TDMS Study 05090-02 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) COUMARIN NTP Experiment-Test: 05090-02 Report: PEIRPT05 Study Type: CHRONIC Date: 09/12/94 Route: GAVAGE Time: 06:23:07 Facility: American Biogenics Corp. Chemical CAS #: 91-64-5 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: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 70 70 70 70 Scheduled Sacrifice 18 20 19 19 Early Deaths Dead 7 5 3 13 Moribund 8 5 5 8 Gavage Death 4 1 2 Survivors Terminal Sacrifice 33 39 42 28 Moribund 1 Animals Examined Microscopically 60 58 58 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (49) (44) (47) (48) Intestine Large, Cecum (50) (46) (48) (50) Intestine Small (52) (46) (48) (50) Intestine Small, Ileum (49) (46) (48) (48) Intestine Small, Jejunum (49) (46) (48) (50) Sarcoma 1 (2%) Liver (58) (50) (53) (59) Alveolar/Bronchiolar Carcinoma, Metastatic 1 (2%) Hemangiosarcoma 1 (2%) Hepatoblastoma 1 (2%) Hepatocellular Carcinoma 3 (6%) 3 (6%) 1 (2%) Hepatocellular Adenoma 9 (16%) 18 (36%) 20 (38%) 10 (17%) Hepatocellular Adenoma, Multiple 8 (16%) 9 (17%) 2 (3%) Histiocytic Sarcoma 1 (2%) 1 (2%) Mesentery (7) (6) (3) (4) Histiocytic Sarcoma 1 (17%) Squamous Cell Carcinoma, Metastatic, Stomach 1 (33%) Pancreas (56) (48) (48) (54) Salivary Glands (59) (50) (51) (60) Leiomyosarcoma, Metastatic 1 (2%) Stomach, Forestomach (56) (50) (50) (55) Squamous Cell Carcinoma 1 (2%) 1 (2%) Squamous Cell Papilloma 1 (2%) 5 (10%) 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (59) (50) (51) (60) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (57) (47) (48) (60) Spindle Cell, Adenoma 1 (2%) Adrenal Gland, Cortex (57) (47) (47) (60) Alveolar/Bronchiolar Carcinoma, Metastatic 1 (2%) Spindle Cell, Adenoma 1 (2%) Adrenal Gland, Medulla (57) (47) (48) (59) Pheochromocytoma Benign 2 (4%) Islets, Pancreatic (57) (48) (48) (56) Adenoma 1 (2%) 2 (4%) 1 (2%) Carcinoma 1 (2%) Pituitary Gland (53) (45) (45) (57) Neoplasm NOS 1 (2%) Pars Distalis, Adenoma 4 (8%) 3 (7%) 4 (9%) Thyroid Gland (55) (49) (50) (56) Bilateral, Follicular Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (2) (1) Posterior, Fibrosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (59) (52) (52) (60) Cystadenoma 2 (3%) 3 (6%) 4 (8%) 2 (3%) Histiocytic Sarcoma 1 (2%) Uterus (58) (55) (51) (60) Hemangioma 1 (2%) Histiocytic Sarcoma 1 (2%) Leiomyosarcoma 1 (2%) Polyp 1 (2%) Sarcoma 1 (2%) Sarcoma Stromal 2 (3%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (59) (48) (49) (60) Lymph Node (57) (49) (49) (59) Mediastinal, Histiocytic Sarcoma 1 (2%) Lymph Node, Mandibular (55) (47) (49) (53) Lymph Node, Mesenteric (53) (45) (48) (56) Squamous Cell Carcinoma, Metastatic, Stomach 1 (2%) Spleen (58) (48) (48) (57) Thymus (51) (44) (49) (51) Alveolar/Bronchiolar Carcinoma, Metastatic 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (59) (51) (56) (60) Fibroma 1 (2%) Fibrosarcoma 1 (2%) 1 (2%) Hemangioma 1 (2%) Subcutaneous Tissue, Leiomyosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (50) (51) (60) Vertebra, Osteosarcoma 1 (2%) Skeletal Muscle (2) (1) Leiomyosarcoma, Metastatic 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (57) (49) (50) (58) Meningioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (59) (50) (50) (60) Alveolar/Bronchiolar Adenoma 2 (3%) 5 (10%) 8 (16%) 17 (28%) Alveolar/Bronchiolar Adenoma, Multiple 5 (8%) Alveolar/Bronchiolar Carcinoma 7 (12%) Nose (58) (50) (51) (59) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (1) (1) (1) (1) Adenoma 1 (100%) 1 (100%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (58) (47) (49) (58) Urinary Bladder (53) (47) (48) (56) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(58) *(58) *(60) Histiocytic Sarcoma 1 (2%) 1 (2%) Lymphoma Malignant 4 (7%) 2 (3%) 1 (2%) Lymphoma Malignant Histiocytic 1 (2%) 1 (2%) Lymphoma Malignant Lymphocytic 6 (10%) 6 (10%) 4 (7%) Lymphoma Malignant Mixed 3 (5%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 26 41 37 36 Total Primary Neoplasms 34 69 66 58 Total Animals with Benign Neoplasms 21 33 34 28 Total Benign Neoplasms 24 47 51 41 Total Animals with Malignant Neoplasms 8 19 13 14 Total Malignant Neoplasms 10 22 14 17 Total Animals with Metastatic Neoplasms 1 1 1 Total Metastatic Neoplasm 2 2 3 Total Animals with Malignant Neoplasms 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: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 70 70 70 70 Scheduled Sacrifice 20 20 20 19 Early Deaths Dead 5 3 1 11 Moribund 1 6 3 Gavage Death 1 1 Survivors Terminal Sacrifice 43 47 42 37 Animals Examined Microscopically 60 58 57 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (50) (47) (47) (48) Squamous Cell Carcinoma, Metastatic, Stomach 1 (2%) Intestine Large, Cecum (57) (47) (49) (51) Intestine Small, Ileum (58) (47) (49) (51) Intestine Small, Jejunum (56) (47) (50) (51) Adenocarcinoma 2 (4%) 1 (2%) Adenoma 1 (2%) Liver (60) (54) (56) (60) Hepatoblastoma 5 (9%) 1 (2%) Hepatocellular Carcinoma 10 (17%) 11 (20%) 5 (9%) 3 (5%) Hepatocellular Carcinoma, Multiple 1 (2%) Hepatocellular Adenoma 15 (25%) 11 (20%) 12 (21%) 16 (27%) Hepatocellular Adenoma, Multiple 11 (18%) 20 (37%) 18 (32%) 14 (23%) Histiocytic Sarcoma 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach 1 (2%) Mesentery (8) (3) (3) (3) Squamous Cell Carcinoma, Metastatic, Stomach 1 (33%) Pancreas (59) (50) (50) (59) Squamous Cell Carcinoma, Metastatic, Stomach 1 (2%) Stomach, Forestomach (58) (49) (50) (56) Squamous Cell Carcinoma 1 (2%) 2 (4%) Squamous Cell Papilloma 2 (3%) 8 (16%) 2 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (50) (50) (60) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (59) (49) (49) (59) Adenoma 1 (2%) Adrenal Gland, Medulla (59) (49) (48) (58) Pheochromocytoma Benign 1 (2%) 1 (2%) Islets, Pancreatic (59) (50) (50) (59) Adenoma 3 (6%) 2 (3%) Thyroid Gland (58) (50) (50) (60) C-Cell, Adenoma 1 (2%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 2 (3%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (59) (50) (50) (59) Preputial Gland (16) (21) (13) (9) Prostate (59) (50) (50) (60) Seminal Vesicle (59) (50) (50) (60) Squamous Cell Carcinoma, Metastatic, Stomach 1 (2%) Testes (59) (50) (50) (59) Interstitial Cell, Adenoma 3 (5%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (59) (50) (50) (59) Lymph Node (59) (50) (49) (60) Histiocytic Sarcoma 1 (2%) Lymph Node, Mandibular (57) (48) (48) (54) Lymph Node, Mesenteric (59) (49) (47) (56) Spleen (59) (50) (51) (59) Histiocytic Sarcoma 1 (2%) Thymus (57) (45) (44) (50) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (59) (51) (51) (60) Basal Cell Adenoma 1 (2%) Tail, Neurofibroma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (59) (50) (50) (60) Skeletal Muscle (1) Diaphragm, Squamous Cell Carcinoma, Metastatic, Stomach 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (59) (50) (50) (59) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (52) (51) (60) Alveolar/Bronchiolar Adenoma 12 (20%) 10 (19%) 12 (24%) 22 (37%) Alveolar/Bronchiolar Adenoma, Multiple 2 (3%) 2 (4%) 5 (8%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) 2 (4%) 1 (2%) Carcinoma, Metastatic 1 (2%) Hepatocellular Carcinoma, Metastatic 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 1 (2%) Hepatocellular Carcinoma, Metastatic, Metastatic 1 (2%) Nose (59) (50) (50) (60) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (3) (1) (1) (1) Adenoma 3 (100%) 1 (100%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (59) (50) (50) (58) Squamous Cell Carcinoma, Metastatic, Stomach 1 (2%) Renal Tubule, Adenoma 1 (2%) Urinary Bladder (59) (50) (50) (57) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(58) *(57) *(60) Histiocytic Sarcoma 1 (2%) Lymphoma Malignant 2 (4%) 1 (2%) Lymphoma Malignant Histiocytic 2 (3%) * Number of animals with any tissue examined microscopically Page 9 NTP Experiment-Test: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(60) *(58) *(57) *(60) Lymphoma Malignant Lymphocytic 3 (5%) 1 (2%) Lymphoma Malignant Mixed 1 (2%) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 05090-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COUMARIN Date: 09/12/94 Route: GAVAGE Time: 06:23:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 50 MG/KG 100MG/KG 200MG/KG CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 42 43 43 45 Total Primary Neoplasms 64 72 69 72 Total Animals with Benign Neoplasms 38 38 37 44 Total Benign Neoplasms 50 54 51 63 Total Animals with Malignant Neoplasms 14 14 16 8 Total Malignant Neoplasms 14 18 18 9 Total Animals with Metastatic Neoplasms 2 1 2 1 Total Metastatic Neoplasm 2 1 8 1 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant Total Uncertain Neoplasms ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 11 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------