TDMS Study 05021-03 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
CI PIGMENT RED 23
NTP Experiment-Test: 05021-03 Report: PEIRPT03
Study Type: CHRONIC Date: 09/03/94
Route: DOSED FEED Time: 21:10:48
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: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS 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 18 11 14 8
Dead 3 5 3 2
Survivors
Terminal Sacrifice 29 34 33 40
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (50)
Autolysis 2 (4%) 2 (4%)
Intestine Large, Colon (50) (1) (50)
Autolysis 1 (2%) 2 (4%)
Parasite Metazoan 6 (12%) 1 (2%)
Intestine Large, Rectum (50) (50)
Autolysis 2 (4%)
Parasite Metazoan 12 (24%) 8 (16%)
Intestine Small, Duodenum (50) (50)
Autolysis 1 (2%) 2 (4%)
Inflammation, Acute 1 (2%)
Intestine Small, Ileum (50) (15) (24) (50)
Autolysis 1 (2%) 2 (4%)
Hyperplasia, Lymphoid 10 (20%) 14 (93%) 24 (100%) 26 (52%)
Inflammation 1 (7%)
Pigmentation 1 (7%) 6 (25%) 10 (20%)
Intestine Small, Jejunum (50) (6) (4) (50)
Autolysis 2 (4%) 2 (4%)
Hyperplasia, Lymphoid 5 (83%) 3 (75%) 4 (8%)
Necrosis, Focal 1 (2%)
Pigmentation 1 (17%) 2 (50%) 2 (4%)
Liver (50) (50) (50) (50)
Basophilic Focus, Multiple 34 (68%) 35 (70%) 37 (74%) 43 (86%)
Bile Stasis 1 (2%)
Clear Cell Focus 2 (4%) 3 (6%) 1 (2%)
Congestion 2 (4%)
Ectasia 1 (2%)
Hematopoietic Cell Proliferation 3 (6%) 1 (2%)
Hepatodiaphragmatic Nodule 7 (14%) 8 (16%) 8 (16%) 9 (18%)
Hyperplasia 3 (6%) 4 (8%) 2 (4%)
Hypertrophy, Focal 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Acute 1 (2%) 1 (2%) 2 (4%)
Inflammation, Chronic 1 (2%) 2 (4%) 1 (2%)
Inflammation, Granulomatous 14 (28%) 13 (26%) 11 (22%) 16 (32%)
Leukocytosis 2 (4%) 1 (2%)
Necrosis 1 (2%) 2 (4%)
Vacuolization Cytoplasmic 8 (16%) 4 (8%) 6 (12%) 5 (10%)
Bile Duct, Hyperplasia 2 (4%) 6 (12%) 3 (6%)
Centrilobular, Necrosis 1 (2%)
Mesentery (4) (2) (7) (5)
Fat, Necrosis, Focal 3 (75%) 1 (50%) 5 (71%) 3 (60%)
Pancreas (50) (50) (50) (50)
Atrophy 2 (4%)
Atrophy, Focal 13 (26%) 8 (16%) 11 (22%) 19 (38%)
Autolysis 1 (2%) 2 (4%)
Ectopic Liver 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 2 (4%)
Duct, Ectasia 1 (2%)
Salivary Glands (50) (50)
Atrophy 1 (2%)
Duct, Inflammation, Chronic 1 (2%)
Stomach, Forestomach (50) (2) (50)
Hyperplasia 3 (6%) 1 (50%) 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 3 (6%) 1 (2%)
Mineralization 1 (2%) 2 (4%)
Ulcer 1 (2%) 1 (50%)
Stomach, Glandular (50) (1) (50)
Autolysis 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 16 (32%) 22 (44%)
Necrosis 1 (100%)
Tongue (1) (1)
Epithelium, Hyperplasia, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Mineralization 1 (100%)
Heart (50) (50)
Inflammation, Chronic 42 (84%) 46 (92%)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (1) (50)
Congestion 3 (6%)
Cyst 1 (2%)
Ectasia 3 (6%) 5 (10%)
Hyperplasia 13 (26%) 18 (36%)
Hypertrophy 10 (20%) 10 (20%)
Vacuolization Cytoplasmic 14 (28%) 7 (14%)
Adrenal Gland, Medulla (49) (1) (1) (50)
Angiectasis 1 (2%)
Hyperplasia 7 (14%) 3 (6%)
Islets, Pancreatic (50) (49) (49) (50)
Atrophy 1 (2%)
Atypia Cellular 2 (4%) 2 (4%)
Autolysis 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (50) (1) (50)
Hyperplasia 1 (100%)
Pituitary Gland (50) (50) (50) (50)
Pars Distalis, Angiectasis 1 (2%) 1 (2%)
Pars Distalis, Cyst 17 (34%) 15 (30%) 7 (14%) 22 (44%)
Pars Distalis, Ectasia 5 (10%) 8 (16%) 3 (6%) 5 (10%)
Pars Distalis, Hemorrhage 1 (2%)
Pars Distalis, Hyperplasia 9 (18%) 10 (20%) 11 (22%) 11 (22%)
Pars Distalis, Hypertrophy 3 (6%) 1 (2%) 1 (2%)
Pars Intermedia, Cyst 1 (2%)
Thyroid Gland (50) (50) (50) (50)
C-Cell, Hyperplasia 33 (66%) 26 (52%) 32 (64%) 24 (48%)
Follicle, Cyst 2 (4%)
Follicle, Dilatation 1 (2%)
Follicular Cell, Hyperplasia 2 (4%) 1 (2%)
Follicular Cell, Hyperplasia, Cystic 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (47) (48) (47) (49)
Atrophy 1 (2%)
Hyperplasia 5 (11%) 3 (6%) 1 (2%) 1 (2%)
Inflammation, Acute 5 (11%) 1 (2%) 5 (11%) 3 (6%)
Inflammation, Chronic 3 (6%) 3 (6%) 2 (4%) 7 (14%)
Duct, Cyst 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Duct, Dilatation 1 (2%)
Duct, Ectasia 1 (2%) 1 (2%)
Ovary (50) (4) (1) (50)
Follicle, Cyst 2 (4%) 1 (25%) 1 (2%)
Uterus (50) (50) (50) (50)
Cyst 2 (4%) 1 (2%)
Dilatation 4 (8%) 3 (6%) 2 (4%) 4 (8%)
Hemorrhage 1 (2%)
Inflammation, Acute 1 (2%)
Necrosis 1 (2%)
Cervix, Cyst 2 (4%)
Cervix, Inflammation, Acute 1 (2%)
Endometrium, Hyperplasia, Cystic 2 (4%)
Vagina (8) (1) (4)
Inflammation, Acute 1 (13%)
Inflammation, Chronic 1 (25%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (1)
Polychromasia 1 (100%)
Bone Marrow (50) (1) (1) (50)
Autolysis 1 (2%)
Hyperplasia 1 (2%)
Hypoplasia 2 (4%) 1 (100%)
Myelofibrosis 2 (4%)
Myeloid Cell, Hyperplasia 1 (2%) 3 (6%)
Lymph Node (50) (2) (2) (50)
Inguinal, Hyperplasia 1 (2%)
Mediastinal, Congestion 1 (2%)
Mesenteric, Congestion 1 (2%) 1 (2%)
Mesenteric, Pigmentation 9 (18%)
Pancreatic, Ectasia 1 (2%)
Pancreatic, Hyperplasia 1 (2%)
Lymph Node, Mandibular (50) (1) (50)
Congestion 4 (8%) 2 (4%)
Hemorrhage 1 (100%)
Hyperplasia 3 (6%)
Hyperplasia, Re Cell 1 (2%)
Spleen (50) (50) (49) (50)
Atrophy, Focal 1 (2%)
Congestion 1 (2%)
Ectasia 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 2 (4%) 1 (2%)
Hematopoietic Cell Proliferation Granulocytic 4 (8%) 3 (6%) 1 (2%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hematopoietic Cell Proliferation Erythrocytic 1 (2%) 3 (6%)
Hemorrhage, Focal 1 (2%)
Infarct 1 (2%)
Thymus (49) (48)
Cyst 3 (6%) 1 (2%)
Medulla, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (38) (32) (50)
Galactocele 1 (2%)
Hyperplasia 4 (8%) 4 (11%) 5 (16%) 4 (8%)
Inflammation, Acute 1 (3%)
Duct, Ectasia 30 (60%) 20 (53%) 22 (69%) 18 (36%)
Duct, Hyperplasia 1 (3%)
Skin (50) (8) (2) (49)
Acanthosis 2 (25%)
Hyperkeratosis 2 (25%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (5) (10) (50)
Osteopetrosis 3 (6%) 5 (100%) 10 (100%) 7 (14%)
Skeletal Muscle (1) (1)
Cyst 1 (100%)
Foreign Body 1 (100%)
Inflammation, Chronic 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (5) (3) (50)
Compression 13 (26%) 3 (60%) 3 (100%) 7 (14%)
Gliosis, Focal 1 (33%)
Meninges, Infiltration Cellular, Lymphocyte 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (4) (8) (50)
Congestion 3 (6%) 2 (25%)
Foreign Body 1 (2%)
Hemorrhage 2 (25%)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Acute 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolus, Infiltration Cellular, Histiocyte 4 (8%) 6 (12%)
Alveolus, Mineralization 1 (2%)
Epithelium, Alveolus, Hyperplasia 1 (2%) 1 (2%)
Nose (50) (50)
Foreign Body 1 (2%) 3 (6%)
Fungus 1 (2%) 2 (4%)
Mucosa, Inflammation, Chronic Active 4 (8%) 5 (10%)
Nasolacrimal Duct, Cyst 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 1 (2%)
Nasolacrimal Duct, Inflammation, Chronic 5 (10%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (1) (2)
Lens, Cataract 1 (100%) 2 (100%) 1 (100%) 1 (50%)
Retina, Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (45) (44) (50)
Autolysis 1 (2%) 2 (4%)
Congestion 3 (7%)
Hydronephrosis 2 (4%) 1 (2%)
Infarct 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 6 (12%) 7 (14%)
Nephropathy 48 (96%) 44 (98%) 43 (98%) 46 (92%)
Cortex, Cyst 1 (2%)
Renal Tubule, Hyperplasia 2 (4%) 2 (4%) 2 (4%)
Renal Tubule, Epithelium, Degeneration 1 (2%)
Ureter (1)
Inflammation, Chronic 1 (100%)
Urinary Bladder (50) (2) (50)
Hyperplasia 1 (50%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (50%)
Metaplasia, Squamous 1 (50%)
Mineralization 1 (50%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 9
Early Deaths
Moribund 24 14 11 11
Dead 4 6 3 5
Moribund Sacrifice 1
Survivors
Terminal Sacrifice 22 29 36 35
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (1) (50)
Autolysis 1 (2%) 1 (100%) 4 (8%)
Diverticulum 1 (2%)
Edema 1 (2%)
Inflammation, Acute 2 (4%)
Parasite Metazoan 1 (2%)
Intestine Large, Colon (50) (1) (50)
Autolysis 1 (2%) 3 (6%)
Hyperplasia, Lymphoid 2 (4%) 2 (4%)
Hyperplasia, Adenomatous 1 (2%)
Mineralization 1 (2%)
Parasite Metazoan 5 (10%) 9 (18%)
Intestine Large, Rectum (50) (1) (50)
Autolysis 1 (2%) 3 (6%)
Mineralization 1 (2%)
Parasite Metazoan 7 (14%) 8 (16%)
Intestine Small, Duodenum (50) (1) (50)
Autolysis 1 (2%) 3 (6%)
Intestine Small, Ileum (50) (7) (17) (50)
Autolysis 2 (4%) 1 (14%) 3 (6%)
Hyperplasia, Lymphoid 11 (22%) 6 (86%) 15 (88%) 15 (30%)
Inflammation 1 (6%)
Pigmentation 6 (35%) 4 (8%)
Intestine Small, Jejunum (50) (1) (5) (50)
Autolysis 2 (4%) 1 (100%) 4 (8%)
Hyperplasia, Lymphoid 5 (10%) 3 (60%) 3 (6%)
Intussusception 1 (20%)
Pigmentation 3 (6%)
Liver (50) (50) (50) (50)
Autolysis 2 (4%) 1 (2%)
Basophilic Focus, Multiple 10 (20%) 2 (4%) 10 (20%) 7 (14%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Clear Cell Focus 2 (4%) 1 (2%) 2 (4%) 5 (10%)
Congestion 1 (2%)
Cyst 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%)
Ectasia 2 (4%) 1 (2%)
Eosinophilic Focus 1 (2%) 1 (2%) 4 (8%)
Eosinophilic Focus, Multiple 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 6 (12%) 6 (12%) 10 (20%) 6 (12%)
Hyperplasia, Focal 3 (6%) 1 (2%) 1 (2%) 5 (10%)
Hypertrophy, Focal 1 (2%) 2 (4%) 4 (8%)
Hypertrophy, Multifocal 1 (2%)
Infarct 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Granulomatous 1 (2%) 1 (2%) 4 (8%)
Leukocytosis 1 (2%) 7 (14%)
Necrosis 1 (2%)
Thrombosis 2 (4%)
Vacuolization Cytoplasmic 5 (10%) 3 (6%) 1 (2%)
Bile Duct, Hyperplasia 10 (20%) 14 (28%) 22 (44%) 17 (34%)
Centrilobular, Necrosis 2 (4%) 1 (2%) 2 (4%)
Centrilobular, Vacuolization Cytoplasmic 2 (4%)
Hepatocyte, Degeneration, Cystic 3 (6%) 6 (12%) 9 (18%)
Mesentery (11) (5) (7) (11)
Autolysis 1 (9%)
Hemorrhage 1 (20%)
Inflammation, Acute 1 (9%)
Inflammation, Chronic 2 (40%) 1 (9%)
Necrosis, Focal 1 (20%) 3 (43%)
Artery, Inflammation, Chronic 1 (9%)
Fat, Necrosis 5 (45%) 1 (20%) 6 (55%)
Pancreas (50) (2) (49)
Atrophy, Diffuse 1 (2%)
Atrophy, Focal 23 (46%) 21 (43%)
Autolysis 2 (4%) 1 (2%)
Cytoplasmic Alteration 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic 1 (2%)
Artery, Hypertrophy 1 (50%)
Artery, Inflammation, Chronic 2 (4%) 3 (6%)
Duct, Cyst 1 (2%)
Salivary Glands (49) (1) (50)
Atrophy 2 (4%) 1 (2%)
Inflammation, Chronic 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Acinar Cell, Cytoplasmic Alteration 1 (2%)
Stomach, Forestomach (50) (1) (50)
Hyperkeratosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hyperplasia 1 (2%) 3 (6%)
Inflammation, Acute 2 (4%)
Mineralization 1 (2%)
Ulcer 1 (2%)
Stomach, Glandular (50) (1) (50)
Autolysis 1 (2%)
Mineralization 3 (6%) 5 (10%)
Ulcer 1 (2%)
Mucosa, Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Aorta, Mineralization 1 (100%)
Heart (50) (3) (5) (50)
Inflammation, Chronic 43 (86%) 1 (33%) 50 (100%)
Mineralization 2 (4%)
Atrium Left, Thrombosis 1 (2%) 2 (67%) 5 (100%) 10 (20%)
Valve, Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (48) (2) (50)
Accessory Adrenal Cortical Nodule 1 (2%)
Cyst 1 (2%)
Hyperplasia 12 (25%) 1 (50%) 18 (36%)
Hypertrophy 4 (8%) 1 (2%)
Vacuolization Cytoplasmic 7 (15%) 1 (50%) 8 (16%)
Adrenal Gland, Medulla (48) (6) (5) (50)
Hyperplasia 6 (13%) 15 (30%)
Thrombosis 1 (20%)
Bilateral, Hyperplasia 1 (2%) 2 (4%)
Islets, Pancreatic (50) (2) (49)
Autolysis 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (49) (1) (1) (49)
Hyperplasia 1 (2%) 1 (100%) 2 (4%)
Pituitary Gland (50) (16) (9) (49)
Pars Distalis, Cyst 7 (14%) 1 (11%) 5 (10%)
Pars Distalis, Ectasia 1 (6%)
Pars Distalis, Hemorrhage 1 (2%) 1 (6%) 1 (2%)
Pars Distalis, Hyperplasia 14 (28%) 2 (13%) 8 (16%)
Pars Distalis, Hypertrophy 9 (18%) 5 (10%)
Pars Distalis, Pigmentation 1 (11%)
Pars Intermedia, Hyperplasia 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Nervosa, Cyst 1 (2%)
Thyroid Gland (50) (50) (49) (50)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 17 (34%) 19 (38%) 19 (39%) 13 (26%)
Follicle, Cyst 2 (4%) 2 (4%)
Follicle, Dilatation 2 (4%) 1 (2%) 3 (6%) 4 (8%)
Follicular Cell, Hyperplasia 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia, Cystic 1 (2%) 5 (10%) 1 (2%)
Follicular Cell, Hypertrophy 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (4) (1)
Inflammation, Chronic Active 1 (25%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (2) (48)
Granuloma Sperm 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Preputial Gland (49) (9) (8) (49)
Cyst 1 (11%)
Hyperplasia 1 (2%)
Inflammation, Acute 9 (18%) 1 (11%) 3 (6%)
Inflammation, Chronic 14 (29%) 1 (11%) 14 (29%)
Inflammation, Chronic Active 1 (11%)
Prostate (50) (3) (2) (49)
Cyst 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Acute 8 (16%) 1 (33%) 2 (100%) 4 (8%)
Inflammation, Chronic 20 (40%) 1 (33%) 23 (47%)
Seminal Vesicle (50) (2) (49)
Dilatation 1 (2%) 1 (50%) 2 (4%)
Inflammation, Acute 1 (50%)
Epithelium, Degeneration 1 (2%)
Testes (50) (44) (44) (49)
Atrophy 1 (2%) 2 (5%)
Hemorrhage 1 (2%)
Bilateral, Interstitial Cell, Hyperplasia 2 (4%) 1 (2%)
Interstitial Cell, Hyperplasia 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (5)
Anemia 2 (40%)
Bone Marrow (50) (2) (50)
Autolysis 2 (4%) 1 (2%)
Hemorrhage 1 (2%)
Hypoplasia 3 (6%)
Myelofibrosis 1 (2%)
Myeloid Cell, Hyperplasia 1 (2%) 1 (50%) 2 (4%)
Lymph Node (49) (7) (9) (48)
Axillary, Hyperplasia, Re Cell 1 (2%)
Inguinal, Hyperplasia, Re Cell 1 (11%)
Mediastinal, Hemorrhage 1 (14%) 1 (11%) 1 (2%)
Mediastinal, Hyperplasia, Re Cell 1 (2%)
Mesenteric, Autolysis 1 (2%)
Mesenteric, Congestion 2 (4%)
Mesenteric, Ectasia 1 (11%)
Mesenteric, Hemorrhage 1 (2%) 1 (11%)
Mesenteric, Hyperplasia, Re Cell 1 (2%)
Mesenteric, Pigmentation 4 (44%) 10 (21%)
Mesenteric, Lymphocyte, Depletion Cellular 1 (2%)
Pancreatic, Congestion 1 (2%)
Pancreatic, Ectasia 2 (4%)
Pancreatic, Hyperplasia 1 (2%) 1 (2%)
Pancreatic, Hyperplasia, Re Cell 1 (14%)
Lymph Node, Mandibular (49) (2) (3) (48)
Congestion 1 (2%)
Ectasia 1 (2%) 1 (33%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia 1 (2%) 1 (33%) 4 (8%)
Hyperplasia, Re Cell 1 (2%)
Spleen (50) (50) (48) (50)
Atrophy 1 (2%)
Autolysis 1 (2%) 1 (2%)
Congestion 4 (8%) 1 (2%) 1 (2%)
Fibrosis 4 (8%) 3 (6%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation Granulocytic 1 (2%) 2 (4%) 3 (6%) 1 (2%)
Hematopoietic Cell Proliferation Erythrocytic 1 (2%)
Infarct 1 (2%)
Necrosis 1 (2%)
Pigmentation 1 (2%)
Thymus (49) (1) (46)
Angiectasis 1 (2%)
Congestion 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (46) (44) (43)
Cyst 1 (2%)
Galactocele 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 4 (8%) 7 (15%) 9 (20%) 6 (14%)
Inflammation, Chronic 1 (2%) 1 (2%)
Duct, Ectasia 3 (6%) 12 (26%) 7 (16%) 5 (12%)
Skin (50) (14) (13) (50)
Acanthosis 1 (7%) 1 (8%)
Congestion 1 (2%)
Cyst Epithelial Inclusion 1 (8%)
Hyperkeratosis 1 (8%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Face, Inflammation, Chronic 1 (2%)
Subcutaneous Tissue, Abscess 1 (2%)
Subcutaneous Tissue, Cyst 1 (7%)
Subcutaneous Tissue, Fibrosis 1 (7%)
Subcutaneous Tissue, Inflammation, Chronic 1 (2%) 1 (7%) 1 (8%)
Tail, Acanthosis 4 (29%)
Tail, Cyst Epithelial Inclusion 2 (4%)
Tail, Hyperkeratosis 4 (29%) 1 (8%) 1 (2%)
Tail, Inflammation, Acute 1 (7%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (1) (50)
Fibrous Osteodystrophy 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (3) (4) (50)
Compression 2 (4%) 1 (33%) 1 (25%) 5 (10%)
Hydrocephalus 1 (2%)
Inflammation, Acute, Multifocal 1 (2%)
Choroid Plexus, Infiltration Cellular,
Lymphocyte 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (6) (3) (50)
Autolysis 1 (2%)
Congestion 1 (2%) 1 (33%) 1 (2%)
Hemorrhage 1 (2%) 1 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Hyperplasia, Lymphoid 5 (10%)
Inflammation, Chronic 2 (4%) 2 (4%)
Inflammation, Granulomatous 1 (2%)
Mineralization 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 5 (10%) 1 (2%)
Perivascular, Infiltration Cellular,
Lymphocyte 1 (2%) 1 (2%)
Nose (50) (1) (1) (49)
Autolysis 1 (2%)
Foreign Body 5 (10%) 5 (10%)
Fungus 4 (8%) 2 (4%)
Hyperkeratosis 1 (100%)
Inflammation, Chronic 4 (8%) 4 (8%)
Inflammation, Chronic Active 1 (100%)
Metaplasia, Squamous 1 (100%)
Mucosa, Inflammation, Chronic Active 9 (18%) 9 (18%)
Mucosa, Glands, Exudate 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 1 (100%)
Nasolacrimal Duct, Inflammation, Chronic 5 (10%) 11 (22%)
Respiratory Epithelium, Hyperplasia 3 (6%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (2)
Bilateral, Lens, Cataract 1 (50%)
Bilateral, Retina, Degeneration 1 (50%)
Cornea, Inflammation, Chronic 1 (50%)
Lens, Cataract 1 (100%) 1 (100%)
Retina, Degeneration 1 (100%)
Retina, Inflammation, Chronic 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (48) (50) (50)
Autolysis 1 (2%) 1 (2%)
Congestion 1 (2%) 2 (4%) 1 (2%)
Inflammation, Acute, Multifocal 1 (2%)
Mineralization 1 (2%)
Nephropathy 49 (98%) 48 (100%) 49 (98%) 49 (98%)
Cortex, Cyst 2 (4%) 2 (4%)
Renal Tubule, Degeneration 1 (2%)
Renal Tubule, Hyperplasia 3 (6%) 6 (13%) 5 (10%) 8 (16%)
Renal Tubule, Hypertrophy, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05021-03 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: 21:10:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Epithelium, Hypertrophy, Focal 1 (2%)
Urinary Bladder (50) (1) (49)
Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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