TDMS Study 05212-05 Pathology Tables
NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 10/25/96 Route: DOSED FEED Time: 07:56:27 CONTROL VS 10,000 PPM STOP Facility: Battelle Columbus Laboratory Chemical CAS #: 604-75-1 Lock Date: 05/12/94 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include 001 0 PPM Include 002 0 PPM Include 011 10,000 PPM STOP Include 012 10,000 PPM STOP a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 10/25/96 Route: DOSED FEED Time: 07:56:27 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 Early Deaths Natural Death 6 6 Moribund Sacrifice 11 19 Accidently Killed 1 Survivors Terminal Sacrifice 32 25 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) Polyp Adenomatous 1 (2%) Liver (50) (49) Histiocytic Sarcoma, Metastatic, Skin 1 (2%) Mesentery (10) (13) Salivary Glands (50) (1) Myoepithelioma 1 (100%) Stomach, Forestomach (50) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (2) Adenoma 1 (50%) Adrenal Medulla (50) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (50) Adenoma 1 (2%) Pituitary Gland (50) (35) Pars Distalis, Adenoma 30 (60%) 23 (66%) Pars Distalis, Adenoma, Multiple 1 (2%) Thyroid Gland (50) (50) Bilateral, C-Cell, Adenoma 2 (4%) C-Cell, Adenoma 6 (12%) 2 (4%) C-Cell, Carcinoma 1 (2%) Page 2 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 10/25/96 Route: DOSED FEED Time: 07:56:27 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (11) Adenoma 6 (12%) 7 (64%) Carcinoma 1 (2%) Bilateral, Adenoma 1 (2%) Ovary (50) (4) Granulosa Cell Tumor Benign 1 (2%) Uterus (50) (5) Polyp Stromal 2 (4%) Sarcoma Stromal 1 (2%) 1 (20%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (4) (4) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (25%) Renal, Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (25%) Lymph Node, Mandibular (50) (3) Squamous Cell Carcinoma, Metastatic, Skin 1 (33%) Lymph Node, Mesenteric (50) (2) Spleen (50) (12) Thymus (50) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (23) Adenoma 1 (2%) Carcinoma 2 (4%) Carcinoma, Multiple 1 (4%) Fibroadenoma 11 (22%) 17 (74%) Fibroadenoma, Multiple 14 (29%) 6 (26%) Skin (50) (6) Fibroma 2 (33%) Squamous Cell Carcinoma 1 (17%) Page 3 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 10/25/96 Route: DOSED FEED Time: 07:56:27 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Histiocytic Sarcoma 1 (17%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (1) Osteosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) Oligodendroglioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (1) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 14 (28%) 15 (30%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 4 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 10/25/96 Route: DOSED FEED Time: 07:56:27 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 43 Total Primary Neoplasms 101 80 Total Animals with Benign Neoplasms 43 38 Total Benign Neoplasms 77 61 Total Animals with Malignant Neoplasms 21 17 Total Malignant Neoplasms 24 19 Total Animals with Metastatic Neoplasms 2 2 Total Metastatic Neoplasm 2 2 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 5 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 10/25/96 Route: DOSED FEED Time: 07:56:27 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 Early Deaths Moribund Sacrifice 25 39 Natural Death 8 11 Survivors Terminal Sacrifice 17 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Jejunum (49) Carcinoma 2 (4%) Leiomyosarcoma 1 (2%) Liver (50) (50) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) 1 (2%) Mesentery (7) (5) Leiomyosarcoma, Metastatic, Intestine Small, Jejunum 1 (14%) Pancreas (50) Acinus, Adenoma 1 (2%) Acinus, Adenoma, Mixed Cell 1 (2%) Stomach, Forestomach (50) (49) Stomach, Glandular (50) (47) Tooth (1) Odontoma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Medulla (50) (1) Pheochromocytoma Malignant 1 (100%) Pheochromocytoma Benign 9 (18%) Bilateral, Pheochromocytoma Benign 5 (10%) Islets, Pancreatic (50) Adenoma 1 (2%) Carcinoma 2 (4%) Pituitary Gland (49) (5) Page 6 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 10/25/96 Route: DOSED FEED Time: 07:56:27 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pars Distalis, Adenoma 17 (35%) 5 (100%) Thyroid Gland (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 9 (18%) 1 (2%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 1 (2%) 2 (4%) Follicular Cell, Carcinoma 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (2) (1) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (1) Preputial Gland (48) (14) Adenoma 6 (13%) 7 (50%) Carcinoma 1 (2%) Bilateral, Adenoma 1 (2%) 3 (21%) Testes (50) (48) Bilateral, Interstitial Cell, Adenoma 35 (70%) 44 (92%) Interstitial Cell, Adenoma 10 (20%) 4 (8%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (5) (9) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (11%) Lymph Node, Mandibular (50) (4) Lymph Node, Mesenteric (49) (4) Spleen (50) (33) Fibroma 1 (2%) Thymus (49) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (2) Adenoma 1 (50%) Carcinoma 1 (50%) Fibroadenoma 4 (8%) Skin (50) (8) Fibroma 3 (6%) 2 (25%) Fibrosarcoma 2 (4%) 1 (13%) Page 7 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 10/25/96 Route: DOSED FEED Time: 07:56:27 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Keratoacanthoma 3 (6%) 2 (25%) Sarcoma 1 (2%) Schwannoma Malignant 3 (6%) Squamous Cell Papilloma 2 (4%) Sebaceous Gland, Adenoma 1 (2%) 2 (25%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (2) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (3) Alveolar/Bronchiolar Adenoma 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Schwannoma Malignant, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (42) Renal Tubule, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) Leukemia Mononuclear 27 (54%) 34 (68%) Lymphoma Malignant 1 (2%) Mesothelioma Malignant 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 8 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 10/25/96 Route: DOSED FEED Time: 07:56:27 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 48 Total Primary Neoplasms 160 116 Total Animals with Benign Neoplasms 47 48 Total Benign Neoplasms 115 74 Total Animals with Malignant Neoplasms 38 35 Total Malignant Neoplasms 45 42 Total Animals with Metastatic Neoplasms 3 1 Total Metastatic Neoplasm 3 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 9 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------