NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 Facility: Cancer Research Centre - Ramazzini Foundation Chemical CAS #: 22839-47-0 Lock Date: None 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: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 150 150 150 150 100 100 Early Deaths Natural Death 150 150 150 150 100 100 Survivors Animals Examined Microscopically 150 150 150 150 100 100 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Liver (149) (150) (149) (148) (99) (99) Adenocarcinoma, Metastatic, Intestine Large, Colon 1 (1%) Adenocarcinoma, Metastatic, Adrenal Cortex 1 (1%) 2 (1%) 2 (1%) 1 (1%) 2 (2%) Cholangiocarcinoma 1 (1%) 1 (1%) Cholangioma 1 (1%) 1 (1%) Fibroangioma 1 (1%) Fibrosarcoma, Metastatic, Peritoneum 1 (1%) Hemangioma 1 (1%) Hemangiosarcoma 1 (1%) Hepatocellular Carcinoma 1 (1%) Hepatocellular Adenoma 2 (1%) 1 (1%) 1 (1%) 1 (1%) 1 (1%) Histiocytic Sarcoma 3 (2%) 1 (1%) 3 (2%) 2 (2%) 5 (5%) Leukemia Granulocytic 1 (1%) 1 (1%) Leukemia Lymphocytic 1 (1%) 1 (1%) Leukemia Monocytic 1 (1%) 4 (3%) 4 (3%) 2 (2%) 2 (2%) Lymphoma Malignant 1 (1%) 2 (1%) 1 (1%) 1 (1%) 3 (3%) Mesothelioma Malignant 1 (1%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (1%) 1 (1%) Bile Duct, Cholangioma 2 (1%) 1 (1%) Stomach, Glandular (1) Lymphoma Lymphocytic 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM None ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (150) (148) (149) (150) (100) (97) Fibroangioma 1 (1%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (1%) Axillary, Adenocarcinoma, Metastatic, Mammary Gland 1 (1%) Axillary, Histiocytic Sarcoma 1 (1%) 1 (1%) 1 (1%) Axillary, Leukemia Monocytic 1 (1%) 1 (1%) Axillary, Inguinal, Histiocytic Sarcoma 1 (1%) Axillary, Inguinal, Liposarcoma, Metastatic, Mammary Gland 1 (1%) Axillary, Inguinal, Mediastinal, Leukemia Monocytic 1 (1%) Axillary, Inguinal, Mediastinal, Lymphoma Lymphocytic 1 (1%) Axillary, Inguinal, Mediastinal, Lymphoma Lymphoblastic 1 (1%) Axillary, Inguinal, Mesenteric, Histiocytic Sarcoma 2 (1%) 1 (1%) 1 (1%) 6 (6%) Axillary, Inguinal, Mesenteric, Leukemia Lymphoblastic 1 (1%) Axillary, Inguinal, Mesenteric, Leukemia Monocytic 1 (1%) 2 (1%) 1 (1%) 1 (1%) 2 (2%) Axillary, Inguinal, Mesenteric, Leukemia Myeloid 1 (1%) Axillary, Inguinal, Mesenteric, Lymphoma Page 3 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Lymphocytic 1 (1%) Axillary, Inguinal, Mesenteric, Lymphoma Lymphoblastic 1 (1%) 1 (1%) 2 (1%) Axillary, Inguinal, Mesenteric, Lymphoma Lympho-immunoblastic 1 (1%) 1 (1%) Axillary, Inguinal, Mandibular, Lymphoma Lymphocytic 1 (1%) Axillary, Mediastinal, Lymphoma Lymphoblastic 1 (1%) Axillary, Mediastinal, Mesenteric, Histiocytic Sarcoma 1 (1%) Axillary, Mediastinal, Mesenteric, Lymphoma Lympho-immunoblastic 1 (1%) Axillary, Mesenteric, Histiocytic Sarcoma 2 (1%) Axillary, Mesenteric, Mandibular, Histiocytic Sarcoma 1 (1%) Deep Cervical, Mediastinal, Mandibular, Leukemia Lymphoblastic 1 (1%) Iliac, Histiocytic Sarcoma 1 (1%) Inguinal, Fibroma 1 (1%) Inguinal, Histiocytic Sarcoma 1 (1%) Inguinal, Lymphoma Lympho-immunoblastic 1 (1%) Inguinal, Renal, Mediastinal, Lymphoma Lympho-immunoblastic 1 (1%) Inguinal, Mesenteric, Leukemia Monocytic 1 (1%) Inguinal, Mesenteric, Lymphoma Lympho-immunoblastic 1 (1%) Lumbar, Adenocarcinoma, Metastatic, Mammary Gland 1 (1%) Lumbar, Histiocytic Sarcoma 1 (1%) Lumbar, Schwannoma Malignant, Metastatic, Uterus 1 (1%) Mandibular, Liposarcoma, Metastatic, Tissue NOS 1 (1%) Mandibular, Squamous Cell Carcinoma, Metastatic, Zymbal's Gland 1 (1%) 1 (1%) Mandibular, Squamous Cell Carcinoma, Metastatic, Ear 1 (1%) Mediastinal, Adenocarcinoma, Metastatic, Adrenal Cortex 1 (1%) Mediastinal, Fibrosarcoma, Metastatic, Peritoneum 1 (1%) Mediastinal, Hemangioma 1 (1%) Page 4 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Mediastinal, Histiocytic Sarcoma 1 (1%) 3 (3%) 1 (1%) Mediastinal, Leukemia Monocytic 1 (1%) 1 (1%) Mediastinal, Lymphoma Lymphocytic 1 (1%) 2 (1%) 2 (1%) 1 (1%) 2 (2%) Mediastinal, Lymphoma Lymphoblastic 1 (1%) 2 (1%) 4 (3%) 4 (3%) 1 (1%) 1 (1%) Mediastinal, Lymphoma Lympho-immunoblastic 2 (1%) 1 (1%) 1 (1%) 1 (1%) 1 (1%) Mediastinal, Mesenteric, Histiocytic Sarcoma 1 (1%) Mediastinal, Mesenteric, Lymphoma Lymphoblastic 1 (1%) 1 (1%) Mediastinal, Mesenteric, Lymphoma Lympho-immunoblastic 1 (1%) Mediastinal, Mesenteric, Pancreatic, Leukemia Monocytic 1 (1%) Mediastinal, Mesenteric, Pancreatic, Lymphoma Lymphoblastic 1 (1%) Mediastinal, Mesenteric, Pancreatic, Lymphoma Lympho-immunoblastic 1 (1%) Mediastinal, Mesenteric, Mandibular, Histiocytic Sarcoma 1 (1%) Mediastinal, Pancreatic, Lymphoma Lymphocytic 1 (1%) Mediastinal, Pancreatic, Lymphoma Lymphoblastic 1 (1%) Mediastinal, Pancreatic, Mandibular, Histiocytic Sarcoma 1 (1%) Mediastinal, Pancreatic, Mandibular, Leukemia Monocytic 1 (1%) Mediastinal, Pancreatic, Mandibular, Leukemia Myeloid 1 (1%) Mediastinal, Mandibular, Histiocytic Sarcoma 1 (1%) Mediastinal, Mandibular, Leukemia Monocytic 1 (1%) 1 (1%) 1 (1%) Mesenteric, Fibroangioma 1 (1%) Mesenteric, Histiocytic Sarcoma 1 (1%) 1 (1%) Mesenteric, Leukemia Monocytic 2 (1%) Mesenteric, Lymphoma Lympho-immunoblastic 1 (1%) 1 (1%) 1 (1%) Mesenteric, Pancreatic, Leukemia Monocytic 1 (1%) Renal, Mediastinal, Histiocytic Sarcoma 1 (1%) Renal, Mediastinal, Lymphoma Lymphoblastic 2 (1%) Renal, Mediastinal, Mandibular, Histiocytic Sarcoma 1 (1%) Spleen (149) (150) (146) (149) (99) (98) Adenocarcinoma, Metastatic, Mammary Gland 1 (1%) Adenocarcinoma, Metastatic, Adrenal Cortex 1 (1%) 1 (1%) 1 (1%) Fibroangioma 1 (1%) 1 (1%) 3 (3%) 4 (4%) Fibroma 1 (1%) 2 (1%) 1 (1%) Page 5 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Hemangiosarcoma 1 (1%) Histiocytic Sarcoma 3 (2%) 2 (1%) 5 (3%) 4 (3%) 7 (7%) 5 (5%) Leukemia Lymphoblastic 1 (1%) Leukemia Monocytic 1 (1%) 5 (3%) 3 (2%) 1 (1%) 2 (2%) Leukemia Myeloid 1 (1%) 1 (1%) Lymphoma Lymphocytic 3 (2%) Lymphoma Lymphoblastic 1 (1%) 2 (1%) 2 (1%) 1 (1%) Lymphoma Lympho-immunoblastic 2 (1%) 1 (1%) 1 (1%) 2 (2%) Mesothelioma Malignant 1 (1%) 1 (1%) Thymus (149) (149) (147) (149) (99) (100) Adenocarcinoma, Metastatic, Adrenal Cortex 1 (1%) Histiocytic Sarcoma 1 (1%) 1 (1%) 1 (1%) 1 (1%) 3 (3%) 4 (4%) Leukemia Lymphoblastic 1 (1%) Leukemia Monocytic 2 (1%) 3 (2%) 1 (1%) 1 (1%) 2 (2%) Leukemia Myeloid 1 (1%) Lymphoma Lymphocytic 2 (1%) 3 (2%) 2 (1%) 1 (1%) 2 (2%) Lymphoma Lymphoblastic 2 (1%) 3 (2%) 6 (4%) 6 (4%) 1 (1%) 2 (2%) Lymphoma Lympho-immunoblastic 2 (1%) 2 (1%) 1 (1%) 1 (1%) 2 (2%) Thymoma Benign 2 (1%) 10 (7%) 4 (3%) 6 (4%) 5 (5%) 4 (4%) Thymoma Malignant 1 (1%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (150) (150) (150) (150) (100) (100) Glioma Malignant, Mixed 1 (1%) 1 (1%) Leukemia Lymphoblastic 1 (1%) Leukemia Myeloid 1 (1%) Lymphoma Lymphoblastic 1 (1%) 1 (1%) Cerebellum, Meninges, Cerebrum, Leukemia Monocytic 1 (1%) Cerebrum, Glioma Malignant, Mixed 1 (1%) Cerebrum, Leukemia Monocytic 1 (1%) Page 6 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - cont Cerebrum, Oligodendroglioma NOS 1 (1%) 1 (1%) Meninges, Leukemia Monocytic 2 (1%) Meninges, Lymphoma Lympho-immunoblastic 1 (1%) 1 (1%) 1 (1%) Meninges, Neoplasm NOS 1 (1%) 2 (1%) 2 (1%) 2 (2%) 1 (1%) Meninges, Squamous Cell Carcinoma, Metastatic, Ear 1 (1%) Meninges, Cerebrum, Lymphoma Lympho-immunoblastic 1 (1%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (149) (150) (148) (149) (99) (99) Adenocarcinoma, Metastatic, Mammary Gland 2 (1%) 2 (1%) 1 (1%) 1 (1%) 1 (1%) Adenocarcinoma, Metastatic, Adrenal Cortex 1 (1%) 2 (2%) Adenoma 1 (1%) Alveolar/Bronchiolar Adenoma 3 (2%) Fibroangioma 2 (1%) Fibrosarcoma 1 (1%) Histiocytic Sarcoma 1 (1%) 3 (2%) 2 (1%) 3 (2%) 6 (6%) 6 (6%) Leukemia Lymphoblastic 1 (1%) Leukemia Monocytic 2 (1%) 5 (3%) 1 (1%) 1 (1%) 2 (2%) Leukemia Myeloid 1 (1%) Liposarcoma, Metastatic, Mammary Gland 1 (1%) Liposarcoma, Metastatic, Uncertain Primary Site 1 (1%) Lymphoma Lymphocytic 1 (1%) Lymphoma Lymphoblastic 1 (1%) 2 (1%) 2 (1%) 1 (1%) Lymphoma Lympho-immunoblastic 5 (3%) 5 (3%) 8 (5%) 6 (4%) 1 (1%) 7 (7%) Osteosarcoma 1 (1%) Osteosarcoma, Metastatic, Bone 1 (1%) 1 (1%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (1%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 2 (1%) 1 (1%) Seminoma Malignant, Metastatic, Uterus 1 (1%) Squamous Cell Carcinoma 2 (1%) 1 (1%) Alveolus, Adenoma 1 (1%) Bronchiole, Adenoma 1 (1%) Bronchus, Adenoma 1 (1%) Pleura (139) (148) (145) (148) (96) (96) Adenocarcinoma, Metastatic, Adrenal Cortex 1 (1%) Leukemia Lymphoblastic 1 (1%) Page 7 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Leukemia Monocytic 2 (1%) 1 (1%) Leukemia Myeloid 1 (1%) Lymphoma Lymphocytic 1 (1%) Lymphoma Lymphoblastic 1 (1%) Lymphoma Lympho-immunoblastic 3 (2%) 1 (1%) Neoplasm NOS 1 (1%) 2 (2%) 1 (1%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM None ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(150) *(150) *(150) *(150) *(100) *(100) Histiocytic Sarcoma 3 (2%) 5 (3%) 8 (5%) 7 (5%) 11 (11%) 7 (7%) Leukemia Granulocytic 1 (1%) 1 (1%) Leukemia Lymphoblastic 1 (1%) Leukemia Lymphocytic 1 (1%) 1 (1%) Leukemia Monocytic 2 (1%) 5 (3%) 4 (3%) 2 (2%) 2 (2%) Leukemia Myeloid 1 (1%) 1 (1%) Lymphoma Lympho-immunoblastic 5 (3%) 5 (3%) 8 (5%) 8 (5%) 2 (2%) 11 (11%) Lymphoma Lymphoblastic 2 (1%) 3 (2%) 7 (5%) 6 (4%) 2 (2%) 2 (2%) Lymphoma Lymphocytic 2 (1%) 5 (3%) 2 (1%) 1 (1%) 2 (2%) Lymphoma Malignant 1 (1%) 2 (1%) 1 (1%) 1 (1%) 3 (3%) Mesothelioma Malignant 1 (1%) 2 (1%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 8 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 20 36 44 39 31 35 Total Primary Neoplasms 21 42 50 49 38 45 Total Animals with Benign Neoplasms 7 14 12 11 10 12 Total Benign Neoplasms 7 15 12 12 12 12 Total Animals with Malignant Neoplasms 13 22 34 28 20 26 Total Malignant Neoplasms 14 24 36 33 21 30 Total Animals with Metastatic Neoplasms 5 7 7 6 3 6 Total Metastatic Neoplasm 6 7 16 8 4 8 Total Animals with Malignant Neoplasms 1 1 Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 3 2 4 5 3 Total Uncertain Neoplasms 3 2 4 5 3 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 9 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 100 Early Deaths Natural Death 100 Survivors Animals Examined Microscopically 100 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Liver (99) Cholangioma 4 (4%) Histiocytic Sarcoma 2 (2%) Leukemia Granulocytic 2 (2%) Leukemia Monocytic 2 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM None ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (99) Axillary, Inguinal, Mesenteric, Leukemia Monocytic 1 (1%) Axillary, Inguinal, Mesenteric, Leukemia Myeloid 1 (1%) Axillary, Mediastinal, Mesenteric, Leukemia Myeloid 1 (1%) Iliac, Schwannoma Malignant, Metastatic, Uterus 1 (1%) Inguinal, Mediastinal, Mesenteric, Histiocytic Sarcoma 1 (1%) Mediastinal, Leukemia Monocytic 1 (1%) Mediastinal, Lymphoma Lymphoblastic 1 (1%) Mediastinal, Lymphoma Lympho-immunoblastic 1 (1%) Mediastinal, Mesenteric, Histiocytic Sarcoma 1 (1%) Mediastinal, Mandibular, Leukemia Myeloid 1 (1%) Mesenteric, Leukemia Monocytic 1 (1%) Renal, Histiocytic Sarcoma 1 (1%) Spleen (100) Fibroangioma 2 (2%) Histiocytic Sarcoma 1 (1%) Leukemia Monocytic 2 (2%) Leukemia Myeloid 2 (2%) Thymus (99) Histiocytic Sarcoma 1 (1%) Leukemia Monocytic 1 (1%) Leukemia Myeloid 2 (2%) Lymphoma Lymphocytic 2 (2%) Lymphoma Lymphoblastic 1 (1%) Lymphoma Lympho-immunoblastic 1 (1%) Thymoma Benign 2 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100000 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (100) Cerebellum, Oligodendroglioma NOS 1 (1%) Cerebrum, Lymphoma Lympho-immunoblastic 1 (1%) Meninges, Leukemia Monocytic 1 (1%) Meninges, Leukemia Myeloid 1 (1%) Meninges, Lymphoma Lympho-immunoblastic 1 (1%) Meninges, Neoplasm NOS 1 (1%) Meninges, Cerebrum, Lymphoma Lympho-immunoblastic 1 (1%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (100) Adenoma 1 (1%) Histiocytic Sarcoma 3 (3%) Leukemia Monocytic 1 (1%) Leukemia Myeloid 2 (2%) Lymphoma Lympho-immunoblastic 11 (11%) Squamous Cell Carcinoma, Metastatic, Oral Mucosa 1 (1%) Pleura (98) Leukemia Myeloid 1 (1%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM None Page 12 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100000 PPM ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(100) Histiocytic Sarcoma 3 (3%) Leukemia Granulocytic 2 (2%) Leukemia Monocytic 2 (2%) Leukemia Myeloid 2 (2%) Lymphoma Lympho-immunoblastic 11 (11%) Lymphoma Lymphoblastic 1 (1%) Lymphoma Lymphocytic 2 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 13 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 30 Total Primary Neoplasms 34 Total Animals with Benign Neoplasms 8 Total Benign Neoplasms 9 Total Animals with Malignant Neoplasms 21 Total Malignant Neoplasms 23 Total Animals with Metastatic Neoplasms 2 Total Metastatic Neoplasm 2 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 2 Total Uncertain Neoplasms 2 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 14 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 150 150 150 150 100 100 Early Deaths Natural Death 150 150 150 150 100 100 Survivors Animals Examined Microscopically 150 149 150 150 100 100 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Liver (148) (148) (149) (148) (100) (100) Adenocarcinoma, Metastatic, Adrenal Cortex 1 (1%) Cholangioma 4 (3%) 2 (1%) 3 (3%) 1 (1%) Hemangiosarcoma 1 (1%) Hemangiosarcoma, Metastatic, Spleen 1 (1%) Hepatocellular Carcinoma 2 (1%) Hepatocellular Adenoma 1 (1%) 1 (1%) 1 (1%) Histiocytic Sarcoma 6 (4%) 2 (1%) 3 (2%) 2 (2%) 1 (1%) Leukemia Granulocytic 1 (1%) 2 (1%) 1 (1%) Leukemia Lymphocytic 1 (1%) Leukemia Monocytic 2 (1%) 2 (1%) 1 (1%) 7 (5%) 2 (2%) 1 (1%) Lymphoma Malignant 2 (1%) 2 (1%) 1 (1%) 1 (1%) Osteosarcoma, Metastatic, Bone 1 (1%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Pituitary Gland (1) Adenocarcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 15 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Mediastinum, Lymphoma Lympho-immunoblastic 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM None ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (1) Leukemia Myeloid 1 (100%) Lymph Node (149) (148) (149) (150) (99) (100) Histiocytic Sarcoma 1 (1%) Lymphoma Lymphoblastic 1 (1%) Lymphoma Lympho-immunoblastic 1 (1%) 2 (1%) Axillary, Histiocytic Sarcoma 1 (1%) Axillary, Leukemia Monocytic 1 (1%) Axillary, Lymphoma Lympho-immunoblastic 1 (1%) Axillary, Inguinal, Histiocytic Sarcoma 1 (1%) Axillary, Inguinal, Lymphoma Lympho-immunoblastic 1 (1%) Axillary, Inguinal, Mediastinal, Leukemia Monocytic 1 (1%) Axillary, Inguinal, Mediastinal, Lymphoma Lympho-immunoblastic 1 (1%) Axillary, Inguinal, Mesenteric, Histiocytic Sarcoma 1 (1%) 1 (1%) 1 (1%) Axillary, Inguinal, Mesenteric, Leukemia Lymphoblastic 1 (1%) Axillary, Inguinal, Mesenteric, Leukemia Monocytic 1 (1%) 1 (1%) 2 (2%) Axillary, Inguinal, Mesenteric, Leukemia Myeloid 2 (1%) 1 (1%) Axillary, Inguinal, Mesenteric, Lymphoma Lympho-immunoblastic 1 (1%) 2 (2%) Axillary, Inguinal, Mandibular, Histiocytic Sarcoma 1 (1%) Axillary, Mediastinal, Histiocytic Sarcoma 1 (1%) Axillary, Mediastinal, Leukemia Monocytic 1 (1%) Axillary, Mesenteric, Leukemia Monocytic 1 (1%) 1 (1%) Page 16 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Axillary, Mesenteric, Mandibular, Leukemia Monocytic 1 (1%) Iliac, Leukemia Monocytic 1 (1%) Inguinal, Fibroangioma 1 (1%) Inguinal, Histiocytic Sarcoma 1 (1%) 1 (1%) Inguinal, Mediastinal, Leukemia Monocytic 1 (1%) Inguinal, Mesenteric, Histiocytic Sarcoma 1 (1%) Inguinal, Mandibular, Lymphoma Lympho-immunoblastic 1 (1%) Lumbar, Histiocytic Sarcoma 1 (1%) Mandibular, Histiocytic Sarcoma 1 (1%) 1 (1%) Mandibular, Leukemia Monocytic 2 (2%) Mandibular, Lymphoma Lympho-immunoblastic 1 (1%) Mediastinal, Adenocarcinoma, Metastatic, Seminal Vesicle 1 (1%) Mediastinal, Histiocytic Sarcoma 4 (3%) Mediastinal, Leukemia Monocytic 2 (1%) Mediastinal, Lymphoma Lymphocytic 1 (1%) Mediastinal, Lymphoma Lympho-immunoblastic 1 (1%) 1 (1%) 2 (1%) 2 (2%) 4 (4%) Mediastinal, Squamous Cell Carcinoma, Metastatic, Zymbal's Gland 1 (1%) Mediastinal, Mesenteric, Lymphoma Lympho-immunoblastic 1 (1%) 1 (1%) 1 (1%) Mediastinal, Mesenteric, Pancreatic, Histiocytic Sarcoma 1 (1%) Mediastinal, Mesenteric, Pancreatic, Leukemia Lymphoblastic 1 (1%) Mediastinal, Mesenteric, Mandibular, Histiocytic Sarcoma 1 (1%) 1 (1%) Mediastinal, Pancreatic, Mandibular, Histiocytic Sarcoma 1 (1%) Mediastinal, Pancreatic, Mandibular, Leukemia Monocytic 1 (1%) Mediastinal, Pancreatic, Mandibular, Leukemia Myeloid 1 (1%) 1 (1%) Mediastinal, Mandibular, Leukemia Lymphoblastic 1 (1%) Mediastinal, Mandibular, Leukemia Monocytic 1 (1%) Mediastinal, Mandibular, Leukemia Myeloid 1 (1%) Mediastinal, Mandibular, Lymphoma Lympho-immunoblastic 1 (1%) 3 (3%) Mesenteric, Fibroangioma 2 (2%) Mesenteric, Histiocytic Sarcoma 2 (1%) 1 (1%) 1 (1%) 1 (1%) 1 (1%) Page 17 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Mesenteric, Leukemia Monocytic 1 (1%) Mesenteric, Lymphoma Lympho-immunoblastic 1 (1%) 2 (1%) 2 (1%) 2 (2%) Mesenteric, Pancreatic, Leiomyosarcoma, Metastatic, Intestine Large, Colon 1 (1%) Pancreatic, Histiocytic Sarcoma 1 (1%) Pancreatic, Leukemia Myeloid 1 (1%) Pancreatic, Lymphoma Lympho-immunoblastic 1 (1%) Renal, Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (1%) Renal, Mediastinal, Lymphoma Lympho-immunoblastic 1 (1%) Spleen (147) (147) (146) (149) (99) (100) Fibroangioma 1 (1%) 1 (1%) 2 (2%) Fibroma 1 (1%) 1 (1%) Fibrosarcoma 1 (1%) Hemangiosarcoma 1 (1%) 2 (1%) Histiocytic Sarcoma 1 (1%) 3 (2%) 1 (1%) 3 (3%) Leukemia Lymphoblastic 1 (1%) 1 (1%) Leukemia Monocytic 2 (1%) 1 (1%) 6 (4%) 2 (2%) 1 (1%) Leukemia Myeloid 1 (1%) 2 (1%) 1 (1%) Lymphoma Lympho-immunoblastic 1 (1%) 2 (1%) 4 (3%) 2 (2%) 6 (6%) Thymus (146) (147) (142) (148) (98) (98) Adenocarcinoma, Metastatic, Seminal Vesicle 1 (1%) Fibroangioma 1 (1%) 1 (1%) Histiocytic Sarcoma 1 (1%) 2 (1%) 5 (3%) 1 (1%) 1 (1%) Leukemia Lymphoblastic 1 (1%) 1 (1%) Leukemia Monocytic 1 (1%) 1 (1%) 4 (3%) Leukemia Myeloid 2 (1%) 1 (1%) Lymphoma Lymphocytic 1 (1%) Lymphoma Lymphoblastic 1 (1%) Lymphoma Lympho-immunoblastic 2 (1%) 1 (1%) 3 (2%) 2 (1%) 2 (2%) 7 (7%) Thymoma Benign 1 (1%) Thymoma Malignant 1 (1%) 1 (1%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 18 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (150) (149) (149) (148) (100) (99) Leukemia Myeloid 2 (1%) Lymphoma Lympho-immunoblastic 1 (1%) Neoplasm NOS 2 (1%) 2 (1%) 2 (2%) Oligodendroglioma NOS 1 (1%) 1 (1%) Cerebrum, Astrocytoma NOS 1 (1%) Cerebrum, Oligodendroglioma NOS 2 (1%) 1 (1%) Meninges, Lymphoma Lympho-immunoblastic 1 (1%) 1 (1%) Meninges, Neoplasm NOS 2 (1%) 1 (1%) 1 (1%) 1 (1%) 3 (3%) 3 (3%) Meninges, Cerebrum, Lymphoma Lympho-immunoblastic 1 (1%) Meninges, Cerebrum, Lymphoma Malignant Lymphocytic 1 (1%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (150) (149) (149) (149) (100) (100) Adenocarcinoma, Metastatic, Seminal Vesicle 1 (1%) Adenoma 1 (1%) Alveolar/Bronchiolar Adenoma 1 (1%) Fibroangioma 1 (1%) 1 (1%) Fibroma 1 (1%) Fibrous Histiocytoma 1 (1%) Hemangiosarcoma 1 (1%) Hemangiosarcoma, Metastatic, Liver 1 (1%) Histiocytic Sarcoma 2 (1%) 2 (1%) 1 (1%) 7 (5%) 2 (2%) 4 (4%) Leukemia Lymphoblastic 1 (1%) Leukemia Monocytic 1 (1%) 2 (1%) 1 (1%) 7 (5%) 2 (2%) 1 (1%) Leukemia Myeloid 2 (1%) 1 (1%) Lymphoma Lymphoblastic 2 (1%) Lymphoma Lympho-immunoblastic 19 (13%) 12 (8%) 21 (14%) 14 (9%) 7 (7%) 10 (10%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (1%) Osteosarcoma, Metastatic, Ear 1 (1%) Squamous Cell Carcinoma 1 (1%) Page 19 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Squamous Cell Carcinoma, Metastatic, Zymbal's Gland 1 (1%) Bronchus, Squamous Cell Carcinoma 1 (1%) Pleura (149) (147) (148) (148) (100) (100) Leukemia Monocytic 1 (1%) Leukemia Myeloid 1 (1%) Lymphoma Lympho-immunoblastic 1 (1%) 1 (1%) 4 (3%) 2 (2%) Neoplasm NOS 1 (1%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (1) Histiocytic Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM None ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(150) *(149) *(150) *(150) *(100) *(100) Histiocytic Sarcoma 8 (5%) 4 (3%) 2 (1%) 10 (7%) 3 (3%) 7 (7%) Leukemia Granulocytic 1 (1%) 2 (1%) 1 (1%) Leukemia Lymphoblastic 1 (1%) 1 (1%) Leukemia Lymphocytic 1 (1%) Leukemia Monocytic 2 (1%) 2 (1%) 1 (1%) 8 (5%) 2 (2%) 1 (1%) Leukemia Myeloid 1 (1%) 2 (1%) 1 (1%) Lymphoma Lympho-immunoblastic 19 (13%) 13 (9%) 22 (15%) 15 (10%) 8 (8%) 13 (13%) Lymphoma Lymphoblastic 3 (2%) Lymphoma Lymphocytic 1 (1%) Lymphoma Malignant 2 (1%) 2 (1%) 1 (1%) 1 (1%) Lymphoma Malignant Lymphocytic 1 (1%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 20 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 0 PPM 80 PPM 400 PPM 2000 PPM 10000 50000 PPM PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 36 31 35 43 24 37 Total Primary Neoplasms 40 34 37 50 30 39 Total Animals with Benign Neoplasms 2 8 5 7 7 Total Benign Neoplasms 2 8 5 8 7 Total Animals with Malignant Neoplasms 34 26 26 37 15 24 Total Malignant Neoplasms 38 29 26 40 18 25 Total Animals with Metastatic Neoplasms 4 2 1 3 Total Metastatic Neoplasm 4 2 3 4 Total Animals with Malignant Neoplasms 1 Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 2 3 3 5 4 7 Total Uncertain Neoplasms 2 3 3 5 4 7 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 21 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 100000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 100 Early Deaths Natural Death 100 Survivors Animals Examined Microscopically 100 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Liver (100) Cholangiocarcinoma 1 (1%) Fibrosarcoma, Metastatic, Tissue NOS 1 (1%) Hepatocellular Carcinoma 1 (1%) Histiocytic Sarcoma 3 (3%) Leukemia Granulocytic 1 (1%) Leukemia Monocytic 1 (1%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM None ____________________________________________________________________________________________________________________________________ Page 22 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 100000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (100) Axillary, Lymphoma Lympho-immunoblastic 1 (1%) Axillary, Inguinal, Mesenteric, Leukemia Myeloid 1 (1%) Axillary, Mediastinal, Mesenteric, Lymphoma Lympho-immunoblastic 1 (1%) Lumbar, Mediastinal, Mandibular, Lymphoma Lympho-immunoblastic 1 (1%) Mandibular, Schwannoma Malignant, Metastatic, Peripheral Nerve 2 (2%) Mandibular, Squamous Cell Carcinoma, Metastatic, Ear 1 (1%) Mediastinal, Lymphoma Lympho-immunoblastic 5 (5%) Mediastinal, Mesenteric, Histiocytic Sarcoma 1 (1%) Mediastinal, Pancreatic, Lymphoma Lympho-immunoblastic 1 (1%) Mediastinal, Mandibular, Leukemia Myeloid 1 (1%) Pancreatic, Histiocytic Sarcoma 1 (1%) Spleen (99) Fibroangioma 4 (4%) Hemangiosarcoma 2 (2%) Histiocytic Sarcoma 1 (1%) Leukemia Monocytic 1 (1%) Leukemia Myeloid 1 (1%) Lymphoma Lympho-immunoblastic 2 (2%) Thymus (94) Leukemia Monocytic 1 (1%) Leukemia Myeloid 1 (1%) Lymphoma Lympho-immunoblastic 7 (7%) Thymoma Malignant 1 (1%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ Page 23 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 100000 PPM ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (99) Leukemia Myeloid 1 (1%) Cerebrum, Lymphoma Malignant Lymphocytic 1 (1%) Cerebrum, Oligodendroglioma NOS 2 (2%) Meninges, Neoplasm NOS 1 (1%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (100) Fibrosarcoma, Metastatic, Tissue NOS 1 (1%) Hemangiosarcoma 1 (1%) Histiocytic Sarcoma 2 (2%) Leukemia Monocytic 1 (1%) Leukemia Myeloid 1 (1%) Lymphoma Lympho-immunoblastic 23 (23%) Bronchus, Adenoma 1 (1%) Pleura (98) Leukemia Monocytic 1 (1%) Leukemia Myeloid 1 (1%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM None ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(100) Histiocytic Sarcoma 4 (4%) Leukemia Granulocytic 1 (1%) Leukemia Monocytic 1 (1%) Leukemia Myeloid 1 (1%) Lymphoma Lympho-immunoblastic 24 (24%) * Number of animals with any tissue examined microscopically Page 24 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 100000 PPM ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(100) Lymphoma Malignant Lymphocytic 1 (1%) ____________________________________________________________________________________________________________________________________ Page 25 NTP Experiment-Test: 00117-66 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a) Report: PEIRPT02 Study Type: CHRONIC-LIFETIME ASPARTAME Date: 11/16/04 Route: DOSED FEED Time: 08:27:20 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS MALE 100000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 39 Total Primary Neoplasms 46 Total Animals with Benign Neoplasms 5 Total Benign Neoplasms 5 Total Animals with Malignant Neoplasms 34 Total Malignant Neoplasms 38 Total Animals with Metastatic Neoplasms 4 Total Metastatic Neoplasm 5 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 3 Total Uncertain Neoplasms 3 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 26 ------------------------------------------------------------ ---------- END OF REPORT ---------- 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