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TDMS Study 05187-09 Pathology Tables


NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 09/16/98       
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:30:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B       
PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2         
------------------------------------------------------------------------------------------------------------------------------------
                                                             STOP STUDY                                                             
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 009    300     MG/KG                                                                 
                                       INCLUDE 010    300     MG/KG                                                                 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 09/16/98
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:30:17
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B
PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2
Rats(FISCHER 344)
-----------------------------
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 Medulla
                                                 Brain
                                                 Clitoral/Preputial Gland
                                                 Heart
                                                 Islets, Pancreatic
                                                 Kidney
                                                 Liver
                                                 Lung
                                                 Pancreas
                                                 Parathyroid Gland
                                                 Pituitary Gland
                                                 Salivary Glands
                                                 Spleen
                                                 Testes
                                                 Thyroid Gland
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08   
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 09/16/98     
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:30:17     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                      
CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B     
PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2       
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF                  METHYLEUGENOL
===============================================================
Male Rats
------------
Organ                                 Morphology
-----                                 ----------
Adrenal Medulla                        Pheochromocytoma Benign
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland               Adenoma
                                       Carcinoma
                                       Carcinoma or Adenoma
Kidney: Renal Tubule                   Adenoma
                                       Carcinoma or Adenoma
Liver                                  Cholangioma
                                       Hepatocellular Adenoma
                                       Hepatocellular Carcinoma
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                                       Hepatocholangiocarcinoma
                                       Hepatocholangioma
Mammary Gland                          Fibroadenoma
                                       Fibroma, Fibroadenoma or Adenoma
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Skin
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
                                       Fibroma
                                       Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
                                       Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
                                       Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
Stomach, Glandular                     Neuroendocrine Tumor, Benign
                                       Neuroendocrine Tumor, Malignant
Testes                                 Adenoma
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                       Mesothelioma: Benign, Malignant, NOS
                                       Mesothelioma: Malignant
                                       Benign Tumors
                                       Malignant Tumors
                                       Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ                                  Morphology
-----                                  ----------
Adrenal Medulla                        Pheochromocytoma Benign
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS
Liver                                  Hepatocellular Adenoma
                                       Hepatocellular Carcinoma
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                                       Hepatocholangiocarcinoma
                                       Hepatocholangioma
Stomach, Glandular                     Neuroendocrine Tumor, Benign
                                       Neuroendocrine Tumor, Malignant
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08   
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 09/16/98     
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:30:17     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                      
CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B     
PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2       
Uterus                                 Polyp Stromal
All Organs                             Malignant Tumors
===============================================================
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 1
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  24/50 (48%)              9/50 (18%)   |           1/50 (2%)                6/50 (12%)      |
|POLY-3 ADJUSTED (b)|                  54.5%                    33.4%        |           2.5%                     16.0%           |
|TERMINAL (d)       |                  9/20 (45%)               0/0 (0%)     |           0/22 (0%)                4/16 (25%)      |
|FIRST INCIDENCE    |                  588                      495          |           698                      641             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.031 *       |
|POLY 3             |                                           P=0.078N     |                                    P=0.047 *       |
|POLY 1.5           |                                           P=0.014N*    |                                    P=0.050         |
|POLY 6             |                                           P=0.447N     |                                    P=0.044 *       |
|LOGISTIC REGRESSION|                                           P=0.303N     |                                    P=0.044 *       |
|COCH-ARM / FISHERS |                                           P<0.001N**   |                                    P=0.056         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  25/50 (50%)              9/50 (18%)   |           1/50 (2%)                6/50 (12%)      |
|POLY-3 ADJUSTED (b)|                  56.8%                    33.4%        |           2.5%                     16.0%           |
|TERMINAL (d)       |                  10/20 (50%)              0/0 (0%)     |           0/22 (0%)                4/16 (25%)      |
|FIRST INCIDENCE    |                  588                      495          |           698                      641             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.031 *       |
|POLY 3             |                                           P=0.052N     |                                    P=0.047 *       |
|POLY 1.5           |                                           P=0.008N**   |                                    P=0.050         |
|POLY 6             |                                           P=0.381N     |                                    P=0.044 *       |
|LOGISTIC REGRESSION|                                           P=0.291N     |                                    P=0.044 *       |
|COCH-ARM / FISHERS |                                           P<0.001N**   |                                    P=0.056         |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 2
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  9/50 (18%)               6/50 (12%)   |           5/48 (10%)               4/48 (8%)       |
|POLY-3 ADJUSTED (b)|                  21.2%                    23.2%        |           13.1%                    11.3%           |
|TERMINAL (d)       |                  4/20 (20%)               0/0 (0%)     |           3/21 (14%)               3/15 (20%)      |
|FIRST INCIDENCE    |                  610                      437          |           679                      620             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.007 **   |                                    P=0.618         |
|POLY 3             |                                           P=0.586      |                                    P=0.556N        |
|POLY 1.5           |                                           P=0.532N     |                                    P=0.538N        |
|POLY 6             |                                           P=0.380      |                                    P=0.580N        |
|LOGISTIC REGRESSION|                                           P=0.564N     |                                    P=0.584N        |
|COCH-ARM / FISHERS |                                           P=0.288N     |                                    P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/50 (10%)               0/50 (0%)    |           1/48 (2%)                0/48 (0%)       |
|POLY-3 ADJUSTED (b)|                  11.9%                    0.0%         |           2.6%                     0.0%            |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |           1/21 (5%)                0/15 (0%)       |
|FIRST INCIDENCE    |                  564                      ---          |           730 (T)                  ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.622N     |                                    P=0.567N        |
|POLY 3             |                                           P=0.190N     |                                    P=0.534N        |
|POLY 1.5           |                                           P=0.087N     |                                    P=0.523N        |
|POLY 6             |                                           P=0.534N     |                                    P=0.548N        |
|LOGISTIC REGRESSION|                                           P=0.215N     |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.028N*    |                                    P=0.500N        |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 3
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  14/50 (28%)              6/50 (12%)   |           6/48 (13%)               4/48 (8%)       |
|POLY-3 ADJUSTED (b)|                  32.4%                    23.2%        |           15.7%                    11.3%           |
|TERMINAL (d)       |                  6/20 (30%)               0/0 (0%)     |           4/21 (19%)               3/15 (20%)      |
|FIRST INCIDENCE    |                  564                      437          |           679                      620             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.020 *    |                                    P=0.543N        |
|POLY 3             |                                           P=0.337N     |                                    P=0.424N        |
|POLY 1.5           |                                           P=0.152N     |                                    P=0.406N        |
|POLY 6             |                                           P=0.686      |                                    P=0.447N        |
|LOGISTIC REGRESSION|                                           P=0.252N     |                                    P=0.458N        |
|COCH-ARM / FISHERS |                                           P=0.039N*    |                                    P=0.370N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                0/49 (0%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  7.2%                     0.0%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  704                      ---          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=1.000N     |                                    (e)             |
|POLY 3             |                                           P=0.380N     |                                    (e)             |
|POLY 1.5           |                                           P=0.235N     |                                    (e)             |
|POLY 6             |                                           P=0.726N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.821N     |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.125N     |                                    (e)             |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 4
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                0/49 (0%)    |           1/50 (2%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  7.2%                     0.0%         |           2.5%                     0.0%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           1/22 (5%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  704                      ---          |           730 (T)                  ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=1.000N     |                                    P=0.564N        |
|POLY 3             |                                           P=0.380N     |                                    P=0.524N        |
|POLY 1.5           |                                           P=0.235N     |                                    P=0.517N        |
|POLY 6             |                                           P=0.726N     |                                    P=0.536N        |
|LOGISTIC REGRESSION|                                           P=0.821N     |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.125N     |                                    P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                8/50 (16%)   |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  7.2%                     31.2%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  712                      528          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    (e)             |
|POLY 3             |                                           P=0.018 *    |                                    (e)             |
|POLY 1.5           |                                           P=0.039 *    |                                    (e)             |
|POLY 6             |                                           P=0.006 **   |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.002 **   |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.100      |                                    (e)             |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 5
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  4/50 (8%)                8/50 (16%)   |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  9.6%                     31.2%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  712                      528          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    (e)             |
|POLY 3             |                                           P=0.039 *    |                                    (e)             |
|POLY 1.5           |                                           P=0.078      |                                    (e)             |
|POLY 6             |                                           P=0.014 *    |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.003 **   |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.178      |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Cholangioma                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     8.5%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  ---                      592          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.037 *    |                                    (e)             |
|POLY 3             |                                           P=0.228      |                                    (e)             |
|POLY 1.5           |                                           P=0.217      |                                    (e)             |
|POLY 6             |                                           P=0.334      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.185      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.247      |                                    (e)             |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 6
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/50 (10%)               32/50 (64%)  |           1/50 (2%)                43/50 (86%)     |
|POLY-3 ADJUSTED (b)|                  12.0%                    83.0%        |           2.5%                     96.5%           |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |           1/22 (5%)                16/16 (100%)    |
|FIRST INCIDENCE    |                  715                      437          |           730 (T)                  459             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                36/50 (72%)  |           0/50 (0%)                22/50 (44%)     |
|POLY-3 ADJUSTED (b)|                  4.8%                     89.1%        |           0.0%                     53.8%           |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                8/16 (50%)      |
|FIRST INCIDENCE    |                  529                      437          |           ---                      459             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P<0.001 **      |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 7
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  7/50 (14%)               45/50 (90%)  |           1/50 (2%)                43/50 (86%)     |
|POLY-3 ADJUSTED (b)|                  16.6%                    99.4%        |           2.5%                     96.5%           |
|TERMINAL (d)       |                  3/20 (15%)               0/0 (0%)     |           1/22 (5%)                16/16 (100%)    |
|FIRST INCIDENCE    |                  529                      437          |           730 (T)                  459             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           |
|     or Hepatoblastoma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  7/50 (14%)               45/50 (90%)  |           1/50 (2%)                43/50 (86%)     |
|POLY-3 ADJUSTED (b)|                  16.6%                    99.4%        |           2.5%                     96.5%           |
|TERMINAL (d)       |                  3/20 (15%)               0/0 (0%)     |           1/22 (5%)                16/16 (100%)    |
|FIRST INCIDENCE    |                  529                      437          |           730 (T)                  459             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P<0.001 **      |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 8
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocholangiocarcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                7/50 (14%)   |           0/50 (0%)                9/50 (18%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     27.1%        |           0.0%                     23.6%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                3/16 (19%)      |
|FIRST INCIDENCE    |                  ---                      506          |           ---                      641             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P=0.003 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P=0.006 **   |                                    P=0.002 **      |
|COCH-ARM / FISHERS |                                           P=0.006 **   |                                    P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocholangioma                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                6/50 (12%)   |           0/50 (0%)                8/50 (16%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     23.1%        |           0.0%                     20.9%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                3/16 (19%)      |
|FIRST INCIDENCE    |                  ---                      502          |           ---                      609             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.003 **   |                                    P=0.003 **      |
|POLY 3             |                                           P=0.004 **   |                                    P=0.003 **      |
|POLY 1.5           |                                           P=0.007 **   |                                    P=0.003 **      |
|POLY 6             |                                           P=0.003 **   |                                    P=0.003 **      |
|LOGISTIC REGRESSION|                                           P=0.029 *    |                                    P=0.004 **      |
|COCH-ARM / FISHERS |                                           P=0.013 *    |                                    P=0.003 **      |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 9
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                0/50 (0%)    |           2/50 (4%)                4/50 (8%)       |
|POLY-3 ADJUSTED (b)|                  2.4%                     0.0%         |           5.1%                     10.6%           |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           2/22 (9%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  730 (T)                  ---          |           730 (T)                  571             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=1.000N     |                                    P=0.246         |
|POLY 3             |                                           P=0.787N     |                                    P=0.320         |
|POLY 1.5           |                                           P=0.649N     |                                    P=0.324         |
|POLY 6             |                                           P=0.967N     |                                    P=0.315         |
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.304         |
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.339         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                0/50 (0%)    |           2/50 (4%)                5/50 (10%)      |
|POLY-3 ADJUSTED (b)|                  2.4%                     0.0%         |           5.1%                     13.3%           |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           2/22 (9%)                2/16 (13%)      |
|FIRST INCIDENCE    |                  730 (T)                  ---          |           730 (T)                  571             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=1.000N     |                                    P=0.137         |
|POLY 3             |                                           P=0.787N     |                                    P=0.199         |
|POLY 1.5           |                                           P=0.649N     |                                    P=0.204         |
|POLY 6             |                                           P=0.967N     |                                    P=0.194         |
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.183         |
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.218         |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 10
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/50 (10%)               6/50 (12%)   |           36/50 (72%)              30/50 (60%)     |
|POLY-3 ADJUSTED (b)|                  12.0%                    23.4%        |           78.7%                    74.3%           |
|TERMINAL (d)       |                  4/20 (20%)               0/0 (0%)     |           15/22 (68%)              14/16 (88%)     |
|FIRST INCIDENCE    |                  610                      380          |           407                      609             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.535         |
|POLY 3             |                                           P=0.231      |                                    P=0.412N        |
|POLY 1.5           |                                           P=0.332      |                                    P=0.288N        |
|POLY 6             |                                           P=0.132      |                                    P=0.593N        |
|LOGISTIC REGRESSION|                                           P=0.291      |                                    P=0.209N        |
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.146N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/50 (10%)               6/50 (12%)   |           36/50 (72%)              30/50 (60%)     |
|POLY-3 ADJUSTED (b)|                  12.0%                    23.4%        |           78.7%                    74.3%           |
|TERMINAL (d)       |                  4/20 (20%)               0/0 (0%)     |           15/22 (68%)              14/16 (88%)     |
|FIRST INCIDENCE    |                  610                      380          |           407                      609             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.535         |
|POLY 3             |                                           P=0.231      |                                    P=0.412N        |
|POLY 1.5           |                                           P=0.332      |                                    P=0.288N        |
|POLY 6             |                                           P=0.132      |                                    P=0.593N        |
|LOGISTIC REGRESSION|                                           P=0.291      |                                    P=0.209N        |
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.146N        |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 11
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/50 (10%)               6/50 (12%)   |           37/50 (74%)              31/50 (62%)     |
|POLY-3 ADJUSTED (b)|                  12.0%                    23.4%        |           80.9%                    75.8%           |
|TERMINAL (d)       |                  4/20 (20%)               0/0 (0%)     |           16/22 (73%)              14/16 (88%)     |
|FIRST INCIDENCE    |                  610                      380          |           407                      571             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.524         |
|POLY 3             |                                           P=0.231      |                                    P=0.374N        |
|POLY 1.5           |                                           P=0.332      |                                    P=0.268N        |
|POLY 6             |                                           P=0.132      |                                    P=0.531N        |
|LOGISTIC REGRESSION|                                           P=0.291      |                                    P=0.205N        |
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.142N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  7/50 (14%)               3/50 (6%)    |           22/50 (44%)              19/49 (39%)     |
|POLY-3 ADJUSTED (b)|                  16.3%                    12.3%        |           51.8%                    48.8%           |
|TERMINAL (d)       |                  3/20 (15%)               0/0 (0%)     |           10/22 (46%)              9/16 (56%)      |
|FIRST INCIDENCE    |                  521                      502          |           549                      477             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.305      |                                    P=0.484         |
|POLY 3             |                                           P=0.530N     |                                    P=0.483N        |
|POLY 1.5           |                                           P=0.340N     |                                    P=0.446N        |
|POLY 6             |                                           P=0.703      |                                    P=0.537N        |
|LOGISTIC REGRESSION|                                           P=0.208N     |                                    P=0.447N        |
|COCH-ARM / FISHERS |                                           P=0.159N     |                                    P=0.373N        |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 12
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       |
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                3/50 (6%)    |           0/50 (0%)                1/50 (2%)       |
|POLY-3 ADJUSTED (b)|                  7.2%                     12.4%        |           0.0%                     2.7%            |
|TERMINAL (d)       |                  3/20 (15%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  730 (T)                  528          |           ---                      653             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.046 *    |                                    P=0.494         |
|POLY 3             |                                           P=0.480      |                                    P=0.501         |
|POLY 1.5           |                                           P=0.552      |                                    P=0.500         |
|POLY 6             |                                           P=0.419      |                                    P=0.501         |
|LOGISTIC REGRESSION|                                           P=0.430      |                                    P=0.499         |
|COCH-ARM / FISHERS |                                           P=0.661N     |                                    P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                4/50 (8%)    |           1/50 (2%)                1/50 (2%)       |
|POLY-3 ADJUSTED (b)|                  2.4%                     16.3%        |           2.5%                     2.7%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  730 (T)                  548          |           724                      660             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.006 **   |                                    P=0.732         |
|POLY 3             |                                           P=0.096      |                                    P=0.756         |
|POLY 1.5           |                                           P=0.121      |                                    P=0.757         |
|POLY 6             |                                           P=0.084      |                                    P=0.754         |
|LOGISTIC REGRESSION|                                           P=0.124      |                                    P=0.749         |
|COCH-ARM / FISHERS |                                           P=0.181      |                                    P=0.753N        |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 13
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        |
|     or Fibrous Histiocytoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                4/50 (8%)    |           1/50 (2%)                2/50 (4%)       |
|POLY-3 ADJUSTED (b)|                  2.4%                     16.3%        |           2.5%                     5.3%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  730 (T)                  548          |           724                      641             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.006 **   |                                    P=0.464         |
|POLY 3             |                                           P=0.096      |                                    P=0.490         |
|POLY 1.5           |                                           P=0.121      |                                    P=0.492         |
|POLY 6             |                                           P=0.084      |                                    P=0.487         |
|LOGISTIC REGRESSION|                                           P=0.124      |                                    P=0.486         |
|COCH-ARM / FISHERS |                                           P=0.181      |                                    P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  7.2%                     8.4%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  3/20 (15%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  730 (T)                  528          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.146      |                                    (e)             |
|POLY 3             |                                           P=0.692      |                                    (e)             |
|POLY 1.5           |                                           P=0.670N     |                                    (e)             |
|POLY 6             |                                           P=0.658      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.623      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    (e)             |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 14
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           |
|     Carcinoma or Keratoacanthoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                3/50 (6%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  7.2%                     12.4%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  3/20 (15%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  730 (T)                  528          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.046 *    |                                    (e)             |
|POLY 3             |                                           P=0.480      |                                    (e)             |
|POLY 1.5           |                                           P=0.552      |                                    (e)             |
|POLY 6             |                                           P=0.419      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.430      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.661N     |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                3/50 (6%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  7.2%                     12.4%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  3/20 (15%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  730 (T)                  528          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.046 *    |                                    (e)             |
|POLY 3             |                                           P=0.480      |                                    (e)             |
|POLY 1.5           |                                           P=0.552      |                                    (e)             |
|POLY 6             |                                           P=0.419      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.430      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.661N     |                                    (e)             |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 15
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Neuroendocrine Tumor, Benign                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |           0/50 (0%)                5/50 (10%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     8.6%         |           0.0%                     12.8%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  ---                      556          |           ---                      477             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.017 *    |                                    P=0.034 *       |
|POLY 3             |                                           P=0.228      |                                    P=0.029 *       |
|POLY 1.5           |                                           P=0.217      |                                    P=0.029 *       |
|POLY 6             |                                           P=0.339      |                                    P=0.029 *       |
|LOGISTIC REGRESSION|                                           P=0.162      |                                    P=0.039 *       |
|COCH-ARM / FISHERS |                                           P=0.247      |                                    P=0.028 *       |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Neuroendocrine Tumor, Malignant                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |           0/50 (0%)                36/50 (72%)     |
|POLY-3 ADJUSTED (b)|                  0.0%                     8.5%         |           0.0%                     86.8%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                16/16 (100%)    |
|FIRST INCIDENCE    |                  ---                      517          |           ---                      560             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.035 *    |                                    P<0.001 **      |
|POLY 3             |                                           P=0.228      |                                    P<0.001 **      |
|POLY 1.5           |                                           P=0.217      |                                    P<0.001 **      |
|POLY 6             |                                           P=0.336      |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P=0.216      |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P=0.247      |                                    P<0.001 **      |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 16
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  46/50 (92%)              43/50 (86%)  |                                                    |
|POLY-3 ADJUSTED (b)|                  96.1%                    97.6%        |                                                    |
|TERMINAL (d)       |                  20/20 (100%)             0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  529                      437          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                                    |
|POLY 3             |                                           P=0.615      |                                                    |
|POLY 1.5           |                                           P=0.681      |                                                    |
|POLY 6             |                                           P=0.680      |                                                    |
|LOGISTIC REGRESSION|                                           P=0.053      |                                                    |
|COCH-ARM / FISHERS |                                           P=0.262N     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  6/50 (12%)               1/48 (2%)    |           2/50 (4%)                2/48 (4%)       |
|POLY-3 ADJUSTED (b)|                  14.5%                    4.6%         |           5.1%                     5.4%            |
|TERMINAL (d)       |                  5/20 (25%)               0/0 (0%)     |           1/22 (5%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  704                      634          |           711                      660             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.145      |                                    P=0.604         |
|POLY 3             |                                           P=0.309N     |                                    P=0.680         |
|POLY 1.5           |                                           P=0.164N     |                                    P=0.681         |
|POLY 6             |                                           P=0.656N     |                                    P=0.676         |
|LOGISTIC REGRESSION|                                           P=0.582      |                                    P=0.661         |
|COCH-ARM / FISHERS |                                           P=0.062N     |                                    P=0.676         |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 17
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                0/48 (0%)    |           0/50 (0%)                2/48 (4%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     0.0%         |           0.0%                     5.4%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  ---                      ---          |           ---                      679             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           (e)          |                                    P=0.191         |
|POLY 3             |                                           (e)          |                                    P=0.230         |
|POLY 1.5           |                                           (e)          |                                    P=0.231         |
|POLY 6             |                                           (e)          |                                    P=0.228         |
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.217         |
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.237         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  6/50 (12%)               1/48 (2%)    |           2/50 (4%)                4/48 (8%)       |
|POLY-3 ADJUSTED (b)|                  14.5%                    4.6%         |           5.1%                     10.7%           |
|TERMINAL (d)       |                  5/20 (25%)               0/0 (0%)     |           1/22 (5%)                2/16 (13%)      |
|FIRST INCIDENCE    |                  704                      634          |           711                      660             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.145      |                                    P=0.238         |
|POLY 3             |                                           P=0.309N     |                                    P=0.316         |
|POLY 1.5           |                                           P=0.164N     |                                    P=0.319         |
|POLY 6             |                                           P=0.656N     |                                    P=0.310         |
|LOGISTIC REGRESSION|                                           P=0.582      |                                    P=0.292         |
|COCH-ARM / FISHERS |                                           P=0.062N     |                                    P=0.319         |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 18
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                3/48 (6%)    |           1/50 (2%)                1/48 (2%)       |
|POLY-3 ADJUSTED (b)|                  4.8%                     13.0%        |           2.5%                     2.7%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  626                      513          |           717                      730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.050      |                                    P=0.693         |
|POLY 3             |                                           P=0.335      |                                    P=0.755         |
|POLY 1.5           |                                           P=0.386      |                                    P=0.755         |
|POLY 6             |                                           P=0.319      |                                    P=0.752         |
|LOGISTIC REGRESSION|                                           P=0.469      |                                    P=0.724         |
|COCH-ARM / FISHERS |                                           P=0.480      |                                    P=0.742         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |           4/50 (8%)                10/50 (20%)     |
|POLY-3 ADJUSTED (b)|                                                        |           10.0%                    25.2%           |
|TERMINAL (d)       |                                                        |           1/22 (5%)                4/16 (25%)      |
|FIRST INCIDENCE    |                                                        |           641                      331             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |                                    P=0.048 *       |
|POLY 3             |                                                        |                                    P=0.065         |
|POLY 1.5           |                                                        |                                    P=0.067         |
|POLY 6             |                                                        |                                    P=0.062         |
|LOGISTIC REGRESSION|                                                        |                                    P=0.074         |
|COCH-ARM / FISHERS |                                                        |                                    P=0.074         |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 19
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                1/50 (2%)    |           0/50 (0%)                3/50 (6%)       |
|POLY-3 ADJUSTED (b)|                  2.4%                     4.3%         |           0.0%                     7.8%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  712                      517          |           ---                      519             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.454      |                                    P=0.112         |
|POLY 3             |                                           P=0.741      |                                    P=0.115         |
|POLY 1.5           |                                           P=0.737      |                                    P=0.116         |
|POLY 6             |                                           P=0.820      |                                    P=0.114         |
|LOGISTIC REGRESSION|                                           P=0.793      |                                    P=0.139         |
|COCH-ARM / FISHERS |                                           P=0.753N     |                                    P=0.121         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           |
|     Undifferentiated                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  26/50 (52%)              1/50 (2%)    |           17/50 (34%)              17/50 (34%)     |
|POLY-3 ADJUSTED (b)|                  56.0%                    4.3%         |           38.3%                    42.3%           |
|TERMINAL (d)       |                  8/20 (40%)               0/0 (0%)     |           5/22 (23%)               4/16 (25%)      |
|FIRST INCIDENCE    |                  521                      572          |           448                      459             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.163N     |                                    P=0.395         |
|POLY 3             |                                           P<0.001N**   |                                    P=0.442         |
|POLY 1.5           |                                           P<0.001N**   |                                    P=0.490         |
|POLY 6             |                                           P=0.033N*    |                                    P=0.387         |
|LOGISTIC REGRESSION|                                           P<0.001N**   |                                    P=0.572         |
|COCH-ARM / FISHERS |                                           P<0.001N**   |                                    P=0.583N        |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 20
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                5/50 (10%)   |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  2.4%                     19.8%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  564                      556          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.017 *    |                                    (e)             |
|POLY 3             |                                           P=0.041 *    |                                    (e)             |
|POLY 1.5           |                                           P=0.058      |                                    (e)             |
|POLY 6             |                                           P=0.030 *    |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.141      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.102      |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Malignant                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                5/50 (10%)   |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  2.4%                     19.8%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  564                      556          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.017 *    |                                    (e)             |
|POLY 3             |                                           P=0.041 *    |                                    (e)             |
|POLY 1.5           |                                           P=0.058      |                                    (e)             |
|POLY 6             |                                           P=0.030 *    |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.141      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.102      |                                    (e)             |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 21
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  49/50 (98%)              46/50 (92%)  |           43/50 (86%)              46/50 (92%)     |
|POLY-3 ADJUSTED (b)|                  99.8%                    99.8%        |           91.9%                    98.9%           |
|TERMINAL (d)       |                  20/20 (100%)             0/0 (0%)     |           20/22 (91%)              16/16 (100%)    |
|FIRST INCIDENCE    |                  521                      380          |           407                      331             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.087         |
|POLY 3             |                                           P=1.000N     |                                    P=0.095         |
|POLY 1.5           |                                           P=0.951N     |                                    P=0.109         |
|POLY 6             |                                           P=1.000      |                                    P=0.119         |
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.083         |
|COCH-ARM / FISHERS |                                           P=0.181N     |                                    P=0.262         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  33/50 (66%)              43/50 (86%)  |           22/50 (44%)              39/50 (78%)     |
|POLY-3 ADJUSTED (b)|                  68.9%                    96.8%        |           48.5%                    87.9%           |
|TERMINAL (d)       |                  12/20 (60%)              0/0 (0%)     |           7/22 (32%)               13/16 (81%)     |
|FIRST INCIDENCE    |                  344                      380          |           407                      459             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.002 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P=0.017 *    |                                    P<0.001 **      |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 22
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                  #                        #            |           #                        #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  50/50 (100%)             46/50 (92%)  |           47/50 (94%)              47/50 (94%)     |
|POLY-3 ADJUSTED (b)|                  100.0%                   99.8%        |           95.8%                    99.7%           |
|TERMINAL (d)       |                  20/20 (100%)             0/0 (0%)     |           20/22 (91%)              16/16 (100%)    |
|FIRST INCIDENCE    |                  344                      380          |           407                      331             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.179         |
|POLY 3             |                                           P=1.000N     |                                    P=0.275         |
|POLY 1.5           |                                           P=0.920N     |                                    P=0.363         |
|POLY 6             |                                           P=1.000N     |                                    P=0.253         |
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.434         |
|COCH-ARM / FISHERS |                                           P=0.059N     |                                    P=0.661N        |
|=================================================================================================================================|
(a)  Number of tumor-bearing animals /  number of animals examined at site.
(b)  Poly-3 adjusted lifetime tumor incidence.
(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.
(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).