https://ntp.niehs.nih.gov/go/6727

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).