TDMS Study 05099-07 Pathology Tables
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
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 NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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
Esophagus (60) (60) (60) (59)
Diverticulum 1 (2%)
Perforation 1 (2%)
Intestine Large, Colon (60) (60) (60) (59)
Parasite Metazoan 8 (13%) 6 (10%) 7 (12%) 5 (8%)
Intestine Large, Rectum (60) (60) (59) (59)
Hyperplasia, Lymphoid 1 (2%)
Parasite Metazoan 3 (5%) 5 (8%) 5 (8%) 7 (12%)
Intestine Large, Cecum (59) (59) (60) (60)
Hemorrhage 1 (2%)
Inflammation, Subacute 1 (2%)
Parasite Metazoan 1 (2%) 1 (2%) 2 (3%)
Liver (60) (60) (60) (60)
Angiectasis 2 (3%) 3 (5%) 7 (12%) 1 (2%)
Basophilic Focus 53 (88%) 51 (85%) 57 (95%) 45 (75%)
Clear Cell Focus 9 (15%) 8 (13%) 11 (18%) 8 (13%)
Cyst 1 (2%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 13 (22%) 13 (22%) 20 (33%) 15 (25%)
Granuloma 16 (27%) 13 (22%) 8 (13%) 4 (7%)
Hematopoietic Cell Proliferation 2 (3%) 1 (2%) 2 (3%)
Hepatodiaphragmatic Nodule 9 (15%) 9 (15%) 6 (10%) 4 (7%)
Inflammation, Chronic 1 (2%) 1 (2%) 2 (3%) 1 (2%)
Mixed Cell Focus 10 (17%) 8 (13%) 11 (18%) 6 (10%)
Bile Duct, Hyperplasia 16 (27%) 11 (18%) 9 (15%) 4 (7%)
Centrilobular, Atrophy 4 (7%) 2 (3%) 2 (3%)
Hepatocyte, Vacuolization Cytoplasmic 4 (7%) 1 (2%)
Kupffer Cell, Pigmentation 3 (5%)
Lobules, Necrosis 2 (3%) 2 (3%) 3 (5%) 3 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (4) (8) (5) (6)
Accessory Spleen 1 (25%)
Fat, Hemorrhage 1 (17%)
Fat, Necrosis 3 (75%) 5 (63%) 5 (100%) 6 (100%)
Pancreas (60) (60) (60) (60)
Atrophy 20 (33%) 19 (32%) 17 (28%) 17 (28%)
Metaplasia, Hepatocyte 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Acinar Cell, Basophilic Focus 1 (2%) 3 (5%)
Acinar Cell, Cytoplasmic Alteration 2 (3%) 2 (3%) 4 (7%) 4 (7%)
Acinar Cell, Hyperplasia, Focal 1 (2%) 3 (5%) 4 (7%) 1 (2%)
Salivary Glands (60) (60) (60) (60)
Atrophy 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (60) (59) (60) (60)
Edema 1 (2%)
Erosion 1 (2%) 1 (2%)
Mineralization 1 (2%)
Ulcer 1 (2%) 1 (2%) 1 (2%)
Mucosa, Hyperplasia 2 (3%) 2 (3%) 1 (2%) 3 (5%)
Stomach, Glandular (60) (60) (60) (60)
Erosion 2 (3%)
Ulcer 1 (2%)
Tongue (1) (1) (1)
Mucosa, Hyperplasia 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (60) (60) (60) (60)
Hemorrhage 1 (2%)
Aorta, Mineralization 1 (2%)
Heart (60) (60) (60) (60)
Cardiomyopathy 13 (22%) 13 (22%) 17 (28%) 9 (15%)
Inflammation, Subacute 1 (2%) 2 (3%)
Mineralization 2 (3%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 13 (22%) 9 (15%) 11 (18%) 16 (27%)
Angiectasis 5 (8%) 1 (2%) 2 (3%)
Cyst 1 (2%) 1 (2%)
Degeneration, Fatty 5 (8%) 11 (18%) 7 (12%) 7 (12%)
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 3
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia, Diffuse 1 (2%)
Hyperplasia, Focal 7 (12%) 6 (10%) 9 (15%) 5 (8%)
Hypertrophy, Focal 6 (10%) 4 (7%) 5 (8%) 4 (7%)
Necrosis 1 (2%) 1 (2%) 1 (2%)
Adrenal Medulla (60) (60) (60) (60)
Hyperplasia 2 (3%) 2 (3%) 2 (3%) 1 (2%)
Necrosis 1 (2%)
Pituitary Gland (60) (59) (60) (60)
Pars Distalis, Angiectasis 13 (22%) 7 (12%) 8 (13%) 10 (17%)
Pars Distalis, Cyst 35 (58%) 31 (53%) 23 (38%) 19 (32%)
Pars Distalis, Hyperplasia 1 (2%)
Pars Distalis, Hyperplasia, Focal 12 (20%) 15 (25%) 13 (22%) 14 (23%)
Pars Intermedia, Angiectasis 2 (3%) 3 (5%) 1 (2%)
Pars Intermedia, Cyst 5 (8%) 5 (8%) 2 (3%) 2 (3%)
Thyroid Gland (60) (60) (60) (60)
Ultimobranchial Cyst 3 (5%) 2 (3%) 3 (5%) 1 (2%)
C-Cell, Hyperplasia 7 (12%) 12 (20%) 11 (18%) 8 (13%)
Follicle, Cyst 4 (7%) 4 (7%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (60) (60) (60) (60)
Ectasia 17 (28%) 15 (25%) 17 (28%) 18 (30%)
Hyperplasia 1 (2%) 2 (3%) 1 (2%) 2 (3%)
Inflammation, Chronic 4 (7%) 17 (28%) 10 (17%) 6 (10%)
Inflammation, Suppurative 4 (7%) 2 (3%) 4 (7%) 8 (13%)
Ovary (60) (60) (60) (60)
Cyst 7 (12%) 4 (7%) 2 (3%) 6 (10%)
Uterus (60) (60) (60) (60)
Cyst 1 (2%)
Hydrometra 6 (10%) 4 (7%) 5 (8%) 2 (3%)
Hyperplasia, Cystic 3 (5%) 2 (3%) 2 (3%)
Endometrium, Hyperplasia, Focal 1 (2%)
Vagina (1) (1)
Hyperplasia 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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)
Hypercellularity 4 (7%) 2 (3%) 2 (3%)
Myelofibrosis 3 (5%) 2 (3%) 1 (2%)
Necrosis 1 (2%)
Lymph Node (12) (9) (9) (7)
Iliac, Ectasia 1 (14%)
Iliac, Hyperplasia, Lymphoid 1 (14%)
Mediastinal, Congestion 1 (14%)
Mediastinal, Ectasia 1 (11%)
Mediastinal, Hemorrhage 6 (50%) 7 (78%) 3 (33%) 3 (43%)
Mediastinal, Pigmentation 7 (58%) 7 (78%) 7 (78%) 3 (43%)
Pancreatic, Hemorrhage 1 (11%) 1 (14%)
Pancreatic, Hyperplasia, Lymphoid 1 (14%)
Pancreatic, Pigmentation 1 (11%)
Renal, Hemorrhage 1 (14%)
Renal, Hyperplasia, Lymphoid 1 (14%)
Renal, Pigmentation 1 (14%)
Lymph Node, Mandibular (60) (58) (60) (60)
Congestion 1 (2%)
Ectasia 7 (12%) 7 (12%) 3 (5%) 1 (2%)
Hemorrhage 3 (5%) 3 (5%) 2 (3%) 4 (7%)
Hyperplasia, Lymphoid 4 (7%) 5 (9%) 4 (7%)
Hyperplasia, Plasma Cell 1 (2%)
Pigmentation 8 (13%) 14 (24%) 6 (10%) 7 (12%)
Lymph Node, Mesenteric (60) (60) (59) (60)
Ectasia 1 (2%)
Hemorrhage 5 (8%) 5 (8%) 3 (5%) 6 (10%)
Hyperplasia, Lymphoid 1 (2%)
Pigmentation 12 (20%) 9 (15%) 12 (20%) 2 (3%)
Spleen (60) (60) (60) (60)
Developmental Malformation 2 (3%)
Fibrosis 3 (5%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 29 (48%) 33 (55%) 38 (63%) 29 (48%)
Hemorrhage 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
Pigmentation, Hemosiderin 46 (77%) 42 (70%) 43 (72%) 47 (78%)
Lymphoid Follicle, Atrophy 1 (2%) 1 (2%)
Lymphoid Follicle, Hyperplasia 1 (2%)
Thymus (59) (59) (60) (60)
Congestion 1 (2%)
Cyst 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%) 6 (10%)
Cortex, Atrophy 1 (2%)
Epithelial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (60) (60) (58)
Ectasia 10 (17%) 10 (17%) 20 (33%) 4 (7%)
Hyperplasia, Lobular 4 (7%)
Skin (60) (60) (60) (60)
Acanthosis 1 (2%) 4 (7%)
Cyst Epithelial Inclusion 1 (2%)
Hyperkeratosis 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Ulcer 2 (3%)
Subcutaneous Tissue, Inflammation, Subacute 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Calvarium, Osteopetrosis 5 (8%) 1 (2%) 1 (2%)
Femur, Osteopetrosis 5 (8%) 3 (5%) 2 (3%)
Skeletal Muscle (2) (1) (1)
Hemorrhage 1 (50%)
Inflammation, Chronic 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Atrophy 1 (2%)
Compression 10 (17%) 12 (20%) 10 (17%) 4 (7%)
Hemorrhage 2 (3%) 2 (3%) 1 (2%)
Hydrocephalus 3 (5%) 3 (5%) 4 (7%)
Mineralization 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Congestion 1 (2%) 3 (5%) 2 (3%) 7 (12%)
Edema 1 (2%) 1 (2%) 2 (3%) 4 (7%)
Foreign Body 1 (2%) 2 (3%) 2 (3%) 8 (13%)
Hemorrhage 2 (3%) 2 (3%)
Infiltration Cellular, Histiocyte 15 (25%) 15 (25%) 11 (18%) 15 (25%)
Inflammation, Subacute 5 (8%) 5 (8%) 2 (3%) 2 (3%)
Metaplasia, Osseous 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 5 (8%) 7 (12%) 5 (8%) 3 (5%)
Nose (60) (60) (60) (60)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Exudate 9 (15%) 9 (15%) 10 (17%) 6 (10%)
Foreign Body 3 (5%) 6 (10%) 4 (7%) 4 (7%)
Fungus 1 (2%) 2 (3%)
Mucosa, Hyperplasia 4 (7%) 2 (3%) 1 (2%) 1 (2%)
Mucosa, Metaplasia, Squamous 1 (2%) 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (5) (2) (2)
Cataract 1 (33%) 3 (60%) 1 (50%) 2 (100%)
Inflammation, Chronic 1 (33%)
Inflammation, Suppurative 1 (33%)
Phthisis Bulbi 2 (40%) 1 (50%)
Retina, Atrophy 2 (67%) 2 (40%) 1 (50%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Concretion 9 (15%) 35 (58%) 43 (72%)
Cyst 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hydronephrosis 3 (5%) 11 (18%)
Infarct 2 (3%) 3 (5%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%) 2 (3%)
Mineralization 53 (88%) 57 (95%) 51 (85%) 50 (83%)
Nephropathy 38 (63%) 42 (70%) 47 (78%) 54 (90%)
Papilla, Necrosis 1 (2%)
Renal Tubule, Cytoplasmic Alteration 1 (2%)
Renal Tubule, Dilatation 2 (3%) 2 (3%) 1 (2%) 6 (10%)
Renal Tubule, Hyperplasia 1 (2%) 1 (2%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation 8 (13%) 6 (10%) 2 (3%)
Transitional Epithelium, Hyperplasia 3 (5%) 7 (12%) 25 (42%) 51 (85%)
Ureter (2) (4)
Concretion 1 (50%) 2 (50%)
Mucosa, Hyperplasia 2 (100%) 4 (100%)
Urethra (1)
Mucosa, Hyperplasia 1 (100%)
Urinary Bladder (59) (60) (60) (60)
Concretion 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 84 MG/KG 168 337.5
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Mucosa, Hyperplasia 2 (3%) 4 (7%) 14 (23%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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
Esophagus (70) (59) (60) (59) (59) (70)
Inflammation, Suppurative 1 (1%)
Perforation 1 (2%) 1 (2%)
Intestine Large, Colon (69) (60) (59) (60) (58) (68)
Inflammation, Subacute 1 (2%)
Parasite Metazoan 10 (14%) 6 (10%) 3 (5%) 4 (7%) 6 (10%) 4 (6%)
Intestine Large, Rectum (69) (60) (60) (60) (59) (69)
Parasite Metazoan 11 (16%) 8 (13%) 5 (8%) 11 (18%) 5 (8%) 8 (12%)
Ulcer 1 (2%)
Intestine Large, Cecum (70) (60) (60) (60) (60) (70)
Dilatation 1 (2%)
Edema 2 (3%)
Inflammation, Subacute 1 (2%)
Parasite Metazoan 2 (3%) 1 (2%)
Ulcer 1 (2%)
Intestine Small, Duodenum (70) (60) (60) (60) (60) (69)
Erosion 1 (2%)
Ulcer 1 (2%)
Intestine Small, Jejunum (70) (60) (59) (60) (59) (69)
Erosion 1 (2%)
Intestine Small, Ileum (69) (60) (59) (60) (60) (69)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic Active 1 (1%)
Ulcer 2 (3%)
Liver (70) (60) (60) (60) (60) (70)
Angiectasis 2 (3%)
Basophilic Focus 35 (50%) 39 (65%) 37 (62%) 29 (48%) 20 (33%) 36 (51%)
Clear Cell Focus 38 (54%) 23 (38%) 27 (45%) 30 (50%) 19 (32%) 22 (31%)
Congestion 1 (1%)
Degeneration, Cystic 4 (6%) 2 (3%) 1 (2%) 1 (1%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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
Developmental Malformation 1 (2%)
Eosinophilic Focus 7 (10%) 8 (13%) 10 (17%) 7 (12%) 9 (15%) 6 (9%)
Granuloma 3 (4%) 3 (5%) 6 (9%)
Hematopoietic Cell Proliferation 2 (3%) 3 (5%) 1 (2%) 1 (2%) 1 (1%)
Hepatodiaphragmatic Nodule 5 (7%) 3 (5%) 3 (5%) 3 (5%) 3 (5%) 3 (4%)
Inflammation, Chronic 1 (1%) 1 (2%) 2 (3%) 1 (2%) 3 (4%)
Inflammation, Subacute 2 (3%) 2 (3%) 1 (1%)
Metaplasia, Osseous 1 (1%)
Mixed Cell Focus 7 (10%) 13 (22%) 6 (10%) 13 (22%) 5 (8%) 8 (11%)
Bile Duct, Hyperplasia 53 (76%) 45 (75%) 44 (73%) 44 (73%) 24 (40%) 41 (59%)
Centrilobular, Atrophy 3 (4%) 4 (7%) 4 (7%) 4 (7%) 3 (4%)
Centrilobular, Necrosis 1 (2%) 1 (1%)
Hepatocyte, Vacuolization Cytoplasmic 10 (14%) 8 (13%) 7 (12%) 4 (7%) 2 (3%) 8 (11%)
Lobules, Necrosis 2 (3%) 3 (5%) 2 (3%) 2 (3%)
Mesentery (19) (19) (17) (19) (14) (18)
Accessory Spleen 1 (5%) 1 (6%) 1 (7%)
Fibrosis 1 (5%)
Fat, Hemorrhage 1 (5%) 1 (6%) 1 (5%)
Fat, Metaplasia, Osseous 1 (5%)
Fat, Necrosis 15 (79%) 16 (84%) 16 (94%) 15 (79%) 11 (79%) 16 (89%)
Pancreas (70) (60) (60) (60) (60) (68)
Atrophy 21 (30%) 22 (37%) 33 (55%) 23 (38%) 24 (40%) 25 (37%)
Pigmentation 1 (2%)
Acinar Cell, Basophilic Focus 1 (1%) 3 (5%) 1 (2%) 2 (3%) 5 (7%)
Acinar Cell, Cytoplasmic Alteration 1 (1%) 2 (3%) 1 (2%) 3 (5%) 15 (25%) 3 (4%)
Acinar Cell, Hyperplasia, Focal 18 (26%) 20 (33%) 14 (23%) 17 (28%) 11 (18%) 16 (24%)
Salivary Glands (70) (60) (59) (60) (60) (70)
Atrophy 1 (2%) 1 (2%) 1 (1%)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (70) (60) (60) (60) (60) (70)
Edema 1 (1%) 1 (2%) 4 (7%) 1 (1%)
Erosion 1 (2%) 2 (3%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%) 1 (2%)
Perforation 1 (2%)
Ulcer 1 (1%) 1 (2%) 1 (2%) 1 (2%) 7 (12%)
Mucosa, Hyperplasia 2 (3%) 9 (15%)
Stomach, Glandular (69) (60) (60) (60) (60) (70)
Cyst 1 (2%)
Erosion 1 (1%) 1 (2%) 1 (2%) 2 (3%)
Mineralization 1 (2%)
Ulcer 1 (1%) 1 (2%) 1 (2%)
Tongue (1) (1)
Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (70) (60) (60) (60) (60) (70)
Embolus 1 (1%)
Hypertrophy 1 (2%) 1 (2%) 5 (8%)
Inflammation, Chronic Active 1 (2%) 2 (3%)
Heart (70) (60) (60) (60) (60) (70)
Cardiomyopathy 36 (51%) 33 (55%) 31 (52%) 33 (55%) 27 (45%) 28 (40%)
Foreign Body 1 (2%)
Inflammation, Subacute 1 (2%) 1 (2%) 1 (1%)
Mineralization 2 (3%)
Thrombosis 1 (1%)
Pericardium, Fibrosis 1 (1%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (70) (60) (60) (60) (60) (70)
Accessory Adrenal Cortical Nodule 21 (30%) 15 (25%) 22 (37%) 16 (27%) 13 (22%) 16 (23%)
Basophilic Focus 1 (2%)
Congestion 1 (1%) 1 (2%)
Cyst 1 (1%) 1 (1%)
Degeneration, Fatty 8 (11%) 4 (7%) 6 (10%) 9 (15%) 9 (15%) 6 (9%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 2 (3%) 1 (1%)
Hemorrhage 2 (3%) 1 (2%)
Hyperplasia, Focal 5 (7%) 3 (5%) 8 (13%) 7 (12%) 3 (5%) 4 (6%)
Hypertrophy, Focal 5 (7%) 2 (3%) 2 (3%) 3 (5%) 3 (4%)
Necrosis 1 (2%) 2 (3%)
Adrenal Medulla (70) (60) (59) (60) (59) (70)
Hyperplasia 15 (21%) 14 (23%) 18 (31%) 16 (27%) 14 (24%) 9 (13%)
Islets, Pancreatic (70) (60) (60) (60) (60) (69)
Hyperplasia 3 (5%) 1 (2%) 1 (2%) 1 (1%)
Parathyroid Gland (65) (60) (58) (59) (55) (66)
Hyperplasia 1 (2%) 1 (2%)
Pituitary Gland (70) (58) (60) (59) (59) (68)
Congestion 1 (1%)
Pars Distalis, Angiectasis 5 (7%) 4 (7%) 1 (2%) 2 (3%) 2 (3%) 4 (6%)
Pars Distalis, Cyst 8 (11%) 7 (12%) 2 (3%) 3 (5%) 9 (15%) 6 (9%)
Pars Distalis, Hyperplasia, Focal 18 (26%) 14 (24%) 12 (20%) 16 (27%) 13 (22%) 8 (12%)
Pars Intermedia, Angiectasis 2 (3%) 1 (2%) 1 (2%) 2 (3%)
Pars Intermedia, Cyst 3 (4%) 1 (2%) 1 (2%) 1 (2%) 2 (3%) 1 (1%)
Pars Intermedia, Hyperplasia 1 (2%)
Pars Nervosa, Gliosis 1 (2%)
Thyroid Gland (70) (60) (60) (60) (60) (70)
Ultimobranchial Cyst 1 (1%) 3 (5%) 5 (8%) 4 (7%) 1 (2%) 5 (7%)
C-Cell, Hyperplasia 14 (20%) 14 (23%) 10 (17%) 11 (18%) 12 (20%) 12 (17%)
Follicle, Cyst 2 (3%) 2 (3%) 3 (5%) 1 (2%) 1 (2%) 3 (4%)
Follicular Cell, Hyperplasia 1 (1%) 1 (2%) 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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
Follicular Cell, Hypertrophy 3 (4%) 3 (5%) 4 (7%) 6 (10%) 6 (9%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (70) (60) (60) (60) (60) (70)
Atypia Cellular 25 (36%) 33 (55%) 36 (60%) 40 (67%) 34 (57%) 27 (39%)
Hypospermia 40 (57%) 33 (55%) 34 (57%) 38 (63%) 36 (60%) 34 (49%)
Preputial Gland (70) (60) (60) (60) (60) (70)
Ectasia 20 (29%) 12 (20%) 17 (28%) 17 (28%) 14 (23%) 14 (20%)
Hyperplasia 1 (1%) 1 (2%) 1 (2%) 2 (3%) 1 (1%)
Inflammation, Chronic 39 (56%) 24 (40%) 26 (43%) 23 (38%) 15 (25%) 40 (57%)
Inflammation, Suppurative 23 (33%) 16 (27%) 17 (28%) 10 (17%) 17 (28%) 21 (30%)
Prostate (70) (60) (60) (60) (60) (70)
Corpora Amylacea 31 (44%) 23 (38%) 30 (50%) 19 (32%) 13 (22%) 26 (37%)
Ectasia 1 (2%) 1 (1%)
Edema 3 (5%)
Hemorrhage 1 (2%) 3 (5%)
Hyperplasia, Lymphoid 1 (1%) 2 (3%)
Inflammation, Suppurative 23 (33%) 32 (53%) 22 (37%) 23 (38%) 24 (40%) 32 (46%)
Epithelium, Hyperplasia 8 (11%) 8 (13%) 8 (13%) 13 (22%) 3 (5%) 4 (6%)
Seminal Vesicle (70) (60) (60) (60) (59) (70)
Dilatation 1 (1%) 2 (3%) 1 (2%) 1 (2%) 4 (7%) 1 (1%)
Hemorrhage 1 (2%) 2 (3%)
Inflammation, Suppurative 2 (3%) 4 (7%)
Testes (70) (60) (59) (60) (60) (70)
Granuloma Sperm 1 (2%)
Interstitial Cell, Hyperplasia 5 (7%) 11 (18%) 9 (15%) 11 (18%) 2 (3%) 10 (14%)
Seminiferous Tubule, Atrophy 4 (7%) 2 (3%) 2 (3%) 2 (3%) 4 (6%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (70) (60) (60) (60) (60) (70)
Hypercellularity 3 (4%) 3 (5%) 3 (5%) 5 (8%) 2 (3%)
Myelofibrosis 1 (2%) 2 (3%)
Lymph Node (9) (16) (15) (14) (10) (7)
Iliac, Pigmentation 1 (6%)
Inguinal, Hyperplasia, Lymphoid 1 (7%)
Mediastinal, Congestion 1 (14%)
Mediastinal, Ectasia 1 (14%)
Mediastinal, Hemorrhage 6 (67%) 7 (44%) 8 (53%) 6 (43%) 4 (40%) 4 (57%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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
Mediastinal, Hyperplasia, Lymphoid 1 (7%) 1 (10%) 1 (14%)
Mediastinal, Pigmentation 5 (56%) 8 (50%) 9 (60%) 7 (50%) 5 (50%) 3 (43%)
Pancreatic, Hemorrhage 1 (6%)
Pancreatic, Hyperplasia, Lymphoid 1 (6%)
Renal, Pigmentation 1 (6%)
Lymph Node, Mandibular (70) (59) (60) (60) (59) (70)
Congestion 1 (2%) 1 (2%)
Ectasia 5 (7%) 7 (12%) 3 (5%) 4 (7%) 5 (7%)
Hemorrhage 7 (10%) 4 (7%) 10 (17%) 1 (2%) 5 (8%) 10 (14%)
Hyperplasia, Lymphoid 6 (9%) 5 (8%) 4 (7%) 7 (12%) 3 (4%)
Hyperplasia, Plasma Cell 1 (1%) 1 (2%) 2 (3%)
Pigmentation 1 (1%) 2 (3%) 3 (5%) 2 (3%)
Lymph Node, Mesenteric (70) (60) (60) (60) (59) (69)
Ectasia 2 (3%)
Hemorrhage 3 (4%) 6 (10%) 2 (3%) 5 (8%) 2 (3%)
Hyperplasia, Lymphoid 2 (3%) 1 (2%) 1 (1%)
Pigmentation 3 (5%) 2 (3%)
Spleen (70) (60) (60) (60) (60) (70)
Developmental Malformation 1 (2%)
Fibrosis 8 (11%) 3 (5%) 8 (13%) 3 (5%) 2 (3%) 3 (4%)
Hematopoietic Cell Proliferation 16 (23%) 12 (20%) 18 (30%) 17 (28%) 25 (42%) 14 (20%)
Hemorrhage 1 (2%)
Hyperplasia, Reticulum Cell 1 (2%)
Metaplasia 1 (2%)
Necrosis 1 (2%)
Pigmentation, Hemosiderin 22 (31%) 20 (33%) 15 (25%) 15 (25%) 34 (57%) 16 (23%)
Lymphoid Follicle, Atrophy 1 (2%) 5 (8%)
Thymus (66) (60) (58) (59) (59) (69)
Cyst 1 (2%) 1 (1%)
Hemorrhage 7 (11%) 1 (2%) 1 (2%) 2 (3%)
Cortex, Atrophy 2 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (67) (58) (58) (57) (59) (68)
Hyperplasia, Cystic 12 (18%) 17 (29%) 9 (16%) 14 (25%) 10 (17%) 10 (15%)
Hyperplasia, Lobular 2 (3%) 1 (2%) 4 (7%) 3 (5%) 6 (10%)
Skin (70) (59) (60) (60) (59) (70)
Acanthosis 2 (3%) 1 (2%)
Cyst Epithelial Inclusion 2 (3%) 4 (7%) 3 (5%) 2 (3%) 1 (2%) 6 (9%)
Foreign Body 1 (2%)
Hemorrhage 1 (1%) 1 (1%)
Hyperkeratosis 2 (3%)
Inflammation, Chronic 1 (1%)
Inflammation, Suppurative 1 (2%) 2 (3%)
Subcutaneous Tissue, Edema 1 (1%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (70) (60) (60) (60) (60) (70)
Calvarium, Osteopetrosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (70) (60) (60) (60) (60) (70)
Atrophy 1 (2%)
Compression 4 (6%) 7 (12%) 5 (8%) 8 (13%) 4 (7%) 4 (6%)
Hemorrhage 1 (2%) 1 (1%)
Hydrocephalus 1 (1%) 5 (8%) 3 (5%) 2 (3%) 2 (3%) 3 (4%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (1%)
Necrosis 1 (1%) 1 (2%)
Peripheral Nerve (1) (1) (2)
Atrophy 1 (50%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (70) (60) (60) (60) (60) (70)
Congestion 1 (1%) 2 (3%) 4 (7%) 1 (2%) 4 (7%) 3 (4%)
Edema 2 (3%) 3 (5%) 1 (2%) 4 (7%) 3 (4%)
Fibrosis 1 (2%) 1 (2%) 1 (1%)
Foreign Body 2 (3%) 5 (8%) 2 (3%) 3 (4%)
Hemorrhage 1 (1%) 6 (10%) 2 (3%) 1 (2%) 1 (1%)
Infiltration Cellular, Histiocyte 8 (11%) 10 (17%) 8 (13%) 1 (2%) 14 (23%) 5 (7%)
Inflammation, Granulomatous 1 (2%) 1 (1%)
Inflammation, Subacute 5 (7%) 8 (13%) 5 (8%) 5 (8%) 5 (8%) 3 (4%)
Inflammation, Suppurative 2 (3%) 1 (2%)
Metaplasia, Osseous 1 (2%) 1 (1%)
Alveolar Epithelium, Hyperplasia 11 (16%) 10 (17%) 4 (7%) 10 (17%) 7 (12%) 4 (6%)
Fat, Mediastinum, Necrosis 1 (1%) 1 (2%)
Nose (70) (60) (60) (60) (60) (70)
Exudate 15 (21%) 17 (28%) 14 (23%) 12 (20%) 15 (25%) 15 (21%)
Foreign Body 4 (6%) 8 (13%) 10 (17%) 1 (2%) 2 (3%) 7 (10%)
Fungus 6 (9%) 3 (5%) 4 (7%) 3 (5%) 2 (3%) 6 (9%)
Mucosa, Hyperplasia 6 (9%) 8 (13%) 1 (2%) 6 (10%) 6 (10%) 8 (11%)
Mucosa, Metaplasia, Squamous 1 (1%) 3 (5%) 2 (3%) 2 (3%) 1 (2%) 5 (7%)
Trachea (70) (60) (60) (60) (60) (70)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (3) (1)
Cataract 2 (100%) 3 (100%)
Phthisis Bulbi 1 (100%)
Retina, Atrophy 2 (100%) 3 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (70) (60) (60) (60) (60) (70)
Concretion 1 (2%) 13 (22%) 33 (55%)
Cyst 1 (1%) 1 (2%) 2 (3%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hydronephrosis 1 (2%) 1 (2%) 28 (47%)
Infarct 1 (2%)
Inflammation, Suppurative 6 (9%) 3 (5%) 7 (12%) 8 (13%) 6 (10%) 8 (11%)
Mineralization 4 (6%) 8 (13%) 10 (17%) 11 (18%) 13 (22%) 6 (9%)
Nephropathy 66 (94%) 60 (100%) 57 (95%) 60 (100%) 58 (97%) 65 (93%)
Papilla, Fibrosis 1 (2%) 1 (2%)
Papilla, Necrosis 1 (2%) 4 (7%)
Renal Tubule, Cytoplasmic Alteration 1 (1%)
Renal Tubule, Dilatation 1 (1%) 1 (2%) 1 (2%) 1 (2%) 13 (22%) 4 (6%)
Renal Tubule, Hyperplasia 1 (2%)
Renal Tubule, Hyperplasia, Oncocytic 1 (2%)
Renal Tubule, Pigmentation 2 (3%) 3 (5%) 4 (7%) 2 (3%) 3 (5%) 1 (1%)
Transitional Epithelium, Hyperplasia 10 (14%) 5 (8%) 10 (17%) 20 (33%) 44 (73%) 4 (6%)
Transitional Epithelium, Hyperplasia,
Atypical 3 (5%)
Transitional Epithelium, Metaplasia 1 (2%)
Ureter (1) (13)
Concretion 3 (23%)
Dilatation 1 (100%) 2 (15%)
Hemorrhage 1 (100%)
Inflammation, Subacute 1 (8%)
Mucosa, Hyperplasia 12 (92%)
Urethra (1) (2) (5) (1)
Concretion 1 (20%)
Hemorrhage 1 (50%)
Inflammation, Subacute 1 (20%)
Bulbourethral Gland, Ectasia 1 (100%) 1 (50%) 1 (100%)
Lumen, Concretion 1 (50%) 2 (40%)
Lumen, Dilatation 1 (50%)
Mucosa, Hyperplasia 1 (50%) 1 (20%)
Mucosa, Metaplasia, Squamous 2 (40%)
Urinary Bladder (70) (60) (59) (60) (60) (67)
Concretion 1 (2%) 10 (17%)
Congestion 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05099-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 07/18/96
Route: GAVAGE Time: 09:24:44
____________________________________________________________________________________________________________________________________
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
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Dilatation 1 (2%) 1 (2%) 2 (3%) 7 (12%)
Hemorrhage 1 (2%) 1 (2%) 4 (7%)
Inflammation, Subacute 3 (5%)
Inflammation, Suppurative 1 (2%)
Mucosa, Hyperplasia 14 (23%) 41 (68%) 1 (1%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
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