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TDMS Study 05007-05 Pathology Tables



                                     INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
                                                           POLYSORBATE 80


NTP Experiment-Test: 05007-05                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/03/94
Route: DOSED FEED                                                                                                 Time: 11:32:39




       Facility:  Southern Research Institute

       Chemical CAS #:  9005-65-6

       Lock Date:  None

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All
































a  Number of animals examined microscopically at site and number of animals with lesion

                                                             Page   1

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