TDMS Study 05099-99 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) SALICYLAZOSULFAPYRIDINE NTP Experiment-Test: 05099-99 Report: PEIRPT03 Study Type: CHRONIC Date: 05/04/95 Route: GAVAGE Time: 14:45:44 05099/08 -VS- 05099/10 COMPARISON Facility: SOUTHERN RESEARCH INSTITUTE Chemical CAS #: 599-79-1 Lock Date: 04/19/94 Cage Range: All Reasons For Removal: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25017 Scheduled Sacrifice 25021 Terminal Sacrifice Removal Date Range: All Treatment Groups: Include 001 0 MG/KG Include 004 RTD 0 MG/KG a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 05099-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/04/95 Route: GAVAGE Time: 14:45:44 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG RTD 0 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 110 Scheduled Sacrifice 42 Early Deaths Moribund Sacrifice 5 6 Natural Death 3 4 Dosing Accident 2 Survivors Terminal Sacrifice 40 Animals Examined Microscopically 50 52 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (52) Hemorrhage 1 (2%) Intestine Large, Cecum (47) (51) Parasite Metazoan 1 (2%) Liver (50) (52) Angiectasis 1 (2%) Basophilic Focus 1 (2%) 2 (4%) Clear Cell Focus 2 (4%) 1 (2%) Eosinophilic Focus 5 (10%) 5 (10%) Eosinophilic Focus, Multiple 1 (2%) Fatty Change, Focal 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) 1 (2%) Inflammation, Subacute 3 (6%) Mineralization 2 (4%) Mixed Cell Focus 2 (4%) Necrosis 3 (6%) 2 (4%) Pigmentation, Bile 1 (2%) 1 (2%) Vacuolization Cytoplasmic 3 (6%) 3 (6%) Bile Duct, Cyst 2 (4%) 1 (2%) Mesentery (4) (6) Fat, Mineralization 1 (17%) Fat, Necrosis 3 (75%) 4 (67%) Pancreas (50) (52) Inflammation, Subacute 1 (2%) Acinus, Depletion Secretory 1 (2%) Duct, Cyst 1 (2%) Stomach, Forestomach (50) (52) Edema 1 (2%) Foreign Body 1 (2%) Hyperplasia 18 (36%) 27 (52%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05099-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/04/95 Route: GAVAGE Time: 14:45:44 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG RTD 0 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Subacute 4 (8%) 12 (23%) Ulcer 3 (6%) 2 (4%) Stomach, Glandular (50) (52) Erosion 1 (2%) Hyperplasia 1 (2%) Mineralization 1 (2%) Pigmentation 1 (2%) Ulcer 1 (2%) Tooth (1) Developmental Malformation 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (52) Polyarteritis 1 (2%) Heart (50) (52) Embolus 1 (2%) Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (52) Accessory Adrenal Cortical Nodule 1 (2%) Embolus 1 (2%) Hyperplasia 8 (16%) Hypertrophy 11 (22%) 8 (15%) Vacuolization Cytoplasmic 1 (2%) Capsule, Hyperplasia 1 (2%) Spindle Cell, Hyperplasia 1 (2%) Adrenal Medulla (50) (52) Embolus 1 (2%) Islets, Pancreatic (50) (52) Embolus 1 (2%) Hyperplasia 2 (4%) 3 (6%) Parathyroid Gland (48) (48) Cyst 2 (4%) Pituitary Gland (44) (48) Pars Distalis, Cyst 1 (2%) Pars Distalis, Hyperplasia 2 (4%) Thyroid Gland (50) (52) Follicle, Cyst 6 (12%) 2 (4%) Follicle, Degeneration 3 (6%) 5 (10%) Follicular Cell, Hyperplasia 9 (18%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05099-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/04/95 Route: GAVAGE Time: 14:45:44 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG RTD 0 MG/KG ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (5) Dilatation 5 (100%) Epididymis (50) (52) Congestion 1 (2%) Granuloma Sperm 1 (2%) Inflammation, Chronic 1 (2%) Mineralization 1 (2%) Preputial Gland (49) (51) Congestion 1 (2%) Inflammation, Subacute 2 (4%) 1 (2%) Duct, Cyst 45 (92%) 44 (86%) Prostate (50) (52) Cyst 1 (2%) Hyperplasia 1 (2%) Inflammation, Suppurative 1 (2%) Seminal Vesicle (50) (52) Atrophy 2 (4%) Dilatation 14 (28%) 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Inflammation, Chronic 1 (2%) Testes (50) (52) Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (52) Myeloid Cell, Hyperplasia 2 (4%) Lymph Node (3) (4) Bronchial, Hyperplasia, Lymphoid 1 (25%) Inguinal, Hyperplasia, Lymphoid 1 (33%) Lymph Node, Mesenteric (50) (52) Angiectasis 17 (34%) 20 (38%) Edema 1 (2%) Hyperplasia, Lymphoid 4 (8%) 5 (10%) Necrosis 1 (2%) Spleen (50) (52) Angiectasis 1 (2%) Atrophy 5 (10%) 2 (4%) Congestion 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05099-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/04/95 Route: GAVAGE Time: 14:45:44 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG RTD 0 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Depletion Cellular 1 (2%) Hematopoietic Cell Proliferation 11 (22%) 6 (12%) Hyperplasia, Lymphoid 5 (10%) 9 (17%) Pigmentation, Hemosiderin 2 (4%) Thymus (45) (51) Atrophy 3 (7%) 2 (4%) Cyst 2 (4%) 1 (2%) Necrosis 1 (2%) Thymocyte, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (52) Subcutaneous Tissue, Inflammation, Chronic 1 (2%) Subcutaneous Tissue, Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (52) Cranium, Hyperostosis 2 (4%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (52) Compression 1 (2%) Embolus 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (52) Alveolar Epithelium, Hyperplasia 4 (8%) 3 (6%) Alveolus, Foreign Body 1 (2%) Alveolus, Hemorrhage 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 3 (6%) Mediastinum, Hemorrhage 1 (2%) Nose (50) (52) Glands, Cyst 1 (2%) Glands, Mineralization 3 (6%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05099-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/04/95 Route: GAVAGE Time: 14:45:44 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG RTD 0 MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (1) External Ear, Inflammation, Granulomatous 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (52) Bacterium 1 (2%) Fibrosis 1 (2%) Glomerulosclerosis 3 (6%) Infarct 5 (10%) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Subacute 2 (4%) 1 (2%) Mineralization 37 (74%) 49 (94%) Cortex, Cyst 5 (10%) 1 (2%) Cortex, Medulla, Inflammation, Suppurative 1 (2%) Pelvis, Necrosis 1 (2%) Renal Tubule, Casts 13 (26%) 13 (25%) Renal Tubule, Degeneration 3 (6%) 1 (2%) Renal Tubule, Regeneration 38 (76%) 36 (69%) Transitional Epithelium, Hyperplasia 1 (2%) Urinary Bladder (50) (52) Dilatation 1 (2%) Inflammation, Subacute 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------