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TDMS Study 96007-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                  REPORT: PEIRPT10   

LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 10/22/03     

EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 16:15:51     

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                      

CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G     

PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6     






SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS

IN THE ANALYSIS OF       TOXIC EQUIVALENCY FACTOR EVALUATION

===============================================================


Female Rats

------------

Organ                                  Morphology

-----                                  ----------

Adrenal Cortex                         Angiectasis

                                       Atrophy

                                       Degeneration Cystic

                                       Hyperplasia

                                       Hypertrophy

                                       Necrosis

                                       Vacuolization Cytoplasmic

Adrenal Medulla                        Hyperplasia

Bone Marrow                            Hyperplasia

Brain                                  Mineralization

Clitoral Gland                         Inflammation

Clitoral Gland: Duct                   Cyst

Eye: Retina                            Atrophy

Harderian Gland                        Inflammation

Heart                                  Cardiomyopathy

Heart: Atrium                          Thrombosis

Intestine Large, Colon                 Parasite Metazoan

Intestine Large, Rectum                Parasite Metazoan

Kidney                                 Accumulation, Hyaline Droplet

                                       Inflammation

                                       Mineralization

                                       Nephropathy

Kidney: Pelvis                         Inflammation

Kidney: Transitional Epithelium        Hyperplasia

Liver                                  Angiectasis

                                       Basophilic Focus

                                       Cholangiofibrosis

                                       Clear Cell Focus

                                       Congestion

                                       Cytoplasmic Alteration

                                       Degeneration Cystic

                                       Eosinophilic Focus

                                       Fatty Change Diffuse

                                       Fatty Change Focal

                                       Hematopoietic Cell Proliferation

                                       Hyperplasia

                                       Inflammation

                                       Mixed Cell Focus

                                       Necrosis

                                       Pigmentation

                                       Toxic Hepatopathy

Liver: Artery                          Inflammation Chronic

Liver: Bile Duct                       Cyst

                                       Fibrosis

                                       Hyperplasia

Liver: Centrilobular                   Degeneration

Liver: Hepatocyte                      Hypertrophy

                                       Multinucleated

NTP                                        STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                 REPORT: PEIRPT10   

LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 10/22/03     

EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 16:15:51     

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                      

CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G     

PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6     


Liver: Oval Cell                       Hyperplasia

Liver: Portal                          Fibrosis

Lung                                   Hemorrhage

                                       Infiltration Cellular Histiocyte

                                       Metaplasia

Lung: Alveolar Epithelium              Metaplasia Bronchiolar

Lymph Node, Mandibular                 Ectasia

                                       Hyperplasia

                                       Hyperplasia Lymphoid

Lymph Node, Mesenteric                 Hyperplasia

Lymph Node: Lumbar                     Ectasia

                                       Hyperplasia

Lymph Node: Mediastinal                Ectasia

                                       Hemorrhage

Mammary Gland                          Cyst

                                       Hyperplasia

Mesentery: Artery                      Inflammation Chronic

Nose                                   Inflammation

Nose: Septum                           Inflammation

Nose: Turbinate, Septum                Inflammation

Oral Mucosa: Gingival                  Hyperplasia

Ovary                                  Atrophy

                                       Cyst

Pancreas                               Inflammation Chronic

Pancreas: Acinus                       Atrophy

                                       Vacuolization Cytoplasmic

Pancreas: Artery                       Inflammation Chronic

Pituitary Gland                        Angiectasis

                                       Vacuolization Cytoplasmic

Pituitary Gland: Pars Distalis         Hyperplasia

Salivary Glands                        Atrophy

Skin                                   Cyst Epithelial Inclusion

Spleen                                 Hematopoietic Cell Proliferation

                                       Hyperplasia Lymphoid

                                       Pigmentation

Stomach, Forestomach                   Hyperkeratosis

                                       Hyperplasia

                                       Inflammation

                                       Ulcer

Stomach, Glandular                     Ulcer

Thymus                                 Atrophy

Thyroid Gland: C-Cell                  Hyperplasia

Thyroid Gland: Follicular Cell         Hypertrophy

Urinary Bladder                        Inflammation

Urinary Bladder: Transitional Epithelium


                                       Hyperplasia

Uterus                                 Inflammation

                                       Metaplasia

Uterus: Endometrium                    Hyperplasia Cystic

===============================================================
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 1


Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Adrenal Cortex                                                                                                                   |

|     Angiectasis                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              11/53 (21%)                                       15/50 (30%)                  |

|POLY-3 RATE (b)    |                              11/45.07                                          15/38.86                     |

|POLY-3 PERCENT (g) |                              24.4%                                             38.6%                        |

|TERMINAL (d)       |                              4/21 (19%)                                        10/21 (48%)                  |

|FIRST INCIDENCE    |                              396                                               641                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.242                      |

|POLY 3             |                                                                                P=0.121                      |

|POLY 1.5           |                                                                                P=0.142                      |

|POLY 6             |                                                                                P=0.109                      |

|LOGISTIC REGRESSION|                                                                                P=0.154                      |

|COCH-ARM / FISHERS |                                                                                P=0.197                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Adrenal Cortex                                                                                                                   |

|     Atrophy                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              27/53 (51%)                                       4/50 (8%)                    |

|POLY-3 RATE (b)    |                              27/46.52                                          4/38.66                      |

|POLY-3 PERCENT (g) |                              58.0%                                             10.4%                        |

|TERMINAL (d)       |                              12/21 (57%)                                       3/21 (14%)                   |

|FIRST INCIDENCE    |                              396                                               578                          |

|-------------------|                                                                                                             |

|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:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 2


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Adrenal Cortex                                                                                                                   |

|     Degeneration Cystic                                                                                                         |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              17/53 (32%)                                       17/50 (34%)                  |

|POLY-3 RATE (b)    |                              17/46.12                                          17/40.19                     |

|POLY-3 PERCENT (g) |                              36.9%                                             42.3%                        |

|TERMINAL (d)       |                              6/21 (29%)                                        10/21 (48%)                  |

|FIRST INCIDENCE    |                              561                                               474                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.525                      |

|POLY 3             |                                                                                P=0.388                      |

|POLY 1.5           |                                                                                P=0.424                      |

|POLY 6             |                                                                                P=0.361                      |

|LOGISTIC REGRESSION|                                                                                P=0.439                      |

|COCH-ARM / FISHERS |                                                                                P=0.501                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Adrenal Cortex                                                                                                                   |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              30/53 (57%)                                       20/50 (40%)                  |

|POLY-3 RATE (b)    |                              30/47.52                                          20/40.70                     |

|POLY-3 PERCENT (g) |                              63.1%                                             49.1%                        |

|TERMINAL (d)       |                              16/21 (76%)                                       11/21 (52%)                  |

|FIRST INCIDENCE    |                              396                                               578                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.081N                     |

|POLY 3             |                                                                                P=0.127N                     |

|POLY 1.5           |                                                                                P=0.109N                     |

|POLY 6             |                                                                                P=0.129N                     |

|LOGISTIC REGRESSION|                                                                                P=0.100N                     |

|COCH-ARM / FISHERS |                                                                                P=0.068N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 3


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Adrenal Cortex                                                                                                                   |

|     Hypertrophy                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              47/53 (89%)                                       46/50 (92%)                  |

|POLY-3 RATE (b)    |                              47/51.08                                          46/48.07                     |

|POLY-3 PERCENT (g) |                              92.0%                                             95.7%                        |

|TERMINAL (d)       |                              20/21 (95%)                                       21/21 (100%)                 |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.500                      |

|POLY 3             |                                                                                P=0.351                      |

|POLY 1.5           |                                                                                P=0.374                      |

|POLY 6             |                                                                                P=0.339                      |

|LOGISTIC REGRESSION|                                                                                P=0.299                      |

|COCH-ARM / FISHERS |                                                                                P=0.408                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Adrenal Cortex                                                                                                                   |

|     Necrosis                                                                                                                    |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    |

|POLY-3 RATE (b)    |                              1/42.92                                           3/39.47                      |

|POLY-3 PERCENT (g) |                              2.3%                                              7.6%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              641                                               578                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.263                      |

|POLY 3             |                                                                                P=0.282                      |

|POLY 1.5           |                                                                                P=0.282                      |

|POLY 6             |                                                                                P=0.290                      |

|LOGISTIC REGRESSION|                                                                                P=0.336                      |

|COCH-ARM / FISHERS |                                                                                P=0.287                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 4


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Adrenal Cortex                                                                                                                   |

|     Vacuolization Cytoplasmic                                                                                                   |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              15/53 (28%)                                       13/50 (26%)                  |

|POLY-3 RATE (b)    |                              15/45.44                                          13/40.76                     |

|POLY-3 PERCENT (g) |                              33.0%                                             31.9%                        |

|TERMINAL (d)       |                              6/21 (29%)                                        6/21 (29%)                   |

|FIRST INCIDENCE    |                              561                                               345                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.480N                     |

|POLY 3             |                                                                                P=0.554N                     |

|POLY 1.5           |                                                                                P=0.538N                     |

|POLY 6             |                                                                                P=0.546N                     |

|LOGISTIC REGRESSION|                                                                                P=0.510N                     |

|COCH-ARM / FISHERS |                                                                                P=0.484N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Adrenal Medulla                                                                                                                  |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              9/53 (17%)                                        15/50 (30%)                  |

|POLY-3 RATE (b)    |                              9/44.75                                           15/39.68                     |

|POLY-3 PERCENT (g) |                              20.1%                                             37.8%                        |

|TERMINAL (d)       |                              2/21 (10%)                                        9/21 (43%)                   |

|FIRST INCIDENCE    |                              581                                               578                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.119                      |

|POLY 3             |                                                                                P=0.057                      |

|POLY 1.5           |                                                                                P=0.066                      |

|POLY 6             |                                                                                P=0.053                      |

|LOGISTIC REGRESSION|                                                                                P=0.070                      |

|COCH-ARM / FISHERS |                                                                                P=0.092                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 5


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Bone Marrow                                                                                                                      |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              43/53 (81%)                                       36/50 (72%)                  |

|POLY-3 RATE (b)    |                              43/50.67                                          36/49.61                     |

|POLY-3 PERCENT (g) |                              84.9%                                             72.6%                        |

|TERMINAL (d)       |                              17/21 (81%)                                       9/21 (43%)                   |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.307N                     |

|POLY 3             |                                                                                P=0.096N                     |

|POLY 1.5           |                                                                                P=0.135N                     |

|POLY 6             |                                                                                P=0.057N                     |

|LOGISTIC REGRESSION|                                                                                P=0.154N                     |

|COCH-ARM / FISHERS |                                                                                P=0.194N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Brain                                                                                                                            |

|     Mineralization                                                                                                              |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/42.60                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         |

|TERMINAL (d)       |                              2/21 (10%)                                        0/21 (0%)                    |

|FIRST INCIDENCE    |                              731 (T)                                           ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.237N                     |

|POLY 3             |                                                                                P=0.275N                     |

|POLY 1.5           |                                                                                P=0.273N                     |

|POLY 6             |                                                                                P=0.269N                     |

|LOGISTIC REGRESSION|                                                                                (e)                          |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 6


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Clitoral Gland                                                                                                                   |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              26/53 (49%)                                       35/49 (71%)                  |

|POLY-3 RATE (b)    |                              26/47.03                                          35/46.06                     |

|POLY-3 PERCENT (g) |                              55.3%                                             76.0%                        |

|TERMINAL (d)       |                              12/21 (57%)                                       15/21 (71%)                  |

|FIRST INCIDENCE    |                              474                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.084                      |

|POLY 3             |                                                                                P=0.022 *                    |

|POLY 1.5           |                                                                                P=0.019 *                    |

|POLY 6             |                                                                                P=0.027 *                    |

|LOGISTIC REGRESSION|                                                                                P=0.018 *                    |

|COCH-ARM / FISHERS |                                                                                P=0.017 *                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Clitoral Gland: Duct                                                                                                             |

|     Cyst                                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              48/53 (91%)                                       35/49 (71%)                  |

|POLY-3 RATE (b)    |                              48/50.84                                          35/46.42                     |

|POLY-3 PERCENT (g) |                              94.4%                                             75.4%                        |

|TERMINAL (d)       |                              21/21 (100%)                                      14/21 (67%)                  |

|FIRST INCIDENCE    |                              474                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.084N                     |

|POLY 3             |                                                                                P=0.005N**                   |

|POLY 1.5           |                                                                                P=0.006N**                   |

|POLY 6             |                                                                                P=0.004N**                   |

|LOGISTIC REGRESSION|                                                                                P=0.015N*                    |

|COCH-ARM / FISHERS |                                                                                P=0.012N*                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 7


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Eye: Retina                                                                                                                      |

|     Atrophy                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              6/53 (11%)                                        6/50 (12%)                   |

|POLY-3 RATE (b)    |                              6/42.60                                           6/38.82                      |

|POLY-3 PERCENT (g) |                              14.1%                                             15.5%                        |

|TERMINAL (d)       |                              6/21 (29%)                                        2/21 (10%)                   |

|FIRST INCIDENCE    |                              731 (T)                                           645                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.619                      |

|POLY 3             |                                                                                P=0.561                      |

|POLY 1.5           |                                                                                P=0.560                      |

|POLY 6             |                                                                                P=0.583                      |

|LOGISTIC REGRESSION|                                                                                P=0.581                      |

|COCH-ARM / FISHERS |                                                                                P=0.578                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Harderian Gland                                                                                                                  |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              6/53 (11%)                                        9/50 (18%)                   |

|POLY-3 RATE (b)    |                              6/43.76                                           9/39.34                      |

|POLY-3 PERCENT (g) |                              13.7%                                             22.9%                        |

|TERMINAL (d)       |                              2/21 (10%)                                        5/21 (24%)                   |

|FIRST INCIDENCE    |                              546                                               629                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.269                      |

|POLY 3             |                                                                                P=0.215                      |

|POLY 1.5           |                                                                                P=0.222                      |

|POLY 6             |                                                                                P=0.224                      |

|LOGISTIC REGRESSION|                                                                                P=0.218                      |

|COCH-ARM / FISHERS |                                                                                P=0.248                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 8


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Heart                                                                                                                            |

|     Cardiomyopathy                                                                                                              |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              36/52 (69%)                                       22/50 (44%)                  |

|POLY-3 RATE (b)    |                              36/47.96                                          22/41.80                     |

|POLY-3 PERCENT (g) |                              75.1%                                             52.6%                        |

|TERMINAL (d)       |                              15/21 (71%)                                       9/21 (43%)                   |

|FIRST INCIDENCE    |                              396                                               520                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.039N*                    |

|POLY 3             |                                                                                P=0.017N*                    |

|POLY 1.5           |                                                                                P=0.014N*                    |

|POLY 6             |                                                                                P=0.018N*                    |

|LOGISTIC REGRESSION|                                                                                P=0.014N*                    |

|COCH-ARM / FISHERS |                                                                                P=0.009N**                   |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Heart: Atrium                                                                                                                    |

|     Thrombosis                                                                                                                  |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              0/52 (0%)                                         2/50 (4%)                    |

|POLY-3 RATE (b)    |                              0/41.64                                           2/38.98                      |

|POLY-3 PERCENT (g) |                              0.0%                                              5.1%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              ---                                               484                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.234                      |

|POLY 3             |                                                                                P=0.229                      |

|POLY 1.5           |                                                                                P=0.230                      |

|POLY 6             |                                                                                P=0.232                      |

|LOGISTIC REGRESSION|                                                                                P=0.269                      |

|COCH-ARM / FISHERS |                                                                                P=0.238                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 9


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Intestine Large, Colon                                                                                                           |

|     Parasite Metazoan                                                                                                           |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/51 (4%)                                         1/49 (2%)                    |

|POLY-3 RATE (b)    |                              2/41.24                                           1/38.17                      |

|POLY-3 PERCENT (g) |                              4.9%                                              2.6%                         |

|TERMINAL (d)       |                              1/21 (5%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              648                                               614                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.529N                     |

|POLY 3             |                                                                                P=0.536N                     |

|POLY 1.5           |                                                                                P=0.535N                     |

|POLY 6             |                                                                                P=0.527N                     |

|LOGISTIC REGRESSION|                                                                                P=0.516N                     |

|COCH-ARM / FISHERS |                                                                                P=0.515N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Intestine Large, Rectum                                                                                                          |

|     Parasite Metazoan                                                                                                           |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              1/53 (2%)                                         5/50 (10%)                   |

|POLY-3 RATE (b)    |                              1/42.60                                           5/38.80                      |

|POLY-3 PERCENT (g) |                              2.4%                                              12.9%                        |

|TERMINAL (d)       |                              1/21 (5%)                                         3/21 (14%)                   |

|FIRST INCIDENCE    |                              731 (T)                                           641                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.097                      |

|POLY 3             |                                                                                P=0.083                      |

|POLY 1.5           |                                                                                P=0.084                      |

|POLY 6             |                                                                                P=0.086                      |

|LOGISTIC REGRESSION|                                                                                P=0.081                      |

|COCH-ARM / FISHERS |                                                                                P=0.090                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 10


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Kidney                                                                                                                           |

|     Accumulation, Hyaline Droplet                                                                                               |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    |

|POLY-3 RATE (b)    |                              0/42.60                                           2/39.00                      |

|POLY-3 PERCENT (g) |                              0.0%                                              5.1%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         1/21 (5%)                    |

|FIRST INCIDENCE    |                              ---                                               394                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.229                      |

|POLY 3             |                                                                                P=0.227                      |

|POLY 1.5           |                                                                                P=0.227                      |

|POLY 6             |                                                                                P=0.229                      |

|LOGISTIC REGRESSION|                                                                                P=0.293                      |

|COCH-ARM / FISHERS |                                                                                P=0.233                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Kidney                                                                                                                           |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/43.25                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.6%                                              0.0%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              604                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.265N                     |

|POLY 3             |                                                                                P=0.281N                     |

|POLY 1.5           |                                                                                P=0.276N                     |

|POLY 6             |                                                                                P=0.281N                     |

|LOGISTIC REGRESSION|                                                                                P=0.232N                     |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 11


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Kidney                                                                                                                           |

|     Mineralization                                                                                                              |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              42/53 (79%)                                       42/50 (84%)                  |

|POLY-3 RATE (b)    |                              42/51.69                                          42/46.21                     |

|POLY-3 PERCENT (g) |                              81.3%                                             90.9%                        |

|TERMINAL (d)       |                              15/21 (71%)                                       19/21 (91%)                  |

|FIRST INCIDENCE    |                              396                                               394                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.448                      |

|POLY 3             |                                                                                P=0.132                      |

|POLY 1.5           |                                                                                P=0.183                      |

|POLY 6             |                                                                                P=0.108                      |

|LOGISTIC REGRESSION|                                                                                P=0.280                      |

|COCH-ARM / FISHERS |                                                                                P=0.357                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Kidney                                                                                                                           |

|     Nephropathy                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              52/53 (98%)                                       41/50 (82%)                  |

|POLY-3 RATE (b)    |                              52/52.55                                          41/45.19                     |

|POLY-3 PERCENT (g) |                              99.0%                                             90.7%                        |

|TERMINAL (d)       |                              21/21 (100%)                                      20/21 (95%)                  |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.134N                     |

|POLY 3             |                                                                                P=0.045N*                    |

|POLY 1.5           |                                                                                P=0.018N*                    |

|POLY 6             |                                                                                P=0.115N                     |

|LOGISTIC REGRESSION|                                                                                P=0.023N*                    |

|COCH-ARM / FISHERS |                                                                                P=0.006N**                   |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 12


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Kidney: Pelvis                                                                                                                   |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/42.71                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         |

|TERMINAL (d)       |                              1/21 (5%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              701                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.236N                     |

|POLY 3             |                                                                                P=0.277N                     |

|POLY 1.5           |                                                                                P=0.273N                     |

|POLY 6             |                                                                                P=0.272N                     |

|LOGISTIC REGRESSION|                                                                                P=0.249N                     |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Kidney: Transitional Epithelium                                                                                                  |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              11/53 (21%)                                       5/50 (10%)                   |

|POLY-3 RATE (b)    |                              11/44.07                                          5/39.18                      |

|POLY-3 PERCENT (g) |                              25.0%                                             12.8%                        |

|TERMINAL (d)       |                              6/21 (29%)                                        1/21 (5%)                    |

|FIRST INCIDENCE    |                              599                                               584                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.113N                     |

|POLY 3             |                                                                                P=0.130N                     |

|POLY 1.5           |                                                                                P=0.127N                     |

|POLY 6             |                                                                                P=0.122N                     |

|LOGISTIC REGRESSION|                                                                                P=0.126N                     |

|COCH-ARM / FISHERS |                                                                                P=0.108N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 13


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Angiectasis                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              5/53 (9%)                                         4/50 (8%)                    |

|POLY-3 RATE (b)    |                              5/43.18                                           4/38.16                      |

|POLY-3 PERCENT (g) |                              11.6%                                             10.5%                        |

|TERMINAL (d)       |                              3/21 (14%)                                        4/21 (19%)                   |

|FIRST INCIDENCE    |                              561                                               731 (T)                      |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.506N                     |

|POLY 3             |                                                                                P=0.587N                     |

|POLY 1.5           |                                                                                P=0.576N                     |

|POLY 6             |                                                                                P=0.584N                     |

|LOGISTIC REGRESSION|                                                                                P=0.549N                     |

|COCH-ARM / FISHERS |                                                                                P=0.537N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Basophilic Focus                                                                                                            |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              8/53 (15%)                                        16/50 (32%)                  |

|POLY-3 RATE (b)    |                              8/43.83                                           16/39.93                     |

|POLY-3 PERCENT (g) |                              18.3%                                             40.1%                        |

|TERMINAL (d)       |                              3/21 (14%)                                        7/21 (33%)                   |

|FIRST INCIDENCE    |                              610                                               520                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.062                      |

|POLY 3             |                                                                                P=0.021 *                    |

|POLY 1.5           |                                                                                P=0.024 *                    |

|POLY 6             |                                                                                P=0.022 *                    |

|LOGISTIC REGRESSION|                                                                                P=0.024 *                    |

|COCH-ARM / FISHERS |                                                                                P=0.036 *                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 14


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Cholangiofibrosis                                                                                                           |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              31/53 (58%)                                       1/50 (2%)                    |

|POLY-3 RATE (b)    |                              31/47.12                                          1/38.16                      |

|POLY-3 PERCENT (g) |                              65.8%                                             2.6%                         |

|TERMINAL (d)       |                              13/21 (62%)                                       1/21 (5%)                    |

|FIRST INCIDENCE    |                              581                                               731 (T)                      |

|-------------------|                                                                                                             |

|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)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Clear Cell Focus                                                                                                            |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         8/50 (16%)                   |

|POLY-3 RATE (b)    |                              2/42.60                                           8/38.16                      |

|POLY-3 PERCENT (g) |                              4.7%                                              21.0%                        |

|TERMINAL (d)       |                              2/21 (10%)                                        8/21 (38%)                   |

|FIRST INCIDENCE    |                              731 (T)                                           731 (T)                      |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.037 *                    |

|POLY 3             |                                                                                P=0.029 *                    |

|POLY 1.5           |                                                                                P=0.031 *                    |

|POLY 6             |                                                                                P=0.028 *                    |

|LOGISTIC REGRESSION|                                                                                P=0.037 *                    |

|COCH-ARM / FISHERS |                                                                                P=0.037 *                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 15


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Congestion                                                                                                                  |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/43.86                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.6%                                              0.0%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              396                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.275N                     |

|POLY 3             |                                                                                P=0.287N                     |

|POLY 1.5           |                                                                                P=0.279N                     |

|POLY 6             |                                                                                P=0.286N                     |

|LOGISTIC REGRESSION|                                                                                P=0.098N                     |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Cytoplasmic Alteration                                                                                                      |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         1/50 (2%)                    |

|POLY-3 RATE (b)    |                              2/42.60                                           1/38.16                      |

|POLY-3 PERCENT (g) |                              4.7%                                              2.6%                         |

|TERMINAL (d)       |                              2/21 (10%)                                        1/21 (5%)                    |

|FIRST INCIDENCE    |                              731 (T)                                           731 (T)                      |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.500N                     |

|POLY 3             |                                                                                P=0.552N                     |

|POLY 1.5           |                                                                                P=0.548N                     |

|POLY 6             |                                                                                P=0.545N                     |

|LOGISTIC REGRESSION|                                                                                P=0.500N                     |

|COCH-ARM / FISHERS |                                                                                P=0.522N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 16


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Degeneration Cystic                                                                                                         |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              4/53 (8%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              4/43.34                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              9.2%                                              0.0%                         |

|TERMINAL (d)       |                              2/21 (10%)                                        0/21 (0%)                    |

|FIRST INCIDENCE    |                              610                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.075N                     |

|POLY 3             |                                                                                P=0.082N                     |

|POLY 1.5           |                                                                                P=0.080N                     |

|POLY 6             |                                                                                P=0.082N                     |

|LOGISTIC REGRESSION|                                                                                P=0.075N                     |

|COCH-ARM / FISHERS |                                                                                P=0.066N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Eosinophilic Focus                                                                                                          |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              44/53 (83%)                                       27/50 (54%)                  |

|POLY-3 RATE (b)    |                              44/51.46                                          27/43.77                     |

|POLY-3 PERCENT (g) |                              85.5%                                             61.7%                        |

|TERMINAL (d)       |                              18/21 (86%)                                       12/21 (57%)                  |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.022N*                    |

|POLY 3             |                                                                                P=0.005N**                   |

|POLY 1.5           |                                                                                P=0.002N**                   |

|POLY 6             |                                                                                P=0.010N*                    |

|LOGISTIC REGRESSION|                                                                                P=0.002N**                   |

|COCH-ARM / FISHERS |                                                                                P<0.001N**                   |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 17


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Fatty Change Diffuse                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              48/53 (91%)                                       10/50 (20%)                  |

|POLY-3 RATE (b)    |                              48/51.82                                          10/40.49                     |

|POLY-3 PERCENT (g) |                              92.6%                                             24.7%                        |

|TERMINAL (d)       |                              19/21 (91%)                                       3/21 (14%)                   |

|FIRST INCIDENCE    |                              396                                               520                          |

|-------------------|                                                                                                             |

|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)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Fatty Change Focal                                                                                                          |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         8/50 (16%)                   |

|POLY-3 RATE (b)    |                              2/43.03                                           8/38.49                      |

|POLY-3 PERCENT (g) |                              4.7%                                              20.8%                        |

|TERMINAL (d)       |                              1/21 (5%)                                         6/21 (29%)                   |

|FIRST INCIDENCE    |                              604                                               645                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.045 *                    |

|POLY 3             |                                                                                P=0.029 *                    |

|POLY 1.5           |                                                                                P=0.031 *                    |

|POLY 6             |                                                                                P=0.029 *                    |

|LOGISTIC REGRESSION|                                                                                P=0.033 *                    |

|COCH-ARM / FISHERS |                                                                                P=0.037 *                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 18


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Hematopoietic Cell Proliferation                                                                                            |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         2/50 (4%)                    |

|POLY-3 RATE (b)    |                              2/43.47                                           2/38.27                      |

|POLY-3 PERCENT (g) |                              4.6%                                              5.2%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         1/21 (5%)                    |

|FIRST INCIDENCE    |                              599                                               702                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.662                      |

|POLY 3             |                                                                                P=0.661                      |

|POLY 1.5           |                                                                                P=0.665                      |

|POLY 6             |                                                                                P=0.662                      |

|LOGISTIC REGRESSION|                                                                                P=0.676                      |

|COCH-ARM / FISHERS |                                                                                P=0.669                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              36/53 (68%)                                       0/50 (0%)                    |

|POLY-3 RATE (b)    |                              36/49.45                                          0/38.16                      |

|POLY-3 PERCENT (g) |                              72.8%                                             0.0%                         |

|TERMINAL (d)       |                              14/21 (67%)                                       0/21 (0%)                    |

|FIRST INCIDENCE    |                              396                                               ---                          |

|-------------------|                                                                                                             |

|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:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 19


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              49/53 (92%)                                       43/50 (86%)                  |

|POLY-3 RATE (b)    |                              49/52.42                                          43/46.89                     |

|POLY-3 PERCENT (g) |                              93.5%                                             91.7%                        |

|TERMINAL (d)       |                              18/21 (86%)                                       20/21 (95%)                  |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.355N                     |

|POLY 3             |                                                                                P=0.530N                     |

|POLY 1.5           |                                                                                P=0.408N                     |

|POLY 6             |                                                                                P=0.650N                     |

|LOGISTIC REGRESSION|                                                                                P=0.314N                     |

|COCH-ARM / FISHERS |                                                                                P=0.230N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Mixed Cell Focus                                                                                                            |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              21/53 (40%)                                       29/50 (58%)                  |

|POLY-3 RATE (b)    |                              21/45.03                                          29/41.58                     |

|POLY-3 PERCENT (g) |                              46.6%                                             69.8%                        |

|TERMINAL (d)       |                              14/21 (67%)                                       19/21 (91%)                  |

|FIRST INCIDENCE    |                              396                                               474                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.060                      |

|POLY 3             |                                                                                P=0.017 *                    |

|POLY 1.5           |                                                                                P=0.022 *                    |

|POLY 6             |                                                                                P=0.018 *                    |

|LOGISTIC REGRESSION|                                                                                P=0.018 *                    |

|COCH-ARM / FISHERS |                                                                                P=0.047 *                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 20


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Necrosis                                                                                                                    |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              17/53 (32%)                                       8/50 (16%)                   |

|POLY-3 RATE (b)    |                              17/46.77                                          8/40.81                      |

|POLY-3 PERCENT (g) |                              36.4%                                             19.6%                        |

|TERMINAL (d)       |                              2/21 (10%)                                        1/21 (5%)                    |

|FIRST INCIDENCE    |                              474                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.064N                     |

|POLY 3             |                                                                                P=0.066N                     |

|POLY 1.5           |                                                                                P=0.057N                     |

|POLY 6             |                                                                                P=0.080N                     |

|LOGISTIC REGRESSION|                                                                                P=0.028N*                    |

|COCH-ARM / FISHERS |                                                                                P=0.046N*                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Pigmentation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              53/53 (100%)                                      45/50 (90%)                  |

|POLY-3 RATE (b)    |                              53/53.00                                          45/47.82                     |

|POLY-3 PERCENT (g) |                              100.0%                                            94.1%                        |

|TERMINAL (d)       |                              21/21 (100%)                                      20/21 (95%)                  |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.270N                     |

|POLY 3             |                                                                                P=0.098N                     |

|POLY 1.5           |                                                                                P=0.056N                     |

|POLY 6             |                                                                                P=0.156N                     |

|LOGISTIC REGRESSION|                                                                                P=0.051N                     |

|COCH-ARM / FISHERS |                                                                                P=0.024N*                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 21


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Toxic Hepatopathy                                                                                                           |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              53/53 (100%)                                      16/50 (32%)                  |

|POLY-3 RATE (b)    |                              53/53.00                                          16/40.19                     |

|POLY-3 PERCENT (g) |                              100.0%                                            39.8%                        |

|TERMINAL (d)       |                              21/21 (100%)                                      9/21 (43%)                   |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|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)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver: Artery                                                                                                                    |

|     Inflammation Chronic                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/43.31                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.6%                                              0.0%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              581                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.269N                     |

|POLY 3             |                                                                                P=0.282N                     |

|POLY 1.5           |                                                                                P=0.276N                     |

|POLY 6             |                                                                                P=0.281N                     |

|LOGISTIC REGRESSION|                                                                                P=0.222N                     |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 22


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver: Bile Duct                                                                                                                 |

|     Cyst                                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              21/53 (40%)                                       6/50 (12%)                   |

|POLY-3 RATE (b)    |                              21/44.46                                          6/38.64                      |

|POLY-3 PERCENT (g) |                              47.2%                                             15.5%                        |

|TERMINAL (d)       |                              14/21 (67%)                                       3/21 (14%)                   |

|FIRST INCIDENCE    |                              612                                               643                          |

|-------------------|                                                                                                             |

|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)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver: Bile Duct                                                                                                                 |

|     Fibrosis                                                                                                                    |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              4/53 (8%)                                         5/50 (10%)                   |

|POLY-3 RATE (b)    |                              4/43.38                                           5/38.27                      |

|POLY-3 PERCENT (g) |                              9.2%                                              13.1%                        |

|TERMINAL (d)       |                              2/21 (10%)                                        4/21 (19%)                   |

|FIRST INCIDENCE    |                              598                                               702                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.478                      |

|POLY 3             |                                                                                P=0.430                      |

|POLY 1.5           |                                                                                P=0.439                      |

|POLY 6             |                                                                                P=0.431                      |

|LOGISTIC REGRESSION|                                                                                P=0.439                      |

|COCH-ARM / FISHERS |                                                                                P=0.463                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 23


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver: Bile Duct                                                                                                                 |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              53/53 (100%)                                      7/50 (14%)                   |

|POLY-3 RATE (b)    |                              53/53.00                                          7/39.33                      |

|POLY-3 PERCENT (g) |                              100.0%                                            17.8%                        |

|TERMINAL (d)       |                              21/21 (100%)                                      2/21 (10%)                   |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|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)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver: Centrilobular                                                                                                             |

|     Degeneration                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              5/53 (9%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              5/43.88                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              11.4%                                             0.0%                         |

|TERMINAL (d)       |                              1/21 (5%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              610                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.047N*                    |

|POLY 3             |                                                                                P=0.047N*                    |

|POLY 1.5           |                                                                                P=0.044N*                    |

|POLY 6             |                                                                                P=0.048N*                    |

|LOGISTIC REGRESSION|                                                                                P=0.037N*                    |

|COCH-ARM / FISHERS |                                                                                P=0.033N*                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 24


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver: Hepatocyte                                                                                                                |

|     Hypertrophy                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              52/53 (98%)                                       22/50 (44%)                  |

|POLY-3 RATE (b)    |                              52/52.59                                          22/43.28                     |

|POLY-3 PERCENT (g) |                              98.9%                                             50.8%                        |

|TERMINAL (d)       |                              21/21 (100%)                                      9/21 (43%)                   |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|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)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver: Hepatocyte                                                                                                                |

|     Multinucleated                                                                                                              |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              51/53 (96%)                                       32/50 (64%)                  |

|POLY-3 RATE (b)    |                              51/52.67                                          32/43.19                     |

|POLY-3 PERCENT (g) |                              96.8%                                             74.1%                        |

|TERMINAL (d)       |                              20/21 (95%)                                       16/21 (76%)                  |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.012N*                    |

|POLY 3             |                                                                                P<0.001N**                   |

|POLY 1.5           |                                                                                P<0.001N**                   |

|POLY 6             |                                                                                P=0.002N**                   |

|LOGISTIC REGRESSION|                                                                                P<0.001N**                   |

|COCH-ARM / FISHERS |                                                                                P<0.001N**                   |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 25


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver: Oval Cell                                                                                                                 |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              53/53 (100%)                                      1/50 (2%)                    |

|POLY-3 RATE (b)    |                              53/53.00                                          1/38.16                      |

|POLY-3 PERCENT (g) |                              100.0%                                            2.6%                         |

|TERMINAL (d)       |                              21/21 (100%)                                      1/21 (5%)                    |

|FIRST INCIDENCE    |                              396                                               731 (T)                      |

|-------------------|                                                                                                             |

|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)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Liver: Portal                                                                                                                    |

|     Fibrosis                                                                                                                    |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              27/53 (51%)                                       1/50 (2%)                    |

|POLY-3 RATE (b)    |                              27/47.36                                          1/38.52                      |

|POLY-3 PERCENT (g) |                              57.0%                                             2.6%                         |

|TERMINAL (d)       |                              11/21 (52%)                                       0/21 (0%)                    |

|FIRST INCIDENCE    |                              474                                               629                          |

|-------------------|                                                                                                             |

|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:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 26


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lung                                                                                                                             |

|     Hemorrhage                                                                                                                  |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/52 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/42.48                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              474                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.249N                     |

|POLY 3             |                                                                                P=0.275N                     |

|POLY 1.5           |                                                                                P=0.269N                     |

|POLY 6             |                                                                                P=0.272N                     |

|LOGISTIC REGRESSION|                                                                                P=0.182N                     |

|COCH-ARM / FISHERS |                                                                                P=0.257N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lung                                                                                                                             |

|     Infiltration Cellular Histiocyte                                                                                            |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              50/52 (96%)                                       41/50 (82%)                  |

|POLY-3 RATE (b)    |                              50/51.42                                          41/44.42                     |

|POLY-3 PERCENT (g) |                              97.2%                                             92.3%                        |

|TERMINAL (d)       |                              20/21 (95%)                                       19/21 (91%)                  |

|FIRST INCIDENCE    |                              396                                               520                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.207N                     |

|POLY 3             |                                                                                P=0.246N                     |

|POLY 1.5           |                                                                                P=0.106N                     |

|POLY 6             |                                                                                P=0.407N                     |

|LOGISTIC REGRESSION|                                                                                P=0.091N                     |

|COCH-ARM / FISHERS |                                                                                P=0.022N*                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 27


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lung                                                                                                                             |

|     Metaplasia                                                                                                                  |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              6/52 (12%)                                        3/50 (6%)                    |

|POLY-3 RATE (b)    |                              6/43.19                                           3/39.10                      |

|POLY-3 PERCENT (g) |                              13.9%                                             7.7%                         |

|TERMINAL (d)       |                              2/21 (10%)                                        0/21 (0%)                    |

|FIRST INCIDENCE    |                              561                                               578                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.293N                     |

|POLY 3             |                                                                                P=0.298N                     |

|POLY 1.5           |                                                                                P=0.292N                     |

|POLY 6             |                                                                                P=0.291N                     |

|LOGISTIC REGRESSION|                                                                                P=0.247N                     |

|COCH-ARM / FISHERS |                                                                                P=0.264N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lung: Alveolar Epithelium                                                                                                        |

|     Metaplasia Bronchiolar                                                                                                      |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              46/52 (88%)                                       31/50 (62%)                  |

|POLY-3 RATE (b)    |                              46/50.05                                          31/41.68                     |

|POLY-3 PERCENT (g) |                              91.9%                                             74.4%                        |

|TERMINAL (d)       |                              19/21 (91%)                                       16/21 (76%)                  |

|FIRST INCIDENCE    |                              396                                               578                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.034N*                    |

|POLY 3             |                                                                                P=0.013N*                    |

|POLY 1.5           |                                                                                P=0.005N**                   |

|POLY 6             |                                                                                P=0.035N*                    |

|LOGISTIC REGRESSION|                                                                                P=0.005N**                   |

|COCH-ARM / FISHERS |                                                                                P=0.002N**                   |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 28


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lymph Node, Mandibular                                                                                                           |

|     Ectasia                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              6/52 (12%)                                        2/49 (4%)                    |

|POLY-3 RATE (b)    |                              6/41.66                                           2/37.52                      |

|POLY-3 PERCENT (g) |                              14.4%                                             5.3%                         |

|TERMINAL (d)       |                              6/21 (29%)                                        2/21 (10%)                   |

|FIRST INCIDENCE    |                              731 (T)                                           731 (T)                      |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.122N                     |

|POLY 3             |                                                                                P=0.171N                     |

|POLY 1.5           |                                                                                P=0.171N                     |

|POLY 6             |                                                                                P=0.159N                     |

|LOGISTIC REGRESSION|                                                                                P=0.122N                     |

|COCH-ARM / FISHERS |                                                                                P=0.155N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lymph Node, Mandibular                                                                                                           |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              16/52 (31%)                                       30/49 (61%)                  |

|POLY-3 RATE (b)    |                              16/44.39                                          30/42.19                     |

|POLY-3 PERCENT (g) |                              36.0%                                             71.1%                        |

|TERMINAL (d)       |                              10/21 (48%)                                       15/21 (71%)                  |

|FIRST INCIDENCE    |                              396                                               410                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.008 **                   |

|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=0.002 **                   |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 29


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lymph Node, Mandibular                                                                                                           |

|     Hyperplasia Lymphoid                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/52 (4%)                                         2/49 (4%)                    |

|POLY-3 RATE (b)    |                              2/42.56                                           2/37.52                      |

|POLY-3 PERCENT (g) |                              4.7%                                              5.3%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         2/21 (10%)                   |

|FIRST INCIDENCE    |                              581                                               731 (T)                      |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.658                      |

|POLY 3             |                                                                                P=0.661                      |

|POLY 1.5           |                                                                                P=0.665                      |

|POLY 6             |                                                                                P=0.663                      |

|LOGISTIC REGRESSION|                                                                                P=0.672                      |

|COCH-ARM / FISHERS |                                                                                P=0.668                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lymph Node, Mesenteric                                                                                                           |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/51 (4%)                                         1/49 (2%)                    |

|POLY-3 RATE (b)    |                              2/41.63                                           1/38.05                      |

|POLY-3 PERCENT (g) |                              4.8%                                              2.6%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              598                                               653                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.542N                     |

|POLY 3             |                                                                                P=0.542N                     |

|POLY 1.5           |                                                                                P=0.538N                     |

|POLY 6             |                                                                                P=0.537N                     |

|LOGISTIC REGRESSION|                                                                                P=0.494N                     |

|COCH-ARM / FISHERS |                                                                                P=0.515N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 30


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lymph Node: Lumbar                                                                                                               |

|     Ectasia                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              0/9 (0%)                                          2/5 (40%)                    |

|POLY-3 RATE (b)    |                              0/6.57                                            2/3.67                       |

|POLY-3 PERCENT (g) |                              0.0%                                              54.5%                        |

|TERMINAL (d)       |                              0/3 (0%)                                          0/0 (0%)                     |

|FIRST INCIDENCE    |                              ---                                               578                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.210                      |

|POLY 3             |                                                                                P=0.111                      |

|POLY 1.5           |                                                                                P=0.118                      |

|POLY 6             |                                                                                P=0.102                      |

|LOGISTIC REGRESSION|                                                                                P=0.137                      |

|COCH-ARM / FISHERS |                                                                                P=0.110                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lymph Node: Lumbar                                                                                                               |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              0/9 (0%)                                          2/5 (40%)                    |

|POLY-3 RATE (b)    |                              0/6.57                                            2/3.89                       |

|POLY-3 PERCENT (g) |                              0.0%                                              51.4%                        |

|TERMINAL (d)       |                              0/3 (0%)                                          0/0 (0%)                     |

|FIRST INCIDENCE    |                              ---                                               474                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.210                      |

|POLY 3             |                                                                                P=0.116                      |

|POLY 1.5           |                                                                                P=0.121                      |

|POLY 6             |                                                                                P=0.107                      |

|LOGISTIC REGRESSION|                                                                                P=0.172                      |

|COCH-ARM / FISHERS |                                                                                P=0.110                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 31


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lymph Node: Mediastinal                                                                                                          |

|     Ectasia                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              3/9 (33%)                                         0/5 (0%)                     |

|POLY-3 RATE (b)    |                              3/7.60                                            0/2.73                       |

|POLY-3 PERCENT (g) |                              39.5%                                             0.0%                         |

|TERMINAL (d)       |                              0/3 (0%)                                          0/0 (0%)                     |

|FIRST INCIDENCE    |                              546                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.136N                     |

|POLY 3             |                                                                                P=0.562N                     |

|POLY 1.5           |                                                                                P=0.404N                     |

|POLY 6             |                                                                                P=0.850N                     |

|LOGISTIC REGRESSION|                                                                                P=0.211N                     |

|COCH-ARM / FISHERS |                                                                                P=0.231N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Lymph Node: Mediastinal                                                                                                          |

|     Hemorrhage                                                                                                                  |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              5/9 (56%)                                         1/5 (20%)                    |

|POLY-3 RATE (b)    |                              5/8.27                                            1/2.84                       |

|POLY-3 PERCENT (g) |                              60.5%                                             35.2%                        |

|TERMINAL (d)       |                              1/3 (33%)                                         0/0 (0%)                     |

|FIRST INCIDENCE    |                              474                                               702                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.214N                     |

|POLY 3             |                                                                                P=0.693N                     |

|POLY 1.5           |                                                                                P=0.484N                     |

|POLY 6             |                                                                                P=0.936N                     |

|LOGISTIC REGRESSION|                                                                                P=0.267N                     |

|COCH-ARM / FISHERS |                                                                                P=0.238N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 32


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Mammary Gland                                                                                                                    |

|     Cyst                                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              1/53 (2%)                                         4/50 (8%)                    |

|POLY-3 RATE (b)    |                              1/42.92                                           4/38.27                      |

|POLY-3 PERCENT (g) |                              2.3%                                              10.5%                        |

|TERMINAL (d)       |                              0/21 (0%)                                         3/21 (14%)                   |

|FIRST INCIDENCE    |                              641                                               702                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.180                      |

|POLY 3             |                                                                                P=0.151                      |

|POLY 1.5           |                                                                                P=0.154                      |

|POLY 6             |                                                                                P=0.152                      |

|LOGISTIC REGRESSION|                                                                                P=0.152                      |

|COCH-ARM / FISHERS |                                                                                P=0.164                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Mammary Gland                                                                                                                    |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              16/53 (30%)                                       19/50 (38%)                  |

|POLY-3 RATE (b)    |                              16/44.03                                          19/40.90                     |

|POLY-3 PERCENT (g) |                              36.3%                                             46.5%                        |

|TERMINAL (d)       |                              10/21 (48%)                                       9/21 (43%)                   |

|FIRST INCIDENCE    |                              614                                               410                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.328                      |

|POLY 3             |                                                                                P=0.230                      |

|POLY 1.5           |                                                                                P=0.231                      |

|POLY 6             |                                                                                P=0.260                      |

|LOGISTIC REGRESSION|                                                                                P=0.199                      |

|COCH-ARM / FISHERS |                                                                                P=0.265                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 33


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Mesentery: Artery                                                                                                                |

|     Inflammation Chronic                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              7/8 (88%)                                         1/1 (100%)                   |

|POLY-3 RATE (b)    |                              7/7.72                                            1/1.00                       |

|POLY-3 PERCENT (g) |                              90.7%                                             100.0%                       |

|TERMINAL (d)       |                              3/3 (100%)                                        0/0 (0%)                     |

|FIRST INCIDENCE    |                              581                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.234N                     |

|POLY 3             |                                                                                P=0.999                      |

|POLY 1.5           |                                                                                P=0.997                      |

|POLY 6             |                                                                                P=1.000                      |

|LOGISTIC REGRESSION|                                                                                (e)                          |

|COCH-ARM / FISHERS |                                                                                P=0.889                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Nose                                                                                                                             |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              4/53 (8%)                                         1/50 (2%)                    |

|POLY-3 RATE (b)    |                              4/42.93                                           1/38.16                      |

|POLY-3 PERCENT (g) |                              9.3%                                              2.6%                         |

|TERMINAL (d)       |                              3/21 (14%)                                        1/21 (5%)                    |

|FIRST INCIDENCE    |                              638                                               731 (T)                      |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.188N                     |

|POLY 3             |                                                                                P=0.224N                     |

|POLY 1.5           |                                                                                P=0.219N                     |

|POLY 6             |                                                                                P=0.219N                     |

|LOGISTIC REGRESSION|                                                                                P=0.199N                     |

|COCH-ARM / FISHERS |                                                                                P=0.200N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 34


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Nose: Septum                                                                                                                     |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/42.93                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         |

|TERMINAL (d)       |                              1/21 (5%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              638                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.257N                     |

|POLY 3             |                                                                                P=0.279N                     |

|POLY 1.5           |                                                                                P=0.274N                     |

|POLY 6             |                                                                                P=0.275N                     |

|LOGISTIC REGRESSION|                                                                                P=0.259N                     |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Nose: Turbinate, Septum                                                                                                          |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/43.48                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.6%                                              0.0%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              561                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.277N                     |

|POLY 3             |                                                                                P=0.284N                     |

|POLY 1.5           |                                                                                P=0.277N                     |

|POLY 6             |                                                                                P=0.283N                     |

|LOGISTIC REGRESSION|                                                                                P=0.196N                     |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 35


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Oral Mucosa: Gingival                                                                                                            |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              16/29 (55%)                                       8/11 (73%)                   |

|POLY-3 RATE (b)    |                              16/24.97                                          8/10.01                      |

|POLY-3 PERCENT (g) |                              64.1%                                             80.0%                        |

|TERMINAL (d)       |                              6/9 (67%)                                         2/2 (100%)                   |

|FIRST INCIDENCE    |                              581                                               345                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.398N                     |

|POLY 3             |                                                                                P=0.350                      |

|POLY 1.5           |                                                                                P=0.332                      |

|POLY 6             |                                                                                P=0.382                      |

|LOGISTIC REGRESSION|                                                                                P=0.208                      |

|COCH-ARM / FISHERS |                                                                                P=0.261                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Ovary                                                                                                                            |

|     Atrophy                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              31/53 (58%)                                       45/49 (92%)                  |

|POLY-3 RATE (b)    |                              31/49.18                                          45/46.77                     |

|POLY-3 PERCENT (g) |                              63.0%                                             96.2%                        |

|TERMINAL (d)       |                              11/21 (52%)                                       20/21 (95%)                  |

|FIRST INCIDENCE    |                              546                                               345                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.021 *                    |

|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:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 36


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Ovary                                                                                                                            |

|     Cyst                                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              13/53 (25%)                                       16/49 (33%)                  |

|POLY-3 RATE (b)    |                              13/45.33                                          16/40.78                     |

|POLY-3 PERCENT (g) |                              28.7%                                             39.2%                        |

|TERMINAL (d)       |                              7/21 (33%)                                        5/21 (24%)                   |

|FIRST INCIDENCE    |                              474                                               578                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.297                      |

|POLY 3             |                                                                                P=0.210                      |

|POLY 1.5           |                                                                                P=0.210                      |

|POLY 6             |                                                                                P=0.242                      |

|LOGISTIC REGRESSION|                                                                                P=0.226                      |

|COCH-ARM / FISHERS |                                                                                P=0.245                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             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)       |                              1/1 (100%)                                        1/1 (100%)                   |

|FIRST INCIDENCE    |                              731 (T)                                           643                          |

|-------------------|                                                                                                             |

|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:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 37


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Pancreas                                                                                                                         |

|     Inflammation Chronic                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              6/51 (12%)                                        4/49 (8%)                    |

|POLY-3 RATE (b)    |                              6/42.58                                           4/37.98                      |

|POLY-3 PERCENT (g) |                              14.1%                                             10.5%                        |

|TERMINAL (d)       |                              2/21 (10%)                                        3/21 (14%)                   |

|FIRST INCIDENCE    |                              581                                               673                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.421N                     |

|POLY 3             |                                                                                P=0.451N                     |

|POLY 1.5           |                                                                                P=0.437N                     |

|POLY 6             |                                                                                P=0.454N                     |

|LOGISTIC REGRESSION|                                                                                P=0.409N                     |

|COCH-ARM / FISHERS |                                                                                P=0.396N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Pancreas: Acinus                                                                                                                 |

|     Atrophy                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              9/51 (18%)                                        4/49 (8%)                    |

|POLY-3 RATE (b)    |                              9/43.33                                           4/37.98                      |

|POLY-3 PERCENT (g) |                              20.8%                                             10.5%                        |

|TERMINAL (d)       |                              3/21 (14%)                                        3/21 (14%)                   |

|FIRST INCIDENCE    |                              581                                               673                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.161N                     |

|POLY 3             |                                                                                P=0.174N                     |

|POLY 1.5           |                                                                                P=0.162N                     |

|POLY 6             |                                                                                P=0.182N                     |

|LOGISTIC REGRESSION|                                                                                P=0.140N                     |

|COCH-ARM / FISHERS |                                                                                P=0.133N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 38


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Pancreas: Acinus                                                                                                                 |

|     Vacuolization Cytoplasmic                                                                                                   |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              42/51 (82%)                                       0/49 (0%)                    |

|POLY-3 RATE (b)    |                              42/47.15                                          0/37.76                      |

|POLY-3 PERCENT (g) |                              89.1%                                             0.0%                         |

|TERMINAL (d)       |                              21/21 (100%)                                      0/21 (0%)                    |

|FIRST INCIDENCE    |                              546                                               ---                          |

|-------------------|                                                                                                             |

|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)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Pancreas: Artery                                                                                                                 |

|     Inflammation Chronic                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              7/51 (14%)                                        2/49 (4%)                    |

|POLY-3 RATE (b)    |                              7/42.11                                           2/38.73                      |

|POLY-3 PERCENT (g) |                              16.6%                                             5.2%                         |

|TERMINAL (d)       |                              4/21 (19%)                                        1/21 (5%)                    |

|FIRST INCIDENCE    |                              581                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.103N                     |

|POLY 3             |                                                                                P=0.100N                     |

|POLY 1.5           |                                                                                P=0.098N                     |

|POLY 6             |                                                                                P=0.097N                     |

|LOGISTIC REGRESSION|                                                                                P=0.070N                     |

|COCH-ARM / FISHERS |                                                                                P=0.090N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 39


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Pituitary Gland                                                                                                                  |

|     Angiectasis                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              9/52 (17%)                                        15/50 (30%)                  |

|POLY-3 RATE (b)    |                              9/43.32                                           15/39.36                     |

|POLY-3 PERCENT (g) |                              20.8%                                             38.1%                        |

|TERMINAL (d)       |                              4/21 (19%)                                        8/21 (38%)                   |

|FIRST INCIDENCE    |                              647                                               614                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.133                      |

|POLY 3             |                                                                                P=0.064                      |

|POLY 1.5           |                                                                                P=0.072                      |

|POLY 6             |                                                                                P=0.065                      |

|LOGISTIC REGRESSION|                                                                                P=0.068                      |

|COCH-ARM / FISHERS |                                                                                P=0.101                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Pituitary Gland                                                                                                                  |

|     Vacuolization Cytoplasmic                                                                                                   |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              0/52 (0%)                                         3/50 (6%)                    |

|POLY-3 RATE (b)    |                              0/42.44                                           3/38.38                      |

|POLY-3 PERCENT (g) |                              0.0%                                              7.8%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         2/21 (10%)                   |

|FIRST INCIDENCE    |                              ---                                               673                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.120                      |

|POLY 3             |                                                                                P=0.106                      |

|POLY 1.5           |                                                                                P=0.108                      |

|POLY 6             |                                                                                P=0.107                      |

|LOGISTIC REGRESSION|                                                                                P=0.106                      |

|COCH-ARM / FISHERS |                                                                                P=0.114                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 40


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Pituitary Gland: Pars Distalis                                                                                                   |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              19/52 (37%)                                       18/50 (36%)                  |

|POLY-3 RATE (b)    |                              19/46.73                                          18/40.67                     |

|POLY-3 PERCENT (g) |                              40.7%                                             44.3%                        |

|TERMINAL (d)       |                              8/21 (38%)                                        9/21 (43%)                   |

|FIRST INCIDENCE    |                              581                                               578                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.565                      |

|POLY 3             |                                                                                P=0.457                      |

|POLY 1.5           |                                                                                P=0.501                      |

|POLY 6             |                                                                                P=0.434                      |

|LOGISTIC REGRESSION|                                                                                P=0.543                      |

|COCH-ARM / FISHERS |                                                                                P=0.559N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Salivary Glands                                                                                                                  |

|     Atrophy                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              0/52 (0%)                                         2/49 (4%)                    |

|POLY-3 RATE (b)    |                              0/41.66                                           2/37.63                      |

|POLY-3 PERCENT (g) |                              0.0%                                              5.3%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         1/21 (5%)                    |

|FIRST INCIDENCE    |                              ---                                               702                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.252                      |

|POLY 3             |                                                                                P=0.226                      |

|POLY 1.5           |                                                                                P=0.226                      |

|POLY 6             |                                                                                P=0.227                      |

|LOGISTIC REGRESSION|                                                                                P=0.227                      |

|COCH-ARM / FISHERS |                                                                                P=0.233                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 41


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Skin                                                                                                                             |

|     Cyst Epithelial Inclusion                                                                                                   |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/42.83                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         |

|TERMINAL (d)       |                              1/21 (5%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              668                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.247N                     |

|POLY 3             |                                                                                P=0.278N                     |

|POLY 1.5           |                                                                                P=0.274N                     |

|POLY 6             |                                                                                P=0.274N                     |

|LOGISTIC REGRESSION|                                                                                P=0.259N                     |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Spleen                                                                                                                           |

|     Hematopoietic Cell Proliferation                                                                                            |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              43/52 (83%)                                       42/49 (86%)                  |

|POLY-3 RATE (b)    |                              43/50.03                                          42/45.72                     |

|POLY-3 PERCENT (g) |                              86.0%                                             91.9%                        |

|TERMINAL (d)       |                              20/21 (95%)                                       21/21 (100%)                 |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.504                      |

|POLY 3             |                                                                                P=0.261                      |

|POLY 1.5           |                                                                                P=0.323                      |

|POLY 6             |                                                                                P=0.216                      |

|LOGISTIC REGRESSION|                                                                                P=0.357                      |

|COCH-ARM / FISHERS |                                                                                P=0.444                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 42


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Spleen                                                                                                                           |

|     Hyperplasia Lymphoid                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              4/52 (8%)                                         1/49 (2%)                    |

|POLY-3 RATE (b)    |                              4/42.29                                           1/38.05                      |

|POLY-3 PERCENT (g) |                              9.5%                                              2.6%                         |

|TERMINAL (d)       |                              2/21 (10%)                                        0/21 (0%)                    |

|FIRST INCIDENCE    |                              641                                               653                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.200N                     |

|POLY 3             |                                                                                P=0.218N                     |

|POLY 1.5           |                                                                                P=0.217N                     |

|POLY 6             |                                                                                P=0.210N                     |

|LOGISTIC REGRESSION|                                                                                P=0.206N                     |

|COCH-ARM / FISHERS |                                                                                P=0.200N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Spleen                                                                                                                           |

|     Pigmentation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              47/52 (90%)                                       42/49 (86%)                  |

|POLY-3 RATE (b)    |                              47/50.25                                          42/45.30                     |

|POLY-3 PERCENT (g) |                              93.5%                                             92.7%                        |

|TERMINAL (d)       |                              21/21 (100%)                                      20/21 (95%)                  |

|FIRST INCIDENCE    |                              396                                               215                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.376N                     |

|POLY 3             |                                                                                P=0.625N                     |

|POLY 1.5           |                                                                                P=0.530N                     |

|POLY 6             |                                                                                P=0.650N                     |

|LOGISTIC REGRESSION|                                                                                P=0.526N                     |

|COCH-ARM / FISHERS |                                                                                P=0.338N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 43


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Stomach, Forestomach                                                                                                             |

|     Hyperkeratosis                                                                                                              |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              3/53 (6%)                                         1/50 (2%)                    |

|POLY-3 RATE (b)    |                              3/43.51                                           1/38.80                      |

|POLY-3 PERCENT (g) |                              6.9%                                              2.6%                         |

|TERMINAL (d)       |                              1/21 (5%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              546                                               520                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.349N                     |

|POLY 3             |                                                                                P=0.358N                     |

|POLY 1.5           |                                                                                P=0.353N                     |

|POLY 6             |                                                                                P=0.354N                     |

|LOGISTIC REGRESSION|                                                                                P=0.260N                     |

|COCH-ARM / FISHERS |                                                                                P=0.331N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Stomach, Forestomach                                                                                                             |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              11/53 (21%)                                       5/50 (10%)                   |

|POLY-3 RATE (b)    |                              11/45.30                                          5/40.27                      |

|POLY-3 PERCENT (g) |                              24.3%                                             12.4%                        |

|TERMINAL (d)       |                              3/21 (14%)                                        1/21 (5%)                    |

|FIRST INCIDENCE    |                              546                                               474                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.143N                     |

|POLY 3             |                                                                                P=0.131N                     |

|POLY 1.5           |                                                                                P=0.127N                     |

|POLY 6             |                                                                                P=0.130N                     |

|LOGISTIC REGRESSION|                                                                                P=0.083N                     |

|COCH-ARM / FISHERS |                                                                                P=0.108N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 44


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Stomach, Forestomach                                                                                                             |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              5/53 (9%)                                         4/50 (8%)                    |

|POLY-3 RATE (b)    |                              5/44.24                                           4/40.11                      |

|POLY-3 PERCENT (g) |                              11.3%                                             10.0%                        |

|TERMINAL (d)       |                              1/21 (5%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              546                                               474                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.565N                     |

|POLY 3             |                                                                                P=0.569N                     |

|POLY 1.5           |                                                                                P=0.566N                     |

|POLY 6             |                                                                                P=0.556N                     |

|LOGISTIC REGRESSION|                                                                                P=0.424N                     |

|COCH-ARM / FISHERS |                                                                                P=0.537N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Stomach, Forestomach                                                                                                             |

|     Ulcer                                                                                                                       |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              4/53 (8%)                                         4/50 (8%)                    |

|POLY-3 RATE (b)    |                              4/43.49                                           4/40.51                      |

|POLY-3 PERCENT (g) |                              9.2%                                              9.9%                         |

|TERMINAL (d)       |                              1/21 (5%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              598                                               474                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.585                      |

|POLY 3             |                                                                                P=0.610                      |

|POLY 1.5           |                                                                                P=0.606                      |

|POLY 6             |                                                                                P=0.624                      |

|LOGISTIC REGRESSION|                                                                                P=0.571N                     |

|COCH-ARM / FISHERS |                                                                                P=0.609                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 45


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Stomach, Glandular                                                                                                               |

|     Ulcer                                                                                                                       |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/43.18                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.6%                                              0.0%                         |

|TERMINAL (d)       |                              0/21 (0%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              604                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.261N                     |

|POLY 3             |                                                                                P=0.281N                     |

|POLY 1.5           |                                                                                P=0.275N                     |

|POLY 6             |                                                                                P=0.279N                     |

|LOGISTIC REGRESSION|                                                                                P=0.240N                     |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Thymus                                                                                                                           |

|     Atrophy                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              42/42 (100%)                                      45/49 (92%)                  |

|POLY-3 RATE (b)    |                              42/42.00                                          45/46.27                     |

|POLY-3 PERCENT (g) |                              100.0%                                            97.3%                        |

|TERMINAL (d)       |                              18/18 (100%)                                      21/21 (100%)                 |

|FIRST INCIDENCE    |                              396                                               410                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.452                      |

|POLY 3             |                                                                                P=0.398N                     |

|POLY 1.5           |                                                                                P=0.230N                     |

|POLY 6             |                                                                                P=0.501N                     |

|LOGISTIC REGRESSION|                                                                                P=0.287N                     |

|COCH-ARM / FISHERS |                                                                                P=0.079N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 46


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Thyroid Gland: C-Cell                                                                                                            |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              23/52 (44%)                                       15/49 (31%)                  |

|POLY-3 RATE (b)    |                              23/45.63                                          15/42.18                     |

|POLY-3 PERCENT (g) |                              50.4%                                             35.6%                        |

|TERMINAL (d)       |                              11/21 (52%)                                       4/21 (19%)                   |

|FIRST INCIDENCE    |                              396                                               410                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.153N                     |

|POLY 3             |                                                                                P=0.113N                     |

|POLY 1.5           |                                                                                P=0.124N                     |

|POLY 6             |                                                                                P=0.087N                     |

|LOGISTIC REGRESSION|                                                                                P=0.111N                     |

|COCH-ARM / FISHERS |                                                                                P=0.114N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Thyroid Gland: Follicular Cell                                                                                                   |

|     Hypertrophy                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              17/52 (33%)                                       6/49 (12%)                   |

|POLY-3 RATE (b)    |                              17/45.27                                          6/38.56                      |

|POLY-3 PERCENT (g) |                              37.6%                                             15.6%                        |

|TERMINAL (d)       |                              9/21 (43%)                                        3/21 (14%)                   |

|FIRST INCIDENCE    |                              396                                               474                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.017N*                    |

|POLY 3             |                                                                                P=0.020N*                    |

|POLY 1.5           |                                                                                P=0.018N*                    |

|POLY 6             |                                                                                P=0.021N*                    |

|LOGISTIC REGRESSION|                                                                                P=0.014N*                    |

|COCH-ARM / FISHERS |                                                                                P=0.013N*                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 47


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Tooth: Peridontal Tissue                                                                                                         |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              18/18 (100%)                                      12/12 (100%)                 |

|POLY-3 RATE (b)    |                              18/18.00                                          12/12.00                     |

|POLY-3 PERCENT (g) |                              100.0%                                            100.0%                       |

|TERMINAL (d)       |                              8/8 (100%)                                        5/5 (100%)                   |

|FIRST INCIDENCE    |                              599                                               345                          |

|-------------------|                                                                                                             |

|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)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Urinary Bladder                                                                                                                  |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              3/53 (6%)                                         2/50 (4%)                    |

|POLY-3 RATE (b)    |                              3/42.71                                           2/38.52                      |

|POLY-3 PERCENT (g) |                              7.0%                                              5.2%                         |

|TERMINAL (d)       |                              2/21 (10%)                                        0/21 (0%)                    |

|FIRST INCIDENCE    |                              701                                               645                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.497N                     |

|POLY 3             |                                                                                P=0.557N                     |

|POLY 1.5           |                                                                                P=0.554N                     |

|POLY 6             |                                                                                P=0.546N                     |

|LOGISTIC REGRESSION|                                                                                P=0.542N                     |

|COCH-ARM / FISHERS |                                                                                P=0.528N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 48


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Urinary Bladder: Transitional Epithelium                                                                                         |

|     Hyperplasia                                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    |

|POLY-3 RATE (b)    |                              2/42.71                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              4.7%                                              0.0%                         |

|TERMINAL (d)       |                              1/21 (5%)                                         0/21 (0%)                    |

|FIRST INCIDENCE    |                              701                                               ---                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.236N                     |

|POLY 3             |                                                                                P=0.277N                     |

|POLY 1.5           |                                                                                P=0.273N                     |

|POLY 6             |                                                                                P=0.272N                     |

|LOGISTIC REGRESSION|                                                                                P=0.249N                     |

|COCH-ARM / FISHERS |                                                                                P=0.262N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Uterus                                                                                                                           |

|     Inflammation                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              5/53 (9%)                                         9/50 (18%)                   |

|POLY-3 RATE (b)    |                              5/43.72                                           9/40.44                      |

|POLY-3 PERCENT (g) |                              11.4%                                             22.3%                        |

|TERMINAL (d)       |                              1/21 (5%)                                         4/21 (19%)                   |

|FIRST INCIDENCE    |                              604                                               484                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.171                      |

|POLY 3             |                                                                                P=0.150                      |

|POLY 1.5           |                                                                                P=0.150                      |

|POLY 6             |                                                                                P=0.161                      |

|LOGISTIC REGRESSION|                                                                                P=0.165                      |

|COCH-ARM / FISHERS |                                                                                P=0.164                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

|=================================================================================================================================|
       Date:  10/22/03                           EXPERIMENT: 96007 TEST: 03                                            Page 49


Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

|=================================================================================================================================|

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Uterus                                                                                                                           |

|     Metaplasia                                                                                                                  |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              17/53 (32%)                                       33/50 (66%)                  |

|POLY-3 RATE (b)    |                              17/46.13                                          33/45.46                     |

|POLY-3 PERCENT (g) |                              36.9%                                             72.6%                        |

|TERMINAL (d)       |                              7/21 (33%)                                        16/21 (76%)                  |

|FIRST INCIDENCE    |                              546                                               394                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.004 **                   |

|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               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

|=================================================================================================================================|

|                                                                                                                                 |

|Uterus: Endometrium                                                                                                              |

|     Hyperplasia Cystic                                                                                                          |

|                                                                                                                                 |

|                                                                                                                                 |

|---------------------------------------------------------------------------------------------------------------------------------|

|LESION RATES       |                                                                                                             |

|-----------        |                                                                                                             |

|OVERALL (a)        |                              19/53 (36%)                                       32/50 (64%)                  |

|POLY-3 RATE (b)    |                              19/44.95                                          32/42.21                     |

|POLY-3 PERCENT (g) |                              42.3%                                             75.8%                        |

|TERMINAL (d)       |                              10/21 (48%)                                       18/21 (86%)                  |

|FIRST INCIDENCE    |                              474                                               474                          |

|-------------------|                                                                                                             |

|STATISTICAL TESTS  |                                                                                                             |

|-------------------|                                                                                                             |

|LIFE TABLE         |                                                                                P=0.014 *                    |

|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=0.004 **                   |

|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).