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TDMS Study 05206-06 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                       CUPRIC SULFATE                                    DATE: 10/15/04       
EXPERIMENT: 05206 TEST: 06                                                                                     TIME: 08:27:45       
TEST TYPE:  SUBCHRON 90-DAY                                                                                    PAGE:       1        
CONT: NO1ES75169                                ROUTE: DOSED FEED                                              NTP C#: 62191B       
PATHOLOGIST: M. RYAN                                                                                           CAS: 7758-99-8       
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                       CUPRIC SULFATE                                    DATE: 10/15/04       
EXPERIMENT: 05206 TEST: 06                                                                                     TIME: 08:27:45       
TEST TYPE:  SUBCHRON 90-DAY                                                                                                         
CONT: NO1ES75169                                ROUTE: DOSED FEED                                              NTP C#: 62191B       
PATHOLOGIST: M. RYAN                                                                                           CAS: 7758-99-8       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                     CUPRIC SULFATE                                                                               
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Gland Cortex                   Hyperplasia                                                                                  
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
                                       Hyperplasia                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 06                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -                      CUPRIC SULFATE   
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            1000 PPM         2000 PPM         4000 PPM         8000 PPM         16,000          | 
|                   |                                                                                               PPM           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland Cortex                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       6/10 (60%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          2/10.00          6/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             20.0%            60.0%            100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       6/10 (60%)       10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.234          P=0.009 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.227          P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.227          P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.227          P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.234          P=0.009 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.237          P=0.005 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            1000 PPM         2000 PPM         4000 PPM         8000 PPM         16,000          | 
|                   |                                                                                               PPM           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland Cortex                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/10 (0%)        5/10 (50%)       8/10 (80%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/10.00          5/10.00          8/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             50.0%            80.0%            100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/10 (0%)        5/10 (50%)       8/10 (80%)       10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.022 *        P<0.001 **       P<0.001 **      | 
|POLY 3             |        (e)              (e)              (e)              P=0.008 **       P<0.001 **       P<0.001N**      | 
|POLY 1.5           |        (e)              (e)              (e)              P=0.008 **       P<0.001 **       P<0.001N**      | 
|POLY 6             |        (e)              (e)              (e)              P=0.008 **       P<0.001 **       P<0.001N**      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.022 *        P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.016 *        P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 06                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                      CUPRIC SULFATE    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            1000 PPM         2000 PPM         4000 PPM         8000 PPM         16,000          | 
|                   |                                                                                               PPM           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Adrenal Gland Medulla                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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 PPM            1000 PPM         2000 PPM         4000 PPM         8000 PPM         16,000          | 
|                   |                                                                                               PPM           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Adrenal Gland Medulla                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|POLY-3 RATE (b)    |        3/10.00          0/0.00           0/0.00           0/0.00           0/0.00           0/10.00         | 
|POLY-3 PERCENT (g) |        30.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.064N         P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.111N        | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.095N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.095N        | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.095N        | 
|LOGISTIC REGRESSION|        P=0.064N         (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.059N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.105N        | 
|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).