TDMS Study 05099-98 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
SALICYLAZOSULFAPYRIDINE
NTP Experiment-Test: 05099-98 Report: PEIRPT03
Study Type: CHRONIC Date: 05/10/95
Route: GAVAGE Time: 11:43:27
05099/07 -VS- 05099/09 COMPARISON
Facility: SOUTHERN RESEARCH INSTITUTE
Chemical CAS #: 599-79-1
Lock Date: 02/03/93
Cage Range: All
Reasons For Removal: 25004 Dead 25018 Dosing Accident
25014 Gavage Death 25005 Interval Sacrifice
25003 Moribund 25019 Moribund Sacrifice
25020 Natural Death 25021 Terminal Sacrifice
Removal Date Range: All
Treatment Groups: Include 001 0 MG/KG AD LIB
Include 004 0 MG/KG RTD
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 05099-98 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/10/95
Route: GAVAGE Time: 11:43:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG
AD LIB RTD
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 110
Scheduled Sacrifice 33
Early Deaths
Moribund Sacrifice 13
Natural Death 1
Dosing Accident 1
Gavage Death 2
Moribund 13
Dead 2
Survivors
Terminal Sacrifice 35
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (49)
Inflammation, Suppurative 1 (2%)
Intestine Large, Colon (49) (50)
Dilatation 1 (2%)
Parasite Metazoan 7 (14%) 8 (16%)
Intestine Large, Rectum (50) (50)
Parasite Metazoan 10 (20%) 9 (18%)
Intestine Large, Cecum (50) (50)
Dilatation 1 (2%)
Edema 1 (2%)
Hemorrhage 1 (2%)
Intestine Small, Ileum (49) (49)
Inflammation, Chronic Active 1 (2%)
Liver (50) (50)
Basophilic Focus 33 (66%) 24 (48%)
Clear Cell Focus 32 (64%) 11 (22%)
Congestion 1 (2%) 1 (2%)
Degeneration, Cystic 4 (8%) 2 (4%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 7 (14%) 9 (18%)
Hepatodiaphragmatic Nodule 5 (10%) 1 (2%)
Inflammation, Subacute 1 (2%)
Mixed Cell Focus 5 (10%) 16 (32%)
Bile Duct, Hyperplasia 45 (90%) 36 (72%)
Centrilobular, Atrophy 3 (6%) 3 (6%)
Hepatocyte, Vacuolization Cytoplasmic 2 (4%) 2 (4%)
Kupffer Cell, Hyperplasia 1 (2%)
Kupffer Cell, Pigmentation 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05099-98 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/10/95
Route: GAVAGE Time: 11:43:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG
AD LIB RTD
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Lobules, Necrosis 1 (2%)
Mesentery (17) (20)
Fat, Necrosis 14 (82%) 18 (90%)
Pancreas (50) (50)
Atrophy 18 (36%) 18 (36%)
Necrosis 1 (2%)
Acinar Cell, Basophilic Focus 1 (2%)
Acinar Cell, Cytoplasmic Alteration 1 (2%) 3 (6%)
Acinar Cell, Hyperplasia, Focal 16 (32%) 8 (16%)
Salivary Glands (50) (50)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (50) (50)
Developmental Malformation 1 (2%)
Edema 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 2 (4%)
Ulcer 1 (2%)
Stomach, Glandular (49) (50)
Edema 1 (2%)
Erosion 1 (2%)
Mineralization 1 (2%)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50)
Embolus 1 (2%)
Hypertrophy 1 (2%)
Inflammation, Chronic Active 1 (2%)
Heart (50) (50)
Cardiomyopathy 23 (46%) 32 (64%)
Inflammation, Subacute 1 (2%)
Pericardium, Fibrosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50)
Accessory Adrenal Cortical Nodule 19 (38%) 15 (30%)
Angiectasis 1 (2%)
Congestion 1 (2%)
Cyst 1 (2%) 1 (2%)
Degeneration, Fatty 8 (16%) 6 (12%)
Hemorrhage 2 (4%) 1 (2%)
Hyperplasia, Focal 4 (8%) 1 (2%)
Hypertrophy, Focal 5 (10%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05099-98 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/10/95
Route: GAVAGE Time: 11:43:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG
AD LIB RTD
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Mineralization, Focal 1 (2%)
Adrenal Medulla (50) (50)
Hyperplasia 15 (30%) 5 (10%)
Pituitary Gland (50) (50)
Congestion 1 (2%)
Pars Distalis, Angiectasis 4 (8%) 4 (8%)
Pars Distalis, Cyst 5 (10%) 7 (14%)
Pars Distalis, Hyperplasia, Focal 15 (30%) 8 (16%)
Pars Intermedia, Angiectasis 1 (2%)
Pars Intermedia, Cyst 2 (4%) 1 (2%)
Thyroid Gland (50) (49)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 14 (28%) 9 (18%)
Follicle, Cyst 1 (2%) 2 (4%)
Follicle, Mineralization 7 (14%)
Follicular Cell, Hyperplasia 1 (2%) 3 (6%)
Follicular Cell, Hypertrophy 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50)
Atypia Cellular 25 (50%) 37 (74%)
Hypospermia 40 (80%) 34 (68%)
Preputial Gland (50) (50)
Ectasia 20 (40%) 10 (20%)
Hyperplasia 1 (2%) 2 (4%)
Inflammation, Chronic 24 (48%) 29 (58%)
Inflammation, Suppurative 19 (38%) 8 (16%)
Prostate (50) (50)
Corpora Amylacea 28 (56%) 27 (54%)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Suppurative 17 (34%) 26 (52%)
Epithelium, Hyperplasia 8 (16%) 14 (28%)
Seminal Vesicle (50) (50)
Dilatation 1 (2%)
Testes (50) (50)
Interstitial Cell, Hyperplasia 1 (2%) 7 (14%)
Seminiferous Tubule, Atrophy 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05099-98 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/10/95
Route: GAVAGE Time: 11:43:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG
AD LIB RTD
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50)
Hypercellularity 3 (6%) 2 (4%)
Lymph Node (9) (11)
Inguinal, Hemorrhage 1 (9%)
Mediastinal, Hemorrhage 6 (67%) 2 (18%)
Mediastinal, Hyperplasia, Lymphoid 1 (9%)
Mediastinal, Infiltration Cellular, Mast Cell 1 (9%)
Mediastinal, Pigmentation 5 (56%) 4 (36%)
Pancreatic, Pigmentation 2 (18%)
Lymph Node, Mandibular (50) (50)
Ectasia 5 (10%) 3 (6%)
Hemorrhage 4 (8%) 3 (6%)
Hyperplasia, Lymphoid 5 (10%) 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Pigmentation 7 (14%)
Lymph Node, Mesenteric (50) (50)
Ectasia 1 (2%)
Hemorrhage 3 (6%) 4 (8%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Pigmentation 4 (8%)
Spleen (50) (50)
Fibrosis 8 (16%) 3 (6%)
Hematopoietic Cell Proliferation 14 (28%) 6 (12%)
Pigmentation, Hemosiderin 14 (28%) 12 (24%)
Thymus (47) (46)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (49)
Hyperplasia, Cystic 11 (23%) 12 (24%)
Hyperplasia, Lobular 2 (4%)
Skin (50) (50)
Acanthosis 1 (2%)
Cyst Epithelial Inclusion 2 (4%) 1 (2%)
Hemorrhage 1 (2%)
Hyperkeratosis 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05099-98 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/10/95
Route: GAVAGE Time: 11:43:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG
AD LIB RTD
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (2)
Hemorrhage 1 (50%)
Inflammation, Suppurative 1 (50%)
Necrosis 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50)
Compression 4 (8%) 5 (10%)
Hemorrhage 1 (2%)
Hydrocephalus 1 (2%) 1 (2%)
Mineralization 1 (2%)
Necrosis 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50)
Congestion 1 (2%) 3 (6%)
Edema 2 (4%)
Foreign Body 4 (8%)
Hemorrhage 2 (4%)
Infiltration Cellular, Histiocyte 8 (16%) 10 (20%)
Inflammation, Subacute 3 (6%) 1 (2%)
Alveolar Epithelium, Hyperplasia 10 (20%) 5 (10%)
Fat, Mediastinum, Necrosis 1 (2%)
Nose (50) (50)
Exudate 15 (30%) 14 (28%)
Foreign Body 4 (8%) 6 (12%)
Fungus 6 (12%) 3 (6%)
Mucosa, Hyperplasia 6 (12%) 3 (6%)
Mucosa, Metaplasia, Squamous 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cataract 1 (100%)
Retina, Atrophy 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05099-98 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 05/10/95
Route: GAVAGE Time: 11:43:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 0 MG/KG
AD LIB RTD
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Cyst 1 (2%)
Fibrosis 1 (2%)
Inflammation, Suppurative 6 (12%)
Mineralization 3 (6%) 2 (4%)
Nephropathy 48 (96%) 43 (86%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation 2 (4%) 2 (4%)
Transitional Epithelium, Hyperplasia 10 (20%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------