TDMS Study 99033-01 Pathology Tables
NTP Experiment-Test: 99033-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02
Study Type: SPECIAL STUDY TRANSGENIC MODEL EVALUATION II(ASPARTAME) Date: 06/05/02
Route: DOSED FEED Time: 11:40:23
FINAL/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 001 VEHICLE CONTROL
Include 002 3125 PPM
Include 003 6250 PPM
Include 004 12500 PPM
Include 005 25000 PPM
Include 006 50000 PPM
Include 008 VEHICLE CONTROL
Include 009 3125 PPM
Include 010 6250 PPM
Include 011 12500 PPM
Include 012 25000 PPM
Include 013 50000 PPM
a Number of animals examined microscopically at site and number of animals with lesion
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NTP Experiment-Test: 99033-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02
Study Type: SPECIAL STUDY TRANSGENIC MODEL EVALUATION II(ASPARTAME) Date: 06/05/02
Route: DOSED FEED Time: 11:40:23
____________________________________________________________________________________________________________________________________
MICE:TGAC (FVB/N) HEMIZYGOUS 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 3 2 3 4 3 2
Natural Death 1 3 3 2 1 5
Survivors
Terminal Sacrifice 11 10 9 9 11 8
Animals Examined Microscopically 15 15 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (15) (15) (14) (15) (14) (11)
Leukemia Erythrocytic 1 (7%) 3 (20%) 1 (7%) 1 (9%)
Sarcoma Stromal, Metastatic, Uterus 1 (7%)
Salivary Glands (15) (1) (11)
Duct, Carcinoma 1 (100%) 1 (9%)
Stomach, Forestomach (14) (13) (13) (15) (14) (10)
Squamous Cell Papilloma 2 (14%) 6 (46%) 1 (8%) 7 (47%) 3 (21%) 5 (50%)
Squamous Cell Papilloma, Multiple 2 (14%) 3 (23%) 3 (23%) 4 (29%)
Tooth (4) (4) (2) (5) (5) (1)
Odontoma 3 (75%) 4 (100%) 2 (100%) 5 (100%) 5 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Pituitary Gland (13) (11) (12) (10) (11) (9)
Leukemia Erythrocytic 1 (9%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
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NTP Experiment-Test: 99033-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02
Study Type: SPECIAL STUDY TRANSGENIC MODEL EVALUATION II(ASPARTAME) Date: 06/05/02
Route: DOSED FEED Time: 11:40:23
____________________________________________________________________________________________________________________________________
MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (15) (15) (13) (14) (14) (10)
Leukemia Erythrocytic 1 (7%)
Uterus (15) (13) (13) (12) (14) (10)
Sarcoma Stromal 1 (8%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (1) (1)
Pancreatic, Sarcoma Stromal, Metastatic,
Uterus 1 (100%)
Lymph Node, Mediastinal (12) (11) (11) (12) (11) (10)
Carcinoma, Metastatic, Salivary Glands 1 (8%)
Spleen (15) (14) (14) (12) (14) (11)
Leukemia Erythrocytic 1 (7%) 3 (21%) 1 (7%) 1 (9%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (15) (3) (1) (3) (12)
Squamous Cell Papilloma 2 (67%) 1 (100%)
Vulva, Squamous Cell Papilloma 1 (7%) 1 (33%) 2 (67%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (15) (12) (13) (13) (14) (10)
Leukemia Erythrocytic 1 (8%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (14) (14) (15) (14) (10)
Alveolar/Bronchiolar Adenoma 1 (7%)
Carcinoma, Metastatic, Salivary Glands 1 (7%)
Leukemia Erythrocytic 1 (7%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 99033-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02
Study Type: SPECIAL STUDY TRANSGENIC MODEL EVALUATION II(ASPARTAME) Date: 06/05/02
Route: DOSED FEED Time: 11:40:23
____________________________________________________________________________________________________________________________________
MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (14) (12) (13) (14) (14) (10)
Leukemia Erythrocytic 1 (8%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(15) *(15) *(15) *(15) *(15) *(15)
Leukemia Erythrocytic 1 (7%) 3 (20%) 1 (7%) 1 (7%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 4
NTP Experiment-Test: 99033-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02
Study Type: SPECIAL STUDY TRANSGENIC MODEL EVALUATION II(ASPARTAME) Date: 06/05/02
Route: DOSED FEED Time: 11:40:23
____________________________________________________________________________________________________________________________________
MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 7 12 8 11 11 7
Total Primary Neoplasms 10 19 8 14 14 8
Total Animals with Benign Neoplasms 7 12 7 9 11 5
Total Benign Neoplasms 9 16 7 12 14 6
Total Animals with Malignant Neoplasms 1 3 1 2 2
Total Malignant Neoplasms 1 3 1 2 2
Total Animals with Metastatic Neoplasms 2
Total Metastatic Neoplasm 4
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
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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NTP Experiment-Test: 99033-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02
Study Type: SPECIAL STUDY TRANSGENIC MODEL EVALUATION II(ASPARTAME) Date: 06/05/02
Route: DOSED FEED Time: 11:40:23
____________________________________________________________________________________________________________________________________
MICE:TGAC (FVB/N) HEMIZYGOUS 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 3 3 1 1 1
Moribund Sacrifice 3 3 4 2 3 4
Survivors
Terminal Sacrifice 9 12 8 12 11 10
Animals Examined Microscopically 15 15 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (13) (15) (14) (15) (14) (14)
Leukemia Erythrocytic 1 (8%) 1 (7%) 2 (13%)
Lymphoma Malignant 1 (7%)
Salivary Glands (13) (2) (2) (14)
Duct, Carcinoma 2 (100%) 1 (50%) 1 (7%)
Stomach, Forestomach (12) (15) (13) (14) (14) (14)
Squamous Cell Papilloma 4 (33%) 1 (7%) 1 (8%) 3 (21%) 4 (29%) 5 (36%)
Squamous Cell Papilloma, Multiple 4 (33%) 4 (27%) 1 (8%) 2 (14%) 2 (14%) 1 (7%)
Tooth (4) (4) (2) (2) (2) (6)
Odontogenic Tumor 2 (50%) 4 (100%) 2 (100%) 2 (100%) 2 (100%) 5 (83%)
Odontoma 1 (17%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (12) (15) (13) (14) (15) (13)
Leukemia Erythrocytic 1 (8%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
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NTP Experiment-Test: 99033-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02
Study Type: SPECIAL STUDY TRANSGENIC MODEL EVALUATION II(ASPARTAME) Date: 06/05/02
Route: DOSED FEED Time: 11:40:23
____________________________________________________________________________________________________________________________________
MICE:TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
None
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (12) (15) (13) (14) (14) (14)
Lymphoma Malignant 1 (7%)
Lymph Node, Mesenteric (13) (15) (13) (14) (15) (14)
Lymphoma Malignant 1 (7%)
Lymph Node, Mediastinal (11) (13) (11) (10) (14) (13)
Leukemia Erythrocytic 1 (9%)
Lymphoma Malignant 1 (8%)
Spleen (13) (15) (13) (15) (14) (14)
Leukemia Erythrocytic 1 (8%) 1 (8%) 2 (13%)
Thymus (12) (14) (12) (13) (14) (12)
Lymphoma Malignant 1 (8%) 1 (8%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (13) (2) (1) (14)
Squamous Cell Papilloma 2 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (12) (15) (14) (15) (14) (14)
Alveolar/Bronchiolar Adenoma 2 (14%) 1 (7%) 2 (14%) 2 (14%)
Leukemia Erythrocytic 1 (7%) 1 (7%)
Lymphoma Malignant 1 (7%) 1 (7%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 99033-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02
Study Type: SPECIAL STUDY TRANSGENIC MODEL EVALUATION II(ASPARTAME) Date: 06/05/02
Route: DOSED FEED Time: 11:40:23
____________________________________________________________________________________________________________________________________
MICE:TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (12) (14)
Adenoma 1 (7%)
Zymbal's Gland (12) (1) (14)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (13) (15) (13) (15) (14) (14)
Leukemia Erythrocytic 1 (7%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(15) *(15) *(15) *(15) *(15) *(15)
Leukemia Erythrocytic 1 (7%) 1 (7%) 2 (13%)
Lymphoma Malignant 1 (7%) 1 (7%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 8
NTP Experiment-Test: 99033-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02
Study Type: SPECIAL STUDY TRANSGENIC MODEL EVALUATION II(ASPARTAME) Date: 06/05/02
Route: DOSED FEED Time: 11:40:23
____________________________________________________________________________________________________________________________________
MICE:TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000
CONTROL PPM PPM PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 10 9 7 8 11 11
Total Primary Neoplasms 11 11 10 10 13 17
Total Animals with Benign Neoplasms 8 6 3 5 8 8
Total Benign Neoplasms 8 7 4 6 9 10
Total Animals with Malignant Neoplasms 1 4 2 2 2
Total Malignant Neoplasms 1 4 2 2 2
Total Animals with Metastatic Neoplasms
Total Metastatic Neoplasm
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 2 4 2 2 2 5
Total Uncertain Neoplasms 2 4 2 2 2 5
____________________________________________________________________________________________________________________________________
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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