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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