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TDMS Study 89009-02 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                   PESTICIDE/FERTILIZER CONTAMINATION--MIXTURE 2                    DATE: 10/18/04       
EXPERIMENT: 89009 TEST: 02                                                                                     TIME: 10:25:27       
TEST TYPE:  SUBCHRON 26-WEEK                                                                                   PAGE:       1        
CONT: NO1-ES-95275                              ROUTE: DOSED WATER                                             NTP C#: C89009       
PATHOLOGIST: J.E. HEATH                                                                                        CAS: PESTFERTMIX2    
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                   PESTICIDE/FERTILIZER CONTAMINATION--MIXTURE 2                    DATE: 10/18/04       
EXPERIMENT: 89009 TEST: 02                                                                                     TIME: 10:25:27       
TEST TYPE:  SUBCHRON 26-WEEK                                                                                                        
CONT: NO1-ES-95275                              ROUTE: DOSED WATER                                             NTP C#: C89009       
PATHOLOGIST: J.E. HEATH                                                                                        CAS: PESTFERTMIX2    
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF      PESTICIDE/FERTILIZER CONTAMINATION--M                                                                       
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Uterus                                 Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 89009 TEST: 02                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -       PESTICIDE/FERTILIZER CONTAMINATION--M                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/20 (10%)       3/20 (15%)       1/20 (5%)        2/20 (10%)       2/20 (10%)                       | 
|POLY-3 RATE (b)    |        2/11.27          3/13.02          1/12.14          2/13.02          2/11.15                          | 
|POLY-3 PERCENT (g) |        17.8%            23.1%            8.2%             15.4%            18.0%                            | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        2/10 (20%)       1/10 (10%)       2/10 (20%)       1/10 (10%)                       | 
|TERMINAL (d)       |        2/10 (20%)       1/10 (10%)       0/10 (0%)        0/10 (0%)        1/9 (11%)                        | 
|FIRST INCIDENCE    |        183 (T)          92 (I)           92 (I)           92 (I)           92 (I)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.633          P=0.500          P=0.500N         P=0.696          P=0.670                          | 
|POLY 3             |        P=0.612          P=0.570          P=0.473N         P=0.649N         P=0.702                          | 
|POLY 1.5           |        P=0.619          P=0.544          P=0.483N         P=0.668N         P=0.695                          | 
|POLY 6             |        P=0.607          P=0.586          P=0.466N         P=0.636N         P=0.706                          | 
|LOGISTIC REGRESSION|        P=0.631N         P=0.500          P=0.500N         P=0.701N         P=0.678                          | 
|COCH-ARM / FISHERS |        P=0.647N         P=0.500          P=0.500N         P=0.698N         P=0.698N                         | 
|ORDER RESTRICTED   |        P=0.585N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/20 (15%)       2/20 (10%)       2/20 (10%)       3/20 (15%)       3/20 (15%)                       | 
|POLY-3 RATE (b)    |        3/12.14          2/12.14          2/11.27          3/13.02          3/13.02                          | 
|POLY-3 PERCENT (g) |        24.7%            16.5%            17.8%            23.1%            23.1%                            | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       1/10 (10%)       0/10 (0%)        2/10 (20%)       2/10 (20%)                       | 
|TERMINAL (d)       |        2/10 (20%)       1/10 (10%)       2/10 (20%)       0/9 (0%)         1/10 (10%)                       | 
|FIRST INCIDENCE    |        92 (I)           92 (I)           183 (T)          51               92 (I)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.510          P=0.500N         P=0.500N         P=0.645          P=0.667                          | 
|POLY 3             |        P=0.561          P=0.500N         P=0.537N         P=0.643N         P=0.643N                         | 
|POLY 1.5           |        P=0.540          P=0.500N         P=0.523N         P=0.653N         P=0.653N                         | 
|POLY 6             |        P=0.573          P=0.500N         P=0.546N         P=0.635N         P=0.635N                         | 
|LOGISTIC REGRESSION|        P=0.503          P=0.500N         P=0.500N         P=0.642N         P=0.671N                         | 
|COCH-ARM / FISHERS |        P=0.505          P=0.500N         P=0.500N         P=0.669N         P=0.669N                         | 
|ORDER RESTRICTED   |        P=0.660N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 89009 TEST: 02                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -       PESTICIDE/FERTILIZER CONTAMINATION--M                 
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/20 (0%)        3/20 (15%)       1/20 (5%)        3/20 (15%)       0/20 (0%)                        | 
|POLY-3 RATE (b)    |        0/11.27          3/11.27          1/11.27          3/11.27          0/10.27                          | 
|POLY-3 PERCENT (g) |        0.0%             26.6%            8.9%             26.6%            0.0%                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)                        | 
|TERMINAL (d)       |        0/10 (0%)        3/10 (30%)       1/10 (10%)       3/10 (30%)       0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              183 (T)          183 (T)          183 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.233N         P=0.111          P=0.500          P=0.111          (e)                              | 
|POLY 3             |        P=0.234N         P=0.101          P=0.500          P=0.101          (e)                              | 
|POLY 1.5           |        P=0.230N         P=0.104          P=0.500          P=0.104          (e)                              | 
|POLY 6             |        P=0.238N         P=0.101          P=0.500          P=0.101          (e)                              | 
|LOGISTIC REGRESSION|        (e)              P=0.111          P=0.500          P=0.111          (e)                              | 
|COCH-ARM / FISHERS |        P=0.213N         P=0.115          P=0.500          P=0.115          (e)                              | 
|ORDER RESTRICTED   |        P=0.224          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/20 (0%)        0/20 (0%)        0/20 (0%)        0/20 (0%)        0/20 (0%)                        | 
|POLY-3 RATE (b)    |        0/11.27          0/11.27          0/11.27          0/10.29          0/11.27                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)                        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 89009 TEST: 02                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -       PESTICIDE/FERTILIZER CONTAMINATION--M                 
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/20 (0%)        1/20 (5%)        0/20 (0%)        0/20 (0%)        0/20 (0%)                        | 
|POLY-3 RATE (b)    |        0/11.27          1/12.14          0/11.27          0/11.27          0/10.27                          | 
|POLY-3 PERCENT (g) |        0.0%             8.2%             0.0%             0.0%             0.0%                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)                        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              92 (I)           ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.721N         P=0.500          (e)              (e)              (e)                              | 
|POLY 3             |        P=0.720N         P=0.515          (e)              (e)              (e)                              | 
|POLY 1.5           |        P=0.722N         P=0.509          (e)              (e)              (e)                              | 
|POLY 6             |        P=0.719N         P=0.519          (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.650N         (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.722N         P=0.500          (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.407N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/20 (5%)        1/20 (5%)        1/20 (5%)        2/20 (10%)       0/20 (0%)                        | 
|POLY-3 RATE (b)    |        1/11.27          1/11.27          1/12.14          2/11.17          0/11.27                          | 
|POLY-3 PERCENT (g) |        8.9%             8.9%             8.2%             17.9%            0.0%                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        1/10 (10%)       1/10 (10%)       0/10 (0%)                        | 
|TERMINAL (d)       |        1/10 (10%)       1/10 (10%)       0/10 (0%)        1/9 (11%)        0/10 (0%)                        | 
|FIRST INCIDENCE    |        183 (T)          183 (T)          92 (I)           92 (I)           ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.298N         P=0.766          P=0.760          P=0.475          P=0.500N                         | 
|POLY 3             |        P=0.304N         P=0.766          P=0.748N         P=0.497          P=0.500N                         | 
|POLY 1.5           |        P=0.302N         P=0.765          P=0.754N         P=0.494          P=0.500N                         | 
|POLY 6             |        P=0.306N         P=0.766          P=0.744N         P=0.499          P=0.500N                         | 
|LOGISTIC REGRESSION|        P=0.297N         P=0.772N         P=0.766N         P=0.482          (e)                              | 
|COCH-ARM / FISHERS |        P=0.299N         P=0.756N         P=0.756N         P=0.500          P=0.500N                         | 
|ORDER RESTRICTED   |        P=0.317N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 89009 TEST: 02                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -       PESTICIDE/FERTILIZER CONTAMINATION--M                 
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Acute                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/20 (0%)        0/20 (0%)        0/20 (0%)        0/20 (0%)        0/20 (0%)                        | 
|POLY-3 RATE (b)    |        0/11.27          0/11.27          0/11.27          0/11.27          0/10.27                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)                        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Acute                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/20 (10%)       1/20 (5%)        2/20 (10%)       1/20 (5%)        0/20 (0%)                        | 
|POLY-3 RATE (b)    |        2/12.14          1/12.14          2/12.14          1/11.17          0/11.27                          | 
|POLY-3 PERCENT (g) |        16.5%            8.2%             16.5%            9.0%             0.0%                             | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       1/10 (10%)       1/10 (10%)       1/10 (10%)       0/10 (0%)                        | 
|TERMINAL (d)       |        1/10 (10%)       0/10 (0%)        1/10 (10%)       0/9 (0%)         0/10 (0%)                        | 
|FIRST INCIDENCE    |        92 (I)           92 (I)           92 (I)           92 (I)           ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.206N         P=0.500N         P=0.696          P=0.512N         P=0.240N                         | 
|POLY 3             |        P=0.217N         P=0.500N         P=0.705          P=0.531N         P=0.246N                         | 
|POLY 1.5           |        P=0.212N         P=0.500N         P=0.703          P=0.522N         P=0.240N                         | 
|POLY 6             |        P=0.221N         P=0.500N         P=0.705          P=0.534N         P=0.250N                         | 
|LOGISTIC REGRESSION|        P=0.206N         P=0.500N         P=0.701N         P=0.486N         P=0.234N                         | 
|COCH-ARM / FISHERS |        P=0.206N         P=0.500N         P=0.698N         P=0.500N         P=0.244N                         | 
|ORDER RESTRICTED   |        P=0.157N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 89009 TEST: 02                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -       PESTICIDE/FERTILIZER CONTAMINATION--M                 
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/20 (0%)        0/20 (0%)        0/20 (0%)        0/20 (0%)        0/20 (0%)                        | 
|POLY-3 RATE (b)    |        0/11.27          0/11.27          0/11.27          0/11.27          0/10.27                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)                        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/20 (10%)       1/20 (5%)        2/20 (10%)       3/20 (15%)       2/20 (10%)                       | 
|POLY-3 RATE (b)    |        2/12.14          1/11.27          2/11.27          3/12.04          2/11.27                          | 
|POLY-3 PERCENT (g) |        16.5%            8.9%             17.8%            24.9%            17.8%                            | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       0/10 (0%)        0/10 (0%)        2/10 (20%)       0/10 (0%)                        | 
|TERMINAL (d)       |        1/10 (10%)       1/10 (10%)       2/10 (20%)       1/9 (11%)        2/10 (20%)                       | 
|FIRST INCIDENCE    |        92 (I)           183 (T)          183 (T)          92 (I)           183 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.623          P=0.500N         P=0.699          P=0.480          P=0.699                          | 
|POLY 3             |        P=0.607          P=0.527N         P=0.677          P=0.496          P=0.677                          | 
|POLY 1.5           |        P=0.612          P=0.517N         P=0.686          P=0.493          P=0.686                          | 
|POLY 6             |        P=0.603          P=0.534N         P=0.670          P=0.499          P=0.670                          | 
|LOGISTIC REGRESSION|        P=0.623          P=0.500N         P=0.704N         P=0.509          P=0.704N                         | 
|COCH-ARM / FISHERS |        P=0.618          P=0.500N         P=0.698N         P=0.500          P=0.698N                         | 
|ORDER RESTRICTED   |        P=0.506          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 89009 TEST: 02                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -       PESTICIDE/FERTILIZER CONTAMINATION--M                 
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|INT SACRIFICE 1 (c)|                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        VEHICLE          0.1X             1X               10X              100X                             | 
|                   |        CONTROL                                                                                              | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/20 (20%)       9/20 (45%)       8/20 (40%)       9/20 (45%)       8/20 (40%)                       | 
|POLY-3 RATE (b)    |        4/11.27          9/11.27          8/11.27          9/10.29          8/11.27                          | 
|POLY-3 PERCENT (g) |        35.5%            79.9%            71.0%            87.4%            71.0%                            | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)                        | 
|TERMINAL (d)       |        4/10 (40%)       9/10 (90%)       8/10 (80%)       9/9 (100%)       8/10 (80%)                       | 
|FIRST INCIDENCE    |        183 (T)          183 (T)          183 (T)          183 (T)          183 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.500          P=0.034 *        P=0.091          P=0.012 *        P=0.091                          | 
|POLY 3             |        P=0.486          P=0.028 *        P=0.086          P=0.009 **       P=0.086                          | 
|POLY 1.5           |        P=0.484          P=0.042 *        P=0.104          P=0.023 *        P=0.104                          | 
|POLY 6             |        P=0.488          P=0.025 *        P=0.082          P=0.006 **       P=0.082                          | 
|LOGISTIC REGRESSION|        P=0.500          P=0.034 *        P=0.091          P=0.012 *        P=0.091                          | 
|COCH-ARM / FISHERS |        P=0.480          P=0.088          P=0.150          P=0.088          P=0.150                          | 
|ORDER RESTRICTED   |        P=0.006 **       (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).