TDMS Study 05130-03 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
C. I. DIRECT BLUE 218
NTP Experiment-Test: 05130-03 Report: PEIRPT03
Study Type: CHRONIC Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
Facility: Microbiological Associates
Chemical CAS #: 10401-500
Lock Date: 11/21/91
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: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 9 9 10 10
Early Deaths
Moribund Sacrifice 12 15 13 16
Natural Death 4 7 6 9
Survivors
Moribund Sacrifice 1
Terminal Sacrifice 35 28 31 25
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Jejunum (48) (45) (49) (47)
Mineralization, Focal 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis, Focal 3 (6%) 1 (2%)
Basophilic Focus 38 (76%) 28 (56%) 41 (82%) 30 (60%)
Clear Cell Focus 11 (22%) 4 (8%) 16 (32%) 12 (24%)
Congestion 2 (4%) 1 (2%) 3 (6%)
Cyst 1 (2%)
Degeneration, Cystic, Focal 2 (4%) 1 (2%)
Developmental Malformation 1 (2%) 5 (10%) 1 (2%)
Eosinophilic Focus 2 (4%) 2 (4%) 3 (6%) 3 (6%)
Fatty Change, Diffuse 4 (8%) 5 (10%) 2 (4%) 1 (2%)
Fatty Change, Focal 14 (28%) 11 (22%) 9 (18%) 18 (36%)
Hematopoietic Cell Proliferation 3 (6%) 1 (2%)
Hemorrhage, Focal 1 (2%)
Hepatodiaphragmatic Nodule 4 (8%) 4 (8%) 2 (4%) 1 (2%)
Hyperplasia, Focal 4 (8%) 1 (2%) 1 (2%)
Inflammation, Chronic, Focal 11 (22%) 9 (18%) 8 (16%) 10 (20%)
Inflammation, Focal, Granulomatous 1 (2%) 2 (4%) 1 (2%)
Mixed Cell Focus 2 (4%) 2 (4%) 4 (8%)
Necrosis, Focal 2 (4%) 1 (2%) 3 (6%)
Bile Duct, Dilatation, Focal 1 (2%)
Bile Duct, Hyperplasia, Focal 3 (6%) 1 (2%) 2 (4%) 2 (4%)
Centrilobular, Necrosis 2 (4%)
Vein, Dilatation 1 (2%) 1 (2%)
Mesentery (8) (6) (3) (6)
Fat, Necrosis, Focal 8 (100%) 3 (50%) 2 (67%) 5 (83%)
Pancreas (50) (48) (50) (48)
Accessory Spleen 1 (2%)
Acinus, Atrophy, Diffuse 1 (2%) 1 (2%)
Acinus, Atrophy, Focal 15 (30%) 9 (19%) 9 (18%) 13 (27%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Acinus, Ectopic Liver, Focal 1 (2%)
Artery, Inflammation, Focal 1 (2%)
Duct, Hyperplasia, Focal 1 (2%)
Salivary Glands (50) (50) (50) (50)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (50) (49) (50) (49)
Acanthosis, Focal 2 (4%) 2 (4%) 3 (6%) 3 (6%)
Hyperplasia, Basal Cell, Focal 1 (2%) 1 (2%) 5 (10%) 11 (22%)
Inflammation, Acute, Focal 2 (4%)
Inflammation, Chronic, Focal 1 (2%) 1 (2%) 1 (2%)
Mineralization, Focal 1 (2%)
Ulcer 1 (2%) 1 (2%) 1 (2%)
Ulcer, Focal 2 (4%) 2 (4%) 2 (4%) 2 (4%)
Stomach, Glandular (50) (48) (50) (48)
Erosion, Focal 1 (2%) 1 (2%)
Inflammation, Chronic Active, Focal 1 (2%)
Ulcer, Focal 1 (2%)
Tongue (1)
Acanthosis, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 22 (44%) 20 (40%) 21 (42%) 14 (28%)
Atrium, Thrombosis 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (49)
Angiectasis, Focal 2 (4%) 5 (10%) 13 (26%) 7 (14%)
Congestion 2 (4%)
Cyst 1 (2%) 1 (2%)
Degeneration, Cystic, Focal 2 (4%) 1 (2%)
Hematopoietic Cell Proliferation, Focal 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Focal 4 (8%) 3 (6%) 7 (14%) 6 (12%)
Hypertrophy, Focal 2 (4%) 3 (6%) 2 (4%) 4 (8%)
Necrosis, Focal 2 (4%)
Vacuolization Cytoplasmic, Diffuse 2 (4%)
Vacuolization Cytoplasmic, Focal 18 (36%) 21 (42%) 16 (32%) 18 (37%)
Adrenal Medulla (49) (50) (47) (49)
Degeneration 1 (2%)
Hyperplasia 7 (14%) 5 (10%) 6 (13%) 3 (6%)
Bilateral, Hyperplasia 2 (4%) 1 (2%) 1 (2%)
Islets, Pancreatic (50) (48) (50) (48)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Parathyroid Gland (45) (43) (39) (44)
Cyst 1 (2%)
Pituitary Gland (50) (47) (49) (47)
Hemorrhage, Focal 1 (2%)
Pars Distalis, Angiectasis 2 (4%) 1 (2%)
Pars Distalis, Angiectasis, Focal 1 (2%)
Pars Distalis, Cyst 10 (20%) 10 (21%) 7 (14%) 11 (23%)
Pars Distalis, Hyperplasia, Focal 13 (26%) 9 (19%) 9 (18%) 14 (30%)
Thyroid Gland (50) (50) (49) (49)
Inflammation 1 (2%) 1 (2%)
C-Cell, Hyperplasia, Diffuse 1 (2%)
C-Cell, Hyperplasia, Focal 10 (20%) 4 (8%) 6 (12%) 11 (22%)
Follicle, Dilatation, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (47) (48) (49) (47)
Hyperplasia 3 (6%) 3 (6%)
Inflammation, Chronic 2 (4%) 1 (2%)
Inflammation, Suppurative 3 (6%) 1 (2%) 2 (4%)
Bilateral, Duct, Dilatation 1 (2%)
Duct, Dilatation 8 (17%) 12 (25%) 15 (31%) 9 (19%)
Ovary (50) (50) (50) (50)
Congestion 1 (2%)
Cyst 3 (6%) 9 (18%) 5 (10%) 4 (8%)
Bilateral, Cyst 1 (2%)
Uterus (50) (50) (50) (50)
Cyst 5 (10%) 7 (14%) 8 (16%) 6 (12%)
Cyst, Multiple 2 (4%) 3 (6%) 2 (4%)
Dilatation 3 (6%) 5 (10%) 6 (12%)
Hypoplasia 1 (2%)
Inflammation, Acute 1 (2%)
Vagina (1) (1) (2) (3)
Cyst 2 (100%)
Hyperplasia, Focal, Squamous 1 (50%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (49) (50) (49)
Atrophy 7 (14%) 4 (8%) 10 (20%) 8 (16%)
Hyperplasia 1 (2%)
Lymph Node (7) (12) (6) (14)
Axillary, Hyperplasia, Lymphoid 1 (7%)
Axillary, Hyperplasia, Plasma Cell 1 (17%)
Iliac, Hyperplasia, Plasma Cell 1 (8%)
Mediastinal, Hemorrhage 1 (14%) 2 (17%) 3 (50%) 4 (29%)
Mediastinal, Infiltration Cellular,
Histiocyte 1 (8%)
Pancreatic, Infiltration Cellular, Histiocyte 1 (7%)
Renal, Hemorrhage 2 (29%) 1 (8%) 1 (17%) 2 (14%)
Lymph Node, Mandibular (49) (50) (50) (50)
Cyst 3 (6%)
Hemorrhage 3 (6%) 1 (2%) 3 (6%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Hyperplasia, Plasma Cell 3 (6%) 1 (2%) 3 (6%)
Lymph Node, Mesenteric (50) (50) (50) (50)
Hemorrhage 6 (12%) 4 (8%) 3 (6%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Spleen (50) (49) (50) (48)
Hematopoietic Cell Proliferation 1 (2%) 2 (4%) 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Thymus (48) (49) (42) (45)
Congestion 1 (2%)
Cyst, Multiple 1 (2%)
Hemorrhage 1 (2%) 2 (4%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Degeneration, Focal 1 (2%)
Galactocele 13 (26%) 14 (28%) 10 (20%) 17 (34%)
Hyperplasia, Focal 1 (2%) 1 (2%) 4 (8%)
Inflammation, Acute, Focal 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic, Focal 1 (2%) 2 (4%) 1 (2%)
Duct, Dilatation 2 (4%) 1 (2%)
Skin (50) (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 5 (10%) 2 (4%) 5 (10%) 1 (2%)
Inflammation, Acute 1 (2%)
Femur, Osteoporosis 1 (2%)
Skeletal Muscle (1) (1)
Diaphragm, Ectopic Tissue 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hemorrhage, Focal 1 (2%) 2 (4%)
Hydrocephalus 1 (2%) 6 (12%) 3 (6%) 5 (10%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Inflammation, Focal 1 (2%)
Meninges, Angiectasis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 2 (4%) 5 (10%)
Hemorrhage, Focal 1 (2%) 3 (6%) 2 (4%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%) 2 (4%)
Infiltration Cellular, Focal, Histiocyte 10 (20%) 7 (14%) 7 (14%) 11 (22%)
Inflammation, Focal 9 (18%) 6 (12%) 11 (22%) 8 (16%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Arteriole, Mineralization, Focal 1 (2%)
Nose (50) (50) (50) (50)
Foreign Body 1 (2%) 1 (2%)
Fungus 1 (2%) 1 (2%) 6 (12%) 8 (16%)
Hemorrhage 1 (2%) 2 (4%)
Inflammation, Acute 2 (4%) 3 (6%) 2 (4%) 3 (6%)
Inflammation, Chronic Active 6 (12%) 6 (12%) 9 (18%) 9 (18%)
Inflammation, Subacute 2 (4%) 5 (10%) 3 (6%) 4 (8%)
Goblet Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (4) (6)
Hemorrhage 1 (25%)
Inflammation, Acute 1 (17%)
Phthisis Bulbi 1 (50%)
Bilateral, Lens, Cataract 2 (50%) 3 (50%)
Bilateral, Retina, Atrophy 2 (50%) 3 (50%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Lens, Cataract 1 (25%) 1 (17%)
Retina, Atrophy 1 (50%) 1 (25%) 1 (17%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Congestion 1 (2%)
Cyst 1 (2%) 1 (2%)
Cyst, Multiple 1 (2%)
Hemorrhage, Focal 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Mineralization, Focal 32 (64%) 25 (50%) 28 (56%) 34 (68%)
Nephropathy 39 (78%) 38 (76%) 41 (82%) 40 (80%)
Pigmentation, Focal 34 (68%) 24 (48%) 28 (56%) 42 (84%)
Bilateral, Hydronephrosis 1 (2%)
Urethra (1)
Cyst 1 (100%)
Urinary Bladder (48) (48) (50) (49)
Hemorrhage 1 (2%)
Mucosa, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 9
Early Deaths
Natural Death 7 3 5 9
Moribund Sacrifice 13 22 16 18
Survivors
Terminal Sacrifice 30 25 29 24
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (46) (49) (49) (49)
Hyperplasia, Focal, Lymphoid 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis, Focal 2 (4%) 7 (14%) 2 (4%)
Basophilic Focus 30 (60%) 26 (52%) 34 (68%) 18 (36%)
Clear Cell Focus 13 (26%) 13 (26%) 19 (38%) 17 (34%)
Congestion 3 (6%) 4 (8%) 4 (8%) 1 (2%)
Degeneration, Cystic, Focal 15 (30%) 13 (26%) 18 (36%) 25 (50%)
Developmental Malformation 2 (4%) 1 (2%)
Eosinophilic Focus 9 (18%) 11 (22%) 15 (30%) 20 (40%)
Fatty Change, Diffuse 1 (2%) 5 (10%) 1 (2%)
Fatty Change, Focal 11 (22%) 11 (22%) 12 (24%) 16 (32%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 1 (2%)
Hyperplasia, Focal 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Inflammation, Chronic, Focal 6 (12%) 2 (4%) 5 (10%) 2 (4%)
Mixed Cell Focus 4 (8%) 1 (2%) 7 (14%)
Necrosis, Focal 2 (4%) 3 (6%) 1 (2%) 3 (6%)
Pigmentation, Focal 1 (2%) 1 (2%)
Bile Duct, Cyst 1 (2%) 2 (4%) 1 (2%)
Bile Duct, Fibrosis 1 (2%)
Bile Duct, Hyperplasia, Focal 6 (12%) 3 (6%) 9 (18%) 2 (4%)
Centrilobular, Atrophy, Focal 1 (2%)
Centrilobular, Necrosis 1 (2%)
Vein, Dilatation 1 (2%)
Mesentery (5) (5) (7) (4)
Fat, Necrosis, Focal 4 (80%) 5 (100%) 5 (71%) 3 (75%)
Pancreas (50) (50) (50) (50)
Accessory Spleen 1 (2%)
Inflammation, Acute, Focal 1 (2%)
Acinus, Atrophy, Diffuse 1 (2%) 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Acinus, Atrophy, Focal 28 (56%) 26 (52%) 29 (58%) 26 (52%)
Acinus, Cytoplasmic Alteration, Focal 1 (2%)
Acinus, Hyperplasia, Focal 1 (2%)
Acinus, Vacuolization Cytoplasmic, Focal 1 (2%)
Artery, Inflammation, Focal 1 (2%) 1 (2%)
Pharynx (1) (9)
Palate, Hyperplasia, Focal, Squamous 2 (22%)
Palate, Inflammation, Chronic Active 1 (100%)
Salivary Glands (50) (50) (50) (50)
Atrophy, Focal 1 (2%)
Hyperplasia, Focal 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Acanthosis, Focal 1 (2%) 1 (2%)
Hyperplasia, Basal Cell, Focal 2 (4%) 10 (20%) 19 (38%)
Hyperplasia, Focal, Plasma Cell 1 (2%)
Hyperplasia, Focal, Squamous 1 (2%) 1 (2%) 6 (12%) 4 (8%)
Inflammation, Chronic, Focal 1 (2%) 1 (2%)
Inflammation, Chronic Active, Focal 2 (4%) 2 (4%)
Ulcer, Focal 4 (8%) 3 (6%) 3 (6%)
Stomach, Glandular (50) (50) (50) (50)
Cyst 1 (2%)
Erosion, Focal 2 (4%) 1 (2%)
Hyperplasia, Basal Cell, Focal 1 (2%)
Inflammation, Acute, Focal 1 (2%)
Ulcer, Focal 3 (6%)
Tooth (1) (1)
Gingiva, Inflammation, Chronic Active 1 (100%)
Peridontal Tissue, Inflammation, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 37 (74%) 31 (62%) 38 (76%) 32 (64%)
Mineralization, Focal 1 (2%) 1 (2%) 1 (2%)
Atrium, Dilatation 2 (4%) 3 (6%) 3 (6%)
Atrium, Thrombosis 6 (12%) 2 (4%) 1 (2%) 1 (2%)
Valve, Degeneration 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (50) (50) (50)
Angiectasis, Focal 1 (2%)
Congestion 1 (2%) 1 (2%)
Cyst 1 (2%)
Cyst, Multiple 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Degeneration, Cystic, Focal 2 (4%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Focal 6 (12%) 6 (12%) 6 (12%) 2 (4%)
Vacuolization Cytoplasmic, Focal 8 (16%) 12 (24%) 3 (6%) 12 (24%)
Adrenal Medulla (49) (50) (50) (50)
Cyst 1 (2%)
Hyperplasia 16 (33%) 12 (24%) 14 (28%) 8 (16%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Bilateral, Hyperplasia 4 (8%) 3 (6%) 3 (6%) 1 (2%)
Islets, Pancreatic (50) (50) (50) (50)
Hyperplasia, Focal 5 (10%) 4 (8%) 7 (14%) 10 (20%)
Parathyroid Gland (43) (47) (46) (45)
Hyperplasia 1 (2%) 2 (4%)
Bilateral, Hyperplasia 1 (2%) 2 (4%)
Pituitary Gland (50) (50) (48) (50)
Angiectasis, Focal 1 (2%) 1 (2%)
Pigmentation, Focal 1 (2%)
Pars Distalis, Cyst 3 (6%) 2 (4%) 3 (6%)
Pars Distalis, Hyperplasia, Focal 12 (24%) 16 (32%) 11 (23%) 18 (36%)
Pars Distalis, Hypertrophy, Focal 1 (2%)
Pars Nervosa, Hyperplasia, Focal 1 (2%)
Thyroid Gland (50) (50) (50) (50)
C-Cell, Hyperplasia, Focal 7 (14%) 6 (12%) 10 (20%) 4 (8%)
Follicle, Dilatation, Focal 4 (8%)
Follicular Cell, Hyperplasia, Focal 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Degeneration, Focal 31 (62%) 38 (76%) 37 (74%) 33 (66%)
Preputial Gland (50) (50) (50) (49)
Hyperplasia 3 (6%) 1 (2%) 2 (4%) 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 5 (10%) 3 (6%) 2 (4%) 1 (2%)
Duct, Dilatation 10 (20%) 17 (34%) 9 (18%) 11 (22%)
Prostate (50) (50) (50) (49)
Abscess 1 (2%) 2 (4%)
Atrophy 10 (20%) 7 (14%) 11 (22%) 13 (27%)
Degeneration, Focal 1 (2%) 1 (2%)
Hyperplasia, Focal 3 (6%) 3 (6%)
Inflammation, Chronic, Focal 1 (2%) 1 (2%) 2 (4%) 4 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Focal, Granulomatous 3 (6%) 2 (4%)
Inflammation, Focal, Suppurative 3 (6%) 2 (4%) 4 (8%) 4 (8%)
Inflammation, Suppurative 3 (6%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Seminal Vesicle (50) (50) (50) (49)
Abscess 1 (2%)
Dilatation 1 (2%)
Hyperplasia, Focal 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Testes (50) (50) (50) (50)
Atrophy 4 (8%) 3 (6%) 4 (8%) 9 (18%)
Cyst 2 (4%)
Cyst, Multiple 1 (2%)
Mineralization, Focal 1 (2%)
Artery, Inflammation, Focal 1 (2%)
Bilateral, Atrophy 2 (4%)
Interstitial Cell, Hyperplasia, Focal 4 (8%) 2 (4%) 1 (2%) 5 (10%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Atrophy 1 (2%)
Hyperplasia 1 (2%) 3 (6%) 4 (8%)
Lymph Node (15) (16) (23) (18)
Axillary, Hyperplasia, Plasma Cell 1 (6%)
Bronchial, Hemorrhage 1 (7%)
Bronchial, Infiltration Cellular, Histiocyte 1 (6%)
Iliac, Cyst 1 (6%)
Iliac, Infiltration Cellular, Histiocyte 1 (6%)
Inguinal, Cyst 1 (6%)
Lumbar, Hemorrhage 1 (4%) 2 (11%)
Lumbar, Hyperplasia, Plasma Cell 1 (6%)
Lumbar, Infiltration Cellular, Histiocyte 2 (9%)
Mediastinal, Cyst 1 (4%)
Mediastinal, Hemorrhage 5 (33%) 2 (13%) 5 (22%) 2 (11%)
Mediastinal, Hyperplasia, Plasma Cell 2 (13%) 1 (4%)
Mediastinal, Infiltration Cellular,
Histiocyte 1 (4%) 1 (6%)
Pancreatic, Hemorrhage 1 (4%) 2 (11%)
Pancreatic, Infiltration Cellular, Histiocyte 1 (4%)
Renal, Hemorrhage 1 (7%) 1 (6%) 1 (4%) 1 (6%)
Renal, Infiltration Cellular, Histiocyte 1 (6%)
Lymph Node, Mandibular (48) (50) (49) (50)
Cyst 3 (6%) 2 (4%) 6 (12%) 3 (6%)
Hemorrhage 3 (6%) 2 (4%) 3 (6%) 2 (4%)
Hyperplasia, Plasma Cell 9 (19%) 10 (20%) 4 (8%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymph Node, Mesenteric (49) (50) (50) (50)
Cyst 1 (2%)
Edema 1 (2%)
Hemorrhage 2 (4%) 2 (4%) 1 (2%) 3 (6%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Spleen (50) (50) (50) (49)
Congestion 1 (2%) 1 (2%)
Depletion Cellular 1 (2%)
Fibrosis, Focal 2 (4%) 1 (2%) 4 (8%) 4 (8%)
Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 2 (4%)
Pigmentation, Hemosiderin 1 (2%)
Capsule, Cyst 1 (2%)
Thymus (48) (40) (49) (48)
Congestion 1 (2%)
Hemorrhage 1 (2%) 1 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (49) (50) (46)
Galactocele 6 (13%) 7 (14%) 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%) 2 (4%) 3 (6%) 2 (4%)
Inflammation, Acute, Focal 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Pigmentation, Focal 1 (2%)
Skin (50) (50) (50) (50)
Acanthosis, Focal 1 (2%)
Subcutaneous Tissue, Inflammation, Acute 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic
Active, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Fibrous Osteodystrophy 1 (2%) 1 (2%)
Hyperostosis 1 (2%)
Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Gliosis, Focal 1 (2%)
Hemorrhage, Focal 1 (2%)
Hydrocephalus 4 (8%) 4 (8%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM - CONT
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Mineralization, Focal 1 (2%)
Necrosis, Focal 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 6 (12%) 1 (2%) 1 (2%) 3 (6%)
Hemorrhage, Focal 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 3 (6%) 3 (6%)
Infiltration Cellular, Focal, Histiocyte 6 (12%) 4 (8%) 6 (12%) 4 (8%)
Inflammation, Focal 7 (14%) 2 (4%) 7 (14%) 7 (14%)
Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 1 (2%) 3 (6%) 2 (4%)
Nose (50) (50) (49) (50)
Congestion 1 (2%) 1 (2%)
Foreign Body 5 (10%) 2 (4%) 3 (6%) 3 (6%)
Fungus 7 (14%) 6 (12%) 16 (33%) 11 (22%)
Hemorrhage 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Inflammation, Acute 7 (14%) 2 (4%) 1 (2%)
Inflammation, Chronic Active 9 (18%) 10 (20%) 20 (41%) 14 (28%)
Inflammation, Subacute 5 (10%) 1 (2%) 3 (6%) 3 (6%)
Glands, Dilatation, Focal 1 (2%)
Olfactory Epithelium, Necrosis, Focal 1 (2%)
Trachea (50) (50) (50) (50)
Inflammation, Chronic Active, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (5) (4) (3) (2)
Inflammation, Chronic 1 (25%)
Phthisis Bulbi 1 (20%) 1 (25%)
Cornea, Degeneration, Focal 1 (33%)
Cornea, Inflammation 1 (20%)
Lens, Cataract 3 (60%) 1 (25%) 1 (33%) 1 (50%)
Lens, Inflammation, Focal, Subacute 1 (20%)
Retina, Atrophy 1 (20%) 2 (50%) 1 (50%)
Zymbal's Gland (48) (48) (48) (48)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:33
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Cyst 2 (4%) 2 (4%)
Hydronephrosis 1 (2%)
Infarct 1 (2%)
Mineralization, Focal 1 (2%)
Nephropathy 48 (96%) 50 (100%) 50 (100%) 46 (92%)
Pigmentation, Focal 12 (24%) 11 (22%) 15 (30%) 23 (46%)
Pelvis, Inflammation, Suppurative 1 (2%)
Urinary Bladder (50) (50) (50) (50)
Abscess 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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