TDMS Study 05087-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) TRIAMTERENE NTP Experiment-Test: 05087-01 Report: PEIRPT05 Study Type: CHRONIC Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 Facility: Battelle Columbus Laboratory Chemical CAS #: 396-01-0 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: 05087-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIAMTERENE Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 150 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 70 70 70 70 Scheduled Sacrifice 20 20 20 20 Early Deaths Moribund Sacrifice 17 11 12 18 Natural Death 4 5 4 3 Survivors Terminal Sacrifice 29 34 34 29 Animals Examined Microscopically 70 61 63 70 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Liver (70) (61) (61) (70) Hepatocellular Adenoma 1 (1%) Hepatocellular Adenoma, Multiple 1 (1%) Mesentery (4) (2) (4) (1) Pancreas (70) (50) (50) (70) Stomach, Forestomach (70) (50) (50) (70) Stomach, Glandular (70) (50) (50) (70) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (70) (50) (50) (70) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (70) (50) (50) (70) Adenoma 2 (3%) 1 (2%) Adrenal Gland, Medulla (70) (50) (50) (70) Pheochromocytoma Malignant 1 (1%) 1 (2%) Pheochromocytoma Benign 1 (2%) 1 (1%) Islets, Pancreatic (70) (50) (50) (70) Adenoma 3 (4%) 2 (4%) 1 (1%) Pituitary Gland (70) (53) (52) (69) Pars Distalis, Adenoma 22 (31%) 21 (40%) 25 (48%) 28 (41%) Pars Distalis, Carcinoma 1 (2%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (70) (50) (50) (70) C-Cell, Adenoma 5 (7%) 11 (22%) 5 (10%) 10 (14%) C-Cell, Adenoma, Multiple 1 (2%) C-Cell, Carcinoma 1 (2%) Page 2 NTP Experiment-Test: 05087-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIAMTERENE Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 150 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Follicle, Adenocarcinoma 1 (2%) Follicle, Adenoma 1 (2%) 1 (1%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Chemodectoma Malignant 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (62) (49) (50) (67) Adenoma 3 (5%) 3 (6%) 4 (8%) 2 (3%) Carcinoma 1 (2%) Bilateral, Adenoma 1 (1%) Ovary (70) (50) (50) (70) Granulosa Cell Tumor Malignant 1 (1%) Granulosa Cell Tumor Benign 1 (1%) Uterus (70) (51) (50) (70) Leiomyoma 2 (3%) Polyp Stromal 5 (7%) 7 (14%) 5 (10%) 5 (7%) Cervix, Squamous Cell Carcinoma 1 (1%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (70) (50) (50) (70) Lymph Node (70) (51) (50) (70) Lymph Node, Mandibular (68) (51) (49) (70) Lymph Node, Mesenteric (68) (48) (50) (68) Spleen (70) (50) (50) (70) Thymus (64) (46) (46) (65) Mediastinum, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (67) (49) (49) (66) Adenoma 4 (6%) 4 (8%) 1 (2%) Fibroadenoma 16 (24%) 11 (22%) 14 (29%) 12 (18%) Fibroadenoma, Multiple 4 (6%) 5 (10%) 2 (4%) 1 (2%) Skin (70) (50) (50) (70) Keratoacanthoma 1 (1%) Subcutaneous Tissue, Fibroma 2 (4%) Subcutaneous Tissue, Fibrosarcoma 1 (1%) Subcutaneous Tissue, Neurofibrosarcoma 1 (1%) Page 3 NTP Experiment-Test: 05087-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIAMTERENE Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 150 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (70) (50) (50) (70) Peripheral Nerve (1) (1) Sciatic, Schwannoma Malignant 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (70) (50) (50) (70) Adenocarcinoma, Metastatic, Thyroid Gland 1 (2%) Alveolar/Bronchiolar Adenoma 1 (1%) 2 (4%) 1 (1%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Granulosa Cell Tumor Malignant, Metastatic, Ovary 1 (1%) Mediastinum, Schwannoma Malignant 1 (1%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (1) Pinna, Fibroma 1 (100%) Pinna, Schwannoma Malignant 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (70) (60) (60) (70) Urinary Bladder (69) (49) (50) (70) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(70) *(61) *(63) *(70) Leukemia Mononuclear 8 (11%) 11 (18%) 7 (11%) 9 (13%) Mesothelioma Malignant 1 (1%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 4 NTP Experiment-Test: 05087-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIAMTERENE Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 150 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 45 42 42 Total Primary Neoplasms 84 77 74 81 Total Animals with Benign Neoplasms 43 39 40 37 Total Benign Neoplasms 65 64 65 70 Total Animals with Malignant Neoplasms 16 13 9 10 Total Malignant Neoplasms 19 13 9 11 Total Animals with Metastatic Neoplasms 1 2 Total Metastatic Neoplasm 1 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: 05087-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIAMTERENE Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 150 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 70 70 70 70 Scheduled Sacrifice 20 20 20 20 Early Deaths Moribund Sacrifice 18 20 18 17 Natural Death 4 5 13 6 Drowned 3 Survivors Terminal Sacrifice 25 25 19 27 Animals Examined Microscopically 70 60 61 70 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (69) (48) (49) (67) Adenocarcinoma 1 (1%) Adenoma 1 (2%) Intestine Small, Jejunum (68) (50) (49) (67) Adenoma 1 (2%) Liver (70) (56) (55) (69) Cholangioma 1 (1%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Hepatocellular Adenoma 4 (7%) 4 (7%) 2 (3%) Hepatocellular Adenoma, Multiple 2 (4%) 1 (1%) Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Mesentery (4) (4) (4) (10) Lipoma 1 (25%) Pancreas (70) (51) (50) (68) Stomach, Forestomach (70) (51) (51) (69) Squamous Cell Papilloma 1 (2%) 1 (1%) Stomach, Glandular (70) (51) (50) (68) Tongue (1) (1) (1) Squamous Cell Carcinoma 1 (100%) Squamous Cell Papilloma 1 (100%) Tooth (1) (1) (1) Gingiva, Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (70) (60) (60) (70) Chemodectoma Benign 1 (2%) Hemangiosarcoma 1 (1%) ____________________________________________________________________________________________________________________________________ Page 6 NTP Experiment-Test: 05087-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIAMTERENE Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 150 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (70) (51) (50) (70) Adenoma 1 (1%) 1 (2%) Adrenal Gland, Medulla (70) (51) (50) (69) Pheochromocytoma Malignant 1 (1%) 2 (4%) Pheochromocytoma Benign 8 (11%) 10 (20%) 7 (14%) 5 (7%) Bilateral, Pheochromocytoma Benign 2 (3%) 1 (2%) 1 (2%) 2 (3%) Islets, Pancreatic (70) (51) (50) (69) Adenoma 2 (3%) 1 (2%) 5 (10%) 1 (1%) Parathyroid Gland (64) (47) (50) (68) Adenoma 1 (2%) Pituitary Gland (70) (52) (49) (69) Pars Distalis, Adenoma 8 (11%) 7 (13%) 7 (14%) 9 (13%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (70) (50) (50) (69) Bilateral, C-Cell, Adenoma 1 (1%) 1 (2%) 1 (2%) 1 (1%) C-Cell, Adenoma 10 (14%) 6 (12%) 11 (22%) 9 (13%) Follicle, Adenoma 1 (1%) 1 (2%) 2 (4%) 2 (3%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Chemodectoma Benign 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (70) (51) (50) (69) Preputial Gland (70) (51) (51) (67) Adenoma 3 (4%) 2 (4%) 5 (10%) 3 (4%) Prostate (68) (49) (50) (69) Seminal Vesicle (69) (48) (50) (69) Testes (70) (51) (56) (69) Bilateral, Interstitial Cell, Adenoma 43 (61%) 43 (84%) 48 (86%) 49 (71%) Interstitial Cell, Adenoma 9 (13%) 5 (10%) 7 (13%) 8 (12%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (70) (51) (50) (70) Lymph Node (70) (51) (50) (70) Pancreatic, Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (1%) Lymph Node, Mandibular (70) (50) (50) (70) Lymph Node, Mesenteric (68) (48) (47) (67) Page 7 NTP Experiment-Test: 05087-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIAMTERENE Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 150 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Spleen (70) (51) (50) (70) Leiomyosarcoma 2 (3%) Thymus (62) (47) (46) (60) Squamous Cell Carcinoma, Metastatic, Lung 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (38) (35) (57) Fibroadenoma 1 (2%) Skin (69) (51) (50) (68) Basal Cell Adenoma 1 (2%) 1 (2%) Basal Cell Carcinoma 1 (2%) Basosquamous Tumor Malignant 2 (3%) Basosquamous Tumor Benign 1 (2%) 1 (1%) Keratoacanthoma 2 (3%) 2 (4%) 1 (2%) 1 (1%) Squamous Cell Papilloma 1 (1%) 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 1 (1%) 2 (4%) 3 (6%) 2 (3%) Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (70) (51) (50) (70) Osteosarcoma 1 (2%) 1 (2%) 1 (1%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (70) (51) (50) (70) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Granular Cell Tumor Benign 1 (1%) Oligodendroglioma Benign 1 (1%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (70) (51) (50) (70) Alveolar/Bronchiolar Adenoma 2 (3%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (2%) Squamous Cell Carcinoma 1 (2%) Nose (70) (51) (50) (70) Squamous Cell Papilloma 1 (2%) Page 8 NTP Experiment-Test: 05087-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIAMTERENE Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 150 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (2) (1) Middle Ear, Squamous Cell Papilloma 1 (50%) Pinna, Fibrosarcoma 1 (100%) Pinna, Squamous Cell Papilloma 1 (50%) Zymbal's Gland (1) (2) Adenoma 1 (100%) Carcinoma 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (70) (51) (52) (70) Adenoma 1 (1%) 1 (2%) Liposarcoma 1 (2%) Urinary Bladder (69) (48) (50) (67) Adenoma 1 (1%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(70) *(60) *(61) *(70) Leukemia Mononuclear 22 (31%) 23 (38%) 19 (31%) 18 (26%) Lymphoma Malignant Histiocytic 1 (2%) Lymphoma Malignant Mixed 1 (1%) Mesothelioma Malignant 2 (3%) 1 (1%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 9 NTP Experiment-Test: 05087-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIAMTERENE Date: 09/11/94 Route: DOSED FEED Time: 11:14:46 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 150 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 55 52 58 60 Total Primary Neoplasms 128 127 136 125 Total Animals with Benign Neoplasms 54 50 58 58 Total Benign Neoplasms 100 95 111 100 Total Animals with Malignant Neoplasms 26 29 24 23 Total Malignant Neoplasms 28 32 25 25 Total Animals with Metastatic Neoplasms 1 3 3 Total Metastatic Neoplasm 1 3 4 Total Animals with Malignant Neoplasms 1 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 10 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------