TDMS Study 05007-06 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
POLYSORBATE 80
NTP Experiment-Test: 05007-06 Report: PEIRPT03
Study Type: CHRONIC Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
Facility: Southern Research Institute
Chemical CAS #: 9005-65-6
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: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60
Scheduled Sacrifice 10 10 10
Early Deaths
Dead 2 3 4
Moribund 25 22 21
Survivors
Terminal Sacrifice 23 25 25
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (48) (49)
Inflammation, Acute 1 (2%)
Mineralization 1 (2%)
Parasite Metazoan 3 (6%) 5 (10%) 2 (4%)
Ulcer 1 (2%)
Intestine Large, Colon (50) (49) (50)
Mineralization 1 (2%)
Parasite Metazoan 5 (10%) 5 (10%) 7 (14%)
Intestine Large, Rectum (50) (50) (48)
Parasite Metazoan 5 (10%) 11 (22%) 7 (15%)
Liver (50) (50) (50)
Angiectasis 3 (6%) 1 (2%)
Basophilic Focus 42 (84%) 37 (74%) 43 (86%)
Developmental Malformation 5 (10%) 4 (8%) 10 (20%)
Fatty Change 6 (12%) 6 (12%) 8 (16%)
Granuloma 5 (10%) 11 (22%) 8 (16%)
Hematopoietic Cell Proliferation 4 (8%) 10 (20%) 2 (4%)
Mineralization 1 (2%)
Necrosis 2 (4%)
Bile Duct, Hyperplasia 23 (46%) 24 (48%) 28 (56%)
Hepatocyte, Hyperplasia 2 (4%) 1 (2%)
Portal, Inflammation, Chronic 15 (30%) 21 (42%) 16 (32%)
Mesentery (10) (4) (3)
Fat, Inflammation, Acute 1 (10%)
Fat, Necrosis 7 (70%) 4 (100%) 3 (100%)
Pancreas (50) (47) (50)
Acinus, Atrophy 19 (38%) 15 (32%) 20 (40%)
Acinus, Hyperplasia 1 (2%) 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Salivary Glands (50) (50) (50)
Inflammation, Acute 2 (4%)
Acinus, Atrophy 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Acinus, Hyperplasia 1 (2%)
Duct, Ectasia 1 (2%)
Duct, Hyperplasia 1 (2%)
Stomach, Forestomach (50) (50) (50)
Edema 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%)
Hyperplasia, Squamous 1 (2%)
Inflammation, Acute 2 (4%)
Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%)
Mineralization 1 (2%) 3 (6%) 2 (4%)
Ulcer 1 (2%) 3 (6%)
Stomach, Glandular (50) (50) (50)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 3 (6%) 6 (12%) 8 (16%)
Mucosa, Dilatation 41 (82%) 39 (78%) 31 (62%)
Mucosa, Ulcer 1 (2%)
Tooth (1) (1) (1)
Peridontal Tissue, Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
Cardiomyopathy, Chronic 44 (88%) 40 (80%) 45 (90%)
Hemorrhage 1 (2%)
Mineralization 1 (2%)
Coronary Artery, Mineralization 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%)
Angiectasis 1 (2%) 4 (8%)
Cyst 1 (2%)
Degeneration, Fatty 26 (52%) 22 (44%) 23 (46%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 7 (14%) 16 (32%) 9 (18%)
Hypertrophy 4 (8%) 4 (8%)
Mineralization 1 (2%)
Pigmentation 28 (56%) 31 (62%) 32 (64%)
Adrenal Gland, Medulla (50) (50) (50)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia 8 (16%) 4 (8%) 6 (12%)
Islets, Pancreatic (50) (47) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia 1 (2%)
Parathyroid Gland (41) (41) (41)
Hyperplasia 1 (2%)
Pituitary Gland (50) (50) (50)
Pars Distalis, Angiectasis 4 (8%) 1 (2%)
Pars Distalis, Cyst 10 (20%) 13 (26%) 15 (30%)
Pars Distalis, Hyperplasia 5 (10%) 13 (26%) 7 (14%)
Pars Distalis, Metaplasia, Osseous 1 (2%)
Pars Intermedia, Cyst 1 (2%) 1 (2%) 2 (4%)
Thyroid Gland (50) (50) (50)
Ultimobranchial Cyst 1 (2%) 2 (4%)
C-Cell, Hyperplasia 33 (66%) 23 (46%) 30 (60%)
Follicle, Ectasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (49) (50)
Abscess 1 (2%) 1 (2%) 1 (2%)
Cyst 1 (2%)
Inflammation, Chronic 10 (21%) 14 (29%) 9 (18%)
Inflammation, Chronic Active 6 (13%) 4 (8%) 3 (6%)
Duct, Ectasia 5 (10%) 2 (4%) 1 (2%)
Duct, Hyperplasia 1 (2%)
Ovary (50) (50) (50)
Hyperplasia, Adenomatous 1 (2%)
Follicle, Cyst 1 (2%)
Periovarian Tissue, Cyst 1 (2%)
Uterus (50) (50) (50)
Ectasia 3 (6%) 3 (6%) 2 (4%)
Hemorrhage 3 (6%)
Inflammation, Acute 1 (2%)
Cervix, Epithelium, Cyst 1 (2%)
Endometrium, Hyperplasia, Cystic 9 (18%) 10 (20%) 13 (26%)
Vagina (6) (9) (5)
Inflammation, Acute 1 (20%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Hemorrhage 1 (2%)
Hyperplasia, Reticulum Cell 1 (2%)
Myelofibrosis 1 (2%) 1 (2%)
Lymph Node (50) (50) (50)
Inguinal, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Congestion 3 (6%) 11 (22%) 5 (10%)
Mediastinal, Hyperplasia, Lymphoid 4 (8%) 3 (6%) 2 (4%)
Mediastinal, Hyperplasia, Reticulum Cell 1 (2%) 1 (2%)
Mediastinal, Pigmentation 1 (2%)
Pancreatic, Congestion 1 (2%)
Lymph Node, Mandibular (50) (50) (50)
Congestion 2 (4%)
Cyst 1 (2%)
Hyperplasia, Lymphoid 31 (62%) 23 (46%) 25 (50%)
Pigmentation 1 (2%)
Lymph Node, Mesenteric (50) (50) (50)
Congestion 2 (4%) 2 (4%)
Hyperplasia, Lymphoid 16 (32%) 11 (22%) 12 (24%)
Hyperplasia, Reticulum Cell 1 (2%) 1 (2%)
Spleen (50) (50) (50)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 44 (88%) 34 (68%) 39 (78%)
Hyperplasia, Histiocytic, Lymphoid 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Infarct 1 (2%)
Necrosis 1 (2%)
Pigmentation 37 (74%) 35 (70%) 42 (84%)
Capsule, Fibrosis 1 (2%)
Capsule, Inflammation, Chronic 1 (2%)
Thymus (47) (46) (47)
Congestion 1 (2%) 3 (6%)
Cyst 2 (4%) 4 (9%) 5 (11%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 3 (6%) 1 (2%) 5 (11%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (48) (50)
Inflammation, Acute 1 (2%)
Acinus, Ectasia 45 (90%) 28 (58%) 35 (70%)
Acinus, Hyperplasia 4 (8%) 3 (6%) 1 (2%)
Duct, Ectasia 12 (24%) 20 (42%) 21 (42%)
Skin (50) (50) (50)
Alopecia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Cyst Epithelial Inclusion 3 (6%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 2 (4%)
Inflammation, Suppurative 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Cranium, Fibrous Osteodystrophy 1 (2%)
Cranium, Inflammation, Chronic 1 (2%)
Cranium, Osteopetrosis 5 (10%) 5 (10%) 3 (6%)
Femur, Fibrous Osteodystrophy 1 (2%)
Femur, Osteopetrosis 1 (2%)
Rib, Hyperplasia 1 (2%)
Skeletal Muscle (1) (3) (2)
Inflammation, Chronic 1 (33%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Compression 19 (38%) 13 (26%) 8 (16%)
Hemorrhage 1 (2%) 2 (4%)
Hydrocephalus 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Congestion 1 (2%) 3 (6%) 9 (18%)
Hemorrhage 13 (26%) 5 (10%) 11 (22%)
Alveolar Epithelium, Hyperplasia 1 (2%) 3 (6%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 28 (56%) 14 (28%) 20 (40%)
Arteriole, Mineralization 27 (54%) 25 (50%) 34 (68%)
Interstitium, Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%)
Mediastinum, Inflammation, Acute 1 (2%)
Peribronchiolar, Inflammation, Acute 1 (2%)
Peribronchiolar, Inflammation, Chronic Active 1 (2%)
Nose (50) (50) (50)
Lumen, Hemorrhage 22 (44%) 17 (34%) 22 (44%)
Lumen, Inflammation, Acute 1 (2%)
Mucosa, Cyst 1 (2%)
Mucosa, Inflammation, Acute 3 (6%) 4 (8%) 3 (6%)
Nasolacrimal Duct, Hemorrhage 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 14 (28%) 9 (18%) 9 (18%)
Olfactory Epithelium, Degeneration 46 (92%) 44 (88%) 44 (88%)
Respiratory Epithelium, Degeneration 30 (60%) 22 (44%) 28 (56%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Vomeronasal Organ, Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (6) (9) (10)
Cataract 5 (83%) 8 (89%) 10 (100%)
Hemorrhage 1 (17%) 2 (22%) 4 (40%)
Synechia 1 (17%) 3 (30%)
Retina, Degeneration 6 (100%) 9 (100%) 10 (100%)
Sclera, Mineralization 1 (11%) 1 (10%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Congestion 1 (2%)
Cyst 3 (6%)
Inflammation, Acute 1 (2%)
Mineralization 1 (2%) 1 (2%)
Nephropathy, Chronic 48 (96%) 43 (86%) 48 (96%)
Pelvis, Inflammation, Acute 2 (4%)
Pelvis, Inflammation, Chronic 1 (2%)
Pelvis, Necrosis 1 (2%)
Renal Tubule, Pigmentation 47 (94%) 47 (94%) 45 (90%)
Urinary Bladder (50) (50) (50)
Calculus Gross Observation 2 (4%)
Hemorrhage 2 (4%)
Inflammation, Chronic 2 (4%)
Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60
Scheduled Sacrifice 10 10 10
Early Deaths
Moribund 14 27 25
Dead 7 5 7
Survivors
Terminal Sacrifice 29 18 18
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (49) (48)
Parasite Metazoan 4 (8%) 5 (10%) 5 (10%)
Intestine Large, Colon (49) (50) (49)
Diverticulum 1 (2%)
Metaplasia, Osseous 1 (2%)
Parasite Metazoan 5 (10%) 4 (8%) 3 (6%)
Arteriole, Inflammation, Chronic 1 (2%)
Intestine Large, Rectum (48) (49) (49)
Parasite Metazoan 3 (6%) 5 (10%) 2 (4%)
Intestine Small, Ileum (49) (47) (49)
Inflammation, Chronic 1 (2%) 1 (2%)
Intestine Small, Jejunum (48) (50) (49)
Inflammation, Chronic Active 1 (2%)
Liver (50) (50) (50)
Angiectasis 4 (8%) 6 (12%)
Basophilic Focus 34 (68%) 21 (42%) 25 (50%)
Clear Cell Focus 1 (2%)
Congestion 1 (2%) 1 (2%)
Developmental Malformation 7 (14%) 9 (18%) 3 (6%)
Focal Cellular Change 2 (4%)
Granuloma 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Necrosis 3 (6%) 8 (16%) 3 (6%)
Vacuolization Cytoplasmic 4 (8%) 2 (4%) 2 (4%)
Arteriole, Inflammation, Chronic 1 (2%)
Bile Duct, Hyperplasia 49 (98%) 44 (88%) 50 (100%)
Portal, Inflammation, Chronic 46 (92%) 45 (90%) 45 (90%)
Mesentery (4) (10) (12)
Arteriole, Inflammation, Chronic 1 (10%)
Artery, Inflammation, Chronic 1 (8%)
Fat, Necrosis 4 (100%) 7 (70%) 8 (67%)
Pancreas (50) (50) (48)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Atrophy 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Acute 1 (2%)
Pigmentation 1 (2%)
Acinus, Atrophy 25 (50%) 22 (44%) 23 (48%)
Acinus, Hyperplasia 1 (2%) 4 (8%)
Artery, Inflammation, Chronic 2 (4%) 2 (4%)
Duct, Ectasia 1 (2%)
Salivary Glands (50) (50) (50)
Infiltration Cellular, Lymphocyte 5 (10%) 1 (2%)
Acinus, Atrophy 1 (2%)
Duct, Mineralization 1 (2%)
Stomach, Forestomach (50) (50) (50)
Edema 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%)
Inflammation, Acute 2 (4%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Mineralization 4 (8%)
Ulcer 1 (2%) 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Stomach, Glandular (49) (50) (50)
Dilatation 1 (2%)
Mineralization 2 (4%) 2 (4%) 1 (2%)
Mucosa, Dilatation 30 (61%) 29 (58%) 24 (48%)
Mucosa, Erosion 2 (4%) 1 (2%)
Mucosa, Ulcer 1 (2%)
Tooth (4)
Peridontal Tissue, Hemorrhage 1 (25%)
Peridontal Tissue, Inflammation, Chronic 1 (25%)
Pulp, Necrosis 1 (25%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (6) (1)
Artery, Inflammation, Chronic 6 (100%) 1 (100%)
Artery, Thrombosis 1 (100%)
Heart (50) (50) (50)
Cardiomyopathy, Chronic 47 (94%) 46 (92%) 45 (90%)
Mineralization 2 (4%) 1 (2%) 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Artery, Mineralization 2 (4%)
Atrium Left, Thrombosis 1 (2%) 2 (4%)
Atrium Right, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (49) (50) (50)
Accessory Adrenal Cortical Nodule 2 (4%) 2 (4%)
Cyst 1 (2%)
Degeneration, Fatty 26 (53%) 21 (42%) 27 (54%)
Hyperplasia 15 (31%) 13 (26%) 14 (28%)
Hypertrophy 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Necrosis 1 (2%) 1 (2%)
Pigmentation 1 (2%) 1 (2%) 6 (12%)
Adrenal Gland, Medulla (50) (50) (50)
Cyst 1 (2%)
Hyperplasia 11 (22%) 22 (44%) 12 (24%)
Islets, Pancreatic (50) (48) (48)
Hyperplasia 1 (2%) 2 (4%) 1 (2%)
Parathyroid Gland (39) (47) (45)
Hypertrophy 1 (3%) 1 (2%) 3 (7%)
Pituitary Gland (50) (49) (50)
Pars Distalis, Cyst 3 (6%) 5 (10%) 2 (4%)
Pars Distalis, Hemorrhage 2 (4%)
Pars Distalis, Hyperplasia 10 (20%) 14 (29%) 12 (24%)
Pars Distalis, Infarct 1 (2%)
Pars Distalis, Infiltration Cellular,
Lymphocyte 1 (2%)
Pars Intermedia, Angiectasis 1 (2%)
Pars Intermedia, Cyst 2 (4%) 2 (4%)
Pars Intermedia, Hyperplasia 1 (2%)
Thyroid Gland (50) (50) (50)
Hemorrhage 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Ultimobranchial Cyst 2 (4%) 1 (2%) 2 (4%)
C-Cell, Hyperplasia 8 (16%) 12 (24%) 12 (24%)
Follicle, Ectasia 6 (12%) 2 (4%) 2 (4%)
Follicle, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (49) (50) (50)
Inflammation, Chronic 4 (8%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Preputial Gland (48) (50) (49)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Abscess 1 (2%) 1 (2%)
Inflammation, Chronic 19 (40%) 18 (36%) 20 (41%)
Inflammation, Chronic Active 13 (27%) 21 (42%) 14 (29%)
Duct, Ectasia 1 (2%) 4 (8%) 2 (4%)
Prostate (50) (50) (50)
Hemorrhage 1 (2%)
Inflammation, Acute 1 (2%) 2 (4%) 1 (2%)
Inflammation, Chronic 6 (12%) 2 (4%) 6 (12%)
Inflammation, Chronic Active 40 (80%) 41 (82%) 32 (64%)
Testes (49) (50) (50)
Atrophy 6 (12%) 7 (14%)
Granuloma Sperm 1 (2%)
Mineralization 1 (2%)
Necrosis 1 (2%) 1 (2%)
Artery, Inflammation, Chronic 3 (6%) 2 (4%)
Interstitial Cell, Hyperplasia 13 (27%) 15 (30%) 14 (28%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (2) (4) (1)
Atypia Cellular 1 (25%)
Bone Marrow (50) (50) (49)
Hemorrhage 1 (2%) 1 (2%) 2 (4%)
Myelofibrosis 1 (2%)
Necrosis 1 (2%)
Lymph Node (49) (50) (50)
Mediastinal, Congestion 1 (2%) 4 (8%) 3 (6%)
Mediastinal, Hemorrhage 1 (2%) 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Infiltration Cellular, Plasma
Cell 1 (2%) 1 (2%) 1 (2%)
Mediastinal, Infiltration Cellular,
Histiocyte 1 (2%)
Mediastinal, Pigmentation 2 (4%)
Pancreatic, Congestion 1 (2%)
Lymph Node, Mandibular (49) (50) (48)
Congestion 1 (2%) 1 (2%) 1 (2%)
Cyst 4 (8%) 6 (12%) 4 (8%)
Hyperplasia, Lymphoid 37 (76%) 31 (62%) 39 (81%)
Inflammation, Acute 1 (2%)
Lymph Node, Mesenteric (49) (50) (49)
Congestion 1 (2%) 3 (6%) 1 (2%)
Cyst 1 (2%)
Edema 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Infiltration Cellular, Plasma Cell 1 (2%)
Inflammation, Acute 1 (2%)
Spleen (50) (50) (50)
Fibrosis 6 (12%) 5 (10%) 4 (8%)
Hematopoietic Cell Proliferation 30 (60%) 31 (62%) 37 (74%)
Hyperplasia, Lymphoid 2 (4%) 3 (6%)
Hyperplasia, Reticulum Cell 1 (2%)
Necrosis 2 (4%)
Pigmentation 25 (50%) 26 (52%) 23 (46%)
Thymus (47) (40) (49)
Congestion 1 (2%) 1 (3%) 1 (2%)
Cyst 1 (3%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (47) (39) (48)
Acinus, Ectasia 20 (43%) 15 (38%) 16 (33%)
Acinus, Hyperplasia 2 (4%)
Duct, Ectasia 1 (2%) 3 (8%) 2 (4%)
Skin (49) (50) (50)
Abscess 2 (4%) 1 (2%)
Alopecia 1 (2%) 1 (2%)
Cyst Epithelial Inclusion 1 (2%) 1 (2%)
Hyperkeratosis 2 (4%)
Inflammation, Chronic 2 (4%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Ulcer 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Hyperostosis 1 (2%)
Cranium, Fibrous Osteodystrophy 1 (2%)
Femur, Fibrous Osteodystrophy 3 (6%)
Femur, Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Compression 5 (10%) 5 (10%) 6 (12%)
Hemorrhage 2 (4%) 2 (4%) 1 (2%)
Hydrocephalus 1 (2%) 1 (2%)
Necrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Congestion 4 (8%) 4 (8%) 5 (10%)
Hemorrhage 5 (10%) 4 (8%) 12 (24%)
Alveolar Epithelium, Hyperplasia 2 (4%)
Alveolus, Infiltration Cellular, Histiocyte 6 (12%) 4 (8%) 13 (26%)
Alveolus, Mineralization 2 (4%)
Arteriole, Mineralization 31 (62%) 35 (70%) 34 (68%)
Bronchiole, Inflammation, Acute 1 (2%)
Interstitium, Inflammation, Chronic 1 (2%) 1 (2%)
Interstitium, Inflammation, Chronic Active 1 (2%)
Peribronchiolar, Inflammation, Chronic Active 1 (2%)
Nose (50) (50) (50)
Lumen, Hemorrhage 9 (18%) 12 (24%) 7 (14%)
Mucosa, Inflammation, Acute 12 (24%) 7 (14%) 9 (18%)
Mucosa, Inflammation, Chronic 2 (4%)
Nasolacrimal Duct, Hemorrhage 3 (6%) 2 (4%)
Nasolacrimal Duct, Inflammation, Acute 14 (28%) 12 (24%) 8 (16%)
Olfactory Epithelium, Degeneration 32 (64%) 34 (68%) 38 (76%)
Respiratory Epithelium, Degeneration 7 (14%) 5 (10%) 7 (14%)
Respiratory Epithelium, Metaplasia, Squamous 1 (2%)
Trachea (50) (50) (50)
Inflammation, Acute 1 (2%)
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SPECIAL SENSES SYSTEM
Ear (1) (2) (2)
Canal, Abscess 1 (100%)
Eye (10) (11) (14)
Cataract 8 (80%) 11 (100%) 12 (86%)
Hemorrhage 3 (30%) 3 (27%) 5 (36%)
Inflammation, Chronic 1 (7%)
Anterior Chamber, Hemorrhage 1 (7%)
Cornea, Inflammation, Acute 1 (7%)
Posterior Chamber, Synechia 1 (10%) 2 (14%)
Retina, Degeneration 9 (90%) 11 (100%) 12 (86%)
Sclera, Mineralization 2 (20%) 1 (9%) 2 (14%)
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URINARY SYSTEM
Kidney (50) (50) (50)
Congestion 1 (2%)
Cyst 2 (4%) 1 (2%)
Infarct 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:07
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Necrosis 1 (2%)
Nephropathy, Chronic 50 (100%) 49 (98%) 49 (98%)
Cortex, Cyst 1 (2%)
Pelvis, Dilatation 1 (2%)
Renal Tubule, Mineralization 1 (2%)
Renal Tubule, Pigmentation 44 (88%) 48 (96%) 42 (84%)
Urethra (3) (2) (3)
Calculus Micro Observation Only 3 (100%) 2 (100%) 3 (100%)
Urinary Bladder (49) (50) (49)
Calculus Micro Observation Only 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 2 (4%)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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