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TDMS Study 05007-06 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  POLYSORBATE 80                                    DATE: 09/03/94       
EXPERIMENT: 05007 TEST: 06                                                                                     TIME: 13:00:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01CP9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60286        
PATHOLOGIST: J. SAGARTZ                      S. EUSTIS                                                         CAS: 9005-65-6       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                  POLYSORBATE 80                                    DATE: 09/03/94      
EXPERIMENT: 05007 TEST: 06                                                                                     TIME: 13:00:00      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01CP9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60286       
PATHOLOGIST: J. SAGARTZ                      S. EUSTIS                                                         CAS: 9005-65-6      
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  POLYSORBATE 80                                    DATE: 09/03/94       
EXPERIMENT: 05007 TEST: 06                                                                                     TIME: 13:00:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01CP9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60286        
PATHOLOGIST: J. SAGARTZ                      S. EUSTIS                                                         CAS: 9005-65-6       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                         IN THE ANALYSIS OF THE STUDY OF POLYSORBATE 80
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Testes                        Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Pituitary Gland: Pars Intermedia
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Malignant Tumors
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE   1
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       0/50 (0%)       0/50 (0%)      |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.6%            0.0%            0.0%          |      4.3%            8.0%            0.0%          |
|TERMINAL (d)           |     1/28 (4%)       0/18 (0%)       0/18 (0%)      |     1/23 (4%)       2/25 (8%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             ---           |      729 (T)         729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.340N        P=0.588N        P=0.588N       |     P=0.337N        P=0.529         P=0.483N       |
|INCIDENTAL TUMOR       |     P=0.340N        P=0.588N        P=0.588N       |     P=0.337N        P=0.529         P=0.483N       |
|LOGISTIC REGRESSION    |     P=0.340N        P=0.588N        P=0.588N       |     P=0.337N        P=0.529         P=0.483N       |
|COCHRAN-ARMITAGE       |     P=0.266N                                       |     P=0.360N                                       |
|FISHER EXACT           |                     P=0.495N        P=0.495N       |                     P=0.500         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    21/50 (42%)     16/50 (32%)     28/50 (56%)     |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     57.0%           52.5%           86.8%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |    14/29 (48%)      6/18 (33%)     14/18 (78%)     |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      561             613             570           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.006 **      P=0.496         P=0.005 **     |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.042 *       P=0.224N        P=0.048 *      |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.030 *       P=0.256N        P=0.032 *      |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.204N        P=0.115        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE   2
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       4/50 (8%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.4%           16.5%            7.5%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/29 (3%)       2/18 (11%)      1/18 (6%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         644             400           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.283         P=0.094         P=0.388        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.345         P=0.150         P=0.436        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.412         P=0.154         P=0.557        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.406                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.181         P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma NOS                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     6/50 (12%)      6/50 (12%)      7/50 (14%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     22.3%           20.4%           24.7%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |     4/23 (17%)      4/25 (16%)      4/25 (16%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      645             610             700           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.491         P=0.566N        P=0.551        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.413         P=0.612         P=0.454        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.471         P=0.604N        P=0.538        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.440                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.620N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE   3
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    21/50 (42%)     19/50 (38%)     29/50 (58%)     |     6/50 (12%)      6/50 (12%)      7/50 (14%)     |
|ADJUSTED (b)           |     57.0%           61.6%           87.0%          |     22.3%           20.4%           24.7%          |
|TERMINAL (d)           |    14/29 (48%)      8/18 (44%)     14/18 (78%)     |     4/23 (17%)      4/25 (16%)      4/25 (16%)     |
|FIRST INCIDENCE (DAYS) |      561             613             400           |      645             610             700           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.003 **      P=0.254         P=0.003 **     |     P=0.491         P=0.566N        P=0.551        |
|INCIDENTAL TUMOR       |     P=0.025 *       P=0.479N        P=0.036 *      |     P=0.413         P=0.612         P=0.454        |
|LOGISTIC REGRESSION    |     P=0.023 *       P=0.499N        P=0.027 *      |     P=0.471         P=0.604N        P=0.538        |
|COCHRAN-ARMITAGE       |     P=0.066                                        |     P=0.440                                        |
|FISHER EXACT           |                     P=0.419N        P=0.081        |                     P=0.620N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma Malignant                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            4.1%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             323             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.667         P=0.240           (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.691         P=0.401           (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.556         P=0.197           (e)          |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.669                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.247           (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE   4
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/48 (10%)      1/50 (2%)       2/49 (4%)      |     3/48 (6%)       3/49 (6%)       3/50 (6%)      |
|ADJUSTED (b)           |     15.0%            3.7%            8.6%          |     11.1%           12.0%            9.1%          |
|TERMINAL (d)           |     3/28 (11%)      0/18 (0%)       1/18 (6%)      |     2/22 (9%)       3/25 (12%)      1/25 (4%)      |
|FIRST INCIDENCE (DAYS) |      561             692             682           |      561             729 (T)         623           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.237N        P=0.186N        P=0.355N       |     P=0.544N        P=0.617N        P=0.633N       |
|INCIDENTAL TUMOR       |     P=0.125N        P=0.083N        P=0.240N       |     P=0.527N        P=0.637N        P=0.614N       |
|LOGISTIC REGRESSION    |     P=0.143N        P=0.098N        P=0.231N       |     P=0.552N        P=0.642N        P=0.645N       |
|COCHRAN-ARMITAGE       |     P=0.126N                                       |     P=0.563N                                       |
|FISHER EXACT           |                     P=0.093N        P=0.209N       |                     P=0.651N        P=0.641N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/48 (10%)      6/50 (12%)      5/49 (10%)     |     7/48 (15%)      5/49 (10%)      4/50 (8%)      |
|ADJUSTED (b)           |     15.8%           21.4%           18.9%          |     23.4%           15.7%           11.8%          |
|TERMINAL (d)           |     3/28 (11%)      2/18 (11%)      1/18 (6%)      |     3/22 (14%)      2/25 (8%)       1/25 (4%)      |
|FIRST INCIDENCE (DAYS) |      640             477             682           |      617             630             610           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.358         P=0.307         P=0.419        |     P=0.190N        P=0.325N        P=0.240N       |
|INCIDENTAL TUMOR       |     P=0.511N        P=0.505         P=0.513N       |     P=0.207N        P=0.440N        P=0.250N       |
|LOGISTIC REGRESSION    |     P=0.542         P=0.521         P=0.570        |     P=0.179N        P=0.352N        P=0.229N       |
|COCHRAN-ARMITAGE       |     P=0.551N                                       |     P=0.189N                                       |
|FISHER EXACT           |                     P=0.529         P=0.617N       |                     P=0.365N        P=0.239N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE   5
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/48 (21%)      7/50 (14%)      7/49 (14%)     |    10/48 (21%)      8/49 (16%)      7/50 (14%)     |
|ADJUSTED (b)           |     29.4%           24.3%           26.2%          |     33.0%           26.7%           20.0%          |
|TERMINAL (d)           |     6/28 (21%)      2/18 (11%)      2/18 (11%)     |     5/22 (23%)      5/25 (20%)      2/25 (8%)      |
|FIRST INCIDENCE (DAYS) |      561             477             682           |      561             630             610           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.503N        P=0.549N        P=0.569N       |     P=0.217N        P=0.323N        P=0.267N       |
|INCIDENTAL TUMOR       |     P=0.205N        P=0.272N        P=0.228N       |     P=0.221N        P=0.431N        P=0.258N       |
|LOGISTIC REGRESSION    |     P=0.271N        P=0.275N        P=0.352N       |     P=0.207N        P=0.361N        P=0.258N       |
|COCHRAN-ARMITAGE       |     P=0.232N                                       |     P=0.223N                                       |
|FISHER EXACT           |                     P=0.266N        P=0.281N       |                     P=0.379N        P=0.266N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Ear                                                                                                                              |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            4.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             575           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.089           (e)           P=0.229        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.064           (e)           P=0.202        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.108           (e)           P=0.292        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE   6
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       5/48 (10%)      3/48 (6%)      |     0/50 (0%)       2/47 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |     13.8%           15.8%           16.7%          |      0.0%            8.3%            0.0%          |
|TERMINAL (d)           |     4/29 (14%)      0/18 (0%)       3/18 (17%)     |     0/23 (0%)       2/24 (8%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         616             729 (T)       |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.499         P=0.323         P=0.560        |     P=0.651N        P=0.247           (e)          |
|INCIDENTAL TUMOR       |     P=0.518N        P=0.518         P=0.560        |     P=0.651N        P=0.247           (e)          |
|LOGISTIC REGRESSION    |     P=0.506N        P=0.446         P=0.560        |     P=0.652N        P=0.247           (e)          |
|COCHRAN-ARMITAGE       |     P=0.451N                                       |     P=0.667                                        |
|FISHER EXACT           |                     P=0.474         P=0.523N       |                     P=0.232           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       6/48 (13%)      3/48 (6%)      |     0/50 (0%)       2/47 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |     13.8%           18.3%           16.7%          |      0.0%            8.3%            0.0%          |
|TERMINAL (d)           |     4/29 (14%)      0/18 (0%)       3/18 (17%)     |     0/23 (0%)       2/24 (8%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         616             729 (T)       |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.497         P=0.219         P=0.560        |     P=0.651N        P=0.247           (e)          |
|INCIDENTAL TUMOR       |     P=0.486N        P=0.416         P=0.560        |     P=0.651N        P=0.247           (e)          |
|LOGISTIC REGRESSION    |     P=0.501N        P=0.323         P=0.560        |     P=0.652N        P=0.247           (e)          |
|COCHRAN-ARMITAGE       |     P=0.455N                                       |     P=0.667                                        |
|FISHER EXACT           |                     P=0.344         P=0.523N       |                     P=0.232           (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE   7
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |      5.7%            0.0%            6.5%          |      0.0%            4.0%           11.3%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |     0/23 (0%)       1/25 (4%)       2/25 (8%)      |
|FIRST INCIDENCE (DAYS) |      698             ---             400           |      ---             729 (T)         708           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.531         P=0.313N        P=0.594        |     P=0.066         P=0.517         P=0.132        |
|INCIDENTAL TUMOR       |     P=0.428N        P=0.120N        P=0.457N       |     P=0.059         P=0.517         P=0.115        |
|LOGISTIC REGRESSION    |     P=0.589N        P=0.251N        P=0.648N       |     P=0.064         P=0.517         P=0.130        |
|COCHRAN-ARMITAGE       |     P=0.622N                                       |     P=0.060                                        |
|FISHER EXACT           |                     P=0.247N        P=0.691N       |                     P=0.500         P=0.121        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.2%            0.0%            5.6%          |      2.7%            6.7%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       1/18 (6%)      |     0/23 (0%)       1/25 (4%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      561             ---             729 (T)       |      640             646             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.605         P=0.500N        P=0.700        |     P=0.354N        P=0.516         P=0.505N       |
|INCIDENTAL TUMOR       |     P=0.604         P=0.419N        P=0.692        |     P=0.374N        P=0.456         P=0.484N       |
|LOGISTIC REGRESSION    |     P=0.657N        P=0.443N        P=0.750N       |     P=0.360N        P=0.500         P=0.508N       |
|COCHRAN-ARMITAGE       |     P=0.669N                                       |     P=0.360N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.753N       |                     P=0.500         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE   8
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            6.1%            2.4%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             619             612           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.368         P=0.259         P=0.500        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.355         P=0.190         P=0.516        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.355         P=0.238         P=0.483        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.360                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.247         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      2.4%            6.1%            2.4%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      617             619             612           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.618N        P=0.520         P=0.755        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.617         P=0.412         P=0.747N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.613         P=0.500         P=0.748        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.622N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE   9
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |    28/50 (56%)     27/50 (54%)     26/50 (52%)     |
|ADJUSTED (b)           |      3.0%            7.3%            0.0%          |     74.8%           68.4%           69.4%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |    14/23 (61%)     13/25 (52%)     14/25 (56%)     |
|FIRST INCIDENCE (DAYS) |      701             675             ---           |      367             532             610           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.452N        P=0.406         P=0.581N       |     P=0.311N        P=0.374N        P=0.340N       |
|INCIDENTAL TUMOR       |     P=0.191N        P=0.701         P=0.362N       |     P=0.421N        P=0.575         P=0.451N       |
|LOGISTIC REGRESSION    |     P=0.383N        P=0.485         P=0.523N       |     P=0.336N        P=0.497N        P=0.374N       |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |     P=0.382N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.500N        P=0.421N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |    29/50 (58%)     27/50 (54%)     26/50 (52%)     |
|ADJUSTED (b)           |      3.0%            7.3%            0.0%          |     75.4%           68.4%           69.4%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |    14/23 (61%)     13/25 (52%)     14/25 (56%)     |
|FIRST INCIDENCE (DAYS) |      701             675             ---           |      367             532             610           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.452N        P=0.406         P=0.581N       |     P=0.259N        P=0.318N        P=0.286N       |
|INCIDENTAL TUMOR       |     P=0.191N        P=0.701         P=0.362N       |     P=0.341N        P=0.519N        P=0.369N       |
|LOGISTIC REGRESSION    |     P=0.383N        P=0.485         P=0.523N       |     P=0.265N        P=0.416N        P=0.300N       |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |     P=0.308N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.420N        P=0.344N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  10
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |    29/50 (58%)     28/50 (56%)     27/50 (54%)     |
|ADJUSTED (b)           |      3.0%            7.3%            0.0%          |     75.4%           69.1%           70.2%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |    14/23 (61%)     13/25 (52%)     14/25 (56%)     |
|FIRST INCIDENCE (DAYS) |      701             675             ---           |      367             532             610           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.452N        P=0.406         P=0.581N       |     P=0.317N        P=0.376N        P=0.345N       |
|INCIDENTAL TUMOR       |     P=0.191N        P=0.701         P=0.362N       |     P=0.414N        P=0.551         P=0.444N       |
|LOGISTIC REGRESSION    |     P=0.383N        P=0.485         P=0.523N       |     P=0.339N        P=0.499N        P=0.377N       |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |     P=0.381N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.500N        P=0.420N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       1/48 (2%)      |     0/50 (0%)       0/47 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.4%           11.1%            5.6%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/29 (3%)       2/18 (11%)      1/18 (6%)      |     0/23 (0%)       0/24 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.457         P=0.335         P=0.652        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.457         P=0.335         P=0.652        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.457         P=0.335         P=0.652        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.609                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.742        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  11
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    30/50 (60%)     23/49 (47%)     26/50 (52%)     |    37/50 (74%)     30/50 (60%)     36/50 (72%)     |
|ADJUSTED (b)           |     74.1%           60.5%           78.5%          |     87.7%           78.1%           89.5%          |
|TERMINAL (d)           |    19/29 (66%)      6/18 (33%)     12/18 (67%)     |    18/23 (78%)     17/25 (68%)     21/25 (84%)     |
|FIRST INCIDENCE (DAYS) |      455             477             454           |      548             466             535           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.257         P=0.521         P=0.232        |     P=0.355N        P=0.102N        P=0.387N       |
|INCIDENTAL TUMOR       |     P=0.334N        P=0.150N        P=0.505N       |     P=0.425N        P=0.175N        P=0.481N       |
|LOGISTIC REGRESSION    |     P=0.286N        P=0.144N        P=0.348N       |     P=0.403N        P=0.092N        P=0.443N       |
|COCHRAN-ARMITAGE       |     P=0.242N                                       |     P=0.457N                                       |
|FISHER EXACT           |                     P=0.135N        P=0.273N       |                     P=0.101N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    30/50 (60%)     23/49 (47%)     26/50 (52%)     |    38/50 (76%)     30/50 (60%)     36/50 (72%)     |
|ADJUSTED (b)           |     74.1%           60.5%           78.5%          |     88.1%           78.1%           89.5%          |
|TERMINAL (d)           |    19/29 (66%)      6/18 (33%)     12/18 (67%)     |    18/23 (78%)     17/25 (68%)     21/25 (84%)     |
|FIRST INCIDENCE (DAYS) |      455             477             454           |      548             466             535           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.257         P=0.521         P=0.232        |     P=0.298N        P=0.078N        P=0.329N       |
|INCIDENTAL TUMOR       |     P=0.334N        P=0.150N        P=0.505N       |     P=0.346N        P=0.125N        P=0.400N       |
|LOGISTIC REGRESSION    |     P=0.286N        P=0.144N        P=0.348N       |     P=0.316N        P=0.058N        P=0.348N       |
|COCHRAN-ARMITAGE       |     P=0.242N                                       |     P=0.372N                                       |
|FISHER EXACT           |                     P=0.135N        P=0.273N       |                     P=0.066N        P=0.410N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  12
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/49 (2%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.4%            5.3%            0.0%          |      8.7%            0.0%            0.0%          |
|TERMINAL (d)           |     1/29 (3%)       0/18 (0%)       0/18 (0%)      |     2/23 (9%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         724             ---           |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.439N        P=0.657         P=0.595N       |     P=0.086N        P=0.219N        P=0.219N       |
|INCIDENTAL TUMOR       |     P=0.316N        P=0.763N        P=0.595N       |     P=0.086N        P=0.219N        P=0.219N       |
|LOGISTIC REGRESSION    |     P=0.426N        P=0.671         P=0.595N       |     P=0.086N        P=0.219N        P=0.219N       |
|COCHRAN-ARMITAGE       |     P=0.332N                                       |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.747         P=0.500N       |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/49 (2%)       0/50 (0%)      |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.4%            5.3%            0.0%          |     10.9%            0.0%            0.0%          |
|TERMINAL (d)           |     1/29 (3%)       0/18 (0%)       0/18 (0%)      |     2/23 (9%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         724             ---           |      617             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.439N        P=0.657         P=0.595N       |     P=0.035N*       P=0.113N        P=0.115N       |
|INCIDENTAL TUMOR       |     P=0.316N        P=0.763N        P=0.595N       |     P=0.035N*       P=0.129N        P=0.108N       |
|LOGISTIC REGRESSION    |     P=0.426N        P=0.671         P=0.595N       |     P=0.036N*       P=0.119N        P=0.117N       |
|COCHRAN-ARMITAGE       |     P=0.332N                                       |     P=0.037N*                                      |
|FISHER EXACT           |                     P=0.747         P=0.500N       |                     P=0.121N        P=0.121N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  13
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            8.3%            3.7%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       1/18 (6%)       0/18 (0%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             644             699           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.299         P=0.180         P=0.454        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.357         P=0.227         P=0.638        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.339         P=0.230         P=0.479        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.360                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.247         P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       5/50 (10%)     |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.9%            8.2%           21.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/29 (7%)       0/18 (0%)       3/18 (17%)     |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         667             597           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.072         P=0.551         P=0.100        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.120         P=0.684N        P=0.122        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.116         P=0.641         P=0.175        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.146                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.691N        P=0.218        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  14
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.9%            0.0%            5.6%          |      3.7%            3.8%            0.0%          |
|TERMINAL (d)           |     2/29 (7%)       0/18 (0%)       1/18 (6%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             729 (T)       |      710             724             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.502N        P=0.348N        P=0.665N       |     P=0.322N        P=0.739N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.502N        P=0.348N        P=0.665N       |     P=0.394N        P=0.724         P=0.557N       |
|LOGISTIC REGRESSION    |     P=0.502N        P=0.348N        P=0.665N       |     P=0.319N        P=0.750N        P=0.492N       |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |     P=0.331N                                       |
|FISHER EXACT           |                     P=0.247N        P=0.500N       |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.9%            0.0%            5.6%          |      0.0%            3.8%            0.0%          |
|TERMINAL (d)           |     2/29 (7%)       0/18 (0%)       1/18 (6%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             729 (T)       |      ---             724             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.502N        P=0.348N        P=0.665N       |     P=0.722N        P=0.524           (e)          |
|INCIDENTAL TUMOR       |     P=0.502N        P=0.348N        P=0.665N       |     P=0.689         P=0.464           (e)          |
|LOGISTIC REGRESSION    |     P=0.502N        P=0.348N        P=0.665N       |     P=0.724N        P=0.519           (e)          |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |     P=0.731                                        |
|FISHER EXACT           |                     P=0.247N        P=0.500N       |                     P=0.500           (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  15
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       4/50 (8%)       7/50 (14%)     |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |     13.8%           15.8%           29.0%          |      3.7%            3.8%            0.0%          |
|TERMINAL (d)           |     4/29 (14%)      1/18 (6%)       4/18 (22%)     |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         644             597           |      710             724             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.080         P=0.428         P=0.094        |     P=0.322N        P=0.739N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.135         P=0.588         P=0.139        |     P=0.394N        P=0.724         P=0.557N       |
|LOGISTIC REGRESSION    |     P=0.144         P=0.570         P=0.184        |     P=0.319N        P=0.750N        P=0.492N       |
|COCHRAN-ARMITAGE       |     P=0.202                                        |     P=0.331N                                       |
|FISHER EXACT           |                     P=0.643N        P=0.262        |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       4/50 (8%)      |     2/50 (4%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.7%           11.0%           14.6%          |      7.1%            6.9%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       1/18 (6%)       1/18 (6%)      |     1/23 (4%)       1/25 (4%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      681             616             647           |      645             700             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.088         P=0.231         P=0.123        |     P=0.167N        P=0.666N        P=0.234N       |
|INCIDENTAL TUMOR       |     P=0.196         P=0.402         P=0.328        |     P=0.199N        P=0.677         P=0.261N       |
|LOGISTIC REGRESSION    |     P=0.119         P=0.301         P=0.159        |     P=0.169N        P=0.689N        P=0.234N       |
|COCHRAN-ARMITAGE       |     P=0.133                                        |     P=0.176N                                       |
|FISHER EXACT           |                     P=0.309         P=0.181        |                     P=0.691N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  16
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            6.7%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             687             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.648N        P=0.267           (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.606         P=0.195           (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.662N        P=0.243           (e)          |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.669                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.247           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Lipoma                                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            4.2%            5.9%          |      0.0%            4.0%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       0/18 (0%)      |     0/23 (0%)       1/25 (4%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             701             570           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.114         P=0.436         P=0.215        |     P=0.720N        P=0.517           (e)          |
|INCIDENTAL TUMOR       |     P=0.195         P=0.615         P=0.297        |     P=0.720N        P=0.517           (e)          |
|LOGISTIC REGRESSION    |     P=0.145         P=0.484         P=0.257        |     P=0.720N        P=0.517           (e)          |
|COCHRAN-ARMITAGE       |     P=0.142                                        |     P=0.731                                        |
|FISHER EXACT           |                     P=0.500         P=0.247        |                     P=0.500           (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  17
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibroma or Fibroma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       4/50 (8%)      |     2/50 (4%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.7%           11.0%           14.6%          |      7.1%            6.9%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       1/18 (6%)       1/18 (6%)      |     1/23 (4%)       1/25 (4%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      681             616             647           |      645             700             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.088         P=0.231         P=0.123        |     P=0.167N        P=0.666N        P=0.234N       |
|INCIDENTAL TUMOR       |     P=0.196         P=0.402         P=0.328        |     P=0.199N        P=0.677         P=0.261N       |
|LOGISTIC REGRESSION    |     P=0.119         P=0.301         P=0.159        |     P=0.169N        P=0.689N        P=0.234N       |
|COCHRAN-ARMITAGE       |     P=0.133                                        |     P=0.176N                                       |
|FISHER EXACT           |                     P=0.309         P=0.181        |                     P=0.691N        P=0.247N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       3/50 (6%)       6/50 (12%)     |     2/50 (4%)       4/50 (8%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.1%           11.0%           20.2%          |      7.1%           13.1%            0.0%          |
|TERMINAL (d)           |     1/29 (3%)       1/18 (6%)       1/18 (6%)      |     1/23 (4%)       1/25 (4%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      681             616             458           |      645             687             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.050         P=0.377         P=0.075        |     P=0.205N        P=0.383         P=0.234N       |
|INCIDENTAL TUMOR       |     P=0.149         P=0.554         P=0.266        |     P=0.272N        P=0.290         P=0.261N       |
|LOGISTIC REGRESSION    |     P=0.087         P=0.485         P=0.134        |     P=0.212N        P=0.346         P=0.234N       |
|COCHRAN-ARMITAGE       |     P=0.090                                        |     P=0.222N                                       |
|FISHER EXACT           |                     P=0.500         P=0.134        |                     P=0.339         P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  18
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.4%            0.0%            6.6%          |      0.0%            6.7%            0.0%          |
|TERMINAL (d)           |     1/29 (3%)       0/18 (0%)       0/18 (0%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             458           |      ---             687             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.282         P=0.595N        P=0.395        |     P=0.648N        P=0.267           (e)          |
|INCIDENTAL TUMOR       |     P=0.415         P=0.595N        P=0.571        |     P=0.606         P=0.195           (e)          |
|LOGISTIC REGRESSION    |     P=0.385         P=0.595N        P=0.545        |     P=0.662N        P=0.243           (e)          |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.669                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.247           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            7.7%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       1/18 (6%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             494           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.074           (e)           P=0.186        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.103           (e)           P=0.227        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.105           (e)           P=0.273        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  19
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    39/49 (80%)     35/50 (70%)     41/50 (82%)     |                                                    |
|ADJUSTED (b)           |     97.5%           94.2%           97.6%          |                                                    |
|TERMINAL (d)           |    28/29 (97%)     16/18 (89%)     17/18 (94%)     |                                                    |
|FIRST INCIDENCE (DAYS) |      470             503             494           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.006 **      P=0.072         P=0.005 **     |                                                    |
|INCIDENTAL TUMOR       |     P=0.176         P=0.439N        P=0.280        |                                                    |
|LOGISTIC REGRESSION    |     P=0.132         P=0.224N        P=0.136        |                                                    |
|COCHRAN-ARMITAGE       |     P=0.431                                        |                                                    |
|FISHER EXACT           |                     P=0.193N        P=0.480        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      2/50 (4%)       2/50 (4%)      |     5/50 (10%)      6/50 (12%)     10/50 (20%)     |
|ADJUSTED (b)           |     19.9%           11.1%           11.1%          |     14.3%           22.9%           34.3%          |
|TERMINAL (d)           |     5/29 (17%)      2/18 (11%)      2/18 (11%)     |     1/23 (4%)       5/25 (20%)      7/25 (28%)     |
|FIRST INCIDENCE (DAYS) |      717             729 (T)         729 (T)       |      617             717             612           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.233N        P=0.329N        P=0.332N       |     P=0.121         P=0.551         P=0.162        |
|INCIDENTAL TUMOR       |     P=0.187N        P=0.263N        P=0.255N       |     P=0.110         P=0.454         P=0.147        |
|LOGISTIC REGRESSION    |     P=0.211N        P=0.291N        P=0.300N       |     P=0.105         P=0.509         P=0.139        |
|COCHRAN-ARMITAGE       |     P=0.080N                                       |     P=0.097                                        |
|FISHER EXACT           |                     P=0.134N        P=0.134N       |                     P=0.500         P=0.131        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  20
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      2/50 (4%)       2/50 (4%)      |     6/50 (12%)      6/50 (12%)     10/50 (20%)     |
|ADJUSTED (b)           |     19.9%           11.1%           11.1%          |     18.1%           22.9%           34.3%          |
|TERMINAL (d)           |     5/29 (17%)      2/18 (11%)      2/18 (11%)     |     2/23 (9%)       5/25 (20%)      7/25 (28%)     |
|FIRST INCIDENCE (DAYS) |      717             729 (T)         729 (T)       |      617             717             612           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.233N        P=0.329N        P=0.332N       |     P=0.194         P=0.566N        P=0.245        |
|INCIDENTAL TUMOR       |     P=0.187N        P=0.263N        P=0.255N       |     P=0.180         P=0.583         P=0.230        |
|LOGISTIC REGRESSION    |     P=0.211N        P=0.291N        P=0.300N       |     P=0.174         P=0.610N        P=0.219        |
|COCHRAN-ARMITAGE       |     P=0.080N                                       |     P=0.161                                        |
|FISHER EXACT           |                     P=0.134N        P=0.134N       |                     P=0.620N        P=0.207        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            2.3%            9.7%          |      6.6%            0.0%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       1/18 (6%)      |     1/23 (4%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             616             700           |      617             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.100         P=0.510         P=0.151        |     P=0.094N        P=0.231N        P=0.236N       |
|INCIDENTAL TUMOR       |     P=0.134         P=0.581         P=0.253        |     P=0.093N        P=0.261N        P=0.222N       |
|LOGISTIC REGRESSION    |     P=0.134         P=0.526         P=0.193        |     P=0.095N        P=0.237N        P=0.237N       |
|COCHRAN-ARMITAGE       |     P=0.142                                        |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.500         P=0.247        |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  21
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     9/50 (18%)     11/50 (22%)     12/50 (24%)     |
|ADJUSTED (b)           |                                                    |     26.1%           37.3%           34.3%          |
|TERMINAL (d)           |                                                    |     2/23 (9%)       8/25 (32%)      5/25 (20%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      367             467             567           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.330         P=0.466         P=0.365        |
|INCIDENTAL TUMOR       |                                                    |     P=0.249         P=0.426         P=0.256        |
|LOGISTIC REGRESSION    |                                                    |     P=0.276         P=0.402         P=0.308        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.271                                        |
|FISHER EXACT           |                                                    |                     P=0.402         P=0.312        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     9/50 (18%)     11/50 (22%)     13/50 (26%)     |
|ADJUSTED (b)           |                                                    |     26.1%           37.3%           35.9%          |
|TERMINAL (d)           |                                                    |     2/23 (9%)       8/25 (32%)      5/25 (20%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      367             467             567           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.255         P=0.466         P=0.289        |
|INCIDENTAL TUMOR       |                                                    |     P=0.184         P=0.426         P=0.190        |
|LOGISTIC REGRESSION    |                                                    |     P=0.203         P=0.402         P=0.229        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.199                                        |
|FISHER EXACT           |                                                    |                     P=0.402         P=0.235        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  22
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    23/50 (46%)     21/50 (42%)     26/50 (52%)     |    26/50 (52%)     10/50 (20%)     13/50 (26%)     |
|ADJUSTED (b)           |     55.8%           56.3%           70.4%          |     65.1%           27.3%           40.2%          |
|TERMINAL (d)           |    12/29 (41%)      4/18 (22%)      8/18 (44%)     |    10/23 (43%)      3/25 (12%)      7/25 (28%)     |
|FIRST INCIDENCE (DAYS) |      464             503             458           |      514             561             568           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.069         P=0.315         P=0.069        |     P=0.007N**      P=0.003N**      P=0.012N*      |
|INCIDENTAL TUMOR       |     P=0.481         P=0.257N        P=0.461        |     P=0.005N**      P=0.002N**      P=0.010N**     |
|LOGISTIC REGRESSION    |     P=0.279         P=0.423N        P=0.315        |     P=0.003N**      P<0.001N**      P=0.006N**     |
|COCHRAN-ARMITAGE       |     P=0.308                                        |     P=0.004N**                                     |
|FISHER EXACT           |                     P=0.420N        P=0.345        |                     P<0.001N**      P=0.007N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            5.5%           10.1%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/29 (0%)       0/18 (0%)       1/18 (6%)      |     0/23 (0%)       0/25 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             637             709           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.132         P=0.222         P=0.148        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.202         P=0.352         P=0.253        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.166         P=0.250         P=0.182        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.176                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.247         P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  23
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    48/50 (96%)     47/50 (94%)     47/50 (94%)     |    47/50 (94%)     44/50 (88%)     46/50 (92%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     97.9%           97.8%          100.0%          |
|TERMINAL (d)           |    29/29 (100%)    18/18 (100%)    18/18 (100%)    |    22/23 (96%)     24/25 (96%)     25/25 (100%)    |
|FIRST INCIDENCE (DAYS) |      455             477             400           |      367             466             535           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.026 *       P=0.037 *       P=0.029 *      |     P=0.331N        P=0.233N        P=0.366N       |
|INCIDENTAL TUMOR       |     P=0.377         P=0.564         P=0.515        |     P=0.420N        P=0.407N        P=0.488N       |
|LOGISTIC REGRESSION    |     P=0.518         P=0.629N        P=0.580        |     P=0.319N        P=0.259N        P=0.396N       |
|COCHRAN-ARMITAGE       |     P=0.412N                                       |     P=0.429N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.243N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    31/50 (62%)     31/50 (62%)     34/50 (68%)     |    35/50 (70%)     21/50 (42%)     20/50 (40%)     |
|ADJUSTED (b)           |     71.0%           74.1%           80.2%          |     78.7%           49.8%           51.5%          |
|TERMINAL (d)           |    17/29 (59%)      8/18 (44%)     10/18 (56%)     |    14/23 (61%)      6/25 (24%)      8/25 (32%)     |
|FIRST INCIDENCE (DAYS) |      455             477             400           |      195             323             432           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.048 *       P=0.137         P=0.050 *      |     P=0.009N**      P=0.018N*       P=0.012N*      |
|INCIDENTAL TUMOR       |     P=0.449         P=0.470N        P=0.449        |     P=0.002N**      P=0.005N**      P=0.004N**     |
|LOGISTIC REGRESSION    |     P=0.288         P=0.578N        P=0.338        |     P=0.002N**      P=0.004N**      P=0.003N**     |
|COCHRAN-ARMITAGE       |     P=0.301                                        |     P=0.002N**                                     |
|FISHER EXACT           |                     P=0.582N        P=0.338        |                     P=0.004N**      P=0.002N**     |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 06                                                 PAGE  24
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    50/50 (100%)    49/50 (98%)     48/50 (96%)     |    49/50 (98%)     48/50 (96%)     48/50 (96%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     98.0%           98.0%          100.0%          |
|TERMINAL (d)           |    29/29 (100%)    18/18 (100%)    18/18 (100%)    |    22/23 (96%)     24/25 (96%)     25/25 (100%)    |
|FIRST INCIDENCE (DAYS) |      455             477             400           |      195             323             432           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.036 *       P=0.038 *       P=0.042 *      |     P=0.339N        P=0.344N        P=0.370N       |
|INCIDENTAL TUMOR       |     P=0.344N          (e)           P=0.581N       |     P=0.369N        P=0.598N        P=0.477N       |
|LOGISTIC REGRESSION    |     P=0.422N          (e)           P=0.657N       |     P=0.324N        P=0.500N        P=0.454N       |
|COCHRAN-ARMITAGE       |     P=0.142N                                       |     P=0.390N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (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.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's 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).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.