TDMS Study 99033-03 Pathology Tables
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:41:46 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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:41:46 ____________________________________________________________________________________________________________________________________ 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 Gallbladder (12) (1) (14) Histiocytic Sarcoma 1 (100%) Intestine Large, Cecum (13) (1) (15) Leiomyoma 1 (100%) Liver (15) (15) (15) (15) (15) (15) Histiocytic Sarcoma 2 (13%) 1 (7%) 1 (7%) 2 (13%) Pancreas (15) (1) (15) Histiocytic Sarcoma 1 (100%) 1 (7%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (15) (15) (15) (15) (15) (15) Hemangiosarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Medulla (15) (15) (13) (13) (15) (15) Histiocytic Sarcoma 1 (7%) Pituitary Gland (10) (13) (13) (12) (11) (12) Adenoma 1 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:41:46 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (15) (15) (15) (15) (15) (15) Histiocytic Sarcoma 3 (20%) 2 (13%) 2 (13%) 2 (13%) 2 (13%) 2 (13%) Uterus (15) (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (15) (15) Histiocytic Sarcoma 4 (27%) 3 (20%) Lymph Node, Mandibular (14) (15) (13) (15) (15) (15) Histiocytic Sarcoma 1 (7%) Lymph Node, Mesenteric (14) (15) (14) (15) (15) (14) Histiocytic Sarcoma 1 (7%) Lymph Node, Mediastinal (14) (15) (12) (13) (12) (12) Histiocytic Sarcoma 1 (7%) Spleen (15) (15) (14) (15) (15) (15) Hemangiosarcoma 1 (7%) Histiocytic Sarcoma 1 (7%) 2 (13%) Thymus (14) (15) (14) (14) (15) (15) Histiocytic Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (13) (15) (15) (15) (15) (15) Hemangiosarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (15) (14) (14) (15) (15) (15) Meninges, Histiocytic Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:41:46 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (14) (14) (15) (15) (15) Alveolar/Bronchiolar Adenoma 1 (7%) Alveolar/Bronchiolar Carcinoma 1 (7%) Histiocytic Sarcoma 1 (7%) 1 (7%) 2 (13%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (15) (15) Adenoma 1 (7%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM None ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(15) *(15) *(15) *(15) *(15) *(15) Histiocytic Sarcoma 5 (33%) 2 (13%) 2 (13%) 2 (13%) 2 (13%) 3 (20%) Leukemia Erythrocytic 1 (7%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 4 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:41:46 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 6 3 5 2 3 6 Total Primary Neoplasms 6 3 5 2 3 6 Total Animals with Benign Neoplasms 1 1 1 1 Total Benign Neoplasms 1 1 1 1 Total Animals with Malignant Neoplasms 5 2 4 2 3 5 Total Malignant Neoplasms 5 2 4 2 3 5 Total Animals with Metastatic Neoplasms Total Metastatic Neoplasm 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 Page 5 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:41:46 ____________________________________________________________________________________________________________________________________ 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) Histiocytic Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (15) (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM None ____________________________________________________________________________________________________________________________________ Page 6 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:41:46 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (15) (15) Histiocytic Sarcoma 2 (13%) Lymph Node, Mandibular (15) (15) (15) (14) (14) (15) Histiocytic Sarcoma 1 (7%) Lymph Node, Mesenteric (15) (15) (15) (14) (14) (15) Histiocytic Sarcoma 1 (7%) Spleen (15) (15) (15) (14) (15) (15) Hemangiosarcoma 1 (7%) Histiocytic Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (15) (15) (15) (15) (15) Alveolar/Bronchiolar Adenoma 1 (7%) 1 (7%) Histiocytic Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:41:46 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (14) (15) (15) Histiocytic Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(15) *(15) *(15) *(15) *(15) *(15) Histiocytic Sarcoma 2 (13%) 1 (7%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 8 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:41:46 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 2 2 1 1 Total Primary Neoplasms 2 2 1 1 Total Animals with Benign Neoplasms 1 1 Total Benign Neoplasms 1 1 Total Animals with Malignant Neoplasms 2 2 Total Malignant Neoplasms 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 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 Page 9 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------