TDMS Study 05169-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
C. I. DIRECT BLUE 15
NTP Experiment-Test: 05169-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
Facility: Hazleton Laboratories America, Inc.
Chemical CAS #: 2429-74-5
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: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 45 75 70
Scheduled Sacrifice 20 10 10 20
Early Deaths
Dead 4 4 12 15
Moribund 6 18 31 31
Survivors
Terminal Sacrifice 40 13 22 4
Animals Examined Microscopically 50 35 65 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (35) (65) (50)
Hyperkeratosis 1 (2%) 1 (2%)
Intestine Large, Cecum (50) (35) (65) (50)
Edema 1 (3%)
Inflammation, Acute 1 (2%) 1 (2%)
Necrosis, Focal 1 (2%)
Ulcer 1 (2%)
Intestine Large, Colon (50) (35) (65) (50)
Descending Colon, Necrosis, Focal 1 (2%)
Intestine Large, Rectum (50) (34) (65) (50)
Inflammation, Acute 1 (2%)
Necrosis, Focal 1 (2%)
Liver (50) (35) (65) (50)
Angiectasis, Focal 3 (6%) 1 (3%) 2 (3%)
Angiectasis, Multifocal 1 (2%) 2 (6%)
Basophilic Focus 34 (68%) 18 (51%) 33 (51%) 23 (46%)
Clear Cell Focus 7 (14%) 3 (9%) 1 (2%) 1 (2%)
Degeneration, Cystic, Focal 1 (3%) 1 (2%)
Eosinophilic Focus 2 (4%) 2 (6%) 3 (5%) 6 (12%)
Erythrophagocytosis 1 (2%)
Fatty Change 1 (2%)
Granuloma 11 (22%) 7 (20%) 5 (8%) 2 (4%)
Hematopoietic Cell Proliferation 5 (10%) 5 (14%) 14 (22%) 13 (26%)
Hepatodiaphragmatic Nodule 10 (20%) 1 (3%) 9 (14%) 2 (4%)
Mixed Cell Focus 1 (2%)
Necrosis, Coagulative 2 (3%)
Necrosis, Multifocal 3 (5%) 2 (4%)
Pigmentation 1 (2%)
Regeneration, Diffuse 1 (2%)
Regeneration, Focal 2 (3%) 3 (6%)
Regeneration, Multifocal 7 (11%) 4 (8%)
Vacuolization Cytoplasmic, Diffuse 2 (4%) 5 (14%) 6 (9%) 6 (12%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Vacuolization Cytoplasmic, Focal 2 (3%) 2 (4%)
Vacuolization Cytoplasmic, Multifocal 2 (4%) 1 (3%) 1 (2%) 1 (2%)
Bile Duct, Cyst 2 (3%)
Bile Duct, Hyperplasia 1 (3%)
Centrilobular, Degeneration, Diffuse 1 (3%) 3 (5%) 3 (6%)
Centrilobular, Necrosis 1 (2%) 1 (2%)
Centrilobular, Necrosis, Diffuse 1 (2%) 2 (4%)
Mesentery (4) (5) (7) (4)
Fat, Necrosis 3 (75%) 4 (80%) 6 (86%) 4 (100%)
Pancreas (49) (35) (65) (49)
Atrophy 9 (18%) 4 (11%) 6 (9%)
Pharynx (4) (21) (12)
Palate, Hyperkeratosis, Focal 1 (5%) 2 (17%)
Palate, Hyperplasia, Focal 2 (50%) 2 (10%)
Palate, Hyperplasia, Focal, Squamous 1 (5%)
Palate, Hyperplasia, Squamous 1 (5%)
Salivary Glands (50) (35) (65) (50)
Atrophy 2 (4%)
Stomach, Forestomach (50) (35) (65) (50)
Acanthosis 1 (2%) 1 (3%) 4 (6%) 3 (6%)
Inflammation, Chronic 1 (2%) 1 (2%)
Ulcer, Focal 1 (2%) 2 (3%) 1 (2%)
Stomach, Glandular (50) (35) (65) (50)
Erosion, Diffuse 1 (3%)
Erosion, Focal 1 (2%) 1 (2%)
Erosion, Multifocal 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization, Diffuse 1 (3%)
Ulcer, Focal 1 (2%)
Tongue (2) (3) (6) (9)
Hyperkeratosis, Focal 1 (11%)
Epithelium, Hyperplasia, Focal 1 (11%)
Tooth (1) (1)
Gingiva, Hyperplasia, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (35) (65) (50)
Cardiomyopathy, Chronic 23 (46%) 14 (40%) 29 (45%) 20 (40%)
Mineralization, Multifocal 1 (3%)
Atrium, Thrombosis 1 (3%) 3 (5%) 5 (10%)
Endocardium, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (35) (65) (50)
Angiectasis 2 (4%)
Congestion 1 (2%)
Hyperplasia, Focal 3 (6%) 1 (3%) 2 (3%)
Hyperplasia, Multifocal 2 (3%)
Hypertrophy, Focal 1 (3%) 1 (2%)
Necrosis, Multifocal 1 (2%)
Vacuolization Cytoplasmic, Diffuse 1 (2%) 2 (6%) 1 (2%) 2 (4%)
Vacuolization Cytoplasmic, Focal 2 (4%) 3 (9%) 1 (2%)
Vacuolization Cytoplasmic, Multifocal 1 (2%) 1 (2%)
Adrenal Gland, Medulla (50) (35) (65) (50)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Focal 1 (3%) 1 (2%)
Hyperplasia, Multifocal 1 (3%) 1 (2%)
Pituitary Gland (49) (35) (65) (49)
Hemorrhage 1 (2%) 1 (3%) 1 (2%)
Pars Distalis, Angiectasis, Focal 2 (4%) 4 (11%) 6 (9%) 4 (8%)
Pars Distalis, Cyst 10 (20%) 9 (26%) 15 (23%) 6 (12%)
Pars Distalis, Cyst, Multiple 1 (2%)
Pars Distalis, Hyperplasia, Focal 2 (4%) 2 (6%) 1 (2%)
Thyroid Gland (49) (35) (65) (50)
Cyst 1 (2%)
C-Cell, Hyperplasia, Focal 2 (4%) 5 (14%) 4 (6%) 2 (4%)
Follicular Cell, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (31) (64) (50)
Atrophy 1 (2%)
Ectasia 10 (20%) 4 (13%) 10 (16%) 12 (24%)
Hyperplasia, Focal 4 (8%) 2 (6%) 4 (6%) 3 (6%)
Hyperplasia, Focal, Squamous 1 (3%) 2 (3%) 1 (2%)
Hyperplasia, Multifocal, Squamous 1 (3%) 2 (3%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Ovary (50) (35) (64) (50)
Cyst 6 (12%) 5 (14%) 6 (9%) 3 (6%)
Uterus (50) (35) (65) (50)
Ectasia, Focal 1 (3%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hydrometra 1 (2%) 1 (2%)
Prolapse 1 (2%)
Cervix, Cyst 2 (4%)
Cervix, Fibrosis 3 (6%) 1 (3%) 2 (3%)
Endometrium, Cyst 3 (6%) 3 (9%) 6 (9%) 2 (4%)
Endometrium, Hyperplasia, Cystic 2 (6%) 2 (3%)
Vagina (2) (1) (1) (1)
Cyst 1 (50%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (35) (64) (49)
Hyperplasia 2 (6%) 2 (3%) 2 (4%)
Hypoplasia 3 (5%)
Myelofibrosis 2 (4%)
Necrosis, Multifocal 1 (3%)
Lymph Node (50) (35) (65) (50)
Axillary, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Congestion 2 (4%)
Mediastinal, Erythrophagocytosis 2 (4%)
Mediastinal, Hemorrhage 1 (3%) 1 (2%)
Mediastinal, Hyperplasia, Re Cell 1 (2%)
Lymph Node, Mandibular (50) (33) (65) (50)
Angiectasis 1 (2%)
Hyperplasia, Lymphoid 1 (3%) 1 (2%) 3 (6%)
Hyperplasia, Re Cell 1 (2%) 1 (3%)
Lymph Node, Mesenteric (50) (34) (65) (50)
Angiectasis 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Re Cell 11 (22%) 7 (21%) 5 (8%) 4 (8%)
Inflammation, Acute 1 (2%)
Spleen (50) (35) (65) (50)
Atrophy 2 (4%) 3 (9%) 1 (2%) 2 (4%)
Hematopoietic Cell Proliferation 5 (10%) 12 (34%) 20 (31%) 18 (36%)
Hyperplasia, Reticulum Cell 1 (3%) 3 (5%)
Necrosis, Multifocal 1 (2%)
Pigmentation 4 (8%) 1 (3%) 5 (8%) 4 (8%)
Thymus (47) (31) (63) (45)
Congestion 1 (2%)
Cyst 1 (2%)
Fibrosis 1 (3%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (34) (63) (44)
Ectasia 1 (2%)
Galactocele 2 (4%) 2 (3%) 2 (5%)
Hyperplasia, Diffuse 1 (2%)
Hyperplasia, Multifocal 1 (2%)
Duct, Ectasia 15 (31%) 6 (18%) 11 (17%) 2 (5%)
Skin (49) (34) (65) (50)
Hyperkeratosis, Focal 1 (2%)
Necrosis, Focal 1 (2%)
Epidermis, Hypoplasia, Focal 1 (2%)
Hair Follicle, Hyperplasia, Basal Cell,
Multifocal 1 (3%)
Subcutaneous Tissue, Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (13) (4) (12) (7)
Sternum, Osteopetrosis 13 (100%) 4 (100%) 10 (83%) 6 (86%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (35) (65) (50)
Compression 3 (6%) 2 (6%) 4 (6%) 2 (4%)
Hemorrhage 1 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (35) (65) (50)
Congestion 1 (2%) 1 (3%) 1 (2%) 2 (4%)
Foreign Body 1 (2%)
Hemorrhage 1 (3%)
Hyperplasia, Lymphoid 42 (84%) 22 (63%) 41 (63%) 35 (70%)
Infiltration Cellular, Histiocyte 6 (12%) 4 (11%) 11 (17%) 6 (12%)
Inflammation, Chronic 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 2 (3%) 1 (2%)
Nose (50) (35) (65) (50)
Foreign Body 1 (2%)
Fungus 2 (6%) 2 (3%) 2 (4%)
Inflammation, Acute 2 (4%) 2 (6%) 4 (6%) 1 (2%)
Metaplasia, Squamous 1 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (4) (1)
Cataract 2 (67%) 2 (50%)
Degeneration 1 (100%)
Cornea, Inflammation, Chronic Active 1 (25%)
Retina, Degeneration 3 (100%) 2 (50%)
Zymbal's Gland (49) (35) (64) (50)
Ectasia 1 (2%) 5 (14%) 13 (20%) 9 (18%)
Hyperplasia, Focal 1 (3%) 2 (4%)
Hyperplasia, Focal, Squamous 2 (6%) 4 (6%) 3 (6%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (35) (65) (50)
Hydronephrosis 1 (2%) 1 (2%) 1 (2%)
Infarct, Acute 1 (2%)
Infarct, Chronic 1 (3%)
Nephropathy, Chronic 45 (90%) 22 (63%) 48 (74%) 29 (58%)
Cortex, Cyst 1 (3%) 1 (2%)
Renal Tubule, Degeneration 1 (2%)
Renal Tubule, Dilatation 1 (2%)
Renal Tubule, Mineralization 1 (3%)
Renal Tubule, Pigmentation 3 (6%) 2 (6%) 4 (6%) 2 (4%)
Transitional Epithelium, Hyperplasia 1 (2%)
Urinary Bladder (50) (35) (65) (50)
Pigmentation, Hemosiderin 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 45 75 70
Scheduled Sacrifice 20 10 10 20
Early Deaths
Dead 5 12 24 12
Moribund 8 15 30 34
Accident 2
Survivors
Terminal Sacrifice 37 8 11 2
Animals Examined Microscopically 50 35 65 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (35) (61) (50)
Erosion 1 (2%)
Inflammation, Acute 1 (3%) 2 (3%)
Necrosis, Focal 1 (2%) 1 (3%) 1 (2%)
Intestine Large, Colon (50) (35) (62) (50)
Necrosis 1 (2%)
Parasite Metazoan 1 (2%)
Thrombosis 1 (2%)
Intestine Large, Rectum (50) (35) (61) (50)
Inflammation, Acute, Multifocal 1 (2%)
Intestine Small, Jejunum (49) (35) (60) (50)
Diverticulum 1 (2%)
Liver (50) (35) (65) (50)
Basophilic Focus 27 (54%) 9 (26%) 19 (29%) 21 (42%)
Clear Cell Focus 1 (2%) 2 (6%) 4 (6%) 3 (6%)
Congestion 1 (3%) 3 (5%)
Degeneration, Cystic, Focal 1 (2%) 3 (9%) 2 (3%) 5 (10%)
Degeneration, Cystic, Multifocal 2 (6%) 8 (12%) 2 (4%)
Eosinophilic Focus 2 (4%) 7 (20%) 15 (23%) 23 (46%)
Granuloma 1 (2%) 1 (3%) 1 (2%) 3 (6%)
Hematopoietic Cell Proliferation 4 (11%) 6 (9%) 13 (26%)
Hepatodiaphragmatic Nodule 7 (14%) 2 (4%)
Infarct, Acute 1 (3%) 1 (2%)
Infarct, Focal 1 (2%)
Infarct, Subacute 1 (2%)
Mixed Cell Focus 1 (2%) 1 (2%) 1 (2%)
Necrosis 1 (2%)
Necrosis, Coagulative 2 (4%) 2 (3%)
Necrosis, Focal 1 (2%) 3 (5%) 2 (4%)
Necrosis, Multifocal 1 (2%) 1 (2%)
Pigmentation 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Regeneration, Diffuse 1 (2%) 3 (6%)
Regeneration, Focal 2 (6%) 1 (2%) 1 (2%)
Regeneration, Multifocal 1 (2%) 3 (9%) 3 (5%) 11 (22%)
Thrombosis 2 (3%) 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Vacuolization Cytoplasmic, Diffuse 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%) 3 (5%) 1 (2%)
Vacuolization Cytoplasmic, Multifocal 1 (2%) 3 (5%) 6 (12%)
Bile Duct, Cyst 1 (2%)
Bile Duct, Hyperplasia 6 (12%) 2 (6%) 2 (3%)
Centrilobular, Degeneration, Diffuse 1 (2%) 1 (3%) 7 (11%) 4 (8%)
Centrilobular, Necrosis 1 (3%)
Centrilobular, Necrosis, Diffuse 1 (2%) 3 (9%) 4 (6%) 2 (4%)
Mesentery (8) (6) (11) (6)
Inflammation, Chronic, Diffuse 1 (13%)
Thrombosis 1 (9%)
Fat, Necrosis 6 (75%) 3 (50%) 7 (64%) 6 (100%)
Pancreas (49) (35) (65) (50)
Accessory Spleen 1 (2%)
Atrophy 7 (14%) 5 (14%) 4 (6%) 3 (6%)
Acinus, Hyperplasia, Focal 1 (2%) 1 (2%)
Pharynx (1) (9) (23) (20)
Palate, Hyperkeratosis, Diffuse 1 (4%)
Palate, Hyperkeratosis, Focal 3 (15%)
Palate, Hyperplasia, Focal 1 (4%)
Salivary Glands (50) (35) (65) (50)
Atrophy 1 (2%)
Edema 1 (2%)
Stomach, Forestomach (49) (35) (65) (50)
Acanthosis 1 (2%) 1 (2%) 1 (2%)
Erosion, Focal 1 (2%)
Erosion, Multifocal 1 (2%)
Hyperplasia, Focal 1 (2%)
Inflammation, Multifocal, Membranous 1 (2%)
Ulcer 1 (2%) 1 (2%)
Stomach, Glandular (49) (34) (65) (50)
Erosion, Focal 3 (5%) 1 (2%)
Erosion, Multifocal 3 (5%) 2 (4%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (35) (65) (50)
Cardiomyopathy, Chronic 35 (70%) 25 (71%) 49 (75%) 39 (78%)
Embolus 1 (2%)
Inflammation, Acute, Multifocal 1 (2%)
Atrium, Thrombosis 2 (4%) 3 (9%) 17 (26%) 12 (24%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Epicardium, Hemorrhage, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (35) (65) (50)
Hyperplasia, Focal 1 (2%) 1 (3%) 2 (3%)
Hypertrophy, Focal 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Diffuse 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%) 1 (2%)
Adrenal Gland, Medulla (50) (35) (65) (50)
Hyperplasia, Focal 2 (4%) 2 (6%) 1 (2%) 2 (4%)
Hyperplasia, Multifocal 2 (4%) 3 (9%) 1 (2%) 3 (6%)
Necrosis, Acute 1 (2%)
Parathyroid Gland (49) (35) (63) (49)
Hyperplasia 1 (2%) 1 (2%)
Pituitary Gland (49) (34) (63) (50)
Pars Distalis, Cyst 1 (2%) 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 1 (3%) 2 (3%)
Thyroid Gland (50) (35) (65) (50)
C-Cell, Hyperplasia, Focal 2 (4%) 2 (3%) 3 (6%)
Follicular Cell, Hyperplasia, Focal 1 (3%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (49) (35) (64) (48)
Atrophy 10 (20%) 6 (17%) 12 (19%) 10 (21%)
Ectasia 5 (10%) 4 (11%) 15 (23%) 14 (29%)
Granuloma 1 (2%)
Hyperplasia 1 (2%)
Hyperplasia, Focal 2 (4%) 2 (4%)
Hyperplasia, Focal, Squamous 3 (6%) 1 (3%) 2 (3%) 2 (4%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Prostate (50) (35) (64) (49)
Hemorrhage 1 (2%)
Hyperplasia, Focal, Glandular 7 (14%) 4 (11%) 6 (9%) 1 (2%)
Hyperplasia, Glandular, Multifocal 3 (6%) 3 (9%) 2 (3%)
Inflammation, Acute 1 (2%) 1 (3%)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Chronic Active 2 (4%) 1 (3%) 4 (6%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Seminal Vesicle (47) (32) (57) (42)
Dilatation 1 (2%)
Hyperplasia, Diffuse, Glandular 1 (3%) 2 (4%) 1 (2%)
Hyperplasia, Focal, Glandular 1 (3%)
Hyperplasia, Glandular, Multifocal 1 (3%)
Inflammation, Acute 1 (3%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%)
Testes (50) (35) (65) (50)
Atrophy 3 (6%) 2 (6%) 8 (12%) 4 (8%)
Interstitial Cell, Hyperplasia 2 (4%) 1 (3%) 9 (14%) 9 (18%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (35) (63) (50)
Hyperplasia 1 (2%) 14 (40%) 20 (32%) 16 (32%)
Hypoplasia 2 (3%)
Myelofibrosis 1 (2%) 2 (3%) 1 (2%)
Lymph Node (50) (35) (64) (50)
Mediastinal, Angiectasis 1 (3%)
Mediastinal, Congestion 2 (3%)
Mediastinal, Hemorrhage 1 (3%) 2 (3%) 2 (4%)
Mediastinal, Pigmentation 1 (3%) 2 (3%)
Pancreatic, Angiectasis 1 (3%)
Renal, Angiectasis 1 (3%)
Lymph Node, Mandibular (50) (35) (62) (50)
Angiectasis 1 (3%) 1 (2%)
Congestion 1 (2%)
Hemorrhage 1 (3%)
Hyperplasia, Lymphoid 1 (3%) 2 (3%) 2 (4%)
Hyperplasia, Re Cell 1 (2%)
Lymph Node, Mesenteric (50) (35) (64) (50)
Angiectasis 1 (2%) 1 (3%) 1 (2%)
Atrophy 1 (3%)
Hemorrhage 1 (2%) 2 (6%) 1 (2%)
Hyperplasia, Re Cell 10 (20%) 3 (9%) 7 (11%) 4 (8%)
Spleen (50) (35) (64) (50)
Atrophy 1 (2%) 3 (9%) 4 (6%) 3 (6%)
Congestion 1 (2%)
Fibrosis, Multifocal 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 3 (9%) 10 (16%) 17 (34%)
Hemorrhage 1 (2%)
Hyperplasia, Diffuse, Reticulum Cell 1 (3%)
Hyperplasia, Focal, Reticulum Cell 1 (2%) 1 (3%) 1 (2%)
Hyperplasia, Multifocal, Reticulum Cell 1 (2%)
Necrosis, Multifocal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Pigmentation 1 (2%)
Thymus (43) (34) (51) (43)
Atrophy 1 (3%) 1 (2%)
Congestion 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (34) (59) (42)
Duct, Ectasia 1 (2%)
Skin (50) (35) (65) (50)
Cyst Epithelial Inclusion 1 (3%) 4 (6%) 1 (2%)
Hemorrhage, Focal 1 (2%)
Hair Follicle, Hyperplasia, Basal Cell, Focal 1 (2%) 1 (3%) 3 (5%)
Hair Follicle, Hyperplasia, Basal Cell,
Multifocal 3 (6%)
Subcutaneous Tissue, Edema 1 (3%) 4 (6%) 1 (2%)
Subcutaneous Tissue, Fibrosis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (1) (1) (1)
Carpal, Osteopetrosis 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (35) (65) (50)
Compression 1 (3%)
Gliosis, Focal 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Acute, Multifocal 1 (2%)
Cerebellum, Necrosis, Focal 1 (3%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (35) (65) (50)
Congestion 4 (8%) 2 (6%) 3 (5%) 1 (2%)
Hemorrhage 1 (2%) 3 (6%)
Hyperplasia, Lymphoid 36 (72%) 18 (51%) 39 (60%) 26 (52%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (3%) 4 (6%) 8 (16%)
Inflammation, Acute 1 (3%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 5 (8%) 4 (8%)
Alveolar Epithelium, Hyperplasia, Multifocal 1 (2%)
Nose (50) (35) (65) (49)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Fungus 13 (26%) 9 (26%) 13 (20%) 4 (8%)
Hyperkeratosis 2 (4%) 4 (11%) 2 (3%) 1 (2%)
Hyperplasia, Glandular 1 (2%) 1 (2%)
Inflammation, Acute 15 (30%) 8 (23%) 18 (28%) 3 (6%)
Metaplasia, Squamous 1 (2%) 3 (9%) 1 (2%)
Necrosis, Diffuse 1 (2%)
Necrosis, Focal 1 (2%)
Necrosis, Multifocal 1 (3%)
Trachea (50) (35) (65) (50)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Necrosis 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (2)
Atrophy 1 (50%)
Cataract 1 (100%)
Synechia 1 (100%)
Retina, Degeneration 1 (100%)
Harderian Gland (1) (2)
Inflammation, Chronic 2 (100%)
Zymbal's Gland (50) (35) (64) (50)
Abscess 1 (2%)
Ectasia 2 (4%) 11 (31%) 8 (13%) 12 (24%)
Hyperplasia, Focal, Squamous 1 (3%) 5 (8%) 5 (10%)
Hyperplasia, Squamous 1 (2%)
Hypertrophy, Diffuse 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (35) (65) (50)
Hydronephrosis 1 (2%)
Inflammation, Acute, Multifocal 1 (2%)
Nephropathy, Chronic 44 (88%) 28 (80%) 56 (86%) 41 (82%)
Cortex, Cyst 1 (2%)
Pelvis, Inflammation, Acute 1 (2%)
Renal Tubule, Degeneration 2 (4%)
Renal Tubule, Hyperplasia, Focal 1 (3%) 1 (2%)
Renal Tubule, Pigmentation 1 (2%) 3 (9%) 1 (2%)
Urinary Bladder (50) (35) (65) (50)
Hemorrhage 2 (4%) 1 (3%) 1 (2%)
Inflammation, Acute 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05169-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 15 Date: 09/18/94
Route: DOSED WATER Time: 03:28:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.063 0.125 0.25
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Transitional Epithelium, Hyperplasia 1 (2%) 1 (3%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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