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TDMS Study 55312-03 Pathology Tables

NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99
Route: SKIN APPLICATION                                                                                           Time: 08:08:11

                                                      2 YEAR CHRONIC RATS




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  68603-42-9

       Lock Date:  09/06/95

       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: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         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                                     15           11           18                                                  
    Moribund Sacrifice                                 7           15           10                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                28           24           21                                                  
    Moribund Sacrifice                                                           1                                                  

  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (50)         (50)                                                
      Perforation                                                                1 (2%)                                             
   Intestine Large, Colon                             (50)         (50)         (50)                                                
      Parasite Metazoan                                2 (4%)       5 (10%)      1 (2%)                                             
   Intestine Large, Rectum                            (50)         (50)         (50)                                                
      Parasite Metazoan                                6 (12%)      4 (8%)       6 (12%)                                            
   Intestine Large, Cecum                             (50)         (50)         (50)                                                
      Parasite Metazoan                                2 (4%)                                                                       
   Intestine Small, Duodenum                          (50)         (50)         (50)                                                
      Epithelium, Ulcer                                                          1 (2%)                                             
   Intestine Small, Jejunum                           (50)         (50)         (50)                                                
      Inflammation, Chronic Active                                  1 (2%)                                                          
   Intestine Small, Ileum                             (50)         (49)         (49)                                                
      Inflammation, Chronic Active                                  1 (2%)                                                          
   Liver                                              (50)         (50)         (50)                                                
      Basophilic Focus                                31 (62%)     17 (34%)      4 (8%)                                             
      Clear Cell Focus                                 5 (10%)      4 (8%)       1 (2%)                                             
      Fibrosis                                         1 (2%)                                                                       
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Hepatodiaphragmatic Nodule                      10 (20%)     11 (22%)     14 (28%)                                            
      Inflammation, Chronic                           29 (58%)     26 (52%)     13 (26%)                                            
      Mixed Cell Focus                                 1 (2%)       2 (4%)                                                          
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
      Vacuolization Cytoplasmic                       23 (46%)     20 (40%)     22 (44%)                                            
      Bile Duct, Hyperplasia                          26 (52%)     21 (42%)     16 (32%)                                            
      Hepatocyte, Degeneration, Cystic                                           1 (2%)                                             
      Hepatocyte, Hyperplasia, Adenomatous             1 (2%)       1 (2%)                                                          
      Hepatocyte, Necrosis                             1 (2%)       2 (4%)                                                          
      Hepatocyte, Centrilobular, Degeneration          2 (4%)       1 (2%)       2 (4%)                                             
      Hepatocyte, Centrilobular, Necrosis              1 (2%)                                                                       
      Serosa, Necrosis, Fibrinoid                      1 (2%)                                                                       
   Mesentery                                          (4)          (5)          (2)                                                 
      Fat, Inflammation, Chronic Active                                          1 (50%)                                            

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fat, Necrosis                                    3 (75%)      4 (80%)      1 (50%)                                            
   Oral Mucosa                                        (1)          (1)          (3)                                                 
      Gingival, Hyperplasia, Squamous                  1 (100%)                                                                     
      Gingival, Inflammation, Chronic Active                                     1 (33%)                                            
      Pharyngeal, Hyperplasia, Squamous                             1 (100%)     1 (33%)                                            
   Pancreas                                           (50)         (50)         (50)                                                
      Inflammation, Granulomatous                      1 (2%)                                                                       
      Acinus, Atrophy                                 19 (38%)     13 (26%)     11 (22%)                                            
   Stomach, Forestomach                               (50)         (50)         (50)                                                
      Edema                                            1 (2%)       1 (2%)       2 (4%)                                             
      Inflammation, Chronic Active                     1 (2%)       3 (6%)      10 (20%)                                            
      Mineralization                                                1 (2%)                                                          
      Epithelium, Hyperplasia                          2 (4%)       5 (10%)     13 (26%)                                            
      Epithelium, Ulcer                                1 (2%)       3 (6%)      11 (22%)                                            
   Stomach, Glandular                                 (50)         (50)         (50)                                                
      Mineralization                                                1 (2%)       1 (2%)                                             
      Epithelium, Erosion                                           1 (2%)       1 (2%)                                             
      Epithelium, Hyperplasia                                                    1 (2%)                                             
      Epithelium, Ulcer                                1 (2%)                                                                       
      Glands, Hyperplasia                                                        1 (2%)                                             
   Tongue                                                                       (1)                                                 
      Hyperplasia, Squamous                                                      1 (100%)                                           
   Tooth                                              (1)                                                                           
      Inflammation, Chronic Active                     1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (50)         (50)         (50)                                                
      Aorta, Mineralization                                         1 (2%)       1 (2%)                                             
      Pulmonary Artery, Mineralization                                           1 (2%)                                             
   Heart                                              (50)         (50)         (50)                                                
      Cardiomyopathy, Chronic                         22 (44%)     16 (32%)     14 (28%)                                            
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mineralization                                   1 (2%)                    1 (2%)                                             
      Atrium, Thrombosis                                            1 (2%)       3 (6%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)                                                
      Accessory Adrenal Cortical Nodule                             1 (2%)                                                          
      Atrophy                                                       1 (2%)                                                          
      Degeneration, Cystic                             8 (16%)      6 (12%)      8 (16%)                                            
      Degeneration, Fatty                             22 (44%)     14 (28%)     16 (32%)                                            
      Fibrosis                                         1 (2%)                                                                       
      Hyperplasia                                     22 (44%)     14 (28%)     11 (22%)                                            

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Hypertrophy                                     10 (20%)      3 (6%)       7 (14%)                                            
      Necrosis                                         1 (2%)                                                                       
   Adrenal Medulla                                    (50)         (50)         (50)                                                
      Hyperplasia                                      1 (2%)       2 (4%)       3 (6%)                                             
   Parathyroid Gland                                  (42)         (46)         (45)                                                
      Hyperplasia                                                   1 (2%)       3 (7%)                                             
   Pituitary Gland                                    (50)         (49)         (50)                                                
      Pars Distalis, Cyst                             23 (46%)     27 (55%)     17 (34%)                                            
      Pars Distalis, Hyperplasia                      20 (40%)     19 (39%)     19 (38%)                                            
      Pars Intermedia, Cyst                            1 (2%)       2 (4%)       2 (4%)                                             
   Thyroid Gland                                      (50)         (50)         (50)                                                
      Ectopic Thymus                                                1 (2%)                                                          
      C-Cell, Hyperplasia                             17 (34%)      7 (14%)      7 (14%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (49)         (50)         (50)                                                
      Hyperplasia                                      4 (8%)       1 (2%)       3 (6%)                                             
      Inflammation, Chronic Active                     6 (12%)      6 (12%)      8 (16%)                                            
      Bilateral, Duct, Cyst                                                      1 (2%)                                             
      Duct, Cyst                                       2 (4%)       1 (2%)       1 (2%)                                             
   Ovary                                              (50)         (50)         (50)                                                
      Cyst                                             7 (14%)      8 (16%)      8 (16%)                                            
   Uterus                                             (50)         (50)         (50)                                                
      Dysplasia                                        1 (2%)                                                                       
      Inflammation, Suppurative                                     1 (2%)                                                          
      Endometrium, Hyperplasia, Cystic                              1 (2%)                                                          
   Vagina                                                                       (2)                                                 
      Inflammation, Suppurative                                                  1 (50%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)                                                
      Atrophy                                          1 (2%)                                                                       
      Hyperplasia                                     12 (24%)     14 (28%)     10 (20%)                                            
   Lymph Node                                         (41)         (36)         (36)                                                
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
      Inguinal, Ectasia                                1 (2%)                                                                       
      Mediastinal, Congestion                                                    1 (3%)                                             
      Mediastinal, Pigmentation, Hemosiderin          38 (93%)     35 (97%)     34 (94%)                                            

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
   Lymph Node, Mandibular                             (50)         (48)         (47)                                                
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
   Spleen                                             (50)         (50)         (50)                                                
      Congestion                                                                 1 (2%)                                             
      Fibrosis                                         1 (2%)                                                                       
      Hematopoietic Cell Proliferation                 3 (6%)       4 (8%)       1 (2%)                                             
      Necrosis                                         1 (2%)                                                                       
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
      Capsule, Fibrosis                                                          1 (2%)                                             
      Capsule, Inflammation, Granulomatous             1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (49)         (50)         (50)                                                
      Cyst                                                          3 (6%)                                                          
      Hyperplasia, Cystic                             44 (90%)     40 (80%)     40 (80%)                                            
   Skin                                               (50)         (50)         (50)                                                
      Cyst Epithelial Inclusion                                     2 (4%)                                                          
      Inflammation, Chronic Active                                  1 (2%)       2 (4%)                                             
      Inflammation, Suppurative                                     1 (2%)                                                          
      Epidermis, Hyperplasia                                        1 (2%)                                                          
      Epidermis, Skin, Site of Application,                                                                                         
          Hyperkeratosis                               3 (6%)      45 (90%)     47 (94%)                                            
      Epidermis, Skin, Site of Application,                                                                                         
          Hyperplasia                                  3 (6%)      46 (92%)     50 (100%)                                           
      Epidermis, Skin, Site of Application,                                                                                         
          Parakeratosis                                1 (2%)      11 (22%)     23 (46%)                                            
      Epidermis, Skin, Site of Application, Ulcer      2 (4%)                    9 (18%)                                            
      Sebaceous Gland, Skin, Site of Application,                                                                                   
           Hyperplasia                                 2 (4%)      46 (92%)     49 (98%)                                            
      Skin, Site of Application, Inflammation,                                                                                      
           Chronic Active                              3 (6%)                    6 (12%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)                                                
      Fibrous Osteodystrophy                                        2 (4%)       2 (4%)                                             
      Osteopetrosis                                    2 (4%)       2 (4%)                                                          
   Skeletal Muscle                                    (3)          (1)                                                              
      Inflammation, Chronic Active                     1 (33%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)                                                
      Hemorrhage                                       1 (2%)       1 (2%)                                                          
   Spinal Cord                                                     (1)                                                              
      Hemorrhage                                                    1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)                                                
      Congestion                                                    1 (2%)                                                          
      Hemorrhage                                                    1 (2%)                                                          
      Inflammation, Chronic Active                     7 (14%)     16 (32%)      9 (18%)                                            
      Inflammation, Granulomatous                      3 (6%)       1 (2%)       1 (2%)                                             
      Metaplasia, Osseous                                                        1 (2%)                                             
      Alveolar Epithelium, Hyperplasia                 2 (4%)       1 (2%)       3 (6%)                                             
      Alveolus, Infiltration Cellular, Histiocyte     22 (44%)     24 (48%)     28 (56%)                                            
      Mediastinum, Necrosis                            1 (2%)                                                                       
   Nose                                               (50)         (50)         (50)                                                
      Inflammation, Chronic Active                     1 (2%)       4 (8%)       3 (6%)                                             
      Nasolacrimal Duct, Inflammation, Suppurative     4 (8%)       3 (6%)       3 (6%)                                             
      Respiratory Epithelium, Hyperplasia              1 (2%)       4 (8%)       3 (6%)                                             
      Respiratory Epithelium, Metaplasia, Squamous                  1 (2%)       2 (4%)                                             
      Vein, Turbinate, Septum, Thrombosis              1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (6)          (2)          (5)                                                 
      Anterior Chamber, Cornea, Iris, Synechia         1 (17%)                                                                      
      Bilateral, Inflammation, Suppurative                                       1 (20%)                                            
      Cornea, Inflammation, Chronic                    1 (17%)                                                                      
      Lens, Cataract                                   5 (83%)      1 (50%)      4 (80%)                                            
      Retina, Atrophy                                  3 (50%)      1 (50%)      3 (60%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)                                                
      Accumulation, Hyaline Droplet                    2 (4%)                                                                       
      Cyst                                             2 (4%)                    1 (2%)                                             
      Mineralization                                  50 (100%)    45 (90%)     47 (94%)                                            
      Nephropathy, Chronic                            47 (94%)     46 (92%)     46 (92%)                                            
      Pigmentation, Hemosiderin                       48 (96%)     46 (92%)     47 (94%)                                            
   Urinary Bladder                                    (50)         (50)         (50)                                                

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Transitional Epithelium, Hyperplasia                          1 (2%)       2 (4%)                                             
                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         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                                28           27           25                                                  
    Natural Death                                     13           11           14                                                  
    Accidently Killed                                  1                                                                            
  Survivors                                                                                                                         
    Terminal Sacrifice                                 8           12           11                                                  

  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (50)         (50)         (50)                                                
      Parasite Metazoan                                2 (4%)       5 (10%)      1 (2%)                                             
   Intestine Large, Rectum                            (50)         (50)         (50)                                                
      Parasite Metazoan                                2 (4%)       5 (10%)                                                         
   Intestine Large, Cecum                             (50)         (50)         (50)                                                
      Inflammation, Chronic Active                     2 (4%)                                                                       
      Parasite Metazoan                                                          1 (2%)                                             
      Ulcer                                            1 (2%)                                                                       
   Intestine Small, Duodenum                          (50)         (50)         (50)                                                
      Epithelium, Ulcer                                                          1 (2%)                                             
   Liver                                              (50)         (50)         (50)                                                
      Basophilic Focus                                 3 (6%)      13 (26%)      3 (6%)                                             
      Clear Cell Focus                                 3 (6%)       6 (12%)      2 (4%)                                             
      Eosinophilic Focus                                            1 (2%)                                                          
      Fibrosis                                                      1 (2%)                                                          
      Hepatodiaphragmatic Nodule                       9 (18%)      9 (18%)      8 (16%)                                            
      Inflammation, Chronic                           20 (40%)     25 (50%)     24 (48%)                                            
      Mineralization                                   1 (2%)                                                                       
      Vacuolization Cytoplasmic                       27 (54%)     36 (72%)     33 (66%)                                            
      Bile Duct, Hyperplasia                          47 (94%)     48 (96%)     50 (100%)                                           
      Hepatocyte, Degeneration, Cystic                 8 (16%)      8 (16%)      3 (6%)                                             
      Hepatocyte, Necrosis                             1 (2%)       3 (6%)       1 (2%)                                             
      Hepatocyte, Centrilobular, Degeneration          2 (4%)       1 (2%)                                                          
      Hepatocyte, Centrilobular, Necrosis              2 (4%)       1 (2%)                                                          
      Portal Vein, Thrombosis                                                    1 (2%)                                             
   Mesentery                                          (8)          (7)          (6)                                                 
      Accessory Spleen                                              1 (14%)                                                         
      Inflammation, Chronic Active                     1 (13%)      1 (14%)                                                         
      Fat, Necrosis                                    7 (88%)      3 (43%)      5 (83%)                                            
   Oral Mucosa                                        (1)          (2)          (2)                                                 
      Gingival, Hyperplasia                                         1 (50%)                                                         
      Gingival, Inflammation, Chronic Active                        1 (50%)      1 (50%)                                            
      Pharyngeal, Hyperplasia, Squamous                             1 (50%)                                                         

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
   Pancreas                                           (50)         (50)         (50)                                                
      Acinus, Atrophy                                 11 (22%)     22 (44%)     25 (50%)                                            
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
   Salivary Glands                                    (50)         (50)         (50)                                                
      Duct, Cyst                                       1 (2%)                                                                       
   Stomach, Forestomach                               (50)         (50)         (50)                                                
      Edema                                            6 (12%)      5 (10%)      8 (16%)                                            
      Foreign Body                                                               1 (2%)                                             
      Inflammation, Chronic Active                    15 (30%)      8 (16%)     14 (28%)                                            
      Mineralization                                   4 (8%)       2 (4%)       2 (4%)                                             
      Perforation                                      4 (8%)       2 (4%)       4 (8%)                                             
      Epithelium, Hyperplasia                         18 (36%)     16 (32%)     18 (36%)                                            
      Epithelium, Ulcer                               13 (26%)      7 (14%)     13 (26%)                                            
   Stomach, Glandular                                 (50)         (50)         (50)                                                
      Inflammation, Chronic Active                     1 (2%)                    2 (4%)                                             
      Mineralization                                   7 (14%)      6 (12%)      4 (8%)                                             
      Epithelium, Erosion                                                        2 (4%)                                             
      Epithelium, Ulcer                                                          3 (6%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (50)         (50)         (50)                                                
      Mineralization                                   1 (2%)                                                                       
      Aorta, Mineralization                            6 (12%)      4 (8%)       4 (8%)                                             
      Pulmonary Artery, Mineralization                 4 (8%)                    2 (4%)                                             
   Heart                                              (50)         (50)         (50)                                                
      Cardiomyopathy, Chronic                         37 (74%)     43 (86%)     42 (84%)                                            
      Inflammation, Suppurative                        1 (2%)                                                                       
      Mineralization                                   5 (10%)      3 (6%)       4 (8%)                                             
      Atrium, Thrombosis                               6 (12%)      1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)                                                
      Accessory Adrenal Cortical Nodule                             2 (4%)       1 (2%)                                             
      Atypia Cellular                                                            1 (2%)                                             
      Degeneration, Cystic                             3 (6%)       4 (8%)       3 (6%)                                             
      Degeneration, Fatty                             36 (72%)     40 (80%)     38 (76%)                                            
      Hyperplasia                                     13 (26%)     21 (42%)     24 (48%)                                            
      Hypertrophy                                      2 (4%)       6 (12%)      5 (10%)                                            
      Necrosis                                         1 (2%)                    1 (2%)                                             
   Adrenal Medulla                                    (50)         (50)         (50)                                                
      Hyperplasia                                     20 (40%)     19 (38%)     16 (32%)                                            
   Islets, Pancreatic                                 (50)         (50)         (50)                                                
      Hyperplasia                                      1 (2%)       1 (2%)                                                          

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
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ENDOCRINE SYSTEM - CONT                                                                                                             
   Parathyroid Gland                                  (48)         (46)         (45)                                                
      Hyperplasia                                     14 (29%)     15 (33%)      8 (18%)                                            
   Pituitary Gland                                    (50)         (50)         (49)                                                
      Pigmentation, Hematoidin                                      1 (2%)                                                          
      Pars Distalis, Cyst                             16 (32%)      7 (14%)      3 (6%)                                             
      Pars Distalis, Hyperplasia                      13 (26%)     10 (20%)     12 (24%)                                            
      Pars Intermedia, Cyst                            1 (2%)                    1 (2%)                                             
   Thyroid Gland                                      (50)         (50)         (50)                                                
      C-Cell, Hyperplasia                              6 (12%)     11 (22%)     11 (22%)                                            
      Follicle, Cyst                                   2 (4%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Coagulating Gland                                               (3)                                                              
      Inflammation, Chronic Active                                  1 (33%)                                                         
      Inflammation, Suppurative                                     2 (67%)                                                         
   Epididymis                                         (50)         (50)         (50)                                                
      Mineralization                                   1 (2%)                                                                       
   Preputial Gland                                    (50)         (50)         (50)                                                
      Hyperplasia                                      3 (6%)       1 (2%)       3 (6%)                                             
      Inflammation, Chronic Active                    47 (94%)     46 (92%)     46 (92%)                                            
   Prostate                                           (50)         (50)         (50)                                                
      Cyst Multilocular                                9 (18%)      8 (16%)      4 (8%)                                             
      Inflammation, Chronic Active                    46 (92%)     47 (94%)     46 (92%)                                            
   Seminal Vesicle                                    (50)         (50)         (50)                                                
      Dilatation                                       1 (2%)                                                                       
   Testes                                             (50)         (50)         (50)                                                
      Arteriole, Inflammation, Chronic                 9 (18%)     11 (22%)     13 (26%)                                            
      Arteriole, Necrosis, Fibrinoid                   9 (18%)     10 (20%)     13 (26%)                                            
      Bilateral, Germinal Epithelium, Atrophy          1 (2%)                    1 (2%)                                             
      Germinal Epithelium, Atrophy                    10 (20%)     15 (30%)     16 (32%)                                            
      Interstitial Cell, Hyperplasia                  12 (24%)     12 (24%)     13 (26%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)                                                
      Atrophy                                          1 (2%)                                                                       
      Hyperplasia                                     22 (44%)     22 (44%)     16 (32%)                                            
   Lymph Node                                         (35)         (30)         (37)                                                
      Mediastinal, Hyperplasia, Lymphoid                            1 (3%)                                                          

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Mediastinal, Pigmentation, Hemosiderin          29 (83%)     26 (87%)     33 (89%)                                            
   Lymph Node, Mandibular                             (50)         (50)         (50)                                                
      Ectasia                                                                    1 (2%)                                             
      Hyperplasia, Plasma Cell                                      1 (2%)                                                          
   Lymph Node, Mesenteric                             (49)         (50)         (50)                                                
      Ectasia                                          1 (2%)       2 (4%)                                                          
      Infiltration Cellular, Histiocyte                1 (2%)                                                                       
   Spleen                                             (50)         (50)         (50)                                                
      Fibrosis                                         6 (12%)      5 (10%)      1 (2%)                                             
      Hematopoietic Cell Proliferation                 1 (2%)       3 (6%)       3 (6%)                                             
      Hyperplasia                                                   1 (2%)                                                          
      Hyperplasia, Lymphoid                                                      1 (2%)                                             
      Necrosis                                         1 (2%)                                                                       
      Red Pulp, Depletion Cellular                     2 (4%)                    1 (2%)                                             
   Thymus                                             (47)         (45)         (48)                                                
      Ectopic Parathyroid Gland                                                  1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (48)         (49)         (50)                                                
      Cyst                                             2 (4%)       6 (12%)      4 (8%)                                             
      Hyperplasia, Cystic                             36 (75%)     44 (90%)     43 (86%)                                            
   Skin                                               (50)         (50)         (50)                                                
      Cyst Epithelial Inclusion                        1 (2%)                                                                       
      Inflammation, Chronic Active                                  2 (4%)                                                          
      Epidermis, Hyperkeratosis                                                  1 (2%)                                             
      Epidermis, Hyperplasia                                                     1 (2%)                                             
      Epidermis, Skin, Site of Application,                                                                                         
          Hyperkeratosis                                           36 (72%)     48 (96%)                                            
      Epidermis, Skin, Site of Application,                                                                                         
          Hyperplasia                                              46 (92%)     50 (100%)                                           
      Epidermis, Skin, Site of Application,                                                                                         
          Parakeratosis                                             9 (18%)     28 (56%)                                            
      Epidermis, Skin, Site of Application, Ulcer                   1 (2%)       1 (2%)                                             
      Prepuce, Inflammation, Chronic Active            1 (2%)                                                                       
      Sebaceous Gland, Skin, Site of Application,                                                                                   
           Hyperplasia                                             45 (90%)     50 (100%)                                           
      Skin, Site of Application, Hemorrhage                         1 (2%)                                                          
      Skin, Site of Application, Inflammation,                                                                                      
           Chronic Active                                           1 (2%)       2 (4%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)                                                
      Callus                                           1 (2%)                                                                       
      Fibrous Osteodystrophy                          10 (20%)     12 (24%)      6 (12%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)                                                
      Hemorrhage                                       1 (2%)       1 (2%)       1 (2%)                                             
      Mineralization                                                             1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)                                                
      Fibrosis                                         1 (2%)       1 (2%)                                                          
      Hemorrhage                                       1 (2%)                                                                       
      Inflammation, Chronic Active                     2 (4%)       8 (16%)      2 (4%)                                             
      Inflammation, Granulomatous                      2 (4%)                                                                       
      Inflammation, Suppurative                        1 (2%)                                                                       
      Mineralization                                   2 (4%)                                                                       
      Alveolar Epithelium, Hyperplasia                 2 (4%)       4 (8%)       1 (2%)                                             
      Alveolus, Infiltration Cellular, Histiocyte      7 (14%)     13 (26%)     12 (24%)                                            
      Interstitium, Mineralization                     2 (4%)       4 (8%)       2 (4%)                                             
   Nose                                               (50)         (50)         (50)                                                
      Inflammation, Chronic Active                     9 (18%)      7 (14%)     10 (20%)                                            
      Inflammation, Suppurative                                     1 (2%)                                                          
      Nasolacrimal Duct, Inflammation, Suppurative     2 (4%)       4 (8%)       4 (8%)                                             
      Respiratory Epithelium, Hyperplasia              9 (18%)      7 (14%)      9 (18%)                                            
      Respiratory Epithelium, Metaplasia, Squamous     3 (6%)       2 (4%)       3 (6%)                                             
      Vein, Turbinate, Septum, Thrombosis              2 (4%)                    2 (4%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (2)          (3)          (8)                                                 
      Cornea, Inflammation, Chronic Active                          1 (33%)                                                         
      Cornea, Mineralization                                        1 (33%)                                                         
      Lens, Cataract                                   2 (100%)     2 (67%)      8 (100%)                                           
      Retina, Atrophy                                  2 (100%)     2 (67%)      8 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             
NTP Experiment-Test: 55312-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                             COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                        Date: 01/28/99  
Route: SKIN APPLICATION                                                                                           Time: 08:08:11  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      50 MG/KG     100                                                    
                                                                             MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)                                                
      Accumulation, Hyaline Droplet                                 1 (2%)       1 (2%)                                             
      Cyst                                             8 (16%)      9 (18%)      7 (14%)                                            
      Hydronephrosis                                   1 (2%)                                                                       
      Mineralization                                   3 (6%)       3 (6%)       3 (6%)                                             
      Nephropathy, Chronic                            49 (98%)     50 (100%)    49 (98%)                                            
      Pigmentation, Hemosiderin                       43 (86%)     44 (88%)     50 (100%)                                           
      Renal Tubule, Hyperplasia                                     2 (4%)                                                          
   Urinary Bladder                                    (50)         (50)         (50)                                                
      Calculus Gross Observation                                    1 (2%)                                                          
      Hemorrhage                                       1 (2%)                                                                       
      Inflammation, Chronic Active                     2 (4%)       1 (2%)                                                          
      Transitional Epithelium, Hyperplasia             1 (2%)                    1 (2%)                                             
                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             
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                             ----------              END OF REPORT             ----------                                           
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