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TDMS Study 05187-09 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 07/20/98       
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 08:53:39       
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         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            52 WEEK SSAC                                                            
                                                                                                                                    

               REASONS FOR REMOVAL:    25017 Scheduled Sacrifice                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     020295 020395                                                                                
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 009    300     MG/KG                                                                 
                                       INCLUDE 010    300     MG/KG                                                                 
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10   
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 07/20/98     
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 08:53:39     
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
-----                                 ----------
Bone Marrow                            Hyperplasia
Liver                                  Degeneration Cystic Focal
                                       Eosinophilic Focus
                                       Mixed Cell Focus
Liver: Hepatocyte                      Hypertrophy
Liver: Oval Cell                       Hyperplasia
Salivary Glands: Submandibular Gland   Cytoplasmic Alteration
Stomach, Glandular                     Atrophy
===============================================================
Female Rats
------------
Organ                                  Morphology
-----                                  ----------
Liver                                  Eosinophilic Focus
                                       Mixed Cell Focus
Liver: Hepatocyte                      Hypertrophy
Liver: Oval Cell                       Hyperplasia
Mammary Gland                          Dilatation
Salivary Glands: Submandibular Gland   Cytoplasmic Alteration
Stomach, Glandular                     Atrophy
===============================================================
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 1
                     Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 143 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/5 (20%)                5/5 (100%)   |           0/5 (0%)                 0/5 (0%)        |
|POLY-3 ADJUSTED (b)|                  84.1%                    100.0%       |           0.0%                     0.0%            |
|INT SACRIFICE 1 (c)|                  1/5 (20%)                5/5 (100%)   |           0/5 (0%)                 0/5 (0%)        |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  361 (I)                  361 (I)      |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.033 *    |                                    (e)             |
|POLY 3             |                                           P<0.001 **   |                                    (e)             |
|POLY 1.5           |                                           P<0.001 **   |                                    (e)             |
|POLY 6             |                                           P<0.001 **   |                                    (e)             |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.024 *    |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Myocardium                                                                                                                |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  4/5 (80%)                3/5 (60%)    |           2/5 (40%)                1/5 (20%)       |
|POLY-3 ADJUSTED (b)|                  98.8%                    97.0%        |           93.4%                    84.1%           |
|INT SACRIFICE 1 (c)|                  4/5 (80%)                3/5 (60%)    |           2/5 (40%)                1/5 (20%)       |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  361 (I)                  361 (I)      |           361 (I)                  361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.500N     |                                    P=0.500N        |
|POLY 3             |                                           P=0.452N     |                                    P=0.359N        |
|POLY 1.5           |                                           P=0.461N     |                                    P=0.383N        |
|POLY 6             |                                           P=0.450N     |                                    P=0.352N        |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.500N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 2
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 143 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/5 (40%)                0/5 (0%)     |           0/5 (0%)                 0/5 (0%)        |
|POLY-3 ADJUSTED (b)|                  93.4%                    0.0%         |           0.0%                     0.0%            |
|INT SACRIFICE 1 (c)|                  2/5 (40%)                0/5 (0%)     |           0/5 (0%)                 0/5 (0%)        |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  361 (I)                  ---          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.227N     |                                    (e)             |
|POLY 3             |                                           P=0.100N     |                                    (e)             |
|POLY 1.5           |                                           P=0.115N     |                                    (e)             |
|POLY 6             |                                           P=0.096N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.222N     |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/5 (100%)               5/5 (100%)   |           4/5 (80%)                2/5 (40%)       |
|POLY-3 ADJUSTED (b)|                  100.0%                   100.0%       |           98.8%                    93.4%           |
|INT SACRIFICE 1 (c)|                  5/5 (100%)               5/5 (100%)   |           4/5 (80%)                2/5 (40%)       |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  361 (I)                  361 (I)      |           361 (I)                  361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           (e)          |                                    P=0.270N        |
|POLY 3             |                                           (e)          |                                    P=0.226N        |
|POLY 1.5           |                                           (e)          |                                    P=0.232N        |
|POLY 6             |                                           (e)          |                                    P=0.224N        |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.262N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 3
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 143 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Basophilic Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/5 (20%)                3/5 (60%)    |           5/5 (100%)               3/5 (60%)       |
|POLY-3 ADJUSTED (b)|                  84.1%                    97.0%        |           100.0%                   97.0%           |
|INT SACRIFICE 1 (c)|                  1/5 (20%)                3/5 (60%)    |           5/5 (100%)               3/5 (60%)       |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  361 (I)                  361 (I)      |           361 (I)                  361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.270      |                                    P=0.227N        |
|POLY 3             |                                           P=0.133      |                                    P=0.207N        |
|POLY 1.5           |                                           P=0.152      |                                    P=0.207N        |
|POLY 6             |                                           P=0.128      |                                    P=0.207N        |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.262      |                                    P=0.222N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Clear Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/5 (20%)                1/5 (20%)    |           1/5 (20%)                2/5 (40%)       |
|POLY-3 ADJUSTED (b)|                  84.1%                    84.1%        |           84.1%                    93.4%           |
|INT SACRIFICE 1 (c)|                  1/5 (20%)                1/5 (20%)    |           1/5 (20%)                2/5 (40%)       |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  361 (I)                  361 (I)      |           361 (I)                  361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.773      |                                    P=0.500         |
|POLY 3             |                                           P=0.567      |                                    P=0.315         |
|POLY 1.5           |                                           P=0.604      |                                    P=0.346         |
|POLY 6             |                                           P=0.557      |                                    P=0.307         |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.778N     |                                    P=0.500         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 4
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 143 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Degeneration Cystic Focal                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 0/5 (0%)        |
|POLY-3 ADJUSTED (b)|                  0.0%                     100.0%       |           0.0%                     0.0%            |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 0/5 (0%)        |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      361 (I)      |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.008 **   |                                    (e)             |
|POLY 3             |                                           P=1.000N     |                                    (e)             |
|POLY 1.5           |                                           P=1.000N     |                                    (e)             |
|POLY 6             |                                           P=1.000N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.006 **   |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.004 **   |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Eosinophilic Focus                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 3/5 (60%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     100.0%       |           0.0%                     97.0%           |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 3/5 (60%)       |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      361 (I)      |           ---                      361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.008 **   |                                    P=0.095         |
|POLY 3             |                                           P=1.000      |                                    P=0.008 **      |
|POLY 1.5           |                                           P=1.000      |                                    P=0.012 *       |
|POLY 6             |                                           P=1.000      |                                    P=0.007 **      |
|LOGISTIC REGRESSION|                                           P=0.006 **   |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.004 **   |                                    P=0.083         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 5
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 143 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatodiaphragmatic Nodule                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 1/5 (20%)    |           2/5 (40%)                0/5 (0%)        |
|POLY-3 ADJUSTED (b)|                  0.0%                     84.1%        |           93.4%                    0.0%            |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 1/5 (20%)    |           2/5 (40%)                0/5 (0%)        |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      361 (I)      |           361 (I)                  ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.500      |                                    P=0.227N        |
|POLY 3             |                                           P=0.170      |                                    P=0.100N        |
|POLY 1.5           |                                           P=0.217      |                                    P=0.115N        |
|POLY 6             |                                           P=0.159      |                                    P=0.096N        |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.222N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Mixed Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     100.0%       |           0.0%                     100.0%          |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      361 (I)      |           ---                      361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.008 **   |                                    P=0.008 **      |
|POLY 3             |                                           P=1.000N     |                                    P=1.000         |
|POLY 1.5           |                                           P=1.000N     |                                    P=1.000         |
|POLY 6             |                                           P=1.000N     |                                    P=1.000         |
|LOGISTIC REGRESSION|                                           P=0.006 **   |                                    P=0.006 **      |
|COCH-ARM / FISHERS |                                           P=0.004 **   |                                    P=0.004 **      |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 6
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 143 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Hepatocyte                                                                                                                |
|     Hypertrophy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     100.0%       |           0.0%                     100.0%          |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      361 (I)      |           ---                      361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.008 **   |                                    P=0.008 **      |
|POLY 3             |                                           P=1.000N     |                                    P=1.000         |
|POLY 1.5           |                                           P=1.000N     |                                    P=1.000         |
|POLY 6             |                                           P=1.000N     |                                    P=1.000         |
|LOGISTIC REGRESSION|                                           P=0.006 **   |                                    P=0.006 **      |
|COCH-ARM / FISHERS |                                           P=0.004 **   |                                    P=0.004 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Oval Cell                                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     100.0%       |           0.0%                     100.0%          |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      361 (I)      |           ---                      361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.008 **   |                                    P=0.008 **      |
|POLY 3             |                                           P=1.000N     |                                    P=1.000         |
|POLY 1.5           |                                           P=1.000N     |                                    P=1.000         |
|POLY 6             |                                           P=1.000N     |                                    P=1.000         |
|LOGISTIC REGRESSION|                                           P=0.006 **   |                                    P=0.006 **      |
|COCH-ARM / FISHERS |                                           P=0.004 **   |                                    P=0.004 **      |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 7
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 143 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Dilatation                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 0/5 (0%)     |           3/5 (60%)                0/5 (0%)        |
|POLY-3 ADJUSTED (b)|                  0.0%                     0.0%         |           97.0%                    0.0%            |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 0/5 (0%)     |           3/5 (60%)                0/5 (0%)        |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      ---          |           361 (I)                  ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           (e)          |                                    P=0.095N        |
|POLY 3             |                                           (e)          |                                    P=0.026N*       |
|POLY 1.5           |                                           (e)          |                                    P=0.029N*       |
|POLY 6             |                                           (e)          |                                    P=0.025N*       |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.083N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Salivary Glands: Submandibular Gland                                                                                             |
|     Cytoplasmic Alteration                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     100.0%       |           0.0%                     100.0%          |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      361 (I)      |           ---                      361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.008 **   |                                    P=0.008 **      |
|POLY 3             |                                           P=1.000N     |                                    P=1.000N        |
|POLY 1.5           |                                           P=1.000N     |                                    P=1.000N        |
|POLY 6             |                                           P=1.000N     |                                    P=1.000N        |
|LOGISTIC REGRESSION|                                           P=0.006 **   |                                    P=0.006 **      |
|COCH-ARM / FISHERS |                                           P=0.004 **   |                                    P=0.004 **      |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 8
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 143 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     100.0%       |           0.0%                     100.0%          |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 5/5 (100%)   |           0/5 (0%)                 5/5 (100%)      |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      361 (I)      |           ---                      361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.008 **   |                                    P=0.008 **      |
|POLY 3             |                                           P=1.000N     |                                    P=1.000         |
|POLY 1.5           |                                           P=1.000N     |                                    P=1.000         |
|POLY 6             |                                           P=1.000N     |                                    P=1.000         |
|LOGISTIC REGRESSION|                                           P=0.006 **   |                                    P=0.006 **      |
|COCH-ARM / FISHERS |                                           P=0.004 **   |                                    P=0.004 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular: Neuroendocrine Cell                                                                                          |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/5 (0%)                 2/5 (40%)    |           0/5 (0%)                 1/5 (20%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     93.4%        |           0.0%                     84.1%           |
|INT SACRIFICE 1 (c)|                  0/5 (0%)                 2/5 (40%)    |           0/5 (0%)                 1/5 (20%)       |
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)     |           0/0 (0%)                 0/0 (0%)        |
|FIRST INCIDENCE    |                  ---                      361 (I)      |           ---                      361 (I)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.227      |                                    P=0.500         |
|POLY 3             |                                           P=0.055      |                                    P=0.170         |
|POLY 1.5           |                                           P=0.073      |                                    P=0.217         |
|POLY 6             |                                           P=0.051      |                                    P=0.159         |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.222      |                                    P=0.500         |
|=================================================================================================================================|

(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).