TDMS Study 05063-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) PHENYLBUTAZONE NTP Experiment-Test: 05063-01 Report: PEIRPT05 Study Type: CHRONIC Date: 09/08/94 Route: GAVAGE Time: 19:21:04 Facility: TSI Mason Research Chemical CAS #: 50-33-9 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: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 Early Deaths Moribund Sacrifice 14 9 14 Natural Death 5 5 14 Accident 1 Survivors Terminal Sacrifice 30 35 21 Natural Death 1 Terminal Sacrifice 1 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (50) (9) (50) Adenocarcinoma 1 (2%) Leiomyosarcoma 1 (11%) Liver (50) (27) (50) Neoplastic Nodule 1 (2%) 2 (7%) Mesentery (2) (5) (10) Sarcoma 1 (20%) Pancreas (50) (9) (50) Adenoma 1 (2%) Salivary Glands (50) (7) (50) Stomach, Forestomach (49) (49) (49) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (49) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (7) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) (50) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) Adrenal Gland, Medulla (50) (50) (50) Pheochromocytoma NOS 1 (2%) Pheochromocytoma Benign 3 (6%) 1 (2%) 2 (4%) Pituitary Gland (48) (49) (50) Pars Distalis, Adenoma 30 (63%) 24 (49%) 21 (42%) Page 2 NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pars Distalis, Adenoma, Multiple 1 (2%) Thyroid Gland (50) (49) (50) C-Cell, Adenoma 2 (4%) 4 (8%) C-Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (36) (11) (41) Adenoma 5 (14%) 4 (36%) Carcinoma 2 (18%) 2 (5%) Squamous Cell Carcinoma 1 (9%) Ovary (50) (14) (50) Granulosa Cell Tumor Malignant 1 (7%) Granulosa Cell Tumor Benign 1 (2%) Uterus (50) (17) (50) Basosquamous Tumor Malignant 1 (6%) Leiomyosarcoma 1 (2%) Polyp Stromal 15 (30%) 7 (41%) 12 (24%) Polyp Stromal, Multiple 1 (2%) Sarcoma Stromal 2 (4%) 3 (18%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (6) (48) Lymph Node (50) (15) (49) Lymph Node, Mandibular (42) (5) (37) Squamous Cell Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Lymph Node, Mesenteric (50) (13) (46) Spleen (50) (50) (50) Thymus (42) (8) (38) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (46) (18) (40) Adenocarcinoma 1 (2%) 1 (6%) Fibroadenoma 18 (39%) 8 (44%) 7 (18%) Fibroadenoma, Multiple 4 (9%) 7 (39%) Skin (50) (12) (49) Page 3 NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Carcinosarcoma 1 (8%) Squamous Cell Papilloma 1 (8%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (8%) 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (2) (1) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) (50) Glioma Benign 1 (10%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (20) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Adrenal Gland 1 (5%) Sarcoma Stromal, Metastatic, Uterus 1 (2%) Squamous Cell Carcinoma, Metastatic, Zymbal's Gland 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (2) Carcinoma 2 (100%) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Carcinoma 1 (2%) Transitional Epithelium, Carcinoma 2 (4%) Urinary Bladder (50) (49) (49) Page 4 NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Leukemia Mononuclear 11 (22%) 6 (12%) 4 (8%) Mesothelioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 46 46 36 Total Primary Neoplasms 103 84 60 Total Animals with Benign Neoplasms 43 39 35 Total Benign Neoplasms 84 62 47 Total Animals with Malignant Neoplasms 19 16 12 Total Malignant Neoplasms 19 22 12 Total Animals with Metastatic Neoplasms 2 1 Total Metastatic Neoplasm 3 1 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: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 Early Deaths Moribund Sacrifice 11 13 16 Natural Death 6 16 7 Accident 1 Survivors Terminal Sacrifice 32 20 27 Terminal Sacrifice 1 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (21) (49) Serosa, Sarcoma, Metastatic, Spleen 1 (5%) Intestine Small, Duodenum (50) (23) (49) Serosa, Ileum, Sarcoma, Metastatic, Spleen 1 (4%) Intestine Small, Ileum (50) (21) (49) Lymphoid Nodule, Fibrosarcoma, Metastatic, Mammary Gland 1 (2%) Liver (50) (50) (50) Neoplastic Nodule 1 (2%) 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Serosa, Sarcoma, Metastatic, Spleen 1 (2%) Serosa, Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Mesentery (4) (5) (3) Sarcoma, Metastatic, Spleen 1 (20%) Sarcoma, Metastatic, Uncertain Primary Site 1 (33%) Pancreas (50) (27) (50) Adenoma 3 (6%) 3 (11%) 4 (8%) Sarcoma, Metastatic, Spleen 1 (4%) Salivary Glands (49) (23) (49) Stomach (50) (50) (50) Stomach, Forestomach (50) (50) (50) Serosa, Sarcoma, Metastatic, Spleen 1 (2%) Serosa, Glandular, Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (20) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (50) (49) (50) Adrenal Gland, Cortex (50) (49) (50) Medulla, Osteosarcoma, Metastatic, Bone 1 (2%) Adrenal Gland, Medulla (50) (48) (49) Pheochromocytoma Malignant 4 (8%) 2 (4%) 2 (4%) Pheochromocytoma Complex 1 (2%) 2 (4%) Pheochromocytoma Benign 9 (18%) 13 (27%) 12 (24%) Pheochromocytoma Benign, Multiple 2 (4%) 1 (2%) Bilateral, Pheochromocytoma NOS 1 (2%) Bilateral, Pheochromocytoma Benign 5 (10%) 4 (8%) 7 (14%) Islets, Pancreatic (50) (22) (50) Adenoma 2 (4%) 1 (5%) Carcinoma 2 (4%) Pituitary Gland (48) (26) (47) Pars Distalis, Adenoma 13 (27%) 9 (35%) 20 (43%) Pars Distalis, Adenoma, Multiple 3 (6%) 1 (4%) 1 (2%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (49) (21) (49) C-Cell, Adenoma 6 (12%) 1 (5%) 2 (4%) C-Cell, Carcinoma 1 (2%) 1 (5%) Follicular Cell, Adenoma 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Lipoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (49) (50) Serosa, Sarcoma, Metastatic, Spleen 1 (2%) Serosa, Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Preputial Gland (43) (25) (47) Adenocarcinoma 1 (4%) 1 (2%) Adenoma 2 (5%) 4 (16%) Carcinoma 1 (2%) Sarcoma 1 (2%) Prostate (50) (21) (46) Page 8 NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Seminal Vesicle (49) (36) (47) Serosa, Sarcoma, Metastatic, Spleen 1 (3%) Testes (50) (49) (50) Bilateral, Interstitial Cell, Adenoma 35 (70%) 32 (65%) 38 (76%) Interstitial Cell, Adenoma 11 (22%) 9 (18%) 10 (20%) Tunic, Sarcoma, Metastatic, Spleen 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (20) (50) Lymph Node (50) (26) (50) Mediastinal, Sarcoma, Metastatic, Spleen 1 (4%) Lymph Node, Mandibular (44) (18) (41) Fibrosarcoma, Metastatic 1 (2%) Lymph Node, Mesenteric (47) (19) (49) Spleen (50) (32) (50) Sarcoma 1 (3%) 1 (2%) Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Thymus (42) (18) (42) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (21) (8) (24) Fibroadenoma 2 (10%) 5 (63%) 3 (13%) Skin (50) (27) (49) Basal Cell Carcinoma 1 (2%) Basosquamous Tumor Malignant 1 (2%) Keratoacanthoma 2 (4%) 1 (4%) 1 (2%) Squamous Cell Papilloma 1 (4%) Sebaceous Gland, Adenoma 1 (4%) Subcutaneous Tissue, Fibroma 3 (6%) 3 (11%) 4 (8%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (4%) Subcutaneous Tissue, Myxosarcoma 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (21) (50) Scapula, Osteosarcoma 1 (5%) Skeletal Muscle (1) (3) (1) Osteosarcoma, Extension, Metastatic 1 (33%) Diaphragm, Sarcoma, Metastatic, Uncertain Page 9 NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - cont Primary Site 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (20) (50) Astrocytoma Malignant 1 (2%) 1 (5%) 1 (2%) Granular Cell Tumor Benign 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (34) (50) Alveolar/Bronchiolar Adenoma 3 (9%) Alveolar/Bronchiolar Carcinoma 2 (4%) Fibrosarcoma, Metastatic, Ear 1 (2%) Osteosarcoma, Metastatic, Bone 1 (3%) Pheochromocytoma Malignant, Metastatic 1 (3%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (3) (1) Pinna, Fibrosarcoma 1 (33%) Eye (1) (3) Lids, Fibroma 1 (100%) Harderian Gland (1) Adenoma 1 (100%) Zymbal's Gland (3) (1) (1) Carcinoma 2 (67%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (50) Bilateral, Renal Tubule, Adenoma 1 (2%) Renal Tubule, Adenoma 2 (4%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (45) (22) (48) Transitional Epithelium, Papilloma 2 (9%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Leukemia Mononuclear 2 (4%) 2 (4%) 2 (4%) * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(50) *(50) *(50) Lymphoma Malignant Lymphocytic 1 (2%) Mesothelioma Benign 1 (2%) Mesothelioma Malignant 3 (6%) 4 (8%) 3 (6%) ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94 Route: GAVAGE Time: 19:21:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 48 50 Total Primary Neoplasms 130 112 125 Total Animals with Benign Neoplasms 49 47 49 Total Benign Neoplasms 105 96 108 Total Animals with Malignant Neoplasms 21 14 14 Total Malignant Neoplasms 25 15 17 Total Animals with Metastatic Neoplasms 2 5 2 Total Metastatic Neoplasm 3 17 8 Total Animals with Malignant Neoplasms 1 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 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------