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 ----------
------------------------------------------------------------