Share This:
https://ntp.niehs.nih.gov/go/3146

TDMS Study 05007-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  POLYSORBATE 80                                    DATE: 09/03/94       
EXPERIMENT: 05007 TEST: 05                                                                                     TIME: 11:42:55       
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: 05                                                                                     TIME: 11:42:55      
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      
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             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
                                                    Epididymis
                                                    Gallbladder
                                                    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: 05                                                                                     TIME: 11:42:55       
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 MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Uterus                        Polyp Stromal
                                                           Sarcoma Stromal or Polyp Stromal
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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)            |     0/49 (0%)       0/16 (0%)       2/50 (4%)      |     0/50 (0%)       0/22 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/0             2/32 (6%)      |     0/30 (0%)       0/0             0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.138           (e)           P=0.231        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.138           (e)           P=0.231        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.138           (e)           P=0.231        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.127                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.253        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma NOS                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       1/16 (6%)       2/50 (4%)      |     0/50 (0%)       0/22 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      3.0%            0.0%            5.2%          |      0.0%            0.0%            7.7%          |
|TERMINAL (d)           |     1/33 (3%)       0/0             1/32 (3%)      |     0/30 (0%)       0/0             2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         651             561           |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.392         P=0.535         P=0.503        |     P=0.120           (e)           P=0.207        |
|INCIDENTAL TUMOR       |     P=0.442         P=0.739         P=0.526        |     P=0.120           (e)           P=0.207        |
|LOGISTIC REGRESSION    |     P=0.399         P=0.469         P=0.507        |     P=0.120           (e)           P=0.207        |
|COCHRAN-ARMITAGE       |     P=0.399                                        |     P=0.119                                        |
|FISHER EXACT           |                     P=0.435         P=0.508        |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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                                                                                                         |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/13 (0%)       2/14 (14%)      0/11 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%           18.2%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/7 (0%)        2/11 (18%)      0/9 (0%)       |     0/30 (0%)       0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.630N        P=0.339           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.630N        P=0.339           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.630N        P=0.339           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.641                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.259           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       3/50 (6%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            8.8%            3.1%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       3/34 (9%)       1/32 (3%)      |     0/30 (0%)       0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.367         P=0.126         P=0.494        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.367         P=0.126         P=0.494        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.367         P=0.126         P=0.494        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.384                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.125         P=0.505        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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)            |     5/49 (10%)      7/23 (30%)      6/50 (12%)     |     2/50 (4%)       1/25 (4%)       2/49 (4%)      |
|ADJUSTED (b)           |     14.6%           47.9%           18.8%          |      6.7%            2.4%            6.4%          |
|TERMINAL (d)           |     4/33 (12%)      3/7 (43%)       6/32 (19%)     |     2/30 (7%)       0/3 (0%)        1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      707             533             729 (T)       |      729 (T)         588             581           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.433         P=0.035 *       P=0.482        |     P=0.533         P=0.601         P=0.637        |
|INCIDENTAL TUMOR       |     P=0.403         P=0.024 *       P=0.523        |     P=0.493         P=0.578         P=0.608        |
|LOGISTIC REGRESSION    |     P=0.466         P=0.034 *       P=0.509        |     P=0.572         P=0.675         P=0.662        |
|COCHRAN-ARMITAGE       |     P=0.460                                        |     P=0.593                                        |
|FISHER EXACT           |                     P=0.038 *       P=0.514        |                     P=0.744N        P=0.684        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/49 (22%)      7/23 (30%)      5/50 (10%)     |     1/50 (2%)       1/25 (4%)       0/49 (0%)      |
|ADJUSTED (b)           |     31.3%           47.9%           13.3%          |      3.3%           33.3%            0.0%          |
|TERMINAL (d)           |     9/33 (27%)      3/7 (43%)       2/32 (6%)      |     1/30 (3%)       1/3 (33%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      640             533             608           |      729 (T)         729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.087N        P=0.235         P=0.096N       |     P=0.395N        P=0.213         P=0.529N       |
|INCIDENTAL TUMOR       |     P=0.099N        P=0.228         P=0.052N       |     P=0.395N        P=0.213         P=0.529N       |
|LOGISTIC REGRESSION    |     P=0.070N        P=0.315         P=0.075N       |     P=0.395N        P=0.213         P=0.529N       |
|COCHRAN-ARMITAGE       |     P=0.072N                                       |     P=0.350N                                       |
|FISHER EXACT           |                     P=0.326         P=0.079N       |                     P=0.559         P=0.505N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/49 (31%)     13/23 (57%)     11/50 (22%)     |     3/50 (6%)       2/25 (8%)       2/49 (4%)      |
|ADJUSTED (b)           |     42.7%           87.9%           30.7%          |     10.0%           35.0%            6.4%          |
|TERMINAL (d)           |    13/33 (39%)      6/7 (86%)       8/32 (25%)     |     3/30 (10%)      1/3 (33%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      640             533             608           |      729 (T)         588             581           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.246N        P=0.011 *       P=0.264N       |     P=0.495N        P=0.189         P=0.569N       |
|INCIDENTAL TUMOR       |     P=0.251N        P=0.006 **      P=0.190N       |     P=0.529N        P=0.175         P=0.598N       |
|LOGISTIC REGRESSION    |     P=0.194N        P=0.026 *       P=0.208N       |     P=0.471N        P=0.327         P=0.555N       |
|COCHRAN-ARMITAGE       |     P=0.205N                                       |     P=0.423N                                       |
|FISHER EXACT           |                     P=0.033 *       P=0.228N       |                     P=0.544         P=0.510N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/49 (31%)     13/23 (57%)     11/50 (22%)     |     3/50 (6%)       2/25 (8%)       2/49 (4%)      |
|ADJUSTED (b)           |     42.7%           87.9%           30.7%          |     10.0%           35.0%            6.4%          |
|TERMINAL (d)           |    13/33 (39%)      6/7 (86%)       8/32 (25%)     |     3/30 (10%)      1/3 (33%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      640             533             608           |      729 (T)         588             581           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.246N        P=0.011 *       P=0.264N       |     P=0.495N        P=0.189         P=0.569N       |
|INCIDENTAL TUMOR       |     P=0.251N        P=0.006 **      P=0.190N       |     P=0.529N        P=0.175         P=0.598N       |
|LOGISTIC REGRESSION    |     P=0.194N        P=0.026 *       P=0.208N       |     P=0.471N        P=0.327         P=0.555N       |
|COCHRAN-ARMITAGE       |     P=0.205N                                       |     P=0.423N                                       |
|FISHER EXACT           |                     P=0.033 *       P=0.228N       |                     P=0.544         P=0.510N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)      5/21 (24%)      5/50 (10%)     |     3/50 (6%)       1/22 (5%)       2/50 (4%)      |
|ADJUSTED (b)           |     15.2%           61.9%           14.5%          |     10.0%            0.0%            7.7%          |
|TERMINAL (d)           |     5/33 (15%)      3/5 (60%)       4/32 (13%)     |     3/30 (10%)      0/0             2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         598             604           |      729 (T)         707             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.547         P=0.016 *       P=0.620        |     P=0.487N        P=0.475         P=0.566N       |
|INCIDENTAL TUMOR       |     P=0.535N        P=0.017 *       P=0.631N       |     P=0.483N        P=0.419         P=0.566N       |
|LOGISTIC REGRESSION    |     P=0.536N        P=0.063         P=0.611N       |     P=0.484N        P=0.286         P=0.566N       |
|COCHRAN-ARMITAGE       |     P=0.545N                                       |     P=0.409N                                       |
|FISHER EXACT           |                     P=0.133         P=0.617N       |                     P=0.643N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/49 (12%)      6/21 (29%)      5/50 (10%)     |     3/50 (6%)       2/22 (9%)       3/50 (6%)      |
|ADJUSTED (b)           |     18.2%           80.9%           14.5%          |     10.0%            0.0%           11.5%          |
|TERMINAL (d)           |     6/33 (18%)      4/5 (80%)       4/32 (13%)     |     3/30 (10%)      0/0             3/26 (12%)     |
|FIRST INCIDENCE (DAYS) |      729 (T)         598             604           |      729 (T)         651             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.458N        P=0.004 **      P=0.514N       |     P=0.492         P=0.211         P=0.597        |
|INCIDENTAL TUMOR       |     P=0.424N        P=0.004 **      P=0.501N       |     P=0.498         P=0.147         P=0.597        |
|LOGISTIC REGRESSION    |     P=0.415N        P=0.030 *       P=0.477N       |     P=0.489         P=0.118         P=0.597        |
|COCHRAN-ARMITAGE       |     P=0.427N                                       |     P=0.580                                        |
|FISHER EXACT           |                     P=0.097         P=0.486N       |                     P=0.486         P=0.661N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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)            |     0/47 (0%)       0/15 (0%)       0/49 (0%)      |    11/46 (24%)      2/20 (10%)     15/48 (31%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     39.1%          100.0%           47.5%          |
|TERMINAL (d)           |     0/33 (0%)       0/0             0/31 (0%)      |    10/27 (37%)      2/2 (100%)     10/26 (38%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      708             729 (T)         581           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.157         P=0.408         P=0.192        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.130         P=0.373         P=0.148        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.125         P=0.340         P=0.151        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.235                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.167N        P=0.287        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.0%            5.9%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       2/34 (6%)       0/32 (0%)      |     0/30 (0%)       0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.368N        P=0.510         P=0.506N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.368N        P=0.510         P=0.506N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.368N        P=0.510         P=0.506N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.355N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.508         P=0.495N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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)            |     1/49 (2%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.0%            5.9%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       2/34 (6%)       0/32 (0%)      |     0/30 (0%)       0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.368N        P=0.510         P=0.506N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.368N        P=0.510         P=0.506N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.368N        P=0.510         P=0.506N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.355N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.508         P=0.495N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)      5/50 (10%)      3/50 (6%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     13.5%           14.3%            9.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     3/33 (9%)       4/34 (12%)      3/32 (9%)      |     0/30 (0%)       0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      538             709             729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.305N        P=0.598N        P=0.364N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.363N        P=0.630N        P=0.492N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.280N        P=0.584N        P=0.344N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.286N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.617N        P=0.346N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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)            |     4/49 (8%)       5/50 (10%)      5/50 (10%)     |     4/50 (8%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |     10.2%           12.6%           12.3%          |     10.5%            0.0%            7.7%          |
|TERMINAL (d)           |     0/33 (0%)       2/34 (6%)       1/32 (3%)      |     0/30 (0%)       0/28 (0%)       2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      580             581             561           |      637             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.454         P=0.558         P=0.524        |     P=0.273N        P=0.085N        P=0.407N       |
|INCIDENTAL TUMOR       |     P=0.511N        P=0.632         P=0.547N       |     P=0.289N        P=0.109N        P=0.427N       |
|LOGISTIC REGRESSION    |     P=0.544         P=0.615         P=0.626        |     P=0.249N        P=0.060N        P=0.374N       |
|COCHRAN-ARMITAGE       |     P=0.444                                        |     P=0.222N                                       |
|FISHER EXACT           |                     P=0.513         P=0.513        |                     P=0.059N        P=0.339N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrous Histiocytoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       3/50 (6%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.8%            7.6%            5.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       1/34 (3%)       0/32 (0%)      |     0/30 (0%)       0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      654             596             637           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.411         P=0.347         P=0.506        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.541         P=0.476         P=0.694        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.408         P=0.290         P=0.507        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.407                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.316         P=0.508        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/49 (18%)      9/50 (18%)     10/50 (20%)     |     4/50 (8%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |     22.9%           23.5%           26.5%          |     10.5%            0.0%            7.7%          |
|TERMINAL (d)           |     4/33 (12%)      6/34 (18%)      6/32 (19%)     |     0/30 (0%)       0/28 (0%)       2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      538             581             561           |      637             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.456         P=0.537N        P=0.507        |     P=0.273N        P=0.085N        P=0.407N       |
|INCIDENTAL TUMOR       |     P=0.509         P=0.550N        P=0.560        |     P=0.289N        P=0.109N        P=0.427N       |
|LOGISTIC REGRESSION    |     P=0.467         P=0.577N        P=0.519        |     P=0.249N        P=0.060N        P=0.374N       |
|COCHRAN-ARMITAGE       |     P=0.468                                        |     P=0.222N                                       |
|FISHER EXACT           |                     P=0.584N        P=0.520        |                     P=0.059N        P=0.339N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)      6/50 (12%)      7/50 (14%)     |     4/50 (8%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |     12.9%           15.3%           18.0%          |     10.5%            0.0%            7.7%          |
|TERMINAL (d)           |     1/33 (3%)       3/34 (9%)       3/32 (9%)      |     0/30 (0%)       0/28 (0%)       2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      580             581             561           |      637             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.341         P=0.557         P=0.401        |     P=0.273N        P=0.085N        P=0.407N       |
|INCIDENTAL TUMOR       |     P=0.485         P=0.620         P=0.585        |     P=0.289N        P=0.109N        P=0.427N       |
|LOGISTIC REGRESSION    |     P=0.336         P=0.495         P=0.393        |     P=0.249N        P=0.060N        P=0.374N       |
|COCHRAN-ARMITAGE       |     P=0.335                                        |     P=0.222N                                       |
|FISHER EXACT           |                     P=0.514         P=0.394        |                     P=0.059N        P=0.339N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            2.9%            6.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       1/34 (3%)       2/32 (6%)      |     0/30 (0%)       0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.135         P=0.506         P=0.231        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.135         P=0.506         P=0.231        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.135         P=0.506         P=0.231        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.145                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.505         P=0.253        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |     10.0%            0.0%            0.0%          |
|TERMINAL (d)           |                                                    |     3/30 (10%)      0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.046N*       P=0.132N        P=0.146N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.046N*       P=0.132N        P=0.146N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.046N*       P=0.132N        P=0.146N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.037N*                                      |
|FISHER EXACT           |                                                    |                     P=0.121N        P=0.121N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     4/50 (8%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |     12.6%            3.6%            0.0%          |
|TERMINAL (d)           |                                                    |     3/30 (10%)      1/28 (4%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      707             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.036N*       P=0.205N        P=0.086N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.036N*       P=0.223N        P=0.083N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.035N*       P=0.211N        P=0.081N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.026N*                                      |
|FISHER EXACT           |                                                    |                     P=0.181N        P=0.059N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       1/50 (2%)       2/50 (4%)      |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            2.6%            6.3%          |      3.3%            0.0%            2.3%          |
|TERMINAL (d)           |     0/33 (0%)       0/34 (0%)       2/32 (6%)      |     1/30 (3%)       0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             707             729 (T)       |      729 (T)         ---             474           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.140         P=0.516         P=0.231        |     P=0.638         P=0.514N        P=0.730        |
|INCIDENTAL TUMOR       |     P=0.151         P=0.739         P=0.231        |     P=0.506N        P=0.514N        P=0.592N       |
|LOGISTIC REGRESSION    |     P=0.142         P=0.520         P=0.231        |     P=0.638N        P=0.514N        P=0.697N       |
|COCHRAN-ARMITAGE       |     P=0.145                                        |     P=0.669N                                       |
|FISHER EXACT           |                     P=0.505         P=0.253        |                     P=0.500N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        2.5%            5.0%          |      UNTREATD        2.5%            5.0%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       2/50 (4%)       2/50 (4%)      |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            5.1%            6.3%          |      3.3%            2.3%            5.5%          |
|TERMINAL (d)           |     0/33 (0%)       0/34 (0%)       2/32 (6%)      |     1/30 (3%)       0/28 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             705             729 (T)       |      729 (T)         499             474           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.175         P=0.264         P=0.231        |     P=0.332         P=0.741         P=0.448        |
|INCIDENTAL TUMOR       |     P=0.206         P=0.527         P=0.231        |     P=0.628         P=0.616N        P=0.669        |
|LOGISTIC REGRESSION    |     P=0.178         P=0.258         P=0.231        |     P=0.431         P=0.729N        P=0.565        |
|COCHRAN-ARMITAGE       |     P=0.180                                        |     P=0.378                                        |
|FISHER EXACT           |                     P=0.253         P=0.253        |                     P=0.753N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       4/50 (8%)       6/50 (12%)     |    18/50 (36%)      9/50 (18%)     11/50 (22%)     |
|ADJUSTED (b)           |      8.3%           11.0%           16.6%          |     49.6%           26.6%           32.9%          |
|TERMINAL (d)           |     2/33 (6%)       3/34 (9%)       3/32 (9%)      |    12/30 (40%)      5/28 (18%)      5/26 (19%)     |
|FIRST INCIDENCE (DAYS) |      575             678             608           |      653             585             409           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.188         P=0.534         P=0.248        |     P=0.162N        P=0.073N        P=0.213N       |
|INCIDENTAL TUMOR       |     P=0.246         P=0.565         P=0.346        |     P=0.127N        P=0.094N        P=0.129N       |
|LOGISTIC REGRESSION    |     P=0.193         P=0.542         P=0.253        |     P=0.125N        P=0.065N        P=0.177N       |
|COCHRAN-ARMITAGE       |     P=0.195                                        |     P=0.068N                                       |
|FISHER EXACT           |                     P=0.511         P=0.254        |                     P=0.035N*       P=0.093N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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 Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       4/50 (8%)       6/50 (12%)     |    18/50 (36%)      9/50 (18%)     11/50 (22%)     |
|ADJUSTED (b)           |      8.3%           11.0%           16.6%          |     49.6%           26.6%           32.9%          |
|TERMINAL (d)           |     2/33 (6%)       3/34 (9%)       3/32 (9%)      |    12/30 (40%)      5/28 (18%)      5/26 (19%)     |
|FIRST INCIDENCE (DAYS) |      575             678             608           |      653             585             409           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.188         P=0.534         P=0.248        |     P=0.162N        P=0.073N        P=0.213N       |
|INCIDENTAL TUMOR       |     P=0.246         P=0.565         P=0.346        |     P=0.127N        P=0.094N        P=0.129N       |
|LOGISTIC REGRESSION    |     P=0.193         P=0.542         P=0.253        |     P=0.125N        P=0.065N        P=0.177N       |
|COCHRAN-ARMITAGE       |     P=0.195                                        |     P=0.068N                                       |
|FISHER EXACT           |                     P=0.511         P=0.254        |                     P=0.035N*       P=0.093N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/49 (31%)     20/50 (40%)     15/50 (30%)     |    17/50 (34%)      5/50 (10%)     19/50 (38%)     |
|ADJUSTED (b)           |     41.2%           46.5%           45.0%          |     52.9%           15.8%           58.4%          |
|TERMINAL (d)           |    12/33 (36%)     12/34 (35%)     14/32 (44%)     |    15/30 (50%)      3/28 (11%)     13/26 (50%)     |
|FIRST INCIDENCE (DAYS) |      538             533             604           |      696             588             474           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.525         P=0.281         P=0.563        |     P=0.218         P=0.006N**      P=0.225        |
|INCIDENTAL TUMOR       |     P=0.503         P=0.289         P=0.520        |     P=0.229         P=0.008N**      P=0.252        |
|LOGISTIC REGRESSION    |     P=0.506N        P=0.288         P=0.543N       |     P=0.207         P=0.007N**      P=0.204        |
|COCHRAN-ARMITAGE       |     P=0.514N                                       |     P=0.368                                        |
|FISHER EXACT           |                     P=0.222         P=0.560N       |                     P=0.004N**      P=0.418        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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 Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    21/49 (43%)     23/50 (46%)     17/50 (34%)     |    22/50 (44%)     11/50 (22%)     17/50 (34%)     |
|ADJUSTED (b)           |     51.2%           48.2%           39.9%          |     55.9%           30.4%           50.0%          |
|TERMINAL (d)           |    13/33 (39%)     10/34 (29%)      7/32 (22%)     |    13/30 (43%)      5/28 (18%)     10/26 (38%)     |
|FIRST INCIDENCE (DAYS) |      575             533             561           |      609             499             409           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.264N        P=0.546         P=0.295N       |     P=0.352N        P=0.053N        P=0.415N       |
|INCIDENTAL TUMOR       |     P=0.091N        P=0.494N        P=0.055N       |     P=0.242N        P=0.045N*       P=0.288N       |
|LOGISTIC REGRESSION    |     P=0.096N        P=0.393N        P=0.116N       |     P=0.261N        P=0.029N*       P=0.347N       |
|COCHRAN-ARMITAGE       |     P=0.212N                                       |     P=0.170N                                       |
|FISHER EXACT           |                     P=0.455         P=0.242N       |                     P=0.016N*       P=0.206N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    32/49 (65%)     34/50 (68%)     31/50 (62%)     |    30/50 (60%)     16/50 (32%)     29/50 (58%)     |
|ADJUSTED (b)           |     74.3%           69.3%           71.8%          |     76.6%           42.9%           77.8%          |
|TERMINAL (d)           |    22/33 (67%)     19/34 (56%)     20/32 (63%)     |    21/30 (70%)      8/28 (29%)     18/26 (69%)     |
|FIRST INCIDENCE (DAYS) |      440             533             561           |      609             499             409           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.473N        P=0.551N        P=0.513N       |     P=0.349         P=0.025N*       P=0.346        |
|INCIDENTAL TUMOR       |     P=0.375N        P=0.450N        P=0.356N       |     P=0.447         P=0.018N*       P=0.486        |
|LOGISTIC REGRESSION    |     P=0.377N        P=0.424N        P=0.445N       |     P=0.399         P=0.012N*       P=0.353        |
|COCHRAN-ARMITAGE       |     P=0.404N                                       |     P=0.460N                                       |
|FISHER EXACT           |                     P=0.472         P=0.447N       |                     P=0.004N**      P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05007 TEST: 05                                                 PAGE  15
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- POLYSORBATE 80
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (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).