TDMS Study 99039-01 Pathology Tables
NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03
Route: DOSED FEED Time: 10:22:02
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
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NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03
Route: DOSED FEED Time: 10:22:02
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.3 % 1.0% 3.0%
CONTROL
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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
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ALIMENTARY SYSTEM
Liver (15) (2) (15)
Stomach, Forestomach (14) (9) (10) (14)
Squamous Cell Papilloma 7 (50%) 6 (67%) 9 (90%) 8 (57%)
Squamous Cell Papilloma, Multiple 2 (14%) 1 (11%)
Tongue (15) (1) (15)
Squamous Cell Carcinoma, Metastatic,
Uncertain Primary Site 1 (7%)
Tooth (2) (1) (6) (4)
Odontogenic Tumor 2 (100%) 6 (100%) 3 (75%)
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CARDIOVASCULAR SYSTEM
None
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ENDOCRINE SYSTEM
Pituitary Gland (12) (14)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
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NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03
Route: DOSED FEED Time: 10:22:02
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.3 % 1.0% 3.0%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Uterus (13) (2) (1) (14)
Sarcoma Stromal 1 (7%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Spleen (15) (3) (15)
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INTEGUMENTARY SYSTEM
Skin (15) (5) (6) (15)
Squamous Cell Papilloma 1 (7%) 2 (40%) 3 (50%) 1 (7%)
Lip, Squamous Cell Papilloma 2 (33%)
Vulva, Squamous Cell Papilloma 2 (13%) 2 (40%) 2 (33%) 3 (20%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15)
Alveolar/Bronchiolar Adenoma 1 (7%) 1 (7%)
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SPECIAL SENSES SYSTEM
Harderian Gland (14) (1) (15)
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NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03
Route: DOSED FEED Time: 10:22:02
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.3 % 1.0% 3.0%
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (1) (15)
Urinary Bladder (13) (15)
Transitional Epithelium, Papilloma 1 (7%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(15) *(14) *(14) *(15)
Leukemia Erythrocytic 2 (13%) 1 (7%) 1 (7%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
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NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03
Route: DOSED FEED Time: 10:22:02
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.3 % 1.0% 3.0%
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 12 10 13 13
Total Primary Neoplasms 17 12 22 19
Total Animals with Benign Neoplasms 11 9 10 10
Total Benign Neoplasms 13 11 16 14
Total Animals with Malignant Neoplasms 2 1 2
Total Malignant Neoplasms 2 1 2
Total Animals with Metastatic Neoplasms 1
Total Metastatic Neoplasm 1
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 2 6 3
Total Uncertain Neoplasms 2 6 3
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 5
NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03
Route: DOSED FEED Time: 10:22:02
____________________________________________________________________________________________________________________________________
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)
Stomach, Forestomach (15) (6) (3) (15)
Squamous Cell Papilloma 5 (33%) 4 (67%) 2 (67%) 6 (40%)
Tooth (4) (3) (2)
Odontogenic Tumor 4 (100%) 3 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Thyroid Gland (15) (15)
Adenoma 1 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
None
____________________________________________________________________________________________________________________________________
Page 6
NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03
Route: DOSED FEED Time: 10:22:02
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.3% 1.0 % 3.0 %
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (15) (15)
Spleen (15) (1) (1) (15)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (15) (7) (8) (15)
Squamous Cell Papilloma 1 (7%) 1 (14%) 2 (25%) 4 (27%)
Dermis, Mast Cell Tumor Benign 1 (7%)
Lip, Squamous Cell Papilloma 2 (13%) 3 (43%) 5 (63%) 2 (13%)
Pinna, Squamous Cell Papilloma 1 (13%)
Prepuce, Squamous Cell Papilloma 1 (7%)
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MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15)
Alveolar/Bronchiolar Adenoma 1 (7%) 1 (7%) 2 (13%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (15) (15)
Adenoma 1 (7%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
None
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NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03
Route: DOSED FEED Time: 10:22:02
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.3% 1.0 % 3.0 %
CONTROL
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(15) *(15) *(15) *(15)
Leukemia Erythrocytic 1 (7%) 1 (7%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 8
NTP Experiment-Test: 99039-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03
Route: DOSED FEED Time: 10:22:02
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.3% 1.0 % 3.0 %
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 12 10 10 10
Total Primary Neoplasms 16 12 11 17
Total Animals with Benign Neoplasms 9 8 9 9
Total Benign Neoplasms 12 9 10 15
Total Animals with Malignant Neoplasms 1 1
Total Malignant Neoplasms 1 1
Total Animals with Metastatic Neoplasms
Total Metastatic Neoplasm
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 4 3 1
Total Uncertain Neoplasms 4 3 1
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
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