TDMS Study 05142-03 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
T-BUTYL ALCOHOL
NTP Experiment-Test: 05142-03 Report: PEIRPT03
Study Type: CHRONIC Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
Facility: Southern Research Institute
Chemical CAS #: 75-65-0
Lock Date: 01/10/92
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: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Natural Death 7 8 7 3
Moribund Sacrifice 15 18 21 35
Survivors
Terminal Sacrifice 28 24 22 12
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (60) (60) (60)
Ulcer 1 (2%)
Mucosa, Hyperplasia 1 (2%)
Intestine Large, Colon (60) (60) (59) (60)
Parasite Metazoan 5 (8%) 3 (5%) 3 (5%) 5 (8%)
Intestine Large, Rectum (59) (59) (59) (60)
Edema 1 (2%)
Parasite Metazoan 11 (19%) 8 (14%) 3 (5%) 6 (10%)
Ulcer 1 (2%)
Intestine Large, Cecum (60) (59) (59) (60)
Dilatation 1 (2%) 1 (2%) 1 (2%)
Edema 1 (2%)
Parasite Metazoan 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Intestine Small, Duodenum (60) (60) (59) (60)
Erosion 3 (5%) 1 (2%)
Intestine Small, Jejunum (60) (59) (59) (60)
Dilatation 1 (2%)
Inflammation, Subacute 1 (2%)
Mucosa, Hyperplasia, Diffuse 1 (2%)
Intestine Small, Ileum (60) (59) (59) (60)
Inflammation, Subacute 1 (2%)
Liver (60) (60) (60) (60)
Angiectasis 6 (10%) 5 (8%) 6 (10%) 4 (7%)
Basophilic Focus 45 (75%) 39 (65%) 36 (60%) 46 (77%)
Clear Cell Focus 10 (17%) 5 (8%) 4 (7%) 2 (3%)
Congestion 1 (2%)
Eosinophilic Focus 2 (3%) 1 (2%)
Granuloma 13 (22%) 13 (22%) 13 (22%) 17 (28%)
Hematopoietic Cell Proliferation 2 (3%) 1 (2%) 1 (2%) 3 (5%)
Hepatodiaphragmatic Nodule 14 (23%) 16 (27%) 19 (32%) 15 (25%)
Hyperplasia, Focal 9 (15%) 11 (18%) 14 (23%) 5 (8%)
Hyperplasia, Lymphoid 3 (5%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Subacute 10 (17%) 16 (27%) 4 (7%) 6 (10%)
Mixed Cell Focus 7 (12%) 9 (15%) 6 (10%) 2 (3%)
Thrombosis 1 (2%)
Bile Duct, Cyst 3 (5%) 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 14 (23%) 22 (37%) 16 (27%) 17 (28%)
Centrilobular, Atrophy 7 (12%) 9 (15%) 7 (12%) 7 (12%)
Centrilobular, Necrosis 1 (2%) 2 (3%) 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 10 (17%) 13 (22%) 12 (20%) 7 (12%)
Kupffer Cell, Hyperplasia 1 (2%) 2 (3%)
Kupffer Cell, Pigmentation 3 (5%) 9 (15%) 5 (8%) 5 (8%)
Lobules, Necrosis 4 (7%) 4 (7%) 2 (3%) 7 (12%)
Mesentery (9) (6) (8) (6)
Accessory Spleen 1 (11%) 1 (17%)
Fat, Necrosis 7 (78%) 6 (100%) 6 (75%) 5 (83%)
Pancreas (60) (60) (59) (60)
Atrophy 17 (28%) 29 (48%) 23 (39%) 23 (38%)
Cyst 1 (2%) 3 (5%)
Ectopic Liver 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Acinar Cell, Cytoplasmic Alteration 4 (7%) 1 (2%) 8 (14%) 9 (15%)
Acinar Cell, Hyperplasia, Focal 2 (3%) 1 (2%)
Salivary Glands (60) (60) (60) (60)
Atrophy 3 (5%) 2 (3%) 1 (2%) 3 (5%)
Inflammation, Suppurative 1 (2%)
Acinar Cell, Cytoplasmic Alteration 1 (2%) 4 (7%) 3 (5%) 5 (8%)
Stomach, Forestomach (60) (60) (60) (60)
Edema 4 (7%) 5 (8%) 8 (13%) 2 (3%)
Erosion 1 (2%) 3 (5%) 1 (2%)
Fibrosis 4 (7%) 2 (3%)
Inflammation, Subacute 1 (2%)
Perforation 3 (5%)
Ulcer 5 (8%) 3 (5%) 9 (15%) 9 (15%)
Mucosa, Hyperplasia 8 (13%) 2 (3%) 16 (27%) 12 (20%)
Stomach, Glandular (60) (60) (60) (60)
Cyst Epithelial Inclusion 1 (2%)
Edema 2 (3%) 3 (5%) 4 (7%)
Erosion 5 (8%) 4 (7%) 2 (3%) 8 (13%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%)
Ulcer 2 (3%) 1 (2%) 4 (7%) 3 (5%)
Epithelium, Dilatation 2 (3%) 3 (5%) 2 (3%) 5 (8%)
Tongue (1) (1) (3)
Hyperplasia 1 (33%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00%
CONTROL
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Fibrosis 1 (100%)
Inflammation, Chronic Active 1 (100%)
Heart (60) (60) (60) (60)
Cardiomyopathy 18 (30%) 15 (25%) 23 (38%) 12 (20%)
Thrombosis 1 (2%) 3 (5%) 1 (2%)
Myocardium, Inflammation, Chronic 1 (2%) 2 (3%)
Myocardium, Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 11 (18%) 11 (18%) 7 (12%) 15 (25%)
Angiectasis 7 (12%) 4 (7%) 8 (13%) 4 (7%)
Atrophy 2 (3%)
Basophilic Focus 1 (2%) 1 (2%)
Congestion 1 (2%) 2 (3%) 1 (2%) 2 (3%)
Cyst 1 (2%)
Hematopoietic Cell Proliferation 4 (7%) 3 (5%) 4 (7%)
Hemorrhage 2 (3%)
Hyperplasia, Diffuse 2 (3%)
Hyperplasia, Focal 6 (10%) 14 (23%) 8 (13%) 9 (15%)
Hypertrophy, Focal 1 (2%) 2 (3%) 1 (2%) 3 (5%)
Metaplasia, Osseous 1 (2%)
Necrosis 1 (2%) 1 (2%)
Pigmentation 2 (3%) 2 (3%) 1 (2%)
Vacuolization Cytoplasmic, Diffuse 1 (2%) 2 (3%) 2 (3%) 1 (2%)
Vacuolization Cytoplasmic, Focal 14 (23%) 12 (20%) 15 (25%) 13 (22%)
Adrenal Medulla (60) (60) (60) (59)
Angiectasis 2 (3%)
Hyperplasia 4 (7%) 10 (17%) 9 (15%) 4 (7%)
Islets, Pancreatic (60) (60) (58) (60)
Hyperplasia 3 (5%) 1 (2%) 2 (3%) 2 (3%)
Parathyroid Gland (57) (60) (57) (60)
Fibrosis 1 (2%)
Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (60) (60) (59) (59)
Hypertrophy, Focal 1 (2%)
Pigmentation 2 (3%) 2 (3%) 3 (5%) 6 (10%)
Pars Distalis, Angiectasis 11 (18%) 10 (17%) 11 (19%) 6 (10%)
Pars Distalis, Atrophy 1 (2%)
Pars Distalis, Cyst 23 (38%) 19 (32%) 23 (39%) 19 (32%)
Pars Distalis, Hyperplasia 16 (27%) 11 (18%) 21 (36%) 18 (31%)
Pars Distalis, Infiltration Cellular,
Histiocyte 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Intermedia, Angiectasis 4 (7%) 2 (3%) 1 (2%) 3 (5%)
Pars Intermedia, Cyst 5 (8%) 6 (10%) 2 (3%) 3 (5%)
Pars Intermedia, Hyperplasia 1 (2%)
Pars Intermedia, Hypertrophy, Focal 1 (2%)
Thyroid Gland (59) (60) (60) (60)
Degeneration, Cystic 1 (2%) 2 (3%)
Ultimobranchial Cyst 1 (2%) 3 (5%) 2 (3%) 3 (5%)
C-Cell, Hyperplasia 21 (36%) 17 (28%) 13 (22%) 13 (22%)
Follicle, Cyst 1 (2%) 2 (3%) 2 (3%) 6 (10%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (59) (60) (60) (60)
Ectasia 1 (2%) 2 (3%) 1 (2%)
Hyperplasia 4 (7%) 4 (7%) 4 (7%) 4 (7%)
Inflammation, Chronic 8 (14%) 3 (5%) 3 (5%) 2 (3%)
Inflammation, Suppurative 4 (7%) 2 (3%) 1 (2%)
Necrosis 1 (2%)
Ovary (60) (60) (60) (60)
Cyst 12 (20%) 14 (23%) 17 (28%) 17 (28%)
Mineralization 1 (2%)
Uterus (60) (60) (60) (60)
Hemorrhage 1 (2%)
Hydrometra 4 (7%) 3 (5%) 2 (3%) 5 (8%)
Hyperplasia, Cystic 2 (3%) 2 (3%) 5 (8%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Pigmentation 1 (2%) 1 (2%) 3 (5%)
Prolapse 1 (2%)
Endometrium, Fibrosis 1 (2%)
Vagina (3) (3) (6) (6)
Cyst 1 (17%)
Exudate 1 (33%) 2 (33%) 1 (17%)
Hyperplasia 1 (17%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Congestion 1 (2%) 1 (2%)
Hypercellularity 2 (3%) 3 (5%) 1 (2%)
Myelofibrosis 4 (7%) 11 (18%) 3 (5%) 5 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymph Node (14) (15) (12) (7)
Mediastinal, Hemorrhage 2 (14%) 1 (7%) 5 (42%)
Mediastinal, Hyperplasia, Histiocytic 1 (7%)
Mediastinal, Pigmentation 2 (14%) 3 (20%) 3 (25%)
Pancreatic, Hemorrhage 1 (7%) 3 (25%)
Pancreatic, Hyperplasia, Lymphoid 1 (7%)
Pancreatic, Pigmentation 1 (7%) 1 (8%)
Renal, Hemorrhage 1 (7%)
Renal, Pigmentation 1 (7%)
Lymph Node, Mandibular (60) (59) (60) (59)
Ectasia 4 (7%) 5 (8%) 8 (13%) 2 (3%)
Hemorrhage 1 (2%) 2 (3%) 3 (5%) 2 (3%)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 3 (5%) 3 (5%) 1 (2%) 4 (7%)
Hyperplasia, Plasma Cell 7 (12%) 8 (14%) 10 (17%) 12 (20%)
Infiltration Cellular, Mast Cell 1 (2%)
Pigmentation 3 (5%) 1 (2%)
Lymph Node, Mesenteric (60) (59) (60) (60)
Ectasia 1 (2%) 1 (2%)
Hemorrhage 3 (5%) 3 (5%) 8 (13%) 3 (5%)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 2 (3%) 5 (8%) 2 (3%)
Hyperplasia, Plasma Cell 2 (3%) 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Mast Cell 1 (2%) 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Pigmentation 1 (2%)
Spleen (60) (60) (60) (60)
Angiectasis 1 (2%)
Congestion 1 (2%)
Developmental Malformation 1 (2%) 1 (2%) 1 (2%)
Fibrosis 4 (7%) 5 (8%) 3 (5%) 5 (8%)
Hematopoietic Cell Proliferation 19 (32%) 19 (32%) 17 (28%) 16 (27%)
Infiltration Cellular, Histiocyte 1 (2%)
Necrosis 2 (3%)
Pigmentation 44 (73%) 42 (70%) 42 (70%) 44 (73%)
Lymphoid Follicle, Atrophy 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Red Pulp, Atrophy 1 (2%) 2 (3%)
Thymus (58) (57) (59) (58)
Congestion 1 (2%) 1 (2%) 2 (3%)
Cyst 1 (2%) 1 (2%) 1 (2%)
Ectopic Parathyroid Gland 1 (2%)
Hemorrhage 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (59) (60) (60)
Hyperplasia, Cystic 41 (68%) 47 (80%) 45 (75%) 51 (85%)
Hyperplasia, Lobular 5 (8%) 7 (12%) 5 (8%) 6 (10%)
Skin (60) (60) (59) (60)
Acanthosis 3 (5%) 4 (7%)
Exudate 2 (3%) 1 (2%)
Inflammation, Subacute 1 (2%)
Ulcer 2 (3%)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Developmental Malformation 1 (2%)
Fibrous Osteodystrophy 1 (2%) 4 (7%) 5 (8%)
Calvarium, Osteopetrosis 20 (33%) 9 (15%) 11 (18%) 10 (17%)
Femur, Osteopetrosis 12 (20%) 7 (12%) 4 (7%) 8 (13%)
Sternum, Osteopetrosis 12 (20%) 8 (13%) 4 (7%) 8 (13%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Compression 16 (27%) 13 (22%) 12 (20%) 10 (17%)
Developmental Malformation 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 2 (3%)
Hydrocephalus 3 (5%) 6 (10%) 1 (2%) 4 (7%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Spinal Cord (1)
Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Congestion 1 (2%) 4 (7%) 4 (7%) 1 (2%)
Edema 3 (5%)
Foreign Body 1 (2%)
Hemorrhage 1 (2%) 2 (3%) 2 (3%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Histiocyte 24 (40%) 19 (32%) 22 (37%) 17 (28%)
Inflammation, Subacute 1 (2%) 3 (5%) 2 (3%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Leukocytosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 4 (7%) 2 (3%) 4 (7%) 2 (3%)
Bronchiole, Epithelium, Hyperplasia 1 (2%)
Nose (60) (60) (60) (60)
Exudate 7 (12%) 11 (18%) 15 (25%) 15 (25%)
Foreign Body 3 (5%) 3 (5%) 5 (8%) 7 (12%)
Fungus 4 (7%) 2 (3%) 5 (8%) 9 (15%)
Glands, Hyperplasia 1 (2%) 1 (2%)
Mucosa, Hyperplasia 7 (12%) 4 (7%) 8 (13%) 8 (13%)
Mucosa, Metaplasia, Squamous 4 (7%) 3 (5%) 4 (7%) 7 (12%)
Mucosa, Necrosis 1 (2%) 2 (3%)
Trachea (60) (60) (60) (60)
Mucosa, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (5) (5) (5)
Cataract 2 (100%) 4 (80%) 5 (100%) 4 (80%)
Hemorrhage 1 (20%)
Retina, Atrophy 2 (100%) 4 (80%) 5 (100%) 4 (80%)
Lacrimal Gland (1)
Ectopic Harderian 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Hemorrhage 1 (2%)
Infarct 1 (2%)
Inflammation, Suppurative 2 (3%) 3 (5%) 13 (22%) 17 (28%)
Mineralization 59 (98%) 60 (100%) 60 (100%) 60 (100%)
Nephropathy 58 (97%) 57 (95%) 58 (97%) 60 (100%)
Interstitial Tissue, Pigmentation 1 (2%) 1 (2%) 1 (2%)
Renal Tubule, Cytoplasmic Alteration 5 (8%) 4 (7%) 3 (5%) 4 (7%)
Renal Tubule, Hyperplasia 1 (2%)
Renal Tubule, Pigmentation 10 (17%) 12 (20%) 6 (10%) 5 (8%)
Transitional Epithelium, Hyperplasia 3 (5%) 17 (28%)
Urinary Bladder (60) (60) (60) (60)
Dilatation 2 (3%)
Hemorrhage 2 (3%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00%
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Mucosa, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 31 35 41 46
Natural Death 9 9 5 3
Survivors
Terminal Sacrifice 10 6 4 1
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (60) (59) (60) (60)
Parasite Metazoan 5 (8%) 4 (7%) 4 (7%) 5 (8%)
Intestine Large, Rectum (59) (58) (59) (60)
Parasite Metazoan 6 (10%) 7 (12%) 6 (10%) 6 (10%)
Intestine Large, Cecum (60) (59) (60) (60)
Dilatation 1 (2%) 1 (2%) 1 (2%)
Edema 1 (2%) 1 (2%)
Erosion 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Parasite Metazoan 2 (3%) 1 (2%)
Intestine Small, Duodenum (58) (53) (55) (60)
Ectopic Tissue 1 (2%)
Erosion 2 (3%) 3 (6%) 8 (15%) 4 (7%)
Inflammation, Suppurative 1 (2%)
Ulcer 1 (2%)
Mucosa, Hyperplasia, Diffuse 1 (2%) 2 (3%)
Intestine Small, Jejunum (60) (57) (60) (60)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Subacute 1 (2%)
Mucosa, Hyperplasia, Diffuse 3 (5%) 3 (5%) 4 (7%) 1 (2%)
Intestine Small, Ileum (60) (58) (59) (60)
Dilatation 1 (2%) 1 (2%)
Fibrosis 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Subacute 1 (2%)
Metaplasia, Osseous 1 (2%)
Mucosa, Hyperplasia, Diffuse 1 (2%)
Liver (60) (60) (60) (60)
Angiectasis 3 (5%) 2 (3%) 6 (10%) 4 (7%)
Basophilic Focus 13 (22%) 19 (32%) 24 (40%) 18 (30%)
Clear Cell Focus 6 (10%) 4 (7%) 3 (5%) 5 (8%)
Congestion 1 (2%) 2 (3%) 2 (3%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Degeneration, Cystic 11 (18%) 8 (13%) 8 (13%) 6 (10%)
Eosinophilic Focus 2 (3%) 3 (5%) 3 (5%)
Granuloma 3 (5%) 3 (5%) 6 (10%) 2 (3%)
Hematopoietic Cell Proliferation 3 (5%) 3 (5%) 2 (3%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 10 (17%) 8 (13%) 6 (10%) 3 (5%)
Hyperplasia, Focal 9 (15%) 7 (12%) 4 (7%) 6 (10%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Inflammation, Subacute 1 (2%) 3 (5%) 4 (7%) 4 (7%)
Mixed Cell Focus 6 (10%) 3 (5%) 3 (5%) 3 (5%)
Thrombosis 1 (2%)
Bile Duct, Cyst 1 (2%) 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 48 (80%) 49 (82%) 47 (78%) 55 (92%)
Centrilobular, Atrophy 9 (15%) 12 (20%) 7 (12%) 16 (27%)
Centrilobular, Necrosis 1 (2%) 2 (3%) 2 (3%)
Hepatocyte, Vacuolization Cytoplasmic 16 (27%) 14 (23%) 13 (22%) 4 (7%)
Kupffer Cell, Pigmentation 3 (5%) 8 (13%) 4 (7%) 2 (3%)
Lobules, Necrosis 4 (7%) 7 (12%) 3 (5%) 1 (2%)
Mesentery (5) (7) (9) (3)
Accessory Spleen 1 (11%) 1 (33%)
Hemorrhage 1 (14%)
Fat, Hemorrhage 1 (20%)
Fat, Necrosis 5 (100%) 5 (71%) 4 (44%) 1 (33%)
Pancreas (60) (59) (60) (60)
Atrophy 34 (57%) 37 (63%) 33 (55%) 25 (42%)
Cyst 1 (2%) 3 (5%)
Fibrosis 1 (2%)
Focal Cellular Change 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Acinar Cell, Cytoplasmic Alteration 8 (13%) 11 (19%) 13 (22%) 11 (18%)
Acinar Cell, Hyperplasia, Focal 10 (17%) 5 (8%) 7 (12%) 1 (2%)
Salivary Glands (60) (60) (60) (60)
Atrophy 2 (3%) 2 (3%) 2 (3%) 2 (3%)
Acinar Cell, Cytoplasmic Alteration 5 (8%) 5 (8%) 4 (7%) 4 (7%)
Stomach, Forestomach (60) (60) (60) (60)
Edema 4 (7%) 7 (12%) 4 (7%) 2 (3%)
Erosion 2 (3%) 1 (2%) 1 (2%) 2 (3%)
Fibrosis 3 (5%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Subacute 2 (3%) 1 (2%) 1 (2%)
Perforation 1 (2%)
Ulcer 7 (12%) 14 (23%) 9 (15%) 3 (5%)
Mucosa, Hyperplasia 12 (20%) 16 (27%) 10 (17%) 7 (12%)
Stomach, Glandular (60) (59) (60) (60)
Cyst Epithelial Inclusion 1 (2%) 1 (2%)
Edema 6 (10%) 2 (3%) 5 (8%) 3 (5%)
Erosion 11 (18%) 5 (8%) 6 (10%) 6 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic 1 (2%) 3 (5%)
Mineralization 4 (7%) 3 (5%) 2 (3%) 2 (3%)
Ulcer 2 (3%) 3 (5%) 7 (12%) 2 (3%)
Epithelium, Dilatation 2 (3%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (6) (3) (1) (1)
Hypertrophy 2 (33%) 1 (100%)
Inflammation, Chronic Active 6 (100%) 3 (100%) 1 (100%) 1 (100%)
Thrombosis 1 (100%)
Heart (60) (60) (60) (60)
Cardiomyopathy 26 (43%) 30 (50%) 29 (48%) 28 (47%)
Thrombosis 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Myocardium, Inflammation, Chronic 1 (2%)
Myocardium, Mineralization 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 14 (23%) 17 (28%) 15 (25%) 14 (23%)
Atrophy 1 (2%)
Basophilic Focus 2 (3%) 1 (2%)
Congestion 1 (2%) 1 (2%)
Cyst 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 2 (3%)
Hemorrhage 1 (2%)
Hyperplasia, Diffuse 1 (2%)
Hyperplasia, Focal 6 (10%) 5 (8%) 7 (12%) 4 (7%)
Hypertrophy, Focal 4 (7%) 1 (2%) 2 (3%)
Necrosis 1 (2%)
Pigmentation 3 (5%) 3 (5%) 1 (2%) 2 (3%)
Vacuolization Cytoplasmic, Diffuse 6 (10%) 6 (10%) 4 (7%) 1 (2%)
Vacuolization Cytoplasmic, Focal 16 (27%) 9 (15%) 17 (28%) 15 (25%)
Adrenal Medulla (60) (60) (60) (60)
Hyperplasia 22 (37%) 21 (35%) 23 (38%) 15 (25%)
Islets, Pancreatic (60) (59) (59) (59)
Hyperplasia 5 (8%) 2 (3%) 3 (5%) 4 (7%)
Parathyroid Gland (60) (56) (59) (58)
Hyperplasia 8 (13%) 9 (16%) 13 (22%) 6 (10%)
Pituitary Gland (59) (60) (59) (58)
Inflammation, Suppurative 1 (2%)
Pigmentation 2 (3%)
Pars Distalis, Angiectasis 2 (3%) 1 (2%) 3 (5%) 4 (7%)
Pars Distalis, Cyst 4 (7%) 4 (7%) 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia 9 (15%) 7 (12%) 9 (15%) 13 (22%)
Pars Distalis, Necrosis 1 (2%)
Pars Intermedia, Angiectasis 1 (2%) 1 (2%)
Pars Intermedia, Cyst 2 (3%) 2 (3%) 1 (2%) 3 (5%)
Pars Nervosa, Hyperplasia 4 (7%) 4 (7%) 4 (7%) 11 (19%)
Thyroid Gland (60) (59) (60) (60)
Degeneration, Cystic 4 (7%) 1 (2%) 3 (5%)
Hypoplasia 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Ultimobranchial Cyst 2 (3%) 1 (2%) 2 (3%)
C-Cell, Hyperplasia 11 (18%) 9 (15%) 2 (3%) 3 (5%)
Follicle, Cyst 7 (12%) 2 (3%) 6 (10%) 7 (12%)
Follicular Cell, Hyperplasia 4 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (60) (60)
Atypia Cellular 15 (25%) 9 (15%) 11 (18%) 10 (17%)
Hypospermia 26 (43%) 22 (37%) 19 (32%) 23 (38%)
Penis (2) (1)
Edema 1 (50%)
Inflammation, Suppurative 2 (100%) 1 (100%)
Preputial Gland (60) (60) (60) (59)
Ectasia 2 (3%) 3 (5%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic 23 (38%) 26 (43%) 23 (38%) 27 (46%)
Inflammation, Suppurative 7 (12%) 5 (8%) 5 (8%) 6 (10%)
Necrosis 1 (2%)
Prostate (60) (60) (60) (60)
Corpora Amylacea 7 (12%) 7 (12%) 9 (15%) 7 (12%)
Ectasia 4 (7%) 1 (2%) 1 (2%) 1 (2%)
Fibrosis 3 (5%) 4 (7%) 3 (5%) 3 (5%)
Hyperplasia, Lymphoid 11 (18%) 8 (13%) 9 (15%) 8 (13%)
Inflammation, Suppurative 52 (87%) 48 (80%) 46 (77%) 37 (62%)
Epithelium, Hyperplasia 2 (3%) 2 (3%) 2 (3%)
Seminal Vesicle (60) (60) (60) (60)
Depletion Cellular 1 (2%)
Fibrosis 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%)
Testes (60) (60) (60) (60)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Mineralization 2 (3%) 1 (2%)
Spermatocele 1 (2%)
Interstitial Cell, Hyperplasia 11 (18%) 20 (33%) 11 (18%) 20 (33%)
Seminiferous Tubule, Atrophy 14 (23%) 18 (30%) 10 (17%) 13 (22%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Congestion 1 (2%)
Hypercellularity 1 (2%) 4 (7%) 2 (3%)
Myelofibrosis 4 (7%) 4 (7%) 2 (3%) 4 (7%)
Lymph Node (19) (11) (15) (20)
Inguinal, Hyperplasia, Plasma Cell 1 (5%)
Lumbar, Hyperplasia, Plasma Cell 1 (9%)
Mediastinal, Hemorrhage 3 (16%) 1 (9%) 3 (20%) 2 (10%)
Mediastinal, Hyperplasia, Lymphoid 1 (5%)
Mediastinal, Hyperplasia, Plasma Cell 1 (5%) 1 (7%)
Mediastinal, Necrosis 1 (7%)
Mediastinal, Pigmentation 1 (5%)
Pancreatic, Ectasia 1 (5%)
Pancreatic, Hemorrhage 1 (5%)
Pancreatic, Hyperplasia, Lymphoid 1 (5%)
Pancreatic, Pigmentation 1 (9%)
Renal, Hemorrhage 1 (5%) 1 (9%)
Renal, Hyperplasia, Plasma Cell 1 (9%)
Renal, Pigmentation 1 (5%)
Lymph Node, Mandibular (60) (58) (59) (60)
Congestion 1 (2%)
Ectasia 5 (8%) 9 (16%) 4 (7%) 7 (12%)
Fibrosis 1 (2%) 1 (2%)
Hemorrhage 4 (7%) 6 (10%) 2 (3%)
Hyperplasia, Lymphoid 1 (2%) 3 (5%) 8 (14%) 3 (5%)
Hyperplasia, Plasma Cell 15 (25%) 19 (33%) 11 (19%) 11 (18%)
Inflammation, Suppurative 1 (2%)
Lymph Node, Mesenteric (59) (59) (60) (60)
Ectasia 1 (2%) 1 (2%) 2 (3%)
Hemorrhage 3 (5%) 4 (7%) 1 (2%) 5 (8%)
Hyperplasia, Lymphoid 2 (3%) 4 (7%) 6 (10%) 1 (2%)
Infiltration Cellular, Mast Cell 1 (2%)
Pigmentation 2 (3%)
Spleen (60) (59) (60) (60)
Congestion 1 (2%)
Developmental Malformation 2 (3%) 1 (2%) 1 (2%)
Fibrosis 11 (18%) 17 (29%) 14 (23%) 14 (23%)
Hematopoietic Cell Proliferation 9 (15%) 12 (20%) 12 (20%) 12 (20%)
Infiltration Cellular, Histiocyte 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Necrosis 3 (5%) 2 (3%) 1 (2%) 1 (2%)
Pigmentation 21 (35%) 35 (59%) 23 (38%) 25 (42%)
Lymphoid Follicle, Atrophy 2 (3%) 2 (3%)
Red Pulp, Atrophy 2 (3%) 1 (2%)
Thymus (54) (59) (57) (56)
Congestion 1 (2%)
Cyst 3 (5%)
Ectopic Parathyroid Gland 1 (2%)
Ectopic Thyroid 1 (2%)
Hemorrhage 1 (2%)
Epithelial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (54) (58) (57) (56)
Hyperplasia, Cystic 26 (48%) 30 (52%) 27 (47%) 16 (29%)
Hyperplasia, Lobular 2 (4%) 2 (3%)
Skin (60) (60) (59) (60)
Acanthosis 4 (7%) 3 (5%) 2 (3%) 2 (3%)
Cyst Epithelial Inclusion 1 (2%) 1 (2%) 1 (2%)
Exudate 2 (3%) 1 (2%) 1 (2%)
Hyperplasia, Basal Cell 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Fibrous Osteodystrophy 10 (17%) 14 (23%) 16 (27%) 10 (17%)
Hyperostosis 2 (3%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
Femur, Osteopetrosis 1 (2%) 1 (2%)
Sternum, Osteopetrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Compression 19 (32%) 18 (30%) 19 (32%) 6 (10%)
Granuloma 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Hydrocephalus 6 (10%) 10 (17%) 12 (20%) 5 (8%)
Mineralization 1 (2%) 2 (3%)
Necrosis 3 (5%)
Vacuolization Cytoplasmic 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Congestion 4 (7%) 1 (2%) 4 (7%)
Edema 1 (2%)
Foreign Body 1 (2%) 1 (2%)
Hemorrhage 2 (3%) 2 (3%) 2 (3%)
Hyperplasia, Lymphoid 3 (5%) 2 (3%)
Infiltration Cellular, Histiocyte 15 (25%) 12 (20%) 12 (20%) 15 (25%)
Inflammation, Subacute 2 (3%) 5 (8%) 7 (12%) 2 (3%)
Inflammation, Suppurative 2 (3%) 1 (2%)
Leukocytosis 1 (2%)
Metaplasia, Osseous 2 (3%) 1 (2%)
Alveolar Epithelium, Hyperplasia 6 (10%) 2 (3%) 6 (10%) 5 (8%)
Nose (60) (60) (60) (60)
Exudate 30 (50%) 26 (43%) 34 (57%) 24 (40%)
Foreign Body 16 (27%) 17 (28%) 18 (30%) 12 (20%)
Fungus 17 (28%) 17 (28%) 22 (37%) 14 (23%)
Mucosa, Hyperplasia 25 (42%) 24 (40%) 24 (40%) 21 (35%)
Mucosa, Metaplasia, Squamous 6 (10%) 9 (15%) 9 (15%) 7 (12%)
Mucosa, Necrosis 2 (3%) 4 (7%)
Trachea (60) (60) (60) (60)
Mucosa, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (4) (3) (2) (3)
Cataract 4 (100%) 3 (100%) 1 (50%) 3 (100%)
Inflammation, Chronic 1 (33%)
Retina, Atrophy 4 (100%) 3 (100%) 3 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Cyst 1 (2%)
Hemorrhage 1 (2%)
Hydronephrosis 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Suppurative 10 (17%) 18 (30%) 12 (20%) 9 (15%)
Mineralization 27 (45%) 30 (50%) 40 (67%) 57 (95%)
Nephropathy 59 (98%) 59 (98%) 60 (100%) 60 (100%)
Thrombosis 1 (2%)
Interstitial Tissue, Pigmentation 1 (2%)
Renal Tubule, Cytoplasmic Alteration 1 (2%)
Renal Tubule, Hyperplasia 3 (5%) 7 (12%) 6 (10%) 6 (10%)
Renal Tubule, Hyperplasia, Oncocytic 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95
Route: DOSED WATER Time: 07:39:32
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50%
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Pigmentation 7 (12%) 9 (15%) 6 (10%) 12 (20%)
Transitional Epithelium, Hyperplasia 25 (42%) 32 (53%) 36 (60%) 40 (67%)
Urinary Bladder (60) (60) (60) (60)
Angiectasis 1 (2%)
Dilatation 2 (3%) 2 (3%) 2 (3%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Inflammation, Subacute 1 (2%)
Inflammation, Suppurative 1 (2%) 2 (3%)
Mucosa, Hyperplasia 3 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 17
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