https://ntp.niehs.nih.gov/go/6751

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: 09:17:33       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B       
PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2         
------------------------------------------------------------------------------------------------------------------------------------
                                                             STOP STUDY                                                             
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 009    300     MG/KG                                                                 
                                       INCLUDE 010    300     MG/KG                                                                 
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10   
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 07/20/98     
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:17:33     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                      
CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B     
PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2       
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF                  METHYLEUGENOL
===============================================================
Male Rats
------------
Organ                                 Morphology
-----                                 ----------
Adrenal Cortex                         Hyperplasia Focal
Adrenal Medulla                        Hyperplasia Focal
Blood Vessel                           Mineralization
Blood Vessel: Aorta                    Mineralization
Bone                                   Fibrous Osteodystrophy
Bone Marrow                            Hyperplasia
Heart: Atrium                          Thrombosis
Heart: Myocardium                      Degeneration
                                       Mineralization
Intestine Large, Colon                 Mineralization
Kidney                                 Nephropathy
Kidney: Renal Tubule                   Hyperplasia Focal
Liver                                  Basophilic Focus
                                       Degeneration Cystic Focal
                                       Eosinophilic Focus
Liver: Bile Duct                       Hyperplasia
Liver: Centrilobular                   Degeneration
Liver: Hepatocyte                      Hypertrophy
Liver: Oval Cell                       Hyperplasia
Lung: Interstitium                     Mineralization
Mammary Gland                          Dilatation
Nose                                   Inflammation
Pancreas                               Hyperplasia Focal
Pancreas: Acinus                       Atrophy
Parathyroid Gland                      Hyperplasia
Pituitary Gland: Pars Distalis         Hyperplasia Focal
Preputial Gland                        Cyst
                                       Hyperplasia Focal
Prostate                               Inflammation Chronic
Salivary Glands: Submandibular Gland   Cytoplasmic Alteration
Seminal Vesicle                        Inflammation
Spleen                                 Fibrosis
                                       Hematopoietic Cell Proliferation
Stomach, Forestomach                   Mineralization
                                       Ulcer
Stomach, Glandular                     Atrophy
                                       Mineralization
                                       Ulcer
Stomach, Glandular: Neuroendocrine Cell
                                       Hyperplasia
Testes: Tunic                          Hyperplasia Mesothelium
Thyroid Gland: C-Cell                  Hyperplasia
===============================================================
Female Rats
------------
Organ                                  Morphology
-----                                  ----------
Adrenal Cortex                         Hyperplasia Focal
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10   
LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 07/20/98     
EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:17:33     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                      
CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B     
PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2       
Bone Marrow                            Hyperplasia
Kidney                                 Nephropathy
Liver                                  Basophilic Focus
                                       Degeneration Cystic Focal
                                       Eosinophilic Focus
Liver: Bile Duct                       Hyperplasia
Liver: Hepatocyte                      Hypertrophy
Liver: Oval Cell                       Hyperplasia
Mammary Gland                          Dilatation
                                       Hyperplasia Focal
Salivary Glands: Submandibular Gland   Cytoplasmic Alteration
Spleen                                 Fibrosis
                                       Hematopoietic Cell Proliferation
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 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  13/50 (26%)              5/50 (10%)   |           13/50 (26%)              5/50 (10%)      |
|POLY-3 ADJUSTED (b)|                  30.5%                    20.0%        |           31.3%                    13.4%           |
|TERMINAL (d)       |                  9/20 (45%)               0/0 (0%)     |           6/22 (27%)               3/16 (19%)      |
|FIRST INCIDENCE    |                  610                      517          |           459                      637             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.017 *    |                                    P=0.102N        |
|POLY 3             |                                           P=0.303N     |                                    P=0.050N        |
|POLY 1.5           |                                           P=0.132N     |                                    P=0.043N*       |
|POLY 6             |                                           P=0.686N     |                                    P=0.061N        |
|LOGISTIC REGRESSION|                                           P=0.518N     |                                    P=0.042N*       |
|COCH-ARM / FISHERS |                                           P=0.033N*    |                                    P=0.033N*       |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  16/50 (32%)              14/50 (28%)  |           4/50 (8%)                6/50 (12%)      |
|POLY-3 ADJUSTED (b)|                  36.1%                    46.7%        |           10.0%                    15.7%           |
|TERMINAL (d)       |                  6/20 (30%)               0/0 (0%)     |           2/22 (9%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  553                      498          |           609                      611             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.297         |
|POLY 3             |                                           P=0.271      |                                    P=0.341         |
|POLY 1.5           |                                           P=0.464      |                                    P=0.349         |
|POLY 6             |                                           P=0.090      |                                    P=0.333         |
|LOGISTIC REGRESSION|                                           P=0.540      |                                    P=0.344         |
|COCH-ARM / FISHERS |                                           P=0.414N     |                                    P=0.370         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 2
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Blood Vessel                                                                                                                     |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                9/50 (18%)   |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  2.4%                     32.6%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  662                      502          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    (e)             |
|POLY 3             |                                           P<0.001 **   |                                    (e)             |
|POLY 1.5           |                                           P=0.002 **   |                                    (e)             |
|POLY 6             |                                           P<0.001 **   |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.016 *    |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.008 **   |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Blood Vessel: Aorta                                                                                                              |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/50 (10%)               10/50 (20%)  |           0/50 (0%)                1/50 (2%)       |
|POLY-3 ADJUSTED (b)|                  11.8%                    37.6%        |           0.0%                     2.7%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  626                      553          |           ---                      659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.493         |
|POLY 3             |                                           P=0.018 *    |                                    P=0.501         |
|POLY 1.5           |                                           P=0.044 *    |                                    P=0.500         |
|POLY 6             |                                           P=0.004 **   |                                    P=0.501         |
|LOGISTIC REGRESSION|                                           P=0.009 **   |                                    P=0.497         |
|COCH-ARM / FISHERS |                                           P=0.131      |                                    P=0.500         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 3
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Fibrous Osteodystrophy                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  8/50 (16%)               21/50 (42%)  |           0/50 (0%)                3/50 (6%)       |
|POLY-3 ADJUSTED (b)|                  18.7%                    64.0%        |           0.0%                     8.0%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  626                      502          |           ---                      611             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.111         |
|POLY 3             |                                           P<0.001 **   |                                    P=0.113         |
|POLY 1.5           |                                           P<0.001 **   |                                    P=0.114         |
|POLY 6             |                                           P<0.001 **   |                                    P=0.111         |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P=0.116         |
|COCH-ARM / FISHERS |                                           P=0.004 **   |                                    P=0.121         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Hyperostosis                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                0/50 (0%)    |           1/50 (2%)                2/50 (4%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     0.0%         |           2.5%                     5.3%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  ---                      ---          |           555                      459             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           (e)          |                                    P=0.489         |
|POLY 3             |                                           (e)          |                                    P=0.490         |
|POLY 1.5           |                                           (e)          |                                    P=0.492         |
|POLY 6             |                                           (e)          |                                    P=0.486         |
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.561         |
|COCH-ARM / FISHERS |                                           (e)          |                                    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 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Fibrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                0/50 (0%)    |           2/50 (4%)                4/50 (8%)       |
|POLY-3 ADJUSTED (b)|                  7.1%                     0.0%         |           5.1%                     10.7%           |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           1/22 (5%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  521                      ---          |           641                      620             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.551N     |                                    P=0.265         |
|POLY 3             |                                           P=0.379N     |                                    P=0.316         |
|POLY 1.5           |                                           P=0.230N     |                                    P=0.322         |
|POLY 6             |                                           P=0.731N     |                                    P=0.308         |
|LOGISTIC REGRESSION|                                           P=0.189N     |                                    P=0.309         |
|COCH-ARM / FISHERS |                                           P=0.121N     |                                    P=0.339         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  18/50 (36%)              18/50 (36%)  |           4/50 (8%)                25/50 (50%)     |
|POLY-3 ADJUSTED (b)|                  41.4%                    55.3%        |           10.1%                    63.1%           |
|TERMINAL (d)       |                  10/20 (50%)              0/0 (0%)     |           3/22 (14%)               14/16 (88%)     |
|FIRST INCIDENCE    |                  564                      380          |           549                      571             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P=0.168      |                                    P<0.001 **      |
|POLY 1.5           |                                           P=0.314      |                                    P<0.001 **      |
|POLY 6             |                                           P=0.045 *    |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P=0.324      |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P=0.582N     |                                    P<0.001 **      |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 5
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Hydrocephalus                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                1/50 (2%)    |           4/50 (8%)                9/50 (18%)      |
|POLY-3 ADJUSTED (b)|                  4.8%                     4.3%         |           10.1%                    23.2%           |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           1/22 (5%)                2/16 (13%)      |
|FIRST INCIDENCE    |                  668                      502          |           597                      477             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.531      |                                    P=0.078         |
|POLY 3             |                                           P=0.778N     |                                    P=0.101         |
|POLY 1.5           |                                           P=0.655N     |                                    P=0.104         |
|POLY 6             |                                           P=0.850      |                                    P=0.097         |
|LOGISTIC REGRESSION|                                           P=0.618N     |                                    P=0.102         |
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.117         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain: Hypothalamus                                                                                                              |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                0/50 (0%)    |           9/50 (18%)               5/50 (10%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     0.0%         |           22.4%                    13.1%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           6/22 (27%)               2/16 (13%)      |
|FIRST INCIDENCE    |                  ---                      ---          |           597                      477             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           (e)          |                                    P=0.339N        |
|POLY 3             |                                           (e)          |                                    P=0.220N        |
|POLY 1.5           |                                           (e)          |                                    P=0.213N        |
|POLY 6             |                                           (e)          |                                    P=0.234N        |
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.223N        |
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.194N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 6
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |           2/48 (4%)                0/48 (0%)       |
|POLY-3 ADJUSTED (b)|                                                        |           5.2%                     0.0%            |
|TERMINAL (d)       |                                                        |           0/21 (0%)                0/15 (0%)       |
|FIRST INCIDENCE    |                                                        |           597                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |                                    P=0.266N        |
|POLY 3             |                                                        |                                    P=0.271N        |
|POLY 1.5           |                                                        |                                    P=0.259N        |
|POLY 6             |                                                        |                                    P=0.289N        |
|LOGISTIC REGRESSION|                                                        |                                    P=0.236N        |
|COCH-ARM / FISHERS |                                                        |                                    P=0.247N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |           2/48 (4%)                1/48 (2%)       |
|POLY-3 ADJUSTED (b)|                                                        |           5.3%                     2.9%            |
|TERMINAL (d)       |                                                        |           1/21 (5%)                1/15 (7%)       |
|FIRST INCIDENCE    |                                                        |           717                      730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |                                    P=0.609N        |
|POLY 3             |                                                        |                                    P=0.539N        |
|POLY 1.5           |                                                        |                                    P=0.526N        |
|POLY 6             |                                                        |                                    P=0.556N        |
|LOGISTIC REGRESSION|                                                        |                                    P=0.582N        |
|COCH-ARM / FISHERS |                                                        |                                    P=0.500N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 7
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Epididymis: Serosa                                                                                                               |
|     Hyperplasia Mesothelium                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |                                                    |
|POLY-3 ADJUSTED (b)|                  0.0%                     8.4%         |                                                    |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  ---                      437          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.124      |                                                    |
|POLY 3             |                                           P=0.226      |                                                    |
|POLY 1.5           |                                           P=0.217      |                                                    |
|POLY 6             |                                           P=0.323      |                                                    |
|LOGISTIC REGRESSION|                                           P=0.360      |                                                    |
|COCH-ARM / FISHERS |                                           P=0.247      |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Atrium                                                                                                                    |
|     Thrombosis                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  6/50 (12%)               0/49 (0%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  14.1%                    0.0%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  553                      ---          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.411N     |                                    (e)             |
|POLY 3             |                                           P=0.147N     |                                    (e)             |
|POLY 1.5           |                                           P=0.059N     |                                    (e)             |
|POLY 6             |                                           P=0.484N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.044N*    |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.014N*    |                                    (e)             |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 8
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Myocardium                                                                                                                |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  45/50 (90%)              25/49 (51%)  |           35/50 (70%)              27/50 (54%)     |
|POLY-3 ADJUSTED (b)|                  92.7%                    71.3%        |           77.5%                    64.0%           |
|TERMINAL (d)       |                  19/20 (95%)              0/0 (0%)     |           16/22 (73%)              9/16 (56%)      |
|FIRST INCIDENCE    |                  521                      380          |           459                      331             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.420N        |
|POLY 3             |                                           P=0.003N**   |                                    P=0.111N        |
|POLY 1.5           |                                           P<0.001N**   |                                    P=0.093N        |
|POLY 6             |                                           P=0.088N     |                                    P=0.145N        |
|LOGISTIC REGRESSION|                                           P=0.012N*    |                                    P=0.104N        |
|COCH-ARM / FISHERS |                                           P<0.001N**   |                                    P=0.074N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Myocardium                                                                                                                |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/50 (10%)               15/49 (31%)  |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  11.8%                    51.3%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  626                      526          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    (e)             |
|POLY 3             |                                           P<0.001 **   |                                    (e)             |
|POLY 1.5           |                                           P<0.001 **   |                                    (e)             |
|POLY 6             |                                           P<0.001 **   |                                    (e)             |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.010 *    |                                    (e)             |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 9
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large, Colon                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                4/50 (8%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     16.1%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  ---                      526          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.022 *    |                                    (e)             |
|POLY 3             |                                           P=0.032 *    |                                    (e)             |
|POLY 1.5           |                                           P=0.039 *    |                                    (e)             |
|POLY 6             |                                           P=0.033 *    |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.091      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.059      |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large, Rectum                                                                                                          |
|     Parasite Metazoan                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/49 (2%)                1/50 (2%)    |           2/50 (4%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  2.5%                     4.3%         |           5.0%                     0.0%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           1/22 (5%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  730 (T)                  556          |           619                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.401      |                                    P=0.275N        |
|POLY 3             |                                           P=0.741      |                                    P=0.261N        |
|POLY 1.5           |                                           P=0.738      |                                    P=0.253N        |
|POLY 6             |                                           P=0.817      |                                    P=0.273N        |
|LOGISTIC REGRESSION|                                           P=0.722      |                                    P=0.245N        |
|COCH-ARM / FISHERS |                                           P=0.747N     |                                    P=0.247N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 10
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small, Duodenum                                                                                                        |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                0/49 (0%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  7.2%                     0.0%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  722                      ---          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=1.000N     |                                    (e)             |
|POLY 3             |                                           P=0.378N     |                                    (e)             |
|POLY 1.5           |                                           P=0.234N     |                                    (e)             |
|POLY 6             |                                           P=0.722N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.125N     |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  49/50 (98%)              47/50 (94%)  |           35/50 (70%)              45/50 (90%)     |
|POLY-3 ADJUSTED (b)|                  99.8%                    99.8%        |           80.5%                    99.0%           |
|TERMINAL (d)       |                  20/20 (100%)             0/0 (0%)     |           22/22 (100%)             16/16 (100%)    |
|FIRST INCIDENCE    |                  521                      219          |           459                      477             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.004 **      |
|POLY 3             |                                           P=1.000      |                                    P<0.001 **      |
|POLY 1.5           |                                           P=0.984N     |                                    P<0.001 **      |
|POLY 6             |                                           P=1.000      |                                    P=0.002 **      |
|LOGISTIC REGRESSION|                                           P=0.346      |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P=0.309N     |                                    P=0.011 *       |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 11
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                2/50 (4%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     8.4%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  ---                      528          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.118      |                                    (e)             |
|POLY 3             |                                           P=0.227      |                                    (e)             |
|POLY 1.5           |                                           P=0.217      |                                    (e)             |
|POLY 6             |                                           P=0.326      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.292      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.247      |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/50 (10%)               3/50 (6%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  11.9%                    12.5%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  642                      540          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.045 *    |                                    (e)             |
|POLY 3             |                                           P=0.683      |                                    (e)             |
|POLY 1.5           |                                           P=0.565N     |                                    (e)             |
|POLY 6             |                                           P=0.580      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.684      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.357N     |                                    (e)             |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 12
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Basophilic Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  23/50 (46%)              6/50 (12%)   |           36/50 (72%)              10/50 (20%)     |
|POLY-3 ADJUSTED (b)|                  52.4%                    22.4%        |           80.9%                    24.9%           |
|TERMINAL (d)       |                  14/20 (70%)              0/0 (0%)     |           21/22 (96%)              2/16 (13%)      |
|FIRST INCIDENCE    |                  564                      299          |           241                      519             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.081      |                                    P<0.001N**      |
|POLY 3             |                                           P=0.013N*    |                                    P<0.001N**      |
|POLY 1.5           |                                           P=0.002N**   |                                    P<0.001N**      |
|POLY 6             |                                           P=0.189N     |                                    P<0.001N**      |
|LOGISTIC REGRESSION|                                           P=0.004N**   |                                    P<0.001N**      |
|COCH-ARM / FISHERS |                                           P<0.001N**   |                                    P<0.001N**      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Clear Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  4/50 (8%)                3/50 (6%)    |           3/50 (6%)                7/50 (14%)      |
|POLY-3 ADJUSTED (b)|                  9.5%                     12.3%        |           7.5%                     17.3%           |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           1/22 (5%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  610                      495          |           549                      281             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.091      |                                    P=0.141         |
|POLY 3             |                                           P=0.592      |                                    P=0.156         |
|POLY 1.5           |                                           P=0.674      |                                    P=0.156         |
|POLY 6             |                                           P=0.506      |                                    P=0.155         |
|LOGISTIC REGRESSION|                                           P=0.646N     |                                    P=0.204         |
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    P=0.159         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 13
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Degeneration Cystic Focal                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  4/50 (8%)                41/50 (82%)  |           0/50 (0%)                29/50 (58%)     |
|POLY-3 ADJUSTED (b)|                  9.5%                     93.5%        |           0.0%                     66.8%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                9/16 (56%)      |
|FIRST INCIDENCE    |                  626                      380          |           ---                      477             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Eosinophilic Focus                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  11/50 (22%)              39/50 (78%)  |           10/50 (20%)              37/50 (74%)     |
|POLY-3 ADJUSTED (b)|                  26.4%                    90.3%        |           25.1%                    77.9%           |
|TERMINAL (d)       |                  7/20 (35%)               0/0 (0%)     |           6/22 (27%)               13/16 (81%)     |
|FIRST INCIDENCE    |                  704                      219          |           679                      281             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P<0.001 **      |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 14
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatodiaphragmatic Nodule                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  4/50 (8%)                0/50 (0%)    |           7/50 (14%)               3/50 (6%)       |
|POLY-3 ADJUSTED (b)|                  9.4%                     0.0%         |           17.0%                    7.9%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           2/22 (9%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  614                      ---          |           459                      528             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.457N     |                                    P=0.230N        |
|POLY 3             |                                           P=0.277N     |                                    P=0.195N        |
|POLY 1.5           |                                           P=0.145N     |                                    P=0.182N        |
|POLY 6             |                                           P=0.649N     |                                    P=0.215N        |
|LOGISTIC REGRESSION|                                           P=0.054N     |                                    P=0.153N        |
|COCH-ARM / FISHERS |                                           P=0.059N     |                                    P=0.159N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Mixed Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                2/50 (4%)    |           6/50 (12%)               7/50 (14%)      |
|POLY-3 ADJUSTED (b)|                  2.4%                     8.2%         |           15.1%                    18.1%           |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           2/22 (9%)                3/16 (19%)      |
|FIRST INCIDENCE    |                  730 (T)                  299          |           683                      477             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.216      |                                    P=0.356         |
|POLY 3             |                                           P=0.423      |                                    P=0.482         |
|POLY 1.5           |                                           P=0.444      |                                    P=0.484         |
|POLY 6             |                                           P=0.465      |                                    P=0.475         |
|LOGISTIC REGRESSION|                                           P=0.745      |                                    P=0.464         |
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.500         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 15
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Necrosis Focal                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                2/50 (4%)    |           0/50 (0%)                1/50 (2%)       |
|POLY-3 ADJUSTED (b)|                  4.8%                     8.3%         |           0.0%                     2.7%            |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  730 (T)                  506          |           ---                      660             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.199      |                                    P=0.487         |
|POLY 3             |                                           P=0.578      |                                    P=0.501         |
|POLY 1.5           |                                           P=0.620      |                                    P=0.500         |
|POLY 6             |                                           P=0.574      |                                    P=0.501         |
|LOGISTIC REGRESSION|                                           P=0.686      |                                    P=0.497         |
|COCH-ARM / FISHERS |                                           P=0.691N     |                                    P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Bile Duct                                                                                                                 |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                1/50 (2%)    |           0/50 (0%)                2/50 (4%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     4.3%         |           0.0%                     5.4%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  ---                      553          |           ---                      679             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.404      |                                    P=0.191         |
|POLY 3             |                                           P=0.585      |                                    P=0.231         |
|POLY 1.5           |                                           P=0.523      |                                    P=0.233         |
|POLY 6             |                                           P=0.794      |                                    P=0.228         |
|LOGISTIC REGRESSION|                                           P=0.591      |                                    P=0.217         |
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.247         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 16
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Bile Duct                                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  36/50 (72%)              28/50 (56%)  |           11/50 (22%)              30/50 (60%)     |
|POLY-3 ADJUSTED (b)|                  77.0%                    76.0%        |           27.0%                    72.9%           |
|TERMINAL (d)       |                  16/20 (80%)              0/0 (0%)     |           6/22 (27%)               16/16 (100%)    |
|FIRST INCIDENCE    |                  521                      18           |           569                      477             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P=0.585N     |                                    P<0.001 **      |
|POLY 1.5           |                                           P=0.299N     |                                    P<0.001 **      |
|POLY 6             |                                           P=0.328      |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P=0.451N     |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P=0.072N     |                                    P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Centrilobular                                                                                                             |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  6/50 (12%)               0/50 (0%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  14.1%                    0.0%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  553                      ---          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.471N     |                                    (e)             |
|POLY 3             |                                           P=0.139N     |                                    (e)             |
|POLY 1.5           |                                           P=0.055N     |                                    (e)             |
|POLY 6             |                                           P=0.473N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.065N     |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.013N*    |                                    (e)             |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 17
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Centrilobular                                                                                                             |
|     Degeneration Fatty                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                0/50 (0%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  4.8%                     0.0%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  626                      ---          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.672N     |                                    (e)             |
|POLY 3             |                                           P=0.544N     |                                    (e)             |
|POLY 1.5           |                                           P=0.380N     |                                    (e)             |
|POLY 6             |                                           P=0.857N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.249N     |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.247N     |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Hepatocyte                                                                                                                |
|     Hypertrophy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                26/50 (52%)  |           1/50 (2%)                31/50 (62%)     |
|POLY-3 ADJUSTED (b)|                  0.0%                     68.9%        |           2.5%                     70.8%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           1/22 (5%)                15/16 (94%)     |
|FIRST INCIDENCE    |                  ---                      18           |           730 (T)                  281             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P<0.001 **      |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 18
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Oval Cell                                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  14/50 (28%)              27/50 (54%)  |           1/50 (2%)                34/50 (68%)     |
|POLY-3 ADJUSTED (b)|                  31.5%                    69.5%        |           2.5%                     77.4%           |
|TERMINAL (d)       |                  5/20 (25%)               0/0 (0%)     |           1/22 (5%)                16/16 (100%)    |
|FIRST INCIDENCE    |                  521                      18           |           730 (T)                  331             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P=0.304      |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P=0.007 **   |                                    P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Inflammation Granulomatous                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                2/49 (4%)    |           1/50 (2%)                2/50 (4%)       |
|POLY-3 ADJUSTED (b)|                  4.8%                     8.6%         |           2.5%                     5.3%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  668                      528          |           641                      659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.099      |                                    P=0.474         |
|POLY 3             |                                           P=0.572      |                                    P=0.487         |
|POLY 1.5           |                                           P=0.613      |                                    P=0.491         |
|POLY 6             |                                           P=0.578      |                                    P=0.483         |
|LOGISTIC REGRESSION|                                           P=0.588      |                                    P=0.494         |
|COCH-ARM / FISHERS |                                           P=0.684      |                                    P=0.500         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 19
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Alveolar Epithelium                                                                                                        |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                1/49 (2%)    |           2/50 (4%)                5/50 (10%)      |
|POLY-3 ADJUSTED (b)|                  0.0%                     4.4%         |           5.1%                     13.3%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           1/22 (5%)                3/16 (19%)      |
|FIRST INCIDENCE    |                  ---                      589          |           644                      641             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.353      |                                    P=0.144         |
|POLY 3             |                                           P=0.589      |                                    P=0.196         |
|POLY 1.5           |                                           P=0.525      |                                    P=0.202         |
|POLY 6             |                                           P=0.800      |                                    P=0.188         |
|LOGISTIC REGRESSION|                                           P=0.533      |                                    P=0.188         |
|COCH-ARM / FISHERS |                                           P=0.495      |                                    P=0.218         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Interstitium                                                                                                               |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                1/49 (2%)    |           0/50 (0%)                1/50 (2%)       |
|POLY-3 ADJUSTED (b)|                  4.8%                     4.5%         |           0.0%                     2.7%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  652                      680          |           ---                      730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.185      |                                    P=0.436         |
|POLY 3             |                                           P=0.795N     |                                    P=0.501         |
|POLY 1.5           |                                           P=0.669N     |                                    P=0.500         |
|POLY 6             |                                           P=0.858      |                                    P=0.502         |
|LOGISTIC REGRESSION|                                           P=0.699      |                                    P=0.436         |
|COCH-ARM / FISHERS |                                           P=0.508N     |                                    P=0.500         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 20
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Interstitium                                                                                                               |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  4/50 (8%)                18/49 (37%)  |           0/50 (0%)                2/50 (4%)       |
|POLY-3 ADJUSTED (b)|                  9.5%                     58.5%        |           0.0%                     5.4%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  626                      502          |           ---                      611             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.205         |
|POLY 3             |                                           P<0.001 **   |                                    P=0.231         |
|POLY 1.5           |                                           P<0.001 **   |                                    P=0.233         |
|POLY 6             |                                           P<0.001 **   |                                    P=0.229         |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P=0.230         |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P=0.247         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mediastinal                                                                                                          |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                0/50 (0%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  4.8%                     0.0%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  639                      ---          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.916N     |                                    (e)             |
|POLY 3             |                                           P=0.539N     |                                    (e)             |
|POLY 1.5           |                                           P=0.378N     |                                    (e)             |
|POLY 6             |                                           P=0.850N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.500N     |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.247N     |                                    (e)             |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 21
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Dilatation                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  13/50 (26%)              1/46 (2%)    |           27/50 (54%)              10/50 (20%)     |
|POLY-3 ADJUSTED (b)|                  29.6%                    4.7%         |           60.7%                    25.6%           |
|TERMINAL (d)       |                  4/20 (20%)               0/0 (0%)     |           11/22 (50%)              5/16 (31%)      |
|FIRST INCIDENCE    |                  521                      589          |           407                      459             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.444N     |                                    P=0.011N*       |
|POLY 3             |                                           P=0.050N     |                                    P<0.001N**      |
|POLY 1.5           |                                           P=0.010N*    |                                    P<0.001N**      |
|POLY 6             |                                           P=0.325N     |                                    P=0.002N**      |
|LOGISTIC REGRESSION|                                           P=0.008N**   |                                    P<0.001N**      |
|COCH-ARM / FISHERS |                                           P<0.001N**   |                                    P<0.001N**      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Galactocele                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  1/50 (2%)                1/46 (2%)    |           10/50 (20%)              5/50 (10%)      |
|POLY-3 ADJUSTED (b)|                  2.4%                     4.6%         |           25.1%                    13.4%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           7/22 (32%)               3/16 (19%)      |
|FIRST INCIDENCE    |                  642                      502          |           598                      620             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.541      |                                    P=0.275N        |
|POLY 3             |                                           P=0.742      |                                    P=0.155N        |
|POLY 1.5           |                                           P=0.732      |                                    P=0.148N        |
|POLY 6             |                                           P=0.830      |                                    P=0.167N        |
|LOGISTIC REGRESSION|                                           P=0.749N     |                                    P=0.174N        |
|COCH-ARM / FISHERS |                                           P=0.731      |                                    P=0.131N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 22
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                0/46 (0%)    |           8/50 (16%)               2/50 (4%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     0.0%         |           19.7%                    5.3%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           2/22 (9%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  ---                      ---          |           597                      641             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           (e)          |                                    P=0.086N        |
|POLY 3             |                                           (e)          |                                    P=0.058N        |
|POLY 1.5           |                                           (e)          |                                    P=0.054N        |
|POLY 6             |                                           (e)          |                                    P=0.066N        |
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.053N        |
|COCH-ARM / FISHERS |                                           (e)          |                                    P=0.046N*       |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/5 (100%)               0/1 (0%)     |           5/6 (83%)                2/3 (67%)       |
|POLY-3 ADJUSTED (b)|                  100.0%                   0.0%         |           90.1%                    81.6%           |
|TERMINAL (d)       |                  2/2 (100%)               0/0 (0%)     |           1/1 (100%)               1/1 (100%)      |
|FIRST INCIDENCE    |                  553                      ---          |           569                      642             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.938N     |                                    P=0.230N        |
|POLY 3             |                                           P=1.000      |                                    P=0.941N        |
|POLY 1.5           |                                           P=1.000N     |                                    P=0.831N        |
|POLY 6             |                                           P=1.000      |                                    P=1.000N        |
|LOGISTIC REGRESSION|                                           (e)          |                                    P=0.700N        |
|COCH-ARM / FISHERS |                                           P=0.167N     |                                    P=0.583N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 23
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  11/50 (22%)              9/50 (18%)   |           8/50 (16%)               3/50 (6%)       |
|POLY-3 ADJUSTED (b)|                  25.4%                    33.7%        |           20.0%                    7.8%            |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |           4/22 (18%)               0/16 (0%)       |
|FIRST INCIDENCE    |                  603                      517          |           609                      331             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.177N        |
|POLY 3             |                                           P=0.362      |                                    P=0.108N        |
|POLY 1.5           |                                           P=0.542      |                                    P=0.106N        |
|POLY 6             |                                           P=0.163      |                                    P=0.113N        |
|LOGISTIC REGRESSION|                                           P=0.390      |                                    P=0.107N        |
|COCH-ARM / FISHERS |                                           P=0.402N     |                                    P=0.100N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |           2/50 (4%)                4/50 (8%)       |
|POLY-3 ADJUSTED (b)|                                                        |           5.0%                     10.6%           |
|TERMINAL (d)       |                                                        |           0/22 (0%)                3/16 (19%)      |
|FIRST INCIDENCE    |                                                        |           598                      281             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |                                    P=0.266         |
|POLY 3             |                                                        |                                    P=0.315         |
|POLY 1.5           |                                                        |                                    P=0.323         |
|POLY 6             |                                                        |                                    P=0.300         |
|LOGISTIC REGRESSION|                                                        |                                    P=0.361         |
|COCH-ARM / FISHERS |                                                        |                                    P=0.339         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 24
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                2/49 (4%)    |           0/50 (0%)                1/50 (2%)       |
|POLY-3 ADJUSTED (b)|                  7.2%                     8.8%         |           0.0%                     2.7%            |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |           0/22 (0%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  652                      638          |           ---                      730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.011 *    |                                    P=0.436         |
|POLY 3             |                                           P=0.683      |                                    P=0.501         |
|POLY 1.5           |                                           P=0.688N     |                                    P=0.500         |
|POLY 6             |                                           P=0.659      |                                    P=0.502         |
|LOGISTIC REGRESSION|                                           P=0.294      |                                    P=0.436         |
|COCH-ARM / FISHERS |                                           P=0.510N     |                                    P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas: Acinus                                                                                                                 |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  20/50 (40%)              10/49 (20%)  |           10/50 (20%)              4/50 (8%)       |
|POLY-3 ADJUSTED (b)|                  45.6%                    36.0%        |           24.6%                    10.4%           |
|TERMINAL (d)       |                  9/20 (45%)               0/0 (0%)     |           4/22 (18%)               1/16 (6%)       |
|FIRST INCIDENCE    |                  553                      299          |           555                      331             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.002 **   |                                    P=0.147N        |
|POLY 3             |                                           P=0.320N     |                                    P=0.084N        |
|POLY 1.5           |                                           P=0.132N     |                                    P=0.080N        |
|POLY 6             |                                           P=0.620      |                                    P=0.093N        |
|LOGISTIC REGRESSION|                                           P=0.194N     |                                    P=0.077N        |
|COCH-ARM / FISHERS |                                           P=0.028N*    |                                    P=0.074N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 25
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas: Artery                                                                                                                 |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  4/50 (8%)                0/49 (0%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  9.7%                     0.0%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  4/20 (20%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  730 (T)                  ---          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=1.000N     |                                    (e)             |
|POLY 3             |                                           P=0.266N     |                                    (e)             |
|POLY 1.5           |                                           P=0.144N     |                                    (e)             |
|POLY 6             |                                           P=0.612N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           (e)          |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.061N     |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  17/48 (35%)              25/46 (54%)  |           0/44 (0%)                3/45 (7%)       |
|POLY-3 ADJUSTED (b)|                  40.5%                    74.9%        |           0.0%                     8.5%            |
|TERMINAL (d)       |                  7/20 (35%)               0/0 (0%)     |           0/18 (0%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  626                      502          |           ---                      659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.105         |
|POLY 3             |                                           P<0.001 **   |                                    P=0.122         |
|POLY 1.5           |                                           P=0.007 **   |                                    P=0.122         |
|POLY 6             |                                           P<0.001 **   |                                    P=0.120         |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P=0.122         |
|COCH-ARM / FISHERS |                                           P=0.050      |                                    P=0.125         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 26
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/48 (4%)                1/46 (2%)    |           0/44 (0%)                0/45 (0%)       |
|POLY-3 ADJUSTED (b)|                  4.9%                     4.6%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/18 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  668                      674          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.200      |                                    (e)             |
|POLY 3             |                                           P=0.800N     |                                    (e)             |
|POLY 1.5           |                                           P=0.674N     |                                    (e)             |
|POLY 6             |                                           P=0.859      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.595      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.516N     |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Angiectasis                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                0/50 (0%)    |           4/50 (8%)                2/49 (4%)       |
|POLY-3 ADJUSTED (b)|                  4.8%                     0.0%         |           9.9%                     5.4%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           1/22 (5%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  529                      ---          |           616                      679             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.569N     |                                    P=0.412N        |
|POLY 3             |                                           P=0.543N     |                                    P=0.388N        |
|POLY 1.5           |                                           P=0.380N     |                                    P=0.374N        |
|POLY 6             |                                           P=0.854N     |                                    P=0.409N        |
|LOGISTIC REGRESSION|                                           P=0.231N     |                                    P=0.360N        |
|COCH-ARM / FISHERS |                                           P=0.247N     |                                    P=0.349N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 27
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                1/50 (2%)    |           3/50 (6%)                3/49 (6%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     4.3%         |           7.5%                     8.1%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           2/22 (9%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  ---                      592          |           569                      660             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.311      |                                    P=0.564         |
|POLY 3             |                                           P=0.586      |                                    P=0.635         |
|POLY 1.5           |                                           P=0.524      |                                    P=0.640         |
|POLY 6             |                                           P=0.798      |                                    P=0.630         |
|LOGISTIC REGRESSION|                                           P=0.531      |                                    P=0.633         |
|COCH-ARM / FISHERS |                                           P=0.500      |                                    P=0.651         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis                                                                                                   |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  11/50 (22%)              1/50 (2%)    |           11/50 (22%)              6/49 (12%)      |
|POLY-3 ADJUSTED (b)|                  26.1%                    4.3%         |           27.0%                    15.9%           |
|TERMINAL (d)       |                  8/20 (40%)               0/0 (0%)     |           6/22 (27%)               3/16 (19%)      |
|FIRST INCIDENCE    |                  529                      556          |           459                      571             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.664      |                                    P=0.268N        |
|POLY 3             |                                           P=0.055N     |                                    P=0.179N        |
|POLY 1.5           |                                           P=0.014N*    |                                    P=0.173N        |
|POLY 6             |                                           P=0.309N     |                                    P=0.188N        |
|LOGISTIC REGRESSION|                                           P=0.244N     |                                    P=0.172N        |
|COCH-ARM / FISHERS |                                           P=0.002N**   |                                    P=0.154N        |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 28
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  5/50 (10%)               4/50 (8%)    |                                                    |
|POLY-3 ADJUSTED (b)|                  12.0%                    16.1%        |                                                    |
|TERMINAL (d)       |                  3/20 (15%)               0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  668                      517          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.028 *    |                                                    |
|POLY 3             |                                           P=0.520      |                                                    |
|POLY 1.5           |                                           P=0.622      |                                                    |
|POLY 6             |                                           P=0.397      |                                                    |
|LOGISTIC REGRESSION|                                           P=0.536      |                                                    |
|COCH-ARM / FISHERS |                                           P=0.500N     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                5/50 (10%)   |                                                    |
|POLY-3 ADJUSTED (b)|                  7.2%                     20.1%        |                                                    |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  642                      513          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                                    |
|POLY 3             |                                           P=0.167      |                                                    |
|POLY 1.5           |                                           P=0.233      |                                                    |
|POLY 6             |                                           P=0.112      |                                                    |
|LOGISTIC REGRESSION|                                           P=0.175      |                                                    |
|COCH-ARM / FISHERS |                                           P=0.357      |                                                    |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 29
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  9/50 (18%)               4/50 (8%)    |                                                    |
|POLY-3 ADJUSTED (b)|                  20.1%                    16.1%        |                                                    |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  521                      502          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.479      |                                                    |
|POLY 3             |                                           P=0.526N     |                                                    |
|POLY 1.5           |                                           P=0.310N     |                                                    |
|POLY 6             |                                           P=0.640      |                                                    |
|LOGISTIC REGRESSION|                                           P=0.055N     |                                                    |
|COCH-ARM / FISHERS |                                           P=0.117N     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Prostate                                                                                                                         |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  16/50 (32%)              9/49 (18%)   |                                                    |
|POLY-3 ADJUSTED (b)|                  35.3%                    33.2%        |                                                    |
|TERMINAL (d)       |                  4/20 (20%)               0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  521                      502          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.020 *    |                                                    |
|POLY 3             |                                           P=0.569N     |                                                    |
|POLY 1.5           |                                           P=0.315N     |                                                    |
|POLY 6             |                                           P=0.411      |                                                    |
|LOGISTIC REGRESSION|                                           P=0.153N     |                                                    |
|COCH-ARM / FISHERS |                                           P=0.091N     |                                                    |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 30
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Salivary Glands: Submandibular Gland                                                                                             |
|     Cytoplasmic Alteration                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  4/50 (8%)                48/48 (100%) |           1/50 (2%)                49/50 (98%)     |
|POLY-3 ADJUSTED (b)|                  9.2%                     100.0%       |           2.5%                     100.0%          |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                16/16 (100%)    |
|FIRST INCIDENCE    |                  344                      18           |           555                      281             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Seminal Vesicle                                                                                                                  |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                3/50 (6%)    |                                                    |
|POLY-3 ADJUSTED (b)|                  0.0%                     12.5%        |                                                    |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  ---                      589          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.007 **   |                                                    |
|POLY 3             |                                           P=0.086      |                                                    |
|POLY 1.5           |                                           P=0.092      |                                                    |
|POLY 6             |                                           P=0.112      |                                                    |
|LOGISTIC REGRESSION|                                           P=0.079      |                                                    |
|COCH-ARM / FISHERS |                                           P=0.121      |                                                    |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 31
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Seminal Vesicle                                                                                                                  |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                3/50 (6%)    |                                                    |
|POLY-3 ADJUSTED (b)|                  0.0%                     12.3%        |                                                    |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  ---                      526          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.069      |                                                    |
|POLY 3             |                                           P=0.086      |                                                    |
|POLY 1.5           |                                           P=0.093      |                                                    |
|POLY 6             |                                           P=0.107      |                                                    |
|LOGISTIC REGRESSION|                                           P=0.186      |                                                    |
|COCH-ARM / FISHERS |                                           P=0.121      |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                1/50 (2%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  4.7%                     4.4%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  564                      674          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.574      |                                    (e)             |
|POLY 3             |                                           P=0.793N     |                                    (e)             |
|POLY 1.5           |                                           P=0.664N     |                                    (e)             |
|POLY 6             |                                           P=0.860      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.533N     |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.500N     |                                    (e)             |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 32
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Fibrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  8/50 (16%)               4/49 (8%)    |           3/50 (6%)                15/50 (30%)     |
|POLY-3 ADJUSTED (b)|                  19.3%                    16.9%        |           7.5%                     38.5%           |
|TERMINAL (d)       |                  4/20 (20%)               0/0 (0%)     |           1/22 (5%)                6/16 (38%)      |
|FIRST INCIDENCE    |                  714                      528          |           641                      620             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P=0.597N     |                                    P<0.001 **      |
|POLY 1.5           |                                           P=0.395N     |                                    P<0.001 **      |
|POLY 6             |                                           P=0.593      |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P=0.084      |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P=0.188N     |                                    P=0.002 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                4/49 (8%)    |           0/50 (0%)                12/50 (24%)     |
|POLY-3 ADJUSTED (b)|                  4.8%                     16.2%        |           0.0%                     30.5%           |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |           0/22 (0%)                4/16 (25%)      |
|FIRST INCIDENCE    |                  729                      506          |           ---                      571             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.027 *    |                                    P<0.001 **      |
|POLY 3             |                                           P=0.188      |                                    P<0.001 **      |
|POLY 1.5           |                                           P=0.236      |                                    P<0.001 **      |
|POLY 6             |                                           P=0.151      |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P=0.339      |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P=0.329      |                                    P<0.001 **      |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 33
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                5/49 (10%)   |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  7.1%                     20.2%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  588                      526          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.017 *    |                                    (e)             |
|POLY 3             |                                           P=0.163      |                                    (e)             |
|POLY 1.5           |                                           P=0.226      |                                    (e)             |
|POLY 6             |                                           P=0.111      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.353      |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.346      |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  7/50 (14%)               1/49 (2%)    |           0/50 (0%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                  16.7%                    4.4%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  3/20 (15%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  639                      521          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.522      |                                    (e)             |
|POLY 3             |                                           P=0.217N     |                                    (e)             |
|POLY 1.5           |                                           P=0.101N     |                                    (e)             |
|POLY 6             |                                           P=0.557N     |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.338N     |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.032N*    |                                    (e)             |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 34
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                29/49 (59%)  |           3/50 (6%)                33/49 (67%)     |
|POLY-3 ADJUSTED (b)|                  0.0%                     76.8%        |           7.3%                     72.0%           |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                6/16 (38%)      |
|FIRST INCIDENCE    |                  ---                      177          |           407                      281             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 3             |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 1.5           |                                           P<0.001 **   |                                    P<0.001 **      |
|POLY 6             |                                           P<0.001 **   |                                    P<0.001 **      |
|LOGISTIC REGRESSION|                                           P<0.001 **   |                                    P<0.001 **      |
|COCH-ARM / FISHERS |                                           P<0.001 **   |                                    P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Inflammation Focal                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  2/50 (4%)                1/49 (2%)    |           0/50 (0%)                0/49 (0%)       |
|POLY-3 ADJUSTED (b)|                  4.7%                     4.4%         |           0.0%                     0.0%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  588                      572          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.635      |                                    (e)             |
|POLY 3             |                                           P=0.792N     |                                    (e)             |
|POLY 1.5           |                                           P=0.668N     |                                    (e)             |
|POLY 6             |                                           P=0.854      |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.511N     |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.508N     |                                    (e)             |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 35
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  10/50 (20%)              20/49 (41%)  |           0/50 (0%)                0/49 (0%)       |
|POLY-3 ADJUSTED (b)|                  23.1%                    63.1%        |           0.0%                     0.0%            |
|TERMINAL (d)       |                  2/20 (10%)               0/0 (0%)     |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  588                      502          |           ---                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    (e)             |
|POLY 3             |                                           P<0.001 **   |                                    (e)             |
|POLY 1.5           |                                           P=0.002 **   |                                    (e)             |
|POLY 6             |                                           P<0.001 **   |                                    (e)             |
|LOGISTIC REGRESSION|                                           P=0.003 **   |                                    (e)             |
|COCH-ARM / FISHERS |                                           P=0.021 *    |                                    (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  4/50 (8%)                8/49 (16%)   |           3/50 (6%)                3/49 (6%)       |
|POLY-3 ADJUSTED (b)|                  9.3%                     29.7%        |           7.5%                     7.9%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           1/22 (5%)                0/16 (0%)       |
|FIRST INCIDENCE    |                  521                      437          |           598                      637             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.012 *    |                                    P=0.622         |
|POLY 3             |                                           P=0.042 *    |                                    P=0.643         |
|POLY 1.5           |                                           P=0.078      |                                    P=0.647         |
|POLY 6             |                                           P=0.016 *    |                                    P=0.637         |
|LOGISTIC REGRESSION|                                           P=0.380      |                                    P=0.655         |
|COCH-ARM / FISHERS |                                           P=0.168      |                                    P=0.651         |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 36
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular: Neuroendocrine Cell                                                                                          |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                8/49 (16%)   |           0/50 (0%)                3/49 (6%)       |
|POLY-3 ADJUSTED (b)|                  0.0%                     30.9%        |           0.0%                     7.9%            |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |           0/22 (0%)                1/16 (6%)       |
|FIRST INCIDENCE    |                  ---                      528          |           ---                      528             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.104         |
|POLY 3             |                                           P<0.001 **   |                                    P=0.114         |
|POLY 1.5           |                                           P<0.001 **   |                                    P=0.115         |
|POLY 6             |                                           P<0.001 **   |                                    P=0.112         |
|LOGISTIC REGRESSION|                                           P=0.002 **   |                                    P=0.121         |
|COCH-ARM / FISHERS |                                           P=0.003 **   |                                    P=0.117         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes: Germinal Epithelium                                                                                                      |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                1/50 (2%)    |                                                    |
|POLY-3 ADJUSTED (b)|                  7.1%                     4.3%         |                                                    |
|TERMINAL (d)       |                  1/20 (5%)                0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  521                      570          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.699      |                                                    |
|POLY 3             |                                           P=0.637N     |                                                    |
|POLY 1.5           |                                           P=0.477N     |                                                    |
|POLY 6             |                                           P=0.876N     |                                                    |
|LOGISTIC REGRESSION|                                           P=0.298N     |                                                    |
|COCH-ARM / FISHERS |                                           P=0.309N     |                                                    |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 37
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes: Interstitial Cell                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  3/50 (6%)                1/50 (2%)    |                                                    |
|POLY-3 ADJUSTED (b)|                  7.0%                     4.3%         |                                                    |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  521                      502          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.689N     |                                                    |
|POLY 3             |                                           P=0.637N     |                                                    |
|POLY 1.5           |                                           P=0.477N     |                                                    |
|POLY 6             |                                           P=0.877N     |                                                    |
|LOGISTIC REGRESSION|                                           P=0.191N     |                                                    |
|COCH-ARM / FISHERS |                                           P=0.309N     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes: Tunic                                                                                                                    |
|     Hyperplasia Mesothelium                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  0/50 (0%)                3/50 (6%)    |                                                    |
|POLY-3 ADJUSTED (b)|                  0.0%                     12.3%        |                                                    |
|TERMINAL (d)       |                  0/20 (0%)                0/0 (0%)     |                                                    |
|FIRST INCIDENCE    |                  ---                      437          |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P=0.045 *    |                                                    |
|POLY 3             |                                           P=0.086      |                                                    |
|POLY 1.5           |                                           P=0.093      |                                                    |
|POLY 6             |                                           P=0.107      |                                                    |
|LOGISTIC REGRESSION|                                           P=0.196      |                                                    |
|COCH-ARM / FISHERS |                                           P=0.121      |                                                    |
|=================================================================================================================================|
       Date:  07/20/98                           EXPERIMENT: 05187 TEST: 09                                            Page 38
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   METHYLEUGENOL
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                  22/50 (44%)              17/48 (35%)  |           32/50 (64%)              32/48 (67%)     |
|POLY-3 ADJUSTED (b)|                  50.8%                    55.3%        |           71.4%                    73.2%           |
|TERMINAL (d)       |                  14/20 (70%)              0/0 (0%)     |           18/22 (82%)              10/16 (63%)     |
|FIRST INCIDENCE    |                  610                      437          |           407                      459             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                           P<0.001 **   |                                    P=0.240         |
|POLY 3             |                                           P=0.461      |                                    P=0.520         |
|POLY 1.5           |                                           P=0.556N     |                                    P=0.496         |
|POLY 6             |                                           P=0.199      |                                    P=0.560         |
|LOGISTIC REGRESSION|                                           P=0.356      |                                    P=0.461         |
|COCH-ARM / FISHERS |                                           P=0.254N     |                                    P=0.474         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |                  0 MG/KG                  300          |           0 MG/KG                  300             |
|                   |                                           MG/KG        |                                    MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Hyperplasia Cystic                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |           2/50 (4%)                0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                                                        |           5.0%                     0.0%            |
|TERMINAL (d)       |                                                        |           0/22 (0%)                0/16 (0%)       |
|FIRST INCIDENCE    |                                                        |           549                      ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |                                    P=0.278N        |
|POLY 3             |                                                        |                                    P=0.263N        |
|POLY 1.5           |                                                        |                                    P=0.254N        |
|POLY 6             |                                                        |                                    P=0.277N        |
|LOGISTIC REGRESSION|                                                        |                                    P=0.231N        |
|COCH-ARM / FISHERS |                                                        |                                    P=0.247N        |
|=================================================================================================================================|
(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).