TR 388 Mouse Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) ETHYLENETHIOUREA NTP Experiment-Test: 05076-02 Report: PEIRPT05 Study Type: CHRONIC Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 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: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 29 50 50 50 Early Deaths Moribund Sacrifice 9 4 6 6 11 9 Natural Death 6 8 2 1 3 5 Survivors Terminal Sacrifice 34 37 21 42 34 36 Natural Death 1 1 1 2 Animals Examined Microscopically 50 50 29 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (49) (13) (8) (8) (16) (14) Squamous Cell Carcinoma 1 (2%) Gallbladder (41) (7) (8) (7) (12) (8) Intestine Large, Cecum (44) (10) (8) (7) (14) (11) Leiomyosarcoma 1 (2%) Intestine Large, Colon (49) (12) (8) (9) (16) (12) Leiomyosarcoma 1 (11%) Intestine Small, Jejunum (46) (12) (10) (8) (19) (13) Liver (50) (49) (28) (50) (50) (50) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) 4 (8%) 2 (4%) 1 (2%) Hemangiosarcoma, Multiple 1 (2%) 1 (2%) Hepatoblastoma 1 (2%) 1 (2%) Hepatocellular Carcinoma 2 (4%) 5 (10%) 2 (7%) 14 (28%) 11 (22%) 9 (18%) Hepatocellular Carcinoma, Multiple 15 (30%) 20 (40%) 14 (28%) Hepatocellular Adenoma 2 (4%) 1 (2%) 2 (7%) 19 (38%) 17 (34%) 14 (28%) Hepatocellular Adenoma, Multiple 14 (28%) 17 (34%) 21 (42%) Histiocytic Sarcoma, Single 1 (4%) 2 (4%) 1 (2%) 2 (4%) Mesentery (6) (2) (1) (1) (1) Fibrosarcoma, Metastatic, Skin 1 (100%) Hemangiosarcoma 1 (17%) Lipoma 1 (17%) Pancreas (50) (11) (8) (7) (16) (13) Salivary Glands (50) (13) (8) (8) (15) (14) Stomach, Forestomach (48) (15) (10) (11) (17) (14) Squamous Cell Papilloma 1 (2%) 1 (7%) 1 (9%) 1 (6%) Stomach, Glandular (48) (11) (8) (8) (15) (13) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (13) (8) (8) (16) (14) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (49) (13) (8) (8) (16) (12) Capsule, Adenoma 1 (6%) Adrenal Gland, Cortex (49) (13) (8) (8) (16) (11) Adrenal Gland, Medulla (48) (13) (8) (8) (16) (11) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (49) (13) (8) (7) (15) (12) Carcinoma 1 (8%) Pituitary Gland (47) (48) (28) (49) (48) (47) Pars Distalis, Adenoma 10 (21%) 11 (23%) 6 (21%) 19 (39%) 14 (29%) 26 (55%) Pars Distalis, Carcinoma 1 (2%) 1 (4%) Pars Intermedia, Adenoma 2 (7%) 1 (2%) 1 (2%) Thyroid Gland (50) (49) (29) (50) (50) (49) Follicular Cell, Adenoma 1 (2%) 1 (3%) 1 (2%) 3 (6%) 1 (2%) Follicular Cell, Adenoma, Multiple 1 (2%) 2 (4%) 9 (18%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (49) (26) (20) (15) (24) (25) Cystadenoma 1 (2%) Cystadenoma, Papillary 1 (7%) 2 (8%) Hemangioma 1 (4%) Luteoma 1 (4%) Uterus (48) (33) (13) (19) (20) (20) Hemangiosarcoma 1 (5%) Histiocytic Sarcoma, Single 1 (5%) Leiomyosarcoma 1 (5%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (13) (8) (8) (16) (13) Femoral, Hemangiosarcoma 1 (2%) Femoral, Histiocytic Sarcoma, Single 1 (13%) 1 (13%) Lymph Node (49) (18) (15) (19) (25) (19) Page 3 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Mandibular, Hemangiosarcoma, Metastatic, Liver 1 (4%) Mandibular, Histiocytic Sarcoma, Single 1 (7%) 2 (11%) 1 (5%) Mandibular, Sarcoma, Metastatic, Uncertain Primary Site 1 (5%) Pancreatic, Leiomyosarcoma, Metastatic, Intestine Large 1 (5%) Lymph Node, Mesenteric (14) (10) (8) (12) (14) (9) Histiocytic Sarcoma, Single 1 (13%) 1 (8%) 1 (11%) Lymph Node, Thoracic (2) Spleen (50) (23) (13) (28) (31) (34) Hemangiosarcoma 1 (2%) 1 (4%) 3 (11%) 1 (3%) 1 (3%) Histiocytic Sarcoma, Single 1 (8%) 1 (4%) 2 (6%) Thymus (39) (7) (4) (6) (12) (5) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (35) (13) (8) (8) (16) (11) Adenocarcinoma 1 (3%) 1 (13%) 2 (25%) 2 (13%) 3 (27%) Fibroadenoma 1 (3%) 1 (8%) Skin (50) (13) (8) (8) (16) (15) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (8%) 1 (7%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) 1 (8%) Subcutaneous Tissue, Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (13) (9) (9) (16) (14) Cranium, Osteosarcoma 1 (2%) 1 (8%) Lumbar, Osteosarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (13) (8) (8) (16) (14) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Histiocytic Sarcoma, Single 1 (13%) 1 (7%) Osteosarcoma, Metastatic, Bone 1 (8%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (29) (50) (50) (50) Adenocarcinoma, Metastatic, Harderian Gland 1 (3%) Alveolar/Bronchiolar Adenoma 2 (4%) 3 (6%) 1 (3%) 7 (14%) 2 (4%) 5 (10%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Alveolar/Bronchiolar Carcinoma 3 (6%) 2 (4%) 1 (2%) 1 (2%) 2 (4%) Fibrosarcoma, Metastatic, Skin 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma, Single 1 (3%) 2 (4%) 1 (2%) 2 (4%) Osteosarcoma, Metastatic, Bone 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (3) (3) (1) (4) (1) (1) Adenocarcinoma 1 (33%) 1 (100%) 2 (50%) Adenoma 2 (67%) 2 (67%) 1 (25%) 1 (100%) 1 (100%) Bilateral, Adenoma 1 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (12) (8) (11) (16) (15) Histiocytic Sarcoma, Single 1 (9%) Renal Tubule, Adenoma, Multiple 1 (2%) Urinary Bladder (48) (12) (8) (9) (13) (11) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(29) *(50) *(50) *(50) Histiocytic Sarcoma 1 (3%) 2 (4%) 1 (2%) 2 (4%) Lymphoma Malignant 1 (2%) 1 (2%) Lymphoma Malignant Histiocytic 1 (2%) 1 (2%) 1 (3%) 1 (2%) Lymphoma Malignant Lymphocytic 5 (10%) 2 (4%) 2 (7%) 2 (4%) 6 (12%) 3 (6%) Lymphoma Malignant Mixed 14 (28%) 11 (22%) 5 (17%) 10 (20%) 17 (34%) 7 (14%) Lymphoma Malignant Undifferentiated Cell 1 (2%) 2 (4%) 2 (4%) 3 (6%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 36 33 20 49 49 50 Total Primary Neoplasms 59 53 26 124 126 131 Total Animals with Benign Neoplasms 17 19 9 42 40 44 Total Benign Neoplasms 22 23 12 65 59 81 Total Animals with Malignant Neoplasms 30 25 13 44 44 38 Total Malignant Neoplasms 37 30 14 59 67 50 Total Animals with Metastatic Neoplasms 2 2 1 3 1 1 Total Metastatic Neoplasm 2 3 1 3 1 2 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 6 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 Early Deaths Natural Death 9 7 Moribund Sacrifice 10 14 Survivors Natural Death 1 Terminal Sacrifice 30 29 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (39) (39) Intestine Small, Jejunum (50) (48) Liver (50) (50) Hemangiosarcoma 2 (4%) Hepatoblastoma 2 (4%) 8 (16%) Hepatoblastoma, Multiple 1 (2%) Hepatocellular Carcinoma 3 (6%) 3 (6%) Hepatocellular Carcinoma, Multiple 44 (88%) 45 (90%) Hepatocellular Adenoma 11 (22%) 10 (20%) Hepatocellular Adenoma, Multiple 3 (6%) 7 (14%) Histiocytic Sarcoma, Single 1 (2%) 2 (4%) Mesentery (2) (1) Pancreas (50) (50) Salivary Glands (49) (50) Histiocytic Sarcoma, Single 1 (2%) Stomach, Forestomach (49) (50) Stomach, Glandular (49) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (50) Histiocytic Sarcoma, Single 1 (2%) Adrenal Gland, Medulla (50) (50) Pheochromocytoma Benign 1 (2%) 1 (2%) Pituitary Gland (49) (47) Pars Distalis, Adenoma 26 (53%) 24 (51%) Page 7 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Thyroid Gland (50) (50) Follicular Cell, Adenoma 4 (8%) 12 (24%) Follicular Cell, Adenoma, Multiple 31 (62%) 26 (52%) Follicular Cell, Carcinoma 8 (16%) 4 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Hepatocellular Carcinoma, Metastatic, Liver 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (50) (48) Cystadenoma 2 (4%) Cystadenoma, Papillary 1 (2%) Granulosa Cell Tumor Benign 1 (2%) Yolk Sac Carcinoma 1 (2%) Uterus (48) (48) Histiocytic Sarcoma, Single 1 (2%) Polyp Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (49) Femoral, Histiocytic Sarcoma, Single 1 (2%) Lymph Node (47) (49) Mandibular, Histiocytic Sarcoma, Single 1 (2%) 2 (4%) Mediastinal, Histiocytic Sarcoma, Single 2 (4%) Renal, Histiocytic Sarcoma, Single 1 (2%) Lymph Node, Mesenteric (4) (9) Hepatocellular Carcinoma, Metastatic, Liver 1 (11%) Histiocytic Sarcoma, Single 2 (22%) Spleen (49) (50) Hemangiosarcoma 1 (2%) 1 (2%) Histiocytic Sarcoma, Single 1 (2%) 2 (4%) Thymus (23) (33) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (33) (37) Adenocarcinoma 1 (3%) Fibroadenoma 1 (3%) Skin (49) (50) Page 8 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) Subcutaneous Tissue, Mast Cell Tumor Benign 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) Alveolar/Bronchiolar Adenoma 4 (8%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Carcinoma, Metastatic, Uncertain Primary Site 1 (2%) Hepatoblastoma, Metastatic, Liver 4 (8%) Hepatocellular Carcinoma, Multiple, Metastatic, Liver 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 7 (14%) 5 (10%) Histiocytic Sarcoma, Single 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (4) (3) Adenocarcinoma 1 (33%) Adenoma 1 (25%) 1 (33%) Histiocytic Sarcoma, Single 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) Renal Tubule, Adenocarcinoma 1 (2%) Urinary Bladder (49) (49) Page 9 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) Histiocytic Sarcoma 2 (4%) 2 (4%) Lymphoma Malignant Histiocytic 1 (2%) Lymphoma Malignant Lymphocytic 6 (12%) 5 (10%) Lymphoma Malignant Mixed 5 (10%) 8 (16%) Lymphoma Malignant Undifferentiated Cell 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 48 50 Total Primary Neoplasms 158 173 Total Animals with Benign Neoplasms 41 43 Total Benign Neoplasms 82 88 Total Animals with Malignant Neoplasms 48 50 Total Malignant Neoplasms 76 85 Total Animals with Metastatic Neoplasms 10 9 Total Metastatic Neoplasm 10 11 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 11 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 34 50 50 50 Early Deaths Moribund Sacrifice 8 7 5 8 10 5 Natural Death 11 10 2 10 8 13 Accidently Killed 5 Survivors Moribund Sacrifice 1 Natural Death 1 1 1 Terminal Sacrifice 30 27 25 31 32 30 Missing 1 1 1 Animals Examined Microscopically 50 49 33 50 50 49 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (22) (8) (18) (15) (19) Periesophageal Tissue, Sarcoma, Metastatic, Skin 1 (13%) Gallbladder (40) (12) (6) (10) (13) (11) Fibrosarcoma, Metastatic, Skin 1 (8%) Intestine Large, Colon (50) (21) (8) (17) (16) (16) Intestine Large, Rectum (48) (19) (8) (17) (15) (16) Squamous Cell Carcinoma 1 (2%) Intestine Small, Ileum (44) (18) (7) (16) (14) (13) Intestine Small, Jejunum (45) (20) (10) (18) (16) (18) Adenocarcinoma 1 (2%) 1 (5%) 1 (10%) Liver (49) (49) (33) (50) (47) (49) Fibrosarcoma, Metastatic, Skin 1 (2%) 1 (2%) Hemangioma 1 (2%) Hemangiosarcoma 2 (4%) 1 (2%) 1 (3%) 2 (4%) 1 (2%) Hemangiosarcoma, Multiple 1 (2%) 1 (2%) 2 (4%) Hepatoblastoma 1 (3%) 1 (2%) 3 (6%) Hepatoblastoma, Multiple 1 (2%) Hepatocellular Carcinoma 9 (18%) 6 (12%) 3 (9%) 11 (22%) 7 (15%) 12 (24%) Hepatocellular Carcinoma, Multiple 4 (8%) 2 (4%) 1 (3%) 8 (16%) 8 (17%) 7 (14%) Hepatocellular Adenoma 8 (16%) 2 (4%) 4 (12%) 12 (24%) 12 (26%) 14 (29%) Hepatocellular Adenoma, Multiple 3 (6%) 4 (8%) 2 (6%) 4 (8%) 3 (6%) 6 (12%) Histiocytic Sarcoma 1 (2%) 1 (3%) 1 (2%) 2 (4%) 1 (2%) Mesentery (6) (1) (1) (1) Fibrosarcoma, Metastatic, Skin 1 (100%) Histiocytic Sarcoma 1 (100%) Pancreas (48) (20) (7) (17) (15) (17) Pharynx (1) Squamous Cell Papilloma 1 (100%) Page 12 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Salivary Glands (50) (21) (8) (19) (15) (17) Sarcoma, Metastatic, Skin 1 (13%) Stomach, Forestomach (49) (24) (7) (17) (16) (22) Squamous Cell Papilloma 2 (8%) 2 (9%) Stomach, Glandular (48) (21) (7) (17) (15) (18) Tooth (5) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (23) (8) (19) (15) (19) Adenocarcinoma, Metastatic, Uncertain Primary Site 2 (9%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (50) (21) (8) (18) (15) (18) Spindle Cell, Subcapsular, Adenoma 1 (2%) Spindle Cell, Subcapsular, Adenoma, Multiple 1 (2%) Adrenal Gland, Medulla (50) (21) (8) (18) (15) (18) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (48) (20) (7) (17) (15) (17) Pituitary Gland (44) (42) (28) (42) (41) (45) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (46) (33) (49) (47) (48) Follicular Cell, Adenoma 1 (2%) 1 (3%) 1 (2%) 1 (2%) 2 (4%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (22) (8) (18) (15) (19) Preputial Gland (2) (2) (1) (2) (4) (3) Carcinoma 1 (25%) Prostate (50) (22) (8) (18) (15) (19) Seminal Vesicle (4) (2) (1) (1) (1) Testes (50) (22) (8) (20) (14) (19) Interstitial Cell, Adenoma 1 (5%) ____________________________________________________________________________________________________________________________________ Page 13 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (1) Bone Marrow (49) (21) (8) (18) (13) (19) Lymph Node (48) (25) (15) (22) (20) (22) Axillary, Fibrosarcoma, Metastatic, Skin 1 (5%) Axillary, Sarcoma, Metastatic 1 (4%) Deep Cervical, Sarcoma, Metastatic, Skin 1 (7%) Inguinal, Hepatoblastoma, Metastatic, Liver 1 (5%) Mandibular, Histiocytic Sarcoma 1 (5%) Lymph Node, Mesenteric (14) (11) (7) (4) (8) (6) Fibrosarcoma, Metastatic, Skin 1 (13%) Histiocytic Sarcoma 1 (14%) 1 (13%) Spleen (49) (25) (12) (21) (24) (24) Hemangiosarcoma 1 (2%) 1 (4%) Histiocytic Sarcoma 1 (4%) Thymus (29) (11) (4) (11) (11) (11) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (26) (14) (23) (25) (26) Schwannoma Malignant 1 (4%) Squamous Cell Carcinoma 1 (4%) Squamous Cell Papilloma 1 (4%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 5 (19%) 4 (29%) 6 (26%) 6 (24%) 8 (31%) Subcutaneous Tissue, Fibrosarcoma, Multiple 1 (4%) Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) 1 (7%) 2 (8%) Subcutaneous Tissue, Histiocytic Sarcoma 1 (4%) Subcutaneous Tissue, Neurofibrosarcoma 1 (4%) 1 (4%) Subcutaneous Tissue, Sarcoma 2 (4%) 1 (4%) 1 (7%) 1 (4%) 3 (12%) Subcutaneous Tissue, Schwannoma Malignant 1 (7%) 1 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (21) (8) (19) (15) (19) ____________________________________________________________________________________________________________________________________ Page 14 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) (33) (50) (47) (49) Adenocarcinoma, Metastatic, Uncertain Primary Site 1 (2%) Alveolar/Bronchiolar Adenoma 4 (8%) 6 (12%) 10 (30%) 6 (12%) 11 (23%) 8 (16%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%) 3 (6%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (3%) 1 (2%) 6 (12%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Hepatoblastoma, Metastatic, Liver 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 10 (20%) 1 (2%) 1 (3%) 2 (4%) 1 (2%) 1 (2%) Histiocytic Sarcoma 2 (4%) 1 (2%) Nose (50) (21) (8) (19) (16) (18) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (4) (1) (3) (3) (1) (3) Adenocarcinoma 1 (33%) Adenoma 1 (25%) 1 (100%) 3 (100%) 2 (67%) 1 (100%) 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (23) (11) (21) (17) (19) Hepatocellular Carcinoma, Metastatic, Liver 1 (5%) 1 (6%) Urinary Bladder (49) (20) (8) (17) (15) (16) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(49) *(33) *(50) *(50) *(49) Histiocytic Sarcoma 1 (2%) 1 (3%) 1 (2%) 2 (4%) 1 (2%) Lymphoma Malignant Histiocytic 1 (2%) 1 (2%) Lymphoma Malignant Lymphocytic 4 (8%) 1 (2%) 1 (3%) 3 (6%) 1 (2%) 2 (4%) Lymphoma Malignant Mixed 2 (4%) 3 (6%) 3 (9%) 2 (4%) 6 (12%) 6 (12%) Lymphoma Malignant Undifferentiated Cell 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 15 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 35 28 25 40 39 48 Total Primary Neoplasms 56 38 40 65 72 90 Total Animals with Benign Neoplasms 16 14 15 23 25 30 Total Benign Neoplasms 22 17 20 27 30 36 Total Animals with Malignant Neoplasms 28 19 16 31 30 41 Total Malignant Neoplasms 34 21 20 38 42 54 Total Animals with Metastatic Neoplasms 10 3 2 3 2 4 Total Metastatic Neoplasm 10 8 4 3 4 5 Total Animals with Malignant Neoplasms 2 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 16 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 Early Deaths Moribund Sacrifice 14 10 Natural Death 13 15 Survivors Terminal Sacrifice 22 24 Natural Death 1 1 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Jejunum (44) (40) Liver (50) (49) Fibrosarcoma, Metastatic, Skin 1 (2%) Hemangiosarcoma 1 (2%) 2 (4%) Hemangiosarcoma, Multiple 1 (2%) Hepatoblastoma 4 (8%) 7 (14%) Hepatoblastoma, Multiple 2 (4%) 3 (6%) Hepatocellular Carcinoma 3 (6%) 5 (10%) Hepatocellular Carcinoma, Multiple 42 (84%) 40 (82%) Hepatocellular Adenoma 4 (8%) 9 (18%) Hepatocellular Adenoma, Multiple 5 (10%) 6 (12%) Histiocytic Sarcoma 1 (2%) 1 (2%) Sarcoma, Metastatic 1 (2%) Mesentery (5) (3) Pancreas (45) (47) Salivary Glands (50) (49) Stomach, Glandular (48) (44) Tooth (4) (1) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) Fibrosarcoma, Metastatic, Skin 1 (2%) Hemangioma 2 (4%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ Page 17 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (49) Adrenal Gland, Medulla (50) (49) Pheochromocytoma Benign 1 (2%) 2 (4%) Pituitary Gland (41) (39) Pars Distalis, Adenoma 8 (20%) 4 (10%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (49) Follicular Cell, Adenoma 8 (16%) 11 (22%) Follicular Cell, Adenoma, Multiple 18 (36%) 22 (45%) Follicular Cell, Carcinoma 8 (16%) Follicular Cell, Carcinoma, Multiple 5 (10%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (49) Preputial Gland (2) (1) Prostate (47) (49) Seminal Vesicle (2) Testes (50) (49) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (1) Bone Marrow (49) (47) Lymph Node (47) (48) Pancreatic, Sarcoma, Metastatic, Skin 1 (2%) Lymph Node, Mesenteric (7) (5) Histiocytic Sarcoma 1 (14%) Spleen (48) (47) Fibrosarcoma, Metastatic, Skin 1 (2%) Hemangiosarcoma 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (49) (50) Basosquamous Tumor Malignant 1 (2%) Squamous Cell Carcinoma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 5 (10%) 5 (10%) Page 18 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Sarcoma 1 (2%) Subcutaneous Tissue, Sarcoma, Multiple 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) Alveolar/Bronchiolar Adenoma 4 (8%) 6 (12%) Alveolar/Bronchiolar Adenoma, Multiple 2 (4%) Alveolar/Bronchiolar Carcinoma 2 (4%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) 2 (4%) Carcinoma, Metastatic, Uncertain Primary Site 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) 1 (2%) Hepatoblastoma, Metastatic, Liver 2 (4%) 3 (6%) Hepatoblastoma, Metastatic, Uncertain Primary Site 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 11 (22%) 21 (43%) Histiocytic Sarcoma 1 (2%) Nose (50) (49) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Pinna, Hemangioma 1 (100%) Harderian Gland (18) (6) Adenocarcinoma 1 (17%) Adenoma 4 (22%) 1 (17%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) Fibrosarcoma, Metastatic, Skin 1 (2%) Renal Tubule, Adenoma 1 (2%) Urinary Bladder (48) (48) Page 19 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) Histiocytic Sarcoma 1 (2%) 1 (2%) Lymphoma Malignant Lymphocytic 3 (6%) 2 (4%) Lymphoma Malignant Mixed 3 (6%) 3 (6%) Lymphoma Malignant Undifferentiated Cell 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 20 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 47 47 Total Primary Neoplasms 136 143 Total Animals with Benign Neoplasms 36 41 Total Benign Neoplasms 59 61 Total Animals with Malignant Neoplasms 46 46 Total Malignant Neoplasms 77 82 Total Animals with Metastatic Neoplasms 17 27 Total Metastatic Neoplasm 21 30 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 21 ------------------------------------------------------------ ---------- END OF REPORT ---------- 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