TDMS Study 05019-03 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
CI PIGMENT RED 3
NTP Experiment-Test: 05019-03 Report: PEIRPT03
Study Type: CHRONIC Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
Facility: Southern Research Institute
Chemical CAS #: 2425-85-6
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: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund 15 7 8 7
Dead 3 2 3 3
Survivors
Terminal Sacrifice 32 40 39 40
Dead 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large (50) (10) (12) (50)
Wall, Inflammation, Subacute 1 (2%)
Intestine Large, Cecum (48) (9) (12) (50)
Parasite Metazoan 2 (4%) 2 (4%)
Intestine Large, Colon (50) (10) (12) (48)
Parasite Metazoan 2 (4%) 2 (20%) 8 (17%)
Intestine Large, Rectum (50) (10) (12) (50)
Parasite Metazoan 10 (20%) 1 (10%) 1 (8%) 6 (12%)
Liver (50) (50) (50) (50)
Angiectasis, Focal 1 (2%)
Angiectasis, Multifocal 2 (4%)
Basophilic Focus 1 (2%) 11 (22%) 17 (34%) 11 (22%)
Basophilic Focus, Multiple 37 (74%) 29 (58%) 26 (52%) 30 (60%)
Clear Cell Focus 2 (4%)
Degeneration, Cystic, Focal 1 (2%) 2 (4%) 3 (6%)
Degeneration, Cystic, Multifocal 1 (2%) 2 (4%)
Eosinophilic Focus 1 (2%) 7 (14%) 13 (26%) 14 (28%)
Eosinophilic Focus, Multiple 5 (10%) 2 (4%)
Granuloma, Multiple 27 (54%) 21 (42%) 43 (86%) 44 (88%)
Hepatodiaphragmatic Nodule 4 (8%) 6 (12%) 12 (24%) 3 (6%)
Mixed Cell Focus 4 (8%) 10 (20%) 13 (26%) 3 (6%)
Mixed Cell Focus, Multiple 6 (12%) 17 (34%) 37 (74%)
Necrosis, Focal 2 (4%)
Necrosis, Multifocal 1 (2%) 1 (2%)
Pigmentation, Multifocal, Cholesterol 3 (6%) 14 (28%) 41 (82%)
Regeneration 6 (12%)
Vacuolization Cytoplasmic, Diffuse 4 (8%) 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Multifocal 1 (2%)
Biliary Tract, Dilatation, Focal 2 (4%) 4 (8%)
Biliary Tract, Proliferation 18 (36%) 12 (24%) 18 (36%) 29 (58%)
Centrilobular, Necrosis 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (6) (6) (10) (4)
Inflammation, Chronic 1 (25%)
Inflammation, Granulomatous 1 (17%)
Fat, Necrosis, Focal 4 (67%) 6 (100%) 10 (100%) 3 (75%)
Pancreas (50) (50) (50) (49)
Basophilic Focus 1 (2%) 1 (2%) 2 (4%) 2 (4%)
Acinus, Atrophy, Multifocal 22 (44%) 33 (66%) 40 (80%) 36 (73%)
Acinus, Hyperplasia, Focal 2 (4%)
Acinus, Hyperplasia, Multifocal 1 (2%)
Artery, Hypertrophy 1 (2%)
Artery, Inflammation, Subacute 1 (2%)
Duct, Hyperplasia 2 (4%)
Pharynx (2) (1)
Hyperplasia 1 (50%)
Salivary Glands (50) (10) (12) (50)
Acinus, Atrophy, Focal 4 (8%) 2 (4%)
Acinus, Atrophy, Multifocal 1 (2%) 1 (8%) 6 (12%)
Stomach, Forestomach (50) (9) (12) (50)
Hyperplasia 2 (17%) 1 (2%)
Inflammation, Subacute 2 (17%) 1 (2%)
Mineralization 1 (2%)
Perforation 1 (8%)
Ulcer 1 (8%) 1 (2%)
Stomach, Glandular (50) (9) (12) (50)
Erosion 1 (8%)
Mineralization 1 (2%) 4 (8%)
Tooth (1)
Dysplasia 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (10) (12) (50)
Cardiomyopathy 33 (66%) 6 (60%) 7 (58%) 34 (68%)
Inflammation, Focal, Subacute 1 (2%) 2 (4%)
Atrium, Thrombosis 1 (10%) 1 (2%)
Valve, Inflammation, Subacute 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (16) (13) (50)
Angiectasis 1 (2%) 1 (6%) 1 (8%) 1 (2%)
Congestion 1 (2%)
Degeneration, Fatty, Focal 8 (16%) 1 (6%) 6 (46%) 15 (30%)
Degeneration, Fatty, Multifocal 3 (19%) 1 (8%)
Hyperplasia, Focal 18 (36%) 3 (19%) 2 (15%) 20 (40%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia, Multifocal 1 (2%)
Hypertrophy, Focal 4 (8%) 1 (8%) 6 (12%)
Inflammation, Granulomatous, Multifocal 1 (2%)
Pigmentation, Multifocal, Cholesterol 1 (2%)
Capsule, Accessory Adrenal Cortical Nodule 4 (8%) 2 (13%) 4 (8%)
Adrenal Gland, Medulla (49) (16) (13) (50)
Hyperplasia, Focal 10 (20%) 2 (13%) 2 (15%) 11 (22%)
Hyperplasia, Multifocal 1 (2%)
Islets, Pancreatic (49) (50) (50) (49)
Hyperplasia 1 (2%)
Parathyroid Gland (50) (9) (12) (50)
Hyperplasia 1 (2%) 1 (2%)
Pituitary Gland (50) (22) (20) (50)
Cyst 1 (5%) 1 (5%)
Pars Distalis, Angiectasis 35 (70%) 15 (68%) 12 (60%) 26 (52%)
Pars Distalis, Cyst 26 (52%) 10 (45%) 6 (30%) 19 (38%)
Pars Distalis, Hemorrhage 2 (9%)
Pars Distalis, Hyperplasia, Focal 15 (30%) 5 (23%) 3 (15%) 14 (28%)
Pars Distalis, Pigmentation, Hemosiderin 24 (48%) 4 (18%) 4 (20%) 9 (18%)
Thyroid Gland (50) (12) (13) (50)
Pigmentation, Focal, Cholesterol 1 (2%)
Ultimobranchial Cyst 1 (2%) 1 (8%) 1 (2%)
C-Cell, Hyperplasia, Focal 8 (16%) 2 (15%) 10 (20%)
Follicle, Cyst 3 (6%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (47) (14) (14) (50)
Hyperplasia 7 (15%) 2 (14%) 1 (7%) 3 (6%)
Inflammation, Subacute 9 (19%) 3 (21%) 2 (4%)
Duct, Cyst 14 (30%) 1 (7%) 2 (14%) 4 (8%)
Ovary (50) (14) (14) (50)
Cyst 5 (10%) 3 (21%) 5 (36%) 8 (16%)
Inflammation, Granulomatous, Multifocal 1 (2%)
Uterus (50) (23) (28) (50)
Dilatation 3 (6%) 2 (9%) 2 (7%) 9 (18%)
Hemorrhage 1 (4%)
Cervix, Abscess 5 (10%) 5 (22%) 12 (43%) 6 (12%)
Cervix, Abscess, Multiple 1 (4%)
Cervix, Cyst 5 (10%) 5 (22%) 13 (46%) 6 (12%)
Cervix, Cyst, Multiple 1 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Endometrium, Hyperplasia, Cystic 1 (2%) 3 (6%)
Mucosa, Cyst 3 (6%) 1 (4%) 6 (12%)
Wall, Cervix, Hypertrophy 1 (2%)
Vagina (7) (5) (1)
Wall, Hypertrophy 1 (14%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (10) (12) (50)
Hyperplasia 8 (16%) 1 (10%) 1 (8%) 9 (18%)
Infiltration Cellular, Histiocyte 2 (4%) 4 (8%)
Myelofibrosis 2 (4%) 2 (4%)
Pigmentation, Multifocal, Cholesterol 2 (4%) 4 (8%)
Lymph Node (50) (50) (50) (50)
Inguinal, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Congestion 2 (4%) 2 (4%) 7 (14%) 4 (8%)
Mediastinal, Ectasia 3 (6%) 4 (8%) 3 (6%)
Mesenteric, Ectasia 2 (4%) 3 (6%)
Mesenteric, Fibrosis, Focal 1 (2%)
Mesenteric, Hyperplasia, Macrophage,
Multifocal 49 (98%) 48 (96%) 48 (96%) 48 (96%)
Mesenteric, Necrosis, Focal 3 (6%) 1 (2%)
Mesenteric, Necrosis, Multifocal 1 (2%) 4 (8%)
Mesenteric, Pigmentation, Multifocal,
Cholesterol 49 (98%) 45 (90%) 47 (94%) 48 (96%)
Pancreatic, Ectasia 2 (4%) 2 (4%)
Pancreatic, Hyperplasia, Macrophage,
Multifocal 2 (4%)
Pancreatic, Pigmentation, Multifocal,
Cholesterol 2 (4%)
Lymph Node, Mandibular (50) (50) (50) (49)
Congestion 1 (2%) 1 (2%) 1 (2%)
Ectasia 21 (42%) 17 (34%) 18 (36%) 21 (43%)
Spleen (50) (50) (50) (50)
Atrophy 1 (2%) 1 (2%) 1 (2%)
Fibrosis, Focal 2 (4%) 3 (6%)
Hematopoietic Cell Proliferation 3 (6%) 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Thymus (49) (11) (12) (50)
Atrophy 1 (2%)
Cyst 3 (6%) 1 (9%) 3 (6%)
Inflammation, Subacute 1 (9%)
Artery, Mediastinum, Inflammation, Subacute 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49) (50)
Duct, Cyst 1 (2%)
Skin (50) (26) (33) (50)
Inflammation, Acute, Focal, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (15) (16) (50)
Fibrous Osteodystrophy 1 (2%)
Inflammation, Chronic 1 (7%)
Cranium, Osteopetrosis 5 (10%) 3 (19%) 7 (14%)
Femur, Osteopetrosis 4 (8%) 3 (20%) 3 (19%) 11 (22%)
Turbinate, Osteopetrosis 2 (4%) 2 (13%) 1 (6%) 9 (18%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (10) (13) (50)
Compression 4 (8%) 1 (10%) 1 (8%) 3 (6%)
Hemorrhage, Multifocal 1 (10%) 1 (2%)
Hydrocephalus 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 1 (2%)
Granuloma, Multiple 1 (2%)
Hemorrhage, Multifocal 1 (2%)
Infiltration Cellular, Diffuse, Histiocyte 1 (2%) 1 (2%)
Pigmentation, Hemosiderin, Multifocal 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 3 (6%)
Mediastinum, Inflammation, Chronic 1 (2%)
Pleura, Congestion, Multifocal 3 (6%)
Pleura, Fibrosis, Focal 1 (2%)
Nose (50) (10) (12) (50)
Foreign Body 2 (4%) 5 (10%)
Fungus 2 (4%) 4 (8%)
Inflammation, Acute, Suppurative 2 (4%) 6 (12%)
Nasolacrimal Duct, Foreign Body 1 (2%)
Nasolacrimal Duct, Inflammation, Subacute 19 (38%) 1 (8%) 21 (42%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (17) (12) (13) (10)
Cataract 17 (100%) 12 (100%) 13 (100%) 10 (100%)
Anterior Chamber, Hemorrhage 2 (17%) 1 (10%)
Posterior Chamber, Hemorrhage 1 (8%)
Retina, Degeneration 17 (100%) 11 (92%) 13 (100%) 10 (100%)
Harderian Gland (1)
Hyperplasia 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (49)
Fibrosis, Focal 1 (2%)
Hydronephrosis 1 (2%) 1 (2%)
Inflammation, Subacute 1 (2%) 1 (2%)
Metaplasia, Focal, Osseous 1 (2%)
Mineralization, Multifocal 1 (2%)
Nephropathy, Chronic 49 (98%) 49 (98%) 50 (100%) 48 (98%)
Artery, Inflammation, Subacute 1 (2%)
Cortex, Cyst 1 (2%)
Papilla, Necrosis 1 (2%)
Papilla, Transitional Epithelium, Hyperplasia 1 (2%) 5 (10%) 4 (8%) 12 (24%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) 2 (4%)
Renal Tubule, Pigmentation, Hemosiderin,
Multifocal 2 (4%)
Urinary Bladder (50) (10) (12) (50)
Calculus Micro Observation Only 1 (2%)
Hemorrhage, Multifocal 1 (2%)
Mucosa, Hyperplasia 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 9 9 9
Early Deaths
Moribund 17 7 16 26
Dead 5 4 7 5
Survivors
Terminal Sacrifice 28 40 28 20
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (9) (22) (50)
Inflammation, Subacute 1 (2%)
Intestine Large, Cecum (49) (10) (19) (50)
Parasite Metazoan 2 (4%) 1 (5%) 3 (6%)
Artery, Inflammation, Subacute 1 (5%)
Artery, Necrosis, Fibrinoid 1 (5%)
Intestine Large, Colon (50) (10) (22) (50)
Parasite Metazoan 2 (4%) 1 (5%) 6 (12%)
Lymphoid Tissue, Inflammation, Subacute 1 (2%)
Lymphoid Tissue, Mineralization 1 (2%)
Wall, Mineralization 1 (2%)
Intestine Large, Rectum (50) (10) (22) (49)
Parasite Metazoan 9 (18%) 4 (8%)
Wall, Mineralization 1 (2%)
Intestine Small, Ileum (50) (9) (19) (49)
Lymphoid Tissue, Inflammation, Subacute 1 (2%)
Lymphoid Tissue, Mineralization 1 (2%)
Intestine Small, Jejunum (50) (10) (20) (49)
Inflammation, Multifocal, Subacute 1 (2%)
Necrosis, Multifocal 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis, Focal 5 (10%) 10 (20%) 4 (8%)
Angiectasis, Multifocal 3 (6%) 20 (40%) 21 (42%) 29 (58%)
Basophilic Focus 18 (36%) 14 (28%) 12 (24%) 7 (14%)
Basophilic Focus, Multiple 3 (6%) 2 (4%) 1 (2%)
Clear Cell Focus 2 (4%) 3 (6%) 2 (4%) 2 (4%)
Congestion 1 (2%) 2 (4%)
Cyst 1 (2%) 1 (2%)
Degeneration, Cystic, Focal 7 (14%) 3 (6%) 5 (10%)
Degeneration, Cystic, Multifocal 2 (4%) 33 (66%) 35 (70%) 36 (72%)
Eosinophilic Focus 5 (10%) 16 (32%) 14 (28%) 4 (8%)
Eosinophilic Focus, Multiple 1 (2%) 21 (42%) 22 (44%) 37 (74%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fibrosis 1 (2%) 1 (2%)
Granuloma 1 (2%)
Granuloma, Multiple 20 (40%) 31 (62%) 27 (54%) 27 (54%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 2 (4%) 5 (10%) 5 (10%) 5 (10%)
Hepatodiaphragmatic Nodule, Multiple, Two 1 (2%)
Inflammation, Subacute 1 (2%) 1 (2%)
Mixed Cell Focus 2 (4%) 14 (28%) 15 (30%) 7 (14%)
Mixed Cell Focus, Multiple 10 (20%) 6 (12%) 8 (16%)
Necrosis, Focal 1 (2%) 1 (2%)
Necrosis, Multifocal 1 (2%) 4 (8%)
Pigmentation, Hemosiderin 1 (2%) 1 (2%) 1 (2%)
Pigmentation, Multifocal, Cholesterol 1 (2%) 1 (2%)
Regeneration 16 (32%) 1 (2%)
Thrombosis 1 (2%)
Vacuolization Cytoplasmic, Diffuse 1 (2%) 1 (2%)
Biliary Tract, Cyst 2 (4%)
Biliary Tract, Proliferation 49 (98%) 45 (90%) 49 (98%) 50 (100%)
Centrilobular, Necrosis 2 (4%) 2 (4%) 2 (4%)
Mesentery (11) (6) (6) (6)
Fat, Inflammation, Chronic, Multifocal 1 (9%)
Fat, Necrosis, Focal 5 (45%) 4 (67%) 3 (50%) 1 (17%)
Fat, Necrosis, Multifocal 2 (18%)
Pancreas (50) (50) (49) (50)
Basophilic Focus 1 (2%) 2 (4%) 6 (12%) 1 (2%)
Acinus, Atrophy, Focal 2 (4%)
Acinus, Atrophy, Multifocal 24 (48%) 32 (64%) 37 (76%) 41 (82%)
Acinus, Hyperplasia, Focal 1 (2%) 1 (2%) 3 (6%) 4 (8%)
Acinus, Hyperplasia, Multifocal 1 (2%) 1 (2%)
Artery, Hypertrophy 1 (2%)
Artery, Inflammation, Subacute 1 (2%) 1 (2%) 3 (6%)
Duct, Cyst 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Salivary Glands (50) (10) (22) (50)
Acinus, Atrophy, Multifocal 1 (2%)
Acinus, Hyperplasia, Multifocal 1 (5%)
Stomach, Forestomach (50) (10) (22) (49)
Edema 3 (14%) 2 (4%)
Erosion 1 (5%)
Hyperplasia 1 (10%) 2 (9%) 1 (2%)
Inflammation, Subacute 1 (10%) 5 (23%) 3 (6%)
Mineralization 1 (2%)
Perforation 1 (5%)
Ulcer 1 (10%) 1 (2%)
Ulcer, Multiple 1 (2%) 2 (9%)
Stomach, Glandular (50) (10) (22) (49)
Edema 2 (9%)
Inflammation, Subacute 2 (9%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mineralization 1 (2%) 5 (23%) 16 (33%)
Tongue (1)
Foreign Body, Multiple 1 (100%)
Granuloma, Multiple 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (5) (7)
Abdominal, Hypertrophy 2 (40%) 4 (57%)
Abdominal, Inflammation, Subacute 1 (20%) 1 (14%)
Abdominal, Mineralization 1 (20%) 4 (57%)
Abdominal, Thrombosis 1 (14%)
Aorta, Mineralization 1 (100%) 2 (40%) 4 (57%)
Heart (50) (11) (27) (50)
Cardiomyopathy 40 (80%) 6 (55%) 22 (81%) 45 (90%)
Fibrosis, Focal 1 (2%) 1 (4%) 1 (2%)
Inflammation, Multifocal, Subacute 1 (2%)
Mineralization, Multifocal 1 (2%) 2 (7%) 5 (10%)
Atrium, Thrombosis 1 (2%) 3 (27%) 5 (19%) 4 (8%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (50) (50)
Cyst 1 (2%)
Degeneration, Fatty, Focal 11 (22%) 12 (24%) 11 (22%) 15 (30%)
Degeneration, Fatty, Multifocal 2 (4%) 1 (2%) 4 (8%) 1 (2%)
Hyperplasia, Focal 8 (16%) 10 (20%) 14 (28%) 16 (32%)
Hyperplasia, Multifocal 2 (4%) 4 (8%)
Inflammation, Granulomatous, Multifocal 2 (4%) 1 (2%)
Necrosis, Multifocal 1 (2%)
Pigmentation, Multifocal, Cholesterol 2 (4%) 1 (2%)
Capsule, Accessory Adrenal Cortical Nodule 2 (4%) 5 (10%) 5 (10%)
Capsule, Hemorrhage 1 (2%)
Adrenal Gland, Medulla (50) (50) (50) (50)
Hyperplasia, Focal 22 (44%) 4 (8%) 9 (18%) 21 (42%)
Hyperplasia, Multifocal 4 (8%) 3 (6%) 5 (10%)
Thrombosis 1 (2%)
Islets, Pancreatic (50) (50) (49) (50)
Hyperplasia 1 (2%)
Parathyroid Gland (48) (12) (21) (49)
Hyperplasia 2 (4%) 2 (17%) 9 (43%) 34 (69%)
Pituitary Gland (50) (16) (25) (50)
Pars Distalis, Angiectasis 18 (36%) 9 (56%) 6 (24%) 7 (14%)
Pars Distalis, Cyst 5 (10%) 3 (19%) 5 (20%) 8 (16%)
Pars Distalis, Hemorrhage 1 (2%) 1 (6%) 2 (8%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia, Focal 5 (10%) 3 (19%) 2 (8%) 8 (16%)
Pars Distalis, Necrosis 2 (8%)
Pars Distalis, Pigmentation, Hemosiderin 2 (4%) 1 (6%) 2 (8%) 1 (2%)
Thyroid Gland (50) (11) (23) (50)
Inflammation, Acute, Suppurative 1 (2%)
Ultimobranchial Cyst 1 (4%) 1 (2%)
C-Cell, Hyperplasia, Focal 4 (8%) 1 (9%) 1 (4%) 5 (10%)
Follicle, Cyst 1 (2%) 1 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1)
Dilatation 1 (100%)
Inflammation 1 (100%)
Epididymis (50) (10) (23) (50)
Granuloma Sperm 1 (2%)
Inflammation, Subacute 1 (2%)
Preputial Gland (49) (13) (25) (50)
Foreign Body 1 (2%)
Hyperplasia 4 (8%) 2 (15%) 1 (2%)
Inflammation, Subacute 5 (10%) 3 (23%) 3 (12%) 4 (8%)
Duct, Cyst 5 (10%) 2 (15%) 2 (8%) 1 (2%)
Prostate (50) (10) (22) (50)
Inflammation, Subacute 31 (62%) 7 (70%) 15 (68%) 22 (44%)
Seminal Vesicle (50) (11) (22) (50)
Dilatation 2 (4%) 1 (9%)
Hyperplasia, Focal 1 (5%)
Inflammation, Subacute 1 (2%) 1 (9%) 1 (5%) 1 (2%)
Testes (50) (49) (48) (50)
Atrophy 10 (20%) 12 (24%) 8 (17%) 7 (14%)
Hemorrhage 1 (2%)
Mineralization 1 (2%) 1 (2%)
Interstitial Cell, Hyperplasia, Focal 3 (6%)
Interstitial Cell, Hyperplasia, Multifocal 5 (10%) 7 (14%) 4 (8%) 10 (20%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (1) (1)
Leukocytosis 1 (100%)
Bone Marrow (50) (10) (22) (49)
Hyperplasia 19 (38%) 3 (14%) 19 (39%)
Myelofibrosis 3 (6%) 1 (10%)
Lymph Node (50) (50) (50) (50)
Axillary, Congestion 1 (2%)
Axillary, Ectasia 1 (2%)
Inguinal, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Amyloid Deposition 1 (2%)
Mediastinal, Congestion 2 (4%) 3 (6%) 6 (12%) 9 (18%)
Mediastinal, Ectasia 4 (8%) 1 (2%) 5 (10%)
Mediastinal, Hyperplasia, Macrophage,
Multifocal 1 (2%)
Mediastinal, Pigmentation, Hemosiderin 1 (2%) 1 (2%)
Mesenteric, Congestion 2 (4%) 2 (4%)
Mesenteric, Ectasia 1 (2%) 6 (12%) 5 (10%) 3 (6%)
Mesenteric, Fibrosis, Focal 2 (4%)
Mesenteric, Giant Cell 1 (2%)
Mesenteric, Hyperplasia, Macrophage,
Multifocal 50 (100%) 47 (94%) 48 (96%) 49 (98%)
Mesenteric, Necrosis, Focal 2 (4%) 2 (4%)
Mesenteric, Necrosis, Multifocal 1 (2%)
Mesenteric, Pigmentation, Multifocal,
Cholesterol 50 (100%) 47 (94%) 48 (96%) 49 (98%)
Pancreatic, Amyloid Deposition 1 (2%)
Pancreatic, Ectasia 1 (2%) 1 (2%)
Pancreatic, Hyperplasia, Macrophage,
Multifocal 1 (2%) 3 (6%) 3 (6%) 5 (10%)
Pancreatic, Pigmentation, Multifocal,
Cholesterol 1 (2%) 4 (8%) 3 (6%) 5 (10%)
Renal, Congestion 1 (2%)
Renal, Hyperplasia, Macrophage, Multifocal 1 (2%) 1 (2%)
Renal, Pigmentation, Multifocal, Cholesterol 1 (2%) 1 (2%)
Lymph Node, Mandibular (48) (50) (50) (50)
Congestion 1 (2%) 1 (2%) 1 (2%)
Ectasia 16 (33%) 17 (34%) 16 (32%) 20 (40%)
Spleen (50) (50) (50) (49)
Fibrosis, Focal 6 (12%) 4 (8%) 8 (16%) 9 (18%)
Fibrosis, Multifocal 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Infiltration Cellular, Lipocyte 1 (2%) 1 (2%)
Necrosis, Focal 1 (2%) 1 (2%)
Capsule, Cyst 1 (2%)
Thymus (44) (10) (19) (49)
Cyst 3 (7%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (13) (24) (48)
Hyperplasia 5 (10%) 2 (15%) 2 (8%) 5 (10%)
Inflammation, Chronic 1 (2%)
Duct, Cyst 13 (26%) 5 (38%) 7 (29%) 11 (23%)
Duct, Inflammation, Subacute 1 (2%)
Skin (50) (31) (47) (50)
Hyperkeratosis, Focal 2 (6%)
Hyperkeratosis, Multifocal 1 (2%)
Hyperplasia, Focal 1 (2%) 2 (6%) 4 (9%) 2 (4%)
Hyperplasia, Multifocal 1 (2%)
Inflammation, Multifocal, Subacute 1 (2%)
Subcutaneous Tissue, Abscess, Focal 1 (2%)
Subcutaneous Tissue, Inflammation, Focal,
Subacute 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (10) (22) (50)
Fibrous Osteodystrophy 1 (2%) 8 (36%) 36 (72%)
Cranium, Hypertrophy, Focal 1 (5%)
Skeletal Muscle (1) (1)
Fibrosis, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (11) (22) (50)
Compression 3 (6%) 2 (9%) 2 (4%)
Hemorrhage, Multifocal 1 (2%) 3 (27%) 4 (18%)
Necrosis, Focal 1 (5%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 1 (2%)
Inflammation, Acute, Suppurative 1 (2%)
Necrosis 2 (4%)
Pigmentation, Hemosiderin, Multifocal 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 2 (4%) 2 (4%)
Alveolar Epithelium, Hyperplasia, Multifocal 1 (2%) 1 (2%) 1 (2%)
Bronchus, Fungus 1 (2%)
Bronchus, Inflammation, Acute, Suppurative 1 (2%)
Pleura, Congestion, Multifocal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Pleura, Fibrosis, Focal 1 (2%) 1 (2%)
Nose (50) (10) (22) (50)
Foreign Body 9 (18%) 1 (10%) 7 (32%) 7 (14%)
Fungus 12 (24%) 9 (41%) 12 (24%)
Hyperkeratosis 1 (5%)
Inflammation, Acute, Suppurative 13 (26%) 1 (10%) 10 (45%) 13 (26%)
Nasolacrimal Duct, Foreign Body 1 (5%)
Nasolacrimal Duct, Inflammation, Acute,
Suppurative 2 (9%)
Nasolacrimal Duct, Inflammation, Subacute 13 (26%) 1 (10%) 22 (44%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (15) (16) (15) (12)
Cataract 13 (87%) 16 (100%) 14 (93%) 10 (83%)
Anterior Chamber, Hemorrhage 3 (19%) 2 (13%)
Anterior Chamber, Inflammation, Acute,
Suppurative 1 (7%)
Conjunctiva, Inflammation, Acute, Suppurative 1 (7%)
Cornea, Fibrosis 2 (13%)
Cornea, Inflammation, Acute, Suppurative 1 (7%)
Cornea, Inflammation, Subacute 1 (6%) 1 (7%)
Lids, Fibrosis, Focal 2 (13%)
Posterior Chamber, Hemorrhage 1 (7%) 4 (25%) 1 (7%)
Retina, Degeneration 13 (87%) 16 (100%) 14 (93%) 12 (100%)
Zymbal's Gland (2) (3)
Inflammation, Acute, Suppurative 1 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (49)
Hydronephrosis 1 (2%) 2 (4%)
Metaplasia, Osseous 1 (2%)
Nephropathy, Chronic 50 (100%) 49 (98%) 50 (100%) 49 (100%)
Cortex, Cyst 1 (2%) 2 (4%) 6 (12%) 2 (4%)
Cortex, Cyst, Multiple 2 (4%) 4 (8%) 7 (14%) 15 (31%)
Papilla, Necrosis 1 (2%)
Papilla, Transitional Epithelium, Hyperplasia 7 (14%) 40 (80%) 43 (86%) 43 (88%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%)
Renal Tubule, Hyperplasia 2 (4%) 3 (6%) 2 (4%) 7 (14%)
Renal Tubule, Mineralization, Multifocal 1 (2%) 2 (4%) 4 (8%)
Urethra (2)
Bulbourethral Gland, Congestion 1 (50%)
Bulbourethral Gland, Dilatation 2 (100%)
Bulbourethral Gland, Inflammation, Subacute 1 (50%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05019-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CI PIGMENT RED 3 Date: 09/03/94
Route: DOSED FEED Time: 14:37:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.6% 1.25% 2.5%
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Urinary Bladder (50) (11) (22) (50)
Inflammation, Subacute 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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