TDMS Study 99039-01 Pathology Tables
NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 02/21/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Time: 10:27:24
FINAL#3/TG.AC MICE
Facility: BIORELIANCE
Chemical CAS #: 55589-62-3
Lock Date: 07/20/01
Cage Range: All
Reasons For Removal: All
Removal Date Range: All
Treatment Groups: Include 001 VEHICLE CONTROL
Include 002 0.3%
Include 003 1.0 %
Include 004 3.0 %
Include 006 VEHICLE CONTROL
Include 007 0.3 %
Include 008 1.0%
Include 009 3.0%
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 1
NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 02/21/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Time: 10:27:24
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.3 % 1.0% 3.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 15 15 15 15
Early Deaths
Moribund Sacrifice 1 2 2
Natural Death 2 3 1 1
Survivors
Accidently Killed 4 3 1
Terminal Sacrifice 8 9 11 12
Animals Examined Microscopically 15 14 14 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (15) (2) (15)
Inflammation, Chronic 2 [1.0] 3 [1.3]
Necrosis, Focal 1 [1.0]
Tension Lipidosis, Focal 1 [1.0]
Hepatocyte, Inflammation, Chronic 1 [1.0]
Hepatocyte, Necrosis, Focal 2 [1.0] 3 [1.0]
Mesentery (2) (1)
Fat, Inflammation, Acute, Focal 1 [4.0]
Fat, Necrosis, Focal 2 [4.0]
Tongue (15) (1) (15)
Ulcer 1 [3.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (14) (1) (15)
Subcapsular, Hyperplasia, Focal 9 [1.0] 6 [1.0]
Zona Reticularis, Vacuolization Cytoplasmic 9 [1.7] 10 [1.6]
____________________________________________________________________________________________________________________________________
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: 99039-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 02/21/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Time: 10:27:24
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.3 % 1.0% 3.0%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Uterus (13) (2) (1) (14)
Endometrium, Hyperplasia, Cystic 7 [1.9] 2 [2.5] 1 [3.0] 10 [1.7]
Vagina (13) (15)
Hyperplasia 1 [2.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (12) (1) (15)
Hyperplasia 1 [2.0] 3 [2.0]
Spleen (15) (3) (15)
Hematopoietic Cell Proliferation 12 [1.5] 3 [2.7] 13 [2.0]
Pigmentation 3 [1.3] 2 [1.0]
Thymus (11) (1) (14)
Atrophy, Diffuse 1 [3.0] 1 [4.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (14) (2) (1) (15)
Mandible, Inflammation, Chronic Active 1 [2.0] 1 [3.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15)
Hemorrhage, Focal 1 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
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: 99039-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 02/21/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Time: 10:27:24
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.3 % 1.0% 3.0%
CONTROL
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Eye (13) (14)
Retina, Atrophy 13 [3.0] 14 [3.0]
Harderian Gland (14) (1) (15)
Infiltration Cellular, Focal, Lymphocyte 1 [1.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (1) (15)
Renal Tubule, Dilatation, Focal 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 4
NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 02/21/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Time: 10:27:24
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.3% 1.0 % 3.0 %
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 15 15 15 15
Early Deaths
Moribund Sacrifice 2 4 2 1
Survivors
Terminal Sacrifice 6 9 7 11
Accidently Killed 7 2 6 3
Animals Examined Microscopically 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (15) (1) (15)
Hematopoietic Cell Proliferation 1 [1.0]
Inflammation, Chronic 1 [1.0]
Hepatocyte, Necrosis, Focal 1 [1.0]
Mesentery (2) (2)
Fat, Necrosis, Focal 2 [4.0] 2 [1.0]
Pancreas (15) (15)
Inflammation, Chronic Active 1 [1.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (14) (15)
Atrophy 10 [2.4] 11 [2.5]
Hypertrophy, Focal 9 [1.2] 5 [1.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (15) (1) (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 5
NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 02/21/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Time: 10:27:24
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.3% 1.0 % 3.0 %
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cyst 1 [1.0] 1 [3.0]
Testes (15) (15)
Germinal Epithelium, Degeneration, Focal 1 [3.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (15) (15)
Hyperplasia 1 [1.0]
Lymph Node, Mandibular (14) (15)
Hyperplasia 2 [3.0] 2 [2.0]
Spleen (15) (1) (1) (15)
Atrophy 1 [4.0]
Hematopoietic Cell Proliferation 10 [1.6] 1 [3.0] 7 [1.1]
Thymus (15) (14)
Atrophy, Diffuse 3 [3.7] 2 [2.5]
Atrophy, Focal 2 [1.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (15) (7) (8) (15)
Sebaceous Gland, Hyperplasia, Focal 1 [1.0]
Subcutaneous Tissue, Pinna, Inflammation,
Acute, Focal 1 [4.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15)
Alveolar Epithelium, Alveolus, Inflammation,
Chronic Active, Focal 1 [1.0]
Nose (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 6
NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 02/21/03
Route: DOSED FEED TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Time: 10:27:24
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.3% 1.0 % 3.0 %
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Glands, Hyperplasia 1 [2.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (15) (15)
Retina, Atrophy 15 [3.0] 14 [3.1]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (1) (15)
Infiltration Cellular, Plasma Cell 1 [3.0]
Renal Tubule, Dilatation, Diffuse 1 [4.0]
Renal Tubule, Dilatation, Focal 2 [1.5]
Urinary Bladder (15) (15)
Edema 1 [3.0]
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
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------