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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: 09:28:42       
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         
------------------------------------------------------------------------------------------------------------------------------------
                                                             CORE 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 003    37 MG/KG                                                                      
                                       INCLUDE 004    37 MG/KG                                                                      
                                       INCLUDE 005    75 MG/KG                                                                      
                                       INCLUDE 006    75 MG/KG                                                                      
                                       INCLUDE 007    150     MG/KG                                                                 
                                       INCLUDE 008    150     MG/KG                                                                 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 09/16/98
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:28:42
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 Cortex
                                                 Adrenal Medulla
                                                 Brain
                                                 Clitoral/Preputial Gland
                                                 Heart
                                                 Islets, Pancreatic
                                                 Kidney
                                                 Liver
                                                 Lung
                                                 Ovary
                                                 Pancreas
                                                 Parathyroid Gland
                                                 Pituitary Gland
                                                 Prostate
                                                 Salivary Glands
                                                 Spleen
                                                 Testes
                                                 Thymus
                                                 Thyroid Gland
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08   
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 09/16/98     
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:28:42     
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
Islets, Pancreatic                     Adenoma
                                       Carcinoma or Adenoma
Kidney: Renal Tubule                   Adenoma
                                       Carcinoma or Adenoma
Liver                                  Hepatocellular Adenoma
                                       Hepatocellular Carcinoma
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
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
                                       Fibrosarcoma
                                       Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
                                       Keratoacanthoma
                                       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
Thyroid Gland: C-Cell                  Adenoma
                                       Carcinoma or 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
-----                                  ----------
Liver                                  Hepatocellular Adenoma
                                       Hepatocellular Carcinoma
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                                       Hepatocholangiocarcinoma
Pituitary Gland: Pars Distalis or Unspecified Site
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08   
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 09/16/98     
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:28:42     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                      
CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B     
PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2       
                                       Adenoma
Stomach, Forestomach                   Squamous Cell Carcinoma or Papilloma Squamous
                                       Squamous Cell Papilloma
Stomach, Glandular                     Neuroendocrine Tumor, Benign
                                       Neuroendocrine Tumor, Malignant
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                       Benign Tumors
                                       Malignant Tumors
                                       Malignant and Benign 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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     24/50 (48%)  17/50 (34%)  11/50 (22%)  10/50 (20%) |1/50 (2%)    1/50 (2%)    2/50 (4%)    2/49 (4%)    |
|POLY-3 ADJUSTED (b)|     54.5%        41.5%        28.2%        29.6%       |2.5%         2.4%         4.8%         5.6%         |
|TERMINAL (d)       |     9/20 (45%)   7/16 (44%)   4/15 (27%)   0/0 (0%)    |0/22 (0%)    0/25 (0%)    1/22 (5%)    0/11 (0%)    |
|FIRST INCIDENCE    |     588          575          619          625         |698          650          702          711          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.172      P=0.383N     P=0.108N     P=0.014 *   |P=0.193      P=0.750N     P=0.516      P=0.340      |
|POLY 3             |     P=0.007N**   P=0.155N     P=0.010N*    P=0.019N*   |P=0.297      P=0.751N     P=0.518      P=0.469      |
|POLY 1.5           |     P=0.003N**   P=0.133N     P=0.007N**   P=0.007N**  |P=0.317      P=0.754N     P=0.512      P=0.484      |
|POLY 6             |     P=0.026N*    P=0.192N     P=0.018N*    P=0.088N    |P=0.263      P=0.748N     P=0.525      P=0.438      |
|LOGISTIC REGRESSION|     P=0.045N*    P=0.180N     P=0.016N*    P=0.132N    |P=0.271      P=0.760N     P=0.526      P=0.400      |
|COCH-ARM / FISHERS |     P=0.002N**   P=0.111N     P=0.006N**   P=0.003N**  |P=0.330      P=0.753N     P=0.500      P=0.492      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     25/50 (50%)  17/50 (34%)  12/50 (24%)  11/50 (22%) |1/50 (2%)    1/50 (2%)    2/50 (4%)    3/49 (6%)    |
|POLY-3 ADJUSTED (b)|     56.8%        41.5%        30.7%        32.1%       |2.5%         2.4%         4.8%         8.2%         |
|TERMINAL (d)       |     10/20 (50%)  7/16 (44%)   4/15 (27%)   0/0 (0%)    |0/22 (0%)    0/25 (0%)    1/22 (5%)    0/11 (0%)    |
|FIRST INCIDENCE    |     588          575          619          575         |698          650          702          576          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.110      P=0.326N     P=0.127N     P=0.008 **  |P=0.077      P=0.750N     P=0.516      P=0.192      |
|POLY 3             |     P=0.009N**   P=0.108N     P=0.011N*    P=0.019N*   |P=0.141      P=0.751N     P=0.518      P=0.278      |
|POLY 1.5           |     P=0.004N**   P=0.092N     P=0.008N**   P=0.007N**  |P=0.152      P=0.754N     P=0.512      P=0.291      |
|POLY 6             |     P=0.031N*    P=0.136N     P=0.019N*    P=0.085N    |P=0.123      P=0.748N     P=0.525      P=0.250      |
|LOGISTIC REGRESSION|     P=0.059N     P=0.134N     P=0.019N*    P=0.129N    |P=0.141      P=0.760N     P=0.526      P=0.278      |
|COCH-ARM / FISHERS |     P=0.002N**   P=0.078N     P=0.006N**   P=0.003N**  |P=0.159      P=0.753N     P=0.500      P=0.301      |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.4%         5.1%         2.6%         0.0%        |2.5%         0.0%         0.0%         2.7%         |
|TERMINAL (d)       |     0/20 (0%)    1/16 (6%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     344          431          467          ---         |719          ---          ---          667          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.339N     P=0.472      P=0.756      P=0.504N    |P=0.521      P=0.484N     P=0.500N     P=0.670      |
|POLY 3             |     P=0.327N     P=0.475      P=0.737      P=0.559N    |P=0.580      P=0.492N     P=0.490N     P=0.745      |
|POLY 1.5           |     P=0.290N     P=0.485      P=0.746      P=0.532N    |P=0.587      P=0.495N     P=0.493N     P=0.755      |
|POLY 6             |     P=0.403N     P=0.460      P=0.722      P=0.606N    |P=0.569      P=0.490N     P=0.486N     P=0.724      |
|LOGISTIC REGRESSION|     P=0.144N     P=0.612      P=0.602N     P=0.431N    |P=0.576      P=0.487N     P=0.484N     P=0.733      |
|COCH-ARM / FISHERS |     P=0.247N     P=0.500      P=0.753N     P=0.500N    |P=0.595      P=0.500N     P=0.500N     P=0.753N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     9/50 (18%)   16/50 (32%)  3/49 (6%)    8/50 (16%)  |5/48 (10%)   8/46 (17%)   6/49 (12%)   3/46 (7%)    |
|POLY-3 ADJUSTED (b)|     21.2%        38.6%        8.0%         23.3%       |13.1%        21.4%        14.6%        8.8%         |
|TERMINAL (d)       |     4/20 (20%)   7/16 (44%)   1/15 (7%)    0/0 (0%)    |3/21 (14%)   5/22 (23%)   3/22 (14%)   1/11 (9%)    |
|FIRST INCIDENCE    |     610          542          568          502         |679          620          676          609          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.117      P=0.036 *    P=0.147N     P=0.024 *   |P=0.495N     P=0.312      P=0.541      P=0.611N     |
|POLY 3             |     P=0.295N     P=0.061      P=0.087N     P=0.521     |P=0.249N     P=0.255      P=0.548      P=0.420N     |
|POLY 1.5           |     P=0.223N     P=0.069      P=0.078N     P=0.603N    |P=0.226N     P=0.254      P=0.535      P=0.396N     |
|POLY 6             |     P=0.437N     P=0.050      P=0.107N     P=0.361     |P=0.294N     P=0.257      P=0.564      P=0.467N     |
|LOGISTIC REGRESSION|     P=0.230N     P=0.064      P=0.080N     P=0.605N    |P=0.310N     P=0.255      P=0.575      P=0.457N     |
|COCH-ARM / FISHERS |     P=0.162N     P=0.083      P=0.065N     P=0.500N    |P=0.212N     P=0.249      P=0.515      P=0.381N     |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   1/50 (2%)    2/49 (4%)    0/50 (0%)   |1/48 (2%)    0/46 (0%)    1/49 (2%)    0/46 (0%)    |
|POLY-3 ADJUSTED (b)|     11.9%        2.6%         5.3%         0.0%        |2.6%         0.0%         2.5%         0.0%         |
|TERMINAL (d)       |     2/20 (10%)   0/16 (0%)    0/15 (0%)    0/0 (0%)    |1/21 (5%)    0/22 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     564          704          502          ---         |730 (T)      ---          721          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.141N     P=0.170N     P=0.327N     P=0.497N    |P=0.519N     P=0.491N     P=0.750N     P=0.629N     |
|POLY 3             |     P=0.037N*    P=0.120N     P=0.260N     P=0.064N    |P=0.423N     P=0.506N     P=0.745N     P=0.526N     |
|POLY 1.5           |     P=0.031N*    P=0.112N     P=0.247N     P=0.045N*   |P=0.416N     P=0.506N     P=0.749N     P=0.516N     |
|POLY 6             |     P=0.053N     P=0.133N     P=0.284N     P=0.115N    |P=0.432N     P=0.505N     P=0.740N     P=0.545N     |
|LOGISTIC REGRESSION|     P=0.027N*    P=0.120N     P=0.216N     P=0.081N    |P=0.487N     (e)          P=0.741N     (e)          |
|COCH-ARM / FISHERS |     P=0.026N*    P=0.102N     P=0.226N     P=0.028N*   |P=0.410N     P=0.511N     P=0.747N     P=0.511N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     14/50 (28%)  17/50 (34%)  5/49 (10%)   8/50 (16%)  |6/48 (13%)   8/46 (17%)   7/49 (14%)   3/46 (7%)    |
|POLY-3 ADJUSTED (b)|     32.4%        40.9%        12.9%        23.3%       |15.7%        21.4%        17.1%        8.8%         |
|TERMINAL (d)       |     6/20 (30%)   7/16 (44%)   1/15 (7%)    0/0 (0%)    |4/21 (19%)   5/22 (23%)   3/22 (14%)   1/11 (9%)    |
|FIRST INCIDENCE    |     564          542          502          502         |679          620          676          609          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.307      P=0.163      P=0.087N     P=0.056     |P=0.436N     P=0.426      P=0.543      P=0.510N     |
|POLY 3             |     P=0.065N     P=0.276      P=0.030N*    P=0.261N    |P=0.195N     P=0.365      P=0.554      P=0.298N     |
|POLY 1.5           |     P=0.041N*    P=0.300      P=0.027N*    P=0.179N    |P=0.174N     P=0.363      P=0.539      P=0.277N     |
|POLY 6             |     P=0.131N     P=0.244      P=0.039N*    P=0.444N    |P=0.236N     P=0.369      P=0.572      P=0.342N     |
|LOGISTIC REGRESSION|     P=0.043N*    P=0.273      P=0.026N*    P=0.220N    |P=0.255N     P=0.365      P=0.585      P=0.348N     |
|COCH-ARM / FISHERS |     P=0.025N*    P=0.333      P=0.022N*    P=0.114N    |P=0.162N     P=0.354      P=0.516      P=0.265N     |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     7.2%         2.6%         0.0%         0.0%        |0.0%         2.4%         0.0%         0.0%         |
|TERMINAL (d)       |     1/20 (5%)    1/16 (6%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     704          730 (T)      ---          ---         |---          646          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.186N     P=0.403N     P=0.221N     P=0.970N    |P=0.599N     P=0.523      (e)          (e)          |
|POLY 3             |     P=0.046N*    P=0.332N     P=0.138N     P=0.178N    |P=0.560N     P=0.509      (e)          (e)          |
|POLY 1.5           |     P=0.045N*    P=0.320N     P=0.130N     P=0.147N    |P=0.562N     P=0.506      (e)          (e)          |
|POLY 6             |     P=0.049N*    P=0.350N     P=0.153N     P=0.246N    |P=0.554N     P=0.513      (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.120N     P=0.374N     P=0.172N     P=0.505N    |P=0.564N     P=0.494      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.044N*    P=0.309N     P=0.121N     P=0.121N    |P=0.567N     P=0.500      (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     7.2%         2.6%         0.0%         0.0%        |2.5%         2.4%         0.0%         0.0%         |
|TERMINAL (d)       |     1/20 (5%)    1/16 (6%)    0/15 (0%)    0/0 (0%)    |1/22 (5%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     704          730 (T)      ---          ---         |730 (T)      646          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.186N     P=0.403N     P=0.221N     P=0.970N    |P=0.286N     P=0.733N     P=0.500N     P=0.638N     |
|POLY 3             |     P=0.046N*    P=0.332N     P=0.138N     P=0.178N    |P=0.235N     P=0.751N     P=0.489N     P=0.516N     |
|POLY 1.5           |     P=0.045N*    P=0.320N     P=0.130N     P=0.147N    |P=0.236N     P=0.754N     P=0.493N     P=0.506N     |
|POLY 6             |     P=0.049N*    P=0.350N     P=0.153N     P=0.246N    |P=0.232N     P=0.746N     P=0.486N     P=0.535N     |
|LOGISTIC REGRESSION|     P=0.120N     P=0.374N     P=0.172N     P=0.505N    |P=0.242N     P=0.756N     (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.044N*    P=0.309N     P=0.121N     P=0.121N    |P=0.236N     P=0.753N     P=0.500N     P=0.500N     |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    6/50 (12%)   6/50 (12%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     7.2%         5.2%         15.8%        18.4%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/20 (5%)    0/16 (0%)    4/15 (27%)   0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     712          673          596          598         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.596N     P=0.106      P<0.001 **  |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.046 *    P=0.531N     P=0.195      P=0.135     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.070      P=0.518N     P=0.213      P=0.181     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.022 *    P=0.551N     P=0.167      P=0.075     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.007 **   P=0.568N     P=0.138      P=0.034 *   |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.107      P=0.500N     P=0.243      P=0.243     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    2/50 (4%)    6/50 (12%)   6/50 (12%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     9.6%         5.2%         15.8%        18.4%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     2/20 (10%)   0/16 (0%)    4/15 (27%)   0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     712          673          596          598         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.443N     P=0.182      P<0.001 **  |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.090      P=0.368N     P=0.310      P=0.226     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.127      P=0.355N     P=0.333      P=0.291     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.048 *    P=0.388N     P=0.273      P=0.135     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.014 *    P=0.413N     P=0.222      P=0.049 *   |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.179      P=0.339N     P=0.370      P=0.370     |(e)          (e)          (e)          (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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   12/50 (24%)  23/50 (46%)  38/50 (76%) |1/50 (2%)    8/50 (16%)   11/49 (22%)  33/49 (67%)  |
|POLY-3 ADJUSTED (b)|     12.0%        29.5%        55.1%        86.8%       |2.5%         19.6%        26.3%        75.1%        |
|TERMINAL (d)       |     2/20 (10%)   5/16 (31%)   8/15 (53%)   0/0 (0%)    |1/22 (5%)    8/25 (32%)   5/22 (23%)   11/11 (100%) |
|FIRST INCIDENCE    |     715          431          522          467         |730 (T)      730 (T)      609          508          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.026 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.023 *    P=0.005 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.042 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.017 *    P=0.002 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.047 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.017 *    P=0.002 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.037 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.017 *    P=0.003 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.039 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.023 *    P=0.003 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.054      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.015 *    P=0.002 **   P<0.001 **   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    14/50 (28%)  25/50 (50%) |0/50 (0%)    0/50 (0%)    4/49 (8%)    8/49 (16%)   |
|POLY-3 ADJUSTED (b)|     4.8%         7.8%         34.7%        64.0%       |0.0%         0.0%         9.7%         21.8%        |
|TERMINAL (d)       |     1/20 (5%)    2/16 (13%)   5/15 (33%)   0/0 (0%)    |0/22 (0%)    0/25 (0%)    2/22 (9%)    5/11 (46%)   |
|FIRST INCIDENCE    |     529          718          502          523         |---          ---          609          589          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.418      P<0.001 **   P<0.001 **  |P<0.001 **   (e)          P=0.073      P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.461      P<0.001 **   P<0.001 **  |P<0.001 **   (e)          P=0.066      P=0.002 **   |
|POLY 1.5           |     P<0.001 **   P=0.478      P<0.001 **   P<0.001 **  |P<0.001 **   (e)          P=0.063      P=0.003 **   |
|POLY 6             |     P<0.001 **   P=0.437      P<0.001 **   P<0.001 **  |P<0.001 **   (e)          P=0.071      P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.474      P<0.001 **   P<0.001 **  |P<0.001 **   (e)          P=0.065      P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.500      P<0.001 **   P<0.001 **  |P<0.001 **   (e)          P=0.056      P=0.003 **   |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     7/50 (14%)   14/50 (28%)  28/50 (56%)  43/50 (86%) |1/50 (2%)    8/50 (16%)   14/49 (29%)  34/49 (69%)  |
|POLY-3 ADJUSTED (b)|     16.6%        34.4%        64.4%        94.0%       |2.5%         19.6%        33.4%        76.6%        |
|TERMINAL (d)       |     3/20 (15%)   7/16 (44%)   9/15 (60%)   0/0 (0%)    |1/22 (5%)    8/25 (32%)   7/22 (32%)   11/11 (100%) |
|FIRST INCIDENCE    |     529          431          502          467         |730 (T)      730 (T)      609          508          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.030 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.023 *    P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.049 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.017 *    P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.057      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.017 *    P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.040 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.017 *    P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.051      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.023 *    P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.070      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.015 *    P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           |
|     or Hepatoblastoma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     7/50 (14%)   14/50 (28%)  28/50 (56%)  43/50 (86%) |1/50 (2%)    8/50 (16%)   14/49 (29%)  34/49 (69%)  |
|POLY-3 ADJUSTED (b)|     16.6%        34.4%        64.4%        94.0%       |2.5%         19.6%        33.4%        76.6%        |
|TERMINAL (d)       |     3/20 (15%)   7/16 (44%)   9/15 (60%)   0/0 (0%)    |1/22 (5%)    8/25 (32%)   7/22 (32%)   11/11 (100%) |
|FIRST INCIDENCE    |     529          431          502          467         |730 (T)      730 (T)      609          508          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.030 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.023 *    P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.049 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.017 *    P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.057      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.017 *    P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.040 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.017 *    P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.051      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.023 *    P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.070      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.015 *    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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocholangiocarcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/49 (0%)    3/49 (6%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         2.6%         3.1%        |0.0%         0.0%         0.0%         8.2%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    2/11 (18%)   |
|FIRST INCIDENCE    |     ---          ---          582          457         |---          ---          ---          534          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.226      (e)          P=0.486      P=0.496     |P=0.003 **   (e)          (e)          P=0.054      |
|POLY 3             |     P=0.175      (e)          P=0.482      P=0.449     |P=0.010 *    (e)          (e)          P=0.105      |
|POLY 1.5           |     P=0.204      (e)          P=0.489      P=0.474     |P=0.010 *    (e)          (e)          P=0.112      |
|POLY 6             |     P=0.130      (e)          P=0.470      P=0.405     |P=0.009 **   (e)          (e)          P=0.092      |
|LOGISTIC REGRESSION|     P=0.291      (e)          P=0.548      P=0.631     |P=0.011 *    (e)          (e)          P=0.113      |
|COCH-ARM / FISHERS |     P=0.236      (e)          P=0.500      P=0.500     |P=0.011 *    (e)          (e)          P=0.117      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |2/50 (4%)    4/50 (8%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.4%         0.0%         5.4%         0.0%        |5.1%         9.7%         2.4%         0.0%         |
|TERMINAL (d)       |     1/20 (5%)    0/16 (0%)    2/15 (13%)   0/0 (0%)    |2/22 (9%)    3/25 (12%)   0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     730 (T)      ---          730 (T)      ---         |730 (T)      650          515          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.417      P=0.545N     P=0.398      P=1.000N    |P=0.156N     P=0.394      P=0.493N     P=0.400N     |
|POLY 3             |     P=0.539N     P=0.514N     P=0.464      P=0.555N    |P=0.093N     P=0.358      P=0.476N     P=0.255N     |
|POLY 1.5           |     P=0.501N     P=0.508N     P=0.478      P=0.529N    |P=0.088N     P=0.351      P=0.485N     P=0.244N     |
|POLY 6             |     P=0.611N     P=0.523N     P=0.440      P=0.601N    |P=0.104N     P=0.367      P=0.467N     P=0.277N     |
|LOGISTIC REGRESSION|     P=0.417      (e)          P=0.398      (e)         |P=0.093N     P=0.365      P=0.505N     (e)          |
|COCH-ARM / FISHERS |     P=0.461N     P=0.500N     P=0.500      P=0.500N    |P=0.086N     P=0.339      P=0.500N     P=0.247N     |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    3/50 (6%)    0/50 (0%)   |2/50 (4%)    4/50 (8%)    1/50 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.4%         0.0%         8.0%         0.0%        |5.1%         9.7%         2.4%         2.7%         |
|TERMINAL (d)       |     1/20 (5%)    0/16 (0%)    3/15 (20%)   0/0 (0%)    |2/22 (9%)    3/25 (12%)   0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     730 (T)      ---          730 (T)      ---         |730 (T)      650          515          609          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.191      P=0.545N     P=0.203      P=1.000N    |P=0.378N     P=0.394      P=0.493N     P=0.669N     |
|POLY 3             |     P=0.611N     P=0.514N     P=0.268      P=0.555N    |P=0.245N     P=0.358      P=0.476N     P=0.524N     |
|POLY 1.5           |     P=0.557N     P=0.508N     P=0.283      P=0.529N    |P=0.236N     P=0.351      P=0.485N     P=0.509N     |
|POLY 6             |     P=0.478      P=0.523N     P=0.245      P=0.601N    |P=0.261N     P=0.367      P=0.467N     P=0.553N     |
|LOGISTIC REGRESSION|     P=0.191      (e)          P=0.203      (e)         |P=0.241N     P=0.365      P=0.505N     P=0.545N     |
|COCH-ARM / FISHERS |     P=0.500N     P=0.500N     P=0.309      P=0.500N    |P=0.232N     P=0.339      P=0.500N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   5/50 (10%)   15/50 (30%)  13/50 (26%) |36/50 (72%)  36/50 (72%)  34/50 (68%)  31/50 (62%)  |
|POLY-3 ADJUSTED (b)|     12.0%        12.6%        38.3%        37.0%       |78.7%        77.9%        75.9%        73.8%        |
|TERMINAL (d)       |     4/20 (20%)   2/16 (13%)   8/15 (53%)   0/0 (0%)    |15/22 (68%)  19/25 (76%)  18/22 (82%)  9/11 (82%)   |
|FIRST INCIDENCE    |     610          579          568          546         |407          347          527          527          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.515      P=0.002 **   P<0.001 **  |P=0.075      P=0.373N     P=0.370N     P=0.136      |
|POLY 3             |     P<0.001 **   P=0.596      P=0.004 **   P=0.008 **  |P=0.306N     P=0.567N     P=0.474N     P=0.376N     |
|POLY 1.5           |     P=0.003 **   P=0.610      P=0.006 **   P=0.016 *   |P=0.198N     P=0.555N     P=0.435N     P=0.259N     |
|POLY 6             |     P<0.001 **   P=0.577      P=0.003 **   P=0.002 **  |P=0.534N     P=0.610N     P=0.553N     P=0.615N     |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.591      P=0.003 **   P=0.008 **  |P=0.198N     P=0.530N     P=0.298N     P=0.258N     |
|COCH-ARM / FISHERS |     P=0.009 **   P=0.630N     P=0.011 *    P=0.033 *   |P=0.134N     P=0.588N     P=0.414N     P=0.198N     |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   5/50 (10%)   16/50 (32%)  13/50 (26%) |36/50 (72%)  36/50 (72%)  34/50 (68%)  32/50 (64%)  |
|POLY-3 ADJUSTED (b)|     12.0%        12.6%        40.8%        37.0%       |78.7%        77.9%        75.9%        75.4%        |
|TERMINAL (d)       |     4/20 (20%)   2/16 (13%)   9/15 (60%)   0/0 (0%)    |15/22 (68%)  19/25 (76%)  18/22 (82%)  9/11 (82%)   |
|FIRST INCIDENCE    |     610          579          568          546         |407          347          527          527          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.515      P<0.001 **   P<0.001 **  |P=0.054      P=0.373N     P=0.370N     P=0.107      |
|POLY 3             |     P<0.001 **   P=0.596      P=0.002 **   P=0.008 **  |P=0.379N     P=0.567N     P=0.474N     P=0.451N     |
|POLY 1.5           |     P=0.002 **   P=0.610      P=0.003 **   P=0.016 *   |P=0.264N     P=0.555N     P=0.435N     P=0.330N     |
|POLY 6             |     P<0.001 **   P=0.577      P<0.001 **   P=0.002 **  |P=0.511      P=0.610N     P=0.553N     P=0.569      |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.591      P<0.001 **   P=0.008 **  |P=0.267N     P=0.530N     P=0.298N     P=0.328N     |
|COCH-ARM / FISHERS |     P=0.009 **   P=0.630N     P=0.006 **   P=0.033 *   |P=0.190N     P=0.588N     P=0.414N     P=0.260N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   5/50 (10%)   16/50 (32%)  13/50 (26%) |37/50 (74%)  38/50 (76%)  35/50 (70%)  32/50 (64%)  |
|POLY-3 ADJUSTED (b)|     12.0%        12.6%        40.8%        37.0%       |80.9%        81.7%        77.0%        75.4%        |
|TERMINAL (d)       |     4/20 (20%)   2/16 (13%)   9/15 (60%)   0/0 (0%)    |16/22 (73%)  20/25 (80%)  18/22 (82%)  9/11 (82%)   |
|FIRST INCIDENCE    |     610          579          568          546         |407          347          515          527          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.515      P<0.001 **   P<0.001 **  |P=0.077      P=0.419N     P=0.369N     P=0.125      |
|POLY 3             |     P<0.001 **   P=0.596      P=0.002 **   P=0.008 **  |P=0.243N     P=0.570      P=0.420N     P=0.344N     |
|POLY 1.5           |     P=0.002 **   P=0.610      P=0.003 **   P=0.016 *   |P=0.158N     P=0.562      P=0.403N     P=0.242N     |
|POLY 6             |     P<0.001 **   P=0.577      P<0.001 **   P=0.002 **  |P=0.440N     P=0.553      P=0.473N     P=0.565N     |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.591      P<0.001 **   P=0.008 **  |P=0.162N     P=0.572      P=0.302N     P=0.250N     |
|COCH-ARM / FISHERS |     P=0.009 **   P=0.630N     P=0.006 **   P=0.033 *   |P=0.113N     P=0.500      P=0.412N     P=0.194N     |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.1%         0.0%         6.3%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     ---          596          ---          633         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.071      P=0.204      (e)          P=0.084     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.184      P=0.224      (e)          P=0.183     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.212      P=0.229      (e)          P=0.208     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.144      P=0.216      (e)          P=0.146     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.219      P=0.241      (e)          P=0.190     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.247      P=0.247      (e)          P=0.247     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.1%         0.0%         6.3%        |0.0%         0.0%         2.4%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     ---          596          ---          633         |---          ---          637          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.071      P=0.204      (e)          P=0.084     |P=0.671      (e)          P=0.511      (e)          |
|POLY 3             |     P=0.184      P=0.224      (e)          P=0.183     |P=0.649      (e)          P=0.512      (e)          |
|POLY 1.5           |     P=0.212      P=0.229      (e)          P=0.208     |P=0.675      (e)          P=0.508      (e)          |
|POLY 6             |     P=0.144      P=0.216      (e)          P=0.146     |P=0.595      (e)          P=0.517      (e)          |
|LOGISTIC REGRESSION|     P=0.219      P=0.241      (e)          P=0.190     |P=0.694      (e)          P=0.489      (e)          |
|COCH-ARM / FISHERS |     P=0.247      P=0.247      (e)          P=0.247     |P=0.694      (e)          P=0.500      (e)          |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Malignant                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |0/50 (0%)    2/50 (4%)    0/49 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|                                                        |0.0%         4.9%         0.0%         0.0%         |
|TERMINAL (d)       |                                                        |0/22 (0%)    1/25 (4%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |                                                        |---          718          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.525N     P=0.267      (e)          (e)          |
|POLY 3             |                                                        |P=0.407N     P=0.246      (e)          (e)          |
|POLY 1.5           |                                                        |P=0.405N     P=0.243      (e)          (e)          |
|POLY 6             |                                                        |P=0.412N     P=0.249      (e)          (e)          |
|LOGISTIC REGRESSION|                                                        |P=0.483N     P=0.253      (e)          (e)          |
|COCH-ARM / FISHERS |                                                        |P=0.410N     P=0.247      (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     7/50 (14%)   8/50 (16%)   8/50 (16%)   2/50 (4%)   |22/50 (44%)  20/50 (40%)  21/50 (42%)  22/50 (44%)  |
|POLY-3 ADJUSTED (b)|     16.3%        19.4%        20.4%        6.3%        |51.8%        46.2%        47.6%        53.0%        |
|TERMINAL (d)       |     3/20 (15%)   1/16 (6%)    3/15 (20%)   0/0 (0%)    |10/22 (46%)  13/25 (52%)  10/22 (46%)  5/11 (46%)   |
|FIRST INCIDENCE    |     521          572          438          670         |549          520          541          527          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.521N     P=0.399      P=0.335      P=0.654     |P=0.042 *    P=0.293N     P=0.448N     P=0.101      |
|POLY 3             |     P=0.185N     P=0.468      P=0.425      P=0.174N    |P=0.439      P=0.378N     P=0.429N     P=0.544      |
|POLY 1.5           |     P=0.113N     P=0.481      P=0.454      P=0.122N    |P=0.478      P=0.388N     P=0.453N     P=0.579      |
|POLY 6             |     P=0.367N     P=0.454      P=0.376      P=0.298N    |P=0.362      P=0.376N     P=0.409N     P=0.460      |
|LOGISTIC REGRESSION|     P=0.057N     P=0.547      P=0.505      P=0.130N    |P=0.402      P=0.363N     P=0.429N     P=0.509      |
|COCH-ARM / FISHERS |     P=0.060N     P=0.500      P=0.500      P=0.080N    |P=0.490      P=0.420N     P=0.500N     P=0.580N     |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma, Basosquamous Tumor Benign, or                                                                           |
|     Trichoepithelioma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         4.9%         2.4%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    2/25 (8%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          730 (T)      690          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.607N     P=0.266      P=0.520      (e)          |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.481N     P=0.245      P=0.511      (e)          |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.468N     P=0.243      P=0.507      (e)          |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.507N     P=0.248      P=0.516      (e)          |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.539N     P=0.266      P=0.508      (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.461N     P=0.247      P=0.500      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous                                                                      |
|     Tumor (benign, malignant or NOS), or Trichoepithelioma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.6%         0.0%         0.0%        |0.0%         4.9%         2.4%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    2/25 (8%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     ---          725          ---          ---         |---          730 (T)      690          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.861      P=0.458      (e)          (e)         |P=0.607N     P=0.266      P=0.520      (e)          |
|POLY 3             |     P=0.589N     P=0.486      (e)          (e)         |P=0.481N     P=0.245      P=0.511      (e)          |
|POLY 1.5           |     P=0.580N     P=0.492      (e)          (e)         |P=0.468N     P=0.243      P=0.507      (e)          |
|POLY 6             |     P=0.606N     P=0.477      (e)          (e)         |P=0.507N     P=0.248      P=0.516      (e)          |
|LOGISTIC REGRESSION|     P=0.853      P=0.453      (e)          (e)         |P=0.539N     P=0.266      P=0.508      (e)          |
|COCH-ARM / FISHERS |     P=0.567N     P=0.500      (e)          (e)         |P=0.461N     P=0.247      P=0.500      (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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            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%)    4/50 (8%)    4/50 (8%)    6/50 (12%)  |0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     7.2%         10.3%        10.6%        18.1%       |0.0%         4.9%         2.4%         0.0%         |
|TERMINAL (d)       |     3/20 (15%)   2/16 (13%)   1/15 (7%)    0/0 (0%)    |0/22 (0%)    2/25 (8%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     730 (T)      704          674          584         |---          730 (T)      690          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.375      P=0.323      P=0.002 **  |P=0.607N     P=0.266      P=0.520      (e)          |
|POLY 3             |     P=0.102      P=0.462      P=0.449      P=0.141     |P=0.481N     P=0.245      P=0.511      (e)          |
|POLY 1.5           |     P=0.137      P=0.479      P=0.469      P=0.185     |P=0.468N     P=0.243      P=0.507      (e)          |
|POLY 6             |     P=0.060      P=0.439      P=0.419      P=0.084     |P=0.507N     P=0.248      P=0.516      (e)          |
|LOGISTIC REGRESSION|     P=0.027 *    P=0.366      P=0.352      P=0.092     |P=0.539N     P=0.266      P=0.508      (e)          |
|COCH-ARM / FISHERS |     P=0.184      P=0.500      P=0.500      P=0.243     |P=0.461N     P=0.247      P=0.500      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    9/50 (18%)   8/50 (16%)   5/50 (10%)  |1/50 (2%)    0/50 (0%)    2/50 (4%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     2.4%         22.3%        20.6%        15.3%       |2.5%         0.0%         4.8%         5.5%         |
|TERMINAL (d)       |     1/20 (5%)    3/16 (19%)   2/15 (13%)   0/0 (0%)    |0/22 (0%)    0/25 (0%)    1/22 (5%)    0/11 (0%)    |
|FIRST INCIDENCE    |     730 (T)      535          619          607         |724          ---          676          620          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.002 **   P=0.006 **   P=0.008 **   P=0.004 **  |P=0.129      P=0.476N     P=0.520      P=0.356      |
|POLY 3             |     P=0.108      P=0.006 **   P=0.011 *    P=0.055     |P=0.217      P=0.492N     P=0.520      P=0.476      |
|POLY 1.5           |     P=0.179      P=0.007 **   P=0.012 *    P=0.075     |P=0.233      P=0.495N     P=0.512      P=0.491      |
|POLY 6             |     P=0.038 *    P=0.005 **   P=0.009 **   P=0.032 *   |P=0.191      P=0.490N     P=0.528      P=0.446      |
|LOGISTIC REGRESSION|     P=0.150      P=0.008 **   P=0.011 *    P=0.051     |P=0.206      P=0.485N     P=0.526      P=0.456      |
|COCH-ARM / FISHERS |     P=0.287      P=0.008 **   P=0.015 *    P=0.102     |P=0.245      P=0.500N     P=0.500      P=0.500      |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        |
|     or Fibrous Histiocytoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    13/50 (26%)  8/50 (16%)   8/50 (16%)  |1/50 (2%)    0/50 (0%)    4/50 (8%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     2.4%         31.9%        20.6%        23.7%       |2.5%         0.0%         9.6%         5.5%         |
|TERMINAL (d)       |     1/20 (5%)    4/16 (25%)   2/15 (13%)   0/0 (0%)    |0/22 (0%)    0/25 (0%)    2/22 (9%)    0/11 (0%)    |
|FIRST INCIDENCE    |     730 (T)      535          619          547         |724          ---          676          620          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P<0.001 **   P=0.008 **   P<0.001 **  |P=0.100      P=0.476N     P=0.197      P=0.356      |
|POLY 3             |     P=0.046 *    P<0.001 **   P=0.011 *    P=0.005 **  |P=0.195      P=0.492N     P=0.195      P=0.476      |
|POLY 1.5           |     P=0.084      P<0.001 **   P=0.012 *    P=0.009 **  |P=0.217      P=0.495N     P=0.189      P=0.491      |
|POLY 6             |     P=0.014 *    P<0.001 **   P=0.009 **   P=0.002 **  |P=0.158      P=0.490N     P=0.202      P=0.446      |
|LOGISTIC REGRESSION|     P=0.064      P<0.001 **   P=0.011 *    P=0.011 *   |P=0.174      P=0.485N     P=0.201      P=0.456      |
|COCH-ARM / FISHERS |     P=0.158      P<0.001 **   P=0.015 *    P=0.015 *   |P=0.237      P=0.500N     P=0.181      P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    0/50 (0%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         7.7%         0.0%         9.3%        |0.0%         0.0%         4.8%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    1/16 (6%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    1/22 (5%)    0/11 (0%)    |
|FIRST INCIDENCE    |     ---          674          ---          547         |---          ---          717          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.011 *    P=0.093      (e)          P=0.035 *   |P=0.479      (e)          P=0.244      (e)          |
|POLY 3             |     P=0.110      P=0.106      (e)          P=0.080     |P=0.537      (e)          P=0.249      (e)          |
|POLY 1.5           |     P=0.132      P=0.112      (e)          P=0.097     |P=0.570      (e)          P=0.245      (e)          |
|POLY 6             |     P=0.080      P=0.099      (e)          P=0.057     |P=0.472      (e)          P=0.253      (e)          |
|LOGISTIC REGRESSION|     P=0.124      P=0.095      (e)          P=0.147     |P=0.518      (e)          P=0.252      (e)          |
|COCH-ARM / FISHERS |     P=0.163      P=0.121      (e)          P=0.121     |P=0.595      (e)          P=0.247      (e)          |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    4/50 (8%)    0/50 (0%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         10.3%        0.0%         9.3%        |0.0%         0.0%         4.8%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    1/16 (6%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    1/22 (5%)    0/11 (0%)    |
|FIRST INCIDENCE    |     ---          664          ---          547         |---          ---          717          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.023 *    P=0.047 *    (e)          P=0.035 *   |P=0.479      (e)          P=0.244      (e)          |
|POLY 3             |     P=0.158      P=0.052      (e)          P=0.080     |P=0.537      (e)          P=0.249      (e)          |
|POLY 1.5           |     P=0.191      P=0.056      (e)          P=0.097     |P=0.570      (e)          P=0.245      (e)          |
|POLY 6             |     P=0.113      P=0.048 *    (e)          P=0.057     |P=0.472      (e)          P=0.253      (e)          |
|LOGISTIC REGRESSION|     P=0.188      P=0.050      (e)          P=0.147     |P=0.518      (e)          P=0.252      (e)          |
|COCH-ARM / FISHERS |     P=0.237      P=0.059      (e)          P=0.121     |P=0.595      (e)          P=0.247      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    4/50 (8%)    5/50 (10%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     7.2%         7.8%         10.6%        15.2%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     3/20 (15%)   2/16 (13%)   1/15 (7%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     730 (T)      704          674          584         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.552      P=0.323      P=0.005 **  |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.151      P=0.631      P=0.449      P=0.235     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.193      P=0.645      P=0.469      P=0.290     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.095      P=0.612      P=0.419      P=0.156     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.054      P=0.548      P=0.352      P=0.169     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.248      P=0.661N     P=0.500      P=0.357     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           |
|     Carcinoma or Keratoacanthoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    4/50 (8%)    6/50 (12%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     7.2%         7.8%         10.6%        18.1%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     3/20 (15%)   2/16 (13%)   1/15 (7%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     730 (T)      704          674          584         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.552      P=0.323      P=0.002 **  |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.080      P=0.631      P=0.449      P=0.141     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.107      P=0.645      P=0.469      P=0.185     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.048 *    P=0.612      P=0.419      P=0.084     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.023 *    P=0.548      P=0.352      P=0.092     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.145      P=0.661N     P=0.500      P=0.243     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    4/50 (8%)    6/50 (12%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     7.2%         7.8%         10.6%        18.1%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     3/20 (15%)   2/16 (13%)   1/15 (7%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     730 (T)      704          674          584         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.552      P=0.323      P=0.002 **  |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.080      P=0.631      P=0.449      P=0.141     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.107      P=0.645      P=0.469      P=0.185     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.048 *    P=0.612      P=0.419      P=0.084     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.023 *    P=0.548      P=0.352      P=0.092     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.145      P=0.661N     P=0.500      P=0.243     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.6%         0.0%         0.0%        |0.0%         0.0%         2.4%         8.2%         |
|TERMINAL (d)       |     0/20 (0%)    1/16 (6%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    1/22 (5%)    2/11 (18%)   |
|FIRST INCIDENCE    |     ---          730 (T)      ---          ---         |---          ---          730 (T)      679          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.864      P=0.455      (e)          (e)         |P=0.003 **   (e)          P=0.500      P=0.042 *    |
|POLY 3             |     P=0.589N     P=0.486      (e)          (e)         |P=0.016 *    (e)          P=0.510      P=0.105      |
|POLY 1.5           |     P=0.581N     P=0.492      (e)          (e)         |P=0.018 *    (e)          P=0.507      P=0.113      |
|POLY 6             |     P=0.606N     P=0.477      (e)          (e)         |P=0.014 *    (e)          P=0.514      P=0.090      |
|LOGISTIC REGRESSION|     (e)          P=0.455      (e)          (e)         |P=0.007 **   (e)          P=0.500      P=0.069      |
|COCH-ARM / FISHERS |     P=0.567N     P=0.500      (e)          (e)         |P=0.020 *    (e)          P=0.500      P=0.121      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.6%         0.0%         0.0%        |0.0%         0.0%         2.4%         5.5%         |
|TERMINAL (d)       |     0/20 (0%)    1/16 (6%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    1/22 (5%)    1/11 (9%)    |
|FIRST INCIDENCE    |     ---          730 (T)      ---          ---         |---          ---          730 (T)      679          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.864      P=0.455      (e)          (e)         |P=0.021 *    (e)          P=0.500      P=0.135      |
|POLY 3             |     P=0.589N     P=0.486      (e)          (e)         |P=0.060      (e)          P=0.510      P=0.220      |
|POLY 1.5           |     P=0.581N     P=0.492      (e)          (e)         |P=0.065      (e)          P=0.507      P=0.230      |
|POLY 6             |     P=0.606N     P=0.477      (e)          (e)         |P=0.052      (e)          P=0.514      P=0.201      |
|LOGISTIC REGRESSION|     (e)          P=0.455      (e)          (e)         |P=0.039 *    (e)          P=0.500      P=0.185      |
|COCH-ARM / FISHERS |     P=0.567N     P=0.500      (e)          (e)         |P=0.070      (e)          P=0.500      P=0.247      |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Neuroendocrine Tumor, Benign                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    13/50 (26%)  9/50 (18%)   |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         9.4%        |0.0%         0.0%         31.0%        23.0%        |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    7/22 (32%)   1/11 (9%)    |
|FIRST INCIDENCE    |     ---          ---          ---          642         |---          ---          676          553          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.003 **   (e)          (e)          P=0.047 *   |P<0.001 **   (e)          P<0.001 **   P<0.001 **   |
|POLY 3             |     P=0.009 **   (e)          (e)          P=0.079     |P<0.001 **   (e)          P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P=0.009 **   (e)          (e)          P=0.096     |P<0.001 **   (e)          P<0.001 **   P=0.002 **   |
|POLY 6             |     P=0.008 **   (e)          (e)          P=0.056     |P<0.001 **   (e)          P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P=0.009 **   (e)          (e)          P=0.092     |P<0.001 **   (e)          P<0.001 **   P=0.003 **   |
|COCH-ARM / FISHERS |     P=0.012 *    (e)          (e)          P=0.121     |P<0.001 **   (e)          P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Neuroendocrine Tumor, Malignant                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    4/50 (8%)   |0/50 (0%)    1/50 (2%)    12/50 (24%)  26/50 (52%)  |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         12.5%       |0.0%         2.4%         28.9%        64.9%        |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    9/22 (41%)   9/11 (82%)   |
|FIRST INCIDENCE    |     ---          ---          ---          660         |---          718          690          548          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   (e)          (e)          P<0.001 **  |P<0.001 **   P=0.523      P<0.001 **   P<0.001 **   |
|POLY 3             |     P=0.002 **   (e)          (e)          P=0.033 *   |P<0.001 **   P=0.508      P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P=0.002 **   (e)          (e)          P=0.045 *   |P<0.001 **   P=0.505      P<0.001 **   P<0.001 **   |
|POLY 6             |     P=0.002 **   (e)          (e)          P=0.020 *   |P<0.001 **   P=0.511      P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   (e)          (e)          P=0.015 *   |P<0.001 **   P=0.513      P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P=0.003 **   (e)          (e)          P=0.059     |P<0.001 **   P=0.500      P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     46/50 (92%)  48/49 (98%)  48/49 (98%)  50/50 (100%)|                                                    |
|POLY-3 ADJUSTED (b)|     96.1%        98.0%        100.0%       100.0%      |                                                    |
|TERMINAL (d)       |     20/20 (100%) 15/16 (94%)  15/15 (100%) 0/0 (0%)    |                                                    |
|FIRST INCIDENCE    |     529          403          438          337         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.106      P=0.043 *    P<0.001 **  |                                                    |
|POLY 3             |     P=0.080      P=0.529      P=0.204      P=0.194     |                                                    |
|POLY 1.5           |     P=0.042 *    P=0.358      P=0.120      P=0.112     |                                                    |
|POLY 6             |     P=0.170      P=0.755      P=0.430      P=0.417     |                                                    |
|LOGISTIC REGRESSION|     P=0.008 **   P=0.126      P=0.037 *    P=0.011 *   |                                                    |
|COCH-ARM / FISHERS |     P=0.035 *    P=0.187      P=0.187      P=0.059     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   4/50 (8%)    2/50 (4%)    3/48 (6%)   |2/50 (4%)    4/49 (8%)    2/49 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     14.5%        10.4%        5.4%         9.8%        |5.1%         9.8%         4.9%         0.0%         |
|TERMINAL (d)       |     5/20 (25%)   4/16 (25%)   2/15 (13%)   0/0 (0%)    |1/22 (5%)    2/25 (8%)    1/22 (5%)    0/11 (0%)    |
|FIRST INCIDENCE    |     704          730 (T)      730 (T)      600         |711          611          683          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.118      P=0.520N     P=0.251N     P=0.022 *   |P=0.212N     P=0.384      P=0.675N     P=0.368N     |
|POLY 3             |     P=0.256N     P=0.416N     P=0.167N     P=0.409N    |P=0.128N     P=0.355      P=0.680N     P=0.255N     |
|POLY 1.5           |     P=0.222N     P=0.395N     P=0.153N     P=0.336N    |P=0.117N     P=0.345      P=0.688N     P=0.244N     |
|POLY 6             |     P=0.317N     P=0.447N     P=0.193N     P=0.547N    |P=0.149N     P=0.368      P=0.671N     P=0.278N     |
|LOGISTIC REGRESSION|     P=0.438      P=0.541N     P=0.296N     P=0.553     |P=0.135N     P=0.352      P=0.672N     P=0.322N     |
|COCH-ARM / FISHERS |     P=0.185N     P=0.370N     P=0.134N     P=0.264N    |P=0.111N     P=0.329      P=0.684      P=0.247N     |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/48 (0%)   |0/50 (0%)    1/49 (2%)    2/49 (4%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         2.5%         4.9%         5.5%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    2/22 (9%)    0/11 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          703          730 (T)      647          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.064      P=0.514      P=0.237      P=0.168      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.138      P=0.506      P=0.245      P=0.221      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.152      P=0.502      P=0.240      P=0.231      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.116      P=0.511      P=0.250      P=0.203      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.111      P=0.508      P=0.237      P=0.215      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.162      P=0.495      P=0.242      P=0.247      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   4/50 (8%)    2/50 (4%)    3/48 (6%)   |2/50 (4%)    5/49 (10%)   4/49 (8%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     14.5%        10.4%        5.4%         9.8%        |5.1%         12.2%        9.8%         5.5%         |
|TERMINAL (d)       |     5/20 (25%)   4/16 (25%)   2/15 (13%)   0/0 (0%)    |1/22 (5%)    2/25 (8%)    3/22 (14%)   0/11 (0%)    |
|FIRST INCIDENCE    |     704          730 (T)      730 (T)      600         |711          611          683          647          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.118      P=0.520N     P=0.251N     P=0.022 *   |P=0.456      P=0.260      P=0.353      P=0.525      |
|POLY 3             |     P=0.256N     P=0.416N     P=0.167N     P=0.409N    |P=0.487N     P=0.232      P=0.355      P=0.669      |
|POLY 1.5           |     P=0.222N     P=0.395N     P=0.153N     P=0.336N    |P=0.459N     P=0.223      P=0.345      P=0.684      |
|POLY 6             |     P=0.317N     P=0.447N     P=0.193N     P=0.547N    |P=0.539N     P=0.244      P=0.366      P=0.637      |
|LOGISTIC REGRESSION|     P=0.438      P=0.541N     P=0.296N     P=0.553     |P=0.538N     P=0.230      P=0.370      P=0.624      |
|COCH-ARM / FISHERS |     P=0.185N     P=0.370N     P=0.134N     P=0.264N    |P=0.440N     P=0.210      P=0.329      P=0.691N     |
|=================================================================================================================================|
       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      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    1/48 (2%)   |1/50 (2%)    1/49 (2%)    1/49 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     4.8%         2.6%         2.7%         3.3%        |2.5%         2.5%         2.5%         2.8%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    1/25 (4%)    1/22 (5%)    1/11 (9%)    |
|FIRST INCIDENCE    |     626          535          674          547         |717          730 (T)      730 (T)      730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.563N     P=0.526N     P=0.563N     P=0.659N    |P=0.457      P=0.733N     P=0.756N     P=0.621      |
|POLY 3             |     P=0.475N     P=0.525N     P=0.539N     P=0.611N    |P=0.601      P=0.755N     P=0.753N     P=0.743      |
|POLY 1.5           |     P=0.452N     P=0.514N     P=0.524N     P=0.565N    |P=0.619      P=0.758N     P=0.757N     P=0.754      |
|POLY 6             |     P=0.512N     P=0.542N     P=0.565N     P=0.686N    |P=0.567      P=0.752N     P=0.748N     P=0.721      |
|LOGISTIC REGRESSION|     P=0.357N     P=0.453N     P=0.491N     P=0.423N    |P=0.506      P=0.747N     P=0.748N     P=0.668      |
|COCH-ARM / FISHERS |     P=0.422N     P=0.500N     P=0.500N     P=0.515N    |P=0.632N     P=0.747      P=0.747      P=0.753N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    2/50 (4%)    1/48 (2%)   |1/50 (2%)    1/49 (2%)    1/49 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     4.8%         5.1%         5.3%         3.3%        |2.5%         2.5%         2.5%         2.8%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    1/25 (4%)    1/22 (5%)    1/11 (9%)    |
|FIRST INCIDENCE    |     626          535          674          547         |717          730 (T)      730 (T)      730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.546      P=0.651      P=0.611      P=0.659N    |P=0.457      P=0.733N     P=0.756N     P=0.621      |
|POLY 3             |     P=0.488N     P=0.669      P=0.655      P=0.611N    |P=0.601      P=0.755N     P=0.753N     P=0.743      |
|POLY 1.5           |     P=0.441N     P=0.680      P=0.670      P=0.565N    |P=0.619      P=0.758N     P=0.757N     P=0.754      |
|POLY 6             |     P=0.571N     P=0.652      P=0.628      P=0.686N    |P=0.567      P=0.752N     P=0.748N     P=0.721      |
|LOGISTIC REGRESSION|     P=0.355N     P=0.667N     P=0.695      P=0.423N    |P=0.506      P=0.747N     P=0.748N     P=0.668      |
|COCH-ARM / FISHERS |     P=0.388N     P=0.691N     P=0.691N     P=0.515N    |P=0.632N     P=0.747      P=0.747      P=0.753N     |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 23
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.1%         0.0%         3.2%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     ---          596          ---          683         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.269      P=0.204      (e)          P=0.227     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.442      P=0.224      (e)          P=0.446     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.488      P=0.229      (e)          P=0.472     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.366      P=0.216      (e)          P=0.401     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.497      P=0.241      (e)          P=0.389     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.539      P=0.247      (e)          P=0.500     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |4/50 (8%)    2/50 (4%)    3/50 (6%)    6/50 (12%)   |
|POLY-3 ADJUSTED (b)|                                                        |10.0%        4.9%         7.2%         16.2%        |
|TERMINAL (d)       |                                                        |1/22 (5%)    2/25 (8%)    1/22 (5%)    3/11 (27%)   |
|FIRST INCIDENCE    |                                                        |641          730 (T)      627          600          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.050      P=0.306N     P=0.477N     P=0.146      |
|POLY 3             |                                                        |P=0.165      P=0.327N     P=0.476N     P=0.319      |
|POLY 1.5           |                                                        |P=0.181      P=0.329N     P=0.484N     P=0.349      |
|POLY 6             |                                                        |P=0.142      P=0.327N     P=0.470N     P=0.263      |
|LOGISTIC REGRESSION|                                                        |P=0.143      P=0.318N     P=0.484N     P=0.297      |
|COCH-ARM / FISHERS |                                                        |P=0.194      P=0.339N     P=0.500N     P=0.370      |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 24
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |4/50 (8%)    3/50 (6%)    3/50 (6%)    6/50 (12%)   |
|POLY-3 ADJUSTED (b)|                                                        |10.0%        7.4%         7.2%         16.2%        |
|TERMINAL (d)       |                                                        |1/22 (5%)    3/25 (12%)   1/22 (5%)    3/11 (27%)   |
|FIRST INCIDENCE    |                                                        |641          730 (T)      627          600          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.063      P=0.455N     P=0.477N     P=0.146      |
|POLY 3             |                                                        |P=0.207      P=0.489N     P=0.476N     P=0.319      |
|POLY 1.5           |                                                        |P=0.225      P=0.491N     P=0.484N     P=0.349      |
|POLY 6             |                                                        |P=0.178      P=0.491N     P=0.470N     P=0.263      |
|LOGISTIC REGRESSION|                                                        |P=0.174      P=0.475N     P=0.484N     P=0.297      |
|COCH-ARM / FISHERS |                                                        |P=0.240      P=0.500N     P=0.500N     P=0.370      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.4%         5.0%         0.0%         3.2%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    0/16 (0%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     712          542          ---          654         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.606      P=0.459      P=0.612N     P=0.422     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.546N     P=0.484      P=0.521N     P=0.696     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.526N     P=0.491      P=0.513N     P=0.728     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.573N     P=0.474      P=0.535N     P=0.633     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.456N     P=0.545      P=0.551N     P=0.675     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.500N     P=0.500      P=0.500N     P=0.753N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 25
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           |
|     Undifferentiated                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     26/50 (52%)  27/50 (54%)  15/50 (30%)  13/50 (26%) |17/50 (34%)  20/50 (40%)  19/50 (38%)  28/50 (56%)  |
|POLY-3 ADJUSTED (b)|     56.0%        65.2%        36.4%        36.1%       |38.3%        45.3%        42.4%        64.8%        |
|TERMINAL (d)       |     8/20 (40%)   12/16 (75%)  5/15 (33%)   0/0 (0%)    |5/22 (23%)   8/25 (32%)   6/22 (27%)   6/11 (55%)   |
|FIRST INCIDENCE    |     521          602          521          467         |448          520          515          541          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.131      P=0.204      P=0.210N     P=0.051     |P<0.001 **   P=0.461      P=0.484      P=0.004 **   |
|POLY 3             |     P=0.008N**   P=0.246      P=0.047N*    P=0.051N    |P=0.007 **   P=0.324      P=0.426      P=0.008 **   |
|POLY 1.5           |     P=0.003N**   P=0.351      P=0.033N*    P=0.019N*   |P=0.011 *    P=0.334      P=0.426      P=0.013 *    |
|POLY 6             |     P=0.042N*    P=0.138      P=0.078N     P=0.195N    |P=0.004 **   P=0.313      P=0.424      P=0.004 **   |
|LOGISTIC REGRESSION|     P=0.006N**   P=0.382      P=0.023N*    P=0.010N*   |P=0.017 *    P=0.326      P=0.390      P=0.023 *    |
|COCH-ARM / FISHERS |     P<0.001N**   P=0.500      P=0.021N*    P=0.007N**  |P=0.017 *    P=0.339      P=0.418      P=0.022 *    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    5/50 (10%)   12/50 (24%) |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.4%         7.7%         12.7%        32.9%       |0.0%         2.4%         0.0%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    1/16 (6%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     564          639          582          409         |---          443          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.257      P=0.091      P<0.001 **  |P=0.562N     P=0.504      (e)          (e)          |
|POLY 3             |     P<0.001 **   P=0.279      P=0.085      P<0.001 **  |P=0.559N     P=0.512      (e)          (e)          |
|POLY 1.5           |     P<0.001 **   P=0.290      P=0.091      P<0.001 **  |P=0.562N     P=0.508      (e)          (e)          |
|POLY 6             |     P<0.001 **   P=0.263      P=0.077      P<0.001 **  |P=0.553N     P=0.516      (e)          (e)          |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.313      P=0.133      P=0.007 **  |P=0.699N     P=0.386      (e)          (e)          |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.309      P=0.102      P<0.001 **  |P=0.567N     P=0.500      (e)          (e)          |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 26
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Malignant                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    5/50 (10%)   12/50 (24%) |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.4%         7.7%         12.7%        32.9%       |0.0%         2.4%         0.0%         0.0%         |
|TERMINAL (d)       |     0/20 (0%)    1/16 (6%)    0/15 (0%)    0/0 (0%)    |0/22 (0%)    0/25 (0%)    0/22 (0%)    0/11 (0%)    |
|FIRST INCIDENCE    |     564          639          582          409         |---          443          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.257      P=0.091      P<0.001 **  |P=0.562N     P=0.504      (e)          (e)          |
|POLY 3             |     P<0.001 **   P=0.279      P=0.085      P<0.001 **  |P=0.559N     P=0.512      (e)          (e)          |
|POLY 1.5           |     P<0.001 **   P=0.290      P=0.091      P<0.001 **  |P=0.562N     P=0.508      (e)          (e)          |
|POLY 6             |     P<0.001 **   P=0.263      P=0.077      P<0.001 **  |P=0.553N     P=0.516      (e)          (e)          |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.313      P=0.133      P=0.007 **  |P=0.699N     P=0.386      (e)          (e)          |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.309      P=0.102      P<0.001 **  |P=0.567N     P=0.500      (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     49/50 (98%)  50/50 (100%) 48/50 (96%)  50/50 (100%)|43/50 (86%)  44/50 (88%)  43/50 (86%)  43/50 (86%)  |
|POLY-3 ADJUSTED (b)|     99.8%        100.0%       98.9%        100.0%      |91.9%        91.2%        91.2%        92.1%        |
|TERMINAL (d)       |     20/20 (100%) 16/16 (100%) 15/15 (100%) 0/0 (0%)    |20/22 (91%)  22/25 (88%)  20/22 (91%)  11/11 (100%) |
|FIRST INCIDENCE    |     521          403          438          337         |407          347          527          508          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.131      P=0.094      P<0.001 **  |P=0.006 **   P=0.390N     P=0.468N     P=0.019 *    |
|POLY 3             |     P=0.878      P=1.000      P=0.843N     P=1.000     |P=0.553      P=0.608N     P=0.610N     P=0.661      |
|POLY 1.5           |     P=0.698      P=0.981      P=0.763N     P=0.981     |P=0.530N     P=0.640N     P=0.607N     P=0.615N     |
|POLY 6             |     P=0.986N     P=1.000      P=0.992N     P=1.000     |P=0.423      P=0.585N     P=0.617N     P=0.567      |
|LOGISTIC REGRESSION|     P=0.281      (e)          P=0.775N     P=0.431     |P=0.532N     P=0.595      P=0.464N     P=0.609N     |
|COCH-ARM / FISHERS |     P=0.461      P=0.500      P=0.500N     P=0.500     |P=0.514N     P=0.500      P=0.613N     P=0.613N     |
|=================================================================================================================================|
       Date:  09/16/98                           EXPERIMENT: 05187 TEST: 09                                            Page 27
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     33/50 (66%)  32/50 (64%)  34/50 (68%)  39/50 (78%) |22/50 (44%)  28/50 (56%)  27/50 (54%)  34/50 (68%)  |
|POLY-3 ADJUSTED (b)|     68.9%        73.1%        74.1%        85.7%       |48.5%        60.0%        59.1%        76.9%        |
|TERMINAL (d)       |     12/20 (60%)  12/16 (75%)  10/15 (67%)  0/0 (0%)    |7/22 (32%)   11/25 (44%)  10/22 (46%)  9/11 (82%)   |
|FIRST INCIDENCE    |     344          431          467          409         |407          443          515          534          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.279      P=0.134      P<0.001 **  |P<0.001 **   P=0.321      P=0.320      P<0.001 **   |
|POLY 3             |     P=0.026 *    P=0.413      P=0.369      P=0.035 *   |P=0.004 **   P=0.178      P=0.205      P=0.003 **   |
|POLY 1.5           |     P=0.042 *    P=0.517      P=0.395      P=0.063     |P=0.007 **   P=0.172      P=0.207      P=0.006 **   |
|POLY 6             |     P=0.013 *    P=0.300      P=0.345      P=0.014 *   |P=0.002 **   P=0.187      P=0.210      P<0.001 **   |
|LOGISTIC REGRESSION|     P=0.044 *    P=0.550N     P=0.500      P=0.200     |P=0.014 *    P=0.137      P=0.202      P=0.013 *    |
|COCH-ARM / FISHERS |     P=0.081      P=0.500N     P=0.500      P=0.133     |P=0.014 *    P=0.159      P=0.212      P=0.013 *    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      37 MG/KG     75 MG/KG     150         |0 MG/KG      37 MG/KG     75 MG/KG     150          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     50/50 (100%) 50/50 (100%) 48/50 (96%)  50/50 (100%)|47/50 (94%)  49/50 (98%)  48/50 (96%)  47/50 (94%)  |
|POLY-3 ADJUSTED (b)|     100.0%       100.0%       98.9%        100.0%      |95.8%        98.0%        99.4%        97.8%        |
|TERMINAL (d)       |     20/20 (100%) 16/16 (100%) 15/15 (100%) 0/0 (0%)    |20/22 (91%)  24/25 (96%)  22/22 (100%) 11/11 (100%) |
|FIRST INCIDENCE    |     344          403          438          337         |407          347          515          508          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   (e)          P=0.119      (e)         |P=0.007 **   P=0.436N     P=0.511N     P=0.022 *    |
|POLY 3             |     P=0.861N     (e)          P=0.796N     (e)         |P=0.384      P=0.485      P=0.305      P=0.514      |
|POLY 1.5           |     P=0.774N     (e)          P=0.634N     (e)         |P=0.580      P=0.450      P=0.385      P=0.634      |
|POLY 6             |     P=0.984N     (e)          P=0.991N     (e)         |P=0.186      P=0.493      P=0.254      P=0.347      |
|LOGISTIC REGRESSION|     P=0.707      (e)          P=0.465N     (e)         |P=0.367N     P=0.338      P=0.652      P=0.583N     |
|COCH-ARM / FISHERS |     P=0.595N     (e)          P=0.247N     (e)         |P=0.477N     P=0.309      P=0.500      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).