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TDMS Study 05196-04 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: TSI Mason Research                                      SODIUM SELENITE                                   DATE: 10/19/04       
EXPERIMENT: 05196 TEST: 04                                                                                     TIME: 07:25:34       
TEST TYPE:  SUBCHRON 90-DAY                                                                                    PAGE:       1        
CONT: N01-ES-75146                              ROUTE: DOSED WATER                                             NTP C#: C04308       
PATHOLOGIST: F. VOELKER                      M. GOAD                                                           CAS: 10102-18-8      
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0       PPM                                                                   
                                       INCLUDE 002    0       PPM                                                                   
                                       INCLUDE 003    2       PPM                                                                   
                                       INCLUDE 004    2       PPM                                                                   
                                       INCLUDE 005    4       PPM                                                                   
                                       INCLUDE 006    4       PPM                                                                   
                                       INCLUDE 007    8       PPM                                                                   
                                       INCLUDE 008    8       PPM                                                                   
                                       INCLUDE 009    16      PPM                                                                   
                                       INCLUDE 010    16      PPM                                                                   
                                       INCLUDE 011    32      PPM                                                                   
                                       INCLUDE 012    32      PPM                                                                   
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: TSI Mason Research                                      SODIUM SELENITE                                   DATE: 10/19/04       
EXPERIMENT: 05196 TEST: 04                                                                                     TIME: 07:25:34       
TEST TYPE:  SUBCHRON 90-DAY                                                                                                         
CONT: N01-ES-75146                              ROUTE: DOSED WATER                                             NTP C#: C04308       
PATHOLOGIST: F. VOELKER                      M. GOAD                                                           CAS: 10102-18-8      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                     SODIUM SELENITE                                                                              
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Lung                                   Adrenal Gland Medulla                                                                        
===============================================================                                                                     
                                                                                                                                   
       Date:  10/19/04                           EXPERIMENT: 05196 TEST: 04                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -                      SODIUM SELENITE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                2                4                8                16               32              | 
|                   |        PPM              PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|POLY-3 RATE (b)    |        1/10.00          0/0.00           0/0.00           0/0.00           0/0.00           1/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             0.0%             10.0%           | 
|TERMINAL (d)       |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.642          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.766         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.760         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.760         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.760         | 
|LOGISTIC REGRESSION|        P=0.642          (e)              (e)              (e)              (e)              P=0.766         | 
|COCH-ARM / FISHERS |        P=0.645          P=1.000          P=1.000          P=1.000          P=1.000          P=0.763N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                2                4                8                16               32              | 
|                   |        PPM              PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/10 (50%)       0/0 (0%)         1/1 (100%)       0/0 (0%)         0/0 (0%)         4/10 (40%)      | 
|POLY-3 RATE (b)    |        5/10.00          0/0.00           1/1.00           0/0.00           0/0.00           4/10.00         | 
|POLY-3 PERCENT (g) |        50.0%            0.0%             100.0%           0.0%             0.0%             40.0%           | 
|TERMINAL (d)       |        5/10 (50%)       0/0 (0%)         1/1 (100%)       0/0 (0%)         0/0 (0%)         4/10 (40%)      | 
|FIRST INCIDENCE    |        92 (T)           ---              92 (T)           ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.350N         P=1.000N         P=0.536          P=1.000N         P=1.000N         P=0.500N        | 
|POLY 3             |        (e)              (e)              P=0.536          (e)              (e)              P=0.500N        | 
|POLY 1.5           |        (e)              (e)              P=0.536          (e)              (e)              P=0.500N        | 
|POLY 6             |        (e)              (e)              P=0.536          (e)              (e)              P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.350N         (e)              P=0.536          (e)              (e)              P=0.500N        | 
|COCH-ARM / FISHERS |        P=0.347N         P=1.000          P=0.545          P=1.000          P=1.000          P=0.500N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/19/04                           EXPERIMENT: 05196 TEST: 04                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                      SODIUM SELENITE   
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                2                4                8                16               32              | 
|                   |        PPM              PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Adrenal Gland Medulla                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|POLY-3 RATE (b)    |        1/10.00          0/0.00           0/0.00           0/0.00           0/0.00           5/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             0.0%             50.0%           | 
|TERMINAL (d)       |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.048 *        P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.077         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.061         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.061         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.061         | 
|LOGISTIC REGRESSION|        P=0.048 *        (e)              (e)              (e)              (e)              P=0.077         | 
|COCH-ARM / FISHERS |        P=0.044 *        P=1.000          P=1.000          P=1.000          P=1.000          P=0.070         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                2                4                8                16               32              | 
|                   |        PPM              PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Adrenal Gland Medulla                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)      | 
|POLY-3 RATE (b)    |        1/10.00          0/0.00           0/0.00           0/0.00           0/0.00           3/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             0.0%             30.0%           | 
|TERMINAL (d)       |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)      | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.207          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.293         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.292         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.292         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.292         | 
|LOGISTIC REGRESSION|        P=0.207          (e)              (e)              (e)              (e)              P=0.293         | 
|COCH-ARM / FISHERS |        P=0.201          P=1.000          P=1.000          P=1.000          P=1.000          P=0.291         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/19/04                           EXPERIMENT: 05196 TEST: 04                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                      SODIUM SELENITE   
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                2                4                8                16               32              | 
|                   |        PPM              PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Stomach Forestomach                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/0.00           0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                2                4                8                16               32              | 
|                   |        PPM              PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Stomach Forestomach                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)      | 
|POLY-3 RATE (b)    |        2/10.00          0/0.00           0/0.00           0/0.00           0/0.00           2/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             0.0%             20.0%           | 
|TERMINAL (d)       |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)      | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.607          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.707         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.702         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.702         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.702         | 
|LOGISTIC REGRESSION|        P=0.607          (e)              (e)              (e)              (e)              P=0.707         | 
|COCH-ARM / FISHERS |        P=0.610          P=1.000          P=1.000          P=1.000          P=1.000          P=0.709N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
                                                                                                                                   
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).