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Incidence Rates Of Nonneoplastic Lesions By Anatomic Site

NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97
Route: SKIN APPLICATION                                                                                           Time: 07:36:55

                                                           CORE STUDY




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  93-83-4

       Lock Date:  01/02/96

       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: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Natural Death                                     24           23           31                                                  
    Moribund Sacrifice                                11            9            5                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                15           18           14                                                  

  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (49)         (50)         (50)                                                
      Foreign Body                                     1 (2%)                                                                       
      Perforation                                                   1 (2%)                                                          
   Intestine Large, Colon                             (47)         (50)         (48)                                                
      Parasite Metazoan                                2 (4%)       3 (6%)       4 (8%)                                             
   Intestine Large, Rectum                            (38)         (47)         (46)                                                
      Parasite Metazoan                                1 (3%)       1 (2%)       2 (4%)                                             
   Intestine Small, Jejunum                           (36)         (38)         (38)                                                
      Inflammation, Chronic Active                                  1 (3%)                                                          
      Necrosis                                                      1 (3%)                                                          
   Liver                                              (50)         (50)         (50)                                                
      Angiectasis                                                   1 (2%)                                                          
      Basophilic Focus                                18 (36%)     15 (30%)     11 (22%)                                            
      Clear Cell Focus                                              1 (2%)                                                          
      Eosinophilic Focus                                            3 (6%)                                                          
      Hepatodiaphragmatic Nodule                       7 (14%)     14 (28%)     11 (22%)                                            
      Hyperplasia                                      1 (2%)                                                                       
      Inflammation, Chronic Active                    13 (26%)      7 (14%)      9 (18%)                                            
      Mixed Cell Focus                                 1 (2%)       2 (4%)                                                          
      Necrosis                                         1 (2%)                                                                       
      Vacuolization Cytoplasmic                        3 (6%)       3 (6%)       2 (4%)                                             
      Bile Duct, Dilatation                                         1 (2%)                                                          
   Mesentery                                          (3)          (3)                                                              
      Fat, Inflammation, Chronic Active                3 (100%)     3 (100%)                                                        
   Pancreas                                           (50)         (50)         (50)                                                
      Fibrosis                                                                   1 (2%)                                             
      Acinus, Atrophy                                  3 (6%)       5 (10%)      1 (2%)                                             
   Stomach, Forestomach                               (50)         (50)         (50)                                                
      Hyperkeratosis                                   1 (2%)       1 (2%)       1 (2%)                                             
      Inflammation, Chronic Active                     1 (2%)       1 (2%)       1 (2%)                                             
      Inflammation, Suppurative                                     1 (2%)                                                          
      Ulcer                                            1 (2%)       5 (10%)      2 (4%)                                             
      Epithelium, Hyperplasia                          1 (2%)       1 (2%)       1 (2%)                                             
   Stomach, Glandular                                 (50)         (50)         (50)                                                

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

                                                             Page    2                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Mineralization                                                             1 (2%)                                             
      Necrosis                                                      1 (2%)                                                          
      Ulcer                                            1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)                                                
      Fibrosis                                                      1 (2%)                                                          
      Inflammation, Chronic Active                    18 (36%)     20 (40%)     14 (28%)                                            
      Thrombosis                                       1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)                                                
      Accessory Adrenal Cortical Nodule                                          2 (4%)                                             
      Angiectasis                                     25 (50%)     19 (38%)     26 (52%)                                            
      Degeneration                                     1 (2%)                    1 (2%)                                             
      Fibrosis                                                      1 (2%)                                                          
      Hematopoietic Cell Proliferation                 1 (2%)                                                                       
      Hemorrhage                                       1 (2%)       1 (2%)       2 (4%)                                             
      Mineralization                                                1 (2%)                                                          
      Pigmentation, Lipofuscin                                                   1 (2%)                                             
      Vacuolization Cytoplasmic                        7 (14%)      7 (14%)      4 (8%)                                             
   Islets, Pancreatic                                 (50)         (50)         (50)                                                
      Vacuolization Cytoplasmic                        1 (2%)                                                                       
   Parathyroid Gland                                  (42)         (43)         (42)                                                
      Hyperplasia                                                                1 (2%)                                             
   Pituitary Gland                                    (50)         (50)         (50)                                                
      Angiectasis                                      3 (6%)       2 (4%)       4 (8%)                                             
      Cyst                                             8 (16%)      6 (12%)      5 (10%)                                            
      Hemorrhage                                                    1 (2%)       1 (2%)                                             
      Pars Distalis, Angiectasis                       8 (16%)      2 (4%)       4 (8%)                                             
      Pars Distalis, Hyperplasia                       4 (8%)       4 (8%)       9 (18%)                                            
   Thyroid Gland                                      (50)         (50)         (50)                                                
      Atrophy                                          1 (2%)                                                                       
      Ultimobranchial Cyst                             2 (4%)       1 (2%)                                                          
      C-Cell, Hyperplasia                              1 (2%)       1 (2%)                                                          
      Follicle, Cyst                                   1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    3                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (49)         (47)         (50)                                                
      Cyst                                             2 (4%)       2 (4%)       1 (2%)                                             
      Hyperplasia                                                   1 (2%)                                                          
      Inflammation, Chronic Active                    46 (94%)     44 (94%)     43 (86%)                                            
   Ovary                                              (50)         (50)         (50)                                                
      Atrophy                                                                    1 (2%)                                             
      Congestion                                                    1 (2%)                                                          
      Cyst                                                          3 (6%)                                                          
      Pigmentation, Lipofuscin                                      1 (2%)                                                          
      Follicle, Cyst                                                1 (2%)                                                          
      Periovarian Tissue, Cyst                         3 (6%)       8 (16%)      3 (6%)                                             
   Oviduct                                            (1)                                                                           
      Cyst                                             1 (100%)                                                                     
   Uterus                                             (50)         (50)         (50)                                                
      Hemorrhage                                       1 (2%)                                                                       
      Hydrometra                                                    4 (8%)       2 (4%)                                             
   Vagina                                             (1)                       (1)                                                 
      Hypertrophy                                      1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)                                                
      Myelofibrosis                                                 1 (2%)                                                          
   Lymph Node                                         (2)          (2)          (1)                                                 
      Ectasia                                          1 (50%)                                                                      
      Pigmentation, Hemosiderin                                     1 (50%)                                                         
      Pigmentation, Lipofuscin                                      1 (50%)                                                         
   Lymph Node, Mesenteric                             (50)         (50)         (50)                                                
      Ectasia                                          1 (2%)       1 (2%)                                                          
      Necrosis                                                      1 (2%)                                                          
   Spleen                                             (50)         (50)         (50)                                                
      Accessory Spleen                                 1 (2%)       1 (2%)                                                          
      Fibrosis                                         3 (6%)                                                                       
      Hematopoietic Cell Proliferation                 1 (2%)                    1 (2%)                                             
      Necrosis                                                      1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (49)         (49)         (50)                                                
      Dilatation                                       9 (18%)     11 (22%)      7 (14%)                                            
      Galactocele                                      1 (2%)       2 (4%)       1 (2%)                                             
      Inflammation, Chronic Active                                  1 (2%)                                                          
   Skin                                               (50)         (50)         (50)                                                
      Sebaceous Gland, Skin, Site of Application,                                                                                   

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

                                                             Page    4                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
INTEGUMENTARY SYSTEM - CONT                                                                                                         
           Hyperplasia                                 2 (4%)      48 (96%)     49 (98%)                                            
      Skin, Site of Application, Hyperkeratosis        1 (2%)      38 (76%)     31 (62%)                                            
      Skin, Site of Application, Hyperplasia           3 (6%)      50 (100%)    50 (100%)                                           
      Skin, Site of Application, Inflammation,                                                                                      
           Chronic Active                              2 (4%)      44 (88%)     48 (96%)                                            
      Skin, Site of Application, Parakeratosis         2 (4%)      27 (54%)     43 (86%)                                            
      Skin, Site of Application, Ulcer                 3 (6%)      20 (40%)     36 (72%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)                                                
      Fibrous Osteodystrophy                                                     1 (2%)                                             
      Osteosclerosis                                   5 (10%)                   1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)                                                
      Congestion                                                    2 (4%)       2 (4%)                                             
      Edema                                                                      1 (2%)                                             
      Inflammation, Chronic Active                     5 (10%)      3 (6%)       4 (8%)                                             
      Mineralization                                                             1 (2%)                                             
      Necrosis                                                      1 (2%)                                                          
      Pigmentation, Hemosiderin                        1 (2%)                    1 (2%)                                             
   Nose                                               (49)         (50)         (50)                                                
      Inflammation, Suppurative                        2 (4%)       2 (4%)       1 (2%)                                             
   Trachea                                            (50)         (50)         (50)                                                
      Inflammation, Chronic Active                                  1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (3)          (3)          (6)                                                 
      Mineralization                                   1 (33%)      1 (33%)      1 (17%)                                            
      Retinal Detachment                                            1 (33%)                                                         
      Lens, Cataract                                                             1 (17%)                                            
      Lens, Mineralization                                          1 (33%)      3 (50%)                                            
      Retina, Degeneration                             2 (67%)      3 (100%)     4 (67%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    5                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)                                                
      Casts Protein                                    1 (2%)                                                                       
      Cyst                                             1 (2%)                                                                       
      Mineralization                                  35 (70%)     37 (74%)     37 (74%)                                            
      Nephropathy                                      9 (18%)      8 (16%)      5 (10%)                                            
      Pigmentation, Hemosiderin                        4 (8%)       3 (6%)                                                          
      Renal Tubule, Degeneration                                    1 (2%)                                                          
      Renal Tubule, Hyperplasia                        2 (4%)       1 (2%)                                                          
      Renal Tubule, Regeneration                       1 (2%)       2 (4%)       2 (4%)                                             
   Urinary Bladder                                    (50)         (49)         (49)                                                
      Inflammation, Chronic Active                                  1 (2%)       2 (4%)                                             
      Mineralization                                                1 (2%)                                                          
                                                                                                                                    

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

                                                             Page    6                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Natural Death                                     16           10           12                                                  
    Moribund Sacrifice                                26           30           24                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                 8           10           14                                                  

  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (49)         (48)         (49)                                                
      Mineralization                                                3 (6%)       2 (4%)                                             
      Parasite Metazoan                                3 (6%)       1 (2%)       2 (4%)                                             
   Intestine Large, Rectum                            (48)         (49)         (48)                                                
      Mineralization                                                1 (2%)       1 (2%)                                             
      Parasite Metazoan                                2 (4%)                    2 (4%)                                             
   Intestine Large, Cecum                             (38)         (41)         (40)                                                
      Mineralization                                                             1 (3%)                                             
   Intestine Small, Duodenum                          (50)         (50)         (50)                                                
      Inflammation, Chronic Active                                  1 (2%)                                                          
      Mineralization                                                2 (4%)       2 (4%)                                             
      Ulcer                                                                      2 (4%)                                             
   Intestine Small, Jejunum                           (42)         (45)         (43)                                                
      Inflammation, Chronic Active                     1 (2%)       1 (2%)                                                          
      Mineralization                                                1 (2%)                                                          
      Ulcer                                                         1 (2%)                                                          
   Intestine Small, Ileum                             (41)         (45)         (45)                                                
      Parasite Metazoan                                1 (2%)                                                                       
      Ulcer                                                         1 (2%)                                                          
   Liver                                              (50)         (50)         (50)                                                
      Angiectasis                                      2 (4%)       2 (4%)       1 (2%)                                             
      Basophilic Focus                                 7 (14%)     11 (22%)      7 (14%)                                            
      Clear Cell Focus                                              2 (4%)       1 (2%)                                             
      Congestion                                       1 (2%)                                                                       
      Degeneration                                     2 (4%)                                                                       
      Eosinophilic Focus                                            1 (2%)                                                          
      Hepatodiaphragmatic Nodule                       4 (8%)       7 (14%)      5 (10%)                                            
      Inflammation, Chronic Active                     2 (4%)       4 (8%)       2 (4%)                                             
      Mixed Cell Focus                                 3 (6%)       3 (6%)       5 (10%)                                            
      Necrosis                                         2 (4%)                    2 (4%)                                             
      Vacuolization Cytoplasmic                       10 (20%)     12 (24%)     15 (30%)                                            
      Bile Duct, Hyperplasia                           3 (6%)       4 (8%)       2 (4%)                                             
   Mesentery                                          (5)          (7)          (3)                                                 
      Mineralization                                   1 (20%)                                                                      

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

                                                             Page    7                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fat, Inflammation, Chronic Active                4 (80%)      5 (71%)      2 (67%)                                            
      Fat, Mineralization                                           2 (29%)                                                         
      Fat, Necrosis                                                 1 (14%)      1 (33%)                                            
   Pancreas                                           (50)         (50)         (50)                                                
      Acinus, Atrophy                                  3 (6%)       6 (12%)      3 (6%)                                             
      Acinus, Hyperplasia                                           1 (2%)                                                          
      Duct, Hyperplasia                                1 (2%)                                                                       
   Stomach, Forestomach                               (50)         (50)         (50)                                                
      Edema                                            5 (10%)      6 (12%)      3 (6%)                                             
      Hyperkeratosis                                  14 (28%)     26 (52%)     11 (22%)                                            
      Hyperplasia, Basal Cell                          2 (4%)       1 (2%)       2 (4%)                                             
      Inflammation, Chronic Active                    12 (24%)     23 (46%)     11 (22%)                                            
      Inflammation, Suppurative                        3 (6%)       3 (6%)       1 (2%)                                             
      Mineralization                                   2 (4%)       1 (2%)       3 (6%)                                             
      Necrosis                                                                   2 (4%)                                             
      Perforation                                      4 (8%)      10 (20%)      1 (2%)                                             
      Ulcer                                           10 (20%)     14 (28%)      7 (14%)                                            
      Epithelium, Hyperplasia                         14 (28%)     25 (50%)     13 (26%)                                            
   Stomach, Glandular                                 (50)         (49)         (50)                                                
      Erosion                                                       1 (2%)                                                          
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mineralization                                  13 (26%)      6 (12%)      8 (16%)                                            
      Necrosis                                                      1 (2%)                                                          
      Perforation                                                   1 (2%)                                                          
      Ulcer                                            2 (4%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (50)         (50)         (50)                                                
      Mineralization                                  12 (24%)      5 (10%)      7 (14%)                                            
   Heart                                              (50)         (49)         (50)                                                
      Inflammation, Chronic Active                    35 (70%)     38 (78%)     33 (66%)                                            
      Mineralization                                   7 (14%)      4 (8%)       7 (14%)                                            
      Thrombosis                                       1 (2%)       4 (8%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)                                                
      Accessory Adrenal Cortical Nodule                             1 (2%)                                                          
      Angiectasis                                      1 (2%)       2 (4%)       2 (4%)                                             
      Degeneration                                                  1 (2%)                                                          
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia                                      4 (8%)                    1 (2%)                                             
      Vacuolization Cytoplasmic                       11 (22%)     23 (46%)     13 (26%)                                            
   Adrenal Medulla                                    (50)         (50)         (49)                                                

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

                                                             Page    8                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Hyperplasia                                      2 (4%)       3 (6%)       5 (10%)                                            
      Mineralization                                                1 (2%)                                                          
   Islets, Pancreatic                                 (50)         (50)         (50)                                                
      Hyperplasia                                                   1 (2%)                                                          
   Parathyroid Gland                                  (45)         (47)         (50)                                                
      Hyperplasia                                     17 (38%)     18 (38%)     12 (24%)                                            
   Pituitary Gland                                    (50)         (50)         (49)                                                
      Cyst                                             1 (2%)       2 (4%)       2 (4%)                                             
      Fibrosis                                         1 (2%)                                                                       
      Hemorrhage                                       2 (4%)                                                                       
      Hyperplasia                                                   2 (4%)       1 (2%)                                             
      Mineralization                                   1 (2%)       2 (4%)       1 (2%)                                             
      Pars Distalis, Angiectasis                       2 (4%)                                                                       
      Pars Distalis, Hyperplasia                       2 (4%)       1 (2%)       1 (2%)                                             
   Thyroid Gland                                      (50)         (50)         (50)                                                
      Atrophy                                          1 (2%)                                                                       
      Ultimobranchial Cyst                             1 (2%)       1 (2%)                                                          
      C-Cell, Hyperplasia                              1 (2%)                    1 (2%)                                             
      Follicle, Cyst                                                3 (6%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Preputial Gland                                    (50)         (50)         (50)                                                
      Cyst                                             8 (16%)      2 (4%)       1 (2%)                                             
      Hyperplasia                                      1 (2%)                                                                       
      Inflammation                                     1 (2%)                                                                       
      Inflammation, Chronic Active                    32 (64%)     35 (70%)     38 (76%)                                            
      Mineralization                                   1 (2%)                    1 (2%)                                             
   Prostate                                           (50)         (50)         (50)                                                
      Cyst                                             1 (2%)                    1 (2%)                                             
      Hyperplasia                                      1 (2%)                                                                       
      Inflammation, Chronic Active                    10 (20%)     10 (20%)      7 (14%)                                            
      Inflammation, Suppurative                        1 (2%)       3 (6%)                                                          
      Mineralization                                                1 (2%)                                                          
   Seminal Vesicle                                    (50)         (50)         (50)                                                
      Inflammation, Chronic Active                     1 (2%)                    2 (4%)                                             
      Mineralization                                                2 (4%)                                                          
   Testes                                             (50)         (50)         (50)                                                
      Cyst                                                                       1 (2%)                                             
      Degeneration                                    16 (32%)     14 (28%)     11 (22%)                                            
      Mineralization                                   4 (8%)       6 (12%)      5 (10%)                                            

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

                                                             Page    9                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Necrosis                                         1 (2%)                                                                       
      Interstitial Cell, Hyperplasia                  28 (56%)     23 (46%)     20 (40%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (49)         (50)                                                
      Hyperplasia                                                   1 (2%)                                                          
      Myelofibrosis                                    2 (4%)                                                                       
   Lymph Node                                         (2)                                                                           
      Ectasia                                          1 (50%)                                                                      
   Lymph Node, Mandibular                             (49)         (49)         (49)                                                
      Ectasia                                          1 (2%)                                                                       
      Hyperplasia                                                   1 (2%)                                                          
   Lymph Node, Mesenteric                             (49)         (48)         (50)                                                
      Congestion                                       1 (2%)                                                                       
      Ectasia                                          2 (4%)       5 (10%)      5 (10%)                                            
      Hemorrhage                                                    1 (2%)                                                          
      Hyperplasia                                                   1 (2%)                                                          
   Spleen                                             (50)         (50)         (50)                                                
      Congestion                                                                 1 (2%)                                             
      Depletion Cellular                                            1 (2%)                                                          
      Fibrosis                                         6 (12%)      6 (12%)      5 (10%)                                            
      Hematopoietic Cell Proliferation                 2 (4%)       6 (12%)      3 (6%)                                             
      Necrosis                                                      1 (2%)       1 (2%)                                             
      Capsule, Hyperplasia                                                       1 (2%)                                             
   Thymus                                             (45)         (42)         (44)                                                
      Atrophy                                          1 (2%)                    2 (5%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (49)         (49)         (49)                                                
      Dilatation                                       9 (18%)     16 (33%)     12 (24%)                                            
      Galactocele                                      6 (12%)      8 (16%)     10 (20%)                                            
      Hyperplasia                                      1 (2%)                                                                       
      Mineralization                                   2 (4%)                                                                       
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
   Skin                                               (50)         (50)         (50)                                                
      Epidermis, Cyst                                               1 (2%)                                                          
      Sebaceous Gland, Skin, Site of Application,                                                                                   
           Hyperplasia                                 1 (2%)      45 (90%)     45 (90%)                                            
      Skin, Site of Application, Fibrosis                                        1 (2%)                                             
      Skin, Site of Application, Hyperkeratosis                    44 (88%)     40 (80%)                                            
      Skin, Site of Application, Hyperplasia                       49 (98%)     47 (94%)                                            
      Skin, Site of Application, Inflammation,                                                                                      
           Chronic Active                                          48 (96%)     41 (82%)                                            

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

                                                             Page   10                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
INTEGUMENTARY SYSTEM - CONT                                                                                                         
      Skin, Site of Application, Mineralization                                  1 (2%)                                             
      Skin, Site of Application, Parakeratosis                     10 (20%)     11 (22%)                                            
      Skin, Site of Application, Ulcer                              7 (14%)      6 (12%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (49)         (50)                                                
      Fibrous Osteodystrophy                           9 (18%)     11 (22%)      6 (12%)                                            
   Skeletal Muscle                                                              (1)                                                 
      Inflammation, Chronic Active                                               1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)                                                
      Hemorrhage                                                                 1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)                                                
      Fibrosis                                                                   2 (4%)                                             
      Hemorrhage                                                    1 (2%)                                                          
      Inflammation, Chronic Active                     5 (10%)                   4 (8%)                                             
      Inflammation, Granulomatous                                   1 (2%)                                                          
      Mineralization                                   5 (10%)      3 (6%)       3 (6%)                                             
      Alveolar Epithelium, Hyperplasia                              1 (2%)       1 (2%)                                             
      Mediastinum, Fibrosis                            1 (2%)                                                                       
      Serosa, Fibrosis                                              1 (2%)                                                          
   Nose                                               (50)         (50)         (50)                                                
      Inflammation, Chronic Active                                  1 (2%)       2 (4%)                                             
      Inflammation, Suppurative                        4 (8%)                    3 (6%)                                             
   Trachea                                            (50)         (50)         (50)                                                
      Inflammation, Chronic Active                     2 (4%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (2)                       (1)                                                 
      Degeneration                                     1 (50%)                                                                      
      Cornea, Edema                                    1 (50%)                                                                      
      Lens, Mineralization                             1 (50%)                   1 (100%)                                           
      Retina, Degeneration                                                       1 (100%)                                           
   Harderian Gland                                                 (1)                                                              
      Hyperplasia                                                   1 (100%)                                                        
____________________________________________________________________________________________________________________________________

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

                                                             Page   11                                                              
NTP Experiment-Test: 91014-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                OLEIC ACID DIETHANOLAMINE CONDENSATE                           Date: 11/25/97  
Route: SKIN APPLICATION                                                                                           Time: 07:36:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100MG/KG                                               
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)                                                
      Accumulation, Hyaline Droplet                                 1 (2%)                                                          
      Casts                                                         1 (2%)                                                          
      Cyst                                             5 (10%)     12 (24%)      4 (8%)                                             
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Inflammation, Suppurative                                     1 (2%)                                                          
      Mineralization                                  10 (20%)      5 (10%)      7 (14%)                                            
      Necrosis                                         1 (2%)                                                                       
      Nephropathy                                     40 (80%)     42 (84%)     40 (80%)                                            
      Pigmentation, Hemosiderin                        5 (10%)      5 (10%)      8 (16%)                                            
      Renal Tubule, Degeneration                       2 (4%)       1 (2%)                                                          
      Renal Tubule, Hyperplasia                        1 (2%)                    1 (2%)                                             
      Renal Tubule, Hyperplasia, Oncocytic                          1 (2%)                                                          
      Renal Tubule, Necrosis                           1 (2%)                                                                       
      Renal Tubule, Regeneration                                    1 (2%)       1 (2%)                                             
   Urinary Bladder                                    (49)         (50)         (50)                                                
      Calculus Micro Observation Only                               1 (2%)                                                          
      Fibrosis                                         1 (2%)                                                                       
      Hemorrhage                                       3 (6%)       1 (2%)       1 (2%)                                             
      Inflammation, Chronic Active                     2 (4%)       2 (4%)       1 (2%)                                             
      Mineralization                                   1 (2%)                    1 (2%)                                             
      Ulcer                                                         1 (2%)                                                          
      Transitional Epithelium, Hyperplasia             1 (2%)                                                                       
                                                                                                                                    

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

                                                             Page   12                                                              
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