TDMS Study 05025-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) ETHYLENE GLYCOL NTP Experiment-Test: 05025-01 Report: PEIRPT05 Study Type: CHRONIC Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 Facility: Southern Research Institute Chemical CAS #: 107-21-1 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: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 9 10 Early Deaths Moribund 9 9 12 12 Dead 8 11 9 1 Survivors Terminal Sacrifice 33 30 30 37 Animals Examined Microscopically 50 50 51 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (20) (21) (50) Gallbladder (48) (18) (21) (49) Intestine Large, Cecum (48) (19) (16) (50) Intestine Large, Colon (49) (19) (19) (50) Sarcoma 1 (5%) Intestine Large, Rectum (49) (19) (17) (50) Intestine Small, Duodenum (47) (18) (17) (50) Intestine Small, Ileum (47) (19) (16) (50) Intestine Small, Jejunum (47) (19) (16) (50) Liver (50) (50) (51) (50) Adenocarcinoma, Multiple, Metastatic, Ovary 1 (2%) Hepatocellular Carcinoma 3 (6%) 4 (8%) 6 (12%) 3 (6%) Hepatocellular Carcinoma, Multiple, Two 1 (2%) Hepatocellular Adenoma 8 (16%) 5 (10%) 8 (16%) 7 (14%) Mesentery (17) (7) (15) (7) Adenocarcinoma, Multiple, Metastatic, Ovary 1 (14%) Sarcoma 1 (14%) 1 (14%) Pancreas (49) (21) (22) (50) Adenocarcinoma, Metastatic, Ovary 1 (5%) Sarcoma 1 (5%) Salivary Glands (49) (20) (21) (50) Stomach, Forestomach (50) (20) (20) (50) Stomach, Glandular (49) (20) (20) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (20) (21) (50) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (21) (21) (50) Adrenal Gland, Medulla (48) (21) (21) (50) Pheochromocytoma Malignant 1 (5%) Pheochromocytoma Benign 1 (5%) 1 (5%) Islets, Pancreatic (49) (19) (21) (50) Adenoma 1 (5%) Pituitary Gland (47) (22) (23) (47) Pars Distalis, Adenoma 17 (36%) 5 (23%) 7 (30%) 16 (34%) Pars Distalis, Carcinoma 1 (4%) Pars Intermedia, Adenoma 1 (5%) 1 (2%) Thyroid Gland (49) (50) (51) (50) Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (2%) 3 (6%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (2) (1) Sarcoma 1 (50%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (49) (25) (25) (48) Adenocarcinoma 1 (4%) Cystadenoma, Papillary 2 (4%) 1 (4%) 1 (4%) 4 (8%) Teratoma NOS 1 (2%) Oviduct (3) (4) (1) Uterus (50) (45) (45) (50) Adenocarcinoma 1 (2%) Leiomyosarcoma 1 (2%) Endometrium, Polyp Stromal 3 (6%) 3 (7%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (20) (21) (50) Lymph Node (50) (24) (22) (50) Mediastinal, Adenocarcinoma, Metastatic, Ovary 1 (4%) Lymph Node, Mandibular (43) (21) (20) (49) Spleen (49) (29) (28) (50) Hemangiosarcoma 1 (4%) Thymus (47) (19) (19) (47) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (20) (21) (50) Adenoacanthoma 1 (2%) Adenocarcinoma 1 (2%) 1 (5%) Skin (49) (43) (40) (50) Subcutaneous Tissue, Fibrosarcoma 2 (5%) Subcutaneous Tissue, Hemangiosarcoma 1 (3%) Subcutaneous Tissue, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (20) (21) (50) Osteosarcoma 1 (5%) 1 (5%) Skeletal Muscle (2) (2) (2) (1) Osteosarcoma, Metastatic, Bone 1 (50%) Abdominal, Sarcoma 1 (100%) Neck, Sarcoma 1 (50%) Thoracic, Sarcoma 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (20) (21) (50) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (51) (50) Adenocarcinoma, Multiple, Metastatic, Greater Than Five, Ovary 1 (2%) Alveolar/Bronchiolar Adenoma 4 (8%) 4 (8%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 2 (4%) 2 (4%) Carcinoma, Metastatic, Harderian Gland 1 (2%) 1 (2%) Carcinoma, Metastatic, Uncertain Primary Site 1 (2%) Hepatocellular Carcinoma, Multiple, Metastatic, Greater Than Five, Liver 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Nose (50) (20) (21) (50) Trachea (49) (20) (21) (50) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (3) (2) (2) (2) Adenoma 2 (67%) 1 (50%) 1 (50%) Carcinoma 1 (50%) 1 (50%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) (50) Osteosarcoma, Metastatic, Bone 1 (2%) Urinary Bladder (49) (19) (21) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(51) *(50) Lymphoma Malignant Histiocytic 2 (4%) 2 (4%) 1 (2%) Lymphoma Malignant Lymphocytic 3 (6%) 3 (6%) 4 (8%) Lymphoma Malignant Mixed 13 (26%) 8 (16%) 3 (6%) 6 (12%) Lymphoma Malignant Undifferentiated Cell 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 39 33 31 36 Total Primary Neoplasms 56 53 49 51 Total Animals with Benign Neoplasms 29 19 19 26 Total Benign Neoplasms 33 23 24 33 Total Animals with Malignant Neoplasms 21 21 22 16 Total Malignant Neoplasms 23 30 25 17 Total Animals with Metastatic Neoplasms 2 2 2 2 Total Metastatic Neoplasm 2 6 3 2 Total Animals with Malignant Neoplasms 1 Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 Total Uncertain Neoplasms 1 ____________________________________________________________________________________________________________________________________ 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: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 6 6 6 6 Early Deaths Dead 15 8 11 16 Moribund 10 14 11 15 Survivors Terminal Sacrifice 29 32 32 23 Animals Examined Microscopically 54 54 54 54 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (51) (19) (16) (48) Sarcoma 1 (2%) Intestine Small, Duodenum (53) (20) (18) (46) Polyp Adenomatous 1 (5%) Intestine Small, Ileum (53) (17) (17) (45) Intestine Small, Jejunum (54) (18) (19) (50) Polyp Adenomatous 2 (4%) 1 (2%) Liver (54) (53) (53) (54) Cholangiocarcinoma 1 (2%) Hemangiosarcoma, Multiple, Two 1 (2%) Hepatocellular Carcinoma 10 (19%) 15 (28%) 10 (19%) 9 (17%) Hepatocellular Carcinoma, Multiple, Two 1 (2%) 2 (4%) Hepatocellular Carcinoma, Multiple, Four 1 (2%) Hepatocellular Adenoma 9 (17%) 6 (11%) 5 (9%) 8 (15%) Hepatocellular Adenoma, Multiple, Two 2 (4%) Serosa, Sarcoma 1 (2%) Mesentery (5) (3) (1) (7) Cholangiocarcinoma, Metastatic, Liver 1 (20%) Hemangiosarcoma 1 (20%) Hepatocellular Carcinoma, Metastatic, Liver 1 (33%) Sarcoma 1 (20%) Pancreas (54) (23) (21) (54) Salivary Glands (53) (21) (20) (54) Stomach, Forestomach (54) (20) (21) (54) Mast Cell Tumor Benign 1 (2%) Stomach, Glandular (54) (20) (21) (54) Tooth (21) (4) (1) (18) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (54) (21) (22) (54) Adenocarcinoma, Metastatic, Uncertain Primary Site 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (54) (20) (21) (54) Adenoma 2 (4%) Capsule, Cholangiocarcinoma, Metastatic, Liver 1 (2%) Capsule, Sarcoma 1 (2%) Subcapsular, Adenoma 1 (2%) 3 (6%) Subcapsular, Adenoma, Multiple 1 (2%) Adrenal Gland, Medulla (54) (21) (21) (53) Pheochromocytoma Benign 1 (2%) 1 (5%) Pituitary Gland (52) (21) (17) (49) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (53) (53) (54) (53) Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (2) Sarcoma 1 (50%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (54) (21) (22) (54) Hemangioma 1 (2%) Prostate (53) (20) (22) (54) Sarcoma 1 (2%) Seminal Vesicle (52) (23) (23) (54) Sarcoma 1 (2%) Testes (54) (22) (22) (54) Interstitial Cell, Adenoma 1 (5%) 1 (2%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (54) (21) (22) (54) Hemangiosarcoma 1 (2%) Lymph Node (54) (33) (27) (54) Lymph Node, Mandibular (45) (19) (17) (51) Spleen (54) (53) (53) (53) Hemangiosarcoma 2 (4%) 1 (2%) Thymus (53) (19) (19) (51) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (54) (45) (43) (54) Basosquamous Tumor Benign 1 (2%) Mast Cell Tumor Benign 1 (2%) Subcutaneous Tissue, Fibroma 2 (4%) 2 (4%) 1 (2%) 2 (4%) Subcutaneous Tissue, Fibrosarcoma 3 (6%) 8 (18%) 5 (12%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma, Multifocal 1 (2%) Subcutaneous Tissue, Fibrosarcoma, Metastatic, Skin 1 (2%) Subcutaneous Tissue, Histiocytic Sarcoma 2 (4%) Subcutaneous Tissue, Sarcoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) Subcutaneous Tissue, Sarcoma, Multiple 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) Subcutaneous Tissue, Schwannoma NOS 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) Diaphragm, Cholangiocarcinoma, Metastatic, Liver 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (54) (25) (32) (54) Adenocarcinoma, Metastatic, Uncertain Primary Site 1 (2%) Alveolar/Bronchiolar Adenoma 6 (11%) 2 (8%) 7 (22%) 3 (6%) Alveolar/Bronchiolar Adenoma, Multiple, Two 1 (3%) Alveolar/Bronchiolar Adenoma, Multiple, Page 9 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Greater Than Five 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (4%) 2 (6%) Alveolar/Bronchiolar Carcinoma, Multiple, Two 1 (4%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Fibrosarcoma, Multiple, Metastatic, Skin 1 (2%) Hepatocellular Carcinoma, Multiple, Metastatic, Four, Liver 1 (3%) Hepatocellular Carcinoma, Multiple, Metastatic, Five, Liver 1 (4%) Hepatocellular Carcinoma, Multiple, Metastatic, Greater Than Five, Liver 1 (3%) Mediastinum, Fibrosarcoma, Metastatic, Skin 1 (2%) Mediastinum, Hepatocellular Carcinoma, Metastatic, Liver 1 (3%) Pleura, Fibrosarcoma, Multiple, Metastatic, Skin 1 (2%) Nose (54) (21) (21) (54) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (2) (3) Adenoma 2 (100%) 2 (67%) Carcinoma 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (54) (53) (53) (54) Carcinoma, Metastatic, Uncertain Primary Site 1 (2%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Capsule, Sarcoma 1 (2%) Renal Tubule, Adenoma 1 (2%) 1 (2%) Urinary Bladder (53) (53) (53) (54) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(54) *(54) *(54) *(54) Histiocytic Sarcoma 2 (4%) Lymphoma Malignant Histiocytic 1 (2%) Lymphoma Malignant Lymphocytic 1 (2%) Lymphoma Malignant Mixed 6 (11%) 3 (6%) 5 (9%) 6 (11%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 34 36 31 33 Total Primary Neoplasms 67 46 44 47 Total Animals with Benign Neoplasms 17 11 13 19 Total Benign Neoplasms 29 14 17 24 Total Animals with Malignant Neoplasms 22 28 23 20 Total Malignant Neoplasms 38 31 27 23 Total Animals with Metastatic Neoplasms 2 2 2 1 Total Metastatic Neoplasm 7 3 4 4 Total Animals with Malignant Neoplasms 1 1 Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 Total Uncertain Neoplasms 1 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 11 ------------------------------------------------------------ ---------- 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