https://ntp.niehs.nih.gov/go/5664

TDMS Study 55323-04 Pathology Tables

NTP Experiment-Test: 55323-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/30/97
Route: SKIN APPLICATION                                                                                           Time: 07:26:42
                                                         2 YEAR CHRONIC
       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: 55323-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/30/97  
Route: SKIN APPLICATION                                                                                           Time: 07:26:42  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        0 MG/KG      100          200                                                    
                                                                MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Natural Death                                      4            2            5                                                  
    Moribund Sacrifice                                 9            7           15                                                  
    Accidently Killed                                                            1                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                37           40           29                                                  
  Missing                                                           1                                                               
  Animals Examined Microscopically                    50           49           50                                                  
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Esophagus                                          (50)         (49)         (50)                                                
      Inflammation, Chronic Active                     1 (2%)                                                                       
   Intestine Small, Duodenum                          (50)         (49)         (50)                                                
      Hyperplasia                                                   1 (2%)                                                          
      Ulcer                                            2 (4%)                                                                       
   Liver                                              (50)         (49)         (50)                                                
      Angiectasis                                                                1 (2%)                                             
      Clear Cell Focus                                 2 (4%)       2 (4%)       1 (2%)                                             
      Degeneration, Fatty, Focal                                    2 (4%)                                                          
      Eosinophilic Focus                              15 (30%)     20 (41%)     23 (46%)                                            
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Hepatodiaphragmatic Nodule                                                 1 (2%)                                             
      Infarct                                          1 (2%)                                                                       
      Mixed Cell Focus                                                           2 (4%)                                             
      Necrosis, Focal                                               2 (4%)                                                          
      Bile Duct, Cyst                                                            1 (2%)                                             
   Mesentery                                          (7)          (10)         (4)                                                 
      Fat, Necrosis                                    7 (100%)    10 (100%)     3 (75%)                                            
   Pancreas                                           (50)         (49)         (50)                                                
      Infiltration Cellular, Lymphocyte                             1 (2%)                                                          
      Inflammation, Chronic                            1 (2%)                                                                       
      Acinus, Atrophy                                  1 (2%)       2 (4%)                                                          
   Stomach, Forestomach                               (50)         (49)         (50)                                                
      Ulcer                                            3 (6%)                                                                       
      Epithelium, Hyperkeratosis                       2 (4%)                                                                       
   Stomach, Glandular                                 (50)         (49)         (50)                                                
      Inflammation, Chronic                            1 (2%)                                                                       
      Ulcer                                                         1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 55323-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/30/97  
Route: SKIN APPLICATION                                                                                           Time: 07:26:42  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        0 MG/KG      100          200                                                    
                                                                MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (50)         (49)         (50)                                                
      Artery, Inflammation, Chronic                                              1 (2%)                                             
      Atrium, Thrombosis                               1 (2%)                    1 (2%)                                             
      Myocardium, Degeneration                         5 (10%)     10 (20%)      5 (10%)                                            
      Myocardium, Mineralization, Focal                                          1 (2%)                                             
      Ventricle, Inflammation, Chronic, Focal          1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Cortex                                     (50)         (49)         (50)                                                
      Accessory Adrenal Cortical Nodule                             1 (2%)                                                          
      Hyperplasia, Focal                               1 (2%)       4 (8%)                                                          
      Necrosis, Acute                                                            1 (2%)                                             
   Adrenal Medulla                                    (50)         (49)         (50)                                                
      Hyperplasia, Focal                               2 (4%)       2 (4%)       2 (4%)                                             
      Necrosis                                                                   1 (2%)                                             
   Islets, Pancreatic                                 (50)         (49)         (50)                                                
      Hyperplasia                                      2 (4%)       9 (18%)      6 (12%)                                            
   Pituitary Gland                                    (47)         (49)         (50)                                                
      Pars Distalis, Angiectasis, Focal                             1 (2%)                                                          
      Pars Distalis, Hyperplasia, Focal               11 (23%)      6 (12%)     11 (22%)                                            
      Pars Distalis, Necrosis, Focal                                             1 (2%)                                             
   Thyroid Gland                                      (50)         (49)         (50)                                                
      Inflammation, Chronic                                         1 (2%)                                                          
      C-Cell, Hyperplasia                                           2 (4%)                                                          
      Follicle, Hyperplasia, Diffuse                                1 (2%)                                                          
      Follicle, Hyperplasia, Focal                    38 (76%)     34 (69%)     36 (72%)                                            
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Clitoral Gland                                     (49)         (47)         (49)                                                
      Cyst                                             1 (2%)       1 (2%)       1 (2%)                                             
   Ovary                                              (50)         (49)         (50)                                                
      Angiectasis                                      1 (2%)       1 (2%)                                                          
      Cyst                                             6 (12%)      9 (18%)      8 (16%)                                            
      Thrombosis                                       1 (2%)                    1 (2%)                                             
   Uterus                                             (50)         (49)         (50)                                                
      Angiectasis                                      1 (2%)       1 (2%)       2 (4%)                                             
      Inflammation, Granulomatous                                                1 (2%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 55323-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/30/97  
Route: SKIN APPLICATION                                                                                           Time: 07:26:42  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        0 MG/KG      100          200                                                    
                                                                MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT                                                                                                               
      Endometrium, Hyperplasia, Cystic                38 (76%)     46 (94%)     39 (78%)                                            
      Myometrium, Hyperplasia                          1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Lymph Node                                         (5)          (4)          (7)                                                 
      Mediastinal, Hyperplasia, Lymphoid               1 (20%)      1 (25%)                                                         
      Renal, Hyperplasia, Lymphoid                     1 (20%)      1 (25%)                                                         
   Lymph Node, Mandibular                             (46)         (48)         (48)                                                
      Hyperplasia, Lymphoid                                                      1 (2%)                                             
   Lymph Node, Mesenteric                             (49)         (48)         (47)                                                
      Angiectasis                                                   1 (2%)                                                          
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
   Spleen                                             (50)         (49)         (50)                                                
      Hematopoietic Cell Proliferation                 7 (14%)      6 (12%)      9 (18%)                                            
      Hyperplasia, Lymphoid                            6 (12%)      3 (6%)       1 (2%)                                             
   Thymus                                             (50)         (47)         (50)                                                
      Ectopic Parathyroid Gland                        1 (2%)                                                                       
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia, Lymphoid                            1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Skin                                               (50)         (49)         (50)                                                
      Epidermis, Skin, Site of Application,                                                                                         
          Hyperplasia                                              42 (86%)     50 (100%)                                           
      Sebaceous Gland, Skin, Site of Application,                                                                                   
           Hyperplasia                                             43 (88%)     45 (90%)                                            
      Skin, Site of Application, Hyperkeratosis        4 (8%)      41 (84%)     48 (96%)                                            
      Skin, Site of Application, Inflammation,                                                                                      
           Chronic Active                                          24 (49%)     40 (80%)                                            
      Skin, Site of Application, Parakeratosis                      3 (6%)       9 (18%)                                            
      Skin, Site of Application, Ulcer                                           3 (6%)                                             
      Subcutaneous Tissue, Edema                                                 1 (2%)                                             
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   Bone                                               (50)         (49)         (50)                                                
      Fibrosis                                         1 (2%)       3 (6%)                                                          
      Fibrous Osteodystrophy                           1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 55323-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/30/97  
Route: SKIN APPLICATION                                                                                           Time: 07:26:42  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        0 MG/KG      100          200                                                    
                                                                MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (50)         (49)         (50)                                                
      Meninges, Infiltration Cellular, Mixed Cell                   1 (2%)                                                          
   Spinal Cord                                                     (1)                                                              
      Axon, Nerve, Degeneration                                     1 (100%)                                                        
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (50)         (49)         (50)                                                
      Hemorrhage, Focal                                1 (2%)                    1 (2%)                                             
      Inflammation, Granulomatous                                                1 (2%)                                             
      Thrombosis                                                                 1 (2%)                                             
      Alveolar Epithelium, Hyperplasia, Focal          2 (4%)       1 (2%)       1 (2%)                                             
      Mediastinum, Inflammation, Chronic Active        1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (50)         (49)         (50)                                                
      Infarct                                          1 (2%)                                                                       
      Nephropathy                                     19 (38%)     30 (61%)     16 (32%)                                            
   Urinary Bladder                                    (50)         (49)         (50)                                                
      Artery, Inflammation, Chronic                                 1 (2%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 55323-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/30/97  
Route: SKIN APPLICATION                                                                                           Time: 07:26:42  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          0 MG/KG      100          200                                                    
                                                                MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 7            6            7                                                  
    Natural Death                                      3            7            2                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                40           37           41                                                  
  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Intestine Small, Jejunum                           (50)         (50)         (50)                                                
      Peyer's Patch, Hyperplasia, Lymphoid                                       1 (2%)                                             
   Liver                                              (50)         (50)         (50)                                                
      Basophilic Focus                                 1 (2%)       2 (4%)       1 (2%)                                             
      Clear Cell Focus                                14 (28%)      7 (14%)      6 (12%)                                            
      Eosinophilic Focus                              15 (30%)      9 (18%)     15 (30%)                                            
      Fibrosis, Focal                                               1 (2%)                                                          
      Hepatodiaphragmatic Nodule                                                 2 (4%)                                             
      Mixed Cell Focus                                 2 (4%)       5 (10%)      2 (4%)                                             
      Necrosis, Focal                                  1 (2%)                    3 (6%)                                             
      Bile Duct, Cyst                                               2 (4%)                                                          
      Bile Duct, Hyperplasia                                                     1 (2%)                                             
      Hepatocyte, Centrilobular, Hypertrophy           1 (2%)       1 (2%)                                                          
   Mesentery                                                       (1)          (2)                                                 
      Artery, Inflammation, Chronic                                 1 (100%)                                                        
      Fat, Necrosis                                                              2 (100%)                                           
   Pancreas                                           (50)         (50)         (50)                                                
      Inflammation, Chronic                                                      1 (2%)                                             
   Stomach, Forestomach                               (50)         (50)         (50)                                                
      Hemorrhage                                                    1 (2%)                                                          
      Hyperkeratosis                                                1 (2%)       1 (2%)                                             
      Hyperplasia, Focal                               1 (2%)                                                                       
      Ulcer                                            1 (2%)                    1 (2%)                                             
   Stomach, Glandular                                 (50)         (50)         (50)                                                
      Ulcer                                            1 (2%)                                                                       
      Epithelium, Hyperplasia, Focal                                1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (50)         (50)         (50)                                                
      Artery, Inflammation, Chronic                    1 (2%)       1 (2%)                                                          
      Myocardium, Degeneration                         5 (10%)      3 (6%)       8 (16%)                                            
      Myocardium, Mineralization                                                 1 (2%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 55323-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/30/97  
Route: SKIN APPLICATION                                                                                           Time: 07:26:42  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          0 MG/KG      100          200                                                    
                                                                MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Cortex                                     (50)         (50)         (50)                                                
      Accessory Adrenal Cortical Nodule                1 (2%)                                                                       
      Angiectasis                                      1 (2%)                                                                       
      Hyperplasia, Focal                              30 (60%)     17 (34%)     24 (48%)                                            
      Hypertrophy                                      1 (2%)                    1 (2%)                                             
      Inflammation, Chronic                            1 (2%)                                                                       
   Adrenal Medulla                                    (50)         (50)         (49)                                                
      Hyperplasia, Focal                                                         2 (4%)                                             
   Islets, Pancreatic                                 (50)         (50)         (50)                                                
      Hyperplasia                                     27 (54%)     28 (56%)     12 (24%)                                            
   Parathyroid Gland                                  (40)         (42)         (43)                                                
      Cyst                                             1 (3%)                                                                       
   Pituitary Gland                                    (48)         (49)         (50)                                                
      Angiectasis                                      1 (2%)                                                                       
      Pars Distalis, Hyperplasia, Focal                             1 (2%)       1 (2%)                                             
   Thyroid Gland                                      (50)         (50)         (50)                                                
      Follicle, Hyperplasia, Focal                    18 (36%)     24 (48%)     36 (72%)                                            
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Epididymis                                         (50)         (50)         (50)                                                
      Granuloma Sperm                                               1 (2%)                                                          
   Preputial Gland                                    (50)         (50)         (50)                                                
      Cyst                                            23 (46%)     19 (38%)     16 (32%)                                            
      Hyperplasia                                                   1 (2%)                                                          
      Inflammation, Granulomatous                                   1 (2%)                                                          
      Inflammation, Suppurative                                     1 (2%)                                                          
      Bilateral, Cyst                                                            2 (4%)                                             
   Seminal Vesicle                                    (50)         (50)         (50)                                                
      Fibrosis                                         1 (2%)       1 (2%)                                                          
      Inflammation, Chronic                                                      1 (2%)                                             
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Lymph Node, Mesenteric                             (49)         (49)         (50)                                                
      Hyperplasia, Lymphoid                                         2 (4%)       2 (4%)                                             
   Spleen                                             (50)         (50)         (50)                                                
      Hematopoietic Cell Proliferation                 6 (12%)      7 (14%)      2 (4%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 55323-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/30/97  
Route: SKIN APPLICATION                                                                                           Time: 07:26:42  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          0 MG/KG      100          200                                                    
                                                                MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hyperplasia, Lymphoid                            3 (6%)       2 (4%)                                                          
   Thymus                                             (45)         (45)         (49)                                                
      Hyperplasia                                                                1 (2%)                                             
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Skin                                               (50)         (50)         (50)                                                
      Hyperkeratosis                                                1 (2%)                                                          
      Epidermis, Skin, Site of Application,                                                                                         
          Hyperplasia                                  4 (8%)      45 (90%)     50 (100%)                                           
      Pinna, Fibrosis, Focal                                        1 (2%)                                                          
      Sebaceous Gland, Skin, Site of Application,                                                                                   
           Hyperplasia                                 1 (2%)      45 (90%)     48 (96%)                                            
      Skin, Site of Application, Hyperkeratosis        3 (6%)      45 (90%)     49 (98%)                                            
      Skin, Site of Application, Inflammation,                                                                                      
           Chronic Active                              1 (2%)      13 (26%)     28 (56%)                                            
      Skin, Site of Application, Parakeratosis                      1 (2%)       5 (10%)                                            
      Skin, Site of Application, Ulcer                                           2 (4%)                                             
      Subcutaneous Tissue, Edema                                    1 (2%)                                                          
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (50)         (50)         (50)                                                
      Inflammation, Granulomatous                                                1 (2%)                                             
      Thrombosis                                                    1 (2%)                                                          
      Alveolar Epithelium, Hyperplasia, Focal          1 (2%)       3 (6%)       2 (4%)                                             
      Mediastinum, Infiltration Cellular, Mast Cell                              1 (2%)                                             
   Nose                                               (50)         (50)         (50)                                                
      Inflammation, Suppurative                                     2 (4%)                                                          
      Polyp, Inflammatory                                                        2 (4%)                                             
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 55323-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               LAURIC ACID DIETHANOLAMINE CONDENSATE                           Date: 07/30/97  
Route: SKIN APPLICATION                                                                                           Time: 07:26:42  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          0 MG/KG      100          200                                                    
                                                                MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Eye                                                                          (3)                                                 
      Degeneration                                                               1 (33%)                                            
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (50)         (50)         (50)                                                
      Infarct                                                       1 (2%)                                                          
      Nephropathy                                     28 (56%)     31 (62%)     33 (66%)                                            
      Artery, Inflammation, Chronic                                 1 (2%)                                                          
      Renal Tubule, Cyst                               2 (4%)       2 (4%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
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