TDMS Study 99033-02 Pathology Tables
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:39:05
FINAL #3/P53 MICE
Facility: BIORELIANCE
Chemical CAS #: 22839-47-0
Lock Date: 07/20/01
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: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:39:05
____________________________________________________________________________________________________________________________________
P53+/-(C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 15 15 15 15 15 15
Early Deaths
Moribund Sacrifice 1 1
Natural Death 1
Survivors
Terminal Sacrifice 14 14 14 15 15 15
Animals Examined Microscopically 15 15 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (15) (15) (15) (15) (15) (15)
Infiltration Cellular, Focal, Lymphocyte 4 [1.0] 3 [1.0] 4 [1.0] 6 [1.0] 4 [1.3] 4 [1.3]
Necrosis, Focal 1 [1.0]
Pigmentation, Focal, Hemosiderin 1 [3.0]
Tension Lipidosis 1
Hepatocyte, Necrosis, Focal 2 [1.0]
Hepatocyte, Vacuolization Cytoplasmic, Focal 1 [1.0]
Salivary Glands (15) (15)
Infiltration Cellular, Focal, Lymphocyte 6 [1.0] 8 [1.8]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (14) (15) (15) (15)
Hyperplasia, Focal 1 [1.0] 1 [1.0] 1 [1.0]
Subcapsular, Hyperplasia, Focal 12 [1.3] 13 [1.0] 13 [1.0] 15 [1.0] 15 [1.0] 15 [1.1]
Pituitary Gland (9) (14) (13) (14) (11) (14)
Pars Intermedia, Hypertrophy 1 [1.0] 2 [1.0] 2 [2.0]
Thyroid Gland (14) (13) (14) (14) (13) (15)
Ectopic Thymus 2 [1.0] 1 [1.0] 1 [1.0] 3 [1.0] 1 [1.0] 2 [1.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY 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 2
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:39:05
____________________________________________________________________________________________________________________________________
P53+/-(C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (15) (15) (14) (15) (15) (15)
Atrophy 1 [3.0]
Cyst 1 [3.0]
Uterus (15) (15) (15) (15) (15) (15)
Hydrometra 1 [2.0]
Endometrium, Hyperplasia, Cystic 14 [1.4] 14 [1.6] 15 [1.7] 14 [1.9] 15 [1.9] 15 [1.9]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (15) (13) (13) (15) (15) (14)
Congestion 1 [1.0]
Hyperplasia 1 [2.0] 2 [2.0] 1 [2.0] 1 [1.0]
Hyperplasia, Histiocytic 1 [2.0]
Hyperplasia, Lymphoid 2 [2.5]
Hyperplasia, Plasma Cell 1 [1.0]
Lymph Node, Mesenteric (15) (14) (14) (14) (15) (15)
Hyperplasia 1 [2.0]
Hyperplasia, Lymphoid 1 [2.0]
Lymph Node, Mediastinal (12) (13) (13) (12) (13) (15)
Hyperplasia, Lymphoid 1 [4.0]
Spleen (15) (15) (15) (15) (15) (15)
Depletion Cellular, Diffuse 1 [4.0]
Hematopoietic Cell Proliferation 3 [2.0] 4 [1.5] 1 [2.0] 3 [1.7] 1 [1.0] 1 [2.0]
Pigmentation 1 [1.0]
Thymus (14) (14) (14) (15) (15) (15)
Atrophy, Focal 1 [1.0]
Hyperplasia 1 [2.0] 1 [3.0]
Hyperplasia, Atypical, Focal 1 [2.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (15) (1) (15)
Femur, Fibrous Osteodystrophy, Focal 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: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:39:05
____________________________________________________________________________________________________________________________________
P53+/-(C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (14) (14) (15) (15) (15)
Medulla, Cyst Epithelial Inclusion 1 [1.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (14) (15) (15) (15)
Infiltration Cellular, Focal, Lymphocyte 1 [1.0] 1 [1.0] 1 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (15) (15)
Infiltration Cellular, Focal, Lymphocyte 1 [1.0] 3 [1.0]
Inflammation, Chronic Active 1 [2.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (14) (15) (15) (15) (15)
Infiltration Cellular, Focal, Lymphocyte 1 [1.0] 1 [1.0]
Glomerulus, Hyalinization 1 [1.0]
Renal Tubule, Dilatation, Diffuse 1 [2.0] 2 [2.0] 3 [1.3]
Renal Tubule, Dilatation, Focal 6 [1.2] 5 [1.0] 2 [1.0] 5 [1.0] 4 [1.0] 4 [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 4
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:39:05
____________________________________________________________________________________________________________________________________
P53+/-(C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 15 15 15 15 15 15
Early Deaths
Natural Death 1 1 1
Moribund Sacrifice 1 1
Survivors
Terminal Sacrifice 14 15 13 15 14 14
Animals Examined Microscopically 15 15 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (15) (15) (15) (15) (14) (15)
Infiltration Cellular, Focal, Lymphocyte 2 [1.0] 2 [1.0] 4 [1.0] 1 [1.0] 2 [1.0] 5 [1.0]
Inflammation, Chronic 1 [1.0]
Inflammation, Chronic Active 3 [1.0] 1 [1.0]
Necrosis, Focal 2 [1.5] 1 [1.0] 1 [1.0]
Hepatocyte, Periportal, Vacuolization
Cytoplasmic, Diffuse 2 [1.0] 4 [2.0]
Salivary Glands (15) (1) (1) (1) (15)
Infiltration Cellular, Focal, Lymphocyte 9 [1.2] 1 [2.0] 1 [1.0] 10 [1.0]
Tooth (1)
Peridontal Tissue, Cyst 1
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (15) (15) (15)
Atrophy 14 [1.4] 14 [1.1] 12 [1.3] 12 [1.2] 10 [1.3] 13 [1.3]
Hypertrophy, Focal 1 [1.0] 3 [1.0] 2 [1.0] 1 [1.0] 3 [1.0]
Subcapsular, Hyperplasia, Focal 1 [1.0] 2 [1.0] 1 [1.0] 2 [1.0] 1 [1.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY 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 5
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:39:05
____________________________________________________________________________________________________________________________________
P53+/-(C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (15) (15) (15) (15) (14) (15)
Epithelium, Degeneration, Focal 1 [3.0]
Testes (15) (15) (15) (15) (14) (15)
Mineralization, Focal 1 [1.0]
Germinal Epithelium, Degeneration, Diffuse 1 [2.0]
Germinal Epithelium, Degeneration, Focal 1 [1.0] 1 [2.0]
Rete Testes, Inflammation, Focal 1 [3.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (14) (15)
Hyperplasia 1 [2.0]
Lymph Node (1)
Iliac, Pigmentation, Focal 1 [1.0]
Lymph Node, Mandibular (14) (15) (14) (15) (14) (15)
Hyperplasia 3 [1.7] 2 [2.0]
Hyperplasia, Plasma Cell 1 [1.0] 2 [1.5]
Lymph Node, Mesenteric (14) (14) (15) (13) (14) (15)
Hyperplasia 1 [2.0]
Lymph Node, Mediastinal (13) (14) (14) (13) (12) (13)
Hyperplasia 1 [1.0]
Spleen (15) (15) (15) (15) (14) (15)
Atrophy 2 [1.5]
Hematopoietic Cell Proliferation 1 [2.0] 2 [3.0]
Hyperplasia, Lymphoid 1 [1.0]
Thymus (14) (15) (15) (14) (15) (14)
Atrophy, Diffuse 1 [4.0]
Atrophy, Focal 2 [2.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL 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 6
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:39:05
____________________________________________________________________________________________________________________________________
P53+/-(C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (14) (15) (15) (15) (14) (15)
Hydrocephalus 1 [2.0]
Corpus Callosum, Medulla, Vacuolization
Cytoplasmic, Focal 1 [1.0]
Medulla, Vacuolization Cytoplasmic, Focal 1 [1.0]
Ventricle, Hydrocephalus 1 [3.0]
Peripheral Nerve (1)
Vacuolization Cytoplasmic, Diffuse 1 [1.0]
Spinal Cord (1)
Vacuolization Cytoplasmic, Focal 1 [2.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15) (14) (15)
Infiltration Cellular, Focal, Lymphocyte 1 [1.0]
Inflammation, Chronic Active, Diffuse 1 [3.0]
Perivascular, Infiltration Cellular,
Lymphocyte 2 [1.0]
Nose (14) (15)
Inflammation, Acute 1 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (14) (1) (15)
Developmental Malformation 1 [3.0]
Harderian Gland (15) (15)
Infiltration Cellular, Focal, Lymphocyte 5 [1.0] 1 [1.0]
Inflammation, Chronic Active 1 [1.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (14) (15) (15) (15) (14) (15)
Infiltration Cellular, Focal, Lymphocyte 1 [1.0] 1 [1.0]
Nephropathy 4 [1.0] 3 [1.0]
Renal Tubule, Dilatation, Diffuse 2 [1.0] 1 [1.0] 1 [1.0]
Renal Tubule, Dilatation, Focal 2 [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
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