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TDMS Study 96007-05 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:40:09       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                FINAL #3/CONTROL VS. TREATED GROUPS                                                 
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 002    6 NG/KG                                                                       
                                       INCLUDE 003    20 NG/KG                                                                      
                                       INCLUDE 004    44 NG/KG                                                                      
                                       INCLUDE 005    92 NG/KG                                                                      
                                       INCLUDE 006    200     NG/KG                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:40:09       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF       TOXIC EQUIVALENCY FACTOR EVALUATION(                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Angiectasis                                                                                  
                                       Atrophy                                                                                      
                                       Degeneration Cystic                                                                          
                                       Hypertrophy                                                                                  
                                       Necrosis                                                                                     
                                       Vacuolization Cytoplasmic                                                                    
Bone Marrow                            Hyperplasia                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Harderian Gland                        Inflammation                                                                                 
Heart                                  Cardiomyopathy                                                                               
                                       Hemorrhage                                                                                   
Heart: Artery                          Inflammation Chronic                                                                         
Intestine Large, Cecum: Artery         Inflammation Chronic                                                                         
Intestine Large, Colon                 Parasite Metazoan                                                                            
Intestine Large, Rectum                Parasite Metazoan                                                                            
Islets, Pancreatic                     Hyperplasia                                                                                  
Kidney                                 Mineralization                                                                               
                                       Nephropathy                                                                                  
                                       Pigmentation                                                                                 
Kidney: Transitional Epithelium        Hyperplasia                                                                                  
Liver                                  Angiectasis                                                                                  
                                       Basophilic Focus                                                                             
                                       Cholangiofibrosis                                                                            
                                       Clear Cell Focus                                                                             
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Hematopoietic Cell Proliferation                                                             
                                       Hyperplasia                                                                                  
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Bile Duct                       Fibrosis                                                                                     
                                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Hypertrophy                                                                                  
                                       Multinucleated                                                                               
Liver: Oval Cell                       Hyperplasia                                                                                  
Lung                                   Metaplasia                                                                                   
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
                                       Metaplasia Bronchiolar                                                                       
Lymph Node, Mandibular                 Hyperplasia                                                                                  
Lymph Node, Mesenteric                 Hyperplasia                                                                                  
Lymph Node: Lumbar                     Ectasia                                                                                      
                                       Hemorrhage                                                                                   
Lymph Node: Mediastinal                Ectasia                                                                                      
Mammary Gland                          Hyperplasia                                                                                  
Mesentery: Artery                      Inflammation Chronic                                                                         
Nose: Respiratory Epithelium           Hyperplasia                                                                                  
Oral Mucosa: Gingival                  Hyperplasia                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:40:09       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
Ovary                                  Cyst                                                                                         
Pancreas                               Cytoplasmic Alteration                                                                       
                                       Inflammation Chronic                                                                         
Pancreas: Acinus                       Vacuolization Cytoplasmic                                                                    
Pancreas: Artery                       Inflammation Chronic                                                                         
Pituitary Gland                        Angiectasis                                                                                  
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Salivary Glands                        Atrophy                                                                                      
Skin                                   Inflammation                                                                                 
                                       Ulcer                                                                                        
Spleen                                 Pigmentation                                                                                 
Spleen: Red Pulp                       Atrophy                                                                                      
Stomach, Forestomach                   Hyperplasia                                                                                  
Stomach, Forestomach: Artery           Inflammation Chronic                                                                         
Stomach, Glandular                     Mineralization                                                                               
Thymus                                 Atrophy                                                                                      
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
Urinary Bladder: Transitional Epithelium                                                                                            
                                       Hyperplasia                                                                                  
Uterus                                 Hemorrhage                                                                                   
                                       Inflammation Chronic                                                                         
                                       Metaplasia                                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        31/53 (58%)      37/53 (70%)      30/53 (57%)      33/52 (63%)      27/53 (51%)      35/53 (66%)     | 
|POLY-3 RATE (b)    |        31/44.10         37/44.05         30/41.40         33/43.41         27/38.23         35/43.16        | 
|POLY-3 PERCENT (g) |        70.3%            84.0%            72.5%            76.0%            70.6%            81.1%           | 
|TERMINAL (d)       |        20/25 (80%)      20/22 (91%)      20/24 (83%)      21/25 (84%)      17/20 (85%)      20/23 (87%)     | 
|FIRST INCIDENCE    |        588              296              393              470              580              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.248          P=0.045 *        P=0.444          P=0.295          P=0.417          P=0.108         | 
|POLY 3             |        P=0.310          P=0.074          P=0.507          P=0.345          P=0.590          P=0.152         | 
|POLY 1.5           |        P=0.352          P=0.103          P=0.527          P=0.369          P=0.506N         P=0.182         | 
|POLY 6             |        P=0.300          P=0.059          P=0.498          P=0.313          P=0.542          P=0.141         | 
|LOGISTIC REGRESSION|        P=0.198          P=0.027 *        P=0.326          P=0.150          P=0.510          P=0.039 *       | 
|COCH-ARM / FISHERS |        P=0.467          P=0.156          P=0.500N         P=0.374          P=0.279N         P=0.274         | 
|ORDER RESTRICTED   |        P=0.151          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        0/53 (0%)        0/53 (0%)        1/52 (2%)        0/53 (0%)        4/53 (8%)       | 
|POLY-3 RATE (b)    |        3/42.22          0/38.07          0/36.67          1/38.12          0/36.13          4/36.61         | 
|POLY-3 PERCENT (g) |        7.1%             0.0%             0.0%             2.6%             0.0%             10.9%           | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        4/23 (17%)      | 
|FIRST INCIDENCE    |        619              ---              ---              675              ---              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.047 *        P=0.155N         P=0.150N         P=0.361N         P=0.160N         P=0.431         | 
|POLY 3             |        P=0.054          P=0.138N         P=0.145N         P=0.342N         P=0.149N         P=0.422         | 
|POLY 1.5           |        P=0.055          P=0.130N         P=0.138N         P=0.328N         P=0.140N         P=0.451         | 
|POLY 6             |        P=0.055          P=0.147N         P=0.152N         P=0.359N         P=0.155N         P=0.393         | 
|LOGISTIC REGRESSION|        P=0.044 *        P=0.135N         P=0.141N         P=0.336N         P=0.144N         P=0.400         | 
|COCH-ARM / FISHERS |        P=0.057          P=0.121N         P=0.121N         P=0.316N         P=0.121N         P=0.500         | 
|ORDER RESTRICTED   |        P=0.019 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        17/53 (32%)      14/53 (26%)      18/52 (35%)      12/53 (23%)      14/53 (26%)     | 
|POLY-3 RATE (b)    |        4/42.40          17/41.16         14/38.67         18/40.53         12/37.63         14/38.15        | 
|POLY-3 PERCENT (g) |        9.4%             41.3%            36.2%            44.4%            31.9%            36.7%           | 
|TERMINAL (d)       |        2/25 (8%)        7/22 (32%)       7/24 (29%)       12/25 (48%)      6/20 (30%)       10/23 (44%)     | 
|FIRST INCIDENCE    |        603              451              570              470              451              513             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.227          P<0.001 **       P=0.007 **       P<0.001 **       P=0.012 *        P=0.005 **      | 
|POLY 3             |        P=0.173          P<0.001 **       P=0.003 **       P<0.001 **       P=0.011 *        P=0.003 **      | 
|POLY 1.5           |        P=0.221          P<0.001 **       P=0.004 **       P<0.001 **       P=0.014 *        P=0.004 **      | 
|POLY 6             |        P=0.137          P<0.001 **       P=0.003 **       P<0.001 **       P=0.010 *        P=0.002 **      | 
|LOGISTIC REGRESSION|        P=0.216          P<0.001 **       P=0.004 **       P<0.001 **       P=0.013 *        P=0.003 **      | 
|COCH-ARM / FISHERS |        P=0.318          P<0.001 **       P=0.009 **       P<0.001 **       P=0.028 *        P=0.009 **      | 
|ORDER RESTRICTED   |        P=0.003 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/53 (15%)       10/53 (19%)      10/53 (19%)      7/52 (13%)       10/53 (19%)      11/53 (21%)     | 
|POLY-3 RATE (b)    |        8/42.51          10/39.47         10/38.48         7/39.37          10/38.01         11/39.44        | 
|POLY-3 PERCENT (g) |        18.8%            25.3%            26.0%            17.8%            26.3%            27.9%           | 
|TERMINAL (d)       |        6/25 (24%)       7/22 (32%)       6/24 (25%)       4/25 (16%)       5/20 (25%)       6/23 (26%)      | 
|FIRST INCIDENCE    |        588              498              420              470              337              329             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.226          P=0.283          P=0.323          P=0.541N         P=0.245          P=0.229         | 
|POLY 3             |        P=0.247          P=0.327          P=0.305          P=0.565N         P=0.295          P=0.237         | 
|POLY 1.5           |        P=0.265          P=0.355          P=0.324          P=0.540N         P=0.320          P=0.261         | 
|POLY 6             |        P=0.235          P=0.296          P=0.296          P=0.594N         P=0.284          P=0.215         | 
|LOGISTIC REGRESSION|        P=0.243          P=0.309          P=0.297          P=0.570N         P=0.295          P=0.251         | 
|COCH-ARM / FISHERS |        P=0.297          P=0.398          P=0.398          P=0.516N         P=0.398          P=0.307         | 
|ORDER RESTRICTED   |        P=0.285          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        42/53 (79%)      43/53 (81%)      43/53 (81%)      46/52 (88%)      44/53 (83%)      45/53 (85%)     | 
|POLY-3 RATE (b)    |        42/48.81         43/46.73         43/44.51         46/48.81         44/46.44         45/47.92        | 
|POLY-3 PERCENT (g) |        86.1%            92.0%            96.6%            94.2%            94.8%            93.9%           | 
|TERMINAL (d)       |        23/25 (92%)      22/22 (100%)     24/24 (100%)     24/25 (96%)      20/20 (100%)     23/23 (100%)    | 
|FIRST INCIDENCE    |        377              321              297              410              241              329             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.153          P=0.187          P=0.253          P=0.186          P=0.079          P=0.131         | 
|POLY 3             |        P=0.215          P=0.244          P=0.049 *        P=0.127          P=0.110          P=0.142         | 
|POLY 1.5           |        P=0.231          P=0.358          P=0.116          P=0.142          P=0.168          P=0.185         | 
|POLY 6             |        P=0.204          P=0.133          P=0.030 *        P=0.114          P=0.089          P=0.108         | 
|LOGISTIC REGRESSION|        P=0.118          P=0.316          P=0.109          P=0.103          P=0.108          P=0.122         | 
|COCH-ARM / FISHERS |        P=0.292          P=0.500          P=0.500          P=0.155          P=0.402          P=0.307         | 
|ORDER RESTRICTED   |        P=0.026 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        0/53 (0%)        2/53 (4%)        0/52 (0%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        4/43.02          0/38.07          2/37.93          0/37.91          2/36.68          0/36.61         | 
|POLY-3 PERCENT (g) |        9.3%             0.0%             5.3%             0.0%             5.5%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        1/20 (5%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        500              ---              301              ---              555              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.170N         P=0.090N         P=0.419N         P=0.091N         P=0.428N         P=0.097N        | 
|POLY 3             |        P=0.146N         P=0.077N         P=0.396N         P=0.077N         P=0.413N         P=0.083N        | 
|POLY 1.5           |        P=0.146N         P=0.070N         P=0.380N         P=0.070N         P=0.391N         P=0.074N        | 
|POLY 6             |        P=0.145N         P=0.086N         P=0.411N         P=0.087N         P=0.428N         P=0.094N        | 
|LOGISTIC REGRESSION|        P=0.137N         P=0.060N         P=0.274N         P=0.063N         P=0.342N         P=0.060N        | 
|COCH-ARM / FISHERS |        P=0.146N         P=0.059N         P=0.339N         P=0.061N         P=0.339N         P=0.059N        | 
|ORDER RESTRICTED   |        P=0.013N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/53 (17%)       13/53 (25%)      14/53 (26%)      7/52 (13%)       17/53 (32%)      9/53 (17%)      | 
|POLY-3 RATE (b)    |        9/42.91          13/41.59         14/41.26         7/39.98          17/38.33         9/38.25         | 
|POLY-3 PERCENT (g) |        21.0%            31.3%            33.9%            17.5%            44.4%            23.5%           | 
|TERMINAL (d)       |        5/25 (20%)       6/22 (27%)       5/24 (21%)       4/25 (16%)       9/20 (45%)       4/23 (17%)      | 
|FIRST INCIDENCE    |        536              321              219              429              500              570             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.536          P=0.156          P=0.128          P=0.438N         P=0.020 *        P=0.472         | 
|POLY 3             |        P=0.499          P=0.201          P=0.135          P=0.452N         P=0.018 *        P=0.497         | 
|POLY 1.5           |        P=0.536N         P=0.215          P=0.139          P=0.428N         P=0.025 *        P=0.534         | 
|POLY 6             |        P=0.461          P=0.186          P=0.137          P=0.484N         P=0.016 *        P=0.468         | 
|LOGISTIC REGRESSION|        P=0.481N         P=0.213          P=0.161          P=0.428N         P=0.019 *        P=0.494         | 
|COCH-ARM / FISHERS |        P=0.436N         P=0.237          P=0.173          P=0.410N         P=0.057          P=0.602N        | 
|ORDER RESTRICTED   |        P=0.156          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/53 (21%)      12/53 (23%)      14/53 (26%)      14/52 (27%)      7/53 (13%)       10/53 (19%)     | 
|POLY-3 RATE (b)    |        11/42.90         12/39.45         14/38.69         14/40.72         7/37.08          10/40.08        | 
|POLY-3 PERCENT (g) |        25.6%            30.4%            36.2%            34.4%            18.9%            25.0%           | 
|TERMINAL (d)       |        7/25 (28%)       7/22 (32%)       9/24 (38%)       9/25 (36%)       4/20 (20%)       3/23 (13%)      | 
|FIRST INCIDENCE    |        500              498              451              470              561              412             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.277N         P=0.361          P=0.255          P=0.289          P=0.383N         P=0.575         | 
|POLY 3             |        P=0.222N         P=0.405          P=0.211          P=0.260          P=0.325N         P=0.572N        | 
|POLY 1.5           |        P=0.215N         P=0.442          P=0.234          P=0.282          P=0.295N         P=0.549N        | 
|POLY 6             |        P=0.221N         P=0.370          P=0.201          P=0.239          P=0.336N         P=0.587N        | 
|LOGISTIC REGRESSION|        P=0.248N         P=0.384          P=0.202          P=0.250          P=0.325N         P=0.546N        | 
|COCH-ARM / FISHERS |        P=0.193N         P=0.500          P=0.324          P=0.304          P=0.219N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.285N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Blood Vessel: Aorta                                                                                                              | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        0/53 (0%)        1/53 (2%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/38.81          0/36.67          1/39.15          2/37.24          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             0.0%             2.6%             5.4%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              467              ---              302              348              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.642N         P=0.487          (e)              P=0.504          P=0.216          (e)             | 
|POLY 3             |        P=0.632          P=0.485          (e)              P=0.487          P=0.212          (e)             | 
|POLY 1.5           |        P=0.650N         P=0.491          (e)              P=0.494          P=0.218          (e)             | 
|POLY 6             |        P=0.612          P=0.479          (e)              P=0.479          P=0.210          (e)             | 
|LOGISTIC REGRESSION|        P=0.574N         P=0.539          (e)              P=0.269          P=0.305          (e)             | 
|COCH-ARM / FISHERS |        P=0.632N         P=0.500          (e)              P=0.500          P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.320          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        2/53 (4%)        0/53 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          2/36.67          0/38.22          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             5.5%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        2/24 (8%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              728 (T)          ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.406N         (e)              P=0.228          (e)              (e)              (e)             | 
|POLY 3             |        P=0.425N         (e)              P=0.209          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.419N         (e)              P=0.216          (e)              (e)              (e)             | 
|POLY 6             |        P=0.426N         (e)              P=0.204          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.228          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.393N         (e)              P=0.248          (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.369N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        38/53 (72%)      32/53 (60%)      37/53 (70%)      35/53 (66%)      42/53 (79%)      41/53 (77%)     | 
|POLY-3 RATE (b)    |        38/52.51         32/50.34         37/51.22         35/48.91         42/52.39         41/50.42        | 
|POLY-3 PERCENT (g) |        72.4%            63.6%            72.2%            71.6%            80.2%            81.3%           | 
|TERMINAL (d)       |        12/25 (48%)      9/22 (41%)       11/24 (46%)      15/25 (60%)      13/20 (65%)      14/23 (61%)     | 
|FIRST INCIDENCE    |        289              289              116              302              113              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.076          P=0.465N         P=0.383          P=0.547N         P=0.112          P=0.184         | 
|POLY 3             |        P=0.034 *        P=0.225N         P=0.581N         P=0.553N         P=0.237          P=0.198         | 
|POLY 1.5           |        P=0.033 *        P=0.197N         P=0.554N         P=0.462N         P=0.243          P=0.217         | 
|POLY 6             |        P=0.041 *        P=0.265N         P=0.575          P=0.524          P=0.228          P=0.197         | 
|LOGISTIC REGRESSION|        P=0.085          P=0.059N         P=0.295N         P=0.232N         P=0.421          P=0.443         | 
|COCH-ARM / FISHERS |        P=0.054          P=0.153N         P=0.500N         P=0.338N         P=0.249          P=0.328         | 
|ORDER RESTRICTED   |        P=0.093          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        52/53 (98%)      47/51 (92%)      46/53 (87%)      51/53 (96%)      47/50 (94%)      47/53 (89%)     | 
|POLY-3 RATE (b)    |        52/52.72         47/49.98         46/49.06         51/52.27         47/48.18         47/49.63        | 
|POLY-3 PERCENT (g) |        98.6%            94.0%            93.8%            97.6%            97.6%            94.7%           | 
|TERMINAL (d)       |        25/25 (100%)     21/22 (96%)      23/24 (96%)      24/25 (96%)      20/20 (100%)     22/23 (96%)     | 
|FIRST INCIDENCE    |        289              289              196              302              113              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.417          P=0.485          P=0.488N         P=0.416          P=0.331          P=0.499         | 
|POLY 3             |        P=0.471N         P=0.212N         P=0.184N         P=0.637N         P=0.645N         P=0.251N        | 
|POLY 1.5           |        P=0.366N         P=0.191N         P=0.116N         P=0.590N         P=0.533N         P=0.163N        | 
|POLY 6             |        P=0.567N         P=0.241N         P=0.264N         P=0.650N         P=0.673N         P=0.382N        | 
|LOGISTIC REGRESSION|        P=0.239N         P=0.164N         P=0.073N         P=0.512N         P=0.388N         P=0.101N        | 
|COCH-ARM / FISHERS |        P=0.188N         P=0.170N         P=0.030N*        P=0.500N         P=0.287N         P=0.056N        | 
|ORDER RESTRICTED   |        P=0.208N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        40/53 (75%)      37/51 (73%)      34/53 (64%)      41/53 (77%)      44/50 (88%)      40/53 (75%)     | 
|POLY-3 RATE (b)    |        40/50.78         37/47.85         34/47.82         41/51.69         44/47.96         40/49.03        | 
|POLY-3 PERCENT (g) |        78.8%            77.3%            71.1%            79.3%            91.7%            81.6%           | 
|TERMINAL (d)       |        18/25 (72%)      14/22 (64%)      14/24 (58%)      17/25 (68%)      19/20 (95%)      17/23 (74%)     | 
|FIRST INCIDENCE    |        289              296              196              302              113              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.150          P=0.448          P=0.439N         P=0.348          P=0.071          P=0.294         | 
|POLY 3             |        P=0.129          P=0.528N         P=0.251N         P=0.571          P=0.055          P=0.458         | 
|POLY 1.5           |        P=0.149          P=0.506N         P=0.220N         P=0.546          P=0.055          P=0.500         | 
|POLY 6             |        P=0.125          P=0.540N         P=0.284N         P=0.600          P=0.065          P=0.437         | 
|LOGISTIC REGRESSION|        P=0.216          P=0.423N         P=0.125N         P=0.589          P=0.090          P=0.566N        | 
|COCH-ARM / FISHERS |        P=0.198          P=0.454N         P=0.145N         P=0.500          P=0.082          P=0.589N        | 
|ORDER RESTRICTED   |        P=0.129          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus                                                                                                                        | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/52 (0%)        2/53 (4%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.03          2/39.88          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              302              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.590N         (e)              (e)              P=0.244          (e)              (e)             | 
|POLY 3             |        P=0.608N         (e)              (e)              P=0.226          (e)              (e)             | 
|POLY 1.5           |        P=0.600N         (e)              (e)              P=0.233          (e)              (e)             | 
|POLY 6             |        P=0.615N         (e)              (e)              P=0.219          (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.522N         (e)              (e)              P=0.134          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.585N         (e)              (e)              P=0.248          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.354          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus                                                                                                                        | 
|     Perforation                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        2/52 (4%)        1/53 (2%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/39.00          2/37.89          1/38.94          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             5.3%             2.6%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              296              300              472              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.244N         P=0.500          P=0.220          P=0.492          (e)              (e)             | 
|POLY 3             |        P=0.273N         P=0.486          P=0.215          P=0.486          (e)              (e)             | 
|POLY 1.5           |        P=0.263N         P=0.492          P=0.219          P=0.493          (e)              (e)             | 
|POLY 6             |        P=0.279N         P=0.479          P=0.213          P=0.478          (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.152N         P=0.551          P=0.501          P=0.487          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.240N         P=0.500          P=0.243          P=0.500          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.349N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Muscularis                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/53 (4%)        1/52 (2%)        1/53 (2%)        1/53 (2%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        0/41.78          2/38.44          1/36.87          1/38.22          1/36.89          1/37.11         | 
|POLY-3 PERCENT (g) |        0.0%             5.2%             2.7%             2.6%             2.7%             2.7%            | 
|TERMINAL (d)       |        0/25 (0%)        1/22 (5%)        0/24 (0%)        1/25 (4%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              624              393              728 (T)          451              577             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.584          P=0.220          P=0.487          P=0.500          P=0.474          P=0.460         | 
|POLY 3             |        P=0.575          P=0.219          P=0.475          P=0.482          P=0.475          P=0.476         | 
|POLY 1.5           |        P=0.589          P=0.226          P=0.479          P=0.491          P=0.481          P=0.485         | 
|POLY 6             |        P=0.562          P=0.211          P=0.473          P=0.473          P=0.473          P=0.469         | 
|LOGISTIC REGRESSION|        P=0.622N         P=0.222          P=0.651          P=0.500          P=0.608          P=0.526         | 
|COCH-ARM / FISHERS |        P=0.614          P=0.248          P=0.495          P=0.500          P=0.500          P=0.500         | 
|ORDER RESTRICTED   |        P=0.333          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Periesophageal Tissue                                                                                                 | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        2/52 (4%)        2/53 (4%)        1/53 (2%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/39.00          2/37.89          2/39.62          1/36.44          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             5.3%             5.1%             2.7%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              296              300              472              642              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.330N         P=0.500          P=0.220          P=0.226          P=0.473          (e)             | 
|POLY 3             |        P=0.360N         P=0.486          P=0.215          P=0.225          P=0.473          (e)             | 
|POLY 1.5           |        P=0.344N         P=0.492          P=0.219          P=0.231          P=0.480          (e)             | 
|POLY 6             |        P=0.372N         P=0.479          P=0.213          P=0.218          P=0.470          (e)             | 
|LOGISTIC REGRESSION|        P=0.234N         P=0.551          P=0.501          P=0.224          P=0.494          (e)             | 
|COCH-ARM / FISHERS |        P=0.312N         P=0.500          P=0.243          P=0.248          P=0.500          (e)             | 
|ORDER RESTRICTED   |        P=0.319          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        16/53 (30%)      9/53 (17%)       10/53 (19%)      13/53 (25%)      8/52 (15%)       6/52 (12%)      | 
|POLY-3 RATE (b)    |        16/42.80         9/39.12          10/38.44         13/40.12         8/36.30          6/38.13         | 
|POLY-3 PERCENT (g) |        37.4%            23.0%            26.0%            32.4%            22.0%            15.7%           | 
|TERMINAL (d)       |        11/25 (44%)      5/22 (23%)       5/24 (21%)       8/25 (32%)       6/20 (30%)       2/23 (9%)       | 
|FIRST INCIDENCE    |        610              624              297              548              662              498             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.056N         P=0.171N         P=0.208N         P=0.416N         P=0.147N         P=0.039N*       | 
|POLY 3             |        P=0.036N*        P=0.116N         P=0.191N         P=0.401N         P=0.104N         P=0.023N*       | 
|POLY 1.5           |        P=0.035N*        P=0.101N         P=0.176N         P=0.366N         P=0.088N         P=0.020N*       | 
|POLY 6             |        P=0.035N*        P=0.133N         P=0.201N         P=0.440N         P=0.118N         P=0.025N*       | 
|LOGISTIC REGRESSION|        P=0.050N         P=0.147N         P=0.219N         P=0.479N         P=0.107N         P=0.032N*       | 
|COCH-ARM / FISHERS |        P=0.034N*        P=0.085N         P=0.129N         P=0.332N         P=0.057N         P=0.017N*       | 
|ORDER RESTRICTED   |        P=0.014N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/53 (28%)      12/53 (23%)      19/52 (37%)      13/53 (25%)      18/53 (34%)      24/52 (46%)     | 
|POLY-3 RATE (b)    |        15/43.14         12/39.52         19/40.33         13/39.50         18/39.38         24/42.25        | 
|POLY-3 PERCENT (g) |        34.8%            30.4%            47.1%            32.9%            45.7%            56.8%           | 
|TERMINAL (d)       |        9/25 (36%)       8/22 (36%)       11/24 (46%)      9/25 (36%)       7/20 (35%)       11/23 (48%)     | 
|FIRST INCIDENCE    |        500              526              246              548              113              443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.006 **       P=0.492N         P=0.189          P=0.485N         P=0.157          P=0.029 *       | 
|POLY 3             |        P=0.007 **       P=0.423N         P=0.172          P=0.522N         P=0.210          P=0.028 *       | 
|POLY 1.5           |        P=0.006 **       P=0.383N         P=0.178          P=0.470N         P=0.239          P=0.030 *       | 
|POLY 6             |        P=0.009 **       P=0.468N         P=0.182          P=0.579N         P=0.213          P=0.032 *       | 
|LOGISTIC REGRESSION|        P=0.004 **       P=0.451N         P=0.150          P=0.568N         P=0.199          P=0.021 *       | 
|COCH-ARM / FISHERS |        P=0.009 **       P=0.328N         P=0.244          P=0.413N         P=0.338          P=0.045 *       | 
|ORDER RESTRICTED   |        P=0.010 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/53 (0%)        0/52 (0%)        0/53 (0%)        0/53 (0%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        2/43.24          0/38.07          0/36.03          0/38.22          0/36.13          0/36.44         | 
|POLY-3 PERCENT (g) |        4.6%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        377              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.257N         P=0.255N         P=0.262N         P=0.248N         P=0.273N         P=0.258N        | 
|POLY 3             |        P=0.222N         P=0.266N         P=0.280N         P=0.265N         P=0.279N         P=0.277N        | 
|POLY 1.5           |        P=0.232N         P=0.255N         P=0.269N         P=0.253N         P=0.267N         P=0.263N        | 
|POLY 6             |        P=0.211N         P=0.279N         P=0.287N         P=0.280N         P=0.288N         P=0.290N        | 
|LOGISTIC REGRESSION|        P=0.219N         P=0.188N         P=0.126N         P=0.246N         P=0.124N         P=0.155N        | 
|COCH-ARM / FISHERS |        P=0.249N         P=0.248N         P=0.252N         P=0.248N         P=0.248N         P=0.252N        | 
|ORDER RESTRICTED   |        P=0.015N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Artery                                                                                                                    | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/52 (0%)        0/53 (0%)        1/53 (2%)        2/52 (4%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.03          0/38.22          1/36.33          2/36.89         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             2.8%             5.4%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              675              597             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.013 *        (e)              (e)              (e)              P=0.462          P=0.205         | 
|POLY 3             |        P=0.014 *        (e)              (e)              (e)              P=0.472          P=0.210         | 
|POLY 1.5           |        P=0.015 *        (e)              (e)              (e)              P=0.479          P=0.218         | 
|POLY 6             |        P=0.014 *        (e)              (e)              (e)              P=0.469          P=0.203         | 
|LOGISTIC REGRESSION|        P=0.014 *        (e)              (e)              (e)              P=0.478          P=0.220         | 
|COCH-ARM / FISHERS |        P=0.015 *        (e)              (e)              (e)              P=0.500          P=0.243         | 
|ORDER RESTRICTED   |        P=0.021 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum: Artery                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        0/53 (0%)        0/52 (0%)        0/51 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/38.07          0/36.67          0/37.91          0/35.40          2/36.69         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             0.0%             0.0%             0.0%             5.5%            | 
|TERMINAL (d)       |        0/25 (0%)        1/22 (5%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        ---              728 (T)          ---              ---              ---              706             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.073          P=0.475          (e)              (e)              (e)              P=0.219         | 
|POLY 3             |        P=0.070          P=0.481          (e)              (e)              (e)              P=0.209         | 
|POLY 1.5           |        P=0.073          P=0.489          (e)              (e)              (e)              P=0.219         | 
|POLY 6             |        P=0.068          P=0.473          (e)              (e)              (e)              P=0.200         | 
|LOGISTIC REGRESSION|        P=0.067          P=0.475          (e)              (e)              (e)              P=0.197         | 
|COCH-ARM / FISHERS |        P=0.077          P=0.500          (e)              (e)              (e)              P=0.248         | 
|ORDER RESTRICTED   |        P=0.021 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/51 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        2/42.66          0/38.07          0/36.67          0/38.22          0/35.40          0/36.61         | 
|POLY-3 PERCENT (g) |        4.7%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        536              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.266N         P=0.274N         P=0.282N         P=0.286N         P=0.280N         P=0.292N        | 
|POLY 3             |        P=0.222N         P=0.263N         P=0.272N         P=0.262N         P=0.280N         P=0.273N        | 
|POLY 1.5           |        P=0.232N         P=0.252N         P=0.262N         P=0.250N         P=0.270N         P=0.259N        | 
|POLY 6             |        P=0.210N         P=0.276N         P=0.281N         P=0.277N         P=0.288N         P=0.287N        | 
|LOGISTIC REGRESSION|        P=0.245N         P=0.220N         P=0.213N         P=0.226N         P=0.220N         P=0.214N        | 
|COCH-ARM / FISHERS |        P=0.250N         P=0.248N         P=0.248N         P=0.248N         P=0.257N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.014N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        5/53 (9%)        5/53 (9%)        1/53 (2%)        1/52 (2%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        4/41.97          5/40.02          5/37.71          1/39.04          1/36.33          1/36.61         | 
|POLY-3 PERCENT (g) |        9.5%             12.5%            13.3%            2.6%             2.8%             2.7%            | 
|TERMINAL (d)       |        3/25 (12%)       0/22 (0%)        3/24 (13%)       0/25 (0%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        678              498              393              410              353              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.046N*        P=0.417          P=0.445          P=0.195N         P=0.248N         P=0.215N        | 
|POLY 3             |        P=0.044N*        P=0.470          P=0.433          P=0.200N         P=0.224N         P=0.222N        | 
|POLY 1.5           |        P=0.041N*        P=0.480          P=0.448          P=0.189N         P=0.214N         P=0.205N        | 
|POLY 6             |        P=0.047N*        P=0.463          P=0.422          P=0.214N         P=0.229N         P=0.239N        | 
|LOGISTIC REGRESSION|        P=0.036N*        P=0.485          P=0.434          P=0.183N         P=0.193N         P=0.236N        | 
|COCH-ARM / FISHERS |        P=0.036N*        P=0.500          P=0.500          P=0.181N         P=0.187N         P=0.181N        | 
|ORDER RESTRICTED   |        P=0.097N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/52 (0%)        0/52 (0%)        2/52 (4%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          0/37.91          0/35.44          2/36.53         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             5.5%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              706             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.011 *        (e)              (e)              (e)              (e)              P=0.219         | 
|POLY 3             |        P=0.009 **       (e)              (e)              (e)              (e)              P=0.208         | 
|POLY 1.5           |        P=0.009 **       (e)              (e)              (e)              (e)              P=0.217         | 
|POLY 6             |        P=0.009 **       (e)              (e)              (e)              (e)              P=0.200         | 
|LOGISTIC REGRESSION|        P=0.009 **       (e)              (e)              (e)              (e)              P=0.197         | 
|COCH-ARM / FISHERS |        P=0.010 *        (e)              (e)              (e)              (e)              P=0.243         | 
|ORDER RESTRICTED   |        P=0.006 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Calculus Micro Observation Only                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        2/53 (4%)        4/53 (8%)        1/52 (2%)        2/53 (4%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        5/41.89          2/38.07          4/36.67          1/38.22          2/36.21          3/37.37         | 
|POLY-3 PERCENT (g) |        11.9%            5.3%             10.9%            2.6%             5.5%             8.0%            | 
|TERMINAL (d)       |        4/25 (16%)       2/22 (9%)        4/24 (17%)       0/25 (0%)        1/20 (5%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        699              728 (T)          728 (T)          645              707              498             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.467N         P=0.274N         P=0.536N         P=0.120N         P=0.308N         P=0.412N        | 
|POLY 3             |        P=0.449N         P=0.255N         P=0.584N         P=0.122N         P=0.278N         P=0.420N        | 
|POLY 1.5           |        P=0.443N         P=0.239N         P=0.562N         P=0.114N         P=0.261N         P=0.397N        | 
|POLY 6             |        P=0.449N         P=0.273N         P=0.601N         P=0.131N         P=0.287N         P=0.440N        | 
|LOGISTIC REGRESSION|        P=0.483N         P=0.294N         P=0.599N         P=0.136N         P=0.287N         P=0.436N        | 
|COCH-ARM / FISHERS |        P=0.425N         P=0.219N         P=0.500N         P=0.107N         P=0.219N         P=0.358N        | 
|ORDER RESTRICTED   |        P=0.224N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        1/52 (2%)        2/53 (4%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          1/38.22          2/36.13          1/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             2.6%             5.5%             2.7%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        2/20 (10%)       1/23 (4%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              645              728 (T)          728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.150          (e)              (e)              P=0.454          P=0.190          P=0.483         | 
|POLY 3             |        P=0.149          (e)              (e)              P=0.482          P=0.206          P=0.474         | 
|POLY 1.5           |        P=0.158          (e)              (e)              P=0.489          P=0.214          P=0.483         | 
|POLY 6             |        P=0.140          (e)              (e)              P=0.475          P=0.201          P=0.465         | 
|LOGISTIC REGRESSION|        P=0.149          (e)              (e)              P=0.497          P=0.190          P=0.483         | 
|COCH-ARM / FISHERS |        P=0.169          (e)              (e)              P=0.495          P=0.248          P=0.500         | 
|ORDER RESTRICTED   |        P=0.133          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/53 (2%)        1/53 (2%)        3/52 (6%)        2/53 (4%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        2/42.16          1/38.07          1/36.82          3/38.64          2/36.47          2/36.61         | 
|POLY-3 PERCENT (g) |        4.7%             2.6%             2.7%             7.8%             5.5%             5.5%            | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        0/24 (0%)        2/25 (8%)        0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        619              728 (T)          689              470              642              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.417          P=0.542N         P=0.543N         P=0.480          P=0.634          P=0.646         | 
|POLY 3             |        P=0.419          P=0.536N         P=0.547N         P=0.460          P=0.641          P=0.643         | 
|POLY 1.5           |        P=0.435          P=0.521N         P=0.535N         P=0.476          P=0.655          P=0.662         | 
|POLY 6             |        P=0.404          P=0.552N         P=0.556N         P=0.441          P=0.634          P=0.623         | 
|LOGISTIC REGRESSION|        P=0.423          P=0.535N         P=0.536N         P=0.486          P=0.655          P=0.637         | 
|COCH-ARM / FISHERS |        P=0.458          P=0.500N         P=0.500N         P=0.491          P=0.691N         P=0.691N        | 
|ORDER RESTRICTED   |        P=0.504          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        37/53 (70%)      45/53 (85%)      42/53 (79%)      43/52 (83%)      43/53 (81%)      31/53 (58%)     | 
|POLY-3 RATE (b)    |        37/49.64         45/50.67         42/49.52         43/49.48         43/50.37         31/46.93        | 
|POLY-3 PERCENT (g) |        74.5%            88.8%            84.8%            86.9%            85.4%            66.1%           | 
|TERMINAL (d)       |        20/25 (80%)      20/22 (91%)      18/24 (75%)      20/25 (80%)      14/20 (70%)      11/23 (48%)     | 
|FIRST INCIDENCE    |        289              289              219              302              241              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.165N         P=0.041 *        P=0.132          P=0.135          P=0.051          P=0.443N        | 
|POLY 3             |        P=0.012N*        P=0.044 *        P=0.143          P=0.083          P=0.123          P=0.236N        | 
|POLY 1.5           |        P=0.008N**       P=0.045 *        P=0.125          P=0.082          P=0.110          P=0.205N        | 
|POLY 6             |        P=0.018N*        P=0.047 *        P=0.193          P=0.099          P=0.157          P=0.255N        | 
|LOGISTIC REGRESSION|        P=0.005N**       P=0.055          P=0.170          P=0.095          P=0.147          P=0.136N        | 
|COCH-ARM / FISHERS |        P=0.006N**       P=0.052          P=0.186          P=0.093          P=0.129          P=0.156N        | 
|ORDER RESTRICTED   |        P=0.011N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/52 (0%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          0/37.91          2/37.24          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             5.4%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              348              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.452          (e)              (e)              (e)              P=0.216          (e)             | 
|POLY 3             |        P=0.428          (e)              (e)              (e)              P=0.212          (e)             | 
|POLY 1.5           |        P=0.445          (e)              (e)              (e)              P=0.218          (e)             | 
|POLY 6             |        P=0.408          (e)              (e)              (e)              P=0.210          (e)             | 
|LOGISTIC REGRESSION|        P=0.490          (e)              (e)              (e)              P=0.305          (e)             | 
|COCH-ARM / FISHERS |        P=0.463          (e)              (e)              (e)              P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.163          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        34/53 (64%)      39/53 (74%)      35/53 (66%)      42/52 (81%)      36/53 (68%)      45/53 (85%)     | 
|POLY-3 RATE (b)    |        34/45.99         39/47.20         35/43.05         42/47.43         36/42.52         45/48.53        | 
|POLY-3 PERCENT (g) |        73.9%            82.6%            81.3%            88.6%            84.7%            92.7%           | 
|TERMINAL (d)       |        20/25 (80%)      19/22 (86%)      23/24 (96%)      24/25 (96%)      19/20 (95%)      21/23 (91%)     | 
|FIRST INCIDENCE    |        377              289              219              302              113              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.018 *        P=0.084          P=0.297          P=0.064          P=0.092          P=0.013 *       | 
|POLY 3             |        P=0.009 **       P=0.201          P=0.261          P=0.041 *        P=0.138          P=0.007 **      | 
|POLY 1.5           |        P=0.010 *        P=0.202          P=0.324          P=0.044 *        P=0.212          P=0.006 **      | 
|POLY 6             |        P=0.015 *        P=0.204          P=0.191          P=0.039 *        P=0.103          P=0.011 *       | 
|LOGISTIC REGRESSION|        P=0.005 **       P=0.110          P=0.222          P=0.020 *        P=0.124          P=0.002 **      | 
|COCH-ARM / FISHERS |        P=0.024 *        P=0.201          P=0.500          P=0.045 *        P=0.419          P=0.012 *       | 
|ORDER RESTRICTED   |        P=0.002 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/53 (0%)        0/53 (0%)        0/52 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        2/42.16          0/38.07          0/36.67          0/37.91          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        4.7%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        619              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.266N         P=0.265N         P=0.265N         P=0.267N         P=0.283N         P=0.280N        | 
|POLY 3             |        P=0.225N         P=0.260N         P=0.269N         P=0.261N         P=0.273N         P=0.270N        | 
|POLY 1.5           |        P=0.234N         P=0.251N         P=0.261N         P=0.252N         P=0.263N         P=0.257N        | 
|POLY 6             |        P=0.214N         P=0.271N         P=0.276N         P=0.273N         P=0.280N         P=0.282N        | 
|LOGISTIC REGRESSION|        P=0.256N         P=0.250N         P=0.257N         P=0.251N         P=0.260N         P=0.257N        | 
|COCH-ARM / FISHERS |        P=0.248N         P=0.248N         P=0.248N         P=0.252N         P=0.248N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.014N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        0/53 (0%)        0/52 (0%)        2/53 (4%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/38.81          0/36.67          0/37.91          2/37.24          1/36.98         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             0.0%             0.0%             5.4%             2.7%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              467              ---              ---              348              624             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.227          P=0.487          (e)              (e)              P=0.216          P=0.454         | 
|POLY 3             |        P=0.225          P=0.485          (e)              (e)              P=0.212          P=0.476         | 
|POLY 1.5           |        P=0.235          P=0.491          (e)              (e)              P=0.218          P=0.484         | 
|POLY 6             |        P=0.215          P=0.479          (e)              (e)              P=0.210          P=0.468         | 
|LOGISTIC REGRESSION|        P=0.273          P=0.539          (e)              (e)              P=0.305          P=0.505         | 
|COCH-ARM / FISHERS |        P=0.247          P=0.500          (e)              (e)              P=0.248          P=0.500         | 
|ORDER RESTRICTED   |        P=0.139          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        0/53 (0%)        0/52 (0%)        5/53 (9%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        1/41.78          1/38.75          0/36.67          0/37.91          5/36.20          1/36.61         | 
|POLY-3 PERCENT (g) |        2.4%             2.6%             0.0%             0.0%             13.8%            2.7%            | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        3/20 (15%)       1/23 (4%)       | 
|FIRST INCIDENCE    |        728 (T)          498              ---              ---              717              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.232          P=0.737          P=0.508N         P=0.500N         P=0.067          P=0.744         | 
|POLY 3             |        P=0.221          P=0.744          P=0.526N         P=0.519N         P=0.071          P=0.731         | 
|POLY 1.5           |        P=0.236          P=0.751          P=0.520N         P=0.512N         P=0.078          P=0.742         | 
|POLY 6             |        P=0.205          P=0.737          P=0.531N         P=0.528N         P=0.066          P=0.720         | 
|LOGISTIC REGRESSION|        P=0.222          P=0.753N         (e)              (e)              P=0.063          P=0.744         | 
|COCH-ARM / FISHERS |        P=0.254          P=0.752N         P=0.500N         P=0.505N         P=0.103          P=0.752N        | 
|ORDER RESTRICTED   |        P=0.067          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        2/53 (4%)        1/53 (2%)        2/52 (4%)        6/53 (11%)       5/53 (9%)       | 
|POLY-3 RATE (b)    |        2/41.78          2/38.75          1/36.82          2/37.91          6/36.20          5/36.69         | 
|POLY-3 PERCENT (g) |        4.8%             5.2%             2.7%             5.3%             16.6%            13.6%           | 
|TERMINAL (d)       |        2/25 (8%)        1/22 (5%)        0/24 (0%)        2/25 (8%)        4/20 (20%)       4/23 (17%)      | 
|FIRST INCIDENCE    |        728 (T)          498              689              728 (T)          717              706             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.025 *        P=0.652          P=0.526N         P=0.697          P=0.080          P=0.180         | 
|POLY 3             |        P=0.022 *        P=0.667          P=0.544N         P=0.659          P=0.089          P=0.165         | 
|POLY 1.5           |        P=0.025 *        P=0.678          P=0.534N         P=0.673          P=0.101          P=0.183         | 
|POLY 6             |        P=0.019 *        P=0.656          P=0.551N         P=0.644          P=0.083          P=0.149         | 
|LOGISTIC REGRESSION|        P=0.020 *        P=0.677          P=0.557N         P=0.697          P=0.077          P=0.150         | 
|COCH-ARM / FISHERS |        P=0.032 *        P=0.691N         P=0.500N         P=0.684          P=0.135          P=0.219         | 
|ORDER RESTRICTED   |        P=0.052          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/53 (11%)       3/53 (6%)        4/53 (8%)        1/52 (2%)        0/53 (0%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        6/42.92          3/38.07          4/36.67          1/37.91          0/36.13          1/36.61         | 
|POLY-3 PERCENT (g) |        14.0%            7.9%             10.9%            2.6%             0.0%             2.7%            | 
|TERMINAL (d)       |        1/25 (4%)        3/22 (14%)       4/24 (17%)       1/25 (4%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        610              728 (T)          728 (T)          728 (T)          ---              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.034N*        P=0.340N         P=0.456N         P=0.095N         P=0.036N*        P=0.105N        | 
|POLY 3             |        P=0.028N*        P=0.303N         P=0.471N         P=0.077N         P=0.026N*        P=0.085N        | 
|POLY 1.5           |        P=0.027N*        P=0.276N         P=0.441N         P=0.068N         P=0.023N*        P=0.073N        | 
|POLY 6             |        P=0.028N*        P=0.339N         P=0.503N         P=0.091N         P=0.030N*        P=0.100N        | 
|LOGISTIC REGRESSION|        P=0.033N*        P=0.294N         P=0.458N         P=0.072N         P=0.024N*        P=0.078N        | 
|COCH-ARM / FISHERS |        P=0.026N*        P=0.244N         P=0.371N         P=0.059N         P=0.013N*        P=0.056N        | 
|ORDER RESTRICTED   |        P=0.013N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        22/53 (42%)      23/53 (43%)      20/53 (38%)      16/52 (31%)      15/53 (28%)      7/53 (13%)      | 
|POLY-3 RATE (b)    |        22/44.73         23/42.87         20/40.67         16/39.96         15/39.21         7/37.90         | 
|POLY-3 PERCENT (g) |        49.2%            53.7%            49.2%            40.0%            38.3%            18.5%           | 
|TERMINAL (d)       |        10/25 (40%)      10/22 (46%)      11/24 (46%)      10/25 (40%)      8/20 (40%)       5/23 (22%)      | 
|FIRST INCIDENCE    |        513              321              393              525              420              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001N**       P=0.291          P=0.545          P=0.269N         P=0.345N         P=0.008N**      | 
|POLY 3             |        P<0.001N**       P=0.417          P=0.587N         P=0.260N         P=0.211N         P=0.002N**      | 
|POLY 1.5           |        P<0.001N**       P=0.452          P=0.550N         P=0.211N         P=0.178N         P<0.001N**      | 
|POLY 6             |        P<0.001N**       P=0.382          P=0.560          P=0.337N         P=0.241N         P=0.005N**      | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.392          P=0.573          P=0.255N         P=0.206N         P=0.003N**      | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.500          P=0.421N         P=0.173N         P=0.111N         P<0.001N**      | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiofibrosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        0/53 (0%)        3/52 (6%)        3/53 (6%)        5/53 (9%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/38.07          0/36.67          3/38.43          3/36.13          5/37.09         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             0.0%             7.8%             8.3%             13.5%           | 
|TERMINAL (d)       |        0/25 (0%)        1/22 (5%)        0/24 (0%)        2/25 (8%)        3/20 (15%)       4/23 (17%)      | 
|FIRST INCIDENCE    |        ---              728 (T)          ---              570              728 (T)          586             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       P=0.475          (e)              P=0.115          P=0.083          P=0.024 *       | 
|POLY 3             |        P=0.002 **       P=0.481          (e)              P=0.104          P=0.094          P=0.021 *       | 
|POLY 1.5           |        P=0.003 **       P=0.489          (e)              P=0.109          P=0.101          P=0.024 *       | 
|POLY 6             |        P=0.002 **       P=0.473          (e)              P=0.098          P=0.090          P=0.019 *       | 
|LOGISTIC REGRESSION|        P=0.002 **       P=0.475          (e)              P=0.108          P=0.083          P=0.021 *       | 
|COCH-ARM / FISHERS |        P=0.004 **       P=0.500          (e)              P=0.118          P=0.121          P=0.028 *       | 
|ORDER RESTRICTED   |        P=0.004 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        13/53 (25%)      6/53 (11%)       10/53 (19%)      3/52 (6%)        6/53 (11%)       11/53 (21%)     | 
|POLY-3 RATE (b)    |        13/43.13         6/38.07          10/36.67         3/38.49          6/36.41          11/36.61        | 
|POLY-3 PERCENT (g) |        30.1%            15.8%            27.3%            7.8%             16.5%            30.1%           | 
|TERMINAL (d)       |        9/25 (36%)       6/22 (27%)       10/24 (42%)      2/25 (8%)        4/20 (20%)       11/23 (48%)     | 
|FIRST INCIDENCE    |        321              728 (T)          728 (T)          548              675              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.323          P=0.108N         P=0.381N         P=0.010N*        P=0.152N         P=0.515N        | 
|POLY 3             |        P=0.330          P=0.099N         P=0.486N         P=0.010N*        P=0.121N         P=0.594N        | 
|POLY 1.5           |        P=0.355          P=0.083N         P=0.438N         P=0.008N**       P=0.102N         P=0.524N        | 
|POLY 6             |        P=0.310          P=0.121N         P=0.531N         P=0.012N*        P=0.131N         P=0.532         | 
|LOGISTIC REGRESSION|        P=0.292          P=0.102N         P=0.475N         P=0.011N*        P=0.116N         P=0.584         | 
|COCH-ARM / FISHERS |        P=0.406          P=0.064N         P=0.319N         P=0.007N**       P=0.064N         P=0.408N        | 
|ORDER RESTRICTED   |        P=0.140N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/53 (28%)      13/53 (25%)      18/53 (34%)      18/52 (35%)      23/53 (43%)      28/53 (53%)     | 
|POLY-3 RATE (b)    |        15/45.03         13/41.26         18/40.23         18/40.45         23/44.28         28/46.89        | 
|POLY-3 PERCENT (g) |        33.3%            31.5%            44.7%            44.5%            52.0%            59.7%           | 
|TERMINAL (d)       |        6/25 (24%)       6/22 (27%)       7/24 (29%)       11/25 (44%)      5/20 (25%)       8/23 (35%)      | 
|FIRST INCIDENCE    |        289              289              561              561              321              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.567N         P=0.234          P=0.257          P=0.041 *        P=0.009 **      | 
|POLY 3             |        P<0.001 **       P=0.521N         P=0.192          P=0.196          P=0.054          P=0.007 **      | 
|POLY 1.5           |        P<0.001 **       P=0.476N         P=0.215          P=0.242          P=0.052          P=0.007 **      | 
|POLY 6             |        P=0.002 **       P=0.570N         P=0.194          P=0.158          P=0.066          P=0.010 *       | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.422N         P=0.246          P=0.262          P=0.083          P=0.012 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.413N         P=0.338          P=0.313          P=0.078          P=0.009 **      | 
|ORDER RESTRICTED   |        P=0.003 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        4/53 (8%)        10/53 (19%)      12/52 (23%)      20/53 (38%)      26/53 (49%)     | 
|POLY-3 RATE (b)    |        1/41.78          4/38.94          10/41.61         12/40.62         20/37.54         26/41.53        | 
|POLY-3 PERCENT (g) |        2.4%             10.3%            24.0%            29.5%            53.3%            62.6%           | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        3/24 (13%)       6/25 (24%)       13/20 (65%)      16/23 (70%)     | 
|FIRST INCIDENCE    |        728 (T)          526              246              472              580              412             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.146          P=0.005 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.157          P=0.003 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.165          P=0.003 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.149          P=0.004 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.160          P=0.011 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.181          P=0.004 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        6/53 (11%)       5/53 (9%)        6/52 (12%)       6/53 (11%)       4/53 (8%)       | 
|POLY-3 RATE (b)    |        5/42.06          6/40.20          5/36.67          6/40.20          6/37.85          4/38.38         | 
|POLY-3 PERCENT (g) |        11.9%            14.9%            13.6%            14.9%            15.9%            10.4%           | 
|TERMINAL (d)       |        4/25 (16%)       3/22 (14%)       5/24 (21%)       1/25 (4%)        2/20 (10%)       0/23 (0%)       | 
|FIRST INCIDENCE    |        651              296              728 (T)          525              500              513             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.440N         P=0.423          P=0.593          P=0.437          P=0.366          P=0.578N        | 
|POLY 3             |        P=0.412N         P=0.468          P=0.542          P=0.468          P=0.425          P=0.558N        | 
|POLY 1.5           |        P=0.400N         P=0.484          P=0.565          P=0.477          P=0.440          P=0.539N        | 
|POLY 6             |        P=0.413N         P=0.447          P=0.523          P=0.462          P=0.427          P=0.571N        | 
|LOGISTIC REGRESSION|        P=0.383N         P=0.506          P=0.526          P=0.475          P=0.428          P=0.534N        | 
|COCH-ARM / FISHERS |        P=0.368N         P=0.500          P=0.629N         P=0.486          P=0.500          P=0.500N        | 
|ORDER RESTRICTED   |        P=0.559N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        24/53 (45%)      28/53 (53%)      27/53 (51%)      24/52 (46%)      39/53 (74%)      31/53 (58%)     | 
|POLY-3 RATE (b)    |        24/48.52         28/47.78         27/46.71         24/42.21         39/47.23         31/46.44        | 
|POLY-3 PERCENT (g) |        49.5%            58.6%            57.8%            56.9%            82.6%            66.8%           | 
|TERMINAL (d)       |        10/25 (40%)      9/22 (41%)       9/24 (38%)       15/25 (60%)      17/20 (85%)      13/23 (57%)     | 
|FIRST INCIDENCE    |        289              393              196              470              113              329             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.041 *        P=0.179          P=0.238          P=0.463          P=0.002 **       P=0.080         | 
|POLY 3             |        P=0.016 *        P=0.240          P=0.268          P=0.307          P<0.001 **       P=0.060         | 
|POLY 1.5           |        P=0.023 *        P=0.248          P=0.279          P=0.403          P<0.001 **       P=0.075         | 
|POLY 6             |        P=0.012 *        P=0.236          P=0.266          P=0.212          P<0.001 **       P=0.049 *       | 
|LOGISTIC REGRESSION|        P=0.047 *        P=0.344          P=0.451          P=0.531          P=0.004 **       P=0.150         | 
|COCH-ARM / FISHERS |        P=0.044 *        P=0.280          P=0.349          P=0.542          P=0.003 **       P=0.122         | 
|ORDER RESTRICTED   |        P=0.005 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        3/53 (6%)        3/53 (6%)        1/52 (2%)        1/53 (2%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        3/41.97          3/39.45          3/39.06          1/38.31          1/36.13          1/37.04         | 
|POLY-3 PERCENT (g) |        7.2%             7.6%             7.7%             2.6%             2.8%             2.7%            | 
|TERMINAL (d)       |        2/25 (8%)        1/22 (5%)        0/24 (0%)        0/25 (0%)        1/20 (5%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        678              289              196              616              728 (T)          603             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.167N         P=0.603          P=0.612          P=0.351N         P=0.392N         P=0.368N        | 
|POLY 3             |        P=0.163N         P=0.634          P=0.630          P=0.338N         P=0.360N         P=0.351N        | 
|POLY 1.5           |        P=0.156N         P=0.647          P=0.636          P=0.325N         P=0.345N         P=0.334N        | 
|POLY 6             |        P=0.169N         P=0.620          P=0.626          P=0.352N         P=0.370N         P=0.366N        | 
|LOGISTIC REGRESSION|        P=0.120N         P=0.651N         P=0.551N         P=0.338N         P=0.366N         P=0.348N        | 
|COCH-ARM / FISHERS |        P=0.139N         P=0.661N         P=0.661N         P=0.316N         P=0.309N         P=0.309N        | 
|ORDER RESTRICTED   |        P=0.300N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        3/52 (6%)        8/53 (15%)       12/53 (23%)     | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          3/38.12          8/36.44          12/37.65        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             7.9%             22.0%            31.9%           | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        2/25 (8%)        5/20 (25%)       8/23 (35%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              675              675              498             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.109          P=0.002 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.102          P=0.002 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.108          P=0.002 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.096          P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              P=0.095          P=0.002 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.118          P=0.003 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        47/53 (89%)      44/53 (83%)      47/53 (89%)      50/52 (96%)      48/53 (91%)      50/53 (94%)     | 
|POLY-3 RATE (b)    |        47/51.32         44/50.12         47/49.49         50/51.75         48/50.99         50/51.75        | 
|POLY-3 PERCENT (g) |        91.6%            87.8%            95.0%            96.6%            94.1%            96.6%           | 
|TERMINAL (d)       |        23/25 (92%)      20/22 (91%)      23/24 (96%)      25/25 (100%)     18/20 (90%)      22/23 (96%)     | 
|FIRST INCIDENCE    |        289              289              116              302              113              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.114          P=0.403          P=0.308          P=0.234          P=0.130          P=0.143         | 
|POLY 3             |        P=0.104          P=0.371N         P=0.378          P=0.236          P=0.449          P=0.232         | 
|POLY 1.5           |        P=0.091          P=0.331N         P=0.445          P=0.196          P=0.442          P=0.230         | 
|POLY 6             |        P=0.144          P=0.454N         P=0.333          P=0.283          P=0.501          P=0.254         | 
|LOGISTIC REGRESSION|        P=0.075          P=0.308N         P=0.494          P=0.141          P=0.444          P=0.217         | 
|COCH-ARM / FISHERS |        P=0.089          P=0.289N         P=0.620N         P=0.141          P=0.500          P=0.244         | 
|ORDER RESTRICTED   |        P=0.086          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        33/53 (62%)      24/53 (45%)      24/53 (45%)      29/52 (56%)      27/53 (51%)      26/53 (49%)     | 
|POLY-3 RATE (b)    |        33/45.39         24/39.87         24/37.89         29/39.73         27/39.18         26/38.39        | 
|POLY-3 PERCENT (g) |        72.7%            60.2%            63.4%            73.0%            68.9%            67.7%           | 
|TERMINAL (d)       |        21/25 (84%)      19/22 (86%)      20/24 (83%)      24/25 (96%)      19/20 (95%)      22/23 (96%)     | 
|FIRST INCIDENCE    |        500              547              587              525              420              498             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.490          P=0.199N         P=0.120N         P=0.371N         P=0.549          P=0.286N        | 
|POLY 3             |        P=0.498          P=0.140N         P=0.232N         P=0.595          P=0.439N         P=0.389N        | 
|POLY 1.5           |        P=0.488N         P=0.092N         P=0.153N         P=0.449N         P=0.335N         P=0.243N        | 
|POLY 6             |        P=0.371          P=0.238N         P=0.350N         P=0.353          P=0.528N         P=0.618N        | 
|LOGISTIC REGRESSION|        P=0.379          P=0.141N         P=0.190N         P=0.546          P=0.464N         P=0.428N        | 
|COCH-ARM / FISHERS |        P=0.371N         P=0.059N         P=0.059N         P=0.316N         P=0.164N         P=0.120N        | 
|ORDER RESTRICTED   |        P=0.460N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        10/53 (19%)      3/53 (6%)        3/52 (6%)        6/53 (11%)       18/53 (34%)     | 
|POLY-3 RATE (b)    |        4/44.47          10/42.96         3/37.19          3/39.69          6/37.09          18/45.30        | 
|POLY-3 PERCENT (g) |        9.0%             23.3%            8.1%             7.6%             16.2%            39.7%           | 
|TERMINAL (d)       |        0/25 (0%)        1/22 (5%)        2/24 (8%)        0/25 (0%)        2/20 (10%)       2/23 (9%)       | 
|FIRST INCIDENCE    |        377              289              570              410              555              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.065          P=0.547N         P=0.547N         P=0.279          P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.060          P=0.597N         P=0.562N         P=0.261          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.066          P=0.570N         P=0.539N         P=0.290          P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.056          P=0.619N         P=0.586N         P=0.244          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.115          P=0.418N         P=0.496N         P=0.406          P=0.002 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.075          P=0.500N         P=0.511N         P=0.371          P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        13/53 (25%)      11/53 (21%)      21/53 (40%)      44/52 (85%)      42/53 (79%)      48/53 (91%)     | 
|POLY-3 RATE (b)    |        13/43.77         11/39.99         21/41.81         44/47.88         42/43.72         48/49.81        | 
|POLY-3 PERCENT (g) |        29.7%            27.5%            50.2%            91.9%            96.1%            96.4%           | 
|TERMINAL (d)       |        7/25 (28%)       6/22 (27%)       11/24 (46%)      24/25 (96%)      20/20 (100%)     22/23 (96%)     | 
|FIRST INCIDENCE    |        321              503              246              410              267              329             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.559N         P=0.053          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.508N         P=0.037 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.471N         P=0.041 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.544N         P=0.039 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.471N         P=0.048 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.408N         P=0.072          P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/53 (4%)        3/53 (6%)        8/52 (15%)       27/53 (51%)      44/53 (83%)     | 
|POLY-3 RATE (b)    |        0/41.78          2/38.44          3/36.87          8/39.30          27/39.30         44/47.12        | 
|POLY-3 PERCENT (g) |        0.0%             5.2%             8.1%             20.4%            68.7%            93.4%           | 
|TERMINAL (d)       |        0/25 (0%)        1/22 (5%)        2/24 (8%)        5/25 (20%)       15/20 (75%)      22/23 (96%)     | 
|FIRST INCIDENCE    |        ---              624              677              470              420              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.220          P=0.105          P=0.004 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.219          P=0.097          P=0.002 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.226          P=0.102          P=0.003 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.211          P=0.094          P=0.002 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.222          P=0.093          P=0.004 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.248          P=0.121          P=0.003 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/53 (13%)       4/53 (8%)        2/53 (4%)        3/52 (6%)        2/53 (4%)        7/53 (13%)      | 
|POLY-3 RATE (b)    |        7/42.31          4/38.30          2/36.67          3/37.91          2/36.15          7/37.91         | 
|POLY-3 PERCENT (g) |        16.6%            10.4%            5.5%             7.9%             5.5%             18.5%           | 
|TERMINAL (d)       |        4/25 (16%)       3/22 (14%)       2/24 (8%)        3/25 (12%)       1/20 (5%)        4/23 (17%)      | 
|FIRST INCIDENCE    |        651              668              728 (T)          728 (T)          721              412             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.215          P=0.363N         P=0.111N         P=0.189N         P=0.145N         P=0.513         | 
|POLY 3             |        P=0.239          P=0.318N         P=0.116N         P=0.202N         P=0.120N         P=0.527         | 
|POLY 1.5           |        P=0.246          P=0.295N         P=0.105N         P=0.184N         P=0.108N         P=0.559         | 
|POLY 6             |        P=0.236          P=0.347N         P=0.126N         P=0.228N         P=0.129N         P=0.496         | 
|LOGISTIC REGRESSION|        P=0.199          P=0.347N         P=0.121N         P=0.221N         P=0.123N         P=0.515         | 
|COCH-ARM / FISHERS |        P=0.259          P=0.263N         P=0.080N         P=0.167N         P=0.080N         P=0.612N        | 
|ORDER RESTRICTED   |        P=0.152          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        4/53 (8%)        2/53 (4%)        2/52 (4%)        3/53 (6%)        6/53 (11%)      | 
|POLY-3 RATE (b)    |        1/41.78          4/38.44          2/36.67          2/37.91          3/36.36          6/37.63         | 
|POLY-3 PERCENT (g) |        2.4%             10.4%            5.5%             5.3%             8.3%             15.9%           | 
|TERMINAL (d)       |        1/25 (4%)        3/22 (14%)       2/24 (8%)        2/25 (8%)        0/20 (0%)        3/23 (13%)      | 
|FIRST INCIDENCE    |        728 (T)          624              728 (T)          728 (T)          675              498             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.035 *        P=0.147          P=0.486          P=0.500          P=0.245          P=0.045 *       | 
|POLY 3             |        P=0.033 *        P=0.153          P=0.455          P=0.466          P=0.257          P=0.039 *       | 
|POLY 1.5           |        P=0.037 *        P=0.163          P=0.466          P=0.479          P=0.269          P=0.045 *       | 
|POLY 6             |        P=0.031 *        P=0.143          P=0.446          P=0.451          P=0.251          P=0.035 *       | 
|LOGISTIC REGRESSION|        P=0.030 *        P=0.138          P=0.486          P=0.500          P=0.245          P=0.041 *       | 
|COCH-ARM / FISHERS |        P=0.045 *        P=0.181          P=0.500          P=0.493          P=0.309          P=0.056         | 
|ORDER RESTRICTED   |        P=0.014 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        2/53 (4%)        2/53 (4%)        2/52 (4%)        1/53 (2%)        13/53 (25%)     | 
|POLY-3 RATE (b)    |        3/42.17          2/38.74          2/36.67          2/38.28          1/36.41          13/40.14        | 
|POLY-3 PERCENT (g) |        7.1%             5.2%             5.5%             5.2%             2.8%             32.4%           | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        2/24 (8%)        1/25 (4%)        0/20 (0%)        5/23 (22%)      | 
|FIRST INCIDENCE    |        619              503              728 (T)          624              651              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.553N         P=0.535N         P=0.543N         P=0.382N         P=0.005 **      | 
|POLY 3             |        P<0.001 **       P=0.539N         P=0.563N         P=0.544N         P=0.359N         P=0.003 **      | 
|POLY 1.5           |        P<0.001 **       P=0.523N         P=0.547N         P=0.527N         P=0.344N         P=0.004 **      | 
|POLY 6             |        P<0.001 **       P=0.557N         P=0.578N         P=0.563N         P=0.367N         P=0.003 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.516N         P=0.569N         P=0.541N         P=0.348N         P=0.006 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.500N         P=0.509N         P=0.309N         P=0.006 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        2/53 (4%)        3/53 (6%)        4/52 (8%)        4/53 (8%)        5/53 (9%)       | 
|POLY-3 RATE (b)    |        4/43.64          2/39.16          3/38.28          4/39.45          4/36.71          5/38.54         | 
|POLY-3 PERCENT (g) |        9.2%             5.1%             7.8%             10.1%            10.9%            13.0%           | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        2/20 (10%)       0/23 (0%)       | 
|FIRST INCIDENCE    |        310              420              451              589              555              443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.189          P=0.404N         P=0.580N         P=0.553          P=0.551          P=0.417         | 
|POLY 3             |        P=0.195          P=0.388N         P=0.571N         P=0.587          P=0.546          P=0.422         | 
|POLY 1.5           |        P=0.207          P=0.368N         P=0.555N         P=0.606          P=0.573          P=0.448         | 
|POLY 6             |        P=0.187          P=0.409N         P=0.581N         P=0.571          P=0.528          P=0.401         | 
|LOGISTIC REGRESSION|        P=0.246          P=0.273N         P=0.392N         P=0.630N         P=0.630N         P=0.578         | 
|COCH-ARM / FISHERS |        P=0.229          P=0.339N         P=0.500N         P=0.631          P=0.642N         P=0.500         | 
|ORDER RESTRICTED   |        P=0.328          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        13/53 (25%)      17/53 (32%)      17/52 (33%)      24/53 (45%)      34/53 (64%)     | 
|POLY-3 RATE (b)    |        2/42.11          13/41.41         17/40.93         17/43.29         24/43.66         34/45.17        | 
|POLY-3 PERCENT (g) |        4.8%             31.4%            41.5%            39.3%            55.0%            75.3%           | 
|TERMINAL (d)       |        0/25 (0%)        4/22 (18%)       7/24 (29%)       4/25 (16%)       10/20 (50%)      15/23 (65%)     | 
|FIRST INCIDENCE    |        651              393              393              470              267              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.002 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.002 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.002 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Multinucleated                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        4/53 (8%)        13/52 (25%)      18/53 (34%)      35/53 (66%)     | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          4/37.39          13/41.43         18/39.88         35/48.44        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             10.7%            31.4%            45.1%            72.3%           | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        2/24 (8%)        5/25 (20%)       7/20 (35%)       13/23 (57%)     | 
|FIRST INCIDENCE    |        ---              ---              570              499              267              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P=0.053          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              P=0.047 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              P=0.050          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              P=0.045 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              P=0.050          P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.059          P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        4/53 (8%)        2/53 (4%)        6/52 (12%)       15/53 (28%)      35/53 (66%)     | 
|POLY-3 RATE (b)    |        1/41.78          4/38.73          2/37.15          6/38.93          15/37.58         35/44.51        | 
|POLY-3 PERCENT (g) |        2.4%             10.3%            5.4%             15.4%            39.9%            78.6%           | 
|TERMINAL (d)       |        1/25 (4%)        2/22 (9%)        1/24 (4%)        4/25 (16%)       8/20 (40%)       18/23 (78%)     | 
|FIRST INCIDENCE    |        728 (T)          624              584              525              500              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.148          P=0.477          P=0.054          P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.155          P=0.459          P=0.044 *        P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.164          P=0.468          P=0.048 *        P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.147          P=0.454          P=0.040 *        P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.149          P=0.463          P=0.045 *        P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.181          P=0.500          P=0.053          P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        44/53 (83%)      44/53 (83%)      40/53 (75%)      40/53 (75%)      41/53 (77%)      36/52 (69%)     | 
|POLY-3 RATE (b)    |        44/49.96         44/48.57         40/45.76         40/47.07         41/44.78         36/42.51        | 
|POLY-3 PERCENT (g) |        88.1%            90.6%            87.4%            85.0%            91.6%            84.7%           | 
|TERMINAL (d)       |        22/25 (88%)      18/22 (82%)      20/24 (83%)      21/25 (84%)      18/20 (90%)      21/23 (91%)     | 
|FIRST INCIDENCE    |        310              432              219              429              348              451             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.309N         P=0.250          P=0.539          P=0.507N         P=0.276          P=0.390N        | 
|POLY 3             |        P=0.350N         P=0.466          P=0.590N         P=0.436N         P=0.406          P=0.424N        | 
|POLY 1.5           |        P=0.166N         P=0.487          P=0.502N         P=0.334N         P=0.536          P=0.234N        | 
|POLY 6             |        P=0.505          P=0.509          P=0.631N         P=0.545N         P=0.366          P=0.633         | 
|LOGISTIC REGRESSION|        P=0.085N         P=0.479          P=0.474N         P=0.301N         P=0.539          P=0.177N        | 
|COCH-ARM / FISHERS |        P=0.055N         P=0.602N         P=0.237N         P=0.237N         P=0.313N         P=0.076N        | 
|ORDER RESTRICTED   |        P=0.413N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        8/53 (15%)       7/53 (13%)       6/53 (11%)       7/53 (13%)       8/52 (15%)      | 
|POLY-3 RATE (b)    |        5/43.26          8/38.96          7/37.70          6/40.97          7/38.10          8/40.24         | 
|POLY-3 PERCENT (g) |        11.6%            20.5%            18.6%            14.6%            18.4%            19.9%           | 
|TERMINAL (d)       |        1/25 (4%)        5/22 (23%)       5/24 (21%)       1/25 (4%)        3/20 (15%)       2/23 (9%)       | 
|FIRST INCIDENCE    |        377              600              561              470              267              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.281          P=0.207          P=0.327          P=0.460          P=0.279          P=0.217         | 
|POLY 3             |        P=0.313          P=0.208          P=0.284          P=0.462          P=0.291          P=0.227         | 
|POLY 1.5           |        P=0.323          P=0.233          P=0.307          P=0.480          P=0.313          P=0.243         | 
|POLY 6             |        P=0.308          P=0.184          P=0.267          P=0.440          P=0.281          P=0.214         | 
|LOGISTIC REGRESSION|        P=0.330          P=0.244          P=0.335          P=0.538          P=0.391          P=0.363         | 
|COCH-ARM / FISHERS |        P=0.326          P=0.278          P=0.380          P=0.500          P=0.380          P=0.265         | 
|ORDER RESTRICTED   |        P=0.266          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)        4/53 (8%)        3/52 (6%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          2/38.22          4/36.48          3/36.67         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.2%             11.0%            8.2%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        2/25 (8%)        0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              728 (T)          667              668             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.010 *        (e)              (e)              P=0.237          P=0.049 *        P=0.100         | 
|POLY 3             |        P=0.009 **       (e)              (e)              P=0.217          P=0.044 *        P=0.096         | 
|POLY 1.5           |        P=0.010 *        (e)              (e)              P=0.227          P=0.048 *        P=0.103         | 
|POLY 6             |        P=0.008 **       (e)              (e)              P=0.207          P=0.043 *        P=0.090         | 
|LOGISTIC REGRESSION|        P=0.009 **       (e)              (e)              P=0.237          P=0.044 *        P=0.090         | 
|COCH-ARM / FISHERS |        P=0.012 *        (e)              (e)              P=0.248          P=0.059          P=0.118         | 
|ORDER RESTRICTED   |        P=0.017 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        14/53 (26%)      17/53 (32%)      12/53 (23%)      20/53 (38%)      8/53 (15%)       3/52 (6%)       | 
|POLY-3 RATE (b)    |        14/42.58         17/40.17         12/37.26         20/40.24         8/36.84          3/37.09         | 
|POLY-3 PERCENT (g) |        32.9%            42.3%            32.2%            49.7%            21.7%            8.1%            | 
|TERMINAL (d)       |        11/25 (44%)      10/22 (46%)      9/24 (38%)       15/25 (60%)      4/20 (20%)       2/23 (9%)       | 
|FIRST INCIDENCE    |        610              451              636              570              662              513             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001N**       P=0.192          P=0.490N         P=0.102          P=0.253N         P=0.007N**      | 
|POLY 3             |        P<0.001N**       P=0.249          P=0.570N         P=0.083          P=0.193N         P=0.006N**      | 
|POLY 1.5           |        P<0.001N**       P=0.281          P=0.529N         P=0.109          P=0.170N         P=0.005N**      | 
|POLY 6             |        P<0.001N**       P=0.225          P=0.596          P=0.062          P=0.200N         P=0.007N**      | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.192          P=0.585          P=0.048 *        P=0.211N         P=0.009N**      | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.335          P=0.411N         P=0.149          P=0.115N         P=0.004N**      | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        6/53 (11%)       5/53 (9%)        9/53 (17%)       23/53 (43%)      28/52 (54%)     | 
|POLY-3 RATE (b)    |        5/41.78          6/38.76          5/37.19          9/38.79          23/37.87         28/39.89        | 
|POLY-3 PERCENT (g) |        12.0%            15.5%            13.4%            23.2%            60.7%            70.2%           | 
|TERMINAL (d)       |        5/25 (20%)       3/22 (14%)       4/24 (17%)       7/25 (28%)       16/20 (80%)      19/23 (83%)     | 
|FIRST INCIDENCE    |        728 (T)          624              570              624              561              513             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.406          P=0.604          P=0.170          P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.447          P=0.556          P=0.148          P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.467          P=0.573          P=0.168          P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.430          P=0.547          P=0.128          P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.394          P=0.528          P=0.112          P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P=0.629N         P=0.195          P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        2/51 (4%)        1/53 (2%)        1/51 (2%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/38.16          2/36.60          1/38.52          1/35.23          1/35.09         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             5.5%             2.6%             2.8%             2.9%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        1/24 (4%)        0/25 (0%)        1/20 (5%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        ---              706              301              645              728 (T)          728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.559          P=0.462          P=0.224          P=0.454          P=0.455          P=0.483         | 
|POLY 3             |        P=0.519          P=0.482          P=0.208          P=0.484          P=0.466          P=0.465         | 
|POLY 1.5           |        P=0.536          P=0.489          P=0.212          P=0.491          P=0.473          P=0.475         | 
|POLY 6             |        P=0.506          P=0.474          P=0.206          P=0.476          P=0.462          P=0.457         | 
|LOGISTIC REGRESSION|        P=0.563          P=0.473          P=0.288          P=0.500          P=0.455          P=0.483         | 
|COCH-ARM / FISHERS |        P=0.569          P=0.500          P=0.238          P=0.500          P=0.490          P=0.490         | 
|ORDER RESTRICTED   |        P=0.315          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        38/53 (72%)      41/53 (77%)      38/51 (75%)      31/53 (58%)      30/51 (59%)      29/51 (57%)     | 
|POLY-3 RATE (b)    |        38/46.17         41/46.30         38/44.92         31/41.86         30/40.64         29/40.56        | 
|POLY-3 PERCENT (g) |        82.3%            88.6%            84.6%            74.1%            73.8%            71.5%           | 
|TERMINAL (d)       |        24/25 (96%)      21/22 (96%)      20/24 (83%)      22/25 (88%)      15/20 (75%)      19/23 (83%)     | 
|FIRST INCIDENCE    |        321              321              196              470              353              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.056N         P=0.110          P=0.335          P=0.215N         P=0.484N         P=0.223N        | 
|POLY 3             |        P=0.016N*        P=0.258          P=0.495          P=0.217N         P=0.222N         P=0.147N        | 
|POLY 1.5           |        P=0.014N*        P=0.284          P=0.442          P=0.146N         P=0.200N         P=0.120N        | 
|POLY 6             |        P=0.020N*        P=0.235          P=0.586          P=0.375N         P=0.216N         P=0.183N        | 
|LOGISTIC REGRESSION|        P=0.023N*        P=0.139          P=0.230          P=0.277N         P=0.338N         P=0.253N        | 
|COCH-ARM / FISHERS |        P=0.011N*        P=0.328          P=0.460          P=0.111N         P=0.120N         P=0.084N        | 
|ORDER RESTRICTED   |        P=0.052N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        0/53 (0%)        0/52 (0%)        0/52 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/38.83          0/36.67          0/37.91          0/35.44          2/36.98         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             0.0%             0.0%             0.0%             5.4%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        ---              451              ---              ---              ---              624             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.067          P=0.492          (e)              (e)              (e)              P=0.206         | 
|POLY 3             |        P=0.070          P=0.485          (e)              (e)              (e)              P=0.211         | 
|POLY 1.5           |        P=0.073          P=0.491          (e)              (e)              (e)              P=0.220         | 
|POLY 6             |        P=0.069          P=0.479          (e)              (e)              (e)              P=0.203         | 
|LOGISTIC REGRESSION|        P=0.080          P=0.541          (e)              (e)              (e)              P=0.214         | 
|COCH-ARM / FISHERS |        P=0.077          P=0.500          (e)              (e)              (e)              P=0.248         | 
|ORDER RESTRICTED   |        P=0.021 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/5 (40%)        1/4 (25%)        0/4 (0%)         0/4 (0%)         1/3 (33%)        0/7 (0%)        | 
|POLY-3 RATE (b)    |        2/4.62           1/2.09           0/1.82           0/2.06           1/2.97           0/4.67          | 
|POLY-3 PERCENT (g) |        43.3%            48.0%            0.0%             0.0%             33.7%            0.0%            | 
|TERMINAL (d)       |        1/3 (33%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/1 (0%)         0/2 (0%)        | 
|FIRST INCIDENCE    |        678              451              ---              ---              675              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.240N         P=0.729          P=0.531N         P=0.515N         P=0.662N         P=0.302N        | 
|POLY 3             |        P=0.116N         P=0.728          P=0.459N         P=0.426N         P=0.669N         P=0.197N        | 
|POLY 1.5           |        P=0.134N         P=0.711N         P=0.388N         P=0.346N         P=0.678N         P=0.171N        | 
|POLY 6             |        P=0.097N         P=0.657          P=0.559N         P=0.552N         P=0.656N         P=0.225N        | 
|LOGISTIC REGRESSION|        P=0.157N         P=0.802N         P=0.759N         P=0.792N         P=0.741N         P=0.212N        | 
|COCH-ARM / FISHERS |        P=0.176N         P=0.595N         P=0.278N         P=0.278N         P=0.714N         P=0.152N        | 
|ORDER RESTRICTED   |        P=0.026N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/5 (40%)        1/4 (25%)        0/4 (0%)         0/4 (0%)         0/3 (0%)         0/7 (0%)        | 
|POLY-3 RATE (b)    |        2/4.42           1/2.09           0/1.82           0/2.06           0/2.77           0/4.67          | 
|POLY-3 PERCENT (g) |        45.2%            48.0%            0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        2/3 (67%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/1 (0%)         0/2 (0%)        | 
|FIRST INCIDENCE    |        728 (T)          451              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.111N         P=0.492          P=1.000N         P=1.000N         P=0.500N         P=0.309N        | 
|POLY 3             |        P=0.053N         P=0.748          P=0.447N         P=0.412N         P=0.321N         P=0.183N        | 
|POLY 1.5           |        P=0.070N         P=0.707N         P=0.381N         P=0.338N         P=0.330N         P=0.164N        | 
|POLY 6             |        P=0.036N*        P=0.697          P=0.545N         P=0.537N         P=0.308N         P=0.196N        | 
|LOGISTIC REGRESSION|        P=0.101N         P=0.901N         (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.114N         P=0.595N         P=0.278N         P=0.278N         P=0.357N         P=0.152N        | 
|ORDER RESTRICTED   |        P=0.011N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/5 (0%)         1/4 (25%)        1/4 (25%)        2/4 (50%)        1/3 (33%)        1/7 (14%)       | 
|POLY-3 RATE (b)    |        0/4.42           1/2.06           1/2.14           2/2.80           1/2.97           1/4.90          | 
|POLY-3 PERCENT (g) |        0.0%             48.6%            46.6%            71.4%            33.7%            20.4%           | 
|TERMINAL (d)       |        0/3 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/1 (0%)         0/2 (0%)        | 
|FIRST INCIDENCE    |        ---              467              638              599              675              668             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.481          P=0.487          P=0.454          P=0.200          P=0.454          P=0.455         | 
|POLY 3             |        P=0.620N         P=0.345          P=0.352          P=0.064          P=0.415          P=0.521         | 
|POLY 1.5           |        P=0.594N         P=0.387          P=0.382          P=0.092          P=0.404          P=0.534         | 
|POLY 6             |        P=0.623          P=0.306          P=0.320          P=0.040 *        P=0.433          P=0.516         | 
|LOGISTIC REGRESSION|        P=0.544N         P=0.983          P=0.387          P=0.157          P=0.315          P=0.541         | 
|COCH-ARM / FISHERS |        P=0.558N         P=0.444          P=0.444          P=0.167          P=0.375          P=0.583         | 
|ORDER RESTRICTED   |        P=0.080          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/5 (0%)         0/4 (0%)         0/4 (0%)         0/4 (0%)         2/3 (67%)        2/7 (29%)       | 
|POLY-3 RATE (b)    |        0/4.42           0/1.32           0/1.82           0/2.06           2/2.80           2/4.72          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             71.5%            42.4%           | 
|TERMINAL (d)       |        0/3 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/1 (100%)       1/2 (50%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              721              716             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.050          (e)              (e)              (e)              P=0.115          P=0.188         | 
|POLY 3             |        P=0.030 *        (e)              (e)              (e)              P=0.047 *        P=0.216         | 
|POLY 1.5           |        P=0.031 *        (e)              (e)              (e)              P=0.049 *        P=0.244         | 
|POLY 6             |        P=0.029 *        (e)              (e)              (e)              P=0.045 *        P=0.194         | 
|LOGISTIC REGRESSION|        P=0.105          (e)              (e)              (e)              P=0.085          P=0.175         | 
|COCH-ARM / FISHERS |        P=0.052          (e)              (e)              (e)              P=0.107          P=0.318         | 
|ORDER RESTRICTED   |        P=0.007 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/5 (0%)         1/4 (25%)        0/4 (0%)         1/4 (25%)        1/3 (33%)        2/7 (29%)       | 
|POLY-3 RATE (b)    |        0/4.42           1/2.09           0/1.82           1/2.78           1/2.80           2/5.58          | 
|POLY-3 PERCENT (g) |        0.0%             48.0%            0.0%             35.9%            35.8%            35.9%           | 
|TERMINAL (d)       |        0/3 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/1 (0%)         1/2 (50%)       | 
|FIRST INCIDENCE    |        ---              451              ---              472              721              329             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.151          P=0.492          (e)              P=0.486          P=0.465          P=0.200         | 
|POLY 3             |        P=0.246          P=0.347          (e)              P=0.403          P=0.401          P=0.266         | 
|POLY 1.5           |        P=0.249          P=0.388          (e)              P=0.428          P=0.397          P=0.279         | 
|POLY 6             |        P=0.240          P=0.307          (e)              P=0.361          P=0.408          P=0.253         | 
|LOGISTIC REGRESSION|        P=0.190          P=0.997          (e)              (e)              P=0.399          P=0.503         | 
|COCH-ARM / FISHERS |        P=0.218          P=0.444          (e)              P=0.444          P=0.375          P=0.318         | 
|ORDER RESTRICTED   |        P=0.091          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/53 (4%)        0/53 (0%)        5/53 (9%)        4/53 (8%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        1/41.81          2/38.38          0/36.67          5/39.84          4/37.01          3/37.13         | 
|POLY-3 PERCENT (g) |        2.4%             5.2%             0.0%             12.6%            10.8%            8.1%            | 
|TERMINAL (d)       |        0/25 (0%)        1/22 (5%)        0/24 (0%)        2/25 (8%)        3/20 (15%)       1/23 (4%)       | 
|FIRST INCIDENCE    |        720              645              ---              429              353              624             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.153          P=0.449          P=0.523N         P=0.095          P=0.132          P=0.259         | 
|POLY 3             |        P=0.148          P=0.470          P=0.526N         P=0.089          P=0.143          P=0.263         | 
|POLY 1.5           |        P=0.160          P=0.482          P=0.520N         P=0.095          P=0.152          P=0.278         | 
|POLY 6             |        P=0.139          P=0.458          P=0.531N         P=0.083          P=0.137          P=0.252         | 
|LOGISTIC REGRESSION|        P=0.167          P=0.460          P=0.532N         P=0.106          P=0.161          P=0.256         | 
|COCH-ARM / FISHERS |        P=0.180          P=0.500          P=0.500N         P=0.103          P=0.181          P=0.309         | 
|ORDER RESTRICTED   |        P=0.111          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        33/53 (62%)      29/53 (55%)      26/53 (49%)      20/53 (38%)      20/53 (38%)      17/53 (32%)     | 
|POLY-3 RATE (b)    |        33/46.61         29/45.46         26/42.61         20/42.24         20/39.35         17/41.09        | 
|POLY-3 PERCENT (g) |        70.8%            63.8%            61.0%            47.3%            50.8%            41.4%           | 
|TERMINAL (d)       |        19/25 (76%)      13/22 (59%)      14/24 (58%)      12/25 (48%)      11/20 (55%)      8/23 (35%)      | 
|FIRST INCIDENCE    |        289              296              219              410              113              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.011N*        P=0.558          P=0.303N         P=0.036N*        P=0.117N         P=0.023N*       | 
|POLY 3             |        P=0.002N**       P=0.300N         P=0.213N         P=0.014N*        P=0.037N*        P=0.003N**      | 
|POLY 1.5           |        P<0.001N**       P=0.294N         P=0.189N         P=0.011N*        P=0.024N*        P=0.002N**      | 
|POLY 6             |        P=0.002N**       P=0.298N         P=0.230N         P=0.021N*        P=0.048N*        P=0.004N**      | 
|LOGISTIC REGRESSION|        P=0.002N**       P=0.335N         P=0.204N         P=0.015N*        P=0.028N*        P=0.003N**      | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.277N         P=0.120N         P=0.010N*        P=0.010N*        P=0.002N**      | 
|ORDER RESTRICTED   |        P=0.002N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        4/53 (8%)        3/53 (6%)        4/53 (8%)        4/53 (8%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        2/41.97          4/38.83          3/36.87          4/39.84          4/36.44          3/36.98         | 
|POLY-3 PERCENT (g) |        4.8%             10.3%            8.1%             10.0%            11.0%            8.1%            | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        2/24 (8%)        1/25 (4%)        2/20 (10%)       2/23 (9%)       | 
|FIRST INCIDENCE    |        678              645              675              429              667              624             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.483          P=0.278          P=0.448          P=0.298          P=0.253          P=0.436         | 
|POLY 3             |        P=0.478          P=0.301          P=0.441          P=0.312          P=0.273          P=0.442         | 
|POLY 1.5           |        P=0.503          P=0.315          P=0.455          P=0.325          P=0.290          P=0.463         | 
|POLY 6             |        P=0.455          P=0.288          P=0.431          P=0.299          P=0.265          P=0.423         | 
|LOGISTIC REGRESSION|        P=0.501          P=0.297          P=0.430          P=0.346          P=0.263          P=0.430         | 
|COCH-ARM / FISHERS |        P=0.543          P=0.339          P=0.500          P=0.339          P=0.339          P=0.500         | 
|ORDER RESTRICTED   |        P=0.395          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Artery                                                                                                                | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/1 (0%)         1/2 (50%)        0/1 (0%)         2/3 (67%)        1/2 (50%)        4/4 (100%)      | 
|POLY-3 RATE (b)    |        0/1.00           1/1.36           0/1.00           2/3.00           1/2.00           4/4.00          | 
|POLY-3 PERCENT (g) |        0.0%             73.7%            0.0%             66.7%            50.0%            100.0%          | 
|TERMINAL (d)       |        0/1 (0%)         1/1 (100%)       0/1 (0%)         1/2 (50%)        1/2 (50%)        2/2 (100%)      | 
|FIRST INCIDENCE    |        ---              728 (T)          ---              548              728 (T)          624             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.013 *        P=0.500          (e)              P=0.292          P=0.638          P=0.075         | 
|POLY 3             |        P=0.051          P=0.570          (e)              P=0.500          P=0.614          P=0.200         | 
|POLY 1.5           |        P=0.052          P=0.593          (e)              P=0.500          P=0.614          P=0.200         | 
|POLY 6             |        P=0.048 *        P=0.534          (e)              P=0.500          P=0.614          P=0.200         | 
|LOGISTIC REGRESSION|        P=0.052          P=0.500          (e)              (e)              P=0.638          (e)             | 
|COCH-ARM / FISHERS |        P=0.053          P=0.667          (e)              P=0.500          P=0.667          P=0.200         | 
|ORDER RESTRICTED   |        P=0.119          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/53 (15%)       3/53 (6%)        8/53 (15%)       11/53 (21%)      7/53 (13%)       6/53 (11%)      | 
|POLY-3 RATE (b)    |        8/44.12          3/38.16          8/38.85          11/42.27         7/38.30          6/38.20         | 
|POLY-3 PERCENT (g) |        18.1%            7.9%             20.6%            26.0%            18.3%            15.7%           | 
|TERMINAL (d)       |        2/25 (8%)        2/22 (9%)        4/24 (17%)       4/25 (16%)       3/20 (15%)       2/23 (9%)       | 
|FIRST INCIDENCE    |        321              706              517              302              321              443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.540N         P=0.168N         P=0.509          P=0.250          P=0.567          P=0.494N        | 
|POLY 3             |        P=0.537N         P=0.148N         P=0.498          P=0.264          P=0.606          P=0.501N        | 
|POLY 1.5           |        P=0.512N         P=0.127N         P=0.522          P=0.286          P=0.586N         P=0.459N        | 
|POLY 6             |        P=0.542          P=0.177N         P=0.482          P=0.241          P=0.584          P=0.545N        | 
|LOGISTIC REGRESSION|        P=0.472N         P=0.106N         P=0.600          P=0.343          P=0.480N         P=0.378N        | 
|COCH-ARM / FISHERS |        P=0.468N         P=0.101N         P=0.607N         P=0.307          P=0.500N         P=0.388N        | 
|ORDER RESTRICTED   |        P=0.365          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        2/53 (4%)        1/53 (2%)        6/53 (11%)       3/53 (6%)       | 
|POLY-3 RATE (b)    |        1/42.34          1/38.36          2/36.87          1/38.69          6/36.71          3/36.61         | 
|POLY-3 PERCENT (g) |        2.4%             2.6%             5.4%             2.6%             16.3%            8.2%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        1/24 (4%)        0/25 (0%)        4/20 (20%)       3/23 (13%)      | 
|FIRST INCIDENCE    |        554              651              675              589              561              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.071          P=0.726          P=0.463          P=0.727          P=0.035 *        P=0.269         | 
|POLY 3             |        P=0.063          P=0.739          P=0.452          P=0.741          P=0.035 *        P=0.254         | 
|POLY 1.5           |        P=0.072          P=0.748          P=0.464          P=0.750          P=0.040 *        P=0.273         | 
|POLY 6             |        P=0.054          P=0.729          P=0.443          P=0.730          P=0.032 *        P=0.237         | 
|LOGISTIC REGRESSION|        P=0.071          P=0.750N         P=0.483          P=0.752N         P=0.041 *        P=0.261         | 
|COCH-ARM / FISHERS |        P=0.089          P=0.752N         P=0.500          P=0.752N         P=0.056          P=0.309         | 
|ORDER RESTRICTED   |        P=0.044 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Septum                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/53 (4%)        3/53 (6%)        2/53 (4%)        5/53 (9%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        1/42.06          2/38.97          3/37.86          2/38.79          5/36.42          3/37.38         | 
|POLY-3 PERCENT (g) |        2.4%             5.1%             7.9%             5.2%             13.7%            8.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        1/24 (4%)        1/25 (4%)        3/20 (15%)       2/23 (9%)       | 
|FIRST INCIDENCE    |        652              420              517              548              662              443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.201          P=0.454          P=0.273          P=0.461          P=0.073          P=0.267         | 
|POLY 3             |        P=0.186          P=0.473          P=0.268          P=0.472          P=0.071          P=0.263         | 
|POLY 1.5           |        P=0.202          P=0.484          P=0.275          P=0.485          P=0.078          P=0.279         | 
|POLY 6             |        P=0.170          P=0.461          P=0.263          P=0.456          P=0.066          P=0.249         | 
|LOGISTIC REGRESSION|        P=0.218          P=0.527          P=0.315          P=0.501          P=0.070          P=0.301         | 
|COCH-ARM / FISHERS |        P=0.229          P=0.500          P=0.309          P=0.500          P=0.103          P=0.309         | 
|ORDER RESTRICTED   |        P=0.106          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/52 (29%)      11/53 (21%)      16/52 (31%)      20/53 (38%)      22/53 (42%)      20/53 (38%)     | 
|POLY-3 RATE (b)    |        15/42.71         11/40.56         16/40.42         20/44.13         22/40.94         20/42.38        | 
|POLY-3 PERCENT (g) |        35.1%            27.1%            39.6%            45.3%            53.7%            47.2%           | 
|TERMINAL (d)       |        9/24 (38%)       4/22 (18%)       7/23 (30%)       9/25 (36%)       10/20 (50%)      10/23 (44%)     | 
|FIRST INCIDENCE    |        500              498              219              410              321              451             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.036 *        P=0.387N         P=0.377          P=0.185          P=0.041 *        P=0.131         | 
|POLY 3             |        P=0.042 *        P=0.288N         P=0.422          P=0.221          P=0.061          P=0.175         | 
|POLY 1.5           |        P=0.043 *        P=0.266N         P=0.432          P=0.227          P=0.071          P=0.185         | 
|POLY 6             |        P=0.044 *        P=0.306N         P=0.429          P=0.219          P=0.061          P=0.175         | 
|LOGISTIC REGRESSION|        P=0.043 *        P=0.289N         P=0.427          P=0.203          P=0.062          P=0.166         | 
|COCH-ARM / FISHERS |        P=0.055          P=0.232N         P=0.500          P=0.224          P=0.124          P=0.224         | 
|ORDER RESTRICTED   |        P=0.044 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        43/53 (81%)      40/53 (75%)      38/53 (72%)      43/52 (83%)      45/52 (87%)      45/53 (85%)     | 
|POLY-3 RATE (b)    |        43/50.40         40/47.87         38/46.23         43/49.92         45/49.03         45/50.44        | 
|POLY-3 PERCENT (g) |        85.3%            83.6%            82.2%            86.1%            91.8%            89.2%           | 
|TERMINAL (d)       |        21/25 (84%)      18/22 (82%)      18/24 (75%)      20/25 (80%)      17/20 (85%)      18/23 (78%)     | 
|FIRST INCIDENCE    |        310              289              300              302              267              329             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.096          P=0.417          P=0.509N         P=0.394          P=0.113          P=0.194         | 
|POLY 3             |        P=0.147          P=0.516N         P=0.442N         P=0.570          P=0.233          P=0.382         | 
|POLY 1.5           |        P=0.103          P=0.442N         P=0.385N         P=0.560          P=0.219          P=0.350         | 
|POLY 6             |        P=0.224          P=0.581N         P=0.465N         P=0.581          P=0.276          P=0.447         | 
|LOGISTIC REGRESSION|        P=0.061          P=0.380N         P=0.311N         P=0.515          P=0.224          P=0.336         | 
|COCH-ARM / FISHERS |        P=0.088          P=0.319N         P=0.180N         P=0.518          P=0.314          P=0.398         | 
|ORDER RESTRICTED   |        P=0.256          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/53 (21%)      18/53 (34%)      20/53 (38%)      17/52 (33%)      18/52 (35%)      13/53 (25%)     | 
|POLY-3 RATE (b)    |        11/42.65         18/42.87         20/42.57         17/40.45         18/38.04         13/40.45        | 
|POLY-3 PERCENT (g) |        25.8%            42.0%            47.0%            42.0%            47.3%            32.1%           | 
|TERMINAL (d)       |        8/25 (32%)       7/22 (32%)       7/24 (29%)       11/25 (44%)      11/20 (55%)      6/23 (26%)      | 
|FIRST INCIDENCE    |        554              451              393              499              337              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.442N         P=0.055          P=0.034 *        P=0.107          P=0.028 *        P=0.302         | 
|POLY 3             |        P=0.413N         P=0.082          P=0.031 *        P=0.085          P=0.033 *        P=0.344         | 
|POLY 1.5           |        P=0.372N         P=0.085          P=0.028 *        P=0.101          P=0.042 *        P=0.365         | 
|POLY 6             |        P=0.453N         P=0.085          P=0.041 *        P=0.072          P=0.030 *        P=0.332         | 
|LOGISTIC REGRESSION|        P=0.373N         P=0.072          P=0.026 *        P=0.070          P=0.031 *        P=0.342         | 
|COCH-ARM / FISHERS |        P=0.311N         P=0.095          P=0.043 *        P=0.122          P=0.085          P=0.408         | 
|ORDER RESTRICTED   |        P=0.091          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/52 (0%)        0/52 (0%)        3/52 (6%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          0/37.91          0/35.44          3/37.50         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             8.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              603             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.086         | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.100         | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.105         | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.097         | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              (e)              P=0.118         | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.118         | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/53 (2%)        1/53 (2%)        1/52 (2%)        0/52 (0%)        4/52 (8%)       | 
|POLY-3 RATE (b)    |        2/42.25          1/38.72          1/37.15          1/38.59          0/35.44          4/37.43         | 
|POLY-3 PERCENT (g) |        4.7%             2.6%             2.7%             2.6%             0.0%             10.7%           | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        588              516              587              499              ---              586             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.073          P=0.539N         P=0.551N         P=0.533N         P=0.291N         P=0.266         | 
|POLY 3             |        P=0.080          P=0.530N         P=0.545N         P=0.532N         P=0.278N         P=0.282         | 
|POLY 1.5           |        P=0.082          P=0.518N         P=0.534N         P=0.519N         P=0.268N         P=0.298         | 
|POLY 6             |        P=0.079          P=0.544N         P=0.553N         P=0.546N         P=0.284N         P=0.269         | 
|LOGISTIC REGRESSION|        P=0.089          P=0.482N         P=0.503N         P=0.494N         P=0.255N         P=0.308         | 
|COCH-ARM / FISHERS |        P=0.088          P=0.500N         P=0.500N         P=0.507N         P=0.252N         P=0.330         | 
|ORDER RESTRICTED   |        P=0.042 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        1/53 (2%)        1/53 (2%)        1/52 (2%)        0/52 (0%)        3/52 (6%)       | 
|POLY-3 RATE (b)    |        3/42.64          1/38.72          1/37.15          1/38.59          0/35.44          3/36.95         | 
|POLY-3 PERCENT (g) |        7.0%             2.6%             2.7%             2.6%             0.0%             8.1%            | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        588              516              587              499              ---              608             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.314          P=0.348N         P=0.365N         P=0.356N         P=0.162N         P=0.575         | 
|POLY 3             |        P=0.340          P=0.340N         P=0.356N         P=0.341N         P=0.155N         P=0.595         | 
|POLY 1.5           |        P=0.344          P=0.326N         P=0.343N         P=0.327N         P=0.145N         P=0.617         | 
|POLY 6             |        P=0.338          P=0.357N         P=0.367N         P=0.359N         P=0.161N         P=0.574         | 
|LOGISTIC REGRESSION|        P=0.355          P=0.287N         P=0.303N         P=0.299N         P=0.128N         P=0.629         | 
|COCH-ARM / FISHERS |        P=0.353          P=0.309N         P=0.309N         P=0.316N         P=0.125N         P=0.652         | 
|ORDER RESTRICTED   |        P=0.211          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/52 (0%)        2/52 (4%)        23/52 (44%)     | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          0/37.91          2/35.47          23/41.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             5.6%             56.1%           | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        1/20 (5%)        13/23 (57%)     | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              721              451             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.203          P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.202          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.210          P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.198          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.197          P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.243          P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 43      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/53 (4%)        1/53 (2%)        2/52 (4%)        4/52 (8%)        11/52 (21%)     | 
|POLY-3 RATE (b)    |        1/42.16          2/38.83          1/36.67          2/38.49          4/36.93          11/38.02        | 
|POLY-3 PERCENT (g) |        2.4%             5.2%             2.7%             5.2%             10.8%            28.9%           | 
|TERMINAL (d)       |        0/25 (0%)        1/22 (5%)        1/24 (4%)        1/25 (4%)        2/20 (10%)       5/23 (22%)      | 
|FIRST INCIDENCE    |        619              451              728 (T)          548              113              586             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.469          P=0.735          P=0.461          P=0.139          P=0.002 **      | 
|POLY 3             |        P<0.001 **       P=0.471          P=0.729          P=0.468          P=0.140          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.483          P=0.737          P=0.480          P=0.149          P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.457          P=0.722          P=0.454          P=0.136          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.523          P=0.743          P=0.499          P=0.230          P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P=0.752N         P=0.493          P=0.176          P=0.002 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        20/53 (38%)      21/53 (40%)      20/53 (38%)      13/53 (25%)      12/53 (23%)      14/53 (26%)     | 
|POLY-3 RATE (b)    |        20/42.80         21/40.48         20/40.83         13/40.08         12/37.55         14/39.27        | 
|POLY-3 PERCENT (g) |        46.7%            51.9%            49.0%            32.4%            32.0%            35.7%           | 
|TERMINAL (d)       |        14/25 (56%)      11/22 (50%)      10/24 (42%)      9/25 (36%)       7/20 (35%)       7/23 (30%)      | 
|FIRST INCIDENCE    |        651              600              301              470              580              513             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.102N         P=0.281          P=0.431          P=0.144N         P=0.220N         P=0.284N        | 
|POLY 3             |        P=0.057N         P=0.398          P=0.505          P=0.127N         P=0.125N         P=0.207N        | 
|POLY 1.5           |        P=0.052N         P=0.434          P=0.503          P=0.111N         P=0.109N         P=0.187N        | 
|POLY 6             |        P=0.059N         P=0.381          P=0.536          P=0.150N         P=0.127N         P=0.219N        | 
|LOGISTIC REGRESSION|        P=0.075N         P=0.272          P=0.386          P=0.194N         P=0.158N         P=0.301N        | 
|COCH-ARM / FISHERS |        P=0.045N*        P=0.500          P=0.579N         P=0.104N         P=0.069N         P=0.149N        | 
|ORDER RESTRICTED   |        P=0.102N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 44      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/53 (0%)        0/53 (0%)        1/53 (2%)        1/53 (2%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        2/41.83          0/38.07          0/36.67          1/38.52          1/36.36          1/37.29         | 
|POLY-3 PERCENT (g) |        4.8%             0.0%             0.0%             2.6%             2.8%             2.7%            | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        715              ---              ---              645              667              498             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.521          P=0.285N         P=0.265N         P=0.539N         P=0.561N         P=0.544N        | 
|POLY 3             |        P=0.551          P=0.258N         P=0.267N         P=0.529N         P=0.549N         P=0.540N        | 
|POLY 1.5           |        P=0.552          P=0.250N         P=0.260N         P=0.515N         P=0.536N         P=0.526N        | 
|POLY 6             |        P=0.551          P=0.268N         P=0.273N         P=0.543N         P=0.555N         P=0.553N        | 
|LOGISTIC REGRESSION|        P=0.541          P=0.277N         P=0.272N         P=0.539N         P=0.556N         P=0.510N        | 
|COCH-ARM / FISHERS |        P=0.551          P=0.248N         P=0.248N         P=0.500N         P=0.500N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.293N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        2/53 (4%)        1/53 (2%)        0/53 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        2/42.16          2/38.69          1/36.87          0/38.22          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        4.7%             5.2%             2.7%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        619              526              675              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.094N         P=0.652          P=0.548N         P=0.267N         P=0.283N         P=0.280N        | 
|POLY 3             |        P=0.085N         P=0.663          P=0.547N         P=0.259N         P=0.273N         P=0.270N        | 
|POLY 1.5           |        P=0.084N         P=0.676          P=0.535N         P=0.249N         P=0.263N         P=0.257N        | 
|POLY 6             |        P=0.085N         P=0.649          P=0.555N         P=0.272N         P=0.280N         P=0.282N        | 
|LOGISTIC REGRESSION|        P=0.085N         P=0.691          P=0.533N         P=0.248N         P=0.260N         P=0.257N        | 
|COCH-ARM / FISHERS |        P=0.081N         P=0.691N         P=0.500N         P=0.248N         P=0.248N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.104N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 45      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        22/53 (42%)      16/53 (30%)      14/53 (26%)      11/53 (21%)      15/53 (28%)      19/53 (36%)     | 
|POLY-3 RATE (b)    |        22/43.51         16/42.15         14/39.78         11/39.69         15/37.25         19/40.77        | 
|POLY-3 PERCENT (g) |        50.6%            38.0%            35.2%            27.7%            40.3%            46.6%           | 
|TERMINAL (d)       |        16/25 (64%)      7/22 (32%)       7/24 (29%)       8/25 (32%)       10/20 (50%)      11/23 (48%)     | 
|FIRST INCIDENCE    |        610              467              301              472              513              412             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.289          P=0.316N         P=0.142N         P=0.025N*        P=0.321N         P=0.531N        | 
|POLY 3             |        P=0.329          P=0.162N         P=0.110N         P=0.023N*        P=0.235N         P=0.440N        | 
|POLY 1.5           |        P=0.357          P=0.159N         P=0.104N         P=0.018N*        P=0.191N         P=0.405N        | 
|POLY 6             |        P=0.303          P=0.164N         P=0.110N         P=0.033N*        P=0.272N         P=0.478N        | 
|LOGISTIC REGRESSION|        P=0.300          P=0.226N         P=0.147N         P=0.037N*        P=0.253N         P=0.532N        | 
|COCH-ARM / FISHERS |        P=0.407          P=0.156N         P=0.075N         P=0.018N*        P=0.111N         P=0.345N        | 
|ORDER RESTRICTED   |        P=0.168N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/53 (0%)        0/51 (0%)        0/53 (0%)        0/51 (0%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        1/41.78          0/38.07          0/35.67          0/38.22          0/35.23          2/35.09         | 
|POLY-3 PERCENT (g) |        2.4%             0.0%             0.0%             0.0%             0.0%             5.7%            | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        728 (T)          ---              ---              ---              ---              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.077          P=0.525N         P=0.508N         P=0.500N         P=0.545N         P=0.471         | 
|POLY 3             |        P=0.079          P=0.519N         P=0.531N         P=0.518N         P=0.534N         P=0.439         | 
|POLY 1.5           |        P=0.079          P=0.511N         P=0.526N         P=0.509N         P=0.527N         P=0.456         | 
|POLY 6             |        P=0.079          P=0.527N         P=0.534N         P=0.527N         P=0.537N         P=0.425         | 
|LOGISTIC REGRESSION|        P=0.077          (e)              (e)              (e)              (e)              P=0.471         | 
|COCH-ARM / FISHERS |        P=0.080          P=0.500N         P=0.510N         P=0.500N         P=0.510N         P=0.485         | 
|ORDER RESTRICTED   |        P=0.034 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 46      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/53 (2%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        2/42.17          1/38.22          0/36.67          0/38.22          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        4.7%             2.6%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        619              689              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.171N         P=0.547N         P=0.269N         P=0.271N         P=0.287N         P=0.285N        | 
|POLY 3             |        P=0.148N         P=0.534N         P=0.269N         P=0.259N         P=0.273N         P=0.270N        | 
|POLY 1.5           |        P=0.151N         P=0.520N         P=0.261N         P=0.249N         P=0.263N         P=0.257N        | 
|POLY 6             |        P=0.144N         P=0.549N         P=0.277N         P=0.272N         P=0.280N         P=0.282N        | 
|LOGISTIC REGRESSION|        P=0.165N         P=0.524N         P=0.257N         P=0.248N         P=0.259N         P=0.256N        | 
|COCH-ARM / FISHERS |        P=0.156N         P=0.500N         P=0.248N         P=0.248N         P=0.248N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.044N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/53 (2%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        2/42.17          1/38.22          0/36.67          0/38.22          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        4.7%             2.6%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        619              689              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.171N         P=0.547N         P=0.269N         P=0.271N         P=0.287N         P=0.285N        | 
|POLY 3             |        P=0.148N         P=0.534N         P=0.269N         P=0.259N         P=0.273N         P=0.270N        | 
|POLY 1.5           |        P=0.151N         P=0.520N         P=0.261N         P=0.249N         P=0.263N         P=0.257N        | 
|POLY 6             |        P=0.144N         P=0.549N         P=0.277N         P=0.272N         P=0.280N         P=0.282N        | 
|LOGISTIC REGRESSION|        P=0.165N         P=0.524N         P=0.257N         P=0.248N         P=0.259N         P=0.256N        | 
|COCH-ARM / FISHERS |        P=0.156N         P=0.500N         P=0.248N         P=0.248N         P=0.248N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.044N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 47      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        49/53 (92%)      49/53 (92%)      48/53 (91%)      51/52 (98%)      46/52 (88%)      50/51 (98%)     | 
|POLY-3 RATE (b)    |        49/51.40         49/51.66         48/50.39         51/51.53         46/48.46         50/50.58        | 
|POLY-3 PERCENT (g) |        95.3%            94.8%            95.3%            99.0%            94.9%            98.9%           | 
|TERMINAL (d)       |        25/25 (100%)     21/22 (96%)      23/24 (96%)      25/25 (100%)     20/20 (100%)     23/23 (100%)    | 
|FIRST INCIDENCE    |        289              289              196              302              113              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.257          P=0.233          P=0.348          P=0.270          P=0.243          P=0.197         | 
|POLY 3             |        P=0.185          P=0.648N         P=0.693N         P=0.274          P=0.666N         P=0.295         | 
|POLY 1.5           |        P=0.189          P=0.632N         P=0.662N         P=0.244          P=0.551N         P=0.259         | 
|POLY 6             |        P=0.185          P=0.683N         P=0.723N         P=0.306          P=0.718          P=0.332         | 
|LOGISTIC REGRESSION|        P=0.154          P=0.606          P=0.617          P=0.170          P=0.539N         P=0.158         | 
|COCH-ARM / FISHERS |        P=0.186          P=0.642N         P=0.500N         P=0.187          P=0.359N         P=0.194         | 
|ORDER RESTRICTED   |        P=0.206          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        52/53 (98%)      45/53 (85%)      50/53 (94%)      48/52 (92%)      49/52 (94%)      51/51 (100%)    | 
|POLY-3 RATE (b)    |        52/53.00         45/49.65         50/51.50         48/50.73         49/50.30         51/51.00        | 
|POLY-3 PERCENT (g) |        98.1%            90.6%            97.1%            94.6%            97.4%            100.0%          | 
|TERMINAL (d)       |        24/25 (96%)      20/22 (91%)      24/24 (100%)     24/25 (96%)      20/20 (100%)     23/23 (100%)    | 
|FIRST INCIDENCE    |        289              289              116              302              241              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.180          P=0.520N         P=0.391          P=0.523N         P=0.247          P=0.276         | 
|POLY 3             |        P=0.057          P=0.086N         P=0.634N         P=0.321N         P=0.673N         P=0.508         | 
|POLY 1.5           |        P=0.040 *        P=0.042N*        P=0.468N         P=0.243N         P=0.585N         P=0.508         | 
|POLY 6             |        P=0.096          P=0.178N         P=0.773          P=0.456N         P=0.741N         P=0.508         | 
|LOGISTIC REGRESSION|        P=0.033 *        P=0.022N*        P=0.318N         P=0.171N         P=0.410N         (e)             | 
|COCH-ARM / FISHERS |        P=0.039 *        P=0.016N*        P=0.309N         P=0.176N         P=0.302N         P=0.510         | 
|ORDER RESTRICTED   |        P=0.064          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 48      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/53 (13%)       8/53 (15%)       7/53 (13%)       6/52 (12%)       12/52 (23%)      4/51 (8%)       | 
|POLY-3 RATE (b)    |        7/44.55          8/41.80          7/40.36          6/40.90          12/40.71         4/38.59         | 
|POLY-3 PERCENT (g) |        15.7%            19.1%            17.3%            14.7%            29.5%            10.4%           | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        1/25 (4%)        2/20 (10%)       0/23 (0%)       | 
|FIRST INCIDENCE    |        310              503              420              302              315              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.376N         P=0.402          P=0.500          P=0.575N         P=0.100          P=0.361N        | 
|POLY 3             |        P=0.377N         P=0.446          P=0.536          P=0.566N         P=0.100          P=0.348N        | 
|POLY 1.5           |        P=0.348N         P=0.463          P=0.547          P=0.541N         P=0.108          P=0.323N        | 
|POLY 6             |        P=0.414N         P=0.434          P=0.537          P=0.597N         P=0.099          P=0.374N        | 
|LOGISTIC REGRESSION|        P=0.274N         P=0.575          P=0.506N         P=0.467N         P=0.229          P=0.208N        | 
|COCH-ARM / FISHERS |        P=0.316N         P=0.500          P=0.612N         P=0.515N         P=0.145          P=0.286N        | 
|ORDER RESTRICTED   |        P=0.255N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Red Pulp                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/53 (0%)        0/53 (0%)        0/52 (0%)        0/52 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        2/42.70          0/38.07          0/36.67          0/37.91          0/35.44          0/36.35         | 
|POLY-3 PERCENT (g) |        4.7%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        310              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.253N         P=0.256N         P=0.258N         P=0.240N         P=0.269N         P=0.249N        | 
|POLY 3             |        P=0.229N         P=0.263N         P=0.272N         P=0.264N         P=0.281N         P=0.274N        | 
|POLY 1.5           |        P=0.238N         P=0.253N         P=0.263N         P=0.254N         P=0.270N         P=0.264N        | 
|POLY 6             |        P=0.219N         P=0.274N         P=0.279N         P=0.275N         P=0.286N         P=0.285N        | 
|LOGISTIC REGRESSION|        P=0.237N         P=0.201N         P=0.165N         P=0.237N         P=0.167N         P=0.195N        | 
|COCH-ARM / FISHERS |        P=0.253N         P=0.248N         P=0.248N         P=0.252N         P=0.252N         P=0.257N        | 
|ORDER RESTRICTED   |        P=0.014N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 49      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        1/53 (2%)        5/53 (9%)        6/53 (11%)       3/52 (6%)        10/53 (19%)     | 
|POLY-3 RATE (b)    |        4/42.72          1/38.81          5/38.12          6/40.38          3/35.70          10/39.37        | 
|POLY-3 PERCENT (g) |        9.4%             2.6%             13.1%            14.9%            8.4%             25.4%           | 
|TERMINAL (d)       |        2/25 (8%)        0/22 (0%)        3/24 (13%)       2/25 (8%)        1/20 (5%)        5/23 (22%)      | 
|FIRST INCIDENCE    |        289              467              219              429              668              329             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.007 **       P=0.215N         P=0.463          P=0.348          P=0.596N         P=0.059         | 
|POLY 3             |        P=0.006 **       P=0.208N         P=0.428          P=0.333          P=0.597N         P=0.048 *       | 
|POLY 1.5           |        P=0.006 **       P=0.197N         P=0.445          P=0.348          P=0.576N         P=0.055         | 
|POLY 6             |        P=0.005 **       P=0.219N         P=0.419          P=0.320          P=0.606N         P=0.043 *       | 
|LOGISTIC REGRESSION|        P=0.009 **       P=0.153N         P=0.536          P=0.394          P=0.546N         P=0.080         | 
|COCH-ARM / FISHERS |        P=0.009 **       P=0.181N         P=0.500          P=0.371          P=0.511N         P=0.075         | 
|ORDER RESTRICTED   |        P=0.004 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        0/53 (0%)        2/53 (4%)        2/52 (4%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        1/41.78          1/38.69          0/36.67          2/39.53          2/35.70          2/36.61         | 
|POLY-3 PERCENT (g) |        2.4%             2.6%             0.0%             5.1%             5.6%             5.5%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        727              526              ---              429              668              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.212          P=0.732          P=0.516N         P=0.486          P=0.438          P=0.466         | 
|POLY 3             |        P=0.206          P=0.744          P=0.526N         P=0.481          P=0.445          P=0.454         | 
|POLY 1.5           |        P=0.218          P=0.750          P=0.520N         P=0.490          P=0.457          P=0.471         | 
|POLY 6             |        P=0.195          P=0.737          P=0.531N         P=0.470          P=0.442          P=0.438         | 
|LOGISTIC REGRESSION|        P=0.227          P=0.758N         P=0.527N         P=0.519          P=0.438          P=0.466         | 
|COCH-ARM / FISHERS |        P=0.232          P=0.752N         P=0.500N         P=0.500          P=0.493          P=0.500         | 
|ORDER RESTRICTED   |        P=0.319          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 50      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        2/53 (4%)        2/53 (4%)        1/52 (2%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/38.69          2/37.64          2/39.53          1/35.47          1/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             5.3%             5.1%             2.8%             2.7%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        1/24 (4%)        0/25 (0%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        ---              526              219              429              721              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.585          P=0.482          P=0.231          P=0.231          P=0.476          P=0.483         | 
|POLY 3             |        P=0.553          P=0.485          P=0.214          P=0.225          P=0.467          P=0.474         | 
|POLY 1.5           |        P=0.572          P=0.491          P=0.220          P=0.231          P=0.475          P=0.483         | 
|POLY 6             |        P=0.536          P=0.478          P=0.210          P=0.218          P=0.464          P=0.465         | 
|LOGISTIC REGRESSION|        P=0.599N         P=0.530          P=0.326          P=0.231          P=0.464          P=0.483         | 
|COCH-ARM / FISHERS |        P=0.607          P=0.500          P=0.248          P=0.248          P=0.495          P=0.500         | 
|ORDER RESTRICTED   |        P=0.266          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Artery                                                                                                     | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        1/52 (2%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          0/38.22          1/35.44          3/36.76         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             2.8%             8.2%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        1/20 (5%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              728 (T)          689             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       (e)              (e)              (e)              P=0.455          P=0.107         | 
|POLY 3             |        P=0.002 **       (e)              (e)              (e)              P=0.467          P=0.097         | 
|POLY 1.5           |        P=0.002 **       (e)              (e)              (e)              P=0.475          P=0.104         | 
|POLY 6             |        P=0.002 **       (e)              (e)              (e)              P=0.464          P=0.090         | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.455          P=0.089         | 
|COCH-ARM / FISHERS |        P=0.002 **       (e)              (e)              (e)              P=0.495          P=0.121         | 
|ORDER RESTRICTED   |        P=0.003 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 51      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        1/53 (2%)        2/53 (4%)        1/52 (2%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          1/37.19          2/39.83          1/35.48          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             2.7%             5.0%             2.8%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              570              410              717              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.549N         (e)              P=0.481          P=0.251          P=0.477          (e)             | 
|POLY 3             |        P=0.576N         (e)              P=0.477          P=0.226          P=0.468          (e)             | 
|POLY 1.5           |        P=0.563N         (e)              P=0.482          P=0.232          P=0.475          (e)             | 
|POLY 6             |        P=0.587N         (e)              P=0.474          P=0.219          P=0.464          (e)             | 
|LOGISTIC REGRESSION|        P=0.507N         (e)              P=0.531          P=0.174          P=0.464          (e)             | 
|COCH-ARM / FISHERS |        P=0.538N         (e)              P=0.500          P=0.248          P=0.495          (e)             | 
|ORDER RESTRICTED   |        P=0.325          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        9/53 (17%)       1/53 (2%)        3/53 (6%)        2/52 (4%)        4/53 (8%)       | 
|POLY-3 RATE (b)    |        2/41.98          9/41.30          1/36.67          3/39.77          2/36.56          4/38.05         | 
|POLY-3 PERCENT (g) |        4.8%             21.8%            2.7%             7.5%             5.5%             10.5%           | 
|TERMINAL (d)       |        1/25 (4%)        2/22 (9%)        1/24 (4%)        1/25 (4%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        675              393              728 (T)          302              348              498             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.526N         P=0.021 *        P=0.531N         P=0.478          P=0.635          P=0.286         | 
|POLY 3             |        P=0.502N         P=0.022 *        P=0.547N         P=0.475          P=0.644          P=0.292         | 
|POLY 1.5           |        P=0.492N         P=0.023 *        P=0.535N         P=0.489          P=0.654          P=0.307         | 
|POLY 6             |        P=0.507N         P=0.021 *        P=0.557N         P=0.458          P=0.640          P=0.278         | 
|LOGISTIC REGRESSION|        P=0.456N         P=0.030 *        P=0.555N         P=0.524          P=0.683N         P=0.332         | 
|COCH-ARM / FISHERS |        P=0.473N         P=0.026 *        P=0.500N         P=0.500          P=0.684          P=0.339         | 
|ORDER RESTRICTED   |        P=0.256N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 52      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        43/53 (81%)      36/49 (73%)      36/50 (72%)      44/52 (85%)      39/49 (80%)      48/51 (94%)     | 
|POLY-3 RATE (b)    |        43/48.07         36/45.02         36/45.09         44/49.53         39/43.28         48/50.00        | 
|POLY-3 PERCENT (g) |        89.5%            80.0%            79.8%            88.8%            90.1%            96.0%           | 
|TERMINAL (d)       |        23/25 (92%)      16/21 (76%)      17/23 (74%)      22/25 (88%)      17/20 (85%)      21/23 (91%)     | 
|FIRST INCIDENCE    |        377              296              219              302              267              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.031 *        P=0.516N         P=0.424N         P=0.339          P=0.330          P=0.089         | 
|POLY 3             |        P=0.010 *        P=0.140N         P=0.139N         P=0.600N         P=0.605          P=0.173         | 
|POLY 1.5           |        P=0.005 **       P=0.164N         P=0.168N         P=0.610          P=0.578          P=0.082         | 
|POLY 6             |        P=0.027 *        P=0.134N         P=0.116N         P=0.598N         P=0.623N         P=0.324         | 
|LOGISTIC REGRESSION|        P=0.003 **       P=0.325N         P=0.348N         P=0.346          P=0.323          P=0.011 *       | 
|COCH-ARM / FISHERS |        P=0.006 **       P=0.246N         P=0.194N         P=0.416          P=0.521N         P=0.042 *       | 
|ORDER RESTRICTED   |        P=0.022 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/53 (28%)      16/53 (30%)      9/51 (18%)       13/53 (25%)      9/51 (18%)       11/51 (22%)     | 
|POLY-3 RATE (b)    |        15/43.91         16/42.27         9/37.05          13/39.17         9/37.41          11/37.65        | 
|POLY-3 PERCENT (g) |        34.2%            37.9%            24.3%            33.2%            24.1%            29.2%           | 
|TERMINAL (d)       |        10/25 (40%)      4/22 (18%)       6/24 (25%)       10/25 (40%)      3/20 (15%)       5/23 (22%)      | 
|FIRST INCIDENCE    |        513              432              570              570              420              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.280N         P=0.348          P=0.179N         P=0.475N         P=0.279N         P=0.385N        | 
|POLY 3             |        P=0.271N         P=0.447          P=0.233N         P=0.556N         P=0.224N         P=0.405N        | 
|POLY 1.5           |        P=0.247N         P=0.463          P=0.211N         P=0.488N         P=0.201N         P=0.362N        | 
|POLY 6             |        P=0.288N         P=0.445          P=0.245N         P=0.556          P=0.237N         P=0.434N        | 
|LOGISTIC REGRESSION|        P=0.272N         P=0.445          P=0.215N         P=0.549N         P=0.203N         P=0.381N        | 
|COCH-ARM / FISHERS |        P=0.212N         P=0.500          P=0.145N         P=0.413N         P=0.145N         P=0.286N        | 
|ORDER RESTRICTED   |        P=0.314N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 53      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/53 (13%)       13/53 (25%)      24/51 (47%)      24/53 (45%)      24/51 (47%)      22/51 (43%)     | 
|POLY-3 RATE (b)    |        7/42.51          13/40.89         24/41.21         24/41.67         24/41.85         22/41.33        | 
|POLY-3 PERCENT (g) |        16.5%            31.8%            58.2%            57.6%            57.4%            53.2%           | 
|TERMINAL (d)       |        3/25 (12%)       6/22 (27%)       11/24 (46%)      15/25 (60%)      8/20 (40%)       10/23 (44%)     | 
|FIRST INCIDENCE    |        651              498              196              472              113              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.011 *        P=0.066          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P=0.005 **       P=0.079          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P=0.005 **       P=0.088          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P=0.008 **       P=0.072          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P=0.005 **       P=0.079          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P=0.009 **       P=0.107          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        33/33 (100%)     25/25 (100%)     22/22 (100%)     30/30 (100%)     29/29 (100%)     29/29 (100%)    | 
|POLY-3 RATE (b)    |        33/33.00         25/25.00         22/22.00         30/30.00         29/29.00         29/29.00        | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           100.0%           100.0%           100.0%          | 
|TERMINAL (d)       |        19/19 (100%)     11/11 (100%)     10/10 (100%)     15/15 (100%)     13/13 (100%)     17/17 (100%)    | 
|FIRST INCIDENCE    |        289              498              300              410              321              443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 54      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Trachea: Peritracheal Tissue                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        2/52 (4%)        1/53 (2%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/39.00          2/37.89          1/38.94          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             5.3%             2.6%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              296              300              472              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.244N         P=0.500          P=0.220          P=0.492          (e)              (e)             | 
|POLY 3             |        P=0.273N         P=0.486          P=0.215          P=0.486          (e)              (e)             | 
|POLY 1.5           |        P=0.263N         P=0.492          P=0.219          P=0.493          (e)              (e)             | 
|POLY 6             |        P=0.279N         P=0.479          P=0.213          P=0.478          (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.152N         P=0.551          P=0.501          P=0.487          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.240N         P=0.500          P=0.243          P=0.500          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.349N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        3/52 (6%)        1/53 (2%)        1/53 (2%)        6/51 (12%)       1/53 (2%)       | 
|POLY-3 RATE (b)    |        2/41.83          3/39.95          1/36.82          1/38.79          6/35.70          1/36.61         | 
|POLY-3 PERCENT (g) |        4.8%             7.5%             2.7%             2.6%             16.8%            2.7%            | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        3/20 (15%)       1/23 (4%)       | 
|FIRST INCIDENCE    |        715              432              689              548              668              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.565          P=0.449          P=0.543N         P=0.523N         P=0.089          P=0.541N        | 
|POLY 3             |        P=0.539          P=0.479          P=0.544N         P=0.526N         P=0.085          P=0.546N        | 
|POLY 1.5           |        P=0.567          P=0.484          P=0.534N         P=0.514N         P=0.094          P=0.529N        | 
|POLY 6             |        P=0.508          P=0.474          P=0.552N         P=0.540N         P=0.082          P=0.563N        | 
|LOGISTIC REGRESSION|        P=0.584N         P=0.538          P=0.555N         P=0.512N         P=0.080          P=0.560N        | 
|COCH-ARM / FISHERS |        P=0.568N         P=0.491          P=0.500N         P=0.500N         P=0.123          P=0.500N        | 
|ORDER RESTRICTED   |        P=0.290          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 55      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Transitional Epithelium                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/52 (2%)        0/53 (0%)        0/53 (0%)        4/51 (8%)        4/53 (8%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/38.42          0/36.67          0/38.22          4/36.78          4/36.69         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             0.0%             0.0%             10.9%            10.9%           | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        3/23 (13%)      | 
|FIRST INCIDENCE    |        ---              498              ---              ---              321              706             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       P=0.483          (e)              (e)              P=0.053          P=0.053         | 
|POLY 3             |        P=0.002 **       P=0.483          (e)              (e)              P=0.045 *        P=0.045 *       | 
|POLY 1.5           |        P=0.002 **       P=0.488          (e)              (e)              P=0.047 *        P=0.050         | 
|POLY 6             |        P<0.001 **       P=0.478          (e)              (e)              P=0.044 *        P=0.040 *       | 
|LOGISTIC REGRESSION|        P=0.002 **       P=0.529          (e)              (e)              P=0.066          P=0.041 *       | 
|COCH-ARM / FISHERS |        P=0.003 **       P=0.495          (e)              (e)              P=0.054          P=0.059         | 
|ORDER RESTRICTED   |        P=0.008 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/52 (0%)        1/52 (2%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          0/37.91          1/36.00          2/38.08         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             2.8%             5.3%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              555              412             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.014 *        (e)              (e)              (e)              P=0.471          P=0.225         | 
|POLY 3             |        P=0.015 *        (e)              (e)              (e)              P=0.470          P=0.217         | 
|POLY 1.5           |        P=0.016 *        (e)              (e)              (e)              P=0.476          P=0.224         | 
|POLY 6             |        P=0.015 *        (e)              (e)              (e)              P=0.469          P=0.210         | 
|LOGISTIC REGRESSION|        P=0.020 *        (e)              (e)              (e)              P=0.537          P=0.316         | 
|COCH-ARM / FISHERS |        P=0.016 *        (e)              (e)              (e)              P=0.495          P=0.248         | 
|ORDER RESTRICTED   |        P=0.023 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 56      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        6/53 (11%)       1/53 (2%)        7/52 (13%)       3/52 (6%)        4/53 (8%)       | 
|POLY-3 RATE (b)    |        3/42.38          6/38.78          1/36.67          7/40.07          3/37.09          4/37.67         | 
|POLY-3 PERCENT (g) |        7.1%             15.5%            2.7%             17.5%            8.1%             10.6%           | 
|TERMINAL (d)       |        2/25 (8%)        4/22 (18%)       1/24 (4%)        3/25 (12%)       0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        536              526              728 (T)          470              348              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.522          P=0.184          P=0.327N         P=0.143          P=0.579          P=0.457         | 
|POLY 3             |        P=0.529          P=0.197          P=0.358N         P=0.132          P=0.600          P=0.436         | 
|POLY 1.5           |        P=0.549          P=0.215          P=0.344N         P=0.142          P=0.612          P=0.460         | 
|POLY 6             |        P=0.512          P=0.179          P=0.370N         P=0.124          P=0.599          P=0.412         | 
|LOGISTIC REGRESSION|        P=0.563          P=0.205          P=0.343N         P=0.155          P=0.634N         P=0.497         | 
|COCH-ARM / FISHERS |        P=0.557N         P=0.244          P=0.309N         P=0.152          P=0.652          P=0.500         | 
|ORDER RESTRICTED   |        P=0.405          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        5/53 (9%)        3/53 (6%)        3/52 (6%)        4/52 (8%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        0/41.78          5/41.13          3/37.89          3/38.22          4/38.22          3/38.42         | 
|POLY-3 PERCENT (g) |        0.0%             12.2%            7.9%             7.9%             10.5%            7.8%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        1/24 (4%)        2/25 (8%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              451              497              645              353              412             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.378          P=0.031 *        P=0.110          P=0.109          P=0.048 *        P=0.106         | 
|POLY 3             |        P=0.383          P=0.029 *        P=0.101          P=0.103          P=0.049 *        P=0.104         | 
|POLY 1.5           |        P=0.400          P=0.029 *        P=0.105          P=0.109          P=0.050          P=0.109         | 
|POLY 6             |        P=0.370          P=0.028 *        P=0.100          P=0.097          P=0.050          P=0.099         | 
|LOGISTIC REGRESSION|        P=0.480          P=0.044 *        P=0.130          P=0.098          P=0.111          P=0.164         | 
|COCH-ARM / FISHERS |        P=0.430          P=0.028 *        P=0.121          P=0.118          P=0.057          P=0.121         | 
|ORDER RESTRICTED   |        P=0.090          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 57      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        17/53 (32%)      25/53 (47%)      21/53 (40%)      36/52 (69%)      31/52 (60%)      35/53 (66%)     | 
|POLY-3 RATE (b)    |        17/45.44         25/45.80         21/42.51         36/48.18         31/45.06         35/46.29        | 
|POLY-3 PERCENT (g) |        37.4%            54.6%            49.4%            74.7%            68.8%            75.6%           | 
|TERMINAL (d)       |        8/25 (32%)       7/22 (32%)       10/24 (42%)      16/25 (64%)      11/20 (55%)      19/23 (83%)     | 
|FIRST INCIDENCE    |        321              289              300              302              267              329             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       P=0.055          P=0.193          P<0.001 **       P=0.003 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.070          P=0.174          P<0.001 **       P=0.002 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.071          P=0.192          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.074          P=0.161          P<0.001 **       P=0.002 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.086          P=0.243          P<0.001 **       P=0.004 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.082          P=0.272          P<0.001 **       P=0.004 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        1/52 (2%)        3/52 (6%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          1/37.91          3/37.42          1/37.26         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             2.6%             8.0%             2.7%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        1/25 (4%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              728 (T)          353              513             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.131          (e)              (e)              P=0.500          P=0.101          P=0.473         | 
|POLY 3             |        P=0.125          (e)              (e)              P=0.481          P=0.099          P=0.477         | 
|POLY 1.5           |        P=0.133          (e)              (e)              P=0.488          P=0.102          P=0.485         | 
|POLY 6             |        P=0.116          (e)              (e)              P=0.472          P=0.100          P=0.470         | 
|LOGISTIC REGRESSION|        P=0.161          (e)              (e)              P=0.500          P=0.180          P=0.555         | 
|COCH-ARM / FISHERS |        P=0.144          (e)              (e)              P=0.495          P=0.118          P=0.500         | 
|ORDER RESTRICTED   |        P=0.076          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 58      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION(         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        31/53 (58%)      29/53 (55%)      29/53 (55%)      33/52 (63%)      39/52 (75%)      37/53 (70%)     | 
|POLY-3 RATE (b)    |        31/47.62         29/44.39         29/43.19         33/43.55         39/45.13         37/45.40        | 
|POLY-3 PERCENT (g) |        65.1%            65.3%            67.2%            75.8%            86.4%            81.5%           | 
|TERMINAL (d)       |        16/25 (64%)      14/22 (64%)      14/24 (58%)      21/25 (84%)      19/20 (95%)      19/23 (83%)     | 
|FIRST INCIDENCE    |        310              289              300              302              321              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.019 *        P=0.434          P=0.491          P=0.307          P=0.019 *        P=0.078         | 
|POLY 3             |        P=0.006 **       P=0.581          P=0.506          P=0.173          P=0.010 *        P=0.049 *       | 
|POLY 1.5           |        P=0.009 **       P=0.522N         P=0.556          P=0.265          P=0.015 *        P=0.074         | 
|POLY 6             |        P=0.004 **       P=0.498          P=0.476          P=0.088          P=0.008 **       P=0.032 *       | 
|LOGISTIC REGRESSION|        P=0.009 **       P=0.496N         P=0.580          P=0.293          P=0.020 *        P=0.081         | 
|COCH-ARM / FISHERS |        P=0.022 *        P=0.422N         P=0.422N         P=0.374          P=0.056          P=0.156         | 
|ORDER RESTRICTED   |        P=0.014 *        (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).