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: 09/13/96 Route: DOSED FEED Time: 09:41:08 STANDARD TREATMENT GROUPS Facility: Battelle Columbus Laboratory Chemical CAS #: 604-75-1 Lock Date: 05/12/94 Cage Range: All Reasons For Removal: 25022 Accidently Killed 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice Removal Date Range: All Treatment Groups: Include 001 0 PPM Include 002 0 PPM Include 003 625 PPM Include 004 625 PPM Include 007 2500 PPM Include 008 2500 PPM Include 009 5000 PPM Include 010 5000 PPM 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: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 6 6 12 3 Moribund Sacrifice 11 18 18 16 Accidently Killed 1 Survivors Terminal Sacrifice 32 26 20 31 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (48) (49) (50) Polyp Adenomatous 1 (2%) Liver (50) (50) (50) (50) Mesentery (10) (9) (4) (6) Pancreas (50) (50) (49) (49) Acinus, Adenoma 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Tongue (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) 1 (2%) Adrenal Medulla (50) (50) (50) (50) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 1 (2%) 3 (6%) 1 (2%) Islets, Pancreatic (50) (50) (49) (49) Adenoma 1 (2%) Parathyroid Gland (42) (38) (38) (33) Adenoma 1 (3%) Pituitary Gland (50) (50) (50) (50) Pars Distalis, Adenoma 30 (60%) 28 (56%) 20 (40%) 12 (24%) Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%) Pars Distalis, 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: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Thyroid Gland (50) (50) (48) (49) C-Cell, Adenoma 6 (12%) 3 (6%) 6 (13%) 2 (4%) C-Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%) Follicular Cell, Adenoma 1 (2%) 2 (4%) Follicular Cell, Carcinoma 1 (2%) 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (50) (50) (50) Adenoma 6 (12%) 3 (6%) 3 (6%) 4 (8%) Carcinoma 1 (2%) 1 (2%) Bilateral, Adenoma 1 (2%) Ovary (50) (50) (50) (50) Granulosa Cell Tumor Benign 1 (2%) Tubulostromal Adenoma 1 (2%) Uterus (50) (50) (50) (50) Polyp Stromal 2 (4%) 4 (8%) 3 (6%) 4 (8%) Sarcoma Stromal 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (4) (2) (9) (3) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (25%) Renal, Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (25%) Lymph Node, Mandibular (50) (48) (48) (49) Lymph Node, Mesenteric (50) (50) (50) (49) Spleen (50) (50) (50) (49) Thymus (50) (48) (46) (47) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (49) (50) Adenoma 1 (2%) 2 (4%) Carcinoma 2 (4%) 3 (6%) Fibroadenoma 11 (22%) 14 (29%) 8 (16%) 12 (24%) Fibroadenoma, Multiple 14 (29%) 5 (10%) 1 (2%) 1 (2%) Skin (50) (50) (50) (50) 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: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Basal Cell Carcinoma 1 (2%) Fibroma 1 (2%) Fibrosarcoma 2 (4%) Keratoacanthoma 1 (2%) Trichoepithelioma 1 (2%) Sebaceous Gland, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Osteosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Astrocytoma Benign 1 (2%) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Oligodendroglioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (49) (49) Alveolar/Bronchiolar Adenoma 2 (4%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (2) Carcinoma 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Nephroblastoma 1 (2%) Urinary Bladder (48) (49) (49) (50) Sarcoma Stromal, Metastatic, Uterus 1 (2%) 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: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Leukemia Mononuclear 14 (28%) 19 (38%) 29 (58%) 18 (36%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically 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: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 49 45 38 Total Primary Neoplasms 101 93 80 67 Total Animals with Benign Neoplasms 43 39 30 26 Total Benign Neoplasms 77 65 45 44 Total Animals with Malignant Neoplasms 21 26 34 22 Total Malignant Neoplasms 24 28 35 23 Total Animals with Metastatic Neoplasms 2 2 1 Total Metastatic Neoplasm 2 2 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 6 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 25 27 33 43 Natural Death 8 12 11 7 Survivors Terminal Sacrifice 17 11 6 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (47) (50) (50) Polyp Adenomatous 1 (2%) Intestine Large, Rectum (50) (48) (49) (50) Polyp Adenomatous 1 (2%) Intestine Small, Jejunum (49) (48) (46) (49) Carcinoma 2 (4%) Leiomyosarcoma 1 (2%) Liver (50) (50) (49) (50) Fibrous Histiocytoma, Metastatic, Lung 1 (2%) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) 3 (6%) Mesentery (7) (6) (4) (4) Leiomyosarcoma, Metastatic, Intestine Small, Jejunum 1 (14%) Leiomyosarcoma, Metastatic, Stomach, Glandular 1 (17%) Oral Mucosa (1) Gingival, Squamous Cell Carcinoma 1 (100%) Pancreas (50) (48) (49) (50) Adenoma 1 (2%) Fibrous Histiocytoma, Metastatic, Lung 1 (2%) Acinus, Adenoma 1 (2%) 1 (2%) Acinus, Adenoma, Mixed Cell 1 (2%) Stomach, Forestomach (50) (48) (50) (50) Leiomyosarcoma 1 (2%) Stomach, Glandular (50) (48) (50) (50) Leiomyosarcoma 1 (2%) Tongue (1) (1) Squamous Cell Carcinoma 1 (100%) Squamous Cell Papilloma 1 (100%) Tooth (1) Odontoma 1 (100%) ____________________________________________________________________________________________________________________________________ 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: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) Fibrous Histiocytoma, Metastatic, Lung 1 (2%) Adrenal Medulla (50) (50) (50) (50) Pheochromocytoma Benign 9 (18%) 8 (16%) 5 (10%) 1 (2%) Bilateral, Pheochromocytoma Benign 5 (10%) 1 (2%) 1 (2%) 2 (4%) Islets, Pancreatic (50) (48) (49) (50) Adenoma 1 (2%) Carcinoma 2 (4%) Pituitary Gland (49) (50) (50) (48) Pars Distalis, Adenoma 17 (35%) 12 (24%) 9 (18%) 2 (4%) Pars Distalis, Adenoma, Multiple 1 (2%) Thyroid Gland (50) (49) (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) 2 (4%) C-Cell, Adenoma 9 (18%) 5 (10%) 4 (8%) 2 (4%) Follicular Cell, Adenoma 1 (2%) 1 (2%) 2 (4%) Follicular Cell, Carcinoma 3 (6%) 3 (6%) 3 (6%) 4 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (2) (1) (1) (2) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (49) (50) (50) Preputial Gland (48) (50) (50) (49) Adenoma 6 (13%) 9 (18%) 5 (10%) 3 (6%) Carcinoma 1 (2%) Fibrous Histiocytoma, Metastatic, Lung 1 (2%) Bilateral, Adenoma 1 (2%) 1 (2%) Seminal Vesicle (50) (50) (50) (50) Testes (50) (50) (50) (50) Bilateral, Interstitial Cell, Adenoma 35 (70%) 42 (84%) 47 (94%) 46 (92%) Interstitial Cell, Adenoma 10 (20%) 6 (12%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ 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: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Fibrous Histiocytoma, Metastatic, Lung 1 (2%) Lymph Node (5) (8) (8) (1) Lymph Node, Mandibular (50) (49) (49) (50) Lymph Node, Mesenteric (49) (49) (50) (47) Spleen (50) (50) (50) (50) Fibroma 1 (2%) Hemangiosarcoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) Thymus (49) (47) (49) (47) Thymoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (44) (48) (48) Carcinoma 1 (2%) Fibroadenoma 4 (8%) 5 (11%) 4 (8%) 2 (4%) Skin (50) (49) (49) (50) Fibroma 3 (6%) 1 (2%) 1 (2%) 2 (4%) Fibrosarcoma 2 (4%) 3 (6%) Keratoacanthoma 3 (6%) 5 (10%) 1 (2%) 2 (4%) Keratoacanthoma, Multiple 1 (2%) Liposarcoma 1 (2%) Osteosarcoma 1 (2%) Sarcoma 1 (2%) Schwannoma Malignant 3 (6%) Squamous Cell Papilloma 2 (4%) 1 (2%) Sebaceous Gland, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Chordoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Astrocytoma Malignant 1 (2%) Fibrous Histiocytoma, Metastatic, Lung 1 (2%) Oligodendroglioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) Chordoma, Metastatic, Bone 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Fibrous Histiocytoma 1 (2%) Schwannoma Malignant, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (1) Carcinoma 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Fibrous Histiocytoma, Metastatic, Lung 1 (2%) Renal Tubule, Adenoma 1 (2%) 3 (6%) 1 (2%) Urinary Bladder (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) 1 (2%) Leukemia Mononuclear 27 (54%) 36 (72%) 33 (66%) 19 (38%) Mesothelioma Malignant 2 (4%) 2 (4%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OXAZEPAM Date: 09/13/96 Route: DOSED FEED Time: 09:41:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 50 50 48 Total Primary Neoplasms 160 151 135 99 Total Animals with Benign Neoplasms 47 50 50 47 Total Benign Neoplasms 115 99 89 71 Total Animals with Malignant Neoplasms 38 43 40 25 Total Malignant Neoplasms 45 52 46 28 Total Animals with Metastatic Neoplasms 3 2 1 Total Metastatic Neoplasm 3 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 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