National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/5304

TDMS Study 96007-03 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 08:53:10       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                 FINAL # 3 RATS CONTROL VS TREATED                                                  
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 002    3 NG/KG                                                                       
                                       INCLUDE 003    10 NG/KG                                                                      
                                       INCLUDE 004    22 NG/KG                                                                      
                                       INCLUDE 005    46 NG/KG                                                                      
                                       INCLUDE 006    100     NG/KG                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 08:53:10       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
                                                                                                                                    
                                                                                                                                    
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                                                                          
                                       Hyperplasia                                                                                  
                                       Hypertrophy                                                                                  
                                       Vacuolization Cytoplasmic                                                                    
Adrenal Medulla                        Hyperplasia                                                                                  
Bone Marrow                            Hyperplasia                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Clitoral Gland: Duct                   Cyst                                                                                         
Harderian Gland                        Inflammation                                                                                 
Heart                                  Cardiomyopathy                                                                               
Intestine Large, Rectum                Parasite Metazoan                                                                            
Kidney                                 Inflammation Chronic                                                                         
                                       Mineralization                                                                               
                                       Nephropathy                                                                                  
Kidney: Transitional Epithelium        Hyperplasia                                                                                  
Liver                                  Angiectasis                                                                                  
                                       Cholangiofibrosis                                                                            
                                       Cytoplasmic Alteration                                                                       
                                       Degeneration Cystic                                                                          
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Hyperplasia                                                                                  
                                       Inflammation                                                                                 
                                       Mixed Cell Focus                                                                             
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Artery                          Inflammation Chronic                                                                         
Liver: Bile Duct                       Cyst                                                                                         
                                       Fibrosis                                                                                     
                                       Hyperplasia                                                                                  
Liver: Centrilobular                   Degeneration                                                                                 
Liver: Hepatocyte                      Hypertrophy                                                                                  
                                       Multinucleated                                                                               
Liver: Oval Cell                       Hyperplasia                                                                                  
Liver: Portal                          Fibrosis                                                                                     
Lung                                   Hemorrhage                                                                                   
                                       Infiltration Cellular Histiocyte                                                             
                                       Metaplasia                                                                                   
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
                                       Metaplasia Bronchiolar                                                                       
Lymph Node, Mandibular                 Ectasia                                                                                      
                                       Hyperplasia                                                                                  
Lymph Node, Mesenteric                 Hyperplasia                                                                                  
Lymph Node: Lumbar                     Ectasia                                                                                      
Lymph Node: Mediastinal                Ectasia                                                                                      
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 08:53:10       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
                                       Hemorrhage                                                                                   
Mammary Gland                          Cyst                                                                                         
                                       Hyperplasia                                                                                  
Mesentery: Artery                      Inflammation Chronic                                                                         
Nose                                   Inflammation                                                                                 
Nose: Nasolacrimal Duct                Inflammation                                                                                 
Nose: Septum                           Inflammation                                                                                 
Oral Mucosa: Gingival                  Hyperplasia                                                                                  
Ovary                                  Atrophy                                                                                      
Pancreas                               Inflammation Chronic                                                                         
Pancreas: Acinus                       Atrophy                                                                                      
                                       Vacuolization Cytoplasmic                                                                    
Pancreas: Artery                       Inflammation Chronic                                                                         
Pituitary Gland                        Angiectasis                                                                                  
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Hyperplasia Lymphoid                                                                         
                                       Pigmentation                                                                                 
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Stomach, Forestomach                   Hyperkeratosis                                                                               
                                       Hyperplasia                                                                                  
                                       Inflammation                                                                                 
                                       Ulcer                                                                                        
Stomach, Glandular                     Mineralization                                                                               
                                       Ulcer                                                                                        
Thymus                                 Atrophy                                                                                      
Thyroid Gland: Follicular Cell         Hyperplasia                                                                                  
                                       Hypertrophy                                                                                  
Tooth: Peridontal Tissue               Inflammation                                                                                 
Urinary Bladder                        Inflammation                                                                                 
Uterus                                 Metaplasia                                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION         
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/53 (21%)      21/54 (39%)      18/53 (34%)      17/53 (32%)      17/53 (32%)      11/53 (21%)     | 
|POLY-3 RATE (b)    |        11/40.84         21/37.32         18/40.08         17/35.48         17/40.70         11/45.07        | 
|POLY-3 PERCENT (g) |        26.9%            56.3%            44.9%            47.9%            41.8%            24.4%           | 
|TERMINAL (d)       |        6/25 (24%)       15/21 (71%)      12/23 (52%)      12/19 (63%)      12/22 (55%)      4/21 (19%)      | 
|FIRST INCIDENCE    |        645              556              550              626              486              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.121N         P=0.005 **       P=0.073          P=0.021 *        P=0.087          P=0.518         | 
|POLY 3             |        P=0.021N*        P=0.005 **       P=0.067          P=0.042 *        P=0.113          P=0.492N        | 
|POLY 1.5           |        P=0.036N*        P=0.011 *        P=0.069          P=0.071          P=0.122          P=0.510N        | 
|POLY 6             |        P=0.017N*        P=0.002 **       P=0.062          P=0.021 *        P=0.096          P=0.509N        | 
|LOGISTIC REGRESSION|        P=0.031N*        P=0.004 **       P=0.074          P=0.024 *        P=0.112          P=0.537N        | 
|COCH-ARM / FISHERS |        P=0.121N         P=0.033 *        P=0.095          P=0.135          P=0.135          P=0.594N        | 
|ORDER RESTRICTED   |        P=0.035N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        4/53 (8%)        5/53 (9%)        5/53 (9%)        27/53 (51%)     | 
|POLY-3 RATE (b)    |        2/39.86          0/34.61          4/39.71          5/34.86          5/39.59          27/46.52        | 
|POLY-3 PERCENT (g) |        5.0%             0.0%             10.1%            14.3%            12.6%            58.0%           | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        3/23 (13%)       3/19 (16%)       3/22 (14%)       12/21 (57%)     | 
|FIRST INCIDENCE    |        646              ---              240              626              590              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.299N         P=0.302          P=0.113          P=0.185          P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.269N         P=0.334          P=0.162          P=0.211          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.254N         P=0.331          P=0.183          P=0.214          P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.287N         P=0.333          P=0.140          P=0.205          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.268N         P=0.335          P=0.149          P=0.208          P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.243N         P=0.339          P=0.219          P=0.219          P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/53 (21%)      15/54 (28%)      21/53 (40%)      18/53 (34%)      17/53 (32%)      17/53 (32%)     | 
|POLY-3 RATE (b)    |        11/41.19         15/37.14         21/40.29         18/37.16         17/42.13         17/46.12        | 
|POLY-3 PERCENT (g) |        26.7%            40.4%            52.1%            48.4%            40.4%            36.9%           | 
|TERMINAL (d)       |        4/25 (16%)       9/21 (43%)       13/23 (57%)      11/19 (58%)      8/22 (36%)       6/21 (29%)      | 
|FIRST INCIDENCE    |        646              490              578              462              486              561             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.392          P=0.117          P=0.026 *        P=0.020 *        P=0.113          P=0.133         | 
|POLY 3             |        P=0.440N         P=0.143          P=0.013 *        P=0.034 *        P=0.134          P=0.214         | 
|POLY 1.5           |        P=0.531N         P=0.187          P=0.015 *        P=0.052          P=0.134          P=0.194         | 
|POLY 6             |        P=0.387N         P=0.104          P=0.011 *        P=0.019 *        P=0.126          P=0.213         | 
|LOGISTIC REGRESSION|        P=0.511N         P=0.134          P=0.018 *        P=0.031 *        P=0.124          P=0.175         | 
|COCH-ARM / FISHERS |        P=0.328          P=0.267          P=0.028 *        P=0.095          P=0.135          P=0.135         | 
|ORDER RESTRICTED   |        P=0.059          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        16/53 (30%)      16/54 (30%)      18/53 (34%)      25/53 (47%)      29/53 (55%)      30/53 (57%)     | 
|POLY-3 RATE (b)    |        16/41.46         16/37.20         18/41.07         25/40.57         29/44.68         30/47.52        | 
|POLY-3 PERCENT (g) |        38.6%            43.0%            43.8%            61.6%            64.9%            63.1%           | 
|TERMINAL (d)       |        10/25 (40%)      11/21 (52%)      12/23 (52%)      11/19 (58%)      14/22 (64%)      16/21 (76%)     | 
|FIRST INCIDENCE    |        487              241              344              417              444              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       P=0.354          P=0.332          P=0.009 **       P=0.008 **       P=0.004 **      | 
|POLY 3             |        P=0.004 **       P=0.431          P=0.396          P=0.024 *        P=0.009 **       P=0.013 *       | 
|POLY 1.5           |        P=0.002 **       P=0.512          P=0.386          P=0.031 *        P=0.008 **       P=0.011 *       | 
|POLY 6             |        P=0.005 **       P=0.338          P=0.392          P=0.019 *        P=0.011 *        P=0.012 *       | 
|LOGISTIC REGRESSION|        P=0.002 **       P=0.410          P=0.385          P=0.018 *        P=0.007 **       P=0.011 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.559N         P=0.418          P=0.055          P=0.009 **       P=0.005 **      | 
|ORDER RESTRICTED   |        P=0.007 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        41/53 (77%)      43/54 (80%)      46/53 (87%)      40/53 (75%)      45/53 (85%)      47/53 (89%)     | 
|POLY-3 RATE (b)    |        41/44.21         43/45.74         46/46.99         40/46.09         45/48.42         47/51.08        | 
|POLY-3 PERCENT (g) |        92.8%            94.0%            97.9%            86.8%            92.9%            92.0%           | 
|TERMINAL (d)       |        25/25 (100%)     20/21 (95%)      23/23 (100%)     18/19 (95%)      22/22 (100%)     20/21 (95%)     | 
|FIRST INCIDENCE    |        474              394              236              338              141              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.326          P=0.088          P=0.159          P=0.103          P=0.145          P=0.101         | 
|POLY 3             |        P=0.381N         P=0.600          P=0.155          P=0.230N         P=0.686          P=0.622N        | 
|POLY 1.5           |        P=0.503          P=0.495          P=0.078          P=0.340N         P=0.456          P=0.446         | 
|POLY 6             |        P=0.203N         P=0.759N         P=0.529          P=0.159N         P=0.581N         P=0.390N        | 
|LOGISTIC REGRESSION|        P=0.552N         P=0.071          P=0.025 *        P=0.405          P=0.167          P=0.506         | 
|COCH-ARM / FISHERS |        P=0.082          P=0.480          P=0.156          P=0.500N         P=0.229          P=0.098         | 
|ORDER RESTRICTED   |        P=0.285N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        2/53 (4%)        1/53 (2%)        3/53 (6%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        0/39.55          1/35.36          2/38.79          1/34.53          3/40.16          1/42.92         | 
|POLY-3 PERCENT (g) |        0.0%             2.8%             5.2%             2.9%             7.5%             2.3%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        1/23 (4%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              462              720              626              578              641             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.498          P=0.487          P=0.231          P=0.441          P=0.129          P=0.505         | 
|POLY 3             |        P=0.523          P=0.478          P=0.232          P=0.473          P=0.121          P=0.516         | 
|POLY 1.5           |        P=0.503          P=0.488          P=0.231          P=0.484          P=0.120          P=0.514         | 
|POLY 6             |        P=0.522          P=0.467          P=0.233          P=0.460          P=0.121          P=0.513         | 
|LOGISTIC REGRESSION|        P=0.440          P=0.539          P=0.232          P=0.497          P=0.121          P=0.492         | 
|COCH-ARM / FISHERS |        P=0.437          P=0.505          P=0.248          P=0.500          P=0.121          P=0.500         | 
|ORDER RESTRICTED   |        P=0.188          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/53 (21%)      7/54 (13%)       12/53 (23%)      21/53 (40%)      18/53 (34%)      15/53 (28%)     | 
|POLY-3 RATE (b)    |        11/40.73         7/35.24          12/40.94         21/38.47         18/41.90         15/45.44        | 
|POLY-3 PERCENT (g) |        27.0%            19.9%            29.3%            54.6%            43.0%            33.0%           | 
|TERMINAL (d)       |        9/25 (36%)       5/21 (24%)       6/23 (26%)       11/19 (58%)      9/22 (41%)       6/21 (29%)      | 
|FIRST INCIDENCE    |        366              548              236              338              185              561             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.116          P=0.341N         P=0.429          P=0.003 **       P=0.059          P=0.195         | 
|POLY 3             |        P=0.263          P=0.322N         P=0.506          P=0.008 **       P=0.092          P=0.354         | 
|POLY 1.5           |        P=0.197          P=0.272N         P=0.488          P=0.012 *        P=0.093          P=0.326         | 
|POLY 6             |        P=0.309          P=0.377N         P=0.528          P=0.005 **       P=0.093          P=0.366         | 
|LOGISTIC REGRESSION|        P=0.177          P=0.340N         P=0.477          P=0.008 **       P=0.087          P=0.306         | 
|COCH-ARM / FISHERS |        P=0.084          P=0.207N         P=0.500          P=0.028 *        P=0.095          P=0.249         | 
|ORDER RESTRICTED   |        P=0.031 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        2/53 (4%)        1/53 (2%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/39.55          1/34.61          2/38.75          1/34.16          0/39.00          0/42.60         | 
|POLY-3 PERCENT (g) |        0.0%             2.9%             5.2%             2.9%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        2/23 (9%)        1/19 (5%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              731 (T)          731 (T)          731 (T)          ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.256N         P=0.465          P=0.219          P=0.445          (e)              (e)             | 
|POLY 3             |        P=0.225N         P=0.473          P=0.232          P=0.471          (e)              (e)             | 
|POLY 1.5           |        P=0.229N         P=0.486          P=0.231          P=0.483          (e)              (e)             | 
|POLY 6             |        P=0.226N         P=0.461          P=0.232          P=0.456          (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              P=0.465          P=0.219          P=0.445          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.242N         P=0.505          P=0.248          P=0.500          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.295N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        19/53 (36%)      10/54 (19%)      18/53 (34%)      7/53 (13%)       10/53 (19%)      9/53 (17%)      | 
|POLY-3 RATE (b)    |        19/41.29         10/36.14         18/40.63         7/35.79          10/39.76         9/44.75         | 
|POLY-3 PERCENT (g) |        46.0%            27.7%            44.3%            19.6%            25.2%            20.1%           | 
|TERMINAL (d)       |        11/25 (44%)      6/21 (29%)       11/23 (48%)      4/19 (21%)       7/22 (32%)       2/21 (10%)      | 
|FIRST INCIDENCE    |        487              526              604              406              578              581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.046N*        P=0.137N         P=0.565          P=0.051N         P=0.086N         P=0.057N        | 
|POLY 3             |        P=0.007N**       P=0.070N         P=0.527N         P=0.010N*        P=0.036N*        P=0.007N**      | 
|POLY 1.5           |        P=0.012N*        P=0.051N         P=0.542N         P=0.007N**       P=0.036N*        P=0.010N*       | 
|POLY 6             |        P=0.005N**       P=0.097N         P=0.511N         P=0.017N*        P=0.041N*        P=0.007N**      | 
|LOGISTIC REGRESSION|        P=0.013N*        P=0.097N         P=0.528N         P=0.017N*        P=0.038N*        P=0.012N*       | 
|COCH-ARM / FISHERS |        P=0.044N*        P=0.036N*        P=0.500N         P=0.006N**       P=0.040N*        P=0.023N*       | 
|ORDER RESTRICTED   |        P=0.003N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        36/53 (68%)      41/54 (76%)      32/53 (60%)      35/53 (66%)      37/53 (70%)      43/53 (81%)     | 
|POLY-3 RATE (b)    |        36/52.64         41/51.71         32/51.50         35/51.56         37/49.92         43/50.67        | 
|POLY-3 PERCENT (g) |        68.4%            79.3%            62.1%            67.9%            74.1%            84.9%           | 
|TERMINAL (d)       |        9/25 (36%)       13/21 (62%)      7/23 (30%)       5/19 (26%)       12/22 (55%)      17/21 (81%)     | 
|FIRST INCIDENCE    |        169              200              47               53               141              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.326          P=0.125          P=0.405N         P=0.284          P=0.400          P=0.177         | 
|POLY 3             |        P=0.024 *        P=0.144          P=0.321N         P=0.561N         P=0.335          P=0.036 *       | 
|POLY 1.5           |        P=0.034 *        P=0.181          P=0.298N         P=0.541N         P=0.387          P=0.055         | 
|POLY 6             |        P=0.015 *        P=0.106          P=0.357N         P=0.581N         P=0.290          P=0.018 *       | 
|LOGISTIC REGRESSION|        P=0.012 *        P=0.492          P=0.209N         P=0.130N         P=0.521          P=0.057         | 
|COCH-ARM / FISHERS |        P=0.056          P=0.240          P=0.272N         P=0.500N         P=0.500          P=0.090         | 
|ORDER RESTRICTED   |        P=0.038 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        1/53 (2%)        0/53 (0%)        2/53 (4%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/39.55          1/34.61          1/38.75          0/34.16          2/39.09          2/42.60         | 
|POLY-3 PERCENT (g) |        0.0%             2.9%             2.6%             0.0%             5.1%             4.7%            | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        1/23 (4%)        0/19 (0%)        1/22 (5%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        ---              731 (T)          731 (T)          ---              708              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.113          P=0.465          P=0.483          (e)              P=0.213          P=0.200         | 
|POLY 3             |        P=0.157          P=0.473          P=0.496          (e)              P=0.234          P=0.254         | 
|POLY 1.5           |        P=0.150          P=0.486          P=0.495          (e)              P=0.236          P=0.252         | 
|POLY 6             |        P=0.155          P=0.461          P=0.497          (e)              P=0.230          P=0.247         | 
|LOGISTIC REGRESSION|        P=0.130          P=0.465          P=0.483          (e)              P=0.223          P=0.200         | 
|COCH-ARM / FISHERS |        P=0.124          P=0.505          P=0.500          (e)              P=0.248          P=0.248         | 
|ORDER RESTRICTED   |        P=0.124          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        41/50 (82%)      40/52 (77%)      35/53 (66%)      34/52 (65%)      28/51 (55%)      26/53 (49%)     | 
|POLY-3 RATE (b)    |        41/46.36         40/46.38         35/47.18         34/44.94         28/43.18         26/47.03        | 
|POLY-3 PERCENT (g) |        88.4%            86.3%            74.2%            75.7%            64.8%            55.3%           | 
|TERMINAL (d)       |        22/25 (88%)      18/21 (86%)      16/23 (70%)      13/19 (68%)      14/22 (64%)      12/21 (57%)     | 
|FIRST INCIDENCE    |        169              264              177              53               185              474             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003N**       P=0.258          P=0.323N         P=0.471          P=0.075N         P=0.039N*       | 
|POLY 3             |        P<0.001N**       P=0.498N         P=0.054N         P=0.074N         P=0.004N**       P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P=0.472N         P=0.065N         P=0.059N         P=0.003N**       P<0.001N**      | 
|POLY 6             |        P<0.001N**       P=0.513N         P=0.050N         P=0.103N         P=0.006N**       P<0.001N**      | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.453N         P=0.063N         P=0.063N         P=0.003N**       P<0.001N**      | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.349N         P=0.052N         P=0.046N*        P=0.003N**       P<0.001N**      | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        34/50 (68%)      37/52 (71%)      41/53 (77%)      42/52 (81%)      41/51 (80%)      48/53 (91%)     | 
|POLY-3 RATE (b)    |        34/44.15         37/46.24         41/49.46         42/46.19         41/46.63         48/50.84        | 
|POLY-3 PERCENT (g) |        77.0%            80.0%            82.9%            90.9%            87.9%            94.4%           | 
|TERMINAL (d)       |        19/25 (76%)      14/21 (67%)      18/23 (78%)      18/19 (95%)      19/22 (86%)      21/21 (100%)    | 
|FIRST INCIDENCE    |        169              264              54               53               141              474             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.075          P=0.129          P=0.124          P=0.008 **       P=0.091          P=0.011 *       | 
|POLY 3             |        P=0.005 **       P=0.462          P=0.320          P=0.045 *        P=0.120          P=0.008 **      | 
|POLY 1.5           |        P=0.005 **       P=0.448          P=0.249          P=0.067          P=0.118          P=0.006 **      | 
|POLY 6             |        P=0.004 **       P=0.481          P=0.397          P=0.025 *        P=0.123          P=0.009 **      | 
|LOGISTIC REGRESSION|        P=0.010 *        P=0.353          P=0.167          P=0.056          P=0.108          P=0.015 *       | 
|COCH-ARM / FISHERS |        P=0.003 **       P=0.448          P=0.199          P=0.105          P=0.116          P=0.004 **      | 
|ORDER RESTRICTED   |        P=0.006 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus                                                                                                                        | 
|     Perforation                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        0/54 (0%)        2/53 (4%)        0/52 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/38.90          0/34.61          2/40.74          0/33.71          0/39.00          0/42.60         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.9%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              47               ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.394N         (e)              P=0.238          (e)              (e)              (e)             | 
|POLY 3             |        P=0.355N         (e)              P=0.247          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.369N         (e)              P=0.245          (e)              (e)              (e)             | 
|POLY 6             |        P=0.346N         (e)              P=0.248          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.392N         (e)              P=0.252          (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.341N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Muscularis                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/52 (2%)        2/54 (4%)        1/53 (2%)        1/52 (2%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        1/39.60          2/35.11          1/38.75          1/33.71          2/39.90          0/42.60         | 
|POLY-3 PERCENT (g) |        2.5%             5.7%             2.6%             3.0%             5.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        1/23 (4%)        1/19 (5%)        1/22 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        492              578              731 (T)          731 (T)          341              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.272N         P=0.450          P=0.751          P=0.719          P=0.480          P=0.475N        | 
|POLY 3             |        P=0.239N         P=0.458          P=0.756          P=0.724          P=0.503          P=0.485N        | 
|POLY 1.5           |        P=0.244N         P=0.480          P=0.757          P=0.740          P=0.506          P=0.485N        | 
|POLY 6             |        P=0.246N         P=0.435          P=0.755          P=0.704          P=0.494          P=0.493N        | 
|LOGISTIC REGRESSION|        P=0.278N         P=0.524          P=0.756N         P=0.762N         P=0.512          P=0.645N        | 
|COCH-ARM / FISHERS |        P=0.275N         P=0.514          P=0.748N         P=0.752N         P=0.507          P=0.495N        | 
|ORDER RESTRICTED   |        P=0.241N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Periesophageal Tissue                                                                                                 | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        0/54 (0%)        3/53 (6%)        0/52 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/38.90          0/34.61          3/41.71          0/33.71          0/39.00          0/42.60         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             7.2%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              47               ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.288N         (e)              P=0.122          (e)              (e)              (e)             | 
|POLY 3             |        P=0.236N         (e)              P=0.131          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.252N         (e)              P=0.128          (e)              (e)              (e)             | 
|POLY 6             |        P=0.226N         (e)              P=0.132          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.675N         (e)              P=0.365          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.288N         (e)              P=0.125          (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.246N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        5/54 (9%)        5/53 (9%)        3/52 (6%)        4/53 (8%)        6/53 (11%)      | 
|POLY-3 RATE (b)    |        5/39.55          5/35.79          5/38.75          3/34.14          4/39.20          6/42.60         | 
|POLY-3 PERCENT (g) |        12.6%            14.0%            12.9%            8.8%             10.2%            14.1%           | 
|TERMINAL (d)       |        5/25 (20%)       3/21 (14%)       5/23 (22%)       2/19 (11%)       3/22 (14%)       6/21 (29%)      | 
|FIRST INCIDENCE    |        731 (T)          526              731 (T)          607              677              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.368          P=0.529          P=0.581          P=0.512N         P=0.575N         P=0.371         | 
|POLY 3             |        P=0.498          P=0.568          P=0.619          P=0.439N         P=0.506N         P=0.553         | 
|POLY 1.5           |        P=0.477          P=0.597          P=0.614          P=0.410N         P=0.503N         P=0.546         | 
|POLY 6             |        P=0.493          P=0.540          P=0.623          P=0.473N         P=0.513N         P=0.536         | 
|LOGISTIC REGRESSION|        P=0.502          P=0.529          P=0.581          P=0.509N         P=0.556N         P=0.371         | 
|COCH-ARM / FISHERS |        P=0.399          P=0.617N         P=0.629N         P=0.369N         P=0.500N         P=0.500         | 
|ORDER RESTRICTED   |        P=0.658          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/53 (23%)      3/54 (6%)        2/53 (4%)        2/52 (4%)        8/53 (15%)       6/53 (11%)      | 
|POLY-3 RATE (b)    |        12/42.07         3/35.42          2/38.75          2/33.87          8/40.78          6/43.76         | 
|POLY-3 PERCENT (g) |        28.5%            8.5%             5.2%             5.9%             19.6%            13.7%           | 
|TERMINAL (d)       |        6/25 (24%)       1/21 (5%)        2/23 (9%)        1/19 (5%)        4/22 (18%)       2/21 (10%)      | 
|FIRST INCIDENCE    |        366              578              731 (T)          690              317              546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.478          P=0.040N*        P=0.009N**       P=0.023N*        P=0.307N         P=0.142N        | 
|POLY 3             |        P=0.482N         P=0.024N*        P=0.005N**       P=0.011N*        P=0.242N         P=0.074N        | 
|POLY 1.5           |        P=0.530N         P=0.017N*        P=0.005N**       P=0.007N**       P=0.234N         P=0.076N        | 
|POLY 6             |        P=0.459N         P=0.034N*        P=0.006N**       P=0.018N*        P=0.265N         P=0.083N        | 
|LOGISTIC REGRESSION|        P=0.538          P=0.017N*        P=0.005N**       P=0.008N**       P=0.230N         P=0.087N        | 
|COCH-ARM / FISHERS |        P=0.457          P=0.011N*        P=0.004N**       P=0.004N**       P=0.229N         P=0.098N        | 
|ORDER RESTRICTED   |        P=0.008N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/53 (19%)      12/54 (22%)      22/53 (42%)      25/52 (48%)      32/53 (60%)      36/52 (69%)     | 
|POLY-3 RATE (b)    |        10/41.81         12/36.26         22/41.99         25/38.88         32/43.24         36/47.96        | 
|POLY-3 PERCENT (g) |        23.9%            33.1%            52.4%            64.3%            74.0%            75.1%           | 
|TERMINAL (d)       |        6/25 (24%)       8/21 (38%)       10/23 (44%)      12/19 (63%)      19/22 (86%)      15/21 (71%)     | 
|FIRST INCIDENCE    |        169              462              429              380              341              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.243          P=0.012 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.256          P=0.005 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.316          P=0.004 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.201          P=0.006 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.325          P=0.007 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.425          P=0.010 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/52 (2%)        2/53 (4%)        1/53 (2%)        0/53 (0%)        0/53 (0%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        1/39.56          2/34.17          1/38.75          0/34.16          0/39.00          2/41.24         | 
|POLY-3 PERCENT (g) |        2.5%             5.9%             2.6%             0.0%             0.0%             4.9%            | 
|TERMINAL (d)       |        0/25 (0%)        2/21 (10%)       1/23 (4%)        0/19 (0%)        0/22 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        701              731 (T)          731 (T)          ---              ---              648             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.458          P=0.437          P=0.751          P=0.557N         P=0.515N         P=0.479         | 
|POLY 3             |        P=0.476          P=0.449          P=0.757          P=0.529N         P=0.503N         P=0.515         | 
|POLY 1.5           |        P=0.472          P=0.471          P=0.756          P=0.516N         P=0.500N         P=0.513         | 
|POLY 6             |        P=0.474          P=0.427          P=0.757          P=0.545N         P=0.507N         P=0.507         | 
|LOGISTIC REGRESSION|        P=0.493          P=0.421          P=0.759          P=0.541N         P=0.504N         P=0.510         | 
|COCH-ARM / FISHERS |        P=0.452          P=0.507          P=0.748N         P=0.495N         P=0.495N         P=0.493         | 
|ORDER RESTRICTED   |        P=0.398          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/52 (12%)       4/54 (7%)        0/53 (0%)        0/52 (0%)        2/53 (4%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        6/39.78          4/34.61          0/38.75          0/33.80          2/39.77          1/42.60         | 
|POLY-3 PERCENT (g) |        15.1%            11.6%            0.0%             0.0%             5.0%             2.4%            | 
|TERMINAL (d)       |        2/25 (8%)        4/21 (19%)       0/23 (0%)        0/19 (0%)        1/22 (5%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        645              731 (T)          ---              ---              444              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.101N         P=0.507N         P=0.023N*        P=0.048N*        P=0.172N         P=0.081N        | 
|POLY 3             |        P=0.066N         P=0.459N         P=0.016N*        P=0.025N*        P=0.130N         P=0.044N*       | 
|POLY 1.5           |        P=0.071N         P=0.410N         P=0.016N*        P=0.020N*        P=0.128N         P=0.045N*       | 
|POLY 6             |        P=0.064N         P=0.519N         P=0.017N*        P=0.033N*        P=0.139N         P=0.050N        | 
|LOGISTIC REGRESSION|        P=0.073N         P=0.495N         P=0.018N*        P=0.027N*        P=0.131N         P=0.047N*       | 
|COCH-ARM / FISHERS |        P=0.094N         P=0.347N         P=0.013N*        P=0.013N*        P=0.129N         P=0.053N        | 
|ORDER RESTRICTED   |        P=0.005N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Calculus Micro Observation Only                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/54 (2%)        1/53 (2%)        3/53 (6%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        1/39.58          1/34.61          1/39.25          3/35.01          2/39.47          0/42.60         | 
|POLY-3 PERCENT (g) |        2.5%             2.9%             2.6%             8.6%             5.1%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        0/23 (0%)        1/19 (5%)        1/22 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        722              731 (T)          578              601              589              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.300N         P=0.722          P=0.754N         P=0.220          P=0.469          P=0.524N        | 
|POLY 3             |        P=0.273N         P=0.730          P=0.759          P=0.261          P=0.499          P=0.485N        | 
|POLY 1.5           |        P=0.283N         P=0.745          P=0.756          P=0.278          P=0.500          P=0.487N        | 
|POLY 6             |        P=0.278N         P=0.715          P=0.761N         P=0.243          P=0.496          P=0.490N        | 
|LOGISTIC REGRESSION|        P=0.301N         P=0.717          P=0.760          P=0.267          P=0.496          P=0.507N        | 
|COCH-ARM / FISHERS |        P=0.330N         P=0.748N         P=0.752N         P=0.309          P=0.500          P=0.500N        | 
|ORDER RESTRICTED   |        P=0.243N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        5/54 (9%)        2/53 (4%)        0/53 (0%)        1/53 (2%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        3/40.58          5/37.88          2/39.64          0/34.16          1/39.70          1/43.05         | 
|POLY-3 PERCENT (g) |        7.4%             13.2%            5.1%             0.0%             2.5%             2.3%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        1/23 (4%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        512              341              348              ---              486              599             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.080N         P=0.305          P=0.521N         P=0.169N         P=0.318N         P=0.290N        | 
|POLY 3             |        P=0.081N         P=0.317          P=0.511N         P=0.152N         P=0.312N         P=0.284N        | 
|POLY 1.5           |        P=0.084N         P=0.337          P=0.512N         P=0.137N         P=0.309N         P=0.285N        | 
|POLY 6             |        P=0.082N         P=0.299          P=0.515N         P=0.173N         P=0.321N         P=0.295N        | 
|LOGISTIC REGRESSION|        P=0.134N         P=0.427          P=0.486N         P=0.121N         P=0.302N         P=0.343N        | 
|COCH-ARM / FISHERS |        P=0.098N         P=0.368          P=0.500N         P=0.121N         P=0.309N         P=0.309N        | 
|ORDER RESTRICTED   |        P=0.050N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        1/53 (2%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        2/39.90          0/34.61          0/38.75          0/34.16          1/39.47          1/43.05         | 
|POLY-3 PERCENT (g) |        5.0%             0.0%             0.0%             0.0%             2.5%             2.3%            | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        631              ---              ---              ---              589              598             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.563          P=0.305N         P=0.261N         P=0.317N         P=0.518N         P=0.493N        | 
|POLY 3             |        P=0.582          P=0.270N         P=0.243N         P=0.273N         P=0.504N         P=0.473N        | 
|POLY 1.5           |        P=0.562          P=0.254N         P=0.244N         P=0.258N         P=0.502N         P=0.477N        | 
|POLY 6             |        P=0.594          P=0.288N         P=0.244N         P=0.293N         P=0.509N         P=0.482N        | 
|LOGISTIC REGRESSION|        P=0.516          P=0.263N         P=0.242N         P=0.267N         P=0.501N         P=0.501N        | 
|COCH-ARM / FISHERS |        P=0.508          P=0.243N         P=0.248N         P=0.248N         P=0.500N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.125N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        2/53 (4%)        1/53 (2%)        1/53 (2%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          2/40.01          1/34.16          1/39.27          2/43.25         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             5.0%             2.9%             2.6%             4.6%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        1/19 (5%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              54               731 (T)          657              604             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.200          (e)              P=0.234          P=0.445          P=0.512          P=0.251         | 
|POLY 3             |        P=0.222          (e)              P=0.239          P=0.471          P=0.499          P=0.257         | 
|POLY 1.5           |        P=0.206          (e)              P=0.237          P=0.483          P=0.499          P=0.254         | 
|POLY 6             |        P=0.229          (e)              P=0.242          P=0.456          P=0.497          P=0.254         | 
|LOGISTIC REGRESSION|        P=0.118          (e)              P=0.321          P=0.445          P=0.499          P=0.222         | 
|COCH-ARM / FISHERS |        P=0.170          (e)              P=0.248          P=0.500          P=0.500          P=0.248         | 
|ORDER RESTRICTED   |        P=0.144          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        1/54 (2%)        0/53 (0%)        1/53 (2%)        1/53 (2%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        5/40.43          1/35.11          0/38.75          1/34.57          1/39.21          0/42.60         | 
|POLY-3 PERCENT (g) |        12.4%            2.9%             0.0%             2.9%             2.6%             0.0%            | 
|TERMINAL (d)       |        4/25 (16%)       0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        361              578              ---              615              675              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.069N         P=0.143N         P=0.041N*        P=0.164N         P=0.128N         P=0.045N*       | 
|POLY 3             |        P=0.047N*        P=0.135N         P=0.033N*        P=0.140N         P=0.107N         P=0.026N*       | 
|POLY 1.5           |        P=0.052N         P=0.120N         P=0.034N*        P=0.124N         P=0.105N         P=0.026N*       | 
|POLY 6             |        P=0.045N*        P=0.152N         P=0.033N*        P=0.160N         P=0.109N         P=0.027N*       | 
|LOGISTIC REGRESSION|        P=0.065N         P=0.109N         P=0.035N*        P=0.116N         P=0.105N         P=0.031N*       | 
|COCH-ARM / FISHERS |        P=0.071N         P=0.098N         P=0.028N*        P=0.103N         P=0.103N         P=0.028N*       | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        40/53 (75%)      39/54 (72%)      30/53 (57%)      32/53 (60%)      42/53 (79%)      42/53 (79%)     | 
|POLY-3 RATE (b)    |        40/47.18         39/49.68         30/44.43         32/44.93         42/49.66         42/51.69        | 
|POLY-3 PERCENT (g) |        84.8%            78.5%            67.5%            71.2%            84.6%            81.3%           | 
|TERMINAL (d)       |        22/25 (88%)      14/21 (67%)      14/23 (61%)      12/19 (63%)      19/22 (86%)      15/21 (71%)     | 
|FIRST INCIDENCE    |        169              241              47               338              185              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.242          P=0.290          P=0.136N         P=0.559          P=0.277          P=0.309         | 
|POLY 3             |        P=0.257          P=0.282N         P=0.032N*        P=0.072N         P=0.609N         P=0.416N        | 
|POLY 1.5           |        P=0.164          P=0.361N         P=0.040N*        P=0.080N         P=0.511          P=0.557N        | 
|POLY 6             |        P=0.372          P=0.205N         P=0.024N*        P=0.071N         P=0.490N         P=0.283N        | 
|LOGISTIC REGRESSION|        P=0.091          P=0.479N         P=0.039N*        P=0.107N         P=0.399          P=0.487         | 
|COCH-ARM / FISHERS |        P=0.053          P=0.436N         P=0.032N*        P=0.072N         P=0.408          P=0.408         | 
|ORDER RESTRICTED   |        P=0.250N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        34/53 (64%)      26/54 (48%)      32/53 (60%)      36/53 (68%)      39/53 (74%)      52/53 (98%)     | 
|POLY-3 RATE (b)    |        34/45.60         26/39.85         32/41.81         36/42.25         39/47.46         52/52.55        | 
|POLY-3 PERCENT (g) |        74.6%            65.3%            76.5%            85.2%            82.2%            99.0%           | 
|TERMINAL (d)       |        21/25 (84%)      17/21 (81%)      21/23 (91%)      19/19 (100%)     21/22 (96%)      21/21 (100%)    | 
|FIRST INCIDENCE    |        169              200              578              197              141              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.338N         P=0.565N         P=0.052          P=0.117          P=0.002 **      | 
|POLY 3             |        P<0.001 **       P=0.219N         P=0.515          P=0.128          P=0.238          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.137N         P=0.539          P=0.232          P=0.232          P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.374N         P=0.496          P=0.043 *        P=0.219          P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.140N         P=0.479N         P=0.241          P=0.191          P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.070N         P=0.421N         P=0.419          P=0.201          P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        1/53 (2%)        0/53 (0%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        2/40.16          1/34.62          1/39.54          0/34.16          2/39.72          0/42.60         | 
|POLY-3 PERCENT (g) |        5.0%             2.9%             2.5%             0.0%             5.0%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        533              729              429              ---              599              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.261N         P=0.540N         P=0.507N         P=0.275N         P=0.685          P=0.237N        | 
|POLY 3             |        P=0.234N         P=0.552N         P=0.505N         P=0.274N         P=0.691          P=0.224N        | 
|POLY 1.5           |        P=0.245N         P=0.528N         P=0.508N         P=0.258N         P=0.692          P=0.225N        | 
|POLY 6             |        P=0.231N         P=0.577N         P=0.505N         P=0.295N         P=0.688          P=0.230N        | 
|LOGISTIC REGRESSION|        P=0.289N         P=0.529N         P=0.479N         P=0.241N         P=0.695N         P=0.248N        | 
|COCH-ARM / FISHERS |        P=0.283N         P=0.493N         P=0.500N         P=0.248N         P=0.691N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.115N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        1/53 (2%)        1/53 (2%)        4/53 (8%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        2/39.55          1/35.51          1/38.75          1/34.16          4/39.99          2/42.71         | 
|POLY-3 PERCENT (g) |        5.1%             2.8%             2.6%             2.9%             10.0%            4.7%            | 
|TERMINAL (d)       |        2/25 (8%)        0/21 (0%)        1/23 (4%)        1/19 (5%)        2/22 (9%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        731 (T)          341              731 (T)          731 (T)          444              701             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.290          P=0.543N         P=0.529N         P=0.596N         P=0.302          P=0.643         | 
|POLY 3             |        P=0.383          P=0.538N         P=0.507N         P=0.551N         P=0.341          P=0.667N        | 
|POLY 1.5           |        P=0.362          P=0.519N         P=0.510N         P=0.530N         P=0.340          P=0.670N        | 
|POLY 6             |        P=0.384          P=0.557N         P=0.506N         P=0.577N         P=0.339          P=0.675N        | 
|LOGISTIC REGRESSION|        P=0.335          P=0.483N         P=0.529N         P=0.596N         P=0.333          P=0.682         | 
|COCH-ARM / FISHERS |        P=0.295          P=0.493N         P=0.500N         P=0.500N         P=0.339          P=0.691N        | 
|ORDER RESTRICTED   |        P=0.357          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        6/54 (11%)       8/53 (15%)       8/53 (15%)       11/53 (21%)      11/53 (21%)     | 
|POLY-3 RATE (b)    |        3/40.54          6/36.81          8/38.75          8/34.92          11/42.13         11/44.07        | 
|POLY-3 PERCENT (g) |        7.4%             16.3%            20.7%            22.9%            26.1%            25.0%           | 
|TERMINAL (d)       |        2/25 (8%)        3/21 (14%)       8/23 (35%)       7/19 (37%)       5/22 (23%)       6/21 (29%)      | 
|FIRST INCIDENCE    |        169              341              731 (T)          453              185              599             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.024 *        P=0.193          P=0.070          P=0.041 *        P=0.020 *        P=0.017 *       | 
|POLY 3             |        P=0.052          P=0.193          P=0.081          P=0.055          P=0.021 *        P=0.027 *       | 
|POLY 1.5           |        P=0.043 *        P=0.214          P=0.082          P=0.070          P=0.021 *        P=0.026 *       | 
|POLY 6             |        P=0.056          P=0.174          P=0.078          P=0.040 *        P=0.022 *        P=0.026 *       | 
|LOGISTIC REGRESSION|        P=0.040 *        P=0.285          P=0.094          P=0.078          P=0.022 *        P=0.023 *       | 
|COCH-ARM / FISHERS |        P=0.023 *        P=0.254          P=0.101          P=0.101          P=0.021 *        P=0.021 *       | 
|ORDER RESTRICTED   |        P=0.018 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        1/53 (2%)        0/53 (0%)        3/53 (6%)        5/53 (9%)       | 
|POLY-3 RATE (b)    |        2/39.55          1/35.17          1/38.75          0/34.16          3/39.00          5/43.18         | 
|POLY-3 PERCENT (g) |        5.1%             2.8%             2.6%             0.0%             7.7%             11.6%           | 
|TERMINAL (d)       |        2/25 (8%)        0/21 (0%)        1/23 (4%)        0/19 (0%)        3/22 (14%)       3/21 (14%)      | 
|FIRST INCIDENCE    |        731 (T)          556              731 (T)          ---              731 (T)          561             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.013 *        P=0.543N         P=0.529N         P=0.300N         P=0.441          P=0.175         | 
|POLY 3             |        P=0.021 *        P=0.541N         P=0.507N         P=0.271N         P=0.494          P=0.252         | 
|POLY 1.5           |        P=0.019 *        P=0.522N         P=0.510N         P=0.256N         P=0.497          P=0.247         | 
|POLY 6             |        P=0.022 *        P=0.560N         P=0.506N         P=0.289N         P=0.486          P=0.243         | 
|LOGISTIC REGRESSION|        P=0.023 *        P=0.536N         P=0.529N         (e)              P=0.441          P=0.234         | 
|COCH-ARM / FISHERS |        P=0.013 *        P=0.493N         P=0.500N         P=0.248N         P=0.500          P=0.219         | 
|ORDER RESTRICTED   |        P=0.043 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/53 (23%)      9/54 (17%)       13/53 (25%)      8/53 (15%)       5/53 (9%)        8/53 (15%)      | 
|POLY-3 RATE (b)    |        12/42.33         9/36.75          13/40.01         8/35.16          5/39.59          8/43.83         | 
|POLY-3 PERCENT (g) |        28.4%            24.5%            32.5%            22.8%            12.6%            18.3%           | 
|TERMINAL (d)       |        4/25 (16%)       4/21 (19%)       7/23 (30%)       5/19 (26%)       2/22 (9%)        3/21 (14%)      | 
|FIRST INCIDENCE    |        492              485              429              592              642              610             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.126N         P=0.505N         P=0.449          P=0.485N         P=0.091N         P=0.283N        | 
|POLY 3             |        P=0.065N         P=0.447N         P=0.432          P=0.382N         P=0.066N         P=0.194N        | 
|POLY 1.5           |        P=0.077N         P=0.383N         P=0.446          P=0.311N         P=0.060N         P=0.191N        | 
|POLY 6             |        P=0.067N         P=0.520N         P=0.402          P=0.478N         P=0.079N         P=0.224N        | 
|LOGISTIC REGRESSION|        P=0.068N         P=0.374N         P=0.475          P=0.323N         P=0.057N         P=0.197N        | 
|COCH-ARM / FISHERS |        P=0.130N         P=0.297N         P=0.500          P=0.229N         P=0.055N         P=0.229N        | 
|ORDER RESTRICTED   |        P=0.104N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiofibrosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/54 (2%)        2/53 (4%)        1/53 (2%)        11/53 (21%)      31/53 (58%)     | 
|POLY-3 RATE (b)    |        1/39.86          1/35.19          2/38.75          1/34.16          11/40.33         31/47.12        | 
|POLY-3 PERCENT (g) |        2.5%             2.8%             5.2%             2.9%             27.3%            65.8%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        2/23 (9%)        1/19 (5%)        6/22 (27%)       13/21 (62%)     | 
|FIRST INCIDENCE    |        645              548              731 (T)          731 (T)          589              581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.716          P=0.468          P=0.682          P=0.002 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.733          P=0.490          P=0.726          P=0.002 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.746          P=0.489          P=0.741          P=0.002 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.718          P=0.489          P=0.706          P=0.002 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.752N         P=0.493          P=0.728          P=0.002 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.748N         P=0.500          P=0.752N         P=0.002 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        1/54 (2%)        1/53 (2%)        4/53 (8%)        2/53 (4%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        5/40.18          1/34.61          1/38.75          4/34.16          2/39.00          2/42.60         | 
|POLY-3 PERCENT (g) |        12.4%            2.9%             2.6%             11.7%            5.1%             4.7%            | 
|TERMINAL (d)       |        3/25 (12%)       1/21 (5%)        1/23 (4%)        4/19 (21%)       2/22 (9%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        548              731 (T)          731 (T)          731 (T)          731 (T)          731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.433N         P=0.142N         P=0.113N         P=0.617          P=0.263N         P=0.262N        | 
|POLY 3             |        P=0.318N         P=0.138N         P=0.108N         P=0.602N         P=0.226N         P=0.191N        | 
|POLY 1.5           |        P=0.338N         P=0.120N         P=0.109N         P=0.559N         P=0.222N         P=0.193N        | 
|POLY 6             |        P=0.315N         P=0.159N         P=0.108N         P=0.624          P=0.236N         P=0.203N        | 
|LOGISTIC REGRESSION|        P=0.351N         P=0.143N         P=0.107N         P=0.632          P=0.225N         P=0.194N        | 
|COCH-ARM / FISHERS |        P=0.406N         P=0.098N         P=0.103N         P=0.500N         P=0.219N         P=0.219N        | 
|ORDER RESTRICTED   |        P=0.111N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        2/39.85          0/34.61          0/38.75          0/34.16          0/39.00          2/43.86         | 
|POLY-3 PERCENT (g) |        5.0%             0.0%             0.0%             0.0%             0.0%             4.6%            | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        648              ---              ---              ---              ---              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.261          P=0.294N         P=0.252N         P=0.310N         P=0.250N         P=0.685N        | 
|POLY 3             |        P=0.267          P=0.269N         P=0.243N         P=0.272N         P=0.241N         P=0.660N        | 
|POLY 1.5           |        P=0.252          P=0.254N         P=0.244N         P=0.257N         P=0.239N         P=0.665N        | 
|POLY 6             |        P=0.278          P=0.287N         P=0.243N         P=0.293N         P=0.246N         P=0.666N        | 
|LOGISTIC REGRESSION|        P=0.197          P=0.269N         P=0.242N         P=0.273N         P=0.241N         P=0.627         | 
|COCH-ARM / FISHERS |        P=0.223          P=0.243N         P=0.248N         P=0.248N         P=0.248N         P=0.691N        | 
|ORDER RESTRICTED   |        P=0.121N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          0/38.75          0/34.16          0/39.00          2/42.60         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             4.7%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.009 **       (e)              (e)              (e)              (e)              P=0.200         | 
|POLY 3             |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.254         | 
|POLY 1.5           |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.252         | 
|POLY 6             |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.247         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.200         | 
|COCH-ARM / FISHERS |        P=0.011 *        (e)              (e)              (e)              (e)              P=0.248         | 
|ORDER RESTRICTED   |        P=0.011 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        2/53 (4%)        0/53 (0%)        4/53 (8%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          0/38.75          2/34.16          0/39.00          4/43.34         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.9%             0.0%             9.2%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        2/19 (11%)       0/22 (0%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              731 (T)          ---              610             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       (e)              (e)              P=0.179          (e)              P=0.057         | 
|POLY 3             |        P=0.003 **       (e)              (e)              P=0.205          (e)              P=0.072         | 
|POLY 1.5           |        P=0.003 **       (e)              (e)              P=0.218          (e)              P=0.070         | 
|POLY 6             |        P=0.003 **       (e)              (e)              P=0.190          (e)              P=0.070         | 
|LOGISTIC REGRESSION|        P=0.005 **       (e)              (e)              P=0.179          (e)              P=0.069         | 
|COCH-ARM / FISHERS |        P=0.003 **       (e)              (e)              P=0.248          (e)              P=0.059         | 
|ORDER RESTRICTED   |        P=0.004 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/53 (21%)      14/54 (26%)      21/53 (40%)      27/53 (51%)      27/53 (51%)      44/53 (83%)     | 
|POLY-3 RATE (b)    |        11/40.67         14/38.67         21/42.52         27/42.49         27/45.20         44/51.46        | 
|POLY-3 PERCENT (g) |        27.1%            36.2%            49.4%            63.6%            59.7%            85.5%           | 
|TERMINAL (d)       |        6/25 (24%)       7/21 (33%)       9/23 (39%)       10/19 (53%)      11/22 (50%)      18/21 (86%)     | 
|FIRST INCIDENCE    |        645              449              550              380              341              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.181          P=0.032 *        P<0.001 **       P=0.002 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.259          P=0.026 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.288          P=0.021 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.233          P=0.035 *        P<0.001 **       P=0.002 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.236          P=0.021 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.344          P=0.028 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        12/53 (23%)      17/53 (32%)      30/53 (57%)      48/53 (91%)     | 
|POLY-3 RATE (b)    |        0/39.55          2/36.25          12/41.24         17/38.36         30/44.14         48/51.82        | 
|POLY-3 PERCENT (g) |        0.0%             5.5%             29.1%            44.3%            68.0%            92.6%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        6/23 (26%)       8/19 (42%)       17/22 (77%)      19/21 (91%)     | 
|FIRST INCIDENCE    |        ---              341              236              338              185              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.231          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.218          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.227          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.208          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.282          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.252          P<0.001 **       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: 03                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        6/54 (11%)       4/53 (8%)        4/53 (8%)        1/53 (2%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        2/39.69          6/36.23          4/38.81          4/34.47          1/39.70          2/43.03         | 
|POLY-3 PERCENT (g) |        5.0%             16.6%            10.3%            11.6%            2.5%             4.7%            | 
|TERMINAL (d)       |        1/25 (4%)        3/21 (14%)       2/23 (9%)        3/19 (16%)       0/22 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        694              526              717              645              486              604             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.148N         P=0.094          P=0.318          P=0.207          P=0.527N         P=0.665         | 
|POLY 3             |        P=0.115N         P=0.102          P=0.325          P=0.273          P=0.500N         P=0.665N        | 
|POLY 1.5           |        P=0.121N         P=0.116          P=0.324          P=0.299          P=0.499N         P=0.669N        | 
|POLY 6             |        P=0.118N         P=0.091          P=0.325          P=0.242          P=0.504N         P=0.673N        | 
|LOGISTIC REGRESSION|        P=0.114N         P=0.109          P=0.325          P=0.228          P=0.500N         P=0.673N        | 
|COCH-ARM / FISHERS |        P=0.149N         P=0.141          P=0.339          P=0.339          P=0.500N         P=0.691N        | 
|ORDER RESTRICTED   |        P=0.191N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/54 (4%)        2/53 (4%)        4/53 (8%)        2/53 (4%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        1/39.86          2/34.61          2/39.26          4/35.69          2/39.35          2/43.47         | 
|POLY-3 PERCENT (g) |        2.5%             5.8%             5.1%             11.2%            5.1%             4.6%            | 
|TERMINAL (d)       |        0/25 (0%)        2/21 (10%)       0/23 (0%)        1/19 (5%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        646              731 (T)          578              533              677              599             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.568N         P=0.419          P=0.493          P=0.122          P=0.478          P=0.529         | 
|POLY 3             |        P=0.562N         P=0.451          P=0.495          P=0.145          P=0.495          P=0.530         | 
|POLY 1.5           |        P=0.578N         P=0.474          P=0.492          P=0.158          P=0.498          P=0.525         | 
|POLY 6             |        P=0.564N         P=0.426          P=0.497          P=0.131          P=0.491          P=0.525         | 
|LOGISTIC REGRESSION|        P=0.570          P=0.435          P=0.495          P=0.176          P=0.497          P=0.457         | 
|COCH-ARM / FISHERS |        P=0.539          P=0.507          P=0.500          P=0.181          P=0.500          P=0.500         | 
|ORDER RESTRICTED   |        P=0.346          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        1/53 (2%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/39.55          2/35.66          0/38.75          1/34.16          2/39.00          0/42.60         | 
|POLY-3 PERCENT (g) |        0.0%             5.6%             0.0%             2.9%             5.1%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        1/19 (5%)        2/22 (9%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              526              ---              731 (T)          731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.467N         P=0.200          (e)              P=0.445          P=0.210          (e)             | 
|POLY 3             |        P=0.450N         P=0.214          (e)              P=0.471          P=0.233          (e)             | 
|POLY 1.5           |        P=0.451N         P=0.224          (e)              P=0.483          P=0.235          (e)             | 
|POLY 6             |        P=0.463N         P=0.205          (e)              P=0.456          P=0.229          (e)             | 
|LOGISTIC REGRESSION|        P=0.453N         P=0.258          (e)              P=0.445          P=0.210          (e)             | 
|COCH-ARM / FISHERS |        P=0.482N         P=0.252          (e)              P=0.500          P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.352N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        3/53 (6%)        7/53 (13%)       36/53 (68%)     | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          0/38.75          3/34.16          7/39.45          36/49.45        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             8.8%             17.7%            72.8%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        3/19 (16%)       4/22 (18%)       14/21 (67%)     | 
|FIRST INCIDENCE    |        ---              ---              ---              731 (T)          673              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.075          P=0.007 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.094          P=0.007 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.104          P=0.007 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.082          P=0.006 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              P=0.075          P=0.007 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.121          P=0.006 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        33/53 (62%)      46/54 (85%)      47/53 (89%)      50/53 (94%)      52/53 (98%)      49/53 (92%)     | 
|POLY-3 RATE (b)    |        33/47.21         46/52.59         47/50.65         50/51.86         52/52.36         49/52.42        | 
|POLY-3 PERCENT (g) |        69.9%            87.5%            92.8%            96.4%            99.3%            93.5%           | 
|TERMINAL (d)       |        17/25 (68%)      16/21 (76%)      23/23 (100%)     19/19 (100%)     22/22 (100%)     18/21 (86%)     | 
|FIRST INCIDENCE    |        351              200              47               53               141              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.176          P=0.008 **       P=0.014 *        P<0.001 **       P=0.002 **       P=0.010 *       | 
|POLY 3             |        P=0.005 **       P=0.022 *        P=0.002 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P=0.002 **       P=0.014 *        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P=0.010 *        P=0.038 *        P=0.002 **       P<0.001 **       P<0.001 **       P=0.003 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.008 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.006 **       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          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        30/53 (57%)      19/54 (35%)      29/53 (55%)      23/53 (43%)      30/53 (57%)      21/53 (40%)     | 
|POLY-3 RATE (b)    |        30/41.81         19/37.69         29/41.41         23/37.31         30/43.75         21/45.03        | 
|POLY-3 PERCENT (g) |        71.8%            50.4%            70.0%            61.6%            68.6%            46.6%           | 
|TERMINAL (d)       |        22/25 (88%)      13/21 (62%)      20/23 (87%)      16/19 (84%)      20/22 (91%)      14/21 (67%)     | 
|FIRST INCIDENCE    |        492              394              578              485              396              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.249N         P=0.109N         P=0.524          P=0.582          P=0.334          P=0.156N        | 
|POLY 3             |        P=0.019N*        P=0.029N*        P=0.530N         P=0.213N         P=0.463N         P=0.009N**      | 
|POLY 1.5           |        P=0.047N*        P=0.023N*        P=0.562N         P=0.164N         P=0.508N         P=0.016N*       | 
|POLY 6             |        P=0.010N*        P=0.038N*        P=0.491N         P=0.297N         P=0.446N         P=0.007N**      | 
|LOGISTIC REGRESSION|        P=0.033N*        P=0.088N         P=0.539N         P=0.422N         P=0.567          P=0.016N*       | 
|COCH-ARM / FISHERS |        P=0.247N         P=0.021N*        P=0.500N         P=0.122N         P=0.578N         P=0.060N        | 
|ORDER RESTRICTED   |        P=0.005N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        4/54 (7%)        4/53 (8%)        8/53 (15%)       10/53 (19%)      17/53 (32%)     | 
|POLY-3 RATE (b)    |        1/39.67          4/36.95          4/40.33          8/38.63          10/42.48         17/46.77        | 
|POLY-3 PERCENT (g) |        2.5%             10.8%            9.9%             20.7%            23.5%            36.4%           | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        1/23 (4%)        1/19 (5%)        2/22 (9%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        701              341              47               373              185              474             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.160          P=0.185          P=0.013 *        P=0.006 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.156          P=0.182          P=0.013 *        P=0.005 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.168          P=0.179          P=0.014 *        P=0.005 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.143          P=0.185          P=0.011 *        P=0.005 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.220          P=0.200          P=0.024 *        P=0.005 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.187          P=0.181          P=0.016 *        P=0.004 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        9/54 (17%)       34/53 (64%)      48/53 (91%)      52/53 (98%)      53/53 (100%)    | 
|POLY-3 RATE (b)    |        4/40.41          9/36.83          34/43.56         48/50.11         52/52.01         53/53.00        | 
|POLY-3 PERCENT (g) |        9.9%             24.4%            78.1%            95.8%            100.0%           100.0%          | 
|TERMINAL (d)       |        1/25 (4%)        4/21 (19%)       18/23 (78%)      18/19 (95%)      22/22 (100%)     21/21 (100%)    | 
|FIRST INCIDENCE    |        533              556              429              197              185              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.069          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.078          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.093          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.067          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.090          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.125          P<0.001 **       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: 03                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        8/53 (15%)       30/53 (57%)      45/53 (85%)      53/53 (100%)    | 
|POLY-3 RATE (b)    |        0/39.55          2/35.11          8/39.47          30/40.91         45/48.20         53/53.00        | 
|POLY-3 PERCENT (g) |        0.0%             5.7%             20.3%            73.3%            93.4%            100.0%          | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        5/23 (22%)       13/19 (68%)      22/22 (100%)     21/21 (100%)    | 
|FIRST INCIDENCE    |        ---              578              578              462              185              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.200          P=0.005 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.211          P=0.003 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.223          P=0.003 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.200          P=0.003 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.223          P=0.004 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.252          P=0.003 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Artery                                                                                                                    | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          0/38.75          0/34.16          0/39.00          2/43.31         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             4.6%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.018 *        (e)              (e)              (e)              (e)              P=0.258         | 
|POLY 3             |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.258         | 
|POLY 1.5           |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.254         | 
|POLY 6             |        P=0.013 *        (e)              (e)              (e)              (e)              P=0.255         | 
|LOGISTIC REGRESSION|        P=0.010 *        (e)              (e)              (e)              (e)              P=0.212         | 
|COCH-ARM / FISHERS |        P=0.011 *        (e)              (e)              (e)              (e)              P=0.248         | 
|ORDER RESTRICTED   |        P=0.012 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        1/54 (2%)        2/53 (4%)        2/53 (4%)        0/53 (0%)        21/53 (40%)     | 
|POLY-3 RATE (b)    |        3/39.85          1/34.61          2/38.76          2/34.72          0/39.00          21/44.46        | 
|POLY-3 PERCENT (g) |        7.5%             2.9%             5.2%             5.8%             0.0%             47.2%           | 
|TERMINAL (d)       |        2/25 (8%)        1/21 (5%)        1/23 (4%)        1/19 (5%)        0/22 (0%)        14/21 (67%)     | 
|FIRST INCIDENCE    |        648              731 (T)          728              557              ---              612             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.382N         P=0.529N         P=0.609N         P=0.136N         P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.357N         P=0.513N         P=0.563N         P=0.122N         P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.332N         P=0.514N         P=0.537N         P=0.120N         P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.384N         P=0.514N         P=0.595N         P=0.125N         P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.379N         P=0.509N         P=0.563N         P=0.124N         P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.302N         P=0.500N         P=0.500N         P=0.121N         P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        1/53 (2%)        3/53 (6%)        4/53 (8%)       | 
|POLY-3 RATE (b)    |        0/39.55          2/35.02          0/38.75          1/34.67          3/40.18          4/43.38         | 
|POLY-3 PERCENT (g) |        0.0%             5.7%             0.0%             2.9%             7.5%             9.2%            | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        0/23 (0%)        0/19 (0%)        1/22 (5%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        ---              613              ---              578              486              598             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.025 *        P=0.186          (e)              P=0.479          P=0.117          P=0.062         | 
|POLY 3             |        P=0.020 *        P=0.210          (e)              P=0.474          P=0.121          P=0.072         | 
|POLY 1.5           |        P=0.019 *        P=0.222          (e)              P=0.484          P=0.120          P=0.070         | 
|POLY 6             |        P=0.020 *        P=0.199          (e)              P=0.461          P=0.120          P=0.070         | 
|LOGISTIC REGRESSION|        P=0.016 *        P=0.214          (e)              P=0.513          P=0.121          P=0.068         | 
|COCH-ARM / FISHERS |        P=0.014 *        P=0.252          (e)              P=0.500          P=0.121          P=0.059         | 
|ORDER RESTRICTED   |        P=0.021 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        4/54 (7%)        7/53 (13%)       22/53 (42%)      40/53 (75%)      53/53 (100%)    | 
|POLY-3 RATE (b)    |        5/40.16          4/35.12          7/39.03          22/38.54         40/45.67         53/53.00        | 
|POLY-3 PERCENT (g) |        12.5%            11.4%            17.9%            57.1%            87.6%            100.0%          | 
|TERMINAL (d)       |        4/25 (16%)       2/21 (10%)       4/23 (17%)       11/19 (58%)      21/22 (96%)      21/21 (100%)    | 
|FIRST INCIDENCE    |        533              578              676              406              317              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.597N         P=0.346          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.584N         P=0.356          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.546N         P=0.355          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.623N         P=0.356          P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.597N         P=0.364          P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.488N         P=0.380          P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        2/54 (4%)        0/53 (0%)        4/53 (8%)        3/53 (6%)        5/53 (9%)       | 
|POLY-3 RATE (b)    |        2/39.97          2/36.33          0/38.75          4/34.98          3/40.40          5/43.88         | 
|POLY-3 PERCENT (g) |        5.0%             5.5%             0.0%             11.4%            7.4%             11.4%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        1/19 (5%)        0/22 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        648              264              ---              592              518              610             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.085          P=0.646          P=0.243N         P=0.225          P=0.501          P=0.224         | 
|POLY 3             |        P=0.076          P=0.660          P=0.244N         P=0.276          P=0.505          P=0.254         | 
|POLY 1.5           |        P=0.069          P=0.678          P=0.244N         P=0.300          P=0.503          P=0.248         | 
|POLY 6             |        P=0.077          P=0.638          P=0.245N         P=0.249          P=0.503          P=0.250         | 
|LOGISTIC REGRESSION|        P=0.041 *        P=0.638N         P=0.242N         P=0.281          P=0.501          P=0.225         | 
|COCH-ARM / FISHERS |        P=0.049 *        P=0.684N         P=0.248N         P=0.339          P=0.500          P=0.219         | 
|ORDER RESTRICTED   |        P=0.110          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        19/54 (35%)      19/53 (36%)      42/53 (79%)      41/53 (77%)      52/53 (98%)     | 
|POLY-3 RATE (b)    |        0/39.55          19/40.44         19/42.70         42/47.70         41/49.86         52/52.59        | 
|POLY-3 PERCENT (g) |        0.0%             47.0%            44.5%            88.0%            82.2%            98.9%           | 
|TERMINAL (d)       |        0/25 (0%)        9/21 (43%)       9/23 (39%)       16/19 (84%)      18/22 (82%)      21/21 (100%)    | 
|FIRST INCIDENCE    |        ---              361              54               197              141              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|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<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Multinucleated                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        16/53 (30%)      26/53 (49%)      36/53 (68%)      51/53 (96%)     | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          16/41.40         26/41.16         36/46.14         51/52.67        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             38.7%            63.2%            78.0%            96.8%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        7/23 (30%)       11/19 (58%)      17/22 (77%)      20/21 (95%)     | 
|FIRST INCIDENCE    |        ---              ---              550              373              317              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P<0.001 **       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: 03                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        4/54 (7%)        3/53 (6%)        20/53 (38%)      38/53 (72%)      53/53 (100%)    | 
|POLY-3 RATE (b)    |        0/39.55          4/35.11          3/39.46          20/37.65         38/44.76         53/53.00        | 
|POLY-3 PERCENT (g) |        0.0%             11.4%            7.6%             53.1%            84.9%            100.0%          | 
|TERMINAL (d)       |        0/25 (0%)        3/21 (14%)       1/23 (4%)        11/19 (58%)      21/22 (96%)      21/21 (100%)    | 
|FIRST INCIDENCE    |        ---              578              578              380              444              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.043 *        P=0.125          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.046 *        P=0.117          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.052          P=0.115          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.040 *        P=0.120          P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.043 *        P=0.117          P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.061          P=0.121          P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Portal                                                                                                                    | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        5/53 (9%)        27/53 (51%)     | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          0/38.75          0/34.16          5/39.43          27/47.36        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             12.7%            57.0%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        2/22 (9%)        11/21 (52%)     | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              657              474             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.030 *        P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.029 *        P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.030 *        P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.028 *        P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.030 *        P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.028 *        P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        2/53 (4%)        0/52 (0%)        0/53 (0%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          2/40.74          0/33.71          0/39.00          0/41.64         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.9%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              47               ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.394N         (e)              P=0.238          (e)              (e)              (e)             | 
|POLY 3             |        P=0.360N         (e)              P=0.243          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.374N         (e)              P=0.241          (e)              (e)              (e)             | 
|POLY 6             |        P=0.350N         (e)              P=0.245          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.397N         (e)              P=0.248          (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.344N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        2/53 (4%)        0/52 (0%)        1/53 (2%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          2/39.68          0/33.71          1/39.47          0/41.64         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             5.0%             0.0%             2.5%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              429              ---              589              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.481N         (e)              P=0.235          (e)              P=0.505          (e)             | 
|POLY 3             |        P=0.470N         (e)              P=0.237          (e)              P=0.500          (e)             | 
|POLY 1.5           |        P=0.487N         (e)              P=0.234          (e)              P=0.500          (e)             | 
|POLY 6             |        P=0.461N         (e)              P=0.240          (e)              P=0.498          (e)             | 
|LOGISTIC REGRESSION|        P=0.562N         (e)              P=0.249          (e)              P=0.501          (e)             | 
|COCH-ARM / FISHERS |        P=0.522N         (e)              P=0.248          (e)              P=0.500          (e)             | 
|ORDER RESTRICTED   |        P=0.389          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        0/53 (0%)        0/52 (0%)        0/53 (0%)        2/52 (4%)       | 
|POLY-3 RATE (b)    |        0/39.55          1/35.31          0/38.75          0/33.71          0/39.00          2/42.48         | 
|POLY-3 PERCENT (g) |        0.0%             2.8%             0.0%             0.0%             0.0%             4.7%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              490              ---              ---              ---              474             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.096          P=0.491          (e)              (e)              (e)              P=0.247         | 
|POLY 3             |        P=0.079          P=0.477          (e)              (e)              (e)              P=0.253         | 
|POLY 1.5           |        P=0.079          P=0.488          (e)              (e)              (e)              P=0.250         | 
|POLY 6             |        P=0.077          P=0.467          (e)              (e)              (e)              P=0.249         | 
|LOGISTIC REGRESSION|        P=0.046 *        P=0.536          (e)              (e)              (e)              P=0.171         | 
|COCH-ARM / FISHERS |        P=0.074          P=0.505          (e)              (e)              (e)              P=0.243         | 
|ORDER RESTRICTED   |        P=0.037 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        41/53 (77%)      46/54 (85%)      43/53 (81%)      43/52 (83%)      49/53 (92%)      50/52 (96%)     | 
|POLY-3 RATE (b)    |        41/48.55         46/49.22         43/46.24         43/44.24         49/50.17         50/51.42        | 
|POLY-3 PERCENT (g) |        84.5%            93.5%            93.0%            97.2%            97.7%            97.2%           | 
|TERMINAL (d)       |        19/25 (76%)      19/21 (91%)      22/23 (96%)      19/19 (100%)     22/22 (100%)     20/21 (95%)     | 
|FIRST INCIDENCE    |        351              241              344              380              141              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.202          P=0.068          P=0.330          P=0.058          P=0.081          P=0.083         | 
|POLY 3             |        P=0.018 *        P=0.121          P=0.146          P=0.026 *        P=0.016 *        P=0.022 *       | 
|POLY 1.5           |        P=0.009 **       P=0.143          P=0.178          P=0.074          P=0.018 *        P=0.015 *       | 
|POLY 6             |        P=0.027 *        P=0.109          P=0.118          P=0.014 *        P=0.012 *        P=0.027 *       | 
|LOGISTIC REGRESSION|        P=0.025 *        P=0.106          P=0.276          P=0.119          P=0.020 *        P=0.015 *       | 
|COCH-ARM / FISHERS |        P=0.002 **       P=0.215          P=0.406          P=0.331          P=0.028 *        P=0.004 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        0/53 (0%)        2/52 (4%)        0/53 (0%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        1/40.25          0/34.61          0/38.75          2/34.74          0/39.00          0/41.64         | 
|POLY-3 PERCENT (g) |        2.5%             0.0%             0.0%             5.8%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        487              ---              ---              373              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.355N         P=0.513N         P=0.504N         P=0.456          P=0.509N         P=0.479N        | 
|POLY 3             |        P=0.347N         P=0.530N         P=0.508N         P=0.449          P=0.506N         P=0.493N        | 
|POLY 1.5           |        P=0.353N         P=0.516N         P=0.508N         P=0.467          P=0.504N         P=0.493N        | 
|POLY 6             |        P=0.347N         P=0.544N         P=0.509N         P=0.427          P=0.511N         P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.442N         P=0.464N         P=0.466N         P=0.543          P=0.495N         P=0.655N        | 
|COCH-ARM / FISHERS |        P=0.377N         P=0.495N         P=0.500N         P=0.493          P=0.500N         P=0.505N        | 
|ORDER RESTRICTED   |        P=0.271N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        2/53 (4%)        2/52 (4%)        0/53 (0%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        2/39.90          1/34.61          2/38.88          2/34.84          0/39.00          0/41.64         | 
|POLY-3 PERCENT (g) |        5.0%             2.9%             5.1%             5.7%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        1/23 (4%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        645              731 (T)          697              485              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.098N         P=0.583N         P=0.671          P=0.593          P=0.264N         P=0.259N        | 
|POLY 3             |        P=0.082N         P=0.550N         P=0.686          P=0.645          P=0.242N         P=0.227N        | 
|POLY 1.5           |        P=0.087N         P=0.527N         P=0.684          P=0.662          P=0.239N         P=0.228N        | 
|POLY 6             |        P=0.082N         P=0.575N         P=0.686          P=0.624          P=0.247N         P=0.234N        | 
|LOGISTIC REGRESSION|        P=0.092N         P=0.562N         P=0.689          P=0.692          P=0.240N         P=0.229N        | 
|COCH-ARM / FISHERS |        P=0.102N         P=0.493N         P=0.691N         P=0.684          P=0.248N         P=0.252N        | 
|ORDER RESTRICTED   |        P=0.146N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        0/53 (0%)        0/52 (0%)        5/53 (9%)        6/52 (12%)      | 
|POLY-3 RATE (b)    |        1/39.55          0/34.61          0/38.75          0/33.71          5/39.04          6/43.19         | 
|POLY-3 PERCENT (g) |        2.5%             0.0%             0.0%             0.0%             12.8%            13.9%           | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        4/22 (18%)       2/21 (10%)      | 
|FIRST INCIDENCE    |        731 (T)          ---              ---              ---              720              561             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.535N         P=0.517N         P=0.555N         P=0.076          P=0.060         | 
|POLY 3             |        P<0.001 **       P=0.527N         P=0.504N         P=0.532N         P=0.096          P=0.070         | 
|POLY 1.5           |        P<0.001 **       P=0.514N         P=0.505N         P=0.520N         P=0.099          P=0.067         | 
|POLY 6             |        P<0.001 **       P=0.539N         P=0.503N         P=0.545N         P=0.091          P=0.069         | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.072          P=0.059         | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.495N         P=0.500N         P=0.505N         P=0.103          P=0.053         | 
|ORDER RESTRICTED   |        P=0.003 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/53 (23%)      0/54 (0%)        0/53 (0%)        0/52 (0%)        0/53 (0%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        12/40.71         0/34.61          0/38.75          0/33.71          0/39.00          0/41.64         | 
|POLY-3 PERCENT (g) |        29.5%            0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        6/25 (24%)       0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        645              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003N**       P=0.002N**       P<0.001N**       P=0.003N**       P<0.001N**       P<0.001N**      | 
|POLY 3             |        P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**      | 
|POLY 6             |        P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**      | 
|LOGISTIC REGRESSION|        P=0.002N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**      | 
|COCH-ARM / FISHERS |        P=0.002N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**       P<0.001N**      | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        19/54 (35%)      33/53 (62%)      35/52 (67%)      45/53 (85%)      46/52 (88%)     | 
|POLY-3 RATE (b)    |        2/39.55          19/38.13         33/43.14         35/42.04         45/47.86         46/50.05        | 
|POLY-3 PERCENT (g) |        5.1%             49.8%            76.5%            83.3%            94.0%            91.9%           | 
|TERMINAL (d)       |        2/25 (8%)        11/21 (52%)      19/23 (83%)      17/19 (90%)      22/22 (100%)     19/21 (91%)     | 
|FIRST INCIDENCE    |        731 (T)          449              578              380              341              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|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<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/51 (0%)        0/54 (0%)        0/52 (0%)        0/50 (0%)        1/51 (2%)        6/52 (12%)      | 
|POLY-3 RATE (b)    |        0/38.56          0/34.61          0/37.95          0/33.43          1/38.33          6/41.66         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             2.6%             14.4%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        6/21 (29%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              590              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.500          P=0.008 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.499          P=0.019 *       | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.499          P=0.020 *       | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.497          P=0.016 *       | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.502          P=0.008 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.500          P=0.014 *       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        25/51 (49%)      31/54 (57%)      23/52 (44%)      22/50 (44%)      15/51 (29%)      16/52 (31%)     | 
|POLY-3 RATE (b)    |        25/42.13         31/44.45         23/41.82         22/38.78         15/39.61         16/44.39        | 
|POLY-3 PERCENT (g) |        59.3%            69.7%            55.0%            56.7%            37.9%            36.0%           | 
|TERMINAL (d)       |        16/25 (64%)      14/21 (67%)      12/23 (52%)      10/19 (53%)      8/22 (36%)       10/21 (48%)     | 
|FIRST INCIDENCE    |        366              241              177              406              590              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.005N**       P=0.054          P=0.525N         P=0.372          P=0.085N         P=0.123N        | 
|POLY 3             |        P<0.001N**       P=0.203          P=0.426N         P=0.495N         P=0.036N*        P=0.020N*       | 
|POLY 1.5           |        P<0.001N**       P=0.224          P=0.433N         P=0.447N         P=0.033N*        P=0.021N*       | 
|POLY 6             |        P<0.001N**       P=0.195          P=0.415N         P=0.557N         P=0.040N*        P=0.026N*       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.159          P=0.440N         P=0.514N         P=0.032N*        P=0.027N*       | 
|COCH-ARM / FISHERS |        P=0.003N**       P=0.253          P=0.386N         P=0.380N         P=0.034N*        P=0.045N*       | 
|ORDER RESTRICTED   |        P=0.003N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/51 (0%)        3/54 (6%)        3/52 (6%)        0/50 (0%)        0/51 (0%)        2/52 (4%)       | 
|POLY-3 RATE (b)    |        0/38.56          3/37.03          3/40.81          0/33.43          0/37.86          2/42.56         | 
|POLY-3 PERCENT (g) |        0.0%             8.1%             7.4%             0.0%             0.0%             4.7%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              200              47               ---              ---              581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.549N         P=0.125          P=0.118          (e)              (e)              P=0.271         | 
|POLY 3             |        P=0.587N         P=0.110          P=0.128          (e)              (e)              P=0.259         | 
|POLY 1.5           |        P=0.590N         P=0.119          P=0.126          (e)              (e)              P=0.257         | 
|POLY 6             |        P=0.590N         P=0.102          P=0.129          (e)              (e)              P=0.254         | 
|LOGISTIC REGRESSION|        P=0.284          P=0.156          P=0.254          (e)              (e)              P=0.189         | 
|COCH-ARM / FISHERS |        P=0.602N         P=0.132          P=0.125          (e)              (e)              P=0.252         | 
|ORDER RESTRICTED   |        P=0.202          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/52 (2%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        1/40.17          0/34.17          0/38.75          0/34.16          2/39.85          2/41.63         | 
|POLY-3 PERCENT (g) |        2.5%             0.0%             0.0%             0.0%             5.0%             4.8%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        469              ---              ---              ---              518              598             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.099          P=0.517N         P=0.513N         P=0.527N         P=0.496          P=0.527         | 
|POLY 3             |        P=0.093          P=0.532N         P=0.507N         P=0.532N         P=0.497          P=0.512         | 
|POLY 1.5           |        P=0.085          P=0.518N         P=0.506N         P=0.518N         P=0.500          P=0.511         | 
|POLY 6             |        P=0.096          P=0.546N         P=0.509N         P=0.549N         P=0.493          P=0.506         | 
|LOGISTIC REGRESSION|        P=0.047 *        P=0.453N         P=0.449N         P=0.449N         P=0.519          P=0.398         | 
|COCH-ARM / FISHERS |        P=0.065          P=0.495N         P=0.495N         P=0.495N         P=0.507          P=0.493         | 
|ORDER RESTRICTED   |        P=0.147          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/2 (50%)        2/6 (33%)        1/3 (33%)        2/5 (40%)        0/6 (0%)         0/9 (0%)        | 
|POLY-3 RATE (b)    |        1/2.00           2/2.88           1/2.62           2/4.38           0/3.39           0/6.57          | 
|POLY-3 PERCENT (g) |        50.0%            69.4%            38.2%            45.7%            0.0%             0.0%            | 
|TERMINAL (d)       |        0/1 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/3 (0%)        | 
|FIRST INCIDENCE    |        717              341              578              578              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.113N         P=0.455          P=0.751          P=0.410          P=0.533N         P=0.543N        | 
|POLY 3             |        P=0.015N*        P=0.706          P=0.712N         P=0.750N         P=0.363N         P=0.192N        | 
|POLY 1.5           |        P=0.015N*        P=0.796          P=0.693N         P=0.724N         P=0.297N         P=0.169N        | 
|POLY 6             |        P=0.020N*        P=0.574          P=0.740N         P=0.784          P=0.491N         P=0.234N        | 
|LOGISTIC REGRESSION|        P=0.028N*        P=0.922          P=0.520N         P=0.456N         P=0.830N         P=0.315N        | 
|COCH-ARM / FISHERS |        P=0.024N*        P=0.643N         P=0.700N         P=0.714N         P=0.250N         P=0.182N        | 
|ORDER RESTRICTED   |        P=0.112N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/2 (0%)         2/6 (33%)        0/3 (0%)         1/5 (20%)        0/6 (0%)         0/9 (0%)        | 
|POLY-3 RATE (b)    |        0/1.94           2/2.76           0/2.11           1/4.07           0/3.39           0/6.57          | 
|POLY-3 PERCENT (g) |        0.0%             72.6%            0.0%             24.6%            0.0%             0.0%            | 
|TERMINAL (d)       |        0/1 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/3 (0%)        | 
|FIRST INCIDENCE    |        ---              448              ---              578              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.241N         P=0.211          (e)              P=0.468          (e)              (e)             | 
|POLY 3             |        P=0.185N         P=0.211          (e)              P=0.649          (e)              (e)             | 
|POLY 1.5           |        P=0.158N         P=0.333          (e)              P=0.661          (e)              (e)             | 
|POLY 6             |        P=0.212N         P=0.109          (e)              P=0.625          (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.183N         P=0.468          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.126N         P=0.536          (e)              P=0.714          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.169N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/2 (0%)         0/6 (0%)         0/3 (0%)         0/5 (0%)         1/6 (17%)        3/9 (33%)       | 
|POLY-3 RATE (b)    |        0/1.94           0/1.48           0/2.11           0/3.56           1/3.87           3/7.60          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             25.9%            39.5%           | 
|TERMINAL (d)       |        0/1 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/3 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              590              546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.005 **       (e)              (e)              (e)              P=0.500          P=0.137         | 
|POLY 3             |        P=0.044 *        (e)              (e)              (e)              P=0.649          P=0.422         | 
|POLY 1.5           |        P=0.036 *        (e)              (e)              (e)              P=0.680          P=0.442         | 
|POLY 6             |        P=0.073          (e)              (e)              (e)              P=0.591          P=0.401         | 
|LOGISTIC REGRESSION|        P=0.024 *        (e)              (e)              (e)              P=0.980          P=0.588         | 
|COCH-ARM / FISHERS |        P=0.023 *        (e)              (e)              (e)              P=0.750          P=0.509         | 
|ORDER RESTRICTED   |        P=0.263          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/2 (0%)         1/6 (17%)        0/3 (0%)         1/5 (20%)        0/6 (0%)         5/9 (56%)       | 
|POLY-3 RATE (b)    |        0/1.94           1/2.43           0/2.11           1/3.65           0/3.39           5/8.27          | 
|POLY-3 PERCENT (g) |        0.0%             41.1%            0.0%             27.4%            0.0%             60.5%           | 
|TERMINAL (d)       |        0/1 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/3 (33%)       | 
|FIRST INCIDENCE    |        ---              264              ---              708              ---              474             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.009 **       P=0.500          (e)              P=0.440          (e)              P=0.059         | 
|POLY 3             |        P=0.015 *        P=0.553          (e)              P=0.632          (e)              P=0.221         | 
|POLY 1.5           |        P=0.013 *        P=0.633          (e)              P=0.653          (e)              P=0.236         | 
|POLY 6             |        P=0.022 *        P=0.443          (e)              P=0.589          (e)              P=0.206         | 
|LOGISTIC REGRESSION|        P=0.007 **       (e)              (e)              P=0.425          (e)              P=0.428         | 
|COCH-ARM / FISHERS |        P=0.016 *        P=0.750          (e)              P=0.714          (e)              P=0.273         | 
|ORDER RESTRICTED   |        P=0.130          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/2 (0%)         0/6 (0%)         1/3 (33%)        1/5 (20%)        2/6 (33%)        1/9 (11%)       | 
|POLY-3 RATE (b)    |        0/1.94           0/1.48           1/2.12           1/3.72           2/4.29           1/7.02          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             47.1%            26.9%            46.7%            14.3%           | 
|TERMINAL (d)       |        0/1 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/3 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              728              690              578              598             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.324          (e)              P=0.492          P=0.438          P=0.242          P=0.515         | 
|POLY 3             |        P=0.515N         (e)              P=0.519          P=0.635          P=0.403          P=0.764         | 
|POLY 1.5           |        P=0.547N         (e)              P=0.548          P=0.654          P=0.451          P=0.774         | 
|POLY 6             |        P=0.568N         (e)              P=0.467          P=0.597          P=0.327          P=0.749         | 
|LOGISTIC REGRESSION|        P=0.575N         (e)              P=0.381          P=0.608          P=0.814          P=0.945         | 
|COCH-ARM / FISHERS |        P=0.589          (e)              P=0.600          P=0.714          P=0.536          P=0.818         | 
|ORDER RESTRICTED   |        P=0.446          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        3/54 (6%)        0/53 (0%)        1/53 (2%)        1/53 (2%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        4/41.40          3/35.67          0/38.75          1/34.87          1/39.04          1/42.92         | 
|POLY-3 PERCENT (g) |        9.7%             8.4%             0.0%             2.9%             2.6%             2.3%            | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        366              556              ---              485              720              641             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.155N         P=0.609N         P=0.078N         P=0.268N         P=0.200N         P=0.176N        | 
|POLY 3             |        P=0.155N         P=0.581N         P=0.068N         P=0.234N         P=0.196N         P=0.167N        | 
|POLY 1.5           |        P=0.161N         P=0.545N         P=0.067N         P=0.210N         P=0.188N         P=0.166N        | 
|POLY 6             |        P=0.156N         P=0.618N         P=0.071N         P=0.267N         P=0.208N         P=0.179N        | 
|LOGISTIC REGRESSION|        P=0.200N         P=0.467N         P=0.055N         P=0.150N         P=0.178N         P=0.245N        | 
|COCH-ARM / FISHERS |        P=0.185N         P=0.489N         P=0.059N         P=0.181N         P=0.181N         P=0.181N        | 
|ORDER RESTRICTED   |        P=0.049N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        25/53 (47%)      21/54 (39%)      24/53 (45%)      22/53 (42%)      18/53 (34%)      16/53 (30%)     | 
|POLY-3 RATE (b)    |        25/44.58         21/38.80         24/42.10         22/37.99         18/43.24         16/44.03        | 
|POLY-3 PERCENT (g) |        56.1%            54.1%            57.0%            57.9%            41.6%            36.3%           | 
|TERMINAL (d)       |        13/25 (52%)      12/21 (57%)      13/23 (57%)      13/19 (68%)      9/22 (41%)       10/21 (48%)     | 
|FIRST INCIDENCE    |        487              462              54               53               141              614             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.041N*        P=0.565          P=0.549          P=0.359          P=0.224N         P=0.126N        | 
|POLY 3             |        P=0.006N**       P=0.518N         P=0.553          P=0.523          P=0.119N         P=0.042N*       | 
|POLY 1.5           |        P=0.008N**       P=0.396N         P=0.584          P=0.510N         P=0.105N         P=0.037N*       | 
|POLY 6             |        P=0.008N**       P=0.539          P=0.507          P=0.353          P=0.153N         P=0.069N        | 
|LOGISTIC REGRESSION|        P=0.008N**       P=0.415N         P=0.543N         P=0.513N         P=0.119N         P=0.028N*       | 
|COCH-ARM / FISHERS |        P=0.035N*        P=0.252N         P=0.500N         P=0.348N         P=0.118N         P=0.055N        | 
|ORDER RESTRICTED   |        P=0.029N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Artery                                                                                                                | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/2 (0%)         1/2 (50%)        0/0 (0%)         0/1 (0%)         4/6 (67%)        7/8 (88%)       | 
|POLY-3 RATE (b)    |        0/0.71           1/1.61           0/0.00           0/0.84           4/5.52           7/7.72          | 
|POLY-3 PERCENT (g) |        0.0%             62.1%            0.0%             0.0%             72.4%            90.7%           | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         3/4 (75%)        3/3 (100%)      | 
|FIRST INCIDENCE    |        ---              200              ---              ---              642              581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.004 **       P=0.455          (e)              (e)              P=0.511          P=0.075         | 
|POLY 3             |        (e)              P=0.659          (e)              (e)              P=0.533          P=0.408         | 
|POLY 1.5           |        (e)              P=0.620          (e)              (e)              P=0.453          P=0.274         | 
|POLY 6             |        (e)              P=0.728          (e)              (e)              P=0.624          P=0.602         | 
|LOGISTIC REGRESSION|        P=0.032 *        P=0.465          (e)              (e)              P=0.602          P=0.249         | 
|COCH-ARM / FISHERS |        P=0.024 *        P=0.500          (e)              (e)              P=0.214          P=0.067         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        0/53 (0%)        3/53 (6%)        5/53 (9%)        4/53 (8%)       | 
|POLY-3 RATE (b)    |        2/40.42          0/34.61          0/38.75          3/35.64          5/41.65          4/42.93         | 
|POLY-3 PERCENT (g) |        5.0%             0.0%             0.0%             8.4%             12.0%            9.3%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        1/19 (5%)        0/22 (0%)        3/21 (14%)      | 
|FIRST INCIDENCE    |        474              ---              ---              373              341              638             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.039 *        P=0.277N         P=0.248N         P=0.433          P=0.216          P=0.306         | 
|POLY 3             |        P=0.046 *        P=0.273N         P=0.246N         P=0.443          P=0.227          P=0.365         | 
|POLY 1.5           |        P=0.041 *        P=0.256N         P=0.246N         P=0.466          P=0.224          P=0.364         | 
|POLY 6             |        P=0.046 *        P=0.292N         P=0.248N         P=0.412          P=0.227          P=0.350         | 
|LOGISTIC REGRESSION|        P=0.016 *        P=0.220N         P=0.228N         P=0.540          P=0.219          P=0.350         | 
|COCH-ARM / FISHERS |        P=0.026 *        P=0.243N         P=0.248N         P=0.500          P=0.219          P=0.339         | 
|ORDER RESTRICTED   |        P=0.056          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Nasolacrimal Duct                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        2/40.42          0/34.61          0/38.75          0/34.16          0/39.00          0/42.60         | 
|POLY-3 PERCENT (g) |        5.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        366              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.249N         P=0.261N         P=0.256N         P=0.267N         P=0.254N         P=0.250N        | 
|POLY 3             |        P=0.219N         P=0.273N         P=0.246N         P=0.276N         P=0.245N         P=0.225N        | 
|POLY 1.5           |        P=0.230N         P=0.257N         P=0.246N         P=0.260N         P=0.242N         P=0.226N        | 
|POLY 6             |        P=0.209N         P=0.290N         P=0.246N         P=0.296N         P=0.249N         P=0.231N        | 
|LOGISTIC REGRESSION|        P=0.268N         P=0.209N         P=0.218N         P=0.213N         P=0.234N         P=0.314N        | 
|COCH-ARM / FISHERS |        P=0.249N         P=0.243N         P=0.248N         P=0.248N         P=0.248N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.008N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          0/38.75          0/34.16          2/40.05          0/42.60         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             5.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              474              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.495          (e)              (e)              (e)              P=0.237          (e)             | 
|POLY 3             |        P=0.540          (e)              (e)              (e)              P=0.239          (e)             | 
|POLY 1.5           |        P=0.524          (e)              (e)              (e)              P=0.239          (e)             | 
|POLY 6             |        P=0.535          (e)              (e)              (e)              P=0.239          (e)             | 
|LOGISTIC REGRESSION|        P=0.418          (e)              (e)              (e)              P=0.240          (e)             | 
|COCH-ARM / FISHERS |        P=0.461          (e)              (e)              (e)              P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.190          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        1/53 (2%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          0/38.75          1/35.03          2/39.91          0/42.60         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             2.9%             5.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              373              518              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.556          (e)              (e)              P=0.508          P=0.246          (e)             | 
|POLY 3             |        P=0.599          (e)              (e)              P=0.476          P=0.239          (e)             | 
|POLY 1.5           |        P=0.585          (e)              (e)              P=0.486          P=0.238          (e)             | 
|POLY 6             |        P=0.592          (e)              (e)              P=0.463          P=0.238          (e)             | 
|LOGISTIC REGRESSION|        P=0.441          (e)              (e)              P=0.562          P=0.239          (e)             | 
|COCH-ARM / FISHERS |        P=0.522          (e)              (e)              P=0.500          P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.257          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Septum                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          0/38.75          0/34.16          0/39.00          2/42.93         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             4.7%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              638             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.015 *        (e)              (e)              (e)              (e)              P=0.229         | 
|POLY 3             |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.256         | 
|POLY 1.5           |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.253         | 
|POLY 6             |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.251         | 
|LOGISTIC REGRESSION|        P=0.015 *        (e)              (e)              (e)              (e)              P=0.251         | 
|COCH-ARM / FISHERS |        P=0.011 *        (e)              (e)              (e)              (e)              P=0.248         | 
|ORDER RESTRICTED   |        P=0.011 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 43      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Turbinate, Septum                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        1/53 (2%)        1/53 (2%)        0/53 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          1/38.88          1/34.16          0/39.00          2/43.48         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             2.6%             2.9%             0.0%             4.6%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        1/19 (5%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              697              731 (T)          ---              561             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.139          (e)              P=0.500          P=0.445          (e)              P=0.273         | 
|POLY 3             |        P=0.135          (e)              P=0.497          P=0.471          (e)              P=0.259         | 
|POLY 1.5           |        P=0.128          (e)              P=0.495          P=0.483          (e)              P=0.255         | 
|POLY 6             |        P=0.138          (e)              P=0.498          P=0.456          (e)              P=0.256         | 
|LOGISTIC REGRESSION|        P=0.124          (e)              P=0.496          P=0.445          (e)              P=0.185         | 
|COCH-ARM / FISHERS |        P=0.110          (e)              P=0.500          P=0.500          (e)              P=0.248         | 
|ORDER RESTRICTED   |        P=0.075          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/2 (50%)        7/9 (78%)        14/16 (88%)      13/16 (81%)      15/22 (68%)      16/29 (55%)     | 
|POLY-3 RATE (b)    |        1/1.13           7/8.69           14/14.70         13/14.96         15/20.33         16/24.97        | 
|POLY-3 PERCENT (g) |        88.9%            80.5%            95.3%            86.9%            73.8%            64.1%           | 
|TERMINAL (d)       |        1/1 (100%)       4/5 (80%)        6/6 (100%)       2/3 (67%)        6/8 (75%)        6/9 (67%)       | 
|FIRST INCIDENCE    |        731 (T)          448              240              533              317              581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.128          P=0.172          P=0.006 **       P<0.001 **       P=0.007 **       P=0.007 **      | 
|POLY 3             |        P=0.011N*        P=0.804N         P=0.990          P=0.878N         P=0.732N         P=0.659N        | 
|POLY 1.5           |        P=0.010N*        P=0.797          P=0.820          P=0.788          P=0.789N         P=0.698N        | 
|POLY 6             |        P=0.022N*        P=0.787N         P=1.000N         P=0.860N         P=0.715N         P=0.670N        | 
|LOGISTIC REGRESSION|        P=0.009N**       P=0.606          P=0.587          P=0.703          P=0.682          P=0.723N        | 
|COCH-ARM / FISHERS |        P=0.016N*        P=0.491          P=0.314          P=0.405          P=0.565          P=0.708         | 
|ORDER RESTRICTED   |        P=0.729N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 44      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        49/51 (96%)      46/53 (87%)      50/53 (94%)      44/53 (83%)      50/53 (94%)      31/53 (58%)     | 
|POLY-3 RATE (b)    |        49/50.31         46/50.52         50/51.00         44/49.02         50/51.02         31/49.18        | 
|POLY-3 PERCENT (g) |        97.4%            91.1%            98.0%            89.8%            98.0%            63.0%           | 
|TERMINAL (d)       |        24/25 (96%)      20/21 (95%)      22/23 (96%)      17/19 (90%)      21/22 (96%)      11/21 (52%)     | 
|FIRST INCIDENCE    |        169              200              177              197              317              546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003N**       P=0.320          P=0.373          P=0.285          P=0.320          P=0.020N*       | 
|POLY 3             |        P<0.001N**       P=0.145N         P=0.681          P=0.098N         P=0.686          P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P=0.110N         P=0.622          P=0.069N         P=0.663          P<0.001N**      | 
|POLY 6             |        P<0.001N**       P=0.230N         P=0.735          P=0.163N         P=0.735          P<0.001N**      | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.091N         P=0.668N         P=0.046N*        P=0.551N         P<0.001N**      | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.090N         P=0.518N         P=0.030N*        P=0.518N         P<0.001N**      | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        14/51 (27%)      16/53 (30%)      13/53 (25%)      15/53 (28%)      14/53 (26%)      13/53 (25%)     | 
|POLY-3 RATE (b)    |        14/40.42         16/37.06         13/41.36         15/38.19         14/41.59         13/45.33        | 
|POLY-3 PERCENT (g) |        34.6%            43.2%            31.4%            39.3%            33.7%            28.7%           | 
|TERMINAL (d)       |        10/25 (40%)      9/21 (43%)       7/23 (30%)       8/19 (42%)       6/22 (27%)       7/21 (33%)      | 
|FIRST INCIDENCE    |        533              490              429              406              486              474             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.341N         P=0.215          P=0.556N         P=0.233          P=0.494          P=0.582N        | 
|POLY 3             |        P=0.178N         P=0.291          P=0.471N         P=0.422          P=0.557N         P=0.358N        | 
|POLY 1.5           |        P=0.212N         P=0.352          P=0.484N         P=0.472          P=0.553N         P=0.373N        | 
|POLY 6             |        P=0.179N         P=0.245          P=0.457N         P=0.362          P=0.560N         P=0.374N        | 
|LOGISTIC REGRESSION|        P=0.223N         P=0.256          P=0.497N         P=0.406          P=0.577N         P=0.400N        | 
|COCH-ARM / FISHERS |        P=0.356N         P=0.464          P=0.454N         P=0.549          P=0.540N         P=0.454N        | 
|ORDER RESTRICTED   |        P=0.275N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 45      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oviduct                                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/2 (100%)       1/1 (100%)       1/2 (50%)        0/0 (0%)         0/1 (0%)         1/1 (100%)      | 
|POLY-3 RATE (b)    |        2/2.00           1/1.00           1/2.00           0/0.00           0/0.61           1/1.00          | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           50.0%            0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        1/1 (100%)       0/0 (0%)         1/2 (50%)        0/0 (0%)         0/0 (0%)         1/1 (100%)      | 
|FIRST INCIDENCE    |        717              729              731 (T)          ---              ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.451N         (e)              P=0.330N         (e)              P=0.533N         (e)             | 
|POLY 3             |        (e)              (e)              P=0.500N         (e)              P=0.333N         (e)             | 
|POLY 1.5           |        (e)              (e)              P=0.500N         (e)              P=0.333N         (e)             | 
|POLY 6             |        (e)              (e)              P=0.500N         (e)              P=0.333N         (e)             | 
|LOGISTIC REGRESSION|        P=0.729          (e)              P=0.330N         (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.681N         (e)              P=0.500N         (e)              P=0.333N         (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/51 (0%)        0/54 (0%)        2/52 (4%)        2/53 (4%)        3/52 (6%)        6/51 (12%)      | 
|POLY-3 RATE (b)    |        0/38.86          0/34.61          2/38.64          2/35.09          3/39.79          6/42.58         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             5.2%             5.7%             7.5%             14.1%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        2/23 (9%)        0/19 (0%)        1/22 (5%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        ---              ---              731 (T)          578              396              581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       (e)              P=0.219          P=0.201          P=0.121          P=0.022 *       | 
|POLY 3             |        P=0.002 **       (e)              P=0.235          P=0.215          P=0.122          P=0.020 *       | 
|POLY 1.5           |        P<0.001 **       (e)              P=0.235          P=0.226          P=0.122          P=0.019 *       | 
|POLY 6             |        P=0.002 **       (e)              P=0.234          P=0.202          P=0.121          P=0.019 *       | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              P=0.219          P=0.256          P=0.128          P=0.015 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.252          P=0.257          P=0.125          P=0.013 *       | 
|ORDER RESTRICTED   |        P=0.003 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 46      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/51 (2%)        2/54 (4%)        4/52 (8%)        4/53 (8%)        4/52 (8%)        9/51 (18%)      | 
|POLY-3 RATE (b)    |        1/38.86          2/34.80          4/38.91          4/35.09          4/39.60          9/43.33         | 
|POLY-3 PERCENT (g) |        2.6%             5.8%             10.3%            11.4%            10.1%            20.8%           | 
|TERMINAL (d)       |        1/25 (4%)        1/21 (5%)        3/23 (13%)       2/19 (11%)       2/22 (9%)        3/21 (14%)      | 
|FIRST INCIDENCE    |        731 (T)          681              659              578              518              581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.005 **       P=0.434          P=0.158          P=0.118          P=0.164          P=0.012 *       | 
|POLY 3             |        P=0.004 **       P=0.461          P=0.177          P=0.147          P=0.183          P=0.013 *       | 
|POLY 1.5           |        P=0.003 **       P=0.485          P=0.176          P=0.164          P=0.183          P=0.011 *       | 
|POLY 6             |        P=0.005 **       P=0.439          P=0.177          P=0.130          P=0.181          P=0.013 *       | 
|LOGISTIC REGRESSION|        P=0.003 **       P=0.428          P=0.173          P=0.147          P=0.183          P=0.010 *       | 
|COCH-ARM / FISHERS |        P=0.002 **       P=0.522          P=0.187          P=0.194          P=0.187          P=0.008 **      | 
|ORDER RESTRICTED   |        P=0.003 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/51 (4%)        0/54 (0%)        0/52 (0%)        1/53 (2%)        2/52 (4%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        2/39.17          0/34.61          0/38.64          1/34.16          2/38.45          0/40.86         | 
|POLY-3 PERCENT (g) |        5.1%             0.0%             0.0%             2.9%             5.2%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        0/23 (0%)        1/19 (5%)        2/22 (9%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        646              ---              ---              731 (T)          731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.459N         P=0.299N         P=0.262N         P=0.613N         P=0.655          P=0.262N        | 
|POLY 3             |        P=0.389N         P=0.265N         P=0.240N         P=0.548N         P=0.688          P=0.227N        | 
|POLY 1.5           |        P=0.405N         P=0.248N         P=0.240N         P=0.522N         P=0.693          P=0.227N        | 
|POLY 6             |        P=0.385N         P=0.285N         P=0.241N         P=0.579N         P=0.679          P=0.236N        | 
|LOGISTIC REGRESSION|        P=0.427N         P=0.263N         P=0.238N         P=0.571N         P=0.685          P=0.228N        | 
|COCH-ARM / FISHERS |        P=0.457N         P=0.234N         P=0.243N         P=0.485N         P=0.684N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.086N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 47      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/51 (2%)        0/54 (0%)        0/52 (0%)        1/53 (2%)        15/52 (29%)      42/51 (82%)     | 
|POLY-3 RATE (b)    |        1/39.16          0/34.61          0/38.64          1/34.16          15/39.85         42/47.15        | 
|POLY-3 PERCENT (g) |        2.6%             0.0%             0.0%             2.9%             37.7%            89.1%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        1/19 (5%)        11/22 (50%)      21/21 (100%)    | 
|FIRST INCIDENCE    |        648              ---              ---              731 (T)          486              546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.561N         P=0.506N         P=0.690          P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.525N         P=0.503N         P=0.730          P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.510N         P=0.503N         P=0.746          P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.540N         P=0.504N         P=0.708          P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.502N         P=0.498N         P=0.732          P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.486N         P=0.495N         P=0.743N         P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/51 (0%)        1/54 (2%)        1/52 (2%)        2/53 (4%)        2/52 (4%)        7/51 (14%)      | 
|POLY-3 RATE (b)    |        0/38.86          1/35.59          1/38.64          2/34.16          2/38.45          7/42.11         | 
|POLY-3 PERCENT (g) |        0.0%             2.8%             2.6%             5.9%             5.2%             16.6%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        1/23 (4%)        2/19 (11%)       2/22 (9%)        4/21 (19%)      | 
|FIRST INCIDENCE    |        ---              200              731 (T)          731 (T)          731 (T)          581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.511          P=0.483          P=0.179          P=0.210          P=0.009 **      | 
|POLY 3             |        P<0.001 **       P=0.482          P=0.499          P=0.209          P=0.234          P=0.010 *       | 
|POLY 1.5           |        P<0.001 **       P=0.495          P=0.498          P=0.224          P=0.237          P=0.010 *       | 
|POLY 6             |        P<0.001 **       P=0.469          P=0.498          P=0.193          P=0.229          P=0.009 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.380          P=0.483          P=0.179          P=0.210          P=0.011 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.514          P=0.505          P=0.257          P=0.252          P=0.006 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 48      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        25/53 (47%)      18/54 (33%)      25/52 (48%)      20/53 (38%)      21/53 (40%)      9/52 (17%)      | 
|POLY-3 RATE (b)    |        25/42.71         18/37.45         25/40.65         20/37.33         21/41.42         9/43.32         | 
|POLY-3 PERCENT (g) |        58.5%            48.1%            61.5%            53.6%            50.7%            20.8%           | 
|TERMINAL (d)       |        14/25 (56%)      11/21 (52%)      13/23 (57%)      12/19 (63%)      11/22 (50%)      4/21 (19%)      | 
|FIRST INCIDENCE    |        474              557              550              453              578              647             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002N**       P=0.385N         P=0.478          P=0.489          P=0.435N         P=0.005N**      | 
|POLY 3             |        P<0.001N**       P=0.228N         P=0.478          P=0.408N         P=0.300N         P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P=0.164N         P=0.470          P=0.315N         P=0.288N         P<0.001N**      | 
|POLY 6             |        P<0.001N**       P=0.307N         P=0.487          P=0.540N         P=0.325N         P<0.001N**      | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.266N         P=0.507          P=0.455N         P=0.282N         P<0.001N**      | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.103N         P=0.541          P=0.216N         P=0.278N         P<0.001N**      | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        1/52 (2%)        4/53 (8%)        3/53 (6%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        1/39.55          0/34.61          1/38.01          4/34.87          3/39.38          0/42.44         | 
|POLY-3 PERCENT (g) |        2.5%             0.0%             2.6%             11.5%            7.6%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        1/23 (4%)        3/19 (16%)       2/22 (9%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        731 (T)          ---              731 (T)          485              621              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.476N         P=0.535N         P=0.744          P=0.115          P=0.270          P=0.535N        | 
|POLY 3             |        P=0.373N         P=0.527N         P=0.753          P=0.141          P=0.303          P=0.486N        | 
|POLY 1.5           |        P=0.395N         P=0.514N         P=0.750          P=0.156          P=0.304          P=0.489N        | 
|POLY 6             |        P=0.374N         P=0.539N         P=0.754          P=0.123          P=0.299          P=0.490N        | 
|LOGISTIC REGRESSION|        P=0.412N         (e)              P=0.744          P=0.136          P=0.294          (e)             | 
|COCH-ARM / FISHERS |        P=0.475N         P=0.495N         P=0.748          P=0.181          P=0.309          P=0.505N        | 
|ORDER RESTRICTED   |        P=0.207N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 49      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        3/54 (6%)        1/52 (2%)        2/53 (4%)        2/53 (4%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        0/39.55          3/34.91          1/38.01          2/34.57          2/39.47          0/42.44         | 
|POLY-3 PERCENT (g) |        0.0%             8.6%             2.6%             5.8%             5.1%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        2/21 (10%)       1/23 (4%)        0/19 (0%)        1/22 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              647              731 (T)          645              589              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.262N         P=0.087          P=0.483          P=0.170          P=0.228          (e)             | 
|POLY 3             |        P=0.239N         P=0.097          P=0.492          P=0.208          P=0.236          (e)             | 
|POLY 1.5           |        P=0.243N         P=0.107          P=0.491          P=0.219          P=0.237          (e)             | 
|POLY 6             |        P=0.249N         P=0.088          P=0.493          P=0.195          P=0.234          (e)             | 
|LOGISTIC REGRESSION|        P=0.235N         P=0.088          P=0.483          P=0.208          P=0.237          (e)             | 
|COCH-ARM / FISHERS |        P=0.276N         P=0.125          P=0.495          P=0.248          P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.239N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        19/53 (36%)      19/54 (35%)      16/52 (31%)      21/53 (40%)      26/53 (49%)      19/52 (37%)     | 
|POLY-3 RATE (b)    |        19/43.37         19/41.40         16/40.26         21/39.02         26/42.48         19/46.73        | 
|POLY-3 PERCENT (g) |        43.8%            45.9%            39.7%            53.8%            61.2%            40.7%           | 
|TERMINAL (d)       |        11/25 (44%)      5/21 (24%)       10/23 (44%)      10/19 (53%)      15/22 (68%)      8/21 (38%)      | 
|FIRST INCIDENCE    |        487              264              578              453              486              581             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.442          P=0.370          P=0.411N         P=0.152          P=0.076          P=0.515         | 
|POLY 3             |        P=0.478N         P=0.510          P=0.437N         P=0.239          P=0.072          P=0.464N        | 
|POLY 1.5           |        P=0.530          P=0.547          P=0.431N         P=0.303          P=0.087          P=0.494N        | 
|POLY 6             |        P=0.455N         P=0.492          P=0.443N         P=0.186          P=0.058          P=0.460N        | 
|LOGISTIC REGRESSION|        P=0.503          P=0.548          P=0.393N         P=0.283          P=0.103          P=0.566N        | 
|COCH-ARM / FISHERS |        P=0.300          P=0.552N         P=0.365N         P=0.421          P=0.119          P=0.551         | 
|ORDER RESTRICTED   |        P=0.362          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 50      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Intermedia                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        0/52 (0%)        0/53 (0%)        1/53 (2%)        1/52 (2%)       | 
|POLY-3 RATE (b)    |        2/40.18          0/34.61          0/38.01          0/34.16          1/39.55          1/42.44         | 
|POLY-3 PERCENT (g) |        5.0%             0.0%             0.0%             0.0%             2.5%             2.4%            | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        526              ---              ---              ---              557              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.529          P=0.264N         P=0.244N         P=0.278N         P=0.506N         P=0.521N        | 
|POLY 3             |        P=0.581          P=0.271N         P=0.249N         P=0.274N         P=0.505N         P=0.481N        | 
|POLY 1.5           |        P=0.560          P=0.255N         P=0.250N         P=0.259N         P=0.503N         P=0.483N        | 
|POLY 6             |        P=0.590          P=0.289N         P=0.249N         P=0.295N         P=0.511N         P=0.491N        | 
|LOGISTIC REGRESSION|        P=0.512          P=0.236N         P=0.242N         P=0.240N         P=0.498N         P=0.501N        | 
|COCH-ARM / FISHERS |        P=0.504          P=0.243N         P=0.252N         P=0.248N         P=0.500N         P=0.507N        | 
|ORDER RESTRICTED   |        P=0.130N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/51 (0%)        0/54 (0%)        0/52 (0%)        2/50 (4%)        1/51 (2%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        0/38.56          0/34.61          0/37.95          2/33.80          1/37.86          0/41.66         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.9%             2.6%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        1/19 (5%)        1/22 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              626              731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.662N         (e)              (e)              P=0.182          P=0.475          (e)             | 
|POLY 3             |        P=0.633N         (e)              (e)              P=0.208          P=0.496          (e)             | 
|POLY 1.5           |        P=0.639N         (e)              (e)              P=0.218          P=0.498          (e)             | 
|POLY 6             |        P=0.641N         (e)              (e)              P=0.195          P=0.493          (e)             | 
|LOGISTIC REGRESSION|        P=0.638N         (e)              (e)              P=0.209          P=0.475          (e)             | 
|COCH-ARM / FISHERS |        P=0.672N         (e)              (e)              P=0.243          P=0.500          (e)             | 
|ORDER RESTRICTED   |        P=0.251          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 51      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/51 (0%)        0/54 (0%)        2/52 (4%)        3/50 (6%)        0/51 (0%)        1/52 (2%)       | 
|POLY-3 RATE (b)    |        0/38.56          0/34.61          2/38.95          3/33.80          0/37.86          1/42.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             5.1%             8.9%             0.0%             2.4%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        1/23 (4%)        2/19 (11%)       0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              54               626              ---              598             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.618          (e)              P=0.229          P=0.079          (e)              P=0.536         | 
|POLY 3             |        P=0.604N         (e)              P=0.239          P=0.095          (e)              P=0.518         | 
|POLY 1.5           |        P=0.616N         (e)              P=0.238          P=0.103          (e)              P=0.516         | 
|POLY 6             |        P=0.604N         (e)              P=0.238          P=0.086          (e)              P=0.512         | 
|LOGISTIC REGRESSION|        P=0.558          (e)              P=0.311          P=0.089          (e)              P=0.465         | 
|COCH-ARM / FISHERS |        P=0.600          (e)              P=0.252          P=0.118          (e)              P=0.505         | 
|ORDER RESTRICTED   |        P=0.221          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Cyst Epithelial Inclusion                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        1/39.55          0/34.61          0/38.75          0/34.16          0/39.00          2/42.83         | 
|POLY-3 PERCENT (g) |        2.5%             0.0%             0.0%             0.0%             0.0%             4.7%            | 
|TERMINAL (d)       |        1/25 (4%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        731 (T)          ---              ---              ---              ---              668             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.085          P=0.535N         P=0.517N         P=0.555N         P=0.525N         P=0.456         | 
|POLY 3             |        P=0.100          P=0.527N         P=0.504N         P=0.529N         P=0.503N         P=0.528         | 
|POLY 1.5           |        P=0.095          P=0.514N         P=0.505N         P=0.517N         P=0.501N         P=0.524         | 
|POLY 6             |        P=0.103          P=0.539N         P=0.503N         P=0.544N         P=0.506N         P=0.521         | 
|LOGISTIC REGRESSION|        P=0.104          (e)              (e)              (e)              (e)              P=0.511         | 
|COCH-ARM / FISHERS |        P=0.083          P=0.495N         P=0.500N         P=0.500N         P=0.500N         P=0.500         | 
|ORDER RESTRICTED   |        P=0.067          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 52      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        2/53 (4%)        0/53 (0%)        0/53 (0%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          2/39.74          0/34.16          0/39.00          1/42.66         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             5.0%             0.0%             0.0%             2.3%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        1/23 (4%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              54               ---              ---              716             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.478          (e)              P=0.229          (e)              (e)              P=0.492         | 
|POLY 3             |        P=0.536          (e)              P=0.238          (e)              (e)              P=0.515         | 
|POLY 1.5           |        P=0.519          (e)              P=0.236          (e)              (e)              P=0.513         | 
|POLY 6             |        P=0.545          (e)              P=0.239          (e)              (e)              P=0.511         | 
|LOGISTIC REGRESSION|        P=0.383          (e)              P=0.305          (e)              (e)              P=0.501         | 
|COCH-ARM / FISHERS |        P=0.482          (e)              P=0.248          (e)              (e)              P=0.500         | 
|ORDER RESTRICTED   |        P=0.297          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        46/51 (90%)      50/54 (93%)      38/53 (72%)      42/53 (79%)      44/52 (85%)      43/52 (83%)     | 
|POLY-3 RATE (b)    |        46/47.32         50/52.86         38/45.09         42/46.12         44/49.47         43/50.03        | 
|POLY-3 PERCENT (g) |        97.2%            94.6%            84.3%            91.1%            88.9%            86.0%           | 
|TERMINAL (d)       |        25/25 (100%)     20/21 (95%)      21/23 (91%)      18/19 (95%)      20/22 (91%)      20/21 (95%)     | 
|FIRST INCIDENCE    |        185              200              47               338              141              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.269N         P=0.069          P=0.222N         P=0.205          P=0.479          P=0.555         | 
|POLY 3             |        P=0.053N         P=0.429N         P=0.017N*        P=0.149N         P=0.087N         P=0.032N*       | 
|POLY 1.5           |        P=0.093N         P=0.559N         P=0.017N*        P=0.129N         P=0.134N         P=0.059N        | 
|POLY 6             |        P=0.041N*        P=0.323N         P=0.017N*        P=0.185N         P=0.058N         P=0.023N*       | 
|LOGISTIC REGRESSION|        P=0.127N         P=0.347          P=0.024N*        P=0.231N         P=0.317N         P=0.085N        | 
|COCH-ARM / FISHERS |        P=0.355N         P=0.463          P=0.015N*        P=0.100N         P=0.290N         P=0.206N        | 
|ORDER RESTRICTED   |        P=0.023N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 53      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/51 (2%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/52 (0%)        4/52 (8%)       | 
|POLY-3 RATE (b)    |        1/39.45          0/34.61          0/38.75          0/34.16          0/38.45          4/42.29         | 
|POLY-3 PERCENT (g) |        2.5%             0.0%             0.0%             0.0%             0.0%             9.5%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        645              ---              ---              ---              ---              641             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       P=0.576N         P=0.522N         P=0.584N         P=0.511N         P=0.161         | 
|POLY 3             |        P=0.002 **       P=0.526N         P=0.504N         P=0.529N         P=0.505N         P=0.199         | 
|POLY 1.5           |        P=0.002 **       P=0.511N         P=0.502N         P=0.514N         P=0.502N         P=0.200         | 
|POLY 6             |        P=0.002 **       P=0.542N         P=0.506N         P=0.546N         P=0.510N         P=0.189         | 
|LOGISTIC REGRESSION|        P=0.003 **       P=0.500N         P=0.495N         P=0.503N         P=0.497N         P=0.195         | 
|COCH-ARM / FISHERS |        P=0.002 **       P=0.486N         P=0.490N         P=0.490N         P=0.495N         P=0.187         | 
|ORDER RESTRICTED   |        P=0.003 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        45/51 (88%)      49/54 (91%)      49/53 (92%)      51/53 (96%)      49/52 (94%)      47/52 (90%)     | 
|POLY-3 RATE (b)    |        45/49.73         49/50.86         49/50.96         51/52.36         49/50.80         47/50.25        | 
|POLY-3 PERCENT (g) |        90.5%            96.3%            96.2%            97.4%            96.5%            93.5%           | 
|TERMINAL (d)       |        23/25 (92%)      20/21 (95%)      23/23 (100%)     18/19 (95%)      21/22 (96%)      21/21 (100%)    | 
|FIRST INCIDENCE    |        169              241              47               53               141              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.360N         P=0.076          P=0.226          P=0.021 *        P=0.192          P=0.287         | 
|POLY 3             |        P=0.552N         P=0.193          P=0.203          P=0.125          P=0.193          P=0.415         | 
|POLY 1.5           |        P=0.532N         P=0.246          P=0.238          P=0.118          P=0.175          P=0.454         | 
|POLY 6             |        P=0.552          P=0.191          P=0.171          P=0.158          P=0.243          P=0.335         | 
|LOGISTIC REGRESSION|        P=0.503N         P=0.395          P=0.333          P=0.148          P=0.228          P=0.496         | 
|COCH-ARM / FISHERS |        P=0.534          P=0.459          P=0.346          P=0.123          P=0.234          P=0.486         | 
|ORDER RESTRICTED   |        P=0.125          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 54      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/51 (8%)        0/54 (0%)        1/53 (2%)        0/53 (0%)        1/52 (2%)        1/52 (2%)       | 
|POLY-3 RATE (b)    |        4/42.10          0/34.61          1/39.74          0/34.16          1/38.63          1/41.88         | 
|POLY-3 PERCENT (g) |        9.5%             0.0%             2.5%             0.0%             2.6%             2.4%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        169              ---              47               ---              683              667             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.348N         P=0.083N         P=0.202N         P=0.085N         P=0.195N         P=0.173N        | 
|POLY 3             |        P=0.300N         P=0.089N         P=0.196N         P=0.092N         P=0.205N         P=0.179N        | 
|POLY 1.5           |        P=0.325N         P=0.074N         P=0.189N         P=0.076N         P=0.194N         P=0.173N        | 
|POLY 6             |        P=0.282N         P=0.107N         P=0.203N         P=0.112N         P=0.216N         P=0.194N        | 
|LOGISTIC REGRESSION|        P=0.592N         P=0.022N*        P=0.042N*        P=0.022N*        P=0.138N         P=0.441N        | 
|COCH-ARM / FISHERS |        P=0.383N         P=0.052N         P=0.170N         P=0.054N         P=0.175N         P=0.175N        | 
|ORDER RESTRICTED   |        P=0.017N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/54 (2%)        1/53 (2%)        1/53 (2%)        2/53 (4%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        1/40.16          1/35.30          1/39.74          1/34.87          2/39.36          3/43.51         | 
|POLY-3 PERCENT (g) |        2.5%             2.8%             2.5%             2.9%             5.1%             6.9%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        533              492              54               485              659              546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.140          P=0.747          P=0.755N         P=0.745          P=0.493          P=0.331         | 
|POLY 3             |        P=0.140          P=0.732          P=0.759          P=0.729          P=0.493          P=0.334         | 
|POLY 1.5           |        P=0.131          P=0.745          P=0.758          P=0.742          P=0.496          P=0.330         | 
|POLY 6             |        P=0.141          P=0.717          P=0.759          P=0.711          P=0.487          P=0.327         | 
|LOGISTIC REGRESSION|        P=0.048 *        P=0.728N         P=0.644N         P=0.731N         P=0.500          P=0.249         | 
|COCH-ARM / FISHERS |        P=0.104          P=0.748N         P=0.752N         P=0.752N         P=0.500          P=0.309         | 
|ORDER RESTRICTED   |        P=0.247          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 55      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        4/54 (7%)        4/53 (8%)        2/53 (4%)        7/53 (13%)       11/53 (21%)     | 
|POLY-3 RATE (b)    |        3/39.67          4/35.31          4/39.80          2/34.96          7/40.91          11/45.30        | 
|POLY-3 PERCENT (g) |        7.6%             11.3%            10.1%            5.7%             17.1%            24.3%           | 
|TERMINAL (d)       |        2/25 (8%)        2/21 (10%)       2/23 (9%)        0/19 (0%)        2/22 (9%)        3/21 (14%)      | 
|FIRST INCIDENCE    |        701              492              54               485              486              546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       P=0.417          P=0.476          P=0.605N         P=0.138          P=0.025 *       | 
|POLY 3             |        P=0.003 **       P=0.436          P=0.502          P=0.558N         P=0.167          P=0.035 *       | 
|POLY 1.5           |        P=0.002 **       P=0.466          P=0.497          P=0.534N         P=0.163          P=0.031 *       | 
|POLY 6             |        P=0.004 **       P=0.405          P=0.505          P=0.587N         P=0.168          P=0.037 *       | 
|LOGISTIC REGRESSION|        P=0.002 **       P=0.415          P=0.500          P=0.552N         P=0.156          P=0.027 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.511          P=0.500          P=0.500N         P=0.160          P=0.021 *       | 
|ORDER RESTRICTED   |        P=0.011 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/54 (2%)        2/53 (4%)        0/53 (0%)        2/53 (4%)        5/53 (9%)       | 
|POLY-3 RATE (b)    |        1/40.42          1/34.62          2/39.31          0/34.16          2/39.91          5/44.24         | 
|POLY-3 PERCENT (g) |        2.5%             2.9%             5.1%             0.0%             5.0%             11.3%           | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        366              729              578              ---              486              546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.021 *        P=0.744          P=0.508          P=0.496N         P=0.496          P=0.128         | 
|POLY 3             |        P=0.019 *        P=0.725          P=0.490          P=0.533N         P=0.496          P=0.122         | 
|POLY 1.5           |        P=0.016 *        P=0.741          P=0.488          P=0.520N         P=0.497          P=0.119         | 
|POLY 6             |        P=0.020 *        P=0.708          P=0.493          P=0.549N         P=0.493          P=0.120         | 
|LOGISTIC REGRESSION|        P=0.009 **       P=0.736N         P=0.526          P=0.436N         P=0.507          P=0.048 *       | 
|COCH-ARM / FISHERS |        P=0.012 *        P=0.748N         P=0.500          P=0.500N         P=0.500          P=0.103         | 
|ORDER RESTRICTED   |        P=0.032 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 56      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        0/53 (0%)        1/53 (2%)        1/53 (2%)        4/53 (8%)       | 
|POLY-3 RATE (b)    |        2/40.54          1/34.62          0/38.75          1/34.87          1/39.20          4/43.49         | 
|POLY-3 PERCENT (g) |        4.9%             2.9%             0.0%             2.9%             2.6%             9.2%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        366              729              ---              485              677              598             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.063          P=0.540N         P=0.247N         P=0.541N         P=0.512N         P=0.342         | 
|POLY 3             |        P=0.062          P=0.555N         P=0.247N         P=0.552N         P=0.512N         P=0.369         | 
|POLY 1.5           |        P=0.058          P=0.531N         P=0.247N         P=0.531N         P=0.507N         P=0.365         | 
|POLY 6             |        P=0.063          P=0.580N         P=0.248N         P=0.578N         P=0.519N         P=0.361         | 
|LOGISTIC REGRESSION|        P=0.044 *        P=0.482N         P=0.213N         P=0.450N         P=0.497N         P=0.286         | 
|COCH-ARM / FISHERS |        P=0.046 *        P=0.493N         P=0.248N         P=0.500N         P=0.500N         P=0.339         | 
|ORDER RESTRICTED   |        P=0.081          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        0/54 (0%)        0/53 (0%)        1/53 (2%)        3/53 (6%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        3/41.09          0/34.61          0/38.75          1/34.37          3/40.69          0/42.60         | 
|POLY-3 PERCENT (g) |        7.3%             0.0%             0.0%             2.9%             7.4%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        169              ---              ---              675              141              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.361N         P=0.166N         P=0.139N         P=0.400N         P=0.657          P=0.129N        | 
|POLY 3             |        P=0.309N         P=0.152N         P=0.129N         P=0.371N         P=0.659          P=0.112N        | 
|POLY 1.5           |        P=0.330N         P=0.137N         P=0.128N         P=0.345N         P=0.661          P=0.112N        | 
|POLY 6             |        P=0.303N         P=0.170N         P=0.131N         P=0.404N         P=0.653          P=0.118N        | 
|LOGISTIC REGRESSION|        P=0.522N         P=0.088N         P=0.089N         P=0.262N         P=0.658N         P=0.229N        | 
|COCH-ARM / FISHERS |        P=0.398N         P=0.118N         P=0.121N         P=0.309N         P=0.661N         P=0.121N        | 
|ORDER RESTRICTED   |        P=0.028N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 57      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/39.55          0/34.61          0/38.75          0/34.16          0/39.00          2/43.18         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             4.6%            | 
|TERMINAL (d)       |        0/25 (0%)        0/21 (0%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              604             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.017 *        (e)              (e)              (e)              (e)              P=0.247         | 
|POLY 3             |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.257         | 
|POLY 1.5           |        P=0.012 *        (e)              (e)              (e)              (e)              P=0.254         | 
|POLY 6             |        P=0.013 *        (e)              (e)              (e)              (e)              P=0.254         | 
|LOGISTIC REGRESSION|        P=0.012 *        (e)              (e)              (e)              (e)              P=0.230         | 
|COCH-ARM / FISHERS |        P=0.011 *        (e)              (e)              (e)              (e)              P=0.248         | 
|ORDER RESTRICTED   |        P=0.011 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        36/51 (71%)      41/52 (79%)      44/52 (85%)      41/49 (84%)      44/46 (96%)      42/42 (100%)    | 
|POLY-3 RATE (b)    |        36/45.37         41/45.88         44/48.28         41/43.55         44/44.09         42/42.00        | 
|POLY-3 PERCENT (g) |        79.3%            89.4%            91.1%            94.2%            99.8%            100.0%          | 
|TERMINAL (d)       |        20/25 (80%)      17/20 (85%)      21/23 (91%)      18/18 (100%)     20/20 (100%)     18/18 (100%)    | 
|FIRST INCIDENCE    |        169              264              47               338              185              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.279          P=0.056          P=0.092          P=0.018 *        P=0.038 *        P=0.055         | 
|POLY 3             |        P<0.001 **       P=0.128          P=0.073          P=0.024 *        P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.148          P=0.058          P=0.032 *        P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.144          P=0.105          P=0.021 *        P=0.002 **       P=0.002 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.136          P=0.050          P=0.041 *        P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.231          P=0.070          P=0.094          P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 58      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        1/54 (2%)        1/53 (2%)        1/51 (2%)        4/53 (8%)        1/52 (2%)       | 
|POLY-3 RATE (b)    |        0/38.90          1/34.61          1/38.75          1/33.58          4/39.18          1/41.66         | 
|POLY-3 PERCENT (g) |        0.0%             2.9%             2.6%             3.0%             10.2%            2.4%            | 
|TERMINAL (d)       |        0/25 (0%)        1/21 (5%)        1/23 (4%)        1/19 (5%)        3/22 (14%)       1/21 (5%)       | 
|FIRST INCIDENCE    |        ---              731 (T)          731 (T)          731 (T)          683              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.277          P=0.465          P=0.483          P=0.445          P=0.050          P=0.465         | 
|POLY 3             |        P=0.375          P=0.477          P=0.499          P=0.471          P=0.060          P=0.514         | 
|POLY 1.5           |        P=0.360          P=0.489          P=0.498          P=0.481          P=0.062          P=0.513         | 
|POLY 6             |        P=0.365          P=0.463          P=0.499          P=0.457          P=0.057          P=0.508         | 
|LOGISTIC REGRESSION|        P=0.310          P=0.465          P=0.483          P=0.445          P=0.054          P=0.465         | 
|COCH-ARM / FISHERS |        P=0.296          P=0.509          P=0.505          P=0.495          P=0.061          P=0.500         | 
|ORDER RESTRICTED   |        P=0.095          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        19/52 (37%)      17/54 (31%)      22/53 (42%)      19/51 (37%)      16/53 (30%)      23/52 (44%)     | 
|POLY-3 RATE (b)    |        19/40.39         17/38.91         22/41.52         19/37.61         16/42.50         23/45.63        | 
|POLY-3 PERCENT (g) |        47.0%            43.7%            53.0%            50.5%            37.7%            50.4%           | 
|TERMINAL (d)       |        12/25 (48%)      9/21 (43%)       15/23 (65%)      9/19 (47%)       7/22 (32%)       11/21 (52%)     | 
|FIRST INCIDENCE    |        646              241              177              380              341              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.300          P=0.475          P=0.249          P=0.220          P=0.465N         P=0.185         | 
|POLY 3             |        P=0.504          P=0.470N         P=0.371          P=0.467          P=0.255N         P=0.461         | 
|POLY 1.5           |        P=0.421          P=0.420N         P=0.360          P=0.502          P=0.273N         P=0.415         | 
|POLY 6             |        P=0.544          P=0.531N         P=0.358          P=0.419          P=0.253N         P=0.461         | 
|LOGISTIC REGRESSION|        P=0.426          P=0.558N         P=0.331          P=0.345          P=0.325N         P=0.375         | 
|COCH-ARM / FISHERS |        P=0.232          P=0.365N         P=0.374          P=0.551          P=0.315N         P=0.275         | 
|ORDER RESTRICTED   |        P=0.565          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 59      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/52 (4%)        2/54 (4%)        0/53 (0%)        0/51 (0%)        0/53 (0%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        2/38.90          2/35.51          0/38.75          0/33.58          0/39.00          0/41.66         | 
|POLY-3 PERCENT (g) |        5.1%             5.6%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        2/25 (8%)        1/21 (5%)        0/23 (0%)        0/19 (0%)        0/22 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        731 (T)          341              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.108N         P=0.645          P=0.256N         P=0.300N         P=0.266N         P=0.277N        | 
|POLY 3             |        P=0.100N         P=0.662          P=0.237N         P=0.271N         P=0.236N         P=0.222N        | 
|POLY 1.5           |        P=0.099N         P=0.681          P=0.239N         P=0.258N         P=0.234N         P=0.223N        | 
|POLY 6             |        P=0.101N         P=0.639          P=0.237N         P=0.288N         P=0.240N         P=0.228N        | 
|LOGISTIC REGRESSION|        P=0.100N         P=0.694N         (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.103N         P=0.677N         P=0.243N         P=0.252N         P=0.243N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.042N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/52 (6%)        4/54 (7%)        4/53 (8%)        7/51 (14%)       10/53 (19%)      17/52 (33%)     | 
|POLY-3 RATE (b)    |        3/39.78          4/35.62          4/40.05          7/35.23          10/40.94         17/45.27        | 
|POLY-3 PERCENT (g) |        7.5%             11.2%            10.0%            19.9%            24.4%            37.6%           | 
|TERMINAL (d)       |        2/25 (8%)        2/21 (10%)       2/23 (9%)        3/19 (16%)       6/22 (27%)       9/21 (43%)      | 
|FIRST INCIDENCE    |        361              485              429              578              444              396             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.418          P=0.472          P=0.085          P=0.027 *        P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.439          P=0.504          P=0.108          P=0.036 *        P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.471          P=0.498          P=0.122          P=0.037 *        P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.409          P=0.508          P=0.094          P=0.034 *        P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.506          P=0.517          P=0.134          P=0.040 *        P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.521          P=0.511          P=0.151          P=0.039 *        P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 60      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/16 (94%)      16/16 (100%)     12/12 (100%)     13/13 (100%)     14/14 (100%)     18/18 (100%)    | 
|POLY-3 RATE (b)    |        15/15.64         16/16.00         12/12.00         13/13.00         14/14.00         18/18.00        | 
|POLY-3 PERCENT (g) |        95.9%            100.0%           100.0%           100.0%           100.0%           100.0%          | 
|TERMINAL (d)       |        9/9 (100%)       9/9 (100%)       5/5 (100%)       4/4 (100%)       6/6 (100%)       8/8 (100%)      | 
|FIRST INCIDENCE    |        185              449              429              53               317              599             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.315          P=0.337          P=0.479          P=0.186          P=0.376          P=0.232         | 
|POLY 3             |        P=0.605          P=0.705          P=0.752          P=0.739          P=0.727          P=0.685         | 
|POLY 1.5           |        P=0.515          P=0.595          P=0.649          P=0.634          P=0.620          P=0.572         | 
|POLY 6             |        P=0.815          P=0.915          P=0.935          P=0.930          P=0.925          P=0.907         | 
|LOGISTIC REGRESSION|        P=0.445          P=0.501          P=0.554          P=0.546          P=0.523          P=0.500         | 
|COCH-ARM / FISHERS |        P=0.440          P=0.500          P=0.571          P=0.552          P=0.533          P=0.471         | 
|ORDER RESTRICTED   |        P=0.048 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/52 (12%)       10/53 (19%)      4/53 (8%)        0/52 (0%)        8/53 (15%)       3/53 (6%)       | 
|POLY-3 RATE (b)    |        6/39.16          10/37.73         4/39.66          0/33.80          8/42.02          3/42.71         | 
|POLY-3 PERCENT (g) |        15.3%            26.5%            10.1%            0.0%             19.0%            7.0%            | 
|TERMINAL (d)       |        4/25 (16%)       5/21 (24%)       2/23 (9%)        0/19 (0%)        4/22 (18%)       2/21 (10%)      | 
|FIRST INCIDENCE    |        697              341              578              ---              141              701             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.180N         P=0.141          P=0.398N         P=0.041N*        P=0.325          P=0.315N        | 
|POLY 3             |        P=0.109N         P=0.174          P=0.359N         P=0.024N*        P=0.441          P=0.198N        | 
|POLY 1.5           |        P=0.119N         P=0.192          P=0.368N         P=0.020N*        P=0.435          P=0.202N        | 
|POLY 6             |        P=0.115N         P=0.157          P=0.352N         P=0.030N*        P=0.435          P=0.210N        | 
|LOGISTIC REGRESSION|        P=0.168N         P=0.184          P=0.372N         P=0.036N*        P=0.404          P=0.251N        | 
|COCH-ARM / FISHERS |        P=0.172N         P=0.220          P=0.359N         P=0.013N*        P=0.402          P=0.235N        | 
|ORDER RESTRICTED   |        P=0.039N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 61      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder: Transitional Epithelium                                                                                         | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/52 (2%)        2/53 (4%)        1/53 (2%)        0/52 (0%)        6/53 (11%)       2/53 (4%)       | 
|POLY-3 RATE (b)    |        1/38.97          2/35.07          1/38.75          0/33.80          6/40.81          2/42.71         | 
|POLY-3 PERCENT (g) |        2.6%             5.7%             2.6%             0.0%             14.7%            4.7%            | 
|TERMINAL (d)       |        1/25 (4%)        1/21 (5%)        1/23 (4%)        0/19 (0%)        3/22 (14%)       1/21 (5%)       | 
|FIRST INCIDENCE    |        731 (T)          341              731 (T)          ---              185              701             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.194          P=0.457          P=0.744          P=0.555N         P=0.053          P=0.455         | 
|POLY 3             |        P=0.266          P=0.463          P=0.760          P=0.528N         P=0.062          P=0.532         | 
|POLY 1.5           |        P=0.251          P=0.481          P=0.759          P=0.517N         P=0.062          P=0.529         | 
|POLY 6             |        P=0.260          P=0.444          P=0.760          P=0.543N         P=0.060          P=0.523         | 
|LOGISTIC REGRESSION|        P=0.196          P=0.517          P=0.744          (e)              P=0.062          P=0.492         | 
|COCH-ARM / FISHERS |        P=0.195          P=0.507          P=0.748N         P=0.500N         P=0.059          P=0.507         | 
|ORDER RESTRICTED   |        P=0.113          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/52 (13%)       6/53 (11%)       12/53 (23%)      9/53 (17%)       11/53 (21%)      5/53 (9%)       | 
|POLY-3 RATE (b)    |        7/40.38          6/35.29          12/42.83         9/36.87          11/43.62         5/43.72         | 
|POLY-3 PERCENT (g) |        17.3%            17.0%            28.0%            24.4%            25.2%            11.4%           | 
|TERMINAL (d)       |        4/25 (16%)       3/21 (14%)       4/23 (17%)       3/19 (16%)       2/22 (9%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        185              556              348              416              141              604             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.227N         P=0.613N         P=0.152          P=0.223          P=0.204          P=0.430N        | 
|POLY 3             |        P=0.138N         P=0.605N         P=0.182          P=0.313          P=0.269          P=0.322N        | 
|POLY 1.5           |        P=0.162N         P=0.562N         P=0.163          P=0.346          P=0.255          P=0.329N        | 
|POLY 6             |        P=0.137N         P=0.594          P=0.204          P=0.278          P=0.282          P=0.334N        | 
|LOGISTIC REGRESSION|        P=0.268N         P=0.539N         P=0.168          P=0.381          P=0.235          P=0.375N        | 
|COCH-ARM / FISHERS |        P=0.262N         P=0.485N         P=0.167          P=0.410          P=0.232          P=0.367N        | 
|ORDER RESTRICTED   |        P=0.163N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 62      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        2/53 (4%)        3/53 (6%)        0/53 (0%)        3/53 (6%)        1/53 (2%)       | 
|POLY-3 RATE (b)    |        0/38.97          2/34.17          3/39.25          0/34.16          3/39.00          1/43.05         | 
|POLY-3 PERCENT (g) |        0.0%             5.9%             7.6%             0.0%             7.7%             2.3%            | 
|TERMINAL (d)       |        0/25 (0%)        2/21 (10%)       2/23 (9%)        0/19 (0%)        3/22 (14%)       0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              731 (T)          578              ---              731 (T)          598             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.594          P=0.200          P=0.118          (e)              P=0.097          P=0.536         | 
|POLY 3             |        P=0.543N         P=0.208          P=0.119          (e)              P=0.118          P=0.520         | 
|POLY 1.5           |        P=0.560N         P=0.221          P=0.118          (e)              P=0.120          P=0.518         | 
|POLY 6             |        P=0.544N         P=0.196          P=0.120          (e)              P=0.113          P=0.516         | 
|LOGISTIC REGRESSION|        P=0.550N         P=0.200          P=0.120          (e)              P=0.097          P=0.463         | 
|COCH-ARM / FISHERS |        P=0.597          P=0.252          P=0.125          (e)              P=0.125          P=0.505         | 
|ORDER RESTRICTED   |        P=0.206          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        29/52 (56%)      31/53 (58%)      28/53 (53%)      23/53 (43%)      32/53 (60%)      17/53 (32%)     | 
|POLY-3 RATE (b)    |        29/45.30         31/45.05         28/46.99         23/43.47         32/47.83         17/46.13        | 
|POLY-3 PERCENT (g) |        64.0%            68.8%            59.6%            52.9%            66.9%            36.9%           | 
|TERMINAL (d)       |        15/25 (60%)      14/21 (67%)      11/23 (48%)      8/19 (42%)       14/22 (64%)      7/21 (33%)      | 
|FIRST INCIDENCE    |        351              241              177              197              317              546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.017N*        P=0.199          P=0.552          P=0.529N         P=0.258          P=0.053N        | 
|POLY 3             |        P=0.002N**       P=0.393          P=0.409N         P=0.189N         P=0.469          P=0.006N**      | 
|POLY 1.5           |        P=0.002N**       P=0.427          P=0.445N         P=0.162N         P=0.441          P=0.006N**      | 
|POLY 6             |        P=0.002N**       P=0.367          P=0.374N         P=0.231N         P=0.485          P=0.007N**      | 
|LOGISTIC REGRESSION|        P=0.007N**       P=0.427          P=0.471N         P=0.149N         P=0.386          P=0.010N*       | 
|COCH-ARM / FISHERS |        P=0.007N**       P=0.466          P=0.458N         P=0.142N         P=0.390          P=0.012N*       | 
|ORDER RESTRICTED   |        P=0.002N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 03                                            Page 63      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 105 weeks                                                            
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|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
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|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
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|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        30/52 (58%)      33/53 (62%)      35/53 (66%)      27/53 (51%)      31/53 (58%)      19/53 (36%)     | 
|POLY-3 RATE (b)    |        30/44.70         33/43.20         35/44.03         27/41.69         31/46.95         19/44.95        | 
|POLY-3 PERCENT (g) |        67.1%            76.4%            79.5%            64.8%            66.0%            42.3%           | 
|TERMINAL (d)       |        15/25 (60%)      17/21 (81%)      19/23 (83%)      14/19 (74%)      14/22 (64%)      10/21 (48%)     | 
|FIRST INCIDENCE    |        361              361              348              197              141              474             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.007N**       P=0.121          P=0.186          P=0.326          P=0.366          P=0.091N        | 
|POLY 3             |        P<0.001N**       P=0.221          P=0.127          P=0.499N         P=0.546N         P=0.011N*       | 
|POLY 1.5           |        P<0.001N**       P=0.276          P=0.137          P=0.398N         P=0.543N         P=0.010N*       | 
|POLY 6             |        P<0.001N**       P=0.179          P=0.118          P=0.553          P=0.592N         P=0.021N*       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.234          P=0.180          P=0.426N         P=0.540          P=0.009N**      | 
|COCH-ARM / FISHERS |        P=0.002N**       P=0.390          P=0.249          P=0.309N         P=0.546          P=0.020N*       | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
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|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
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|Vagina                                                                                                                           | 
|     Inflammation                                                                                                                | 
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|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/0 (0%)         0/1 (0%)         0/1 (0%)         2/3 (67%)        0/3 (0%)         0/1 (0%)        | 
|POLY-3 RATE (b)    |        0/0.00           0/0.31           0/0.97           2/2.24           0/2.18           0/0.56          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             89.4%            0.0%             0.0%            | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         1/1 (100%)       0/1 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              690              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.591N         (e)              (e)              P=0.455          (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|        P=0.719N         (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.506N         (e)              (e)              P=1.000          (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
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(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).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.