TDMS Study 05161-05 Pathology Tables
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
RATS/FINAL#1
Facility: Southern Research Institute
Chemical CAS #: 23246-96-0
Lock Date: 11/17/99
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: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50 50 50
Early Deaths
Natural Death 6 11 6 12 2 31
Dosing Accident 2 6 3 2 3
Moribund Sacrifice 9 11 13 14 16 19
Survivors
Terminal Sacrifice 33 22 28 22 29
Animals Examined Microscopically 50 50 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (48) (50) (48) (50) (49) (50)
Inflammation, Chronic 2 (4%)
Perforation 1 (2%)
Intestine Large, Colon (49) (50) (50) (47) (50) (50)
Diverticulum 1 (2%)
Intestine Large, Cecum (50) (50) (48) (47) (50) (50)
Edema 1 (2%)
Liver (50) (50) (50) (50) (50) (50)
Angiectasis 2 (4%) 1 (2%) 2 (4%) 5 (10%) 1 (2%)
Basophilic Focus 45 (90%) 46 (92%) 44 (88%) 42 (84%) 40 (80%) 20 (40%)
Clear Cell Focus 9 (18%) 8 (16%) 9 (18%) 13 (26%) 22 (44%) 2 (4%)
Cyst 1 (2%)
Degeneration, Cystic 1 (2%) 1 (2%)
Eosinophilic Focus 1 (2%) 2 (4%) 6 (12%) 4 (8%) 12 (24%) 13 (26%)
Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 4 (8%) 1 (2%) 3 (6%)
Hemorrhage 2 (4%) 1 (2%) 7 (14%)
Hepatodiaphragmatic Nodule 13 (26%) 8 (16%) 9 (18%) 6 (12%) 4 (8%) 5 (10%)
Infiltration Cellular, Mixed Cell 9 (18%) 7 (14%) 9 (18%) 8 (16%) 15 (30%) 3 (6%)
Mixed Cell Focus 8 (16%) 10 (20%) 10 (20%) 11 (22%) 23 (46%) 5 (10%)
Necrosis, Focal 4 (8%) 2 (4%) 3 (6%) 4 (8%) 4 (8%) 15 (30%)
Bile Duct, Hyperplasia 2 (4%) 1 (2%) 4 (8%) 4 (8%) 3 (6%) 10 (20%)
Hepatocyte, Cytomegaly 7 (14%) 23 (46%) 32 (64%) 29 (58%)
Hepatocyte, Hyperplasia, Atypical 1 (2%)
Hepatocyte, Hyperplasia, Focal 1 (2%)
Hepatocyte, Hyperplasia, Regenerative 8 (16%) 50 (100%)
Hepatocyte, Vacuolization Cytoplasmic 4 (8%) 5 (10%) 7 (14%) 4 (8%) 3 (6%) 5 (10%)
Kupffer Cell, Pigmentation 2 (4%) 3 (6%) 2 (4%) 6 (12%) 4 (8%)
Mesentery (10) (10) (18) (14) (13) (5)
Accessory Spleen 2 (20%) 1 (6%) 2 (14%) 1 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 8 (80%) 10 (100%) 18 (100%) 12 (86%) 9 (69%) 3 (60%)
Pancreas (50) (50) (50) (46) (50) (50)
Atrophy 10 (20%) 3 (6%) 9 (18%) 8 (17%) 4 (8%) 4 (8%)
Acinus, Hyperplasia, Focal 3 (6%) 1 (2%) 1 (2%)
Salivary Glands (50) (50) (50) (50) (50) (50)
Atrophy 1 (2%) 2 (4%)
Stomach, Forestomach (50) (50) (50) (49) (49) (50)
Ulcer 2 (4%)
Epithelium, Hyperplasia 1 (2%) 5 (10%) 1 (2%) 1 (2%) 3 (6%)
Stomach, Glandular (50) (50) (50) (49) (49) (50)
Erosion 2 (4%) 1 (2%) 9 (18%)
Hemorrhage 1 (2%)
Mineralization 1 (2%)
Ulcer 2 (4%) 7 (14%)
Tooth (1)
Malformation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50) (50) (50)
Cardiomyopathy 12 (24%) 15 (30%) 8 (16%) 13 (26%) 8 (16%) 6 (12%)
Thrombosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 6 (12%) 2 (4%) 6 (12%) 4 (8%) 2 (4%) 7 (14%)
Atrophy 1 (2%)
Degeneration, Fatty 9 (18%) 9 (18%) 12 (24%) 8 (16%) 13 (26%) 3 (6%)
Hyperplasia, Diffuse 3 (6%) 1 (2%)
Hyperplasia, Focal 4 (8%) 5 (10%) 6 (12%) 4 (8%) 9 (18%) 3 (6%)
Hypertrophy 1 (2%) 1 (2%)
Hypertrophy, Focal 9 (18%) 5 (10%) 7 (14%) 2 (4%) 4 (8%) 2 (4%)
Necrosis 1 (2%)
Adrenal Medulla (50) (49) (50) (50) (50) (50)
Hyperplasia 1 (2%) 3 (6%) 3 (6%) 3 (6%)
Pituitary Gland (50) (48) (50) (49) (50) (49)
Pars Distalis, Angiectasis 6 (12%) 6 (13%) 8 (16%) 8 (16%) 9 (18%) 7 (14%)
Pars Distalis, Cyst 16 (32%) 11 (23%) 19 (38%) 16 (33%) 17 (34%) 19 (39%)
Pars Distalis, Hyperplasia 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 10 (20%) 8 (17%) 9 (18%) 11 (22%) 7 (14%) 6 (12%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Intermedia, Angiectasis 1 (2%) 1 (2%) 1 (2%)
Pars Intermedia, Cyst 1 (2%) 1 (2%)
Thyroid Gland (49) (50) (49) (49) (50) (50)
Ultimobranchial Cyst 1 (2%) 2 (4%) 1 (2%) 2 (4%)
C-Cell, Hyperplasia 22 (45%) 9 (18%) 24 (49%) 15 (31%) 20 (40%) 10 (20%)
Follicle, Cyst 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (49) (49) (48) (49) (50)
Cyst 5 (10%) 2 (4%) 3 (6%) 1 (2%) 4 (8%) 3 (6%)
Hyperplasia 3 (6%) 5 (10%) 4 (8%) 2 (4%) 2 (4%)
Inflammation, Chronic 4 (8%) 5 (10%) 4 (8%) 3 (6%) 4 (8%)
Ovary (50) (49) (50) (50) (50) (50)
Cyst 11 (22%) 7 (14%) 8 (16%) 9 (18%) 6 (12%) 9 (18%)
Infiltration Cellular, Mixed Cell 1 (2%)
Uterus (50) (50) (50) (50) (50) (50)
Hydrometra 5 (10%) 7 (14%) 6 (12%) 6 (12%) 6 (12%)
Hyperplasia, Cystic 4 (8%) 3 (6%) 7 (14%) 5 (10%) 2 (4%) 9 (18%)
Inflammation, Chronic 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50) (50) (50)
Hyperplasia 6 (12%) 3 (6%) 8 (16%) 7 (14%) 10 (20%) 32 (64%)
Inflammation, Granulomatous 1 (2%)
Myelofibrosis 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Lymph Node (26) (24) (36) (19) (21) (40)
Iliac, Pigmentation 1 (4%)
Mediastinal, Congestion 4 (15%) 3 (13%) 3 (8%) 3 (16%) 1 (5%) 9 (23%)
Mediastinal, Hemorrhage 5 (19%) 8 (33%) 9 (25%) 5 (26%) 7 (33%) 25 (63%)
Mediastinal, Infiltration Cellular,
Histiocyte 1 (4%)
Mediastinal, Pigmentation 23 (88%) 22 (92%) 32 (89%) 15 (79%) 16 (76%) 31 (78%)
Pancreatic, Hemorrhage 2 (5%)
Pancreatic, Hyperplasia, Histiocytic 1 (4%) 1 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Pancreatic, Hyperplasia, Lymphoid 1 (4%) 1 (4%) 1 (3%) 1 (5%)
Pancreatic, Pigmentation 1 (4%) 2 (6%) 4 (19%) 1 (3%)
Renal, Pigmentation 2 (6%) 2 (10%) 1 (3%)
Lymph Node, Mandibular (50) (49) (48) (50) (50) (50)
Ectasia 3 (6%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 2 (4%) 3 (6%) 1 (2%) 5 (10%) 5 (10%)
Pigmentation 5 (10%) 2 (4%) 2 (4%) 11 (22%) 3 (6%)
Lymph Node, Mesenteric (50) (50) (50) (47) (49) (49)
Congestion 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 2 (4%) 3 (6%) 4 (9%) 6 (12%)
Hyperplasia 1 (2%)
Inflammation, Granulomatous 1 (2%)
Pigmentation 3 (6%) 1 (2%) 2 (4%) 2 (4%) 3 (6%) 2 (4%)
Spleen (50) (50) (50) (50) (50) (50)
Congestion 1 (2%) 3 (6%) 7 (14%)
Fibrosis 1 (2%) 1 (2%) 2 (4%) 2 (4%)
Hematopoietic Cell Proliferation 24 (48%) 33 (66%) 25 (50%) 26 (52%) 27 (54%) 34 (68%)
Hyperplasia, Stromal 1 (2%)
Necrosis 1 (2%)
Pigmentation 37 (74%) 41 (82%) 35 (70%) 34 (68%) 35 (70%) 29 (58%)
Thymus (48) (48) (46) (48) (50) (49)
Cyst 1 (2%)
Hemorrhage 2 (4%) 2 (4%)
Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50) (49) (49)
Hyperplasia 48 (96%) 46 (92%) 46 (92%) 45 (90%) 44 (90%) 43 (88%)
Skin (50) (50) (49) (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%)
Hemorrhage 1 (2%)
Hyperkeratosis 1 (2%)
Inflammation, Chronic 1 (2%)
Ulcer 1 (2%)
Epidermis, Hyperplasia 1 (2%)
Subcutaneous Tissue, Edema 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM - CONT
Bone (50) (50) (50) (50) (50) (50)
Cranium, Osteopetrosis 10 (20%) 10 (20%) 12 (24%) 6 (12%) 7 (14%)
Femur, Osteopetrosis 12 (24%) 7 (14%) 9 (18%) 15 (30%) 14 (28%) 9 (18%)
Skeletal Muscle (1) (1) (2) (6)
Hemorrhage 4 (67%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50) (50) (50)
Compression 9 (18%) 11 (22%) 15 (30%) 6 (12%) 12 (24%) 2 (4%)
Hemorrhage 1 (2%) 1 (2%) 3 (6%)
Hydrocephalus 3 (6%) 4 (8%) 8 (16%) 1 (2%) 10 (20%) 3 (6%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50) (50) (50)
Congestion 4 (8%) 7 (14%) 2 (4%) 8 (16%) 1 (2%) 1 (2%)
Edema 1 (2%) 2 (4%)
Hemorrhage 4 (8%) 7 (14%) 1 (2%) 3 (6%) 5 (10%) 19 (38%)
Infiltration Cellular, Histiocyte 46 (92%) 41 (82%) 48 (96%) 44 (88%) 49 (98%) 42 (84%)
Inflammation, Chronic 1 (2%)
Inflammation, Granulomatous 1 (2%)
Metaplasia, Osseous 2 (4%)
Alveolar Epithelium, Hyperplasia 5 (10%) 4 (8%) 10 (20%) 5 (10%) 5 (10%) 7 (14%)
Nose (50) (50) (50) (49) (50) (50)
Foreign Body 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 3 (6%) 2 (4%) 1 (2%)
Olfactory Epithelium, Degeneration 1 (2%) 1 (2%)
Respiratory Epithelium, Hyperplasia 1 (2%) 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cataract 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50) (50) (50)
Cyst 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Hydronephrosis 1 (2%) 1 (2%)
Infarct 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Nephropathy 32 (64%) 32 (64%) 33 (66%) 30 (60%) 38 (76%) 28 (56%)
Papilla, Fibrosis, Focal 1 (2%)
Pelvis, Mineralization 1 (2%)
Renal Tubule, Cytoplasmic Alteration 1 (2%) 1 (2%)
Renal Tubule, Dilatation 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Renal Tubule, Hyaline Droplet 33 (66%) 23 (46%) 30 (60%) 26 (52%) 26 (52%) 9 (18%)
Renal Tubule, Mineralization 1 (2%)
Renal Tubule, Necrosis 1 (2%) 1 (2%) 6 (12%)
Renal Tubule, Pigmentation 38 (76%) 28 (56%) 31 (62%) 31 (62%) 41 (82%) 23 (46%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%) 5 (10%)
Urinary Bladder (50) (50) (50) (48) (50) (50)
Edema 1 (2%) 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 1.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50
Early Deaths
Moribund Sacrifice 1 9
Natural Death 36
Dosing Accident 2
Survivors
Terminal Sacrifice 49 3
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50)
Perforation 1 (2%)
Intestine Large, Cecum (50) (49)
Edema 1 (2%) 3 (6%)
Intestine Small, Duodenum (50) (50)
Hemorrhage 1 (2%)
Necrosis 1 (2%)
Liver (50) (50)
Basophilic Focus 32 (64%) 21 (42%)
Clear Cell Focus 3 (6%) 5 (10%)
Degeneration, Cystic 1 (2%) 3 (6%)
Eosinophilic Focus 3 (6%) 15 (30%)
Hematopoietic Cell Proliferation 2 (4%)
Hemorrhage 4 (8%)
Hepatodiaphragmatic Nodule 4 (8%) 4 (8%)
Infiltration Cellular, Mixed Cell 8 (16%)
Metaplasia, Osseous 1 (2%)
Mixed Cell Focus 3 (6%) 7 (14%)
Necrosis, Focal 23 (46%)
Bile Duct, Hyperplasia 48 (96%) 37 (74%)
Hepatocyte, Cytomegaly 32 (64%)
Hepatocyte, Hyperplasia, Atypical 1 (2%)
Hepatocyte, Hyperplasia, Regenerative 49 (98%)
Hepatocyte, Vacuolization Cytoplasmic 30 (60%) 5 (10%)
Kupffer Cell, Pigmentation 1 (2%)
Mesentery (8) (9)
Accessory Spleen 1 (13%) 1 (11%)
Fat, Necrosis 7 (88%) 3 (33%)
Pancreas (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 1.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Atrophy 7 (14%) 7 (14%)
Acinus, Cytoplasmic Alteration 1 (2%)
Acinus, Hyperplasia, Focal 1 (2%)
Salivary Glands (50) (50)
Atrophy 1 (2%)
Necrosis 2 (4%)
Stomach, Forestomach (50) (50)
Edema 2 (4%)
Ulcer 3 (6%)
Stomach, Glandular (50) (50)
Erosion 10 (20%)
Hemorrhage 1 (2%)
Ulcer 6 (12%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50)
Cardiomyopathy 32 (64%) 28 (56%)
Myocardium, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (50)
Accessory Adrenal Cortical Nodule 8 (16%) 1 (2%)
Degeneration, Fatty 5 (10%) 4 (8%)
Hyperplasia, Diffuse 1 (2%)
Hyperplasia, Focal 3 (6%) 1 (2%)
Hypertrophy 1 (2%)
Necrosis 1 (2%)
Pituitary Gland (50) (49)
Pars Distalis, Cyst 4 (8%) 2 (4%)
Pars Distalis, Hyperplasia, Focal 5 (10%) 4 (8%)
Thyroid Gland (50) (50)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 4 (8%) 1 (2%)
Follicle, Cyst 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: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 1.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50)
Atypia Cellular 9 (18%) 9 (18%)
Preputial Gland (50) (50)
Inflammation, Chronic 24 (48%) 16 (32%)
Prostate (50) (50)
Inflammation, Chronic 18 (36%) 15 (30%)
Testes (50) (50)
Atrophy 3 (6%) 6 (12%)
Interstitial Cell, Hyperplasia 22 (44%) 12 (24%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49)
Hyperplasia 1 (2%) 36 (73%)
Myelofibrosis 1 (2%)
Lymph Node (13) (39)
Bronchial, Hemorrhage 1 (3%)
Bronchial, Pigmentation 1 (3%)
Iliac, Necrosis 1 (3%)
Mediastinal, Congestion 3 (23%) 11 (28%)
Mediastinal, Hemorrhage 3 (23%) 20 (51%)
Mediastinal, Hyperplasia 1 (8%)
Mediastinal, Necrosis 1 (3%)
Mediastinal, Pigmentation 10 (77%) 20 (51%)
Pancreatic, Hemorrhage 2 (5%)
Pancreatic, Pigmentation 2 (5%)
Renal, Hemorrhage 3 (8%)
Renal, Necrosis 1 (3%)
Renal, Pigmentation 3 (8%)
Lymph Node, Mandibular (50) (50)
Congestion 1 (2%)
Hemorrhage 2 (4%) 1 (2%)
Pigmentation 1 (2%) 1 (2%)
Lymph Node, Mesenteric (50) (50)
Congestion 4 (8%)
Hemorrhage 1 (2%) 8 (16%)
Pigmentation 1 (2%)
Spleen (50) (49)
Congestion 24 (49%)
Fibrosis 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 1.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hematopoietic Cell Proliferation 1 (2%) 23 (47%)
Hyperplasia, Reticulum Cell 1 (2%)
Necrosis 1 (2%)
Thymus (49) (49)
Hemorrhage 4 (8%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (42) (38)
Cyst 1 (2%) 1 (3%)
Hyperplasia 5 (12%) 2 (5%)
Skin (50) (50)
Cyst Epithelial Inclusion 1 (2%) 1 (2%)
Hyperkeratosis 1 (2%)
Subcutaneous Tissue, Fibrosis 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50)
Femur, Osteopetrosis 2 (4%)
Skeletal Muscle (1) (5)
Hemorrhage 3 (60%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50)
Compression 2 (4%)
Hydrocephalus 1 (2%)
Spinal Cord (5)
Hemorrhage 1 (20%)
Necrosis 1 (20%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50)
Edema 5 (10%)
Hemorrhage 1 (2%) 21 (42%)
Infiltration Cellular, Polymorphonuclear 1 (2%)
Infiltration Cellular, Histiocyte 42 (84%) 32 (64%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:05:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 1.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Metaplasia, Osseous 2 (4%) 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (6%) 1 (2%)
Nose (50) (50)
Foreign Body 5 (10%) 5 (10%)
Hemorrhage 1 (2%) 2 (4%)
Inflammation, Chronic 7 (14%) 5 (10%)
Respiratory Epithelium, Hyperplasia 7 (14%) 6 (12%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Glomerulosclerosis 1 (2%)
Hydronephrosis 2 (4%)
Infarct 1 (2%)
Inflammation, Suppurative 1 (2%)
Nephropathy 47 (94%) 38 (76%)
Renal Tubule, Hyaline Droplet 1 (2%) 3 (6%)
Renal Tubule, Necrosis 6 (12%)
Renal Tubule, Pigmentation 1 (2%) 4 (8%)
Transitional Epithelium, Hyperplasia 2 (4%)
Urinary Bladder (50) (50)
Hemorrhage 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
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