TDMS Study 99033-02 Pathology Tables
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:32:25
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
Page 1
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:32:25
____________________________________________________________________________________________________________________________________
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 (27%) 3 (20%) 4 (27%) 6 (40%) 4 (27%) 4 (27%)
Necrosis, Focal 1 (7%)
Pigmentation, Focal, Hemosiderin 1 (7%)
Tension Lipidosis 1 (7%)
Hepatocyte, Necrosis, Focal 2 (13%)
Hepatocyte, Vacuolization Cytoplasmic, Focal 1 (7%)
Salivary Glands (15) (15)
Infiltration Cellular, Focal, Lymphocyte 6 (40%) 8 (53%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (14) (15) (15) (15)
Hyperplasia, Focal 1 (7%) 1 (7%) 1 (7%)
Subcapsular, Hyperplasia, Focal 12 (80%) 13 (87%) 13 (93%) 15 (100%) 15 (100%) 15 (100%)
Pituitary Gland (9) (14) (13) (14) (11) (14)
Pars Intermedia, Hypertrophy 1 (8%) 2 (18%) 2 (14%)
Thyroid Gland (14) (13) (14) (14) (13) (15)
Ectopic Thymus 2 (14%) 1 (8%) 1 (7%) 3 (21%) 1 (8%) 2 (13%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:32:25
____________________________________________________________________________________________________________________________________
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 (7%)
Cyst 1 (7%)
Uterus (15) (15) (15) (15) (15) (15)
Hydrometra 1 (7%)
Endometrium, Hyperplasia, Cystic 14 (93%) 14 (93%) 15 (100%) 14 (93%) 15 (100%) 15 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (15) (13) (13) (15) (15) (14)
Congestion 1 (7%)
Hyperplasia 1 (7%) 2 (15%) 1 (7%) 1 (7%)
Hyperplasia, Histiocytic 1 (7%)
Hyperplasia, Lymphoid 2 (13%)
Hyperplasia, Plasma Cell 1 (7%)
Lymph Node, Mesenteric (15) (14) (14) (14) (15) (15)
Hyperplasia 1 (7%)
Hyperplasia, Lymphoid 1 (7%)
Lymph Node, Mediastinal (12) (13) (13) (12) (13) (15)
Hyperplasia, Lymphoid 1 (8%)
Spleen (15) (15) (15) (15) (15) (15)
Depletion Cellular, Diffuse 1 (7%)
Hematopoietic Cell Proliferation 3 (20%) 4 (27%) 1 (7%) 3 (20%) 1 (7%) 1 (7%)
Pigmentation 1 (7%)
Thymus (14) (14) (14) (15) (15) (15)
Atrophy, Focal 1 (7%)
Hyperplasia 1 (7%) 1 (7%)
Hyperplasia, Atypical, Focal 1 (7%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (15) (1) (15)
Femur, Fibrous Osteodystrophy, Focal 1 (7%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:32:25
____________________________________________________________________________________________________________________________________
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 (7%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (14) (15) (15) (15)
Infiltration Cellular, Focal, Lymphocyte 1 (7%) 1 (7%) 1 (7%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (15) (15)
Infiltration Cellular, Focal, Lymphocyte 1 (7%) 3 (20%)
Inflammation, Chronic Active 1 (7%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (14) (15) (15) (15) (15)
Infiltration Cellular, Focal, Lymphocyte 1 (7%) 1 (7%)
Glomerulus, Hyalinization 1 (7%)
Renal Tubule, Dilatation, Diffuse 1 (7%) 2 (14%) 3 (20%)
Renal Tubule, Dilatation, Focal 6 (40%) 5 (36%) 2 (13%) 5 (33%) 4 (27%) 4 (27%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:32:25
____________________________________________________________________________________________________________________________________
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 (13%) 2 (13%) 4 (27%) 1 (7%) 2 (14%) 5 (33%)
Inflammation, Chronic 1 (7%)
Inflammation, Chronic Active 3 (20%) 1 (7%)
Necrosis, Focal 2 (13%) 1 (7%) 1 (7%)
Hepatocyte, Periportal, Vacuolization
Cytoplasmic, Diffuse 2 (13%) 4 (27%)
Salivary Glands (15) (1) (1) (1) (15)
Infiltration Cellular, Focal, Lymphocyte 9 (60%) 1 (100%) 1 (100%) 10 (67%)
Tooth (1)
Peridontal Tissue, Cyst 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (15) (15) (15)
Atrophy 14 (93%) 14 (93%) 12 (80%) 12 (80%) 10 (67%) 13 (87%)
Hypertrophy, Focal 1 (7%) 3 (20%) 2 (13%) 1 (7%) 3 (20%)
Subcapsular, Hyperplasia, Focal 1 (7%) 2 (13%) 1 (7%) 2 (13%) 1 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:32:25
____________________________________________________________________________________________________________________________________
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 (7%)
Testes (15) (15) (15) (15) (14) (15)
Mineralization, Focal 1 (7%)
Germinal Epithelium, Degeneration, Diffuse 1 (7%)
Germinal Epithelium, Degeneration, Focal 1 (7%) 1 (7%)
Rete Testes, Inflammation, Focal 1 (7%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (14) (15)
Hyperplasia 1 (7%)
Lymph Node (1)
Iliac, Pigmentation, Focal 1 (100%)
Lymph Node, Mandibular (14) (15) (14) (15) (14) (15)
Hyperplasia 3 (20%) 2 (13%)
Hyperplasia, Plasma Cell 1 (7%) 2 (13%)
Lymph Node, Mesenteric (14) (14) (15) (13) (14) (15)
Hyperplasia 1 (7%)
Lymph Node, Mediastinal (13) (14) (14) (13) (12) (13)
Hyperplasia 1 (8%)
Spleen (15) (15) (15) (15) (14) (15)
Atrophy 2 (13%)
Hematopoietic Cell Proliferation 1 (7%) 2 (13%)
Hyperplasia, Lymphoid 1 (7%)
Thymus (14) (15) (15) (14) (15) (14)
Atrophy, Diffuse 1 (7%)
Atrophy, Focal 2 (14%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 99033-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:32:25
____________________________________________________________________________________________________________________________________
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 (7%)
Corpus Callosum, Medulla, Vacuolization
Cytoplasmic, Focal 1 (7%)
Medulla, Vacuolization Cytoplasmic, Focal 1 (7%)
Ventricle, Hydrocephalus 1 (7%)
Peripheral Nerve (1)
Vacuolization Cytoplasmic, Diffuse 1 (100%)
Spinal Cord (1)
Vacuolization Cytoplasmic, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15) (14) (15)
Infiltration Cellular, Focal, Lymphocyte 1 (7%)
Inflammation, Chronic Active, Diffuse 1 (7%)
Perivascular, Infiltration Cellular,
Lymphocyte 2 (14%)
Nose (14) (15)
Inflammation, Acute 1 (7%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (14) (1) (15)
Developmental Malformation 1 (100%)
Harderian Gland (15) (15)
Infiltration Cellular, Focal, Lymphocyte 5 (33%) 1 (7%)
Inflammation, Chronic Active 1 (7%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (14) (15) (15) (15) (14) (15)
Infiltration Cellular, Focal, Lymphocyte 1 (7%) 1 (7%)
Nephropathy 4 (29%) 3 (20%)
Renal Tubule, Dilatation, Diffuse 2 (13%) 1 (7%) 1 (7%)
Renal Tubule, Dilatation, Focal 2 (13%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
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