TDMS Study 05128-06 Pathology Tables
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
Facility: Southern Research Institute
Chemical CAS #: 8003-22-3
Lock Date: 01/12/93
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: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 9 10 9
Early Deaths
Moribund Sacrifice 25 23 12 25
Natural Death 3 2 1 3
Survivors
Terminal Sacrifice 22 26 37 23
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (60) (58) (59) (60)
Parasite Metazoan 5 (8%) 4 (7%) 3 (5%)
Intestine Large, Rectum (59) (59) (59) (59)
Edema 1 (2%)
Parasite Metazoan 5 (8%) 4 (7%) 6 (10%) 3 (5%)
Intestine Large, Cecum (60) (60) (59) (59)
Edema 1 (2%) 1 (2%) 2 (3%)
Parasite Metazoan 1 (2%)
Ulcer 1 (2%)
Intestine Small, Duodenum (60) (60) (60) (59)
Ulcer 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Intestine Small, Jejunum (59) (60) (60) (60)
Epithelium, Hyperplasia 1 (2%)
Intestine Small, Ileum (58) (60) (59) (58)
Epithelium, Hyperplasia 1 (2%)
Liver (60) (60) (60) (60)
Angiectasis 1 (2%) 2 (3%) 3 (5%) 1 (2%)
Basophilic Focus 39 (65%) 28 (47%) 13 (22%) 13 (22%)
Clear Cell Focus 10 (17%) 19 (32%) 33 (55%) 34 (57%)
Cyst 3 (5%) 4 (7%)
Cytoplasmic Alteration 2 (3%)
Degeneration, Cystic 1 (2%)
Eosinophilic Focus 10 (17%) 9 (15%) 15 (25%) 16 (27%)
Granuloma 10 (17%) 1 (2%) 2 (3%) 1 (2%)
Hematopoietic Cell Proliferation 2 (3%) 1 (2%) 2 (3%) 7 (12%)
Hepatodiaphragmatic Nodule 7 (12%) 5 (8%) 7 (12%) 5 (8%)
Inflammation, Subacute 5 (8%) 5 (8%) 10 (17%) 12 (20%)
Mixed Cell Focus 12 (20%) 19 (32%) 20 (33%) 16 (27%)
Necrosis, Focal 2 (3%) 2 (3%) 5 (8%) 4 (7%)
Thrombosis 1 (2%) 2 (3%) 2 (3%)
Bile Duct, Hyperplasia 15 (25%) 11 (18%) 33 (55%) 42 (70%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Bile Duct, Pigmentation 55 (92%) 56 (93%) 59 (98%)
Centrilobular, Atrophy 4 (7%) 9 (15%) 5 (8%) 5 (8%)
Centrilobular, Necrosis 1 (2%) 1 (2%)
Hepatocyte, Cytologic Alterations 15 (25%) 41 (68%) 49 (82%)
Hepatocyte, Pigmentation 43 (72%) 54 (90%) 59 (98%)
Hepatocyte, Vacuolization Cytoplasmic 6 (10%) 6 (10%) 2 (3%) 4 (7%)
Kupffer Cell, Pigmentation 9 (15%) 11 (18%) 16 (27%) 41 (68%)
Mesentery (12) (20) (8) (14)
Accessory Spleen 1 (8%) 2 (14%)
Angiectasis 1 (8%)
Fat, Necrosis 9 (75%) 18 (90%) 8 (100%) 11 (79%)
Pancreas (60) (60) (60) (60)
Atrophy 11 (18%) 19 (32%) 20 (33%) 15 (25%)
Necrosis 1 (2%)
Acinar Cell, Cytoplasmic Alteration 3 (5%) 2 (3%) 2 (3%)
Acinar Cell, Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%)
Salivary Glands (60) (55) (60) (59)
Atrophy 8 (15%) 8 (13%) 15 (25%)
Stomach, Forestomach (60) (60) (60) (60)
Edema 5 (8%) 2 (3%) 4 (7%)
Fibrosis 1 (2%)
Ulcer 4 (7%) 1 (2%) 3 (5%)
Mucosa, Hyperplasia 5 (8%) 17 (28%) 31 (52%) 27 (45%)
Stomach, Glandular (60) (60) (60) (60)
Edema 2 (3%) 2 (3%) 2 (3%)
Erosion 2 (3%) 1 (2%) 2 (3%)
Mineralization 2 (3%)
Ulcer 1 (2%) 2 (3%)
Tooth (1)
Developmental Malformation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (60) (60) (60) (60)
Hypertrophy 1 (2%)
Heart (60) (60) (60) (60)
Cardiomyopathy 17 (28%) 18 (30%) 18 (30%) 12 (20%)
Mineralization 1 (2%)
Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 5 (8%) 17 (28%) 13 (22%) 14 (23%)
Angiectasis 2 (3%) 2 (3%)
Degeneration, Fatty 9 (15%) 10 (17%) 9 (15%) 5 (8%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Diffuse 1 (2%) 1 (2%)
Hyperplasia, Focal 3 (5%) 2 (3%) 2 (3%) 1 (2%)
Hypertrophy 2 (3%)
Hypertrophy, Focal 3 (5%) 2 (3%) 3 (5%)
Necrosis 1 (2%) 1 (2%)
Adrenal Medulla (58) (60) (59) (59)
Hyperplasia 3 (5%) 1 (2%) 4 (7%)
Islets, Pancreatic (60) (60) (59) (60)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (58) (57) (57) (59)
Hyperplasia 1 (2%)
Pituitary Gland (60) (60) (60) (60)
Pars Distalis, Angiectasis 11 (18%) 6 (10%) 17 (28%) 13 (22%)
Pars Distalis, Cyst 29 (48%) 28 (47%) 34 (57%) 26 (43%)
Pars Distalis, Hyperplasia, Focal 10 (17%) 6 (10%) 10 (17%) 9 (15%)
Pars Intermedia, Angiectasis 3 (5%) 1 (2%) 1 (2%)
Pars Intermedia, Cyst 1 (2%) 2 (3%) 2 (3%)
Pars Intermedia, Hyperplasia 2 (3%)
Thyroid Gland (60) (60) (60) (60)
Ultimobranchial Cyst 3 (5%) 7 (12%) 5 (8%) 5 (8%)
C-Cell, Hyperplasia 13 (22%) 7 (12%) 10 (17%) 9 (15%)
Follicle, Cyst 4 (7%) 4 (7%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (59) (59) (59) (60)
Cyst 2 (3%) 4 (7%) 3 (5%) 1 (2%)
Hyperplasia 3 (5%) 1 (2%) 2 (3%) 1 (2%)
Inflammation, Chronic 2 (3%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 2 (3%) 1 (2%)
Ovary (60) (60) (60) (60)
Cyst 14 (23%) 17 (28%) 17 (28%) 19 (32%)
Uterus (60) (60) (60) (60)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hydrometra 2 (3%) 9 (15%) 4 (7%) 10 (17%)
Hyperplasia, Cystic 5 (8%) 1 (2%) 4 (7%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Hyperplasia 4 (7%) 1 (2%) 3 (5%) 5 (8%)
Infiltration Cellular, Histiocyte 1 (2%)
Myelofibrosis 3 (5%) 2 (3%) 3 (5%) 3 (5%)
Necrosis 1 (2%)
Lymph Node (10) (13) (13) (17)
Deep Cervical, Pigmentation 1 (8%)
Iliac, Pigmentation 1 (6%)
Inguinal, Hyperplasia, Lymphoid 1 (10%)
Mediastinal, Hemorrhage 2 (20%) 4 (31%) 5 (38%) 4 (24%)
Mediastinal, Hyperplasia, Lymphoid 2 (15%) 1 (8%) 1 (6%)
Mediastinal, Pigmentation 6 (60%) 9 (69%) 8 (62%) 10 (59%)
Pancreatic, Granuloma 1 (6%)
Pancreatic, Hemorrhage 1 (10%) 2 (12%)
Pancreatic, Hyperplasia, Lymphoid 1 (10%) 1 (8%) 2 (12%)
Pancreatic, Pigmentation 1 (10%) 2 (15%) 6 (46%) 8 (47%)
Renal, Hemorrhage 1 (8%) 1 (6%)
Renal, Hyperplasia, Lymphoid 1 (6%)
Renal, Pigmentation 1 (8%) 1 (6%)
Lymph Node, Mandibular (60) (60) (60) (58)
Ectasia 1 (2%) 3 (5%) 7 (12%) 5 (9%)
Hemorrhage 13 (22%) 11 (18%) 17 (28%) 7 (12%)
Hyperplasia, Lymphoid 5 (8%) 10 (17%) 14 (23%) 13 (22%)
Pigmentation 24 (40%) 28 (47%) 21 (35%) 21 (36%)
Lymph Node, Mesenteric (60) (60) (60) (60)
Hemorrhage 5 (8%) 1 (2%) 1 (2%) 2 (3%)
Hyperplasia, Lymphoid 2 (3%) 5 (8%) 5 (8%) 2 (3%)
Pigmentation 1 (2%) 1 (2%)
Spleen (60) (59) (60) (60)
Congestion 1 (2%)
Developmental Malformation 1 (2%)
Fibrosis 3 (5%) 5 (8%) 4 (7%)
Hematopoietic Cell Proliferation 28 (47%) 23 (39%) 30 (50%) 32 (53%)
Infiltration Cellular, Histiocyte 1 (2%)
Metaplasia, Osseous 1 (2%)
Necrosis 1 (2%) 1 (2%) 1 (2%)
Pigmentation 37 (62%) 37 (63%) 32 (53%) 38 (63%)
Lymphoid Follicle, Atrophy 2 (3%)
Thymus (60) (58) (59) (58)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (60) (60) (60)
Hyperplasia 47 (78%) 42 (70%) 37 (62%) 42 (70%)
Skin (59) (60) (60) (60)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Arthrosis 1 (2%)
Fibrous Osteodystrophy 1 (2%)
Hyperostosis 1 (2%)
Cranium, Osteopetrosis 6 (10%) 7 (12%) 3 (5%) 3 (5%)
Femur, Osteopetrosis 5 (8%) 7 (12%) 1 (2%) 2 (3%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Developmental Malformation 9 (15%) 11 (18%) 8 (13%) 14 (23%)
Gliosis 1 (2%)
Hemorrhage 1 (2%)
Hydrocephalus 2 (3%) 4 (7%)
Peripheral Nerve (2) (2) (2)
Degeneration 1 (50%)
Inflammation, Chronic 1 (50%)
Spinal Cord (3) (2) (2)
Necrosis 1 (33%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Edema 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 6 (10%)
Infiltration Cellular, Histiocyte 38 (63%) 34 (57%) 37 (62%) 43 (72%)
Inflammation, Subacute 6 (10%) 1 (2%) 4 (7%)
Alveolar Epithelium, Hyperplasia 1 (2%) 2 (3%) 3 (5%) 6 (10%)
Nose (60) (60) (60) (60)
Exudate 5 (8%) 5 (8%) 3 (5%) 2 (3%)
Foreign Body 2 (3%) 1 (2%) 2 (3%)
Mucosa, Hyperplasia 4 (7%) 2 (3%) 2 (3%)
Mucosa, Metaplasia, Squamous 3 (5%) 2 (3%) 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (1)
Atrophy 1 (100%)
Cataract 2 (100%) 1 (100%)
Hemorrhage 1 (100%)
Retina, Degeneration 2 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Inflammation, Suppurative 1 (2%)
Mineralization 58 (97%) 58 (97%) 54 (90%) 42 (70%)
Nephropathy 51 (85%) 53 (88%) 53 (88%) 59 (98%)
Renal Tubule, Cytoplasmic Alteration 1 (2%) 2 (3%) 1 (2%) 1 (2%)
Renal Tubule, Necrosis 1 (2%) 1 (2%)
Renal Tubule, Pigmentation 10 (17%) 57 (95%) 60 (100%) 60 (100%)
Transitional Epithelium, Hyperplasia 2 (3%) 6 (10%) 10 (17%) 5 (8%)
Urinary Bladder (60) (60) (60) (60)
Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 9 9 6
Early Deaths
Moribund Sacrifice 29 29 41 49
Natural Death 2 2 1 3
Survivors
Terminal Sacrifice 19 20 8 2
Other 1
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (59) (59) (58) (59)
Edema 1 (2%) 1 (2%)
Parasite Metazoan 5 (8%) 4 (7%) 9 (16%) 3 (5%)
Intestine Large, Rectum (60) (58) (60) (60)
Parasite Metazoan 10 (17%) 1 (2%) 5 (8%) 8 (13%)
Intestine Large, Cecum (60) (59) (59) (60)
Edema 1 (2%) 4 (7%) 8 (14%) 12 (20%)
Parasite Metazoan 2 (3%) 2 (3%) 2 (3%) 3 (5%)
Intestine Small, Duodenum (60) (60) (60) (60)
Erosion 1 (2%)
Epithelium, Hyperplasia 1 (2%) 4 (7%) 22 (37%) 21 (35%)
Intestine Small, Jejunum (60) (59) (60) (60)
Cyst 1 (2%)
Inflammation, Chronic 2 (3%)
Ulcer 1 (2%)
Epithelium, Hyperplasia 3 (5%) 10 (17%) 12 (20%)
Intestine Small, Ileum (59) (59) (59) (60)
Epithelium, Hyperplasia 3 (5%) 10 (17%) 8 (13%)
Liver (60) (60) (60) (60)
Angiectasis 6 (10%) 6 (10%) 11 (18%) 12 (20%)
Basophilic Focus 15 (25%) 9 (15%) 6 (10%) 8 (13%)
Clear Cell Focus 9 (15%) 15 (25%) 16 (27%) 19 (32%)
Congestion 3 (5%)
Cyst 2 (3%)
Degeneration, Cystic 15 (25%) 19 (32%) 10 (17%) 13 (22%)
Developmental Malformation 2 (3%)
Eosinophilic Focus 7 (12%) 7 (12%) 14 (23%) 12 (20%)
Granuloma 3 (5%) 2 (3%) 1 (2%)
Hematopoietic Cell Proliferation 5 (8%) 1 (2%)
Hepatodiaphragmatic Nodule 2 (3%) 2 (3%) 3 (5%)
Inflammation, Subacute 1 (2%) 2 (3%) 11 (18%) 5 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mixed Cell Focus 1 (2%) 10 (17%) 9 (15%) 11 (18%)
Necrosis, Focal 2 (3%) 11 (18%) 3 (5%) 3 (5%)
Thrombosis 2 (3%) 4 (7%) 1 (2%) 6 (10%)
Bile Duct, Hyperplasia 53 (88%) 26 (43%) 18 (30%) 33 (55%)
Bile Duct, Pigmentation 47 (78%) 60 (100%) 60 (100%)
Centrilobular, Atrophy 14 (23%) 17 (28%) 8 (13%) 15 (25%)
Centrilobular, Necrosis 1 (2%)
Hepatocyte, Cytologic Alterations 28 (47%) 53 (88%) 48 (80%)
Hepatocyte, Pigmentation 23 (38%) 53 (88%) 57 (95%)
Hepatocyte, Vacuolization Cytoplasmic 5 (8%) 1 (2%) 2 (3%)
Kupffer Cell, Pigmentation 7 (12%) 15 (25%) 23 (38%) 31 (52%)
Mesentery (12) (12) (10) (13)
Accessory Spleen 1 (8%)
Angiectasis 1 (8%) 1 (8%)
Cyst 1 (8%)
Fat, Necrosis 12 (100%) 12 (100%) 10 (100%) 12 (92%)
Oral Mucosa (2) (3) (4)
Hyperplasia 1 (25%)
Pancreas (60) (60) (60) (60)
Atrophy 26 (43%) 32 (53%) 27 (45%) 24 (40%)
Basophilic Focus 1 (2%) 3 (5%) 2 (3%) 1 (2%)
Edema 3 (5%) 10 (17%) 16 (27%) 22 (37%)
Inflammation, Chronic 1 (2%)
Metaplasia 1 (2%) 1 (2%)
Thrombosis 2 (3%)
Acinar Cell, Cytoplasmic Alteration 5 (8%) 11 (18%) 8 (13%)
Acinar Cell, Hyperplasia, Focal 6 (10%) 3 (5%) 6 (10%) 9 (15%)
Salivary Glands (60) (60) (59) (60)
Atrophy 1 (2%) 1 (2%) 5 (8%) 7 (12%)
Basophilic Focus 1 (2%)
Edema 1 (2%) 6 (10%) 21 (35%)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (60) (60) (60) (60)
Edema 5 (8%) 10 (17%) 15 (25%) 13 (22%)
Perforation 1 (2%)
Ulcer 5 (8%) 3 (5%) 5 (8%) 5 (8%)
Mucosa, Hyperplasia 4 (7%) 13 (22%) 19 (32%) 21 (35%)
Stomach, Glandular (60) (60) (60) (60)
Edema 7 (12%) 2 (3%) 7 (12%) 8 (13%)
Erosion 2 (3%) 1 (2%) 1 (2%)
Ulcer 1 (2%)
Tongue (1) (1) (1) (4)
Hyperplasia 1 (25%)
Epithelium, Hyperplasia 1 (25%)
Tooth (1) (3)
Necrosis 1 (100%) 2 (67%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (60) (60) (60) (59)
Hypertrophy 1 (2%) 3 (5%) 3 (5%)
Inflammation, Subacute 1 (2%) 2 (3%) 3 (5%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Thrombosis 3 (5%) 2 (3%) 3 (5%)
Heart (60) (60) (60) (60)
Cardiomyopathy 44 (73%) 35 (58%) 35 (58%) 30 (50%)
Mineralization 2 (3%)
Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 10 (17%) 21 (35%) 13 (22%) 14 (23%)
Angiectasis 1 (2%) 1 (2%)
Degeneration, Fatty 11 (18%) 5 (8%) 7 (12%) 6 (10%)
Hyperplasia, Diffuse 2 (3%)
Hyperplasia, Focal 1 (2%) 2 (3%) 2 (3%)
Hypertrophy, Focal 5 (8%) 2 (3%) 2 (3%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
Adrenal Medulla (60) (59) (60) (60)
Hyperplasia 13 (22%) 20 (34%) 18 (30%) 19 (32%)
Islets, Pancreatic (60) (60) (60) (60)
Hyperplasia 1 (2%)
Parathyroid Gland (57) (55) (57) (58)
Cyst 1 (2%)
Hyperplasia 3 (5%) 9 (16%) 15 (26%) 17 (29%)
Pituitary Gland (60) (59) (58) (58)
Pars Distalis, Angiectasis 7 (12%) 2 (3%) 6 (10%) 3 (5%)
Pars Distalis, Cyst 4 (7%) 6 (10%) 5 (9%) 7 (12%)
Pars Distalis, Hyperplasia, Focal 12 (20%) 7 (12%) 6 (10%) 10 (17%)
Pars Intermedia, Angiectasis 1 (2%) 1 (2%) 1 (2%)
Pars Intermedia, Cyst 2 (3%) 3 (5%) 3 (5%)
Pars Nervosa, Developmental Malformation 1 (2%)
Thyroid Gland (60) (60) (59) (60)
Ultimobranchial Cyst 2 (3%) 4 (7%) 2 (3%) 4 (7%)
C-Cell, Hyperplasia 2 (3%) 6 (10%) 1 (2%) 6 (10%)
Follicle, Cyst 1 (2%) 2 (3%) 6 (10%) 7 (12%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (59) (60) (60) (60)
Atypia Cellular 19 (32%) 28 (47%) 27 (45%) 23 (38%)
Edema 1 (2%) 3 (5%) 5 (8%) 14 (23%)
Granuloma Sperm 1 (2%) 1 (2%)
Hypospermia 26 (44%) 37 (62%) 38 (63%) 29 (48%)
Preputial Gland (59) (59) (60) (60)
Cyst 3 (5%) 4 (7%) 1 (2%)
Hyperplasia 2 (3%) 1 (2%) 2 (3%)
Inflammation, Chronic 15 (25%) 9 (15%) 12 (20%) 6 (10%)
Inflammation, Suppurative 8 (14%) 5 (8%) 7 (12%) 1 (2%)
Prostate (60) (60) (60) (59)
Corpora Amylacea 18 (30%) 29 (48%) 25 (42%) 18 (31%)
Edema 1 (2%) 2 (3%) 2 (3%) 12 (20%)
Inflammation, Suppurative 37 (62%) 29 (48%) 36 (60%) 38 (64%)
Epithelium, Hyperplasia 6 (10%) 5 (8%) 3 (5%) 1 (2%)
Seminal Vesicle (60) (60) (60) (60)
Edema 1 (2%) 1 (2%)
Testes (59) (60) (60) (60)
Interstitial Cell, Hyperplasia 13 (22%) 8 (13%) 7 (12%) 6 (10%)
Seminiferous Tubule, Atrophy 4 (7%) 4 (7%) 2 (3%) 6 (10%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Hemorrhage 5 (8%) 3 (5%)
Hyperplasia 3 (5%) 1 (2%) 4 (7%) 4 (7%)
Myelofibrosis 3 (5%) 3 (5%) 1 (2%) 4 (7%)
Lymph Node (22) (25) (30) (47)
Hemorrhage 2 (7%) 4 (9%)
Hyperplasia, Lymphoid 2 (7%) 4 (9%)
Pigmentation 1 (3%) 2 (4%)
Axillary, Ectasia 1 (3%)
Axillary, Hemorrhage 1 (3%)
Axillary, Hyperplasia, Lymphoid 1 (3%)
Axillary, Pigmentation 1 (3%)
Deep Cervical, Hemorrhage 2 (7%)
Deep Cervical, Hyperplasia, Lymphoid 1 (3%)
Deep Cervical, Pigmentation 2 (9%) 4 (13%) 1 (2%)
Iliac, Ectasia 1 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Iliac, Hemorrhage 1 (2%)
Iliac, Hyperplasia, Lymphoid 1 (2%)
Iliac, Pigmentation 1 (3%) 1 (2%)
Inguinal, Hemorrhage 2 (7%) 2 (4%)
Inguinal, Hyperplasia, Lymphoid 2 (7%) 2 (4%)
Mediastinal, Ectasia 3 (10%) 1 (2%)
Mediastinal, Hemorrhage 2 (9%) 5 (20%) 9 (30%) 17 (36%)
Mediastinal, Hyperplasia, Lymphoid 11 (37%) 17 (36%)
Mediastinal, Pigmentation 10 (45%) 11 (44%) 15 (50%) 23 (49%)
Pancreatic, Ectasia 2 (9%)
Pancreatic, Hemorrhage 1 (4%) 1 (3%)
Pancreatic, Hyperplasia, Lymphoid 1 (3%) 6 (13%)
Pancreatic, Pigmentation 1 (5%) 3 (12%) 3 (10%) 12 (26%)
Renal, Ectasia 1 (2%)
Renal, Hemorrhage 1 (3%) 2 (4%)
Renal, Hyperplasia, Lymphoid 1 (3%) 4 (9%)
Renal, Pigmentation 3 (14%) 1 (3%) 11 (23%)
Lymph Node, Mandibular (60) (59) (59) (59)
Ectasia 7 (12%) 8 (14%) 9 (15%) 3 (5%)
Hemorrhage 11 (18%) 4 (7%) 10 (17%) 12 (20%)
Hyperplasia, Lymphoid 8 (13%) 13 (22%) 22 (37%) 25 (42%)
Pigmentation 6 (10%) 6 (10%) 7 (12%) 8 (14%)
Lymph Node, Mesenteric (60) (59) (60) (60)
Ectasia 8 (13%) 1 (2%) 2 (3%) 3 (5%)
Hemorrhage 10 (17%) 7 (12%)
Hyperplasia, Lymphoid 3 (5%) 2 (3%) 10 (17%) 14 (23%)
Pigmentation 1 (2%)
Spleen (60) (60) (60) (60)
Congestion 1 (2%) 3 (5%) 1 (2%)
Fibrosis 15 (25%) 16 (27%) 19 (32%) 17 (28%)
Hematopoietic Cell Proliferation 15 (25%) 12 (20%) 16 (27%) 16 (27%)
Metaplasia, Lipocyte 2 (3%)
Necrosis 1 (2%)
Pigmentation 9 (15%) 12 (20%) 14 (23%) 11 (18%)
Lymphoid Follicle, Hyperplasia 1 (2%)
Thymus (58) (58) (58) (59)
Hyperplasia 1 (2%)
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INTEGUMENTARY SYSTEM
Mammary Gland (58) (57) (56) (58)
Hyperplasia 23 (40%) 11 (19%) 12 (21%) 7 (12%)
Skin (60) (58) (60) (60)
Cyst Epithelial Inclusion 3 (5%) 1 (2%) 1 (2%)
Hyperkeratosis 4 (7%) 3 (5%) 3 (5%) 8 (13%)
Ulcer 2 (3%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Epidermis, Hyperplasia 5 (8%) 5 (9%) 5 (8%) 9 (15%)
Subcutaneous Tissue, Edema 1 (2%) 4 (7%) 16 (27%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Fibrous Osteodystrophy 2 (3%) 8 (13%) 18 (30%) 14 (23%)
Hyperostosis 1 (2%) 1 (2%)
Skeletal Muscle (1) (2) (5) (9)
Edema 1 (50%) 4 (80%) 9 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Developmental Malformation 8 (13%) 4 (7%) 4 (7%) 3 (5%)
Hemorrhage 2 (3%) 1 (2%)
Hydrocephalus 2 (3%) 1 (2%) 1 (2%)
Thrombosis 1 (2%)
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RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Congestion 2 (3%)
Cyst 1 (2%)
Edema 1 (2%) 6 (10%) 10 (17%) 19 (32%)
Hemorrhage 2 (3%) 2 (3%) 3 (5%)
Infiltration Cellular, Histiocyte 19 (32%) 15 (25%) 20 (33%) 15 (25%)
Inflammation, Subacute 2 (3%) 7 (12%) 2 (3%) 4 (7%)
Metaplasia, Osseous 2 (3%)
Alveolar Epithelium, Hyperplasia 4 (7%) 6 (10%) 2 (3%) 3 (5%)
Nose (60) (60) (60) (60)
Exudate 8 (13%) 7 (12%) 10 (17%) 10 (17%)
Foreign Body 2 (3%) 2 (3%) 6 (10%)
Mucosa, Hyperplasia 5 (8%) 8 (13%) 9 (15%) 8 (13%)
Mucosa, Metaplasia, Squamous 7 (12%) 4 (7%) 7 (12%) 8 (13%)
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SPECIAL SENSES SYSTEM
Eye (1) (4)
Cataract 1 (100%) 1 (25%)
Congestion 1 (25%)
Hemorrhage 2 (50%)
Retina, Degeneration 1 (100%) 1 (25%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96
Route: DOSED FEED Time: 23:34:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5%
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Cyst 1 (2%) 6 (10%) 7 (12%) 8 (13%)
Hydronephrosis 2 (3%) 1 (2%)
Infarct 1 (2%)
Inflammation, Suppurative 1 (2%) 5 (8%) 4 (7%)
Mineralization 6 (10%) 2 (3%)
Nephropathy 60 (100%) 60 (100%) 60 (100%) 60 (100%)
Pelvis, Hemorrhage 1 (2%)
Renal Tubule, Hyperplasia 4 (7%) 3 (5%)
Renal Tubule, Pigmentation 18 (30%) 50 (83%) 56 (93%) 60 (100%)
Transitional Epithelium, Hyperplasia 11 (18%) 23 (38%) 29 (48%) 34 (57%)
Urinary Bladder (60) (60) (60) (60)
Hemorrhage 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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