TDMS Study 99033-03 Pathology Tables
NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:40:00 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 NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:40:00 ____________________________________________________________________________________________________________________________________ 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 Liver (15) (15) (15) (15) (15) (15) Hematopoietic Cell Proliferation 2 (13%) Infiltration Cellular, Focal, Lymphocyte 1 (7%) Infiltration Cellular, Lymphocyte 1 (7%) Inflammation, Chronic Active 1 (7%) Necrosis, Focal 1 (7%) 2 (13%) Hepatocyte, Necrosis, Focal 1 (7%) Hepatocyte, Periportal, Vacuolization Cytoplasmic 2 (13%) Salivary Glands (15) (15) Infiltration Cellular, Focal, Lymphocyte 4 (27%) 5 (33%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (15) (15) (15) (15) (15) (15) Myocardium, Necrosis, Focal 1 (7%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (13) (15) (15) (15) Accessory Adrenal Cortical Nodule 1 (7%) Subcapsular, Hyperplasia, Focal 14 (93%) 15 (100%) 12 (92%) 15 (100%) 15 (100%) 15 (100%) Thyroid Gland (15) (15) (15) (15) (15) (15) Ectopic Thymus 2 (13%) Ultimobranchial Cyst 1 (7%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:40:00 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Abdominal, Fat, Hemorrhage, Focal 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (15) (15) (15) (15) (15) (15) Cyst 1 (7%) Uterus (15) (15) (15) (15) (15) (15) Endometrium, Hyperplasia, Cystic 14 (93%) 13 (87%) 13 (87%) 15 (100%) 15 (100%) 14 (93%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (14) (15) (13) (15) (15) (15) Hyperplasia 1 (7%) Inflammation, Chronic Active 1 (7%) Lymph Node, Mesenteric (14) (15) (14) (15) (15) (14) Hyperplasia, Histiocytic 1 (7%) Spleen (15) (15) (14) (15) (15) (15) Accessory Spleen 1 (7%) Hematopoietic Cell Proliferation 5 (33%) 2 (13%) 4 (29%) 3 (20%) 2 (13%) 3 (20%) Pigmentation 1 (7%) Thymus (14) (15) (14) (14) (15) (15) Atrophy, Diffuse 1 (7%) Atrophy, Focal 1 (7%) 1 (7%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (15) (15) Cranium, Osteoporosis 1 (7%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (15) (14) (14) (15) (15) (15) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:40:00 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - CONT Granuloma 1 (7%) Cerebellum, Medulla, Vacuolization Cytoplasmic 1 (7%) Spinal Cord (1) Vacuolization Cytoplasmic 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (14) (14) (15) (15) (15) Alveolar Epithelium, Hyperplasia, Focal 1 (7%) Alveolus, Crystals 1 (7%) Nose (15) (15) Olfactory Epithelium, Atrophy 1 (7%) Olfactory Epithelium, Hyaline Droplet 2 (13%) 3 (20%) Respiratory Epithelium, Hyaline Droplet 1 (7%) 2 (13%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (14) (15) Cataract 1 (7%) Harderian Gland (15) (15) Hyperplasia 1 (7%) Infiltration Cellular, Lymphocyte 1 (7%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (13) (15) (15) (15) Nephropathy 1 (7%) 1 (7%) Glomerulus, Hyalinization 1 (7%) Renal Tubule, Dilatation, Diffuse 1 (7%) 1 (7%) 1 (7%) Renal Tubule, Dilatation, Focal 10 (67%) 7 (47%) 5 (38%) 5 (33%) 5 (33%) 9 (60%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:40:00 ____________________________________________________________________________________________________________________________________ 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) Infiltration Cellular, Focal, Lymphocyte 3 (20%) 1 (7%) Inflammation, Acute 2 (13%) Necrosis, Focal 2 (13%) 3 (20%) 1 (7%) 4 (27%) Hepatocyte, Necrosis, Focal 1 (7%) 1 (7%) 1 (7%) 1 (7%) Hepatocyte, Vacuolization Cytoplasmic, Diffuse 1 (7%) Hepatocyte, Periportal, Vacuolization Cytoplasmic 6 (40%) 11 (73%) 14 (93%) 8 (57%) 13 (87%) 13 (87%) Salivary Glands (15) (15) Infiltration Cellular, Focal, Lymphocyte 12 (80%) 11 (73%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (15) (14) (15) (15) Accessory Adrenal Cortical Nodule 1 (7%) Subcapsular, Hyperplasia, Focal 2 (13%) 1 (7%) 1 (7%) 4 (27%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:40:00 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (15) (15) (15) (15) (15) (15) Inflammation, Chronic Active, Focal 1 (7%) Bilateral, Spermatozoa, Degeneration 1 (7%) Testes (15) (15) (15) (14) (14) (15) Germinal Epithelium, Degeneration 1 (7%) 1 (7%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (15) (15) (15) (14) (14) (15) Hyperplasia 1 (7%) 1 (7%) Necrosis 1 (7%) Lymph Node, Mesenteric (15) (15) (15) (14) (14) (15) Hyperplasia 2 (13%) Spleen (15) (15) (15) (14) (15) (15) Atrophy, Diffuse 1 (7%) 1 (7%) Hematopoietic Cell Proliferation 1 (7%) 2 (13%) 3 (21%) 1 (7%) Pigmentation 1 (7%) Lymphoid Follicle, Atrophy 1 (7%) Thymus (15) (14) (15) (13) (15) (15) Atrophy, Diffuse 1 (7%) 1 (7%) 1 (7%) Atrophy, Focal 1 (7%) 2 (14%) 1 (7%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (15) (15) (15) (14) (15) (15) Cerebellum, Medulla, Vacuolization Cytoplasmic 1 (7%) 1 (7%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 99033-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:40:00 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 CONTROL PPM PPM PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (15) (15) (15) (15) (15) Infiltration Cellular, Focal, Lymphocyte 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (15) (15) Infiltration Cellular, Lymphocyte 2 (13%) 2 (13%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (14) (15) (15) Nephropathy 2 (13%) 7 (47%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------