TDMS Study 05144-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
SAFFLOWER OIL
NTP Experiment-Test: 05144-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/17/94
Route: GAVAGE Time: 19:47:02
Facility: TSI Mason Research
Chemical CAS #: 8001-23-8
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: 05144-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SAFFLOWER OIL Date: 09/17/94
Route: GAVAGE Time: 19:47:02
____________________________________________________________________________________________________________________________________
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 9
Early Deaths
Natural Death 8 8 3 10
Moribund Sacrifice 12 9 7 5
Survivors
Terminal Sacrifice 30 33 40 36
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (56) (59) (58) (58)
Ulcer 1 (2%)
Intestine Large, Rectum (57) (57) (57) (56)
Submucosa, Edema 1 (2%)
Intestine Small, Duodenum (58) (60) (58) (58)
Mucosa, Hyperplasia, Diffuse 1 (2%)
Intestine Small, Jejunum (55) (58) (57) (55)
Mucosa, Hyperplasia, Diffuse 1 (2%)
Intestine Small, Ileum (55) (59) (58) (56)
Fibrosis 1 (2%)
Inflammation, Chronic Active 1 (2%)
Ulcer 1 (2%)
Liver (60) (60) (60) (60)
Basophilic Focus 36 (60%) 34 (57%) 41 (68%) 42 (70%)
Clear Cell Focus 23 (38%) 22 (37%) 25 (42%) 35 (58%)
Cyst 2 (3%)
Eosinophilic Focus 5 (8%) 2 (3%) 4 (7%) 2 (3%)
Fatty Change, Diffuse 1 (2%) 6 (10%)
Fatty Change, Focal 7 (12%) 4 (7%) 7 (12%) 10 (17%)
Hepatodiaphragmatic Nodule 4 (7%) 3 (5%) 2 (3%) 2 (3%)
Hepatodiaphragmatic Nodule, Multiple 1 (2%)
Hyperplasia 4 (7%) 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Mixed Cell Focus 1 (2%) 2 (3%) 2 (3%) 6 (10%)
Necrosis 4 (7%) 4 (7%) 4 (7%) 4 (7%)
Pigmentation 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Thrombosis 3 (5%)
Centrilobular, Degeneration 1 (2%)
Mesentery (10) (8) (11) (7)
Abscess 1 (9%)
Inflammation, Chronic Active 1 (13%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05144-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SAFFLOWER OIL Date: 09/17/94
Route: GAVAGE Time: 19:47:02
____________________________________________________________________________________________________________________________________
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 (9%)
Fat, Hemorrhage 1 (13%)
Fat, Inflammation, Chronic Active 2 (20%) 1 (14%)
Fat, Mineralization 1 (10%) 1 (13%)
Fat, Necrosis 8 (80%) 5 (63%) 9 (82%) 6 (86%)
Pancreas (60) (60) (59) (59)
Acinus, Atrophy 48 (80%) 45 (75%) 41 (69%) 43 (73%)
Acinus, Fibrosis 1 (2%)
Acinus, Hyperplasia 10 (17%) 15 (25%) 33 (56%) 37 (63%)
Artery, Inflammation, Chronic Active 1 (2%) 3 (5%) 1 (2%) 1 (2%)
Vein, Angiectasis 1 (2%)
Salivary Glands (60) (59) (60) (60)
Hyperplasia 2 (3%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Duct, Metaplasia 1 (2%)
Duct, Metaplasia, Squamous 14 (23%) 11 (19%) 10 (17%) 13 (22%)
Stomach, Forestomach (60) (60) (60) (60)
Hyperkeratosis 11 (18%) 17 (28%) 20 (33%) 24 (40%)
Hyperplasia, Basal Cell 21 (35%) 17 (28%) 26 (43%) 29 (48%)
Inflammation, Chronic 1 (2%)
Ulcer 3 (5%) 2 (3%) 2 (3%) 4 (7%)
Stomach, Glandular (59) (60) (59) (59)
Erosion 8 (14%) 6 (10%) 1 (2%) 2 (3%)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Metaplasia, Squamous 1 (2%)
Mineralization 1 (2%)
Mucosa, Hyperplasia, Diffuse 1 (2%)
Tongue (1) (1)
Hyperkeratosis 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Cardiomyopathy 56 (93%) 56 (93%) 49 (82%) 51 (85%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%)
Thrombosis 2 (3%) 3 (5%) 1 (2%)
Atrium, Dilatation 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05144-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SAFFLOWER OIL Date: 09/17/94
Route: GAVAGE Time: 19:47:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0
ML/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (59) (60) (58)
Hyperplasia 1 (2%) 1 (2%) 4 (7%)
Inflammation, Granulomatous 1 (2%)
Metaplasia, Osseous 1 (2%)
Necrosis 1 (2%)
Thrombosis 1 (2%)
Adrenal Medulla (59) (58) (59) (58)
Hyperplasia 23 (39%) 24 (41%) 16 (27%) 19 (33%)
Islets, Pancreatic (59) (60) (59) (58)
Hyperplasia 5 (8%) 4 (7%) 4 (7%) 5 (9%)
Parathyroid Gland (55) (50) (50) (51)
Hyperplasia 2 (4%) 1 (2%)
Pituitary Gland (60) (58) (59) (59)
Congestion 1 (2%)
Pars Distalis, Angiectasis 4 (7%) 6 (10%) 3 (5%) 5 (8%)
Pars Distalis, Cyst 2 (3%) 8 (14%) 1 (2%) 2 (3%)
Pars Distalis, Hyperplasia 9 (15%) 16 (28%) 11 (19%) 10 (17%)
Pars Intermedia, Angiectasis 1 (2%)
Pars Nervosa, Cyst 1 (2%)
Thyroid Gland (58) (59) (58) (58)
C-Cell, Hyperplasia 10 (17%) 6 (10%) 9 (16%) 19 (33%)
Follicle, Cyst 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (1) (1)
Abdominal, Ectopic Tissue 1 (100%)
Oral, Hyperplasia, Squamous 1 (100%)
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GENITAL SYSTEM
Preputial Gland (60) (60) (59) (58)
Abscess 5 (8%) 6 (10%) 4 (7%) 5 (9%)
Cyst 3 (5%) 2 (3%) 1 (2%) 1 (2%)
Dilatation 8 (13%) 2 (3%)
Dilatation, Multiple 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Prostate (59) (59) (58) (58)
Hyperplasia 1 (2%) 5 (8%) 2 (3%) 3 (5%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Metaplasia, Squamous 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05144-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SAFFLOWER OIL Date: 09/17/94
Route: GAVAGE Time: 19:47:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0
ML/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Interstitium, Edema 1 (2%)
Seminal Vesicle (60) (59) (60) (59)
Depletion Cellular 18 (30%)
Testes (60) (60) (59) (60)
Interstitial Cell, Hyperplasia 8 (13%) 11 (18%) 6 (10%) 11 (18%)
Seminiferous Tubule, Atrophy 3 (5%) 3 (5%) 1 (2%) 2 (3%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (25) (19) (18) (8)
Inguinal, Infiltration Cellular, Plasma Cell 1 (6%)
Mediastinal, Angiectasis 2 (8%) 1 (5%) 3 (17%) 3 (38%)
Mediastinal, Ectasia 1 (5%)
Mediastinal, Hematopoietic Cell Proliferation 1 (4%)
Mediastinal, Hemorrhage 1 (4%)
Mediastinal, Hyperplasia, Lymphoid 1 (6%)
Mediastinal, Infiltration Cellular, Plasma
Cell 1 (6%)
Mediastinal, Infiltration Cellular,
Polymorphonuclear 1 (6%)
Mediastinal, Inflammation, Acute 1 (5%)
Mediastinal, Pigmentation 2 (8%) 5 (26%)
Mediastinal, Lymphatic, Ectasia 1 (4%)
Pancreatic, Angiectasis 1 (5%) 1 (13%)
Pancreatic, Hyperplasia, Lymphoid 3 (12%) 1 (5%) 3 (17%)
Pancreatic, Infiltration Cellular, Histiocyte 1 (4%) 1 (5%)
Pancreatic, Pigmentation 1 (4%)
Renal, Angiectasis 1 (4%)
Renal, Infiltration Cellular, Histiocyte 1 (4%)
Lymph Node, Mandibular (60) (56) (57) (59)
Angiectasis 4 (7%)
Congestion 1 (2%)
Ectasia 2 (4%) 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Infiltration Cellular, Plasma Cell 3 (5%)
Inflammation, Acute 1 (2%)
Pigmentation 2 (4%)
Lymphatic, Ectasia 1 (2%) 1 (2%)
Lymph Node, Mesenteric (59) (60) (59) (58)
Angiectasis 1 (2%) 3 (5%) 2 (3%)
Congestion 1 (2%)
Ectasia 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Pigmentation 1 (2%)
Spleen (60) (60) (58) (60)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05144-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SAFFLOWER OIL Date: 09/17/94
Route: GAVAGE Time: 19:47:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0
ML/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Angiectasis 1 (2%)
Atrophy 1 (2%)
Depletion Lymphoid 2 (3%) 1 (2%) 1 (2%)
Developmental Malformation 1 (2%)
Fibrosis 14 (23%) 4 (7%)
Hematocyst 1 (2%)
Hematopoietic Cell Proliferation 2 (3%) 8 (13%) 6 (10%) 6 (10%)
Infarct 3 (5%) 3 (5%)
Pigmentation 1 (2%) 13 (22%) 2 (3%)
Pigmentation, Hemosiderin 1 (2%)
Lymphoid Follicle, Atrophy 1 (2%)
Thymus (50) (51) (51) (52)
Depletion Lymphoid 1 (2%)
Hemorrhage 1 (2%)
Epithelial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (52) (53) (51)
Galactocele 2 (4%) 1 (2%)
Skin (58) (59) (60) (60)
Cyst Epithelial Inclusion 2 (3%) 2 (3%)
Erosion 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%)
Hyperplasia, Basal Cell 1 (2%)
Inflammation, Chronic Active 1 (2%)
Foot, Acanthosis 1 (2%)
Foot, Inflammation, Chronic Active 1 (2%)
Subcutaneous Tissue, Granuloma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (50) (50) (50) (51)
Fibrosis 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Abdominal, Fibrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Congestion 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05144-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SAFFLOWER OIL Date: 09/17/94
Route: GAVAGE Time: 19:47:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0
ML/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (59)
Congestion 2 (3%) 2 (3%) 2 (3%) 2 (3%)
Edema 1 (2%) 1 (2%)
Fibrosis 1 (2%) 1 (2%)
Hemorrhage 2 (3%) 1 (2%) 2 (3%)
Hemorrhage, Focal 1 (2%)
Infiltration Cellular, Histiocyte 4 (7%) 11 (18%) 5 (8%)
Inflammation, Acute 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%)
Alveolar Epithelium, Hyperplasia 4 (7%) 2 (3%) 3 (5%) 3 (5%)
Alveolus, Foreign Body 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Alveolus, Inflammation, Acute 1 (2%)
Alveolus, Pigmentation, Focal 1 (2%)
Bronchiole, Metaplasia, Squamous 1 (2%)
Interstitium, Inflammation, Chronic Active 1 (2%)
Mediastinum, Abscess 1 (2%)
Nose (60) (60) (60) (60)
Foreign Body 7 (12%) 50 (83%) 48 (80%) 51 (85%)
Fungus 24 (40%) 46 (77%) 41 (68%) 41 (68%)
Hyperkeratosis 1 (2%)
Inflammation, Acute 26 (43%) 59 (98%) 60 (100%) 59 (98%)
Metaplasia, Squamous 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 1 (2%)
Respiratory Epithelium, Hyperplasia 13 (22%) 48 (80%) 56 (93%) 53 (88%)
Respiratory Epithelium, Metaplasia, Squamous 16 (27%) 39 (65%) 34 (57%) 29 (48%)
Vein, Thrombosis 1 (2%)
Trachea (59) (60) (60) (59)
Lumen, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (2) (1) (1)
Inflammation, Chronic Active 1 (100%) 1 (100%)
Eye (2) (2)
Inflammation, Chronic Active 1 (50%)
Cornea, Necrosis 1 (50%)
Lens, Cataract 1 (50%) 1 (50%)
Retina, Atrophy 1 (50%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05144-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SAFFLOWER OIL Date: 09/17/94
Route: GAVAGE Time: 19:47:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 ML/KG 2.5 MLKG 5.0 MLKG 10.0
ML/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (58)
Cyst 2 (3%) 3 (5%)
Degeneration, Hyaline 1 (2%)
Glomerulosclerosis 1 (2%)
Nephropathy 59 (98%) 56 (93%) 50 (83%) 55 (95%)
Pigmentation 5 (8%)
Renal Tubule, Degeneration 1 (2%)
Urinary Bladder (58) (59) (59) (57)
Calculus Gross Observation 4 (7%) 3 (5%) 3 (5%)
Calculus Micro Observation Only 4 (7%) 2 (3%) 3 (5%)
Inflammation, Chronic Active 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
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