TDMS Study 05163-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
C. I. ACID RED 114
NTP Experiment-Test: 05163-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
Facility: Hazleton Laboratories America, Inc.
Chemical CAS #: 6459-94-5
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: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.015 0.03 0.06
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 45 75 70
Scheduled Sacrifice 20 10 10 20
Early Deaths
Dead 4 6 17 13
Moribund 10 16 41 37
Accident 1
Survivors
Terminal Sacrifice 36 13 6
Animals Examined Microscopically 50 35 65 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (35) (63) (49)
Edema 1 (3%)
Hemorrhage 1 (2%)
Inflammation, Acute 1 (3%)
Ulcer 2 (3%) 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Intestine Large, Colon (50) (35) (63) (48)
Hemorrhage 1 (2%)
Parasite Metazoan 3 (5%) 1 (2%)
Intestine Large, Rectum (50) (35) (64) (49)
Diverticulum 1 (2%)
Parasite Metazoan 1 (2%) 3 (9%) 5 (8%)
Intestine Small, Ileum (50) (35) (63) (50)
Parasite Metazoan 1 (2%) 1 (2%) 1 (2%)
Liver (50) (35) (64) (50)
Angiectasis 1 (2%) 3 (9%) 6 (9%) 3 (6%)
Basophilic Focus 38 (76%) 20 (57%) 38 (59%) 17 (34%)
Clear Cell Focus 1 (2%) 1 (2%)
Congestion 1 (2%)
Cyst 3 (5%)
Degeneration, Cystic 5 (14%) 25 (39%) 14 (28%)
Eosinophilic Focus 12 (34%) 38 (59%) 42 (84%)
Fatty Change, Diffuse 2 (3%)
Fatty Change, Focal 1 (2%) 4 (8%)
Fatty Change, Multifocal 1 (3%) 6 (9%) 3 (6%)
Fibrosis, Focal 1 (2%)
Hematocyst 1 (3%) 1 (2%)
Hematopoietic Cell Proliferation 7 (20%) 15 (23%) 9 (18%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 9 (18%) 3 (9%) 5 (8%) 9 (18%)
Hyperplasia, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.015 0.03 0.06
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Infiltration Cellular, Polymorphonuclear 1 (2%)
Inflammation, Granulomatous, Multifocal 22 (44%) 6 (17%) 2 (3%) 1 (2%)
Mixed Cell Focus 2 (4%) 9 (26%) 8 (13%) 15 (30%)
Necrosis, Coagulative, Multifocal 1 (2%) 1 (3%) 2 (3%) 4 (8%)
Necrosis, Focal 1 (2%)
Regeneration 2 (6%) 3 (5%) 1 (2%)
Bile Duct, Cyst 1 (2%)
Bile Duct, Hyperplasia 10 (20%) 7 (20%) 4 (6%)
Centrilobular, Fatty Change 3 (9%) 1 (2%) 1 (2%)
Centrilobular, Necrosis, Coagulative 1 (2%) 2 (6%) 6 (9%) 4 (8%)
Periportal, Fatty Change 1 (2%) 1 (2%)
Mesentery (4) (1) (4) (11)
Inflammation, Chronic 1 (100%)
Fat, Necrosis, Focal 4 (100%) 2 (50%)
Pancreas (50) (35) (62) (50)
Necrosis, Focal 1 (2%)
Acinus, Atrophy 10 (20%) 4 (11%) 6 (10%) 1 (2%)
Acinus, Hyperplasia, Focal 2 (3%)
Salivary Glands (48) (35) (64) (50)
Acinus, Atrophy 1 (3%) 1 (2%)
Adventitia, Inflammation, Chronic 1 (2%)
Stomach, Forestomach (50) (35) (64) (50)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Inflammation, Acute 2 (6%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Ulcer 1 (3%) 3 (5%) 2 (4%)
Stomach, Glandular (50) (35) (64) (50)
Degeneration, Cystic 1 (2%)
Edema 1 (2%)
Erosion 3 (5%) 4 (8%)
Mineralization 1 (2%) 1 (2%) 4 (8%)
Tooth (1) (1) (2)
Peridontal Tissue, Hyperplasia 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (35) (64) (49)
Cardiomyopathy 8 (16%) 5 (14%) 8 (13%) 2 (4%)
Mineralization 1 (2%) 1 (2%) 2 (4%)
Atrium, Dilatation 1 (3%)
Atrium, Thrombosis 1 (2%) 2 (6%) 6 (9%) 1 (2%)
Valve, Inflammation, Chronic Active 1 (3%)
Valve, Thrombosis 1 (3%) 2 (3%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.015 0.03 0.06
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (35) (64) (50)
Angiectasis 4 (8%) 5 (14%) 5 (8%) 8 (16%)
Atrophy 1 (3%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 2 (4%)
Hemorrhage 1 (2%)
Hyperplasia, Focal 1 (2%)
Necrosis, Focal 1 (3%) 1 (2%)
Necrosis, Multifocal 1 (2%) 1 (3%) 1 (2%)
Vacuolization Cytoplasmic, Diffuse 1 (2%) 1 (3%) 2 (3%)
Vacuolization Cytoplasmic, Focal 3 (6%) 4 (11%) 10 (16%) 6 (12%)
Vacuolization Cytoplasmic, Multifocal 1 (2%) 2 (6%) 3 (5%)
Bilateral, Necrosis, Focal 1 (2%)
Bilateral, Vacuolization Cytoplasmic, Focal 2 (3%)
Bilateral, Vacuolization Cytoplasmic,
Multifocal 1 (2%)
Adrenal Gland, Medulla (50) (35) (64) (50)
Hyperplasia, Focal 5 (10%) 5 (14%) 11 (17%) 2 (4%)
Hyperplasia, Multifocal 1 (2%) 2 (6%) 4 (6%)
Parathyroid Gland (48) (34) (62) (47)
Hyperplasia 5 (11%)
Pituitary Gland (50) (35) (64) (49)
Angiectasis 6 (12%) 2 (6%) 5 (8%)
Congestion 1 (2%)
Cyst 10 (20%) 8 (23%) 22 (34%) 7 (14%)
Hemorrhage 2 (4%)
Pigmentation, Hemosiderin 1 (2%)
Pars Distalis, Cyst 1 (2%)
Pars Distalis, Hyperplasia, Focal 3 (9%) 1 (2%) 1 (2%)
Thyroid Gland (50) (35) (64) (50)
Ultimobranchial Cyst 1 (2%) 2 (4%)
C-Cell, Hyperplasia, Focal 4 (8%) 3 (9%) 3 (5%) 1 (2%)
Follicle, Cyst 1 (3%) 2 (3%)
Follicular Cell, Hyperplasia, Focal 1 (2%) 1 (3%) 3 (5%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (2)
Mineralization 1 (50%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.015 0.03 0.06
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (32) (62) (50)
Hyperplasia, Focal, Glandular 4 (8%) 2 (6%) 8 (13%) 2 (4%)
Hyperplasia, Focal, Squamous 1 (2%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Duct, Ectasia 1 (2%) 3 (9%) 3 (5%) 8 (16%)
Ovary (50) (35) (64) (49)
Bilateral, Periovarian Tissue, Cyst 1 (2%)
Interstitium, Cyst 1 (3%)
Periovarian Tissue, Cyst 2 (4%) 1 (2%) 3 (6%)
Uterus (50) (35) (64) (49)
Decidual Reaction 1 (2%)
Hemorrhage 1 (3%)
Hydrometra 2 (4%) 1 (3%) 2 (3%) 2 (4%)
Cervix, Cyst 2 (4%) 1 (3%)
Cervix, Inflammation, Suppurative 1 (2%)
Endometrium, Cyst 1 (2%) 2 (6%) 5 (8%)
Endometrium, Hyperplasia 1 (3%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (35) (63) (50)
Atrophy 4 (8%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Multifocal, Re Cell 1 (2%)
Myelofibrosis 2 (6%) 1 (2%)
Lymph Node (50) (35) (64) (49)
Iliac, Hyperplasia, Plasma Cell 1 (2%)
Iliac, Sinus, Ectasia 1 (2%)
Inguinal, Hyperplasia, Plasma Cell 1 (2%)
Mediastinal, Hemorrhage 10 (20%) 7 (20%) 7 (11%) 8 (16%)
Mediastinal, Hyperplasia, Plasma Cell 1 (3%) 1 (2%)
Mediastinal, Hyperplasia, Re Cell 1 (2%)
Pancreatic, Hemorrhage 1 (2%)
Lymph Node, Mandibular (46) (35) (64) (48)
Congestion 1 (2%) 1 (2%)
Hemorrhage 2 (4%) 2 (6%) 2 (3%) 5 (10%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 9 (20%) 9 (26%) 23 (36%) 15 (31%)
Hyperplasia, Re Cell 2 (3%)
Adventitia, Inflammation, Chronic 1 (2%)
Sinus, Ectasia 6 (13%) 6 (17%) 3 (5%) 2 (4%)
Lymph Node, Mesenteric (50) (35) (64) (48)
Hemorrhage 1 (2%) 1 (3%) 4 (6%) 4 (8%)
Hyperplasia, Re Cell 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.015 0.03 0.06
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Infiltration Cellular, Mast Cell 1 (2%)
Spleen (50) (35) (63) (50)
Depletion Lymphoid 5 (10%)
Fibrosis 1 (3%) 2 (3%)
Hematopoietic Cell Proliferation 3 (6%) 8 (23%) 20 (32%) 16 (32%)
Hyperplasia, Focal, Re Cell 1 (3%)
Inflammation, Granulomatous 1 (2%)
Necrosis 1 (2%)
Pigmentation, Hemosiderin 1 (3%) 4 (6%) 4 (8%)
Capsule, Hemorrhage 1 (2%)
Red Pulp, Atrophy 2 (3%) 1 (2%)
Thymus (40) (30) (59) (42)
Ectopic Parathyroid Gland 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Epithelial Cell, Hyperplasia 25 (63%) 20 (67%) 29 (49%) 17 (40%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (35) (58) (45)
Galactocele 1 (3%) 2 (3%)
Hyperplasia, Nodular 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%)
Duct, Ectasia 6 (12%) 4 (11%) 3 (5%)
Skin (50) (35) (65) (49)
Acanthosis, Focal 1 (2%)
Inflammation, Suppurative 1 (2%)
Ulcer, Multifocal 1 (2%)
Hair Follicle, Hyperplasia, Basal Cell, Focal 1 (3%)
Subcutaneous Tissue, Inflammation, Acute 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (3) (7) (10)
Cartilage, Sternum, Degeneration 1 (10%)
Cranium, Fibrous Osteodystrophy 1 (14%) 8 (80%)
Sternum, Fibrous Osteodystrophy 1 (14%) 2 (20%)
Sternum, Osteopetrosis 3 (100%) 5 (71%) 1 (10%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.015 0.03 0.06
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (35) (64) (50)
Hemorrhage 1 (2%) 3 (9%) 6 (9%) 2 (4%)
Necrosis, Focal 1 (2%)
Brain Stem, Compression 12 (24%) 9 (26%) 1 (2%)
Meninges, Inflammation, Subacute 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (35) (65) (50)
Congestion 1 (2%) 2 (6%) 2 (3%) 2 (4%)
Edema 1 (3%) 1 (2%)
Hemorrhage 2 (6%) 4 (6%) 1 (2%)
Infiltration Cellular, Histiocyte 13 (26%) 22 (63%) 32 (49%) 27 (54%)
Mineralization 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 6 (12%) 5 (14%) 13 (20%) 12 (24%)
Alveolar Epithelium, Hyperplasia, Multifocal 1 (3%) 2 (3%) 8 (16%)
Bronchiole, Foreign Body 1 (2%)
Bronchiole, Inflammation, Acute 1 (2%) 2 (3%)
Interstitium, Inflammation 1 (2%) 1 (3%) 1 (2%)
Peribronchiolar, Inflammation, Chronic 1 (2%)
Peribronchiolar, Alveolus, Inflammation,
Acute 1 (2%) 2 (3%)
Nose (50) (35) (63) (49)
Fungus 2 (4%) 1 (2%)
Hemorrhage 1 (3%) 1 (2%) 2 (4%)
Inflammation, Suppurative 4 (8%) 2 (6%) 9 (14%) 3 (6%)
Trachea (50) (35) (64) (50)
Ectopic Tissue 1 (2%)
Inflammation, Suppurative 1 (2%)
Adventitia, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (2) (5) (3)
Cataract 3 (100%) 2 (100%) 3 (60%)
Inflammation, Chronic 1 (20%)
Necrosis 1 (33%)
Anterior Chamber, Inflammation, Suppurative 1 (20%) 1 (33%)
Retina, Degeneration 2 (67%) 3 (60%)
Zymbal's Gland (50) (35) (63) (49)
Abscess 1 (2%)
Ectasia 1 (2%) 2 (4%)
Hyperplasia, Focal, Glandular 1 (2%) 2 (3%)
Hyperplasia, Focal, Squamous 3 (5%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.015 0.03 0.06
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Hyperplasia, Multifocal, Squamous 1 (2%)
Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (35) (64) (50)
Cyst 2 (3%)
Fatty Change 1 (3%)
Fibrosis, Focal 1 (3%)
Hydronephrosis 2 (4%)
Inflammation, Suppurative 1 (2%)
Karyomegaly 11 (22%)
Nephropathy 48 (96%) 32 (91%) 60 (94%) 48 (96%)
Pigmentation 1 (3%) 1 (2%)
Interstitial Tissue, Fibrosis, Focal 1 (3%)
Interstitial Tissue, Inflammation 1 (3%) 1 (2%)
Renal Tubule, Hyperplasia, Focal 1 (2%)
Urinary Bladder (49) (35) (64) (49)
Ectasia 2 (3%)
Hemorrhage 2 (3%)
Hyperplasia, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.007 0.015 0.03
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 45 75 70
Scheduled Sacrifice 19 10 10 20
Early Deaths
Dead 13 11 16 16
Moribund 13 9 23 33
Survivors
Terminal Sacrifice 23 15 26 1
Dead 1
Surplus 1
Animals Examined Microscopically 50 35 65 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (35) (64) (49)
Edema 2 (4%)
Hemorrhage 1 (3%)
Intestine Large, Colon (50) (35) (64) (50)
Diverticulum 1 (2%)
Erosion 1 (2%)
Parasite Metazoan 3 (6%) 1 (3%) 6 (9%) 3 (6%)
Intestine Large, Rectum (50) (34) (64) (50)
Inflammation, Chronic Active 1 (3%)
Inflammation, Suppurative 1 (3%)
Parasite Metazoan 3 (6%) 3 (9%) 4 (6%) 3 (6%)
Ulcer 1 (2%)
Intestine Small, Ileum (50) (35) (64) (49)
Inflammation, Granulomatous 1 (2%)
Ulcer 1 (3%)
Liver (50) (35) (65) (50)
Angiectasis 3 (6%) 2 (6%) 2 (3%)
Basophilic Focus 16 (32%) 15 (43%) 23 (35%) 25 (50%)
Clear Cell Focus 2 (4%) 2 (3%) 2 (4%)
Cyst 1 (2%)
Cytoplasmic Alteration, Focal 1 (3%)
Degeneration, Cystic 6 (12%) 13 (37%) 33 (51%) 31 (62%)
Eosinophilic Focus 6 (12%) 5 (14%) 19 (29%) 26 (52%)
Fatty Change, Diffuse 1 (2%)
Fatty Change, Focal 1 (2%) 2 (3%)
Fatty Change, Multifocal 2 (3%) 5 (10%)
Hematocyst 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 2 (6%) 6 (9%) 14 (28%)
Hepatodiaphragmatic Nodule 3 (6%) 1 (3%) 8 (12%) 4 (8%)
Hepatodiaphragmatic Nodule, Multiple 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.007 0.015 0.03
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Infarct 1 (2%) 1 (3%) 4 (6%) 5 (10%)
Inflammation, Granulomatous, Multifocal 1 (2%) 1 (2%) 1 (2%)
Mixed Cell Focus 7 (14%) 9 (26%) 24 (37%) 14 (28%)
Necrosis, Coagulative, Focal 1 (2%)
Necrosis, Coagulative, Multifocal 1 (2%) 3 (6%)
Regeneration 2 (4%) 1 (3%) 3 (5%) 1 (2%)
Bile Duct, Cyst 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 33 (66%) 23 (66%) 31 (48%) 10 (20%)
Centrilobular, Fatty Change 3 (9%) 2 (3%) 2 (4%)
Centrilobular, Hemorrhage 1 (2%)
Centrilobular, Necrosis, Coagulative 3 (6%) 3 (9%) 8 (12%) 18 (36%)
Centrilobular, Necrosis, Coagulative, Focal 1 (2%)
Periportal, Fatty Change 1 (2%)
Portal Vein, Thrombosis 1 (2%)
Serosa, Fibrosis, Focal 2 (4%)
Serosa, Pigmentation, Focal 2 (4%)
Mesentery (11) (6) (1) (6)
Hemorrhage 1 (9%)
Artery, Inflammation, Chronic Active 1 (9%)
Fat, Necrosis, Focal 8 (73%) 3 (50%) 1 (100%) 5 (83%)
Pancreas (50) (35) (64) (49)
Metaplasia 1 (2%)
Acinus, Atrophy 13 (26%) 7 (20%) 18 (28%) 7 (14%)
Acinus, Hyperplasia, Focal 1 (2%) 1 (3%) 2 (4%)
Artery, Inflammation, Chronic Active 1 (2%)
Salivary Glands (49) (35) (64) (50)
Edema 1 (2%)
Stomach, Forestomach (50) (35) (65) (50)
Erosion 1 (2%)
Hyperplasia 2 (4%)
Inflammation, Acute 2 (3%)
Inflammation, Chronic Active 1 (2%)
Ulcer 4 (8%) 1 (3%) 2 (3%) 2 (4%)
Stomach, Glandular (50) (35) (65) (50)
Degeneration, Cystic 1 (2%)
Erosion 1 (2%) 3 (5%) 6 (12%)
Inflammation, Chronic 1 (2%) 1 (3%)
Inflammation, Focal, Suppurative 1 (2%)
Ulcer 2 (3%)
Artery, Inflammation, Chronic Active 1 (2%)
Tooth (1)
Dysplasia 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.007 0.015 0.03
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (35) (65) (50)
Cardiomyopathy 24 (48%) 17 (49%) 36 (55%) 24 (48%)
Inflammation, Suppurative 1 (2%)
Atrium, Dilatation 1 (2%) 2 (6%) 1 (2%) 1 (2%)
Atrium, Thrombosis 5 (10%) 4 (11%) 18 (28%) 18 (36%)
Ventricle Right, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (50) (35) (63) (50)
Bilateral, Hyperplasia, Focal 2 (4%)
Adrenal Gland, Cortex (50) (35) (63) (50)
Angiectasis 1 (2%) 2 (3%)
Atrophy 1 (2%)
Necrosis, Diffuse 1 (2%)
Vacuolization Cytoplasmic, Diffuse 1 (2%)
Vacuolization Cytoplasmic, Focal 2 (4%) 1 (3%) 8 (13%) 3 (6%)
Vacuolization Cytoplasmic, Multifocal 1 (2%) 2 (6%) 2 (4%)
Adrenal Gland, Medulla (50) (35) (63) (49)
Hyperplasia, Focal 11 (22%) 5 (14%) 20 (32%) 11 (22%)
Hyperplasia, Multifocal 1 (2%) 1 (3%) 6 (10%) 2 (4%)
Necrosis, Diffuse 1 (2%)
Bilateral, Hyperplasia, Focal 1 (3%) 1 (2%)
Bilateral, Hyperplasia, Multifocal 1 (2%)
Pituitary Gland (50) (35) (65) (47)
Angiectasis 2 (4%) 2 (6%) 3 (5%) 1 (2%)
Cyst 5 (10%) 3 (9%) 3 (5%) 1 (2%)
Ectopic Tissue 1 (2%)
Hemorrhage 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Pars Distalis, Hyperplasia, Focal 1 (2%) 1 (3%) 2 (3%) 3 (6%)
Thyroid Gland (50) (35) (65) (49)
Ultimobranchial Cyst 1 (3%) 2 (3%)
C-Cell, Hyperplasia, Focal 1 (2%) 1 (3%) 4 (6%)
Follicle, Cyst 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia, Focal 1 (3%) 2 (3%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (3) (3)
Inflammation, Chronic 1 (100%) 1 (33%)
Thrombosis, Chronic 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.007 0.015 0.03
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (35) (64) (50)
Granuloma Sperm 1 (2%)
Inflammation, Chronic Active 1 (2%)
Preputial Gland (44) (34) (60) (48)
Hyperplasia, Focal, Glandular 1 (2%) 1 (2%)
Hyperplasia, Focal, Squamous 1 (3%)
Inflammation, Chronic Active 1 (2%) 3 (5%) 5 (10%)
Inflammation, Suppurative 1 (2%) 1 (3%) 3 (5%) 1 (2%)
Duct, Ectasia 3 (7%) 2 (3%) 4 (8%)
Prostate (50) (34) (64) (50)
Atrophy 2 (4%) 4 (12%) 3 (5%)
Hyperplasia, Focal 2 (4%) 6 (18%) 10 (16%) 2 (4%)
Hyperplasia, Multifocal 3 (6%) 1 (3%) 3 (5%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (3%) 3 (5%) 8 (16%)
Inflammation, Suppurative 2 (4%) 3 (9%) 1 (2%)
Seminal Vesicle (49) (34) (65) (48)
Atrophy 30 (61%) 24 (71%) 51 (78%) 18 (38%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (3%)
Testes (50) (35) (64) (50)
Giant Cell 1 (2%) 1 (2%)
Granuloma Sperm 1 (2%)
Hypospermia 5 (10%) 8 (23%) 6 (9%) 3 (6%)
Mineralization 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Bilateral, Hypospermia 2 (4%)
Interstitial Cell, Hyperplasia 6 (12%) 3 (9%) 3 (5%) 8 (16%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (35) (64) (50)
Atrophy 4 (8%) 1 (3%) 1 (2%)
Hemorrhage 2 (4%)
Myelofibrosis 1 (3%) 1 (2%) 1 (2%)
Lymph Node (49) (35) (65) (50)
Mediastinal, Hemorrhage 7 (14%) 8 (23%) 5 (8%) 11 (22%)
Mediastinal, Pigmentation, Hemosiderin 1 (2%) 1 (3%) 1 (2%)
Mediastinal, Sinus, Ectasia 1 (2%)
Pancreatic, Hemorrhage 1 (2%) 1 (2%)
Lymph Node, Mandibular (49) (35) (65) (49)
Fibrosis 1 (2%)
Hemorrhage 4 (8%) 1 (3%) 2 (3%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 8 (16%) 8 (23%) 2 (3%) 9 (18%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.007 0.015 0.03
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Sinus, Ectasia 5 (10%) 7 (20%) 13 (20%) 6 (12%)
Lymph Node, Mesenteric (49) (35) (64) (50)
Fibrosis 1 (2%)
Hemorrhage 1 (2%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Re Cell 1 (2%)
Sinus, Ectasia 1 (2%) 1 (3%)
Spleen (50) (35) (64) (50)
Ectopic Tissue 1 (2%)
Edema 1 (3%)
Fibrosis 1 (2%) 3 (9%) 2 (3%) 3 (6%)
Hematopoietic Cell Proliferation 3 (6%) 4 (11%) 3 (5%) 21 (42%)
Hemorrhage 1 (2%)
Necrosis 1 (2%) 1 (3%) 1 (2%) 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Red Pulp, Atrophy 2 (3%)
Thymus (41) (22) (47) (40)
Congestion 1 (2%)
Hemorrhage 3 (7%) 2 (9%) 2 (5%)
Epithelial Cell, Hyperplasia 20 (49%) 8 (36%) 19 (40%) 14 (35%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (46) (31) (61) (37)
Galactocele 1 (3%) 1 (3%)
Hyperplasia, Nodular 1 (2%) 1 (2%)
Skin (50) (35) (65) (50)
Cyst Epithelial Inclusion 1 (2%) 1 (3%) 1 (2%)
Hyperkeratosis, Focal 1 (2%) 1 (2%)
Ulcer 1 (2%) 1 (3%)
Epidermis, Hyperplasia, Basal Cell, Focal 1 (3%)
Hair Follicle, Hyperplasia, Basal Cell, Focal 1 (2%)
Sebaceous Gland, Hyperplasia, Focal 3 (5%) 1 (2%)
Subcutaneous Tissue, Edema 1 (2%) 2 (4%)
Subcutaneous Tissue, Inflammation, Acute 2 (3%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (2)
Sternum, Osteopetrosis 1 (50%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.007 0.015 0.03
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (35) (64) (50)
Hemorrhage 5 (10%) 2 (6%) 7 (11%) 2 (4%)
Inflammation, Suppurative 1 (2%)
Brain Stem, Compression 3 (6%) 2 (6%) 3 (5%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (35) (65) (50)
Congestion 3 (6%) 1 (2%) 2 (4%)
Granuloma, Multifocal 1 (3%)
Hemorrhage 1 (2%) 1 (2%) 3 (6%)
Infiltration Cellular, Histiocyte 9 (18%) 11 (31%) 18 (28%) 9 (18%)
Pigmentation, Focal 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 4 (11%) 5 (8%) 6 (12%)
Alveolar Epithelium, Hyperplasia, Multifocal 4 (6%) 2 (4%)
Bronchiole, Inflammation, Acute 1 (2%) 2 (4%)
Capillary, Thrombosis 1 (2%) 2 (4%)
Interstitium, Inflammation 4 (8%) 1 (3%) 4 (6%) 7 (14%)
Nose (50) (35) (65) (50)
Foreign Body 1 (2%)
Fungus 2 (4%) 7 (20%) 8 (12%) 5 (10%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%) 1 (2%)
Hyperplasia, Multifocal 1 (2%)
Inflammation, Suppurative 10 (20%) 11 (31%) 15 (23%) 14 (28%)
Ulcer 1 (2%)
Trachea (50) (35) (65) (50)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (1)
Cataract 2 (100%) 1 (100%)
Necrosis 1 (100%)
Retina, Degeneration 2 (100%)
Zymbal's Gland (50) (35) (64) (50)
Ectasia 2 (4%)
Hyperplasia, Focal, Squamous 1 (2%)
Inflammation, Suppurative 2 (3%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05163-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. ACID RED 114 Date: 09/17/94
Route: DOSED WATER Time: 21:51:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.007 0.015 0.03
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (35) (65) (50)
Cyst 1 (3%) 1 (2%) 1 (2%)
Hydronephrosis 1 (2%)
Infarct 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Nephropathy 47 (94%) 34 (97%) 65 (100%) 46 (92%)
Pigmentation 3 (6%) 2 (6%) 2 (3%)
Interstitial Tissue, Fibrosis, Focal 1 (3%)
Urinary Bladder (50) (34) (64) (50)
Ectasia 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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