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TDMS Study 05206-05 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                       CUPRIC SULFATE                                    DATE: 10/15/04       
EXPERIMENT: 05206 TEST: 05                                                                                     TIME: 08:22:38       
TEST TYPE:  SUBCHRON 90-DAY                                                                                    PAGE:       1        
CONT: NO1ES75169                                ROUTE: DOSED FEED                                              NTP C#: 62191B       
PATHOLOGIST: A. SINGER                                                                                         CAS: 7758-99-8       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 PPM                                                                         
                                       INCLUDE 002    0 PPM                                                                         
                                       INCLUDE 005    500 PPM                                                                       
                                       INCLUDE 006    500 PPM                                                                       
                                       INCLUDE 009    1000 PPM                                                                      
                                       INCLUDE 010    1000 PPM                                                                      
                                       INCLUDE 013    2000 PPM                                                                      
                                       INCLUDE 014    2000 PPM                                                                      
                                       INCLUDE 017    4000 PPM                                                                      
                                       INCLUDE 018    4000 PPM                                                                      
                                       INCLUDE 021    8000 PPM                                                                      
                                       INCLUDE 022    8000 PPM                                                                      
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                       CUPRIC SULFATE                                    DATE: 10/15/04       
EXPERIMENT: 05206 TEST: 05                                                                                     TIME: 08:22:38       
TEST TYPE:  SUBCHRON 90-DAY                                                                                                         
CONT: NO1ES75169                                ROUTE: DOSED FEED                                              NTP C#: 62191B       
PATHOLOGIST: A. SINGER                                                                                         CAS: 7758-99-8       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                     CUPRIC SULFATE                                                                               
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Heart                                  Adrenal Gland Cortex                                                                         
Kidney                                 Cytoplasmic Alteration                                                                       
                                       Nephropathy                                                                                  
Kidney: Proximal Convoluted Renal Tubule                                                                                            
                                       Karyomegaly                                                                                  
Liver                                  Adrenal Gland Cortex                                                                         
Stomach Forestomach                    Hyperplasia                                                                                  
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Kidney                                 Cytoplasmic Alteration                                                                       
                                       Pigmentation                                                                                 
Kidney: Proximal Convoluted Renal Tubule                                                                                            
                                       Karyomegaly                                                                                  
Kidney: Renal Tubule                   Degeneration                                                                                 
Liver                                  Adrenal Gland Cortex                                                                         
                                       Hepatodiaphragmatic Nodule                                                                   
                                       Inflammation Focal                                                                           
Stomach Forestomach                    Hyperplasia                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                      CUPRIC SULFATE                   
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Adrenal Gland Cortex                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Adrenal Gland Cortex                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/10 (90%)       0/0 (0%)         0/1 (0%)         0/0 (0%)         0/0 (0%)         10/10 (100%)    | 
|POLY-3 RATE (b)    |        9/10.00          0/0.00           0/0.00           0/0.00           0/0.00           10/10.00        | 
|POLY-3 PERCENT (g) |        90.0%            0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        9/10 (90%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         10/10 (100%)    | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.309          P=1.000          P=1.000          P=1.000          P=1.000N         P=0.500         | 
|POLY 3             |        (e)              (e)              P=0.943N         (e)              (e)              P=0.500         | 
|POLY 1.5           |        (e)              (e)              P=0.933N         (e)              (e)              P=0.500         | 
|POLY 6             |        (e)              (e)              P=0.943N         (e)              (e)              P=0.500         | 
|LOGISTIC REGRESSION|        P=0.304          (e)              (e)              (e)              (e)              P=0.500         | 
|COCH-ARM / FISHERS |        P=0.188          P=1.000          P=0.182N         P=1.000          P=1.000          P=0.500         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Adrenal Gland Cortex                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|POLY-3 RATE (b)    |        10/10.00         0/0.00           0/0.00           0/0.00           0/0.00           5/10.00         | 
|POLY-3 PERCENT (g) |        100.0%           0.0%             0.0%             0.0%             0.0%             50.0%           | 
|TERMINAL (d)       |        10/10 (100%)     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=0.012N*        (e)              (e)              (e)              (e)              P=0.022N*       | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.008N**      | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.008N**      | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.008N**      | 
|LOGISTIC REGRESSION|        P=0.012N*        (e)              (e)              (e)              (e)              P=0.022N*       | 
|COCH-ARM / FISHERS |        P=0.010N*        (e)              (e)              (e)              (e)              P=0.016N*       | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Adrenal Gland Cortex                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/0.00           1/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             10.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.309          (e)              (e)              (e)              (e)              P=0.500         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|COCH-ARM / FISHERS |        P=0.304          (e)              (e)              (e)              (e)              P=0.500         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/9 (0%)         0/10 (0%)        3/10 (30%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/9.00           0/10.00          3/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             30.0%            100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/9 (0%)         0/10 (0%)        3/10 (30%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.111          P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.095          P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.095          P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.095          P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.111          P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.105          P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        1/10 (10%)       9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          1/9.00           9/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             11.1%            90.0%            100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        1/9 (11%)        9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              92 (T)           92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P=0.479          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              P=0.479          P<0.001 **       P<0.001N**       P<0.001N**      | 
|POLY 1.5           |        P<0.001 **       (e)              P=0.480          P<0.001 **       P<0.001N**       P<0.001N**      | 
|POLY 6             |        P<0.001 **       (e)              P=0.479          P<0.001 **       P<0.001N**       P<0.001N**      | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.479          P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     9/9 (100%)       10/10 (100%)     8/10 (80%)       9/10 (90%)       6/10 (60%)      | 
|POLY-3 RATE (b)    |        10/10.00         9/9.00           10/10.00         8/10.00          9/10.00          6/10.00         | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           80.0%            90.0%            60.0%           | 
|TERMINAL (d)       |        10/10 (100%)     9/9 (100%)       10/10 (100%)     8/10 (80%)       9/10 (90%)       6/10 (60%)      | 
|FIRST INCIDENCE    |        92 (T)           92 (T)           92 (T)           92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002N**       (e)              (e)              P=0.234N         P=0.500N         P=0.051N        | 
|POLY 3             |        P<0.001N**       (e)              (e)              P=0.227N         P=0.500N         P=0.033N*       | 
|POLY 1.5           |        P<0.001N**       (e)              (e)              P=0.227N         P=0.500N         P=0.033N*       | 
|POLY 6             |        P<0.001N**       (e)              (e)              P=0.227N         P=0.500N         P=0.033N*       | 
|LOGISTIC REGRESSION|        P=0.002N**       (e)              (e)              P=0.234N         P=0.500N         P=0.051N        | 
|COCH-ARM / FISHERS |        P=0.002N**       (e)              (e)              P=0.237N         P=0.500N         P=0.043N*       | 
|ORDER RESTRICTED   |        P=0.002N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        1/10 (10%)       1/10 (10%)       0/10 (0%)        2/10 (20%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          1/9.00           1/10.00          0/10.00          2/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             11.1%            10.0%            0.0%             20.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        1/9 (11%)        1/10 (10%)       0/10 (0%)        2/10 (20%)      | 
|FIRST INCIDENCE    |        ---              ---              92 (T)           92 (T)           ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.111          (e)              P=0.479          P=0.500          (e)              P=0.234         | 
|POLY 3             |        P=0.106          (e)              P=0.479          P=0.500          (e)              P=0.227         | 
|POLY 1.5           |        P=0.106          (e)              P=0.480          P=0.500          (e)              P=0.227         | 
|POLY 6             |        P=0.106          (e)              P=0.479          P=0.500          (e)              P=0.227         | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.479          P=0.500          (e)              P=0.234         | 
|COCH-ARM / FISHERS |        P=0.104          (e)              P=0.500          P=0.500          (e)              P=0.237         | 
|ORDER RESTRICTED   |        P=0.055          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/9.00           0/10.00          0/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        0/10 (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            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/9.00           0/10.00          0/10.00          2/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             20.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        2/10 (20%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.234         | 
|POLY 3             |        P=0.008 **       (e)              (e)              (e)              (e)              P=0.227         | 
|POLY 1.5           |        P=0.008 **       (e)              (e)              (e)              (e)              P=0.227         | 
|POLY 6             |        P=0.008 **       (e)              (e)              (e)              (e)              P=0.227         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.234         | 
|COCH-ARM / FISHERS |        P=0.010 *        (e)              (e)              (e)              (e)              P=0.237         | 
|ORDER RESTRICTED   |        P=0.007 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Proximal Convoluted Renal Tubule                                                                                         | 
|     Karyomegaly                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/9.00           0/10.00          0/10.00          0/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001N**       (e)              (e)              (e)              (e)              P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       (e)              (e)              (e)              (e)              P<0.001N**      | 
|POLY 6             |        P<0.001N**       (e)              (e)              (e)              (e)              P<0.001N**      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Proximal Convoluted Renal Tubule                                                                                         | 
|     Karyomegaly                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/9.00           0/10.00          0/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/9.00           0/10.00          0/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        0/10 (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            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        3/10 (30%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/9.00           0/10.00          0/10.00          3/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             30.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        3/10 (30%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.111         | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.095         | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.095         | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.095         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.111         | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.105         | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Adrenal Gland Cortex                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/10 (0%)        1/10 (10%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/10.00          1/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             10.0%            100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/10 (0%)        1/10 (10%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.500          P<0.001 **       P<0.001 **      | 
|POLY 3             |        (e)              (e)              (e)              P=0.500          P<0.001N**       P<0.001 **      | 
|POLY 1.5           |        (e)              (e)              (e)              P=0.500          P<0.001N**       P<0.001 **      | 
|POLY 6             |        (e)              (e)              (e)              P=0.500          P<0.001N**       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.500          P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.500          P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Adrenal Gland Cortex                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/1 (0%)         0/2 (0%)         0/10 (0%)        6/10 (60%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/1.00           0/2.00           0/10.00          6/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             60.0%            100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/1 (0%)         0/2 (0%)         0/10 (0%)        6/10 (60%)       10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.009 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.009 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.005 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         1/10 (10%)       1/10 (10%)       0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        1/10.00          0/0.00           1/10.00          1/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             10.0%            10.0%            0.0%             0.0%            | 
|TERMINAL (d)       |        1/10 (10%)       0/0 (0%)         1/10 (10%)       1/10 (10%)       0/10 (0%)        0/10 (0%)       | 
|FIRST INCIDENCE    |        92 (T)           ---              92 (T)           92 (T)           ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.202N         P=1.000N         P=0.766          P=0.766          P=0.500N         P=0.500N        | 
|POLY 3             |        (e)              (e)              P=0.760          P=0.760          P=0.500N         P=0.500N        | 
|POLY 1.5           |        (e)              (e)              P=0.760          P=0.760          P=0.500N         P=0.500N        | 
|POLY 6             |        (e)              (e)              P=0.760          P=0.760          P=0.500N         P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.202N         (e)              P=0.766          P=0.766          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.200N         P=1.000          P=0.763N         P=0.763N         P=0.500N         P=0.500N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       1/1 (100%)       2/2 (100%)       2/10 (20%)       0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        2/10.00          1/1.00           2/2.00           2/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            100.0%           100.0%           20.0%            0.0%             0.0%            | 
|TERMINAL (d)       |        2/10 (20%)       1/1 (100%)       2/2 (100%)       2/10 (20%)       0/10 (0%)        0/10 (0%)       | 
|FIRST INCIDENCE    |        92 (T)           92 (T)           92 (T)           92 (T)           ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.020N*        P=0.305          P=0.095          P=0.707          P=0.234N         P=0.234N        | 
|POLY 3             |        P=0.005N**       P=0.286          P=0.053          P=0.702          P=0.227N         P=0.227N        | 
|POLY 1.5           |        P=0.005N**       P=0.286          P=0.053          P=0.702          P=0.227N         P=0.227N        | 
|POLY 6             |        P=0.005N**       P=0.286          P=0.053          P=0.702          P=0.227N         P=0.227N        | 
|LOGISTIC REGRESSION|        P=0.020N*        P=0.305          P=0.095          P=0.707          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.019N*        P=0.273          P=0.091          P=0.709N         P=0.237N         P=0.237N        | 
|ORDER RESTRICTED   |        P=0.003N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/10.00          0/10.00          0/10.00          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%)         0/10 (0%)        0/10 (0%)        0/10 (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            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/1 (0%)         0/2 (0%)         0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        2/10.00          0/1.00           0/2.00           0/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        2/10 (20%)       0/1 (0%)         0/2 (0%)         0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.129N         P=0.795N         P=0.630N         P=0.234N         P=0.234N         P=0.234N        | 
|POLY 3             |        P=0.124N         P=0.786N         P=0.627N         P=0.227N         P=0.227N         P=0.227N        | 
|POLY 1.5           |        P=0.124N         P=0.786N         P=0.627N         P=0.227N         P=0.227N         P=0.227N        | 
|POLY 6             |        P=0.124N         P=0.786N         P=0.627N         P=0.227N         P=0.227N         P=0.227N        | 
|LOGISTIC REGRESSION|        P=0.129N         (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.127N         P=0.818N         P=0.682N         P=0.237N         P=0.237N         P=0.237N        | 
|ORDER RESTRICTED   |        P=0.007N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|POLY-3 RATE (b)    |        2/10.00          0/0.00           0/0.00           0/0.00           0/0.00           1/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             0.0%             10.0%           | 
|TERMINAL (d)       |        2/10 (20%)       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=0.380N         P=1.000N         P=1.000N         P=1.000          P=1.000          P=0.500N        | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.500N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.500N        | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.380N         (e)              (e)              (e)              (e)              P=0.500N        | 
|COCH-ARM / FISHERS |        P=0.377N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.500N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/1 (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=1.000          P=1.000          P=1.000          P=1.000          P=0.766         | 
|POLY 3             |        (e)              (e)              P=0.943N         (e)              (e)              P=0.760         | 
|POLY 1.5           |        (e)              (e)              P=0.943N         (e)              (e)              P=0.760         | 
|POLY 6             |        (e)              (e)              P=0.943N         (e)              (e)              P=0.760         | 
|LOGISTIC REGRESSION|        P=0.645N         (e)              (e)              (e)              (e)              P=0.766         | 
|COCH-ARM / FISHERS |        P=0.626          P=1.000          P=0.909N         P=1.000          P=1.000          P=0.763N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Adrenal Gland Cortex                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/10 (70%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         8/10 (80%)      | 
|POLY-3 RATE (b)    |        7/10.00          0/0.00           0/0.00           0/0.00           0/0.00           8/10.00         | 
|POLY-3 PERCENT (g) |        70.0%            0.0%             0.0%             0.0%             0.0%             80.0%           | 
|TERMINAL (d)       |        7/10 (70%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         8/10 (80%)      | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              ---              92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.401          P=1.000N         P=1.000N         P=1.000          P=1.000          P=0.500         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|LOGISTIC REGRESSION|        P=0.401          (e)              (e)              (e)              (e)              P=0.500         | 
|COCH-ARM / FISHERS |        P=0.398          P=1.000          P=1.000          P=1.000          P=1.000          P=0.500         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Adrenal Gland Cortex                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/15/04                           EXPERIMENT: 05206 TEST: 05                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      CUPRIC SULFATE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach Forestomach                                                                                                              | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/1 (0%)         0/10 (0%)        10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/1.00           0/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             100.0%           100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/1 (0%)         0/10 (0%)        10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001N**       (e)              (e)              P<0.001 **       P<0.001N**       P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       (e)              (e)              P<0.001 **       P<0.001N**       P<0.001N**      | 
|POLY 6             |        P<0.001N**       (e)              (e)              P<0.001 **       P<0.001N**       P<0.001N**      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            500 PPM          1000 PPM         2000 PPM         4000 PPM         8000 PPM        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach Forestomach                                                                                                              | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/10 (0%)        7/10 (70%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/9.00           7/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             70.0%            100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/9 (0%)         7/10 (70%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.003 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        (e)              (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        (e)              (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        (e)              (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.003 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.002 **       P<0.001 **       P<0.001 **      | 
|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).