TDMS Study 05130-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
C. I. DIRECT BLUE 218
NTP Experiment-Test: 05130-02 Report: PEIRPT03
Study Type: CHRONIC Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
Facility: Microbiological Associates
Chemical CAS #: 10401-500
Lock Date: 10/29/91
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: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 5 8 1 3
Natural Death 4 2 2 5
Moribund 3 2
Accidently Killed 1
Survivors
Terminal Sacrifice 37 40 46 38
Missing 1 1 1
Animals Examined Microscopically 49 50 49 49
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (47) (45) (46) (42)
Dilatation 1 (2%) 1 (2%)
Intestine Large, Cecum (47) (50) (48) (45)
Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Duodenum (46) (50) (48) (46)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Intussusception 1 (2%)
Liver (49) (50) (49) (49)
Angiectasis, Focal 4 (8%) 3 (6%)
Basophilic Focus 4 (8%) 2 (4%) 6 (12%) 7 (14%)
Clear Cell Focus 2 (4%) 2 (4%) 1 (2%) 12 (24%)
Cyst 1 (2%)
Eosinophilic Focus 11 (22%) 7 (14%) 11 (22%) 21 (43%)
Fatty Change, Focal 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Infiltration Cellular, Focal, Lymphocyte 2 (4%) 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Mixed Cell Focus 1 (2%) 1 (2%)
Necrosis, Focal 2 (4%) 1 (2%) 2 (4%)
Centrilobular, Cytomegaly 1 (2%)
Mesentery (6) (5) (3) (5)
Fat, Necrosis, Focal 6 (100%) 2 (40%) 3 (100%) 3 (60%)
Pancreas (49) (50) (48) (49)
Accessory Spleen 1 (2%) 1 (2%)
Fibrosis, Focal 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Inflammation, Chronic Active, Focal 2 (4%) 1 (2%)
Acinar Cell, Atrophy 2 (4%)
Acinar Cell, Hypertrophy, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Duct, Dilatation 2 (4%) 2 (4%)
Salivary Glands (49) (50) (49) (48)
Arteriole, Inflammation, Chronic, Multifocal 1 (2%)
Stomach, Forestomach (49) (50) (48) (49)
Hyperplasia, Focal 1 (2%) 2 (4%)
Ulcer, Focal 2 (4%) 2 (4%) 1 (2%)
Stomach, Glandular (49) (50) (48) (49)
Inflammation, Acute, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (49) (50) (49) (49)
Cardiomyopathy 1 (2%)
Arteriole, Inflammation, Chronic, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (49) (48) (48)
Cyst 1 (2%) 3 (6%)
Cytoplasmic Alteration, Focal 1 (2%) 4 (8%) 1 (2%)
Degeneration, Focal 1 (2%) 1 (2%)
Hemorrhage, Focal 7 (15%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Hypertrophy, Focal 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Adrenal Medulla (49) (49) (48) (47)
Congestion 1 (2%)
Degeneration, Focal 1 (2%)
Hyperplasia, Focal 1 (2%) 1 (2%)
Islets, Pancreatic (49) (50) (48) (49)
Hyperplasia, Focal 1 (2%) 2 (4%)
Parathyroid Gland (33) (34) (40) (40)
Infiltration Cellular, Focal, Lymphocyte 1 (3%)
Pituitary Gland (48) (50) (49) (45)
Pars Distalis, Angiectasis, Focal 2 (4%)
Pars Distalis, Cyst 1 (2%) 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 6 (13%) 11 (22%) 7 (14%) 3 (7%)
Thyroid Gland (49) (50) (49) (49)
Infiltration Cellular, Focal, Lymphocyte 2 (4%)
Inflammation, Chronic Active, Focal 1 (2%)
Arteriole, Inflammation, Chronic, Focal 1 (2%)
C-Cell, Hyperplasia, Focal 1 (2%) 1 (2%)
Follicle, Dilatation, Focal 2 (4%) 1 (2%)
Follicular Cell, Hyperplasia, Focal 11 (22%) 9 (18%) 7 (14%) 6 (12%)
Follicular Cell, Hypertrophy, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (1) (1)
Inflammation, Chronic Active 1 (100%) 1 (100%)
Duct, Dilatation 1 (100%)
Ovary (47) (50) (48) (49)
Abscess 2 (4%)
Angiectasis 1 (2%) 3 (6%)
Cyst 12 (26%) 17 (34%) 15 (31%) 28 (57%)
Ectopic Tissue 1 (2%)
Hematocyst 1 (2%) 3 (6%) 2 (4%)
Hemorrhage, Focal 1 (2%)
Hyperplasia, Tubular 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%) 1 (2%)
Inflammation, Chronic, Focal 2 (4%)
Mineralization, Focal 1 (2%) 1 (2%)
Pigmentation, Focal 1 (2%)
Bilateral, Abscess 1 (2%)
Follicle, Hyperplasia, Cystic, Focal 1 (2%)
Uterus (49) (50) (49) (49)
Dilatation 13 (27%) 12 (24%) 15 (31%) 9 (18%)
Ectopic Tissue, Focal 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 2 (4%)
Thrombosis, Focal 1 (2%)
Endometrium, Hyperplasia, Cystic 31 (63%) 42 (84%) 38 (78%) 31 (63%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (50) (49) (49)
Angiectasis, Focal 1 (2%)
Congestion 1 (2%)
Hyperplasia 5 (10%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node (9) (10) (8) (7)
Iliac, Hyperplasia, Lymphoid 1 (11%)
Iliac, Hyperplasia, Plasma Cell 1 (11%) 1 (14%)
Lumbar, Hyperplasia, Lymphoid 3 (33%) 1 (10%) 1 (13%)
Lumbar, Hyperplasia, Plasma Cell 1 (11%)
Mediastinal, Hyperplasia, Lymphoid 1 (11%) 1 (14%)
Mediastinal, Hyperplasia, Plasma Cell 1 (11%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Renal, Hyperplasia, Lymphoid 2 (22%)
Renal, Hyperplasia, Plasma Cell 2 (22%) 1 (14%)
Lymph Node, Mandibular (49) (48) (48) (47)
Congestion 1 (2%)
Cyst 2 (4%) 3 (6%) 2 (4%) 3 (6%)
Edema 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 3 (6%) 7 (15%) 4 (8%) 2 (4%)
Hyperplasia, Plasma Cell 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Infiltration Cellular, Mast Cell 1 (2%)
Inflammation, Acute 1 (2%)
Lymph Node, Mesenteric (46) (48) (47) (46)
Angiectasis, Focal 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 5 (11%) 2 (4%) 1 (2%) 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Necrosis 1 (2%) 1 (2%)
Spleen (48) (50) (49) (49)
Amyloid Deposition, Focal 1 (2%)
Depletion Lymphoid 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 10 (21%) 9 (18%) 3 (6%) 6 (12%)
Hyperplasia, Lymphoid 6 (13%) 5 (10%) 10 (20%) 5 (10%)
Thymus (46) (48) (48) (46)
Atrophy 1 (2%)
Cyst 1 (2%) 2 (4%) 1 (2%)
Depletion Lymphoid 1 (2%) 1 (2%)
Hemorrhage, Focal 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 3 (6%) 2 (4%)
Necrosis 1 (2%) 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (49) (50) (49) (49)
Acanthosis, Focal 1 (2%)
Inflammation, Acute, Focal 1 (2%) 1 (2%)
Inflammation, Chronic Active, Focal 1 (2%) 4 (8%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (49) (50) (49) (49)
Fibrous Osteodystrophy 1 (2%)
Intervertebral Disc, Dysplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (50) (49) (49)
Hemorrhage, Focal 1 (2%)
Hydrocephalus 1 (2%)
Mineralization, Focal 29 (59%) 45 (90%) 34 (69%) 38 (78%)
Necrosis, Focal 1 (2%)
Artery, Inflammation, Chronic, Focal 1 (2%)
Spinal Cord (1)
Infiltration Cellular, Focal, Histiocyte 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (50) (49) (49)
Congestion 1 (2%) 1 (2%) 1 (2%)
Hemorrhage, Focal 1 (2%) 1 (2%) 1 (2%)
Hemorrhage, Multifocal 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Infiltration Cellular, Focal, Histiocyte 2 (4%)
Alveolar Epithelium, Hyperplasia, Focal 2 (4%)
Arteriole, Hypertrophy, Focal 1 (2%)
Interstitium, Inflammation, Focal 1 (2%) 3 (6%)
Nose (49) (50) (49) (49)
Congestion 1 (2%)
Inflammation, Acute, Focal 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (2) (1)
Arteriole, Inflammation, Chronic, Focal 1 (50%)
Pinna, Inflammation, Chronic Active, Focal 1 (100%)
Eye (2) (1) (1)
Cornea, Inflammation, Chronic 2 (100%)
Lens, Cataract 1 (100%) 1 (100%)
Zymbal's Gland (38) (38) (37) (32)
Inflammation, Acute, Focal 1 (3%) 1 (3%)
Inflammation, Chronic Active 1 (3%)
Duct, Dilatation 1 (3%) 1 (3%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (50) (49) (49)
Infarct, Chronic, Focal 1 (2%) 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Metaplasia, Focal, Osseous 2 (4%) 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Nephropathy 4 (8%) 3 (6%) 5 (10%) 3 (6%)
Artery, Inflammation, Chronic, Focal 1 (2%)
Glomerulus, Inflammation, Chronic 1 (2%) 1 (2%)
Renal Tubule, Dilatation, Focal 2 (4%)
Urinary Bladder (48) (50) (48) (49)
Dilatation 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active, Focal 2 (4%)
Arteriole, Inflammation, Chronic, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 9 10 10 10
Early Deaths
Accidently Killed 1
Natural Death 3 2 5 4
Moribund Sacrifice 2 2 3 1
Survivors
Terminal Sacrifice 44 46 42 45
Missing 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (45) (47) (46) (47)
Hyperplasia 1 (2%)
Inflammation, Acute 2 (4%)
Intestine Large, Colon (48) (50) (50) (49)
Diverticulum 1 (2%)
Intestine Large, Cecum (48) (49) (48) (48)
Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Duodenum (48) (48) (47) (49)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Acute, Focal 1 (2%)
Intestine Small, Jejunum (49) (49) (49) (49)
Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis, Focal 1 (2%) 1 (2%)
Basophilic Focus 7 (14%) 5 (10%) 4 (8%) 9 (18%)
Clear Cell Focus 8 (16%) 5 (10%) 5 (10%) 4 (8%)
Cytomegaly, Focal 1 (2%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 13 (26%) 12 (24%) 10 (20%) 28 (56%)
Fatty Change, Focal 1 (2%) 3 (6%) 4 (8%)
Hematopoietic Cell Proliferation 1 (2%)
Infarct, Chronic 1 (2%)
Inflammation, Chronic, Focal 1 (2%) 1 (2%)
Leukocytosis 1 (2%) 1 (2%)
Mixed Cell Focus 3 (6%) 5 (10%) 2 (4%) 1 (2%)
Necrosis, Focal 4 (8%) 3 (6%)
Mesentery (3) (1)
Fat, Necrosis, Focal 3 (100%)
Pancreas (49) (50) (50) (50)
Cyst 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Acinar Cell, Atrophy 1 (2%) 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Hyperplasia, Focal 1 (2%) 3 (6%) 1 (2%)
Inflammation, Chronic Active, Focal 1 (2%)
Ulcer, Focal 1 (2%) 1 (2%) 1 (2%)
Stomach, Glandular (50) (50) (50) (50)
Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 1 (2%)
Inflammation, Acute, Focal 1 (2%)
Inflammation, Chronic Active, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%)
Atrophy 1 (2%)
Hemorrhage, Focal 1 (2%)
Hyperplasia, Focal 1 (2%) 2 (4%) 2 (4%) 3 (6%)
Hypertrophy, Focal 1 (2%) 1 (2%) 3 (6%) 4 (8%)
Adrenal Medulla (50) (50) (50) (50)
Hyperplasia, Focal 1 (2%) 1 (2%)
Islets, Pancreatic (49) (50) (50) (50)
Hyperplasia, Focal 1 (2%) 1 (2%)
Parathyroid Gland (41) (43) (42) (43)
Cyst 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Pituitary Gland (49) (48) (48) (48)
Pars Distalis, Cyst 1 (2%) 2 (4%)
Pars Distalis, Hyperplasia, Focal 2 (4%)
Pars Nervosa, Cyst 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Follicle, Dilatation, Focal 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia, Focal 3 (6%) 1 (2%) 5 (10%)
Follicular Cell, Hypertrophy, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Granuloma Sperm 2 (4%) 2 (4%)
Inflammation, Chronic, Focal 1 (2%) 2 (4%)
Preputial Gland (29) (23) (23) (21)
Inflammation, Chronic Active 2 (7%) 2 (9%) 1 (5%)
Duct, Dilatation 27 (93%) 23 (100%) 22 (96%) 21 (100%)
Prostate (50) (49) (50) (50)
Dilatation 1 (2%)
Hyperplasia, Focal 2 (4%) 4 (8%) 6 (12%) 2 (4%)
Seminal Vesicle (50) (50) (50) (50)
Dilatation 2 (4%) 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Testes (50) (50) (50) (50)
Angiectasis, Focal 1 (2%)
Atrophy 1 (2%)
Atrophy, Focal 1 (2%)
Degeneration, Focal 1 (2%) 1 (2%)
Seminiferous Tubule, Degeneration, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Angiectasis, Focal 1 (2%) 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Lymph Node (4) (1) (2) (3)
Hyperplasia, Lymphoid 1 (50%)
Bronchial, Hyperplasia, Lymphoid 1 (25%)
Mediastinal, Congestion 1 (33%)
Renal, Hyperplasia, Lymphoid 1 (25%)
Lymph Node, Mandibular (46) (49) (49) (48)
Cyst 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 4 (9%) 4 (8%) 4 (8%) 1 (2%)
Hyperplasia, Plasma Cell 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Lymph Node, Mesenteric (48) (49) (50) (50)
Hemorrhage 3 (6%) 3 (6%) 2 (4%)
Hyperplasia, Lymphoid 2 (4%) 4 (8%) 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Necrosis 1 (2%)
Spleen (49) (50) (50) (50)
Developmental Malformation 1 (2%)
Hematopoietic Cell Proliferation 3 (6%) 3 (6%) 3 (6%) 4 (8%)
Hyperplasia, Lymphoid 2 (4%) 4 (8%) 2 (4%)
Lymphocyte, Necrosis, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Thymus (49) (45) (46) (42)
Cyst 2 (4%) 2 (4%) 3 (7%) 2 (5%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Inflammation, Chronic Active, Focal 1 (2%) 3 (6%)
Subcutaneous Tissue, Abscess 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hemorrhage, Focal 1 (2%) 1 (2%)
Mineralization, Focal 36 (72%) 42 (84%) 43 (86%) 43 (86%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Hemorrhage, Focal 1 (2%)
Infiltration Cellular, Focal, Histiocyte 2 (4%) 1 (2%)
Leukocytosis 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 5 (10%) 2 (4%) 3 (6%) 2 (4%)
Interstitium, Inflammation, Focal 4 (8%) 1 (2%) 3 (6%) 2 (4%)
Nose (50) (50) (50) (50)
Congestion 1 (2%) 1 (2%)
Inflammation, Acute, Focal 3 (6%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (2)
Middle Ear, Inflammation, Chronic Active,
Focal 1 (50%)
Eye (1) (2) (2)
Cornea, Inflammation, Chronic 1 (50%) 1 (50%)
Lens, Cataract 1 (50%)
Zymbal's Gland (39) (34) (42) (37)
Inflammation, Chronic Active 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:52
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Duct, Dilatation 1 (2%) 1 (3%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Infarct, Chronic, Focal 2 (4%)
Metaplasia, Focal, Osseous 1 (2%)
Mineralization, Focal 1 (2%)
Nephropathy 25 (50%) 20 (40%) 30 (60%) 19 (38%)
Renal Tubule, Dilatation, Focal 1 (2%) 1 (2%) 3 (6%) 2 (4%)
Urinary Bladder (50) (50) (50) (50)
Dilatation 1 (2%) 1 (2%)
Metaplasia, Focal, Osseous 1 (2%)
Transitional Epithelium, Hyperplasia, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
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