TDMS Study 05099-07 Pathology Tables
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 Facility: Southern Research Institute Chemical CAS #: 599-79-1 Lock Date: 02/03/93 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: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Natural Death 2 2 5 4 Moribund Sacrifice 12 13 14 11 Dosing Accident 1 1 9 Survivors Natural Death 1 Terminal Sacrifice 34 33 31 26 Moribund Sacrifice 1 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (60) (60) (60) (59) Schwannoma Malignant 1 (2%) Intestine Small, Duodenum (60) (60) (60) (60) Leiomyoma 1 (2%) Liver (60) (60) (60) (60) Carcinoma, Metastatic, Uterus 1 (2%) Hepatocellular Adenoma 1 (2%) Histiocytic Sarcoma, Metastatic, Skin 1 (2%) Mesentery (4) (8) (5) (6) Carcinoma, Metastatic, Uterus 1 (13%) Fibroma 1 (13%) Pancreas (60) (60) (60) (60) Pharynx (1) (1) Squamous Cell Carcinoma 1 (100%) Squamous Cell Papilloma 1 (100%) Stomach, Forestomach (60) (59) (60) (60) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (60) (60) (60) (60) Tongue (1) (1) (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Schwannoma Malignant 3 (5%) 3 (5%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Adenoma 1 (2%) 1 (2%) 1 (2%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Adrenal Medulla (60) (60) (60) (60) Ganglioneuroma 1 (2%) Pheochromocytoma Benign 3 (5%) Bilateral, Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (60) (60) (60) (60) Adenoma 1 (2%) 1 (2%) 1 (2%) Carcinoma 1 (2%) Pituitary Gland (60) (59) (60) (60) Pars Distalis, Adenoma 27 (45%) 20 (34%) 24 (40%) 13 (22%) Pars Distalis, Carcinoma 2 (3%) Thyroid Gland (60) (60) (60) (60) C-Cell, Adenoma 3 (5%) 5 (8%) 2 (3%) 5 (8%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 2 (3%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (60) (60) (60) (60) Adenoma 2 (3%) 3 (5%) 2 (3%) 2 (3%) Carcinoma 1 (2%) 2 (3%) 1 (2%) Ovary (60) (60) (60) (60) Granulosa Cell Tumor Benign 1 (2%) Uterus (60) (60) (60) (60) Adenoma 1 (2%) Carcinoma 1 (2%) Polyp Stromal 6 (10%) 8 (13%) 8 (13%) 4 (7%) Polyp Stromal, Multiple 1 (2%) Sarcoma Stromal 1 (2%) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Lymph Node (12) (9) (9) (7) Lymph Node, Mandibular (60) (58) (60) (60) Lymph Node, Mesenteric (60) (60) (59) (60) Spleen (60) (60) (60) (60) Thymus (59) (59) (60) (60) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (60) (60) (58) Adenoma 1 (2%) 2 (3%) Carcinoma 2 (3%) 3 (5%) 1 (2%) Fibroadenoma 18 (30%) 8 (13%) 18 (30%) 5 (9%) Fibroadenoma, Multiple 4 (7%) 1 (2%) 2 (3%) Skin (60) (60) (60) (60) Histiocytic Sarcoma 1 (2%) Keratoacanthoma 1 (2%) 1 (2%) 1 (2%) Sarcoma 1 (2%) Squamous Cell Papilloma 3 (5%) Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (2) (1) (1) Carcinoma, Metastatic, Uterus 1 (100%) Rhabdomyosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Astrocytoma Malignant 1 (2%) Carcinoma, Metastatic, Pituitary Gland 3 (5%) Glioma Malignant, Mixed 1 (2%) Meningioma Malignant 1 (2%) Spinal Cord (2) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Histiocytic Sarcoma, Metastatic, Skin 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Nose (60) (60) (60) (60) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Renal Tubule, Carcinoma 1 (2%) Transitional Epithelium, Papilloma 2 (3%) Urinary Bladder (59) (60) (60) (60) Papilloma 2 (3%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 15 (25%) 9 (15%) 9 (15%) 3 (5%) Lymphoma Malignant 1 (2%) 1 (2%) Lymphoma Malignant Mixed 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 46 43 49 33 Total Primary Neoplasms 91 72 88 50 Total Animals with Benign Neoplasms 42 32 45 27 Total Benign Neoplasms 69 50 70 37 Total Animals with Malignant Neoplasms 22 20 17 12 Total Malignant Neoplasms 22 21 18 13 Total Animals with Metastatic Neoplasms 5 2 Total Metastatic Neoplasm 8 3 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: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG 84 MG/KG 168 337.5 337.5 FEED RTD MG/KG MG/KG STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 70 60 60 60 60 70 Scheduled Sacrifice 10 10 10 10 10 10 Early Deaths Moribund Sacrifice 13 16 11 16 15 13 Natural Death 1 1 2 2 10 4 Dosing Accident 1 2 4 1 2 3 Survivors Terminal Sacrifice 35 31 33 30 23 30 Natural Death 1 Animals Examined Microscopically 70 60 60 60 60 70 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (69) (60) (59) (60) (58) (68) Adenoma 1 (2%) Carcinoma 1 (1%) Intestine Large, Rectum (69) (60) (60) (60) (59) (69) Polyp 1 (2%) Intestine Large, Cecum (70) (60) (60) (60) (60) (70) Sarcoma 1 (2%) Intestine Small, Duodenum (70) (60) (60) (60) (60) (69) Carcinoma 1 (1%) Intestine Small, Jejunum (70) (60) (59) (60) (59) (69) Intestine Small, Ileum (69) (60) (59) (60) (60) (69) Leiomyosarcoma 1 (1%) Liver (70) (60) (60) (60) (60) (70) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Hepatocellular Carcinoma 1 (2%) 1 (2%) Hepatocellular Adenoma 2 (3%) 2 (3%) 1 (2%) Histiocytic Sarcoma 1 (2%) Leiomyosarcoma, Metastatic, Stomach, Forestomach 1 (1%) Osteosarcoma, Metastatic, Bone 1 (2%) Osteosarcoma, Metastatic, Tissue NOS 1 (2%) Sarcoma, Metastatic, Intestine Large, Cecum 1 (2%) Mesentery (19) (19) (17) (19) (14) (18) Fibrous Histiocytoma 1 (5%) Leiomyosarcoma, Metastatic, Stomach, Forestomach 1 (5%) Osteosarcoma, Metastatic, Tissue NOS 1 (5%) Sarcoma, Metastatic, Intestine Large, Cecum 1 (5%) Pancreas (70) (60) (60) (60) (60) (68) Page 7 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG 84 MG/KG 168 337.5 337.5 FEED RTD MG/KG MG/KG STOP ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Fibrous Histiocytoma 1 (1%) Leiomyosarcoma, Metastatic, Stomach, Forestomach 1 (1%) Mixed Tumor Benign 1 (2%) 1 (2%) Sarcoma, Metastatic, Intestine Large, Cecum 1 (2%) Acinar Cell, Adenoma 9 (13%) 10 (17%) 6 (10%) 5 (8%) 10 (17%) 2 (3%) Acinar Cell, Adenoma, Multiple 3 (4%) 2 (3%) 2 (3%) 2 (3%) Acinar Cell, Carcinoma, Multiple 1 (1%) Pharynx (2) (1) Squamous Cell Carcinoma 1 (50%) Squamous Cell Papilloma 1 (50%) 1 (100%) Salivary Glands (70) (60) (59) (60) (60) (70) Adenoma 1 (2%) Schwannoma Malignant 1 (2%) Schwannoma Malignant, Metastatic, Skin 1 (1%) Stomach, Forestomach (70) (60) (60) (60) (60) (70) Leiomyosarcoma 1 (1%) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (1%) Stomach, Glandular (69) (60) (60) (60) (60) (70) Tongue (1) (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (70) (60) (60) (60) (60) (70) Vena Cava, Chordoma, Metastatic, Spinal Cord 1 (2%) Heart (70) (60) (60) (60) (60) (70) Schwannoma Benign 1 (2%) 2 (3%) 1 (1%) Schwannoma Malignant 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (70) (60) (60) (60) (60) (70) Adenoma 1 (2%) 2 (3%) Histiocytic Sarcoma 1 (2%) Adrenal Medulla (70) (60) (59) (60) (59) (70) Pheochromocytoma Malignant 1 (2%) 1 (2%) 2 (3%) Pheochromocytoma Complex 1 (1%) Pheochromocytoma Benign 12 (17%) 7 (12%) 6 (10%) 5 (8%) 7 (12%) 4 (6%) Bilateral, Pheochromocytoma Benign 3 (4%) 2 (3%) 1 (2%) 1 (2%) 1 (2%) 1 (1%) Islets, Pancreatic (70) (60) (60) (60) (60) (69) Adenoma 2 (3%) 2 (3%) 3 (5%) 6 (10%) 5 (8%) 1 (1%) Carcinoma 1 (1%) 1 (2%) 1 (2%) Pituitary Gland (70) (58) (60) (59) (59) (68) Page 8 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG 84 MG/KG 168 337.5 337.5 FEED RTD MG/KG MG/KG STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Ganglioneuroma 1 (1%) Pars Distalis, Adenoma 15 (21%) 23 (40%) 19 (32%) 18 (31%) 18 (31%) 20 (29%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (70) (60) (60) (60) (60) (70) Bilateral, C-Cell, Carcinoma 1 (2%) C-Cell, Adenoma 3 (4%) 6 (10%) 9 (15%) 5 (8%) 6 (10%) 4 (6%) C-Cell, Carcinoma 2 (3%) 1 (2%) 2 (3%) 1 (2%) 2 (3%) Follicular Cell, Adenoma 4 (6%) 3 (5%) 1 (2%) Follicular Cell, Carcinoma 1 (1%) 1 (2%) 2 (3%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (1) (1) Osteosarcoma 1 (100%) Sarcoma, Metastatic, Intestine Large, Cecum 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (70) (60) (60) (60) (60) (70) Preputial Gland (70) (60) (60) (60) (60) (70) Adenoma 1 (1%) 1 (2%) 3 (5%) 5 (7%) Carcinoma 2 (3%) 1 (2%) 3 (5%) 2 (3%) Prostate (70) (60) (60) (60) (60) (70) Adenoma 1 (2%) Seminal Vesicle (70) (60) (60) (60) (59) (70) Testes (70) (60) (59) (60) (60) (70) Bilateral, Interstitial Cell, Adenoma 50 (71%) 40 (67%) 43 (73%) 45 (75%) 52 (87%) 37 (53%) Interstitial Cell, Adenoma 4 (6%) 13 (22%) 5 (8%) 11 (18%) 3 (5%) 9 (13%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (70) (60) (60) (60) (60) (70) Histiocytic Sarcoma 1 (2%) Lymph Node (9) (16) (15) (14) (10) (7) Inguinal, Fibrous Histiocytoma, Metastatic, Skin 1 (10%) Mediastinal, Osteosarcoma, Metastatic, Tissue NOS 1 (7%) Mediastinal, Sarcoma, Metastatic, Intestine Large, Cecum 1 (6%) Pancreatic, Histiocytic Sarcoma 1 (7%) Lymph Node, Mandibular (70) (59) (60) (60) (59) (70) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (70) (60) (60) (60) (59) (69) Page 9 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG 84 MG/KG 168 337.5 337.5 FEED RTD MG/KG MG/KG STOP ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Sarcoma, Metastatic, Intestine Large, Cecum 1 (2%) Spleen (70) (60) (60) (60) (60) (70) Fibrosarcoma 1 (2%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Leiomyosarcoma, Metastatic, Stomach, Forestomach 1 (1%) Osteosarcoma, Metastatic, Tissue NOS 1 (2%) Sarcoma, Metastatic, Intestine Large, Cecum 1 (2%) Thymus (66) (60) (58) (59) (59) (69) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (67) (58) (58) (57) (59) (68) Carcinoma 1 (2%) Fibroadenoma 3 (4%) 1 (2%) 4 (7%) 4 (7%) 3 (5%) 4 (6%) Fibroadenoma, Multiple 1 (2%) Skin (70) (59) (60) (60) (59) (70) Basal Cell Adenoma 2 (3%) 3 (5%) Basal Cell Carcinoma 1 (2%) Keratoacanthoma 3 (4%) 2 (3%) 3 (5%) 3 (5%) 2 (3%) 3 (4%) Squamous Cell Papilloma 1 (1%) 2 (3%) 2 (3%) 3 (5%) 1 (2%) 1 (1%) Trichoepithelioma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 2 (3%) 3 (5%) 5 (8%) 1 (2%) 3 (5%) 6 (9%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (1%) Subcutaneous Tissue, Liposarcoma 1 (2%) Subcutaneous Tissue, Schwannoma Benign 1 (1%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) 1 (2%) 2 (3%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (70) (60) (60) (60) (60) (70) Hamartoma 1 (2%) Osteosarcoma 1 (2%) 1 (1%) Skeletal Muscle (1) (1) (1) (1) (1) (1) Fibrous Histiocytoma 1 (100%) Hemangiosarcoma 1 (100%) Histiocytic Sarcoma 1 (100%) Osteosarcoma, Metastatic, Tissue NOS 1 (100%) Sarcoma, Metastatic, Intestine Large, Cecum 1 (100%) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG 84 MG/KG 168 337.5 337.5 FEED RTD MG/KG MG/KG STOP ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (70) (60) (60) (60) (60) (70) Astrocytoma Malignant 1 (1%) Glioma Malignant 1 (2%) Granular Cell Tumor Benign 1 (2%) Meningioma Benign 1 (1%) Spinal Cord (1) (1) (1) (1) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (70) (60) (60) (60) (60) (70) Alveolar/Bronchiolar Adenoma 2 (3%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (1%) 2 (3%) Chordoma, Metastatic, Spinal Cord 1 (2%) Histiocytic Sarcoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) 1 (1%) Osteosarcoma, Metastatic, Tissue NOS 1 (2%) Sarcoma, Metastatic, Intestine Large, Cecum 1 (2%) Nose (70) (60) (60) (60) (60) (70) Squamous Cell Carcinoma 1 (1%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (2) Carcinoma 1 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (70) (60) (60) (60) (60) (70) Lipoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (1%) Renal Tubule, Adenoma 1 (2%) 1 (2%) Urinary Bladder (70) (60) (59) (60) (60) (67) Papilloma 2 (3%) 4 (7%) Papilloma, Multiple 2 (3%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(70) *(60) *(60) *(60) *(60) *(70) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 13 (19%) 10 (17%) 18 (30%) 12 (20%) 3 (5%) 10 (14%) Mesothelioma Malignant 1 (1%) 1 (2%) 1 (2%) 2 (3%) 3 (5%) 2 (3%) * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG 84 MG/KG 168 337.5 337.5 FEED RTD MG/KG MG/KG STOP ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(70) *(60) *(60) *(60) *(60) *(70) ____________________________________________________________________________________________________________________________________ Page 12 NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96 Route: GAVAGE Time: 19:12:10 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG 84 MG/KG 168 337.5 337.5 FEED RTD MG/KG MG/KG STOP ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 58 59 56 59 58 56 Total Primary Neoplasms 156 141 143 152 134 133 Total Animals with Benign Neoplasms 58 59 54 58 57 52 Total Benign Neoplasms 124 122 114 124 122 106 Total Animals with Malignant Neoplasms 25 16 24 23 9 21 Total Malignant Neoplasms 32 19 29 28 12 27 Total Animals with Metastatic Neoplasms 2 1 4 5 4 Total Metastatic Neoplasm 5 9 12 13 7 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 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------