https://ntp.niehs.nih.gov/go/11641

TDMS Study 97013-94 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 12/08/03       
EXPERIMENT: 97013 TEST: 94                                                                                     TIME: 14:44:33       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013H       
PATHOLOGIST: MISSING                                                                                           CAS: 7789-38-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                            FINAL#1 MICE                                                            
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 12/08/03       
EXPERIMENT: 97013 TEST: 94                                                                                     TIME: 14:44:33       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013H       
PATHOLOGIST: MISSING                                                                                           CAS: 7789-38-0       
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF        WATER DISINFECTION MODEL (SODIUM BR                                                                       
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Cortex                         Hypertrophy                                                                                  
Epididymis                             Degeneration                                                                                 
Kidney                                 Hydronephrosis                                                                               
                                       Nephropathy                                                                                  
Kidney: Renal Tubule                   Degeneration                                                                                 
                                       Hypertrophy                                                                                  
Pituitary Gland: Pars Distalis         Hypertrophy                                                                                  
Testes: Bilateral, Germinal Epithelium                                                                                              
                                       Degeneration                                                                                 
Testes: Germinal Epithelium            Degeneration                                                                                 
Testes: Interstitial Cell              Hyperplasia                                                                                  
Thymus                                 Atrophy                                                                                      
Thyroid Gland                          Infiltration Cellular Lymphocyte                                                             
Thyroid Gland: Follicle                Depletion Secretory                                                                          
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex: Subcapsular            Hyperplasia                                                                                  
Kidney                                 Mineralization                                                                               
                                       Nephropathy                                                                                  
Kidney: Renal Tubule                   Degeneration                                                                                 
                                       Hypertrophy                                                                                  
Liver                                  Inflammation Chronic                                                                         
Ovary                                  Atrophy                                                                                      
Pituitary Gland: Pars Distalis         Cyst                                                                                         
                                       Hypertrophy                                                                                  
Spleen                                 Hematopoietic Cell Proliferation                                                             
Stomach, Forestomach: Epithelium       Hyperkeratosis                                                                               
                                       Hyperplasia                                                                                  
Thymus                                 Atrophy                                                                                      
Thyroid Gland                          Infiltration Cellular Lymphocyte                                                             
Thyroid Gland: Follicle                Depletion Secretory                                                                          
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SO
DIUM BR                                                                                                                             
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/10 (50%)   7/10 (70%)   6/10 (60%)   1/10 (10%)  |0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     5/7.25       7/7.33       6/7.78       1/7.49      |0/7.62       0/7.61       0/6.52       0/4.58       | 
|POLY-3 PERCENT (g) |     69.0%        95.4%        77.1%        13.4%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     5/6 (83%)    7/7 (100%)   6/6 (100%)   1/4 (25%)   |0/7 (0%)     0/5 (0%)     0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     295 (T)      295 (T)      295 (T)      295 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.018N*    P=0.469      P=0.500      P=0.130N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P<0.001N**   P=0.218      P=0.599      P=0.030N*   |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P<0.001N**   P=0.219      P=0.566      P=0.037N*   |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P<0.001N**   P=0.303      P=0.638      P=0.027N*   |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.018N*    P=0.469      P=0.500      P=0.130N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.017N*    P=0.325      P=0.500      P=0.070N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)   |1/10 (10%)   2/10 (20%)   0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       0/7.78       0/7.49      |1/7.62       2/7.69       0/6.52       0/4.58       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |13.1%        26.0%        0.0%         0.0%         | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     0/4 (0%)    |1/7 (14%)    1/5 (20%)    0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |295 (T)      287          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.285N     P=0.421      P=0.612N     P=0.748N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.188N     P=0.503      P=0.531N     P=0.597N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.155N     P=0.506      P=0.514N     P=0.563N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.226N     P=0.497      P=0.545N     P=0.629N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.227N     P=0.483      (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.126N     P=0.500      P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.276N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Subcapsular                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)   |5/10 (50%)   6/10 (60%)   1/10 (10%)   0/10 (0%)    | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       0/7.78       0/7.49      |5/9.01       6/7.77       1/6.52       0/4.58       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |55.5%        77.3%        15.4%        0.0%         | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     0/4 (0%)    |3/7 (43%)    4/5 (80%)    1/4 (25%)    0/2 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |93           287          295 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.028N*    P=0.329      P=0.197N     P=0.141N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.005N**   P=0.340      P=0.140N     P=0.086N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P<0.001N**   P=0.390      P=0.097N     P=0.041N*    | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.015N*    P=0.293      P=0.183N     P=0.156N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.003N**   P=0.510      P=0.074N     P=0.024N*    | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P<0.001N**   P=0.500      P=0.070N     P=0.016N*    | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.014N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   1/10 (10%)   0/10 (0%)    7/10 (70%)  |                                                    | 
|POLY-3 RATE (b)    |     1/7.72       1/7.33       0/7.78       7/8.48      |                                                    | 
|POLY-3 PERCENT (g) |     13.0%        13.6%        0.0%         82.5%       |                                                    | 
|TERMINAL (d)       |     0/6 (0%)     1/7 (14%)    0/6 (0%)     3/4 (75%)   |                                                    | 
|FIRST INCIDENCE    |     239          295 (T)      ---          246         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.743N     P=0.473N     P=0.022 *   |                                                    | 
|POLY 3             |     P<0.001 **   P=0.754      P=0.498N     P=0.002 **  |                                                    | 
|POLY 1.5           |     P<0.001 **   P=0.751      P=0.496N     P=0.002 **  |                                                    | 
|POLY 6             |     P<0.001 **   P=0.760      P=0.504N     P=0.002 **  |                                                    | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.770      P=0.514N     P=0.011 *   |                                                    | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.763N     P=0.500N     P=0.010 *   |                                                    | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Hydronephrosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%)  |0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       0/7.78       2/7.89      |0/7.62       0/7.61       0/6.52       0/4.58       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         25.3%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     0/4 (0%)    |0/7 (0%)     0/5 (0%)     0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          ---          263         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.037 *    (e)          (e)          P=0.236     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.037 *    (e)          (e)          P=0.241     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.038 *    (e)          (e)          P=0.238     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.036 *    (e)          (e)          P=0.242     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.041 *    (e)          (e)          P=0.233     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.040 *    (e)          (e)          P=0.237     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.027 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%)  |0/10 (0%)    0/10 (0%)    1/10 (10%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       0/7.78       1/7.60      |0/7.62       0/7.61       1/7.46       2/5.78       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         13.2%       |0.0%         0.0%         13.4%        34.6%        | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     0/4 (0%)    |0/7 (0%)     0/5 (0%)     0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          ---          284         |---          ---          115          8            | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.152      (e)          (e)          P=0.464     |P=0.042 *    (e)          P=0.545      P=0.180      | 
|POLY 3             |     P=0.192      (e)          (e)          P=0.510     |P=0.033 *    (e)          P=0.496      P=0.157      | 
|POLY 1.5           |     P=0.194      (e)          (e)          P=0.509     |P=0.038 *    (e)          P=0.506      P=0.186      | 
|POLY 6             |     P=0.183      (e)          (e)          P=0.505     |P=0.029 *    (e)          P=0.486      P=0.134      | 
|LOGISTIC REGRESSION|     P=0.182      (e)          (e)          P=0.501     |P=0.109      (e)          P=0.380      P=0.308      | 
|COCH-ARM / FISHERS |     P=0.184      (e)          (e)          P=0.500     |P=0.055      (e)          P=0.500      P=0.237      | 
|ORDER RESTRICTED   |     P=0.127      (e)          (e)          (e)         |P=0.033 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/10 (70%)   6/10 (60%)   7/10 (70%)   10/10 (100%)|6/10 (60%)   6/10 (60%)   8/10 (80%)   8/10 (80%)   | 
|POLY-3 RATE (b)    |     7/8.22       6/8.30       7/9.41       10/10.00    |6/9.03       6/8.12       8/8.26       8/8.09       | 
|POLY-3 PERCENT (g) |     85.2%        72.3%        74.4%        100.0%      |66.4%        73.9%        96.8%        98.9%        | 
|TERMINAL (d)       |     6/6 (100%)   5/7 (71%)    5/6 (83%)    4/4 (100%)  |4/7 (57%)    3/5 (60%)    4/4 (100%)   2/2 (100%)   | 
|FIRST INCIDENCE    |     93           93           144          127         |57           255          144          8            | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.013 *    P=0.350N     P=0.672N     P=0.077     |P=0.002 **   P=0.478      P=0.109      P=0.027 *    | 
|POLY 3             |     P=0.126      P=0.482N     P=0.514N     P=0.319     |P=0.032 *    P=0.573      P=0.147      P=0.123      | 
|POLY 1.5           |     P=0.083      P=0.533N     P=0.590N     P=0.167     |P=0.050      P=0.592      P=0.199      P=0.154      | 
|POLY 6             |     P=0.188      P=0.373N     P=0.421N     P=0.865     |P=0.028 *    P=0.561      P=0.121      P=0.116      | 
|LOGISTIC REGRESSION|     P=0.050      P=0.531N     P=0.667N     P=0.116     |P=0.054      P=0.674N     P=0.292      P=0.239      | 
|COCH-ARM / FISHERS |     P=0.043 *    P=0.500N     P=0.686N     P=0.105     |P=0.157      P=0.675N     P=0.314      P=0.314      | 
|ORDER RESTRICTED   |     P=0.111      (e)          (e)          (e)         |P=0.037 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Cortex                                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   0/10 (0%)    0/10 (0%)    1/10 (10%)  |0/10 (0%)    2/10 (20%)   0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     1/7.25       0/7.33       0/7.78       1/7.60      |0/7.62       2/7.69       0/6.52       0/4.58       | 
|POLY-3 PERCENT (g) |     13.8%        0.0%         0.0%         13.2%       |0.0%         26.0%        0.0%         0.0%         | 
|TERMINAL (d)       |     1/6 (17%)    0/7 (0%)     0/6 (0%)     0/4 (0%)    |0/7 (0%)     1/5 (20%)    0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     295 (T)      ---          ---          284         |---          287          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.460      P=0.469N     P=0.500N     P=0.694     |P=0.448N     P=0.203      (e)          (e)          | 
|POLY 3             |     P=0.545      P=0.498N     P=0.486N     P=0.756N    |P=0.345N     P=0.223      (e)          (e)          | 
|POLY 1.5           |     P=0.552      P=0.505N     P=0.489N     P=0.754N    |P=0.294N     P=0.226      (e)          (e)          | 
|POLY 6             |     P=0.526      P=0.484N     P=0.483N     P=0.763N    |P=0.402N     P=0.218      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.526      (e)          (e)          P=0.769     |P=0.383N     P=0.217      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.537      P=0.500N     P=0.500N     P=0.763N    |P=0.259N     P=0.237      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.381N     (e)          (e)          (e)         |P=0.347N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Glomerulus                                                                                                               | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/10 (20%)   0/10 (0%)    0/10 (0%)    2/10 (20%)  |0/10 (0%)    1/10 (10%)   2/10 (20%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     2/8.97       0/7.33       0/7.78       2/8.83      |0/7.62       1/8.49       2/7.48       1/4.75       | 
|POLY-3 PERCENT (g) |     22.3%        0.0%         0.0%         22.6%       |0.0%         11.8%        26.7%        21.1%        | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     0/4 (0%)    |0/7 (0%)     0/5 (0%)     0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     93           ---          ---          127         |---          144          144          277          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.465      P=0.265N     P=0.240N     P=0.657N    |P=0.215      P=0.523      P=0.235      P=0.331      | 
|POLY 3             |     P=0.464      P=0.274N     P=0.259N     P=0.701     |P=0.197      P=0.522      P=0.216      P=0.407      | 
|POLY 1.5           |     P=0.462      P=0.269N     P=0.248N     P=0.703     |P=0.242      P=0.518      P=0.227      P=0.439      | 
|POLY 6             |     P=0.449      P=0.268N     P=0.267N     P=0.694     |P=0.164      P=0.520      P=0.208      P=0.379      | 
|LOGISTIC REGRESSION|     P=0.228      P=0.115N     P=0.260N     P=0.613     |P=0.408      P=0.488      P=0.228      P=0.393      | 
|COCH-ARM / FISHERS |     P=0.420      P=0.237N     P=0.237N     P=0.709N    |P=0.369      P=0.500      P=0.237      P=0.500      | 
|ORDER RESTRICTED   |     P=0.265      (e)          (e)          (e)         |P=0.232      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    1/10 (10%)   8/10 (80%)  |0/10 (0%)    0/10 (0%)    0/10 (0%)    7/10 (70%)   | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       1/8.52       8/8.48      |0/7.62       0/7.61       0/6.52       7/7.40       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         11.7%        94.3%       |0.0%         0.0%         0.0%         94.6%        | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     4/4 (100%)  |0/7 (0%)     0/5 (0%)     0/4 (0%)     2/2 (100%)   | 
|FIRST INCIDENCE    |     ---          ---          188          246         |---          ---          ---          8            | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   (e)          P=0.523      P<0.001 **  |P<0.001 **   (e)          (e)          P<0.001 **   | 
|POLY 3             |     P<0.001 **   (e)          P=0.532      P<0.001 **  |P<0.001 **   (e)          (e)          P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   (e)          P=0.522      P<0.001 **  |P<0.001 **   (e)          (e)          P<0.001 **   | 
|POLY 6             |     P<0.001 **   (e)          P=0.541      P<0.001 **  |P<0.001 **   (e)          (e)          P<0.001 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   (e)          P=0.430      P<0.001 **  |P<0.001 **   (e)          (e)          P=0.002 **   | 
|COCH-ARM / FISHERS |     P<0.001 **   (e)          P=0.500      P<0.001 **  |P<0.001 **   (e)          (e)          P=0.002 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    1/10 (10%)   6/10 (60%)  |0/10 (0%)    0/10 (0%)    2/10 (20%)   5/10 (50%)   | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       1/7.78       6/7.96      |0/7.62       0/7.61       2/7.22       5/6.71       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         12.9%        75.4%       |0.0%         0.0%         27.7%        74.5%        | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     1/6 (17%)    4/4 (100%)  |0/7 (0%)     0/5 (0%)     1/4 (25%)    2/2 (100%)   | 
|FIRST INCIDENCE    |     ---          ---          295 (T)      263         |---          ---          197          188          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   (e)          P=0.500      P=0.004 **  |P<0.001 **   (e)          P=0.167      P=0.003 **   | 
|POLY 3             |     P<0.001 **   (e)          P=0.514      P<0.001 **  |P<0.001 **   (e)          P=0.208      P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   (e)          P=0.511      P<0.001 **  |P<0.001 **   (e)          P=0.220      P=0.002 **   | 
|POLY 6             |     P<0.001 **   (e)          P=0.517      P<0.001 **  |P<0.001 **   (e)          P=0.200      P<0.001 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   (e)          P=0.500      P=0.004 **  |P<0.001 **   (e)          P=0.226      P=0.011 *    | 
|COCH-ARM / FISHERS |     P<0.001 **   (e)          P=0.500      P=0.005 **  |P<0.001 **   (e)          P=0.237      P=0.016 *    | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   0/10 (0%)    2/10 (20%)   1/10 (10%)  |3/10 (30%)   4/10 (40%)   6/10 (60%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     1/7.81       0/7.33       2/8.20       1/7.60      |3/9.01       4/8.04       6/8.24       1/5.54       | 
|POLY-3 PERCENT (g) |     12.8%        0.0%         24.4%        13.2%       |33.3%        49.8%        72.8%        18.0%        | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     1/6 (17%)    0/4 (0%)    |1/7 (14%)    2/5 (40%)    3/4 (75%)    0/2 (0%)     | 
|FIRST INCIDENCE    |     224          ---          246          284         |93           255          115          93           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.394      P=0.527N     P=0.533      P=0.740     |P=0.512      P=0.432      P=0.121      P=0.476N     | 
|POLY 3             |     P=0.424      P=0.513N     P=0.518      P=0.759     |P=0.578      P=0.425      P=0.116      P=0.489N     | 
|POLY 1.5           |     P=0.442      P=0.513N     P=0.515      P=0.763N    |P=0.434N     P=0.445      P=0.146      P=0.415N     | 
|POLY 6             |     P=0.383      P=0.507N     P=0.521      P=0.746     |P=0.412      P=0.411      P=0.096      P=0.566N     | 
|LOGISTIC REGRESSION|     P=0.428      P=0.491N     P=0.498      P=0.772     |P=0.232N     P=0.501      P=0.188      P=0.201N     | 
|COCH-ARM / FISHERS |     P=0.420      P=0.500N     P=0.500      P=0.763N    |P=0.212N     P=0.500      P=0.185      P=0.291N     | 
|ORDER RESTRICTED   |     P=0.381      (e)          (e)          (e)         |P=0.186N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/10 (50%)   5/10 (50%)   7/10 (70%)   4/10 (40%)  |10/10 (100%) 6/10 (60%)   7/10 (70%)   5/10 (50%)   | 
|POLY-3 RATE (b)    |     5/7.81       5/8.06       7/8.94       4/8.26      |10/10.00     6/8.04       7/8.24       5/6.94       | 
|POLY-3 PERCENT (g) |     64.0%        62.0%        78.3%        48.4%       |100.0%       74.6%        85.0%        72.1%        | 
|TERMINAL (d)       |     4/6 (67%)    4/7 (57%)    5/6 (83%)    2/4 (50%)   |7/7 (100%)   4/5 (80%)    4/4 (100%)   2/2 (100%)   | 
|FIRST INCIDENCE    |     224          192          188          218         |57           255          115          93           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.432      P=0.578N     P=0.366      P=0.642     |P=0.250      P=0.314N     P=0.640      P=0.540      | 
|POLY 3             |     P=0.374N     P=0.666N     P=0.459      P=0.449N    |P=0.155N     P=0.158N     P=0.350N     P=0.117N     | 
|POLY 1.5           |     P=0.370N     P=0.682      P=0.413      P=0.457N    |P=0.096N     P=0.112N     P=0.205N     P=0.058N     | 
|POLY 6             |     P=0.420N     P=0.616N     P=0.503      P=0.462N    |P=0.259N     P=0.188N     P=0.496N     P=0.221N     | 
|LOGISTIC REGRESSION|     P=0.388N     P=0.671      P=0.370      P=0.465N    |P=0.113N     P=0.035N*    P=0.100N     P=0.030N*    | 
|COCH-ARM / FISHERS |     P=0.452N     P=0.672N     P=0.325      P=0.500N    |P=0.052N     P=0.043N*    P=0.105N     P=0.016N*    | 
|ORDER RESTRICTED   |     P=0.321N     (e)          (e)          (e)         |P=0.069N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Fatty Change                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/10 (20%)   0/10 (0%)    1/10 (10%)   0/10 (0%)   |0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)    | 
|POLY-3 RATE (b)    |     2/7.25       0/7.33       1/7.78       0/7.49      |0/7.62       0/7.61       1/6.60       0/4.58       | 
|POLY-3 PERCENT (g) |     27.6%        0.0%         12.9%        0.0%        |0.0%         0.0%         15.2%        0.0%         | 
|TERMINAL (d)       |     2/6 (33%)    0/7 (0%)     1/6 (17%)    0/4 (0%)    |0/7 (0%)     0/5 (0%)     0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     295 (T)      ---          295 (T)      ---         |---          ---          287          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.335N     P=0.196N     P=0.500N     P=0.323N    |P=0.512      (e)          P=0.469      (e)          | 
|POLY 3             |     P=0.236N     P=0.217N     P=0.473N     P=0.211N    |P=0.478      (e)          P=0.471      (e)          | 
|POLY 1.5           |     P=0.229N     P=0.227N     P=0.480N     P=0.213N    |P=0.524      (e)          P=0.487      (e)          | 
|POLY 6             |     P=0.258N     P=0.200N     P=0.469N     P=0.218N    |P=0.430      (e)          P=0.459      (e)          | 
|LOGISTIC REGRESSION|     P=0.335N     (e)          P=0.500N     (e)         |P=0.569      (e)          P=0.462      (e)          | 
|COCH-ARM / FISHERS |     P=0.246N     P=0.237N     P=0.500N     P=0.237N    |P=0.650      (e)          P=0.500      (e)          | 
|ORDER RESTRICTED   |     P=0.056N     (e)          (e)          (e)         |P=0.380      (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/10 (50%)   6/10 (60%)   6/10 (60%)   3/10 (30%)  |7/10 (70%)   4/10 (40%)   4/10 (40%)   3/10 (30%)   | 
|POLY-3 RATE (b)    |     5/7.25       6/7.33       6/7.78       3/7.49      |7/7.62       4/7.69       4/7.46       3/5.28       | 
|POLY-3 PERCENT (g) |     69.0%        81.8%        77.1%        40.0%       |91.9%        52.0%        53.6%        56.9%        | 
|TERMINAL (d)       |     5/6 (83%)    6/7 (86%)    6/6 (100%)   3/4 (75%)   |7/7 (100%)   3/5 (60%)    3/4 (75%)    2/2 (100%)   | 
|FIRST INCIDENCE    |     295 (T)      295 (T)      295 (T)      295 (T)     |295 (T)      287          115          197          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.602N     P=0.735      P=0.500      P=0.677N    |P=0.317      P=0.421N     P=0.672N     P=0.443      | 
|POLY 3             |     P=0.082N     P=0.517      P=0.599      P=0.265N    |P=0.215N     P=0.099N     P=0.108N     P=0.171N     | 
|POLY 1.5           |     P=0.097N     P=0.469      P=0.566      P=0.279N    |P=0.157N     P=0.111N     P=0.099N     P=0.113N     | 
|POLY 6             |     P=0.096N     P=0.622      P=0.638      P=0.274N    |P=0.288N     P=0.091N     P=0.124N     P=0.277N     | 
|LOGISTIC REGRESSION|     P=0.602N     P=0.735      P=0.500      P=0.677N    |P=0.350N     P=0.152N     P=0.220N     P=0.454N     | 
|COCH-ARM / FISHERS |     P=0.178N     P=0.500      P=0.500      P=0.325N    |P=0.105N     P=0.185N     P=0.185N     P=0.089N     | 
|ORDER RESTRICTED   |     P=0.079N     (e)          (e)          (e)         |P=0.123N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/9 (22%)    0/10 (0%)    4/10 (40%)   1/7 (14%)   |2/9 (22%)    4/10 (40%)   2/10 (20%)   2/9 (22%)    | 
|POLY-3 RATE (b)    |     2/6.81       0/7.33       4/10.00      1/6.12      |2/8.58       4/7.96       2/7.30       2/6.48       | 
|POLY-3 PERCENT (g) |     29.4%        0.0%         40.0%        16.4%       |23.3%        50.3%        27.4%        30.9%        | 
|TERMINAL (d)       |     2/6 (33%)    0/7 (0%)     0/6 (0%)     0/3 (0%)    |1/7 (14%)    3/5 (60%)    0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     295 (T)      ---          144          218         |93           255          197          93           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.475      P=0.196N     P=0.390      P=0.633N    |P=0.492      P=0.233      P=0.626      P=0.593      | 
|POLY 3             |     P=0.515      P=0.201N     P=0.527      P=0.541N    |P=0.535N     P=0.268      P=0.644      P=0.597      | 
|POLY 1.5           |     P=0.505      P=0.206N     P=0.480      P=0.548N    |P=0.473N     P=0.282      P=0.672      P=0.642      | 
|POLY 6             |     P=0.477      P=0.192N     P=0.566      P=0.553N    |P=0.572      P=0.265      P=0.634      P=0.545      | 
|LOGISTIC REGRESSION|     P=0.343      (e)          P=0.340      P=0.582N    |P=0.300N     P=0.372      P=0.597N     P=0.318N     | 
|COCH-ARM / FISHERS |     P=0.400      P=0.211N     P=0.370      P=0.600N    |P=0.388N     P=0.370      P=0.667N     P=0.712N     | 
|ORDER RESTRICTED   |     P=0.397      (e)          (e)          (e)         |P=0.470      (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |2/2 (100%)   0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|POLY-3 RATE (b)    |     0/0.00       0/0.00       0/0.00       0/0.00      |2/2.00       0/0.00       0/0.00       0/0.00       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |100.0%       0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |2/2 (100%)   0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |295 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |1/10 (10%)   0/9 (0%)     1/10 (10%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |                                                        |1/7.62       0/7.60       1/6.52       2/5.27       | 
|POLY-3 PERCENT (g) |                                                        |13.1%        0.0%         15.4%        38.0%        | 
|TERMINAL (d)       |                                                        |1/7 (14%)    0/5 (0%)     1/4 (25%)    1/2 (50%)    | 
|FIRST INCIDENCE    |                                                        |295 (T)      ---          295 (T)      199          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.035 *    P=0.567N     P=0.638      P=0.180      | 
|POLY 3             |                                                        |P=0.123      P=0.500N     P=0.730      P=0.363      | 
|POLY 1.5           |                                                        |P=0.141      P=0.499N     P=0.750      P=0.408      | 
|POLY 6             |                                                        |P=0.111      P=0.506N     P=0.713      P=0.319      | 
|LOGISTIC REGRESSION|                                                        |P=0.103      (e)          P=0.638      P=0.374      | 
|COCH-ARM / FISHERS |                                                        |P=0.204      P=0.526N     P=0.763N     P=0.500      | 
|ORDER RESTRICTED   |                                                        |P=0.107      (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |1/10 (10%)   3/9 (33%)    1/10 (10%)   0/10 (0%)    | 
|POLY-3 RATE (b)    |                                                        |1/8.04       3/7.96       1/6.52       0/4.58       | 
|POLY-3 PERCENT (g) |                                                        |12.4%        37.7%        15.4%        0.0%         | 
|TERMINAL (d)       |                                                        |0/7 (0%)     2/5 (40%)    1/4 (25%)    0/2 (0%)     | 
|FIRST INCIDENCE    |                                                        |246          255          295 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.335N     P=0.257      P=0.664      P=0.638N     | 
|POLY 3             |                                                        |P=0.270N     P=0.281      P=0.716      P=0.605N     | 
|POLY 1.5           |                                                        |P=0.193N     P=0.286      P=0.743      P=0.568N     | 
|POLY 6             |                                                        |P=0.365N     P=0.269      P=0.690      P=0.641N     | 
|LOGISTIC REGRESSION|                                                        |P=0.193N     P=0.269      P=0.758      P=0.538N     | 
|COCH-ARM / FISHERS |                                                        |P=0.116N     P=0.249      P=0.763N     P=0.500N     | 
|ORDER RESTRICTED   |                                                        |P=0.258N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)   |3/10 (30%)   2/10 (20%)   0/9 (0%)     0/10 (0%)    | 
|POLY-3 RATE (b)    |     1/7.25       0/7.33       0/7.78       0/7.49      |3/8.04       2/7.61       0/6.32       0/4.58       | 
|POLY-3 PERCENT (g) |     13.8%        0.0%         0.0%         0.0%        |37.3%        26.3%        0.0%         0.0%         | 
|TERMINAL (d)       |     1/6 (17%)    0/7 (0%)     0/6 (0%)     0/4 (0%)    |2/7 (29%)    2/5 (40%)    0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     295 (T)      ---          ---          ---         |246          295 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.407N     P=0.469N     P=0.500N     P=0.581N    |P=0.109N     P=0.633N     P=0.210N     P=0.351N     | 
|POLY 3             |     P=0.349N     P=0.498N     P=0.486N     P=0.493N    |P=0.052N     P=0.529N     P=0.135N     P=0.223N     | 
|POLY 1.5           |     P=0.345N     P=0.505N     P=0.489N     P=0.492N    |P=0.039N*    P=0.509N     P=0.117N     P=0.163N     | 
|POLY 6             |     P=0.354N     P=0.484N     P=0.483N     P=0.501N    |P=0.067N     P=0.560N     P=0.155N     P=0.297N     | 
|LOGISTIC REGRESSION|     P=0.407N     (e)          (e)          (e)         |P=0.056N     P=0.500N     P=0.128N     P=0.188N     | 
|COCH-ARM / FISHERS |     P=0.350N     P=0.500N     P=0.500N     P=0.500N    |P=0.032N*    P=0.500N     P=0.124N     P=0.105N     | 
|ORDER RESTRICTED   |     P=0.112N     (e)          (e)          (e)         |P=0.101N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%)  |0/10 (0%)    0/10 (0%)    2/9 (22%)    6/10 (60%)   | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       0/7.78       2/7.89      |0/7.62       0/7.61       2/7.02       6/6.40       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         25.3%       |0.0%         0.0%         28.5%        93.8%        | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     0/4 (0%)    |0/7 (0%)     0/5 (0%)     1/4 (25%)    2/2 (100%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          263         |---          ---          197          188          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.037 *    (e)          (e)          P=0.236     |P<0.001 **   (e)          P=0.167      P<0.001 **   | 
|POLY 3             |     P=0.037 *    (e)          (e)          P=0.241     |P<0.001 **   (e)          P=0.200      P<0.001 **   | 
|POLY 1.5           |     P=0.038 *    (e)          (e)          P=0.238     |P<0.001 **   (e)          P=0.205      P<0.001 **   | 
|POLY 6             |     P=0.036 *    (e)          (e)          P=0.242     |P<0.001 **   (e)          P=0.198      P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.041 *    (e)          (e)          P=0.233     |P<0.001 **   (e)          P=0.204      P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.040 *    (e)          (e)          P=0.237     |P<0.001 **   (e)          P=0.211      P=0.005 **   | 
|ORDER RESTRICTED   |     P=0.027 *    (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland: Duct                                                                                                            | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/0 (0%)     2/2 (100%)   2/3 (67%)    1/1 (100%)  |                                                    | 
|POLY-3 RATE (b)    |     0/0.00       2/2.00       2/2.58       1/1.00      |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         100.0%       77.5%        100.0%      |                                                    | 
|TERMINAL (d)       |     0/0 (0%)     2/2 (100%)   2/2 (100%)   1/1 (100%)  |                                                    | 
|FIRST INCIDENCE    |     ---          295 (T)      295 (T)      295 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=1.000N     (e)          P=1.000      (e)         |                                                    | 
|POLY 3             |     (e)          (e)          (e)          (e)         |                                                    | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |                                                    | 
|POLY 6             |     (e)          (e)          (e)          (e)         |                                                    | 
|LOGISTIC REGRESSION|     (e)          (e)          P=1.000      (e)         |                                                    | 
|COCH-ARM / FISHERS |     P=0.764N     (e)          P=1.000      (e)         |                                                    | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/9 (33%)    4/9 (44%)    3/9 (33%)    1/8 (13%)   |5/6 (83%)    3/8 (38%)    2/8 (25%)    3/4 (75%)    | 
|POLY-3 RATE (b)    |     3/7.00       4/8.03       3/7.52       1/6.41      |5/6.00       3/7.49       2/5.46       3/4.00       | 
|POLY-3 PERCENT (g) |     42.9%        49.8%        39.9%        15.6%       |83.3%        40.1%        36.7%        75.0%        | 
|TERMINAL (d)       |     3/6 (50%)    3/7 (43%)    3/6 (50%)    1/3 (33%)   |5/6 (83%)    3/5 (60%)    2/3 (67%)    1/2 (50%)    | 
|FIRST INCIDENCE    |     295 (T)      192          295 (T)      295 (T)     |295 (T)      295 (T)      295 (T)      199          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.364N     P=0.586      P=0.710      P=0.588N    |P=0.206      P=0.430N     P=0.605N     P=0.374      | 
|POLY 3             |     P=0.154N     P=0.594      P=0.657N     P=0.311N    |P=0.587      P=0.134N     P=0.138N     P=0.668N     | 
|POLY 1.5           |     P=0.142N     P=0.553      P=0.661N     P=0.306N    |P=0.604      P=0.122N     P=0.081N     P=0.668N     | 
|POLY 6             |     P=0.196N     P=0.644      P=0.654N     P=0.341N    |P=0.593      P=0.156N     P=0.208N     P=0.668N     | 
|LOGISTIC REGRESSION|     P=0.145N     P=0.514      P=0.710      P=0.588N    |P=0.446      P=0.430N     P=0.605N     (e)          | 
|COCH-ARM / FISHERS |     P=0.158N     P=0.500      P=0.690N     P=0.335N    |P=0.568N     P=0.121N     P=0.051N     P=0.667N     | 
|ORDER RESTRICTED   |     P=0.210N     (e)          (e)          (e)         |P=0.233N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    1/10 (10%)   2/10 (20%)   0/10 (0%)   |3/10 (30%)   3/10 (30%)   6/10 (60%)   4/10 (40%)   | 
|POLY-3 RATE (b)    |     0/7.25       1/8.06       2/8.94       0/7.49      |3/8.04       3/8.04       6/8.24       4/7.19       | 
|POLY-3 PERCENT (g) |     0.0%         12.4%        22.4%        0.0%        |37.3%        37.3%        72.8%        55.7%        | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     0/4 (0%)    |2/7 (29%)    1/5 (20%)    3/4 (75%)    1/2 (50%)    | 
|FIRST INCIDENCE    |     ---          192          188          ---         |246          255          115          93           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.542N     P=0.500      P=0.285      (e)         |P=0.038 *    P=0.596      P=0.086      P=0.179      | 
|POLY 3             |     P=0.585N     P=0.521      P=0.276      (e)         |P=0.186      P=0.688N     P=0.169      P=0.422      | 
|POLY 1.5           |     P=0.577N     P=0.507      P=0.258      (e)         |P=0.239      P=0.682N     P=0.194      P=0.466      | 
|POLY 6             |     P=0.622N     P=0.540      P=0.296      (e)         |P=0.123      P=0.680      P=0.144      P=0.351      | 
|LOGISTIC REGRESSION|     P=0.654      P=0.529      P=0.184      (e)         |P=0.243      P=0.689N     P=0.166      P=0.503      | 
|COCH-ARM / FISHERS |     P=0.590N     P=0.500      P=0.237      (e)         |P=0.297      P=0.686N     P=0.185      P=0.500      | 
|ORDER RESTRICTED   |     P=0.346N     (e)          (e)          (e)         |P=0.229      (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/10 (20%)   2/10 (20%)   1/10 (10%)   2/10 (20%)  |1/10 (10%)   2/10 (20%)   1/10 (10%)   7/10 (70%)   | 
|POLY-3 RATE (b)    |     2/8.28       2/9.03       1/8.52       2/8.38      |1/8.59       2/7.69       1/6.60       7/9.06       | 
|POLY-3 PERCENT (g) |     24.2%        22.2%        11.7%        23.9%       |11.7%        26.0%        15.2%        77.3%        | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     0/4 (0%)    |0/7 (0%)     1/5 (20%)    0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |     224          93           188          218         |93           287          287          8            | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.510N     P=0.670      P=0.471N     P=0.655N    |P<0.001 **   P=0.461      P=0.755      P=0.013 *    | 
|POLY 3             |     P=0.571N     P=0.673N     P=0.489N     P=0.704N    |P<0.001 **   P=0.459      P=0.702      P=0.003 **   | 
|POLY 1.5           |     P=0.560N     P=0.685N     P=0.486N     P=0.697N    |P<0.001 **   P=0.470      P=0.727      P=0.003 **   | 
|POLY 6             |     P=0.592N     P=0.664N     P=0.501N     P=0.698     |P<0.001 **   P=0.450      P=0.685      P=0.003 **   | 
|LOGISTIC REGRESSION|     P=0.546      P=0.675N     P=0.558N     P=0.694     |P=0.006 **   P=0.496      P=0.773      P=0.022 *    | 
|COCH-ARM / FISHERS |     P=0.563N     P=0.709N     P=0.500N     P=0.709N    |P=0.003 **   P=0.500      P=0.763N     P=0.010 *    | 
|ORDER RESTRICTED   |     P=0.592N     (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/10 (40%)   2/10 (20%)   3/10 (30%)   5/10 (50%)  |5/10 (50%)   6/10 (60%)   4/10 (40%)   8/10 (80%)   | 
|POLY-3 RATE (b)    |     4/9.25       2/9.03       3/8.52       5/8.38      |5/9.58       6/8.57       4/7.30       8/9.06       | 
|POLY-3 PERCENT (g) |     43.3%        22.2%        35.2%        59.7%       |52.2%        70.0%        54.8%        88.3%        | 
|TERMINAL (d)       |     1/6 (17%)    0/7 (0%)     2/6 (33%)    3/4 (75%)   |3/7 (43%)    4/5 (80%)    2/4 (50%)    1/2 (50%)    | 
|FIRST INCIDENCE    |     93           93           188          218         |57           144          197          8            | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.207      P=0.354N     P=0.480N     P=0.414     |P=0.013 *    P=0.331      P=0.583      P=0.047 *    | 
|POLY 3             |     P=0.182      P=0.326N     P=0.553N     P=0.418     |P=0.103      P=0.386      P=0.643      P=0.106      | 
|POLY 1.5           |     P=0.208      P=0.333N     P=0.534N     P=0.447     |P=0.115      P=0.398      P=0.660N     P=0.112      | 
|POLY 6             |     P=0.149      P=0.317N     P=0.579N     P=0.376     |P=0.110      P=0.372      P=0.622      P=0.116      | 
|LOGISTIC REGRESSION|     P=0.193      P=0.231N     P=0.553N     P=0.482     |P=0.187      P=0.497      P=0.492N     P=0.303      | 
|COCH-ARM / FISHERS |     P=0.237      P=0.314N     P=0.500N     P=0.500     |P=0.175      P=0.500      P=0.500N     P=0.175      | 
|ORDER RESTRICTED   |     P=0.198      (e)          (e)          (e)         |P=0.057      (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Bilateral, Germinal Epithelium                                                                                           | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    3/10 (30%)   8/10 (80%)  |                                                    | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       3/8.52       8/8.48      |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         35.2%        94.3%       |                                                    | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     2/6 (33%)    4/4 (100%)  |                                                    | 
|FIRST INCIDENCE    |     ---          ---          188          246         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   (e)          P=0.124      P<0.001 **  |                                                    | 
|POLY 3             |     P<0.001 **   (e)          P=0.120      P<0.001 **  |                                                    | 
|POLY 1.5           |     P<0.001 **   (e)          P=0.112      P<0.001 **  |                                                    | 
|POLY 6             |     P<0.001 **   (e)          P=0.129      P<0.001 **  |                                                    | 
|LOGISTIC REGRESSION|     P<0.001 **   (e)          P=0.106      P<0.001 **  |                                                    | 
|COCH-ARM / FISHERS |     P<0.001 **   (e)          P=0.105      P<0.001 **  |                                                    | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   1/10 (10%)   5/10 (50%)   8/10 (80%)  |                                                    | 
|POLY-3 RATE (b)    |     1/7.72       1/7.33       5/8.70       8/8.48      |                                                    | 
|POLY-3 PERCENT (g) |     13.0%        13.6%        57.5%        94.3%       |                                                    | 
|TERMINAL (d)       |     0/6 (0%)     1/7 (14%)    3/6 (50%)    4/4 (100%)  |                                                    | 
|FIRST INCIDENCE    |     239          295 (T)      188          246         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.743N     P=0.115      P=0.008 **  |                                                    | 
|POLY 3             |     P<0.001 **   P=0.754      P=0.076      P<0.001 **  |                                                    | 
|POLY 1.5           |     P<0.001 **   P=0.751      P=0.071      P<0.001 **  |                                                    | 
|POLY 6             |     P<0.001 **   P=0.760      P=0.079      P<0.001 **  |                                                    | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.770      P=0.075      P=0.003 **  |                                                    | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.763N     P=0.070      P=0.003 **  |                                                    | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Interstitial Cell                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    3/10 (30%)  |                                                    | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       0/7.78       3/7.89      |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         38.0%       |                                                    | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     1/4 (25%)   |                                                    | 
|FIRST INCIDENCE    |     ---          ---          ---          263         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.006 **   (e)          (e)          P=0.099     |                                                    | 
|POLY 3             |     P=0.005 **   (e)          (e)          P=0.101     |                                                    | 
|POLY 1.5           |     P=0.005 **   (e)          (e)          P=0.100     |                                                    | 
|POLY 6             |     P=0.005 **   (e)          (e)          P=0.100     |                                                    | 
|LOGISTIC REGRESSION|     P=0.009 **   (e)          (e)          P=0.105     |                                                    | 
|COCH-ARM / FISHERS |     P=0.009 **   (e)          (e)          P=0.105     |                                                    | 
|ORDER RESTRICTED   |     P=0.004 **   (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/10 (50%)   1/10 (10%)   3/9 (33%)    6/9 (67%)   |2/10 (20%)   5/10 (50%)   6/10 (60%)   9/10 (90%)   | 
|POLY-3 RATE (b)    |     5/10.00      1/8.30       3/9.00       6/9.00      |2/9.58       5/9.00       6/9.30       9/9.30       | 
|POLY-3 PERCENT (g) |     50.0%        12.0%        33.3%        66.7%       |20.9%        55.5%        64.5%        96.8%        | 
|TERMINAL (d)       |     1/6 (17%)    0/7 (0%)     0/6 (0%)     0/3 (0%)    |0/7 (0%)     1/5 (20%)    1/4 (25%)    2/2 (100%)   | 
|FIRST INCIDENCE    |     93           93           144          127         |57           144          115          8            | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.201      P=0.120N     P=0.320N     P=0.497     |P<0.001 **   P=0.211      P=0.125      P=0.005 **   | 
|POLY 3             |     P=0.119      P=0.106N     P=0.398N     P=0.398     |P<0.001 **   P=0.141      P=0.061      P<0.001 **   | 
|POLY 1.5           |     P=0.107      P=0.093N     P=0.398N     P=0.398     |P<0.001 **   P=0.136      P=0.066      P<0.001 **   | 
|POLY 6             |     P=0.126      P=0.115N     P=0.398N     P=0.398     |P<0.001 **   P=0.150      P=0.061      P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.039 *    P=0.029N*    (e)          (e)         |P=0.007 **   P=0.145      P=0.086      P=0.008 **   | 
|COCH-ARM / FISHERS |     P=0.084      P=0.070N     P=0.395N     P=0.395     |P=0.003 **   P=0.175      P=0.085      P=0.003 **   | 
|ORDER RESTRICTED   |     P=0.089      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/10 (30%)   1/10 (10%)   0/9 (0%)     1/9 (11%)   |0/10 (0%)    0/10 (0%)    1/10 (10%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     3/7.25       1/7.33       0/6.96       1/6.60      |0/7.62       0/7.61       1/7.22       1/4.58       | 
|POLY-3 PERCENT (g) |     41.4%        13.6%        0.0%         15.2%       |0.0%         0.0%         13.9%        21.9%        | 
|TERMINAL (d)       |     3/6 (50%)    1/7 (14%)    0/6 (0%)     0/3 (0%)    |0/7 (0%)     0/5 (0%)     0/4 (0%)     1/2 (50%)    | 
|FIRST INCIDENCE    |     295 (T)      295 (T)      ---          284         |---          ---          197          295 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.376N     P=0.224N     P=0.101N     P=0.521N    |P=0.099      (e)          P=0.473      P=0.252      | 
|POLY 3             |     P=0.231N     P=0.274N     P=0.089N     P=0.314N    |P=0.133      (e)          P=0.489      P=0.401      | 
|POLY 1.5           |     P=0.227N     P=0.292N     P=0.096N     P=0.314N    |P=0.147      (e)          P=0.498      P=0.436      | 
|POLY 6             |     P=0.241N     P=0.246N     P=0.082N     P=0.329N    |P=0.126      (e)          P=0.483      P=0.365      | 
|LOGISTIC REGRESSION|     P=0.290N     P=0.224N     (e)          P=0.415N    |P=0.175      (e)          P=0.496      P=0.252      | 
|COCH-ARM / FISHERS |     P=0.247N     P=0.291N     P=0.124N     P=0.333N    |P=0.203      (e)          P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.071N     (e)          (e)          (e)         |P=0.165      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    4/9 (44%)   |0/10 (0%)    2/9 (22%)    7/10 (70%)   8/10 (80%)   | 
|POLY-3 RATE (b)    |     0/7.25       0/7.33       0/7.78       4/7.98      |0/7.62       2/7.68       7/8.18       8/8.06       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         50.1%       |0.0%         26.0%        85.6%        99.3%        | 
|TERMINAL (d)       |     0/6 (0%)     0/7 (0%)     0/6 (0%)     1/4 (25%)   |0/7 (0%)     1/5 (20%)    4/4 (100%)   2/2 (100%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          263         |---          287          144          93           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.002 **   (e)          (e)          P=0.053     |P<0.001 **   P=0.203      P<0.001 **   P<0.001 **   | 
|POLY 3             |     P<0.001 **   (e)          (e)          P=0.034 *   |P<0.001 **   P=0.223      P<0.001 **   P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   (e)          (e)          P=0.030 *   |P<0.001 **   P=0.225      P<0.001 **   P<0.001 **   | 
|POLY 6             |     P<0.001 **   (e)          (e)          P=0.037 *   |P<0.001 **   P=0.218      P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.002 **   (e)          (e)          P=0.044 *   |P<0.001 **   P=0.218      P=0.002 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P<0.001 **   (e)          (e)          P=0.033 *   |P<0.001 **   P=0.211      P=0.002 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Depletion Secretory                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/10 (30%)   4/10 (40%)   4/10 (40%)   7/9 (78%)   |1/10 (10%)   8/9 (89%)    9/10 (90%)   10/10 (100%) | 
|POLY-3 RATE (b)    |     3/7.81       4/8.06       4/8.38       7/7.98      |1/7.62       8/8.92       9/9.20       10/10.00     | 
|POLY-3 PERCENT (g) |     38.4%        49.6%        47.8%        87.7%       |13.1%        89.7%        97.8%        100.0%       | 
|TERMINAL (d)       |     2/6 (33%)    3/7 (43%)    2/6 (33%)    4/4 (100%)  |1/7 (14%)    5/5 (100%)   4/4 (100%)   2/2 (100%)   | 
|FIRST INCIDENCE    |     224          192          246          263         |295 (T)      144          115          8            | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.026 *    P=0.555      P=0.536      P=0.050     |P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 **   | 
|POLY 3             |     P=0.034 *    P=0.521      P=0.547      P=0.042 *   |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 1.5           |     P=0.037 *    P=0.495      P=0.534      P=0.046 *   |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 6             |     P=0.027 *    P=0.558      P=0.565      P=0.032 *   |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.053      P=0.489      P=0.536      P=0.078     |P<0.001 **   P=0.002 **   P<0.001 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.032 *    P=0.500      P=0.500      P=0.051     |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P=0.029 *    (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    6/10 (60%)   8/10 (80%)   8/9 (89%)   |0/10 (0%)    8/9 (89%)    10/10 (100%) 10/10 (100%) | 
|POLY-3 RATE (b)    |     0/7.25       6/8.31       8/8.38       8/8.40      |0/7.62       8/8.12       10/10.00     10/10.00     | 
|POLY-3 PERCENT (g) |     0.0%         72.2%        95.5%        95.2%       |0.0%         98.6%        100.0%       100.0%       | 
|TERMINAL (d)       |     0/6 (0%)     5/7 (71%)    6/6 (100%)   4/4 (100%)  |0/7 (0%)     5/5 (100%)   4/4 (100%)   2/2 (100%)   | 
|FIRST INCIDENCE    |     ---          89           246          246         |---          255          115          8            | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.013 *    P=0.002 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 3             |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 6             |     P<0.001 **   P=0.002 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.007 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.005 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 94                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 43 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/10 (0%)    3/10 (30%)   0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |                                                        |0/7.62       3/7.96       0/6.52       0/4.58       | 
|POLY-3 PERCENT (g) |                                                        |0.0%         37.7%        0.0%         0.0%         | 
|TERMINAL (d)       |                                                        |0/7 (0%)     2/5 (40%)    0/4 (0%)     0/2 (0%)     | 
|FIRST INCIDENCE    |                                                        |---          255          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.323N     P=0.086      (e)          (e)          | 
|POLY 3             |                                                        |P=0.229N     P=0.096      (e)          (e)          | 
|POLY 1.5           |                                                        |P=0.180N     P=0.095      (e)          (e)          | 
|POLY 6             |                                                        |P=0.288N     P=0.096      (e)          (e)          | 
|LOGISTIC REGRESSION|                                                        |P=0.232N     P=0.102      (e)          (e)          | 
|COCH-ARM / FISHERS |                                                        |P=0.161N     P=0.105      (e)          (e)          | 
|ORDER RESTRICTED   |                                                        |P=0.250N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |8/10 (80%)   7/10 (70%)   5/10 (50%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |                                                        |8/8.04       7/8.12       5/7.48       2/5.27       | 
|POLY-3 PERCENT (g) |                                                        |99.5%        86.2%        66.9%        38.0%        | 
|TERMINAL (d)       |                                                        |7/7 (100%)   4/5 (80%)    3/4 (75%)    1/2 (50%)    | 
|FIRST INCIDENCE    |                                                        |246          255          144          199          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.353N     P=0.542      P=0.674N     P=0.502N     | 
|POLY 3             |                                                        |P=0.005N**   P=0.470N     P=0.111N     P=0.008N**   | 
|POLY 1.5           |                                                        |P<0.001N**   P=0.455N     P=0.079N     P=0.002N**   | 
|POLY 6             |                                                        |P=0.019N*    P=0.495N     P=0.178N     P=0.029N*    | 
|LOGISTIC REGRESSION|                                                        |P=0.015N*    P=0.465N     P=0.190N     P=0.040N*    | 
|COCH-ARM / FISHERS |                                                        |P=0.003N**   P=0.500N     P=0.175N     P=0.012N*    | 
|ORDER RESTRICTED   |                                                        |P=0.004N**   (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).