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TDMS Study 55323-03 Pathology Tables

NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97
Route: SKIN APPLICATION                                                                                           Time: 12:22:52

                                                           CORE STUDY




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  120-40-1

       Lock Date:  07/13/95

       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: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

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

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Natural Death                                     11           12           22                                                  
    Moribund Sacrifice                                10           12            5                                                  
    Accidently Killed                                  1                         1                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                28           26           22                                                  

  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (45)         (46)         (43)                                                
      Parasite Metazoan                                2 (4%)       4 (9%)       3 (7%)                                             
   Intestine Large, Rectum                            (42)         (45)         (43)                                                
      Inflammation, Chronic Active                                               1 (2%)                                             
      Parasite Metazoan                                2 (5%)       2 (4%)       1 (2%)                                             
   Intestine Large, Cecum                             (40)         (40)         (31)                                                
      Inflammation, Chronic Active                                  1 (3%)                                                          
   Intestine Small, Duodenum                          (49)         (49)         (49)                                                
      Inflammation, Chronic Active                                  1 (2%)                                                          
      Ulcer                                                                      1 (2%)                                             
   Intestine Small, Jejunum                           (42)         (43)         (38)                                                
      Mineralization                                                1 (2%)                                                          
   Intestine Small, Ileum                             (48)         (42)         (37)                                                
      Parasite Metazoan                                                          1 (3%)                                             
   Liver                                              (50)         (50)         (50)                                                
      Basophilic Focus                                 1 (2%)                    1 (2%)                                             
      Clear Cell Focus                                 1 (2%)       3 (6%)       2 (4%)                                             
      Eosinophilic Focus                                            3 (6%)       2 (4%)                                             
      Hepatodiaphragmatic Nodule                      12 (24%)     17 (34%)     12 (24%)                                            
      Inflammation, Chronic Active                    13 (26%)     15 (30%)      4 (8%)                                             
      Mixed Cell Focus                                              1 (2%)                                                          
      Necrosis                                                      4 (8%)                                                          
      Vacuolization Cytoplasmic                        3 (6%)       6 (12%)      2 (4%)                                             
      Bile Duct, Hyperplasia                                        1 (2%)                                                          
      Central Vein, Dilatation                                      1 (2%)                                                          
      Hepatocyte, Hyperplasia                          1 (2%)       1 (2%)       1 (2%)                                             
   Mesentery                                          (5)          (2)          (4)                                                 
      Necrosis                                                      1 (50%)                                                         
      Fat, Inflammation, Chronic Active                4 (80%)      1 (50%)      3 (75%)                                            
      Fat, Mineralization                                                        2 (50%)                                            
   Oral Mucosa                                        (1)          (1)                                                              
      Hyperplasia                                      1 (100%)                                                                     
   Pancreas                                           (50)         (50)         (49)                                                

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

                                                             Page    2                                                              
NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Inflammation, Chronic Active                                               1 (2%)                                             
      Necrosis                                                      1 (2%)                                                          
      Acinus, Atrophy                                  3 (6%)       5 (10%)      1 (2%)                                             
      Arteriole, Thrombosis                                                      1 (2%)                                             
   Stomach, Forestomach                               (50)         (50)         (50)                                                
      Hemorrhage                                                    1 (2%)                                                          
      Inflammation, Chronic Active                                  2 (4%)       2 (4%)                                             
      Ulcer                                            2 (4%)       2 (4%)       1 (2%)                                             
   Stomach, Glandular                                 (50)         (50)         (49)                                                
      Erosion                                          3 (6%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (50)         (50)         (50)                                                
      Inflammation, Chronic Active                                               1 (2%)                                             
   Heart                                              (50)         (50)         (49)                                                
      Hemorrhage                                                                 1 (2%)                                             
      Mineralization                                                1 (2%)                                                          
      Myocardium, Inflammation, Chronic Active        27 (54%)     31 (62%)     35 (71%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)                                                
      Accessory Adrenal Cortical Nodule                2 (4%)       2 (4%)       3 (6%)                                             
      Angiectasis                                      2 (4%)                                                                       
      Degeneration                                     1 (2%)                                                                       
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Hemorrhage                                       2 (4%)       2 (4%)       1 (2%)                                             
      Hyperplasia                                      1 (2%)       2 (4%)       1 (2%)                                             
      Hypertrophy                                                   1 (2%)                                                          
      Mineralization                                                1 (2%)                                                          
      Necrosis                                         1 (2%)                    1 (2%)                                             
      Vacuolization Cytoplasmic                        5 (10%)      4 (8%)       7 (14%)                                            
   Adrenal Medulla                                    (50)         (50)         (50)                                                
      Hyperplasia                                                                1 (2%)                                             
   Parathyroid Gland                                  (47)         (40)         (45)                                                
      Hyperplasia                                      1 (2%)                    2 (4%)                                             
   Pituitary Gland                                    (50)         (50)         (49)                                                
      Cyst                                             8 (16%)      5 (10%)      3 (6%)                                             
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia                                      4 (8%)                    2 (4%)                                             
      Thrombosis                                       1 (2%)                                                                       
      Pars Distalis, Angiectasis                       1 (2%)       2 (4%)                                                          
      Pars Distalis, Hyperplasia                       1 (2%)       2 (4%)                                                          
   Thyroid Gland                                      (50)         (50)         (50)                                                

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

                                                             Page    3                                                              
NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      C-Cell, Hyperplasia                              2 (4%)       5 (10%)      3 (6%)                                             
      Follicle, Cyst                                                1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (49)         (48)         (48)                                                
      Cyst                                             4 (8%)                    1 (2%)                                             
      Inflammation, Chronic Active                    30 (61%)     34 (71%)     36 (75%)                                            
      Mineralization                                                1 (2%)                                                          
      Necrosis                                                                   1 (2%)                                             
   Ovary                                              (50)         (50)         (50)                                                
      Follicle, Cyst                                   3 (6%)       1 (2%)       1 (2%)                                             
      Periovarian Tissue, Cyst                         5 (10%)      8 (16%)      5 (10%)                                            
   Uterus                                             (50)         (50)         (50)                                                
      Congestion                                                                 1 (2%)                                             
      Cyst                                                                       1 (2%)                                             
      Hemorrhage                                       1 (2%)                                                                       
      Hydrometra                                       4 (8%)       4 (8%)       8 (16%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)                                                
      Inflammation, Chronic Active                                  2 (4%)                                                          
      Myelofibrosis                                                 1 (2%)                                                          
   Lymph Node                                         (3)          (3)          (1)                                                 
      Hemorrhage                                                    1 (33%)                                                         
      Pigmentation, Hemosiderin                        1 (33%)                                                                      
   Lymph Node, Mandibular                             (49)         (50)         (49)                                                
      Atrophy                                          1 (2%)                                                                       
      Hemorrhage                                                    1 (2%)                                                          
   Lymph Node, Mesenteric                             (50)         (50)         (50)                                                
      Ectasia                                                       1 (2%)       1 (2%)                                             
      Hemorrhage                                                    1 (2%)       1 (2%)                                             
      Pigmentation, Lipofuscin                                      2 (4%)       4 (8%)                                             
      Arteriole, Inflammation, Chronic Active                                    1 (2%)                                             
   Spleen                                             (50)         (50)         (50)                                                
      Angiectasis                                                                1 (2%)                                             
      Congestion                                       1 (2%)       1 (2%)       1 (2%)                                             
      Fibrosis                                                                   1 (2%)                                             
      Hematopoietic Cell Proliferation                              1 (2%)                                                          

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

                                                             Page    4                                                              
NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Necrosis                                         1 (2%)       1 (2%)                                                          
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
      Thrombosis                                       3 (6%)                                                                       
   Thymus                                             (44)         (49)         (48)                                                
      Atrophy                                          2 (5%)       1 (2%)                                                          
      Hemorrhage                                                                 1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (50)         (50)                                                
      Dilatation                                      35 (70%)     40 (80%)     32 (64%)                                            
      Fibrosis                                         1 (2%)                                                                       
      Galactocele                                      1 (2%)                                                                       
      Hyperplasia, Cystic, Focal                       1 (2%)                                                                       
      Hyperplasia, Focal                               2 (4%)       3 (6%)       2 (4%)                                             
   Skin                                               (50)         (50)         (50)                                                
      Parakeratosis                                                 1 (2%)       1 (2%)                                             
      Epidermis, Skin, Site of Application,                                                                                         
          Hyperplasia                                  5 (10%)     33 (66%)     44 (88%)                                            
      Sebaceous Gland, Skin, Site of Application,                                                                                   
           Hyperplasia                                 3 (6%)      41 (82%)     45 (90%)                                            
      Skin, Site of Application, Hyperkeratosis                    20 (40%)     29 (58%)                                            
      Skin, Site of Application, Inflammation,                                                                                      
           Chronic Active                              3 (6%)      35 (70%)     34 (68%)                                            
      Skin, Site of Application, Parakeratosis         2 (4%)      12 (24%)     25 (50%)                                            
      Skin, Site of Application, Ulcer                 3 (6%)       2 (4%)      10 (20%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)                                                
      Hemorrhage                                                    2 (4%)                                                          
      Inflammation, Chronic Active                                  1 (2%)                                                          
   Spinal Cord                                        (1)                       (1)                                                 
      Hemorrhage                                       1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    5                                                              
NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)                                                
      Congestion                                                    1 (2%)       3 (6%)                                             
      Hemorrhage                                                                 2 (4%)                                             
      Inflammation, Chronic Active                     2 (4%)       2 (4%)       8 (16%)                                            
      Mineralization                                  23 (46%)     18 (36%)     19 (38%)                                            
      Interstitium, Fibrosis                           2 (4%)       2 (4%)                                                          
   Nose                                               (50)         (50)         (50)                                                
      Inflammation, Suppurative                        4 (8%)       1 (2%)       2 (4%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)          (1)          (6)                                                 
      Cataract                                                                   1 (17%)                                            
      Synechia                                                      1 (100%)                                                        
      Lens, Mineralization                             1 (100%)                  3 (50%)                                            
      Posterior Chamber, Hemorrhage                                              1 (17%)                                            
      Retina, Degeneration                             1 (100%)                  1 (17%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)                                                
      Cyst                                             2 (4%)                    2 (4%)                                             
      Inflammation, Chronic Active                                               2 (4%)                                             
      Mineralization                                  24 (48%)     23 (46%)     27 (54%)                                            
      Necrosis                                                                   1 (2%)                                             
      Nephropathy                                     40 (80%)     41 (82%)     40 (80%)                                            
      Pigmentation, Hemosiderin                        2 (4%)       2 (4%)       2 (4%)                                             
      Renal Tubule, Regeneration                       2 (4%)       4 (8%)       2 (4%)                                             
   Urinary Bladder                                    (49)         (49)         (47)                                                
      Inflammation, Chronic Active                                  3 (6%)                                                          
      Mineralization                                                1 (2%)                                                          
      Pigmentation, Hemosiderin                                                  1 (2%)                                             
                                                                                                                                    

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

                                                             Page    6                                                              
NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

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

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                31           29           25                                                  
    Natural Death                                      7            3            8                                                  
    Accidently Killed                                                            1                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                12           18           16                                                  

  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (49)         (50)         (46)                                                
      Cyst                                                          1 (2%)                                                          
      Parasite Metazoan                                4 (8%)                                                                       
   Intestine Large, Rectum                            (48)         (49)         (47)                                                
      Parasite Metazoan                                2 (4%)       2 (4%)       5 (11%)                                            
   Intestine Large, Cecum                             (41)         (47)         (44)                                                
      Ulcer                                            1 (2%)                                                                       
   Intestine Small, Duodenum                          (50)         (50)         (50)                                                
      Ulcer                                            1 (2%)                                                                       
   Intestine Small, Jejunum                           (45)         (50)         (46)                                                
      Inflammation, Chronic                                                      1 (2%)                                             
   Liver                                              (50)         (50)         (50)                                                
      Eosinophilic Focus                               1 (2%)                                                                       
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Hepatodiaphragmatic Nodule                       5 (10%)      8 (16%)      6 (12%)                                            
      Hypertrophy                                                   1 (2%)                                                          
      Inflammation, Chronic Active                     6 (12%)      4 (8%)       3 (6%)                                             
      Necrosis                                         2 (4%)                    2 (4%)                                             
      Vacuolization Cytoplasmic                       11 (22%)     14 (28%)     15 (30%)                                            
      Bile Duct, Hyperplasia                           7 (14%)      6 (12%)      6 (12%)                                            
      Periportal, Fibrosis                                          1 (2%)                                                          
   Mesentery                                          (12)         (8)          (6)                                                 
      Arteriole, Inflammation, Chronic Active                       1 (13%)                                                         
      Fat, Inflammation, Chronic Active               12 (100%)     6 (75%)      2 (33%)                                            
      Fat, Mineralization                              6 (50%)      4 (50%)      1 (17%)                                            
      Fat, Necrosis                                                              1 (17%)                                            
   Pancreas                                           (50)         (50)         (50)                                                
      Cyst                                             1 (2%)                                                                       
      Inflammation, Chronic Active                                  1 (2%)                                                          
      Acinus, Atrophy                                  5 (10%)      5 (10%)     11 (22%)                                            
      Arteriole, Inflammation, Chronic Active                                    1 (2%)                                             
   Salivary Glands                                    (50)         (50)         (50)                                                
      Atrophy                                                                    1 (2%)                                             

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

                                                             Page    7                                                              
NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
   Stomach, Forestomach                               (50)         (50)         (50)                                                
      Edema                                                                      2 (4%)                                             
      Fibrosis                                                      1 (2%)                                                          
      Hyperkeratosis                                   1 (2%)       2 (4%)       1 (2%)                                             
      Hyperplasia                                      1 (2%)       2 (4%)                                                          
      Inflammation, Chronic Active                    10 (20%)      6 (12%)      7 (14%)                                            
      Mineralization                                   1 (2%)                                                                       
      Ulcer                                           11 (22%)      5 (10%)      3 (6%)                                             
   Stomach, Glandular                                 (50)         (50)         (50)                                                
      Erosion                                          1 (2%)                                                                       
      Mineralization                                   1 (2%)                    3 (6%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (50)         (50)         (50)                                                
      Mineralization                                                             2 (4%)                                             
   Heart                                              (50)         (50)         (50)                                                
      Mineralization                                   2 (4%)                    2 (4%)                                             
      Thrombosis                                                    1 (2%)       1 (2%)                                             
      Myocardium, Inflammation, Chronic Active        36 (72%)     39 (78%)     41 (82%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)                                                
      Accessory Adrenal Cortical Nodule                1 (2%)       7 (14%)      6 (12%)                                            
      Degeneration                                                  1 (2%)       1 (2%)                                             
      Hyperplasia                                                                3 (6%)                                             
      Mineralization                                   1 (2%)                                                                       
      Pigmentation, Lipofuscin                         1 (2%)                                                                       
      Thrombosis                                       1 (2%)                                                                       
      Vacuolization Cytoplasmic                       19 (38%)     21 (42%)     22 (44%)                                            
   Adrenal Medulla                                    (50)         (50)         (50)                                                
      Hyperplasia                                      4 (8%)       2 (4%)       1 (2%)                                             
      Mineralization                                                             1 (2%)                                             
   Parathyroid Gland                                  (47)         (45)         (47)                                                
      Hyperplasia                                     16 (34%)     17 (38%)     13 (28%)                                            
   Pituitary Gland                                    (50)         (50)         (50)                                                
      Cyst                                                          1 (2%)                                                          
      Hyperplasia                                                   1 (2%)       1 (2%)                                             
      Mineralization                                                             1 (2%)                                             
   Thyroid Gland                                      (50)         (50)         (50)                                                
      Ultimobranchial Cyst                             1 (2%)                                                                       
      C-Cell, Hyperplasia                              3 (6%)                    3 (6%)                                             
      Follicle, Cyst                                   4 (8%)                    2 (4%)                                             
____________________________________________________________________________________________________________________________________

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

                                                             Page    8                                                              
NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Penis                                                           (1)                                                              
      Congestion                                                    1 (100%)                                                        
   Preputial Gland                                    (50)         (50)         (50)                                                
      Cyst                                             1 (2%)       1 (2%)       1 (2%)                                             
      Inflammation, Chronic Active                    50 (100%)    46 (92%)     43 (86%)                                            
      Inflammation, Suppurative                                     1 (2%)       1 (2%)                                             
   Prostate                                           (50)         (50)         (49)                                                
      Cyst                                                          1 (2%)       1 (2%)                                             
      Fibrosis                                                                   1 (2%)                                             
      Inflammation, Chronic Active                     7 (14%)      5 (10%)      3 (6%)                                             
   Seminal Vesicle                                    (50)         (50)         (49)                                                
      Inflammation, Chronic Active                     1 (2%)       1 (2%)       2 (4%)                                             
   Testes                                             (50)         (50)         (50)                                                
      Degeneration                                    15 (30%)     16 (32%)     17 (34%)                                            
      Inflammation, Chronic Active                     2 (4%)       4 (8%)       5 (10%)                                            
      Mineralization                                   4 (8%)       6 (12%)      7 (14%)                                            
      Necrosis                                         1 (2%)                                                                       
      Interstitial Cell, Hyperplasia                   3 (6%)       2 (4%)       4 (8%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)                                                
      Myelofibrosis                                    1 (2%)                                                                       
      Necrosis                                         1 (2%)                                                                       
   Lymph Node                                         (2)          (4)                                                              
      Angiectasis                                      1 (50%)                                                                      
      Congestion                                                    1 (25%)                                                         
   Lymph Node, Mandibular                             (50)         (50)         (50)                                                
      Hyperplasia                                                   1 (2%)                                                          
   Lymph Node, Mesenteric                             (50)         (50)         (50)                                                
      Amyloid Deposition                                            1 (2%)                                                          
      Atrophy                                          2 (4%)                    1 (2%)                                             
      Congestion                                                    1 (2%)                                                          
      Ectasia                                          1 (2%)       2 (4%)       1 (2%)                                             
      Necrosis                                                                   1 (2%)                                             
   Spleen                                             (50)         (50)         (50)                                                
      Congestion                                       8 (16%)      5 (10%)      5 (10%)                                            
      Fibrosis                                         3 (6%)       3 (6%)       3 (6%)                                             
      Hematopoietic Cell Proliferation                 1 (2%)       1 (2%)       1 (2%)                                             

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

                                                             Page    9                                                              
NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hemorrhage                                                                 1 (2%)                                             
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
      Lymphoid Follicle, Depletion Cellular            1 (2%)                                                                       
      Red Pulp, Hyperplasia                            1 (2%)                                                                       
   Thymus                                             (44)         (50)         (47)                                                
      Atrophy                                          7 (16%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (50)         (49)                                                
      Dilatation                                      28 (56%)     34 (68%)     31 (63%)                                            
      Galactocele                                      6 (12%)      7 (14%)      9 (18%)                                            
      Hyperplasia                                      8 (16%)      9 (18%)      5 (10%)                                            
      Hyperplasia, Cystic, Focal                                                 1 (2%)                                             
      Hyperplasia, Focal                               5 (10%)      8 (16%)      5 (10%)                                            
      Pigmentation, Hemosiderin                                     1 (2%)                                                          
   Skin                                               (50)         (50)         (50)                                                
      Hemorrhage                                       1 (2%)                                                                       
      Hyperkeratosis                                   1 (2%)                                                                       
      Parakeratosis                                    1 (2%)                                                                       
      Epidermis, Pinna, Hyperplasia                                              1 (2%)                                             
      Epidermis, Skin, Site of Application,                                                                                         
          Hyperplasia                                              29 (58%)     44 (88%)                                            
      Pinna, Parakeratosis                                                       1 (2%)                                             
      Sebaceous Gland, Skin, Site of Application,                                                                                   
           Hyperplasia                                             27 (54%)     44 (88%)                                            
      Skin, Site of Application, Edema                                           1 (2%)                                             
      Skin, Site of Application, Hyperkeratosis                    23 (46%)     25 (50%)                                            
      Skin, Site of Application, Inflammation,                                                                                      
           Chronic Active                                          10 (20%)     28 (56%)                                            
      Skin, Site of Application, Parakeratosis                     21 (42%)     33 (66%)                                            
      Skin, Site of Application, Ulcer                              4 (8%)      25 (50%)                                            
      Subcutaneous Tissue, Fibrosis                    1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)                                                
      Fibrous Osteodystrophy                           1 (2%)                    1 (2%)                                             
      Osteosclerosis                                   1 (2%)                                                                       
   Skeletal Muscle                                                              (1)                                                 
      Hemorrhage                                                                 1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page   10                                                              
NTP Experiment-Test: 55323-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/17/97  
Route: SKIN APPLICATION                                                                                           Time: 12:22:52  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)                                                
      Hydrocephalus                                    1 (2%)                    1 (2%)                                             
      Mineralization                                                             1 (2%)                                             
      Vacuolization Cytoplasmic                                     1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)                                                
      Cyst                                                          1 (2%)                                                          
      Hemorrhage                                                                 1 (2%)                                             
      Inflammation, Chronic Active                     1 (2%)       3 (6%)       4 (8%)                                             
      Mineralization                                  21 (42%)     22 (44%)     34 (68%)                                            
      Alveolar Epithelium, Hyperplasia                 1 (2%)                    1 (2%)                                             
      Interstitium, Fibrosis                                        2 (4%)                                                          
   Nose                                               (50)         (50)         (50)                                                
      Inflammation, Chronic Active                                               1 (2%)                                             
      Inflammation, Suppurative                       11 (22%)      5 (10%)      3 (6%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                             (1)          (2)                                                 
      Mineralization                                                             1 (50%)                                            
      Lens, Mineralization                                          1 (100%)     1 (50%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)                                                
      Cyst                                             7 (14%)      4 (8%)       6 (12%)                                            
      Fibrosis                                                      1 (2%)                                                          
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mineralization                                   1 (2%)       1 (2%)       3 (6%)                                             
      Nephropathy                                     42 (84%)     40 (80%)     40 (80%)                                            
      Pigmentation, Hemosiderin                        2 (4%)       2 (4%)                                                          
      Renal Tubule, Regeneration                       2 (4%)       1 (2%)       1 (2%)                                             
   Urinary Bladder                                    (50)         (50)         (50)                                                
      Hemorrhage                                                                 1 (2%)                                             
      Necrosis                                                                   1 (2%)                                             
                                                                                                                                    

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

                                                             Page   11                                                              
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