TDMS Study 99035-01 Pathology Tables
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/31/04
Route: GAVAGE TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Time: 13:23:06
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
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/31/04
Route: GAVAGE TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Time: 13:23:06
____________________________________________________________________________________________________________________________________
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 [1.0] 2 [1.0]
Eosinophilic Focus 1
Hematopoietic Cell Proliferation 2 [1.0] 3 [1.7] 1 [2.0] 1 [1.0] 2 [1.0]
Infiltration Cellular, Lymphoid 3 [1.7] 1 [1.0] 1 [1.0] 1 [1.0]
Inflammation 1 [1.0]
Inflammation, Chronic 11 [1.0] 10 [1.0] 8 [1.0] 8 [1.0] 7 [1.0]
Mixed Cell Focus 1 1
Necrosis, Focal 5 [1.6] 2 [1.0] 2 [2.0]
Midzonal, Fatty Change 1 [2.0]
Stomach, Forestomach (15) (15) (15) (15) (15)
Epithelium, Hyperplasia 1 [1.0] 4 [1.3]
Stomach, Glandular (15) (15) (15) (15) (15)
Metaplasia, Squamous 1 [2.0]
Mineralization 4 [1.3] 2 [1.0]
Epithelium, Ectasia 1 [1.0]
Muscularis, Mineralization 2 [1.5]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (15) (15) (15) (15) (15)
Inflammation, Chronic 1 [2.0]
Myocardium, Mineralization 1 [1.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (15) (15)
Hematopoietic Cell Proliferation 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 2
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/31/04
Route: GAVAGE TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Time: 13:23:06
____________________________________________________________________________________________________________________________________
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 [1.0] 1 [2.0]
Mineralization 1 [1.0]
Vacuolization Cytoplasmic, Focal 1 [1.0]
Subcapsular, Hyperplasia 15 [1.5] 15 [1.5] 10 [1.5] 14 [1.6] 15 [1.7]
Pituitary Gland (15) (15) (15) (15) (15)
Necrosis 1 [3.0]
Pars Distalis, Hyperplasia, Focal 1 [2.0] 1 [1.0] 2 [1.5] 1 [1.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (1)
Pigmentation, Melanin 1 [2.0]
Ovary (15) (15) (15) (15) (15)
Cyst 4 [1.0] 2 [2.0]
Uterus (15) (15) (15) (15) (15)
Endometrium, Hyperplasia, Cystic 13 [1.6] 14 [1.8] 10 [1.9] 14 [1.8] 9 [1.9]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (15) (15) (15) (15) (15)
Hyperplasia 1 [3.0]
Lymph Node (13) (15) (15) (13) (14)
Lumbar, Hyperplasia, Lymphoid 1 [1.0]
Mediastinal, Hyperplasia, Lymphoid 2 [2.5] 1 [3.0]
Pancreatic, Hyperplasia, Lymphoid 1 [4.0]
Renal, Hyperplasia, Lymphoid 1 [4.0]
Lymph Node, Mandibular (15) (15) (15) (15) (15)
Hyperplasia, Lymphoid 1 [3.0] 1 [3.0]
Lymph Node, Mesenteric (15) (15) (15) (15) (15)
Hyperplasia, Lymphoid 1 [2.0]
Inflammation, Suppurative 1 [2.0]
Spleen (15) (15) (15) (15) (15)
Hematopoietic Cell Proliferation 9 [1.8] 5 [2.8] 10 [2.5] 10 [1.6] 10 [2.1]
Thymus (15) (15) (15) (15) (15)
Atrophy 2 [2.5] 1 [2.0] 3 [3.3]
Hyperplasia, Lymphoid 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 3
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/31/04
Route: GAVAGE TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Time: 13:23:06
____________________________________________________________________________________________________________________________________
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 [2.0]
Skin (15) (15) (15) (15) (15)
Subcutaneous Tissue, Edema 1 [2.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (15) (15) (15) (15) (15)
Hyperostosis 1 [3.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (15) (15) (15) (15)
Cerebellum, Gliosis 1 [2.0]
Cerebellum, Neuronopathy 1 [1.0] 3 [2.7]
Cerebrum, Cyst Epithelial Inclusion 1
Cerebrum, Hemorrhage 1 [1.0]
Medulla, Gliosis 2 [1.5]
Medulla, Neuronopathy 3 [2.3]
Thalamus, Gliosis 1 [1.0]
Thalamus, Neuronopathy 3 [3.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15) (15)
Inflammation 8 [2.0] 8 [1.8] 7 [1.9] 5 [2.2] 3 [1.7]
Inflammation, Granulomatous 1 [1.0]
Alveolar Epithelium, Hyperplasia, Focal 1 [4.0] 2 [3.0] 1 [3.0] 1 [1.0]
Arteriole, Inflammation, Acute 1 [1.0]
Bronchus, Foreign Body 1 [2.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 4
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/31/04
Route: GAVAGE TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Time: 13:23:06
____________________________________________________________________________________________________________________________________
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 [3.0]
Metaplasia, Osseous 1 [1.0]
Nephropathy 12 [1.0] 12 [1.0] 10 [1.0] 14 [1.0] 9 [1.0]
Renal Tubule, Accumulation, Hyaline Droplet 2 [2.5] 1 [2.0] 3 [2.0]
Urinary Bladder (15) (15) (15) (15) (15)
Inflammation, Chronic 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 5
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/31/04
Route: GAVAGE TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Time: 13:23:06
____________________________________________________________________________________________________________________________________
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 [3.0]
Intestine Small, Jejunum (15) (15) (15) (15) (15)
Peyer's Patch, Hyperplasia, Atypical 1 [3.0]
Peyer's Patch, Hyperplasia, Lymphoid 1 [2.0]
Liver (15) (15) (15) (15) (15)
Angiectasis, Focal 1 [2.0]
Basophilic Focus 1
Degeneration, Cystic 1 [1.0]
Eosinophilic Focus 1
Fatty Change, Focal 1 [1.0]
Hematopoietic Cell Proliferation 1 [1.0] 2 [1.0] 1 [1.0]
Hemorrhage 1 [1.0]
Infiltration Cellular, Lymphoid 1 [1.0] 2 [1.0] 2 [1.0] 1 [1.0]
Inflammation, Chronic 6 [1.0] 9 [1.0] 8 [1.0] 9 [1.0] 2 [1.0]
Mixed Cell Focus 1
Necrosis, Focal 1 [3.0] 2 [2.0] 2 [2.5] 5 [2.2]
Mesentery (1)
Fat, Necrosis 1 [3.0]
Stomach, Forestomach (15) (15) (15) (15) (15)
Inflammation, Chronic 1 [3.0]
Ulcer 1 [2.0] 3 [1.7]
Epithelium, Hyperplasia 1 [2.0] 1 [2.0] 6 [2.5]
Stomach, Glandular (15) (15) (15) (15) (15)
Inflammation, Chronic 1 [2.0]
Mineralization 10 [1.5] 5 [1.6] 1 [1.0]
Ulcer 1 [2.0]
Epithelium, Hyperplasia 1 [1.0]
Glands, Ectasia 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 6
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/31/04
Route: GAVAGE TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Time: 13:23:06
____________________________________________________________________________________________________________________________________
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 [2.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (15) (15) (15) (15) (15)
Infiltration Cellular, Mast Cell 1 [1.0]
Epicardium, Inflammation, Chronic 1 [1.0]
Myocardium, Degeneration 2 [1.5] 2 [1.0]
Myocardium, Mineralization 2 [1.0] 1 [1.0] 5 [1.6]
Myocardium, Necrosis 2 [2.5]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (14) (15)
Hyperplasia, Focal 1 [1.0] 1 [2.0]
Subcapsular, Hyperplasia 1 [1.0] 2 [1.0] 2 [1.0] 3 [1.0] 1 [1.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (15) (15) (15) (15) (15)
Fibrosis 1 [3.0]
Preputial Gland (1)
Inflammation, Suppurative 1 [4.0]
Testes (15) (15) (15) (15) (15)
Germinal Epithelium, Degeneration 1 [2.0] 1 [3.0]
Germinal Epithelium, Mineralization 1 [1.0]
Germinal Epithelium, Necrosis 1 [1.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (14) (14) (15) (13) (13)
Mediastinal, Hyperplasia, Lymphoid 1 [3.0]
Lymph Node, Mandibular (15) (15) (15) (15) (15)
Hyperplasia, Lymphoid 2 [2.0] 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 7
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/31/04
Route: GAVAGE TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Time: 13:23:06
____________________________________________________________________________________________________________________________________
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 [3.0]
Necrosis 1 [3.0]
Lymph Node, Mesenteric (15) (15) (15) (14) (15)
Hematopoietic Cell Proliferation 1 [2.0]
Hyperplasia, Lymphoid 2 [2.0] 1 [3.0] 1 [4.0]
Inflammation, Suppurative 1 [2.0] 1 [3.0]
Necrosis 1 [2.0]
Spleen (15) (15) (15) (15) (15)
Angiectasis 1 [2.0]
Atrophy 1 [2.0] 2 [1.5]
Hematopoietic Cell Proliferation 4 [2.0] 7 [1.7] 7 [1.4] 5 [2.0] 5 [2.2]
Thymus (15) (15) (15) (15) (15)
Atrophy 2 [2.0] 1 [3.0] 4 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (15) (15) (15) (15) (15)
Ulcer 1 [2.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (15) (15) (15) (15) (15)
Hyperostosis 1 [1.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (15) (15) (15) (15)
Mineralization 1 [1.0]
Cerebellum, Gliosis 2 [1.5]
Cerebellum, Hemorrhage, Focal 1 [2.0]
Cerebellum, Neuronopathy 3 [3.3]
Cerebrum, Hemorrhage 1 [3.0]
Cerebrum, Necrosis, Focal 2 [3.0]
Hippocampus, Hemorrhage 1 [3.0]
Hippocampus, Necrosis 1 [3.0] 1 [3.0]
Medulla, Gliosis 2 [1.0]
Medulla, Neuronopathy 3 [1.0]
Thalamus, Gliosis 2 [1.0]
Thalamus, Neuronopathy 5 [2.2]
Spinal Cord (1)
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 8
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/31/04
Route: GAVAGE TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Time: 13:23:06
____________________________________________________________________________________________________________________________________
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 [2.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15) (15)
Hemorrhage 1 [3.0]
Inflammation 3 [2.0] 7 [2.3] 5 [2.4] 4 [2.0] 2 [1.5]
Inflammation, Granulomatous 1 [1.0]
Alveolar Epithelium, Hyperplasia, Focal 2 [1.0] 2 [1.0] 2 [1.5]
Bronchiole, Hyperplasia 1 [2.0]
Vein, Thrombosis 1 [3.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (15) (15) (15) (15)
Hydronephrosis 1 [4.0]
Infarct 1 [2.0]
Nephropathy 4 [1.0] 5 [1.0] 5 [1.0] 4 [1.0] 4 [1.0]
Renal Tubule, Accumulation, Hyaline Droplet 1 [3.0] 1 [2.0]
Urinary Bladder (15) (15) (15) (15) (15)
Inflammation, Chronic 1 [4.0]
Transitional Epithelium, Hyperplasia 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 9
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