TDMS Study 05007-05 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
POLYSORBATE 80
NTP Experiment-Test: 05007-05 Report: PEIRPT05
Study Type: CHRONIC Date: 09/03/94
Route: DOSED FEED Time: 11:32:42
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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
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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
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ALIMENTARY SYSTEM
Esophagus (49) (22) (49)
Gallbladder (46) (18) (47)
Intestine Large, Rectum (48) (17) (47)
Leiomyoma 1 (2%)
Intestine Small, Ileum (47) (18) (45)
Intestine Small, Jejunum (48) (19) (47)
Fibrosarcoma, Metastatic, Mesentery 1 (2%)
Liver (50) (25) (49)
Hepatocellular Carcinoma 1 (2%) 1 (4%)
Hepatocellular Adenoma 2 (4%) 1 (4%) 2 (4%)
Mesentery (10) (5) (13)
Fibrosarcoma 1 (8%)
Fibrosarcoma, Metastatic, Skin 1 (10%)
Pancreas (47) (22) (48)
Fibrosarcoma, Metastatic, Mesentery 1 (2%)
Salivary Glands (46) (18) (46)
Stomach, Forestomach (49) (50) (49)
Glandular, Fibrosarcoma, Metastatic,
Mesentery 1 (2%)
Stomach, Glandular (49) (49) (48)
Tooth (1)
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CARDIOVASCULAR SYSTEM
Heart (49) (22) (50)
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Page 2
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (22) (50)
Adrenal Gland, Medulla (50) (22) (50)
Pheochromocytoma NOS 2 (4%)
Islets, Pancreatic (47) (21) (48)
Pituitary Gland (46) (20) (48)
Pars Distalis, Adenoma 11 (24%) 2 (10%) 15 (31%)
Thyroid Gland (49) (19) (46)
Follicle, Adenoma 1 (2%) 1 (2%)
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GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Ovary (48) (36) (50)
Adenoma 1 (2%)
Granulosa Cell Tumor Benign 1 (3%)
Luteoma 1 (2%)
Uterus (50) (42) (50)
Leiomyoma 1 (2%)
Endometrium, Polyp Stromal 3 (6%)
Endometrium, Sarcoma Stromal 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (22) (50)
Hemangiosarcoma, Metastatic, Spleen 1 (2%)
Lymph Node (49) (26) (49)
Lymph Node, Mandibular (46) (16) (46)
Lymph Node, Mesenteric (48) (23) (48)
Spleen (49) (25) (49)
Hemangiosarcoma 1 (4%) 1 (2%)
Thymus (48) (20) (48)
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INTEGUMENTARY SYSTEM
Mammary Gland (49) (19) (48)
Adenocarcinoma 1 (2%)
Skin (50) (38) (50)
Sebaceous Gland, Carcinoma 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 4 (8%) 2 (4%)
Page 3
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Subcutaneous Tissue, Hemangioma 1 (2%)
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MUSCULOSKELETAL SYSTEM
Bone (50) (22) (50)
Sternum, Osteosarcoma 1 (2%)
Skeletal Muscle (2)
Hemangiosarcoma, Metastatic, Spleen 1 (50%)
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NERVOUS SYSTEM
Brain (50) (22) (50)
Spinal Cord (1) (1)
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RESPIRATORY SYSTEM
Lung (50) (22) (50)
Alveolar/Bronchiolar Adenoma 3 (6%) 1 (5%) 2 (4%)
Alveolar/Bronchiolar Carcinoma 1 (5%) 1 (2%)
Nose (49) (22) (50)
Trachea (49) (21) (47)
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SPECIAL SENSES SYSTEM
Eye (1) (1)
Harderian Gland (1)
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URINARY SYSTEM
Kidney (50) (23) (50)
Urinary Bladder (49) (18) (48)
Hemangioma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Lymphoma Malignant Lymphocytic 5 (10%) 3 (6%) 3 (6%)
Lymphoma Malignant Mixed 12 (24%) 6 (12%) 8 (16%)
Lymphoma Malignant Undifferentiated Cell 1 (2%)
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* Number of animals with any tissue examined microscopically
Page 4
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 30 16 29
Total Primary Neoplasms 47 18 44
Total Animals with Benign Neoplasms 17 5 19
Total Benign Neoplasms 22 5 24
Total Animals with Malignant Neoplasms 22 11 17
Total Malignant Neoplasms 25 13 18
Total Animals with Metastatic Neoplasms 1 2
Total Metastatic Neoplasm 1 5
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 2
Total Uncertain Neoplasms 2
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 5
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:42
____________________________________________________________________________________________________________________________________
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
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ALIMENTARY SYSTEM
Intestine Large, Cecum (47) (16) (50)
Intestine Small, Duodenum (46) (16) (49)
Intestine Small, Ileum (46) (15) (48)
Intestine Small, Jejunum (46) (16) (49)
Liver (49) (23) (50)
Hemangiosarcoma 1 (4%)
Hepatocellular Carcinoma 11 (22%) 7 (30%) 5 (10%)
Hepatocellular Adenoma 5 (10%) 7 (30%) 6 (12%)
Neoplasm NOS 1 (2%)
Mesentery (1) (5) (3)
Squamous Cell Carcinoma, Metastatic, Stomach 1 (20%)
Pancreas (48) (17) (50)
Salivary Glands (49) (16) (49)
Stomach, Forestomach (48) (50) (50)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (2%)
Stomach, Glandular (48) (50) (50)
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CARDIOVASCULAR SYSTEM
Heart (49) (16) (50)
____________________________________________________________________________________________________________________________________
Page 6
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (49) (16) (50)
Adenoma 2 (4%)
Adrenal Gland, Medulla (49) (16) (50)
Pheochromocytoma NOS 1 (2%) 1 (6%) 2 (4%)
Islets, Pancreatic (48) (17) (50)
Pituitary Gland (47) (15) (49)
Pars Intermedia, Adenoma 1 (7%)
Thyroid Gland (49) (16) (49)
Follicle, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (49) (16) (50)
Preputial Gland (13) (14) (11)
Squamous Cell Carcinoma 2 (14%)
Prostate (49) (17) (50)
Seminal Vesicle (49) (16) (49)
Testes (49) (17) (50)
Interstitial Cell, Adenoma 1 (2%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (49) (17) (50)
Lymph Node (49) (28) (50)
Lymph Node, Mandibular (49) (14) (49)
Lymph Node, Mesenteric (48) (28) (46)
Spleen (48) (21) (49)
Hemangioma 1 (2%)
Thymus (47) (16) (49)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (49) (42) (50)
Squamous Cell Carcinoma 1 (2%) 1 (2%)
Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 5 (10%) 5 (12%) 3 (6%)
Subcutaneous Tissue, Fibrosarcoma 4 (8%) 5 (12%) 5 (10%)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) 3 (7%) 2 (4%)
Page 7
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Subcutaneous Tissue, Hemangioma 1 (2%) 1 (2%)
Subcutaneous Tissue, Neurofibrosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (2)
Sarcoma 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (16) (50)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (21) (50)
Alveolar/Bronchiolar Adenoma 5 (10%) 5 (24%) 5 (10%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (5%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 2 (10%) 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (3) (1)
Adenoma 3 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (16) (50)
Urinary Bladder (47) (16) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(49) *(50) *(50)
Leukemia Granulocytic 1 (2%)
Lymphoma Malignant Histiocytic 1 (2%)
Lymphoma Malignant Lymphocytic 2 (4%)
Lymphoma Malignant Mixed 3 (6%) 2 (4%) 5 (10%)
Mesothelioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 8
NTP Experiment-Test: 05007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 11:32:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 32 34 31
Total Primary Neoplasms 41 51 44
Total Animals with Benign Neoplasms 15 20 15
Total Benign Neoplasms 17 23 20
Total Animals with Malignant Neoplasms 21 23 17
Total Malignant Neoplasms 22 27 22
Total Animals with Metastatic Neoplasms 1 3 2
Total Metastatic Neoplasm 1 3 2
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 2 1 2
Total Uncertain Neoplasms 2 1 2
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
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