TDMS Study 05021-04 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
CI PIGMENT RED 23
NTP Experiment-Test: 05021-04 Report: PEIRPT03
Study Type: CHRONIC Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
Facility: Southern Research Institute
Chemical CAS #: 6471-49-4
Lock Date: None
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: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund 11 7 11 10
Dead 4 8 3 4
Accident 1
Survivors
Terminal Sacrifice 35 34 36 35
Missing 1
Animals Examined Microscopically 50 50 50 49
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (15) (14) (48)
Inflammation, Chronic 2 (13%)
Gallbladder (46) (12) (12) (46)
Epithelium, Cytoplasmic Alteration 1 (2%)
Wall, Mucocele 3 (7%) 1 (2%)
Intestine Large, Cecum (47) (47) (48) (46)
Lymphoid Tissue, Hyperplasia, Lymphoid 3 (6%) 5 (11%) 3 (6%) 2 (4%)
Lymphoid Tissue, Pigmentation 2 (4%) 5 (11%)
Submucosa, Edema 1 (2%)
Intestine Large, Rectum (46) (48) (48) (46)
Inflammation, Chronic 1 (2%) 1 (2%)
Polyarteritis 1 (2%)
Intestine Small, Duodenum (46) (46) (47) (46)
Erosion 1 (2%)
Polyarteritis 1 (2%)
Submucosa, Inflammation, Acute 1 (2%)
Intestine Small, Ileum (46) (45) (48) (46)
Lymphoid Tissue, Pigmentation 1 (2%) 1 (2%)
Intestine Small, Jejunum (46) (46) (48) (47)
Lymphoid Tissue, Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Lymphoid Tissue, Hyperplasia, Plasma Cell 1 (2%)
Lymphoid Tissue, Hyperplasia, Re Cell 1 (2%)
Lymphoid Tissue, Pigmentation 12 (26%) 25 (52%) 31 (66%)
Liver (49) (49) (50) (48)
Clear Cell Focus 1 (2%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 9 (18%) 4 (8%) 7 (14%) 3 (6%)
Inflammation, Acute 2 (4%) 1 (2%) 2 (4%) 2 (4%)
Inflammation, Chronic 4 (8%) 2 (4%)
Mitotic Alteration 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Polyarteritis 1 (2%)
Hepatocyte, Cytomegaly, Focal 2 (4%)
Hepatocyte, Necrosis 2 (4%) 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 2 (4%) 3 (6%) 1 (2%) 1 (2%)
Kupffer Cell, Hyperplasia 1 (2%)
Mesentery (7) (4) (3)
Inflammation, Acute 2 (29%)
Inflammation, Chronic 2 (29%)
Fat, Necrosis 3 (43%) 2 (50%) 2 (67%)
Pancreas (49) (14) (15) (47)
Cytoplasmic Alteration 1 (2%)
Inflammation, Acute 3 (6%) 1 (7%)
Inflammation, Chronic 1 (7%)
Polyarteritis 1 (7%)
Acinar Cell, Atrophy 2 (4%) 3 (21%) 1 (7%)
Duct, Ectasia 3 (6%) 1 (7%) 1 (7%) 1 (2%)
Perivascular, Inflammation, Chronic 1 (2%)
Salivary Glands (49) (16) (14) (49)
Inflammation, Acute 1 (6%)
Stomach, Forestomach (49) (49) (50) (49)
Abscess 4 (8%) 5 (10%) 28 (56%) 32 (65%)
Angiectasis 1 (2%)
Hyperkeratosis 2 (4%) 1 (2%) 3 (6%) 18 (37%)
Inflammation, Chronic 2 (4%) 3 (6%)
Ulcer 2 (4%) 6 (12%) 30 (60%) 38 (78%)
Epithelium, Cyst 1 (2%)
Epithelium, Hyperplasia 4 (8%) 9 (18%) 27 (54%) 20 (41%)
Epithelium, Hyperplasia, Multiple 2 (4%) 5 (10%) 16 (32%) 27 (55%)
Submucosa, Edema 1 (2%)
Stomach, Glandular (48) (48) (50) (45)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 9 (19%) 4 (8%) 6 (12%) 10 (22%)
Ulcer 1 (2%)
Mucosa, Cyst 1 (2%)
Mucosa, Hyperplasia 2 (4%)
Submucosa, Edema 1 (2%)
Tongue (1)
Angiectasis 1 (100%)
Tooth (2)
Incisor, Abscess 1 (50%)
Incisor, Developmental Malformation 1 (50%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1)
Aorta, Polyarteritis 1 (100%)
Pulmonary Artery, Inflammation, Acute 1 (100%)
Heart (50) (16) (14) (49)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 4 (8%) 1 (6%) 1 (7%) 2 (4%)
Atrioventricular Valve, Thrombosis 1 (2%)
Epicardium, Fibrosis 1 (2%)
Interstitium, Fibrosis 4 (8%) 3 (6%)
Myocardium, Degeneration 2 (4%)
Myocardium, Inflammation 1 (6%)
Myocardium, Inflammation, Acute 1 (6%)
Myocardium, Mineralization 1 (2%) 1 (6%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (49) (15) (14) (48)
Congestion 1 (7%)
Hematopoietic Cell Proliferation 2 (4%)
Hyperplasia, Focal 1 (2%)
Hypertrophy, Diffuse 1 (7%)
Hypertrophy, Focal 1 (2%) 2 (4%)
Inflammation, Acute 1 (2%) 1 (7%)
Corticomedullary Junction, Pigmentation 46 (94%) 3 (21%) 45 (94%)
Extra Adrenal Tissue, Accessory Adrenal
Cortical Nodule 1 (2%) 1 (7%)
Spindle Cell, Hyperplasia 49 (100%) 14 (93%) 14 (100%) 47 (98%)
Adrenal Gland, Medulla (49) (15) (14) (47)
Hyperplasia 2 (4%) 1 (7%) 3 (6%)
Parathyroid Gland (49) (10) (14) (49)
Cyst 4 (8%) 3 (6%)
Ectopic Thymus 1 (2%) 1 (2%)
Pituitary Gland (50) (23) (16) (47)
Pars Distalis, Angiectasis 1 (2%) 2 (9%) 2 (4%)
Pars Distalis, Cyst 1 (2%)
Pars Distalis, Degeneration, Cystic 2 (4%) 3 (6%)
Pars Distalis, Hyperplasia 10 (20%) 3 (13%) 2 (13%) 11 (23%)
Pars Intermedia, Hyperplasia 1 (2%)
Thyroid Gland (50) (15) (14) (49)
Inflammation, Acute 2 (4%) 1 (2%)
Ultimobranchial Cyst 1 (7%) 1 (7%) 2 (4%)
Follicle, Cyst 5 (10%) 7 (14%)
Follicular Cell, Hyperplasia 6 (12%) 1 (7%) 1 (7%) 11 (22%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (47) (20) (28) (48)
Abscess 8 (17%) 4 (20%) 2 (7%) 2 (4%)
Atrophy 24 (51%) 6 (30%) 6 (21%) 28 (58%)
Cyst 1 (2%) 2 (7%)
Hyperplasia, Tubular 1 (2%)
Inflammation, Acute 1 (2%)
Mineralization 1 (2%)
Pigmentation, Ceroid 35 (74%) 9 (45%) 14 (50%) 43 (90%)
Polyarteritis 1 (5%)
Follicle, Cyst 11 (23%) 1 (5%) 10 (36%) 13 (27%)
Follicle, Hemorrhage 1 (2%) 1 (4%) 1 (2%)
Periovarian Tissue, Cyst 1 (2%) 1 (4%)
Periovarian Tissue, Inflammation, Acute 2 (4%)
Periovarian Tissue, Inflammation, Chronic 2 (4%) 1 (2%)
Uterus (49) (41) (39) (49)
Abscess 1 (2%) 1 (2%)
Exudate, Purulent 6 (12%) 1 (2%) 4 (8%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hydrometra 5 (10%) 1 (2%) 3 (8%) 1 (2%)
Polyarteritis 1 (2%)
Endometrium, Cyst 1 (2%) 3 (8%)
Endometrium, Hyperplasia, Cystic 41 (84%) 28 (68%) 29 (74%) 43 (88%)
Endometrium, Inflammation, Acute 2 (4%) 1 (2%) 1 (2%)
Endometrium, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (49) (49) (49)
Hypocellularity 4 (8%) 2 (4%)
Myelofibrosis 21 (43%) 14 (29%) 27 (55%) 26 (53%)
Erythroid Cell, Hyperplasia 1 (2%)
Myeloid Cell, Hyperplasia 13 (27%) 7 (14%) 5 (10%) 7 (14%)
Lymph Node (50) (48) (50) (49)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Iliac, Edema 1 (2%)
Iliac, Hyperplasia, Plasma Cell 1 (2%) 1 (2%) 2 (4%)
Iliac, Inflammation, Chronic 1 (2%)
Mediastinal, Abscess 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mediastinal, Edema 1 (2%)
Mediastinal, Hematopoietic Cell Proliferation 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Mediastinal, Hyperplasia, Plasma Cell 3 (6%) 1 (2%)
Mediastinal, Inflammation, Acute 1 (2%) 1 (2%)
Mediastinal, Inflammation, Chronic 2 (4%)
Mesenteric, Abscess 1 (2%)
Mesenteric, Angiectasis 1 (2%) 2 (4%)
Mesenteric, Autolysis 1 (2%) 2 (4%)
Mesenteric, Hematopoietic Cell Proliferation 1 (2%) 2 (4%) 1 (2%)
Mesenteric, Hyperplasia, Lymphoid 11 (22%) 14 (29%) 8 (16%) 9 (18%)
Mesenteric, Hyperplasia, Plasma Cell 2 (4%) 1 (2%)
Mesenteric, Inflammation, Acute 3 (6%) 1 (2%) 1 (2%)
Mesenteric, Inflammation, Chronic 2 (4%) 1 (2%)
Mesenteric, Pigmentation 4 (8%) 26 (52%) 29 (59%)
Mesenteric, Lymphocyte, Necrosis 1 (2%)
Pancreatic, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Pancreatic, Inflammation, Granulomatous 1 (2%)
Renal, Abscess 1 (2%)
Renal, Hyperplasia, Lymphoid 1 (2%)
Renal, Hyperplasia, Plasma Cell 2 (4%) 1 (2%) 2 (4%)
Renal, Inflammation, Acute 1 (2%)
Renal, Lymphocyte, Necrosis 1 (2%)
Lymph Node, Mandibular (49) (18) (15) (49)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Lymphoid 4 (8%)
Inflammation, Acute 1 (6%) 1 (2%)
Inflammation, Granulomatous 1 (2%)
Arteriole, Amyloid Deposition 1 (2%)
Spleen (50) (21) (25) (48)
Angiectasis 1 (2%)
Hematopoietic Cell Proliferation 23 (46%) 7 (33%) 15 (60%) 17 (35%)
Hyperplasia, Lymphoid 6 (12%) 2 (8%) 9 (19%)
Red Pulp, Depletion Cellular 1 (2%)
Thymus (18) (7) (14) (39)
Atrophy 1 (6%) 2 (29%) 2 (14%) 4 (10%)
Cyst 3 (17%) 2 (14%) 4 (10%)
Hyperplasia, Lymphoid 1 (7%) 2 (5%)
Cortex, Necrosis 1 (6%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (15) (15) (48)
Inflammation, Chronic 2 (4%)
Acinus, Hyperplasia 1 (7%) 3 (6%)
Duct, Dilatation 1 (2%) 1 (7%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Duct, Ectasia 1 (7%)
Skin (49) (48) (48) (49)
Dermis, Fibrosis 1 (2%)
Dermis, Inflammation, Acute 2 (4%) 1 (2%)
Dermis, Inflammation, Chronic 25 (51%) 25 (52%) 28 (58%) 21 (43%)
Epidermis, Pigmentation 1 (2%)
Subcutaneous Tissue, Abscess 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (15) (14) (49)
Cerebellum, Compression 1 (2%)
Cerebrum, Compression 1 (7%) 2 (4%)
Cerebrum, Degeneration 1 (2%)
Meninges, Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Thalamus, Mineralization 44 (88%) 12 (80%) 8 (57%) 35 (71%)
Third Ventricle, Infiltration Cellular,
Lipocyte 1 (2%)
Spinal Cord (1)
Nerve, Demyelination 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (49) (49)
Congestion 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Inflammation, Acute 2 (4%) 2 (4%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%)
Alveolus, Mineralization 1 (2%)
Artery, Foreign Body 1 (2%)
Artery, Mineralization 1 (2%) 1 (2%)
Pleura, Inflammation, Acute 1 (2%)
Pleura, Inflammation, Chronic 4 (8%) 3 (6%)
Nose (50) (15) (14) (49)
Exudate, Purulent 1 (2%)
Foreign Body 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Nasolacrimal Duct, Exudate, Purulent 1 (2%)
Nasolacrimal Duct, Inflammation, Chronic 1 (2%)
Sinus, Exudate, Acute 1 (7%)
Vomeronasal Organ, Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (2)
Phthisis Bulbi 1 (100%) 2 (100%)
Cornea, Inflammation, Chronic 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (17) (15) (49)
Casts Protein 7 (14%) 6 (12%)
Infarct, Chronic 3 (6%) 1 (6%) 1 (2%)
Nephropathy 24 (49%) 2 (12%) 1 (7%) 26 (53%)
Cortex, Metaplasia, Osseous 2 (4%) 6 (12%)
Corticomedullary Junction, Embolus Bacterial,
Focal 1 (2%)
Glomerulus, Amyloid Deposition 1 (2%)
Glomerulus, Inflammation,
Membranoproliferative 6 (12%) 1 (6%) 1 (7%) 3 (6%)
Proximal Convoluted Renal Tubule,
Degeneration, Hyaline 1 (2%) 2 (4%)
Proximal Convoluted Renal Tubule, Renal
Tubule, Degeneration, Hyaline 2 (12%) 1 (7%)
Proximal Convoluted Renal Tubule, Renal
Tubule, Pigmentation 1 (7%)
Renal Tubule, Dilatation 1 (2%) 3 (6%)
Renal Tubule, Hypertrophy 1 (6%)
Renal Tubule, Mineralization 1 (6%) 1 (7%)
Renal Tubule, Pigmentation 1 (7%)
Urinary Bladder (47) (15) (12) (46)
Polyarteritis 2 (13%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 8 7 8 9
Early Deaths
Dead 10 22 8 6
Moribund 12 14 17 15
Survivors
Terminal Sacrifice 29 17 27 30
Missing 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (40) (20) (20) (43)
Inflammation, Chronic Active 2 (5%)
Epithelium, Cytoplasmic Alteration 2 (5%)
Wall, Mucocele 1 (2%)
Intestine Large, Cecum (42) (42) (48) (46)
Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%)
Lymphoid Tissue, Pigmentation 1 (2%)
Intestine Large, Colon (45) (42) (50) (46)
Inflammation, Chronic 1 (2%)
Intestine Large, Rectum (44) (41) (50) (46)
Inflammation, Acute 1 (2%)
Intestine Small, Duodenum (43) (36) (46) (45)
Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Ileum (42) (39) (47) (45)
Inflammation, Acute 1 (2%)
Lymphoid Tissue, Hyperplasia 1 (2%)
Lymphoid Tissue, Pigmentation 2 (4%)
Intestine Small, Jejunum (42) (37) (47) (45)
Lymphoid Tissue, Hyperplasia 1 (2%)
Lymphoid Tissue, Hyperplasia, Lymphoid 2 (5%) 2 (5%) 7 (15%) 7 (16%)
Lymphoid Tissue, Inflammation, Chronic 1 (2%) 1 (2%)
Lymphoid Tissue, Pigmentation 4 (11%) 14 (30%) 10 (22%)
Liver (49) (50) (50) (49)
Basophilic Focus 2 (4%) 1 (2%)
Clear Cell Focus 1 (2%)
Hematopoietic Cell Proliferation 3 (6%) 7 (14%) 2 (4%) 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 2 (4%) 1 (2%)
Hepatocyte, Necrosis 3 (6%) 8 (16%) 6 (12%) 3 (6%)
Hepatocyte, Vacuolization Cytoplasmic 1 (2%)
Serosa, Fibrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Sinusoid, Dilatation 1 (2%) 1 (2%)
Mesentery (3) (2)
Fat, Congestion 1 (33%)
Fat, Necrosis 2 (67%)
Pancreas (49) (31) (25) (47)
Inflammation, Chronic 1 (3%) 1 (4%)
Acinar Cell, Atrophy 1 (2%) 1 (2%)
Salivary Glands (49) (32) (22) (48)
Duct, Ectasia 1 (2%)
Duct, Submandibular Gland, Hyperplasia 1 (2%)
Stomach, Forestomach (49) (48) (50) (48)
Hyperkeratosis 1 (2%) 3 (6%) 5 (10%)
Infiltration Cellular, Mast Cell 1 (2%)
Inflammation, Acute 1 (2%) 3 (6%)
Ulcer 1 (2%)
Epithelium, Hyperplasia 1 (2%) 1 (2%) 7 (15%)
Stomach, Glandular (49) (48) (50) (44)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic 2 (4%)
Mineralization 9 (18%) 7 (15%) 4 (8%) 7 (16%)
Ulcer, Focal 1 (2%)
Mucosa, Granuloma 1 (2%)
Mucosa, Hyperplasia 4 (8%) 2 (4%) 3 (7%)
Tooth (3) (3) (1) (4)
Incisor, Developmental Malformation 3 (100%) 3 (100%) 1 (100%) 3 (75%)
Incisor, Inflammation, Chronic Active 1 (25%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1)
Aorta, Inflammation, Chronic 1 (100%)
Carotid Artery, Aneurysm 1 (100%)
Heart (49) (32) (23) (50)
Inflammation, Acute 2 (6%) 1 (2%)
Inflammation, Chronic 2 (4%)
Artery, Polyarteritis, Chronic 1 (2%)
Atrioventricular Valve, Inflammation, Chronic 1 (2%)
Atrium, Thrombosis 1 (3%)
Endocardium, Inflammation, Acute 1 (3%)
Interstitium, Fibrosis 7 (14%) 3 (9%) 2 (9%) 7 (14%)
Myocardium, Degeneration 1 (2%) 1 (3%) 2 (9%) 2 (4%)
Myocardium, Mineralization 1 (3%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (48) (32) (23) (48)
Clear Cell Focus 3 (6%) 1 (2%)
Clear Cell Focus, Focal 1 (2%)
Cyst 1 (2%)
Hematocyst 1 (2%)
Hemorrhage, Focal 1 (2%)
Hyperplasia, Focal 1 (2%) 1 (4%) 2 (4%)
Hypertrophy, Focal 8 (17%) 2 (6%) 4 (17%) 9 (19%)
Necrosis 1 (4%)
Extra Adrenal Tissue, Accessory Adrenal
Cortical Nodule 1 (2%) 2 (4%)
Spindle Cell, Hyperplasia 41 (85%) 21 (66%) 15 (65%) 41 (85%)
Unilateral, Atrophy 1 (4%)
Adrenal Gland, Medulla (48) (32) (23) (48)
Hyperplasia 2 (4%) 3 (9%) 2 (4%)
Hyperplasia, Focal 1 (4%)
Unilateral, Necrosis 1 (4%)
Islets, Pancreatic (49) (30) (23) (47)
Cyst 1 (2%)
Hyperplasia 1 (2%)
Parathyroid Gland (46) (26) (20) (47)
Cyst 2 (4%) 2 (8%) 1 (5%) 1 (2%)
Ectopic Thymus 1 (2%)
Pituitary Gland (41) (29) (22) (48)
Pars Distalis, Congestion 1 (3%)
Pars Distalis, Cyst 1 (2%) 1 (3%) 3 (6%)
Pars Distalis, Hyperplasia 1 (2%) 1 (2%)
Thyroid Gland (49) (30) (23) (50)
Inflammation, Acute 1 (4%)
Inflammation, Chronic 1 (2%)
Ultimobranchial Cyst 1 (2%) 1 (3%)
Follicle, Cyst 4 (8%) 3 (6%)
Follicular Cell, Hyperplasia 2 (4%) 1 (3%) 1 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1)
Lumen, Dilatation 1 (100%)
Epididymis (49) (32) (23) (50)
Fibrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Granuloma Sperm 2 (4%)
Hemorrhage 1 (2%)
Hypospermia 2 (4%) 1 (2%)
Inflammation, Chronic 1 (2%) 2 (9%) 1 (2%)
Inflammation, Subacute 1 (2%)
Spermatocele 1 (2%)
Unilateral, Necrosis 1 (4%)
Penis (1) (1) (1)
Cyst 1 (100%)
Inflammation, Acute 1 (100%) 1 (100%)
Preputial Gland (9) (6) (9) (11)
Abscess 1 (11%) 1 (17%) 1 (11%) 1 (9%)
Inflammation, Acute 3 (27%)
Inflammation, Chronic 6 (67%) 3 (50%) 4 (36%)
Duct, Ectasia 6 (67%) 4 (67%) 7 (78%) 8 (73%)
Prostate (48) (32) (23) (48)
Hemorrhage 1 (2%)
Inflammation, Acute 2 (4%) 5 (16%) 1 (4%) 1 (2%)
Inflammation, Chronic 1 (2%) 2 (6%) 1 (4%)
Inflammation, Chronic Active 2 (4%)
Seminal Vesicle (49) (32) (25) (48)
Depletion Cellular 1 (2%) 1 (3%) 1 (4%)
Inflammation, Acute 2 (6%) 1 (4%)
Inflammation, Chronic 2 (4%) 2 (6%) 1 (4%) 1 (2%)
Lumen, Dilatation 1 (2%)
Testes (49) (32) (23) (49)
Polyarteritis, Chronic 1 (2%) 1 (4%)
Interstitial Cell, Hyperplasia 1 (2%)
Interstitium, Pigmentation 1 (2%)
Seminiferous Tubule, Atrophy 4 (8%) 2 (9%) 4 (8%)
Seminiferous Tubule, Degeneration 1 (2%)
Seminiferous Tubule, Dilatation 1 (2%)
Seminiferous Tubule, Giant Cell 3 (6%) 1 (4%) 1 (2%)
Seminiferous Tubule, Mineralization 1 (2%)
Unilateral, Necrosis 1 (4%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (31) (22) (48)
Erythroid Cell, Hyperplasia 3 (6%)
Myeloid Cell, Hyperplasia 13 (27%) 1 (3%) 2 (9%) 12 (25%)
Lymph Node (49) (50) (49) (48)
Iliac, Hyperplasia, Lymphoid 1 (2%)
Iliac, Hyperplasia, Plasma Cell 1 (2%)
Inguinal, Autolysis 1 (2%)
Inguinal, Hematopoietic Cell Proliferation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Inguinal, Hyperplasia, Lymphoid 3 (6%)
Inguinal, Hyperplasia, Plasma Cell 1 (2%) 2 (4%)
Inguinal, Lymphocyte, Necrosis 2 (4%) 2 (4%)
Mesenteric, Angiectasis 10 (20%) 8 (16%) 9 (18%) 13 (27%)
Mesenteric, Autolysis 2 (4%)
Mesenteric, Congestion 1 (2%) 1 (2%)
Mesenteric, Hematopoietic Cell Proliferation 14 (29%) 10 (20%) 8 (16%) 9 (19%)
Mesenteric, Hyperplasia, Lymphoid 16 (33%) 10 (20%) 16 (33%) 22 (46%)
Mesenteric, Inflammation, Acute 4 (8%) 4 (8%) 1 (2%) 6 (13%)
Mesenteric, Inflammation, Chronic 1 (2%)
Mesenteric, Pigmentation 8 (16%) 14 (29%) 16 (33%)
Mesenteric, Thrombosis 1 (2%) 2 (4%)
Mesenteric, Lymphocyte, Necrosis 2 (4%) 2 (4%) 3 (6%)
Renal, Lymphocyte, Hyperplasia 1 (2%)
Renal, Lymphocyte, Necrosis 1 (2%)
Lymph Node, Mandibular (48) (27) (21) (48)
Hyperplasia, Lymphoid 1 (4%) 1 (5%) 2 (4%)
Hyperplasia, Plasma Cell 1 (2%)
Hyperplasia, Re Cell 1 (2%)
Pigmentation 1 (5%)
Lymphocyte, Necrosis 1 (5%)
Spleen (49) (31) (26) (47)
Angiectasis 1 (3%) 1 (4%)
Hematopoietic Cell Proliferation 20 (41%) 15 (48%) 13 (50%) 16 (34%)
Hyperplasia, Lymphoid 5 (10%) 2 (6%) 3 (12%) 6 (13%)
Hyperplasia, Re Cell 1 (2%)
Capsule, Inflammation, Chronic 1 (2%)
Lymphocyte, Depletion Cellular 1 (3%)
Lymphocyte, Necrosis 2 (4%) 3 (10%) 2 (8%) 1 (2%)
Red Pulp, Depletion Cellular 1 (3%)
Thymus (39) (18) (14) (32)
Atrophy 7 (18%) 10 (56%) 3 (21%) 7 (22%)
Cyst 12 (31%) 2 (11%) 3 (21%) 13 (41%)
Inflammation, Acute 1 (3%)
Cortex, Necrosis 4 (10%) 2 (11%) 3 (9%)
Medulla, Atrophy 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (1)
Acinus, Duct, Dilatation 1 (100%)
Skin (49) (50) (48) (50)
Parakeratosis 1 (2%)
Ulcer 4 (8%) 4 (8%) 3 (6%) 2 (4%)
Dermis, Fibrosis 1 (2%) 4 (8%)
Dermis, Inflammation, Acute 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Dermis, Inflammation, Chronic 19 (39%) 16 (32%) 13 (27%) 12 (24%)
Dermis, Mineralization 1 (2%) 2 (4%)
Epidermis, Hyperkeratosis 1 (2%)
Epithelium, Hyperplasia 3 (6%) 2 (4%) 3 (6%)
Prepuce, Inflammation, Chronic 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (32) (23) (50)
Joint, Arthrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (32) (23) (49)
Perivascular, Fibrosis, Focal 1 (2%)
Thalamus, Mineralization 39 (78%) 14 (44%) 9 (39%) 34 (69%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (49) (50) (50)
Congestion 2 (4%) 3 (6%) 3 (6%) 2 (4%)
Hemorrhage 2 (4%) 2 (4%)
Inflammation, Acute 2 (4%) 2 (4%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Peribronchial, Glands, Exudate 1 (2%)
Peribronchiolar, Cyst 1 (2%)
Perivascular, Inflammation, Chronic 1 (2%)
Pleura, Fibrosis 1 (2%)
Pleura, Inflammation, Chronic 1 (2%)
Nose (49) (32) (23) (49)
Exudate, Purulent 3 (6%) 1 (4%) 1 (2%)
Foreign Body 1 (2%)
Inflammation, Acute 2 (4%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Lumen, Hemorrhage 1 (2%)
Nasolacrimal Duct, Exudate 1 (2%)
Nasolacrimal Duct, Foreign Body 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 1 (2%)
Submucosa, Cyst 1 (2%)
Vomeronasal Organ, Exudate, Purulent 1 (2%)
Vomeronasal Organ, Foreign Body 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1)
Phthisis Bulbi 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (33) (23) (50)
Cyst 2 (4%) 1 (3%)
Infarct, Chronic 1 (2%) 2 (6%) 3 (13%)
Inflammation, Acute 1 (2%)
Nephropathy 37 (76%) 12 (36%) 12 (52%) 37 (74%)
Artery, Polyarteritis, Chronic 1 (2%)
Cortex, Metaplasia, Osseous 1 (4%) 1 (2%)
Cortex, Renal Tubule, Necrosis, Acute 1 (2%)
Medulla, Congestion 1 (2%) 1 (3%) 2 (9%)
Papilla, Necrosis 1 (3%)
Pelvis, Inflammation, Acute 1 (2%) 2 (6%)
Proximal Convoluted Renal Tubule,
Degeneration, Hyaline 1 (2%)
Renal Tubule, Dilatation 2 (4%) 2 (6%) 1 (4%) 5 (10%)
Renal Tubule, Hypertrophy 1 (2%) 1 (3%) 1 (2%)
Renal Tubule, Mineralization 11 (22%) 3 (9%) 1 (4%) 10 (20%)
Urethra (4) (1) (1) (1)
Calculus Micro Observation Only 1 (100%)
Inflammation, Acute 3 (75%) 1 (100%)
Bulbourethral Gland, Ectasia 1 (25%) 1 (100%)
Bulbourethral Gland, Inflammation, Acute 1 (25%) 1 (100%)
Urinary Bladder (44) (28) (22) (46)
Inflammation, Acute 1 (4%)
Inflammation, Chronic 1 (2%) 1 (4%) 1 (5%) 1 (2%)
Transitional Epithelium, Hyperplasia 2 (7%) 1 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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