National Toxicology Program

National Toxicology Program
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TDMS Study 93023-07 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  2,4-HEXADIENAL                                    DATE: 02/15/01       
EXPERIMENT: 93023 TEST: 07                                                                                     TIME: 11:14:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 93023B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 142-83-6        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           FINAL #1/MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  2,4-HEXADIENAL                                    DATE: 02/15/01       
EXPERIMENT: 93023 TEST: 07                                                                                     TIME: 11:14:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 93023B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 142-83-6        
Mice(B6C3F1)                                                                                                                        
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pituitary Gland                                                                    
                                                 Spleen                                                                             
                                                 Testes                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  2,4-HEXADIENAL                                    DATE: 02/15/01       
EXPERIMENT: 93023 TEST: 07                                                                                     TIME: 11:14:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 93023B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 142-83-6        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                  2,4-HEXADIENAL                                                                                  
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Medulla                        Pheochromocytoma Benign                                                                      
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS                                            
Liver                                  Hepatocellular Adenoma                                                                       
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                          
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                          
                                       Squamous Cell Carcinoma                                                                      
                                       Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                    
Stomach, Forestomach                   Squamous Cell Carcinoma or Papilloma Squamous                                                
                                       Squamous Cell Papilloma                                                                      
Tongue                                 Squamous Cell Carcinoma                                                                      
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Harderian Gland                        Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Liver                                  Hepatocellular Adenoma                                                                       
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Carcinoma or Adenoma                                                                         
Skeletal Muscle                        Sarcoma                                                                                      
Skin                                   Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                 
                                       Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                  
Stomach, Forestomach                   Squamous Cell Carcinoma                                                                      
                                       Squamous Cell Carcinoma or Papilloma Squamous                                                
                                       Squamous Cell Papilloma                                                                      
Uterus                                 Hemangiosarcoma                                                                              
All Organs                             Benign Tumors                                                                                
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  02/15/01                           EXPERIMENT: 93023 TEST: 07                                            Page 1       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)        -                   2,4-HEXADIENAL               
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0            30           60           120         |0            30           60           120          | 
|                   |     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY    |MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    6/50 (12%)   6/50 (12%)   4/50 (8%)   |0/50 (0%)    0/48 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     4/48.54      6/44.73      6/47.82      4/45.44     |0/47.56      0/44.73      0/46.55      0/46.05      | 
|POLY-3 PERCENT (g) |     8.2%         13.4%        12.6%        8.8%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     4/44 (9%)    6/39 (15%)   5/44 (11%)   4/39 (10%)  |0/42 (0%)    0/37 (0%)    0/37 (0%)    0/39 (0%)    | 
|FIRST INCIDENCE    |     729 (T)      729 (T)      704          729 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.556N     P=0.295      P=0.371      P=0.576     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.538N     P=0.320      P=0.361      P=0.606     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.525N     P=0.338      P=0.363      P=0.619     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.553N     P=0.302      P=0.360      P=0.592     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.553N     P=0.295      P=0.356      P=0.576     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.370      P=0.370      P=0.643N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0            30           60           120         |0            30           60           120          | 
|                   |     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY    |MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |1/50 (2%)    0/48 (0%)    0/49 (0%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     0/47.97      0/44.73      0/47.72      2/45.44     |1/47.56      0/44.73      0/45.55      0/45.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.4%        |2.1%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/44 (0%)    0/39 (0%)    0/44 (0%)    2/39 (5%)   |1/42 (2%)    0/37 (0%)    0/36 (0%)    0/38 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |729 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.041 *    (e)          (e)          P=0.212     |P=0.317N     P=0.525N     P=0.531N     P=0.520N     | 
|POLY 3             |     P=0.045 *    (e)          (e)          P=0.225     |P=0.302N     P=0.512N     P=0.509N     P=0.511N     | 
|POLY 1.5           |     P=0.045 *    (e)          (e)          P=0.231     |P=0.303N     P=0.511N     P=0.506N     P=0.509N     | 
|POLY 6             |     P=0.044 *    (e)          (e)          P=0.219     |P=0.301N     P=0.515N     P=0.513N     P=0.514N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.212     |P=0.317N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.047 *    (e)          (e)          P=0.253     |P=0.305N     P=0.510N     P=0.505N     P=0.505N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/15/01                           EXPERIMENT: 93023 TEST: 07                                            Page 2       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   2,4-HEXADIENAL                
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0            30           60           120         |0            30           60           120          | 
|                   |     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY    |MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/49 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |1/50 (2%)    0/48 (0%)    1/49 (2%)    0/49 (0%)    | 
|POLY-3 RATE (b)    |     0/47.97      0/44.73      0/47.72      2/45.44     |1/47.56      0/44.73      1/45.55      0/45.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.4%        |2.1%         0.0%         2.2%         0.0%         | 
|TERMINAL (d)       |     0/44 (0%)    0/39 (0%)    0/44 (0%)    2/39 (5%)   |1/42 (2%)    0/37 (0%)    1/36 (3%)    0/38 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |729 (T)      ---          729 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.041 *    (e)          (e)          P=0.212     |P=0.424N     P=0.525N     P=0.727      P=0.520N     | 
|POLY 3             |     P=0.045 *    (e)          (e)          P=0.225     |P=0.411N     P=0.512N     P=0.751      P=0.511N     | 
|POLY 1.5           |     P=0.045 *    (e)          (e)          P=0.231     |P=0.411N     P=0.511N     P=0.753      P=0.509N     | 
|POLY 6             |     P=0.044 *    (e)          (e)          P=0.219     |P=0.413N     P=0.515N     P=0.746      P=0.514N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.212     |P=0.424N     (e)          P=0.727      (e)          | 
|COCH-ARM / FISHERS |     P=0.047 *    (e)          (e)          P=0.253     |P=0.408N     P=0.510N     P=0.747      P=0.505N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0            30           60           120         |0            30           60           120          | 
|                   |     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY    |MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   6/50 (12%)   3/50 (6%)    4/50 (8%)   |7/50 (14%)   6/50 (12%)   2/50 (4%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     7/48.58      6/44.73      3/47.72      4/45.44     |7/47.56      6/46.57      2/46.55      1/46.05      | 
|POLY-3 PERCENT (g) |     14.4%        13.4%        6.3%         8.8%        |14.7%        12.9%        4.3%         2.2%         | 
|TERMINAL (d)       |     6/44 (14%)   6/39 (15%)   3/44 (7%)    4/39 (10%)  |7/42 (17%)   6/37 (16%)   2/37 (5%)    1/39 (3%)    | 
|FIRST INCIDENCE    |     718          729 (T)      729 (T)      729 (T)     |729 (T)      729 (T)      729 (T)      729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.204N     P=0.593N     P=0.162N     P=0.336N    |P=0.014N*    P=0.598N     P=0.113N     P=0.041N*    | 
|POLY 3             |     P=0.183N     P=0.563N     P=0.166N     P=0.301N    |P=0.011N*    P=0.516N     P=0.084N     P=0.034N*    | 
|POLY 1.5           |     P=0.178N     P=0.540N     P=0.164N     P=0.287N    |P=0.011N*    P=0.510N     P=0.082N     P=0.033N*    | 
|POLY 6             |     P=0.188N     P=0.587N     P=0.167N     P=0.317N    |P=0.011N*    P=0.526N     P=0.089N     P=0.035N*    | 
|LOGISTIC REGRESSION|     P=0.200N     P=0.611N     P=0.166N     P=0.332N    |P=0.014N*    P=0.598N     P=0.113N     P=0.041N*    | 
|COCH-ARM / FISHERS |     P=0.168N     P=0.500N     P=0.159N     P=0.262N    |P=0.011N*    P=0.500N     P=0.080N     P=0.030N*    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/15/01                           EXPERIMENT: 93023 TEST: 07                                            Page 3       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   2,4-HEXADIENAL                
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0            30           60           120         |0            30           60           120          | 
|                   |     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY    |MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/48.76      4/45.05      1/47.72      1/45.44     |0/47.56      0/46.57      2/46.86      0/46.05      | 
|POLY-3 PERCENT (g) |     4.1%         8.9%         2.1%         2.2%        |0.0%         0.0%         4.3%         0.0%         | 
|TERMINAL (d)       |     1/44 (2%)    3/39 (8%)    1/44 (2%)    1/39 (3%)   |0/42 (0%)    0/37 (0%)    0/37 (0%)    0/39 (0%)    | 
|FIRST INCIDENCE    |     670          643          729 (T)      729 (T)     |---          ---          649          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.258N     P=0.286      P=0.505N     P=0.543N    |P=0.576      (e)          P=0.224      (e)          | 
|POLY 3             |     P=0.251N     P=0.302      P=0.508N     P=0.524N    |P=0.574      (e)          P=0.234      (e)          | 
|POLY 1.5           |     P=0.243N     P=0.314      P=0.505N     P=0.516N    |P=0.578      (e)          P=0.236      (e)          | 
|POLY 6             |     P=0.259N     P=0.289      P=0.510N     P=0.534N    |P=0.570      (e)          P=0.231      (e)          | 
|LOGISTIC REGRESSION|     P=0.234N     P=0.340      P=0.490N     P=0.500N    |P=0.606      (e)          P=0.244      (e)          | 
|COCH-ARM / FISHERS |     P=0.230N     P=0.339      P=0.500N     P=0.500N    |P=0.589      (e)          P=0.247      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0            30           60           120         |0            30           60           120          | 
|                   |     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY    |MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/50 (18%)   10/50 (20%)  4/50 (8%)    5/50 (10%)  |7/50 (14%)   6/50 (12%)   4/50 (8%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     9/48.81      10/45.05     4/47.72      5/45.44     |7/47.56      6/46.57      4/46.86      1/46.05      | 
|POLY-3 PERCENT (g) |     18.4%        22.2%        8.4%         11.0%       |14.7%        12.9%        8.5%         2.2%         | 
|TERMINAL (d)       |     7/44 (16%)   9/39 (23%)   4/44 (9%)    5/39 (13%)  |7/42 (17%)   6/37 (16%)   2/37 (5%)    1/39 (3%)    | 
|FIRST INCIDENCE    |     670          643          729 (T)      729 (T)     |729 (T)      729 (T)      649          729 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.112N     P=0.386      P=0.123N     P=0.271N    |P=0.024N*    P=0.598N     P=0.334N     P=0.041N*    | 
|POLY 3             |     P=0.097N     P=0.423      P=0.125N     P=0.235N    |P=0.020N*    P=0.516N     P=0.270N     P=0.034N*    | 
|POLY 1.5           |     P=0.092N     P=0.451      P=0.122N     P=0.220N    |P=0.019N*    P=0.510N     P=0.266N     P=0.033N*    | 
|POLY 6             |     P=0.104N     P=0.395      P=0.127N     P=0.254N    |P=0.020N*    P=0.526N     P=0.277N     P=0.035N*    | 
|LOGISTIC REGRESSION|     P=0.101N     P=0.410      P=0.123N     P=0.247N    |P=0.022N*    P=0.598N     P=0.282N     P=0.041N*    | 
|COCH-ARM / FISHERS |     P=0.083N     P=0.500      P=0.117N     P=0.194N    |P=0.018N*    P=0.500N     P=0.262N     P=0.030N*    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  02/15/01                           EXPERIMENT: 93023 TEST: 07                                            Page 4       
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                   2,4-HEXADIENAL                
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0            30           60           120         |0            30           60           120          | 
|                   |     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY    |MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Jejunum                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#


			
    			
    		
		
										 									
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