TDMS Study 05145-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) TRICAPRYLIN NTP Experiment-Test: 05145-01 Report: PEIRPT03 Study Type: CHRONIC Date: 09/17/94 Route: GAVAGE Time: 20:47:57 Facility: TSI Mason Research Chemical CAS #: 538-23-8 Lock Date: 12/26/91 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: 05145-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRICAPRYLIN Date: 09/17/94 Route: GAVAGE Time: 20:47:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0 ML/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 10 10 7 Early Deaths Moribund Sacrifice 15 13 15 17 Natural Death 4 7 4 13 Survivors Moribund Sacrifice 1 Terminal Sacrifice 29 30 30 22 Natural Death 2 1 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (57) (56) (58) (51) Ulcer 1 (2%) Intestine Small, Duodenum (59) (56) (58) (49) Hyperplasia, Adenomatous 1 (2%) Ulcer 1 (2%) Intestine Small, Ileum (56) (56) (58) (49) Inflammation, Acute 1 (2%) Ulcer 1 (2%) 1 (2%) 1 (2%) Liver (60) (60) (60) (58) Basophilic Focus 35 (58%) 39 (65%) 34 (57%) 31 (53%) Clear Cell Focus 10 (17%) 20 (33%) 22 (37%) 13 (22%) Congestion 1 (2%) 2 (3%) Cyst 1 (2%) Cyst Multilocular 1 (2%) Eosinophilic Focus 7 (12%) 4 (7%) 6 (10%) 3 (5%) Fatty Change, Diffuse 1 (2%) 2 (3%) Fatty Change, Focal 4 (7%) 2 (3%) 3 (5%) Fibrosis 1 (2%) 1 (2%) Hepatodiaphragmatic Nodule 3 (5%) 5 (8%) 7 (12%) 6 (10%) Hyperplasia 1 (2%) 5 (8%) 2 (3%) Hypertrophy 1 (2%) Infarct 1 (2%) Mixed Cell Focus 7 (12%) 7 (12%) 7 (12%) 4 (7%) Necrosis 3 (5%) 2 (3%) 3 (5%) 1 (2%) Necrosis, Focal 1 (2%) Thrombosis 1 (2%) 1 (2%) Bile Duct, Hyperplasia 1 (2%) Centrilobular, Degeneration 1 (2%) Mesentery (9) (14) (4) (6) Thrombosis 1 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05145-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRICAPRYLIN Date: 09/17/94 Route: GAVAGE Time: 20:47:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0 ML/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Artery, Inflammation, Chronic Active 1 (7%) Fat, Hemorrhage 1 (7%) Fat, Inflammation, Chronic Active 1 (11%) 1 (17%) Fat, Mineralization 1 (11%) 2 (14%) Fat, Necrosis 3 (33%) 8 (57%) 1 (25%) 4 (67%) Pancreas (59) (59) (59) (57) Atrophy 1 (2%) Congestion 1 (2%) Inflammation, Chronic Active 1 (2%) Thrombosis 2 (3%) Acinus, Atrophy 37 (63%) 41 (69%) 38 (64%) 29 (51%) Acinus, Basophilic Focus 1 (2%) 1 (2%) Acinus, Hyperplasia 11 (19%) 11 (19%) 24 (41%) 35 (61%) Artery, Hyperplasia 2 (3%) 1 (2%) 1 (2%) 3 (5%) Artery, Inflammation, Chronic Active 2 (3%) 4 (7%) 4 (7%) 2 (4%) Artery, Mineralization 1 (2%) Pharynx (1) (1) Thrombosis 1 (100%) Salivary Glands (60) (59) (58) (58) Cyst 1 (2%) Duct, Metaplasia, Squamous 10 (17%) 14 (24%) 4 (7%) 8 (14%) Stomach, Forestomach (60) (60) (59) (59) Erosion 1 (2%) Hyperkeratosis 1 (2%) 1 (2%) 5 (8%) Hyperplasia, Basal Cell 2 (3%) 5 (8%) 10 (17%) 20 (34%) Hyperplasia, Basal Cell, Diffuse 1 (2%) 1 (2%) Hyperplasia, Basal Cell, Focal 2 (3%) 1 (2%) 2 (3%) 2 (3%) Hyperplasia, Diffuse, Squamous 1 (2%) Inflammation, Acute 3 (5%) Mineralization, Focal 1 (2%) Ulcer 4 (7%) 1 (2%) 2 (3%) Stomach, Glandular (60) (58) (59) (57) Erosion 6 (10%) 3 (5%) 7 (12%) 5 (9%) Hyperplasia, Lymphoid 5 (8%) Inflammation, Chronic Active 2 (3%) 1 (2%) Mineralization 1 (2%) 6 (10%) 2 (4%) Tongue (2) (1) Hemorrhage, Focal 1 (100%) Tooth (1) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05145-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRICAPRYLIN Date: 09/17/94 Route: GAVAGE Time: 20:47:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0 ML/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (59) (58) Cardiomyopathy 53 (88%) 53 (88%) 54 (92%) 49 (84%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Chronic Active 1 (2%) Thrombosis 5 (8%) 7 (12%) 4 (7%) 2 (3%) Atrium, Dilatation 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (59) (59) (58) Hemorrhage 1 (2%) Hypertrophy 1 (2%) 1 (2%) Hypoplasia 1 (2%) Vacuolization Cytoplasmic 1 (2%) Vacuolization Cytoplasmic, Diffuse 1 (2%) Adrenal Medulla (60) (59) (59) (58) Hyperplasia 22 (37%) 20 (34%) 22 (37%) 18 (31%) Islets, Pancreatic (59) (58) (59) (56) Hyperplasia 7 (12%) 5 (9%) 3 (5%) 1 (2%) Parathyroid Gland (50) (56) (57) (53) Cyst 1 (2%) Hyperplasia 1 (2%) 1 (2%) Pituitary Gland (60) (57) (59) (58) Pars Distalis, Angiectasis 3 (5%) 1 (2%) 3 (5%) 2 (3%) Pars Distalis, Congestion 1 (2%) Pars Distalis, Cyst 2 (3%) 2 (4%) 2 (3%) 4 (7%) Pars Distalis, Hyperplasia 11 (18%) 11 (19%) 10 (17%) 6 (10%) Pars Distalis, Vacuolization Cytoplasmic 1 (2%) Pars Intermedia, Cyst 1 (2%) 1 (2%) Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (57) (56) (59) (54) Fibrosis 1 (2%) C-Cell, Hyperplasia 7 (12%) 6 (11%) 9 (15%) 3 (6%) Follicle, Cyst 1 (2%) Follicular Cell, Hyperplasia 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05145-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRICAPRYLIN Date: 09/17/94 Route: GAVAGE Time: 20:47:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0 ML/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (59) (58) (60) (58) Abscess 3 (5%) 4 (7%) 6 (10%) 3 (5%) Cyst 1 (2%) Dilatation 2 (3%) 1 (2%) 2 (3%) Hyperplasia 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 2 (3%) 1 (2%) Necrosis 1 (2%) Prostate (59) (59) (59) (59) Hyperplasia 3 (5%) 9 (15%) 6 (10%) 7 (12%) Inflammation, Acute 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Seminal Vesicle (59) (60) (60) (59) Concretion 1 (2%) Hyperplasia 1 (2%) Inflammation, Acute 1 (2%) Testes (59) (60) (60) (59) Interstitial Cell, Hyperplasia 6 (10%) 8 (13%) 7 (12%) 10 (17%) Seminiferous Tubule, Atrophy 6 (10%) 6 (10%) 1 (2%) 3 (5%) Seminiferous Tubule, Giant Cell 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (25) (25) (25) (16) Lymphatic, Ectasia 1 (4%) Mediastinal, Angiectasis 3 (12%) 2 (8%) 3 (12%) 9 (56%) Mediastinal, Congestion 1 (4%) Mediastinal, Ectasia 5 (20%) Mediastinal, Hyperplasia 1 (4%) Mediastinal, Hyperplasia, Lymphoid 1 (4%) Mediastinal, Infiltration Cellular, Mast Cell 1 (4%) 2 (8%) Mediastinal, Infiltration Cellular, Histiocyte 2 (8%) Mediastinal, Pigmentation 3 (12%) 2 (8%) 3 (12%) 1 (6%) Mediastinal, Lymphatic, Ectasia 1 (4%) Pancreatic, Angiectasis 1 (4%) 1 (6%) Pancreatic, Ectasia 1 (4%) 1 (4%) 1 (6%) Pancreatic, Hyperplasia, Lymphoid 2 (8%) 2 (8%) 1 (6%) Pancreatic, Infiltration Cellular, Histiocyte 1 (4%) Pancreatic, Pigmentation 1 (4%) Pancreatic, Lymphatic, Ectasia 1 (4%) 2 (8%) Renal, Pigmentation 1 (4%) Lymph Node, Mandibular (59) (56) (59) (57) Angiectasis 1 (2%) 1 (2%) Ectasia 1 (2%) 2 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05145-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRICAPRYLIN Date: 09/17/94 Route: GAVAGE Time: 20:47:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0 ML/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia, Lymphoid 2 (3%) Infiltration Cellular, Plasma Cell 2 (4%) Infiltration Cellular, Histiocyte 1 (2%) Lymph Node, Mesenteric (58) (59) (60) (55) Angiectasis 2 (3%) 1 (2%) 2 (4%) Ectasia 4 (7%) 2 (3%) 2 (3%) 1 (2%) Hyperplasia, Lymphoid 2 (3%) Infiltration Cellular, Histiocyte 3 (5%) Lymphatic, Ectasia 1 (2%) 1 (2%) Spleen (59) (60) (59) (58) Angiectasis 1 (2%) Depletion Lymphoid 1 (2%) 1 (2%) 3 (5%) Developmental Malformation 1 (2%) 1 (2%) 1 (2%) Fibrosis 8 (14%) 13 (22%) 16 (27%) 9 (16%) Hematopoietic Cell Proliferation 11 (19%) 9 (15%) 11 (19%) 7 (12%) Hemorrhage 1 (2%) Infarct 2 (3%) 1 (2%) 1 (2%) Mineralization 1 (2%) Pigmentation 3 (5%) Capsule, Fibrosis 1 (2%) Lymphoid Follicle, Atrophy 2 (3%) Thymus (56) (55) (56) (53) Congestion 1 (2%) Cyst 1 (2%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (51) (48) (47) (47) Galactocele 2 (4%) Hemorrhage, Focal 1 (2%) Skin (59) (59) (58) (59) Cyst 1 (2%) Cyst Epithelial Inclusion 1 (2%) 1 (2%) 1 (2%) Developmental Malformation 1 (2%) Hyperkeratosis 2 (3%) 2 (3%) Inflammation, Chronic Active 1 (2%) 1 (2%) Ulcer 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Hyperostosis 1 (2%) 1 (2%) Skeletal Muscle (50) (50) (47) (53) Atrophy 3 (6%) 1 (2%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05145-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRICAPRYLIN Date: 09/17/94 Route: GAVAGE Time: 20:47:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0 ML/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - CONT Infiltration Cellular, Histiocyte 1 (2%) Mineralization 1 (2%) Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (59) (60) Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (58) Congestion 1 (2%) 1 (2%) Edema 2 (3%) 2 (3%) Fungus 1 (2%) Hemorrhage 2 (3%) 2 (3%) 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) 6 (10%) 4 (7%) 4 (7%) Inflammation, Acute 1 (2%) 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) Alveolar Epithelium, Hyperplasia 3 (5%) 1 (2%) Mediastinum, Inflammation 1 (2%) Pleura, Inflammation, Chronic Active 1 (2%) Nose (60) (59) (60) (59) Fungus 21 (35%) 7 (12%) 12 (20%) 5 (8%) Hyperkeratosis 1 (2%) 2 (3%) Inflammation, Acute 24 (40%) 11 (19%) 15 (25%) 5 (8%) Respiratory Epithelium, Hyperplasia 1 (2%) 3 (5%) Respiratory Epithelium, Metaplasia, Squamous 9 (15%) 3 (5%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) (3) Hemorrhage 1 (33%) Necrosis 2 (67%) Lens, Cataract 1 (100%) 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (56) Cyst 2 (3%) 1 (2%) 2 (3%) 1 (2%) Hydronephrosis 1 (2%) Infarct 1 (2%) Nephropathy 56 (93%) 51 (85%) 50 (83%) 31 (55%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05145-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRICAPRYLIN Date: 09/17/94 Route: GAVAGE Time: 20:47:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0 ML/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Cortex, Mineralization 2 (3%) Renal Tubule, Hyperplasia 1 (2%) Transitional Epithelium, Hyperplasia 2 (3%) Urinary Bladder (58) (57) (58) (55) Calculus Gross Observation 3 (5%) Calculus Micro Observation Only 3 (5%) 1 (2%) Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------