National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/4913

TDMS Study 96007-01 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                    DATE: 10/01/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:23:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                   FINAL #3/RATS CONTROL VS. STOP                                                   
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 009    1000 NG/KG/STOP                                                               
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                    DATE: 10/01/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:23:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
                                                                                                                                    
                                                                                                                                    
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                                                                                  
                                       Necrosis                                                                                     
                                       Vacuolization Cytoplasmic                                                                    
Adrenal Medulla                        Hyperplasia                                                                                  
Blood Vessel: Aorta                    Mineralization                                                                               
Bone Marrow                            Hyperplasia                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Clitoral Gland: Duct                   Cyst                                                                                         
Esophagus: Muscularis                  Inflammation                                                                                 
Harderian Gland                        Inflammation                                                                                 
Heart                                  Cardiomyopathy                                                                               
Heart: Epicardium                      Inflammation                                                                                 
Intestine Large, Rectum                Parasite Metazoan                                                                            
Kidney                                 Casts Protein                                                                                
                                       Inflammation Chronic                                                                         
                                       Mineralization                                                                               
                                       Nephropathy                                                                                  
Kidney: Pelvis                         Dilatation                                                                                   
                                       Inflammation                                                                                 
Kidney: Transitional Epithelium        Hyperplasia                                                                                  
Liver                                  Angiectasis                                                                                  
                                       Basophilic Focus                                                                             
                                       Clear Cell Focus                                                                             
                                       Degeneration Cystic                                                                          
                                       Eosinophilic Focus                                                                           
                                       Fatty Change Diffuse                                                                         
                                       Fatty Change Focal                                                                           
                                       Hepatocyte, Multinucleate                                                                    
                                       Inflammation                                                                                 
                                       Mixed Cell Focus                                                                             
                                       Necrosis                                                                                     
                                       Pigmentation                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Bile Duct                       Cyst                                                                                         
                                       Fibrosis                                                                                     
                                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Degeneration                                                                                 
                                       Hypertrophy                                                                                  
Lung                                   Infiltration Cellular Histiocyte                                                             
                                       Inflammation Chronic                                                                         
                                       Inflammation Granulomatous                                                                   
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
                                       Metaplasia Bronchiolar                                                                       
Lung: Serosa                           Inflammation                                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                    DATE: 10/01/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:23:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
Lymph Node, Mandibular                 Ectasia                                                                                      
                                       Hyperplasia                                                                                  
Lymph Node, Mesenteric                 Atrophy                                                                                      
                                       Hemorrhage                                                                                   
                                       Hyperplasia                                                                                  
Mammary Gland                          Cyst                                                                                         
                                       Hyperplasia                                                                                  
                                       Inflammation Granulomatous                                                                   
Nose: Respiratory Epithelium           Hyperplasia                                                                                  
Nose: Turbinate                        Inflammation                                                                                 
Oral Mucosa: Gingival                  Hyperplasia                                                                                  
Ovary                                  Atrophy                                                                                      
                                       Cyst                                                                                         
Pancreas                               Inflammation Chronic                                                                         
Pancreas: Acinus                       Atrophy                                                                                      
Parathyroid Gland                      Hyperplasia                                                                                  
Pituitary Gland                        Angiectasis                                                                                  
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Salivary Glands                        Cyst                                                                                         
Skin                                   Cyst                                                                                         
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Pigmentation                                                                                 
Spleen: Lymphoid Follicle              Atrophy                                                                                      
Stomach, Forestomach                   Edema                                                                                        
                                       Hyperplasia                                                                                  
                                       Ulcer                                                                                        
Thymus                                 Atrophy                                                                                      
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
Tooth: Peridontal Tissue               Inflammation                                                                                 
                                       Inflammation Chronic                                                                         
Urinary Bladder                        Inflammation                                                                                 
Uterus                                 Inflammation                                                                                 
                                       Metaplasia                                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/52 (21%)                                       14/50 (28%)                  | 
|POLY-3 RATE (b)    |                              11/34.50                                          14/39.70                     | 
|POLY-3 PERCENT (g) |                              31.9%                                             35.3%                        | 
|TERMINAL (d)       |                              4/15 (27%)                                        10/28 (36%)                  | 
|FIRST INCIDENCE    |                              541                                               320                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.367N                     | 
|POLY 3             |                                                                                P=0.470                      | 
|POLY 1.5           |                                                                                P=0.411                      | 
|POLY 6             |                                                                                P=0.534                      | 
|LOGISTIC REGRESSION|                                                                                P=0.459                      | 
|COCH-ARM / FISHERS |                                                                                P=0.283                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/52 (2%)                                         9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              1/31.36                                           9/39.83                      | 
|POLY-3 PERCENT (g) |                              3.2%                                              22.6%                        | 
|TERMINAL (d)       |                              1/15 (7%)                                         6/28 (21%)                   | 
|FIRST INCIDENCE    |                              727 (T)                                           328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.054                      | 
|POLY 3             |                                                                                P=0.020 *                    | 
|POLY 1.5           |                                                                                P=0.014 *                    | 
|POLY 6             |                                                                                P=0.032 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.012 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.007 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/52 (21%)                                       20/50 (40%)                  | 
|POLY-3 RATE (b)    |                              11/34.41                                          20/41.28                     | 
|POLY-3 PERCENT (g) |                              32.0%                                             48.5%                        | 
|TERMINAL (d)       |                              4/15 (27%)                                        12/28 (43%)                  | 
|FIRST INCIDENCE    |                              496                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.390                      | 
|POLY 3             |                                                                                P=0.103                      | 
|POLY 1.5           |                                                                                P=0.068                      | 
|POLY 6             |                                                                                P=0.165                      | 
|LOGISTIC REGRESSION|                                                                                P=0.085                      | 
|COCH-ARM / FISHERS |                                                                                P=0.032 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              23/52 (44%)                                       26/50 (52%)                  | 
|POLY-3 RATE (b)    |                              23/38.88                                          26/41.59                     | 
|POLY-3 PERCENT (g) |                              59.2%                                             62.5%                        | 
|TERMINAL (d)       |                              7/15 (47%)                                        17/28 (61%)                  | 
|FIRST INCIDENCE    |                              309                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.147N                     | 
|POLY 3             |                                                                                P=0.464                      | 
|POLY 1.5           |                                                                                P=0.409                      | 
|POLY 6             |                                                                                P=0.526                      | 
|LOGISTIC REGRESSION|                                                                                P=0.515                      | 
|COCH-ARM / FISHERS |                                                                                P=0.279                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              34/52 (65%)                                       42/50 (84%)                  | 
|POLY-3 RATE (b)    |                              34/39.07                                          42/45.97                     | 
|POLY-3 PERCENT (g) |                              87.0%                                             91.4%                        | 
|TERMINAL (d)       |                              15/15 (100%)                                      25/28 (89%)                  | 
|FIRST INCIDENCE    |                              391                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.112N                     | 
|POLY 3             |                                                                                P=0.351                      | 
|POLY 1.5           |                                                                                P=0.137                      | 
|POLY 6             |                                                                                P=0.621N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.165                      | 
|COCH-ARM / FISHERS |                                                                                P=0.026 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/52 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/31.80                                           2/38.11                      | 
|POLY-3 PERCENT (g) |                              3.1%                                              5.3%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         1/28 (4%)                    | 
|FIRST INCIDENCE    |                              600                                               625                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.626                      | 
|POLY 3             |                                                                                P=0.546                      | 
|POLY 1.5           |                                                                                P=0.526                      | 
|POLY 6             |                                                                                P=0.573                      | 
|LOGISTIC REGRESSION|                                                                                P=0.533                      | 
|COCH-ARM / FISHERS |                                                                                P=0.485                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/52 (10%)                                        6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              5/32.65                                           6/39.42                      | 
|POLY-3 PERCENT (g) |                              15.3%                                             15.2%                        | 
|TERMINAL (d)       |                              3/15 (20%)                                        2/28 (7%)                    | 
|FIRST INCIDENCE    |                              496                                               537                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.493N                     | 
|POLY 3             |                                                                                P=0.615N                     | 
|POLY 1.5           |                                                                                P=0.569                      | 
|POLY 6             |                                                                                P=0.535N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.550                      | 
|COCH-ARM / FISHERS |                                                                                P=0.472                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/52 (15%)                                        9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              8/33.72                                           9/38.38                      | 
|POLY-3 PERCENT (g) |                              23.7%                                             23.5%                        | 
|TERMINAL (d)       |                              3/15 (20%)                                        7/28 (25%)                   | 
|FIRST INCIDENCE    |                              496                                               618                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.312N                     | 
|POLY 3             |                                                                                P=0.593N                     | 
|POLY 1.5           |                                                                                P=0.567                      | 
|POLY 6             |                                                                                P=0.533N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.563N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.464                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Blood Vessel: Aorta                                                                                                              | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              3/32.76                                           1/38.15                      | 
|POLY-3 PERCENT (g) |                              9.2%                                              2.6%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              583                                               611                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.231N                     | 
|POLY 3             |                                                                                P=0.242N                     | 
|POLY 1.5           |                                                                                P=0.268N                     | 
|POLY 6             |                                                                                P=0.215N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.328N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.331N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              47/53 (89%)                                       34/50 (68%)                  | 
|POLY-3 RATE (b)    |                              47/52.12                                          34/49.61                     | 
|POLY-3 PERCENT (g) |                              90.2%                                             68.5%                        | 
|TERMINAL (d)       |                              10/15 (67%)                                       13/28 (46%)                  | 
|FIRST INCIDENCE    |                              126                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.002N**                   | 
|POLY 3             |                                                                                P=0.005N**                   | 
|POLY 1.5           |                                                                                P=0.006N**                   | 
|POLY 6             |                                                                                P=0.006N**                   | 
|LOGISTIC REGRESSION|                                                                                P=0.068N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.010N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              28/50 (56%)                                       32/48 (67%)                  | 
|POLY-3 RATE (b)    |                              28/40.18                                          32/44.43                     | 
|POLY-3 PERCENT (g) |                              69.7%                                             72.0%                        | 
|TERMINAL (d)       |                              9/14 (64%)                                        18/28 (64%)                  | 
|FIRST INCIDENCE    |                              222                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.131N                     | 
|POLY 3             |                                                                                P=0.497                      | 
|POLY 1.5           |                                                                                P=0.394                      | 
|POLY 6             |                                                                                P=0.581N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.294                      | 
|COCH-ARM / FISHERS |                                                                                P=0.191                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              29/50 (58%)                                       39/48 (81%)                  | 
|POLY-3 RATE (b)    |                              29/40.97                                          39/46.84                     | 
|POLY-3 PERCENT (g) |                              70.8%                                             83.3%                        | 
|TERMINAL (d)       |                              8/14 (57%)                                        21/28 (75%)                  | 
|FIRST INCIDENCE    |                              126                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.352N                     | 
|POLY 3             |                                                                                P=0.112                      | 
|POLY 1.5           |                                                                                P=0.053                      | 
|POLY 6             |                                                                                P=0.213                      | 
|LOGISTIC REGRESSION|                                                                                P=0.014 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.011 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Esophagus: Muscularis                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/52 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/30.96                                           1/37.75                      | 
|POLY-3 PERCENT (g) |                              6.5%                                              2.7%                         | 
|TERMINAL (d)       |                              1/14 (7%)                                         1/28 (4%)                    | 
|FIRST INCIDENCE    |                              547                                               727 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.326N                     | 
|POLY 3             |                                                                                P=0.413N                     | 
|POLY 1.5           |                                                                                P=0.447N                     | 
|POLY 6             |                                                                                P=0.375N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.435N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.515N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         9/50 (18%)                   | 
|POLY-3 RATE (b)    |                              2/32.88                                           9/38.56                      | 
|POLY-3 PERCENT (g) |                              6.1%                                              23.3%                        | 
|TERMINAL (d)       |                              0/15 (0%)                                         7/28 (25%)                   | 
|FIRST INCIDENCE    |                              321                                               554                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.123                      | 
|POLY 3             |                                                                                P=0.042 *                    | 
|POLY 1.5           |                                                                                P=0.033 *                    | 
|POLY 6             |                                                                                P=0.058                      | 
|LOGISTIC REGRESSION|                                                                                P=0.036 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.020 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              9/52 (17%)                                        15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              9/35.59                                           15/39.99                     | 
|POLY-3 PERCENT (g) |                              25.3%                                             37.5%                        | 
|TERMINAL (d)       |                              2/15 (13%)                                        12/28 (43%)                  | 
|FIRST INCIDENCE    |                              201                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.501                      | 
|POLY 3             |                                                                                P=0.178                      | 
|POLY 1.5           |                                                                                P=0.150                      | 
|POLY 6             |                                                                                P=0.218                      | 
|LOGISTIC REGRESSION|                                                                                P=0.110                      | 
|COCH-ARM / FISHERS |                                                                                P=0.101                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Epicardium                                                                                                                | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/52 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/32.82                                           1/38.66                      | 
|POLY-3 PERCENT (g) |                              6.1%                                              2.6%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              126                                               320                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.473N                     | 
|POLY 3             |                                                                                P=0.428N                     | 
|POLY 1.5           |                                                                                P=0.459N                     | 
|POLY 6             |                                                                                P=0.391N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.709                      | 
|COCH-ARM / FISHERS |                                                                                P=0.515N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Rectum                                                                                                          | 
|     Parasite Metazoan                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/52 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/30.87                                           1/38.13                      | 
|POLY-3 PERCENT (g) |                              6.5%                                              2.6%                         | 
|TERMINAL (d)       |                              2/15 (13%)                                        0/28 (0%)                    | 
|FIRST INCIDENCE    |                              727 (T)                                           618                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.325N                     | 
|POLY 3             |                                                                                P=0.408N                     | 
|POLY 1.5           |                                                                                P=0.444N                     | 
|POLY 6             |                                                                                P=0.367N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.409N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.515N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              4/31.53                                           3/39.40                      | 
|POLY-3 PERCENT (g) |                              12.7%                                             7.6%                         | 
|TERMINAL (d)       |                              3/15 (20%)                                        0/28 (0%)                    | 
|FIRST INCIDENCE    |                              688                                               337                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.289N                     | 
|POLY 3             |                                                                                P=0.367N                     | 
|POLY 1.5           |                                                                                P=0.424N                     | 
|POLY 6             |                                                                                P=0.304N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.476N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.533N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/31.89                                           0/37.75                      | 
|POLY-3 PERCENT (g) |                              6.3%                                              0.0%                         | 
|TERMINAL (d)       |                              1/15 (7%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              574                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.155N                     | 
|POLY 3             |                                                                                P=0.188N                     | 
|POLY 1.5           |                                                                                P=0.208N                     | 
|POLY 6             |                                                                                P=0.167N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.213N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              32/53 (60%)                                       45/50 (90%)                  | 
|POLY-3 RATE (b)    |                              32/42.76                                          45/47.81                     | 
|POLY-3 PERCENT (g) |                              74.8%                                             94.1%                        | 
|TERMINAL (d)       |                              12/15 (80%)                                       27/28 (96%)                  | 
|FIRST INCIDENCE    |                              126                                               320                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.427N                     | 
|POLY 3             |                                                                                P=0.004 **                   | 
|POLY 1.5           |                                                                                P=0.002 **                   | 
|POLY 6             |                                                                                P=0.011 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.002 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              32/53 (60%)                                       38/50 (76%)                  | 
|POLY-3 RATE (b)    |                              32/43.26                                          38/42.94                     | 
|POLY-3 PERCENT (g) |                              74.0%                                             88.5%                        | 
|TERMINAL (d)       |                              11/15 (73%)                                       26/28 (93%)                  | 
|FIRST INCIDENCE    |                              126                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.108N                     | 
|POLY 3             |                                                                                P=0.046 *                    | 
|POLY 1.5           |                                                                                P=0.044 *                    | 
|POLY 6             |                                                                                P=0.072                      | 
|LOGISTIC REGRESSION|                                                                                P=0.185                      | 
|COCH-ARM / FISHERS |                                                                                P=0.068                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/32.37                                           1/38.50                      | 
|POLY-3 PERCENT (g) |                              6.2%                                              2.6%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              574                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.444N                     | 
|POLY 3             |                                                                                P=0.424N                     | 
|POLY 1.5           |                                                                                P=0.456N                     | 
|POLY 6             |                                                                                P=0.389N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.593N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.522N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/32.53                                           0/37.75                      | 
|POLY-3 PERCENT (g) |                              6.2%                                              0.0%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              541                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.208N                     | 
|POLY 3             |                                                                                P=0.193N                     | 
|POLY 1.5           |                                                                                P=0.211N                     | 
|POLY 6             |                                                                                P=0.174N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.280N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Transitional Epithelium                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              4/32.45                                           2/37.75                      | 
|POLY-3 PERCENT (g) |                              12.3%                                             5.3%                         | 
|TERMINAL (d)       |                              2/15 (13%)                                        2/28 (7%)                    | 
|FIRST INCIDENCE    |                              554                                               727 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.150N                     | 
|POLY 3             |                                                                                P=0.260N                     | 
|POLY 1.5           |                                                                                P=0.292N                     | 
|POLY 6             |                                                                                P=0.224N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.258N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.367N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         8/50 (16%)                   | 
|POLY-3 RATE (b)    |                              3/31.69                                           8/37.75                      | 
|POLY-3 PERCENT (g) |                              9.5%                                              21.2%                        | 
|TERMINAL (d)       |                              2/15 (13%)                                        8/28 (29%)                   | 
|FIRST INCIDENCE    |                              644                                               727 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.380                      | 
|POLY 3             |                                                                                P=0.152                      | 
|POLY 1.5           |                                                                                P=0.125                      | 
|POLY 6             |                                                                                P=0.191                      | 
|LOGISTIC REGRESSION|                                                                                P=0.287                      | 
|COCH-ARM / FISHERS |                                                                                P=0.083                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/53 (13%)                                        16/50 (32%)                  | 
|POLY-3 RATE (b)    |                              7/32.51                                           16/39.85                     | 
|POLY-3 PERCENT (g) |                              21.5%                                             40.2%                        | 
|TERMINAL (d)       |                              3/15 (20%)                                        11/28 (39%)                  | 
|FIRST INCIDENCE    |                              541                                               537                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.275                      | 
|POLY 3             |                                                                                P=0.068                      | 
|POLY 1.5           |                                                                                P=0.044 *                    | 
|POLY 6             |                                                                                P=0.116                      | 
|LOGISTIC REGRESSION|                                                                                P=0.080                      | 
|COCH-ARM / FISHERS |                                                                                P=0.020 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              2/31.38                                           5/37.75                      | 
|POLY-3 PERCENT (g) |                              6.4%                                              13.3%                        | 
|TERMINAL (d)       |                              2/15 (13%)                                        5/28 (18%)                   | 
|FIRST INCIDENCE    |                              727 (T)                                           727 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.520                      | 
|POLY 3             |                                                                                P=0.285                      | 
|POLY 1.5           |                                                                                P=0.252                      | 
|POLY 6             |                                                                                P=0.332                      | 
|LOGISTIC REGRESSION|                                                                                P=0.520                      | 
|COCH-ARM / FISHERS |                                                                                P=0.195                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/31.38                                           3/38.35                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              7.8%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         1/28 (4%)                    | 
|FIRST INCIDENCE    |                              ---                                               618                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.213                      | 
|POLY 3             |                                                                                P=0.148                      | 
|POLY 1.5           |                                                                                P=0.133                      | 
|POLY 6             |                                                                                P=0.170                      | 
|LOGISTIC REGRESSION|                                                                                P=0.147                      | 
|COCH-ARM / FISHERS |                                                                                P=0.111                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              11/53 (21%)                                       12/50 (24%)                  | 
|POLY-3 RATE (b)    |                              11/34.24                                          12/41.51                     | 
|POLY-3 PERCENT (g) |                              32.1%                                             28.9%                        | 
|TERMINAL (d)       |                              5/15 (33%)                                        5/28 (18%)                   | 
|FIRST INCIDENCE    |                              405                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.300N                     | 
|POLY 3             |                                                                                P=0.472N                     | 
|POLY 1.5           |                                                                                P=0.566N                     | 
|POLY 6             |                                                                                P=0.362N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.531                      | 
|COCH-ARM / FISHERS |                                                                                P=0.437                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         12/50 (24%)                  | 
|POLY-3 RATE (b)    |                              5/33.58                                           12/40.50                     | 
|POLY-3 PERCENT (g) |                              14.9%                                             29.6%                        | 
|TERMINAL (d)       |                              2/15 (13%)                                        8/28 (29%)                   | 
|FIRST INCIDENCE    |                              126                                               320                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.242                      | 
|POLY 3             |                                                                                P=0.105                      | 
|POLY 1.5           |                                                                                P=0.076                      | 
|POLY 6             |                                                                                P=0.151                      | 
|LOGISTIC REGRESSION|                                                                                P=0.037 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.042 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         11/50 (22%)                  | 
|POLY-3 RATE (b)    |                              2/32.02                                           11/40.35                     | 
|POLY-3 PERCENT (g) |                              6.3%                                              27.3%                        | 
|TERMINAL (d)       |                              1/15 (7%)                                         5/28 (18%)                   | 
|FIRST INCIDENCE    |                              519                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.057                      | 
|POLY 3             |                                                                                P=0.020 *                    | 
|POLY 1.5           |                                                                                P=0.012 *                    | 
|POLY 6             |                                                                                P=0.036 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.012 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.005 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocyte, Multinucleate                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         20/50 (40%)                  | 
|POLY-3 RATE (b)    |                              0/31.38                                           20/42.63                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              46.9%                        | 
|TERMINAL (d)       |                              0/15 (0%)                                         12/28 (43%)                  | 
|FIRST INCIDENCE    |                              ---                                               320                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              36/53 (68%)                                       46/50 (92%)                  | 
|POLY-3 RATE (b)    |                              36/42.80                                          46/47.33                     | 
|POLY-3 PERCENT (g) |                              84.1%                                             97.2%                        | 
|TERMINAL (d)       |                              15/15 (100%)                                      27/28 (96%)                  | 
|FIRST INCIDENCE    |                              176                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.187N                     | 
|POLY 3             |                                                                                P=0.011 *                    | 
|POLY 1.5           |                                                                                P=0.004 **                   | 
|POLY 6             |                                                                                P=0.069                      | 
|LOGISTIC REGRESSION|                                                                                P=0.018 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.002 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              21/53 (40%)                                       36/50 (72%)                  | 
|POLY-3 RATE (b)    |                              21/34.34                                          36/42.34                     | 
|POLY-3 PERCENT (g) |                              61.2%                                             85.0%                        | 
|TERMINAL (d)       |                              12/15 (80%)                                       27/28 (96%)                  | 
|FIRST INCIDENCE    |                              541                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.513                      | 
|POLY 3             |                                                                                P=0.006 **                   | 
|POLY 1.5           |                                                                                P=0.003 **                   | 
|POLY 6             |                                                                                P=0.014 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.014 *                    | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              4/34.03                                           4/40.42                      | 
|POLY-3 PERCENT (g) |                              11.8%                                             9.9%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              176                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.561N                     | 
|POLY 3             |                                                                                P=0.536N                     | 
|POLY 1.5           |                                                                                P=0.584N                     | 
|POLY 6             |                                                                                P=0.480N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.336                      | 
|COCH-ARM / FISHERS |                                                                                P=0.609                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         48/50 (96%)                  | 
|POLY-3 RATE (b)    |                              1/32.06                                           48/48.85                     | 
|POLY-3 PERCENT (g) |                              3.1%                                              98.3%                        | 
|TERMINAL (d)       |                              0/15 (0%)                                         28/28 (100%)                 | 
|FIRST INCIDENCE    |                              496                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         15/50 (30%)                  | 
|POLY-3 RATE (b)    |                              0/31.38                                           15/41.40                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              36.2%                        | 
|TERMINAL (d)       |                              0/15 (0%)                                         9/28 (32%)                   | 
|FIRST INCIDENCE    |                              ---                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              3/31.38                                           5/38.42                      | 
|POLY-3 PERCENT (g) |                              9.6%                                              13.0%                        | 
|TERMINAL (d)       |                              3/15 (20%)                                        4/28 (14%)                   | 
|FIRST INCIDENCE    |                              727 (T)                                           502                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.629N                     | 
|POLY 3             |                                                                                P=0.460                      | 
|POLY 1.5           |                                                                                P=0.412                      | 
|POLY 6             |                                                                                P=0.522                      | 
|LOGISTIC REGRESSION|                                                                                P=0.521                      | 
|COCH-ARM / FISHERS |                                                                                P=0.325                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              4/32.23                                           4/38.16                      | 
|POLY-3 PERCENT (g) |                              12.4%                                             10.5%                        | 
|TERMINAL (d)       |                              3/15 (20%)                                        3/28 (11%)                   | 
|FIRST INCIDENCE    |                              391                                               607                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.354N                     | 
|POLY 3             |                                                                                P=0.538N                     | 
|POLY 1.5           |                                                                                P=0.587N                     | 
|POLY 6             |                                                                                P=0.474N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.556N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.609                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         16/50 (32%)                  | 
|POLY-3 RATE (b)    |                              3/32.67                                           16/42.48                     | 
|POLY-3 PERCENT (g) |                              9.2%                                              37.7%                        | 
|TERMINAL (d)       |                              1/15 (7%)                                         9/28 (32%)                   | 
|FIRST INCIDENCE    |                              496                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.018 *                    | 
|POLY 3             |                                                                                P=0.004 **                   | 
|POLY 1.5           |                                                                                P=0.002 **                   | 
|POLY 6             |                                                                                P=0.009 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              3/33.04                                           0/37.75                      | 
|POLY-3 PERCENT (g) |                              9.1%                                              0.0%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              354                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.092N                     | 
|POLY 3             |                                                                                P=0.090N                     | 
|POLY 1.5           |                                                                                P=0.102N                     | 
|POLY 6             |                                                                                P=0.077N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.170N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.132N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         21/50 (42%)                  | 
|POLY-3 RATE (b)    |                              0/31.38                                           21/42.58                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              49.3%                        | 
|TERMINAL (d)       |                              0/15 (0%)                                         13/28 (46%)                  | 
|FIRST INCIDENCE    |                              ---                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/53 (77%)                                       42/50 (84%)                  | 
|POLY-3 RATE (b)    |                              41/47.06                                          42/45.67                     | 
|POLY-3 PERCENT (g) |                              87.1%                                             92.0%                        | 
|TERMINAL (d)       |                              12/15 (80%)                                       25/28 (89%)                  | 
|FIRST INCIDENCE    |                              201                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.024N*                    | 
|POLY 3             |                                                                                P=0.324                      | 
|POLY 1.5           |                                                                                P=0.300                      | 
|POLY 6             |                                                                                P=0.403                      | 
|LOGISTIC REGRESSION|                                                                                P=0.536                      | 
|COCH-ARM / FISHERS |                                                                                P=0.274                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              5/32.66                                           0/37.75                      | 
|POLY-3 PERCENT (g) |                              15.3%                                             0.0%                         | 
|TERMINAL (d)       |                              2/15 (13%)                                        0/28 (0%)                    | 
|FIRST INCIDENCE    |                              309                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.010N*                    | 
|POLY 3             |                                                                                P=0.018N*                    | 
|POLY 1.5           |                                                                                P=0.023N*                    | 
|POLY 6             |                                                                                P=0.013N*                    | 
|LOGISTIC REGRESSION|                                                                                P=0.030N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.033N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              3/32.04                                           0/37.75                      | 
|POLY-3 PERCENT (g) |                              9.4%                                              0.0%                         | 
|TERMINAL (d)       |                              1/15 (7%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              611                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.062N                     | 
|POLY 3             |                                                                                P=0.085N                     | 
|POLY 1.5           |                                                                                P=0.098N                     | 
|POLY 6             |                                                                                P=0.072N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.092N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.132N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              12/32.58                                          0/37.75                      | 
|POLY-3 PERCENT (g) |                              36.8%                                             0.0%                         | 
|TERMINAL (d)       |                              7/15 (47%)                                        0/28 (0%)                    | 
|FIRST INCIDENCE    |                              600                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001N**                   | 
|POLY 3             |                                                                                P<0.001N**                   | 
|POLY 1.5           |                                                                                P<0.001N**                   | 
|POLY 6             |                                                                                P<0.001N**                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001N**                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001N**                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         32/50 (64%)                  | 
|POLY-3 RATE (b)    |                              0/31.38                                           32/44.16                     | 
|POLY-3 PERCENT (g) |                              0.0%                                              72.5%                        | 
|TERMINAL (d)       |                              0/15 (0%)                                         19/28 (68%)                  | 
|FIRST INCIDENCE    |                              ---                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Serosa                                                                                                                     | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/32.84                                           1/38.66                      | 
|POLY-3 PERCENT (g) |                              6.1%                                              2.6%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              126                                               320                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.476N                     | 
|POLY 3             |                                                                                P=0.428N                     | 
|POLY 1.5           |                                                                                P=0.461N                     | 
|POLY 6             |                                                                                P=0.392N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.693                      | 
|COCH-ARM / FISHERS |                                                                                P=0.522N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/52 (2%)                                         3/49 (6%)                    | 
|POLY-3 RATE (b)    |                              1/31.47                                           3/37.57                      | 
|POLY-3 PERCENT (g) |                              3.2%                                              8.0%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         3/28 (11%)                   | 
|FIRST INCIDENCE    |                              660                                               727 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.513                      | 
|POLY 3             |                                                                                P=0.357                      | 
|POLY 1.5           |                                                                                P=0.333                      | 
|POLY 6             |                                                                                P=0.389                      | 
|LOGISTIC REGRESSION|                                                                                P=0.440                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              18/52 (35%)                                       21/49 (43%)                  | 
|POLY-3 RATE (b)    |                              18/36.75                                          21/42.70                     | 
|POLY-3 PERCENT (g) |                              49.0%                                             49.2%                        | 
|TERMINAL (d)       |                              8/15 (53%)                                        11/28 (39%)                  | 
|FIRST INCIDENCE    |                              222                                               337                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.253N                     | 
|POLY 3             |                                                                                P=0.578                      | 
|POLY 1.5           |                                                                                P=0.464                      | 
|POLY 6             |                                                                                P=0.453N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.366                      | 
|COCH-ARM / FISHERS |                                                                                P=0.259                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/52 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/31.36                                           2/39.10                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.1%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.264                      | 
|POLY 3             |                                                                                P=0.269                      | 
|POLY 1.5           |                                                                                P=0.254                      | 
|POLY 6             |                                                                                P=0.292                      | 
|LOGISTIC REGRESSION|                                                                                P=0.152                      | 
|COCH-ARM / FISHERS |                                                                                P=0.238                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/52 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/31.83                                           0/37.75                      | 
|POLY-3 PERCENT (g) |                              6.3%                                              0.0%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              618                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.157N                     | 
|POLY 3             |                                                                                P=0.187N                     | 
|POLY 1.5           |                                                                                P=0.207N                     | 
|POLY 6             |                                                                                P=0.166N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.205N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.257N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/52 (6%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              3/33.26                                           2/38.16                      | 
|POLY-3 PERCENT (g) |                              9.0%                                              5.2%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         1/28 (4%)                    | 
|FIRST INCIDENCE    |                              222                                               607                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.378N                     | 
|POLY 3             |                                                                                P=0.427N                     | 
|POLY 1.5           |                                                                                P=0.459N                     | 
|POLY 6             |                                                                                P=0.386N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.597N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.519N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/52 (15%)                                        13/50 (26%)                  | 
|POLY-3 RATE (b)    |                              8/33.57                                           13/39.81                     | 
|POLY-3 PERCENT (g) |                              23.8%                                             32.7%                        | 
|TERMINAL (d)       |                              3/15 (20%)                                        9/28 (32%)                   | 
|FIRST INCIDENCE    |                              405                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.567                      | 
|POLY 3             |                                                                                P=0.275                      | 
|POLY 1.5           |                                                                                P=0.221                      | 
|POLY 6             |                                                                                P=0.353                      | 
|LOGISTIC REGRESSION|                                                                                P=0.244                      | 
|COCH-ARM / FISHERS |                                                                                P=0.140                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              32/52 (62%)                                       22/50 (44%)                  | 
|POLY-3 RATE (b)    |                              32/43.06                                          22/42.25                     | 
|POLY-3 PERCENT (g) |                              74.3%                                             52.1%                        | 
|TERMINAL (d)       |                              11/15 (73%)                                       14/28 (50%)                  | 
|FIRST INCIDENCE    |                              126                                               320                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001N**                   | 
|POLY 3             |                                                                                P=0.020N*                    | 
|POLY 1.5           |                                                                                P=0.029N*                    | 
|POLY 6             |                                                                                P=0.013N*                    | 
|LOGISTIC REGRESSION|                                                                                P=0.045N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.057N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Inflammation Granulomatous                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/52 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/31.43                                           0/37.75                      | 
|POLY-3 PERCENT (g) |                              6.4%                                              0.0%                         | 
|TERMINAL (d)       |                              1/15 (7%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              709                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.122N                     | 
|POLY 3             |                                                                                P=0.184N                     | 
|POLY 1.5           |                                                                                P=0.205N                     | 
|POLY 6             |                                                                                P=0.161N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.144N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.257N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/32.23                                           1/37.75                      | 
|POLY-3 PERCENT (g) |                              6.2%                                              2.7%                         | 
|TERMINAL (d)       |                              1/15 (7%)                                         1/28 (4%)                    | 
|FIRST INCIDENCE    |                              391                                               727 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.353N                     | 
|POLY 3             |                                                                                P=0.430N                     | 
|POLY 1.5           |                                                                                P=0.461N                     | 
|POLY 6             |                                                                                P=0.392N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.508N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.522N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Turbinate                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         1/50 (2%)                    | 
|POLY-3 RATE (b)    |                              2/31.81                                           1/38.13                      | 
|POLY-3 PERCENT (g) |                              6.3%                                              2.6%                         | 
|TERMINAL (d)       |                              1/15 (7%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              603                                               618                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.368N                     | 
|POLY 3             |                                                                                P=0.421N                     | 
|POLY 1.5           |                                                                                P=0.455N                     | 
|POLY 6             |                                                                                P=0.381N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.469N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.522N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa: Gingival                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/1 (100%)                                        3/6 (50%)                    | 
|POLY-3 RATE (b)    |                              1/1.00                                            3/5.40                       | 
|POLY-3 PERCENT (g) |                              100.0%                                            55.6%                        | 
|TERMINAL (d)       |                              1/1 (100%)                                        2/3 (67%)                    | 
|FIRST INCIDENCE    |                              727 (T)                                           659                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.711                      | 
|POLY 3             |                                                                                P=0.305N                     | 
|POLY 1.5           |                                                                                P=0.295N                     | 
|POLY 6             |                                                                                P=0.327N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.753N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.571N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              45/52 (87%)                                       47/50 (94%)                  | 
|POLY-3 RATE (b)    |                              45/46.65                                          47/49.79                     | 
|POLY-3 PERCENT (g) |                              96.5%                                             94.4%                        | 
|TERMINAL (d)       |                              14/15 (93%)                                       26/28 (93%)                  | 
|FIRST INCIDENCE    |                              126                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.026N*                    | 
|POLY 3             |                                                                                P=0.496N                     | 
|POLY 1.5           |                                                                                P=0.680                      | 
|POLY 6             |                                                                                P=0.417N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.363                      | 
|COCH-ARM / FISHERS |                                                                                P=0.176                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/52 (23%)                                       17/50 (34%)                  | 
|POLY-3 RATE (b)    |                              12/33.36                                          17/40.39                     | 
|POLY-3 PERCENT (g) |                              36.0%                                             42.1%                        | 
|TERMINAL (d)       |                              7/15 (47%)                                        12/28 (43%)                  | 
|FIRST INCIDENCE    |                              547                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.424N                     | 
|POLY 3             |                                                                                P=0.375                      | 
|POLY 1.5           |                                                                                P=0.285                      | 
|POLY 6             |                                                                                P=0.496                      | 
|LOGISTIC REGRESSION|                                                                                P=0.371                      | 
|COCH-ARM / FISHERS |                                                                                P=0.158                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oviduct                                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/1 (100%)                                        2/2 (100%)                   | 
|POLY-3 RATE (b)    |                              1/1.00                                            2/2.00                       | 
|POLY-3 PERCENT (g) |                              100.0%                                            100.0%                       | 
|TERMINAL (d)       |                              0/0 (0%)                                          1/1 (100%)                   | 
|FIRST INCIDENCE    |                              709                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                (e)                          | 
|POLY 3             |                                                                                (e)                          | 
|POLY 1.5           |                                                                                (e)                          | 
|POLY 6             |                                                                                (e)                          | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                (e)                          | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/51 (10%)                                        4/48 (8%)                    | 
|POLY-3 RATE (b)    |                              5/32.80                                           4/38.24                      | 
|POLY-3 PERCENT (g) |                              15.2%                                             10.5%                        | 
|TERMINAL (d)       |                              3/15 (20%)                                        3/28 (11%)                   | 
|FIRST INCIDENCE    |                              391                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.244N                     | 
|POLY 3             |                                                                                P=0.395N                     | 
|POLY 1.5           |                                                                                P=0.446N                     | 
|POLY 6             |                                                                                P=0.334N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.490N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.539N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/51 (10%)                                        7/48 (15%)                   | 
|POLY-3 RATE (b)    |                              5/31.43                                           7/38.69                      | 
|POLY-3 PERCENT (g) |                              15.9%                                             18.1%                        | 
|TERMINAL (d)       |                              4/15 (27%)                                        5/28 (18%)                   | 
|FIRST INCIDENCE    |                              705                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.483N                     | 
|POLY 3             |                                                                                P=0.521                      | 
|POLY 1.5           |                                                                                P=0.451                      | 
|POLY 6             |                                                                                P=0.608                      | 
|LOGISTIC REGRESSION|                                                                                P=0.553                      | 
|COCH-ARM / FISHERS |                                                                                P=0.337                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/47 (0%)                                         2/44 (5%)                    | 
|POLY-3 RATE (b)    |                              0/27.62                                           2/34.33                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.8%                         | 
|TERMINAL (d)       |                              0/13 (0%)                                         1/25 (4%)                    | 
|FIRST INCIDENCE    |                              ---                                               660                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.355                      | 
|POLY 3             |                                                                                P=0.269                      | 
|POLY 1.5           |                                                                                P=0.253                      | 
|POLY 6             |                                                                                P=0.291                      | 
|LOGISTIC REGRESSION|                                                                                P=0.299                      | 
|COCH-ARM / FISHERS |                                                                                P=0.231                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              14/51 (27%)                                       14/48 (29%)                  | 
|POLY-3 RATE (b)    |                              14/33.32                                          14/38.62                     | 
|POLY-3 PERCENT (g) |                              42.0%                                             36.3%                        | 
|TERMINAL (d)       |                              7/15 (47%)                                        9/27 (33%)                   | 
|FIRST INCIDENCE    |                              546                                               592                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.126N                     | 
|POLY 3             |                                                                                P=0.391N                     | 
|POLY 1.5           |                                                                                P=0.479N                     | 
|POLY 6             |                                                                                P=0.295N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.363N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.513                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              18/51 (35%)                                       17/48 (35%)                  | 
|POLY-3 RATE (b)    |                              18/36.64                                          17/38.07                     | 
|POLY-3 PERCENT (g) |                              49.1%                                             44.7%                        | 
|TERMINAL (d)       |                              4/15 (27%)                                        13/27 (48%)                  | 
|FIRST INCIDENCE    |                              400                                               607                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.084N                     | 
|POLY 3             |                                                                                P=0.435N                     | 
|POLY 1.5           |                                                                                P=0.459N                     | 
|POLY 6             |                                                                                P=0.429N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.327N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.578                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              0/29.97                                           2/37.57                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.3%                         | 
|TERMINAL (d)       |                              0/14 (0%)                                         2/28 (7%)                    | 
|FIRST INCIDENCE    |                              ---                                               727 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.400                      | 
|POLY 3             |                                                                                P=0.270                      | 
|POLY 1.5           |                                                                                P=0.255                      | 
|POLY 6             |                                                                                P=0.291                      | 
|LOGISTIC REGRESSION|                                                                                P=0.400                      | 
|COCH-ARM / FISHERS |                                                                                P=0.238                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/52 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/31.84                                           2/37.75                      | 
|POLY-3 PERCENT (g) |                              3.1%                                              5.3%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         2/28 (7%)                    | 
|FIRST INCIDENCE    |                              583                                               727 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.664                      | 
|POLY 3             |                                                                                P=0.543                      | 
|POLY 1.5           |                                                                                P=0.524                      | 
|POLY 6             |                                                                                P=0.568                      | 
|LOGISTIC REGRESSION|                                                                                P=0.569                      | 
|COCH-ARM / FISHERS |                                                                                P=0.485                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              39/52 (75%)                                       37/50 (74%)                  | 
|POLY-3 RATE (b)    |                              39/47.51                                          37/45.78                     | 
|POLY-3 PERCENT (g) |                              82.1%                                             80.8%                        | 
|TERMINAL (d)       |                              8/15 (53%)                                        21/28 (75%)                  | 
|FIRST INCIDENCE    |                              126                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.025N*                    | 
|POLY 3             |                                                                                P=0.547N                     | 
|POLY 1.5           |                                                                                P=0.524N                     | 
|POLY 6             |                                                                                P=0.572N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.472N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.544N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              49/52 (94%)                                       50/50 (100%)                 | 
|POLY-3 RATE (b)    |                              49/49.42                                          50/50.00                     | 
|POLY-3 PERCENT (g) |                              99.2%                                             100.0%                       | 
|TERMINAL (d)       |                              15/15 (100%)                                      28/28 (100%)                 | 
|FIRST INCIDENCE    |                              126                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.013N*                    | 
|POLY 3             |                                                                                P=0.958                      | 
|POLY 1.5           |                                                                                P=0.514                      | 
|POLY 6             |                                                                                P=1.000                      | 
|LOGISTIC REGRESSION|                                                                                P=0.307                      | 
|COCH-ARM / FISHERS |                                                                                P=0.129                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/52 (0%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              0/31.36                                           4/40.76                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              9.8%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.082                      | 
|POLY 3             |                                                                                P=0.093                      | 
|POLY 1.5           |                                                                                P=0.078                      | 
|POLY 6             |                                                                                P=0.115                      | 
|LOGISTIC REGRESSION|                                                                                P=0.008 **                   | 
|COCH-ARM / FISHERS |                                                                                P=0.054                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/52 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/31.67                                           2/39.26                      | 
|POLY-3 PERCENT (g) |                              3.2%                                              5.1%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              644                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.546                      | 
|POLY 3             |                                                                                P=0.555                      | 
|POLY 1.5           |                                                                                P=0.531                      | 
|POLY 6             |                                                                                P=0.585                      | 
|LOGISTIC REGRESSION|                                                                                P=0.394                      | 
|COCH-ARM / FISHERS |                                                                                P=0.485                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/52 (6%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              3/32.29                                           2/39.26                      | 
|POLY-3 PERCENT (g) |                              9.3%                                              5.1%                         | 
|TERMINAL (d)       |                              1/15 (7%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              391                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.382N                     | 
|POLY 3             |                                                                                P=0.398N                     | 
|POLY 1.5           |                                                                                P=0.440N                     | 
|POLY 6             |                                                                                P=0.348N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.599N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.519N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/52 (6%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              3/32.17                                           0/37.75                      | 
|POLY-3 PERCENT (g) |                              9.3%                                              0.0%                         | 
|TERMINAL (d)       |                              1/15 (7%)                                         0/28 (0%)                    | 
|FIRST INCIDENCE    |                              574                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.070N                     | 
|POLY 3             |                                                                                P=0.085N                     | 
|POLY 1.5           |                                                                                P=0.098N                     | 
|POLY 6             |                                                                                P=0.073N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.102N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.129N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              37/50 (74%)                                       39/43 (91%)                  | 
|POLY-3 RATE (b)    |                              37/45.02                                          39/42.09                     | 
|POLY-3 PERCENT (g) |                              82.2%                                             92.7%                        | 
|TERMINAL (d)       |                              9/15 (60%)                                        23/26 (89%)                  | 
|FIRST INCIDENCE    |                              126                                               284                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.083N                     | 
|POLY 3             |                                                                                P=0.118                      | 
|POLY 1.5           |                                                                                P=0.081                      | 
|POLY 6             |                                                                                P=0.162                      | 
|LOGISTIC REGRESSION|                                                                                P=0.052                      | 
|COCH-ARM / FISHERS |                                                                                P=0.033 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/52 (23%)                                       18/47 (38%)                  | 
|POLY-3 RATE (b)    |                              12/33.93                                          18/40.66                     | 
|POLY-3 PERCENT (g) |                              35.4%                                             44.3%                        | 
|TERMINAL (d)       |                              5/15 (33%)                                        12/28 (43%)                  | 
|FIRST INCIDENCE    |                              541                                               337                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.526N                     | 
|POLY 3             |                                                                                P=0.285                      | 
|POLY 1.5           |                                                                                P=0.197                      | 
|POLY 6             |                                                                                P=0.391                      | 
|LOGISTIC REGRESSION|                                                                                P=0.213                      | 
|COCH-ARM / FISHERS |                                                                                P=0.077                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              9/52 (17%)                                        22/47 (47%)                  | 
|POLY-3 RATE (b)    |                              9/37.19                                           22/42.68                     | 
|POLY-3 PERCENT (g) |                              24.2%                                             51.5%                        | 
|TERMINAL (d)       |                              2/15 (13%)                                        13/28 (46%)                  | 
|FIRST INCIDENCE    |                              201                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.094                      | 
|POLY 3             |                                                                                P=0.008 **                   | 
|POLY 1.5           |                                                                                P=0.004 **                   | 
|POLY 6             |                                                                                P=0.021 *                    | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P=0.002 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              10/12 (83%)                                       11/12 (92%)                  | 
|POLY-3 RATE (b)    |                              10/12.00                                          11/11.24                     | 
|POLY-3 PERCENT (g) |                              83.3%                                             97.8%                        | 
|TERMINAL (d)       |                              5/7 (71%)                                         7/7 (100%)                   | 
|FIRST INCIDENCE    |                              405                                               537                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.596N                     | 
|POLY 3             |                                                                                P=0.320                      | 
|POLY 1.5           |                                                                                P=0.384                      | 
|POLY 6             |                                                                                P=0.275                      | 
|LOGISTIC REGRESSION|                                                                                P=0.489                      | 
|COCH-ARM / FISHERS |                                                                                P=0.500                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth: Peridontal Tissue                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/12 (17%)                                        0/12 (0%)                    | 
|POLY-3 RATE (b)    |                              2/9.81                                            0/9.21                       | 
|POLY-3 PERCENT (g) |                              20.4%                                             0.0%                         | 
|TERMINAL (d)       |                              2/7 (29%)                                         0/7 (0%)                     | 
|FIRST INCIDENCE    |                              727 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.231N                     | 
|POLY 3             |                                                                                P=0.248N                     | 
|POLY 1.5           |                                                                                P=0.238N                     | 
|POLY 6             |                                                                                P=0.261N                     | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.239N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/51 (8%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              4/32.86                                           3/38.55                      | 
|POLY-3 PERCENT (g) |                              12.2%                                             7.8%                         | 
|TERMINAL (d)       |                              0/15 (0%)                                         1/28 (4%)                    | 
|FIRST INCIDENCE    |                              391                                               607                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.344N                     | 
|POLY 3             |                                                                                P=0.402N                     | 
|POLY 1.5           |                                                                                P=0.438N                     | 
|POLY 6             |                                                                                P=0.359N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.529N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.511N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/52 (23%)                                       11/50 (22%)                  | 
|POLY-3 RATE (b)    |                              12/35.65                                          11/39.62                     | 
|POLY-3 PERCENT (g) |                              33.7%                                             27.8%                        | 
|TERMINAL (d)       |                              2/15 (13%)                                        8/28 (29%)                   | 
|FIRST INCIDENCE    |                              391                                               454                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.155N                     | 
|POLY 3             |                                                                                P=0.375N                     | 
|POLY 1.5           |                                                                                P=0.422N                     | 
|POLY 6             |                                                                                P=0.333N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.437N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.543N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              26/52 (50%)                                       28/50 (56%)                  | 
|POLY-3 RATE (b)    |                              26/41.07                                          28/45.45                     | 
|POLY-3 PERCENT (g) |                              63.3%                                             61.6%                        | 
|TERMINAL (d)       |                              7/15 (47%)                                        14/28 (50%)                  | 
|FIRST INCIDENCE    |                              321                                               320                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.161N                     | 
|POLY 3             |                                                                                P=0.520N                     | 
|POLY 1.5           |                                                                                P=0.572                      | 
|POLY 6             |                                                                                P=0.460N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.409                      | 
|COCH-ARM / FISHERS |                                                                                P=0.342                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           1000 NG/                     | 
|                   |                                                                                KG/STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              23/52 (44%)                                       31/50 (62%)                  | 
|POLY-3 RATE (b)    |                              23/35.31                                          31/42.28                     | 
|POLY-3 PERCENT (g) |                              65.1%                                             73.3%                        | 
|TERMINAL (d)       |                              12/15 (80%)                                       22/28 (79%)                  | 
|FIRST INCIDENCE    |                              496                                               328                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.233N                     | 
|POLY 3             |                                                                                P=0.273                      | 
|POLY 1.5           |                                                                                P=0.163                      | 
|POLY 6             |                                                                                P=0.447                      | 
|LOGISTIC REGRESSION|                                                                                P=0.274                      | 
|COCH-ARM / FISHERS |                                                                                P=0.055                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
                                                                                                                                   
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.