4 (80%) Bilateral, Carcinoma 1 (20%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) Renal Tubule, Adenoma 3 (6%) Renal Tubule, Carcinoma 1 (2%) Transitional Epithelium, Carcinoma 1 (2%) Urinary Bladder (49) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) Leukemia Mononuclear 26 (52%) 29 (58%) Lymphoma Malignant Histiocytic 1 (2%) Mesothelioma Malignant 3 (6%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 21 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:35:00 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 45 50 Total Primary Neoplasms 179 212 Total Animals with Benign Neoplasms 45 49 Total Benign Neoplasms 116 125 Total Animals with Malignant Neoplasms 41 50 Total Malignant Neoplasms 63 87 Total Animals with Metastatic Neoplasms 3 6 Total Metastatic Neoplasm 3 11 Total Animals with Malignant Neoplasms 1 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 22 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------ --multipart-boundary Content-type: text/plain Range: bytes 136947-136947/136947 --multipart-boundary--