TDMS Study 05007-05 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
POLYSORBATE 80
NTP Experiment-Test: 05007-05 Report: PEIRPT03
Study Type: CHRONIC Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
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: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60
Scheduled Sacrifice 9 10 10
Early Deaths
Dead 13 15 15
Moribund 8 7 9
Survivors
Terminal Sacrifice 30 28 26
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (46) (18) (47)
Infiltration Cellular, Lymphocyte 20 (43%) 2 (11%) 17 (36%)
Intestine Large, Cecum (48) (18) (44)
Inflammation, Chronic Active 1 (2%)
Intestine Small, Duodenum (48) (19) (47)
Serosa, Inflammation, Chronic Active 1 (2%)
Intestine Small, Ileum (47) (18) (45)
Serosa, Inflammation, Chronic Active 1 (2%)
Intestine Small, Jejunum (48) (19) (47)
Serosa, Inflammation, Chronic Active 1 (2%)
Liver (50) (25) (49)
Cytomegaly 1 (2%)
Fatty Change 2 (4%)
Focal Cellular Change 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 20 (40%) 6 (24%) 21 (43%)
Infiltration Cellular, Lymphocyte 23 (46%) 4 (16%) 23 (47%)
Inflammation, Acute 3 (6%) 1 (4%) 5 (10%)
Necrosis 2 (4%) 3 (12%) 2 (4%)
Vacuolization Cytoplasmic 2 (4%)
Hepatocyte, Hyperplasia 1 (2%)
Serosa, Inflammation, Acute 1 (2%)
Serosa, Inflammation, Chronic 1 (2%)
Mesentery (10) (5) (13)
Cyst 1 (20%)
Inflammation, Acute 4 (40%) 3 (60%) 8 (62%)
Inflammation, Chronic Active 2 (20%) 1 (8%)
Fat, Necrosis 2 (20%)
Pancreas (47) (22) (48)
Abscess 1 (2%)
Infiltration Cellular, Lymphocyte 21 (45%) 1 (5%) 15 (31%)
Inflammation, Acute 2 (4%)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 1 (2%) 1 (5%) 1 (2%)
Acinus, Atrophy 2 (4%) 1 (5%)
Duct, Cyst 2 (4%)
Duct, Ectasia 2 (4%)
Salivary Glands (46) (18) (46)
Infiltration Cellular, Lymphocyte 40 (87%) 12 (67%) 31 (67%)
Acinus, Atrophy 1 (2%)
Stomach, Forestomach (49) (50) (49)
Cyst Epithelial Inclusion 1 (2%)
Erosion 1 (2%) 1 (2%)
Hyperplasia, Squamous 4 (8%) 8 (16%) 26 (53%)
Infiltration Cellular, Lymphocyte 1 (2%) 6 (12%)
Inflammation, Acute 2 (4%) 4 (8%) 3 (6%)
Inflammation, Chronic Active 2 (4%) 13 (27%)
Inflammation, Subacute 1 (2%)
Mineralization 2 (4%)
Ulcer 1 (2%) 7 (14%)
Stomach, Glandular (49) (49) (48)
Infiltration Cellular, Lymphocyte 15 (31%) 9 (18%) 13 (27%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%) 3 (6%)
Mineralization 3 (6%) 2 (4%)
Mucosa, Ectasia 1 (2%)
Mucosa, Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (49) (22) (50)
Embolus Bacterial 1 (2%)
Infiltration Cellular, Lymphocyte 9 (18%) 3 (14%) 8 (16%)
Inflammation, Acute 3 (6%) 3 (6%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%)
Epicardium, Inflammation, Acute 2 (4%)
Ventricle, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (50) (22) (50)
Capsule, Inflammation, Acute 1 (2%)
Capsule, Inflammation, Chronic Active 1 (2%)
Adrenal Gland, Cortex (50) (22) (50)
Congestion 1 (2%) 2 (4%)
Cyst 1 (2%)
Degeneration, Fatty 3 (6%) 4 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia 2 (4%)
Inflammation, Acute 2 (4%) 1 (2%)
Pigmentation 35 (70%) 5 (23%) 32 (64%)
Spindle Cell, Hyperplasia 50 (100%) 22 (100%) 49 (98%)
Adrenal Gland, Medulla (50) (22) (50)
Hyperplasia 2 (4%) 2 (4%)
Islets, Pancreatic (47) (21) (48)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 1 (2%)
Parathyroid Gland (26) (9) (27)
Infiltration Cellular, Lymphocyte 1 (4%)
Pituitary Gland (46) (20) (48)
Congestion 1 (2%)
Pars Distalis, Angiectasis 1 (2%) 2 (10%)
Pars Distalis, Cyst 4 (9%) 1 (2%)
Pars Distalis, Hyperplasia 8 (17%) 3 (15%) 8 (17%)
Thyroid Gland (49) (19) (46)
Infiltration Cellular, Lymphocyte 8 (16%) 5 (11%)
Inflammation, Chronic 1 (2%)
Follicle, Ectasia 8 (16%) 2 (11%) 5 (11%)
Follicle, Hyperplasia 3 (6%) 1 (5%) 2 (4%)
Follicular Cell, Ectasia 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (48) (36) (50)
Abscess 9 (19%) 13 (36%) 16 (32%)
Angiectasis 1 (2%)
Hemorrhage 2 (4%) 1 (2%)
Mineralization 1 (2%) 1 (2%)
Follicle, Cyst 3 (6%) 1 (3%) 3 (6%)
Periovarian Tissue, Cyst 5 (10%) 13 (36%) 8 (16%)
Uterus (50) (42) (50)
Abscess 2 (4%) 3 (7%) 1 (2%)
Angiectasis 1 (2%) 1 (2%)
Hydrometra 1 (2%) 1 (2%) 1 (2%)
Endometrium, Abscess 1 (2%)
Endometrium, Angiectasis 1 (2%)
Endometrium, Hyperplasia, Cystic 44 (88%) 37 (88%) 45 (90%)
Endometrium, Inflammation, Acute 9 (18%) 10 (24%) 17 (34%)
Endometrium, Metaplasia, Squamous 1 (2%) 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (22) (50)
Angiectasis 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Myelofibrosis 21 (42%) 1 (5%) 13 (26%)
Myeloid Cell, Hyperplasia 34 (68%) 14 (64%) 38 (76%)
Lymph Node (49) (26) (49)
Iliac, Hyperplasia, Lymphoid 2 (4%) 1 (4%)
Mediastinal, Hyperplasia, Lymphoid 3 (6%) 5 (19%) 6 (12%)
Mediastinal, Inflammation, Acute 1 (4%) 2 (4%)
Pancreatic, Hyperplasia, Lymphoid 1 (4%)
Renal, Hyperplasia, Lymphoid 2 (4%) 6 (23%) 6 (12%)
Renal, Inflammation, Acute 1 (2%) 2 (8%) 1 (2%)
Lymph Node, Mandibular (46) (16) (46)
Congestion 1 (2%)
Hyperplasia, Lymphoid 39 (85%) 9 (56%) 39 (85%)
Inflammation, Acute 1 (2%)
Pigmentation 24 (52%) 1 (6%) 22 (48%)
Lymph Node, Mesenteric (48) (23) (48)
Angiectasis 1 (2%)
Congestion 4 (8%) 2 (9%) 1 (2%)
Hyperplasia, Lymphoid 24 (50%) 9 (39%) 32 (67%)
Inflammation, Acute 4 (8%) 3 (6%)
Pigmentation 1 (2%) 1 (2%)
Spleen (49) (25) (49)
Hematopoietic Cell Proliferation 46 (94%) 18 (72%) 44 (90%)
Hyperplasia, Lymphoid 19 (39%) 5 (20%) 11 (22%)
Inflammation, Acute 4 (8%) 1 (4%) 3 (6%)
Pigmentation 28 (57%) 4 (16%) 26 (53%)
Capsule, Inflammation, Chronic 1 (2%) 1 (4%)
Thymus (48) (20) (48)
Cyst 6 (13%) 7 (15%)
Edema 1 (2%)
Hyperplasia, Lymphoid 18 (38%) 6 (30%) 12 (25%)
Inflammation, Acute 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (19) (48)
Acinus, Ectasia 9 (18%) 1 (5%) 13 (27%)
Duct, Ectasia 1 (2%) 5 (26%) 4 (8%)
Skin (50) (38) (50)
Inflammation, Chronic 18 (36%) 6 (16%) 15 (30%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Inflammation, Multifocal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Head, Ulcer 1 (3%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (22) (50)
Cranium, Inflammation, Chronic 2 (4%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (22) (50)
Compression 1 (2%)
Gliosis 1 (2%)
Hemorrhage 1 (2%)
Hydrocephalus 1 (5%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Mineralization 26 (52%) 9 (41%) 27 (54%)
Meninges, Hemorrhage 1 (2%)
Meninges, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (22) (50)
Abscess 1 (2%)
Congestion 2 (4%) 4 (18%) 4 (8%)
Hemorrhage 2 (4%) 1 (5%) 3 (6%)
Infiltration Cellular, Lymphocyte 48 (96%) 18 (82%) 42 (84%)
Alveolar Epithelium, Hyperplasia 2 (4%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 4 (8%) 2 (9%) 2 (4%)
Arteriole, Inflammation, Chronic Active 1 (2%)
Bronchiole, Inflammation, Acute 1 (2%)
Interstitium, Inflammation, Acute 2 (4%) 2 (9%) 5 (10%)
Interstitium, Inflammation, Chronic 1 (2%)
Interstitium, Inflammation, Chronic Active 1 (2%)
Mediastinum, Atypia Cellular 1 (2%)
Mediastinum, Inflammation, Acute 1 (2%) 1 (5%) 3 (6%)
Peribronchial, Inflammation, Acute 1 (5%) 1 (2%)
Pleura, Inflammation, Acute 1 (5%) 1 (2%)
Nose (49) (22) (50)
Lumen, Hemorrhage 20 (41%) 5 (23%) 13 (26%)
Mucosa, Inflammation, Acute 1 (2%)
Nasolacrimal Duct, Hemorrhage 7 (14%) 1 (5%) 11 (22%)
Nasolacrimal Duct, Inflammation, Acute 1 (2%)
Olfactory Epithelium, Degeneration 48 (98%) 19 (86%) 49 (98%)
Respiratory Epithelium, Degeneration 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (23) (50)
Amyloid Deposition 1 (4%)
Infiltration Cellular, Lymphocyte 43 (86%) 14 (61%) 40 (80%)
Inflammation, Acute 1 (2%) 2 (9%) 2 (4%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (4%)
Metaplasia, Osseous 3 (6%) 1 (2%)
Mineralization 1 (2%)
Capsule, Inflammation, Chronic Active 1 (2%)
Renal Tubule, Casts Protein 12 (24%) 1 (4%) 11 (22%)
Renal Tubule, Ectasia 20 (40%) 2 (9%) 15 (30%)
Renal Tubule, Mineralization 2 (4%) 1 (4%)
Renal Tubule, Necrosis 16 (32%) 11 (22%)
Renal Tubule, Regeneration 15 (30%) 11 (22%)
Urinary Bladder (49) (18) (48)
Infiltration Cellular, Lymphocyte 32 (65%) 11 (61%) 35 (73%)
Inflammation, Acute 1 (2%)
Serosa, Inflammation, Chronic Active 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60
Scheduled Sacrifice 7 7 10
Early Deaths
Moribund 9 11 9
Dead 9 8 9
Survivors
Terminal Sacrifice 32 34 32
Dead 1
Missing 1
Other 1
Animals Examined Microscopically 49 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (44) (15) (49)
Ectasia 1 (7%)
Infiltration Cellular, Lymphocyte 15 (34%) 2 (13%) 18 (37%)
Epithelium, Degeneration 1 (2%)
Intestine Large, Cecum (47) (16) (50)
Serosa, Inflammation, Chronic Active 1 (2%)
Intestine Small, Duodenum (46) (16) (49)
Serosa, Inflammation, Chronic Active 1 (2%)
Intestine Small, Ileum (46) (15) (48)
Inflammation, Acute 1 (2%)
Intestine Small, Jejunum (46) (16) (49)
Hyperplasia, Lymphoid 1 (2%)
Serosa, Inflammation, Chronic Active 1 (2%)
Liver (49) (23) (50)
Angiectasis 1 (2%)
Cytomegaly 1 (2%)
Developmental Malformation 1 (4%)
Fatty Change 3 (6%)
Focal Cellular Change 2 (4%) 1 (4%) 2 (4%)
Hematopoietic Cell Proliferation 9 (18%) 7 (14%)
Infarct 1 (2%)
Infiltration Cellular, Lymphocyte 12 (24%) 5 (22%) 7 (14%)
Necrosis 3 (6%) 3 (13%) 4 (8%)
Vacuolization Cytoplasmic 1 (2%)
Bile Duct, Cyst 1 (4%) 1 (2%)
Hepatocyte, Hypertrophy 1 (2%)
Portal, Inflammation, Chronic 2 (4%)
Mesentery (1) (5) (3)
Hemorrhage 1 (33%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic 1 (33%)
Inflammation, Chronic Active 1 (33%)
Fat, Necrosis 1 (100%) 3 (60%)
Pancreas (48) (17) (50)
Infiltration Cellular 1 (2%)
Infiltration Cellular, Lymphocyte 7 (15%) 3 (18%) 10 (20%)
Acinus, Atrophy 2 (12%) 1 (2%)
Acinus, Hyperplasia 1 (2%)
Duct, Cyst 1 (6%) 2 (4%)
Salivary Glands (49) (16) (49)
Infiltration Cellular, Lymphocyte 38 (78%) 9 (56%) 42 (86%)
Acinus, Atrophy 1 (2%)
Stomach, Forestomach (48) (50) (50)
Erosion 1 (2%)
Hyperkeratosis 1 (2%)
Hyperplasia, Squamous 3 (6%) 4 (8%) 19 (38%)
Infiltration Cellular, Lymphocyte 3 (6%) 6 (12%)
Inflammation, Acute 3 (6%) 5 (10%)
Inflammation, Chronic Active 1 (2%) 7 (14%)
Mineralization 1 (2%) 2 (4%) 6 (12%)
Ulcer 1 (2%) 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Glandular, Cyst Epithelial Inclusion 1 (2%)
Stomach, Glandular (48) (50) (50)
Erosion 1 (2%)
Infiltration Cellular, Lymphocyte 13 (27%) 10 (20%) 22 (44%)
Inflammation, Acute 5 (10%) 2 (4%) 2 (4%)
Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%)
Mineralization 2 (4%) 2 (4%) 9 (18%)
Mucosa, Dilatation 1 (2%)
Mucosa, Ectasia 4 (8%) 1 (2%) 3 (6%)
Mucosa, Erosion 3 (6%)
Mucosa, Inflammation, Acute 1 (2%)
Mucosa, Mineralization 1 (2%)
Mucosa, Ulcer 1 (2%)
Tooth (1) (1)
Pulp, Inflammation, Chronic 1 (100%)
Pulp, Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (49) (16) (50)
Infiltration Cellular, Lymphocyte 6 (12%) 7 (14%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (49) (16) (50)
Cyst 1 (2%)
Hyperplasia 1 (2%)
Hypertrophy 7 (14%) 11 (22%)
Spindle Cell, Hyperplasia 48 (98%) 14 (88%) 46 (92%)
Spindle Cell, Hyperplasia, Lymphoid 1 (6%) 1 (2%)
Adrenal Gland, Medulla (49) (16) (50)
Hyperplasia 2 (4%) 1 (6%) 2 (4%)
Islets, Pancreatic (48) (17) (50)
Infiltration Cellular, Lymphocyte 1 (2%)
Pituitary Gland (47) (15) (49)
Pars Distalis, Cyst 3 (6%)
Pars Distalis, Hyperplasia 2 (4%) 4 (8%)
Pars Intermedia, Cyst 1 (2%) 1 (2%)
Thyroid Gland (49) (16) (49)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (6%) 4 (8%)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 1 (2%) 1 (2%)
Follicle, Ectasia 1 (2%) 1 (6%) 1 (2%)
Follicle, Hyperplasia 4 (8%) 2 (4%)
Follicle, Hyperplasia, Cystic 1 (6%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (49) (16) (50)
Infiltration Cellular, Lymphocyte 19 (39%) 4 (25%) 25 (50%)
Serosa, Inflammation, Chronic Active 1 (2%)
Penis (2) (3)
Inflammation, Acute 2 (100%) 2 (67%)
Preputial Gland (13) (14) (11)
Abscess 4 (31%) 5 (36%) 1 (9%)
Infiltration Cellular, Lymphocyte 3 (21%) 1 (9%)
Inflammation, Chronic 3 (23%) 1 (7%) 4 (36%)
Inflammation, Chronic Active 4 (31%) 3 (21%) 5 (45%)
Duct, Cyst 1 (8%) 2 (14%) 1 (9%)
Duct, Ectasia 1 (9%)
Prostate (49) (17) (50)
Ectasia 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%)
Seminal Vesicle (49) (16) (49)
Ectasia 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 2 (4%) 4 (8%)
Inflammation, Chronic 3 (6%)
Serosa, Inflammation, Chronic Active 1 (2%)
Testes (49) (17) (50)
Atrophy 2 (4%)
Granuloma Sperm 1 (2%)
Mineralization 1 (2%) 3 (18%) 2 (4%)
Necrosis 1 (6%)
Spermatogenic Arrest 1 (2%)
Interstitial Cell, Hyperplasia 16 (33%) 9 (18%)
Seminiferous Tubule, Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (1)
Atypia Cellular 1 (100%)
Bone Marrow (49) (17) (50)
Angiectasis 1 (2%)
Hyperplasia, Reticulum Cell 1 (2%)
Myelofibrosis 2 (4%)
Myeloid Cell, Hyperplasia 35 (71%) 12 (71%) 36 (72%)
Lymph Node (49) (28) (50)
Iliac, Hyperplasia, Lymphoid 1 (2%)
Inguinal, Hyperplasia, Lymphoid 1 (2%) 3 (11%)
Mediastinal, Congestion 1 (4%)
Mediastinal, Hyperplasia, Lymphoid 2 (7%) 1 (2%)
Renal, Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mandibular (49) (14) (49)
Hyperplasia 1 (2%)
Hyperplasia, Lymphoid 40 (82%) 4 (29%) 37 (76%)
Pigmentation 10 (20%) 1 (7%) 9 (18%)
Lymph Node, Mesenteric (48) (28) (46)
Angiectasis 2 (7%) 3 (7%)
Congestion 12 (25%) 11 (39%) 10 (22%)
Hemorrhage 1 (2%) 2 (7%)
Hyperplasia 1 (2%)
Hyperplasia, Lymphoid 33 (69%) 15 (54%) 35 (76%)
Inflammation, Acute 5 (10%) 1 (4%) 3 (7%)
Inflammation, Chronic 1 (4%)
Spleen (48) (21) (49)
Angiectasis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Atrophy 2 (4%)
Hematopoietic Cell Proliferation 26 (54%) 13 (62%) 35 (71%)
Hyperplasia, Glandular 1 (2%)
Hyperplasia, Lymphoid 7 (15%) 2 (10%) 10 (20%)
Pigmentation 11 (23%) 2 (10%) 9 (18%)
Capsule, Inflammation, Chronic Active 1 (2%)
Thymus (47) (16) (49)
Cyst 8 (17%) 1 (6%) 9 (18%)
Hyperplasia, Lymphoid 1 (6%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (49) (42) (50)
Alopecia 1 (2%)
Angiectasis 1 (2%)
Erosion 1 (2%) 1 (2%) 1 (2%)
Fibrosis, Focal 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic 18 (37%) 15 (36%) 24 (48%)
Inflammation, Chronic Active 4 (8%) 1 (2%) 3 (6%)
Metaplasia, Osseous 1 (2%)
Ulcer 8 (16%) 6 (14%) 5 (10%)
Epithelium, Hyperplasia 1 (2%)
Prepuce, Inflammation, Acute 1 (2%)
Prepuce, Inflammation, Chronic 1 (2%)
Prepuce, Ulcer 1 (2%)
Subcutaneous Tissue, Abscess 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic
Active 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (2)
Abscess 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (16) (50)
Mineralization 40 (82%) 9 (56%) 29 (58%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (21) (50)
Congestion 4 (8%) 1 (5%) 4 (8%)
Hemorrhage 5 (10%) 1 (5%) 4 (8%)
Infiltration Cellular, Lymphocyte 42 (86%) 12 (57%) 43 (86%)
Infiltration Cellular, Histiocyte 1 (2%)
Alveolar Epithelium, Hyperplasia 4 (8%) 2 (4%)
Alveolus, Infiltration Cellular, Histiocyte 6 (12%) 2 (4%)
Alveolus, Inflammation, Acute 1 (2%)
Bronchiole, Inflammation, Acute 4 (8%)
Bronchiole, Inflammation, Chronic Active 1 (2%)
Interstitium, Inflammation, Acute 1 (2%)
Nose (49) (16) (49)
Lumen, Hemorrhage 24 (49%) 5 (31%) 29 (59%)
Mucosa, Inflammation, Acute 1 (2%) 3 (6%)
Nasolacrimal Duct, Hemorrhage 3 (6%) 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 1 (2%) 4 (25%) 1 (2%)
Olfactory Epithelium, Degeneration 26 (53%) 6 (38%) 23 (47%)
Respiratory Epithelium, Degeneration 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (2)
Atrophy 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (16) (50)
Congestion 1 (6%)
Hemorrhage 1 (6%)
Infiltration Cellular, Lymphocyte 43 (88%) 12 (75%) 46 (92%)
Inflammation, Chronic 2 (13%)
Metaplasia, Osseous 3 (6%) 1 (2%)
Glomerulus, Ectasia 1 (2%)
Glomerulus, Renal Tubule, Mineralization 1 (6%)
Pelvis, Inflammation, Acute 2 (4%)
Renal Tubule, Casts Protein 4 (8%) 4 (8%)
Renal Tubule, Ectasia 8 (16%) 1 (6%) 7 (14%)
Renal Tubule, Mineralization 12 (24%) 1 (6%) 5 (10%)
Renal Tubule, Necrosis 14 (29%) 1 (6%) 23 (46%)
Renal Tubule, Pigmentation 1 (2%)
Renal Tubule, Regeneration 33 (67%) 3 (19%) 36 (72%)
Urethra (9) (5) (15)
Calculus Micro Observation Only 9 (100%) 5 (100%) 14 (93%)
Infiltration Cellular, Lymphocyte 1 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:39
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Urinary Bladder (47) (16) (50)
Ectasia 2 (13%)
Infiltration Cellular, Lymphocyte 20 (43%) 4 (25%) 25 (50%)
Inflammation, Chronic 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------