TDMS Study 05099-08 Pathology Tables
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
Facility: Southern Research Institute
Chemical CAS #: 599-79-1
Lock Date: 04/19/94
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: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Accidently Killed 1 1
Moribund Sacrifice 5 6 8 6
Natural Death 2 3 4 4
Dosing Accident 1 2
Survivors
Terminal Sacrifice 41 41 36 38
Accidently Killed 1
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (60) (60) (60)
Inflammation, Chronic 1 (2%) 1 (2%)
Perforation 1 (2%)
Intestine Large, Cecum (59) (59) (58) (56)
Edema 1 (2%)
Inflammation, Subacute 1 (2%)
Intestine Small, Duodenum (60) (59) (58) (56)
Hyperplasia 1 (2%)
Necrosis 1 (2%)
Intestine Small, Jejunum (59) (59) (58) (56)
Dilatation 1 (2%)
Peyer's Patch, Hyperplasia, Lymphoid 2 (3%)
Intestine Small, Ileum (59) (59) (58) (55)
Dilatation 1 (2%)
Inflammation, Subacute 1 (2%)
Liver (60) (60) (60) (59)
Angiectasis 2 (3%) 1 (2%)
Basophilic Focus 1 (2%) 1 (2%) 1 (2%)
Clear Cell Focus 1 (2%) 1 (2%) 1 (2%)
Congestion 1 (2%) 1 (2%)
Cytologic Alterations 3 (5%) 6 (10%) 8 (14%)
Depletion Glycogen 1 (2%)
Eosinophilic Focus 6 (10%) 14 (23%) 13 (22%) 16 (27%)
Eosinophilic Focus, Multiple 4 (7%) 2 (3%) 4 (7%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Subacute 2 (3%) 2 (3%) 3 (5%) 4 (7%)
Mineralization 1 (2%)
Mixed Cell Focus 2 (3%) 2 (3%) 1 (2%)
Necrosis 3 (5%) 5 (8%) 2 (3%)
Pigmentation, Bile 1 (2%) 1 (2%)
Thrombosis 1 (2%)
Vacuolization Cytoplasmic 3 (5%) 1 (2%) 1 (2%)
Bile Duct, Cyst 2 (3%) 1 (2%)
Mesentery (7) (11) (3) (5)
Cyst 1 (14%)
Inflammation, Subacute 1 (14%)
Polyarteritis 2 (29%)
Fat, Inflammation, Subacute 1 (20%)
Fat, Necrosis 4 (57%) 11 (100%) 1 (33%) 4 (80%)
Pancreas (60) (59) (60) (59)
Edema 1 (2%) 1 (2%)
Fibrosis 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Subacute 1 (2%)
Polyarteritis 1 (2%)
Acinus, Atrophy 1 (2%) 4 (7%) 1 (2%)
Acinus, Depletion Secretory 1 (2%) 1 (2%)
Acinus, Necrosis 1 (2%) 1 (2%)
Duct, Cyst 1 (2%) 1 (2%) 1 (2%)
Salivary Glands (59) (60) (60) (60)
Acinus, Atrophy 1 (2%)
Stomach, Forestomach (60) (59) (60) (59)
Diverticulum 1 (2%) 1 (2%)
Edema 1 (2%)
Hyperplasia 13 (22%) 7 (12%) 6 (10%) 4 (7%)
Inflammation, Subacute 2 (3%) 2 (3%) 1 (2%)
Mineralization 1 (2%) 1 (2%)
Polyarteritis 1 (2%)
Ulcer 2 (3%) 1 (2%)
Stomach, Glandular (60) (59) (60) (59)
Cyst 3 (5%) 1 (2%) 1 (2%)
Edema 2 (3%)
Erosion 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Inflammation, Subacute 2 (3%)
Mineralization 3 (5%) 8 (14%) 4 (7%) 5 (8%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Cardiomyopathy 1 (2%)
Congestion 1 (2%)
Degeneration 1 (2%)
Fibrosis 1 (2%) 1 (2%) 1 (2%)
Foreign Body 1 (2%)
Hemorrhage 1 (2%)
Mineralization 1 (2%) 1 (2%)
Pericardium, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Cyst 2 (3%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia 2 (3%) 3 (5%) 4 (7%)
Hypertrophy 1 (2%) 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Capsule, Hyperplasia 1 (2%)
Spindle Cell, Hyperplasia 1 (2%) 1 (2%)
X-Zone, Vacuolization Cytoplasmic 1 (2%) 3 (5%) 2 (3%)
Adrenal Medulla (60) (60) (60) (60)
Hyperplasia 2 (3%) 1 (2%)
Islets, Pancreatic (60) (60) (60) (60)
Hyperplasia 1 (2%)
Pituitary Gland (59) (55) (60) (56)
Pars Distalis, Cyst 1 (2%)
Pars Distalis, Hyperplasia 13 (22%) 12 (22%) 7 (12%) 8 (14%)
Pars Intermedia, Hyperplasia 1 (2%)
Thyroid Gland (60) (60) (60) (60)
Polyarteritis 1 (2%)
Follicle, Cyst 6 (10%) 4 (7%) 3 (5%)
Follicle, Degeneration 3 (5%) 9 (15%) 9 (15%) 14 (23%)
Follicular Cell, Hyperplasia 20 (33%) 5 (8%) 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (60) (60) (60) (60)
Atrophy 1 (2%)
Hemorrhage 1 (2%)
Necrosis 1 (2%)
Duct, Cyst 16 (27%) 21 (35%) 24 (40%) 15 (25%)
Ovary (59) (59) (59) (59)
Cyst 9 (15%) 13 (22%) 14 (24%) 5 (8%)
Hemorrhage 1 (2%)
Mineralization 1 (2%)
Thrombosis 1 (2%)
Uterus (60) (60) (60) (59)
Cyst 1 (2%)
Dilatation 4 (7%) 18 (30%) 14 (23%) 11 (19%)
Hemorrhage 3 (5%) 1 (2%)
Hydrometra 1 (2%)
Hyperplasia, Cystic 51 (85%) 48 (80%) 51 (85%) 50 (85%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%)
Thrombosis 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Atrophy 1 (2%)
Lymph Node (8) (7) (11) (4)
Hyperplasia, Lymphoid 1 (25%)
Inguinal, Hyperplasia, Lymphoid 1 (14%) 1 (25%)
Mediastinal, Hyperplasia, Lymphoid 2 (25%) 2 (29%) 3 (27%)
Renal, Hyperplasia, Lymphoid 1 (14%)
Lymph Node, Mandibular (59) (60) (60) (59)
Angiectasis 2 (3%)
Hyperplasia, Lymphoid 4 (7%) 1 (2%) 2 (3%) 4 (7%)
Pigmentation 1 (2%)
Lymph Node, Mesenteric (59) (60) (60) (58)
Angiectasis 3 (5%) 2 (3%)
Hyperplasia, Lymphoid 1 (2%) 2 (3%) 2 (3%) 4 (7%)
Necrosis 2 (3%) 2 (3%)
Spleen (60) (60) (60) (59)
Atrophy 1 (2%) 1 (2%) 2 (3%)
Congestion 1 (2%) 1 (2%)
Cyst 1 (2%)
Hematopoietic Cell Proliferation 9 (15%) 28 (47%) 29 (48%) 33 (56%)
Hyperplasia, Lymphoid 18 (30%) 28 (47%) 17 (28%) 15 (25%)
Pigmentation, Hemosiderin 14 (23%) 47 (78%) 49 (82%) 56 (95%)
Polyarteritis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Thymus (60) (59) (59) (59)
Atrophy 1 (2%) 1 (2%) 2 (3%) 4 (7%)
Cyst 2 (3%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Inflammation, Granulomatous 1 (2%)
Thymocyte, Necrosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (60) (60) (60)
Duct, Cyst 1 (2%)
Skin (60) (60) (60) (60)
Cyst Epithelial Inclusion 1 (2%)
Hyperkeratosis 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Subacute 1 (2%) 1 (2%)
Subcutaneous Tissue, Abscess 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
Subcutaneous Tissue, Fibrosis 1 (2%)
Subcutaneous Tissue, Foreign Body 1 (2%)
Subcutaneous Tissue, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Cranium, Fibrous Osteodystrophy 1 (2%) 2 (3%)
Cranium, Hyperostosis 1 (2%)
Femur, Fibrous Osteodystrophy 3 (5%) 2 (3%)
Skeletal Muscle (1) (2) (1)
Abscess 1 (100%)
Foreign Body 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Compression 1 (2%) 2 (3%)
Cyst Epithelial Inclusion 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Vacuolization Cytoplasmic 1 (2%) 1 (2%)
Spinal Cord (2) (1) (2)
Vacuolization Cytoplasmic 1 (50%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Congestion 1 (2%)
Foreign Body 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 2 (3%) 2 (3%)
Hyperplasia, Macrophage 1 (2%)
Inflammation, Subacute 1 (2%) 1 (2%)
Pigmentation 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (5%) 3 (5%)
Alveolus, Infiltration Cellular, Histiocyte 2 (3%) 3 (5%)
Mediastinum, Inflammation, Chronic 1 (2%) 1 (2%)
Nose (60) (60) (60) (60)
Glands, Cyst 2 (3%) 4 (7%)
Glands, Mineralization 1 (2%) 2 (3%)
Lumen, Exudate 1 (2%) 2 (3%) 1 (2%)
Lumen, Foreign Body 1 (2%)
Olfactory Epithelium, Degeneration 8 (13%) 11 (18%) 12 (20%) 6 (10%)
Respiratory Epithelium, Mineralization 2 (3%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (59)
Fibrosis 1 (2%)
Glomerulosclerosis 2 (3%) 1 (2%)
Metaplasia, Osseous 5 (8%) 2 (3%) 1 (2%)
Mineralization 14 (23%) 27 (45%) 24 (40%) 13 (22%)
Polyarteritis 1 (2%)
Cortex, Cyst 1 (2%)
Pelvis, Mineralization 1 (2%)
Renal Tubule, Casts 26 (43%) 26 (43%) 26 (43%) 34 (58%)
Renal Tubule, Degeneration 3 (5%) 1 (2%)
Renal Tubule, Dilatation 1 (2%)
Renal Tubule, Pigmentation, Hemosiderin 1 (2%)
Renal Tubule, Regeneration 17 (28%) 17 (28%) 14 (23%) 17 (29%)
Urinary Bladder (60) (60) (60) (60)
Dilatation 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Polyarteritis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60 60
Scheduled Sacrifice 10 10 10 10 10
Early Deaths
Moribund Sacrifice 5 3 4 3 4
Natural Death 3 1 5 6
Dosing Accident 2 1
Survivors
Terminal Sacrifice 40 45 41 41 46
Animals Examined Microscopically 60 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (60) (60) (60) (60)
Hemorrhage 1 (2%) 1 (2%)
Gallbladder (59) (59) (58) (59) (58)
Fibrosis 1 (2%)
Inflammation, Suppurative 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Intestine Large, Cecum (57) (60) (56) (56) (60)
Parasite Metazoan 1 (2%)
Intestine Small, Duodenum (57) (60) (57) (57) (60)
Dilatation 1 (2%)
Inflammation, Subacute 1 (2%)
Necrosis 1 (2%)
Ulcer 1 (2%)
Intestine Small, Jejunum (57) (60) (56) (57) (60)
Hyperplasia, Glandular 1 (2%)
Peyer's Patch, Hyperplasia, Lymphoid 2 (4%)
Intestine Small, Ileum (57) (60) (56) (56) (60)
Inflammation, Chronic 1 (2%)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Liver (60) (60) (60) (60) (60)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Basophilic Focus 1 (2%) 4 (7%)
Clear Cell Focus 3 (5%) 2 (3%) 15 (25%) 4 (7%) 8 (13%)
Clear Cell Focus, Multiple 1 (2%) 3 (5%)
Cytologic Alterations 2 (3%) 8 (13%) 10 (17%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 5 (8%) 1 (2%) 17 (28%) 19 (32%) 14 (23%)
Eosinophilic Focus, Multiple 1 (2%) 2 (3%) 3 (5%) 9 (15%)
Fatty Change, Focal 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hepatodiaphragmatic Nodule 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Subacute 3 (5%) 1 (2%) 1 (2%) 1 (2%)
Mineralization 2 (3%) 1 (2%) 3 (5%)
Mixed Cell Focus 2 (3%) 4 (7%) 1 (2%) 2 (3%)
Necrosis 3 (5%) 2 (3%) 6 (10%) 5 (8%) 3 (5%)
Pigmentation, Bile 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Vacuolization Cytoplasmic 13 (22%) 7 (12%) 12 (20%) 8 (13%)
Bile Duct, Cyst 2 (3%)
Bile Duct, Hyperplasia 1 (2%)
Mesentery (4) (2) (4) (1) (1)
Hemorrhage 1 (25%)
Inflammation, Subacute 1 (25%)
Fat, Inflammation, Subacute 1 (50%)
Fat, Necrosis 3 (75%) 1 (50%) 2 (50%) 1 (100%) 1 (100%)
Pancreas (60) (60) (60) (60) (60)
Inflammation, Subacute 1 (2%) 1 (2%)
Necrosis 1 (2%)
Polyarteritis 1 (2%)
Acinus, Atrophy 1 (2%) 2 (3%)
Acinus, Depletion Secretory 1 (2%)
Duct, Cyst 1 (2%)
Salivary Glands (60) (60) (60) (60) (60)
Vacuolization Cytoplasmic 1 (2%)
Submandibular Gland, Depletion Secretory 2 (3%) 1 (2%)
Stomach, Forestomach (60) (60) (60) (59) (60)
Cyst 1 (2%)
Diverticulum 1 (2%)
Edema 1 (2%) 1 (2%)
Hyperplasia 18 (30%) 25 (42%) 13 (22%) 12 (20%) 10 (17%)
Inflammation, Subacute 4 (7%) 13 (22%) 5 (8%) 3 (5%) 2 (3%)
Mineralization 1 (2%)
Ulcer 3 (5%) 2 (3%) 3 (5%) 2 (3%)
Stomach, Glandular (60) (60) (60) (58) (60)
Atypia Cellular 2 (3%)
Cyst 3 (5%)
Erosion 1 (2%) 1 (2%)
Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Inflammation, Subacute 1 (2%) 2 (3%)
Mineralization 1 (2%) 14 (23%) 9 (16%) 7 (12%)
Necrosis 1 (2%)
Pigmentation 1 (2%)
Polyarteritis 1 (2%)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60) (60)
Cardiomyopathy 1 (2%)
Embolus 1 (2%)
Fibrosis 1 (2%)
Mineralization 1 (2%) 1 (2%)
Polyarteritis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (59) (59) (60)
Accessory Adrenal Cortical Nodule 1 (2%) 2 (3%)
Cyst 1 (2%)
Embolus 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia 8 (13%) 12 (20%) 9 (15%) 6 (10%)
Hypertrophy 12 (20%) 9 (15%) 12 (20%) 14 (24%) 13 (22%)
Necrosis 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Capsule, Hyperplasia 1 (2%) 7 (12%) 5 (8%)
Adrenal Medulla (60) (60) (59) (59) (60)
Embolus 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 2 (3%)
Islets, Pancreatic (60) (60) (60) (60) (60)
Embolus 1 (2%)
Hyperplasia 2 (3%) 4 (7%) 1 (2%) 3 (5%)
Parathyroid Gland (58) (58) (57) (57) (59)
Cyst 2 (3%)
Pituitary Gland (54) (56) (56) (57) (57)
Pars Distalis, Cyst 4 (7%) 2 (4%)
Pars Distalis, Hyperplasia 1 (2%)
Thyroid Gland (60) (60) (60) (60) (60)
Polyarteritis 1 (2%)
Follicle, Cyst 6 (10%) 4 (7%) 7 (12%) 12 (20%) 9 (15%)
Follicle, Degeneration 4 (7%) 3 (5%) 4 (7%) 1 (2%) 4 (7%)
Follicular Cell, Hyperplasia 9 (15%) 1 (2%) 4 (7%) 3 (5%) 2 (3%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (5) (1) (1)
Dilatation 5 (100%) 1 (100%)
Inflammation, Chronic 1 (100%)
Epididymis (60) (60) (60) (60) (60)
Congestion 1 (2%)
Granuloma Sperm 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 1 (2%)
Preputial Gland (59) (60) (59) (59) (60)
Congestion 1 (2%)
Inflammation, Subacute 2 (3%) 1 (2%) 1 (2%)
Duct, Cyst 49 (83%) 50 (83%) 48 (81%) 41 (69%) 45 (75%)
Prostate (60) (60) (60) (60) (60)
Cyst 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Subacute 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Polyarteritis 1 (2%)
Seminal Vesicle (60) (60) (60) (60) (60)
Atrophy 2 (3%) 2 (3%) 2 (3%)
Dilatation 14 (23%) 1 (2%) 2 (3%) 4 (7%)
Inflammation, Chronic 1 (2%) 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Testes (60) (60) (60) (60) (60)
Atrophy 1 (2%) 1 (2%)
Mineralization 1 (2%)
Thrombosis 1 (2%)
Interstitial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60) (60)
Atrophy 2 (3%)
Myeloid Cell, Hyperplasia 2 (3%)
Lymph Node (3) (1) (3) (3) (4)
Inguinal, Angiectasis 1 (33%)
Inguinal, Hyperplasia, Lymphoid 1 (33%) 1 (33%)
Inguinal, Infiltration Cellular, Mast Cell 1 (25%)
Inguinal, Pigmentation 1 (33%)
Mediastinal, Angiectasis 1 (33%)
Mediastinal, Hematopoietic Cell Proliferation 1 (33%)
Mediastinal, Hyperplasia, Lymphoid 1 (33%) 1 (33%) 1 (25%)
Pancreatic, Angiectasis 1 (33%)
Renal, Hyperplasia, Lymphoid 1 (25%)
Lymph Node, Mandibular (60) (59) (59) (59) (59)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Lymph Node, Mesenteric (60) (58) (60) (60) (60)
Angiectasis 17 (28%) 23 (40%) 18 (30%) 18 (30%) 13 (22%)
Hyperplasia, Lymphoid 4 (7%) 3 (5%) 3 (5%) 3 (5%) 3 (5%)
Infiltration Cellular, Histiocyte 1 (2%)
Necrosis 1 (2%)
Spleen (60) (60) (60) (59) (60)
Atrophy 5 (8%) 1 (2%) 2 (3%)
Congestion 1 (2%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 13 (22%) 3 (5%) 24 (40%) 30 (51%) 23 (38%)
Hyperplasia, Lymphoid 5 (8%) 8 (13%) 12 (20%) 10 (17%) 7 (12%)
Pigmentation, Hemosiderin 2 (3%) 1 (2%) 29 (48%) 42 (71%) 57 (95%)
Capsule, Inflammation, Subacute 1 (2%)
Thymus (54) (56) (53) (56) (56)
Atrophy 3 (6%) 2 (4%) 1 (2%) 1 (2%)
Cyst 2 (4%) 1 (2%) 4 (8%) 7 (13%) 2 (4%)
Mineralization 1 (2%)
Polyarteritis 1 (2%)
Thymocyte, Necrosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (60) (60) (60) (60)
Hyperkeratosis 1 (2%)
Subcutaneous Tissue, Edema 1 (2%) 1 (2%)
Subcutaneous Tissue, Hemorrhage 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic 1 (2%)
Subcutaneous Tissue, Inflammation, Subacute 1 (2%)
Subcutaneous Tissue, Metaplasia, Osseous 1 (2%)
Subcutaneous Tissue, Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60) (60)
Cranium, Hyperostosis 2 (3%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60) (60)
Compression 1 (2%)
Embolus 1 (2%)
Hydrocephalus 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60) (60)
Congestion 1 (2%)
Hyperplasia, Macrophage 1 (2%) 3 (5%) 1 (2%)
Alveolar Epithelium, Hyperplasia 4 (7%) 3 (5%) 5 (8%) 5 (8%) 8 (13%)
Alveolus, Foreign Body 1 (2%) 1 (2%)
Alveolus, Hemorrhage 1 (2%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 4 (7%) 1 (2%) 3 (5%) 2 (3%)
Mediastinum, Hemorrhage 1 (2%) 1 (2%)
Mediastinum, Inflammation, Chronic 1 (2%)
Nose (60) (60) (60) (60) (60)
Glands, Cyst 1 (2%) 1 (2%) 4 (7%)
Glands, Fibrosis 1 (2%)
Lumen, Inflammation, Subacute 1 (2%)
Nasolacrimal Duct, Exudate 1 (2%)
Olfactory Epithelium, Degeneration 1 (2%) 2 (3%) 8 (13%) 2 (3%)
Olfactory Epithelium, Hyperplasia 1 (2%)
Respiratory Epithelium, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cornea, Inflammation, Subacute 1 (100%)
Harderian Gland (3) (3) (5) (1) (2)
Inflammation, Chronic 1 (20%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60) (60)
Bacterium 1 (2%) 1 (2%)
Fibrosis 1 (2%) 1 (2%) 1 (2%)
Glomerulosclerosis 3 (5%) 1 (2%) 2 (3%)
Infarct 1 (2%) 2 (3%) 2 (3%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic, Suppurative 1 (2%)
Inflammation, Subacute 2 (3%)
Metaplasia, Osseous 1 (2%) 2 (3%)
Mineralization 45 (75%) 50 (83%) 46 (77%) 46 (77%) 35 (58%)
Polyarteritis 1 (2%)
Cortex, Cyst 5 (8%) 4 (7%) 1 (2%) 7 (12%) 1 (2%)
Cortex, Medulla, Inflammation, Suppurative 1 (2%)
Pelvis, Inflammation, Subacute 1 (2%)
Pelvis, Necrosis 1 (2%)
Renal Tubule, Casts 14 (23%) 9 (15%) 11 (18%) 12 (20%) 4 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:16:26
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Degeneration 3 (5%) 1 (2%) 1 (2%) 1 (2%)
Renal Tubule, Regeneration 45 (75%) 46 (77%) 46 (77%) 48 (80%) 28 (47%)
Transitional Epithelium, Hyperplasia 1 (2%)
Urethra (1)
Hemorrhage 1 (100%)
Inflammation, Subacute 1 (100%)
Urinary Bladder (60) (60) (60) (60) (60)
Dilatation 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 2 (3%) 1 (2%)
Inflammation, Subacute 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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