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
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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
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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%)
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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
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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
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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
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