TDMS Study 05212-03 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) OXAZEPAM NTP Experiment-Test: 05212-03 Report: PEIRPT05 Study Type: CHRONIC Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 Facility: Battelle Columbus Laboratory Chemical CAS #: 604-75-1 Lock Date: 02/20/92 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: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Natural Death 3 2 26 35 Moribund Sacrifice 8 7 22 15 Survivors Terminal Sacrifice 39 41 2 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (60) (60) (60) (60) Histiocytic Sarcoma 1 (2%) Intestine Small, Jejunum (60) (60) (60) (60) Liver (60) (60) (60) (60) Hepatoblastoma 1 (2%) 8 (13%) 9 (15%) Hepatoblastoma, Multiple 1 (2%) Hepatocellular Carcinoma 10 (17%) 4 (7%) 9 (15%) 4 (7%) Hepatocellular Carcinoma, Multiple 1 (2%) 42 (70%) 50 (83%) Hepatocellular Adenoma 13 (22%) 17 (28%) 6 (10%) 6 (10%) Hepatocellular Adenoma, Multiple 13 (22%) 19 (32%) 38 (63%) 40 (67%) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) Mesentery (3) (3) Histiocytic Sarcoma 1 (33%) Teratoma Malignant, Metastatic, Ovary 1 (33%) Fat, Lipoma 1 (33%) Pancreas (60) (60) (60) (60) Histiocytic Sarcoma 1 (2%) Salivary Glands (60) (60) (60) (60) Fibrosarcoma, Metastatic, Skin 1 (2%) Stomach, Forestomach (60) (60) (60) (60) Squamous Cell Papilloma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Capsule, Adenoma 1 (2%) Capsule, Histiocytic Sarcoma 1 (2%) Pituitary Gland (60) (59) (53) (59) Pars Distalis, Adenoma 3 (5%) 9 (15%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (60) (60) (60) (60) Follicular Cell, Adenoma 4 (7%) 5 (8%) 6 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (60) (60) (58) (60) Cystadenoma 1 (2%) 3 (5%) 1 (2%) Granulosa Cell Tumor Malignant 1 (2%) Granulosa Cell Tumor Benign 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) Luteoma 2 (3%) Teratoma Malignant 1 (2%) 1 (2%) Follicle, Adenoma 1 (2%) 2 (3%) Uterus (60) (60) (60) (59) Histiocytic Sarcoma 1 (2%) Leiomyosarcoma 1 (2%) Polyp Stromal 1 (2%) 1 (2%) Cervix, Histiocytic Sarcoma 1 (2%) 1 (2%) Endometrium, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Lymph Node (3) (2) (1) Pancreatic, Histiocytic Sarcoma 1 (50%) Renal, Teratoma Malignant, Metastatic, Ovary 1 (33%) Thoracic, Histiocytic Sarcoma 1 (50%) Lymph Node, Bronchial (1) Lymph Node, Mandibular (58) (57) (58) (54) Fibrosarcoma, Metastatic, Skin 1 (2%) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (58) (56) (48) (47) Histiocytic Sarcoma 1 (2%) Page 3 NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Teratoma Malignant, Metastatic, Ovary 1 (2%) Lymph Node, Mediastinal (1) (2) (3) Histiocytic Sarcoma 1 (50%) Spleen (60) (60) (60) (59) Histiocytic Sarcoma 1 (2%) Thymus (60) (58) (44) (43) Histiocytic Sarcoma 1 (2%) 1 (2%) Thymoma NOS 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (59) (60) (60) (60) Subcutaneous Tissue, Fibrosarcoma 1 (2%) Subcutaneous Tissue, Fibrosarcoma, Multiple 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Melanoma NOS 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (60) (60) (60) (60) Diaphragm, Teratoma Malignant, Metastatic, Ovary 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Alveolar/Bronchiolar Adenoma 3 (5%) 1 (2%) 1 (2%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 3 (5%) 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Hepatoblastoma, Metastatic, Liver 2 (3%) 2 (3%) Hepatocellular Carcinoma, Metastatic, Liver 3 (5%) 2 (3%) 8 (13%) 10 (17%) Histiocytic Sarcoma 1 (2%) Teratoma Malignant, Metastatic, Ovary 1 (2%) Trachea (60) (60) (60) (60) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (2) (1) External Ear, Fibrosarcoma 1 (100%) Harderian Gland (3) (3) (1) (1) Adenoma 1 (33%) 3 (100%) 1 (100%) 1 (100%) Carcinoma 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Histiocytic Sarcoma 2 (3%) Teratoma Malignant, Metastatic, Ovary 1 (2%) Urinary Bladder (60) (60) (60) (60) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Histiocytic Sarcoma 1 (2%) 2 (3%) 1 (2%) Lymphoma Malignant 1 (2%) Lymphoma Malignant Lymphocytic 2 (3%) 2 (3%) 1 (2%) Lymphoma Malignant Mixed 1 (2%) 1 (2%) 2 (3%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 40 45 59 57 Total Primary Neoplasms 63 77 122 118 Total Animals with Benign Neoplasms 31 42 47 48 Total Benign Neoplasms 41 59 55 54 Total Animals with Malignant Neoplasms 19 15 52 54 Total Malignant Neoplasms 21 17 66 64 Total Animals with Metastatic Neoplasms 6 2 8 12 Total Metastatic Neoplasm 12 2 10 12 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 1 1 Total Uncertain Neoplasms 1 1 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: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 2 4 22 30 Natural Death 3 2 13 20 Survivors Terminal Sacrifice 45 44 15 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (57) (60) (54) (32) Histiocytic Sarcoma 1 (2%) Intestine Large, Colon (59) (60) (60) (59) Intestine Small, Duodenum (59) (60) (59) (60) Polyp Adenomatous 1 (2%) Intestine Small, Jejunum (59) (60) (60) (60) Carcinoma 1 (2%) 1 (2%) Liver (59) (60) (60) (60) Hemangiosarcoma, Multiple 1 (2%) 1 (2%) Hemangiosarcoma, Metastatic, Skin 1 (2%) Hepatoblastoma 2 (3%) 20 (33%) 13 (22%) Hepatoblastoma, Multiple 1 (2%) 1 (2%) Hepatocellular Carcinoma 8 (14%) 4 (7%) 7 (12%) 6 (10%) Hepatocellular Carcinoma, Multiple 1 (2%) 2 (3%) 42 (70%) 53 (88%) Hepatocellular Adenoma 10 (17%) 12 (20%) 7 (12%) 5 (8%) Hepatocellular Adenoma, Multiple 7 (12%) 9 (15%) 36 (60%) 36 (60%) Histiocytic Sarcoma 1 (2%) 1 (2%) Sarcoma, Metastatic, Kidney 1 (2%) Mesentery (2) (2) (2) (2) Histiocytic Sarcoma 1 (50%) 1 (50%) Fat, Hepatocellular Carcinoma, Metastatic, Liver 1 (50%) Pancreas (59) (60) (60) (60) Hepatoblastoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) Salivary Glands (60) (60) (60) (60) Stomach, Forestomach (60) (60) (60) (60) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (59) (60) (59) (60) Adenoma 1 (2%) Capsule, Adenoma 6 (10%) 4 (7%) Capsule, Hepatoblastoma, Metastatic, Liver 1 (2%) Capsule, Histiocytic Sarcoma 1 (2%) Adrenal Medulla (59) (60) (60) (60) Pheochromocytoma Benign 1 (2%) Pituitary Gland (58) (60) (52) (47) Pars Distalis, Adenoma 1 (2%) Thyroid Gland (59) (60) (60) (60) Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Prostate (59) (60) (60) (60) Hepatoblastoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Testes (60) (60) (60) (60) Interstitial Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Hemangiosarcoma 1 (2%) Lymph Node (2) (1) (1) (2) Lumbar, Histiocytic Sarcoma 1 (50%) Popliteal, Histiocytic Sarcoma 1 (100%) Renal, Hepatoblastoma, Metastatic, Liver 1 (100%) Lymph Node, Mandibular (54) (54) (52) (52) Carcinoma, Metastatic, Harderian Gland 1 (2%) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (58) (57) (55) (50) Histiocytic Sarcoma 1 (2%) 1 (2%) Page 8 NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Sarcoma, Metastatic, Kidney 1 (2%) Lymph Node, Mediastinal (1) (1) Histiocytic Sarcoma 1 (100%) Spleen (59) (60) (60) (60) Hemangiosarcoma 1 (2%) Hemangiosarcoma, Metastatic, Skin 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) Thymus (52) (52) (46) (40) Histiocytic Sarcoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (60) (60) (60) (60) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Melanoma NOS 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (60) (60) (60) (60) Hemangiosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Alveolar/Bronchiolar Adenoma 11 (18%) 12 (20%) 5 (8%) 1 (2%) Alveolar/Bronchiolar Adenoma, Multiple 2 (3%) 6 (10%) Alveolar/Bronchiolar Carcinoma 2 (3%) 1 (2%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Hemangiosarcoma 1 (2%) Hepatoblastoma, Metastatic, Liver 1 (2%) 7 (12%) 5 (8%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 3 (5%) 10 (17%) 17 (28%) Histiocytic Sarcoma 1 (2%) Sarcoma, Metastatic, Kidney 1 (2%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) External Ear, Fibrosarcoma 1 (100%) Eye (2) (2) Carcinoma, Metastatic, Harderian Gland 1 (50%) 1 (50%) Ciliary Body, Adenoma 1 (50%) Harderian Gland (3) (2) (1) Adenoma 1 (33%) 1 (50%) 1 (100%) Carcinoma 1 (33%) 1 (50%) Bilateral, Adenoma 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Histiocytic Sarcoma 1 (2%) 1 (2%) Sarcoma 1 (2%) Urinary Bladder (59) (60) (60) (59) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Histiocytic Sarcoma 1 (2%) 1 (2%) Lymphoma Malignant Lymphocytic 1 (2%) Lymphoma Malignant Mixed 2 (3%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/18/94 Route: DOSED FEED Time: 09:53:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 125 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 39 40 59 60 Total Primary Neoplasms 59 69 125 118 Total Animals with Benign Neoplasms 32 35 46 42 Total Benign Neoplasms 41 48 51 44 Total Animals with Malignant Neoplasms 17 19 51 60 Total Malignant Neoplasms 18 21 73 74 Total Animals with Metastatic Neoplasms 2 4 21 22 Total Metastatic Neoplasm 2 7 27 22 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 11 ------------------------------------------------------------ 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