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TDMS Study 96007-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08

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


Rats(SPRAGUE-DAWLEY)

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

FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE

BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES

ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.

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

                                                 Adrenal Cortex

                                                 Adrenal Medulla

                                                 Brain

                                                 Heart

                                                 Islets, Pancreatic

                                                 Kidney

                                                 Liver

                                                 Lung

                                                 Ovary

                                                 Pancreas

                                                 Parathyroid Gland

                                                 Pituitary Gland

                                                 Spleen

                                                 Thymus

                                                 Thyroid Gland

                                                 Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08   

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 Medulla                        Pheochromocytoma Benign

                                       Pheochromocytoma: Benign, Complex, Malignant, NOS

Heart                                  Schwannoma Malignant

Liver                                  Cholangiocarcinoma

                                       Hepatocellular Adenoma

                                       Hepatocellular Carcinoma, Hepatocellular Adenoma or Cholangiocarcinoma

                                       Hepatocholangioma

Lung                                   Cystic Keratinizing Epithelioma

Mammary Gland                          Fibroadenoma

                                       Fibroma, Fibroadenoma or Adenoma

                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma

Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)


                                       Squamous Cell Carcinoma

                                       Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma

Oral Mucosa                            Squamous Cell Carcinoma

Pancreas                               Carcinoma

                                       Carcinoma or Adenoma

Pituitary Gland: Pars Distalis or Unspecified Site


                                       Adenoma

Skin                                   Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma

Thyroid Gland: C-Cell                  Adenoma

                                       Carcinoma or Adenoma

Uterus                                 Carcinoma

                                       Polyp Stromal

                                       Squamous Cell Carcinoma

All Organs                             Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type

                                       Benign Tumors

                                       Malignant Tumors

                                       Malignant and Benign Tumors

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)        -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Adrenal Medulla                                                                                                                  |

|     Pheochromocytoma Benign                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

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

|POLY-3 RATE (b)    |                              3/43.18                                           1/38.27                      |

|POLY-3 PERCENT (g) |                              7.0%                                              2.6%                         |

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

|FIRST INCIDENCE    |                              642                                               702                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.305N                     |

|POLY 3             |                                                                                P=0.361N                     |

|POLY 1.5           |                                                                                P=0.355N                     |

|POLY 6             |                                                                                P=0.358N                     |

|LOGISTIC REGRESSION|                                                                                P=0.341N                     |

|COCH-ARM / FISHERS |                                                                                P=0.331N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Adrenal Medulla                                                                                                                  |

|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              3/53 (6%)                                         2/50 (4%)                    |

|POLY-3 RATE (b)    |                              3/43.18                                           2/38.27                      |

|POLY-3 PERCENT (g) |                              7.0%                                              5.2%                         |

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

|FIRST INCIDENCE    |                              642                                               702                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.497N                     |

|POLY 3             |                                                                                P=0.567N                     |

|POLY 1.5           |                                                                                P=0.559N                     |

|POLY 6             |                                                                                P=0.564N                     |

|LOGISTIC REGRESSION|                                                                                P=0.547N                     |

|COCH-ARM / FISHERS |                                                                                P=0.528N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Heart                                                                                                                            |

|     Schwannoma Malignant                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              0/52 (0%)                                         3/50 (6%)                    |

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

|POLY-3 PERCENT (g) |                              0.0%                                              7.7%                         |

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

|FIRST INCIDENCE    |                              ---                                               484                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.121                      |

|POLY 3             |                                                                                P=0.110                      |

|POLY 1.5           |                                                                                P=0.110                      |

|POLY 6             |                                                                                P=0.112                      |

|LOGISTIC REGRESSION|                                                                                P=0.120                      |

|COCH-ARM / FISHERS |                                                                                P=0.114                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Cholangiocarcinoma                                                                                                          |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              25/53 (47%)                                       2/50 (4%)                    |

|POLY-3 RATE (b)    |                              25/45.58                                          2/38.16                      |

|POLY-3 PERCENT (g) |                              54.9%                                             5.2%                         |

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

|FIRST INCIDENCE    |                              610                                               729                          |

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

|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 3


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Hepatocellular Adenoma                                                                                                      |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              13/53 (25%)                                       2/50 (4%)                    |

|POLY-3 RATE (b)    |                              13/43.52                                          2/38.29                      |

|POLY-3 PERCENT (g) |                              29.9%                                             5.2%                         |

|TERMINAL (d)       |                              7/21 (33%)                                        0/21 (0%)                    |

|FIRST INCIDENCE    |                              642                                               702                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.003N**                   |

|POLY 3             |                                                                                P=0.004N**                   |

|POLY 1.5           |                                                                                P=0.004N**                   |

|POLY 6             |                                                                                P=0.003N**                   |

|LOGISTIC REGRESSION|                                                                                P=0.003N**                   |

|COCH-ARM / FISHERS |                                                                                P=0.003N**                   |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Hepatocellular Carcinoma, Hepatocellular Adenoma or                                                                         |

|     Cholangiocarcinoma                                                                                                          |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              29/53 (55%)                                       4/50 (8%)                    |

|POLY-3 RATE (b)    |                              29/46.02                                          4/38.30                      |

|POLY-3 PERCENT (g) |                              63.0%                                             10.4%                        |

|TERMINAL (d)       |                              14/21 (67%)                                       1/21 (5%)                    |

|FIRST INCIDENCE    |                              610                                               702                          |

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

|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 4


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Liver                                                                                                                            |

|     Hepatocholangioma                                                                                                           |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR 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                      |

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

|                                                                                                                                 |

|Lung                                                                                                                             |

|     Cystic Keratinizing Epithelioma                                                                                             |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              9/52 (17%)                                        0/50 (0%)                    |

|POLY-3 RATE (b)    |                              9/42.72                                           0/38.16                      |

|POLY-3 PERCENT (g) |                              21.1%                                             0.0%                         |

|TERMINAL (d)       |                              4/21 (19%)                                        0/21 (0%)                    |

|FIRST INCIDENCE    |                              610                                               ---                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.004N**                   |

|POLY 3             |                                                                                P=0.003N**                   |

|POLY 1.5           |                                                                                P=0.003N**                   |

|POLY 6             |                                                                                P=0.003N**                   |

|LOGISTIC REGRESSION|                                                                                P=0.003N**                   |

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

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Mammary Gland                                                                                                                    |

|     Fibroadenoma                                                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              24/53 (45%)                                       32/50 (64%)                  |

|POLY-3 RATE (b)    |                              24/47.04                                          32/44.58                     |

|POLY-3 PERCENT (g) |                              51.0%                                             71.8%                        |

|TERMINAL (d)       |                              12/21 (57%)                                       13/21 (62%)                  |

|FIRST INCIDENCE    |                              396                                               345                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.105                      |

|POLY 3             |                                                                                P=0.027 *                    |

|POLY 1.5           |                                                                                P=0.028 *                    |

|POLY 6             |                                                                                P=0.035 *                    |

|LOGISTIC REGRESSION|                                                                                P=0.034 *                    |

|COCH-ARM / FISHERS |                                                                                P=0.044 *                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Mammary Gland                                                                                                                    |

|     Fibroma, Fibroadenoma or Adenoma                                                                                            |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              24/53 (45%)                                       32/50 (64%)                  |

|POLY-3 RATE (b)    |                              24/47.04                                          32/44.58                     |

|POLY-3 PERCENT (g) |                              51.0%                                             71.8%                        |

|TERMINAL (d)       |                              12/21 (57%)                                       13/21 (62%)                  |

|FIRST INCIDENCE    |                              396                                               345                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.105                      |

|POLY 3             |                                                                                P=0.027 *                    |

|POLY 1.5           |                                                                                P=0.028 *                    |

|POLY 6             |                                                                                P=0.035 *                    |

|LOGISTIC REGRESSION|                                                                                P=0.034 *                    |

|COCH-ARM / FISHERS |                                                                                P=0.044 *                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Mammary Gland                                                                                                                    |

|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              24/53 (45%)                                       33/50 (66%)                  |

|POLY-3 RATE (b)    |                              24/47.04                                          33/45.18                     |

|POLY-3 PERCENT (g) |                              51.0%                                             73.0%                        |

|TERMINAL (d)       |                              12/21 (57%)                                       13/21 (62%)                  |

|FIRST INCIDENCE    |                              396                                               345                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.080                      |

|POLY 3             |                                                                                P=0.019 *                    |

|POLY 1.5           |                                                                                P=0.018 *                    |

|POLY 6             |                                                                                P=0.027 *                    |

|LOGISTIC REGRESSION|                                                                                P=0.022 *                    |

|COCH-ARM / FISHERS |                                                                                P=0.027 *                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |

|     Squamous Cell Carcinoma                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              10/53 (19%)                                       5/50 (10%)                   |

|POLY-3 RATE (b)    |                              10/45.45                                          5/40.28                      |

|POLY-3 PERCENT (g) |                              22.0%                                             12.4%                        |

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

|FIRST INCIDENCE    |                              546                                               520                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.202N                     |

|POLY 3             |                                                                                P=0.193N                     |

|POLY 1.5           |                                                                                P=0.186N                     |

|POLY 6             |                                                                                P=0.189N                     |

|LOGISTIC REGRESSION|                                                                                P=0.115N                     |

|COCH-ARM / FISHERS |                                                                                P=0.160N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |

|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              10/53 (19%)                                       5/50 (10%)                   |

|POLY-3 RATE (b)    |                              10/45.45                                          5/40.28                      |

|POLY-3 PERCENT (g) |                              22.0%                                             12.4%                        |

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

|FIRST INCIDENCE    |                              546                                               520                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.202N                     |

|POLY 3             |                                                                                P=0.193N                     |

|POLY 1.5           |                                                                                P=0.186N                     |

|POLY 6             |                                                                                P=0.189N                     |

|LOGISTIC REGRESSION|                                                                                P=0.115N                     |

|COCH-ARM / FISHERS |                                                                                P=0.160N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Oral Mucosa                                                                                                                      |

|     Squamous Cell Carcinoma                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              10/53 (19%)                                       5/50 (10%)                   |

|POLY-3 RATE (b)    |                              10/45.45                                          5/40.28                      |

|POLY-3 PERCENT (g) |                              22.0%                                             12.4%                        |

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

|FIRST INCIDENCE    |                              546                                               520                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.202N                     |

|POLY 3             |                                                                                P=0.193N                     |

|POLY 1.5           |                                                                                P=0.186N                     |

|POLY 6             |                                                                                P=0.189N                     |

|LOGISTIC REGRESSION|                                                                                P=0.115N                     |

|COCH-ARM / FISHERS |                                                                                P=0.160N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Pancreas                                                                                                                         |

|     Carcinoma                                                                                                                   |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

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

|POLY-3 RATE (b)    |                              2/41.18                                           1/37.76                      |

|POLY-3 PERCENT (g) |                              4.9%                                              2.7%                         |

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

|FIRST INCIDENCE    |                              641                                               731 (T)                      |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.513N                     |

|POLY 3             |                                                                                P=0.541N                     |

|POLY 1.5           |                                                                                P=0.538N                     |

|POLY 6             |                                                                                P=0.534N                     |

|LOGISTIC REGRESSION|                                                                                P=0.522N                     |

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

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Pancreas                                                                                                                         |

|     Carcinoma or Adenoma                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              3/51 (6%)                                         1/49 (2%)                    |

|POLY-3 RATE (b)    |                              3/41.18                                           1/37.76                      |

|POLY-3 PERCENT (g) |                              7.3%                                              2.7%                         |

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

|FIRST INCIDENCE    |                              641                                               731 (T)                      |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.315N                     |

|POLY 3             |                                                                                P=0.345N                     |

|POLY 1.5           |                                                                                P=0.342N                     |

|POLY 6             |                                                                                P=0.337N                     |

|LOGISTIC REGRESSION|                                                                                P=0.320N                     |

|COCH-ARM / FISHERS |                                                                                P=0.324N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors 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 or Unspecified Site                                                                               |

|     Adenoma                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              11/52 (21%)                                       19/50 (38%)                  |

|POLY-3 RATE (b)    |                              11/44.01                                          19/39.99                     |

|POLY-3 PERCENT (g) |                              25.0%                                             47.5%                        |

|TERMINAL (d)       |                              4/21 (19%)                                        9/21 (43%)                   |

|FIRST INCIDENCE    |                              604                                               584                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.081                      |

|POLY 3             |                                                                                P=0.023 *                    |

|POLY 1.5           |                                                                                P=0.028 *                    |

|POLY 6             |                                                                                P=0.023 *                    |

|LOGISTIC REGRESSION|                                                                                P=0.027 *                    |

|COCH-ARM / FISHERS |                                                                                P=0.049 *                    |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Skin                                                                                                                             |

|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        |

|     or Fibrous Histiocytoma                                                                                                     |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

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

|POLY-3 RATE (b)    |                              1/42.65                                           2/39.00                      |

|POLY-3 PERCENT (g) |                              2.3%                                              5.1%                         |

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

|FIRST INCIDENCE    |                              717                                               394                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.493                      |

|POLY 3             |                                                                                P=0.479                      |

|POLY 1.5           |                                                                                P=0.480                      |

|POLY 6             |                                                                                P=0.484                      |

|LOGISTIC REGRESSION|                                                                                P=0.533                      |

|COCH-ARM / FISHERS |                                                                                P=0.478                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors 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                                                                                                            |

|     Adenoma                                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              11/52 (21%)                                       13/49 (27%)                  |

|POLY-3 RATE (b)    |                              11/43.05                                          13/38.54                     |

|POLY-3 PERCENT (g) |                              25.6%                                             33.7%                        |

|TERMINAL (d)       |                              6/21 (29%)                                        7/21 (33%)                   |

|FIRST INCIDENCE    |                              638                                               584                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.401                      |

|POLY 3             |                                                                                P=0.288                      |

|POLY 1.5           |                                                                                P=0.300                      |

|POLY 6             |                                                                                P=0.295                      |

|LOGISTIC REGRESSION|                                                                                P=0.307                      |

|COCH-ARM / FISHERS |                                                                                P=0.344                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Thyroid Gland: C-Cell                                                                                                            |

|     Carcinoma or Adenoma                                                                                                        |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                                                                                                             |

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

|OVERALL (a)        |                              11/52 (21%)                                       14/49 (29%)                  |

|POLY-3 RATE (b)    |                              11/43.05                                          14/38.54                     |

|POLY-3 PERCENT (g) |                              25.6%                                             36.3%                        |

|TERMINAL (d)       |                              6/21 (29%)                                        8/21 (38%)                   |

|FIRST INCIDENCE    |                              638                                               584                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.319                      |

|POLY 3             |                                                                                P=0.208                      |

|POLY 1.5           |                                                                                P=0.221                      |

|POLY 6             |                                                                                P=0.211                      |

|LOGISTIC REGRESSION|                                                                                P=0.228                      |

|COCH-ARM / FISHERS |                                                                                P=0.264                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Uterus                                                                                                                           |

|     Carcinoma                                                                                                                   |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

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

|POLY-3 RATE (b)    |                              1/42.66                                           2/38.16                      |

|POLY-3 PERCENT (g) |                              2.3%                                              5.2%                         |

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

|FIRST INCIDENCE    |                              716                                               731 (T)                      |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.500                      |

|POLY 3             |                                                                                P=0.475                      |

|POLY 1.5           |                                                                                P=0.477                      |

|POLY 6             |                                                                                P=0.477                      |

|LOGISTIC REGRESSION|                                                                                P=0.501                      |

|COCH-ARM / FISHERS |                                                                                P=0.478                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Uterus                                                                                                                           |

|     Polyp Stromal                                                                                                               |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              8/53 (15%)                                        4/50 (8%)                    |

|POLY-3 RATE (b)    |                              8/44.05                                           4/38.16                      |

|POLY-3 PERCENT (g) |                              18.2%                                             10.5%                        |

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

|FIRST INCIDENCE    |                              598                                               729                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.206N                     |

|POLY 3             |                                                                                P=0.259N                     |

|POLY 1.5           |                                                                                P=0.245N                     |

|POLY 6             |                                                                                P=0.266N                     |

|LOGISTIC REGRESSION|                                                                                P=0.229N                     |

|COCH-ARM / FISHERS |                                                                                P=0.209N                     |

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|Uterus                                                                                                                           |

|     Squamous Cell Carcinoma                                                                                                     |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

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

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

|POLY-3 PERCENT (g) |                              0.0%                                              5.2%                         |

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

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

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.237                      |

|POLY 3             |                                                                                P=0.225                      |

|POLY 1.5           |                                                                                P=0.226                      |

|POLY 6             |                                                                                P=0.226                      |

|LOGISTIC REGRESSION|                                                                                P=0.237                      |

|COCH-ARM / FISHERS |                                                                                P=0.233                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|All Organs                                                                                                                       |

|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |

|     NOS, or Undifferentiated Cell Type                                                                                          |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

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

|POLY-3 RATE (b)    |                              2/42.60                                           1/39.05                      |

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

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

|FIRST INCIDENCE    |                              731 (T)                                           345                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.509N                     |

|POLY 3             |                                                                                P=0.541N                     |

|POLY 1.5           |                                                                                P=0.540N                     |

|POLY 6             |                                                                                P=0.531N                     |

|LOGISTIC REGRESSION|                                                                                P=0.451N                     |

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

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|All Organs                                                                                                                       |

|     Benign Tumors                                                                                                               |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              42/53 (79%)                                       41/50 (82%)                  |

|POLY-3 RATE (b)    |                              42/49.59                                          41/45.87                     |

|POLY-3 PERCENT (g) |                              84.7%                                             89.4%                        |

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

|FIRST INCIDENCE    |                              396                                               345                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.526                      |

|POLY 3             |                                                                                P=0.343                      |

|POLY 1.5           |                                                                                P=0.356                      |

|POLY 6             |                                                                                P=0.388                      |

|LOGISTIC REGRESSION|                                                                                P=0.274                      |

|COCH-ARM / FISHERS |                                                                                P=0.459                      |

|ORDER RESTRICTED   |                                                                                (e)                          |

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|All Organs                                                                                                                       |

|     Malignant Tumors                                                                                                            |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              34/53 (64%)                                       19/50 (38%)                  |

|POLY-3 RATE (b)    |                              34/48.63                                          19/42.85                     |

|POLY-3 PERCENT (g) |                              69.9%                                             44.3%                        |

|TERMINAL (d)       |                              14/21 (67%)                                       9/21 (43%)                   |

|FIRST INCIDENCE    |                              546                                               345                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.023N*                    |

|POLY 3             |                                                                                P=0.008N**                   |

|POLY 1.5           |                                                                                P=0.007N**                   |

|POLY 6             |                                                                                P=0.010N*                    |

|LOGISTIC REGRESSION|                                                                                P=0.008N**                   |

|COCH-ARM / FISHERS |                                                                                P=0.007N**                   |

|ORDER RESTRICTED   |                                                                                (e)                          |

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


Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION

                                         Terminal Sacrifice at 105 weeks 

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

|                   |                                                                                                             |

|                   |                                                      Females                                                |

|Dose               |                              100                                               100 NG/                      |

|                   |                              NG/KG                                             KG/STOP                      |

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

|                                                                                                                                 |

|All Organs                                                                                                                       |

|     Malignant and Benign Tumors                                                                                                 |

|                                                                                                                                 |

|                                                                                                                                 |

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

|TUMOR RATES        |                              #                                                 #                            |

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

|OVERALL (a)        |                              50/53 (94%)                                       46/50 (92%)                  |

|POLY-3 RATE (b)    |                              50/51.78                                          46/48.66                     |

|POLY-3 PERCENT (g) |                              96.6%                                             94.5%                        |

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

|FIRST INCIDENCE    |                              396                                               345                          |

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

|STATISTICAL TESTS  |                                                                                                             |

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

|LIFE TABLE         |                                                                                P=0.458N                     |

|POLY 3             |                                                                                P=0.501N                     |

|POLY 1.5           |                                                                                P=0.526N                     |

|POLY 6             |                                                                                P=0.464N                     |

|LOGISTIC REGRESSION|                                                                                P=0.613N                     |

|COCH-ARM / FISHERS |                                                                                P=0.467N                     |

|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).