TDMS Study 99033-03 Pathology Tables
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:45:56
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
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:45:56
____________________________________________________________________________________________________________________________________
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 [2.0]
Infiltration Cellular, Focal, Lymphocyte 1 [1.0]
Infiltration Cellular, Lymphocyte 1 [2.0]
Inflammation, Chronic Active 1 [1.0]
Necrosis, Focal 1 [1.0] 2 [1.0]
Hepatocyte, Necrosis, Focal 1 [1.0]
Hepatocyte, Periportal, Vacuolization
Cytoplasmic 2 [1.0]
Salivary Glands (15) (15)
Infiltration Cellular, Focal, Lymphocyte 4 [1.0] 5 [1.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (15) (15) (15) (15) (15) (15)
Myocardium, Necrosis, Focal 1 [1.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (13) (15) (15) (15)
Accessory Adrenal Cortical Nodule 1 [1.0]
Subcapsular, Hyperplasia, Focal 14 [1.1] 15 [1.2] 12 [1.4] 15 [1.1] 15 [1.1] 15 [1.1]
Thyroid Gland (15) (15) (15) (15) (15) (15)
Ectopic Thymus 2 [1.0]
Ultimobranchial Cyst 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 2
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:45:56
____________________________________________________________________________________________________________________________________
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 [2.0]
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (15) (15) (15) (15) (15) (15)
Cyst 1
Uterus (15) (15) (15) (15) (15) (15)
Endometrium, Hyperplasia, Cystic 14 [1.9] 13 [1.9] 13 [2.0] 15 [2.1] 15 [1.9] 14 [1.9]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (14) (15) (13) (15) (15) (15)
Hyperplasia 1 [2.0]
Inflammation, Chronic Active 1 [3.0]
Lymph Node, Mesenteric (14) (15) (14) (15) (15) (14)
Hyperplasia, Histiocytic 1 [3.0]
Spleen (15) (15) (14) (15) (15) (15)
Accessory Spleen 1 [2.0]
Hematopoietic Cell Proliferation 5 [2.2] 2 [1.5] 4 [1.8] 3 [2.0] 2 [2.0] 3 [2.0]
Pigmentation 1 [1.0]
Thymus (14) (15) (14) (14) (15) (15)
Atrophy, Diffuse 1 [1.0]
Atrophy, Focal 1 [2.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (15) (15)
Cranium, Osteoporosis 1 [1.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (14) (14) (15) (15) (15)
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: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:45:56
____________________________________________________________________________________________________________________________________
P16(INK4A)/(+/-) (C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM - CONT
Granuloma 1 [2.0]
Cerebellum, Medulla, Vacuolization
Cytoplasmic 1 [1.0]
Spinal Cord (1)
Vacuolization Cytoplasmic 1 [3.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (14) (14) (15) (15) (15)
Alveolar Epithelium, Hyperplasia, Focal 1 [1.0]
Alveolus, Crystals 1 [4.0]
Nose (15) (15)
Olfactory Epithelium, Atrophy 1 [1.0]
Olfactory Epithelium, Hyaline Droplet 2 [2.0] 3 [1.7]
Respiratory Epithelium, Hyaline Droplet 1 [2.0] 2 [1.5]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (14) (15)
Cataract 1
Harderian Gland (15) (15)
Hyperplasia 1 [3.0]
Infiltration Cellular, Lymphocyte 1 [1.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (15) (13) (15) (15) (15)
Nephropathy 1 [1.0] 1 [1.0]
Glomerulus, Hyalinization 1 [2.0]
Renal Tubule, Dilatation, Diffuse 1 [2.0] 1 [2.0] 1 [2.0]
Renal Tubule, Dilatation, Focal 10 [1.0] 7 [1.0] 5 [1.0] 5 [1.0] 5 [1.0] 9 [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: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:45:56
____________________________________________________________________________________________________________________________________
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 [1.0] 1 [1.0]
Inflammation, Acute 2 [1.0]
Necrosis, Focal 2 [1.5] 3 [1.0] 1 [1.0] 4 [1.3]
Hepatocyte, Necrosis, Focal 1 [1.0] 1 [1.0] 1 [1.0] 1 [1.0]
Hepatocyte, Vacuolization Cytoplasmic,
Diffuse 1 [1.0]
Hepatocyte, Periportal, Vacuolization
Cytoplasmic 6 [1.0] 11 [1.5] 14 [1.2] 8 [1.1] 13 [1.1] 13 [1.5]
Salivary Glands (15) (15)
Infiltration Cellular, Focal, Lymphocyte 12 [1.0] 11 [1.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (14) (15) (15)
Accessory Adrenal Cortical Nodule 1 [1.0]
Subcapsular, Hyperplasia, Focal 2 [1.0] 1 [1.0] 1 [1.0] 4 [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: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:45:56
____________________________________________________________________________________________________________________________________
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 [2.0]
Bilateral, Spermatozoa, Degeneration 1 [1.0]
Testes (15) (15) (15) (14) (14) (15)
Germinal Epithelium, Degeneration 1 [2.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (15) (15) (15) (14) (14) (15)
Hyperplasia 1 [2.0] 1 [2.0]
Necrosis 1 [1.0]
Lymph Node, Mesenteric (15) (15) (15) (14) (14) (15)
Hyperplasia 2 [2.0]
Spleen (15) (15) (15) (14) (15) (15)
Atrophy, Diffuse 1 [4.0] 1 [4.0]
Hematopoietic Cell Proliferation 1 [2.0] 2 [3.0] 3 [2.0] 1 [4.0]
Pigmentation 1 [1.0]
Lymphoid Follicle, Atrophy 1 [1.0]
Thymus (15) (14) (15) (13) (15) (15)
Atrophy, Diffuse 1 [3.0] 1 [1.0] 1 [4.0]
Atrophy, Focal 1 [2.0] 2 [1.0] 1 [1.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (15) (15) (14) (15) (15)
Cerebellum, Medulla, Vacuolization
Cytoplasmic 1 [1.0] 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 6
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 03/05/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ASPARTAME) Time: 11:45:56
____________________________________________________________________________________________________________________________________
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 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (15) (15)
Infiltration Cellular, Lymphocyte 2 [1.0] 2 [1.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (15) (15) (14) (15) (15)
Nephropathy 2 [1.0] 7 [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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