TDMS Study 05007-06 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
POLYSORBATE 80
NTP Experiment-Test: 05007-06 Report: PEIRPT05
Study Type: CHRONIC Date: 09/03/94
Route: DOSED FEED Time: 12:48:09
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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC POLYSORBATE 80 Date: 09/03/94
Route: DOSED FEED Time: 12:48:09
____________________________________________________________________________________________________________________________________
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
Esophagus (49) (50) (50)
Squamous Cell Carcinoma 1 (2%)
Intestine Large, Cecum (50) (48) (49)
Intestine Large, Colon (50) (49) (50)
Intestine Large, Rectum (50) (50) (48)
Leiomyosarcoma 1 (2%)
Intestine Small, Duodenum (50) (48) (50)
Adenocarcinoma 1 (2%)
Intestine Small, Ileum (50) (48) (49)
Intestine Small, Jejunum (50) (48) (49)
Liver (50) (50) (50)
Hepatocellular Adenoma 1 (2%) 3 (6%)
Histiocytic Sarcoma 1 (2%)
Mesentery (10) (4) (3)
Pancreas (50) (47) (50)
Salivary Glands (50) (50) (50)
Stomach, Forestomach (50) (50) (50)
Stomach, Glandular (50) (50) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (50)
Adenoma 1 (2%) 2 (4%)
Adrenal Gland, Medulla (50) (50) (50)
Pheochromocytoma NOS 6 (12%) 6 (12%) 7 (14%)
Page 2
NTP Experiment-Test: 05007-06 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: 12:48:09
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Islets, Pancreatic (50) (47) (50)
Adenoma 2 (4%)
Parathyroid Gland (41) (41) (41)
Adenoma 1 (2%)
Pituitary Gland (50) (50) (50)
Pars Distalis, Adenoma 37 (74%) 30 (60%) 36 (72%)
Pars Distalis, Carcinoma 1 (2%)
Pars Distalis, Histiocytic Sarcoma 1 (2%)
Pars Intermedia, Adenoma 2 (4%)
Pars Intermedia, Carcinoma 1 (2%)
Thyroid Gland (50) (50) (50)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
C-Cell, Adenoma 5 (10%) 6 (12%) 10 (20%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (49) (50)
Adenoma 3 (6%) 3 (6%) 3 (6%)
Carcinoma 7 (15%) 5 (10%) 4 (8%)
Squamous Cell Carcinoma 1 (2%) 1 (2%)
Ovary (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Uterus (50) (50) (50)
Endometrium, Polyp Stromal 9 (18%) 11 (22%) 12 (24%)
Endometrium, Sarcoma Stromal 1 (2%)
Vagina (6) (9) (5)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (2) (1)
Bone Marrow (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Lymph Node (50) (50) (50)
Lymph Node, Mandibular (50) (50) (50)
Lymph Node, Mesenteric (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Spleen (50) (50) (50)
Page 3
NTP Experiment-Test: 05007-06 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: 12:48:09
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Histiocytic Sarcoma 1 (2%)
Thymus (47) (46) (47)
Thymoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (48) (50)
Adenocarcinoma 2 (4%) 1 (2%)
Adenoma 1 (2%)
Fibroadenoma 28 (56%) 27 (56%) 26 (52%)
Skin (50) (50) (50)
Squamous Cell Carcinoma 1 (2%)
Head, Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 2 (4%) 2 (4%)
Subcutaneous Tissue, Fibrosarcoma 2 (4%)
Subcutaneous Tissue, Lipoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (3) (2)
Lipoma 1 (50%)
Rhabdomyosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Carcinoma, Deep Invasion, Metastatic,
Pituitary Gland 2 (4%)
Oligodendroglioma Malignant 2 (4%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Nose (50) (50) (50)
Nasolacrimal Duct, Squamous Cell Carcinoma 1 (2%)
Trachea (50) (50) (50)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05007-06 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: 12:48:09
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1) (2)
Adenoma 1 (50%)
Squamous Cell Carcinoma 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Urinary Bladder (50) (50) (50)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 26 (52%) 10 (20%) 13 (26%)
Lymphoma Malignant Mixed 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05007-06 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: 12:48:09
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 48 48
Total Primary Neoplasms 138 118 124
Total Animals with Benign Neoplasms 47 44 46
Total Benign Neoplasms 91 87 93
Total Animals with Malignant Neoplasms 35 21 20
Total Malignant Neoplasms 41 25 24
Total Animals with Metastatic Neoplasms 2 1
Total Metastatic Neoplasm 2 2
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 6 6 7
Total Uncertain Neoplasms 6 6 7
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 6
NTP Experiment-Test: 05007-06 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: 12:48:09
____________________________________________________________________________________________________________________________________
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)
Intestine Large, Colon (49) (50) (49)
Intestine Large, Rectum (48) (49) (49)
Intestine Small, Duodenum (49) (50) (49)
Hemangiosarcoma, Metastatic, Spleen 1 (2%)
Intestine Small, Ileum (49) (47) (49)
Intestine Small, Jejunum (48) (50) (49)
Liver (50) (50) (50)
Hepatocellular Adenoma 2 (4%) 2 (4%)
Mesentery (4) (10) (12)
Pancreas (50) (50) (48)
Acinus, Adenoma 1 (2%) 2 (4%) 1 (2%)
Salivary Glands (50) (50) (50)
Stomach, Forestomach (50) (50) (50)
Stomach, Glandular (49) (50) (50)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (49) (50) (50)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Adrenal Gland, Medulla (50) (50) (50)
Pheochromocytoma Malignant 1 (2%) 4 (8%) 2 (4%)
Page 7
NTP Experiment-Test: 05007-06 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: 12:48:09
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pheochromocytoma Benign 17 (34%) 12 (24%) 21 (42%)
Bilateral, Pheochromocytoma Benign 4 (8%) 4 (8%) 7 (14%)
Islets, Pancreatic (50) (48) (48)
Adenoma 4 (8%) 5 (10%) 3 (6%)
Carcinoma 1 (2%)
Pituitary Gland (50) (49) (50)
Pars Distalis, Adenoma 30 (60%) 23 (47%) 26 (52%)
Pars Intermedia, Adenoma 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50)
C-Cell, Adenoma 6 (12%) 2 (4%) 2 (4%)
Follicle, Adenocarcinoma 1 (2%)
Follicle, Adenoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (49) (50) (50)
Preputial Gland (48) (50) (49)
Adenoma 5 (10%) 1 (2%) 2 (4%)
Carcinoma 5 (10%) 6 (12%) 5 (10%)
Squamous Cell Carcinoma 1 (2%) 1 (2%)
Prostate (50) (50) (50)
Seminal Vesicle (50) (50) (50)
Testes (49) (50) (50)
Interstitial Cell, Adenoma 39 (80%) 35 (70%) 41 (82%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (2) (4) (1)
Bone Marrow (50) (50) (49)
Lymph Node (49) (50) (50)
Lymph Node, Mandibular (49) (50) (48)
Lymph Node, Mesenteric (49) (50) (49)
Spleen (50) (50) (50)
Sarcoma 2 (4%)
Thymus (47) (40) (49)
Neoplasm NOS 1 (3%)
Thymoma NOS 1 (2%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05007-06 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: 12:48:09
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (47) (39) (48)
Fibroadenoma 1 (2%) 2 (5%)
Neurofibrosarcoma, Deep Invasion, Metastatic,
Skin 1 (2%)
Skin (49) (50) (50)
Basal Cell Carcinoma 2 (4%) 1 (2%)
Keratoacanthoma 2 (4%) 2 (4%) 5 (10%)
Squamous Cell Papilloma 2 (4%) 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 3 (6%) 4 (8%)
Subcutaneous Tissue, Lipoma 1 (2%) 2 (4%)
Subcutaneous Tissue, Neurofibroma 1 (2%)
Subcutaneous Tissue, Neurofibrosarcoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Cranium, Osteosarcoma 1 (2%)
Skeletal Muscle (2)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Astrocytoma NOS 1 (2%)
Hemangioma 1 (2%)
Neuroblastoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Nose (50) (50) (50)
Mucosa, Squamous Cell Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (2) (2)
Canal, Squamous Cell Carcinoma 2 (100%)
Pinna, Neurofibroma 1 (50%)
Eye (10) (11) (14)
Lids, Squamous Cell Carcinoma 1 (10%)
Page 9
NTP Experiment-Test: 05007-06 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: 12:48:09
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - cont
Zymbal's Gland (1)
Squamous Cell Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Carcinoma 1 (2%)
Urinary Bladder (49) (50) (49)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Leukemia Mononuclear 23 (46%) 21 (42%) 26 (52%)
Lymphoma Malignant Lymphocytic 1 (2%)
Lymphoma Malignant Mixed 1 (2%)
Mesothelioma Benign 1 (2%)
Mesothelioma Malignant 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05007-06 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: 12:48:09
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 49 48
Total Primary Neoplasms 156 134 167
Total Animals with Benign Neoplasms 48 47 47
Total Benign Neoplasms 119 95 120
Total Animals with Malignant Neoplasms 31 31 34
Total Malignant Neoplasms 36 38 46
Total Animals with Metastatic Neoplasms 1 1
Total Metastatic Neoplasm 1 1
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1 1 1
Total Uncertain Neoplasms 1 1 1
____________________________________________________________________________________________________________________________________
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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