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https://ntp.niehs.nih.gov/go/1775

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%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 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%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 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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                             ----------              END OF REPORT             ----------                                           
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