Share This:
https://ntp.niehs.nih.gov/go/17047

TDMS Study 96021-01 Pathology Tables


NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 10/09/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 12:01:34       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                    FINAL #3 CONTROL VS. TREATED                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 UG/KG                                                                       
                                       INCLUDE 002    10 UG/KG                                                                      
                                       INCLUDE 003    100     UG/KG                                                                 
                                       INCLUDE 004    300     UG/KG                                                                 
                                       INCLUDE 005    1000    UG/KG                                                                 
                                       INCLUDE 006    3000    UG/KG                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 10/09/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 12:01:34       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF      TOXIC EQUIVALENCY FACTOR EVALUATION (                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Angiectasis                                                                                  
                                       Hematopoietic Cell Proliferation                                                             
                                       Hyperplasia                                                                                  
                                       Hypertrophy                                                                                  
Bone Marrow                            Hyperplasia                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Clitoral Gland: Duct                   Cyst                                                                                         
Harderian Gland                        Inflammation                                                                                 
Heart                                  Cardiomyopathy                                                                               
Intestine Large, Rectum                Parasite Metazoan                                                                            
Kidney                                 Mineralization                                                                               
                                       Nephropathy                                                                                  
Liver                                  Basophilic Focus                                                                             
                                       Clear Cell Focus                                                                             
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Mixed Cell Focus                                                                             
                                       Pigmentation                                                                                 
Liver: Bile Duct                       Hyperplasia                                                                                  
Liver: Centrilobular                   Degeneration                                                                                 
Liver: Hepatocyte                      Hypertrophy                                                                                  
Liver: Oval Cell                       Hyperplasia                                                                                  
Lung                                   Infiltration Cellular Histiocyte                                                             
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
Lymph Node, Mandibular                 Hyperplasia                                                                                  
Lymph Node: Mediastinal                Congestion                                                                                   
                                       Ectasia                                                                                      
                                       Hyperplasia                                                                                  
Lymph Node: Renal                      Ectasia                                                                                      
Mammary Gland                          Hyperplasia                                                                                  
Nose                                   Inflammation                                                                                 
Nose: Turbinate                        Inflammation                                                                                 
Oral Mucosa: Gingival                  Hyperplasia                                                                                  
Ovary                                  Atrophy                                                                                      
                                       Inflammation Chronic                                                                         
Oviduct                                Inflammation Chronic                                                                         
Pancreas: Acinus                       Hyperplasia                                                                                  
                                       Vacuolization Cytoplasmic                                                                    
Pituitary Gland                        Angiectasis                                                                                  
Spleen                                 Hematopoietic Cell Proliferation                                                             
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Stomach, Forestomach                   Hyperkeratosis                                                                               
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
Tooth: Peridontal Tissue               Inflammation                                                                                 
Uterus                                 Inflammation                                                                                 
                                       Inflammation Chronic                                                                         
                                       Metaplasia                                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 10/09/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 12:01:34       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
===============================================================                                                                     
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (        
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        21/53 (40%)      23/54 (43%)      34/53 (64%)      25/53 (47%)      29/53 (55%)      21/51 (41%)     | 
|POLY-3 RATE (b)    |        21/42.96         23/34.81         34/45.38         25/39.94         29/42.63         21/35.81        | 
|POLY-3 PERCENT (g) |        48.9%            66.1%            74.9%            62.6%            68.0%            58.7%           | 
|TERMINAL (d)       |        12/24 (50%)      13/16 (81%)      24/28 (86%)      16/21 (76%)      15/20 (75%)      15/21 (71%)     | 
|FIRST INCIDENCE    |        502              360              429              443              514              452             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.376N         P=0.050          P=0.058          P=0.152          P=0.051          P=0.314         | 
|POLY 3             |        P=0.420N         P=0.084          P=0.006 **       P=0.137          P=0.046 *        P=0.251         | 
|POLY 1.5           |        P=0.332N         P=0.184          P=0.007 **       P=0.170          P=0.059          P=0.350         | 
|POLY 6             |        P=0.541N         P=0.033 *        P=0.006 **       P=0.109          P=0.039 *        P=0.164         | 
|LOGISTIC REGRESSION|        P=0.388N         P=0.095          P=0.012 *        P=0.171          P=0.062          P=0.293         | 
|COCH-ARM / FISHERS |        P=0.269N         P=0.454          P=0.010 *        P=0.278          P=0.086          P=0.515         | 
|ORDER RESTRICTED   |        P=0.061          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        1/53 (2%)        2/53 (4%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          1/36.33          2/38.40          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             2.8%             5.2%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        1/21 (5%)        1/20 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              731 (T)          715              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.679          (e)              (e)              P=0.473          P=0.215          (e)             | 
|POLY 3             |        P=0.639          (e)              (e)              P=0.486          P=0.233          (e)             | 
|POLY 1.5           |        P=0.655          (e)              (e)              P=0.488          P=0.235          (e)             | 
|POLY 6             |        P=0.624          (e)              (e)              P=0.485          P=0.230          (e)             | 
|LOGISTIC REGRESSION|        P=0.674          (e)              (e)              P=0.473          P=0.223          (e)             | 
|COCH-ARM / FISHERS |        P=0.681          (e)              (e)              P=0.500          P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.280          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/53 (17%)       12/54 (22%)      15/53 (28%)      13/53 (25%)      12/53 (23%)      13/51 (25%)     | 
|POLY-3 RATE (b)    |        9/40.67          12/33.09         15/41.93         13/38.58         12/40.17         13/36.59        | 
|POLY-3 PERCENT (g) |        22.1%            36.3%            35.8%            33.7%            29.9%            35.5%           | 
|TERMINAL (d)       |        5/24 (21%)       6/16 (38%)       13/28 (46%)      6/21 (29%)       5/20 (25%)       6/21 (29%)      | 
|FIRST INCIDENCE    |        437              527              591              530              617              479             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.318          P=0.088          P=0.212          P=0.179          P=0.250          P=0.136         | 
|POLY 3             |        P=0.363          P=0.137          P=0.125          P=0.180          P=0.292          P=0.142         | 
|POLY 1.5           |        P=0.372          P=0.191          P=0.124          P=0.187          P=0.301          P=0.158         | 
|POLY 6             |        P=0.366          P=0.102          P=0.134          P=0.185          P=0.289          P=0.139         | 
|LOGISTIC REGRESSION|        P=0.307          P=0.134          P=0.156          P=0.184          P=0.295          P=0.152         | 
|COCH-ARM / FISHERS |        P=0.384          P=0.331          P=0.123          P=0.237          P=0.313          P=0.206         | 
|ORDER RESTRICTED   |        P=0.169          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        0/53 (0%)        1/53 (2%)        0/53 (0%)        3/51 (6%)       | 
|POLY-3 RATE (b)    |        0/39.01          1/31.63          0/41.12          1/36.95          0/38.33          3/34.54         | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             0.0%             2.7%             0.0%             8.7%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              527              ---              530              ---              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.016 *        P=0.450          (e)              P=0.477          (e)              P=0.097         | 
|POLY 3             |        P=0.018 *        P=0.458          (e)              P=0.489          (e)              P=0.097         | 
|POLY 1.5           |        P=0.019 *        P=0.473          (e)              P=0.490          (e)              P=0.101         | 
|POLY 6             |        P=0.017 *        P=0.447          (e)              P=0.490          (e)              P=0.096         | 
|LOGISTIC REGRESSION|        P=0.026 *        P=0.562          (e)              P=0.540          (e)              P=0.129         | 
|COCH-ARM / FISHERS |        P=0.022 *        P=0.505          (e)              P=0.500          (e)              P=0.114         | 
|ORDER RESTRICTED   |        P=0.009 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/53 (34%)      24/54 (44%)      27/53 (51%)      27/53 (51%)      28/53 (53%)      11/51 (22%)     | 
|POLY-3 RATE (b)    |        18/42.09         24/37.35         27/43.51         27/42.98         28/44.72         11/34.55        | 
|POLY-3 PERCENT (g) |        42.8%            64.3%            62.1%            62.8%            62.6%            31.8%           | 
|TERMINAL (d)       |        11/24 (46%)      11/16 (69%)      20/28 (71%)      13/21 (62%)      10/20 (50%)      8/21 (38%)      | 
|FIRST INCIDENCE    |        418              310              514              269              452              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.016N*        P=0.012 *        P=0.159          P=0.035 *        P=0.033 *        P=0.207N        | 
|POLY 3             |        P=0.011N*        P=0.035 *        P=0.048 *        P=0.042 *        P=0.042 *        P=0.222N        | 
|POLY 1.5           |        P=0.006N**       P=0.064          P=0.051          P=0.039 *        P=0.038 *        P=0.175N        | 
|POLY 6             |        P=0.021N*        P=0.023 *        P=0.051          P=0.053          P=0.055          P=0.279N        | 
|LOGISTIC REGRESSION|        P=0.006N**       P=0.039 *        P=0.075          P=0.034 *        P=0.033 *        P=0.198N        | 
|COCH-ARM / FISHERS |        P=0.005N**       P=0.181          P=0.058          P=0.058          P=0.039 *        P=0.117N        | 
|ORDER RESTRICTED   |        P=0.010N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        48/53 (91%)      35/54 (65%)      45/53 (85%)      35/53 (66%)      42/53 (79%)      41/51 (80%)     | 
|POLY-3 RATE (b)    |        48/49.83         35/42.29         45/48.98         35/43.86         42/46.92         41/44.17        | 
|POLY-3 PERCENT (g) |        96.3%            82.8%            91.9%            79.8%            89.5%            92.8%           | 
|TERMINAL (d)       |        24/24 (100%)     15/16 (94%)      28/28 (100%)     18/21 (86%)      20/20 (100%)     20/21 (95%)     | 
|FIRST INCIDENCE    |        211              250              418              443              341              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.265          P=0.547          P=0.121N         P=0.116N         P=0.465N         P=0.538         | 
|POLY 3             |        P=0.291          P=0.009N**       P=0.250N         P=0.004N**       P=0.114N         P=0.342N        | 
|POLY 1.5           |        P=0.316          P=0.003N**       P=0.249N         P=0.004N**       P=0.095N         P=0.237N        | 
|POLY 6             |        P=0.296          P=0.027N*        P=0.299N         P=0.005N**       P=0.170N         P=0.478N        | 
|LOGISTIC REGRESSION|        P=0.272          P=0.016N*        P=0.181N         P=0.005N**       P=0.069N         P=0.288N        | 
|COCH-ARM / FISHERS |        P=0.369          P<0.001N**       P=0.278N         P=0.002N**       P=0.087N         P=0.115N        | 
|ORDER RESTRICTED   |        P=0.066N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        2/53 (4%)        1/53 (2%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          2/37.08          1/39.07          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.4%             2.6%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              568              467              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.619N         (e)              (e)              P=0.232          P=0.508          (e)             | 
|POLY 3             |        P=0.615N         (e)              (e)              P=0.225          P=0.500          (e)             | 
|POLY 1.5           |        P=0.608N         (e)              (e)              P=0.226          P=0.501          (e)             | 
|POLY 6             |        P=0.621N         (e)              (e)              P=0.227          P=0.499          (e)             | 
|LOGISTIC REGRESSION|        P=0.588N         (e)              (e)              P=0.238          P=0.466          (e)             | 
|COCH-ARM / FISHERS |        P=0.596N         (e)              (e)              P=0.248          P=0.500          (e)             | 
|ORDER RESTRICTED   |        P=0.287          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/54 (4%)        1/53 (2%)        2/53 (4%)        3/53 (6%)        3/51 (6%)       | 
|POLY-3 RATE (b)    |        1/39.58          2/31.01          1/41.24          2/37.08          3/40.06          3/33.85         | 
|POLY-3 PERCENT (g) |        2.5%             6.5%             2.4%             5.4%             7.5%             8.9%            | 
|TERMINAL (d)       |        0/24 (0%)        2/16 (13%)       0/28 (0%)        0/21 (0%)        0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        551              731 (T)          700              568              467              486             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.174          P=0.368          P=0.751N         P=0.476          P=0.304          P=0.250         | 
|POLY 3             |        P=0.162          P=0.416          P=0.752N         P=0.477          P=0.309          P=0.250         | 
|POLY 1.5           |        P=0.175          P=0.447          P=0.755N         P=0.480          P=0.308          P=0.264         | 
|POLY 6             |        P=0.150          P=0.388          P=0.746N         P=0.478          P=0.308          P=0.240         | 
|LOGISTIC REGRESSION|        P=0.192          P=0.426          P=0.756          P=0.517          P=0.289          P=0.289         | 
|COCH-ARM / FISHERS |        P=0.194          P=0.507          P=0.752N         P=0.500          P=0.309          P=0.294         | 
|ORDER RESTRICTED   |        P=0.204          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/53 (19%)      8/54 (15%)       14/53 (26%)      16/53 (30%)      12/53 (23%)      14/51 (27%)     | 
|POLY-3 RATE (b)    |        10/39.40         8/33.44          14/41.49         16/40.22         12/40.57         14/35.63        | 
|POLY-3 PERCENT (g) |        25.4%            23.9%            33.7%            39.8%            29.6%            39.3%           | 
|TERMINAL (d)       |        8/24 (33%)       2/16 (13%)       11/28 (39%)      6/21 (29%)       4/20 (20%)       9/21 (43%)      | 
|FIRST INCIDENCE    |        656              261              696              486              510              432             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.182          P=0.480          P=0.396          P=0.092          P=0.309          P=0.137         | 
|POLY 3             |        P=0.191          P=0.552N         P=0.277          P=0.123          P=0.432          P=0.141         | 
|POLY 1.5           |        P=0.206          P=0.496N         P=0.263          P=0.111          P=0.420          P=0.162         | 
|POLY 6             |        P=0.176          P=0.589N         P=0.308          P=0.156          P=0.456          P=0.131         | 
|LOGISTIC REGRESSION|        P=0.160          P=0.603N         P=0.369          P=0.087          P=0.375          P=0.105         | 
|COCH-ARM / FISHERS |        P=0.221          P=0.382N         P=0.243          P=0.129          P=0.406          P=0.210         | 
|ORDER RESTRICTED   |        P=0.144          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/53 (34%)      14/54 (26%)      19/53 (36%)      14/53 (26%)      20/53 (38%)      12/51 (24%)     | 
|POLY-3 RATE (b)    |        18/41.52         14/34.65         19/45.35         14/39.63         20/41.42         12/34.21        | 
|POLY-3 PERCENT (g) |        43.4%            40.4%            41.9%            35.3%            48.3%            35.1%           | 
|TERMINAL (d)       |        11/24 (46%)      7/16 (44%)       11/28 (39%)      6/21 (29%)       10/20 (50%)      9/21 (43%)      | 
|FIRST INCIDENCE    |        502              479              443              452              590              514             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.310N         P=0.463          P=0.489N         P=0.386N         P=0.287          P=0.287N        | 
|POLY 3             |        P=0.373N         P=0.489N         P=0.533N         P=0.300N         P=0.406          P=0.305N        | 
|POLY 1.5           |        P=0.298N         P=0.403N         P=0.581N         P=0.303N         P=0.411          P=0.247N        | 
|POLY 6             |        P=0.463N         P=0.555N         P=0.471N         P=0.283N         P=0.415          P=0.365N        | 
|LOGISTIC REGRESSION|        P=0.278N         P=0.530N         P=0.543          P=0.330N         P=0.384          P=0.302N        | 
|COCH-ARM / FISHERS |        P=0.228N         P=0.243N         P=0.500          P=0.263N         P=0.420          P=0.169N        | 
|ORDER RESTRICTED   |        P=0.424N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Blood Vessel: Aorta                                                                                                              | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/52 (4%)        1/54 (2%)        0/53 (0%)        1/53 (2%)        1/53 (2%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        2/39.69          1/31.45          0/41.12          1/36.86          1/39.07          0/33.11         | 
|POLY-3 PERCENT (g) |        5.0%             3.2%             0.0%             2.7%             2.6%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        551              600              ---              568              467              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.314N         P=0.615N         P=0.240N         P=0.532N         P=0.513N         P=0.302N        | 
|POLY 3             |        P=0.309N         P=0.580N         P=0.229N         P=0.526N         P=0.506N         P=0.279N        | 
|POLY 1.5           |        P=0.300N         P=0.548N         P=0.230N         P=0.518N         P=0.499N         P=0.265N        | 
|POLY 6             |        P=0.319N         P=0.608N         P=0.225N         P=0.531N         P=0.515N         P=0.291N        | 
|LOGISTIC REGRESSION|        P=0.284N         P=0.474N         P=0.246N         P=0.464N         P=0.495N         P=0.223N        | 
|COCH-ARM / FISHERS |        P=0.291N         P=0.486N         P=0.243N         P=0.493N         P=0.493N         P=0.252N        | 
|ORDER RESTRICTED   |        P=0.129N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        34/53 (64%)      41/54 (76%)      40/53 (75%)      38/53 (72%)      42/53 (79%)      46/51 (90%)     | 
|POLY-3 RATE (b)    |        34/49.96         41/52.65         40/52.69         38/50.69         42/51.29         46/51.00        | 
|POLY-3 PERCENT (g) |        68.1%            77.9%            75.9%            75.0%            81.9%            90.2%           | 
|TERMINAL (d)       |        11/24 (46%)      6/16 (38%)       17/28 (61%)      12/21 (57%)      13/20 (65%)      16/21 (76%)     | 
|FIRST INCIDENCE    |        399              250              418              59               341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.033 *        P=0.025 *        P=0.427          P=0.213          P=0.114          P=0.013 *       | 
|POLY 3             |        P=0.006 **       P=0.180          P=0.250          P=0.288          P=0.077          P=0.004 **      | 
|POLY 1.5           |        P=0.005 **       P=0.162          P=0.211          P=0.287          P=0.074          P=0.003 **      | 
|POLY 6             |        P=0.009 **       P=0.210          P=0.299          P=0.289          P=0.084          P=0.008 **      | 
|LOGISTIC REGRESSION|        P=0.004 **       P=0.397          P=0.097          P=0.339          P=0.067          P=0.004 **      | 
|COCH-ARM / FISHERS |        P=0.003 **       P=0.132          P=0.145          P=0.266          P=0.065          P<0.001 **      | 
|ORDER RESTRICTED   |        P=0.004 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        1/53 (2%)        1/53 (2%)        2/53 (4%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        1/39.53          0/31.01          1/41.24          1/36.64          2/38.74          0/33.11         | 
|POLY-3 PERCENT (g) |        2.5%             0.0%             2.4%             2.7%             5.2%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        571              ---              700              647              636              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.489N         P=0.556N         P=0.743N         P=0.750          P=0.492          P=0.549N        | 
|POLY 3             |        P=0.478N         P=0.548N         P=0.752N         P=0.744          P=0.493          P=0.535N        | 
|POLY 1.5           |        P=0.471N         P=0.530N         P=0.755N         P=0.747          P=0.497          P=0.525N        | 
|POLY 6             |        P=0.485N         P=0.564N         P=0.745N         P=0.743          P=0.488          P=0.543N        | 
|LOGISTIC REGRESSION|        P=0.475N         P=0.471N         P=0.759          P=0.758N         P=0.500          P=0.485N        | 
|COCH-ARM / FISHERS |        P=0.467N         P=0.495N         P=0.752N         P=0.752N         P=0.500          P=0.510N        | 
|ORDER RESTRICTED   |        P=0.414N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Hydrocephalus                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        2/53 (4%)        1/53 (2%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          2/37.11          1/38.71          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.4%             2.6%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              443              625              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.610N         (e)              (e)              P=0.225          P=0.506          (e)             | 
|POLY 3             |        P=0.615N         (e)              (e)              P=0.225          P=0.498          (e)             | 
|POLY 1.5           |        P=0.608N         (e)              (e)              P=0.227          P=0.500          (e)             | 
|POLY 6             |        P=0.622N         (e)              (e)              P=0.226          P=0.497          (e)             | 
|LOGISTIC REGRESSION|        P=0.593N         (e)              (e)              P=0.250          P=0.500          (e)             | 
|COCH-ARM / FISHERS |        P=0.596N         (e)              (e)              P=0.248          P=0.500          (e)             | 
|ORDER RESTRICTED   |        P=0.286          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        52/53 (98%)      45/51 (88%)      41/52 (79%)      48/53 (91%)      48/51 (94%)      46/50 (92%)     | 
|POLY-3 RATE (b)    |        52/52.22         45/47.19         41/47.75         48/50.33         48/49.57         46/47.75        | 
|POLY-3 PERCENT (g) |        99.6%            95.4%            85.9%            95.4%            96.8%            96.3%           | 
|TERMINAL (d)       |        24/24 (100%)     14/14 (100%)     23/27 (85%)      21/21 (100%)     20/20 (100%)     21/21 (100%)    | 
|FIRST INCIDENCE    |        211              250              418              59               341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.320          P=0.119          P=0.020N*        P=0.513          P=0.524          P=0.439         | 
|POLY 3             |        P=0.340          P=0.149N         P=0.004N**       P=0.190N         P=0.353N         P=0.270N        | 
|POLY 1.5           |        P=0.329          P=0.078N         P=0.002N**       P=0.161N         P=0.303N         P=0.195N        | 
|POLY 6             |        P=0.333          P=0.449N         P=0.012N*        P=0.241N         P=0.487N         P=0.516N        | 
|LOGISTIC REGRESSION|        P=0.283          P=0.122N         P<0.001N**       P=0.167N         P=0.277N         P=0.223N        | 
|COCH-ARM / FISHERS |        P=0.300          P=0.050N         P=0.002N**       P=0.103N         P=0.294N         P=0.164N        | 
|ORDER RESTRICTED   |        P=0.077N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        49/53 (92%)      40/51 (78%)      36/52 (69%)      43/53 (81%)      45/51 (88%)      41/50 (82%)     | 
|POLY-3 RATE (b)    |        49/52.16         40/45.70         36/47.08         43/48.32         45/49.57         41/47.01        | 
|POLY-3 PERCENT (g) |        93.9%            87.5%            76.5%            89.0%            90.8%            87.2%           | 
|TERMINAL (d)       |        22/24 (92%)      11/14 (79%)      20/27 (74%)      20/21 (95%)      18/20 (90%)      17/21 (81%)     | 
|FIRST INCIDENCE    |        211              250              429              59               341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.371          P=0.247          P=0.012N*        P=0.467N         P=0.550          P=0.522N        | 
|POLY 3             |        P=0.542          P=0.203N         P=0.008N**       P=0.275N         P=0.403N         P=0.193N        | 
|POLY 1.5           |        P=0.496          P=0.113N         P=0.004N**       P=0.182N         P=0.375N         P=0.149N        | 
|POLY 6             |        P=0.563N         P=0.320N         P=0.017N*        P=0.424N         P=0.453N         P=0.239N        | 
|LOGISTIC REGRESSION|        P=0.409          P=0.049N*        P=0.002N**       P=0.094N         P=0.343N         P=0.091N        | 
|COCH-ARM / FISHERS |        P=0.417          P=0.039N*        P=0.002N**       P=0.075N         P=0.346N         P=0.096N        | 
|ORDER RESTRICTED   |        P=0.150N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Muscularis                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        3/54 (6%)        0/53 (0%)        1/53 (2%)        2/53 (4%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/39.01          3/32.98          0/41.12          1/37.10          2/39.22          1/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             9.1%             0.0%             2.7%             5.1%             3.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        ---              310              ---              452              579              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.577          P=0.097          (e)              P=0.496          P=0.246          P=0.473         | 
|POLY 3             |        P=0.518          P=0.091          (e)              P=0.490          P=0.238          P=0.467         | 
|POLY 1.5           |        P=0.548          P=0.100          (e)              P=0.491          P=0.238          P=0.476         | 
|POLY 6             |        P=0.491          P=0.084          (e)              P=0.491          P=0.238          P=0.461         | 
|LOGISTIC REGRESSION|        P=0.613          P=0.203          (e)              P=0.583          P=0.237          P=0.473         | 
|COCH-ARM / FISHERS |        P=0.600          P=0.125          (e)              P=0.500          P=0.248          P=0.490         | 
|ORDER RESTRICTED   |        P=0.287          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        1/53 (2%)        0/53 (0%)        1/52 (2%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        2/39.23          0/31.01          1/41.23          0/36.33          1/37.78          0/33.11         | 
|POLY-3 PERCENT (g) |        5.1%             0.0%             2.4%             0.0%             2.7%             0.0%            | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        672              ---              701              ---              696              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.373N         P=0.328N         P=0.437N         P=0.254N         P=0.529N         P=0.276N        | 
|POLY 3             |        P=0.341N         P=0.293N         P=0.483N         P=0.254N         P=0.513N         P=0.276N        | 
|POLY 1.5           |        P=0.344N         P=0.271N         P=0.489N         P=0.251N         P=0.510N         P=0.265N        | 
|POLY 6             |        P=0.341N         P=0.313N         P=0.471N         P=0.256N         P=0.518N         P=0.284N        | 
|LOGISTIC REGRESSION|        P=0.371N         P=0.306N         P=0.474N         P=0.254N         P=0.516N         P=0.278N        | 
|COCH-ARM / FISHERS |        P=0.357N         P=0.243N         P=0.500N         P=0.248N         P=0.507N         P=0.257N        | 
|ORDER RESTRICTED   |        P=0.088N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        20/53 (38%)      9/54 (17%)       13/53 (25%)      16/53 (30%)      16/53 (30%)      16/49 (33%)     | 
|POLY-3 RATE (b)    |        20/42.61         9/32.73          13/41.57         16/40.05         16/41.33         16/35.66        | 
|POLY-3 PERCENT (g) |        46.9%            27.5%            31.3%            40.0%            38.7%            44.9%           | 
|TERMINAL (d)       |        11/24 (46%)      5/16 (31%)       10/28 (36%)      9/21 (43%)       10/20 (50%)      10/21 (48%)     | 
|FIRST INCIDENCE    |        211              557              674              269              360              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.238          P=0.144N         P=0.046N*        P=0.410N         P=0.423N         P=0.478N        | 
|POLY 3             |        P=0.242          P=0.064N         P=0.098N         P=0.333N         P=0.288N         P=0.518N        | 
|POLY 1.5           |        P=0.248          P=0.037N*        P=0.100N         P=0.328N         P=0.279N         P=0.472N        | 
|POLY 6             |        P=0.236          P=0.097N         P=0.093N         P=0.331N         P=0.309N         P=0.552N        | 
|LOGISTIC REGRESSION|        P=0.195          P=0.050N         P=0.071N         P=0.323N         P=0.276N         P=0.475N        | 
|COCH-ARM / FISHERS |        P=0.243          P=0.012N*        P=0.104N         P=0.269N         P=0.269N         P=0.371N        | 
|ORDER RESTRICTED   |        P=0.298N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        22/52 (42%)      18/54 (33%)      19/53 (36%)      19/53 (36%)      23/53 (43%)      24/51 (47%)     | 
|POLY-3 RATE (b)    |        22/42.16         18/37.44         19/43.18         19/40.93         23/43.20         24/36.80        | 
|POLY-3 PERCENT (g) |        52.2%            48.1%            44.0%            46.4%            53.2%            65.2%           | 
|TERMINAL (d)       |        14/24 (58%)      6/16 (38%)       12/28 (43%)      9/21 (43%)       9/20 (45%)       16/21 (76%)     | 
|FIRST INCIDENCE    |        399              250              522              263              452              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.073          P=0.381          P=0.184N         P=0.490N         P=0.350          P=0.180         | 
|POLY 3             |        P=0.034 *        P=0.441N         P=0.288N         P=0.375N         P=0.549          P=0.157         | 
|POLY 1.5           |        P=0.054          P=0.372N         P=0.297N         P=0.364N         P=0.544          P=0.230         | 
|POLY 6             |        P=0.022 *        P=0.477N         P=0.268N         P=0.385N         P=0.564          P=0.111         | 
|LOGISTIC REGRESSION|        P=0.063          P=0.452N         P=0.257N         P=0.400N         P=0.497          P=0.146         | 
|COCH-ARM / FISHERS |        P=0.102          P=0.226N         P=0.316N         P=0.316N         P=0.534          P=0.387         | 
|ORDER RESTRICTED   |        P=0.085          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        2/54 (4%)        0/53 (0%)        1/53 (2%)        0/53 (0%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/38.79          2/32.06          0/41.12          1/37.04          0/38.33          1/33.77         | 
|POLY-3 PERCENT (g) |        0.0%             6.2%             0.0%             2.7%             0.0%             3.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              393              ---              486              ---              509             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.590          P=0.186          (e)              P=0.487          (e)              P=0.461         | 
|POLY 3             |        P=0.550          P=0.197          (e)              P=0.491          (e)              P=0.472         | 
|POLY 1.5           |        P=0.570          P=0.212          (e)              P=0.493          (e)              P=0.480         | 
|POLY 6             |        P=0.532          P=0.185          (e)              P=0.491          (e)              P=0.468         | 
|LOGISTIC REGRESSION|        P=0.620          P=0.298          (e)              P=0.572          (e)              P=0.553         | 
|COCH-ARM / FISHERS |        P=0.606          P=0.257          (e)              P=0.505          (e)              P=0.495         | 
|ORDER RESTRICTED   |        P=0.315          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        2/54 (4%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/38.79          2/32.06          0/41.12          0/36.33          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.2%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              393              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.399N         P=0.186          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.441N         P=0.197          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.422N         P=0.212          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.458N         P=0.185          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.381N         P=0.298          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.389N         P=0.257          (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.183N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        1/53 (2%)        0/53 (0%)        1/53 (2%)        2/50 (4%)       | 
|POLY-3 RATE (b)    |        0/39.01          1/31.56          1/41.91          0/36.33          1/38.93          2/33.80         | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             2.4%             0.0%             2.6%             5.9%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        ---              557              429              ---              541              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.137          P=0.446          P=0.512          (e)              P=0.486          P=0.219         | 
|POLY 3             |        P=0.126          P=0.458          P=0.514          (e)              P=0.500          P=0.205         | 
|POLY 1.5           |        P=0.131          P=0.473          P=0.509          (e)              P=0.500          P=0.212         | 
|POLY 6             |        P=0.121          P=0.446          P=0.523          (e)              P=0.499          P=0.201         | 
|LOGISTIC REGRESSION|        P=0.147          P=0.539          P=0.365          (e)              P=0.491          P=0.251         | 
|COCH-ARM / FISHERS |        P=0.136          P=0.505          P=0.500          (e)              P=0.500          P=0.233         | 
|ORDER RESTRICTED   |        P=0.074          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/54 (4%)        3/53 (6%)        7/53 (13%)       5/53 (9%)        5/50 (10%)      | 
|POLY-3 RATE (b)    |        1/39.01          2/32.35          3/41.75          7/38.34          5/40.49          5/34.16         | 
|POLY-3 PERCENT (g) |        2.6%             6.2%             7.2%             18.3%            12.4%            14.6%           | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        2/28 (7%)        4/21 (19%)       1/20 (5%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        731 (T)          479              522              452              452              591             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.132          P=0.409          P=0.346          P=0.023 *        P=0.094          P=0.068         | 
|POLY 3             |        P=0.129          P=0.435          P=0.329          P=0.026 *        P=0.108          P=0.071         | 
|POLY 1.5           |        P=0.136          P=0.457          P=0.320          P=0.026 *        P=0.106          P=0.076         | 
|POLY 6             |        P=0.128          P=0.418          P=0.345          P=0.027 *        P=0.111          P=0.070         | 
|LOGISTIC REGRESSION|        P=0.147          P=0.540          P=0.318          P=0.030 *        P=0.103          P=0.071         | 
|COCH-ARM / FISHERS |        P=0.148          P=0.507          P=0.309          P=0.030 *        P=0.103          P=0.090         | 
|ORDER RESTRICTED   |        P=0.061          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        3/54 (6%)        1/53 (2%)        0/53 (0%)        0/53 (0%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/39.01          3/32.30          1/41.12          0/36.33          0/38.33          1/33.69         | 
|POLY-3 PERCENT (g) |        0.0%             9.3%             2.4%             0.0%             0.0%             3.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        1/28 (4%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              502              731 (T)          ---              ---              548             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.621N         P=0.084          P=0.531          (e)              (e)              P=0.444         | 
|POLY 3             |        P=0.633N         P=0.088          P=0.511          (e)              (e)              P=0.471         | 
|POLY 1.5           |        P=0.619N         P=0.098          P=0.506          (e)              (e)              P=0.478         | 
|POLY 6             |        P=0.645N         P=0.081          P=0.518          (e)              (e)              P=0.467         | 
|LOGISTIC REGRESSION|        P=0.590N         P=0.120          P=0.531          (e)              (e)              P=0.526         | 
|COCH-ARM / FISHERS |        P=0.591N         P=0.125          P=0.500          (e)              (e)              P=0.490         | 
|ORDER RESTRICTED   |        P=0.314N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Calculus Micro Observation Only                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        5/54 (9%)        4/53 (8%)        7/53 (13%)       5/53 (9%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        3/39.32          5/32.34          4/42.05          7/37.97          5/39.56          1/33.87         | 
|POLY-3 PERCENT (g) |        7.6%             15.5%            9.5%             18.4%            12.6%            3.0%            | 
|TERMINAL (d)       |        2/24 (8%)        2/16 (13%)       2/28 (7%)        4/21 (19%)       3/20 (15%)       0/21 (0%)       | 
|FIRST INCIDENCE    |        644              479              418              263              383              452             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.119N         P=0.198          P=0.578          P=0.133          P=0.296          P=0.364N        | 
|POLY 3             |        P=0.128N         P=0.252          P=0.537          P=0.139          P=0.358          P=0.359N        | 
|POLY 1.5           |        P=0.117N         P=0.287          P=0.523          P=0.141          P=0.360          P=0.346N        | 
|POLY 6             |        P=0.141N         P=0.227          P=0.558          P=0.139          P=0.353          P=0.369N        | 
|LOGISTIC REGRESSION|        P=0.106N         P=0.251          P=0.514          P=0.142          P=0.352          P=0.331N        | 
|COCH-ARM / FISHERS |        P=0.103N         P=0.368          P=0.500          P=0.160          P=0.358          P=0.324N        | 
|ORDER RESTRICTED   |        P=0.168N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        2/54 (4%)        2/53 (4%)        1/53 (2%)        0/53 (0%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        3/39.60          2/32.20          2/42.40          1/36.90          0/38.33          1/33.32         | 
|POLY-3 PERCENT (g) |        7.6%             6.2%             4.7%             2.7%             0.0%             3.0%            | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        590              479              514              555              ---              675             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.296N         P=0.625N         P=0.471N         P=0.352N         P=0.139N         P=0.380N        | 
|POLY 3             |        P=0.275N         P=0.594N         P=0.469N         P=0.330N         P=0.123N         P=0.368N        | 
|POLY 1.5           |        P=0.269N         P=0.560N         P=0.481N         P=0.326N         P=0.121N         P=0.351N        | 
|POLY 6             |        P=0.285N         P=0.621N         P=0.451N         P=0.332N         P=0.128N         P=0.382N        | 
|LOGISTIC REGRESSION|        P=0.263N         P=0.513N         P=0.524N         P=0.314N         P=0.123N         P=0.358N        | 
|COCH-ARM / FISHERS |        P=0.267N         P=0.491N         P=0.500N         P=0.309N         P=0.121N         P=0.324N        | 
|ORDER RESTRICTED   |        P=0.160N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        1/53 (2%)        2/53 (4%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        1/39.23          0/31.01          1/41.12          2/36.55          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        2.6%             0.0%             2.4%             5.5%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        1/28 (4%)        1/21 (5%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        672              ---              731 (T)          675              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.302N         P=0.574N         P=0.719N         P=0.489          P=0.507N         P=0.538N        | 
|POLY 3             |        P=0.276N         P=0.546N         P=0.751N         P=0.475          P=0.505N         P=0.534N        | 
|POLY 1.5           |        P=0.279N         P=0.529N         P=0.754N         P=0.480          P=0.502N         P=0.525N        | 
|POLY 6             |        P=0.276N         P=0.562N         P=0.744N         P=0.473          P=0.509N         P=0.541N        | 
|LOGISTIC REGRESSION|        P=0.299N         P=0.543N         P=0.747N         P=0.475          P=0.502N         P=0.528N        | 
|COCH-ARM / FISHERS |        P=0.288N         P=0.495N         P=0.752N         P=0.500          P=0.500N         P=0.510N        | 
|ORDER RESTRICTED   |        P=0.360N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/54 (4%)        3/53 (6%)        2/53 (4%)        2/53 (4%)        3/51 (6%)       | 
|POLY-3 RATE (b)    |        1/39.01          2/31.85          3/41.12          2/36.55          2/38.33          3/33.11         | 
|POLY-3 PERCENT (g) |        2.6%             6.3%             7.3%             5.5%             5.2%             9.1%            | 
|TERMINAL (d)       |        1/24 (4%)        1/16 (6%)        3/28 (11%)       1/21 (5%)        2/20 (10%)       3/21 (14%)      | 
|FIRST INCIDENCE    |        731 (T)          393              731 (T)          675              731 (T)          731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.320          P=0.388          P=0.360          P=0.473          P=0.436          P=0.255         | 
|POLY 3             |        P=0.303          P=0.430          P=0.323          P=0.477          P=0.494          P=0.247         | 
|POLY 1.5           |        P=0.318          P=0.455          P=0.316          P=0.480          P=0.498          P=0.262         | 
|POLY 6             |        P=0.289          P=0.408          P=0.336          P=0.478          P=0.489          P=0.237         | 
|LOGISTIC REGRESSION|        P=0.298          P=0.490          P=0.360          P=0.472          P=0.436          P=0.255         | 
|COCH-ARM / FISHERS |        P=0.336          P=0.507          P=0.309          P=0.500          P=0.500          P=0.294         | 
|ORDER RESTRICTED   |        P=0.218          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        0/53 (0%)        3/53 (6%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/32.01          0/41.12          0/36.33          3/38.34          1/34.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.3%             0.0%             0.0%             7.8%             2.9%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        2/20 (10%)       0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              557              ---              ---              729              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.375          P=0.183          (e)              (e)              P=0.095          P=0.492         | 
|POLY 3             |        P=0.331          P=0.196          (e)              (e)              P=0.114          P=0.473         | 
|POLY 1.5           |        P=0.356          P=0.209          (e)              (e)              P=0.117          P=0.481         | 
|POLY 6             |        P=0.310          P=0.186          (e)              (e)              P=0.111          P=0.468         | 
|LOGISTIC REGRESSION|        P=0.402          P=0.254          (e)              (e)              P=0.097          (e)             | 
|COCH-ARM / FISHERS |        P=0.391          P=0.252          (e)              (e)              P=0.121          P=0.490         | 
|ORDER RESTRICTED   |        P=0.122          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        40/53 (75%)      42/54 (78%)      41/53 (77%)      39/53 (74%)      40/53 (75%)      41/51 (80%)     | 
|POLY-3 RATE (b)    |        40/47.84         42/47.44         41/49.99         39/47.32         40/50.76         41/47.66        | 
|POLY-3 PERCENT (g) |        83.6%            88.5%            82.0%            82.4%            78.8%            86.0%           | 
|TERMINAL (d)       |        21/24 (88%)      15/16 (94%)      23/28 (82%)      17/21 (81%)      12/20 (60%)      17/21 (81%)     | 
|FIRST INCIDENCE    |        399              250              429              263              341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.263          P=0.025 *        P=0.346N         P=0.393          P=0.374          P=0.178         | 
|POLY 3             |        P=0.494          P=0.327          P=0.525N         P=0.551N         P=0.355N         P=0.482         | 
|POLY 1.5           |        P=0.450          P=0.355          P=0.582N         P=0.560N         P=0.449N         P=0.437         | 
|POLY 6             |        P=0.539          P=0.345          P=0.450N         P=0.529N         P=0.243N         P=0.548         | 
|LOGISTIC REGRESSION|        P=0.306          P=0.260          P=0.547          P=0.576          P=0.588          P=0.311         | 
|COCH-ARM / FISHERS |        P=0.323          P=0.479          P=0.500          P=0.500N         P=0.589N         P=0.357         | 
|ORDER RESTRICTED   |        P=0.539N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        34/53 (64%)      23/54 (43%)      24/53 (45%)      33/53 (62%)      28/53 (53%)      34/51 (67%)     | 
|POLY-3 RATE (b)    |        34/46.35         23/36.65         24/44.38         33/41.71         28/43.84         34/41.25        | 
|POLY-3 PERCENT (g) |        73.4%            62.8%            54.1%            79.1%            63.9%            82.4%           | 
|TERMINAL (d)       |        18/24 (75%)      12/16 (75%)      16/28 (57%)      18/21 (86%)      14/20 (70%)      19/21 (91%)     | 
|FIRST INCIDENCE    |        211              250              418              443              360              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.041 *        P=0.463N         P=0.019N*        P=0.427          P=0.390N         P=0.239         | 
|POLY 3             |        P=0.028 *        P=0.194N         P=0.035N*        P=0.337          P=0.212N         P=0.196         | 
|POLY 1.5           |        P=0.038 *        P=0.091N         P=0.034N*        P=0.415          P=0.187N         P=0.292         | 
|POLY 6             |        P=0.019 *        P=0.353N         P=0.038N*        P=0.293          P=0.252N         P=0.117         | 
|LOGISTIC REGRESSION|        P=0.023 *        P=0.106N         P=0.026N*        P=0.494          P=0.163N         P=0.290         | 
|COCH-ARM / FISHERS |        P=0.053          P=0.020N*        P=0.039N*        P=0.500N         P=0.162N         P=0.475         | 
|ORDER RESTRICTED   |        P=0.021 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/31.89          0/41.12          0/36.33          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.3%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              502              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.406N         P=0.182          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.441N         P=0.195          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.424N         P=0.209          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.458N         P=0.184          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.387N         P=0.247          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.390N         P=0.252          (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.182N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        4/54 (7%)        2/53 (4%)        4/53 (8%)        5/53 (9%)        4/51 (8%)       | 
|POLY-3 RATE (b)    |        1/39.13          4/32.69          2/41.12          4/36.70          5/39.13          4/35.08         | 
|POLY-3 PERCENT (g) |        2.6%             12.2%            4.9%             10.9%            12.8%            11.4%           | 
|TERMINAL (d)       |        0/24 (0%)        1/16 (6%)        2/28 (7%)        2/21 (10%)       3/20 (15%)       0/21 (0%)       | 
|FIRST INCIDENCE    |        701              250              731 (T)          675              613              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.219          P=0.116          P=0.556          P=0.160          P=0.089          P=0.137         | 
|POLY 3             |        P=0.216          P=0.127          P=0.517          P=0.158          P=0.099          P=0.145         | 
|POLY 1.5           |        P=0.228          P=0.145          P=0.511          P=0.161          P=0.101          P=0.151         | 
|POLY 6             |        P=0.211          P=0.115          P=0.529          P=0.157          P=0.097          P=0.145         | 
|LOGISTIC REGRESSION|        P=0.239          P=0.195          P=0.547          P=0.155          P=0.098          P=0.185         | 
|COCH-ARM / FISHERS |        P=0.251          P=0.187          P=0.500          P=0.181          P=0.103          P=0.170         | 
|ORDER RESTRICTED   |        P=0.123          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        5/54 (9%)        2/53 (4%)        4/53 (8%)        6/53 (11%)       4/51 (8%)       | 
|POLY-3 RATE (b)    |        1/39.13          5/33.35          2/41.12          4/36.81          6/39.16          4/34.84         | 
|POLY-3 PERCENT (g) |        2.6%             15.0%            4.9%             10.9%            15.3%            11.5%           | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        2/28 (7%)        1/21 (5%)        3/20 (15%)       1/21 (5%)       | 
|FIRST INCIDENCE    |        701              250              731 (T)          675              621              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.256          P=0.062          P=0.556          P=0.166          P=0.051          P=0.137         | 
|POLY 3             |        P=0.239          P=0.067          P=0.517          P=0.158          P=0.054          P=0.143         | 
|POLY 1.5           |        P=0.257          P=0.078          P=0.511          P=0.162          P=0.055          P=0.150         | 
|POLY 6             |        P=0.227          P=0.061          P=0.529          P=0.159          P=0.052          P=0.141         | 
|LOGISTIC REGRESSION|        P=0.276          P=0.119          P=0.547          P=0.156          P=0.053          P=0.177         | 
|COCH-ARM / FISHERS |        P=0.290          P=0.107          P=0.500          P=0.181          P=0.056          P=0.170         | 
|ORDER RESTRICTED   |        P=0.091          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        2/54 (4%)        2/53 (4%)        1/53 (2%)        8/53 (15%)       4/51 (8%)       | 
|POLY-3 RATE (b)    |        5/40.04          2/32.33          2/41.77          1/36.33          8/39.19          4/33.32         | 
|POLY-3 PERCENT (g) |        12.5%            6.2%             4.8%             2.8%             20.4%            12.0%           | 
|TERMINAL (d)       |        2/24 (8%)        0/16 (0%)        1/28 (4%)        1/21 (5%)        5/20 (25%)       3/21 (14%)      | 
|FIRST INCIDENCE    |        442              310              514              731 (T)          613              675             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.196          P=0.346N         P=0.175N         P=0.138N         P=0.223          P=0.592N        | 
|POLY 3             |        P=0.166          P=0.310N         P=0.197N         P=0.123N         P=0.256          P=0.615N        | 
|POLY 1.5           |        P=0.187          P=0.273N         P=0.205N         P=0.118N         P=0.266          P=0.583N        | 
|POLY 6             |        P=0.147          P=0.343N         P=0.185N         P=0.127N         P=0.247          P=0.640N        | 
|LOGISTIC REGRESSION|        P=0.194          P=0.201N         P=0.216N         P=0.116N         P=0.262          P=0.604N        | 
|COCH-ARM / FISHERS |        P=0.219          P=0.211N         P=0.219N         P=0.103N         P=0.278          P=0.525N        | 
|ORDER RESTRICTED   |        P=0.130          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        16/53 (30%)      17/54 (31%)      25/53 (47%)      13/53 (25%)      10/53 (19%)      10/51 (20%)     | 
|POLY-3 RATE (b)    |        16/42.46         17/36.28         25/46.80         13/38.64         10/41.56         10/35.62        | 
|POLY-3 PERCENT (g) |        37.7%            46.9%            53.4%            33.6%            24.1%            28.1%           | 
|TERMINAL (d)       |        7/24 (29%)       6/16 (38%)       12/28 (43%)      6/21 (29%)       4/20 (20%)       5/21 (24%)      | 
|FIRST INCIDENCE    |        502              250              429              457              467              432             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.042N*        P=0.154          P=0.169          P=0.455N         P=0.215N         P=0.281N        | 
|POLY 3             |        P=0.021N*        P=0.271          P=0.094          P=0.441N         P=0.127N         P=0.252N        | 
|POLY 1.5           |        P=0.017N*        P=0.349          P=0.077          P=0.412N         P=0.124N         P=0.211N        | 
|POLY 6             |        P=0.030N*        P=0.225          P=0.123          P=0.470N         P=0.138N         P=0.300N        | 
|LOGISTIC REGRESSION|        P=0.021N*        P=0.334          P=0.060          P=0.397N         P=0.131N         P=0.209N        | 
|COCH-ARM / FISHERS |        P=0.018N*        P=0.526          P=0.055          P=0.332N         P=0.129N         P=0.154N        | 
|ORDER RESTRICTED   |        P=0.044N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/53 (11%)       5/54 (9%)        5/53 (9%)        0/53 (0%)        0/53 (0%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        6/39.13          5/32.17          5/41.12          0/36.33          0/38.33          2/33.11         | 
|POLY-3 PERCENT (g) |        15.3%            15.5%            12.2%            0.0%             0.0%             6.0%            | 
|TERMINAL (d)       |        5/24 (21%)       3/16 (19%)       5/28 (18%)       0/21 (0%)        0/20 (0%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        701              438              731 (T)          ---              ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.112N         P=0.504          P=0.389N         P=0.025N*        P=0.027N*        P=0.177N        | 
|POLY 3             |        P=0.107N         P=0.619          P=0.465N         P=0.018N*        P=0.015N*        P=0.189N        | 
|POLY 1.5           |        P=0.104N         P=0.589N         P=0.478N         P=0.018N*        P=0.015N*        P=0.174N        | 
|POLY 6             |        P=0.111N         P=0.583          P=0.441N         P=0.018N*        P=0.016N*        P=0.201N        | 
|LOGISTIC REGRESSION|        P=0.119N         P=0.565          P=0.383N         P=0.021N*        P=0.019N*        P=0.179N        | 
|COCH-ARM / FISHERS |        P=0.108N         P=0.487N         P=0.500N         P=0.013N*        P=0.013N*        P=0.148N        | 
|ORDER RESTRICTED   |        P=0.024N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/53 (23%)      2/54 (4%)        16/53 (30%)      19/53 (36%)      23/53 (43%)      18/51 (35%)     | 
|POLY-3 RATE (b)    |        12/40.39         2/31.67          16/43.75         19/40.37         23/44.86         18/40.96        | 
|POLY-3 PERCENT (g) |        29.7%            6.3%             36.6%            47.1%            51.3%            44.0%           | 
|TERMINAL (d)       |        8/24 (33%)       1/16 (6%)        9/28 (32%)       7/21 (33%)       9/20 (45%)       5/21 (24%)      | 
|FIRST INCIDENCE    |        507              507              418              507              452              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.012 *        P=0.031N*        P=0.411          P=0.073          P=0.015 *        P=0.074         | 
|POLY 3             |        P=0.043 *        P=0.012N*        P=0.329          P=0.077          P=0.030 *        P=0.129         | 
|POLY 1.5           |        P=0.026 *        P=0.008N**       P=0.298          P=0.073          P=0.023 *        P=0.114         | 
|POLY 6             |        P=0.074          P=0.018N*        P=0.381          P=0.097          P=0.046 *        P=0.162         | 
|LOGISTIC REGRESSION|        P=0.010 *        P=0.015N*        P=0.297          P=0.061          P=0.018 *        P=0.107         | 
|COCH-ARM / FISHERS |        P=0.014 *        P=0.004N**       P=0.255          P=0.100          P=0.019 *        P=0.114         | 
|ORDER RESTRICTED   |        P=0.004 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        7/54 (13%)       2/53 (4%)        11/53 (21%)      21/53 (40%)      17/51 (33%)     | 
|POLY-3 RATE (b)    |        3/39.88          7/34.47          2/41.30          11/38.71         21/44.01         17/37.33        | 
|POLY-3 PERCENT (g) |        7.5%             20.3%            4.8%             28.4%            47.7%            45.5%           | 
|TERMINAL (d)       |        0/24 (0%)        2/16 (13%)       1/28 (4%)        6/21 (29%)       8/20 (40%)       8/21 (38%)      | 
|FIRST INCIDENCE    |        608              393              683              457              452              432             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.082          P=0.442N         P=0.017 *        P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.100          P=0.484N         P=0.014 *        P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.119          P=0.489N         P=0.015 *        P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.086          P=0.475N         P=0.014 *        P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.195          P=0.487N         P=0.017 *        P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.168          P=0.500N         P=0.021 *        P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        0/54 (0%)        3/53 (6%)        5/53 (9%)        4/53 (8%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        4/39.26          0/31.01          3/41.36          5/37.11          4/39.10          1/33.11         | 
|POLY-3 PERCENT (g) |        10.2%            0.0%             7.3%             13.5%            10.2%            3.0%            | 
|TERMINAL (d)       |        2/24 (8%)        0/16 (0%)        1/28 (4%)        3/21 (14%)       2/20 (10%)       1/21 (5%)       | 
|FIRST INCIDENCE    |        696              ---              700              507              514              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.303N         P=0.127N         P=0.410N         P=0.426          P=0.587          P=0.234N        | 
|POLY 3             |        P=0.290N         P=0.096N         P=0.471N         P=0.464          P=0.643          P=0.232N        | 
|POLY 1.5           |        P=0.284N         P=0.081N         P=0.483N         P=0.468          P=0.644N         P=0.217N        | 
|POLY 6             |        P=0.300N         P=0.111N         P=0.452N         P=0.464          P=0.639          P=0.245N        | 
|LOGISTIC REGRESSION|        P=0.311N         P=0.111N         P=0.443N         P=0.454          P=0.632          P=0.235N        | 
|COCH-ARM / FISHERS |        P=0.284N         P=0.057N         P=0.500N         P=0.500          P=0.642N         P=0.194N        | 
|ORDER RESTRICTED   |        P=0.226N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        20/53 (38%)      22/54 (41%)      13/53 (25%)      18/53 (34%)      16/53 (30%)      14/51 (27%)     | 
|POLY-3 RATE (b)    |        20/46.75         22/44.58         13/48.98         18/43.57         16/45.68         14/41.31        | 
|POLY-3 PERCENT (g) |        42.8%            49.4%            26.5%            41.3%            35.0%            33.9%           | 
|TERMINAL (d)       |        5/24 (21%)       2/16 (13%)       0/28 (0%)        3/21 (14%)       3/20 (15%)       1/21 (5%)       | 
|FIRST INCIDENCE    |        399              250              429              222              341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.283N         P=0.175          P=0.112N         P=0.530N         P=0.351N         P=0.349N        | 
|POLY 3             |        P=0.261N         P=0.334          P=0.069N         P=0.529N         P=0.288N         P=0.259N        | 
|POLY 1.5           |        P=0.223N         P=0.375          P=0.081N         P=0.501N         P=0.274N         P=0.227N        | 
|POLY 6             |        P=0.302N         P=0.304          P=0.057N         P=0.545N         P=0.309N         P=0.285N        | 
|LOGISTIC REGRESSION|        P=0.109N         P=0.305N         P=0.123N         P=0.331N         P=0.238N         P=0.064N        | 
|COCH-ARM / FISHERS |        P=0.180N         P=0.452          P=0.104N         P=0.420N         P=0.269N         P=0.182N        | 
|ORDER RESTRICTED   |        P=0.207N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        44/53 (83%)      39/54 (72%)      44/53 (83%)      47/53 (89%)      48/53 (91%)      45/51 (88%)     | 
|POLY-3 RATE (b)    |        44/49.23         39/47.02         44/49.13         47/49.54         48/51.05         45/47.50        | 
|POLY-3 PERCENT (g) |        89.4%            82.9%            89.6%            94.9%            94.0%            94.7%           | 
|TERMINAL (d)       |        20/24 (83%)      12/16 (75%)      25/28 (89%)      20/21 (95%)      20/20 (100%)     21/21 (100%)    | 
|FIRST INCIDENCE    |        399              250              429              59               341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.135          P=0.188          P=0.286N         P=0.199          P=0.171          P=0.146         | 
|POLY 3             |        P=0.085          P=0.249N         P=0.627          P=0.238          P=0.298          P=0.252         | 
|POLY 1.5           |        P=0.087          P=0.184N         P=0.609N         P=0.255          P=0.277          P=0.287         | 
|POLY 6             |        P=0.090          P=0.349N         P=0.585          P=0.221          P=0.281          P=0.220         | 
|LOGISTIC REGRESSION|        P=0.075          P=0.250N         P=0.517N         P=0.175          P=0.190          P=0.188         | 
|COCH-ARM / FISHERS |        P=0.093          P=0.134N         P=0.602N         P=0.289          P=0.195          P=0.317         | 
|ORDER RESTRICTED   |        P=0.077          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        29/53 (55%)      19/54 (35%)      29/53 (55%)      25/53 (47%)      24/53 (45%)      15/51 (29%)     | 
|POLY-3 RATE (b)    |        29/42.75         19/33.52         29/44.08         25/39.82         24/41.75         15/37.02        | 
|POLY-3 PERCENT (g) |        67.8%            56.7%            65.8%            62.8%            57.5%            40.5%           | 
|TERMINAL (d)       |        20/24 (83%)      13/16 (81%)      23/28 (82%)      17/21 (81%)      15/20 (75%)      9/21 (43%)      | 
|FIRST INCIDENCE    |        418              479              429              452              452              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.016N*        P=0.472N         P=0.272N         P=0.502N         P=0.440N         P=0.029N*       | 
|POLY 3             |        P=0.003N**       P=0.201N         P=0.511N         P=0.392N         P=0.205N         P=0.008N**      | 
|POLY 1.5           |        P=0.005N**       P=0.109N         P=0.532N         P=0.375N         P=0.207N         P=0.007N**      | 
|POLY 6             |        P=0.002N**       P=0.338N         P=0.475N         P=0.393N         P=0.200N         P=0.007N**      | 
|LOGISTIC REGRESSION|        P=0.016N*        P=0.272N         P=0.468N         P=0.407N         P=0.225N         P=0.019N*       | 
|COCH-ARM / FISHERS |        P=0.013N*        P=0.033N*        P=0.577N         P=0.280N         P=0.219N         P=0.008N**      | 
|ORDER RESTRICTED   |        P=0.005N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/53 (13%)       7/54 (13%)       7/53 (13%)       5/53 (9%)        12/53 (23%)      10/51 (20%)     | 
|POLY-3 RATE (b)    |        7/42.63          7/35.48          7/43.63          5/38.94          12/44.53         10/38.36        | 
|POLY-3 PERCENT (g) |        16.4%            19.7%            16.0%            12.8%            27.0%            26.1%           | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        1/20 (5%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        442              261              429              263              341              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.085          P=0.437          P=0.561N         P=0.443N         P=0.160          P=0.192         | 
|POLY 3             |        P=0.087          P=0.467          P=0.597N         P=0.443N         P=0.174          P=0.213         | 
|POLY 1.5           |        P=0.090          P=0.522          P=0.602N         P=0.424N         P=0.170          P=0.229         | 
|POLY 6             |        P=0.085          P=0.419          P=0.582N         P=0.463N         P=0.171          P=0.204         | 
|LOGISTIC REGRESSION|        P=0.114          P=0.360N         P=0.553          P=0.274N         P=0.142          P=0.388         | 
|COCH-ARM / FISHERS |        P=0.096          P=0.598N         P=0.612N         P=0.380N         P=0.156          P=0.269         | 
|ORDER RESTRICTED   |        P=0.206          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/54 (2%)        2/53 (4%)        5/53 (9%)        5/53 (9%)        9/51 (18%)      | 
|POLY-3 RATE (b)    |        1/39.56          1/31.63          2/41.86          5/37.57          5/38.99          9/34.75         | 
|POLY-3 PERCENT (g) |        2.5%             3.2%             4.8%             13.3%            12.8%            25.9%           | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        2/21 (10%)       3/20 (15%)       4/21 (19%)      | 
|FIRST INCIDENCE    |        557              528              527              322              541              501             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.698          P=0.506          P=0.093          P=0.083          P=0.006 **      | 
|POLY 3             |        P<0.001 **       P=0.709          P=0.520          P=0.088          P=0.096          P=0.003 **      | 
|POLY 1.5           |        P<0.001 **       P=0.728          P=0.512          P=0.090          P=0.099          P=0.004 **      | 
|POLY 6             |        P<0.001 **       P=0.691          P=0.533          P=0.086          P=0.091          P=0.003 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.717N         P=0.472          P=0.104          P=0.101          P=0.005 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.748N         P=0.500          P=0.103          P=0.103          P=0.007 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        2/54 (4%)        2/53 (4%)        3/53 (6%)        5/53 (9%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        3/39.38          2/31.56          2/41.12          3/36.49          5/39.40          2/33.11         | 
|POLY-3 PERCENT (g) |        7.6%             6.3%             4.9%             8.2%             12.7%            6.0%            | 
|TERMINAL (d)       |        1/24 (4%)        1/16 (6%)        2/28 (7%)        2/21 (10%)       3/20 (15%)       2/21 (10%)      | 
|FIRST INCIDENCE    |        664              557              731 (T)          691              452              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.577          P=0.663N         P=0.426N         P=0.612          P=0.308          P=0.568N        | 
|POLY 3             |        P=0.548          P=0.600N         P=0.480N         P=0.628          P=0.355          P=0.579N        | 
|POLY 1.5           |        P=0.572          P=0.564N         P=0.487N         P=0.635          P=0.358          P=0.557N        | 
|POLY 6             |        P=0.522          P=0.631N         P=0.468N         P=0.624          P=0.349          P=0.597N        | 
|LOGISTIC REGRESSION|        P=0.569          P=0.605N         P=0.454N         P=0.629          P=0.349          P=0.587N        | 
|COCH-ARM / FISHERS |        P=0.585N         P=0.491N         P=0.500N         P=0.661N         P=0.358          P=0.518N        | 
|ORDER RESTRICTED   |        P=0.540          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        2/53 (4%)        2/53 (4%)        2/53 (4%)        3/51 (6%)       | 
|POLY-3 RATE (b)    |        2/39.48          1/31.12          2/41.12          2/36.55          2/38.33          3/33.81         | 
|POLY-3 PERCENT (g) |        5.1%             3.2%             4.9%             5.5%             5.2%             8.9%            | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        2/28 (7%)        1/21 (5%)        2/20 (10%)       2/21 (10%)      | 
|FIRST INCIDENCE    |        590              701              731 (T)          675              731 (T)          486             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.251          P=0.617N         P=0.655N         P=0.662          P=0.642          P=0.424         | 
|POLY 3             |        P=0.258          P=0.582N         P=0.680N         P=0.667          P=0.685          P=0.429         | 
|POLY 1.5           |        P=0.266          P=0.552N         P=0.685N         P=0.672          P=0.690          P=0.447         | 
|POLY 6             |        P=0.249          P=0.608N         P=0.671N         P=0.665          P=0.677          P=0.416         | 
|LOGISTIC REGRESSION|        P=0.239          P=0.577N         P=0.673N         P=0.672          P=0.686          P=0.452         | 
|COCH-ARM / FISHERS |        P=0.271          P=0.493N         P=0.691N         P=0.691N         P=0.691N         P=0.482         | 
|ORDER RESTRICTED   |        P=0.351          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        3/54 (6%)        2/53 (4%)        14/53 (26%)      10/53 (19%)      17/51 (33%)     | 
|POLY-3 RATE (b)    |        5/39.38          3/31.01          2/41.68          14/37.17         10/40.51         17/35.92        | 
|POLY-3 PERCENT (g) |        12.7%            9.7%             4.8%             37.7%            24.7%            47.3%           | 
|TERMINAL (d)       |        3/24 (13%)       3/16 (19%)       1/28 (4%)        12/21 (57%)      5/20 (25%)       12/21 (57%)     | 
|FIRST INCIDENCE    |        664              731 (T)          553              530              502              432             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.587N         P=0.173N         P=0.008 **       P=0.099          P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.493N         P=0.191N         P=0.009 **       P=0.135          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.440N         P=0.201N         P=0.011 *        P=0.134          P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.543N         P=0.177N         P=0.007 **       P=0.138          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.565N         P=0.193N         P=0.009 **       P=0.123          P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.347N         P=0.219N         P=0.020 *        P=0.132          P=0.003 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        10/54 (19%)      4/53 (8%)        2/53 (4%)        2/53 (4%)        5/51 (10%)      | 
|POLY-3 RATE (b)    |        2/39.58          10/37.48         4/42.53          2/37.17          2/39.78          5/36.11         | 
|POLY-3 PERCENT (g) |        5.1%             26.7%            9.4%             5.4%             5.0%             13.9%           | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        1/28 (4%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        551              352              514              530              383              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.526          P=0.007 **       P=0.368          P=0.659          P=0.659          P=0.172         | 
|POLY 3             |        P=0.528          P=0.009 **       P=0.370          P=0.672          P=0.693N         P=0.177         | 
|POLY 1.5           |        P=0.546          P=0.010 *        P=0.357          P=0.675          P=0.692N         P=0.186         | 
|POLY 6             |        P=0.514          P=0.009 **       P=0.391          P=0.674          P=0.695          P=0.174         | 
|LOGISTIC REGRESSION|        P=0.553N         P=0.045 *        P=0.322          P=0.694N         P=0.688          P=0.299         | 
|COCH-ARM / FISHERS |        P=0.567          P=0.015 *        P=0.339          P=0.691N         P=0.691N         P=0.203         | 
|ORDER RESTRICTED   |        P=0.184          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        5/54 (9%)        5/53 (9%)        24/53 (45%)      39/53 (74%)      41/51 (80%)     | 
|POLY-3 RATE (b)    |        0/39.01          5/32.97          5/42.57          24/40.31         39/44.99         41/46.12        | 
|POLY-3 PERCENT (g) |        0.0%             15.2%            11.8%            59.5%            86.7%            88.9%           | 
|TERMINAL (d)       |        0/24 (0%)        2/16 (13%)       3/28 (11%)       15/21 (71%)      20/20 (100%)     19/21 (91%)     | 
|FIRST INCIDENCE    |        ---              360              429              443              452              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.016 *        P=0.046 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.018 *        P=0.038 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.022 *        P=0.035 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.015 *        P=0.043 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.035 *        P=0.030 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.030 *        P=0.028 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        1/53 (2%)        0/53 (0%)        4/51 (8%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          1/36.49          0/38.33          4/33.34         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             2.7%             0.0%             12.0%           | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        3/21 (14%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              691              ---              668             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.485          (e)              P=0.047 *       | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.487          (e)              P=0.041 *       | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.489          (e)              P=0.046 *       | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.487          (e)              P=0.039 *       | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              P=0.486          (e)              P=0.040 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.500          (e)              P=0.054         | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Serosa                                                                                                                    | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        2/53 (4%)        0/53 (0%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          2/41.61          0/36.33          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              656              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.461N         (e)              P=0.288          (e)              (e)              (e)             | 
|POLY 3             |        P=0.394N         (e)              P=0.251          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.407N         (e)              P=0.246          (e)              (e)              (e)             | 
|POLY 6             |        P=0.380N         (e)              P=0.262          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.443N         (e)              P=0.242          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.437N         (e)              P=0.248          (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.390N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        45/52 (87%)      40/54 (74%)      40/53 (75%)      40/53 (75%)      27/53 (51%)      28/51 (55%)     | 
|POLY-3 RATE (b)    |        45/48.19         40/46.36         40/48.58         40/44.56         27/44.57         28/38.75        | 
|POLY-3 PERCENT (g) |        93.4%            86.3%            82.4%            89.8%            60.6%            72.3%           | 
|TERMINAL (d)       |        23/24 (96%)      13/16 (81%)      23/28 (82%)      20/21 (95%)      12/20 (60%)      16/21 (76%)     | 
|FIRST INCIDENCE    |        410              250              418              360              341              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.015N*        P=0.151          P=0.087N         P=0.505N         P=0.021N*        P=0.058N        | 
|POLY 3             |        P<0.001N**       P=0.179N         P=0.066N         P=0.380N         P<0.001N**       P=0.002N**      | 
|POLY 1.5           |        P<0.001N**       P=0.135N         P=0.069N         P=0.265N         P<0.001N**       P<0.001N**      | 
|POLY 6             |        P=0.006N**       P=0.223N         P=0.075N         P=0.551N         P<0.001N**       P=0.014N*       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.316N         P=0.078N         P=0.293N         P<0.001N**       P=0.002N**      | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.085N         P=0.116N         P=0.116N         P<0.001N**       P<0.001N**      | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/52 (12%)       7/54 (13%)       2/53 (4%)        6/53 (11%)       7/53 (13%)       9/51 (18%)      | 
|POLY-3 RATE (b)    |        6/40.63          7/34.41          2/41.12          6/37.04          7/40.36          9/35.33         | 
|POLY-3 PERCENT (g) |        14.8%            20.3%            4.9%             16.2%            17.4%            25.5%           | 
|TERMINAL (d)       |        3/24 (13%)       1/16 (6%)        2/28 (7%)        5/21 (24%)       0/20 (0%)        5/21 (24%)      | 
|FIRST INCIDENCE    |        410              360              731 (T)          486              467              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.069          P=0.297          P=0.113N         P=0.534          P=0.459          P=0.186         | 
|POLY 3             |        P=0.055          P=0.371          P=0.126N         P=0.556          P=0.495          P=0.187         | 
|POLY 1.5           |        P=0.064          P=0.418          P=0.127N         P=0.576          P=0.503          P=0.215         | 
|POLY 6             |        P=0.049 *        P=0.343          P=0.123N         P=0.538          P=0.491          P=0.173         | 
|LOGISTIC REGRESSION|        P=0.076          P=0.567          P=0.128N         P=0.600          P=0.517          P=0.247         | 
|COCH-ARM / FISHERS |        P=0.082          P=0.529          P=0.129N         P=0.606N         P=0.515          P=0.275         | 
|ORDER RESTRICTED   |        P=0.109          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        20/52 (38%)      21/54 (39%)      16/53 (30%)      11/53 (21%)      9/53 (17%)       6/51 (12%)      | 
|POLY-3 RATE (b)    |        20/41.45         21/36.66         16/41.75         11/37.11         9/38.86          6/34.40         | 
|POLY-3 PERCENT (g) |        48.3%            57.3%            38.3%            29.6%            23.2%            17.4%           | 
|TERMINAL (d)       |        13/24 (54%)      10/16 (63%)      12/28 (43%)      8/21 (38%)       7/20 (35%)       4/21 (19%)      | 
|FIRST INCIDENCE    |        555              250              656              613              621              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001N**       P=0.093          P=0.132N         P=0.086N         P=0.035N*        P=0.007N**      | 
|POLY 3             |        P<0.001N**       P=0.274          P=0.237N         P=0.065N         P=0.013N*        P=0.003N**      | 
|POLY 1.5           |        P<0.001N**       P=0.364          P=0.235N         P=0.056N         P=0.011N*        P=0.002N**      | 
|POLY 6             |        P<0.001N**       P=0.219          P=0.234N         P=0.077N         P=0.018N*        P=0.005N**      | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.223          P=0.165N         P=0.056N         P=0.013N*        P=0.005N**      | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.561          P=0.246N         P=0.038N*        P=0.012N*        P=0.002N**      | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        37/51 (73%)      36/52 (69%)      30/53 (57%)      33/51 (65%)      37/53 (70%)      38/51 (75%)     | 
|POLY-3 RATE (b)    |        37/46.48         36/43.85         30/45.65         33/43.53         37/46.61         38/43.34        | 
|POLY-3 PERCENT (g) |        79.6%            82.1%            65.7%            75.8%            79.4%            87.7%           | 
|TERMINAL (d)       |        18/24 (75%)      14/16 (88%)      20/28 (71%)      16/21 (76%)      16/20 (80%)      19/21 (91%)     | 
|FIRST INCIDENCE    |        211              250              429              59               360              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.094          P=0.088          P=0.054N         P=0.523N         P=0.365          P=0.175         | 
|POLY 3             |        P=0.049 *        P=0.486          P=0.088N         P=0.423N         P=0.598N         P=0.204         | 
|POLY 1.5           |        P=0.069          P=0.565          P=0.073N         P=0.362N         P=0.543N         P=0.288         | 
|POLY 6             |        P=0.040 *        P=0.405          P=0.120N         P=0.507N         P=0.568          P=0.147         | 
|LOGISTIC REGRESSION|        P=0.113          P=0.579          P=0.053N         P=0.325N         P=0.485N         P=0.310         | 
|COCH-ARM / FISHERS |        P=0.147          P=0.439N         P=0.067N         P=0.261N         P=0.464N         P=0.500         | 
|ORDER RESTRICTED   |        P=0.104          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/51 (2%)        1/52 (2%)        2/53 (4%)        1/51 (2%)        3/53 (6%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        1/38.11          1/31.26          2/41.12          1/35.02          3/38.75          1/33.11         | 
|POLY-3 PERCENT (g) |        2.6%             3.2%             4.9%             2.9%             7.7%             3.0%            | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        2/28 (7%)        1/21 (5%)        1/20 (5%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        731 (T)          250              731 (T)          731 (T)          647              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.610          P=0.721          P=0.554          P=0.733          P=0.279          P=0.733         | 
|POLY 3             |        P=0.590          P=0.715          P=0.527          P=0.742          P=0.310          P=0.729         | 
|POLY 1.5           |        P=0.608          P=0.733          P=0.522          P=0.746          P=0.315          P=0.740         | 
|POLY 6             |        P=0.573          P=0.699          P=0.536          P=0.742          P=0.305          P=0.720         | 
|LOGISTIC REGRESSION|        P=0.617          P=0.668N         P=0.554          P=0.733          P=0.298          P=0.733         | 
|COCH-ARM / FISHERS |        P=0.617N         P=0.748N         P=0.515          P=0.752N         P=0.324          P=0.752N        | 
|ORDER RESTRICTED   |        P=0.493          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/3 (0%)         1/3 (33%)        2/3 (67%)        0/2 (0%)         0/5 (0%)         2/6 (33%)       | 
|POLY-3 RATE (b)    |        0/0.78           1/1.49           2/2.38           0/1.48           0/3.41           2/4.77          | 
|POLY-3 PERCENT (g) |        0.0%             67.2%            84.0%            0.0%             0.0%             41.9%           | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/2 (0%)         1/3 (33%)       | 
|FIRST INCIDENCE    |        ---              507              501              ---              ---              438             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.458          P=0.455          P=0.265          (e)              (e)              P=0.468         | 
|POLY 3             |        P=0.637N         P=0.669          P=0.509          (e)              (e)              P=0.641         | 
|POLY 1.5           |        P=0.685          P=0.562          P=0.298          (e)              (e)              P=0.538         | 
|POLY 6             |        P=0.576N         P=0.932          P=0.931          (e)              (e)              P=0.734         | 
|LOGISTIC REGRESSION|        P=0.554          P=0.521          P=0.469          (e)              (e)              P=0.436         | 
|COCH-ARM / FISHERS |        P=0.538          P=0.500          P=0.200          (e)              (e)              P=0.417         | 
|ORDER RESTRICTED   |        P=0.569N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/3 (0%)         0/3 (0%)         0/3 (0%)         0/2 (0%)         1/5 (20%)        2/6 (33%)       | 
|POLY-3 RATE (b)    |        0/0.78           0/0.82           0/1.59           0/1.48           1/4.31           2/3.98          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             23.2%            50.2%           | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/2 (0%)         2/3 (67%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              341              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.295          (e)              (e)              (e)              P=0.504          P=1.000N        | 
|POLY 3             |        P=0.160          (e)              (e)              (e)              P=0.741          P=0.626         | 
|POLY 1.5           |        P=0.130          (e)              (e)              (e)              P=0.691          P=0.513         | 
|POLY 6             |        P=0.205          (e)              (e)              (e)              P=0.778          P=0.758         | 
|LOGISTIC REGRESSION|        P=0.095          (e)              (e)              (e)              (e)              P=1.000N        | 
|COCH-ARM / FISHERS |        P=0.083          (e)              (e)              (e)              P=0.625          P=0.417         | 
|ORDER RESTRICTED   |        P=0.488          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/3 (100%)       0/3 (0%)         0/3 (0%)         0/2 (0%)         0/5 (0%)         0/6 (0%)        | 
|POLY-3 RATE (b)    |        3/3.00           0/0.82           0/1.59           0/1.48           0/3.41           0/3.98          | 
|POLY-3 PERCENT (g) |        100.0%           0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/2 (0%)         0/3 (0%)        | 
|FIRST INCIDENCE    |        399              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.268N         P=0.170N         P=0.112N         P=0.131N         P=0.126N         P=0.151N        | 
|POLY 3             |        P<0.001N**       P=0.096N         P=0.002N**       P<0.001N**       P<0.001N**       P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**      | 
|POLY 6             |        P<0.001N**       P=1.000N         P=0.165N         P<0.001N**       P<0.001N**       P<0.001N**      | 
|LOGISTIC REGRESSION|        P=0.206N         P=0.051N         P=0.162N         (e)              P=0.042N*        P=0.062N        | 
|COCH-ARM / FISHERS |        P=0.126N         P=0.050N         P=0.050N         P=0.100N         P=0.018N*        P=0.012N*       | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/3 (0%)         0/3 (0%)         0/3 (0%)         0/2 (0%)         0/5 (0%)         2/6 (33%)       | 
|POLY-3 RATE (b)    |        0/0.78           0/0.82           0/1.59           0/1.48           0/3.41           2/5.22          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             38.4%           | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/2 (0%)         0/3 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              514             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.006 **       (e)              (e)              (e)              (e)              P=0.184         | 
|POLY 3             |        P=0.106          (e)              (e)              (e)              (e)              P=0.646         | 
|POLY 1.5           |        P=0.072          (e)              (e)              (e)              (e)              P=0.546         | 
|POLY 6             |        P=0.168          (e)              (e)              (e)              (e)              P=0.724         | 
|LOGISTIC REGRESSION|        P=0.026 *        (e)              (e)              (e)              (e)              P=0.272         | 
|COCH-ARM / FISHERS |        P=0.044 *        (e)              (e)              (e)              (e)              P=0.417         | 
|ORDER RESTRICTED   |        P=0.516          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/3 (67%)        1/3 (33%)        0/3 (0%)         0/2 (0%)         0/5 (0%)         0/6 (0%)        | 
|POLY-3 RATE (b)    |        2/2.43           1/1.45           0/1.59           0/1.48           0/3.41           0/3.98          | 
|POLY-3 PERCENT (g) |        82.4%            69.2%            0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/2 (0%)         0/3 (0%)        | 
|FIRST INCIDENCE    |        399              528              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.269N         P=0.572N         P=0.233N         P=0.253N         P=0.240N         P=0.261N        | 
|POLY 3             |        P=0.043N*        P=0.854N         P=0.229N         P=0.241N         P=0.050N         P=0.027N*       | 
|POLY 1.5           |        P=0.060N         P=0.682N         P=0.186N         P=0.255N         P=0.052N         P=0.027N*       | 
|POLY 6             |        P=0.024N*        P=0.998N         P=0.340N         P=0.260N         P=0.040N*        P=0.029N*       | 
|LOGISTIC REGRESSION|        P=0.213N         P=0.507N         (e)              (e)              P=0.188N         (e)             | 
|COCH-ARM / FISHERS |        P=0.127N         P=0.500N         P=0.200N         P=0.300N         P=0.107N         P=0.083N        | 
|ORDER RESTRICTED   |        P=0.002N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/3 (0%)         0/3 (0%)         0/3 (0%)         0/2 (0%)         0/5 (0%)         2/6 (33%)       | 
|POLY-3 RATE (b)    |        0/0.78           0/0.82           0/1.59           0/1.48           0/3.41           2/3.98          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             50.2%           | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/2 (0%)         2/3 (67%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.309          (e)              (e)              (e)              (e)              P=1.000N        | 
|POLY 3             |        P=0.058          (e)              (e)              (e)              (e)              P=0.626         | 
|POLY 1.5           |        P=0.052          (e)              (e)              (e)              (e)              P=0.513         | 
|POLY 6             |        P=0.068          (e)              (e)              (e)              (e)              P=0.758         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=1.000N        | 
|COCH-ARM / FISHERS |        P=0.044 *        (e)              (e)              (e)              (e)              P=0.417         | 
|ORDER RESTRICTED   |        P=0.397          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        0/53 (0%)        2/53 (4%)        1/53 (2%)        3/51 (6%)       | 
|POLY-3 RATE (b)    |        2/39.84          1/31.85          0/41.12          2/36.33          1/38.43          3/33.11         | 
|POLY-3 PERCENT (g) |        5.0%             3.1%             0.0%             5.5%             2.6%             9.1%            | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        0/28 (0%)        2/21 (10%)       0/20 (0%)        3/21 (14%)      | 
|FIRST INCIDENCE    |        399              393              ---              731 (T)          706              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.155          P=0.587N         P=0.221N         P=0.649          P=0.525N         P=0.440         | 
|POLY 3             |        P=0.136          P=0.577N         P=0.230N         P=0.661          P=0.513N         P=0.416         | 
|POLY 1.5           |        P=0.145          P=0.549N         P=0.233N         P=0.668          P=0.507N         P=0.439         | 
|POLY 6             |        P=0.126          P=0.601N         P=0.223N         P=0.657          P=0.519N         P=0.398         | 
|LOGISTIC REGRESSION|        P=0.147          P=0.366N         P=0.265N         P=0.684          P=0.500N         P=0.441         | 
|COCH-ARM / FISHERS |        P=0.157          P=0.493N         P=0.248N         P=0.691N         P=0.500N         P=0.482         | 
|ORDER RESTRICTED   |        P=0.145          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        22/53 (42%)      23/54 (43%)      32/53 (60%)      27/53 (51%)      32/53 (60%)      22/51 (43%)     | 
|POLY-3 RATE (b)    |        22/43.38         23/37.94         32/46.73         27/43.99         32/45.28         22/36.86        | 
|POLY-3 PERCENT (g) |        50.7%            60.6%            68.5%            61.4%            70.7%            59.7%           | 
|TERMINAL (d)       |        12/24 (50%)      9/16 (56%)       19/28 (68%)      13/21 (62%)      12/20 (60%)      13/21 (62%)     | 
|FIRST INCIDENCE    |        211              250              429              59               467              432             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.507N         P=0.105          P=0.168          P=0.142          P=0.038 *        P=0.319         | 
|POLY 3             |        P=0.467          P=0.239          P=0.056          P=0.204          P=0.034 *        P=0.271         | 
|POLY 1.5           |        P=0.526N         P=0.320          P=0.045 *        P=0.193          P=0.032 *        P=0.348         | 
|POLY 6             |        P=0.372          P=0.201          P=0.081          P=0.230          P=0.042 *        P=0.220         | 
|LOGISTIC REGRESSION|        P=0.435N         P=0.299          P=0.049 *        P=0.189          P=0.035 *        P=0.331         | 
|COCH-ARM / FISHERS |        P=0.376N         P=0.533          P=0.040 *        P=0.218          P=0.040 *        P=0.512         | 
|ORDER RESTRICTED   |        P=0.126          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        2/53 (4%)        3/53 (6%)        0/53 (0%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/32.41          2/41.23          3/36.74          0/38.33          1/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.2%             4.9%             8.2%             0.0%             3.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        1/28 (4%)        2/21 (10%)       0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        ---              393              701              613              ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.433N         P=0.193          P=0.277          P=0.104          (e)              P=0.473         | 
|POLY 3             |        P=0.443N         P=0.198          P=0.249          P=0.107          (e)              P=0.467         | 
|POLY 1.5           |        P=0.432N         P=0.211          P=0.244          P=0.109          (e)              P=0.476         | 
|POLY 6             |        P=0.453N         P=0.188          P=0.258          P=0.107          (e)              P=0.461         | 
|LOGISTIC REGRESSION|        P=0.424N         P=0.342          P=0.262          P=0.108          (e)              P=0.473         | 
|COCH-ARM / FISHERS |        P=0.416N         P=0.252          P=0.248          P=0.121          (e)              P=0.490         | 
|ORDER RESTRICTED   |        P=0.291          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        6/54 (11%)       3/53 (6%)        6/53 (11%)       6/53 (11%)       3/51 (6%)       | 
|POLY-3 RATE (b)    |        1/39.01          6/33.97          3/41.75          6/38.92          6/38.96          3/33.11         | 
|POLY-3 PERCENT (g) |        2.6%             17.7%            7.2%             15.4%            15.4%            9.1%            | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        2/28 (7%)        2/21 (10%)       3/20 (15%)       3/21 (14%)      | 
|FIRST INCIDENCE    |        731 (T)          310              522              360              579              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.546N         P=0.032 *        P=0.346          P=0.049 *        P=0.044 *        P=0.255         | 
|POLY 3             |        P=0.532          P=0.035 *        P=0.329          P=0.053          P=0.053          P=0.247         | 
|POLY 1.5           |        P=0.574          P=0.041 *        P=0.320          P=0.052          P=0.055          P=0.262         | 
|POLY 6             |        P=0.490          P=0.031 *        P=0.345          P=0.057          P=0.051          P=0.237         | 
|LOGISTIC REGRESSION|        P=0.523N         P=0.075          P=0.318          P=0.064          P=0.051          P=0.255         | 
|COCH-ARM / FISHERS |        P=0.516N         P=0.059          P=0.309          P=0.056          P=0.056          P=0.294         | 
|ORDER RESTRICTED   |        P=0.121          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Goblet Cell                                                                                                                | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        2/53 (4%)        1/53 (2%)        2/53 (4%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          2/41.73          1/36.33          2/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             2.8%             5.2%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        1/28 (4%)        1/21 (5%)        2/20 (10%)       0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              530              731 (T)          731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.497N         (e)              P=0.249          P=0.473          P=0.198          (e)             | 
|POLY 3             |        P=0.489N         (e)              P=0.252          P=0.486          P=0.232          (e)             | 
|POLY 1.5           |        P=0.485N         (e)              P=0.246          P=0.488          P=0.235          (e)             | 
|POLY 6             |        P=0.491N         (e)              P=0.262          P=0.485          P=0.229          (e)             | 
|LOGISTIC REGRESSION|        P=0.503N         (e)              P=0.231          P=0.473          P=0.198          (e)             | 
|COCH-ARM / FISHERS |        P=0.484N         (e)              P=0.248          P=0.500          P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.313          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Nasolacrimal Duct                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        2/39.01          0/31.01          0/41.12          0/36.33          0/38.33          2/33.11         | 
|POLY-3 PERCENT (g) |        5.1%             0.0%             0.0%             0.0%             0.0%             6.0%            | 
|TERMINAL (d)       |        2/24 (8%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        731 (T)          ---              ---              ---              ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.151          P=0.330N         P=0.204N         P=0.267N         P=0.278N         P=0.648         | 
|POLY 3             |        P=0.157          P=0.291N         P=0.225N         P=0.253N         P=0.240N         P=0.635         | 
|POLY 1.5           |        P=0.158          P=0.271N         P=0.230N         P=0.250N         P=0.238N         P=0.650         | 
|POLY 6             |        P=0.153          P=0.310N         P=0.217N         P=0.253N         P=0.243N         P=0.624         | 
|LOGISTIC REGRESSION|        P=0.151          (e)              (e)              (e)              (e)              P=0.648         | 
|COCH-ARM / FISHERS |        P=0.156          P=0.243N         P=0.248N         P=0.248N         P=0.248N         P=0.676         | 
|ORDER RESTRICTED   |        P=0.095          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        2/53 (4%)        0/53 (0%)        1/53 (2%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          2/42.71          0/36.33          1/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.7%             0.0%             2.6%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        1/20 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              429              ---              731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.508N         (e)              P=0.252          (e)              P=0.464          (e)             | 
|POLY 3             |        P=0.489N         (e)              P=0.258          (e)              P=0.497          (e)             | 
|POLY 1.5           |        P=0.494N         (e)              P=0.250          (e)              P=0.499          (e)             | 
|POLY 6             |        P=0.483N         (e)              P=0.269          (e)              P=0.494          (e)             | 
|LOGISTIC REGRESSION|        P=0.497N         (e)              P=0.099          (e)              P=0.464          (e)             | 
|COCH-ARM / FISHERS |        P=0.510N         (e)              P=0.248          (e)              P=0.500          (e)             | 
|ORDER RESTRICTED   |        P=0.432          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Septum                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        3/54 (6%)        5/53 (9%)        3/53 (6%)        7/53 (13%)       6/51 (12%)      | 
|POLY-3 RATE (b)    |        4/40.77          3/32.94          5/41.91          3/38.34          7/39.64          6/34.73         | 
|POLY-3 PERCENT (g) |        9.8%             9.1%             11.9%            7.8%             17.7%            17.3%           | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        3/28 (11%)       0/21 (0%)        3/20 (15%)       2/21 (10%)      | 
|FIRST INCIDENCE    |        211              310              501              360              579              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.147          P=0.618N         P=0.562          P=0.534N         P=0.231          P=0.283         | 
|POLY 3             |        P=0.129          P=0.615N         P=0.517          P=0.534N         P=0.241          P=0.270         | 
|POLY 1.5           |        P=0.141          P=0.574N         P=0.509          P=0.530N         P=0.248          P=0.293         | 
|POLY 6             |        P=0.121          P=0.652N         P=0.535          P=0.533N         P=0.235          P=0.257         | 
|LOGISTIC REGRESSION|        P=0.165          P=0.289N         P=0.474          P=0.380N         P=0.263          P=0.376         | 
|COCH-ARM / FISHERS |        P=0.160          P=0.489N         P=0.500          P=0.500N         P=0.263          P=0.346         | 
|ORDER RESTRICTED   |        P=0.261          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Turbinate                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/53 (15%)       3/54 (6%)        5/53 (9%)        9/53 (17%)       10/53 (19%)      10/51 (20%)     | 
|POLY-3 RATE (b)    |        8/42.11          3/33.77          5/41.91          9/39.90          10/40.29         10/36.05        | 
|POLY-3 PERCENT (g) |        19.0%            8.9%             11.9%            22.6%            24.8%            27.7%           | 
|TERMINAL (d)       |        2/24 (8%)        0/16 (0%)        4/28 (14%)       3/21 (14%)       4/20 (20%)       4/21 (19%)      | 
|FIRST INCIDENCE    |        211              261              429              360              360              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.065          P=0.197N         P=0.224N         P=0.424          P=0.345          P=0.293         | 
|POLY 3             |        P=0.049 *        P=0.181N         P=0.275N         P=0.450          P=0.353          P=0.258         | 
|POLY 1.5           |        P=0.055          P=0.146N         P=0.277N         P=0.452          P=0.372          P=0.291         | 
|POLY 6             |        P=0.044 *        P=0.221N         P=0.270N         P=0.458          P=0.332          P=0.234         | 
|LOGISTIC REGRESSION|        P=0.070          P=0.017N*        P=0.306N         P=0.560          P=0.399          P=0.402         | 
|COCH-ARM / FISHERS |        P=0.066          P=0.095N         P=0.278N         P=0.500          P=0.398          P=0.364         | 
|ORDER RESTRICTED   |        P=0.087          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        21/21 (100%)     10/12 (83%)      16/16 (100%)     11/12 (92%)      16/16 (100%)     25/25 (100%)    | 
|POLY-3 RATE (b)    |        21/21.00         10/11.60         16/16.00         11/12.00         16/16.00         25/25.00        | 
|POLY-3 PERCENT (g) |        100.0%           86.2%            100.0%           91.7%            100.0%           100.0%          | 
|TERMINAL (d)       |        10/10 (100%)     2/3 (67%)        10/10 (100%)     7/8 (88%)        8/8 (100%)       12/12 (100%)    | 
|FIRST INCIDENCE    |        211              310              418              528              383              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.024 *        P=0.405N         (e)              P=0.056N         (e)              (e)             | 
|POLY 3             |        P=0.270          P=0.161N         (e)              P=0.387N         (e)              (e)             | 
|POLY 1.5           |        P=0.248          P=0.135N         (e)              P=0.387N         (e)              (e)             | 
|POLY 6             |        P=0.306          P=0.220N         (e)              P=0.387N         (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.241          P=0.073N         (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.233          P=0.125N         (e)              P=0.364N         (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.171          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        47/53 (89%)      43/53 (81%)      42/53 (79%)      38/53 (72%)      44/53 (83%)      39/50 (78%)     | 
|POLY-3 RATE (b)    |        47/51.19         43/47.35         42/49.67         38/45.27         44/48.54         39/46.48        | 
|POLY-3 PERCENT (g) |        91.8%            90.8%            84.6%            83.9%            90.7%            83.9%           | 
|TERMINAL (d)       |        22/24 (92%)      14/16 (88%)      22/28 (79%)      18/21 (86%)      18/20 (90%)      15/21 (71%)     | 
|FIRST INCIDENCE    |        211              250              418              263              383              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.526          P=0.122          P=0.102N         P=0.288N         P=0.498          P=0.502N        | 
|POLY 3             |        P=0.254N         P=0.578N         P=0.188N         P=0.164N         P=0.567N         P=0.171N        | 
|POLY 1.5           |        P=0.297N         P=0.480N         P=0.170N         P=0.101N         P=0.461N         P=0.166N        | 
|POLY 6             |        P=0.221N         P=0.598N         P=0.198N         P=0.242N         P=0.649N         P=0.166N        | 
|LOGISTIC REGRESSION|        P=0.400N         P=0.364N         P=0.132N         P=0.046N*        P=0.285N         P=0.128N        | 
|COCH-ARM / FISHERS |        P=0.370N         P=0.208N         P=0.145N         P=0.025N*        P=0.289N         P=0.116N        | 
|ORDER RESTRICTED   |        P=0.164N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        14/53 (26%)      7/53 (13%)       17/53 (32%)      17/53 (32%)      16/53 (30%)      17/50 (34%)     | 
|POLY-3 RATE (b)    |        14/41.40         7/32.97          17/43.79         17/39.33         16/40.30         17/36.24        | 
|POLY-3 PERCENT (g) |        33.8%            21.2%            38.8%            43.2%            39.7%            46.9%           | 
|TERMINAL (d)       |        6/24 (25%)       3/16 (19%)       11/28 (39%)      9/21 (43%)       9/20 (45%)       12/21 (57%)     | 
|FIRST INCIDENCE    |        557              261              443              360              479              443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.097          P=0.288N         P=0.502          P=0.240          P=0.299          P=0.175         | 
|POLY 3             |        P=0.090          P=0.171N         P=0.398          P=0.256          P=0.370          P=0.165         | 
|POLY 1.5           |        P=0.102          P=0.127N         P=0.376          P=0.270          P=0.396          P=0.199         | 
|POLY 6             |        P=0.073          P=0.228N         P=0.425          P=0.248          P=0.327          P=0.133         | 
|LOGISTIC REGRESSION|        P=0.080          P=0.146N         P=0.380          P=0.255          P=0.386          P=0.166         | 
|COCH-ARM / FISHERS |        P=0.114          P=0.071N         P=0.335          P=0.335          P=0.415          P=0.266         | 
|ORDER RESTRICTED   |        P=0.062          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        2/53 (4%)        1/53 (2%)        5/53 (9%)        7/50 (14%)      | 
|POLY-3 RATE (b)    |        0/39.01          0/30.84          2/41.12          1/36.55          5/38.97          7/33.89         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.9%             2.7%             12.8%            20.7%           | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        2/28 (7%)        0/21 (0%)        2/20 (10%)       4/21 (19%)      | 
|FIRST INCIDENCE    |        ---              ---              731 (T)          675              617              501             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P=0.272          P=0.507          P=0.031 *        P=0.006 **      | 
|POLY 3             |        P<0.001 **       (e)              P=0.249          P=0.487          P=0.029 *        P=0.004 **      | 
|POLY 1.5           |        P<0.001 **       (e)              P=0.244          P=0.489          P=0.030 *        P=0.004 **      | 
|POLY 6             |        P<0.001 **       (e)              P=0.256          P=0.487          P=0.029 *        P=0.003 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              P=0.272          P=0.488          P=0.030 *        P=0.004 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.248          P=0.500          P=0.028 *        P=0.005 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oviduct                                                                                                                          | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/38 (3%)        2/44 (5%)        1/35 (3%)        1/39 (3%)        0/45 (0%)       | 
|POLY-3 RATE (b)    |        0/37.44          1/22.64          2/34.18          1/23.85          1/28.49          0/29.26         | 
|POLY-3 PERCENT (g) |        0.0%             4.4%             5.9%             4.2%             3.5%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/13 (0%)        2/22 (9%)        1/12 (8%)        1/16 (6%)        0/19 (0%)       | 
|FIRST INCIDENCE    |        ---              557              731 (T)          731 (T)          731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.315N         P=0.446          P=0.218          P=0.362          P=0.419          (e)             | 
|POLY 3             |        P=0.328N         P=0.402          P=0.216          P=0.410          P=0.445          (e)             | 
|POLY 1.5           |        P=0.318N         P=0.414          P=0.214          P=0.415          P=0.448          (e)             | 
|POLY 6             |        P=0.337N         P=0.396          P=0.220          P=0.404          P=0.441          (e)             | 
|LOGISTIC REGRESSION|        P=0.322N         P=0.486          P=0.218          P=0.362          P=0.419          (e)             | 
|COCH-ARM / FISHERS |        P=0.303N         P=0.432          P=0.216          P=0.412          P=0.438          (e)             | 
|ORDER RESTRICTED   |        P=0.319          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oviduct                                                                                                                          | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/38 (0%)        2/44 (5%)        1/35 (3%)        5/39 (13%)       7/45 (16%)      | 
|POLY-3 RATE (b)    |        1/37.44          0/22.08          2/34.18          1/24.06          5/29.02          7/30.90         | 
|POLY-3 PERCENT (g) |        2.7%             0.0%             5.9%             4.2%             17.2%            22.7%           | 
|TERMINAL (d)       |        1/24 (4%)        0/13 (0%)        2/22 (9%)        0/12 (0%)        3/16 (19%)       3/19 (16%)      | 
|FIRST INCIDENCE    |        731 (T)          ---              731 (T)          675              617              486             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.622N         P=0.469          P=0.686          P=0.053          P=0.019 *       | 
|POLY 3             |        P<0.001 **       P=0.602N         P=0.468          P=0.659          P=0.049 *        P=0.012 *       | 
|POLY 1.5           |        P<0.001 **       P=0.588N         P=0.464          P=0.664          P=0.051          P=0.014 *       | 
|POLY 6             |        P<0.001 **       P=0.611N         P=0.475          P=0.652          P=0.047 *        P=0.012 *       | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              P=0.469          P=0.651          P=0.047 *        P=0.015 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.568N         P=0.452          P=0.657          P=0.055          P=0.020 *       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        1/53 (2%)        1/53 (2%)        0/53 (0%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        2/39.01          0/31.01          1/41.12          1/36.33          0/38.33          2/33.11         | 
|POLY-3 PERCENT (g) |        5.1%             0.0%             2.4%             2.8%             0.0%             6.0%            | 
|TERMINAL (d)       |        2/24 (8%)        0/16 (0%)        1/28 (4%)        1/21 (5%)        0/20 (0%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        731 (T)          ---              731 (T)          731 (T)          ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.327          P=0.330N         P=0.446N         P=0.547N         P=0.278N         P=0.648         | 
|POLY 3             |        P=0.343          P=0.291N         P=0.482N         P=0.525N         P=0.240N         P=0.635         | 
|POLY 1.5           |        P=0.343          P=0.271N         P=0.489N         P=0.520N         P=0.238N         P=0.650         | 
|POLY 6             |        P=0.340          P=0.310N         P=0.469N         P=0.527N         P=0.243N         P=0.624         | 
|LOGISTIC REGRESSION|        P=0.327          (e)              P=0.446N         P=0.547N         (e)              P=0.648         | 
|COCH-ARM / FISHERS |        P=0.335          P=0.243N         P=0.500N         P=0.500N         P=0.248N         P=0.676         | 
|ORDER RESTRICTED   |        P=0.285          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        1/53 (2%)        1/53 (2%)        0/53 (0%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        1/39.01          0/31.01          1/41.12          1/36.33          0/38.33          2/33.11         | 
|POLY-3 PERCENT (g) |        2.6%             0.0%             2.4%             2.8%             0.0%             6.0%            | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        1/28 (4%)        1/21 (5%)        0/20 (0%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        731 (T)          ---              731 (T)          731 (T)          ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.213          P=0.581N         P=0.728N         P=0.733          P=0.536N         P=0.453         | 
|POLY 3             |        P=0.222          P=0.545N         P=0.749N         P=0.746          P=0.503N         P=0.443         | 
|POLY 1.5           |        P=0.224          P=0.529N         P=0.754N         P=0.748          P=0.501N         P=0.458         | 
|POLY 6             |        P=0.220          P=0.560N         P=0.742N         P=0.745          P=0.506N         P=0.432         | 
|LOGISTIC REGRESSION|        P=0.213          (e)              P=0.728N         P=0.733          (e)              P=0.453         | 
|COCH-ARM / FISHERS |        P=0.220          P=0.495N         P=0.752N         P=0.752N         P=0.500N         P=0.485         | 
|ORDER RESTRICTED   |        P=0.169          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        3/39.01          0/31.01          0/41.12          0/36.33          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        7.7%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        3/24 (13%)       0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        731 (T)          ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.267N         P=0.199N         P=0.094N         P=0.143N         P=0.153N         P=0.143N        | 
|POLY 3             |        P=0.235N         P=0.164N         P=0.109N         P=0.131N         P=0.121N         P=0.149N        | 
|POLY 1.5           |        P=0.241N         P=0.146N         P=0.113N         P=0.129N         P=0.120N         P=0.141N        | 
|POLY 6             |        P=0.234N         P=0.181N         P=0.102N         P=0.131N         P=0.122N         P=0.155N        | 
|LOGISTIC REGRESSION|        P=0.267N         (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.263N         P=0.118N         P=0.121N         P=0.121N         P=0.121N         P=0.129N        | 
|ORDER RESTRICTED   |        P=0.004N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        1/53 (2%)        1/53 (2%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          1/36.55          1/38.95          2/34.31         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             2.7%             2.6%             5.8%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              675              529              438             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.041 *        (e)              (e)              P=0.507          P=0.491          P=0.206         | 
|POLY 3             |        P=0.047 *        (e)              (e)              P=0.487          P=0.500          P=0.209         | 
|POLY 1.5           |        P=0.049 *        (e)              (e)              P=0.489          P=0.500          P=0.215         | 
|POLY 6             |        P=0.046 *        (e)              (e)              P=0.487          P=0.499          P=0.206         | 
|LOGISTIC REGRESSION|        P=0.057          (e)              (e)              P=0.488          P=0.488          P=0.273         | 
|COCH-ARM / FISHERS |        P=0.051          (e)              (e)              P=0.500          P=0.500          P=0.238         | 
|ORDER RESTRICTED   |        P=0.046 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/49 (4%)        0/46 (0%)        0/50 (0%)        1/47 (2%)        0/46 (0%)        1/48 (2%)       | 
|POLY-3 RATE (b)    |        2/36.68          0/27.75          0/38.12          1/32.21          0/32.50          1/31.77         | 
|POLY-3 PERCENT (g) |        5.5%             0.0%             0.0%             3.1%             0.0%             3.2%            | 
|TERMINAL (d)       |        2/23 (9%)        0/15 (0%)        0/25 (0%)        1/18 (6%)        0/16 (0%)        0/20 (0%)       | 
|FIRST INCIDENCE    |        731 (T)          ---              ---              731 (T)          ---              432             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.608          P=0.336N         P=0.219N         P=0.586N         P=0.320N         P=0.537N        | 
|POLY 3             |        P=0.615          P=0.303N         P=0.228N         P=0.545N         P=0.264N         P=0.550N        | 
|POLY 1.5           |        P=0.617          P=0.284N         P=0.229N         P=0.538N         P=0.258N         P=0.536N        | 
|POLY 6             |        P=0.612          P=0.319N         P=0.224N         P=0.552N         P=0.273N         P=0.560N        | 
|LOGISTIC REGRESSION|        P=0.606          (e)              (e)              P=0.586N         (e)              P=0.514N        | 
|COCH-ARM / FISHERS |        P=0.616          P=0.263N         P=0.242N         P=0.516N         P=0.263N         P=0.508N        | 
|ORDER RESTRICTED   |        P=0.180N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 43      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/53 (28%)      16/54 (30%)      20/53 (38%)      26/53 (49%)      28/53 (53%)      14/50 (28%)     | 
|POLY-3 RATE (b)    |        15/41.30         16/33.39         20/43.37         26/40.45         28/42.22         14/34.86        | 
|POLY-3 PERCENT (g) |        36.3%            47.9%            46.1%            64.3%            66.3%            40.2%           | 
|TERMINAL (d)       |        8/24 (33%)       9/16 (56%)       13/28 (46%)      14/21 (67%)      14/20 (70%)      8/21 (38%)      | 
|FIRST INCIDENCE    |        211              506              429              443              497              486             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.404N         P=0.125          P=0.396          P=0.016 *        P=0.006 **       P=0.484         | 
|POLY 3             |        P=0.448N         P=0.212          P=0.237          P=0.006 **       P=0.003 **       P=0.456         | 
|POLY 1.5           |        P=0.396N         P=0.303          P=0.220          P=0.008 **       P=0.004 **       P=0.502         | 
|POLY 6             |        P=0.505N         P=0.153          P=0.275          P=0.007 **       P=0.003 **       P=0.427         | 
|LOGISTIC REGRESSION|        P=0.418N         P=0.197          P=0.247          P=0.009 **       P=0.005 **       P=0.463         | 
|COCH-ARM / FISHERS |        P=0.342N         P=0.525          P=0.204          P=0.023 *        P=0.009 **       P=0.574N        | 
|ORDER RESTRICTED   |        P=0.035 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        1/53 (2%)        0/53 (0%)        1/53 (2%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        2/39.01          0/31.01          1/41.23          0/36.33          1/38.47          0/32.96         | 
|POLY-3 PERCENT (g) |        5.1%             0.0%             2.4%             0.0%             2.6%             0.0%            | 
|TERMINAL (d)       |        2/24 (8%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        731 (T)          ---              701              ---              696              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.369N         P=0.330N         P=0.444N         P=0.267N         P=0.546N         P=0.267N        | 
|POLY 3             |        P=0.342N         P=0.291N         P=0.481N         P=0.253N         P=0.505N         P=0.275N        | 
|POLY 1.5           |        P=0.345N         P=0.271N         P=0.488N         P=0.250N         P=0.502N         P=0.267N        | 
|POLY 6             |        P=0.341N         P=0.310N         P=0.467N         P=0.253N         P=0.509N         P=0.281N        | 
|LOGISTIC REGRESSION|        P=0.371N         (e)              P=0.453N         (e)              P=0.518N         (e)             | 
|COCH-ARM / FISHERS |        P=0.361N         P=0.243N         P=0.500N         P=0.248N         P=0.500N         P=0.262N        | 
|ORDER RESTRICTED   |        P=0.088N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 44      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        23/53 (43%)      18/54 (33%)      22/53 (42%)      16/53 (30%)      23/53 (43%)      25/50 (50%)     | 
|POLY-3 RATE (b)    |        23/43.52         18/37.90         22/46.11         16/38.87         23/43.74         25/39.73        | 
|POLY-3 PERCENT (g) |        52.9%            47.5%            47.7%            41.2%            52.6%            62.9%           | 
|TERMINAL (d)       |        13/24 (54%)      4/16 (25%)       12/28 (43%)      10/21 (48%)      10/20 (50%)      12/21 (57%)     | 
|FIRST INCIDENCE    |        507              438              443              452              497              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.060          P=0.458          P=0.340N         P=0.218N         P=0.410          P=0.180         | 
|POLY 3             |        P=0.054          P=0.394N         P=0.389N         P=0.192N         P=0.578N         P=0.230         | 
|POLY 1.5           |        P=0.058          P=0.331N         P=0.425N         P=0.166N         P=0.574N         P=0.249         | 
|POLY 6             |        P=0.057          P=0.420N         P=0.348N         P=0.223N         P=0.579N         P=0.240         | 
|LOGISTIC REGRESSION|        P=0.051          P=0.369N         P=0.467N         P=0.158N         P=0.567          P=0.210         | 
|COCH-ARM / FISHERS |        P=0.065          P=0.192N         P=0.500N         P=0.113N         P=0.578N         P=0.318         | 
|ORDER RESTRICTED   |        P=0.117          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        46/53 (87%)      48/54 (89%)      52/53 (98%)      48/53 (91%)      46/53 (87%)      47/51 (92%)     | 
|POLY-3 RATE (b)    |        46/50.02         48/51.77         52/52.78         48/50.29         46/51.38         47/48.75        | 
|POLY-3 PERCENT (g) |        92.0%            92.7%            98.5%            95.5%            89.5%            96.4%           | 
|TERMINAL (d)       |        23/24 (96%)      14/16 (88%)      28/28 (100%)     20/21 (95%)      19/20 (95%)      21/21 (100%)    | 
|FIRST INCIDENCE    |        399              250              418              222              341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.349          P=0.026 *        P=0.521          P=0.224          P=0.330          P=0.143         | 
|POLY 3             |        P=0.460          P=0.601          P=0.097          P=0.360          P=0.465N         P=0.269         | 
|POLY 1.5           |        P=0.494          P=0.561          P=0.064          P=0.332          P=0.509N         P=0.279         | 
|POLY 6             |        P=0.433          P=0.683          P=0.171          P=0.446          P=0.410N         P=0.291         | 
|LOGISTIC REGRESSION|        P=0.489          P=0.436          P=0.041 *        P=0.258          P=0.612          P=0.199         | 
|COCH-ARM / FISHERS |        P=0.508          P=0.485          P=0.030 *        P=0.380          P=0.612N         P=0.286         | 
|ORDER RESTRICTED   |        P=0.258          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 45      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        47/53 (89%)      42/54 (78%)      47/53 (89%)      49/53 (92%)      49/53 (92%)      46/51 (90%)     | 
|POLY-3 RATE (b)    |        47/51.94         42/45.63         47/49.60         49/51.60         49/50.56         46/47.77        | 
|POLY-3 PERCENT (g) |        90.5%            92.0%            94.8%            95.0%            96.9%            96.3%           | 
|TERMINAL (d)       |        22/24 (92%)      15/16 (94%)      28/28 (100%)     20/21 (95%)      19/20 (95%)      20/21 (95%)     | 
|FIRST INCIDENCE    |        211              250              418              59               360              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.220          P=0.145          P=0.263N         P=0.237          P=0.250          P=0.217         | 
|POLY 3             |        P=0.175          P=0.539          P=0.308          P=0.296          P=0.155          P=0.203         | 
|POLY 1.5           |        P=0.165          P=0.517N         P=0.438          P=0.311          P=0.202          P=0.268         | 
|POLY 6             |        P=0.214          P=0.410          P=0.196          P=0.302          P=0.158          P=0.187         | 
|LOGISTIC REGRESSION|        P=0.182          P=0.286N         P=0.585N         P=0.391          P=0.369          P=0.446         | 
|COCH-ARM / FISHERS |        P=0.220          P=0.105N         P=0.620N         P=0.371          P=0.371          P=0.527         | 
|ORDER RESTRICTED   |        P=0.102          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        6/54 (11%)       2/53 (4%)        3/53 (6%)        3/53 (6%)        3/51 (6%)       | 
|POLY-3 RATE (b)    |        1/39.45          6/33.78          2/41.67          3/37.82          3/39.41          3/34.51         | 
|POLY-3 PERCENT (g) |        2.5%             17.8%            4.8%             7.9%             7.6%             8.7%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        603              479              636              443              617              501             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.511          P=0.031 *        P=0.542          P=0.284          P=0.310          P=0.234         | 
|POLY 3             |        P=0.500          P=0.033 *        P=0.519          P=0.289          P=0.304          P=0.257         | 
|POLY 1.5           |        P=0.525          P=0.040 *        P=0.512          P=0.290          P=0.305          P=0.268         | 
|POLY 6             |        P=0.483          P=0.030 *        P=0.533          P=0.290          P=0.303          P=0.254         | 
|LOGISTIC REGRESSION|        P=0.579          P=0.064          P=0.495          P=0.343          P=0.306          P=0.315         | 
|COCH-ARM / FISHERS |        P=0.570          P=0.059          P=0.500          P=0.309          P=0.309          P=0.294         | 
|ORDER RESTRICTED   |        P=0.269          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 46      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Red Pulp                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        2/53 (4%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          2/37.11          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.4%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              443              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.547N         (e)              (e)              P=0.225          (e)              (e)             | 
|POLY 3             |        P=0.547N         (e)              (e)              P=0.225          (e)              (e)             | 
|POLY 1.5           |        P=0.546N         (e)              (e)              P=0.227          (e)              (e)             | 
|POLY 6             |        P=0.550N         (e)              (e)              P=0.226          (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.539N         (e)              (e)              P=0.250          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.544N         (e)              (e)              P=0.248          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.376          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        0/53 (0%)        0/53 (0%)        1/53 (2%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        0/39.01          1/31.97          0/41.12          0/36.33          1/38.34          2/33.98         | 
|POLY-3 PERCENT (g) |        0.0%             3.1%             0.0%             0.0%             2.6%             5.9%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              250              ---              ---              729              586             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.058          P=0.508          (e)              (e)              P=0.473          P=0.188         | 
|POLY 3             |        P=0.055          P=0.461          (e)              (e)              P=0.497          P=0.207         | 
|POLY 1.5           |        P=0.060          P=0.475          (e)              (e)              P=0.499          P=0.213         | 
|POLY 6             |        P=0.053          P=0.448          (e)              (e)              P=0.494          P=0.204         | 
|LOGISTIC REGRESSION|        P=0.076          P=0.665          (e)              (e)              P=0.482          P=0.236         | 
|COCH-ARM / FISHERS |        P=0.068          P=0.505          (e)              (e)              P=0.500          P=0.238         | 
|ORDER RESTRICTED   |        P=0.045 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 47      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        4/54 (7%)        2/53 (4%)        6/53 (11%)       4/53 (8%)        4/51 (8%)       | 
|POLY-3 RATE (b)    |        3/39.67          4/32.27          2/41.61          6/37.17          4/38.59          4/35.48         | 
|POLY-3 PERCENT (g) |        7.6%             12.4%            4.8%             16.1%            10.4%            11.3%           | 
|TERMINAL (d)       |        2/24 (8%)        2/16 (13%)       0/28 (0%)        4/21 (19%)       1/20 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        507              250              656              526              696              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.419          P=0.337          P=0.432N         P=0.197          P=0.447          P=0.410         | 
|POLY 3             |        P=0.425          P=0.388          P=0.478N         P=0.207          P=0.485          P=0.438         | 
|POLY 1.5           |        P=0.437          P=0.430          P=0.487N         P=0.213          P=0.493          P=0.449         | 
|POLY 6             |        P=0.418          P=0.353          P=0.461N         P=0.205          P=0.476          P=0.439         | 
|LOGISTIC REGRESSION|        P=0.446          P=0.484          P=0.494N         P=0.212          P=0.488          P=0.524         | 
|COCH-ARM / FISHERS |        P=0.458          P=0.511          P=0.500N         P=0.244          P=0.500          P=0.478         | 
|ORDER RESTRICTED   |        P=0.431          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        3/53 (6%)        3/53 (6%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          3/36.86          3/39.24          2/34.27         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             8.1%             7.6%             5.8%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        2/21 (10%)       0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              568              579              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.127          (e)              (e)              P=0.101          P=0.121          P=0.206         | 
|POLY 3             |        P=0.126          (e)              (e)              P=0.108          P=0.119          P=0.208         | 
|POLY 1.5           |        P=0.131          (e)              (e)              P=0.109          P=0.119          P=0.215         | 
|POLY 6             |        P=0.123          (e)              (e)              P=0.108          P=0.119          P=0.206         | 
|LOGISTIC REGRESSION|        P=0.141          (e)              (e)              P=0.110          P=0.121          P=0.269         | 
|COCH-ARM / FISHERS |        P=0.143          (e)              (e)              P=0.121          P=0.121          P=0.238         | 
|ORDER RESTRICTED   |        P=0.076          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 48      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        0/53 (0%)        2/53 (4%)        2/53 (4%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          1/31.72          0/41.12          2/36.69          2/38.81          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             0.0%             5.5%             5.2%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              479              ---              675              636              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.535N         P=0.473          (e)              P=0.227          P=0.236          (e)             | 
|POLY 3             |        P=0.555N         P=0.459          (e)              P=0.223          P=0.235          (e)             | 
|POLY 1.5           |        P=0.535N         P=0.474          (e)              P=0.225          P=0.237          (e)             | 
|POLY 6             |        P=0.572N         P=0.447          (e)              P=0.224          P=0.234          (e)             | 
|LOGISTIC REGRESSION|        P=0.507N         P=0.599          (e)              P=0.223          P=0.236          (e)             | 
|COCH-ARM / FISHERS |        P=0.503N         P=0.505          (e)              P=0.248          P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.268          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        2/53 (4%)        3/53 (6%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          2/36.86          3/39.24          1/33.59         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.4%             7.6%             3.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              568              579              586             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.283          (e)              (e)              P=0.214          P=0.121          P=0.449         | 
|POLY 3             |        P=0.270          (e)              (e)              P=0.224          P=0.119          P=0.470         | 
|POLY 1.5           |        P=0.283          (e)              (e)              P=0.226          P=0.119          P=0.477         | 
|POLY 6             |        P=0.261          (e)              (e)              P=0.225          P=0.119          P=0.467         | 
|LOGISTIC REGRESSION|        P=0.303          (e)              (e)              P=0.230          P=0.121          P=0.509         | 
|COCH-ARM / FISHERS |        P=0.307          (e)              (e)              P=0.248          P=0.121          P=0.490         | 
|ORDER RESTRICTED   |        P=0.126          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 49      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        1/53 (2%)        2/53 (4%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        1/39.23          0/31.01          1/41.46          2/36.48          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        2.6%             0.0%             2.4%             5.5%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        672              ---              636              693              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.306N         P=0.574N         P=0.720N         P=0.467          P=0.507N         P=0.538N        | 
|POLY 3             |        P=0.277N         P=0.546N         P=0.749N         P=0.475          P=0.505N         P=0.534N        | 
|POLY 1.5           |        P=0.279N         P=0.529N         P=0.753N         P=0.479          P=0.502N         P=0.525N        | 
|POLY 6             |        P=0.278N         P=0.562N         P=0.741N         P=0.472          P=0.509N         P=0.541N        | 
|LOGISTIC REGRESSION|        P=0.296N         P=0.543N         P=0.761N         P=0.474          P=0.502N         P=0.528N        | 
|COCH-ARM / FISHERS |        P=0.288N         P=0.495N         P=0.752N         P=0.500          P=0.500N         P=0.510N        | 
|ORDER RESTRICTED   |        P=0.361N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        2/53 (4%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          2/36.48          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.5%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              693              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.558N         (e)              (e)              P=0.209          (e)              (e)             | 
|POLY 3             |        P=0.549N         (e)              (e)              P=0.222          (e)              (e)             | 
|POLY 1.5           |        P=0.548N         (e)              (e)              P=0.224          (e)              (e)             | 
|POLY 6             |        P=0.553N         (e)              (e)              P=0.221          (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.559N         (e)              (e)              P=0.219          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.544N         (e)              (e)              P=0.248          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.374          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 50      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        8/54 (15%)       8/53 (15%)       10/53 (19%)      10/53 (19%)      2/51 (4%)       | 
|POLY-3 RATE (b)    |        5/40.87          8/35.58          8/44.05          10/38.79         10/40.92         2/33.11         | 
|POLY-3 PERCENT (g) |        12.2%            22.5%            18.2%            25.8%            24.4%            6.0%            | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        2/28 (7%)        4/21 (19%)       5/20 (25%)       2/21 (10%)      | 
|FIRST INCIDENCE    |        551              250              429              452              467              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.086N         P=0.163          P=0.326          P=0.109          P=0.113          P=0.318N        | 
|POLY 3             |        P=0.115N         P=0.187          P=0.324          P=0.101          P=0.124          P=0.308N        | 
|POLY 1.5           |        P=0.087N         P=0.217          P=0.307          P=0.106          P=0.129          P=0.278N        | 
|POLY 6             |        P=0.154N         P=0.167          P=0.348          P=0.098          P=0.115          P=0.339N        | 
|LOGISTIC REGRESSION|        P=0.059N         P=0.410          P=0.243          P=0.121          P=0.133          P=0.257N        | 
|COCH-ARM / FISHERS |        P=0.060N         P=0.290          P=0.278          P=0.132          P=0.132          P=0.235N        | 
|ORDER RESTRICTED   |        P=0.094N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        38/48 (79%)      38/53 (72%)      37/52 (71%)      35/53 (66%)      41/53 (77%)      30/47 (64%)     | 
|POLY-3 RATE (b)    |        38/45.92         38/44.44         37/47.29         35/45.23         41/48.12         30/40.74        | 
|POLY-3 PERCENT (g) |        82.8%            85.5%            78.3%            77.4%            85.2%            73.6%           | 
|TERMINAL (d)       |        19/23 (83%)      13/16 (81%)      21/27 (78%)      16/21 (76%)      17/20 (85%)      11/18 (61%)     | 
|FIRST INCIDENCE    |        211              352              429              263              341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.434N         P=0.074          P=0.264N         P=0.547N         P=0.241          P=0.515N        | 
|POLY 3             |        P=0.182N         P=0.470          P=0.381N         P=0.344N         P=0.481          P=0.208N        | 
|POLY 1.5           |        P=0.148N         P=0.582          P=0.329N         P=0.273N         P=0.563          P=0.147N        | 
|POLY 6             |        P=0.232N         P=0.444          P=0.409N         P=0.385N         P=0.398          P=0.262N        | 
|LOGISTIC REGRESSION|        P=0.211N         P=0.461N         P=0.235N         P=0.147N         P=0.515N         P=0.070N        | 
|COCH-ARM / FISHERS |        P=0.172N         P=0.263N         P=0.245N         P=0.105N         P=0.509N         P=0.076N        | 
|ORDER RESTRICTED   |        P=0.169N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 51      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/48 (0%)        3/53 (6%)        0/52 (0%)        0/53 (0%)        0/53 (0%)        0/47 (0%)       | 
|POLY-3 RATE (b)    |        0/35.93          3/32.64          0/40.12          0/36.33          0/38.33          0/29.69         | 
|POLY-3 PERCENT (g) |        0.0%             9.2%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/23 (0%)        0/16 (0%)        0/27 (0%)        0/21 (0%)        0/20 (0%)        0/18 (0%)       | 
|FIRST INCIDENCE    |        ---              261              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.275N         P=0.112          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.318N         P=0.101          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.300N         P=0.113          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.335N         P=0.092          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.243N         P=0.310          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.272N         P=0.141          (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.121N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        19/51 (37%)      17/52 (33%)      23/53 (43%)      17/53 (32%)      19/53 (36%)      16/51 (31%)     | 
|POLY-3 RATE (b)    |        19/40.16         17/33.23         23/42.07         17/38.74         19/40.97         16/35.74        | 
|POLY-3 PERCENT (g) |        47.3%            51.2%            54.7%            43.9%            46.4%            44.8%           | 
|TERMINAL (d)       |        12/24 (50%)      9/16 (56%)       20/28 (71%)      9/21 (43%)       11/20 (55%)      11/21 (52%)     | 
|FIRST INCIDENCE    |        555              528              530              526              479              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.395N         P=0.237          P=0.503          P=0.564N         P=0.407          P=0.551N        | 
|POLY 3             |        P=0.323N         P=0.461          P=0.320          P=0.467N         P=0.557N         P=0.504N        | 
|POLY 1.5           |        P=0.289N         P=0.566          P=0.331          P=0.448N         P=0.536N         P=0.434N        | 
|POLY 6             |        P=0.386N         P=0.389          P=0.308          P=0.475N         P=0.589N         P=0.585N        | 
|LOGISTIC REGRESSION|        P=0.406N         P=0.335          P=0.421          P=0.494N         P=0.582          P=0.554N        | 
|COCH-ARM / FISHERS |        P=0.282N         P=0.390N         P=0.331          P=0.364N         P=0.522N         P=0.338N        | 
|ORDER RESTRICTED   |        P=0.517N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 52      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/51 (2%)        0/52 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        1/38.95          0/30.30          0/41.12          0/36.33          2/38.75          2/33.81         | 
|POLY-3 PERCENT (g) |        2.6%             0.0%             0.0%             0.0%             5.2%             5.9%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        399              ---              ---              ---              647              486             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.067          P=0.538N         P=0.496N         P=0.520N         P=0.500          P=0.452         | 
|POLY 3             |        P=0.068          P=0.549N         P=0.489N         P=0.514N         P=0.498          P=0.451         | 
|POLY 1.5           |        P=0.072          P=0.531N         P=0.490N         P=0.509N         P=0.505          P=0.467         | 
|POLY 6             |        P=0.065          P=0.565N         P=0.485N         P=0.518N         P=0.492          P=0.439         | 
|LOGISTIC REGRESSION|        P=0.081          P=0.340N         P=0.661N         P=0.371N         P=0.516          P=0.573         | 
|COCH-ARM / FISHERS |        P=0.076          P=0.495N         P=0.490N         P=0.490N         P=0.515          P=0.500         | 
|ORDER RESTRICTED   |        P=0.112          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/51 (10%)       9/52 (17%)       9/53 (17%)       12/53 (23%)      10/53 (19%)      17/51 (33%)     | 
|POLY-3 RATE (b)    |        5/39.16          9/34.89          9/43.62          12/38.19         10/41.39         17/39.62        | 
|POLY-3 PERCENT (g) |        12.8%            25.8%            20.6%            31.4%            24.2%            42.9%           | 
|TERMINAL (d)       |        3/24 (13%)       3/16 (19%)       5/28 (18%)       8/21 (38%)       3/20 (15%)       6/21 (29%)      | 
|FIRST INCIDENCE    |        507              261              418              452              360              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.004 **       P=0.087          P=0.275          P=0.035 *        P=0.118          P=0.002 **      | 
|POLY 3             |        P=0.004 **       P=0.126          P=0.254          P=0.040 *        P=0.149          P=0.002 **      | 
|POLY 1.5           |        P=0.004 **       P=0.150          P=0.241          P=0.045 *        P=0.151          P=0.002 **      | 
|POLY 6             |        P=0.004 **       P=0.107          P=0.273          P=0.037 *        P=0.146          P=0.002 **      | 
|LOGISTIC REGRESSION|        P=0.005 **       P=0.279          P=0.210          P=0.045 *        P=0.151          P=0.005 **      | 
|COCH-ARM / FISHERS |        P=0.005 **       P=0.206          P=0.217          P=0.065          P=0.150          P=0.004 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 53      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        33/34 (97%)      13/13 (100%)     19/19 (100%)     21/22 (95%)      23/23 (100%)     35/35 (100%)    | 
|POLY-3 RATE (b)    |        33/33.44         13/13.00         19/19.00         21/22.00         23/23.00         35/35.00        | 
|POLY-3 PERCENT (g) |        98.7%            100.0%           100.0%           95.5%            100.0%           100.0%          | 
|TERMINAL (d)       |        14/14 (100%)     4/4 (100%)       12/12 (100%)     9/10 (90%)       10/10 (100%)     17/17 (100%)    | 
|FIRST INCIDENCE    |        211              261              418              222              383              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.030 *        P=0.161N         P=0.011N*        P=0.136N         P=0.210N         P=0.384         | 
|POLY 3             |        P=0.484          P=0.969          P=0.943          P=0.554N         P=0.927          P=0.890         | 
|POLY 1.5           |        P=0.429          P=0.852          P=0.790          P=0.606N         P=0.758          P=0.685         | 
|POLY 6             |        P=0.556          P=1.000          P=1.000          P=0.481N         P=1.000          P=1.000         | 
|LOGISTIC REGRESSION|        P=0.368          P=0.645          P=0.657          P=0.662N         P=0.585          P=0.490         | 
|COCH-ARM / FISHERS |        P=0.368          P=0.723          P=0.642          P=0.636N         P=0.596          P=0.493         | 
|ORDER RESTRICTED   |        P=0.335          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/53 (15%)       11/53 (21%)      6/53 (11%)       8/53 (15%)       13/53 (25%)      9/50 (18%)      | 
|POLY-3 RATE (b)    |        8/41.11          11/35.14         6/42.66          8/37.88          13/42.45         9/36.88         | 
|POLY-3 PERCENT (g) |        19.5%            31.3%            14.1%            21.1%            30.6%            24.4%           | 
|TERMINAL (d)       |        3/24 (13%)       4/16 (25%)       3/28 (11%)       3/21 (14%)       6/20 (30%)       3/21 (14%)      | 
|FIRST INCIDENCE    |        442              261              443              555              383              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.309          P=0.131          P=0.312N         P=0.543          P=0.137          P=0.359         | 
|POLY 3             |        P=0.313          P=0.174          P=0.356N         P=0.539          P=0.174          P=0.399         | 
|POLY 1.5           |        P=0.325          P=0.212          P=0.366N         P=0.552          P=0.173          P=0.413         | 
|POLY 6             |        P=0.303          P=0.147          P=0.341N         P=0.535          P=0.172          P=0.394         | 
|LOGISTIC REGRESSION|        P=0.343          P=0.288          P=0.390N         P=0.567          P=0.165          P=0.474         | 
|COCH-ARM / FISHERS |        P=0.343          P=0.307          P=0.388N         P=0.607N         P=0.165          P=0.447         | 
|ORDER RESTRICTED   |        P=0.346          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 54      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Transitional Epithelium                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        3/53 (6%)        2/53 (4%)        3/53 (6%)        2/53 (4%)        3/50 (6%)       | 
|POLY-3 RATE (b)    |        0/39.01          3/31.56          2/41.12          3/36.70          2/38.40          3/34.22         | 
|POLY-3 PERCENT (g) |        0.0%             9.5%             4.9%             8.2%             5.2%             8.8%            | 
|TERMINAL (d)       |        0/24 (0%)        1/16 (6%)        2/28 (7%)        1/21 (5%)        1/20 (5%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        ---              622              731 (T)          675              715              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.291          P=0.073          P=0.272          P=0.114          P=0.215          P=0.099         | 
|POLY 3             |        P=0.277          P=0.084          P=0.249          P=0.107          P=0.233          P=0.095         | 
|POLY 1.5           |        P=0.289          P=0.094          P=0.244          P=0.109          P=0.235          P=0.099         | 
|POLY 6             |        P=0.268          P=0.077          P=0.256          P=0.107          P=0.230          P=0.094         | 
|LOGISTIC REGRESSION|        P=0.290          P=0.086          P=0.272          P=0.107          P=0.223          P=0.124         | 
|COCH-ARM / FISHERS |        P=0.309          P=0.121          P=0.248          P=0.121          P=0.248          P=0.111         | 
|ORDER RESTRICTED   |        P=0.090          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Adenomyosis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        0/53 (0%)        1/53 (2%)        0/53 (0%)        1/50 (2%)       | 
|POLY-3 RATE (b)    |        2/39.39          1/31.01          0/41.12          1/36.33          0/38.33          1/32.95         | 
|POLY-3 PERCENT (g) |        5.1%             3.2%             0.0%             2.8%             0.0%             3.0%            | 
|TERMINAL (d)       |        1/24 (4%)        1/16 (6%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        621              731 (T)          ---              731 (T)          ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.635N         P=0.620N         P=0.211N         P=0.531N         P=0.253N         P=0.558N        | 
|POLY 3             |        P=0.634N         P=0.582N         P=0.227N         P=0.528N         P=0.243N         P=0.562N        | 
|POLY 1.5           |        P=0.629N         P=0.552N         P=0.231N         P=0.522N         P=0.240N         P=0.547N        | 
|POLY 6             |        P=0.643N         P=0.610N         P=0.221N         P=0.533N         P=0.247N         P=0.574N        | 
|LOGISTIC REGRESSION|        P=0.646N         P=0.600N         P=0.230N         P=0.525N         P=0.240N         P=0.563N        | 
|COCH-ARM / FISHERS |        P=0.627N         P=0.493N         P=0.248N         P=0.500N         P=0.248N         P=0.522N        | 
|ORDER RESTRICTED   |        P=0.263N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 55      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/32.05          0/41.12          0/36.33          0/38.33          0/32.95         | 
|POLY-3 PERCENT (g) |        0.0%             6.2%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              506              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.410N         P=0.191          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.444N         P=0.196          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.426N         P=0.210          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.459N         P=0.186          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.390N         P=0.265          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.393N         P=0.252          (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.184N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        6/54 (11%)       6/53 (11%)       2/53 (4%)        16/53 (30%)      8/50 (16%)      | 
|POLY-3 RATE (b)    |        5/40.20          6/34.19          6/42.45          2/36.33          16/41.62         8/36.27         | 
|POLY-3 PERCENT (g) |        12.4%            17.6%            14.1%            5.5%             38.5%            22.1%           | 
|TERMINAL (d)       |        3/24 (13%)       0/16 (0%)        4/28 (14%)       2/21 (10%)       7/20 (35%)       3/21 (14%)      | 
|FIRST INCIDENCE    |        442              250              501              731 (T)          452              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.064          P=0.332          P=0.577          P=0.262N         P=0.006 **       P=0.196         | 
|POLY 3             |        P=0.054          P=0.386          P=0.539          P=0.257N         P=0.005 **       P=0.206         | 
|POLY 1.5           |        P=0.057          P=0.424          P=0.523          P=0.247N         P=0.006 **       P=0.215         | 
|POLY 6             |        P=0.053          P=0.363          P=0.563          P=0.265N         P=0.005 **       P=0.206         | 
|LOGISTIC REGRESSION|        P=0.063          P=0.558          P=0.504          P=0.240N         P=0.007 **       P=0.259         | 
|COCH-ARM / FISHERS |        P=0.065          P=0.513          P=0.500          P=0.219N         P=0.007 **       P=0.240         | 
|ORDER RESTRICTED   |        P=0.023 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 56      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        5/53 (9%)        4/53 (8%)        2/53 (4%)        8/50 (16%)      | 
|POLY-3 RATE (b)    |        2/39.39          1/31.67          5/41.33          4/38.05          2/39.57          8/35.02         | 
|POLY-3 PERCENT (g) |        5.1%             3.2%             12.1%            10.5%            5.1%             22.8%           | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        4/28 (14%)       1/21 (5%)        0/20 (0%)        3/21 (14%)      | 
|FIRST INCIDENCE    |        621              506              674              322              502              486             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.009 **       P=0.598N         P=0.288          P=0.315          P=0.672          P=0.031 *       | 
|POLY 3             |        P=0.010 *        P=0.575N         P=0.234          P=0.319          P=0.693N         P=0.026 *       | 
|POLY 1.5           |        P=0.010 *        P=0.548N         P=0.228          P=0.320          P=0.692N         P=0.029 *       | 
|POLY 6             |        P=0.010 *        P=0.599N         P=0.246          P=0.323          P=0.696N         P=0.025 *       | 
|LOGISTIC REGRESSION|        P=0.009 **       P=0.512N         P=0.251          P=0.351          P=0.695          P=0.031 *       | 
|COCH-ARM / FISHERS |        P=0.010 *        P=0.493N         P=0.219          P=0.339          P=0.691N         P=0.037 *       | 
|ORDER RESTRICTED   |        P=0.005 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        23/53 (43%)      29/54 (54%)      27/53 (51%)      17/53 (32%)      27/53 (51%)      32/50 (64%)     | 
|POLY-3 RATE (b)    |        23/45.42         29/42.63         27/46.84         17/40.45         27/43.75         32/41.90        | 
|POLY-3 PERCENT (g) |        50.6%            68.0%            57.6%            42.0%            61.7%            76.4%           | 
|TERMINAL (d)       |        11/24 (46%)      9/16 (56%)       15/28 (54%)      8/21 (38%)       12/20 (60%)      16/21 (76%)     | 
|FIRST INCIDENCE    |        399              250              418              452              452              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.025 *        P=0.024 *        P=0.473          P=0.293N         P=0.201          P=0.021 *       | 
|POLY 3             |        P=0.007 **       P=0.065          P=0.316          P=0.275N         P=0.190          P=0.007 **      | 
|POLY 1.5           |        P=0.009 **       P=0.087          P=0.303          P=0.243N         P=0.223          P=0.010 *       | 
|POLY 6             |        P=0.006 **       P=0.061          P=0.346          P=0.296N         P=0.171          P=0.006 **      | 
|LOGISTIC REGRESSION|        P=0.014 *        P=0.159          P=0.282          P=0.185N         P=0.273          P=0.020 *       | 
|COCH-ARM / FISHERS |        P=0.017 *        P=0.191          P=0.280          P=0.158N         P=0.280          P=0.029 *       | 
|ORDER RESTRICTED   |        P=0.007 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 57      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        1/53 (2%)        2/53 (4%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          1/36.33          2/38.33          0/32.95         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             2.8%             5.2%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        1/21 (5%)        2/20 (10%)       0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              731 (T)          731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.676          (e)              (e)              P=0.473          P=0.198          (e)             | 
|POLY 3             |        P=0.644          (e)              (e)              P=0.486          P=0.232          (e)             | 
|POLY 1.5           |        P=0.657          (e)              (e)              P=0.488          P=0.235          (e)             | 
|POLY 6             |        P=0.632          (e)              (e)              P=0.485          P=0.229          (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.473          P=0.198          (e)             | 
|COCH-ARM / FISHERS |        P=0.677          (e)              (e)              P=0.500          P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.279          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Cervix                                                                                                                   | 
|     Hyperplasia Stromal                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)        0/50 (0%)       | 
|POLY-3 RATE (b)    |        1/39.28          0/31.01          0/41.12          0/36.33          2/39.10          0/32.95         | 
|POLY-3 PERCENT (g) |        2.6%             0.0%             0.0%             0.0%             5.1%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        1/20 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        656              ---              ---              ---              452              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.693N         P=0.578N         P=0.465N         P=0.507N         P=0.474          P=0.543N        | 
|POLY 3             |        P=0.695N         P=0.547N         P=0.491N         P=0.516N         P=0.498          P=0.535N        | 
|POLY 1.5           |        P=0.689N         P=0.529N         P=0.494N         P=0.512N         P=0.500          P=0.527N        | 
|POLY 6             |        P=0.702          P=0.562N         P=0.485N         P=0.518N         P=0.494          P=0.542N        | 
|LOGISTIC REGRESSION|        P=0.683N         P=0.532N         P=0.498N         P=0.508N         P=0.500          P=0.524N        | 
|COCH-ARM / FISHERS |        P=0.684N         P=0.495N         P=0.500N         P=0.500N         P=0.500          P=0.515N        | 
|ORDER RESTRICTED   |        P=0.323N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/09/03                           EXPERIMENT: 96021 TEST: 01                                            Page 58      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        37/53 (70%)      29/54 (54%)      32/53 (60%)      28/53 (53%)      25/53 (47%)      21/50 (42%)     | 
|POLY-3 RATE (b)    |        37/47.57         29/39.48         32/47.80         28/41.68         25/43.18         21/39.37        | 
|POLY-3 PERCENT (g) |        77.8%            73.5%            66.9%            67.2%            57.9%            53.4%           | 
|TERMINAL (d)       |        18/24 (75%)      12/16 (75%)      18/28 (64%)      15/21 (71%)      13/20 (65%)      10/21 (48%)     | 
|FIRST INCIDENCE    |        410              250              418              322              479              387             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.040N*        P=0.397          P=0.117N         P=0.233N         P=0.103N         P=0.057N        | 
|POLY 3             |        P=0.007N**       P=0.406N         P=0.156N         P=0.170N         P=0.025N*        P=0.009N**      | 
|POLY 1.5           |        P=0.007N**       P=0.229N         P=0.166N         P=0.122N         P=0.017N*        P=0.006N**      | 
|POLY 6             |        P=0.009N**       P=0.589N         P=0.147N         P=0.228N         P=0.039N*        P=0.015N*       | 
|LOGISTIC REGRESSION|        P=0.011N*        P=0.246N         P=0.182N         P=0.092N         P=0.014N*        P=0.007N**      | 
|COCH-ARM / FISHERS |        P=0.011N*        P=0.065N         P=0.208N         P=0.055N         P=0.015N*        P=0.004N**      | 
|ORDER RESTRICTED   |        P=0.007N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).