TDMS Study 99035-01 Pathology Tables
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04
Route: GAVAGE Time: 12:51:24
FINAL #1
Facility: Battelle Columbus Laboratory
Chemical CAS #: 556-52-5
Lock Date: 09/24/01
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: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04
Route: GAVAGE Time: 12:51:24
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 15 15 15 15 15
Early Deaths
Moribund Sacrifice 2 1 2 1 4
Natural Death 1 2
Survivors
Terminal Sacrifice 13 14 12 14 9
Animals Examined Microscopically 15 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (15) (15) (15) (15) (15)
Angiectasis, Focal 1 (7%) 2 (13%)
Eosinophilic Focus 1 (7%)
Hematopoietic Cell Proliferation 2 (13%) 3 (20%) 1 (7%) 1 (7%) 2 (13%)
Infiltration Cellular, Lymphoid 3 (20%) 1 (7%) 1 (7%) 1 (7%)
Inflammation 1 (7%)
Inflammation, Chronic 11 (73%) 10 (67%) 8 (53%) 8 (53%) 7 (47%)
Mixed Cell Focus 1 (7%) 1 (7%)
Necrosis, Focal 5 (33%) 2 (13%) 2 (13%)
Midzonal, Fatty Change 1 (7%)
Stomach, Forestomach (15) (15) (15) (15) (15)
Epithelium, Hyperplasia 1 (7%) 4 (27%)
Stomach, Glandular (15) (15) (15) (15) (15)
Metaplasia, Squamous 1 (7%)
Mineralization 4 (27%) 2 (13%)
Epithelium, Ectasia 1 (7%)
Muscularis, Mineralization 2 (13%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (15) (15) (15) (15) (15)
Inflammation, Chronic 1 (7%)
Myocardium, Mineralization 1 (7%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (15) (15)
Hematopoietic Cell Proliferation 1 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04
Route: GAVAGE Time: 12:51:24
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia, Focal 2 (13%) 1 (7%)
Mineralization 1 (7%)
Vacuolization Cytoplasmic, Focal 1 (7%)
Subcapsular, Hyperplasia 15 (100%) 15 (100%) 10 (67%) 14 (93%) 15 (100%)
Pituitary Gland (15) (15) (15) (15) (15)
Necrosis 1 (7%)
Pars Distalis, Hyperplasia, Focal 1 (7%) 1 (7%) 2 (13%) 1 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (1)
Pigmentation, Melanin 1 (100%)
Ovary (15) (15) (15) (15) (15)
Cyst 4 (27%) 2 (13%)
Uterus (15) (15) (15) (15) (15)
Endometrium, Hyperplasia, Cystic 13 (87%) 14 (93%) 10 (67%) 14 (93%) 9 (60%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (15) (15) (15) (15) (15)
Hyperplasia 1 (7%)
Lymph Node (13) (15) (15) (13) (14)
Lumbar, Hyperplasia, Lymphoid 1 (7%)
Mediastinal, Hyperplasia, Lymphoid 2 (15%) 1 (7%)
Pancreatic, Hyperplasia, Lymphoid 1 (7%)
Renal, Hyperplasia, Lymphoid 1 (7%)
Lymph Node, Mandibular (15) (15) (15) (15) (15)
Hyperplasia, Lymphoid 1 (7%) 1 (7%)
Lymph Node, Mesenteric (15) (15) (15) (15) (15)
Hyperplasia, Lymphoid 1 (7%)
Inflammation, Suppurative 1 (7%)
Spleen (15) (15) (15) (15) (15)
Hematopoietic Cell Proliferation 9 (60%) 5 (33%) 10 (67%) 10 (67%) 10 (67%)
Thymus (15) (15) (15) (15) (15)
Atrophy 2 (13%) 1 (7%) 3 (20%)
Hyperplasia, Lymphoid 1 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04
Route: GAVAGE Time: 12:51:24
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (15) (15) (15) (15) (15)
Hyperplasia 1 (7%)
Skin (15) (15) (15) (15) (15)
Subcutaneous Tissue, Edema 1 (7%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (15) (15) (15) (15) (15)
Hyperostosis 1 (7%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (15) (15) (15) (15)
Cerebellum, Gliosis 1 (7%)
Cerebellum, Neuronopathy 1 (7%) 3 (20%)
Cerebrum, Cyst Epithelial Inclusion 1 (7%)
Cerebrum, Hemorrhage 1 (7%)
Medulla, Gliosis 2 (13%)
Medulla, Neuronopathy 3 (20%)
Thalamus, Gliosis 1 (7%)
Thalamus, Neuronopathy 3 (20%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15) (15)
Inflammation 8 (53%) 8 (53%) 7 (47%) 5 (33%) 3 (20%)
Inflammation, Granulomatous 1 (7%)
Alveolar Epithelium, Hyperplasia, Focal 1 (7%) 2 (13%) 1 (7%) 1 (7%)
Arteriole, Inflammation, Acute 1 (7%)
Bronchus, Foreign Body 1 (7%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04
Route: GAVAGE Time: 12:51:24
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (15) (15) (15) (15)
Infiltration Cellular, Lymphoid 1 (7%)
Metaplasia, Osseous 1 (7%)
Nephropathy 12 (80%) 12 (80%) 10 (67%) 14 (93%) 9 (60%)
Renal Tubule, Accumulation, Hyaline Droplet 2 (13%) 1 (7%) 3 (20%)
Urinary Bladder (15) (15) (15) (15) (15)
Inflammation, Chronic 1 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04
Route: GAVAGE Time: 12:51:24
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 15 15 15 15 15
Early Deaths
Natural Death 2 1 1 1 3
Moribund Sacrifice 1 4
Dosing Accident 1
Survivors
Terminal Sacrifice 13 14 13 14 7
Animals Examined Microscopically 15 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (1)
Inflammation, Acute 1 (100%)
Intestine Small, Jejunum (15) (15) (15) (15) (15)
Peyer's Patch, Hyperplasia, Atypical 1 (7%)
Peyer's Patch, Hyperplasia, Lymphoid 1 (7%)
Liver (15) (15) (15) (15) (15)
Angiectasis, Focal 1 (7%)
Basophilic Focus 1 (7%)
Degeneration, Cystic 1 (7%)
Eosinophilic Focus 1 (7%)
Fatty Change, Focal 1 (7%)
Hematopoietic Cell Proliferation 1 (7%) 2 (13%) 1 (7%)
Hemorrhage 1 (7%)
Infiltration Cellular, Lymphoid 1 (7%) 2 (13%) 2 (13%) 1 (7%)
Inflammation, Chronic 6 (40%) 9 (60%) 8 (53%) 9 (60%) 2 (13%)
Mixed Cell Focus 1 (7%)
Necrosis, Focal 1 (7%) 2 (13%) 2 (13%) 5 (33%)
Mesentery (1)
Fat, Necrosis 1 (100%)
Stomach, Forestomach (15) (15) (15) (15) (15)
Inflammation, Chronic 1 (7%)
Ulcer 1 (7%) 3 (20%)
Epithelium, Hyperplasia 1 (7%) 1 (7%) 6 (40%)
Stomach, Glandular (15) (15) (15) (15) (15)
Inflammation, Chronic 1 (7%)
Mineralization 10 (67%) 5 (33%) 1 (7%)
Ulcer 1 (7%)
Epithelium, Hyperplasia 1 (7%)
Glands, Ectasia 1 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04
Route: GAVAGE Time: 12:51:24
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Muscularis, Mineralization 1 (7%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (15) (15) (15) (15) (15)
Infiltration Cellular, Mast Cell 1 (7%)
Epicardium, Inflammation, Chronic 1 (7%)
Myocardium, Degeneration 2 (13%) 2 (13%)
Myocardium, Mineralization 2 (13%) 1 (7%) 5 (33%)
Myocardium, Necrosis 2 (13%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (14) (15)
Hyperplasia, Focal 1 (7%) 1 (7%)
Subcapsular, Hyperplasia 1 (7%) 2 (13%) 2 (13%) 3 (21%) 1 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (15) (15) (15) (15) (15)
Fibrosis 1 (7%)
Preputial Gland (1)
Inflammation, Suppurative 1 (100%)
Testes (15) (15) (15) (15) (15)
Germinal Epithelium, Degeneration 1 (7%) 1 (7%)
Germinal Epithelium, Mineralization 1 (7%)
Germinal Epithelium, Necrosis 1 (7%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (14) (14) (15) (13) (13)
Mediastinal, Hyperplasia, Lymphoid 1 (7%)
Lymph Node, Mandibular (15) (15) (15) (15) (15)
Hyperplasia, Lymphoid 2 (13%) 1 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04
Route: GAVAGE Time: 12:51:24
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Inflammation, Suppurative 1 (7%)
Necrosis 1 (7%)
Lymph Node, Mesenteric (15) (15) (15) (14) (15)
Hematopoietic Cell Proliferation 1 (7%)
Hyperplasia, Lymphoid 2 (13%) 1 (7%) 1 (7%)
Inflammation, Suppurative 1 (7%) 1 (7%)
Necrosis 1 (7%)
Spleen (15) (15) (15) (15) (15)
Angiectasis 1 (7%)
Atrophy 1 (7%) 2 (13%)
Hematopoietic Cell Proliferation 4 (27%) 7 (47%) 7 (47%) 5 (33%) 5 (33%)
Thymus (15) (15) (15) (15) (15)
Atrophy 2 (13%) 1 (7%) 4 (27%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (15) (15) (15) (15) (15)
Ulcer 1 (7%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (15) (15) (15) (15) (15)
Hyperostosis 1 (7%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (15) (15) (15) (15)
Mineralization 1 (7%)
Cerebellum, Gliosis 2 (13%)
Cerebellum, Hemorrhage, Focal 1 (7%)
Cerebellum, Neuronopathy 3 (20%)
Cerebrum, Hemorrhage 1 (7%)
Cerebrum, Necrosis, Focal 2 (13%)
Hippocampus, Hemorrhage 1 (7%)
Hippocampus, Necrosis 1 (7%) 1 (7%)
Medulla, Gliosis 2 (13%)
Medulla, Neuronopathy 3 (20%)
Thalamus, Gliosis 2 (13%)
Thalamus, Neuronopathy 5 (33%)
Spinal Cord (1)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04
Route: GAVAGE Time: 12:51:24
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM - CONT
Axon, Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15) (15)
Hemorrhage 1 (7%)
Inflammation 3 (20%) 7 (47%) 5 (33%) 4 (27%) 2 (13%)
Inflammation, Granulomatous 1 (7%)
Alveolar Epithelium, Hyperplasia, Focal 2 (13%) 2 (13%) 2 (13%)
Bronchiole, Hyperplasia 1 (7%)
Vein, Thrombosis 1 (7%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (15) (15) (15) (15)
Hydronephrosis 1 (7%)
Infarct 1 (7%)
Nephropathy 4 (27%) 5 (33%) 5 (33%) 4 (27%) 4 (27%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (7%) 1 (7%)
Urinary Bladder (15) (15) (15) (15) (15)
Inflammation, Chronic 1 (7%)
Transitional Epithelium, Hyperplasia 1 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
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