TDMS Study 99033-03 Pathology Tables
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:40:00
FINAL #3 TG:P16 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: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:40:00
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (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
Natural Death 2 2
Moribund Sacrifice 1
Survivors
Terminal Sacrifice 13 15 13 15 15 14
Animals Examined Microscopically 15 15 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (15) (15) (15) (15) (15) (15)
Hematopoietic Cell Proliferation 2 (13%)
Infiltration Cellular, Focal, Lymphocyte 1 (7%)
Infiltration Cellular, Lymphocyte 1 (7%)
Inflammation, Chronic Active 1 (7%)
Necrosis, Focal 1 (7%) 2 (13%)
Hepatocyte, Necrosis, Focal 1 (7%)
Hepatocyte, Periportal, Vacuolization
Cytoplasmic 2 (13%)
Salivary Glands (15) (15)
Infiltration Cellular, Focal, Lymphocyte 4 (27%) 5 (33%)
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CARDIOVASCULAR SYSTEM
Heart (15) (15) (15) (15) (15) (15)
Myocardium, Necrosis, Focal 1 (7%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (13) (15) (15) (15)
Accessory Adrenal Cortical Nodule 1 (7%)
Subcapsular, Hyperplasia, Focal 14 (93%) 15 (100%) 12 (92%) 15 (100%) 15 (100%) 15 (100%)
Thyroid Gland (15) (15) (15) (15) (15) (15)
Ectopic Thymus 2 (13%)
Ultimobranchial Cyst 1 (7%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
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NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:40:00
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Abdominal, Fat, Hemorrhage, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (15) (15) (15) (15) (15) (15)
Cyst 1 (7%)
Uterus (15) (15) (15) (15) (15) (15)
Endometrium, Hyperplasia, Cystic 14 (93%) 13 (87%) 13 (87%) 15 (100%) 15 (100%) 14 (93%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (14) (15) (13) (15) (15) (15)
Hyperplasia 1 (7%)
Inflammation, Chronic Active 1 (7%)
Lymph Node, Mesenteric (14) (15) (14) (15) (15) (14)
Hyperplasia, Histiocytic 1 (7%)
Spleen (15) (15) (14) (15) (15) (15)
Accessory Spleen 1 (7%)
Hematopoietic Cell Proliferation 5 (33%) 2 (13%) 4 (29%) 3 (20%) 2 (13%) 3 (20%)
Pigmentation 1 (7%)
Thymus (14) (15) (14) (14) (15) (15)
Atrophy, Diffuse 1 (7%)
Atrophy, Focal 1 (7%) 1 (7%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (15) (15)
Cranium, Osteoporosis 1 (7%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (14) (14) (15) (15) (15)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:40:00
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM - CONT
Granuloma 1 (7%)
Cerebellum, Medulla, Vacuolization
Cytoplasmic 1 (7%)
Spinal Cord (1)
Vacuolization Cytoplasmic 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (14) (14) (15) (15) (15)
Alveolar Epithelium, Hyperplasia, Focal 1 (7%)
Alveolus, Crystals 1 (7%)
Nose (15) (15)
Olfactory Epithelium, Atrophy 1 (7%)
Olfactory Epithelium, Hyaline Droplet 2 (13%) 3 (20%)
Respiratory Epithelium, Hyaline Droplet 1 (7%) 2 (13%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (14) (15)
Cataract 1 (7%)
Harderian Gland (15) (15)
Hyperplasia 1 (7%)
Infiltration Cellular, Lymphocyte 1 (7%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (15) (13) (15) (15) (15)
Nephropathy 1 (7%) 1 (7%)
Glomerulus, Hyalinization 1 (7%)
Renal Tubule, Dilatation, Diffuse 1 (7%) 1 (7%) 1 (7%)
Renal Tubule, Dilatation, Focal 10 (67%) 7 (47%) 5 (38%) 5 (33%) 5 (33%) 9 (60%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:40:00
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (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 1
Survivors
Terminal Sacrifice 14 14 15 14 14 15
Animals Examined Microscopically 15 15 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (15) (15) (15) (14) (15) (15)
Infiltration Cellular, Focal, Lymphocyte 3 (20%) 1 (7%)
Inflammation, Acute 2 (13%)
Necrosis, Focal 2 (13%) 3 (20%) 1 (7%) 4 (27%)
Hepatocyte, Necrosis, Focal 1 (7%) 1 (7%) 1 (7%) 1 (7%)
Hepatocyte, Vacuolization Cytoplasmic,
Diffuse 1 (7%)
Hepatocyte, Periportal, Vacuolization
Cytoplasmic 6 (40%) 11 (73%) 14 (93%) 8 (57%) 13 (87%) 13 (87%)
Salivary Glands (15) (15)
Infiltration Cellular, Focal, Lymphocyte 12 (80%) 11 (73%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (14) (15) (15)
Accessory Adrenal Cortical Nodule 1 (7%)
Subcapsular, Hyperplasia, Focal 2 (13%) 1 (7%) 1 (7%) 4 (27%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:40:00
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (15) (15) (15) (15) (15) (15)
Inflammation, Chronic Active, Focal 1 (7%)
Bilateral, Spermatozoa, Degeneration 1 (7%)
Testes (15) (15) (15) (14) (14) (15)
Germinal Epithelium, Degeneration 1 (7%) 1 (7%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (15) (15) (15) (14) (14) (15)
Hyperplasia 1 (7%) 1 (7%)
Necrosis 1 (7%)
Lymph Node, Mesenteric (15) (15) (15) (14) (14) (15)
Hyperplasia 2 (13%)
Spleen (15) (15) (15) (14) (15) (15)
Atrophy, Diffuse 1 (7%) 1 (7%)
Hematopoietic Cell Proliferation 1 (7%) 2 (13%) 3 (21%) 1 (7%)
Pigmentation 1 (7%)
Lymphoid Follicle, Atrophy 1 (7%)
Thymus (15) (14) (15) (13) (15) (15)
Atrophy, Diffuse 1 (7%) 1 (7%) 1 (7%)
Atrophy, Focal 1 (7%) 2 (14%) 1 (7%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (15) (15) (14) (15) (15)
Cerebellum, Medulla, Vacuolization
Cytoplasmic 1 (7%) 1 (7%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03
Route: DOSED FEED Time: 11:40:00
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15) (15) (15)
Infiltration Cellular, Focal, Lymphocyte 1 (7%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (15) (15)
Infiltration Cellular, Lymphocyte 2 (13%) 2 (13%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (15) (15) (14) (15) (15)
Nephropathy 2 (13%) 7 (47%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
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